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109 products
Benefits:
- Indicated in cases of anemia, convalescence, postoperative care.
- Complete and balanced formula with 11 nutrients that promote red blood cell synthesis.
- Rich in iron, copper, vitamins B2, B6, B9, B12, and K3, essential for red blood cells and hemoglobin synthesis.
- With Vitamin C, for better iron absorption.
- Contains moderate levels of Phosphorus.
- Suitable for animals with kidney conditions.
- Nutritional support for pregnant or lactating females.
Highly palatable chewable tablets!
SUPRA RC 5 contains: Iron 20mg, Copper 1mg, B1 2mg, B2 1mg, B3 10mg, B6 1mg, B9 50µg, B12 25µg, Vit C 10mg, Vit E 11.25 IU, Vit K3 0.25mg
Advantix is an external antiparasitic product containing imidacloprid and permethrin, and is very effective in treating flea and tick infestations for one month after a single application.
Composition
Each dose (pipette) contains:
| Pipette | Imidacloprid | Permethrin | E321 | |
| Advantix spot-on solution for dogs up to 4 kg | 0.4 ml | 40 mg | 200 mg | 0.4 mg |
| Advantix spot-on solution for dogs from 4 kg to 10 kg | 1.0 ml | 100 mg | 500 mg | 1.0 mg |
| Advantix spot-on solution for dogs from 10 kg to 25 kg | 2.5 ml | 250 mg | 1250 mg | 2.5 mg |
| Advantix spot-on solution for dogs over 25 kg | 4.0 ml | 400 mg | 2000 mg | 4.0 mg |
Excipients: Butylhydroxytoluene 1.0 mg/ml (E321, as an antioxidant):
Indications
For the treatment and prevention of flea infestation (Ctenocephalides canis, Ctenocephalides felis).
Fleas on dogs are killed within one day of treatment. One treatment prevents future flea infestations for four weeks. The product
can be used as part of a treatment strategy against flea allergy dermatitis (FAD).
The product exhibits acaricidal and repellent activity for up to four weeks (Rhipicephalus sanguineus, Ixodes
ricinus) or three weeks (Dermacentor reticulatus) against tick infestations.
Ticks already present on the dog may not be killed within two days of treatment and may remain attached and visible. Therefore, it is
recommended to remove ticks present on the dog at the time of treatment to prevent their attachment and blood feeding.
One treatment provides repellent (anti-feeding) action against sandflies for two weeks (Phlebotomus papatasi) or three
weeks (Phlebotomus perniciosus) against mosquitoes for two (Aedes aegypti) and four (Culex pipiens) weeks and for stable flies
(Stomoxys calcitrans) for four weeks.
Sandflies Phlebotomus perniciosus 3 weeks
Phlebotomus papatasi 2 weeks
Mosquitoes Aedes aegypti 2 weeks
Culex pipiens 4 weeks
Stable fly Stomoxys calcitrans 4 weeks
Contraindications
In the absence of available data, the product should not be used in puppies younger than 7 weeks.
Do not use in cases of known hypersensitivity to the active substances.
Do not use in cats.
Adverse reactions
Transient dermal sensitivity (with increased pruritus, alopecia, and erythema at the application site) or apathy may rarely occur.
Poisoning in dogs after accidental ingestion may occur in rare cases. In these cases, neurological signs such as
tremors and apathy may also appear. Symptomatic treatment should be applied under veterinary supervision. There is no specific antidote.
If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.
Target species
Dogs.
Dosage for each species, route(s) of administration, and method of administration
Dosing regimen:
The minimum recommended dose is: 10 mg/kg body weight (b.w.) imidacloprid and 50 mg/kg body weight (b.w.) permethrin, equivalent to
0.1ml/kg b.w. Advantix spot-on solution for dogs.
Dog weight (kg) Pipette size to be used Volume (ml) Imidacloprid (mg/kg b.w.) Permethrin (mg/kg b.w.)
>25 kg - 40 kg Advantix spot-on solution for dogs over 25 kg 4.0 ml 10 - 16 50 - 80
> 40 kg the appropriate combination of pipettes should be used
| Dog weight (kg) | Pipette size to be used | Volume (ml) | Imidacloprid (mg/kg b.w.) | Permethrin (mg/kg b.w.) |
| <=4 kg | Advantix spot-on solution for dogs up to 4 kg | 0.4 ml | minimum 10 | minimum 50 |
| >4 kg - 10 kg | Advantix spot-on solution for dogs from 4 kg to 10 kg | 1.0 ml | 10 - 25 | 50 - 125 |
| >10 kg - 25 kg | Advantix spot-on solution for dogs from 10 kg to 25 kg | 2.5 ml | 10 - 25 | 50 - 125 |
| >25 kg - 40 kg | Advantix spot-on solution for dogs over 25 kg | 4.0 ml | 10 - 16 | 50 - 80 |
| > 40 kg | the appropriate combination of pipettes should be used |
To reduce re-infestations with new fleas, it is recommended that all dogs in a family (household) be treated. Other pets in
the same family or household should be treated with appropriate products. For fleas originating from the animal's environment,
the additional use of an appropriate product for the treatment against adult fleas and their developmental stages is recommended. The product is effective even if the animal is wet. However, prolonged exposure to water should be avoided. If prolonged exposure
to water occurs, the effectiveness of the product decreases. Even in this case, it should not be treated more frequently than once a week. If it is
necessary to shampoo the animal, it is advisable to apply Advantix spot-on solution for dogs after two weeks
to ensure the effectiveness of the product.
Method of administration.
Remove one pipette from the package. Hold the pipette upright, twist the cap, and remove it. Turn the cap upside down and use it to
unseal the pipette (by twisting and pressing on the seal, as shown in the photo).
For dogs weighing 10 kg or less:
With the dog standing, part the hair between the shoulder blades until the skin is visible. Apply the tip of the pipette directly to the skin and
by firmly squeezing several times, empty the contents of the pipette. Apply only to uninjured skin.
For dogs weighing more than 10 kg:
With the dog standing, the entire contents of the Advantix spot-on solution for dogs pipette will be applied evenly in four places
starting from between the shoulder blades and extending to the base of the tail. At each spot, part the hair until the skin is visible. Apply the tip of the pipette to the skin and
gently squeeze to release some of the solution onto the skin.
Recommendations for correct administration
For external use only.
Apply only to uninjured skin.
Do not apply a large amount of solution in a single spot, as this may run off the sides of the dog.
Withdrawal period
Not applicable.
Special precautions for storage
Keep out of the sight and reach of children.
Do not freeze.
After opening the aluminum pouch, store in a dry place and do not store at temperatures above 30°C.
The abbreviation used for the expiry date on the label, pipette, and pouch is EXP.
Special precautions for use in animals
The contents of the pipette should not come into contact with the eyes or mouth of the treated dog.
Pay attention to the correct administration of the product as described in the "Method of administration" section. In particular, oral ingestion
by licking the application site or contact with other animals should be avoided.
Do not use in cats.
This product is highly toxic to cats and can cause death due to the physiological peculiarities of cats
which are unable to metabolize certain compounds, including permethrin. To prevent accidental exposure of
cats to this product, treated dogs should be kept separate from cats after treatment until the application site is dry.
Measures should be taken to ensure that cats do not lick the application site of dogs that have been treated with this product. Seek
immediate veterinary assistance if this occurs.
Consult your veterinarian before using this product in sick and debilitated animals.
As the product is dangerous to aquatic organisms, treated dogs must under no circumstances be allowed to enter any surface waters
for at least 48 hours after treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid contact with skin, eyes, or mouth. Do not eat, drink, or smoke during product application.
Wash hands thoroughly after product application.
If the product accidentally gets on the skin, wash the area immediately with soap and water.
Individuals with known skin sensitivity may be particularly sensitive to this product.
If the product accidentally gets into the eyes, rinse the eyes with plenty of water. If skin or ocular symptoms persist, or the product is
accidentally swallowed, seek immediate medical advice and show the doctor the product leaflet.
Treated dogs should not be allowed to play, especially with children, until the application site is dry. To be safe, treat dogs, for
example, in the evening. In this case, treated dogs are not allowed to sleep with their owners, especially if they are children.
Special precautions for the disposal of unused product or waste materials, if any
After use, place the cap back on the pipette. Any unused veterinary medicinal product or waste materials derived from the use of such
products should be disposed of in accordance with local requirements.
Other information
Advantix spot-on solution for dogs is a topical ectoparasiticide containing imidacloprid and permethrin.
This combination acts as an insecticide, acaricide, and repellent.
Imidacloprid is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified
as a chloronicotinyl nitroguanidine. Imidacloprid is effective against adult fleas and their larval stages. In addition to
its efficacy against adult fleas, the larvicidal efficacy of the substance for areas in the animal's habitat has also been demonstrated.
The product provides repellent (anti-feeding) action against ticks, sandflies, and mosquitoes, thereby preventing
parasite blood feeding and reducing the risk of transmitting vector-borne diseases (Canine Vector-Borne Disease or
CVBD, such as borreliosis, rickettsiosis, ehrlichiosis, leishmaniasis).
It can be used during pregnancy and lactation.
The solvent in Advantix spot-on solution for dogs may stain certain materials such as leather, fabrics, plastic, and finished surfaces. Allow
the application site to dry before contact with such materials.
Packaging:
Pipettes of 0.4 ml, 1.0 ml, 2.5 ml, 4.0 ml
Blister containing 1, 2, 3, 4, or 6 individual pipettes.
Not all package sizes may be marketed.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.
Marketing Authorization Holder
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
Milk Can - Soluble powdered milk formula contains proteins, vitamins, and trace elements. Suitable for puppies from their first day of life, as well as pregnant females and older animals.
Target species: Dogs, cats
Administration method:
Preparation/administration instructions:
Mix one scoop of powdered milk (10g) with a little lukewarm water.
Add water until the mixture reaches 50 ml.
The preparation's temperature should be approx. 37°C.
Oral administration.
Adult pregnant females: as a secondary meal for 10 days before farrowing, until the day of farrowing.
Puppies: Administer according to the table.
Administer quantitatively until the puppies are satiated.
Ingredients:
Dehydrated milk and dairy products, vegetable oils and fats, cereals, minerals, lysine, methionine.
Analytical compounds:
Fats and oils ..........26%
Proteins........................30%
Ash.........................6.5%
Fiber............................0.5%
Calcium.........................1.20%
Phosphorus.........................0.75%
Sodium..........................0.45%
Magnesium...................0.10%
Potassium.......................1.15%
Additives/kg:
TRACE ELEMENTS
Iron (sulfate)E1...............60 mg
Zinc (sulfate)E6...............60 mg
Magnesium (sulfate) E5......50 mg
VITAMINS
Iodine (calcium iodate)E2......1mg
Selenium (Sodium Selenite)E8...0.36mg
Cobalt (carbonate)E3.............0.3mg
A (E672)........................11250IU
D3 (E671).......................2000IU
E (α-tocopherol)(3a700).......40IU
C (E300)............................60 mg
B1.................................3.75mg
K3.................................1.25mg
Storage conditions:
Store in a place protected from moisture and direct sunlight, at temperatures up to 25°C.
Keep the container properly closed.
Packaging:
250 g/ 400g with included measuring spoon
Additional information:
CAUTION! For veterinary use only! Keep out of reach of children! Follow the administration instructions on the label.
Neuro Support - Formula indicated to support the optimal functioning of the nervous system in dogs and cats and to support elderly animals suffering from cognitive disorders and other types of physiological deficiencies that occur during the aging process.
Ingredients: fish oil, stearic acid, mono-, di- and triglycerides, dried acerola (Malpighia grabla), dried marigold (Tagetes erecta) - source of zeaxanthin and lutein, soy lecithin.
Nutritional additives (g/kg):
Vitamin E 22.4 g, Taurine 4.5 g, Zinc oxide 2.8 g, Niacinamide 1 g, Calcium-D-pantothenate 1 g, Vitamin A 0.2 g, Vitamin B1 0.09 g, Vitamin B6 0.09 g, Folic acid 0.02 g, Biotin 0.009 g, Vitamin B12 0.002 g, Selenium 0.0004 g.
Sensory additives (g/kg): grape extract (Vitis vinifera) 53.8 g, green tea leaf extract (Camellia sinensis) 32.6 g, turmeric extract (Curcuma longa) 31.4 g, Beta carotene 9.0 g.
Technological additives: colloidal silica 4.34 g.
Dosage: 1 capsule per 10 kg body weight. The capsule can be administered whole, its content can be mixed with food or applied directly into the animal's mouth.
The dose can only be modified at the recommendation of the veterinarian.
Analytical compounds:
crude protein 2.84%, crude ash 7.53%, crude fat
>50%, crude fiber <70%, moisture 0.74%.
Storage conditions: Store in a dry place, at room temperature (maximum 25˚C).
Protect from direct light.
Keep out of reach of children or animals.
>50%, crude fiber <70%, moisture 0.74%.
Packaging: bottle of 45 capsules
Liquid formula against excessive shedding!
