Temodal Capsules 100mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TEMOZOLOMIDE

Boleh didapati daripada:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

TEMOZOLOMIDE

Unit dalam pakej:

5Capsule Capsules; 5 Capsule Capsules

Dikeluarkan oleh:

ORION CORPORATION, ORION PHARMA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TEMODAL
® CAPSULE
Temozolomide (20 mg, 100 mg)
_______________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What TEMODAL is used for
2.
How TEMODAL works
3.
Before you take TEMODAL
4.
How to take TEMODAL
5.
While you are taking TEMODAL
6.
Side effects
7.
Storage and Disposal of TEMODAL
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT TEMODAL IS USED FOR
TEMODAL is used for the treatment of
specific forms of brain tumours:
•
in people with newly-diagnosed
brain tumour concomitantly with
radiotherapy and then as adjuvant
treatment.
•
in people with malignant brain
tumour, showing recurrence or
progression after standard therapy.
HOW TEMODAL WORKS
TEMODAL contains a medicine called
temozolomide. This medicine is an
antitumour agent. It works by killing
cancer cells and stopping cancer cells
from growing and multiplying.
BEFORE YOU TAKE TEMODAL
-
_When you must not take it _
DO NOT TAKE TEMODAL
•
if you are allergic to
‘temozolomide dacarbazine’
(DTIC) or any of the other
ingredients of this medicine (listed
in “
PRODUCT DESCRIPTION
”).
Signs of allergic reaction include
hives, itchy or skin rash, swelling
of the face, lips, tongue or throat,
breathlessness, wheezing, or a tight
feeling in your chest.
•
if you or your partner are pregnant
or intend to become pregnant.
•
if you are breastfeeding.
•
if you have a very low level of
white blood cells, red blood cells or
platelets.
-
_Before you start to take it _
Talk to your doctor, pharmacist or nurse
before taking TEMODAL,
•
if you vomit frequently. Your
doctor may give you medicine to
control the vomiting.
•
if you are anaemic or have blood
clotting problems.
•
if you intend to have children.
TEMODAL may cause infertility in
men.
•
if you have liver or kidney
problems. TEMODAL could cause
hepatitis B to become active again,
which can be fatal in some cases.
•
if you have aller

Ciri produk

TEMODAL CAPSULES
S-CCDS -MK7365 -MTL -01201 7
TEMODAL ® Capsules
Brand of temozolomide
This insert contains basic prescribing information only . For more comprehensive information,
a Professional Brochure is available to physicians on request.
FOR ORAL A DMINISTRATION
DESCRIPTION :
TEMODAL Capsules for oral administration contain temozolomide, an imidazotetrazine
derivative. The chemical name of temozolomide is 3, 4 -dihydro -3-methyl -4-oxoimidazo[5,1 -
d]-as -tetrazine -8-carboxamide. The structural formula i s:
Temozolomide
The material is a white to light tan/light pink powder with a molecular formula of C 6H6N6O2
and a molecular weight of 194.15. The molecule is stable at acidic pH (7, hence can be administered orally. The prodrug, te mozolomide, is rapidly hydrolysed
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.
Each capsule contains either 20 mg or 100 mg of temozolomid e. The inactive ingredients for
TEMODAL Capsules are lactose anhydrous, colloidal silicon dioxide, sodium starch
glycolate, tartaric acid, and stearic acid. Gelatin capsule shells contain titanium dioxide. The
capsules are imprinted with pharmaceutical ink .