Negara: Inggris
Bahasa: Inggris
Sumber: VMD (Veterinary Medicines Directorate)
Fipronil
Beaphar B.V.
QP53AX15
Fipronil
Cutaneous spray, solution
NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person
Cats, Dogs
Ectoparasiticide
Authorized
2017-10-18
Issued October 2017 AN: 00456/2016 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprotec Spray 2.5 mg/ml Cutaneous Spray, Solution for Cats and Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains: ACTIVE SUBSTANCE: Fipronil 2.5 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous Spray, Solution Clear, colourless liquid 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and prevention of flea (_Ctenocephalides _spp.) and tick (_Ixodes _spp., including _Ixodes ricinus_) infestations in cats and dogs. Treatment of biting lice infestations in dogs (_Trichodectes canis_) and cats (_Felicola _ _subrostratus_). Insecticidal efficacy against new infestations with adult fleas persists for up to 2 months in cats and up to 3 months in dogs, depending on environmental challenge. The product has a persistent acaricidal efficacy for up to one month against ticks, depending on the level of environmental challenge. 4.3 CONTRAINDICATIONS Do not use on sick (systemic diseases, fever…) or convalescent animals Do not use in rabbits, as adverse reactions and even death could occur. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Issued October 2017 AN: 00456/2016 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not exceed the recommended dosage. Avoid contact with the animal’s eyes. In the case of accidental eye contact immediately and thoroughly flush the eyes with water. Do not spray directly onto areas of broken skin. Allow treated animals to dry in a well ventilated room (see also section 4.5). Do not confine animals in an enclosed space or pet carrier until the coat is totally dry. In the absence of specific tolerance and efficacy data, the product is not recommended for the treatment of species other than cats and dogs. For optimum efficacy, it is not recommended to bathe or shampoo Baca dokumen lengkapnya