מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
KETOPROFEN
Ecuphar Veterinaria S.L.U.
QM01AE03
KETOPROFEN
150 Mg/Ml
Solution for Injection
POM
Bovine, Equine - Food, Porcine
Ketoprofen
N.S.A.I.D
Authorised
2016-12-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DINALGEN 150 mg/ml solution for injection for cattle, pigs and horses. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Ketoprofen 150 mg EXCIPIENTS: Benzyl alcohol (E1519) 10 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless to yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs and horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: - Reduction of inflammation and pain associated with post-partum, musculoskeletal disorders and lameness. - Reduction of fever associated with bovine respiratory disease. - Reduction of inflammation, fever and pain in acute clinical mastitis in combination with antimicrobial therapy where appropriate. Pigs: - Reduction of pyrexia in cases of respiratory disease and Postpartum Dysglactia Syndrome-PDS-(Metritis Mastitis Agalactia syndrome) in sows, in combination with antimicrobial therapy, where appropriate. Horses: - Reduction of inflammation and pain associated with osteoarticular and musculoskeletal disorders (lameness, laminitis, osteoarthritis, synovitis, tendinitis, etc.). - Reduction of postoperative pain and inflammation. - Reduction of visceral pain associated with colic. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 02/12/2016_ _CRN 7025133_ _page number: 1_ 4.3 CONTRAINDICATIONS Do not use in animals where there is the possibility of gastro-intestinal ulceration or bleeding, in order not to aggravate their situation. Do not use in animals suffering from cardiac, hepatic, or renal disease. Do not use in cases of known hypersensitivity to ketoprofen קרא את המסמך השלם