RIMADYL Cattle 50 mg/ml Solution for Injection

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Carprofen

Dostopno od:

Zoetis Belgium S.A.

Koda artikla:

QM01AE91

INN (mednarodno ime):

Carprofen

Odmerek:

50 milligram(s)/millilitre

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cattle

Terapevtsko območje:

carprofen

Terapevtske indikacije:

N.S.A.I.D.

Status dovoljenje:

Authorised

Datum dovoljenje:

2014-02-28

Lastnosti izdelka

Health Products Regulatory Authority
18 August 2017
CRN000V05
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
RIMADYL Cattle 50 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Carprofen 50 mg
EXCIPIENTS:
Ethanol 0.1 ml
Benzyl Alcohol 10mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection. Clear, pale straw yellow solution.
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
known hypersensitivity to the active substance or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
18 August 2017
CRN000V05
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
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 of treatment.
Do not administer other NSAID’s concurrently or within 24 hours of
each other.
As NSAID therapy can be accompanied by gastro-intestinal 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 skin contact
with the
veterinary medicinal product. Should this occur, wash