Land: Storbritannien
Språk: engelska
Källa: HMA (Heads of Medicines Agencies)
carprofen 50 mg/ml
Le Vet B.V
QM01AE91
Solution for injection
carprofen
Cattle
2013-01-23
Issued: May 2013 AN: 01920/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Carprodolor 50 mg/ml solution for injection for cattle Carprodolor vet. 50 mg/ml solution for injection for cattle (FI) Carprosan 50 mg/ml solution for injection for cattle (ES, PT) Carprosan vet. 50 mg/ml solution for injection for cattle (NO, SE, DK, IS) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per ml: ACTIVE SUBSTANCE: Carprofen 50 mg EXCIPIENT(S): Ethanol 96% 0.1 ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection Clear pale straw coloured liquid 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES The product is indicated as an adjunct to antimicrobial therapy to reduce clinical signs in acute infectious respiratory disease and acute mastitis in cattle. 4.3 CONTRAINDICATIONS Do not use in animals suffering from cardiac, hepatic or renal impairment. Do not use in animals suffering from gastro-intestinal ulceration or bleeding. Do not use where there is evidence of a blood dyscrasia. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Issued: May 2013 AN: 01920/2011 Page 2 of 6 4.4 SPECIAL WARNINGS None 4.5 SPECIAL PRECAUTIONS FOR USE I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided. Do not exceed the stated dose or the duration Läs hela dokumentet