País: Reino Unido
Língua: inglês
Origem: VMD (Veterinary Medicines Directorate)
Fipronil
Bob Martin (UK) Ltd
QP53AX15
Fipronil
Spot-on solution
AVM-GSL - Authorised Veterinary Medicine – General Sales List
Dogs
Ectoparasiticide
Authorized
2011-05-27
Revised: June 2017 AN: 00104/2017 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT UK: Bob Martin Clear Spot On Solution 402 mg for Extra Large Dogs ES: Bob Martin Clear Fipronil 402 mg solution spot on for Extra Large Dogs FR: Bob Martin Vetcare Spot On Fipronil solution 402 mg for Extra Large Dogs IT: Fleaclear Spot-on Solution 402 mg for Extra Large Dogs NL: Kruidvat Flea Drops 402 mg solution for Extra Large Dogs PL: Bob Martin Clear 402 mg Spot On Solution for Extra Large Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 4.02 mL pipette contains: ACTIVE SUBSTANCE: Fipronil 402.000 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.804 mg Butylhydroxytoluene (E321) 0.402 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear, pale amber solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of flea infestations (_Ctenocephalides_ _ felis_). Insecticidal efficacy against new infestations with adult fleas persists for 8 weeks. Treatment of tick (_Rhipicephalus sanguineus_ and _Ixodes ricinus_) infestations. The product has persistent acaricidal efficacy for up to 4 weeks against ticks (_Rhipicephalus_ _sanguineus, Ixodes ricinus, Dermacentor reticulatus_). If _Dermacentor reticulatus_ ticks are already present when the product is applied, not all of the ticks may be killed within 48 hours, but they will be killed within a week. Page 1 of 6 Revised: June 2017 AN: 00104/2017 4.3 CONTRAINDICATIONS Do not use on puppies less than 2 months old and /or weighing less than 2kg. DO NOT USE IN RABBITS! Adverse drug reactions and even death could occur. This product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing. Do not use on animals with known hypersensitivity to the active substance or to any of the excipients. Do not use in animals that are unwell, are undergoing treatment for or are recovering from illness. 4.4 SPECIAL WARNINGS FOR EACH T Leia o documento completo