Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Levamisole hydrochloride
Norbrook Laboratories (Ireland) Limited
QP52AE01
Levamisole hydrochloride
200 milligram(s)/millilitre
Pour-on solution
LR: Licensed Retailer as defined in national legislation
levamisole
Authorised
1997-12-12
Health Products Regulatory Authority 03 May 2019 CRN0091QM Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Levacide Pour-on 200 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Levamisole (as lavamisole hydrochloride) 200 mg/ml Excipients: Patent Blue (E131) 1 mg/ml For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Pour-on Solution A dark blue non-aqueous solution for external use. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Levacide Pour-on 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 Gastro-intestinal worms - _Trichostrongylus_ spp; _Cooperia_ spp; _Ostertagia ostertagi _(except inhibited _O. ostertagi _larvae); _Haemonchus_ spp; _Nematodirus_ spp; _Bunostomum_ spp; _Oesophagostomum _spp. 4.3 CONTRAINDICATIONS Do not use in animals producing milk for human consumption. Do not use in animals with known hypersensitivity to the active ingredients. 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, 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 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 Läs hela dokumentet