Temozolomide Hexal

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

temozolomide

Disponible depuis:

Hexal AG

Code ATC:

L01AX03

DCI (Dénomination commune internationale):

temozolomide

Groupe thérapeutique:

Antineoplastic agents

Domaine thérapeutique:

Glioma; Glioblastoma

indications thérapeutiques:

For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of 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.

Descriptif du produit:

Revision: 17

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2010-03-15

Notice patient

171
B. PACKAGE LEAFLET
Medicinal product no longer authorised
172
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOZOLOMIDE HEXAL 5 MG HARD CAPSULES
TEMOZOLOMIDE HEXAL 20 MG HARD CAPSULES
TEMOZOLOMIDE HEXAL 100 MG HARD CAPSULES
TEMOZOLOMIDE HEXAL 140 MG HARD CAPSULES
TEMOZOLOMIDE HEXAL 180 MG HARD CAPSULES
TEMOZOLOMIDE HEXAL 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 Hexal is and what it is used for
2.
What you need to know before you take Temozolomide Hexal
3.
How to take Temozolomide Hexal
4.
Possible side effects
5.
How to store Temozolomide Hexal
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE HEXAL IS AND WHAT IT IS USED FOR
Temozolomide Hexal contains a medicine called temozolomide. This
medicine is an antitumour
agent.
Temozolomide Hexal is used for the treatment of specific forms of
brain tumours:
•
in adults with newly-diagnosed glioblastoma multiforme. Temozolomide
Hexal 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 Hexal is used in
these tumours if they
return or get worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE HEXAL
_ _
DO NOT TAKE TEMOZOLOMIDE HEXAL
•
if you are allergic to temozolomide or any of the other ingredients of
this med

Résumé des caractéristiques du produit

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Temozolomide Hexal 5 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 5 mg of temozolomide.
Excipient with known effect:
Each hard capsule contains 168 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
_ _
The hard capsules have a white coloured body, a green coloured cap,
and are imprinted with black
ink. The cap is imprinted with “TMZ”. The body is imprinted with
“5”.
Each capsule is approximately 15.8 mm in length.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Temozolomide Hexal 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 Hexal 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 Hexal 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)