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Date: Wednesday, May 22, 2024 20:16

Release 2.59
Cartrophen Vet 100mg/ml Solution for Injection
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Locomotor (including navicular and osteoarthritis)
Active ingredient: Pentosan Polysulphate Sodium
Product:Cartrophen Vet
Product index: Cartrophen Vet
Incorporating:
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.
Cartrophen Vet is indicated for the treatment of lameness and pain of degenerative joint disease/osteoarthrosis (non-infectious arthrosis) in the skeletally mature dog.
Dosage and administration
Dosage
3 mg Pentosan Polysulphate Sodium/kg bodyweight on four occasions, with an interval of 5–7 days between each administration.
Administration
By aseptic subcutaneous injection only of 0.3 ml Cartrophen Vet/10 kg bodyweight. An appropriately graduated syringe must be used to allow accurate administration of the required dose volume.
Contra-indications, warnings, etc
Cartrophen Vet is contra-indicated for the treatment of septic arthritis. In this case, appropriate antimicrobial therapy should be instigated.
Do not use in dogs with advanced liver or kidney impairment, or evidence of infection.
Do not use in dogs with blood disorders, coagulation disorders, bleeding or malignancy (especially haemangiosarcoma). Pentosan polysulfate has an anticoagulant effect.
Do not use during the peri-operative period.
Do not use in the skeletally immature dog (ie dogs whose long bone growth plates have not closed).
A clinical effect may not be observed until after the second injection of the course of treatment.
Dogs should be weighed prior to administration to ensure accurate dosing.
Use with caution in dogs with history of pulmonary lacerations. Caution is also recommended in cases of hepatic impairment.
No more than 3 courses of 4 injections should be administered in a 12 month period.
Laboratory studies in rabbits showed embryotoxic effects associated with a primary effect on the parent at repeated daily doses 2.5 times the recommended therapeutic dose.
The safety of the product in the pregnant bitch has not been studied, therefore use is not recommended in these circumstances.
The product should not be used at the time of parturition due to its anticoagulant effects.
NSAIDs and in particular aspirin should not be used in combination with pentosan polysulfate sodium as they may affect thrombocyte adhesion and potentiate the anticoagulant activity of the product. Corticosteroids have been shown to be antagonistic to a number of actions of pentosan polysulfate sodium. Furthermore, use of anti-inflammatory drugs may result in a premature increase in the dog's activity, which may interfere with the therapeutic activity of the product.
Do not use concurrently with steroids or non-steroidal anti-inflammatory drugs, including aspirin and phenylbutazone.
Do not use concurrently with heparin, warfarin or other anti-coagulants.
Pharmaceutical precautions
Do not exceed the standard dose. Increasing the recommended dose may result in exacerbation of stiffness and discomfort.
Do not store above 25°C. Keep container in the outer carton in order to protect from light. Keep out of the reach of children.
Following withdrawal of the first dose, use the product within 3 months. Discard unused material. 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
Normal precautions should be observed. Care should be taken to avoid accidental self-injection. Wash splashes from eyes and skin immediately with water. Wash hands after use.
Legal category
Legal category: POM-V
Packaging quantities
Multidose vials of 10 ml.
Further information
Nil.
Marketing Authorisation Number
Vm 15519/4001
Significant changes