Land: Ungarn
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
fipronil 2.5 mg/ml
Krka d.d.
QP53AX15
Cutaneous spray, solution
fipronil
Cats, Dogs
2012-07-25
_ _ _ _ 1/10 UNITED KINGDOM VETERINARY MEDICINES DIRECTORATE WOODHAM LANE NEW HAW ADDLESTONE SURREY KT15 3LS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT FYPRYST 2.5 MG/ML CUTANEOUS SPRAY SOLUTION FOR CATS AND DOGS Fypryst 2.5 mg/ml Cutaneous Spray Solution for Cats and Dogs UK/V/0407/001/DC Krka Dd Application for Decentralised Procedure Publicly Available Assessment Report 2/10 MODULE 1 PRODUCT SUMMARY EU Procedure number UK/V/0407/001/DC Name, strength and pharmaceutical form Fypryst 2.5 mg/ml Cutaneous Spray Solution for Cats and Dogs Applicant KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia Active substance Fipronil ATC Vetcode QP53AX15 Target species Cats and Dogs Indication for use The treatment and prevention of flea and tick infestations in cats and dogs, and as part of a treatment strategy for Flea Allergy Dermatitis in cats and dogs. The product is active against _Ixodes_ spp. including _Ixodes ricinus_, important as the vector of Lyme disease. The product controls infestations with _Trichodectes canis _biting lice on dogs, and _Felicola subrostratus_ biting lice on cats. The product is active for up to 3 months against fleas in dogs, and up to 2 months in cats, depending on the environmental challenge. It is effective against tick infestations for up to one month in dogs and cats, depending on the level of environmental challenge. Fypryst 2.5 mg/ml Cutaneous Spray Solution for Cats and Dogs UK/V/0407/001/DC Krka Dd Application for Decentralised Procedure Publicly Available Assessment Report 3/10 MODULE 2 The Summary of Product Læs hele dokumentet
Issued: November 2012 AN. 00628/2011 Page 1 of 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fypryst 2.5 mg/ml cutaneous spray, solution for cats and dogs Fipronil 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains ACTIVE SUBSTANCE: Fipronil 2.5 mg EXCIPIENTS: For a 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 The treatment and prevention of flea and tick infestations in cats and dogs, and as part of a treatment strategy for Flea Allergy Dermatitis in cats and dogs. The product is active against _Ixodes_ spp. including _Ixodes ricinus_, important as the vector of Lyme disease. The product controls infestations with _Trichodectes canis _ biting lice on dogs, and _Felicola subrostratus_ biting lice on cats. The product is active for up to 3 months against fleas in dogs, and up to 2 months in cats, depending on the environmental challenge. It is effective against tick infestations for up to one month in dogs and cats, 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 excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not exceed the recommended dosage. Issued: November 2012 AN. 00 Læs hele dokumentet