Carprieve 50 Mg/Ml Solution For Injection For Cattle
Revised: November 2013
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norocarp 50 mg/ml Solution for Injection for Cattle (RMS and CMS except
Denmark, Germany, Norway, United Kingdom, France and Italy)
Norodyl 50mg/ml Solution for Injection for Cattle (Denmark and Norway)
Carprieve 50mg/ml Solution for Injection for Cattle (United Kingdom, Germany, France and Italy)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carprofen 50 mg/ml
Ethanol (anhydrous) 100 mg/ml
Sodium Formaldehyde Sulphoxylate 2.0 mg/ml
For a full list of excipients, see section 6.1
Solution for Injection.
A clear colourless to pale yellow solution.
4. CLINICAL PARTICULARS
4.1 Target species
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.
Do not use in animals suffering from cardiac, hepatic or renal impairment.
Do not use in animals suffering from gastrointestinal 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.
For use in pregnant animals refer to section 4.7.
4.4 Special Warnings
4.5 Special precautions for use
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.
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
product. Wash off any splashes immediately. Take care to avoid accidental
4.6 Adverse reactions (frequency and seriousness)
Studies in cattle have shown that a transient local reaction may form at the site of subcutaneous injection, however this should disappear within 24 hours after the injection.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during
pregnancy. Use only accordingly to the benefit/risk assessment by the
4.8 Interaction with other medicinal products and other forms of interaction
In common with other NSAIDs, carprofen should not be administered
simultaneously with another product of the NSAID or glucocorticoid class.
Animals should be carefully monitored if carprofen is administered
simultaneously with an anticoagulant. NSAIDs are highly bound to plasma
proteins and may compete with other highly bound drugs, which can lead to
Concurrent administration of potential nephrotoxic drugs should be avoided.
4.9 Amounts to be administered and administration route
Single subcutaneous or intravenous injection at a dosage of 1.4 mg carprofen
per kilogram (1m1/35kg) bodyweight in combination with antibiotic therapy,
Do not exceed 10 broachings per vial. If more than 10 broachings are
required, the use of a draw-off needle is recommended.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No systemic adverse effects were reported after intravenous or subcutaneous
administration of up to 3 times the recommended dose. There is no specific
antidote for carprofen overdosage but general supportive therapy, as applied to
clinical overdosage with NSAIDs should be applied.
4.11 Withdrawal period(s)
Milk: Zero hours.
Meat and offal: 21 days.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group:Anti-inflammatory and anti-rheumatic products,
Propionic acid derivatives.
5.1 Pharmacodynamic properties
Carprofen (CPF), (±)-6-chloro-a-methylcarbazole-2-acetic acid, is a nonsteroidal
anti-inflammatory drug (NSAID) with analgesic and anti-pyretic
properties. It is a derivative of phenylpropionic acid and a member of the
arylpropionic acid class of NSAIDs. As a representative of the 2-
arylpropionic family, it contains a chiral center at C2 of the propionic moiety
and therefore, exists in 2 sterioisomeric forms, the (+)-S and (-)-R
In vitro studies have shown carprofen to be a cyclo-oxygenase inhibitor.
However, the inhibition of prostaglandin synthesis by carprofen is slight in
relation to its anti-inflammatory and analgesic potency. The precise mode of
action is unclear.
Studies have shown that carprofen has potent antipyretic activity and
significantly reduces the inflammatory response in lung tissue in cases of
acute, pyrexic infectious disease in cattle.
5.2 Pharmacokinetic properties
After a single subcutaneous administration of the product at 1.4 mg carprofen
per kilogram bodyweight the maximum plasma concentration (C.) of 10.4
μg/ml was reached after (T.) 7.2 hours.
Carprofen is highly bound to plasma proteins. It is well distributed in the
tissues with the highest concentrations found in kidney and liver followed by
fat and muscle. Carprofen has a plasma elimination half-life of 70 hours.
Carprofen is eliminated primarily in the faeces, indicating that the biliary
secretion plays an important role.
Metabolism: Carprofen (parent) is the main component in all tissues. Carprofen
(parent compound) is slowly metabolised primarily by ring hydroxylation,
hydroxylation at the a-carbon and by conjugation of the carboxylic acid group
with glucuronic acid. The 8-hydroxylated metabolite and unmetabolised
carprofen predominate in the faeces. Bile samples are comprised of conjugated
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium formaldehyde sulphoxylate
Polyethylene glycol 600
Polyethylene glycol 4000
Water for Injection
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
Shelf-life after first opening the immediate packaging: 28 days
6.4 Special precautions for storage
Protect from light.
6.5 Nature and composition of immediate packaging
Norocarp Injection for Cattle is available in 1 x 50m1, 5 x 50m1, 6 x 50m1, 10 x
50m1 and 12 x 50m1 multidose amber glass (Type I) vials, sealed with 20mm
bromobutyl bungs and 20mm aluminium seals.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from
such veterinary medicinal products should be disposed of in accordance with
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
Date:21 July 2009
10. DATE OF REVISION OF THE TEXT
Date: November 2013
20 November 2013
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