CARPRODOLOR 50 MG/ML SOLUTION INJECTABLE POUR BOVINS
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
24-09-2013
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Active ingredient:
carprofen 50 mg/ml
Available from:
Le Vet B.V
ATC code:
QM01AE91
Pharmaceutical form:
Solution for injection
Therapeutic group:
carprofen
Therapeutic area:
Cattle
Authorization date:
2013-01-23
Summary of Product characteristics
Issued: May 2013
AN: 01920/2011
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Carprodolor 50 mg/ml solution for injection for cattle
Carprodolor vet. 50 mg/ml solution for injection for cattle (FI)
Carprosan 50 mg/ml solution for injection for cattle (ES, PT)
Carprosan vet. 50 mg/ml solution for injection for cattle (NO, SE, DK, IS)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml:
ACTIVE SUBSTANCE:
Carprofen
50 mg
EXCIPIENT(S):
Ethanol 96%
0.1 ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
Clear pale straw coloured liquid
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 clinical
signs in acute infectious respiratory disease and acute mastitis in cattle.
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 cases of hypersensitivity to the active substance or to any of the
excipients.
Issued: May 2013
AN: 01920/2011
Page 2 of 6
4.4 SPECIAL WARNINGS
None
4.5 SPECIAL PRECAUTIONS FOR USE
I.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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
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