Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CARPROFEN
Krka, d.d., Novo mesto
QM01AE91
CARPROFEN
50 Milligram
Tablets
POM
Canine
Carprofen
N.S.A.I.D
Authorised
2010-12-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Carprox vet 50 mg tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Carprofen 50 mg EXCIPIENTS: Ferric oxide red (E172) 1.52 mg Ferric oxide black (E172) 0.95 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round, dark brown, marbled tablets with visible darker spots, one-side scored and bevel-edged. The tablets can be divided into two equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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 dogs 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Refer to Sections 4.3 and 4.5. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 13/11/2015_ _CRN 7022149_ _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, dogs may require careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity. NSAIDs ca Read the complete document