Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Fipronil; (S)-methoprene
Chanelle Pharmaceuticals Manufacturing Limited
QP53AX65
Fipronil; (S)-methoprene
402, 361.8 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
fipronil, combinations
Ectoparasiticide
Authorised
2018-04-20
Health Products Regulatory Authority 06 November 2020 CRN009YGJ Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Zeronil Combo 402 mg/361.8 mg Spot-on Solution for Extra Large Dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pipette of 4.02 ml contains: ACTIVE SUBSTANCES: Fipronil 402.00 mg (S)-methoprene 361.80 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.80 mg Butylhydroxytoluene (E321) 0.40 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution. Clear amber solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES - To be used against infestations with fleas, alone or in association with ticks and/or biting lice. - Treatment of flea infestations (_Ctenocephalides _spp.). Insecticidal efficacy against new infestations with adult fleas persist for 8 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity) and larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for eight weeks after application. - Treatment of tick infestations (_Ixodes ricinus_, _Dermacentor variabilis_, _Dermacentor reticulatus_, _Rhipicephalus sanguineus_). The product has a persistent acaricidal efficacy for up to 4 weeks against ticks. - Treatment of infestations with biting lice (_Trichodectes canis_). The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). 4.3 CONTRAINDICATIONS In the absence of available data, the product should not be used on puppies less than 8 weeks old and/or weighing less than 2 kg. Do not use on sick (e.g. systemic diseases, fever) or convalescent animals. Do not use in rabbits, as adverse reactions with even mortality could occur. In absence of studies, the use of the product is not recommended in non-target species. This product is specifically developed for dogs. Do not use in cats and ferrets, as this could lead to overdosing. 4.4 SPECIAL WARNINGS FOR Прочитать полный документ