Product Description

NAME OF THE VETERINARY MEDICINAL PRODUCT Cartrophen Vet 100 mg/mL solution for injection for Dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Pentosan Polysulfate Sodium 100.00 mg Excipients Benzyl Alcohol 10.45 mg For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM Solution for injection A clear colourless to slightly yellow aqueous solution for subcutaneous administration.

4. CLINICAL PARTICULARS 4.1 Target species Dog

4.2 Indications for use, specifying the target species For the treatment of lameness and pain of degenerative joint disease/osteoarthrosis (non-infectious arthrosis) in the skeletally mature dog.

4.3 Contraindications Do not use 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 (i.e. dogs whose long bone growth plates have not closed).

4.4 Special warnings for each target species A clinical effect may not be observed until after the second injection of the course of treatment.

4.5 Special precautions for use i. Special precautions for use in animals 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. Do not exceed the standard dose. Increasing the recommended dose may result in exacerbation of stiffness and discomfort. No more than 3 courses of 4 injections should be administered in a 12 month period. ii. Special precautions for the person administering the veterinary medicinal product to animals Care should be taken to avoid accidental self-injection. In the event of accidental injection, seek medical advice immediately and show the package leaflet or label to the physician. Wash splashes from eyes and skin immediately with water. Wash hands after use.

4.6 Adverse reactions (frequency and seriousness) Emesis, diarrhoea, lethargy and anorexia have been reported following the use of pentosan polysulfate. These signs may be the result of a hypersensitivity reaction and may require appropriate symptomatic treatment including antihistamine administration.

Administration of the product at recommended dose rates results in increases of activated partial thromboplastin time (aPTT) and thrombin time (TT) which may persist for up to 24 hours after administration in healthy dogs. This very rarely results in clinical effects, but because of the fibrinolytic action of pentosan polysulfate sodium, the possibility of internal bleeding from a tumour or vascular abnormality should be considered if signs develop. It is recommended that the animal should be monitored for signs of blood loss and treated appropriately Bleeding disorders such as nasal bleeding, haemorrhagic diarrhoea and haematomas have been reported. Local reactions such as a transient swelling have been observed post injection. 4.7 Use during pregnancy, lactation or lay Laboratory studies in rabbits showed embryotoxic effects associated with a primary effect on the parent at repeated daily doses 2.5 times the recommended 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.

For full Details see Data Sheet

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