البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: VMD (Veterinary Medicines Directorate)
Ivermectin
Chanelle Pharmaceuticals Manufacturing Ltd
QP54AA01
Ivermectin
Oral solution
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Sheep
Endectocide
Authorized
2010-07-08
Revised: October 2014 AN: 00740/2014 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ANIMEC 0.8mg/ml Oral Solution for Sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each ml contains: Ivermectin 0.8mg Excipient(s): Benzyl Alcohol (E1519) 28.6mg Butylhydroxyanisole (E320) 0.10 mg Propyl Gallate (E310) 0.10 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Solution. A transparent, yellow coloured solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infections with the following parasites: Nematodes Gastrointestinal roundworms (adult and fourth larval stage) Haemonchus contortus Teladorsagia circumcincta Trichostrongylus spp. Cooperia spp. Nematodirus spp. Including N. battus Strongyloides papillosus Chabertia ovina Lungworms(adult and fourth larval stage) Dictyocaulus filaria Revised: October 2014 AN: 00740/2014 Page 2 of 6 Arthropods Nasal bot (all larval stages) Oestrus ovis 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient or any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH 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 or misadministration of the product. Resistance to ivermectin (an avermectin) has been reported in Teladorsagia in sheep and goats within the EU and it is common in Haemonchus in sheep outside the EU. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematode and recommendations on how to limit further selection for resistance to anthelmintics. Suspected clinical cases of resistance to anthelm اقرأ الوثيقة كاملة