Profexx 50 mg/ml Solution for Injection for Cattle

Composition

Each ml contains:

Active substance:

Carprofen 50 mg

Excipients:

Benzyl alcohol (E1519) 10 mg

Ethanol 96% 0.104 ml

6.1 List of excipients

Benzyl alcohol (E1519)

Ethanol 96%

Ethanolamine

Macrogol 400

Poloxamer 188

Water for injections

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Pharmaceutical form

Solution for injection

Clear, colourless to yellow coloured solution.

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Pharmacological properties

Pharmacotherapeutic group: Anti-inflammatory and Anti-rheumatic products, nonsteroids

ATC Vet Code: QM01AE91

5.1 Pharmacodynamic properties

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 NSAID’s 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, pyrexic 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.

5.2 Pharmacokinetic particulars

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.

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.

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

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

An adjunct to antimicrobial therapy to reduce clinical signs in acute infectious respiratory disease and acute mastitis in cattle.

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Dosage

For subcutaneous and intravenous use.

Single injection at a dosage of 1.4 mg carprofen/ kg body weight (corresponding to 1 ml of the veterinary the product/35 kg bodyweight) in combination with antibiotic therapy, as appropriate.

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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 a 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

* transient local reaction

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 use in animals:

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, 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 (NSAID’s) 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. Benzyl alcohol and macrogol may cause hypersensitivity (allergic) reactions. People with known (hyper)sensitivity to carprofen, NSAIDs, benzyl alcohol or macrogol should administer the veterinary medicinal product with caution. Avoid contact with skin. Wash off any splashes immediately with clean, running water. Seek medical attention if irritation persists.

Take care to avoid 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

Other precautions:

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy:

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

NSAID’s 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 were used, macrolides, tetracyclines, cephalosporins and potentiated penicillins without known interactions.

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Overdose

In clinical studies, no adverse signs 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 NSAID’s, should be applied.

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Special warnings

None.

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Withdrawal period

Meat and offal: 21 days

Milk: zero hours

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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

One clear glass (type II) vial with a grey bromobutyl rubber stopper and aluminium cap in a cardboard box.

Pack sizes:

Cardboard box with 1 vial of 50 ml.

Cardboard box with 1 vial of 100 ml.

Cardboard box with 1 vial of 250 ml.

Not all pack sizes may be marketed.

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Storage

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

This veterinary medicinal product does not require any special temperature storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months

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. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

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Additional information

Vm 36408/5027

9 DATE OF FIRST AUTHORISATION

27 March 2024

10 DATE OF REVISION OF THE TEXT

March 2024

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

POM-V

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Registration holder

Alfasan Nederland B.V.

Kuipersweg 9

3449 JA Woerden

The Netherlands

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