Guaranteed effect in 3-6 weeks!
Norwegian anchovy oil
Norwegian sardine oil
Zinc
Biotin
Linseed oil
Wheat germ oil
Vitamins: A, E, D, B6
Add to food, 1 teaspoon/day
Tasty (chicken flavor) and easy to administer
The ideal Omega-3/Omega-6 ratio, antioxidants, vitamins and minerals to combat excessive shedding.
Strengthens optimal skin and coat health.
For maximum and rapid efficiency, it is recommended to use SHED-X shampoos concomitantly.
Indications:
The product supports the improvement of non-specific immunity in dogs and cats, both at humoral and cellular levels. It is indicated for growing or elderly animals, for animals at high risk of infections or viral and bacterial diseases, and for pregnant females to stimulate maternal immunity, which will then be transferred to the offspring.
Target species: dogs, cats
Administration method:
Cats and dogs under 10 kg body weight: 1 capsule/day
Dogs over 10 kg body weight: 2 capsules/day
Twist Off capsules are highly palatable and easy to administer even to cats. They ensure the quality and freshness of the ingredients, which can oxidize very quickly. Only the content or the capsule itself can be administered. The correct dosage and administration period depend on the individual needs of the animal and will be determined by a veterinarian.
Ingredients:
2.20.1 Soybean oil, 12.1.5 yeast (beta-glucan), 1.11.11 HMB (hydroxy-3-methylbutyrate-3 calcium salts), 13.6.2 glycerol monostearate, 2.21.1 soybean lecithin. Additives: Valeriana officinalis 10mg.
Description:
Beta-glucan, present in the product's composition, is one of the most well-known substances with immunostimulatory properties. It can directly stimulate the body's antimicrobial mechanism or support and strengthen the effects of preventive vaccines. Oral administration of beta-glucan increases both mucosal and serum titers of specific IgG and IgA antibodies. The exact action of beta-glucan on the body depends on its binding to specific receptors of macrophage, neutrophil, monocyte, or dendritic cells and NK cells. Currently, the substance is widely used in the production of immune-stimulating supplements for dogs and cats.
Beta-hydroxy-Beta-methylbutyric acid (HMB), in addition to its well-known anti-catabolic action, is also used to perfect and enhance the metabolic and phagocytic activity of immune cells, by increasing the number of antibody-producing cells, which leads to the stimulation of the cellular immune system.
Packaging: 60 capsules bottle
Storage conditions:
Store in a place protected from moisture and direct sunlight, at temperatures up to 25°C.
Analytical compounds:
Proteins 5.17%, Oils and fats 52.1%, Ash (including mineral compounds) 9.14%, Moisture 2.48%.
Additional information:
ATTENTION! For veterinary use only! Keep out of reach of children! Follow the instructions on the packaging. Contact your veterinarian before using or extending the use of this product, as dosage or method of use may change depending on the individual symptoms of the animal.
The liquid consistency of this herbal product guarantees effective performance. Formed over thousands of years, the active elements in this natural extract represent a unique source of nutrients! The 100% natural ingredients help with:
- normal stomach and intestinal function
- improving metabolism
- stimulating blood production
- improving coat appearance
Ingredients: pure peat (99%), fennel (1%).
Additives: silicon dioxide 6.70%, iron 1.14%, aluminum 0.12%, calcium 5.50% magnesium 0.40%, phosphate 0.22%, ether extract 1.27%, water-insoluble nitrogen 0.75%, easily water-soluble proteins 1.35%, hardly water-soluble proteins 4.20%, sulfur not present as sulfate 0.43%, carbonic acid 2.58%, oils and resins 19%, water-soluble organic substances 8.21%, humic acid 13.10%, humic substances present 4.00%, vegetable glue and lignin 13.90%, sodium 0.35%, hemicellulose 1.65%, cellulose 2.95%.
Analysis
| protein | 0.77 % |
| fat | 0.26 % |
| fiber | 1.18 % |
| ash | 0.87 % |
| calcium | 5.5 % |
| magnesium | 0.4 % |
| iron | 1.14 mg |
| moisture | 89.0 % |
| hemicellulose | 1.65 % |
| humine and lignin | 13.9 % |
| humic acid | 13.1 % |
| humic substances | 4.0 % |
| silicic acid | 6.7 % |
| carbonic acid | 2.58 % |
| water-soluble proteins | 1.35 % |
| sodium | 0.35 % |
| water-insoluble nitrogen | 0.75 % |
| phosphate | 0.22 % |
| hardly water-soluble proteins | 4.2 % |
| water-soluble organic substances | 8.21 % |
| cellulose | 2.95 % |
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Active substances:
|
NEXGARD SPECTRA |
Afoxolaner (mg) |
Milbemycin oxime (mg) |
| chewable tablets for dogs 2-3.5 kg | 9.375 | 1.875 |
PHARMACEUTICAL FORM
Chewable tablets.
Mottled red to reddish-brown, round (tablets for dogs 2-3.5 kg) or rectangular (tablets for dogs > 3.5-7.5 kg, tablets for dogs > 7.5-15 kg, tablets for dogs > 15-30 kg and tablets for dogs > 30-60 kg) chewable tablets.
CLINICAL PARTICULARS
Target species: Dogs
Indications for use, specifying the target species
For the treatment of flea and tick infestations in dogs when concurrent prevention of heartworm disease and/or treatment of gastrointestinal nematode infestations is indicated.
Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks. Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) in dogs for 4 weeks.
Fleas and ticks must attach to the host and commence feeding to be exposed to the active substance.
Treatment of adult gastrointestinal nematode infestations of the following species: roundworms (Toxocara canis and Toxocara leonina), hookworms (Ancylostoma caninum and Ancylostoma braziliense) and whipworms (Trichuris vulpis).
Prevention of heartworm disease (Dirofilaria immitis larval stage) if administered monthly.
Contraindications: Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Parasites must start feeding on the host to be exposed to afoxolaner; therefore, the risk of transmission of infectious diseases cannot be excluded.
Resistance of parasites to any particular class of antiparasitics may develop following frequent, repeated use of a product of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species to limit the possibility of future resistance selection.
Maintaining the efficacy of macrocyclic lactones is essential for the control of Dirofilaria immitis. To minimize the risk of resistance selection, it is recommended to test dogs for both circulating antigens and blood microfilariae at the beginning of each preventive treatment period.
Only negative animals should be treated.
Special precautions for use
Special precautions for use in animals
In the absence of available data, treatment of puppies younger than 8 weeks of age and/or dogs weighing less than 2 kg should only be carried out based on a risk/benefit assessment by the veterinary surgeon.
Dogs living in heartworm endemic areas should be tested for adult heartworm infestation before administering NEXGARD SPECTRA. Infested dogs should be treated with an adulticide chosen by the veterinary surgeon to eliminate adult heartworms. NEXGARD SPECTRA is not indicated for the elimination of microfilariae.
The recommended dose should be strictly followed for Collie dogs or other related breeds.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
- This product, if ingested, can cause gastrointestinal disturbances.
- Keep the tablets in the blister and the blister in the carton until use.
- In case of accidental ingestion, especially by children, seek medical advice immediately and show the product label.
- Wash hands after use.
Adverse reactions (frequency and seriousness)
In clinical studies, no serious adverse reactions were attributed to the combination of afoxolaner with milbemycin oxime. Less frequent reactions such as vomiting, diarrhoea, lethargy, anorexia and pruritus were observed. These reactions generally resolved spontaneously and were of short duration.
The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- Common (more than 1 but less than 10 animals in 100 animals)
- Uncommon (more than 1 but less than 10 animals in 1,000 animals)
- Rare (more than 1 but less than 10 animals in 10,000 animals)
- Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have not shown any teratogenic effects or any negative effect on the reproductive capacity of males and females. The safety of the veterinary medicinal product has not been established during pregnancy and lactation or for breeding dogs. Use only according to the benefit-risk assessment by the veterinary surgeon.
Interaction with other medicinal products or other forms of interaction
Milbemycin oxime is a substrate of p-glycoprotein (P-gp), and can therefore interact with other P-gp substrates (e.g., digoxin, doxorubicin) or other macrocyclic lactones. Therefore, concomitant treatment with other P-gp substrates may lead to increased toxicity.
Amounts to be administered and administration route
For oral administration.
Dosage:
The product should be administered at a dose of 2.50-5.36 mg/kg afoxolaner and 0.50-1.07 mg/kg milbemycin oxime body weight in accordance with the following table:
| Dog weight (kg) | Concentration and number of chewable tablets to be administered | ||||
|
NEXGARD SPECTRA 9 mg/ 2 mg |
NEXGARD SPECTRA 19 mg/ 4 mg |
NEXGARD SPECTRA 38 mg/ 8 mg |
NEXGARD SPECTRA 75 mg/ 15 mg |
NEXGARD SPECTRA 150 mg/ 30 mg |
|
|
2-3.5 |
1 |
|
|
|
|
|
>3.5-7.5 |
|
1 |
|
|
|
|
>7.5-15 |
|
|
1 |
|
|
|
>15-30 |
|
|
|
1 |
|
|
>30-60 |
|
|
|
|
1 |
For dogs over 60 kg body weight, the appropriate combination of chewable tablets should be used.
Method of administration:
The tablets are chewable and palatable to most dogs. If the dog does not accept the tablets directly, they can be administered with food.
Treatment schedule:
The treatment schedule should be based on the veterinary diagnosis and the local epidemiological situation.
NEXGARD SPECTRA can be used as a seasonal preventive treatment against fleas and ticks (replacing treatment with a monovalent product acting only against fleas and ticks) in dogs concurrently infested with gastrointestinal nematodes. A single treatment is effective against gastrointestinal nematodes. After treating nematode infestations, treatment against flea and tick infestations can be continued by applying the monovalent product.
Disease: Heartworm disease:
NEXGARD SPECTRA kills Dirofilaria immitis larvae for one month after their transmission by mosquitoes, therefore the product must be administered at regular monthly intervals throughout the vector-prone periods, starting from the month after the first exposure to mosquitoes. Treatment should continue until one month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended to administer the treatment on the same day of the month.
If replacing another heartworm prevention product, the first treatment with NEXGARD SPECTRA should begin on the day the previous medication was due.
Dogs living in or travelling to a heartworm endemic region may be infested with adult heartworms. No therapeutic effect against adult Dirofilaria immitis has been established. Therefore, it is recommended that all dogs aged 8 months or older living in heartworm endemic areas be tested for adult heartworm infestation before being treated with a heartworm prevention product.
Overdose (symptoms, emergency procedures, antidotes), if applicable
No adverse reactions were observed in healthy puppies over 8 weeks of age after 6 treatments with 5 times the maximum dose.
Withdrawal period: Not applicable.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: antiparasitic products, endectocides, milbemycin combinations.
ATC veterinary code: QP54AB51
Pharmacodynamic properties
Afoxolaner:
Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family.
Afoxolaner acts by interacting with chloride ion channels, primarily those with a binding site for the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic chloride ion transfers across the cell membrane. This results in uncontrolled activity of the central nervous system and the death of insects and mites. The selective toxicity of afoxolaner between insects/mites and mammals is a consequence of the characteristic sensitivity of insect/mite GABA receptors versus those of mammals.
Afoxolaner is active against adult fleas as well as against some tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum and Haemaphysalis longicornis.
The product kills fleas before they lay eggs and thus prevents household contamination. It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Milbemycin oxime:
Milbemycin oxime is an antiparasitic endectocide belonging to the macrocyclic lactone group. Milbemycin oxime is a mixture of milbemycin A4 and milbemycin A3 (in a ratio of 20:80 for A3:A4). It is isolated from the fermentation of Streptomyces milbemycinicus.
Milbemycin oxime acts by disrupting glutamate-activated neurotransmission in invertebrates. Milbemycin oxime increases the membrane permeability of nematodes and insects to chloride ions through glutamate-controlled chloride ion channels (related to GABA and glycine receptors in vertebrates).
This leads to hyperpolarisation of the neuromuscular membrane and paralysis and death of the parasites.
Pharmacokinetic particulars
Afoxolaner is very rapidly absorbed systemically. The absolute bioavailability obtained was 88%. The mean peak plasma concentration (Cmax) was 1822 ± 165 ng/ml, 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose.
The volume of distribution of Afoxolaner in tissues is 2.6 ± 0.6 l/kg and the clearance value is 5.0 ± 1.2 ml/h/kg. The half-life is approximately 2 weeks in dogs.
Plasma concentrations of Milbemycin oxime increase rapidly in the first 1-2 hours (Tmax) indicating rapid absorption from the tablet. The absolute bioavailability obtained was 81% for factor A3 and 65% for A4 respectively. The mean peak plasma concentration (Cmax), after oral administration was 1.6 ± 0.4 days and 42 ± 11 ng/ml for A3, 3.3 ± 1.4 days and 246 ± 71 ng/ml for A4.
The volume of distribution of Milbemycin oxime in tissues is 2.7 ± 0.4 and 2.6 ± 0.6 l/kg for A3 and A4 forms respectively. Both forms have a low clearance value of 75 ± 22 ml/h/kg for A3 and 41 ± 12 ml/h/kg for A4.
