Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: VMD (Veterinary Medicines Directorate)
Levamisole Hydrochloride
Norbrook Laboratories Limited
QP52AE01
Levamisole Hydrochloride
Pour-on solution
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Cattle
Anthelmintic
Authorized
1997-10-07
Revised: 17 th December 2008 AN: 00809/2008 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Levacide Pour-On Solution 20 %w/v 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: W/V Levamisole 20.0 % (as Levamisole Hydrochloride 26.2 %) EXCIPIENTS: Patent blue (E131) 0.1 % For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Pour-on solution. A dark blue solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Levamisole is a broad-spectrum anthelmintic indicated for use in cattle in the treatment and control of nematode infections such as parasitic gastro-enteritis and lungworm disease caused by the following mature and developing immature gastro-intestinal and pulmonary nematodes: Lungworms - _Dictyocaulus viviparus_ Gastrointestinal worms - _Trichostrongylus_ spp, _Cooperia_ spp, _Ostertagia_ _ostertagi_ (except inhibited _O. _ _ostertagi_ larvae), _Haemonchus_ spp, _Nematodirus_ spp, _Bunostomum_ spp, _Oesophagostomum_ spp. Revised: 17 th December 2008 AN: 00809/2008 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In cases of lungworm infection coughing may persist for some time after treatment due to tissue damage. For external use only. Do not treat animals when wet, and where possible, for one hour post treatment, prevent treated animals from being exposed to rain. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS 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 Aqra d-dokument sħiħ