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.
