Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
CEFALEXIN (AS CEFALEXIN MONOHYDRATE) PH. EUR
Forum Products Limited
QJ01DB01
CEFALEXIN (AS CEFALEXIN MONOHYDRATE) PH. EUR
250 mg/tablet
Film Coated Tablet
POM
Canine
Cefalexin
Antibacterial
Authorised
2012-02-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cephorum 250 mg film-coated tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active ingredient: Cefalexin 250 mg (equivalent to cefalexin monohydrate 263 mg) Excipients: Titanium dioxide (E171) 0.55 mg Excipient qsp 1 tablet of 355 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Round, white to yellowish, biconvex tablet, scored on one side. ‘CX’ is imprinted above the scoreline, ‘250’ is imprinted below the scoreline. The tablets are not divisible. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the treatment of urinary tract infections in dogs caused by_ Klebsiella pneumoniae_ and for the treatment of bacterial skin infections in dogs, when susceptible organisms are present. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substance, to other cephalosporins, to other substances of the -lactam group or to any of the excipients. Do not use in rabbits, gerbils, guinea pigs and hamsters. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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_ _ _ _1_ _3_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _4_ _2_ _2_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Use of the pro Lue koko asiakirja