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For cats infected or at risk of concurrent cestode, nematode, and ectoparasite infections.
Ectoparasites: Treatment of flea infestations (Ctenocephalides felis). One treatment provides immediate and persistent flea-killing activity for one month.
Cestodes: Treatment of tapeworm infections (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis, Joyeuxiella pasqualei, and Joyeuxiella fuhrmanni).
Nematodes:
- Treatment of gastrointestinal nematode infections (L3, L4 larvae and adults of Toxocara cati, L4 larvae and adults of Ancyclostoma tubaeforme and Ancyclostoma ceylanicum, and adult forms of Toxascaris leonina and Ancyclostoma braziliense).
- Treatment of feline lungworm infections (L4 larvae and adults of Troglostrongylus brevior)
- Treatment of bladder worm infections (Capillaria plica).
The veterinary medicinal product is indicated exclusively when all three groups are targeted at the same time.
NexGard Combo helps to:
- eliminate fleas, ticks, and ear mites
- prevent heartworm disease
- treat gastrointestinal nematodes, bladder and lungworms, as well as tapeworm infections.
Active ingredients: esafoxolaner - 10.80 mg, eprinomectin - 3.60 mg, praziquantel - 74.70 mg.
External and internal parasite infection is common in cats and is significant worldwide. NexGard Combo offers efficacy against both types of parasites.
Method of administration:
- cut the blister along the dotted line, then peel off the foil
- remove the applicator and hold it upright
- slowly pull back the plunger, twist, and remove the cap
- part the fur along the midline of the neck, between the base of the skull and the shoulder blades, so that the skin is visible
- position the tip of the applicator on the skin and apply all the contents directly to the skin in one spot.
The product should be applied to dry skin in a place where the cat cannot lick it.
For long-haired breeds, greater care is needed to ensure the product reaches the skin directly and not the fur for optimal efficacy.
For external use only.
Store the unused applicator in its original packaging.
Ectoparasites
- Treatment of flea infestations (Ctenocephalides felis). One treatment provides immediate and persistent flea killing activity for one month.
- The product can be part of a treatment strategy for the control of flea allergy dermatitis (FAD).
- Treatment of tick infestations. One treatment provides immediate and persistent tick killing activity against Ixodes scapularis for one month and against Ixodes ricinus for five weeks.
- Treatment of ear mite infestation (Otodectes cynotis).
Cestodes
Treatment of tapeworm infections (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis, Joyeuxiella pasqualei and Joyeuxiella fuhrmanni).
Nematodes
- Prevention of heartworm disease (Dirofilaria immitis) for one month.
- Treatment of gastrointestinal nematode infections (L3, L4 larvae and adults of Toxocara cati,
L4 larvae and adults of Ancyclostoma tubaeforme and Ancyclostoma ceylanicum and adult forms of
Toxascaris leonina and Ancyclostoma braziliense).
- Treatment of feline lungworm infections (L4 larvae and adults of Troglostrongylus
brevior).
- Treatment of bladder worm infections (Capillaria plica).
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
ADVERSE REACTIONS
In clinical studies, hypersalivation, diarrhoea, transient skin reactions at the application site (local alopecia, pruritus), anorexia, lethargy and emesis were uncommonly observed shortly after administration. Most reactions are mild, short-lived and self-limiting.
The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 treated animals showing adverse reactions)
- Common (more than 1 but less than 10 animals in 100 treated animals)
- Uncommon (more than 1 but less than 10 animals in 1,000 treated animals)
- Rare (more than 1 but less than 10 animals in 10,000 treated animals)
- Very rare (less than 1 animal in 10,000 treated animals, including isolated reports).
If you notice any adverse reactions, even those not already listed in this package leaflet, or believe the medicinal product has not been effective, please inform your veterinary surgeon.
Dosage
The minimum recommended doses are 1.44 mg esafoxolaner, 0.48 mg eprinomectin and 10 mg praziquantel per kg body weight.
RECOMMENDATIONS FOR CORRECT ADMINISTRATION
Use the applicator sized according to the cat's weight (0.3 or 0.9 ml, see "declaration of active substance(s) and other ingredients" section)
1. Use scissors to cut the blister along the dotted line, then peel off the foil.
2. Remove the applicator from the packaging and hold it upright.
3. Slowly pull back the plunger, twist and remove the cap.
4. Part the fur in the middle of the neck, between the base of the skull and the shoulder blades, so that the skin is visible.
