SUMMARY OF PRODUCT CHARACTERISTICS

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)

Active Substance:

Carprofen 50 mg/ml

Excipients:

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

Cattle.

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.

4.3 Contraindications

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

None.

4.5 Special precautions for use

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.

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

self-injection.

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

responsible veterinarian.

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

toxic effects.

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,

as appropriate.

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.

ATCvet code:QMO1AE91

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

enantiomers.

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

carprofen.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol (anhydrous)

Sodium formaldehyde sulphoxylate

Polyethylene glycol 600

Polyethylene glycol 4000

L-Arginine

Sodium Hydroxide

Water for Injection

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: 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

local requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

County Down

BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER

Vm02000/4295

9. DATE OF FIRST AUTHORISATION

Date:21 July 2009

10. DATE OF REVISION OF THE TEXT

Date: November 2013

20 November 2013