Carprodolor 50 mg/ml solution for injection for cattle

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Carprofen

Disponível em:

Le Vet Beheer B.V.

Código ATC:

QM01AE91

DCI (Denominação Comum Internacional):

Carprofen

Dosagem:

50 milligram(s)/millilitre

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Cattle

Área terapêutica:

carprofen

Indicações terapêuticas:

N.S.A.I.D.

Status de autorização:

Authorised

Data de autorização:

2013-04-12

Características técnicas

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