Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
TiGenix N.V.
M09AX02
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Other drugs for disorders of the musculo-skeletal system
Cartilage Diseases
Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1 and 5 cm².
Revision: 6
Withdrawn
2009-10-05
20 B. PACKAGE LEAFLET Medicinal product no longer authorised 21 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ CHONDROCELECT 10,000 CELLS/MICROLITRE IMPLANTATION SUSPENSION Characterised viable autologous cartilage cells expanded _ex vivo_ expressing specific marker proteins READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, surgeon or physical therapist. - If you get any of the side effects, talk to your doctor, surgeon or physical therapist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What ChondroCelect is and what it is used for 2. What you need to know before you use ChondroCelect 3. How to use ChondroCelect 4. Possible side effects 5. How to store ChondroCelect 6. Contents of the pack and other information 1. WHAT CHONDROCELECT IS AND WHAT IT IS USED FOR ChondroCelect consists of autologous cultured cartilage cells. The product is made from a small sample of cartilage cells (a biopsy) taken from your knee. • AUTOLOGOUS means that your own cells are used to make ChondroCelect. • CARTILAGE is a tissue that is present in every joint. It protects the ends of our bones and allows our joints to function smoothly. ChondroCelect is used to repair single symptomatic cartilage defects in the femoral condyle of the knee in adults. A defect can be caused by acute trauma, such as a fall. It can also be caused by repetitive trauma, as a result of overweight or due to incorrect weight-bearing on the knee as a result of a knee deformity. • The FEMORAL CONDYLE is the end of the thigh bone, which forms part of your knee. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHONDROCELECT _ _ DO NOT USE CHONDROCELECT IF YOU: - are allergic to any of the ingredients of ChondroCelect (listed in section 6) or to bovine serum - suffer from advanced osteoarthritis (degenerative joint disease) in your Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT ChondroCelect 10,000 cells/microlitre implantation suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Characterised viable autologous cartilage cells expanded _ex vivo_ expressing specific marker proteins. 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of product contains 4 million autologous human cartilage cells in 0.4 ml cell suspension, corresponding to a concentration of 10,000 cells/microlitre. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Implantation suspension Before re-suspension the cells are settled to the bottom of the container forming an off-white layer and the excipient is a clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults. Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1-5cm². 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ChondroCelect must be administered by an appropriately qualified surgeon and is restricted to hospital use only. ChondroCelect is solely intended for autologous use and should be administered in conjunction with debridement (preparation of the defect bed), a physical seal of the lesion (placement of a biological membrane, preferentially a collagen membrane) and rehabilitation. Posology The amount of cells to be administered is dependent on the size (surface in cm²) of the cartilage defect. Each product contains an individual treatment dose with sufficient number of cells to treat the pre- defined lesion size, as measured at biopsy procurement. The recommended dose of ChondroCelect is 0.8 to 1 million cells/cm², corresponding with 80 to 100 mic Lugege kogu dokumenti