Country: European Union
Language: English
Source: EMA (European Medicines Agency)
eptotermin alfa
Olympus Biotech International Limited
M05BC02
eptotermin alfa
Drugs for treatment of bone diseases, Bone morphogenetic proteins
Tibial Fractures
Treatment of nonunion of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible.
Revision: 13
Withdrawn
2001-05-17
18 B. PACKAGE LEAFLET Medicinal product no longer authorised 19 PACKAGE LEAFLET: INFORMATION FOR THE USER OSIGRAFT 3.3 MG POWDER FOR SUSPENSION FOR IMPLANTATION eptotermin alfa READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Osigraft is and what it is used for 2. Before you use Osigraft 3. How to use Osigraft 4. Possible side effects 5 How to store Osigraft 6. Further information 1. WHAT OSIGRAFT IS AND WHAT IT IS USED FOR Osigraft is a type of medicine known as a bone morphogenetic protein (BMP). This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it. Osigraft is implanted in adult patients with fractures of the tibia which have failed to heal for at least 9 month duration in cases where treatment with autograft (transplanted bone from your hip) has failed or should not be used. 2. BEFORE YOU USE OSIGRAFT DO NOT USE OSIGRAFT - if you are allergic to eptotermin alfa or collagen, the other ingredient of Osigraft (see section 6). - if you are an adolescent and your skeleton is not yet fully formed (still growing). - if you are a child (below 18 years old) - if you have an autoimmune disease (disease arising from or directed against your own tissues), including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren’s syndrome and dermatomyositis/ polymyositis. - if you have active infection at the site of non-union (inflammation and drainage at the site of injury) or active systemic infection. - if your doctor determines that you have inadequate skin coverage (at the fracture site) and inadequate blood supply at your site of surgery. - for vertebral (spine) fractures. - for treating non-union resulting from pathological (disease-related) fractures, metabolic bone disea Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Osigraft 3.3 mg powder for suspension for implantation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 3.3 mg of eptotermin alfa* *Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for suspension for implantation. White to off-white granular powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of non-union of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Osigraft should be used by an appropriately qualified surgeon. The recommended dose is one single administration in adults. Depending on the size of the bone defect, more than one 1 g vial of Osigraft may be required. The recommended maximum dose should not exceed 2 vials since efficacy in the treatment on non-unions requiring higher doses has not been established. Paediatric population Osigraft is contraindicated in children and adolescents (less than 18 years old) and the skeletally immature (see section 4.3). Method of administration: Intraosseous use. The reconstituted product is administered by direct surgical placement at the non-union site in contact with the prepared bone surface. The surrounding soft tissues are then closed around the implant. Experience from controlled clinical trials is limited to stabilisation of the fracture by intramedullary nailing. 1. Using sterile technique, remove the vial from its packaging. 2. Lift the plastic flip-top and remove the crimp from the vial. Handle the crimp with care. The edges of the crimp are sharp and may cut or damage gloves. 3. Using your thumb, pry up the edge of the stopper. Once the vacuum is broken, remove the vial stopper while holding the vial upright to prevent loss Read the complete document