Temomedac
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
28-03-2022
Produktets egenskaber
(SPC)
28-03-2022
Offentlige vurderingsrapport
(PAR)
05-08-2014
Aktiv bestanddel:
temozolomide
Tilgængelig fra:
medac Gesellschaft für klinische Spezialpräparate mbH
ATC-kode:
L01AX03
INN (International Name):
temozolomide
Terapeutisk gruppe:
Antineoplastic agents
Terapeutisk område:
Glioma; Glioblastoma
Terapeutiske indikationer:
Temomedac 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 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.
Produkt oversigt:
Revision: 15
Autorisation status:
Authorised
Autorisation dato:
2010-01-25
Indlægsseddel
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOMEDAC 5 MG HARD CAPSULES
TEMOMEDAC 20 MG HARD CAPSULES
TEMOMEDAC 100 MG HARD CAPSULES
TEMOMEDAC 140 MG HARD CAPSULES
TEMOMEDAC 180 MG HARD CAPSULES
TEMOMEDAC 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 Temomedac is and what it is used for
2.
What you need to know before you take Temomedac
3.
How to take Temomedac
4.
Possible side effects
5.
How to store Temomedac
6.
Contents of the pack and other information
1.
WHAT TEMOMEDAC IS AND WHAT IT IS USED FOR
Temomedac contains a medicine called temozolomide. This medicine is an
antitumour agent.
Temomedac is used for the treatment of specific forms of brain
tumours:
-
in adults with newly-diagnosed glioblastoma multiforme. Temomedac 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. Temomedac is used in these
tumours if they return or get
worse after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOMEDAC
DO NOT TAKE TEMOMEDAC
-
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 wheezin
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Temomedac 5 mg hard capsules
Temomedac 20 mg hard capsules
Temomedac 100 mg hard capsules
Temomedac 140 mg hard capsules
Temomedac 180 mg hard capsules
Temomedac 250 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Temomedac 5 mg hard capsules
Each hard capsule contains 5 mg temozolomide.
Temomedac 20 mg hard capsules
Each hard capsule contains 20 mg temozolomide.
Temomedac 100 mg hard capsules
Each hard capsule contains 100 mg temozolomide.
Temomedac 140 mg hard capsules
Each hard capsule contains 140 mg temozolomide.
Temomedac 180 mg hard capsules
Each hard capsule contains 180 mg temozolomide.
Temomedac 250 mg hard capsules
Each hard capsule contains 250 mg temozolomide.
_Excipient with known effect _
Temomedac 5 mg hard capsules
Each hard capsule contains 87 mg of anhydrous lactose.
Temomedac 20 mg hard capsules
Each hard capsule contains 72 mg of anhydrous lactose and sunset
yellow FCF (E110).
Temomedac 100 mg hard capsules
Each hard capsule contains 84 mg of anhydrous lactose.
Temomedac 140 mg hard capsules
Each hard capsule contains 117 mg of anhydrous lactose.
Temomedac 180 mg hard capsules
Each hard capsule contains 150 mg of anhydrous lactose.
Temomedac 250 mg hard capsules
Each hard capsule contains 209 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
3
Temomedac 5 mg hard capsules
The hard capsules (length approx. 16 mm) have a white opaque body and
cap with two stripes in green
ink on the cap and with “T 5 mg” in green ink on the body.
Temomedac 20 mg hard capsules
The hard capsules (length approx. 18 mm) have a white opaque body and
cap with two stripes in
orange ink on the cap and with “T 20 mg” in orange ink on the
body.
Temomedac 100 mg hard capsules
The hard capsules (length approx. 20 mm) have a white opaque body and
cap with two stripes in pink
ink on the cap and with “T 100 mg” in pink ink on the body.
Temomedac 140 mg
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