PHARMACEUTICAL PARTICULARS
List of excipients
- Corn starch
- Soy protein
- Braised beef flavour
- Povidone (E1201)
- Macrogol 400
- Macrogol 4000
- Macrogol 15 hydroxystearate
- Glycerol (E422)
- Medium-chain triglycerides
- Citric acid monohydrate (E330)
- Butylhydroxytoluene (E321)
Incompatibilities: Not applicable.
Shelf life: Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Special precautions for storage: Keep the blister in the secondary packaging to protect from light.
Nature and composition of primary packaging
This veterinary medicinal product is individually packaged in thermoformed PVC blisters sealed on the back with aluminium foil (Aclar/PVC/Alu).
1 cardboard box containing one blister with 1, 3 or 6 chewable tablets.
Not all package sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Active substances:
|
NEXGARD SPECTRA |
Afoxolaner (mg) |
Milbemycin oxime (mg) |
| chewable tablets for dogs weighing 7.5-15 kg | 37.50 | 7.50 |
PHARMACEUTICAL FORM
Chewable tablets.
Marbled, red to reddish-brown, round (tablets for dogs weighing 2-3.5 kg) or rectangular (tablets for dogs weighing > 3.5-7.5 kg, tablets for dogs weighing > 7.5-15 kg, tablets for dogs weighing > 15-30 kg, and tablets for dogs weighing > 30-60 kg) tablets.
CLINICAL PARTICULARS
Target species: Dogs
Indications for use, specifying the target species
For the treatment of flea and tick infestations in dogs when concurrent prevention of heartworm disease and/or treatment of gastrointestinal nematode infestations is indicated.
Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks. Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) in dogs for 4 weeks.
Fleas and ticks must attach to the host and begin feeding to be exposed to the active substance.
Treatment of adult gastrointestinal nematode infestations of the following species: roundworms (Toxocara canis and Toxocara leonina), hookworms (Ancyclostoma caninum and Ancyclostoma braziliense) and whipworms (Trichuris vulpis).
Prevention of heartworm disease (Dirofilaria immitis larval stage) if administered monthly.
Contraindications: Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Parasites must begin feeding on the host to be exposed to afoxolaner; therefore, the risk of transmission of infectious diseases cannot be excluded.
Resistance of parasites to a particular class of antiparasitic medicines may develop as a result of frequent use of a compound from that class. Therefore, the use of this product should be based on the evaluation of each case and local epidemiological information regarding the current susceptibility of the target species to limit the possibility of future selection of resistance.
Maintaining the efficacy of macrocyclic lactones is essential in the control of Dirofilaria immitis. To minimize the risk of resistance selection, it is recommended to test dogs for both circulating antigens and blood microfilariae at the beginning of each preventive treatment period.
Only negative animals should be treated.
Special precautions for use
Special precautions for use in animals
In the absence of available data, treatment of puppies younger than 8 weeks and/or dogs weighing less than 2 kg should only be carried out based on a risk/benefit assessment by the veterinarian.
Dogs living in heartworm endemic areas should be tested for adult heartworm infestation before administering NEXGARD SPECTRA. Infested dogs should be treated with an adulticide at the discretion of the veterinarian to eliminate adult heartworms. NEXGARD SPECTRA is not indicated for the elimination of microfilariae.
The recommended dose should be strictly followed for Collie dogs or other related breeds.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
- This product, if ingested, may cause gastrointestinal disturbances.
- Keep tablets in blisters and blisters in the box until use.
- In case of accidental ingestion, especially by children, seek medical advice immediately and show the product label.
- Wash hands after use.
Adverse reactions (frequency and seriousness)
In clinical studies, no serious adverse reactions attributable to the afoxolaner and milbemycin oxime combination were observed. Less common reactions such as vomiting, diarrhoea, lethargy, anorexia and pruritus were observed. These reactions generally resolved spontaneously and were short-lived.
The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- Common (more than 1 but less than 10 animals in 100 animals)
- Uncommon (more than 1 but less than 10 animals in 1,000 animals)
- Rare (more than 1 but less than 10 animals in 10,000 animals)
- Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have not shown teratogenic effects or any negative effect on the reproductive capacity of males and females. The safety of the veterinary medicinal product has not been established during pregnancy and lactation or for breeding dogs. Use in accordance with the benefit-risk assessment by the veterinarian.
Interactions with other medicinal products or other forms of interaction
Milbemycin oxime is a substrate of p-glycoprotein (P-gp), and can therefore interact with other P-gp substrates (e.g., digoxin, doxorubicin) or other macrocyclic lactones. Therefore, concomitant treatment with other P-gp substrates may lead to increased toxicity.
Amounts to be administered and administration route
For oral administration.
Dosage:
The product should be administered at a dose of 2.50-5.36 mg/kg of afoxolaner and 0.50-1.07 mg/kg milbemycin oxime body weight according to the following table:
| Dog weight (kg) | Concentration and number of chewable tablets to be administered | ||||
|
NEXGARD SPECTRA 9 mg/ 2 mg |
NEXGARD SPECTRA 19 mg/ 4 mg |
NEXGARD SPECTRA 38 mg/ 8 mg |
NEXGARD SPECTRA 75 mg/ 15 mg |
NEXGARD SPECTRA 150 mg/ 30 mg |
|
|
2-3.5 |
1 |
|
|
|
|
|
>3.5-7.5 |
|
1 |
|
|
|
|
>7.5-15 |
|
|
1 |
|
|
|
>15-30 |
|
|
|
1 |
|
|
>30-60 |
|
|
|
|
1 |
For dogs over 60 kg body weight, the necessary combination of chewable tablets should be used.
Method of administration:
The tablets are chewable and palatable for most dogs. If the dog does not accept the tablets directly, they can be administered with food.
Treatment regimen:
The treatment regimen should be based on veterinary diagnosis and the local epidemiological situation.
NEXGARD SPECTRA can be used as seasonal preventive treatment against fleas and ticks (replacing treatment with a monovalent product acting only against fleas and ticks) in dogs concomitantly infested with gastrointestinal nematodes. A single treatment is effective against gastrointestinal nematodes. After treating nematode infestations, treatment against flea and tick infestations can be continued by applying the monovalent product.
Disease: Heartworm disease:
NEXGARD SPECTRA kills Dirofilaria immitis larvae for one month after transmission by mosquitoes, therefore the product should be administered at regular monthly intervals throughout the vector-prone periods, starting from the month after the first exposure to mosquitoes. Treatment should be continued until one month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended to administer the treatment on the same day of the month.
If replacing another heartworm prevention product, the first treatment with NEXGARD SPECTRA should begin on the day the previous medication was due to be administered.
Dogs living in or travelling to a heartworm region may be infested with adult heartworms. No therapeutic effect against adult Dirofilaria immitis has been established. Therefore, it is recommended that all dogs older than 8 months or more, living in heartworm endemic areas, be tested for adult heartworm infestation before being treated with a heartworm prevention product.
Overdose (symptoms, emergency procedures, antidotes), if applicable
No adverse reactions were observed in healthy puppies over 8 weeks of age after 6 treatments with 5 times the maximum dose.
Withdrawal period: Not applicable.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: antiparasitic products, endectocides, milbemycin combinations.
Veterinary ATC code: QP54AB51
Pharmacodynamic properties
Afoxolaner:
Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family.
Afoxolaner acts by interacting with chloride ion channels, mainly those with a binding site for the gamma-aminobutyric acid (GABA) neurotransmitter, thus blocking pre- and post-synaptic chloride ion transfers across the cell membrane. This results in uncontrolled activity of the central nervous system and the death of insects and mites. The selective toxicity of afoxolaner between insects/mites and mammals is a consequence of the characteristic sensitivity of GABA receptors in insects/mites versus those in mammals.
Afoxolaner is active against adult fleas as well as some tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum and Haemaphysalis longicornis.
The product kills fleas before they lay eggs and thus prevents household contamination. It can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Milbemycin oxime:
Milbemycin oxime is an antiparasitic endectocide belonging to the macrocyclic lactone group. Milbemycin oxime is a mixture of milbemycin A4 and milbemycin A3 (in a ratio of 20:80 for A3:A4). It is isolated from the fermentation of Streptomyces milbemycinicus.
Milbemycin oxime acts by disrupting glutamate-activated neurotransmission in invertebrates. Milbemycin oxime increases the membrane permeability of nematodes and insects to chloride ions through glutamate-controlled chloride ion channels (linked to GABA and glycine receptors in vertebrates).
This leads to hyperpolarization of the neuromuscular membrane and paralysis and death of parasites.
Pharmacokinetic particulars
Afoxolaner is absorbed very quickly systemically. The absolute bioavailability obtained was 88%. The mean maximum plasma concentration (Cmax) was 1822 ± 165 ng/ml, 2-4 hours (Tmax) after a dose of 2.5 mg/kg afoxolaner.
The tissue distribution volume of Afoxolaner is 2.6 ± 0.6 l/kg and the clearance value is 5.0 ± 1.2 ml/h/kg. The half-life is approximately 2 weeks in dogs.
Plasma concentrations of Milbemycin oxime increase rapidly in the first 1-2 hours (Tmax) indicating rapid absorption from the tablet. The absolute bioavailability obtained was 81% for factor A3 and 65% for A4 respectively. The mean maximum plasma concentration (Cmax) after oral administration was 1.6 ± 0.4 days and 42 ± 11 ng/ml for A3, 3.3 ± 1.4 days and 246 ± 71 ng/ml for A4.
The tissue distribution volume of Milbemycin oxime is 2.7 ± 0.4 and 2.6 ± 0.6 l/kg for A3 and A4 forms respectively. Both forms have a low clearance value of 75 ± 22 ml/h/kg for A3 and 41 ± 12 ml/h/kg for A4.
PHARMACEUTICAL PARTICULARS
List of excipients
- Maize starch
- Soya proteins
- Braised beef flavour
- Povidone (E1201)
- Macrogol 400
- Macrogol 4000
- Macrogol 15 hydroxystearate
- Glycerol (E422)
- Medium-chain triglycerides
- Citric acid monohydrate (E330)
- Butylhydroxytoluene (E321)
Incompatibilities: Not applicable.
Shelf life: Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Special precautions for storage: Keep the blister in the secondary packaging to protect from light.
Nature and composition of primary packaging
This veterinary medicinal product is individually packed in thermoformed PVC blisters sealed on the back with aluminium foil (Aclar/PVC/Alu).
1 cardboard box containing one blister with 1, 3 and 6 chewable tablets.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from the use of such products should be disposed of in accordance with local requirements.
Advocate 40 Dogs (0 - 4 kg), 3 pipettes
Chemical composition:
- Imidacloprid: 100mg/ml
- Moxidectin: 25mg/ml
Pharmaceutical form:
- Antiparasitic solution for cutaneous application.
Indications:
for the treatment and prevention of flea infestations (Ctenocephalides spp.).
- reduces the incidence of flea allergies.
- larval stages are killed on the animal and in the surrounding environment of treated animals.
for the prevention of heartworm infestations (Dirofilaria immitis)
for the treatment and control of:
- roundworms Toxocara canis, T. leonina (including L1 larval stage and immature adult forms).
- hookworms Ancylostoma caninum, A. braziliense, Uncinaria stenocephala.
- whipworms Trichuris vulpis.
- generalized demodicosis Demodex canis.
- sarcoptic mange Sarcoptes scabiei.
- ear mites Otodectes cynotis.
- lice Trichodectes canis. Linognathus setosus for 6 weeks.
Dosage and administration:
- For dogs between 0 - 4 kg, one tube of Advocate 40 is used;
- Administration is done in the dorsal area at the base of the neck for small dogs, and for large dogs, it can be done in several spots along the back.
- The product is applied to the skin, avoiding contact with the dog's mouth or eyes.
- The dog's skin must be intact and free of lesions.
- It can be administered to pregnant or lactating bitches.
- The product retains its effectiveness after bathing or exposure to rain.
- To reduce re-infestation with new fleas, it is recommended that all dogs in a household be treated. Other pets in the same family or household should be treated with appropriate products.
Contraindications:
- Do not use in cats. Do not use in puppies under 7 weeks of age.
Other information:
- for the prevention of heartworm infestation, treatment should begin one month before the mosquito season (the host that transmits the larvae) and continue once a month until the mosquito season passes.
- for tapeworms (cestodes), internal antiparasitics should be used as ADVOCATE does not act on them, only on roundworms and hookworms.
- for demodicosis, 2 to 4 monthly treatments are required for beneficial effects.
- for mange (auricular, sarcoptic), a single treatment is necessary for complete elimination of parasites and signs of disease.
Important: Advocate 40 falls under the pharmacy category. Consult your veterinarian for diagnosis and prescription of medication according to the specific needs of your dog or cat.
Advocate 400 Dogs (> 25 kg), 3 pipettes
Chemical composition:
- Imidacloprid: 100mg/ml
- Moxidectin: 25mg/ml
Pharmaceutical form:
- Antiparasitic solution for cutaneous application.
