QUALITATIVE AND QUANTITATIVE COMPOSITION
Each grilled meat flavoured tablet contains Carprofen 20 mg/tablet, 50mg/tablet or 100mg/tablet
PHARMACEUTICAL FORM
Grilled meat flavoured tablets. A plain round flat bevelled edge white tablet with a breakline on one side. The tablets can be broken into equal halves.
Target species
Dogs.
Indications for use, specifying the target species
Reduction of inflammation and pain caused by musculo-skeletal disorders and degenerative joint disease. As a follow up to parenteral analgesia in the management of post-operative pain for soft tissue surgery..
Contraindications
Do not use in cats. Do not use in case of hypersensitivity to active substance or to any of the excipients. Do not use in dogs suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia.
Special warnings for each target species
Use in dogs less than 6 weeks of age, or in aged dogs, may involve additional risk. If such a use cannot be avoided, dogs may require careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity.
Concurrent administration of potential nephrotoxic drugs should be avoided. NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated.
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.
Special precautions for use
Special precautions to be taken by the person administering the medicinal product to animals
In the event of accidental ingestion of the tablets, seek medical advice and show the doctor the package leaflet. Wash hands after handling the product.
Adverse reactions (frequency and seriousness)
Typical undesirable effects associated with NSAIDs, such as vomiting, soft faeces/diarrhoea, faecal occult blood, loss of appetite and lethargy have been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. If adverse reactions occur, use of the product should be stopped and the advice of a veterinarian should be sought. As with other NSAIDs there is a risk of rare renal or idiosyncratic hepatic adverse events.
Use during pregnancy, lactation or lay
Studies in laboratory species (rat and rabbit) have shown evidence of foetotoxic effects of carprofen at doses close to the therapeutic dose. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use in pregnant or lactating bitches.
Interaction with other medicinal products and other forms of interaction
Carprofen must not be administered with glucocorticoids. Refer also to "Special Precautions for Use".
Amounts to be administered and administration route
For oral administration. 4 mg carprofen per kg bodyweight per day. An initial dose of 4 mg carprofen per kg bodyweight per day given as a single daily dose or in two equally divided doses may, subject to clinical response, be reduced after 7 days to 2 mg carprofen/kg bodyweight/day given as a single dose. Duration of treatment will be dependant upon the response seen. Long term treatment should be under regular veterinary supervision. To extend analgesic and anti-inflammatory cover post-operatively, parenteral preoperative treatment may be followed with Carprofen tablets at 4mg/kg/day for 2 days. Do not exceed the stated dose.
Overdose (symptoms, emergency procedures, antidotes)
No signs of toxicity appeared when dogs were treated with Carprofen at levels up to 6 mg/kg twice daily for 7 days (3 times the recommended dose rate of 4mg/kg) and 6mg/kg once daily for a further 7 days (1.5 the recommended dose rate of 4 mg/kg). There is no specific antidote for carprofen overdosage but general supportive therapy, as applied to clinical overdosage with NSAIDs should be applied.
Withdrawal period
Not applicable.
Incompatibilities
In the absence of compatibility studies, this product should not be mixed with other veterinary medicinal products.
Shelf life
Canidryl 20mg and 50mg tablets:
Shelf-life when packed in blister packs: 4 years
Shelf-life when packed in HDPE containers: 3 years
Canidryl 100mg Tablets
Shelf-life: 3 years.
Any divided and unused tablets should be discarded immediately.
Special precautions for storage
Store in a dry place in the original package. Protect from light.
Nature and composition of immediate packaging
Pack sizes for Blister Packs
6, 10, 14, 20, 28, 30, 42, 50, 56, 60, 70, 84, 98, 100, 140, 180, 200, 250, 280, 300, 500 and 1000 tablets.
Pack sizes for Containers
The container pack sizes are as follows:
6, 10, 14, 20, 28, 30, 42, 50, 60 ,70, 84, 98, 100, 140, 180, 200, 250, 280, 300, 500, 1000
Not all pack sizes may be marketed.
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 product should be disposed of in accordance with local requirements.
Reg. Numbers:
20mg: 46047/05-07-2007/K-0164901
50mg: 46138/05-07-2007/K-0164902
100mg: 46140/05-07-2007/K-0164903
