国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Carprofen
Le Vet Beheer B.V.
QM01AE91
Carprofen
50 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
carprofen
N.S.A.I.D.
Authorised
2013-04-12
1 _ _ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Carprodolor 50 mg/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Carprofen 50 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t _ _ Ethanol 96% 0.1 ml Macrogol 400 Poloxamer 188 Ethanolamine (for pH adjustment) Water for injections Clear yellowish solution 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES The product is indicated as an adjunct to antimicrobial therapy to reduce clinical signs in acute infectious respiratory disease and acute mastitis in cattle. 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 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. 3.4 SPECIAL WARNINGS None. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: 2 Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided. Do not exceed the stated dose or the duration of treatment. Do not administer other NSAID’s (non-steroidal anti-inflammatory drugs) concurrently or within 24 hours of each other. As NSAID therapy can be accompanied by GI or renal impairment, adjunctive fluid therapy should be considered especially in the case of acute mastitis treatment. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Carprofen, in common with other NSAIDs, has been shown to exhibit photosensitising potential in laboratory studies. Avoid contact with skin and eyes. Should this occur, wash t 阅读完整的文件