Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
KETOPROFEN
Vetpharma Animal Health, S.L.
QM01AE03
KETOPROFEN
100 Mg/Ml
Solution for Injection
POM
Bovine, Equine - Food, Porcine
Ketoprofen
N.S.A.I.D
Authorised
2012-02-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT NEFOTEK 100 mg/ml solution for injection for cattle, horses and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection A clear, colourless to yellow solution. Free from visible particles. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs and horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _Cattle:_ Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal system and the udder. _Pigs:_ Anti-inflammatory and antipyretic treatment of Postpartum Dysgalactia Syndrome –PDS - (Metritis Mastitis Agalactia Syndrome) and respiratory diseases. _Horses:_ Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal system and joints. Symptomatic analgesic treatment for colic. Postoperative pain and swelling. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, or to any of the excipients. Do not use in animals suffering from gastro-intestinal lesions, haemorrhagic diathesis, blood dyscrasia, impaired hepatic, cardiac or renal function. Do not use in foals in their first month of life. Do not use other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. ACTIVE SUBSTANCE: Ketoprofen 100 mg EXCIPIENTS: Benzyl alcohol (E1519) 10 mg 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_ _ Read the complete document