Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
darvadstrocel
Takeda Pharma A/S
L04
darvadstrocel
Immunosuppressants
Rectal Fistula
Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.
Revision: 11
Authorised
2018-03-23
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALOFISEL 5 × 10 6 CELLS/ML DISPERSION FOR INJECTION darvadstrocel 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 doctor or surgeon. − If you get any side effects, talk to your surgeon or doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Alofisel is and what it is used for 2. What you need to know before you are given Alofisel 3. How Alofisel is given 4. Possible side effects 5. How to store Alofisel 6. Contents of the pack and other information 1. WHAT ALOFISEL IS AND WHAT IT IS USED FOR The active ingredient of Alofisel is darvadstrocel which consists of stem cells which are taken from the fat tissue of a healthy adult donor (so-called allogenic stem cells) and then grown in a laboratory. Adult stem cells are a special type of cells found in many adult tissues, whose primary role is the repair of the tissue in which they are found. Alofisel is a medicine used for the treatment of complex perianal fistulas in adult patients with Crohn´s disease (a disease causing inflammation of the gut) when the other symptoms of the disease are controlled or have a mild intensity. Perianal fistulas are abnormal channels that connect parts of the lower bowel (rectum and anus) and the skin near the anus, so that one or more openings appear near the anus. Perianal fistulas are described as complex if they have multiple channels and openings, if they penetrate deep inside your body or if they are associated with other complications such as collections of pus (infected liquid also called abscesses). Perianal fistulas can cause pain, irritation and discharge of pus through the openings to the skin. Alofisel is used when the fistulas have not responded sufficiently well to previous treatment. When injected close to th Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Alofisel 5 × 10 6 cells/mL dispersion for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Alofisel (darvadstrocel) is expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells - eASC). 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 30 × 10 6 cells (eASC) in 6 mL of dispersion, corresponding to a concentration of 5 × 10 6 cells/mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersion for injection (injection). The dispersion of cells may have settled in the bottom of the vial forming a sediment. After gentle re-suspension, the product is a white to yellowish homogeneous dispersion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used only after conditioning of the fistulas (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which Alofisel is indicated. Posology A single dose of darvadstrocel consists of 120 × 10 6 cells supplied in 4 vials. Each vial contains 30 × 10 6 cells in 6 mL of dispersion. The full content of the 4 vials must be administered for the treatment of up to two internal openings and up to three external openings. This means that with a dose of 120 × 10 6 cells it is possible to treat up to three fistula tracts that open to the perianal area. The efficacy or safety of repeat administration of Alofisel has not been established. _ _ Special populations _ _ _Elderly _ Data on the use of darvadstrocel in the elderly population are limited, however, given the cell-based nature of darvadstrocel a Прочитать полный документ