WINTHROP OXALIPLATIN oxaliplatin 100mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Oxaliplatin

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Oxaliplatin

Patient Information leaflet

WINTHROP
® OXALIPLATIN
_Oxaliplatin powder for injection_
CONSUMER MEDICINE INFORMATION
PLEASE READ THIS LEAFLET BEFORE YOU ARE GIVEN THIS MEDICINE.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Winthrop Oxaliplatin
injection.
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 has weighed the
risks of using Winthrop Oxaliplatin
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT WINTHROP
OXALIPLATIN IS USED FOR
Winthrop Oxaliplatin is used to treat
cancer of the oesophagus/stomach,
large intestine and rectum (colorectal
cancer). Winthrop Oxaliplatin is used
in combination with other anti-cancer
drugs; capecitabine, bevacizumab,
epirubicin, fluorouracil (FU), and/or
folinic acid. The active ingredient in
Winthrop Oxaliplatin is called
oxaliplatin.
Cancer cells are normal cells which
have changed so that they grow in an
uncontrolled way. Oxaliplatin works
by interfering with cancer cell
growth. Because of the similarities
between cancer cells and normal
cells, anti cancer drugs often have
unwanted effects on the body.
Your doctors have decided to treat
you with Winthrop Oxaliplatin
because they believe that the benefit
of Winthrop Oxaliplatin treatment
will be greater than the unwanted
effects.
Many of the side effects from anti
cancer drugs are predictable and can
be prevented or lessened. Your
doctor and other staff will take all of
the precautions needed to reduce the
unwanted effects of treatment.
Winthrop Oxaliplatin is only
available on a prescription from your
doctor.
BEFORE YOU ARE GIVEN
WINTHROP OXALIPLATIN
_WHEN YOU MUST NOT RECEIVE_
_IT_
YOU SHOULD NOT BE GIVEN WINTHROP
OXALIPLATIN IF YOU ARE ALLERGIC TO
THE ACTIVE INGREDIENT 'OXALIPLATIN'.
If you have had an allergic reaction
to oxaliplatin before, you should not
receive it again.
YOU MUST NOT RECEIVE WINTHROP
OXALIPLATI

Summary of Product characteristics

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PRODUCT INFORMATION
WINTHROP OXALIPLATIN
NAME OF DRUG
WINTHROP OXALIPLATIN
®
Oxaliplatin powder for injection
DESCRIPTION
Oxaliplatin is designated chemically as
[_SP_-4-2]-(1_R_,2_R_)-(cyclohexane-1,2-diamine-k
2
_N,N_´(oxalato(2-
)-k
2
_O_
1
,_O_
2
]platinum (II)
The empirical formula of oxaliplatin is C
8
H
14
N
2
O
4
Pt and its molecular weight is 397.3.
Oxaliplatin has the following chemical structure:
CAS Number: 61 825-94-3
Oxaliplatin is a white to off-white crystalline powder. It is slightly
soluble in water, very slightly soluble
in methanol and practically insoluble in ethanol.
Winthrop Oxaliplatin powder for injection contains oxaliplatin and
lactose.
PHARMACOLOGY
PHARMACODYNAMICS
Oxaliplatin is an antineoplastic drug belonging to a new class of
platinum based compounds in which
the
platinum
atom
is
complexed
with
1,2-diaminocyclohexane
(DACH)
and
an
oxalate
group.
Oxaliplatin is a single enantiomer, the Cis-[oxalato(trans-
λ
-1,2-DACH) platinum].
Oxaliplatin exhibits a wide spectrum of both _ in vitro_ cytotoxicity
and _ in vivo_ antitumour activity in a
variety
of
tumour
model
systems,
including
human
colorectal
cancer
models.
Oxaliplatin
also
demonstrates _in vitro _and_ in vivo_ activity in various cisplatin
resistant models.
A synergistic cytotoxic action has been observed in combination with
fluorouracil both _in vitro_ and _in _
_vivo_.
Studies on the mechanism of action of oxaliplatin, although not
completely elucidated, show that the
aqua-derivatives resulting from the biotransformation of oxaliplatin
interact with DNA to form both
inter- and intra-strand cross links, resulting in the disruption of
DNA synthesis leading to cytotoxic and
antitumour effects.
PHARMACOKINETICS
The
pharmacokinetics
of
individual
active
compounds
have
not
been
determined.
The
pharmacokinetics of ultrafiltrable platinum, representing a mixture of
all unbound, active and inactive
platinum species, following a two hour infusion of oxaliplatin at