Indications:
for the treatment and prevention of flea infestations (Ctenocephalides spp.).
- reduces the incidence of flea allergy dermatitis.
- larval stages are killed on the animal and in the surrounding environment of treated animals.
for the prevention of heartworm infestations (Dirofilaria immitis)
for the treatment and control of:
- roundworms Toxocara canis, T. leonina (including L1 larval stage and immature adult forms).
- hookworms Ancylostoma caninum, A. braziliense, Uncinaria stenocephala.
- whipworms Trichuris vulpis.
- generalized demodicosis Demodex canis.
- sarcoptic mange Sarcoptes scabiei.
- ear mites Otodectes cynotis.
- lice Trichodectes canis. Linognathus setosus for 6 weeks.
Dosage and administration:
- For dogs under 40 kg, one tube is used, and for dogs over 40 kg, two tubes of Advocate 400 are used.
- Administration is done in the dorsal area at the base of the neck for small dogs, and for large dogs, it can be done in several places along the back.
- The product is applied to the skin, avoiding contact with the dog's mouth or eyes.
- The dog's skin must be intact and without lesions.
- It can be administered to pregnant or lactating bitches.
- The product retains its efficacy after bathing or exposure to rain.
- To reduce re-infestations with new fleas, it is recommended that all dogs in a family (household) be treated. Other pets in the same family or household should be treated with appropriate products.
Contraindications:
- Not for use in cats.
- Not for use in puppies under 7 weeks of age.
Further information:
- for the prevention of heartworm infestation, it is recommended to start treatment one month before the mosquito season (the vector that transmits the larvae) begins and to continue once a month until the mosquito season ends.
- for tapeworms (cestodes), it is recommended to use internal antiparasitics as ADVOCATE does not act on them, but only on roundworms and hookworms.
- for demodicosis, 2 to 4 monthly treatments are necessary to achieve beneficial effects.
- for mange (ear, sarcoptic), a single treatment is usually sufficient for complete elimination of parasites and signs of disease.
Important: Advocate 400 falls under the pharmacy category. Consult your veterinarian for diagnosis, prescription of medication or diet according to your dog's (cat's) specific needs.
Liquid antiparasitic solution for cutaneous application, packaged in single-use pipettes.
PACKAGE LEAFLET FOR Cardboard box with 3 pipettes
Frontline Tri-Act spot-on solution for dogs 2-5 kg
DECLARATION OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Spot-on solution.
Clear, colourless to brownish-yellow solution.
Active substances/Excipients:
See section "dosage for each target species"
TARGET SPECIES
Dogs
Caution!!!
Due to the unique physiology of cats, which are unable to metabolise certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.
In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separated from treated dogs until the application site is dry.
It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, seek immediate veterinary advice.
INDICATION (INDICATIONS)
For the treatment and prevention of flea and/or tick infestations when repellent (anti-feeding) activity against sandflies, stable flies and/or mosquitoes is needed.
For the treatment and prevention of Ctenocephalides felis flea infestations and the prevention of Ctenocephalides canis flea infestations. The product kills C. felis fleas on the animal within 24 hours. A single
treatment prevents a new flea infestation for 4 weeks. The product can be part of a treatment strategy for the control of flea allergy dermatitis if this diagnosis has
been established by a veterinarian.
The product has repellent efficacy against ticks (Dermacentor reticulatus) starting from 7 days and up to 4 weeks after treatment. However, a single tick may attach and detach within the first 24 hours after infestation.
The product has immediate acaricidal efficacy against Rhipicephalus sanguineus and Ixodes ricinus species, but if ticks are present at the time of application, they may not die within the first 48 hours after treatment.
The product has persistent acaricidal efficacy against ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus) for 4 weeks.
The product has repellent (anti-feeding) efficacy for 3 weeks against sandflies (Phlebotomus perniciosus) and for 4 weeks against mosquitoes (Culex pipiens).
The product has persistent insecticidal efficacy against sandflies (Phlebotomus perniciosus) for 3 weeks.
The product repels and kills stable flies (Stomoxys calcitrans) for five weeks.
CONTRAINDICATIONS
Do not use on sick or convalescent animals.
Do not use on cats and rabbits as it may cause adverse reactions and even death.
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
ADVERSE REACTIONS
Among the very rare suspected adverse reactions, transient reactions at the application site (skin discoloration, local alopecia, pruritus, erythema) and generalised pruritus or alopecia have been reported after use. Hypersalivation, reversible neurological reactions (increased sensitivity to stimuli, hyperactivity, muscle tremors, depression, other neurological reactions) or vomiting have also been reported.
Slight hypersalivation and vomiting may occur if the product is ingested, should the animal lick the application area.
If you notice any serious reactions or other effects not mentioned in this package leaflet, please inform your veterinarian.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Topical administration to the skin (spot-on).
The following table defines which pipette should be used depending on the dog's weight:
Active ingredients Excipients
Frontline Tri-Act spot-on solution for dogs Dosed unit volume Fipronil (mg) Permethrin (mg) Butylhydroxytoluene (E321) (mg)
Very small dogs 2-5kg 0.5 33.8 252.4 0.563
Small dogs 5-10kg 1 67.6 504.8 1.125
Medium dogs 10-20kg 2 135.2 1009.6 2.250
Large dogs 20-40kg 4 270.4 2019.2 4.500
XL dogs 40-60kg 6 405.6 3028.8 6.750
Dogs > 60 kg Use the appropriate combination of pipettes
Treatment scheme
The product should be used after confirming infestation or risk of infestation with fleas and/or ticks, concurrently with the need for repellent (anti-feeding) activity against sandflies and/or mosquitoes and/or stable flies.
Depending on the recurrence of the risk of infestation with these ectoparasites, repeated treatment may be established. In these cases, the minimum treatment interval is at least 4 weeks.
ADVICE ON CORRECT ADMINISTRATION
Choose the appropriate pipette for the dog's weight. For dogs weighing more than 60 kg, the necessary combination of pipettes will be used until the appropriate quantity for the dog's weight is reached.
The product should be applied in two areas where the dog cannot reach, so that it cannot lick the application site.
These application sites are one at the base of the neck above the shoulder blades and the other on the midline of the neck between the base of the skull and the shoulder blades.
Remove the blister foil from the package and peel off a blister. Use scissors to cut the blister along the dotted line to remove the pipette or fold the marked corner and tear open.
Hold the pipette upright, away from your face or body, cut the tip of the pipette with scissors. Part the dog's fur until the skin is visible. Position the tip of the pipette on the skin.
Squeeze the pipette and apply approximately half of the content to the midline of the dog's neck, between the base of the skull and the shoulder blades. Repeat the application at the base of the neck, above the shoulder blades, emptying the pipette.
To achieve the best results, make sure you apply the product directly to the skin and not to the fur.
WITHDRAWAL PERIOD
Not applicable
SPECIAL PRECAUTIONS FOR STORAGE
Keep out of the sight and reach of children.
Store in the original packaging.
Do not store above 25 °C
Do not use after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
SPECIAL WARNING(S)
Special warnings for each target species
A single tick or a mosquito or sandfly bite may already be attached to the animal. For this reason, the transmission of pathogens by these arthropods cannot be excluded if conditions are favourable.
The product remains effective against fleas when treated animals occasionally enter water (e.g. swimming, bathing). However, dogs should not be allowed to swim and should not be shampooed for 48 hours after treatment.
Avoid frequent swimming or shampooing of treated dogs as this may affect the maintenance of product efficacy.
To reduce re-infestation due to the emergence of new fleas, it is recommended that all dogs in the household be treated. Animals living in the same space should be treated with a veterinary medicinal product suitable for their species.
To reduce the risk of environmental infestation, it is recommended to use additional appropriate environmental treatment
against fleas and their developmental stages.
Special precautions for use in animals
In the absence of specific studies, the use of this product is not recommended for dogs younger than 8 weeks or weighing less than 2 kg.
Avoid contact of the product with the animal's eyes.
It is very important to ensure that the product is applied in an area where the animal cannot lick the product and also to ensure that animals do not lick each other after
treatment.
Due to the unique physiology of cats, which are unable to metabolise certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.
In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separated from treated dogs until the application site is dry.
It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, seek immediate veterinary advice.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
For veterinary use only.
This product may cause skin and eye irritation. Therefore, contact of the product with the skin or eyes must be avoided. Do not open the pipette near or towards the face. If accidentally sprayed into the eyes or if the eyes become irritated during product administration, immediate thorough washing with water is recommended. If ophthalmic irritation persists, seek medical advice.
Persons with known hypersensitivity to fipronil and/or permethrin should avoid contact with this product.
The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat during product application. Wash hands after use. In case of ingestion, rinse mouth with water and seek medical advice if you feel unwell.
As the excipient N-methylpyrrolidone can cause fetotoxicity and teratogenicity following prolonged exposure, pregnant women are advised to wear gloves to avoid contact with the product.
Avoid handling the animal until the application site is dry; children should also not play with animals until their fur is dry.
Therefore, it is recommended that animals are not treated during the day but in the evening, and that treated animals sleep alone during the night, not with their owners and especially not with children.
Keep pipettes in the original packaging and, once used, empty pipettes must be disposed of immediately in an appropriate manner to prevent further access.
Other precautions
The product can have harmful effects on aquatic organisms. Treated dogs should not be allowed to swim in watercourses for 2 days after treatment.
Use during pregnancy and lactation
Laboratory studies with fipronil and permethrin produced no teratogenic or embryotoxic effects. No studies have been conducted with this product on animals during pregnancy or lactation.
N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to have a teratogenic effect in laboratory animals after repeated exposure to high doses.
Use only based on a benefit/risk assessment by the veterinarian.
Overdose
Safety of use was evaluated in healthy adult dogs treated with a dose up to 5 times higher than the maximum recommended dose (treated 3 times at monthly intervals) and in puppies (8 weeks old, treated once). Among the known adverse reactions, mild neurological symptoms,
vomiting, and diarrhea may occur. These symptoms are transient and usually disappear without treatment within 1-2 days. Animals should always be treated with the pipette corresponding to their weight.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF APPLICABLE
Any unused veterinary medicinal product or waste material derived from such products
must be disposed of in accordance with local requirements.
Do not contaminate lakes, watercourses, or drains with this product or empty pipettes.
OTHER INFORMATION
Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil kills fleas in 24
hours, ticks and lice in 48 hours after exposure.
Permethrin belongs to type I pyrethroids, which are acaricides and insecticides with repellent activity.
Permethrin in the product provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.
Liquid antiparasitic solution for cutaneous application, packaged in single-use pipettes.
PACKAGE LEAFLET FOR Cardboard box with 3 pipettes
Frontline Tri-Act spot-on solution for dogs 5-10 kg
DECLARATION OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Spot-on solution.
Clear, colorless to brownish-yellow solution.
Active substances/Excipients:
See "dosage for each target species" section
TARGET SPECIES
Dogs
Caution!!!
Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.
In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and urgently seek veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.
It is important that cats do not lick the site where the veterinary medicinal product has been applied to dogs. In case of such exposure, seek veterinary advice immediately.
INDICATION(S)
For the treatment and prevention of flea and/or tick infestations when repellent (anti-feeding) activity against sandflies, stable flies and/or mosquitoes is required.
For the treatment and prevention of flea infestations by Ctenocephalides felis and the prevention of flea infestations by Ctenocephalides canis. The product kills C. felis fleas on the animal within 24 hours. A single
treatment prevents new flea infestations for 4 weeks. The product can be part of a treatment strategy for the control of flea allergy dermatitis if this diagnosis has
been established by the veterinarian.
The product has repellent efficacy against ticks (Dermacentor reticulatus) starting from 7 days and up to 4 weeks after treatment. However, a single tick may attach and detach within the first 24 hours after infestation.
The product has immediate acaricidal efficacy against Rhipicephalus sanguineus and Ixodes ricinus, but if ticks are present at the time of application, they may not die within the first 48 hours after treatment.
The product has persistent acaricidal efficacy against ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus) for 4 weeks.
The product has repellent (anti-feeding) efficacy for 3 weeks against sandflies (Phlebotomus perniciosus) and for 4 weeks against mosquitoes (Culex pipiens).
The product has persistent insecticidal efficacy against sandflies (Phlebotomus perniciosus) for 3 weeks.
The product repels and kills stable flies (Stomoxys calcitrans) for five weeks.
CONTRAINDICATIONS
Do not use on sick or convalescing animals.
Do not use on cats and rabbits as it may cause adverse reactions and even death.
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
ADVERSE REACTIONS
Among the suspected, very rare adverse reactions reported after use, transient reactions have occurred
on the skin at the application site (skin discoloration, local alopecia, pruritus, erythema) and generalized pruritus or alopecia. Hypersalivation, reversible neurological reactions (increased sensitivity to stimuli, hyperactivity, muscle tremors, depression, other neurological reactions) or vomiting have also been reported.
Mild hypersalivation and vomiting may occur if the product is ingested, if the animal licks the application site.
