OXALIPLATIN WKT oxaliplatin 50mg/10 mL concentrate for solution for infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxaliplatin, Quantity: 50 mg

Available from:

Wockhardt Bio Pty Ltd

INN (International Name):

Oxaliplatin

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: nitrogen; water for injections

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oxaliplatin is indicated for adjuvant treatment of stage III (Duke?s C) colon cancer, in combination with fluoropyrimidine agent.,Oxaliplatin in combination with fluorouracil and folinic acid is indicated for the treatment of advanced colorectal cancer.,Oxaliplatin in combination with capecitabine, with or without bevacizumab, is indicated for the treatment of patients with metastatic colorectal cancer,Oxaliplatin in combination with epirubicin and either capecitabine or fluorouracil, is indicated for the treatment of patients with advanced oesophagogastric cancer.

Product summary:

Visual Identification: Clear, colorless solution containing 5 mg/ml Oxaliplatin.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-10-13

Patient Information leaflet

OXALIPLATIN WKT
(
_Oxaliplatin_
)
CONSUMER MEDICINE INFORMATION
other staff will take all of the
aware of
WHAT IS IN THIS LEAFLET
precautions needed to reduce the
• you are taking any other
unwanted effects of treatment.
This leaflet answers some common
medicines, including medicines
that you have bought without a
questions about Oxaliplatin injection. It
does
not
contain
all
the
available
information.
Oxaliplatin WKT is only available
on a prescription from your doctor.
prescription from a pharmacy,
supermarket or health food shop.
Your doctor or pharmacist can tell you
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
WKT
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
WKT IS USED FOR
Oxaliplatin
WKT
is
used
to
treat
cancer
of
the
oesophagus/stomach,
large intestine and rectum (colorectal
cancer).
Oxaliplatin WKT is used in
combination with other anti-cancer
drugs;
capecitabine,
bevacizumab,
epirubicin, fluorouracil (FU), and/or
folinic acid. The active ingredient in
Oxaliplatin WKT 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.
BEFORE YOU ARE GIVEN
OXALIPLATIN WKT
_WHEN YOU MUST NOT RECEIVE IT _
YOU SHOULD NOT BE GIVEN OXALIPLATIN
WKT
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
WKT 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 contraception is required
during treatment with oxaliplatin.
You should discuss this with your
doctor. Nursing mothers are advised
not to breastfeed while receiving

Summary of Product characteristics

OXALIPLATIN WKT V2.3
Version 2.3
Page 1 of 38
AUSTRALIAN PRODUCT INFORMATION – OXALIPLATIN WKT
(OXILAPLATIN) CONCENTRATED INJECTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Oxilaplatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OXALIPLATIN WKT is available as a concentrated solution for infusion
in 50mg/10mL and
100mg/20mL vials
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.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Concentrated injection for intravenous infusion in a clear glass vial
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Oxaliplatin is indicated for adjuvant treatment of stage III (Duke’s
C) colon cancer, in
combination with fluoropyrimidine agent.
Oxaliplatin in combination with fluorouracil and folinic acid is
indicated for the treatment of
advanced colorectal cancer.
Oxaliplatin in combination with capecitabine, with or without
bevacizumab, is indicated for
the treatment of patients with metastatic colorectal cancer.
Oxaliplatin in combination with epirubicin and either capecitabine or
fluorouracil, is indicated
for the treatment of patients with advanced oesophagogastric cancer.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
In combination with fluorouracil and folinic acid for adjuvant
treatment of colon cancer, the
recommended dose of oxaliplatin is 85 mg/m
2
intravenously repeated every two weeks for 12
cycles (6 months).
In combination with capecitabine for adjuvant treatment of colon
cancer, the recommended
dose of oxaliplatin is 130 mg/m
2
, administered as an intravenous infusion over 2 hours on day
OXALIPLATIN WKT V2.3
Version 2.3
Page 2 of 38
1 of a three week cycle. For the recommended doses of capecitabine
(see Section 5.1
PHARMACODYNAMIC PROPERTIES
).
In combination with fluorouracil and folinic acid for the treatment of
advanced colorectal
cancer, the recommended dose of oxaliplatin is 85mg/m
2
intravenously re