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Oxaliplatin Concentrated Injection 50 mg/10 mL and 100 mg/20 mL
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before
you are given this medicine.
This leaflet answers some common
questions about Oxaliplatin Accord.
It does not contain all the available
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 this medicine against the benefits
they expect it will have for you.
If you have any concerns about
taking this medicine, ask your doctor
Keep this leaflet with this medicine.
You may need to read it again.
What Oxaliplatin Accord
is used for
Oxaliplatin Accord is used to treat
cancer of the large intestine and rectum
(colorectal cancer). Oxaliplatin Accord
is used in combination with other anti-
cancer drugs; fluorouracil (FU), and
folinic acid. The active ingredient in
Oxaliplatin Accord 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 Accord because they
believe that the benefit of Oxaliplatin
Accord 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.
This medicine is only available with a
Before you are given
When you must not be
You should not be given Oxaliplatin
if you are allergic to the active
If you have had an allergic reaction to
oxaliplatin before, you should not
receive it again.
You must not be given Oxaliplatin
if you are pregnant or
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 oxaliplatin, as the effect
of breast milk from such patients is
You must not be given it if you have
severe kidney disease.
What you should tell
You must tell your doctor if:
You have had a reaction to any other
You have severe kidney disease,
You have nerve damage
You have any other medical
condition that he or she is not aware
You are taking any other medicines,
including medicines that you have
bought without a prescription from a
pharmacy, supermarket or health
Your doctor or pharmacist can tell you
what to do if you are taking any of these
How Oxaliplatin Accord
Oxaliplatin Accord will be given to you
as an infusion into one of your veins
(this is called an intravenous infusion).
The infusion will be given over 2 - 6
The dose of Oxaliplatin Accord is
calculated according to your body
surface area, which is calculated from
your weight and height. The usual dose
is 85 mg/m² every two weeks. Your
doctor may change the dose in some
Each course of treatment is called a
cycle; your doctor will tell you how
many cycles you will receive.
Oxaliplatin Accord will be used with
fluorouracil (FU) and folinic acid.
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recommended in children.
While you are using
Things you must do:
Avoid cold foods and drinks and cover
skin prior to exposure to cold during or
within 48 hours following being given
oxaliplatin, since neurological effects
may be brought on or worsened by
exposure to cold.
Contact your doctor immediately if you
develop fever, particularly in
association with persistent diarrhoea or
evidence of infection since this may
indicate low blood count.
Contact your doctor if persistent
vomiting, diarrhoea, signs of
dehydration, cough or breathing
difficulties or signs of allergic reaction
Visual disturbance is a rare side effect
of Oxaliplatin Accord. Contact your
doctor if this happens to you, and do not
drive or use machinery until your vision
Tell your doctor or nurse as soon as
possible if you do not feel well while
Oxaliplatin Accord is being given to
You should also tell your doctor if
you do not feel well between courses
of Oxaliplatin Accord.
All medicines can have side effects. It is
important to understand the side effects
that Oxaliplatin Accord
even though you may not experience
them. As well as the predictable side
effects of Oxaliplatin Accord, there are
other effects that occur much more
If you have any side effects or notice
anything unusual it is important to
inform your doctor before your next
Your doctor will decide whether such
effects are because of your treatment,
and what action needs to be taken.
This section explains the side effects of
Oxaliplatin Accord, and some of the
checks made before each treatment to
prevent excessive side effects.
. Before each
treatment with Oxaliplatin Accord
you will be examined for any
condition that may be affected by
chemotherapy (for example,
infection, or loss of feeling). This
will include those conditions
caused by previous treatment, those
caused by your disease, and those
caused by other things.
Loss of feeling.
can affect nerves in the hands and
feet. This is common soon after
treatment and can appear as
tingling or numbness in the fingers
or toes, and may be made worse by
cold temperatures or by contact
with cold water or other cold
objects. These symptoms often go
away between treatments, but may
last longer and get worse with
repeated treatment. In some
patients the limbs may become
weak or painful. However, in most
patients these symptoms improve
after treatment is stopped.
Tell your doctor if any of these things
happen. Your doctor will examine you
before treatment to see if you are
Nausea and Vomiting.
nausea and vomiting is uncommon
with Oxaliplatin Accord. Mild
nausea and vomiting is more
common. Medication to prevent the
sickness caused by Oxaliplatin
will be given before
treatment, and may sometimes be
continued after treatment.
Severe diarrhoea may
occur during treatment with Oxaliplatin
If you suffer from persistent or severe
diarrhoea or vomiting, contact your
doctor urgently for treatment advice.
Low Blood Counts.
