Temozolomide Accord
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-06-2023
Charakterystyka produktu
(SPC)
27-06-2023
Sprawozdanie z oceny publicznego
(PAR)
01-07-2015
Składnik aktywny:
temozolomide
Dostępny od:
Accord Healthcare S.L.U.
Kod ATC:
L01AX03
INN (International Nazwa):
temozolomide
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Glioma; Glioblastoma
Wskazania:
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.
Podsumowanie produktu:
Revision: 23
Status autoryzacji:
Authorised
Data autoryzacji:
2010-03-15
Ulotka dla pacjenta
61
B. PACKAGE LEAFLET
62
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMOZOLOMIDE ACCORD 5 MG HARD CAPSULES
TEMOZOLOMIDE ACCORD 20 MG HARD CAPSULES
TEMOZOLOMIDE ACCORD 100 MG HARD CAPSULES
TEMOZOLOMIDE ACCORD 140 MG HARD CAPSULES
TEMOZOLOMIDE ACCORD 180 MG HARD CAPSULES
TEMOZOLOMIDE ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Temozolomide Accord
3.
How to take Temozolomide Accord
4.
Possible side effects
5.
How to store Temozolomide Accord
6.
Contents of the pack and other information
1.
WHAT TEMOZOLOMIDE ACCORD IS AND WHAT IT IS USED FOR
Temozolomide is an antitumour-r medicine.
Temozolomide Accord capsules is used for the treatment of specific
forms of brain tumours:
-
In adults with newly-diagnosedglioblastoma multiforme. Temozolomide 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, glioblastoma multiforme
or anaplastic Astrocytoma. Tamozolomide is used in these tumours if
they return or get worse
after standard treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE ACCORD
DO NOT TAKE TEMOZOLOMIDE ACCORD
-
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 another anti-cancer medicine
called
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Temozolomide Accord 5 mg hard capsules.
Temozolomide Accord 20 mg hard capsules.
Temozolomide Accord 100 mg hard capsules.
Temozolomide Accord 140 mg hard capsules.
Temozolomide Accord 180 mg hard capsules.
Temozolomide Accord 250 mg hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5mg hard capsules
Each hard capsule contains 5 mg temozolomide.
Excipient with known effect:
Each hard capsule contains 168 mg of anhydrous lactose.
20mg hard capsules
Each hard capsule contains 20 mg temozolomide.
Excipients with known effect:
Each hard capsule contains 14.6 mg of anhydrous lactose.
100mg hard capsules
Each hard capsule contains 100 mg temozolomide.
Excipients with known effect:
Each hard capsule contains 73 mg of anhydrous lactose.
140mg hard capsules
Each hard capsule contains 140 mg temozolomide.
Excipients with known effect:
Each hard capsule contains 102.2 mg of anhydrous lactose.
180mg hard capsules
Each hard capsule contains 180 mg temozolomide.
Excipients with known effect:
Each hardcapsule contains 131.4 mg of anhydrous lactose.
250mg hard capsules
Each hard capsule contains 250 mg temozolomide.
Excipients with known effect:
Each hard capsule contains 182.5 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
5mg hard capsule.
3
The hard capsules are green/white hard gelatin capsules imprinted
‘TMZ’ on cap & ‘5’ on body.Each
capsule is approximately 15 mm in length.
20 mg hard capsule.
The hard capsules are yellow/ white hard gelatin capsules, imprinted
‘TMZ’ on cap & ‘20’ on body.
Each capsule is approximately 11 mm in length.
100mg hard capsule.
The hard capsules are pink/white hard gelatin capsules, imprinted
‘TMZ’ on cap & ‘100’ on body.
Each capsule is approximately 15 mm in length.
140mg hard capsule.
The hard capsules are transparent blue/white hard gelatin capsules,
imprinted ‘TMZ’ on cap & ‘140’ on
body.
Each capsule is approximately 19
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