Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Temozolomide
Sun Pharmaceutical Industries Europe B.V.
L01AX03
Temozolomide
140mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 8718309123260
PACKAGE LEAFLET: INFORMATION FOR THE USER TEMOZOLOMIDE SUN 140 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 SUN is and what it is used for 2. What you need to know before you take Temozolomide SUN 3. How to take Temozolomide SUN 4. Possible side effects 5. How to store Temozolomide SUN 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE SUN IS AND WHAT IT IS USED FOR Temozolomide SUN contains a medicine called temozolomide. This medicine is an antitumour agent. Temozolomide SUN is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. Temozolomide SUN is at 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 SUN is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE SUN DO NOT TAKE TEMOZOLOMIDE SUN - 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 itchiness, breathlessness or wheezing, or swelling of the face, lips, tongue or throat. - if the numbers of certain kinds of blood Прочитать полный документ
OBJECT 1 TEMOZOLOMIDE 140 MG HARD CAPSULES Summary of Product Characteristics Updated 21-Jun-2018 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 1. Name of the medicinal product Temozolomide SUN 140 mg hard capsules 2. Qualitative and quantitative composition Each hard capsule contains 140 mg temozolomide. Excipient with known effect Each hard capsule contains 127.121 mg of lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule (capsule). Hard gelatin capsules, with white opaque cap and body, imprinted in blue ink. The cap is imprinted with '929'. The body is imprinted with '140 mg' and two stripes. 4. Clinical particulars 4.1 Therapeutic indications Temozolomide SUN 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 SUN 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 SUN 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 m Прочитать полный документ