5. Place the tip of the applicator on the skin and apply the entire contents directly onto the skin in one spot.
The product should be applied to dry skin in an area where the cat cannot lick it off. In long-haired breeds, extra care should be taken to apply the product directly to the skin and not to the fur to ensure optimal efficacy.
Treatment schedule:
For the treatment of flea and/or tick and/or ear mite infestations and the concomitant treatment of gastrointestinal and/or pulmonary and/or bladder nematodes and cestodes, a single dose of the product should be applied. The necessity and frequency of treatment(s) should be in accordance with the veterinary surgeon's advice and take into account the local epidemiological situation and the animal's lifestyle (e.g., whether it has outdoor access).
Endemic areas without cardiovascular heartworm disease:
Cats not at permanent risk of heartworm infection should be treated according to a program prescribed by the veterinary surgeon, adapted to each individual situation of re-infection/parasite infestation. Otherwise, a product with a narrower spectrum of action that provides appropriate treatment against relevant parasites should be used.
Endemic areas with cardiovascular heartworm disease:
Cats living in areas endemic for cardiovascular heartworm disease and recognized as hunters may be treated at monthly intervals to ensure adequate prevention against cardiovascular heartworm disease and treatment of possible cestode re-infection. Otherwise, a product with a narrower spectrum of action should be used for continued treatment. Prevention of cardiovascular heartworm disease by killing Dirofilaria immitis larvae should begin within one month
after the first exposure to mosquitoes and continue until 1 month after the last exposure to mosquitoes.
Ear mites
In case of ear mites, request a new veterinary examination 4 weeks after treatment to
decide if additional treatment with a product with a narrower spectrum of action is necessary.
SPECIAL PRECAUTIONS FOR STORAGE
Keep out of the sight and reach of children.
Keep unused applicators in the original packaging to protect from light.
Opened applicators must be disposed of immediately as waste.
Do not use this veterinary medicinal product after the expiry date marked on the box after EXP.
SPECIAL WARNINGS
Special precautions for the target species:
Avoid shampooing the animal within 2 days after administration as the efficacy of the product in this case has not been tested.
Ticks and fleas must start feeding on the cat to be exposed to esafoxolaner, therefore the risk of arthropod-borne disease transmission cannot be excluded.
Cats living in heartworm endemic areas or those that have travelled to such areas, may be infected with adult heartworms. Although the product can be safely administered to cats infected with adult heartworms, no therapeutic effect against adult Dirofilaria immitis heartworms has been established. Therefore, it is recommended that all cats 6 months of age or older, living in heartworm endemic areas, be tested for adult heartworm infection before being treated with the product for heartworm prevention.
Tapeworm infection may recur if intermediate hosts such as fleas, mice etc. are not controlled. Some cats in the patent period of Joyeuxiella spp. or Dipylidium caninum infection may still have high proportions of young parasite forms which may be less sensitive to this product; therefore, post-treatment monitoring is recommended for these infections.
Resistance of parasites to a particular class of antiparasitic drugs can develop as a result of repeated use of a compound from that class over an extended period. Therefore, epidemiological information regarding the current susceptibility of the target species should be considered to limit the possibility of future selection of resistance.
To reduce re-infestations once new fleas appear, it is recommended that all cats in the household be treated. Any other animal species living in the same household should be treated with a product intended for them.
Fleas in any of their developmental stages can infest a cat's basket, bedding and usual resting areas, such as carpets and soft furnishings. In cases of major infestations and before implementing control measures, these areas should be treated with an appropriate product and regularly vacuumed.
Special precautions for use in animals
For spot-on application only. Do not inject, administer orally or by any other route. Avoid contact with the cat's eyes. In case of accidental ocular exposure, immediately rinse the eye area with clean water. If ocular irritation persists, seek veterinary advice.
It is very important that the veterinary medicinal product is applied to the skin in an area where the cat cannot lick the product, in the posterior region of the neck, between the shoulders. Ensure that animals do not lick each other until the treated area is no longer visible. Oral ingestion of the veterinary medicinal product has been observed to cause hypersalivation in cats.
The safety of the veterinary medicinal product has not been tested in kittens under 8 weeks of age. The product should not be used in cats weighing less than 0.8 kg and/or less than 8 weeks of age.
The veterinary medicinal product should be used exclusively against confirmed mixed infections or if cats are at significant risk of such mixed infections with ectoparasites and nematodes (including for heartworm prevention) and when treatment against cestodes is indicated at the same time. In the absence of co-infestation risk, an antiparasitic with a narrower spectrum of action should be used as a first-line treatment.
