Norocarp 5.0% w/v Large Animal Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Carprofen

Available from:

Norbrook Laboratories Limited

ATC code:

Anti-inf

INN (International Name):

Carprofen

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Expired

Authorization date:

2006-01-30

Summary of Product characteristics

Revised: November 2010
AN: 00399/2010
Page 1 of 5
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norocarp 5.0% w/v Large Animal Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Carprofen
5.0% w/v
EXCIPIENTS:
Ethanol
10.0% v/v (as preservative)
Sodium Formaldehyde Sulphoxylate
0.20% w/v (as antioxidant)
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
Young cattle (under 12 months of age)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In young cattle (under 12 months old) the product is indicated as
adjunctive therapy
for the control of acute inflammation associated with respiratory
disease. The
cause of the condition should be determined and treated with an
appropriate
antimicrobial.
4.3
CONTRAINDICATIONS
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.
Do not use in animals suffering from cardiac, hepatic or renal
disease, where there
is a possibility of gastrointestinal ulceration or bleeding, or where
there is evidence
of a blood dyscrasia or hypersensitivity to the product.
Revised: November 2010
AN: 00399/2010
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in animals suffering from cardiac, hepatic or renal
disease, where there
is a possibility of gastrointestinal ulceration or bleeding, or
hypersensitivity to the
product. As with other NSAIDs there is a risk of rare renal or
idiosyncratic hepatic
adverse events.
Use in animals 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