Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
KETOPROFEN
Le Vet Beheer B.V.
QM01AE03
KETOPROFEN
100 Mg/Ml
Solution for Injection
POM
Bovine, Equine - Food, Porcine
Ketoprofen
N.S.A.I.D
Authorised
2013-05-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ketodolor 100 mg/ml solution for injection for horses, cattle, pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Clear yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, cattle, pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _Horses:_ - alleviation of inflammation and pain associated with musculoskeletal disorders - alleviation of visceral pain associated with colic. _Cattle:_ - alleviation of pain (e.g. from pressure trauma) resulting from parturient paresis; - 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; - alleviation of pain associated with udder oedema following calving. - reducing pain associated with lameness. _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. Each ml contains: ACTIVE SUBSTANCE: Ketoprofen 100 mg EXCIPIENTS: Benzyl alcohol (E1519) 10 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 Read the complete document