The reason for prescribing and the frequency of use of this product should take into account the individual needs of the cat based on clinical assessment, the animal's lifestyle and the epidemiological situation (including zoonotic risk, if relevant) so that the decision to use it is taken exclusively in situations of infection or risk of combined infection.
The veterinary medicinal product should not be used in other cats without prior veterinary consultation.
Repeated treatments should be limited to specific individual situations (see treatment application recommendations in the "Recommendations for correct administration" section) with a minimum interval between treatments of 4 weeks. Safety has not been evaluated beyond 6 months (see also "Special precautions for the target species" and "Overdose" sections), therefore a maximum of 6 consecutive months of treatment in a 12-month period is recommended.
Echinococcosis represents a risk to humans and is one of the diseases monitored by the World Organisation for Animal Health (OIE). In cases of echinococcosis, specific treatment, monitoring, and human protection regulations must be followed. Experts or parasitology institutes should be consulted.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not smoke, drink or eat while handling the product.
Wash hands immediately after use.
Used applicators should be disposed of immediately and should not be left within the sight or reach of children.
Avoid finger contact with the contents of the applicator. If this occurs, wash with soap and water. This veterinary medicinal product may cause eye irritation which, in exceptional cases, can be severe. In case of accidental eye contact, rinse immediately and thoroughly with water. Remove contact lenses, if worn, within the first 5 minutes and continue rinsing. Seek medical advice and show the product leaflet or label to the physician.
Ensure that the area where the product was applied is no longer visible before touching the application site. Children should not play with treated animals until the application site is no longer visible and it is recommended that recently treated animals do not sleep with owners, especially children. It is recommended to treat animals in the evening to reduce contact with people after treatment.
Persons with known hypersensitivity to esafoxolaner, eprinomectin or praziquantel or to any of the excipients should not handle this veterinary medicinal product.
As fetotoxic and teratogenic effects are described in laboratory animals following significant daily exposure to glycerol formal, pregnant women should wear gloves during administration to avoid direct contact with the product.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. As fetotoxic and teratogenic effects are described in laboratory animals following significant daily exposure to glycerol formal, it should only be used in accordance with the veterinary surgeon's risk/benefit assessment.
Overdose :
Safety in use has been evaluated in healthy kittens, 8 weeks of age or older, that received up to 5 times the maximum recommended dose, treated up to 6 times, at 4-week intervals. No adverse reactions were observed at 3 times the maximum recommended dose. At 5 times the maximum recommended dose, a single severe neurological adverse reaction (ataxia, disorientation, apathy, tremor, hypothermia and pupil dilation) was observed after the third treatment and was reversible after washing the application site, emergency measures and symptomatic treatment. In some animals, at 5 times the maximum recommended dose, dark red subcutaneous areas were observed at the treatment application site.
BROADLINE spot-on solution for cats < 2.5 kg
BROADLINE spot-on solution for cats 2.5 – 7.5 kg
Marketing Authorization Holder: MERIAL 29, Avenue Tony Garnier, FR-69007 LYON, France.
Manufacturer responsible for batch release: MERIAL 4 Chemin du Calquet, FR-31300 Toulouse, France
ACTIVE SUBSTANCES AND OTHER INGREDIENTS Each metered dose (applicator) contains:
|
BROADLINE spot-on solution |
Volume of metered dose (ml) |
Fipronil (mg) |
S-methoprene (mg) |
Eprinomectin (mg) |
Praziquantel (mg) |
|
Cats < 2.5 kg |
0.3 |
24.9 |
30.0 |
1.20 |
24.9 |
|
Cats 2.5-7.5 kg |
0.9 |
74.7 |
90.0 |
3.60 |
74.7 |
Excipient: Butylhydroxytoluene.
INDICATIONS:
For cats with or at risk of concurrent infestations with tapeworms, roundworms and ectoparasites. The veterinary medicinal product is specifically indicated when all three groups are targeted at the same time. Ectoparasites - Treatment and prevention of flea infestations (Ctenocephalides felis). Eliminates fleas within 24 hours of application. One treatment provides protection against new infestations for at least one month. - Prevention of environmental contamination with fleas by inhibiting the development of fleas at all stages (eggs, larvae and pupae) for over one month. - The product can be part of a treatment strategy for the control of flea allergy dermatitis (FAD). - Treatment and prevention of tick infestations (Ixodes ricinus). Eliminates ticks within 48 hours of application. One treatment provides protection against new infestations for up to 3 weeks.
