WARNINGS
To allow exposure of parasites to afoxolaner, they must begin feeding on the host; therefore, the risk of transmission of diseases from the parasite cannot be completely excluded. When treating parasite infestations, all animals in contact must be treated simultaneously with an appropriate product. Fleas, at every stage of growth, can infest the dog’s bed and usual resting areas such as carpets and upholstered furniture. These areas, in case of massive flea infestations at the beginning of antiparasitic treatment, should be treated with an appropriate environmental product and then regularly cleaned with a vacuum cleaner. Special precautions for use in animals: in the absence of available data, consult a veterinarian before treating puppies under 8 weeks of age and/or canids weighing less than 2 kg. Special precautions to be taken by the person administering the veterinary medicine to animals: to prevent children from accessing the veterinary medicine, remove only one tablet from the blister at a time. Store the blister with the remaining chewable tablets in the box. Wash hands after handling the product. No adverse reactions have been noted in healthy Beagle puppies over 8 weeks of age treated with a dosage equal to 5 times the maximum dose repeated 6 times at intervals of two to four weeks. Main incompatibility: not applicable.
PHARMACEUTICAL CATEGORY
Ectoparasiticides for systemic use.
STORAGE
This veterinary medicine does not require any special storage conditions. Shelf life of the veterinary medicine packaged for sale: 3 years.
CONTRAINDICATIONS/ADVERSE EFFECTS
Do not use in cases of hypersensitivity to the active ingredient or to any of the excipients.
NAME
FRONTPRO CHEWABLE TABLETS FOR DOGS
EXCIPIENTS
Corn starch, purified soy protein, braised beef flavor, povidone (E1201), macrogol 400, macrogol 4000, macrogol 15 hydroxystearate, glycerol (E422), medium-chain triglycerides.
ADVERSE EFFECTS
Neurological signs (seizures, ataxia, and muscle tremors), itching, lethargy, anorexia, and mild gastrointestinal disturbances (vomiting, diarrhea) 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 conventions: very common (more than 1 in 10 treated animals shows 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).
PREGNANCY AND LACTATION
Laboratory studies conducted in rats and rabbits did not show the existence of teratogenic effects or any adverse reaction on the reproductive capacity of male and female subjects. The safety of the veterinary medicine during pregnancy and lactation in breeding dogs has not been established. Consult a veterinarian before treatment during pregnancy and lactation or before use in breeding dogs.
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 eliminates ticks for up to one month. To be exposed to the active ingredient, fleas and ticks must attach to the host and begin feeding.
INTERACTIONS
None known.
DOSAGE
For oral use. Dosage: the product should be administered at doses of 2.7 to 7 mg/kg body weight as per the following scheme. Dog body weight: 2-4 kg; dosage and number of chewable tablets to administer; frontpro 11 mg: 1. Dog body weight: >4-10 kg; dosage and number of chewable tablets to administer; frontpro 28 mg: 1. Dog body weight: >10-25 kg; dosage and number of chewable tablets to administer; frontpro 68 mg: 1. Dog body weight: >25-50 kg; dosage and number of chewable tablets to administer; frontpro 136 mg: 1. For dogs weighing over 50 kg, use an appropriate combination of chewable tablets with different/equal dosages. The tablets should not be divided. Method of administration: the tablets are chewable and palatable for most dogs. It is possible to administer the tablets with food in case the dog does not accept to take 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 peak seasonal periods for fleas and/or ticks, based on the local epidemiological situation.
ACTIVE INGREDIENTS
Each chewable tablet contains, 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 complete list of excipients, see paragraph 6.1.
SAFETY IN TARGET SPECIES
No adverse reactions have been noted in healthy Beagle puppies over 8 weeks of age treated with a dosage equal to 5 times the maximum dose repeated 6 times at intervals of two to four weeks.
TARGET SPECIES
Dogs.
WITHDRAWAL TIME
Not applicable.
USE/ROUTE OF ADMINISTRATION
For oral use.