Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Pentosan polysulphate sodium
Chanelle Pharmaceuticals Manufacturing Limited
QM01AX90
Pentosan polysulphate sodium
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
pentosan polysulfate sodium
Authorised
2018-07-20
Health Products Regulatory Authority 05 May 2021 CRN00C56S Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Osteopen 100 mg/ml Solution for injection for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Pentosan Polysulphate Sodium 100 mg/ml EXCIPIENTS: Benzyl Alcohol E1519 10.45 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. A clear pale yellow aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of lameness and pain of degenerative joint disease/osteoarthritis (non-infectious arthrosis) in the skeletally mature dog. 4.3 CONTRAINDICATIONS Do not use in 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 known cases of hypersensitivity to the active substance or to any of the excipients. Do not use in the skeletally immature dog (i.e. dogs whose long bone growth plates have not closed). As pentosan polysulphate has an anticoagulant effect, do not use in dogs with blood disorders, coagulation disorders, bleeding, trauma or malignancy (especially haemangiosarcoma) or during the peri-operative period within 6 – 8 hours of surgery. Do not use in arthritides of immunological origin (e.g. rheumatoid arthritis). 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 Special precautions for use in animals Do not exceed the standard dose. Increasing the recommended dose may result in exacerbation of stiffness and discomfort. Because of the fibrinolytic action of pentosan polysulphate sodium, the possibility of internal bleeding from a tumour or vascular abnormality should be considered and appropriate therapeutic action taken. It has bee Read the complete document