Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
temozolomide
Sandoz GmbH
L01AX03
temozolomide
Antineoplastic agents
Glioma; Glioblastoma
For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Revision: 17
Withdrawn
2010-03-15
132 B. PACKAGE LEAFLET Medicinal product no longer authorised 133 PACKAGE LEAFLET: INFORMATION FOR THE USER TEMOZOLOMIDE SANDOZ 5 MG HARD CAPSULES TEMOZOLOMIDE SANDOZ 20 MG HARD CAPSULES TEMOZOLOMIDE SANDOZ 100 MG HARD CAPSULES TEMOZOLOMIDE SANDOZ 140 MG HARD CAPSULES TEMOZOLOMIDE SANDOZ 180 MG HARD CAPSULES TEMOZOLOMIDE SANDOZ 250 MG HARD CAPSULES temozolomide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Temozolomide Sandoz is and what it is used for 2. What you need to know before you take Temozolomide Sandoz 3. How to take Temozolomide Sandoz 4. Possible side effects 5. How to store Temozolomide Sandoz 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE SANDOZ IS AND WHAT IT IS USED FOR Temozolomide Sandoz contains a medicine called temozolomide. This medicine is an antitumour agent. Temozolomide Sandoz is used for the treatment of specific forms of brain tumours: • in adults with newly-diagnosed glioblastoma multiforme. Temozolomide Sandoz is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment). • in children 3 years and older and adult patients with malignant glioma , such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide Sandoz is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE SANDOZ _ _ DO NOT TAKE TEMOZOLOMIDE SANDOZ • if you are allergic to temozolomide or any of the other ingredi Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Temozolomide Sandoz 5 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg of temozolomide. Excipient with known effect: Each hard capsule contains 168 mg of anhydrous lactose. For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Hard capsule (capsule). _ _ The hard capsules have a white coloured body, a green coloured cap, and are imprinted with black ink. The cap is imprinted with “TMZ”. The body is imprinted with “5”. _ _ Each capsule is approximately 15.8 mm in length. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Temozolomide Sandoz is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment, - children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Temozolomide Sandoz should only be prescribed by physicians experienced in the oncological treatment of brain tumours. Anti-emetic therapy may be administered (see section 4.4). Posology _ _ _Adult patients with newly-diagnosed glioblastoma multiforme _ Temozolomide Sandoz is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase). _ _ _Concomitant phase _ TMZ is administered orally at a dose of 75 mg/m 2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions). No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria. TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) Прочетете целия документ