Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
TRICLABENDAZOLE, LEVAMISOLE HYDROCHLORIDE
Novartis Animal Health UK Ltd
QP52AC30
TRICLABENDAZOLE, LEVAMISOLE HYDROCHLORIDE
19.5 %w/v
Oral Suspension
LM-Licensed Merchant
Bovine
Combinations of benzimidazoles and related substances
Endoparasiticide
Transfer Pending
2010-05-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Endex 19.5 % w/v Oral Suspension for Cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral suspension. A white to off-white aqueous suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the simultaneous treatment and control of mature and developing immature infections of stomach worms _(Haemonchus, Ostertagia, Trichostrongylus axei_), gut worms (_Trichostrongylus, Cooperia, Nematodirus, Bunostomum,_ _Oesophagostomum_) and lung worms (_Dictyocaulus) _as well as all forms of liver fluke infection (early immature, immature and adult stages of _Fasciola hepatica _and _Fasciola gigantica_) in cattle. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredients. Do not use for the control of inhibited Type II Ostertagia infestations. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Endex 19.5% is not suitable for sheep. Active substance Triclabendazole 12.0 % w/v Levamisole hydrochloride 7.5 % w/v Excipients Methyl parahydroxybenzoate E218 0.08 % w/v Propyl parahydroxybenzoate E216 0.03 % w/v Benzoic acid E210 0.1 % w/v Sodium metabisulphite E223 0.25 % w/v For a full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 21/03/2016_ _CRN 7023313_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The product is effective on the mature and developing immature stages of Ostertagia, but is not indicated for the control of inhibited larvae (i.e. Type II ostertagiasis). SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY M Прочитајте комплетан документ