OXALIPLATIN ACCORD oxaliplatin 50 mg/10 mL concentrated injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
09-08-2022
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
oxaliplatin, Quantity: 50 mg
Available from:
Accord Healthcare Pty Ltd
INN (International Name):
Oxaliplatin
Pharmaceutical form:
Injection, concentrated
Composition:
Excipient Ingredients: water for injections; lactose monohydrate
Administration route:
Intravenous Infusion
Units in package:
1 vial
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
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.
Product summary:
Visual Identification: A clear, colourless solution in a clear glass vial. When examined under suitable conditions of visibility it should be practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Registered
Authorization date:
2014-10-09
Patient Information leaflet
Version 4.0
Page 1 of 4
OXALIPLATIN ACCORD
_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
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 this medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
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, 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with a
doctor's prescription.
BEFORE YOU ARE GIVEN
OXALIPLATIN ACCORD
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN OXALIPLATIN
ACCORD IF YOU ARE ALLERGIC TO THE ACTIVE
INGREDIENT OXALIPLATIN.
If you have had a
Read the complete document
Summary of Product characteristics
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
OXALIPLATIN ACCORD (OXALIPLATIN) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Oxaliplatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxaliplatin
Accord,
concentrated
injection
is
presented
in
vials
containing
50
mg/10
mL
and
100 mg/20 mL oxaliplatin.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Oxaliplatin Accord, concentrated injection is a clear, colourless
solution in a clear glass vial.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
In combination with fluorouracil and folinic acid the recommended dose
for the treatment of advanced
colorectal cancer is 85 mg/m
2
intravenously repeated every two weeks.
In combination with fluorouracil and folinic acid the recommended dose
for adjuvant treatment is 85
mg/m
2
intravenously repeated every two weeks for 12 cycles (6 months).
DOSAGE MODIFICATION
Prior to each treatment cycle, patients should be evaluated for
toxicity and the dose of oxaliplatin adjusted
accordingly.
_NEUROLOGICAL TOXICITY _
If acute neurological reactions occur e.g. acute pharyngolaryngeal
dysaesthesia, increase the oxaliplatin
infusion time from 2 hours to 6 hours. This decreases C
max
by 30% and may lessen acute toxicities.
If sensory loss or paraesthesia persists longer than 7 days or
interferes with function (grade 2 toxicity),
reduce oxaliplatin dose by 25%.
If sensory loss or paraesthesia interferes with activities of daily
living (grade 3 toxicity), oxaliplatin
should be discontinued.
_HAEMATOLOGICAL TOXICITY _
If haematological toxicity (neutrophils <1.5x10
9
/L or platelets <75x10
9
/L) is present before starting
treatment or prior to the next course:
•
Delay treatment until neutrophil count is ≥1.5x10
9
/L and platele
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