Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: VMD (Veterinary Medicines Directorate)
Levamisole Hydrochloride
Norbrook Laboratories Limited
QP52AE01
Levamisole Hydrochloride
Oral solution
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Cattle, Sheep
Anthelmintic
Authorized
1987-02-03
Revised: 09 June 2010 AN: 00154/2010 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Levacide Low Volume 7.5% Oral Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 7.5% w/v Levamisole Hydrochloride EXCIPIENTS: 0.15% w/v Methyl Hydroxybenzoate as antimicrobial preservative 0.011% w/v Tartrazine (E102) as dye 0.15% w/v Sodium Metabisulphite as an antioxidant 0.05% w/v Disodium Edetate Dihydrate as an antioxidant For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Oral solution A clear yellow liquid 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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. These include: _Haemonchus _spp, _Ostertagia _spp (except inhibited Ostertagia larvae in cattle), _Nematodirus_ spp, _Trichostrongylus_ spp, _Cooperia _spp, _Oesophagostomum _spp, _Chabertia _spp, _Bunostomum _spp and _Dictyocaulus _spp. 4.3 CONTRAINDICATIONS Animals must not be treated within a period of 14 days before or after treatment with organophosphorus compounds. Revised: 09 June 2010 AN: 00154/2010 Page 2 of 5 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 (if any) Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results Aqra d-dokument sħiħ