Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
PRAZIQUANTEL
Bayer Limited
QP52AA01
PRAZIQUANTEL
90 mg/g
Oral Gel
LM-Licensed Merchant
Equine - Food
Praziquantel
Endoparasiticide
Authorised
2002-02-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Equitape 90 mg/g Oral Gel for Horses. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Praziquantel …………………...........................90.0 mg EXCIPIENTS Propyl Parahydroxybenzoate (E 216) …………0.2 mg Methyl Parahydroxybenzoate (E 218) …………1.4 mg Excipients ad……………………………………1.0 g For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral Gel. White soft gel. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horse. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections with cestodes of the species _Anoplocephala perfoliata_, sensitive to praziquantel. 4.3 CONTRAINDICATIONS None known. Milk: see section 4.11. (Do not use in mares from which milk is taken for human consumption). IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/01/2012_ _CRN 7011335_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES As tapeworm infestation is unlikely to occur in horses before two months of age, treatment of foals below this age is not considered necessary. In order to limit excretion of the product and its metabolites on the pasture horses should remain stabled for 2 days after treatment. Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. MRLs for milk have not been established. See section 4.11 Withdrawal periods. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCTS TO ANIMALS Wash hands thoroughly after treating animals. Any spillage of the product Baca dokumen lengkapnya