Carprofen Norbrook 50 mg/ml Solution for Injection for Cattle

Composition

Each ml contains:

Active substance:

Carprofen 50 mg

Excipients:

A clear colourless to pale yellow solution.

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Pharmacological properties

4.1 ATCvet code:

QM01AE91

4.2 Pharmacodynamics

Carprofen is a member of the 2-arylpropionic acid group of non-steroidal anti-inflammatory drugs and possesses anti-inflammatory, analgesic, and antipyretic activity.

Carprofen, like most other NSAIDs is an inhibitor of the enzyme cyclo-oxygenase of the arachidonic acid cascade. 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, pyretic infectious respiratory disease in cattle. Studies in cattle with experimentally induced acute mastitis have shown that carprofen administered intravenously has potent antipyretic activity and improves heart rate and rumen function.

4.3 Pharmacokinetics

Absorption: Following a single subcutaneous dose of 1.4 mg carprofen/kg the maximum plasma concentration (Cmax) of 15.4 µg/ml was reached after (Tmax) 7 – 19 hours.

Distribution: The highest carprofen concentrations are found in bile and plasma and more than 98% of carprofen is bound to plasma proteins. Carprofen was well distributed in the tissues with the highest concentrations found in kidney and liver followed by fat and muscle.

Metabolism: Carprofen (parent compound) 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 unmetabolized carprofen predominate in the faeces. Bile samples are comprised of conjugated carprofen.

Elimination: Carprofen has a plasma elimination half-life of 70 hours. Carprofen is primarily excreted in the faeces, indicating that the biliary secretion plays an important role.

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Target species

Cattle.

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Indications

This veterinary medicinal product is indicated as an adjunct to antimicrobial therapy to reduce clinical signs in acute infectious respiratory disease and acute mastitis in cattle.

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Dosage

Subcutaneous or intravenous use.

Single subcutaneous or intravenous injection at a dosage of 1.4 mg carprofen/kg bodyweight (corresponding to 1ml of the veterinary medicinal product/35kg bodyweight) in combination with antibiotic therapy, as appropriate. When treating groups of animals, use a draw-off needle or a multi-dose syringe to avoid excessive broaching of the stopper. The maximum number of broachings should be limited to 3.

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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 blood dyscrasia.

Do not use in cases of hypersensitivity to the active substance, or to any of the excipients.

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Adverse reactions

Cattle.

1Transient, lasting no more than 24 hours

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Avoid use in dehydrated, hypovolaemic or hypotensive animals, 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 non-steroidal anti-inflammatory drugs (NSAIDs) 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 the affected areas immediately. Administer the veterinary medicinal product with caution to avoid accidental self-injection. In case of accidental self-injection, seek medical advice and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy.

Pregnancy:

Use only according to the benefit/risk assessment by the responsible veterinarian.

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Interactions

In common with other NSAIDs, carprofen should not be administered simultaneously with another veterinary medicinal product of the NSAID or glucocorticoid class.

NSAIDs are highly bound to plasma proteins and may compete with other highly bound drugs, such that concomitant administration may result in toxic effects.

However, during clinical studies in cattle four different antibiotic classes (macrolides, tetracyclines, cephalosporins and potentiated penicillins) were used in combination with a carprofen containing veterinary medicinal product without known interactions.

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Overdose

In clinical studies, no adverse events were reported after intravenous and subcutaneous administration of up to 5 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.

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Special warnings

None.

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Withdrawal period

Meat and offal: 21 days.

Milk: Zero days.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

50 ml multidose amber type I glass vial with bromobutyl rubber stopper and aluminium seals in a cardboard box.

Pack sizes:

Cardboard box containing 1 vial of 50 ml.

Cardboard box containing 5 vials of 50 ml.

Cardboard box containing 6 vials of 50 ml.

Cardboard box containing 12 vials of 50 ml.

For multi-vial pack sizes, each vial will be packed in an individual carton within an outer cardboard box.

Not all pack sizes may be marketed.

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Storage

Keep the bottle in the outer carton in order to protect from light.

Store in an upright position.

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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

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

UK(NI) Vm 02000/3012

UK(GB) Vm 02000/5020

8 DATE OF FIRST AUTHORISATION

17 December 2025

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall

Approved: 12 February 2026

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Registration holder

Norbrook Laboratories Limited

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