Name
FRONTPRO CHEWABLE TABLETS FOR DOGS
Pharmacotherapeutic Category
Ectoparasiticides for systemic use.
Active Ingredients
Each chewable tablet contains the active ingredient. Chewable tablets for dogs 2-4 kg; afoxolaner: 11.3 mg. Chewable tablets for dogs >4-10 kg; afoxolaner: 28.3 mg. Chewable tablets for dogs >10- 25 kg; afoxolaner: 68 mg. Chewable tablets for dogs >25-50 kg; afoxolaner: 136 mg. For the full list of excipients, see section 6.1.
Excipients
Maize starch, purified soy protein, braised beef flavouring, povidone (E1201), macrogol 400, macrogol 4000, macrogol 15 hydroxystearate, glycerol (E422), medium-chain triglycerides.
Indications
Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for at least 5 weeks. Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) in dogs. One treatment kills ticks for up to one month. Fleas and ticks must attach to the host and start feeding in order to be exposed to the active substance.
Contraindications/Undesirable Effects
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Safety in the Target Species
No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age treated with a dose equal to 5 times the maximum dose repeated 6 times at intervals of two to four weeks.
Dosage
For oral use. Dosage: the product should be administered at doses of 2.7 to 7 mg/kg body weight according to the following table. Dog body weight: 2-4 kg; strength and number of chewable tablets to be administered; frontpro 11 mg: 1. Dog body weight: >4-10 kg; strength and number of chewable tablets to be administered; frontpro 28 mg: 1. Dog body weight: >10-25 kg; strength and number of chewable tablets to be administered; frontpro 68 mg:1. Dog body weight: >25-50 kg; strength and number of chewable tablets to be administered; frontpro 136 mg: 1. For dogs over 50 kg body weight, use an appropriate combination of chewable tablets of different/equal strengths. The tablets must not be divided. Method of administration: the tablets are chewable and palatable for most dogs. The tablets can be given with food if the dog does not accept them directly. Treatment schedule. Treatment of flea and tick infestations: for optimal control of flea and tick infestations, the product should be administered at monthly intervals during the flea and/or tick seasons, based on the local epidemiological situation.
Storage
This veterinary medicinal product does not require any special storage conditions. Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Warnings
Parasites need to start feeding on the host to become exposed to afoxolaner; therefore the risk of transmission of parasite-borne diseases cannot be excluded. When treating parasite infestations, all animals in contact should be treated at the same time with a suitable product. Fleas, at every stage of growth, can infest the dog's basket and usual resting areas such as carpets and soft furnishings. In case of massive flea infestation and at the start of antiparasitic treatment, these areas should be treated with a suitable environmental product and then vacuumed regularly. Special precautions for use in animals: in the absence of available data, a veterinarian should be consulted before treating puppies less than 8 weeks of age and/or dogs weighing less than 2 kg. Special precautions to be taken by the person administering the veterinary medicinal product to animals: to prevent children from accessing the veterinary medicine, remove only one tablet at a time from the blister. Put the blister with the remaining chewable tablets back into the box. Wash hands after handling the product. No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age treated with a dose equal to 5 times the maximum dose repeated 6 times at intervals of two to four weeks. Major incompatibilities: not applicable.
Withdrawal Periods
Not applicable.
Target Species
Dogs.
Interactions
None known.
Undesirable Effects
Neurological signs (convulsions, ataxia and muscle tremors), itching, lethargy, anorexia and mild gastrointestinal disorders (vomiting, diarrhoea) have been reported very rarely. Most of the reported adverse reactions were self-limiting and of short duration. The frequency of adverse reactions is defined using the following convention: very common (more than 1 in 10 animals treated displaying adverse reactions); common (more than 1 but less than 10 animals in 100 animals treated); uncommon (more than 1 but less than 10 animals in 1,000 animals treated); rare (more than 1 but less than 10 animals in 10,000 animals treated); very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pregnancy and Lactation
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects or any adverse effect on the reproductive capacity of males and females. The safety of the veterinary medicinal product during pregnancy and lactation or in breeding dogs has not been established. Consult a veterinarian before treatment during pregnancy and lactation or before use in breeding dogs.
