Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
temozolomide
medac Gesellschaft für klinische Spezialpräparate mbH
L01AX03
temozolomide
Antineoplastic agents
Glioma; Glioblastoma
Temomedac hard capsules 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.
Revision: 15
Authorised
2010-01-25
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER TEMOMEDAC 5 MG HARD CAPSULES TEMOMEDAC 20 MG HARD CAPSULES TEMOMEDAC 100 MG HARD CAPSULES TEMOMEDAC 140 MG HARD CAPSULES TEMOMEDAC 180 MG HARD CAPSULES TEMOMEDAC 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 Temomedac is and what it is used for 2. What you need to know before you take Temomedac 3. How to take Temomedac 4. Possible side effects 5. How to store Temomedac 6. Contents of the pack and other information 1. WHAT TEMOMEDAC IS AND WHAT IT IS USED FOR Temomedac contains a medicine called temozolomide. This medicine is an antitumour agent. Temomedac is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. Temomedac 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. Temomedac is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOMEDAC DO NOT TAKE TEMOMEDAC - 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 dacarbazine (an anticancer medicine sometimes called DTIC). Signs of allergic reaction include feeling itchy, breathlessness or wheezin Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Temomedac 5 mg hard capsules Temomedac 20 mg hard capsules Temomedac 100 mg hard capsules Temomedac 140 mg hard capsules Temomedac 180 mg hard capsules Temomedac 250 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Temomedac 5 mg hard capsules Each hard capsule contains 5 mg temozolomide. Temomedac 20 mg hard capsules Each hard capsule contains 20 mg temozolomide. Temomedac 100 mg hard capsules Each hard capsule contains 100 mg temozolomide. Temomedac 140 mg hard capsules Each hard capsule contains 140 mg temozolomide. Temomedac 180 mg hard capsules Each hard capsule contains 180 mg temozolomide. Temomedac 250 mg hard capsules Each hard capsule contains 250 mg temozolomide. _Excipient with known effect _ Temomedac 5 mg hard capsules Each hard capsule contains 87 mg of anhydrous lactose. Temomedac 20 mg hard capsules Each hard capsule contains 72 mg of anhydrous lactose and sunset yellow FCF (E110). Temomedac 100 mg hard capsules Each hard capsule contains 84 mg of anhydrous lactose. Temomedac 140 mg hard capsules Each hard capsule contains 117 mg of anhydrous lactose. Temomedac 180 mg hard capsules Each hard capsule contains 150 mg of anhydrous lactose. Temomedac 250 mg hard capsules Each hard capsule contains 209 mg of anhydrous lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). 3 Temomedac 5 mg hard capsules The hard capsules (length approx. 16 mm) have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body. Temomedac 20 mg hard capsules The hard capsules (length approx. 18 mm) have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body. Temomedac 100 mg hard capsules The hard capsules (length approx. 20 mm) have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body. Temomedac 140 mg Đọc toàn bộ tài liệu