Tapeworms - Treatment of tapeworm infestations (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis). // Roundworms - Treatment of gastrointestinal roundworm infestations (L3, L4 larvae and adults of Toxocara cati, L4 larvae and adults of Ancyclostoma tubaeforme and adult forms of Toxocara leonina and Ancyclostoma brazilienze). - Treatment of bladder worm infestations (Capillaria plica). - Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
CONTRAINDICATIONS
Do not use in sick animals (e.g. systemic diseases, fever) or during convalescence. Do not use in rabbits. Do not use in case of hypersensitivity to the active substances or to any of the excipients.
ADVERSE REACTIONS
After treatment, the coat may temporarily appear sticky at the application site. This is normal and resolves spontaneously. Mild and transient skin reactions at the application site (local alopecia, pruritus) may occur, which will disappear without treatment. If the cat licks its coat after treatment, temporary excessive salivation may be observed. Ingestion of the product may lead to vomiting and/or transient neurological symptoms such as ataxia, disorientation, apathy and pupil dilation. All these symptoms resolve spontaneously within 24 hours. Correct application will minimize the occurrence of these reactions. If you notice serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.
TARGET SPECIES: Cats
ROUTE AND METHOD OF ADMINISTRATION:
Spot-on administration. The minimum recommended doses are 10 mg/kg body weight for fipronil, 12 mg/kg for (S)-methoprene, 0.5 mg/kg for eprinomectin and 10 mg/kg for praziquantel. The product should only be used if a mixed infestation is confirmed or if there is a risk of mixed infestation with ectoparasites and nematodes (including for heartworm prevention) and when concomitant treatment against tapeworms is indicated. In the absence of a risk of concomitant contamination, a narrow-spectrum parasiticide is recommended as the first treatment solution. The indication for use should be adapted according to the cat's needs determined by clinical assessment, the animal's lifestyle and the local epidemiological situation (including zoonotic risks where applicable) so that it is used exclusively in situations of infestation or risk of mixed infestation. Treatment should not be extrapolated from one animal to another without veterinary advice. For the prevention of cardiovascular dirofilariasis (Dirofilaria immitis larvae), the product should be applied starting 1 month before the first exposure to mosquitoes.
RECOMMENDATIONS FOR CORRECT ADMINISTRATION Choose the appropriate applicator according to the cat's weight. Use scissors to cut the blister along the dotted line, then peel off the foil. Remove the applicator from the packaging and hold it with the tip facing up. Slowly pull back the plunger, twist and remove the cap. Part the fur in the middle of the neck, between the base of the skull and the shoulder blades, so that the skin is visible. Position the applicator tip on the skin and apply the entire contents directly onto the skin in one spot. The product should be applied to dry skin in areas where the cat cannot lick itself. For long-haired breeds, special attention should be paid to applying the product directly to the skin and not to the fur to ensure optimal efficacy.
STORAGE Keep out of the sight and reach of children. Store in the original cardboard packaging to protect from light. Do not use this veterinary product after the expiry date marked on the box after EXP.
Special precautions for each target species: Ensure that animals do not lick each other after treatment. After treatment, ticks are generally killed within 48 hours of infestation without performing hematophagous activity. However, it is possible that some ticks may remain on the animal, and for this reason, the transmission of infectious diseases cannot be completely ruled out. There is no available data regarding the effect of bathing/shampooing on the efficacy of the product in cats. Brief contact of the animal with water once a month after product application is unlikely to significantly reduce product efficacy. However, as a precaution, bathing the animal for 2 days after treatment is not recommended. Tapeworm infestation may recur if intermediate hosts such as fleas, mice, etc. are not controlled. Parasite resistance to a particular class of antiparasitic drugs can develop as a result of frequent use of a compound from that class. Therefore, available information regarding the current susceptibility of the target species should be considered to limit the possibility of future selection of resistance. Cats living in endemic areas of cardiovascular heartworm disease or those that have traveled to such areas may be infested with adult heartworms. Although the product can be administered to cats infected with adult heartworms, no therapeutic effect against adult Dirofilaria immitis heartworms has been established. Therefore, it is recommended that all cats aged 6 months or older living in endemic areas of cardiovascular heartworm disease be tested for adult heartworm infestation before prophylactic product application.
Special precautions for use in animals: For spot-on application only. Do not inject, administer orally or by any other route of administration. Avoid contact with the cat's eyes. The safety of BROADLINE has not been tested for intervals shorter than 2 weeks or in kittens weighing less than 0.6 kg and/or aged 7 weeks.
