帝盟多凍晶注射劑

Land: Taiwan

Sprog: kinesisk

Kilde: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Aktiv bestanddel:

TEMOZOLOMIDE

Tilgængelig fra:

美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)

ATC-kode:

L01AX03

Lægemiddelform:

凍晶注射劑

Sammensætning:

TEMOZOLOMIDE (1004002000) MG

Enheder i pakken:

小瓶裝;;盒裝

Klasse:

製　劑

Recept type:

限由醫師使用

Fremstillet af:

BAXTER ONCOLOGY GMBH KANTSTR. 2, 33790 HALLE/WESTFALEN, GERMANY DE

Terapeutisk område:

temozolomide

Terapeutiske indikationer:

新診斷的多形神經膠母細胞瘤,與放射治療同步進行,然後作為輔助性治療。給予標準治療後復發性或惡化之惡性神經膠質瘤,例如:多形神經膠母細胞瘤或退行性星狀細胞瘤。

Produkt oversigt:

註銷日期: 2014/12/25; 註銷理由: 自請註銷; 有效日期: 2015/07/28; 英文品名: Temodal Powder for solution for infusion

Autorisation status:

已註銷

Autorisation dato:

2010-07-28

Indlægsseddel

TEMODAL
® POWDER FOR SOLUTION FOR INFUSION
1. NAME OF THE MEDICINAL PRODUCT
Temodal 2.5 mg/ml powder for solution for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of temozolomide.
After reconstitution, 1 ml solution for infusion contains 2.5 mg
temozolomide.
Excipient: Each vial contains 2.4 mmol sodium.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for infusion. White powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Temodal is indicated for the treatment of:
- patients with newly-diagnosed glioblastoma multiforme concomitantly
with radiotherapy (RT) and then as adjuvant
treatment.
- 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
Temodal 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
Temodal is administered in combination with focal radiotherapy
(concomitant phase) followed by up to 6 cycles of
temozolomide (TMZ) monotherapy (adjuvant phase).
Concomitant phase
TMZ is administered 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
nonhaematological
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
-thrombocyte count ≥ 100 x 10
9
/l
-common toxicity criteria (CTC) non-haematological toxicity ≤ Grade
1 (except for alopecia,nausea and vomiting). During
treatment a complete blood count should be obtained weekly. TMZ
administration should be tempora