Nogron 5 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TEMOZOLOMIDE

Beschikbaar vanaf:

Egis Pharmaceuticals Plc

ATC-code:

L01AX03

INN (Algemene Internationale Benaming):

TEMOZOLOMIDE

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT, AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT (E468) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Temozolomide

Product samenvatting:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); LACTOSE 0-WATER; NATRIUMZETMEELGLYCOLAAT (E468); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TITAANDIOXIDE (E 171); WIJNSTEENZUUR, (L (+) Vorm) (E 334); ZWARTE INKT;

Autorisatie datum:

2012-11-19

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
NOGRON 5 MG HARDE CAPSULES
NOGRON 20 MG HARDE CAPSULES
NOGRON 100 MG HARDE CAPSULES
NOGRON 140 MG HARDE CAPSULES
NOGRON 180 MG HARDE CAPSULES
NOGRON 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 or pharmacist.
-
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 Nogron is and what it is used for
2.
What you need to know before you take Nogron
3.
How to take Nogron
4.
Possible side effects
5.
How to store Nogron
6.
Contents of the pack and other information
1.
WHAT NOGRON IS AND WHAT IT IS USED FOR
Nogron contains a medicine called temozolomide. This medicine is an
antitumour agent.
Nogron is used for the treatment of patients with specific forms of
brain tumours:
-
in adults with newly-diagnosed glioblastoma multiforme. Nogron 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. Nogron is used in
these tumours
if they return or get worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOGRON
DO NOT TAKE NOGRON
-
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 feeling
itchy,
breathlessness or wheezing, swelling of the face, lips, tongue or
throat.
-
if

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nogron 5 mg harde capsules
Nogron 20 mg harde capsules
Nogron 100 mg harde capsules
Nogron 140 mg harde capsules
Nogron 180 mg harde capsules
Nogron 250 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 5 mg temozolomide.
Each hard capsule contains 20 mg temozolomide.
Each hard capsule contains 100 mg temozolomide.
Each hard capsule contains 140 mg temozolomide.
Each hard capsule contains 180 mg temozolomide.
Each hard capsule contains 250 mg temozolomide.
Excipient with known effect
Each 5 mg hard capsule contains 399.3mg mg of anhydrous lactose.
Each 20 mg hard capsule contains 384.3 mg of anhydrous lactose.
Each 100 mg hard capsule contains 61.7 mg of anhydrous lactose.
Each 140 mg hard capsule contains 86.4 mg of anhydrous lactose.
Each 180 mg hard capsule contains 111.1 mg of anhydrous lactose.
Each 250 mg hard capsule contains 154.3 mg of anhydrous lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
5 mg: Hard gelatine capsules size 0 (green opaque cap/white opaque
body) with 5 printed in
black ink on the body.
20 mg: Hard gelatine capsules size 0 (orange opaque cap /white opaque
body) with 20 printed
in black ink on the body.
100 mg: Hard gelatine capsules size 0 (purple opaque cap /white opaque
body) with 100
printed in black ink on the body
140 mg: Hard gelatine capsules size 0 (blue opaque cap /white opaque
body) with 140 printed
in black ink on the body
180 mg: Hard gelatine capsules size 0 (chocolate brown opaque cap
/white opaque body) with
180 printed in black ink on the body
250 mg: Hard gelatine capsules size 0 (white opaque cap /white opaque
body) with 250
printed in black ink on the body
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nogron hard capsules is indicated for the treatment of:

adult patients with newly-diagnosed glioblastoma multiforme
concomitantly with
radiotherapy (RT) and subsequently as monotherapy treatment.

children