TemoRel Hard Capsule 100 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TEMOZOLOMIDE

Boleh didapati daripada:

Mansa Healthcare Sdn Bhd

INN (Nama Antarabangsa):

TEMOZOLOMIDE

Unit dalam pakej:

5 Capsules

Dikeluarkan oleh:

Reliance Life Sciences Pvt. Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TEMOREL HARD CAPSULES
Temozolomide (100mg, and 250mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What TemoRel is used for
2.
How TemoRel works
3.
Before you use TemoRel
4.
How to use TemoRel
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of TemoRel
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TEMOREL IS USED FOR
TemoRel is used for the treatment of
specific forms of brain tumors:
•
Newly-diagnosed glioblastoma
multiforme initially along. with
radiotherapy and then alone
•
Malignant glioma, such as
glioblastoma multiforme or
anaplastic astrocytoma, . if these
tumors return or get worse after
standard treatment.
HOW TEMOREL WORKS
TemoRel
contains
a
medicine
called
temozolomide.
This
medicine
is
an
anti-tumour agent. It exhibits schedule-
dependent
antineoplastic
activity
by
interfering with DNA replication.
BEFORE YOU USE TEMOREL
-
When you must not use it
● Have had an allergic reaction to
dacarbazine (DTIC), or any other
ingredient in this medicine (listed
under “Product Description “).
Signs of allergic reactions 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
planning to be pregnant
● If you are breast-feeding
● If you are having very low levels of
while blood cells, red blood cells or
platelets.
-
Before you start to use it
Tell your doctor, pharmacist or nurse
before taking TemoRel
•
If you vomit frequently. Your
doctor may give you a medicine to
control your vomiting.
•
If you are anaemic or have blood
clotting problems
•
If you are planning to have children.
TemoRel may cause infertility in
men.
•
If you have liver or kidney
problems, TemoRel may re-activate
hepatitis B and may lead to death in
some cases.
•
If you are allergic to any other
medicines, other substances like
food, preservatives or dyes.
CHILDREN AND ADOLESCENTS
Do not give thi

Ciri produk

PACKAGE INSERT FOR
TEMOREL HARD CAPSULE 100MG AND 250MG
PRODUCT NAME
TemoRel Hard Capsule 100mg
TemoRel Hard Capsule 250mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each hard capsule contains:
Temozolomide 100mg
Temozolomide 250mg
PRODUCT DESCRIPTION
TEMOREL HARD CAPSULE 100MG:
Size “1” hard gelatin capsule with pink colored opaque cap and
white colored opaque body,
black colored printing text “TEMOZOLOMIDE” on cap and “100 mg”
on body having off
white to light pink coloured powder inside the capsule.
TEMOREL HARD CAPSULE 250MG:
Size “0” hard gelatin capsule with white colored opaque cap and
white colored opaque
body, black colored printing text “TEMOZOLOMIDE” on cap and “250
mg” on body having
off white to light pink coloured powder inside the capsule.
PHARMACODYNAMICS
Antineoplastic agents - Other alkylating agents
Temozolomide is a triazene, which undergoes rapid chemical conversion
at physiologic pH to
the active monomethyl triazenoimidazole carboxamide (MTIC). The
cytotoxicity of MTIC is
thought to be due primarily to alkylation at the O
6
position of guanine with additional alkylation
also occurring at the N
7
position. Cytotoxic lesions that develop subsequently are thought to
involve aberrant repair of the methyl adduct.
PHARMACOKINETICS
Temozolomide (TMZ) is spontaneously hydrolyzed at physiologic pH
primarily to the active
species,
3-methyl-(triazen-1-yl)imidazole-4-carboxamide
(MTIC).
MTIC
is
spontaneously
hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC), a known
intermediate in purine and
nucleic acid biosynthesis, and to methylhydrazine, which is believed
to be the active alkylating
species. The cytotoxicity of MTIC is thought to be primarily due to
alkylation of DNA mainly at
the O
6
and N
7
positions of guanine. Relative to the AUC of TMZ, the exposure to MTIC
and AIC
is ~ 2.4 % and 23 %, respectively. The t1/2 of MTIC was similar to
that of TMZ, 1.8 hr.
Absorption
After oral administration to adult patients, TMZ is absorbed rapidly,
with peak concentrations
reached as ear