Decree No. 136 of December 23, 2014 decentralised procedure # 0502/ -5/001 UK/V/DC.
Veterinary medicinal product: EFFITIX 26.8 mg/240 mg spot-on solution for very small dogs-EFFITIX 67 mg/600 mg spot-on solution for small dogs-EFFITIX 134mg/1200 mg solution spot-on for medium dogs-EFFITIX 268 mg/2400 mg solution spot-on for large dogs-EFFITIX 402 mg/mg solution spot-on for large dogs under the conditions specified below.
A.I.C. holder: Virbac-1 ere Avenue-2065 m-L.I.D.-06516 Carros-France.
Manufacturer responsible for batch release: Virbac-1 ere Avenue-2065 m-L.I.D.-06516 Carros-France.
Authorised pack sizes and numbers of 28.6 mg/240 mg A.I.C.: «Effitix» spot-on solution for very small dogs: 0.44 pipet 1 ml Pack-A.I.C. # 104680018;
Pack of 4 ml-0.44 A.I.C. syphon # 104680020;
Pack of 24 ml-0.44 A.I.C. syphon # 104680032;
Pack of 60 pipettes of 0.44-A.I.C. # 104680044;
«Effitix 67 mg/600 mg» spot-on solution for small dogs: 1.10 pipet 1 ml Pack-A.I.C. # 104680057;
A.I.C. 4-Pack 1.10 syphon ml-# 104680069;
Pack of 24 ml-1.10 A.I.C. syphon # 104680071;
Pack of 60 ml-1.10 A.I.C. syphon # 104680083;
«Effitix 134 mg/1200 mg» spot-on solution for medium size: 2.20 pipet 1 ml Pack-A.I.C. # 104680095;
Pack of 4 ml-2.20 A.I.C. syphon # 104680107;
Pack of 24 ml-2.20 A.I.C. syphon # 104680119;
Pack of 60 ml-2.20 A.I.C. syphon # 104680121;
«Effitix 268 mg/2400 mg» solution spot-on for large dogs: 4.40 pipet 1 ml Pack-A.I.C. # 104680133;
Pack of 4 ml-4.40 A.I.C. syphon # 104680145;
Pack of 24 ml-4.40 A.I.C. syphon # 104680158;
Pack of 60 ml-4.40 A.I.C. syphon # 104680160;
«Effitix 402 mg/3600 mg» solution spot-on for large dogs: 6.60 pipet 1 ml Pack-A.I.C. # 104680172;
Pack of 4 ml-6.60 A.I.C. syphon # 104680184;
Pack of 24 6.60 ml pipettes-A.I.C. # 104680196;
Pack of 60 ml-6.60 A.I.C. syphon # 104680208.
Composition: «Effitix 28.6 mg/240 mg» spot-on solution for very small dogs, each pipette from 0.44 ml contains: active ingredients: fipronil 26.8 mg;
permethrin 239.8 mg;
«Effitix 67 mg/600 mg» spot-on solution for small dogs, each pipette from 1.1 ml contains: active ingredients: fipronil 67.1 mg;
permethrin 599.5 mg;
«Effitix 134 mg/1200 mg» spot-on solution for medium sized dogs, each pipette 2.20 ml contains: active ingredients: fipronil 134.2 mg;
permethrin 1199.0 mg;
«Effitix 268 mg/2400 mg» solution spot-on for large dogs, each pipette from 4.4. ml contains: active ingredients: fipronil 268.4 mg;
permethrin 2398.0 mg;
«Effetix 402 mg/3600 mg» solution spot-on for large dogs, each pipette 6.6 ml contains: active ingredients: fipronil 402.6 mg;
permethrin 3597.0 mg;
excipients: so as stated in the documentation of pharmaceutical techniques acquired to acts.
Target species: dogs.
Medical indications: in dogs, to be used against the flea infestation and/or ticks, when it's also needed a business repellent (anti-puncture) against the flebotoni and/or mosquitoes: fleas: for the treatment and prevention of flea infestations (Ctenocephalides spp). Fleas on dogs are killed within 24 hours after treatment. One treatment prevents the infestation from new adult parasites for four weeks. The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD) when this was prevedentemente diagnosed by a vet;
mints: one treatment prevents the infestation of ticks for four weeks (Dermacentor reticulatus and Rhipicephalus sanguineus, Ixodes ricinus). If there are ticks when the product is applied, not all ticks are torn down within 48 hours, but they can be killed in a week. The treatment reduces indirectly, for 4 weeks after application, the risk of transmission of diseases transmitted by infected ticks per 4 weeks (canine babesiosis);
sandflies and mosquitoes: a treatment determines a business repellent (anti-puncture) against sand flies (Phlebotomus perniciosus) and mosquitos (Culex pipiens, Aedes aegypti) for four weeks.
Withdrawal period: not applicable.
Validity: validity of the veterinary medicinal product as packaged for sale: 2 years;
period of validity after first opening the immediate packaging: use immediately.
Dispensing scheme: the sale isn't restricted to pharmacies and is not subject to veterinary prescription.
Effective of the Decree: immediate effect.