Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
(S)-Methoprene; Fipronil
Vet-Agro Multi-Trade Company Sp z o.o.
QP53AX65
(S)-Methoprene; Fipronil
402,361.8 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
fipronil, combinations
Authorised
2020-03-06
Health Products Regulatory Authority 26 March 2020 CRN008PLN Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprex Duo XL 402 mg + 361.8 mg spot-on solution for 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) 0.80mg Butylhydroxytoluene (E321) 0.40 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution Clear greenish-yellow solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (>40 kg) 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 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), where this has been previously diagnosed by a veterinary surgeon. 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 Read the complete document