BROADLINE is not intended for use in dogs. Certain dog breeds may have increased susceptibility to macrocyclic lactones, which can cause neurotoxic effects. Ingestion by breeds such as Collies, Old English Sheepdogs, and mixed or related breeds should therefore be avoided. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Do not smoke, drink or eat while handling the product. Wash hands thoroughly after use. Avoid contact of fingers with the contents of the applicator. If this occurs, wash with soap and water. In case of accidental contact with eyes, rinse thoroughly with water as the product may cause mild eye irritation. If eye irritation persists or adverse effects occur, seek medical advice and show the doctor the product leaflet or label. Avoid handling the animal until the application site is dry, and children should not play with the animals during this period. Therefore, it is recommended that recently treated animals do not sleep with their owners, especially children. Persons with known hypersensitivity to any of the active substances or excipients should not handle this veterinary medicinal product. Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies for each active substance performed on rats and rabbits have not demonstrated teratogenic, fetotoxic, or maternotoxic effects. Use only in accordance with the risk/benefit assessment of the veterinarian. Overdose: Safety has been demonstrated in healthy kittens aged 7 weeks or older who received a dose up to 5 times the maximum permitted dose (e.g., up to 15 times the recommended dose), treated up to 6 times, at four-week intervals. Safety has also been demonstrated in healthy adult cats treated 3 times at 2-week intervals with a dose up to 5 times the recommended dose. Transient neurological signs such as ataxia, disorientation, apathy, and dilated pupils may be observed, which usually resolve spontaneously the next day – see their description in section 6. Cats infected with adult heartworms tolerated up to 3 times the maximum permitted dose (e.g., up to 9 times the recommended dose), 3 treatments at 4-week intervals, without any adverse effects.
DISPOSAL OF UNUSED PRODUCT OR WASTE, IF APPLICABLE Medicines must not be disposed of in lakes, watercourses or ditches due to the danger to fish and other aquatic organisms. Ask your veterinarian for information on how to dispose of medicines that are no longer needed.
Frontline Combo Cat
- Used in the treatment and prevention of flea (Ctenocephalides spp.) and tick (Rhipicephalus spp., Dermatocentor spp., Ixodes spp.) infestations in cats.
- Treatment and control of flea allergy dermatitis in cats.
- Prevention of flea multiplication by stopping the development of eggs, larvae, and pupae from eggs laid by fleas for 6 weeks after application.
- Prevention and treatment of louse infestations in cats.
Presentation:
- is a treatment that kills fleas and ticks by contact of the parasite with the medicine applied to your pet's skin.
- After application, it does not enter the animal's bloodstream, but concentrates in the sebum of its skin (a thin surface layer), thus being stored in the sebaceous glands. It is characterized, therefore, by storage for several weeks after application, being resistant to rain, baths, and shampoos.
- Respecting a 48-hour interval between application and water exposure, and without exceeding one bath and one shampoo per week, FRONTLINE remains effective even after bathing and shampooing.
- Fleas and ticks are killed when they come into contact with the insecticidal molecule on your animal's skin. It acts on the nervous system of parasites, which die due to nervous hyperexcitation. FRONTLINE provides additional security against fleas: it also contains an insect growth regulator. This regulator prevents the infestation of the home with eggs laid before the flea's death.
Product mode of action:
-
On fleas
- kills adult fleas within 24 hours of them coming onto the animal. FRONTLINE Combo offers double security: it also prevents the contamination of the home with flea eggs and larvae.
-
On ticks
- eliminates over 90% of ticks within 48 hours of their attachment to the cat, thus reducing the risk of disease transmission. This risk is highest 48 hours after the tick attaches to the animal.
-
On animal lice
- kills lice present on the animal within a maximum of 48 hours.
Composition: 1 pipette contains
- Fipronil 50.00 mg;
- S – methoprene 60.00 mg;
- Butylhydroxyanisole 0.10 mg;
- Butylhydroxytoluene 0.05 mg;
- Ethanol 39.50 mg;
- Excipient q.s.p 0.50 ml
Pharmaceutical form:
Solution for cutaneous application.
Contraindications:
- The product should not be used on cats younger than 8 weeks or weighing less than 1 kg.
- Do not use on sick animals (systemic diseases, fever) or during convalescence.
- Do not use on rabbits, as it may cause adverse reactions and even death of the animal.
Side effects:
- Slight hypersalivation in case of accidental ingestion of the product into the oral cavity.
- In special cases, cutaneous reactions may occur at the application site (skin discoloration, local alopecia, pruritus, erythema). Itching and generalized alopecia have been reported after use. In exceptional cases, hypersalivation, reversible neurological reactions (agitation, depression, nervousness), vomiting, or respiratory symptoms have been reported.