If you notice any serious reactions or other effects not mentioned in this package leaflet, please inform your veterinarian.
DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
Topical application to the skin (spot-on).
The following table defines which pipette should be used depending on the dog's weight:
Active Ingredients Excipients
Frontline Tri-Act spot-on Volume of unit Fipronil (mg) Permethrin Butylhydroxytoluene
solution for dogs dosed (mg) (E321) (mg)
Very small dogs 2-5kg 0.5 33.8 252.4 0.563
Small dogs 5-10kg 1 67.6 504.8 1.125
Medium dogs 10-20kg 2 135.2 1009.6 2.250
Large dogs 20-40kg 4 270.4 2019.2 4.500
XL dogs 40-60kg 6 405.6 3028.8 6.750
Dogs > 60 kg Use the appropriate combination of pipettes
Treatment schedule
The product should be used after confirmation of infestation or risk of infestation with fleas and/or ticks, simultaneously with the need for repellent (anti-feeding) activity against sandflies and/or mosquitoes and/or stable flies.
Depending on the recurrence of the risk of infestation with these ectoparasites, repeated treatment may also be established. In these cases, the minimum treatment interval is at least 4 weeks.
ADVICE ON CORRECT ADMINISTRATION
Choose the pipette appropriate for the dog's weight. For dogs weighing over 60 kg, the necessary combination of pipettes should be used until the amount appropriate for the dog's weight is reached.
The product should be applied in two areas where the dog cannot reach, so that it cannot lick the application site.
These application sites are one at the base of the neck above the shoulder blades and the other on the midline of the neck between the base of the skull and the shoulder blades.
Remove the blister foil from the package and detach one blister. Use scissors to cut the blister along the dotted line to remove the pipette or fold the marked corner and tear open.
Hold the pipette upright, away from your face or body, cut the tip of the pipette with scissors. Part the dog's fur so that the skin is visible. Position the tip of the pipette on the skin.
Squeeze the pipette and apply approximately half of the content to the midline of the dog's neck, between the base of the skull and the shoulder blades. Repeat the application at the base of the neck, above the shoulder blades, emptying the pipette.
To obtain the best results, make sure to apply the product directly to the skin and not to the fur.
WAITING PERIOD
Not applicable
SPECIAL PRECAUTIONS FOR STORAGE
Keep out of the sight and reach of children.
Store in the original packaging.
Do not store above 25 °C
Do not use after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
SPECIAL WARNING(S)
Special warnings for each target species
A single tick or a bite from a mosquito or sandfly may already be present on the animal. For this reason, the transmission of pathogens by these arthropods cannot be excluded, if conditions are favorable.
The product remains effective against fleas when treated animals occasionally enter water (e.g. swimming, bathing). However, dogs should not be allowed to swim and should not be shampooed for 48 hours after treatment.
Avoid swimming or frequent shampooing of treated dogs as this may affect the maintenance of the product's efficacy.
To reduce re-infestation due to the appearance of new fleas, it is recommended that all dogs in the household be treated. Animals living in the same area should be treated with a veterinary medicinal product suitable for their species.
To reduce the risk of environmental infestation, it is recommended to use an additional treatment
appropriate for the environment in which the animals live, against fleas and their developmental stages.
Special precautions for use in animals
In the absence of specific studies, the use of this product is not recommended for dogs less than 8 weeks old or weighing less than 2 kg.
Avoid contact of the product with the animal's eyes.
It is very important to ensure that the product is applied in an area where the animal cannot lick the product and also to ensure that animals do not lick each other after
treatment.
Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.
In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and urgently seek veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.
It is important that cats do not lick the site where the veterinary medicinal product has been applied to dogs. In case of such exposure, seek veterinary advice immediately.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
For veterinary use only.
This product can cause skin and eye irritation. Therefore, contact of the product with the skin or eyes must be avoided.
Do not open the pipette near or towards the face. If accidentally sprayed into the eyes or if the eyes become irritated during administration of the product, immediate rinsing with plenty of water is recommended. If ocular irritation persists, seek medical advice.
Persons with known hypersensitivity to fipronil and/or permethrin should avoid contact with this product.
The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat during product application. Wash hands after use. In case of ingestion, rinse mouth with water and seek medical advice if you feel unwell.
As the excipient N-methylpyrrolidone can cause fetotoxicity and teratogenicity after prolonged exposure, it is recommended that pregnant women wear gloves to avoid contact with the product.
Avoid handling the animal until the application site is dry; children should also not play with the animals until their fur is dry.
Therefore, it is recommended that animals are not treated during the day but in the evening, and during the night, treated animals should sleep alone, not with owners and especially not with children.
Keep pipettes in the original packaging and once used, empty pipettes must be disposed of immediately in an appropriate manner, to prevent subsequent access.
Other precautions
The product can be harmful to aquatic organisms. Treated dogs should not be allowed to swim in watercourses for 2 days after treatment.
Use during pregnancy and lactation
Laboratory studies with fipronil and permethrin produced no teratogenic or embryotoxic effects. No studies have been conducted with this product on animals during pregnancy or lactation.
N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to have a teratogenic effect in laboratory animals after repeated exposure to high doses.
Use only after a benefit/risk assessment by the veterinarian.
Overdose
Safety of use has been evaluated in healthy adult dogs treated with a dose up to 5 times higher
than the maximum recommended dose (treated 3 times at monthly intervals) and in puppies (8 weeks old, treated once). Known adverse reactions may include mild neurological symptoms,
vomiting and diarrhea. These symptoms are transient and usually disappear without treatment within 1-2 days. Animals should always be treated with the pipette corresponding to their weight.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE, IF APPLICABLE
Any unused veterinary medicinal product or waste derived from the use of such products
must be disposed of in accordance with local requirements.
Do not contaminate lakes, watercourses or drains with this product or empty pipettes.
OTHER INFORMATION
Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil kills fleas within 24 hours, ticks and lice within 48 hours of exposure.
Permethrin belongs to the Type I pyrethroid class, which are acaricides and insecticides with repellent activity.
Permethrin in the product provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.
Liquid antiparasitic solution for cutaneous application, packaged in single-dose pipettes.
PACKAGE LEAFLET FOR Cardboard box with 3 pipettes
Frontline Tri-Act spot-on solution for dogs 10-20 kg
DECLARATION OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Spot-on solution.
Clear, colourless to brownish-yellow solution.
Active substances/Excipients:
See section "Dosage for each target species"
TARGET SPECIES
Dogs
Caution!!!
Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species that may be fatal.
In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.
It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, seek immediate veterinary advice.
INDICATION (INDICATIONS)
For the treatment and prevention of flea and/or tick infestations when repellent (anti-feeding) activity against sandflies, flies, and/or mosquitoes is required.
For the treatment and prevention of flea infestations with Ctenocephalides felis and the prevention of flea infestations with Ctenocephalides canis. The product kills C. felis fleas on the animal within 24 hours. A single
treatment prevents new flea infestation for 4 weeks. The product can be part of the treatment strategy for the control of flea allergy dermatitis if this diagnosis has
been established by a veterinarian.
The product has repellent efficacy against ticks (Dermacentor reticulatus) from 7 days up to 4 weeks after treatment. However, a single tick may attach and detach within the first 24 hours after infestation.
The product has immediate acaricidal efficacy against Rhipicephalus sanguineus and Ixodes ricinus species, but if ticks are present at the time of application, they may not die within the first 48 hours after treatment.
The product has persistent acaricidal efficacy against ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus) for 4 weeks.
The product has repellent (anti-feeding) efficacy for 3 weeks against sandflies (Phlebotomus perniciosus) and for 4 weeks against mosquitoes (Culex pipiens).
The product has persistent insecticidal efficacy against sandflies (Phlebotomus perniciosus) for 3 weeks.
The product repels and kills stable flies (Stomoxys calcitrans) for five weeks.
CONTRAINDICATIONS
Do not use on sick or convalescing animals.
Do not use on cats and rabbits as it may cause adverse reactions and even death.
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
ADVERSE REACTIONS
Among the suspected, very rare adverse reactions, transient skin reactions at the application site (skin discolouration, local alopecia, pruritus, erythema) and generalised pruritus or alopecia have been reported after use. Hypersalivation, reversible neurological reactions (increased sensitivity to stimuli, hyperactivity, muscle tremors, depression, other neurological reactions) or vomiting have also been reported.
Mild hypersalivation and vomiting may occur if the product is ingested, for example, if the animal licks the application area.
If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
Topical application on the skin (spot-on).
The following table defines which pipette should be used depending on the dog's weight:
Active ingredients Excipients
Frontline Tri-Act spot- Volume of unit Fipronil (mg) Permethrin Butylhydroxytoluene
on for dogs dosed (mg) (E321) (mg)
Very small dogs 2-5kg 0.5 33.8 252.4 0.563
Small dogs 5-10kg 1 67.6 504.8 1.125
Medium dogs 10-20kg 2 135.2 1009.6 2.250
Large dogs 20-40kg 4 270.4 2019.2 4.500
XL dogs 40-60kg 6 405.6 3028.8 6.750
Dogs > 60 kg Use the appropriate combination of pipettes
Treatment regimen
The product should be used after confirmation of infestation or risk of infestation with fleas and/or ticks, simultaneously with the need for repellent (anti-feeding) activity against sandflies and/or mosquitoes and/or flies.
Depending on the recurrence of the risk of infestation with these ectoparasites, repeated treatment may be established. In these cases, the minimum treatment interval is at least 4 weeks.
ADVICE ON CORRECT ADMINISTRATION
Select the appropriate pipette for the dog's weight. For dogs weighing more than 60 kg, the necessary combination of pipettes should be used until the appropriate quantity for the dog's weight is reached.
The product should be applied in two areas where the dog cannot reach, so that it cannot lick the application site. These application sites are one at the base of the neck above the shoulder blades and the other on the midline of the neck between the base of the skull and the shoulder blades.
Remove the blister foil from the packaging and tear off one blister. Use scissors to cut the blister along the dotted line to remove the pipette or fold the marked corner and tear open.
Hold the pipette upright, away from your face or body, cut the tip of the pipette with scissors. Part the dog's fur until the skin is visible. Position the pipette tip on the skin.
Squeeze the pipette and apply approximately half of the content to the midline of the dog's neck, between the base of the skull and the shoulder blades. Repeat the application at the base of the neck, above the shoulder blades, emptying the pipette.
For best results, ensure the product is applied directly to the skin and not to the fur.
WITHDRAWAL PERIOD
Not applicable
SPECIAL PRECAUTIONS FOR STORAGE
Keep out of the sight and reach of children.
Store in the original packaging.
Do not store above 25 °C
Do not use after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
SPECIAL WARNING(S)
Special warnings for each target species
A single tick or a mosquito or sandfly bite may already be present on the animal. Therefore, the transmission of pathogens by these arthropods cannot be excluded if conditions are favourable.
The product remains effective against fleas when treated animals occasionally enter water (e.g., swimming, bathing). However, dogs should not be allowed to swim or be shampooed for 48 hours after treatment application.
Avoid swimming or frequent shampooing of treated dogs as this may affect the maintenance of product efficacy.
In order to reduce re-infestation due to the emergence of new fleas, it is recommended that all dogs in the household be treated. Animals living in the same environment should be treated with a veterinary medicinal product appropriate for their species.
To reduce the risk of environmental infestation, it is recommended to use an additional appropriate treatment for the environment in which the animals live, against fleas and their developmental stages.
Special precautions for use in animals
In the absence of specific studies, the use of this product is not recommended for dogs less than 8 weeks old or weighing less than 2 kg.
Avoid contact of the product with the animal's eyes.
It is very important to ensure that the product is applied in an area where the animal cannot lick the product, and also to ensure that animals do not lick each other after
treatment.
Due to the unique physiology of cats, which are unable to metabolize certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species that may be fatal.
In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.
It is important that cats do not lick the application site of the veterinary medicinal product on dogs. In case of such exposure, seek immediate veterinary advice.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
For veterinary use only.
This product may cause skin and eye irritation. Consequently, contact of the product with skin or eyes should be avoided. Do not open the pipette near or towards the face. If accidentally sprayed into the eyes or if eyes become irritated during administration of the product, immediate abundant washing with water is recommended. If ophthalmic irritation persists, seek medical advice.
Persons with known hypersensitivity to fipronil and/or permethrin should avoid contact with this product.
The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat during product application. Wash hands after use. In case of swallowing, rinse mouth with water and seek medical advice if you feel unwell.
As the excipient N-methylpyrrolidone may cause foetotoxicity and teratogenicity following prolonged exposure, it is recommended that pregnant women wear gloves to avoid contact with the product.
Avoid handling the animal until the application site has dried. Children should also not play with the animals until the fur is dry.
Therefore, it is recommended that animals are not treated during the day but in the evening, and treated animals should sleep alone during the night, not with owners and especially not with children.
Store pipettes in the original packaging, and once used, empty pipettes should be disposed of immediately in an appropriate manner to prevent subsequent access.
