Introduction

Company name: Arthropharm (Europe) Limited

Address: 42 Upper Ramone Park

Portadown

Co Armagh

BT63 5TD

Northern Ireland

Telephone and Fax: 028 3833 1078

Presentation

A clear colourless to slightly yellow aqueous solution for subcutaneous administration. Each ml contains:

100 mg Pentosan Polysulphate Sodium

0.01 ml Benzyl Alcohol

Uses

Pentosan Polysulphate Sodium is a semi-synthetic polymer with a mean molecular weight of 4000 Daltons, with anti-inflammatory activity, and modulating effects on cartilage and synovial metabolism and an affinity for cartilage. In addition, it has fibrinolytic, lipolytic and mild anti-coagulant activities. The therapeutic activity of the product arises from the action of Pentosan Polysulphate Sodium on the underlying pathological processes of osteoarthritis (disease modifying osteoarthritis drug or DMOAD) and results in analgesic and regenerative effects. Cartrophen Vet has been shown to produce equal improvement in the clinical signs of osteoarthritis when compared to the NSAID, carprofen.

Cartrophen Vet is indicated for the treatment of lameness and pain of osteoarthritis (non-infectious arthrosis) and related musculoskeletal disorders in the dog.

Dosage and administration

Dosage

3 mg Pentosan Polysulphate Sodium/kg bodyweight on four occasions, with an interval of 5–7 days.

Administration

By aseptic subcutaneous injection only of 0.3 ml Cartrophen Vet/10 kg bodyweight. For accurate dosing use must be made of an insulin-type syringe.

Contra-indications, warnings, etc

Cartrophen Vet is contra-indicated for the treatment of septic arthritis. In this case, appropriate antimicrobial therapy should be instigated.

Cartrophen Vet has an effect on blood coagulation due to its fibrinolytic activity that lasts for up to 6–8 hours after administration. This is of no clinical significance in the normal dog.

Do not use in dogs with uncontrolled bleeding, trauma, infection, advanced liver or kidney impairment and cancer, especially haemangiosarcoma. It has been reported that a dog which had suffered pulmonary lacerations twelve months previously had severe pulmonary bleeding after an injection of Cartrophen Vet. Use with caution in dogs with a history of pulmonary lacerations.

Rarely, reaction to the injection may occur within 24 hours in an apparently healthy animal. In these circumstances treatment should be discontinued and symptomatic relief given. Because of the fibrinolytic action of Cartrophen Vet, the possibility of internal bleeding from a tumour or vascular abnormality should be considered and appropriate therapeutic action taken. It is recommended that the PCV and capillary filling time should be monitored.

NSAIDs and in particular aspirin should not be used in combination with Cartrophen Vet as they may affect thrombocyte adhesion and potentiate the anticoagulant activity of Cartrophen Vet. Corticosteroids have been shown to be antagonistic to a number of actions of Cartrophen Vet. Furthermore, use of anti-inflammatory drugs may result in a premature increase in the dog's activity which may interfere with the disease-modifying activity of Cartrophen Vet.

Do not use concurrently with steroids or non-steroidal anti-inflammatory drugs, including aspirin and phenylbutazone, or within 24 hours of such administration.

Occasional emesis may occur following injection.

Pharmaceutical precautions

Do not exceed the standard dose.

Store upright in a refrigerator (2-8°C). Protect from light. Keep out of the reach of children.

Following withdrawal of the first dose, use the contents within 28 days. Discard unused material. Keep container in outer carton. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

When the container is broached (opened) for the first time, using the in-use shelf life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. The discard date should be written in the space provided on the carton.

Operator warning

Care should be taken to avoid accidental self-injection. Wash splashes from eyes and skin immediately with water. Wash hands after use.