Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
pyriproxyfen, dinotefuran
CEVA Santé Animale
QP53AX73
pyriproxyfen, dinotefuran
Cats
Antiparasitic products, insecticides and repellents, Other ectoparasiticides for topical use, pyriproxyfen, combinations
Treatment and prevention of flea infestations (Ctenocephalides felis) on cats.One application prevents flea infestation for one month. It also prevents the multiplication of fleas by inhibiting flea emergence in the environment of the cat for 3 months.
Revision: 5
Authorised
2014-06-06
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: VECTRA FELIS 423 MG/42.3 MG SPOT-ON SOLUTION FOR CATS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Ceva Santé Animale, 10, av. de La Ballastière, 33500 Libourne, France Manufacturer responsible for batch release: Ceva Santé Animale, 10, av. de La Ballastière, 33500 Libourne, France AB7 SANTE, Chemin des Monges, 31450 Deyme, France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Vectra Felis 423 mg/42.3 mg spot-on solution for cats dinotefuran/pyriproxyfen 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each 0.9 ml spot-on applicator delivers: 423 mg dinotefuran and 42.3 mg pyriproxyfen. Colourless to pale yellow spot-on solution. 4. INDICATION(S) This veterinary medicine kills fleas ( _Ctenocephalides felis_ ) on infested cats and prevents further infestations for one month. It also prevents the multiplication of fleas, by inhibiting immature flea emergence in the cat’s environment, for 3 months. 5. CONTRAINDICATIONS Do not use in cats or kittens weighing less than 0.6 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 6. ADVERSE REACTIONS Slight scales, transient erythema and alopecia can be observed in rare cases, which usually disappear spontaneously without treatment. Transient neurological signs such as muscle tremors or lethargy may occur very rarely and in particular after application site licking. Transient cosmetic effects such as wet hair and a white dry residue may occur at the application site very rarely and may persist up to 7 days; however, these effects are usually not noticeable after 48 hours. These changes do not affect the safety or the efficacy of the veterinary medicinal product. Other application site disorders such as erythema, pruritus, lesions and inflammation may occur very rarely. Hyperactivity and tachypnoea may occur very rarely. The frequency of a Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vectra Felis 423 mg/42.3 mg spot-on solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Each 0.9 ml spot-on applicator delivers: Dinotefuran………………….. 423 mg Pyriproxyfen………………… 42.3 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and prevention of flea infestations ( _Ctenocephalides felis_ ) on cats. One application prevents flea infestation for one month. It also prevents the multiplication of fleas by inhibiting flea emergence in the environment of the cat for 3 months. 4.3 CONTRAINDICATIONS Do not use in cats or kittens weighing less than 0.6 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES All cats within the household should be treated. Dogs in the household should only be treated with a veterinary medicinal product authorised for use in that species. Fleas can infest the cat’s basket, bedding and regular resting areas such as carpets and soft furnishings. In case of massive flea infestation and at the beginning of the control measures, these areas should be treated with a suitable insecticide and then vacuumed regularly. The impact of shampooing on the efficacy of the veterinary medicinal product has not been evaluated. In case of suspicion of dermatitis (itch and skin irritation), seek for veterinary advice. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The safety of the product has not been established in cats younger than 7 weeks or weighing less than 0.6 kg (see section 4.3). After accidental ingestion of the product, transient reactions such as salivation, abnormal faeces and emesis may occur, however these should resolve without treatment wit Lesen Sie das vollständige Dokument