Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PRAZIQUANTEL PH. EUR., PYRANTEL EMBONATE
Bayer Limited
QP52AA51
PRAZIQUANTEL PH. EUR., PYRANTEL EMBONATE
30/345
Tablets
CAM-Companion Animal Medicine
Feline
Praziquantel, combinations
Endoparasiticide
Authorised
2004-08-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Drontal Cat XL Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Film-coated tablet. White to yellowish, ellipsoid, biconvex, unscored tablet. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of gastrointestinal roundworms and tapeworms: _Toxocara cati, Toxascaris leonina, Dipylidium caninum,_ _Taenia taeniaeformis._ 4.3 CONTRAINDICATIONS Do not use simultaneously with piperazine compounds. Not intended for use in kittens less than 6 weeks of age. Until sufficient studies have been performed with this combination, do not use during pregnancy. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Fleas serve as intermediate hosts for one common type of tapeworm –_ Dipylidium caninum_. Tapeworm infestation is certain to re-occur unless control of intermediate hosts such as fleas, mice etc is undertaken. As a precautionary measure to prevent the establishment of_ E. multilocularis_ in the UK or Ireland, it is recommended that all cats entering the country be treated with praziquantel. Each tablet contains: ACTIVE SUBSTANCES Pyrantel embonate 345 mg Praziquantel 30 mg EXCIPIENTS Titanium dioxide E171 (colouring agent) 2.60 mg For a full list of excipients see section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _8_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _6_ _6_ _2_ _4_ _p_ _a_ _ Read the complete document