Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CARPROFEN
Norbrook Laboratories Limited
QM01AE91
CARPROFEN
50 Mg/Ml
Solution for Injection
POM
Bovine
Carprofen
N.S.A.I.D
Authorised
2007-05-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Carprieve 50 mg/ml Solution for Injection for Cattle. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Carprofen 50 mg EXCIPIENTS: Ethanol (anhydrous) 100 mg Sodium Formaldehyde Sulphoxylate 2 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for Injection. A clear colourless to pale yellow solution. 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 pyrexia in acute cases of infectious respiratory disease in cattle. 4.3 CONTRAINDICATIONS Do not use in animals suffering from cardiac, hepatic or renal impairment. Do not use in animals suffering from gastrointestinal ulceration or bleeding. Do not use where there is evidence of a blood dyscrasia. Do not use in animals with known hypersensitivity to the product. For use in pregnant animals refer to section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/10/2012_ _CRN 7012931_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Do not exceed the stated dose or the duration of treatment. Do not administer other NSAIDs concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects. Use in any animal less than 6 weeks of age, or in aged animals, may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management. Avoid use in Read the complete document