Other precautions
The product may adversely affect aquatic organisms. Treated dogs should not be allowed to swim in watercourses for 2 days after treatment.
Use during pregnancy and lactation
Laboratory studies with fipronil and permethrin have not produced any teratogenic or embryotoxic effects. No studies have been conducted with this product on animals during pregnancy or lactation.
N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to have a teratogenic effect in laboratory animals after repeated exposure to high doses.
Use only based on a benefit/risk assessment by the veterinary surgeon.
Overdose
Safety of use was evaluated in healthy adult dogs treated with a dose up to 5 times the maximum recommended dose (treated 3 times at monthly intervals) and in puppies (8 weeks old, treated once). Known adverse reactions may include mild neurological symptoms,
vomiting and diarrhoea. These symptoms are transient and usually resolve without treatment within 1-2 days. Animals should always be treated with the pipette appropriate for their weight.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such products
should be disposed of in accordance with local requirements.
Do not contaminate ponds, watercourses or ditches with this product or empty pipettes.
OTHER INFORMATION
Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil kills fleas within 24 hours,
ticks and lice within 48 hours of exposure.
Permethrin belongs to the Type I pyrethroid class, which are acaricides and insecticides with repellent activity.
Permethrin in the product provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.
Liquid antiparasitic solution for cutaneous application packaged in single-use pipettes.
PACKAGE LEAFLET FOR Cardboard box with 3 pipettes
Frontline Tri-Act spot-on solution for dogs 40-60 kg
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Spot-on solution.
Clear, colourless to yellow-brown solution.
Active substances/Excipients:
See section "dosage for each target species"
TARGET SPECIES
Dogs
Caution!!!
Due to the unique physiology of cats, which are unable to metabolise certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.
In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.
It is important that cats do not lick the site where the veterinary medicinal product has been applied to dogs. In case of such exposure, seek veterinary advice immediately.
INDICATION (INDICATIONS)
For the treatment and prevention of flea and/or tick infestations when repellent (anti-feeding) activity against sandflies, flies and/or mosquitoes is required.
For the treatment and prevention of infestations with fleas Ctenocephalides felis and prevention of infestations with fleas Ctenocephalides canis. The product kills C. felis fleas on the animal within 24 hours. A single
treatment prevents new flea infestation for 4 weeks. The product can be part of a treatment strategy for the control of flea allergy dermatitis if this diagnosis has been
established by the veterinarian.
The product has repellent efficacy against ticks (Dermacentor reticulatus) starting from 7 days and up to 4 weeks after treatment. However, a single tick can attach and detach within the first 24 hours after infestation.
The product has immediate acaricidal efficacy against Rhipicephalus sanguineus and Ixodes ricinus species, but if ticks are present at the time of application, they may not die within the first 48 hours after treatment.
The product has persistent acaricidal efficacy against ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus) for 4 weeks.
The product has repellent (anti-feeding) efficacy for 3 weeks against sandflies (Phlebotomus perniciosus) and for 4 weeks against mosquitoes (Culex pipiens).
The product has persistent insecticidal efficacy against sandflies (Phlebotomus perniciosus) for 3 weeks.
The product repels and kills stable flies (Stomoxys calcitrans) for five weeks.
CONTRAINDICATIONS
Do not use on sick or convalescing animals.
Do not use on cats and rabbits as it can cause adverse reactions and even death.
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
ADVERSE REACTIONS
Among the very rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, local alopecia, pruritus, erythema) and generalized pruritus or alopecia have been reported after use. Hypersalivation, reversible neurological reactions (increased sensitivity to stimuli, hyperactivity, muscle tremors, depression, other neurological reactions) or vomiting have also been reported.
Mild hypersalivation and vomiting may occur if the product is ingested, if the animal licks the application site.
If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.
DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
Topical administration to the skin (spot-on).
The following table defines which pipette should be used depending on the dog's weight:
Active ingredients Excipients
Frontline Tri-Act spot-on solution for dogs. Volume of dosed unit. Fipronil (mg) Permethrin (mg) Butylated hydroxytoluene (E321) (mg)
Very small dogs 2-5kg 0.5 33.8 252.4 0.563
Small dogs 5-10kg 1 67.6 504.8 1.125
Medium dogs 10-20kg 2 135.2 1009.6 2.250
Large dogs 20-40kg 4 270.4 2019.2 4.500
XL dogs 40-60kg 6 405.6 3028.8 6.750
Dogs > 60 kg Use the appropriate combination of pipettes
Treatment scheme
The product should be used after confirmation of infestation or risk of infestation with fleas and/or ticks, along with the need for repellent (anti-feeding) activity against sandflies and/or mosquitoes and/or flies.
Depending on the recurrence of infestation risk with these ectoparasites, treatment repetition can also be established. In these cases, the minimum treatment interval is at least 4 weeks.
RECOMMENDATIONS FOR CORRECT ADMINISTRATION
Select the appropriate pipette for the dog's weight. For dogs weighing more than 60 kg,
the necessary combination of pipettes should be used until the appropriate quantity for the dog's weight is reached.
The product should be applied in two areas where the dog cannot reach, so that it cannot lick the application site.
These application sites are one at the base of the neck above the shoulder blades and the other on the midline of the neck between the base of the skull and the shoulder blades.
Remove the blister foil from the packaging and detach one blister. Use scissors to cut the blister along the dotted line to remove the pipette, or fold the marked corner and tear it open.
Hold the pipette upright, away from your face or body, and cut the tip of the pipette with scissors. Part the dog's fur until the skin is visible. Position the tip of the pipette on the skin.
Squeeze the pipette and apply approximately half of the content to the midline of the dog's neck, between the base of the skull and the shoulder blades. Repeat the application at the base of the neck, above the shoulder blades, emptying the pipette.
To achieve the best results, ensure that the product is applied directly to the skin and not to the fur.
WITHDRAWAL PERIOD
Not applicable
SPECIAL PRECAUTIONS FOR STORAGE
Keep out of the sight and reach of children.
Store in the original packaging.
Do not store above 25 °C.
Do not use after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
SPECIAL WARNING(S)
Special warnings for each target species
A single tick or a bite from a mosquito or sandfly may already be present on the animal. For this reason, the transmission of pathogens by these arthropods cannot be excluded if conditions are favourable.
The product remains effective against fleas when treated animals occasionally enter water (e.g. swimming, bathing). However, dogs should not be allowed to swim or be shampooed for 48 hours after treatment application.
Avoid swimming or frequent shampooing of treated dogs as this may affect the maintenance of product efficacy.
To reduce re-infestation due to the appearance of new fleas, it is recommended that all dogs in the household be treated. Animals living in the same area should be treated with a veterinary medicinal product suitable for their species.
To reduce the risk of environmental infestation, it is recommended to use additional appropriate treatment
for the animals' environment, against fleas and their developmental stages.
Special precautions for use in animals
In the absence of specific studies, the use of this product is not recommended for dogs younger than 8 weeks or weighing less than 2 kg.
Avoid contact of the product with the animal's eyes.
It is very important to ensure that the product is applied in an area where the animal cannot lick the product, and also to ensure that animals do not lick each other after
treatment.
Due to the unique physiology of cats, which are unable to metabolise certain compounds, including permethrin, this veterinary medicinal product can cause convulsions in this species, which can be fatal.
In case of accidental exposure, it is recommended to wash the cat with shampoo or soap and seek urgent veterinary advice. To prevent accidental exposure of cats to this product, keep cats separate from treated dogs until the application site is dry.
It is important that cats do not lick the site where the veterinary medicinal product has been applied to dogs. In case of such exposure, seek veterinary advice immediately.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
For veterinary use only.
This product may cause skin and eye irritation. Therefore, contact of the product with skin or eyes should be avoided. Do not open the pipette near or towards the face. If accidentally sprayed into the eyes or if the eyes become irritated during product administration, immediate thorough washing with water is recommended. If eye irritation persists, seek medical advice.
Persons with known hypersensitivity to fipronil or/and permethrin should avoid contact with this product.
The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat while applying the product. Wash hands after use. In case of ingestion, rinse mouth with water and seek medical advice if you feel unwell.
As the excipient N-methylpyrrolidone may cause foetotoxicity and teratogenicity following prolonged exposure, pregnant women are advised to wear gloves to avoid contact with the product.
Avoid handling the animal until the application site is dry; children should also not play with the animals until the fur is dry.
Therefore, it is recommended that animals are not treated during the day but in the evening, and that treated animals sleep alone during the night, not with their owners and especially not with children.
Keep pipettes in the original packaging and once used, empty pipettes should be disposed of immediately in an appropriate manner to prevent subsequent access.
Other precautions
The product may be harmful to aquatic organisms. Treated dogs should not be allowed to swim in watercourses for 2 days after treatment.
Use during pregnancy and lactation
Laboratory studies with fipronil and permethrin produced no teratogenic or embryotoxic effects. No studies have been conducted with this product on animals during pregnancy or lactation.
N-methylpyrrolidone, an excipient of the veterinary medicinal product, has been shown to have a teratogenic effect in laboratory animals after repeated exposure to high doses.
Use only after a benefit/risk assessment by the veterinarian.
Overdose
Safety of use has been evaluated in healthy adult dogs treated with a dose up to 5 times higher than the maximum recommended dose (treated 3 times at monthly intervals) and in puppies (8 weeks old, treated once). Known adverse reactions may include mild neurological symptoms, vomiting and diarrhoea. These symptoms are transient and usually disappear without treatment within 1-2 days. Animals should always be treated with the pipette corresponding to their weight.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE, IF APPLICABLE
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products
should be disposed of in accordance with local requirements.
Do not contaminate lakes, watercourses or drains with this product or empty pipettes.
OTHER INFORMATION
Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil kills fleas in 24
hours, ticks and lice in 48 hours after exposure.
Permethrin belongs to type I pyrethroids, which are acaricides and insecticides with repellent activity.
Permethrin in the product provides repellent activity against sandflies (>80% for 4 weeks), mosquitoes and ticks.
Orthomolecular nutrition for animals suffering from gum and oral mucosa conditions.
Dental diseases, especially periodontitis, affect a high percentage of dogs of various breeds and ages.
Bacteria and tartar accumulate in the oral cavity, generating free radicals and toxins. These will inflame soft tissues and damage teeth.
The GingiVet formula was created to heal gum wounds. In addition, the high antioxidant content blocks complications caused by free radicals.
Target species: dogs, cats
LYSINE
- Participates in the synthesis of collagen, antibodies, hormones, enzymes, etc. It is currently administered for nutritional support in feline herpesvirus infections.
GLYCINE
- It is the most important substance for collagen synthesis. It has antioxidant and anti-inflammatory properties at the level of the epithelial cells of the gums. Oral administration of glycine has been shown to reduce periodontal bone mass loss.
COENZYME Q10
- Essential antioxidant substance for mitochondrial metabolism. The gingival tissue of patients with periodontal diseases shows clear deficiencies of coenzyme Q10. Supplementation significantly improved their condition.
VITIS VINIFERA EXTRACT (grape seeds)
- Acts as a powerful antioxidant due to its levels of proanthocyanidins, which block free radicals involved in the development of periodontitis. Protects connective tissue from bacterial collagenase.
ALPHA-LIPOIC ACID
- Universal antioxidant that easily penetrates and crosses the cell membrane. It is fat and water-soluble. It also promotes the recycling of endogenous and exogenous antioxidants.
ZINC
- Zinc deficiency increases gum permeability, facilitating bacterial penetration. Zinc intake accelerates the healing of bleeding gum wounds.
FOLIC ACID
- Facilitates wound healing and reduces inflammation, strengthening the oral barrier against infections.
VITAMIN B-12
- Its levels are inversely proportional to periodontal diseases. It participates in wound healing, promotes the repair of bleeding gums.
L-SELENOMETHIONINE
- Exerts a remarkable antioxidant effect: it is a scavenger of reactive oxygen species and is part of antioxidant enzymes, such as GPx (glutathione peroxidase). In addition, it has demonstrated immunomodulatory properties.
Storage conditions:
Store in a dry place, away from direct sunlight, at temperatures up to 25°C.
Ingredients / tablet:
- L-Lysine: 400 mg,
- Glycine: 200 mg,
- Coenzyme Q10: 20 mg,
- Vitis vinifera (grape seed extract): 20 mg,
- Lipoic Acid: 10 mg,
- Zinc methionine chelate: 50 mg (Zinc: 10 mg),
- Folic Acid: 200 mcg,
- Vitamin B12: 100 mcg,
- L-Selenomethionine: 350 mcg (Selenium: 7 mcg),
- Excipients
Administration:
1 tab / 10 kg/ bw/ day
The dosage and method of administration depend on the individual needs of each animal and will be determined only by the veterinarian!
Product for dogs and cats suffering from digestive disorders and ailments.
The ingredients in the formula support the digestive juices in the stomach, pancreas, and liver.
Ingredients: L-ornithine aspartate, Lecithin, Calcium Phosphate, Licorice Extract (Glycyrrhiza L.), Magnesium Stearate, Stearic Acid.
