Temozam 20 Capsules 20mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TEMOZOLOMIDE

Boleh didapati daripada:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (Nama Antarabangsa):

TEMOZOLOMIDE

Unit dalam pakej:

5Capsule Capsules

Dikeluarkan oleh:

Fresenius Kabi Oncology Limited (XI Route)

Risalah maklumat

1
Consumer Medication Information Leaflet (RiMUP)
TEMOZAM CAPSULES
Temozolomide (20mg, 100mg)
WHAT IS THIS LEAFLET?
1. What TEMOZAM is and what it is
prescribe medicine to help you
prevent development of a serious
patients who are taking TEMOZAM.
You should stop breast-feeding while
used for
form
of
chest
infection
called
receiving
treatment
with
2. How does Temozam works
Pneumocystis jirovecii pneumonia
TEMOZAM.
3. What you need to know before you
(PCP).
take TEMOZAM
- If you have ever had or might now
4. HOW TO TAKE TEMOZAM
4. How to take TEMOZAM
have
a
hepatitis
B
infection.
Always take this medicine exactly as
5. While you are using TEMOZAM
TEMOZAM can cause hepatitis B to
your doctor or pharmacist has told
6. Possible side effects
become active again. Patients will be
you, preferably at the same time each
7. How to store and dispose
carefully checked by their doctor for
day.
TEMOZAM
signs of hepatitis B infection before
8. Product Description
treatment is started.
Take the capsules on an empty
- If you have low counts of red blood
stomach; for example, at least one
1. WHAT TEMOZAM IS AND WHAT IT
cells (anaemia), white blood cells and
hour before you plan to eat breakfast.
IS USED FOR
TEMOZAM contains a medicine
platelets, or blood clotting problems
before starting the treatment, or if
Swallow the capsule(s) whole with a
glass of water. Do not open, crush or
called temozolomide. This medicine
you develop them during treatment.
chew the capsules. If a capsule is
is an antitumour agent to treat
Your blood will be tested frequently
damaged,
avoid
contact
of
the
specific forms of brain tumours:
during treatment to monitor the side
powder with your skin, eyes or nose.
-
Newly-diagnosed
glioblastoma
effects of TEMOZAM on your blood
If you accidentally get some in your
multiforme.
cells. Your doctor may decide to
eyes or nose, flush the area with
-
Malignant
glioma,
such
as
reduce the dose, interrupt, stop or
water.
glioblastoma
multiforme
or
change your treatment. You may also
anaplastic astrocytoma.
2.
HOW TEMOZAM

Ciri produk

TEMOZAM CAPS PI MYS B-II
Black
Font: Times New Roman
Font Size: 9 Pt.
23 November 2018 Version: 11
Final Packaging Site: Baddi-II
Mfg. Site: Baddi-II
\\fre-kp-fp01\PDD-Artworks\ROW\MGE & Asian
Countries\Malaysia\Baddi-2\Temozam\2015 October\Temozam Caps PI MYS
B-II.indd
Form No.: SOP/PDD/014-02 Rev. 00
Font: Times New Roman
Dimension: 350x280 mm
Folding Size: 35x35 mm
_(Outline of folding size for indication purpose only,_
_ it should be removed before final printing.)_
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
TEMOZOLOMIDE CAPSULES
TEMOZAM
DESCRIPTION:
Temozam capsules are size “4” hard gelatin capsules having white
opaque body and
yellow opaque cap with “20 mg” and “Temozolomide” imprinted in
black on body
and cap and Size “3” hard gelatin capsules have white opaque body
and Swedish
orange opaque cap with “100 mg” and “Temozolomide” imprinted
in black on body
and cap respectively, containing white to light tan/light pink powder.
COMPOSITION:
TEMOZAM- 20
Each capsule contains:
Temozolomide ..................... 20 mg
TEMOZAM- 100
Each capsule contains:
Temozolomide ..................... 100 mg
CHEMICAL STRUCTURE:
TEMOZAM contains temozolomide, an imidazotetrazine derivative. The
chemical
name
of
temozolomide
is
3,
4-dihydro-3-methyl-4-oxoimidazo
[5,1-d]-1,2,3,5-
tetrazine-8-carboxamide. The structural formula is:
The material is a white to light tan/light pink powder with a
molecular formula of
C
6
H
6
N
6
O
2
and a molecular weight of 194.15. The molecule is stable at acidic pH
(<5)
and labile at pH >7; hence TEMOZAM can be administered orally and
intravenously.
The prodrug, temozolomide, is rapidly hydrolyzed to the active
5-(3-methyltriazen-
1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH
values, with
hydrolysis taking place even faster at alkaline pH.
PHARMACOLOGY:
MECHANISM OF ACTION
Temozolomide is not directly active but undergoes rapid nonenzymatic
conversion
at physiologic pH to the reactive compound
5-(3-methyltriazen-1-y