Norocarp
SUMMARY OF PRODUCT CHARACTERISTICS
Name of the veterinary medicinal product
Norocarp 20 mg tablets
Norocarp 50 mg tablets
qualitative and quantitative composition
Active substance
One tablet contains 20 mg or 50 mg carprofen
Excipients
For a full list of excipients, see section 6.1.
pharmaceutical form
Tablet
White/off white round tablet
Clinical particulars
Target species
Dog.
Indications for use, specifying the target species
Anti-inflammatory and analgesic treatment of disorders in muscles, joints and skeleton and the treatment of post surgical pain in dogs.
Contraindications
Do not use for animals that are suffering from gastrointestinal disorders (including invasive GI tract surgery), haemostatic disorders, kidney disorders, moderate/severe liver or heart disorders or for animals showing signs of individual hypersensitivity to the product.
Do not use in cats.
Special Warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Caution is required when used to treat dogs less than 6 weeks of age, or very old dogs. Special precaution should be taken when medicating dehydrated, hypovolaemic animals or animals suffering from heart or, liver diseases or infections. Refer to Section 4.3. Simultaneous use of potent nephrotoxic drugs or other NSAIDs should be avoided.
Response to long term therapy should be monitored at regular intervals by a veterinary surgeon.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
None.
Adverse reactions (frequency and seriousness)
Undesirable effects of using NSAID-products include vomiting, diarrhoea, gastrointestinal bleeding, inappetence, lethargy and liver and kidney disorders. These effects are usually temporary but can in rare cases be serious and in few cases be lethal.
As with other NSAIDs there is risk of rare renal or idiosyncratic hepatic adverse effects.
Use during pregnancy, lactation or lay
In the absence of specific studies in pregnant bitches, such use is not indicated. Carprofen passes to milk and should not be administered to lactating bitches.
Interaction with other medicinal products and other forms of interaction
Carprofen should not be administered simultaneous to or within 24 hrs of administration with other NSAIDs or steroids or together with anticoagulants. Carprofen is highly protein bound and may therefore compete with other highly protein bound drugs.
Amounts to be administered and administration route
For oral use.
The dose is 4 mg/kg bodyweight per day. The dose should be split and administered on two occasions in equal amounts. At treatment periods exceeding 14 days the dog should be regularly examined by a veterinary surgeon.
In order to prolong the anti-inflammatory and analgetic effect post operatively, parenteral treatment can be followed by peroral Norocarp Tablets at a dose of 4 mg per kg per day, split in two doses and administered on two occasions in equal amounts, for up to 5 days.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Symptomatic treatment should be initiated. For further information, see section 4.6.
Withdrawal period
Not applicable.
pharmacological properties
Pharmacotherapeutic group: Non-steroidal anti-inflammatory/antireumatic drug (NSAID)
ATCvet-code: QM01AE91
Pharmacodynamic properties
Carprofen (CPF), (±)-6-chloro-a-methylcarbazole-2-acetic acid, is a non steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic effect belonging to the group of propionic acid derivatives. It is a derivate of phenylpropionic acid and belongs to the NSAID-group of arylpropionic acids. As a representative of the 2-arylpropionic family it contains a chiral center at C2 of the propionic moiety and is available in two different stereoisomeric forms. – (+)-S- and (-)-R-enantiomers.
The mechanism of action is not fully understood. Carprofen inhibits the enzyme cyclo-oxygenase in the prostaglandin synthesis. However the inhibition is weak in relation to its anti-inflammatory and analgesic effect. At therapeutic doses for dogs the inhibition of cyclo-oxygenase (prostaglandin or thromboxane) and lipoxygenase (leucotriene) is negligible or absent.
Pharmacokinetic properties
Carprofen is rapidly absorbed and maximal serum concentration (ca 20-30 microgram/ml) is reached within 2 hrs following oral administration of 4 mg/kg bodyweight. The bioavailability is >90% and the protein binding level is >99%. The t½is approximately 6 hrs (4,1-7,9). Excretion is mainly via the bile, 70% of an i.v. dose is excreted in a metabolised way via the faecal route and 8-15% via urine.
Pharmaceutical particulars
List of excipients
Microcrystalline Cellulose
Lactose Monohydrate
Crosscarmellose Sodium
Povidone K30
Sodium Lauril Sulphate
Magnesium Stearate
Incompatibilities
Not applicable
Shelf life
2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
Tablet container of polypropylene sealed with a polyethylene cap
20 mg: 100 and 500 tablets.
50 mg: 100 and 500 tablets.
Blister of PVC/aluminium:
20 mg: 10, 20 and 100 tablets.
50 mg: 10, 20, 100 and 500 tablets.
Not all pack sizes may be
marketed.
Special precautions for the disposal of unused medicinal product or waste materials, derived from the use of such products
Not applicable.
Marketing Authorisation Holder
Norbrook Laboratories Limited
Station Works
Camlough Road
NEWRY
Co. Down, BT35 6JP
Northern Ireland
Marketing Authorisation number(s)
20 mg: 17689
50 mg: 17690
Date of first authorisation/renewal of the authorisation
Date of first authorisation: 11 March 2005
Date of latest renewal: 11 March 2010
Date of revision of the text
19 March 2010