Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Levamisole hydrochloride
Norbrook Laboratories (Ireland) Limited
QP52AE01
Levamisole hydrochloride
75 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
levamisole
Authorised
1989-10-01
Health Products Regulatory Authority 25 January 2019 CRN008SVL Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Levacide Injection 75 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance Levamisole (as levamisole hydrochloride) 75 mg Excipients Methyl Parahydroxybenzoate (E218) 1.5 mg Sodium Metabisulphite 1.5 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless sterile solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Levacide Injection is a broad spectrum anthelmintic for use in the treatment and control of nematode infections. It should be used in cases of parasitic gastro-enteritis and lungworm disease caused by mature and developing immature forms of those organisms sensitive to treatment with Levamisole Hydrochloride including the following: LUNGWORMS (ADULT AND LARVAL STAGES): _Dictyocaulus_ spp. GASTRO-INTESTINAL WORMS (ADULT AND LARVAL STAGES): _Trichostrongylus_ spp. _Cooperia_ spp. Health Products Regulatory Authority 25 January 2019 CRN008SVL Page 2 of 5 _Ostertagia_ spp. (except inhibited _Ostertagia_ larvae in cattle) _Haemonchus_ spp. _Nematodirus_ spp. _Bunostomum_ spp. _Oesophagostomum_ spp._Chabertia_ spp. 4.3 CONTRAINDICATIONS Do not use in animals known to be hypersensitive to Levamisole. 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 bodyweight, misadministration of the product, or lack of calibration of the dosing device. Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where Прочитайте повний документ