Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
spheroids of human autologous matrix-associated chondrocytes
CO.DON Gmbh
M09AX02
spheroids of human autologous matrix-associated chondrocytes
Other drugs for disorders of the musculo-skeletal system
Cartilage Diseases
Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Repair Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults.,
Revision: 8
Authorised
2017-07-10
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SPHEROX 10-70 SPHEROIDS/CM 2 IMPLANTATION SUSPENSION spheroids of human autologous matrix-associated chondrocytes READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN WITH 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 or physical therapist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Spherox is and what it is used for 2. What you need to know before you are given Spherox 3. How to use Spherox 4. Possible side effects 5. How to store Spherox 6. Contents of the pack and other information 1. WHAT SPHEROX IS AND WHAT IT IS USED FOR Spherox is a medicine used to REPAIR DAMAGE TO THE CARTILAGE OF THE KNEE in adults and in adolescents whose bones in the joint have finished growing. Cartilage is a hard smooth layer inside your joints, on the ends of the bones. It protects the bones and allows joints to work smoothly. Spherox is used in adults, or adolescents whose bones have finished growing, when the cartilage in the knee joint is damaged, for example by acute injury, such as a fall or long-term wear due to incorrect weight bearing on the joint. Spherox is used to treat defects up to 10 cm² in size. Spherox consists of so-called spheroids. A spheroid looks like a tiny pearl made of cartilage cells and cartilage material derived from your own body. To make the spheroids, a small cartilage sample is taken from one of your joints during a minor operation, and then grown in the laboratory to make the medicine. The spheroids are implanted by surgery to the damaged cartilage area and stick to the damaged part. They are then expected to repair the damage with healthy and functional cartilage over time. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SPHEROX DO NOT USE SPHEROX IF • the bones in the knee joi Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Spherox 10-70 spheroids/cm 2 implantation suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Spheroids of human autologous matrix-associated chondrocytes for implantation suspended in isotonic sodium chloride solution. 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION Spheroids are spherical aggregates of _ex vivo_ expanded human autologous chondrocytes and self- synthesized extracellular matrix. Each pre-filled syringe or applicator contains a specific number of spheroids according to the defect size (10-70 spheroids/cm 2 ) to be treated. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Implantation suspension. White to yellowish spheroids of matrix-associated autologous chondrocytes in a clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm 2 in adults and adolescents with closed epiphyseal growth plate in the affected joint. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Spherox is intended for autologous use only. It must be administered by a specialised orthopedic surgeon and in a medical facility. Posology 10-70 spheroids are applied per square centimetre defect. _Elderly _ The safety and efficacy of Spherox in patients aged over 50 years have not been established. No data are available. _Paediatric population _ The safety and efficacy of Spherox in children and adolescents with still open epiphyseal growth plate in the affected joint have not been established. No data are available. 3 Method of administration For intraarticular use. Spherox is administered to patients by intraarticular implantation. The treatment with Spherox is a two-step procedure. In a first step, a biopsy must be performed during a surgical procedure (preferably an arthros Lugege kogu dokumenti