Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CARPROFEN
Zoetis Ireland Limited
QM01AE91
CARPROFEN
50 Mg/Ml
Solution for Injection
POM
Canine, Feline
Carprofen
N.S.A.I.D
Authorised
2015-04-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Rimadyl Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. A clear, sterile, mixed micelle solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs: For the control of post-operative pain and inflammation following orthopaedic and soft tissue (including intra- ocular) surgery. Cats: For the control of post-operative pain following surgery. 4.3 CONTRAINDICATIONS Do not administer by intra-muscular injection. Do not exceed the stated dose or the duration of treatment. Do not use in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal ulceration or bleeding or where there is evidence of blood dyscrasia or hypersensitivity to the product. As with other NSAIDs, there is a risk of rare renal or idiosyncratic hepatic adverse events. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Due to the longer half life in cats and narrower therapeutic index, particular care should be taken not to exceed the recommended dose and the use of a 1ml graduated syringe is recommended to measure the dose accurately. Active Substance Carprofen 50 mg/ml Excipients Benzyl Alcohol 10 mg/ml HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 31/03/2016_ _CRN 7022415_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Use in any animals less than 6 weeks of age, or in aged animals, may involve additional risk. If such a use cannot be avoided, animals may require careful clinical management. Read the complete document