- Do not exceed the recommended dose.
Pharmaceutical precautions:
- It is very important to ensure that the product is applied in an area where the cat cannot lick the product and also to ensure that animals do not lick each other after treatment.
- The animal should not be bathed for 2 days after treatment administration.
- A single tick may already be present on the animal. For this reason, the transmission of an infectious disease cannot be excluded.
Use during pregnancy:
- Frontline COMBO pipettes for cats can be used in pregnant and lactating cats.
Administration and dosage:
- The minimum interval between treatments is 4 weeks.
Route of administration:
- External, by skin application.
Dosage:
- Apply one 0.5 ml pipette to the skin in the area between the shoulder blades.
Method of administration:
- Remove the pipette from the packaging and break off the tip at the pre-cut section.
- Part the fur to apply directly to the skin.
- Place the tip on the skin between the animal's two shoulders and squeeze the pipette several times to empty the entire contents into one or two spots.
Overdose (symptoms, emergency procedures, antidotes)
- The fur may appear sticky in the application area when more than one dose is applied.
- If this phenomenon occurs, it will disappear within 24 hours after treatment.
Precautions:
- Avoid spraying into the animal's eyes.
Recommendations for the person administering the treatment:
- This product can cause irritation of the mucous membranes and eyes. Consequently, contact of the product with the mouth or eyes must be avoided.
- Animals and people with hypersensitivity to insecticides or alcohol should avoid contact with Frontline COMBO Cat pipettes.
- Avoid contact with fingers; if this happens, wash hands with soap and water.
- If accidentally sprayed into the eyes, washing with water is recommended.
- Wash hands thoroughly with soap and water after administering the treatment.
- Avoid handling the animal until the application site dries; also, children should not play with the animals until the fur is dry.
- Therefore, it is recommended to apply the treatment in the evening, and during the night, cats should sleep alone, not with one of the owners and especially not with children.
- Do not smoke, eat, or drink while administering the treatment.
Important: Frontline Combo Cat falls under the Veterinary Pharmacy category. Consult your veterinarian for diagnosis, prescription of medication, or diet based on the specific needs of your dog or cat. PetMart Specialist can answer any questions you have about diets, medications, and their administration methods and necessity.
Amflee Cat 50 mg is an antiparasitic pipette for cats, which prevents and treats flea and tick infestations.
1 pipette (0.50 ml) contains:
- Active substance: Fipronil 50 mg
- Other substances: Butylhydroxyanisole (E320) 0.10 mg Butylhydroxytoluene (E321) 0.05 mg
Used for:
- Treatment and prevention of flea (Ctenocephalides felis) and tick (Rhipicephalus spp., Dermacentor spp., Ixodes spp.) infestations in cats.
- Treatment and control of flea allergy dermatitis (FAD) in cats.
- Prevention and treatment of infestations with chewing lice Felicola subrostratus in cats.
Contraindications:
- Do not administer to kittens younger than 8 weeks or weighing less than 1 kg.
- Do not administer to sick animals (systemic diseases, fever) or those in convalescence.
- Do not administer to rabbits due to the risk of severe adverse reactions or even death.
Avoid contact of the product with the animal's eyes and mouth.
Precautions:
- Ticks on animals should be removed before using the product to reduce the risk of transmissible diseases.
- The product should be applied in a sheltered place where the animal cannot lick itself.
- Bathing cats is not recommended for two days after product application.
- Ticks may appear sporadically. Thus, complete exclusion of infection with diseases in unfavorable conditions is impossible. Generally, ticks will die within 24-48 hours after infestation without feeding on the animal's blood.
- Animals or people with known hypersensitivity to insecticides or alcohol should avoid contact with the Amflee spot-on solution. Avoid direct hand contact with the product. In case of accidental contact, wash hands with soap and water.
- In case of contact with eyes, wash thoroughly with clean water. Wash hands after use. Do not handle treated animals or allow children to play with them until the application site has dried. Therefore, it is not recommended to apply the treatment during the day, but rather in the evening before bedtime, and animals should not be allowed to sleep with owners, especially with children.
- Do not smoke, drink, or eat while applying the product.
Possible adverse reactions:
- If animals lick themselves, short-term hypersalivation may occur, mainly due to the excipients.
- Extremely rare adverse reactions: transient skin reactions at the application site (discoloration and hair loss, pruritus and erythema) and generalized pruritus with alopecia.
- Exceptionally, after use, reversible neurological symptoms (hyperesthesia, depression, nervousness), hypersalivation or vomiting have been observed.
