国家: 英国
语言: 英文
来源: VMD (Veterinary Medicines Directorate)
Ketoprofen
Ecuphar Veterinaria S.L.U.
QM01AE03
Ketoprofen
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Horses, Pigs
Anti Inflammatory NSAID
Authorized
2010-09-23
Revised: April 2022 AN: 02927/2021 Page 1 of 7 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. Revised: April 2022 AN: 02927/2021 Page 2 of 7 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. 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 or acetyl-salcylic acid or to any of the excipients. Do not use in animals with evidence of blood dyscrasia or coagulopathy. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECA 阅读完整的文件