Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
ex vivo expanded autologous human corneal epithelial cells containing stem cells
Holostem s.r.l
S01XA19
ex vivo expanded autologous human corneal epithelial cells containing stem cells
Ophthalmologicals
Stem Cell Transplantation; Corneal Diseases
Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.
Revision: 10
Authorised
2015-02-17
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HOLOCLAR 79,000 – 316,000 CELLS/CM 2 LIVING TISSUE EQUIVALENT _Ex vivo_ expanded autologous human corneal epithelial cells containing stem cells. 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 the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 surgeon. - If you get any side effects, talk to your surgeon. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Holoclar is and what it is used for 2. What you need to know before you are given Holoclar 3. How Holoclar is given 4. Possible side effects 5. How Holoclar is stored 6. Contents of the pack and other information 1. WHAT HOLOCLAR IS AND WHAT IT IS USED FOR Holoclar is a medicine used for replacing damaged cells of the cornea (the clear layer that covers the coloured iris at the front of the eye) including limbal cells which normally help to maintain the health of your eye. Holoclar consists of a layer of your own cells which have been grown ( _ex vivo_ expanded) from a sample of limbal cells taken from your eye during a small surgical procedure called a biopsy. Each preparation of Holoclar is made individually and is for a single treatment only, although treatments can be repeated. The cells used to make Holoclar are known as autologous limbal cells: • AUTOLOGOUS means that they are your own cells. • The LIMBUS is part of the eye. It is the rim surrounding the coloured centre (iris) of your eye. The picture shows where the limbus is in your eye. • The limbus contains LIMBAL CELLS which normally help to maintain the health of your eye and some of these are STEM CELLS which can make Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 Holoclar 79,000 - 316,000 cells/cm 2 living tissue equivalent 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION _Ex vivo_ expanded autologous human corneal epithelial cells containing stem cells. 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION Holoclar consists of a transparent circular sheet of 300,000 to 1,200,000 viable autologous human corneal epithelial cells (79,000 - 316,000 cells/ cm 2 ), including on average 3.5 % (0.4 to 16 %) limbal stem cells, and stem cell-derived transient amplifying and terminally differentiated cells, attached on a supportive 2.2 cm diameter fibrin layer and maintained in the transport medium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Living tissue equivalent. Transparent, circular sheet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. A minimum of 1 - 2 mm 2 of undamaged limbus is required for biopsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Holoclar must be administered by an appropriately trained and qualified surgeon and is restricted to hospital use only. _ _ Posology This medicinal product is intended for autologous use only. The amount of cells to be administered is dependent on the size (surface in cm²) of the corneal surface. Each preparation of Holoclar contains an individual treatment dose with sufficient number of cells to cover the entire corneal surface. The recommended do Pročitajte cijeli dokument