Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Temozolomide
Clonmel Healthcare Ltd
L01AX; L01AX03
Temozolomide
5 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Other alkylating agents; temozolomide
Marketed
2010-05-21
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER TEMOZOLOMIDE CLONMEL 5MG HARD CAPSULES TEMOZOLOMIDE CLONMEL 20MG HARD CAPSULES TEMOZOLOMIDE CLONMEL 100MG HARD CAPSULES TEMOZOLOMIDE CLONMEL 140MG HARD CAPSULES TEMOZOLOMIDE CLONMEL 180MG HARD CAPSULES TEMOZOLOMIDE CLONMEL 250MG 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 Clonmel is and what it is used for 2. What you need to know before you take Temozolomide Clonmel 3. How to take Temozolomide Clonmel 4. Possible side effects 5. How to store Temozolomide Clonmel 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE CLONMEL IS AND WHAT IT IS USED FOR Temozolomide Clonmel contains a medicine called temozolomide. This medicine is an antitumour agent. Temozolomide Clonmel is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. Temozolomide Clonmel 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 Clonmel is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE CLONMEL DO NOT TAKE TEMOZOLOMIDE CLONMEL - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6). - if you Perskaitykite visą dokumentą
Health Products Regulatory Authority 06 April 2023 CRN00DHTG Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Temozolomide Clonmel 5mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg temozolomide. Excipient with known effect Each hard capsule contains 87 mg lactose and 0.21 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. The hard capsules 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 with a diameter of approximately 5.7 mm and a length of approximately 15.9 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Temozolomide Clonmel 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Temozolomide Clonmel 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 Clonmel 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/m² 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 concomit Perskaitykite visą dokumentą