Norocarp 50 mg/ml Solution for Injection for Cattle

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Carprofen

Dostępny od:

Norbrook Laboratories (Ireland) Limited

Kod ATC:

QM01AE91

INN (International Nazwa):

Carprofen

Dawkowanie:

50 milligram(s)/millilitre

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

carprofen

Status autoryzacji:

Authorised

Data autoryzacji:

2005-09-09

Charakterystyka produktu

Health Products Regulatory Authority
25 June 2019
CRN0094PM
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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.
Health Products Regulatory Authority
25 June 2019
CRN0094PM
Page 2 of 4
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,