Accord can affect the body's ability
to make blood cells. There are three
types of blood cells checked before
each treatment; platelets, which
help control bleeding; white blood
cells, which help fight infection;
and red blood cells which move
oxygen around the body. If your
blood count is too low, your
treatment may be postponed, or the
Tell your doctor if you notice any
bruising or abnormal bleeding, or
have an infection. These may be signs
of a low blood count.
patients may experience a sudden,
temporary feeling of difficulty with
swallowing or breathing. This
sensation, if it occurs, usually
happens during the infusion or
within hours after the infusion. It
may be triggered by swallowing a
cold drink. Although unpleasant,
this feeling does not last long, and
goes away by itself.
Tell your doctor if this happens to
Other known side effects of Oxaliplatin
mucositis (sore lips or mouth
changes to liver function
mild hair loss (alopecia)
inflammation around the injection
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abnormal tongue sensation
feeling of chest pressure
voice disturbance (rare)
loss of hearing (rare)
lung disorders (rare)
visual disturbance (rare)
Other side effects not listed above
may also occur in some patients. Tell
your doctor if you notice anything
else that is making you feel unwell.
If you receive too much
Your doctor will decide what dose of
Oxaliplatin Accord you need, and this
will be given under close supervision,
usually in a hospital setting. The risk of
an overdosage in these circumstances is
low. In the event of an overdose
occurring, your doctor will decide on
the treatment necessary.
Store below 25°C. Protect from light.
Do not freeze.
Shelf life after dilution
After dilution in 5% glucose, chemical
and physical in-use stability has been
demonstrated for up to 48 hours at 2°C
to 8°C and for 24 hours at 25°C.
From a microbiological point of view,
the infusion preparation should be used
immediately. If not used immediately,
in-use storage times and conditions
prior to use are the responsibility of the
user and would normally not be longer
than 24 hours at 2°C to 8°C unless
dilution has taken place in controlled
and validated aseptic conditions.
Special precautions for
DO NOT use injection equipment
DO NOT administer undiluted.
DO NOT mix or administer with
sodium chloride injection or any
other solution containing chlorides
DO NOT mix with any other
medication or administer
simultaneously by the same infusion
line (in particular fluorouracil and
folinic acid). A Y-tube may be used
USE ONLY the recommended
diluents (see below).
Any diluted solution that shows
evidence of precipitation should not
be used and should be destroyed.
Preparation of Infusion Solution
Dilution before Infusion
Oxaliplatin injection MUST be further
diluted in an infusion solution of 250-
500 mL of 5% glucose injection. From a
microbiological and chemical point of
view, this infusion preparation should
be used immediately. Inspect visually
prior to use. Only clear solutions
without particles should be used. The
product is for single use in one patient
only. Discard any residue. NEVER use
sodium chloride solution for dilution.
The administration of oxaliplatin does
not require prehydration. Oxaliplatin
diluted in 250 to 500 mL of a glucose
5% injection must be infused either by
central venous line or peripheral vein
over 2 to 6 hours. When oxaliplatin is
administered with fluorouracil, the
oxaliplatin infusion should precede that
Oxaliplatin can be co-administered with
folinic acid infusion using a Y-tube
placed immediately before the site of
injection. The drugs should not be
combined in the same infusion bag.
Folinic acid must be diluted using
isotonic infusion solutions such as 5%
glucose solution but NOT sodium
chloride solutions or alkaline solutions.
Flush the line after oxaliplatin
While oxaliplatin has minimal to no
vesicant potential, extravasation may
result in local pain and inflammation
which may be severe and lead to
complications especially when
oxaliplatin is infused through a
peripheral vein. In case of oxaliplatin
extravasation, the infusion must be
stopped immediately and the usual local
symptomatic treatment initiated.
All materials that have been used for
dilution and administration must be
destroyed according to local statutory
Do not use it after the expiry date
(EXP) printed on the vial.
This is not all the information that is
available on Oxaliplatin Accord. If you
have any more questions or are not sure
about anything ask to your doctor or
What it looks like
comes as a
concentrated solution in a glass vial.
Pack size: 1 vial.
Each Oxaliplatin Accord
the active ingredient, oxaliplatin 50 mg
or 100 mg.
Beside the active ingredient Oxaliplatin
concentrated injection contains
lactose monohydrate and water for
Name and Address of the
Accord Healthcare Pty Ltd
Lvl 24, 570 Bourke Street
Melbourne, VIC, 3000
Australian Registration Numbers
50 mg/10 mL: AUST R 209719
100 mg/20 mL: AUST R 209720
Date of preparation
This leaflet was prepared on 10