Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
KETOPROFEN
Kela n.v.
QM01AE03
KETOPROFEN
100 Mg/Ml
Solution for Injection
POM
Bovine, Equine - Food, Porcine
Ketoprofen
N.S.A.I.D
Authorised
2012-02-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Kelaprofen 100 mg/ml, solution for injection for cattle, horses and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per ml ACTIVE SUBSTANCE: Ketoprofen 100 mg EXCIPIENTS: Benzyl alcohol (E1519) 10 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless or yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, cattle, pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Horse - the alleviation of inflammation and pain associated with musculoskeletal disorders; - the alleviation of visceral pain associated with colic. Cattle - the supportive treatment of parturient paresis associated with calving; - reducing the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with antimicrobial therapy as appropriate; - improving the recovery rate in acute clinical mastitis, including acute endotoxin mastitis, caused by Gram- negative micro-organisms, in conjunction with antimicrobial therapy; - reducing oedema of the udder associated with calving. Pigs - reducing the pyrexia and respiratory rate associated with bacterial or viral respiratory disease when used in conjunction with antimicrobial therapy as appropriate; - the supportive treatment of Mastitis Metritis Agalactia Syndrome in sows, in conjunction with antimicrobial therapy as appropriate. 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_ Preberite celoten dokument