Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Closantel sodium dihydrate; Mebendazole
Elanco GmbH
QP52A
Closantel sodium dihydrate; Mebendazole
50, 75 milligram(s)/millilitre
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
ANTHELMINTICS
Authorised
2012-06-08
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Flukiver Combi 50 mg/ml + 75 mg/ml oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES: 50 mg Closantel (as closantel sodium dihydrate) 75 mg Mebendazole EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Propylene Glycol Microcrystalline Cellulose and Sodium Croscarmellose Hypromellose Sodium Lauryl Sulphate Simethicone Emulsion 30% Water Purified White to faintly cream-coloured suspension. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Sheep and lambs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the treatment of mixed parasitic infestations where the action of both active substances is required. TREMATODES Liver flukes: _Fasciola hepatica_ (adults + 5-8 week-immatures) NEMATODES Roundworms _Haemonchus contortus_ (adults, immatures, inhibited stages and BZ-resistant strains) _Bunostomum_ sp. (adults) _Chabertia ovina_ (adults + immatures) _Oesophagostomum_ spp. (adults) _Capillaria_ spp. (adults) _Cooperia_ spp. (adults) _Nematodirus_ spp. (adults + immatures) _Teladorsagia circumcincta_ (adults + immatures) _Trichostrongylus axei_ (adults) _Trichostrongylus colubriformis_ (adults + immatures) _Trichostrongylus vitrinus_ (adults) Lungworms _Dictyocaulus filaria_ (adults + immatures) CESTODES _Avitellina _ spp. _Moniezia_ spp. ARTHROPODS _Oestrus ovis_ (nasal bot) 1st, 2nd and 3rd instar 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 3.4 SPECIAL WARNINGS 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. • Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any). Suspected clinical cases of resistance to anthelmintics shou Perskaitykite visą dokumentą