OXALIPLATIN KABI PFI oxaliplatin 100 mg powder for injection vial

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

oxaliplatin

Verfügbar ab:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (Internationale Bezeichnung):

Oxaliplatin

Berechtigungsstatus:

Registered

Gebrauchsinformation

CMI for Oxaliplatin Kabi PFI
March 2011
OxaPFICMI090311
OXALIPLATIN KABI PFI
Oxaliplatin Kabi PFI powder for injection (50 mg, 100 mg and 150 mg)
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
OXALIPLATIN KABI PFI. 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 OXALIPLATIN
KABI PFI 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 OXALIPLATIN
KABI PFI IS USED FOR
OXALIPLATIN KABI PFI is used
to
treat
cancer
of
the
large
intestine
and
rectum
(colorectal
cancer). OXALIPLATIN KABI PFI
is used in combination with two
other
anti-cancer
drugs,
fluorouracil (FU), and folinic acid.
The
active
ingredient
in
OXALIPLATIN KABI PFI 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
OXALIPLATIN
KABI PFI
because they
believe
that the benefit of OXALIPLATIN
KABI PFI treatment will be greater
than the unwanted effects.
Many
of
the
side
effects
from
anticancer 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.
OXALIPLATIN KABI PFI is only
available on a prescription from
your doctor.
BEFORE YOU ARE GIVEN
OXALIPLATIN KABI
PFI
_WHEN YOU MUST NOT RECEIVE IT _
YOU
SHOULD
NOT
BE
GIVEN
OXALIPLATIN KABI PFI 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
OX

Fachinformation

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Page 1 of 20
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PRODUCT INFORMATION
NAME OF THE MEDICINE
Oxaliplatin Kabi PFI Powder for Injection
CHEMICAL STRUCTURE
Oxaliplatin has the following chemical structure:
CAS Number: 61 825-94-3.
DESCRIPTION
Oxaliplatin
is
designated
chemically
as
[S_P_-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 is a white to off-white crystalline powder. It is slightly
soluble in water,
very slightly soluble in methanol and practically insoluble in
ethanol.
Oxaliplatin Kabi PFI 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-l-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.
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Page 2 of 20
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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
ox