Temodal
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
23-02-2024
Charakterystyka produktu
(SPC)
23-02-2024
Sprawozdanie z oceny publicznego
(PAR)
01-03-2012
Składnik aktywny:
temozolomide
Dostępny od:
Merck Sharp & Dohme B.V.
Kod ATC:
L01AX03
INN (International Nazwa):
temozolomide
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Glioma; Glioblastoma
Wskazania:
Temodal hard capsules is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy 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.
Podsumowanie produktu:
Revision: 37
Status autoryzacji:
Authorised
Data autoryzacji:
1999-01-26
Ulotka dla pacjenta
1
ANNEX I
SUMMARY
OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PROD
UCT
Temodal 5
mg hard capsules
Temodal 20
mg hard capsules
Temodal 100
mg hard capsu
les
Temodal 140
mg hard capsules
Temodal 180
mg hard capsules
Temodal 250 mg
hard capsules
2.
QUALITATIVE
AND QU
ANTITATIVE COMPOSITION
5
mg hard capsules
Each hard capsu
le contains
5
mg temozolomide.
Excipient(s)
with known effe
ct:
Ea
ch hard capsule contains 132.8
mg of anhydrous
lactose.
20
mg hard capsules
Each hard cap
sule contains 20
mg temozolomide.
Excipient(s)
with known effect:
Each hard capsule contains 182.2
mg of anhyd
rous lactose.
100 mg hard capsules
Each hard capsule contains 100
mg temozolomide.
Excipient(s)
with known effect:
Each hard capsule contains
175.7
mg of anhydrous lactose.
140 mg ha
rd capsules
Each hard capsule contains 140
mg temozolomide
.
Excipient(s)
with known effect:
Each hard capsule contains 246
mg of anhydrous lactose.
180
mg hard capsules
Each hard capsule contains 180
mg temozolo
mide.
Excipient(s)
with known effe
ct:
E
ach hard capsule contains 316.3
mg of anhydrous lactose.
250 mg hard capsules
Each hard capsule contains 250
mg temozolomide.
Excipient(s)
with known effect
:
Each hard capsule contains 154.3
mg of
anhydrous lacto
se.
For the full
list of excipient
s, see section 6.1.
3.
PHARMACEUTICAL FORM
5 mg hard capsule (capsule).
The hard capsules have an opaque
white body, an opaque green cap, and are imprinted w
ith black ink.
The cap is imprinted with “
TEMODAL
”. T
he body
is imprinted with
"5
mg", the Sch
ering-Plough
logo and two stripes.
3
20 mg
hard capsule
(capsule)
The hard capsules
have an opaque white body, an opaque yellow cap, and are imprinted
with black
ink. The cap is imprinted with “
TEMODAL
”. The
body is impri
n
ted with "20
mg", the Schering
-
Plough lo
go and two stripes.
100
mg hard capsul
e (capsule)
The hard capsules
have an opaque white body, an opaque pink cap, and are imprinted with
black in
k.
The cap is imprinted with “
TEMODAL
”. The bod
y is imprinted with
"100
m
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Charakterystyka produktu
1
ANNEX I
SUMMARY
OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PROD
UCT
Temodal 5
mg hard capsules
Temodal 20
mg hard capsules
Temodal 100
mg hard capsu
les
Temodal 140
mg hard capsules
Temodal 180
mg hard capsules
Temodal 250 mg
hard capsules
2.
QUALITATIVE
AND QU
ANTITATIVE COMPOSITION
5
mg hard capsules
Each hard capsu
le contains
5
mg temozolomide.
Excipient(s)
with known effe
ct:
Ea
ch hard capsule contains 132.8
mg of anhydrous
lactose.
20
mg hard capsules
Each hard cap
sule contains 20
mg temozolomide.
Excipient(s)
with known effect:
Each hard capsule contains 182.2
mg of anhyd
rous lactose.
100 mg hard capsules
Each hard capsule contains 100
mg temozolomide.
Excipient(s)
with known effect:
Each hard capsule contains
175.7
mg of anhydrous lactose.
140 mg ha
rd capsules
Each hard capsule contains 140
mg temozolomide
.
Excipient(s)
with known effect:
Each hard capsule contains 246
mg of anhydrous lactose.
180
mg hard capsules
Each hard capsule contains 180
mg temozolo
mide.
Excipient(s)
with known effe
ct:
E
ach hard capsule contains 316.3
mg of anhydrous lactose.
250 mg hard capsules
Each hard capsule contains 250
mg temozolomide.
Excipient(s)
with known effect
:
Each hard capsule contains 154.3
mg of
anhydrous lacto
se.
For the full
list of excipient
s, see section 6.1.
3.
PHARMACEUTICAL FORM
5 mg hard capsule (capsule).
The hard capsules have an opaque
white body, an opaque green cap, and are imprinted w
ith black ink.
The cap is imprinted with “
TEMODAL
”. T
he body
is imprinted with
"5
mg", the Sch
ering-Plough
logo and two stripes.
3
20 mg
hard capsule
(capsule)
The hard capsules
have an opaque white body, an opaque yellow cap, and are imprinted
with black
ink. The cap is imprinted with “
TEMODAL
”. The
body is impri
n
ted with "20
mg", the Schering
-
Plough lo
go and two stripes.
100
mg hard capsul
e (capsule)
The hard capsules
have an opaque white body, an opaque pink cap, and are imprinted with
black in
k.
The cap is imprinted with “
TEMODAL
”. The bod
y is imprinted with
"100
m
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