Država: Velika Britanija
Jezik: angleščina
Source: VMD (Veterinary Medicines Directorate)
Closantel
Elanco Europe Ltd
QP52AG09
Closantel
Oral suspension
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Sheep
Anthelmintic flukicide
Authorized
1986-12-01
Revised: October 2020 AN: 00844/2020 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Flukiver 5% w/v Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: MG/ML Closantel 50.00 (as Closantel Sodium Dihydrate 54.375) For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension Off-white to slightly yellow, homogeneous suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep and lambs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the control of chronic and subacute fascioliasis (due to _Fasciola hepatica_) in sheep and lambs. For the control of _Oestrus ovis_ (Sheep Nasal Bot Fly)_._ For the control of inhibited, immature and adult stages of _Haemonchus contortus_ (Barber Pole Worm) including benzimidazole resistant strains. Flukiver is active against mature and immature flukes. _Fluke activity:_ _Stage_ _Percentage kill_ Adults 97-100 % 6-8 weeks immature 91-95% 5 weeks immature 91% 3-4 weeks immature 23-73 % Ticks (_Ixodes ricinus_) feeding on sheep at the time of treatment are likely to produce fewer viable eggs. Revised: October 2020 AN: 00844/2020 Page 2 of 5 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR TARGET SPECIES 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 should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. Resistance Preberite celoten dokument