帝盟多膠囊５毫克

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:

膠囊劑

Sammensætning:

TEMOZOLOMIDE (1004002000) MG

Enheder i pakken:

玻璃瓶裝

Klasse:

製　劑

Recept type:

須由醫師處方使用

Fremstillet af:

ORION CORPORATION TENGSTROMINKATU 8, FIN-20360 TURKU, FINLAND. FI

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: 2015/01/05; 註銷理由: 自請註銷; 有效日期: 2016/12/05; 英文品名: TEMODAL CAPSULES 5MG

Autorisation status:

已註銷

Autorisation dato:

2001-12-05

Indlægsseddel

TEMODAL
®
Capsules
Brand of temozolomide
For Oral Administration
DESCRIPTION
Temozolomide (SCH 52365), the active ingredient of TEMODAL is an
imidazotetrazine derivative. Its chemical
name is
3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide.
The molecular weight is 194.15, the
molecular formula is C
6
H
6
N
6
O
2
and the structural formula is:
The temozolomide molecule is stable at acidic pH, (< 5) and hence can
be administered orally. Temozolomide is
readily hydrolyzed to the active 5-(3-methyltriazen-1-yl)
imidazole-4-carboxamide (MTIC) at neutral pH values, with
the hydrolysis taking place even faster at alkaline pH.
TEMODAL Capsules
Each TEMODAL Capsule contains 5, 20, 100, 140, 180 or 250 mg
temozolomide, a hard white opaque capsule
body, with a colored cap and is imprinted with black ink. Excipients
are listed below.
TEMODAL 5 mg: opaque white capsule body with an opaque green cap. The
capsule shell contains gelatin,
titanium
dioxide,
sodium
lauryl
sulfate,
yellow
iron
oxide and
FD&C
Blue
#2 and
is imprinted
with
black
pharmaceutical ink, which contains shellac, dehydrated alcohol,
isopropyl alcohol, butyl alcohol, propylene glycol,
water, ammonium hydroxide, potassium hydroxide, and black iron oxide.
TEMODAL 20 mg: opaque white body with a yellow cap. The capsule shell
contains gelatin, titanium dioxide,
sodium lauryl sulfate and yellow iron oxide and is imprinted with
black pharmaceutical ink, which contains shellac,
dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene
glycol, water, ammonium hydroxide, potassium
hydroxide, and black iron oxide.
TEMODAL 100 mg: opaque white body with an opaque pink cap. The capsule
shell contains gelatin, titanium
dioxide, sodium lauryl sulfate and red iron oxide and is imprinted
with black pharmaceutical ink, which contains
shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol,
propylene glycol, water, ammonium hydroxide,
potassium hydroxide, and black iron oxide.
TEMODAL 140 mg: opaque white body with a blue cap. The capsule shell