Dosage: Dogs - 1 tablet / 15 kg BW, once a day; Cats - 1/2 tablet / animal, once a day.
HISTAMINE CONTROL NUTRITIONAL COFACTORS that support histamine neutralization. Allergic reactions occur as an exaggerated response of the body to the absorption of a foreign substance (allergen). At that moment, histamine is released, present in mast cells, cells concentrated in the skin and respiratory tract.
Histamine is the chemical mediator that appears following allergenic reactions, and consequently the main cause of symptoms caused by allergies. Antihistamines are substances that block the action of histamine. The most commonly used are corticosteroids, which, in addition to their anti-inflammatory action, also have an immunosuppressive role.
HISTAMINE CONTROL has been formulated based on natural substances with nutritional properties that can be used by the body to combat histamine. It can be recommended as an alternative or adjuvant in corticosteroid treatment. It regulates the immune system by reducing the body's immune reactions to allergenic factors.
1. INGREDIENTS: Each tablet contains: Quercetin 125 mg, Bromelain 50 mg, MSM 150 mg, Grape seed extract 75 mg, Dimethylglycine 50 mg, Ascorbic acid 125 mg, Zinc lactate 50 mg, Magnesium citrate 50 mg.
2. INDICATIONS: Neutralizes histamine production in allergic processes: food allergies, asthma, allergic rhinitis, eczema, and urticaria.
3. PROPERTIES: Quercetin - a bioflavonoid with antioxidant action. It compensates for the modulating activity of vitamin C in inflammatory processes. It inhibits both the enzymes involved in the appearance of prostaglandins and leukotrienes - the main mediators of inflammation, and the production of histamine by stabilizing the level of basophils and mast cells. It acts directly on the intestines to reduce allergenic symptoms caused by food. Researchers in Brazil and Korea have successfully protected animals from food allergies by administering Quercetin orally or by inhalation. Bromelain - a proteolytic enzyme extracted from the pineapple stem, primarily helps improve protein digestion. It activates anti-inflammatory prostaglandins and thus has a beneficial action on inflammation, edema, and pain caused by fibrinolysis. It has anti-inflammatory effects even in cases of ulcerative colitis. Many scientific studies have been published in the last 10 years, demonstrating that the anti-inflammatory and analgesic action of bromelain is as effective or more effective than that of synthetic anti-inflammatory drugs. MSM (methylsulfonylmethane) - a natural source of sulfur, acts as an adjuvant in treating allergies due to the fact that it blocks the attachment of histamine to sensitive mucosal tissues. Thus, it reduces the associated symptoms of respiratory allergies and successfully combats itching in cases of allergic dermatitis. Grape seed extract - has a special effect in combating inflammation that appears as an allergic response. Proanthocyanidins have increased antioxidant power against free radicals produced in lipid peroxidation processes. Dimethylglycine - a nutrient derived from glycine, which has regulatory properties on the immune system. It facilitates the absorption of oxygen into cells, neutralizing complex free radicals. Ascorbic acid - Vitamin C - a very powerful antioxidant against free radicals involved in inflammatory processes. It has an antihistamine effect and intervenes in the correction and proper functioning of the immune system. Zinc - a cofactor of superoxide dismutase, a reference antioxidant in the body, is involved in the formation of over 100 enzymatic processes. Zinc ions stabilize the plasma membrane of mast cells, reducing and modulating the release of histamine. Magnesium - magnesium deficiency studied in experimental animals (mice) is manifested by hyperemia, increased IgE, neutrophilia, or eosinophilia. It increases the level of pro-inflammatory cytokines, mast cell degranulation, histanemia, and splenomegaly.
4. ADMINISTRATION METHOD: Target animals: Dogs, cats. Administer orally, if possible, without mixing with food. 1 tablet / 10 kg body weight / twice a day. Small cats and dogs ½ tablet / twice a day.
5. PACKAGING: Plastic bottle - 60 tablets
6. STORAGE: Store in conditions protected from moisture and direct sunlight, at room temperature.
7. CAUTION! For veterinary use only! Keep out of reach of children! Please contact your veterinarian before recommending or using this product, as changes in dosage or method of use may occur depending on individual symptoms.
Kalmvet 300mg - 60 Twist-Off Capsules is recommended for calming stress and anxiety in pets. The Twist-Off capsules are practical and easy to administer, even to cats. They ensure the quality and durability of fatty acids, which oxidize very quickly.
Properties and method of use:
Tryptophan is an amino acid precursor to the neurotransmitter called serotonin. An increase in the amount of tryptophan in the animal's diet will lead to an increase in its concentration in the brain, which will significantly boost the production of serotonin. Once released into the synaptic clefts, serotonin can bind to various subtypes of receptors. Through its action on these receptors located in different parts of the brain, serotonin controls several physiological functions, such as hormone release, pain perception, appetite, mood, and behavior.
Studies in dogs have shown that an increase in brain serotonin levels can reduce the occurrence of aggression and self-inflicted wounds and enhance the dog's stress resistance.
Chamomilla recutita (chamomile) provides anti-anxiety properties, among many other biological qualities. Apigenin, a component of chamomile extract, binds to benzodiazepine receptors and thus exhibits mild calming properties for both pain and anxiety. Besides apigenin, another compound in chamomile, namely gamma-aminobutyric acid (GABA), contains other substances that bind to benzodiazepine and GABA receptors in the brain, thus having the specific calming effect offered by chamomile.
Valeriana officinalis (valerian) is a plant known since ancient times for its calming and soothing properties. The mechanism of valerian's action is based on the presence of terpenes, primarily valerenic acids and gamma-aminobutyric acid (GABA). The active substances that make up valerian extract bind to several types of neurotransmitter receptors, including 5-HT%A, which are involved in regulating anxiety. The anti-anxiety effect conferred by valerian extract has been proven in many animal species and even in humans.
Dosage:
Dogs and cats up to 10kg/bw - 1 capsule/day
Dogs weighing 10-25kg/bw - 2 capsules/day
Dogs weighing over 25kg/bw - 3 capsules/day
Important: Consult your veterinarian for diagnosis, prescription of medication, or diet according to your dog's (cat's) specific needs. This product is dispensed only with a prescription.
Dia-Tab is a food supplement in tablet form for dogs with acute diarrhea. The product is an adjuvant in cases of acute intestinal absorption disorders. Pectins, derived from fruits, form a protective film on the intestinal mucosa.
Bentonite is a mineral with a water absorption capacity of up to 70%, and montmorillonite protects the digestive tract by capturing toxins. Fructo-oligosaccharides belong to the category of prebiotics and are responsible for restoring beneficial intestinal flora, while betaine acts together with pepsin and normalizes gastric acidity.
The formula also contains electrolytes to replace those lost during diarrheal episodes, ensuring prompt energy intake and complete restoration of the body's hydro-electrolyte balance.
Composition: Pectins, sugar, sodium chloride, potassium chloride, medicinal herbs, bentonite, montmorillonite, fructo-oligosaccharides (FOS), betaine, electrolytes.
Feeding recommendations
| Dog's weight (kg) | Recommended daily amount (tablets/day) |
| < 10 | ½ once a day, for 2-3 days |
| < 20 | 1 twice a day, for 2-3 days |
| > 20 | 1 three times a day, for 2-3 days |
Advantix is an external antiparasitic product containing imidacloprid and permethrin, and is very effective in treating flea and tick infestations for one month after a single application.
Composition
Each dose (pipette) contains:
| Pipette | Imidacloprid | Permethrin | E321 | |
| Advantix spot-on solution for dogs up to 4 kg | 0.4 ml | 40 mg | 200 mg | 0.4 mg |
| Advantix spot-on solution for dogs from 4 kg to 10 kg | 1.0 ml | 100 mg | 500 mg | 1.0 mg |
| Advantix spot-on solution for dogs from 10 kg to 25 kg | 2.5 ml | 250 mg | 1250 mg | 2.5 mg |
| Advantix spot-on solution for dogs over 25 kg | 4.0 ml | 400 mg | 2000 mg | 4.0 mg |
Excipients: Butylated hydroxytoluene 1.0 mg/ml (E321, as antioxidant):
Indications
For the treatment and prevention of flea infestation (Ctenocephalides canis, Ctenocephalides felis).
Fleas on the dog are killed within one day after treatment. One treatment prevents future flea infestations for four weeks. The product
can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
The product has acaricidal and repellent activity for up to four weeks (Rhipicephalus sanguineus, Ixodes
ricinus) or three weeks (Dermacentor reticulatus) against tick infestations.
Ticks already present on the dog may not be killed within two days after treatment and may remain attached and visible. Therefore, it is
recommended to remove ticks present on the dog at the time of treatment to prevent them from attacking and feeding on blood.
One treatment provides repellent (anti-feeding) action against sandflies for two weeks (Phlebotomus papatasi) or three
weeks (Phlebotomus perniciosus) against mosquitoes for two (Aedes aegypti) and four (Culex pipiens) weeks and for stable flies
(Stomoxys calcitrans) for four weeks.
Sandflies Phlebotomus perniciosus 3 weeks
Phlebotomus papatasi 2 weeks
Mosquitoes Aedes aegypti 2 weeks
Culex pipiens 4 weeks
Stable fly Stomoxys calcitrans 4 weeks
Contraindications
In the absence of available data, the product should not be used on puppies younger than 7 weeks.
Do not use in cases of known hypersensitivity to the active substances.
Do not use on cats.
Adverse reactions
Rarely, transient dermal sensitivity (with increased pruritus, alopecia and erythema at the application site) or apathy may occur.
Poisoning of dogs after accidental ingestion may occur in rare cases. In these cases, neurological signs such as
tremors and apathy may also occur. Symptomatic treatment should be applied under the supervision of a veterinarian. There is no specific antidote.
If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.
Target species
Dogs.
Dosage for each species, route(s) of administration and method of administration
Dosing scheme:
The minimum recommended dose is: 10 mg/kg body weight (b.w.) imidacloprid and 50 mg/kg body weight (b.w.) permethrin, equivalent to
0.1ml/kg b.w. Advantix spot-on solution for dogs.
Dog weight (kg) Pipette size to be used Volume (ml) Imidacloprid (mg/kg b.w.) Permethrin (mg/kg b.w.)
>25 kg - 40 kg Advantix spot-on solution for dogs over 25 kg 4.0 ml 10 - 16 50 - 80
> 40 kg, the appropriate combination of pipettes should be used
| Dog weight (kg) | Pipette size to be used | Volume (ml) | Imidacloprid (mg/kg b.w.) | Permethrin (mg/kg b.w.) |
| <=4 kg | Advantix spot-on solution for dogs up to 4 kg | 0.4 ml | minimum 10 | minimum 50 |
| >4 kg - 10 kg | Advantix spot-on solution for dogs from 4 kg to 10 kg | 1.0 ml | 10 - 25 | 50 - 125 |
| >10 kg - 25 kg | Advantix spot-on solution for dogs from 10 kg to 25 kg | 2.5 ml | 10 - 25 | 50 - 125 |
| >25 kg - 40 kg | Advantix spot-on solution for dogs over 25 kg | 4.0 ml | 10 - 16 | 50 - 80 |
| > 40 kg | the appropriate combination of pipettes should be used |
To reduce re-infestations with new fleas, it is recommended that all dogs in a household be treated. Other pets in
the same family or household must be treated with appropriate products. For fleas originating from the animal's environment,
the additional use of an appropriate product for the treatment against adult fleas and their developmental stages is recommended. The product is active even if the animal is wet. However, prolonged exposure to water should be avoided. In case of prolonged exposure
to water, the efficacy of the product decreases. Even in this case, it should not be treated more frequently than once a week. If it is
necessary to shampoo the animal, it is advisable to apply Advantix spot-on solution for dogs after two weeks
to ensure the efficacy of the product.
Method of administration.
Remove one pipette from the package. Hold the pipette upright, twist and remove the cap. Turn the cap upside down and use it to break the seal of the pipette (by twisting and pressing on the seal, as shown in the photo).
For dogs weighing 10 kg or less:
With the dog standing, part the hair between the shoulder blades until the skin is visible. Apply the tip of the pipette directly to the skin and
squeeze firmly several times to empty the contents of the pipette. Apply only to unbroken skin.
For dogs weighing more than 10 kg:
With the dog standing, the entire contents of the Advantix spot-on solution for dogs pipette will be applied evenly in four places,
starting between the shoulder blades and extending to the base of the tail. At each site, part the hair until the skin is visible. Apply the tip of the pipette to the skin and
gently squeeze to release some of the solution onto the skin.
Recommendations for correct administration
For external use only.
Apply only to unbroken skin.
Do not apply a large amount of solution in one place as it may run down the sides of the dog.
Withdrawal period
Not applicable.
Special precautions for storage
Keep out of the sight and reach of children.
Do not freeze.
After opening the aluminum pouch, store in a dry place and do not store above 30°C.
The abbreviation used for the expiry date on the label, pipette and pouch is EXP.
Special precautions for use in animals
The contents of the pipette must not come into contact with the eyes and mouth of the treated dog.
