Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
(S)-Methoprene, Fipronil
Krka d.d., Novo Mesto
QP53AX65
(S)-Methoprene, Fipronil
Spot-on solution
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Ectoparasiticide; Insect Growth Regulator
Expired
2014-03-27
AN: 00136/2013 Issued: March 2014 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fypryst Combo 134 mg/ 120.6 mg spot-on solution for medium dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1.34 ml pipette contains: ACTIVE SUBSTANCE: Fipronil 134 mg S-Methoprene 120.6 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.27 mg Butylhydroxytoluene (E321) 0.13 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 10-20 kg 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of dogs, dosage defined by bodyweight grouping (refer to section 4.9): - 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 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 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. AN: 00136/2013 Issued: March 2014 Page 2 of 6 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 recommend Read the complete document