Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
eptotermin alfa
Olympus Biotech International Limited
M05BC02
eptotermin alfa
Drugs for treatment of bone diseases
Spondylolisthesis
Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Revision: 9
Withdrawn
2009-02-19
B. PACKAGE LEAFLET 23 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OPGENRA 3.3 MG POWDER FOR IMPLANTATION SUSPENSION eptotermin alfa This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE ADMINISTERED THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Opgenra is and what it is used for. 2. What you need to know before you are administered Opgenra. 3. How to use Opgenra. 4. Possible side effects. 5 How to store Opgenra. 6. Contents of the pack and other information. 1. WHAT OPGENRA IS AND WHAT IT IS USED FOR Opgenra contains the active substance eptotermin alfa. Opgenra 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. Opgenra is implanted in adult patients with slippage of the spine (spondylolisthesis) in cases where treatment with autograft (transplanted bone from your hip) has failed or must not be used. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE ADMINISTERED OPGENRA DO NOT USE OPGENRA - if you are allergic to eptotermin alfa or to any of the ingredients of this medicine (see section 6). - if you have an autoimmune disease (disease arising from or directed against your own tissues), including Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren’s syndrome and dermatomyositis/ polymyositis. - if you have an active infection in your spine or have been told that you have an active internal (systemic) infection. - if y Izlasiet visu dokumentu
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Opgenra 3.3 mg powder for implantation suspension. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 1g powder with 3.3 mg of eptotermin alfa*. After reconstitution, Opgenra contains 1 mg/ml eptotermin alfa. *Eptotermin alfa is human recombinant osteogenic protein 1 (OP-1) produced in Chinese hamster ovary (CHO) cell line. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for implantation suspension. The powder containing the active substance is granular and white to off-white. The powder containing the excipient carmellose (carboxymethylcellulose) is yellowish white. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should be used by an appropriately qualified surgeon. Posology Opgenra is intended only for single use in each patient. Treatment requires a single surgery. To fuse a single level of the lumbar region of the spine, one unit of medicinal product is used on each side of the spine. The maximum human dose should not exceed 2 units since efficacy and safety for spinal fusion requiring higher doses has not been established. _Paediatric population _ Opgenra is contraindicated in children (<12 years old), adolescents (12-18 years old) and the skeletally immature (see section 4.3). _Renal/hepatic impairment _ Care should be used when Opgenra is used in patients with renal or hepatic impairment (see section 4.4). 2 Medicinal product no longer authorised Method of administration For intrao Izlasiet visu dokumentu