Pay attention to the correct administration of the product as described in the "Method of administration" section. In particular, oral ingestion
by licking the application site or contact with other animals should be avoided.
Do not use on cats.
This product is highly toxic to cats and can cause death due to the physiological peculiarities of cats
who are unable to metabolize certain compounds, including permethrin. To prevent accidental exposure of
cats to this product, treated dogs should be kept separate from cats after treatment until the application site is dry.
Measures should be taken to ensure that cats do not lick the application site of dogs that have been treated with this product. Seek
immediate veterinary assistance if this happens.
Consult your veterinarian before using this product on sick and debilitated animals.
As the product is dangerous to aquatic organisms, treated dogs must not be allowed to enter any surface water
for at least 48 hours after treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid contact with skin, eyes or mouth. Do not eat, drink or smoke during product application.
Wash hands thoroughly after product application.
If the product accidentally gets on the skin, wash the area immediately with soap and water.
People with known skin sensitivity may be particularly sensitive to this product.
If the product accidentally gets into the eyes, wash the eyes with plenty of water. If skin or eye symptoms persist, or the product is
accidentally swallowed, seek immediate medical advice and show the product leaflet to the doctor.
Treated dogs should not be allowed to play, especially with children, until the application site is dry. To be safe, treat dogs, for
example, in the evening. In this case, treated dogs are not allowed to sleep with their owners, especially if they are children.
Special precautions for the disposal of unused product or waste materials, if any
After use, replace the cap on the pipette. Any unused veterinary medicinal product or waste material derived from the use of such
products should be disposed of in accordance with local requirements.
Other information
Advantix spot-on solution for dogs is a topical ectoparasiticide containing imidacloprid and permethrin.
This combination acts as an insecticide, acaricide and repellent.
Imidacloprid is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified
as chloronicotinyl nitroguanidine. Imidacloprid is effective against adult fleas and their larval stages. In addition to
its efficacy against adult fleas, the larvicidal efficacy of the substance has also been demonstrated for sites in the animal's habitat.
The product provides repellent (anti-feeding) action against ticks, sandflies and mosquitoes, thereby preventing
parasite blood feeding and reducing the risk of transmission of vector-borne diseases (Canine Vector-Borne Disease or
CVBD, such as borreliosis, rickettsiosis, ehrlichiosis, leishmaniasis).
It can be used during gestation and lactation.
The solvent in Advantix spot-on solution for dogs may stain certain materials such as leather, fabrics, plastic and finished surfaces. Allow
the application site to dry before contact with such materials.
Packaging:
Pipettes of 0.4 ml, 1.0 ml, 2.5 ml, 4.0 ml
Blister containing 1, 2, 3, 4 or 6 individual pipettes.
Not all package sizes may be marketed.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Marketing Authorisation Holder
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
Dietary supplement for supporting renal function in cases of chronic kidney disease in dogs and cats.
Dialix Lespedeza PLUS 5 contains:
Lespedeza 100mg - increases diuresis and reduces uremia
CaCO3 150mg - reduces intestinal phosphorus absorption.
Contains flavonoids that cause renal vasodilation and stimulate the renal parenchyma.
Suitable for long-term use.
Administration:
1 tab/ 1 kg BW/ every 12 h
Dietary supplement for kidney function support in chronic kidney disease in dogs and cats.
Lespedeza capitata (300 mg in DL 15) - increases diuresis and reduces uremia.
Contains flavonoids that cause renal vasodilation and stimulate the renal parenchyma.
Very safe: subacute toxicity tests (5x, 30 days) and chronic toxicity tests (5x, 90 days) produced no changes
in weight, nor clinical, hematological or histopathological changes.
Ideal for prolonged management of kidney disease.
Suitable for long-term use.
Directions for use:
1 tablet/ 5 kg BW/ every 12 h
Benefits:
- Indicated in cases of anemia, convalescence, postoperative care.
- Complete and balanced formula with 11 nutrients that promote red blood cell synthesis.
- Rich in iron, copper, vitamins B2, B6, B9, B12, and K3, essential for red blood cells and hemoglobin synthesis.
- With Vitamin C, for better iron absorption.
- Contains moderate levels of Phosphorus
- Suitable for animals with kidney conditions.
- Nutritional support for pregnant or lactating females
Highly palatable chewable tablets!
SUPRA RC 15: Iron 60mg, Copper 3mg, B1 6mg, B2 6mg, B3 30mg, B6 3mg, B9 150µg, B12 75µg, Vit C 30mg, Vit E 33.75 IU, Vit K3 0.75mg.
Advantix is an external antiparasitic product containing imidacloprid and permethrin, and is very effective in treating flea and tick infestations for one month after a single application.
Composition
Each dose (pipette) contains:
| Pipette | Imidacloprid | Permethrin | E321 | |
| Advantix spot-on solution for dogs up to 4 kg | 0.4 ml | 40 mg | 200 mg | 0.4 mg |
| Advantix spot-on solution for dogs from 4 kg to 10 kg | 1.0 ml | 100 mg | 500 mg | 1.0 mg |
| Advantix spot-on solution for dogs from 10 kg to 25 kg | 2.5 ml | 250 mg | 1250 mg | 2.5 mg |
| Advantix spot-on solution for dogs over 25 kg | 4.0 ml | 400 mg | 2000 mg | 4.0 mg |
Excipients: Butylhydroxytoluene 1.0 mg/ml (E321, as antioxidant):
Indications
For the treatment and prevention of flea infestation (Ctenocephalides canis, Ctenocephalides felis).
Fleas on dogs are killed within one day of treatment. One treatment prevents future flea infestations for four weeks. The product
can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
The product exhibits acaricidal and repellent activity for up to four weeks (Rhipicephalus sanguineus, Ixodes
ricinus) or three weeks (Dermacentor reticulatus) against tick infestations.
Ticks already present on the dog may not be killed within two days after treatment and may remain attached and visible. Therefore, it is
recommended to remove ticks present on the dog at the time of treatment to prevent their attachment and blood feeding.
One treatment provides repellent (anti-feeding) action against sand flies for two weeks (Phlebotomus papatasi) or three
weeks (Phlebotomus perniciosus) against mosquitoes for two (Aedes aegypti) and four (Culex pipiens) weeks, and against stable flies
(Stomoxys calcitrans) for four weeks.
Sand flies Phlebotomus perniciosus 3 weeks
Phlebotomus papatasi 2 weeks
Mosquitoes Aedes aegypti 2 weeks
Culex pipiens 4 weeks
Stable fly Stomoxys calcitrans 4 weeks
Contraindications
In the absence of available data, the product should not be used in puppies younger than 7 weeks.
Do not use in cases of known hypersensitivity to the active substances.
Do not use in cats.
Adverse reactions
Transient dermal sensitivity (with increased pruritus, alopecia, and erythema at the application site) or apathy may rarely occur.
Poisoning of dogs after accidental ingestion may occur in rare cases. In these cases, neurological signs such as
tremors and apathy may also appear. Symptomatic treatment should be applied under the supervision of a veterinarian. There is no specific antidote.
If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.
Target species
Dogs.
Dosage for each species, route(s) of administration and method of administration
Dosing schedule:
The minimum recommended dose is: 10 mg / kg body weight (b.w.) imidacloprid and 50 mg / kg body weight (b.w.) permethrin equivalent to
0.1ml/kg b.w. Advantix spot-on solution for dogs.
Dog weight (kg) Pipette size to be used Volume (ml) Imidacloprid (mg/kg b.w.) Permethrin (mg/kg b.w.)
>25 kg - 40 kg Advantix spot-on solution for dogs over 25 kg 4.0 ml 10 - 16 50 - 80
> 40 kg the appropriate combination of pipettes should be used
| Dog weight (kg) | Pipette size to be used | Volume (ml) | Imidacloprid (mg/kg b.w.) | Permethrin (mg/kg b.w.) |
| <=4 kg | Advantix spot-on solution for dogs up to 4 kg | 0.4 ml | minimum 10 | minimum 50 |
| >4 kg - 10 kg | Advantix spot-on solution for dogs from 4 kg to 10 kg | 1.0 ml | 10 - 25 | 50 - 125 |
| >10 kg - 25 kg | Advantix spot-on solution for dogs from 10 kg to 25 kg | 2.5 ml | 10 - 25 | 50 - 125 |
| >25 kg - 40 kg | Advantix spot-on solution for dogs over 25 kg | 4.0 ml | 10 - 16 | 50 - 80 |
| > 40 kg | the appropriate combination of pipettes should be used |
To reduce re-infestation with new fleas, it is recommended that all dogs in a household be treated. Other pets in
the same household must be treated with appropriate products. For fleas originating from the animal's environment,
the additional use of an appropriate product for the treatment against adult fleas and their developmental stages is recommended. The product is active even if the animal is wet. However, prolonged exposure to water should be avoided. If prolonged exposure
to water occurs, the efficacy of the product decreases. Even in this case, treatment should not be more frequent than once a week. If
the animal needs to be washed with shampoo, it is best to apply Advantix spot-on solution for dogs after two weeks
to ensure the product's effectiveness.
Method of administration.
Remove a pipette from the package. Hold the pipette upright, twist the cap, and remove it. Turn the cap upside down and use
it to unseal the pipette (by twisting and pressing on the seal, as shown in the photo).
For dogs weighing 10 kg or less:
With the dog standing, part the hair between the shoulder blades until the skin is visible. Apply the tip of the pipette directly to the skin and
by squeezing firmly several times, empty the contents of the pipette. Apply only to unbroken skin.
For dogs weighing more than 10 kg:
With the dog standing, the entire content of the Advantix spot-on solution pipette for dogs should be applied evenly in four places
starting between the shoulder blades and extending to the base of the tail. At each location, part the hair until the skin is visible. Apply the tip of the pipette to the skin and
gently squeeze to release some of the solution onto the skin.
Recommendations for correct administration
For external use only.
Apply only to unbroken skin.
Do not apply a large amount of solution in one spot as this may run down the sides of the dog.
Withdrawal period
Not applicable.
Special precautions for storage
Keep out of the reach and sight of children.
Do not freeze.
After opening the aluminum pouch, store in a dry place and do not store at temperatures above 30°C.
The abbreviation used for the expiry date on the label, pipette, and pouch is EXP.
Special precautions for use in animals
The content of the pipette should not come into contact with the eyes and mouth of the treated dog.
Pay attention to the correct administration of the product as described in the "Method of administration" section. In particular, oral ingestion
by licking the application site or contact with other animals should be avoided.
Do not use in cats.
This product is very toxic to cats and can cause death due to the physiological particularities of cats
which are unable to metabolize certain compounds including permethrin. To prevent accidental exposure of
cats to this product, treated dogs should be kept separate from cats after treatment until the application site is dry.
Measures should be taken to ensure that cats do not lick the application site of dogs that have been treated with this product. Seek
immediate veterinary assistance if this occurs.
Consult your veterinarian before using this product in sick and debilitated animals.
As the product is hazardous to aquatic organisms, treated dogs must under no circumstances be allowed to enter any surface waters
for at least 48 hours after treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid contact with skin, eyes, or mouth. Do not eat, drink, or smoke while applying the product.
Wash hands thoroughly after applying the product.
If the product accidentally gets on the skin, wash the area immediately with soap and water.
Individuals with known skin sensitivity may be particularly sensitive to this product.
If the product accidentally gets into the eyes, wash the eyes with plenty of water. If skin or eye symptoms persist, or the product is
accidentally swallowed, seek immediate medical advice and show the doctor the product leaflet.
Treated dogs should not be allowed to play, especially with children, until the application site is dry. To be safe, treat dogs, for
example, in the evening. In this case, treated dogs are not allowed to sleep with their owners, especially if they are children.
Special precautions for the disposal of unused product or waste materials, if any
After use, replace the cap on the pipette. Any unused veterinary medicinal product or waste materials derived from such
products should be disposed of in accordance with local requirements.
Other information
Advantix spot-on solution for dogs is a topical ectoparasiticide containing imidacloprid and permethrin.
This combination acts as an insecticide, acaricide, and repellent.
Imidacloprid is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified
as a chloronicotinyl nitroguanidine. Imidacloprid is effective against adult fleas and their larval stages. In addition to
its efficacy against adult fleas, the larvicidal efficacy of the substance has also been demonstrated for areas in the animal's habitat.
The product provides repellent (anti-feeding) action against ticks, sand flies, and mosquitoes, thus preventing
parasite blood feeding and reducing the risk of transmission of vector-borne diseases (Canine Vector-Borne Disease or
CVBD, such as Lyme disease, rickettsiosis, ehrlichiosis, leishmaniasis).
It can be used during gestation and lactation.
The solvent in Advantix spot-on solution for dogs may stain certain materials such as leather, fabrics, plastic, and finished surfaces. Allow
the application site to dry before contact with such materials.
Packaging:
Pipettes of 0.4 ml, 1.0 ml, 2.5 ml, 4.0 ml
Blister containing 1, 2, 3, 4, or 6 individual pipettes.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Marketing Authorisation Holder
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
