Norocarp 50 mg/ml Solution for Injection for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carprofen

Available from:

Norbrook Laboratories Limited

ATC code:

QM01AE91

INN (International Name):

Carprofen

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

carprofen

Therapeutic indications:

N.S.A.I.D.

Authorization status:

Authorised

Authorization date:

2005-09-09

Summary of Product characteristics

Health Products Regulatory Authority
19 September 2017
CRN000VH0
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norocarp 50 mg/ml Solution for Injection for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Carprofen
50 mg/ml
Excipients
Ethanol (anhydrous)
0.1 ml/ml
Sodium Formaldehyde Sulphoxylate
2.0 mg/ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduction of pyrexia in acute cases of infectious respiratory disease
in cattle, in
combination with appropriate anti-infective therapy.
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 animals with known hypersensitivity to the product.
Do not use in pregnant animals refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
19 September 2017
CRN000VH0
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
I)SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the stated dose or the duration of treatment.
Do not administer other NSAIDs concurrently or within 24 hours of each
other. Some
NSAIDs may be highly bound to plasma proteins and compete with other
highly
bound drugs, which can lead to toxic effects.
Use in any animal less than 6 weeks of age, or in aged animals, may
involve
additional risk. If such use cannot be avoided animals may require a
reduced dosage
and careful clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is a
potential risk of increased renal toxicity.Also refer to section 4.8.
II)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
p