OXALIPLATIN KABI oxaliplatin 100mg / 20mL injection concentrated vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

oxaliplatin, Quantity: 5 mg/mL

Dostupno od:

Fresenius Kabi Australia Pty Ltd

INN (International ime):

Oxaliplatin

Farmaceutski oblik:

Injection, concentrated

Sastav:

Excipient Ingredients: succinic acid; sodium hydroxide; water for injections

Administracija rute:

Intravenous Infusion

Jedinice u paketu:

100 mg / 20 mL - 1's

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: - adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour. - treatment of advanced colorectal cancer.

Proizvod sažetak:

Visual Identification: clear, colourless liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2010-06-24

Uputa o lijeku

CMI for Oxaliplatin Kabi
May, 2010
OxaKabiCMI060510
1
OXALIPLATIN KABI
® CONCENTRATED
INJECTION 5MG/ML
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
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 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 OXALIPLATIN IS
USED FOR
Oxaliplatin is used to treat cancer
of the large intestine and rectum
(colorectal
cancer).
Oxaliplatin
is
used
with
two
other
anti-cancer
drugs, fluorouracil (FU), and folinic
acid.
The
active
ingredient
in
Oxaliplatin Kabi is 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 because they
believe
that
the
benefit
of
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.
Oxaliplatin is only available on a
prescription from your doctor.
BEFORE YOU ARE GIVEN
OXALIPLATIN
_WHEN YOU MUST NOT BE RECEIVE IT _
You should not be given 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 Oxaliplatin if
you are pregnant or breastfeeding.
Oxaliplatin may cause birth defects
if you are being treated with it at
the time of conception or it is given
to
women
who
are
already
pregnant.
Adequate
con

Svojstava lijeka

Filename: OxaKabiPI060510 Page 1 of 23
PRODUCT INFORMATION
OXALIPLATIN KABI
® CONCENTRATED INJECTION
NAME OF THE MEDICINE
Oxaliplatin. Oxaliplatin concentrated injection 5mg/mL is a solution
intended for infusion
by dilution with 5% Glucose Injection prior to intravenous infusion.
Oxaliplatin is an antineoplastic substance belonging to a new class of
platinum-based
compounds. Oxaliplatin is described 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) or (_SP_-4-2)-[(1_R_,2_R_)-cyclohexane-1,2-
diamine-k_N,_k_N_´] [ethanedioato(2-)-k_O_
1
,k_O_
2
] platinum.
Oxaliplatin has the following chemical structure:
Empirical formula:
C
8
H
14
N
2
O
4
Pt
Molecular weight:
397.3
CAS Number:
61 825-94-3
DESCRIPTION
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_ concentrated injection also contains succinic acid,
sodium hydroxide
and water for injections.
PHARMACOLOGY
Oxaliplatin is an antineoplastic active substance 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]
.
PHARMACODYNAMICS
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.
Filename: OxaKabiPI060510 Page 2 of 23
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 cros