Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Temsirolimus
Pfizer Europe MA EEIG
L01XE09
temsirolimus
Antineoplastic agents
Carcinoma, Renal Cell; Lymphoma, Mantle-Cell
Renal-cell carcinomaTorisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.Mantle-cell lymphomaTorisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).
Revision: 33
Authorised
2007-11-19
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Torisel IV use 2. METHOD OF ADMINISTRATION See package leaflet 3. EXPIRY DATE EXP 4. BATCH NUMBER Lot 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.2 ml 6. OTHER Contains: polysorbate 80 (E 433), macrogol 400, anhydrous ethanol. 37 B. PACKAGE LEAFLET 38 Package leaflet: Information for the patient Torisel 30 mg concentrate and solvent for solution for infusion temsirolimus 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, pharmacist or nurse. - If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possibleside effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Torisel is and what it is used for 2. What you need to know before you receive Torisel 3. How Torisel is given 4. Possible side effects 5. How to store Torisel 6. Contents of the pack and other information 1. What Torisel is and what it is used for Torisel contains the active substance temsirolimus. Temsirolimus is a selective inhibitor of the enzyme mTOR (mammalian target of rapamycin) that blocks tumour cell growth and division. Torisel is used to treat the following types of cancer in adults: - Advanced cancer of the kidney (renal cancer). - Previously treated mantle cell lymphoma, a type of cancer affecting the lymph nodes. 2. What you need to know before you receive Torisel Do not use Torisel - if you are allergic to temsirolimus, to polysorbate 80 or to any of the other ingredients listed in section 6. - if you are allergic to sirolimus (used to prevent the body from rejecting transplanted kidneys) since sirolimus is released from temsirolimus in the body. - if you have mantle cell lymphoma and liver problems. Warnings and precautions Talk to your doctor, phar Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Torisel 30 mg concentrate and solvent for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of concentrate for solution for infusion contains 30 mg temsirolimus. After first dilution of the concentrate with 1.8 ml of solvent, the concentration of temsirolimus is 10 mg/ml (see section 4.2). Excipients with known effect Ethanol 1 vial of concentrate contains 474 mg of anhydrous ethanol which is equivalent to 394.6 mg/ml (39.46% w/v). 1.8 ml of the solvent provided contains 358 mg anhydrous ethanol which is equivalent to 199.1 mg/ml (19.91% w/v). Propylene glycol 1 vial of concentrate contains 604 mg of propylene glycol which is equivalent to 503.3 mg/ml (50.33% w/v). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for solution for infusion (sterile concentrate). The concentrate is a clear, colourless to light-yellow solution, free from visible particulates. The solvent is a clear to slightly turbid, light-yellow to yellow solution, free from visible particulates. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Renal cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors (see section 5.1). Mantle cell lymphoma Torisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1). 4.2 Posology and method of administration This medicinal product must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. 3 Posology Patients should be given intravenous diphenhydramine 25 mg to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose of temsirolimus (see section 4.4). Treatment with Torisel should continue until the patient is no longer clinically benefiting from therapy or until Lesen Sie das vollständige Dokument