Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
PRAZIQUANTEL PH. EUR., PYRANTEL EMBONATE, FEBANTEL PH. EUR.
Bayer Limited
QP52AC55
PRAZIQUANTEL PH. EUR., PYRANTEL EMBONATE, FEBANTEL PH. EUR.
50/144/150
Tablets
CAM-Companion Animal Medicine
Canine
Febantel, combinations
Endoparasiticide
Authorised
2005-10-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Drontal Plus Flavour Bone Shaped Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. A pale brown to brown, bone shaped tablet scored on both sides for oral administration to dogs. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the control of the following roundworms and tapeworms in dogs and puppies: 4.3 CONTRAINDICATIONS Do not use simultaneously with piperazine compounds Do not exceed the stated dosage when treating pregnant bitches. 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. ACTIVE SUBSTANCE MG/TABLET Febantel 150.0 Pyrantel embonate 144.0 Praziquantel 50.0 RELEVANT CONSTITUENTS OF THE EXCIPIENTS Artificial beef flavour Irradiated 116.5 Ascarids: _Toxocara canis, Toxascaris leonina_ (adult and late immature forms) Hookworms:_ Uncinaria stenocephala, Ancylostoma canium_ (adults) Whipworms:_ Trichuris vulpis_ (adults) Tapeworms: _Echinococcus_ spp._ Taenia_ spp. and_ Dipylidium caninum_ (adult and immature forms). 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_ _g_ _e_ _ Přečtěte si celý dokument