TEMOZOLOMIDE ACTAVIS 5 Milligram Capsules Hard

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

TEMOZOLOMIDE

متاح من:

Actavis Group PTC ehf

ATC رمز:

L01AX03

INN (الاسم الدولي):

TEMOZOLOMIDE

جرعة:

5 Milligram

الشكل الصيدلاني:

Capsules Hard

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المجال العلاجي:

Other alkylating agents

الوضع إذن:

Authorised

تاريخ الترخيص:

2014-08-22

نشرة المعلومات

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

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Temozolomide Actavis 5mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg hard capsule contains 5 mg temozolomide.
Excipient(s) with known effect:
Each hard capsule contains 399.3 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
The 5 mg hard capsule are size 0 (21.7 mm in length), have an opaque
white body, an opaque green cap. The body is
imprinted with "5" in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Temozolomide Actavis is indicated for the treatment of:
-
adult patients with newly-diagnosed glioblastoma multiforme
concomitantly with radiotherapy (RT) 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Temozolomide Actavis 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_
Temozolomide Actavis is administered in combination with focal
radiotherapy (concomitant phase) followed by up to
6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
_Concomitant phase_
TMZ is administered orally 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 non-haematological 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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y