ORION TEMOZOLOMIDE temozolomide 180 mg capsule bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
22-05-2019
Active ingredient:
temozolomide
Available from:
Orion Laboratories Pty Ltd T/A Perrigo Australia
INN (International Name):
Temozolomide
Authorization status:
Registered
Patient Information leaflet
ORION TEMOZOLOMIDE CAPSULES
CONSUMER MEDICINE INFORMATION
PLEASE READ THIS INFORMATION CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE_ _
_(Temozolomide 5mg, 20mg, 100mg, 140mg, 180mg and 250mg) _
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions
about
Orion
Temozolomide
Capsules.
It
does
not
contain
all
the
available
information.
It does not take the place of talking
to your doctor or pharmacist.
All
medicines
have
benefits
and
risks.
Your
doctor
or
pharmacist
has weighed the benefits against
the
risks
of
you
taking
this
medicine.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may want to read it again.
WHAT ORION TEMOZOLOMIDE
CAPSULES IS USED FOR
Orion
Temozolomide
Capsules
is
used
to
treat
patients
with
brain
tumours.
Orion
Temozolomide
Capsules is also used to treat adult
patients with advanced metastatic
malignant melanoma.
Your
doctor,
however,
may
prescribe
Orion
Temozolomide
Capsules for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
ORION
TEMOZOLOMIDE
CAPSULES
HAS
BEEN PRESCRIBED FOR YOU.
Orion
Temozolomide
Capsules
belongs to a group of medicines
called
cytotoxic
or
chemotherapy
medicines.
Orion
Temozolomide
Capsules
works by killing cancer cells from
growing and multiplying.
This medicine is only available with
a doctor’s prescription.
_USE IN CHILDREN _
Orion Temozolomide Capsules are
used to treat children 3 years and
older, with specific forms of brain
tumour (glioblastoma multiforme or
anaplastic
astrocytoma,
showing
recurrence
or
progression
after
standard therapy).
BEFORE YOU TAKE ORION
TEMOZOLOMIDE CAPSULES
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE ORION TEMOZOLOMIDE
CAPSULES IF:
1. YOU
ARE
ALLERGIC
TO
TEMOZOLOMIDE,
DACARBAZINE
(DTIC)
OR
ANY
OF
THE
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms
of
an
allergic
reaction may include:
- hives, itching or skin rash
- swelling of the face, lips or
tongue.
This
may
lead
to
difficulty swallowing.
- shortness of breath, dif
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Summary of Product characteristics
PRODUCT INFORMATION
ORION TEMOZOLOMIDE CAPSULES
NAME OF THE MEDICINE
Temozolomide TEMOZOLOMIDE
Chemical Name:
imidazo[5,1-_d_]-1,2,3,5-tetrazine-8-carboxamide,3,4-dihydro-3-methyl-4-oxo
CAS Registry Number: 85622-93-1
Molecular Formula: C
6
H
6
N
6
O
2
Molecular Weight: 194.15
Temozolomide is slightly soluble in water and methanol and practically
insoluble in ethanol.
DESCRIPTION
Each Orion Temozolomide Capsule contains temozolomide (5mg, 20mg,
100mg, 140mg, 180mg or
250mg).
Inactive ingredients: anhydrous lactose, sodium starch glycolate,
stearic acid, tartaric acid and
colloidal anhydrous silica.
Capsule shell: gelatine and titanium dioxide (E171).
Printing ink: TekPrint SB-4020 Green Ink
[ARTG No. 2652]
(Orion Temozolomide 5mg Capsules);
TekPrint
SB-2008
Orange
Ink
[ARTG
No.
107473]
(Orion
Temozolomide
20mg
Capsules);
Pink
TekPrint
SW-1105
[ARTG
No.
3325]
(Orion
Temozolomide
100mg
Capsules);
TekPrint
SB-6018
Blue
Ink
[ARTG
No.
2653]
(
Orion
Temozolomide
140mg
Capsules);
TekPrint
SW-1102
Red
Ink
[ARTG
No.
107015]
(Orion
Temozolomide
180mg
Capsules)
and
OPACODE monogramming ink S-1-277002 black [ARTG No. 107581]
(Orion Temozolomide 250mg
Capsules).
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Temozolomide is an imidazotetrazine alkylating agent with antitumor
activity, which undergoes rapid
chemical
conversion
in
the
systemic
circulation
at
physiologic
pH
to
the
active
compound,
monomethyl triazeno imidazole 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.
_PRE-CLINICAL SAFETY DATA _
Single-dose toxicity studies of temozolomide were conducted in mice,
rats and dogs. Estimated LD
50
doses by the oral route were moderately higher in the rat
(approximately 1900mg/m
2
) than in the
mouse (approximately 1000mg/m
2
). The minimum lethal dose in dogs was 600mg/m
2
. In the single-
dose st
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