Land: Írland
Tungumál: enska
Heimild: 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
2005-09-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Norocarp 50 mg/ml Solution for Injection for Cattle. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 Reduction of pyrexia in acute cases of infectious respiratory disease in cattle, in combination with appropriate anti-infective therapy. 4.3 CONTRAINDICATIONS Do not use in animals suffering from cardiac, hepatic or renal impairment. Do not use in animals suffering from gastro-intestinal 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. Do not use in pregnant animals refer to section 4.7. Active substance Carprofen 50 mg/ml Excipients Ethanol (anhydrous) 100 mg/ml Sodium Formaldehyde Sulphoxylate 2.0 mg/ml For a full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 03/12/2014_ _CRN 7019269_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE I) 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 Lestu allt skjalið