Name
FRONTPRO CHEWABLE TABLETS FOR DOGS
Pharmacotherapeutic group
Ectoparasiticides for systemic use.
Active substances
Each chewable tablet contains the active substance. 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 flavour, 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/Adverse 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 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 bodyweight according to the following table. Dog bodyweight: 2-4 kg; strength and number of chewable tablets to administer; frontpro 11 mg: 1. Dog bodyweight: >4-10 kg; strength and number of chewable tablets to administer; frontpro 28 mg: 1. Dog bodyweight: >10-25 kg; strength and number of chewable tablets to administer; frontpro 68 mg:1. Dog bodyweight: >25-50 kg; strength and number of chewable tablets to administer; frontpro 136 mg: 1. For dogs over 50 kg bodyweight, use an appropriate combination of chewable tablets of different/same strengths. The tablets must not be divided. Method of administration: the tablets are chewable and palatable to most dogs. The tablets can be given with food if the dog will not take them directly. Treatment schedule. Treatment of flea and tick infestations: for optimal control of flea and tick infestations, the product should be given at monthly intervals during the flea and/or tick season, 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 be 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 all life stages can infest the dog's bed 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 veterinary surgeon should be consulted before treating puppies under 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 product, remove only one tablet at a time from the blister. Return the blister with the remaining chewable tablets to the box. Wash hands after handling the product. No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age treated with 5 times the maximum dose repeated 6 times at intervals of two to four weeks. Major incompatibilities: not applicable.
Withdrawal period
Not applicable.
Target species
Dogs.
Interactions
None known.
Adverse effects
Neurological signs (convulsions, ataxia and muscle tremors), itching, lethargy, anorexia and mild gastrointestinal disorders (vomiting, diarrhoea) have been reported very rarely. Most 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 of 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 veterinary surgeon before treatment during pregnancy and lactation or before use in breeding dogs.
