Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
monepantel
Elanco GmbH
QP52AX09
monepantel
Sheep
Anthelmintics,
Zolvix oral solution is a broad spectrum anthelmintic for the treatment and control of gastro-intestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes. Spectrum of activity includes fourth larvae and adults of: , Haemonchus contortus*;, Teladorsagia circumcincta*;, Teladorsagia trifurcata*;, Teladorsagia davtiani*;, Trichostrongylus axei*;, Trichostrongylus colubriformis;, Trichostrongylus vitrinus;, Cooperia curticei;, Cooperia oncophora;, Nematodirus battus;, Nematodirus filicollis;, Nematodirus spathiger;, Chabertia ovina;, Oesophagostomum venulosum. , * including inhibited larvae. The veterinary medicinal product is effective against strains of these parasites resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.,
Revision: 14
Authorised
2009-11-04
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET: ZOLVIX 25 mg/ml oral solution for sheep 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany Manufacturer responsible for batch release: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep Monepantel 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each ml of ZOLVIX orange clear oral solution contains 25 mg of monepantel Other ingredients: RRR-α-tocopherol Beta-carotene Maize oil Propylene glycol Macrogolglycerol hydroxystearate Polysorbate 80 Propylene glycol monocaprylate Propylene glycol dicaprylocaprate 15 4. INDICATION(S) ZOLVIX oral solution is a broad spectrum anthelmintic for the treatment and control of gastro- intestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes. Spectrum of activity includes fourth larvae and adults of: _Haemonchus contortus* _ _Teladorsagia circumcincta* _ _T. trifurcata* _ _T. davtiani* _ _Trichostrongylus axei* _ _T. colubriformis _ _T. vitrinus _ _Cooperia curticei _ _C. oncophora _ _Nematodirus battus _ _N. filicollis _ _N. spathiger _ _Chabertia ovina _ _Oesophagostomum venulosum _ *Including inhibited larvae 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS None known. If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Sheep 16 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dose table Bodyweight, kg Dose, ml 10 – 15 1.5 16 – 20 2 21 – 25 2.5 26 – 30 3 31 – 35 3.5 36 – 40 4 41 – 50 5 51 – 60 6 61 – 70 7 > 70 KG 1 ml for each additional 10 kg Administer orally with a suitable dose device. 9. ADVICE ON CORRECT ADMINISTRAT Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each ml contains 25 mg of monepantel EXCIPIENT: RRR-α-tocopherol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Orange clear solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES ZOLVIX oral solution is a broad spectrum anthelmintic for the treatment and control of gastro- intestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes. Spectrum of activity includes fourth larvae and adults of: _Haemonchus contortus* _ _Teladorsagia circumcincta* _ _Teladorsagia trifurcata* _ _Teladorsagia davtiani* _ _Trichostrongylus axei* _ _Trichostrongylus colubriformis _ _Trichostrongylus vitrinus _ _Cooperia curticei _ _Cooperia oncophora _ _Nematodirus battus _ _Nematodirus filicollis _ _Nematodirus spathiger _ _Chabertia ovina _ _Oesophagostomum venulosum _ * including inhibited larvae 3 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The efficacy has not been established in sheep weighing less than 10 kg. Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: • Too frequent and repeated use of anthelmintics from the same class, over an extended period of time. It is recommended that product is used not more than twice in one year. • Underdose, which may be due to underestimation of body weight, misadministration of the veterinary medicinal product, or lack of calibration of the dose device. In order to help delay the development of resistance, users are advised to check the success of the treatment (e.g. clinical appearance, faecal egg counts). Suspected clinical cases of resistance to anthelmintics should be further investigated using appropria Belgenin tamamını okuyun