- Avoid overdosage.
Use during pregnancy and lactation - The safety of the product has been demonstrated in breeding females, pregnant females, and lactating females, receiving doses three times higher than the therapeutic dose. The Amflee spot-on solution can be applied to breeding females, pregnant females, and lactating females.
Administration:
- Due to the lack of clinical safety tests, the minimum interval between applications is 4 weeks.
- Administration quantity: Apply the content of a single 0.5 ml pipette to the skin, between the shoulder blades.
- Method of administration: remove the pipette from the packaging, hold it vertically with the tip facing upwards, and unscrew the cap. Use the other end of the removed cap to pierce the pipette's seal. Part the animal's hair along the midline between the shoulder blades to make the skin visible, then place the tip of the pipette on the skin and squeeze the tube several times to empty it directly onto the skin.
- One dose provides protection against flea infestation for a period of 5 weeks. The product is effective against ticks for 2 weeks.
BROADLINE spot-on solution for cats < 2.5 kg
BROADLINE spot-on solution for cats weighing 2.5 – 7.5 kg
Marketing Authorization Holder: MERIAL 29, Avenue Tony Garnier, FR-69007 LYON, France.
Manufacturer responsible for batch release: MERIAL 4 Chemin du Calquet, FR-31300 Toulouse, France
ACTIVE SUBSTANCES AND OTHER INGREDIENTS Each metered dose (applicator) contains:
|
BROADLINE spot-on solution |
Volume of metered dose (ml) |
Fipronil (mg) |
S-methoprene (mg) |
Eprinomectin (mg) |
Praziquantel (mg) |
|
Cats < 2.5 kg |
0.3 |
24.9 |
30.0 |
1.20 |
24.9 |
|
Cats weighing 2.5-7.5 kg |
0.9 |
74.7 |
90.0 |
3.60 |
74.7 |
Excipient: Butylated hydroxytoluene.
INDICATIONS:
For cats infested with or at risk of concurrent infestation with cestodes, nematodes and ectoparasites. The veterinary medicinal product is specifically indicated when all three groups are targeted simultaneously. Ectoparasites - Treatment and prevention of flea infestations (Ctenocephalides felis). Eliminates fleas within 24 hours of application. One treatment provides protection against new infestation for at least one month. - Prevention of environmental contamination with fleas by inhibiting the development of fleas at all stages of development (eggs, larvae and pupae) for over one month. - The product can be part of a treatment strategy for the control of flea allergy dermatitis (FAD). - Treatment and prevention of tick infestations (Ixodes ricinus). Eliminates ticks within 48 hours of application. One treatment provides protection against new infestation for up to 3 weeks.
Cestodes - Treatment of tapeworm infestations (cestodes) (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis). // Nematodes - Treatment of gastrointestinal nematode infestations (L3, L4 larvae and adults of Toxocara cati, L4 larvae and adults of Ancyclostoma tubaeforme and adult forms of Toxocara leonina and Ancyclostoma braziliense). - Treatment of bladder worm infestations (Capillaria plica). - Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
CONTRAINDICATIONS
Do not use on sick animals (e.g., systemic diseases, fever) or during convalescence. Do not use on rabbits. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
ADVERSE REACTIONS
After treatment, the coat may temporarily appear sticky at the application site. This is normal and self-resolving. Mild and transient skin reactions may occur at the application site (local alopecia, pruritus) which will disappear without treatment. If the cat licks its coat after treatment, temporary excessive salivation may be observed. Ingestion of the product can lead to vomiting and/or transient neurological symptoms such as ataxia, disorientation, apathy and pupil dilation. All these symptoms resolve spontaneously within 24 hours. Correct application will minimize the occurrence of these reactions. If you notice serious reactions or other effects not mentioned in this leaflet, please inform your veterinarian.
TARGET SPECIES: Cats
ROUTE AND METHOD OF ADMINISTRATION:
Spot-on administration. The recommended minimum doses are 10 mg/kg body weight for fipronil, 12 mg/kg for (S)-methoprene, 0.5 mg/kg for eprinomectin and 10 mg/kg for praziquantel. The product should only be used if mixed infestation is confirmed or if there is a risk of mixed infestation with ectoparasites and nematodes (including for heartworm prevention) and when concomitant cestode treatment is indicated. In the absence of a risk of concurrent contamination, a narrow-spectrum parasiticide is recommended as a first treatment option. The indication for use should be adapted according to the cat's needs determined by clinical evaluation, the animal's lifestyle and the local epidemiological situation (including zoonotic risks where applicable) so that it is used exclusively in situations of mixed infestation or risk of mixed infestation. Treatment should not be extrapolated from one animal to another without veterinary approval. For the prevention of cardiovascular dirofilariasis (Dirofilaria immitis larvae), the product should be applied starting 1 month before the first exposure to mosquitoes.
