Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
pentosan polysulfate sodium 100 mg
Arthropharm (Europe) Limited
QM01AX90
Solution for injection
Pentosan polysulfate
Dogs Non Food
2011-10-20
Revised: May 2013 AN: 00194/2012 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Anarthron 100mg/mL solution for injection for dogs (AT, BE, FR, NL, UK) Cartrophen Vet 100mg/mL solution for injection for dogs (IS, NO, PL) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pentosan Polysulfate Sodium 100mg/ml Benzyl Alcohol 0.01ml/ml 3. PHARMACEUTICAL FORM Solution for injection A clear, colourless pale yellow solution. 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 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 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). Revised: May 2013 AN: 00194/2012 Page 2 of 6 4.4 SPECIAL WARNINGS 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 Read the complete document