QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Active substances:
|
NEXGARD SPECTRA
|
Afoxolaner
(mg)
|
Milbemycin oxime (mg)
|
| chewable tablets for dogs 7.5-15 kg |
150.00 |
30.00 |
PHARMACEUTICAL FORM
Chewable tablets.
Mottled red to reddish-brown tablets, 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).
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 (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 case of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Parasites need to 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 antiparasitic medicinal products may develop following frequent, repeated use of a compound of that class. Therefore, the use of this product should be based on an individual case assessment and local epidemiological information about the current susceptibility of the target species to limit the possibility of future selection of resistance.
Maintaining the efficacy of macrocyclic lactones is essential for the control of Dirofilaria immitis. To minimise the risk of resistance selection, it is recommended to test dogs for both circulating antigens and blood microfilariae at the start of each preventative 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 administration of 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 in Collie breed 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 to the physician.
- Wash hands after use.
Adverse reactions (frequency and seriousness)
In clinical studies, no serious adverse reactions attributable to the combination of afoxolaner with milbemycin oxime were observed. Less common reactions such as vomiting, diarrhoea, lethargy, anorexia and pruritus have been 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 effects on the reproductive capacity of males and females. The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs. Use only according to the benefit-risk assessment by the veterinarian.
Interactions with other medicinal products and other forms of interaction
Milbemycin oxime is a substrate of P-glycoprotein (P-gp), and thus may 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 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 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 regimen:
The treatment regimen should be based on the veterinary diagnosis and 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 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, so the product should be administered at regular monthly intervals throughout the vector season, starting the month after the first exposure to mosquitoes. Treatment should continue until the month following 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.
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, primarily those with a binding site for the gamma-aminobutyric acid (GABA) neurotransmitter, thereby blocking pre- and post-synaptic chloride ion transfers across the cell membrane. This results in uncontrolled activity of the central nervous system and 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 several 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 endectocidal antiparasitic 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 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 maximum plasma concentration (Cmax) was 1822 ± 165 ng/ml, at 2-4 hours (Tmax) after a dose of 2.5 mg/kg afoxolaner.
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.
Milbemycin oxime plasma concentrations rise rapidly within 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 volume of distribution of Milbemycin oxime in tissues is 2.7 ± 0.4 and 2.6 ± 0.6 l/kg for A3 and A4, respectively. Both forms have low clearance values 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 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 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 the use of such products should be disposed of in accordance with local requirements.
