Carprodolor 50 mg/ml solution for injection for cattle

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Carprofen

Verfügbar ab:

Le Vet Beheer B.V.

ATC-Code:

QM01AE91

INN (Internationale Bezeichnung):

Carprofen

Dosierung:

50 milligram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Cattle

Therapiebereich:

carprofen

Anwendungsgebiete:

N.S.A.I.D.

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2013-04-12

Fachinformation

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