Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
carprofen 50 mg/ml
CP Pharma Handelsgesellschaft mbH
QM01AE91
Solution for injection
carprofen
Cattle Food
2012-01-25
Carprosol 50 mg/ml solution for injection for cattle PART 1 B 1 Summary of Product Characteristics version 2012/01 page 1 of 4 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Carprosol 50 mg/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Carprofen 50 mg Excipients: Ethanol 96% 0.1 ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, light yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES An adjunct treatment to antimicrobial therapy to reduce clinical signs in acute infectious respiratory disease and in acute mastitis in cattle. 4.3 CONTRAINDICATIONS Do not use in animals suffering from cardiac, hepatic or renal disease. Do not use in animals suffering from gastro-intestinal ulceration or bleeding. Do not use if there is evidence of blood dyscrasia. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS - Avoid use in dehydrated or hypovolaemic animals or animals with hypotension, because there is a potential risk of increased renal toxicity. - Concurrent administration of potentially nephrotoxic drugs should be avoided. - The recommended dose and duration of treatment should not be exceeded. Carprosol 50 mg/ml solution for injection for cattle PART 1 B 1 Summary of Product Characteristics version 2012/01 page 2 of Read the complete document