Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
temozolomide
Accord Healthcare S.L.U.
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: 23
Authorised
2010-03-15
61 B. PACKAGE LEAFLET 62 PACKAGE LEAFLET: INFORMATION FOR THE USER TEMOZOLOMIDE ACCORD 5 MG HARD CAPSULES TEMOZOLOMIDE ACCORD 20 MG HARD CAPSULES TEMOZOLOMIDE ACCORD 100 MG HARD CAPSULES TEMOZOLOMIDE ACCORD 140 MG HARD CAPSULES TEMOZOLOMIDE ACCORD 180 MG HARD CAPSULES TEMOZOLOMIDE ACCORD 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 Accord is and what it is used for 2. What you need to know before you take Temozolomide Accord 3. How to take Temozolomide Accord 4. Possible side effects 5. How to store Temozolomide Accord 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE ACCORD IS AND WHAT IT IS USED FOR Temozolomide is an antitumour-r medicine. Temozolomide Accord capsules is used for the treatment of specific forms of brain tumours: - In adults with newly-diagnosedglioblastoma multiforme. Temozolomide 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, glioblastoma multiforme or anaplastic Astrocytoma. Tamozolomide is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE ACCORD DO NOT TAKE TEMOZOLOMIDE ACCORD - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6). - if you have had an allergic reaction to another anti-cancer medicine called Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 5 mg hard capsules. Temozolomide Accord 20 mg hard capsules. Temozolomide Accord 100 mg hard capsules. Temozolomide Accord 140 mg hard capsules. Temozolomide Accord 180 mg hard capsules. Temozolomide Accord 250 mg hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5mg hard capsules Each hard capsule contains 5 mg temozolomide. Excipient with known effect: Each hard capsule contains 168 mg of anhydrous lactose. 20mg hard capsules Each hard capsule contains 20 mg temozolomide. Excipients with known effect: Each hard capsule contains 14.6 mg of anhydrous lactose. 100mg hard capsules Each hard capsule contains 100 mg temozolomide. Excipients with known effect: Each hard capsule contains 73 mg of anhydrous lactose. 140mg hard capsules Each hard capsule contains 140 mg temozolomide. Excipients with known effect: Each hard capsule contains 102.2 mg of anhydrous lactose. 180mg hard capsules Each hard capsule contains 180 mg temozolomide. Excipients with known effect: Each hardcapsule contains 131.4 mg of anhydrous lactose. 250mg hard capsules Each hard capsule contains 250 mg temozolomide. Excipients with known effect: Each hard capsule contains 182.5 mg of anhydrous lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 5mg hard capsule. 3 The hard capsules are green/white hard gelatin capsules imprinted ‘TMZ’ on cap & ‘5’ on body.Each capsule is approximately 15 mm in length. 20 mg hard capsule. The hard capsules are yellow/ white hard gelatin capsules, imprinted ‘TMZ’ on cap & ‘20’ on body. Each capsule is approximately 11 mm in length. 100mg hard capsule. The hard capsules are pink/white hard gelatin capsules, imprinted ‘TMZ’ on cap & ‘100’ on body. Each capsule is approximately 15 mm in length. 140mg hard capsule. The hard capsules are transparent blue/white hard gelatin capsules, imprinted ‘TMZ’ on cap & ‘140’ on body. Each capsule is approximately 19 Прочетете целия документ