País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Levamisole hydrochloride
Norbrook Laboratories (Ireland) Limited
QP52AE01
Levamisole hydrochloride
75 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
levamisole
Authorised
1989-10-01
Health Products Regulatory Authority 24 January 2019 CRN008TFG Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Levacide Low Volume Worm Drench 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 Tartrazine (E102) 0.11 mg Sodium Metabisulphite 1.5 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. A yellow viscous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Levacide Low Volume 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. Lungworms: Dictyocaulus spp. Health Products Regulatory Authority 24 January 2019 CRN008TFG Page 2 of 5 Gastrointestinal worms: Trichostrongylus spp. Cooperia spp. Ostertagia spp. (except inhibited Ostertagia larvae) Haemonchus spp. Nematodirus spp. Bunostomum spp. Oesophagostomum spp. Chabertia spp. 4.3 CONTRAINDICATIONS Do not use in animals known to be hypersensitive to Levamisole. Do not use in animals producing milk for human consumption. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Care should be taken when treating heavily pregnant animals or animals under stress from adverse weather conditions, poor nutrition, penning, handling etc.. Levacide Low Volume Worm Drench is not effective against Type II Ostertagiasis (winter scours) in cattle. In cases of lungworm infections, coughing may persist for a considerable time following successful treatment with Levacide Low Volume Worm Drench. This is due to tissue damage caused by the parasites. Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimate Leia o documento completo