Država: Velika Britanija
Jezik: angleščina
Source: VMD (Veterinary Medicines Directorate)
Ketoprofen
Kela – Kempisch Laboratorium – Kela Laboratoria NV
QM01AE03
Ketoprofen
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Horses, Pigs
Anti Inflammatory NSAID
Authorized
2012-02-27
Revised: October 2022 AN: 01658/2022 Page 1 of 6 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 Each ml contains: 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. - 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. Revised: October 2022 AN: 01658/2022 Page 2 of 6 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substances or to any of the excipients. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other, corticosteroids, diuretics and anticoagulants. Do not use in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, or Preberite celoten dokument