Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
TEMOZOLOMIDE
Actavis Group PTC ehf
L01AX03
TEMOZOLOMIDE
180 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Other alkylating agents
Authorised
2014-08-22
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER TEMOZOLOMIDE ACTAVIS 5 MG HARD CAPSULES TEMOZOLOMIDE ACTAVIS 20 MG HARD CAPSULES TEMOZOLOMIDE ACTAVIS 100 MG HARD CAPSULES TEMOZOLOMIDE ACTAVIS 140 MG HARD CAPSULES TEMOZOLOMIDE ACTAVIS 180 MG HARD CAPSULES TEMOZOLOMIDE ACTAVIS 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 Actavis is and what it is used for 2. What you need to know before you take Temozolomide Actavis 3. How to take Temozolomide Actavis 4. Possible side effects 5. How to store Temozolomide Actavis 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE ACTAVIS IS AND WHAT IT IS USED FOR Temozolomide Actavis contains a medicine called temozolomide. This medicine is an antitumour agent. Temozolomide Actavis is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. Temozolomide Actavis 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 Actavis is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE ACTAVIS DO NOT TAKE TEMOZOLOMIDE ACTAVIS: - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in secti সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Temozolomide Actavis 180mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 180 mg hard capsule contains 180 mg temozolomide. Excipient(s) with known effect: Each hard capsule contains 111.1 mg of anhydrous lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. The180 mg hard capsule are size 0 (21.7 mm in length), have an opaque white body, an opaque chocolate brown cap. The body is imprinted with "180" in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Temozolomide Actavis 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 Actavis 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 Actavis 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 neutrophil count (ANC) 1.5 x 10 9 /l H E A L T H P R O D U C T S R E G U L A T O R Y সম্পূর্ণ নথি পড়ুন