RECOMMENDATIONS FOR CORRECT ADMINISTRATION Choose the appropriate applicator according to the cat's weight. Use scissors to cut the blister along the dotted line, then peel off the foil. Remove the applicator from the package and hold it upright. Pull the plunger back slowly, twist and remove the cap. Part the fur in the middle of the neck, between the base of the skull and the shoulder blades, so that the skin is visible. Position the tip of the applicator on the skin and apply the entire contents directly onto the skin in one spot. The product must be applied to dry skin in areas where the cat cannot lick itself. For long-haired breeds, particular care must be taken to apply the product directly to the skin and not to the fur to ensure optimal efficacy.
STORAGE Keep out of the sight and reach of children. Store in the original cardboard packaging to protect from light. Do not use this veterinary product after the expiry date marked on the box after EXP.
Special precautions for each target species: Ensure that animals do not lick each other after treatment. After treatment, ticks are generally killed within 48 hours of infestation without engaging in blood-feeding activity. However, some ticks may remain on the animal and for this reason, the transmission of infectious diseases cannot be completely ruled out. No data are available regarding the effect of bathing/shampooing on the product's efficacy in cats. Brief water contact once a month after product application is unlikely to significantly reduce the product's efficacy. However, as a precaution, bathing the animal for 2 days after treatment is not recommended. Tapeworm infestation may recur if intermediate hosts such as fleas, mice, etc. are not controlled. Parasite resistance to a particular class of antiparasitic drugs can develop as a result of frequent use of a compound from that class. Therefore, available information regarding the current susceptibility of the target species should be taken into account to limit the possibility of future selection of resistance. Cats living in heartworm endemic areas or those that have traveled to such areas may be infested with adult heartworms. Although the product can be administered to cats infected with adult heartworms, no therapeutic effect against adult Dirofilaria immitis heartworms has been established. Therefore, it is recommended that all cats aged 6 months or older living in heartworm endemic areas be tested for adult heartworm infestation before prophylactic product application.
Special precautions for use in animals: For spot-on application only. Do not inject, administer orally or by any other route of administration. Avoid contact with the cat's eyes. The safety of BROADLINE has not been tested for intervals shorter than 2 weeks or in kittens weighing less than 0.6 kg and/or aged 7 weeks.
BROADLINE is not intended for use in dogs. Certain dog breeds may have increased susceptibility to macrocyclic lactones, which can cause neurotoxic effects. Ingestion by breeds such as Collies, English Sheepdogs, and mixed or related breeds should therefore be avoided. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Do not smoke, drink or eat while handling the product. Wash hands thoroughly after use. Avoid contact of fingers with the applicator contents. If this happens, wash with soap and water. In case of accidental eye contact, rinse thoroughly with water as the product may cause mild eye irritation. If eye irritation persists or adverse effects occur, seek medical advice and show the doctor the product leaflet or label. Avoid handling the animal until the application site is dry, and children should not play with the animals during this period. Therefore, it is recommended that recently treated animals do not sleep with their owners, especially children. Persons with known hypersensitivity to any of the active substances or excipients should not handle this veterinary medicinal product. Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies for each active substance performed on rats and rabbits have not shown teratogenic, feto-toxic, materno-toxic effects. Use only in accordance with the veterinarian's risk/benefit assessment. Overdose: Safety has been demonstrated in healthy kittens aged 7 weeks or older who received a dose up to 5 times the maximum allowed dose (e.g., up to 15 times the recommended dose), treated up to 6 times, at four-week intervals. Safety has also been demonstrated in healthy adult cats treated 3 times at 2-week intervals with a dose up to 5 times the recommended dose. Transient neurological signs such as ataxia, disorientation, apathy and dilated pupils may be observed, which usually resolve spontaneously the next day – see their description in section 6. Cats infected with adult heartworms tolerated up to 3 times the maximum allowed dose (e.g., up to 9 times the recommended dose), 3 treatments at 4-week intervals, without any adverse effects.
DISPOSAL OF UNUSED PRODUCT OR WASTE, IF APPLICABLE Medicines must not be disposed of in lakes, watercourses or ditches due to the danger to fish and other aquatic organisms. Ask your veterinarian for information on how to dispose of medicines that are no longer needed.


