SUMMARY OF PRODUCT CHARACTERISTIC

1. NAME OF THE MEDICINAL PRODUCT

RIMADYL Cattle 50 mg/ml Solution for Injection

(AT, BG, CY, CZ, DE, EE, EL, ES, HU, IE, IT, LT, LV, NL, PL, PT, RO, SK, SL, UK)

RIMADYL Bovis 50 mg/ml Solution for Injection (BE, FR, LU,)

RIMADYL Bovis vet. 50 mg/ml Solution for Injection (DK, FI, IS. NO, SE)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains :
Active substance: Carprofen 50 mg

Excipients: Ethanol 0.1 ml

Benzyl Alcohol 10 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear, pale straw yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle.

4.2 Indications for use, specifying the target species

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

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 cases of known hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

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 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.

4.6 Adverse reactions (frequency and seriousness)

Studies in cattle have shown that a transient local reaction may form at the site of the injection.

4.7 Use during pregnancy, lactation or lay

In the absence of any specific studies in pregnant cattle, use only after a risk/benefit assessment has been performed by the attending veterinary surgeon.

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 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.

4.9 Amounts to be administered and administration route

Single subcutaneous or intravenous injection at a dosage of 1.4 mg carprofen/ kg body weight (1 ml/35 kg) in combination with antibiotic therapy, as appropriate.

When treating groups of animals, use a draw-off needle to avoid excessive broaching of the stopper. The maximum number of broachings should be limited to 20.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

4.11 Withdrawal periods

Meat and offal: 21 days

Milk: Zero hours

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and Anti-rheumatic products, non-steroids

ATC vet code: QM01AE91

5.1 Pharmacodynamic properties

Carprofen is a member of the 2-arylpropionic acid group of non-steroidal anti-inflammatory drugs (NSAID’s) 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

Absorption:Following a single subcutaneous dose of 1.4 mg carprofen/kg the maximum plasma concentration (C_max) of 15.4 μg/ml was reached after (T_max) 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) is the main component in all tissues. Carprofen (parent compound) is slowly metabolised primarily by ring hydroxylation, hydroxylation at the α-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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol

Benzyl Alcohol

Macrogol 400

Poloxamer 188

Ethanolamine

Water for injections

6.2 Incompatibilities

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: 3 years

Shelf-life after first opening the immediate packaging: 28 days.

6.4 Special Precautions for Storage

Do not store above 30°C

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

6.5 Nature and composition of immediate packaging

Cardboard box containing one multidose amber glass (Type I) vial of either 50 ml, 100 ml or 250 ml capped with bromobutyl rubber stopper retained by an aluminium crimped seal.

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

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5^thFloor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm:42058/4118

9. DATE OF FIRST AUTHORISATION

Date:11 November 2008

10 DATE OF REVISION OF THE TEXT

Date:January 2014

04 March 2014