Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Temozolomide
Fairmed Healthcare GmbH
L01AX; L01AX03
Temozolomide
20 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Other alkylating agents; temozolomide
Not marketed
2013-06-28
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ TEMOZOLOMIDE FAIR-MED 5 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 20 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 100 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 140 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 180 MG HARD CAPSULES TEMOZOLOMIDE FAIR-MED 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 FAIR-MED is and what it is used for 2. What you need to know before you use Temozolomide FAIR-MED 3. How to use Temozolomide FAIR-MED 4. Possible side effects 5. How to store Temozolomide FAIR-MED 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE FAIR-MED IS AND WHAT IT IS USED FOR Temozolomide FAIR-MED contains a medicine called temozolomide. This medicine is an antitumour agent. Temozolomide FAIR-MED is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. Temozolomide FAIR-MED 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 FAIR-MED is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEMOZOLOMIDE FAIR-MED DO NOT USE TEMOZOLOMIDE FAIR-MED - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in sect Preberite celoten dokument
Health Products Regulatory Authority 17 May 2022 CRN00CK4J Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Temozolomide FAIR-MED 20 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20 mg temozolomide. Excipient with known effect: Each 20 mg hard capsule contains 384.3 mg of anhydrous lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. The hard gelatin capsules are size 0 and have an orange opaque cap /white opaque body with 20 printed in black ink on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Temozolomide FAIR-MED hard capsules is indicated for the treatment of - adult patients with newly diagonsed glioblastoma multiforme concomitantly with radiopathy (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 aplastic astrocytoma, showing recurrence or progression after standard therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Temozolomide FAIR-MED hard capsules 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 FAIR-MED hard capsules 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) if all of the following conditions are met: - absolute neutrop Preberite celoten dokument