Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
(S)-methoprene; Fipronil
Norbrook Laboratories Limited
QP53AX65
(S)-methoprene; Fipronil
402/361.8 mg/pipette
Spot-on solution
LM: Licensed Merchant as defined in relevant national legislation
Dogs
fipronil, combinations
Ectoparasiticide
Authorised
2017-05-26
Health Products Regulatory Authority 17 July 2017 CRN000TS2 Page 1 of 8 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Norbrook Fipronil and (S)-Methoprene 402 mg / 361.8 mg spot-on solution for very large dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pipette of 4.02 ml contains: ACTIVE SUBSTANCES: Fipronil 402 mg (S)-methoprene 361.8 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 A clear, yellow solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of dogs weighing over 40 kg bodyweight: 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 persists for 8 weeks. Prevention of the multiplication of fleas by inhibiting of 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 _ Health Products Regulatory Authority 17 July 2017 CRN000TS2 Page 2 of 8 _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_). 4.3 CONTRAINDICATIONS In the absence of available data, the product should not be used on puppies less than 8 weeks old. 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 or ferrets, as this could lead to overdosing. Do not use in cases of hypersensitivity t Lire le document complet