Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CARPROFEN
Norbrook Laboratories Limited
QM01AE91
CARPROFEN
50 Milligram
Tablets
POM
Canine
Carprofen
N.S.A.I.D
Authorised
2006-12-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Carprogesic 50 mg Tablets for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Carprofen 50 mg EXCIPIENTS: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets: A white/off white circular tablet with a break line on one face and “50” scored on the opposing face. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In the dog: Reduction of inflammation and pain caused by musculoskeletal disorders and degenerative joint disease. As a follow up to parenteral analgesia in the management of post operative pain. 4.3 CONTRAINDICATIONS Do not use in cats. Do not use in pregnant or lactating bitches. Do not use in puppies less than 4 months of age. Do not use in case of hypersensitivity to active substance or to any of the excipients. Do not use in dogs suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia. Do not use in animals suffering from hemorrhagic syndrome. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Refer to statements under Sections 4.3 and 4.5 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 03/12/2014_ _CRN 7019269_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS: Use in aged dogs may involve additional risk. If such a use cannot be avoided, such dogs may require a reduced dosage and careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as Read the complete document