Introduction

Chanelle combined

Chanelle Vet UK Ltd

Address: CBX11 West Wing

382-390 Midsummer Boulevard

Milton Keynes, Bucks MK9 2RG

Telephone: 01908 843636

Fax: 01908 847401

Website: www.chanellevetuk.com

Company name: Chanelle Animal Health Limited

7 Rodney Street

Liverpool

L1 9HZ

Tel & Fax: 01568 750432

Website: www.chanellegroup.ie

Qualitative and quantitative composition

Active ingredient

Carprofen 20 mg/tablet, 50mg/tablet or 100mg/tablet

Pharmaceutical form

Tablet. A plain round flat bevelled edge white tablet with a breakline on one side.

Clinical particulars

Target Species

Dogs

Indications for Use

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.

Contra-indications

Do not use in cats. Do not use in pregnant or lactating bitches. 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

Refer to "Contra-indications" and "Special Precautions for use".

Special Precautions for use

Special Precautions for use in Animals

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 to be taken by the Person Administering the 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. An initial dose of 2 to 4 mg carprofen per kg bodyweight per day is recommended to be given as a single daily dose or in two equally divided doses. Subject to clinical response, the dose may be continued after 7 days at a dose rate of 2mg carprofen/kg bodyweight/day given as a single dose. Duration of treatment will be dependent upon the reponse 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 as required. 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 periods

Not applicable.

Pharmaceutical particulars

Shelf-life of the veterinary medicinal product as packaged for sale is 3 years. Discard half tablets.

Store in a dry place in the original package. Protect from light.

Nature and composition of immediate packaging

(i) White High Density Polyethylene (HDPE) Twist-off plastic containers with child proof tamper evident Polypropylene white twist-off closures. (ii) Blister packs made up of a PVC/PVdC (250um/40g/m2) with a 20mu Hard Temper Aluminium Foil.

Pack sizes

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 and volumes are as follows:

Pack Size:	Container Volume:
6, 10, 14, 20, 28, 30, 42, 50, 60, 70, 84	15ml
98, 100, 140	30ml
180, 200	50ml
250, 280, 300	75ml
500	100ml
1000	250ml

Not all pack sizes may be marketed.

Special Precautions for the Disposal of Unused Veterinary Medicinal Product or Waste Materials Dervied from the use of such products: Any unused product or waste material should be disposed of in accordance with national requirements.