Temozolomide Devatis 180 mg, harde capsules

Negara: Belanda

Bahasa: Belanda

Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Bahan aktif:

TEMOZOLOMIDE 180 mg/stuk

INN (Nama Internasional):

TEMOZOLOMIDE 180 mg/stuk

Bentuk farmasi:

Capsule, hard

Komposisi:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT

Rute administrasi :

Oraal gebruik

Tanggal Otorisasi:

2021-09-27

Selebaran informasi

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEMOZOLOMIDE DEVATIS 5 MG HARDE CAPSULES
TEMOZOLOMIDE DEVATIS 20 MG HARDE CAPSULES
TEMOZOLOMIDE DEVATIS 100 MG HARDE CAPSULES
TEMOZOLOMIDE DEVATIS 140 MG HARDE CAPSULES
TEMOZOLOMIDE DEVATIS 180 MG HARDE CAPSULES
TEMOZOLOMIDE DEVATIS 250 MG HARDE 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 Devatis is and what it is used for
2.
What you need to know before you take Temozolomide Devatis
3.
How to take Temozolomide Devatis
4.
Possible side effects
5.
How to store Temozolomide Devatis
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE DEVATIS IS AND WHAT IT IS USED FOR
Temozolomide Devatis contains a medicine called temozolomide. This
medicine is an antitumour
agent.
Temozolomide Devatis is used for the treatment of specific forms of
brain tumours:
-
in adults with newly-diagnosed glioblastoma multiforme. Temozolomide
Devatis 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 Devatis is used in
these tumours if they
return or get worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE DEVATIS
DO NOT TAKE TEMOZOLOMIDE DEVATIS
-
if you are allergic to temozolomide or any of the other ingredients of
this medicine (listed i

Karakteristik produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Temozolomide Devatis 5 mg harde capsules
Temozolomide Devatis 20 mg harde capsules
Temozolomide Devatis 100 mg harde capsules
Temozolomide Devatis 140 mg harde capsules
Temozolomide Devatis 180 mg harde capsules
Temozolomide Devatis 250 mg harde capsules
temozolomide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_5 mg capsules _
Each hard capsule contains 5 mg temozolomide.
Excipient(s) with known effect
Each hard capsule contains 132.8 mg of anhydrous lactose.
_20 mg capsules _
Each hard capsule contains 20 mg temozolomide.
Excipient(s) with known effect
Each hard capsule contains 182.2 mg of anhydrous lactose.
_100 mg 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 capsules _
Each hard capsule contains 140 mg temozolomide.
Excipient(s) with known effect
Each hard capsule contains 246.0 mg of anhydrous lactose.
_180 mg capsules _
Each hard capsule contains 180 mg temozolomide.
Excipient(s) with known effect
Each hard capsule contains 316.3 mg of anhydrous lactose.
_250 mg capsules _
Each hard capsule contains 250 mg temozolomide.
Excipient(s) with known effect
Each hard capsule contains 154.3 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
5 mg capsules
2
Size 3 hard gelatin capsules with an opaque light green cap and an
opaque white body imprinted with
“5 mg”. The capsules are filled with white to light pink powder.
20 mg capsules
Size 2 hard gelatin capsules with a rich yellow cap and an opaque
white body imprinted with “20 mg”.
The capsules are filled with white to light pink powder.
100 mg capsules
Size 1 hard gelatin capsules with a flesh-coloured cap and an opaque
white body imprinted with “100
mg”. The capsules are filled with white to light pink powder.
140 mg capsules
Size 0 hard gelatin capsules with a transparent light blue cap and an
opaque wh