DBL OXALIPLATIN oxaliplatin concentrate for infusion vial 50mg/10mL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxaliplatin, Quantity: 50 mg

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Oxaliplatin

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

50 mg/ 10 mL; single vial pack

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: vial containing clear, colourless solution practically free of particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2009-02-20

Patient Information leaflet

DBL™ OXALIPLATIN FOR
INJECTION & DBL™
OXALIPLATIN CONCENTRATE
_oxaliplatin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Oxaliplatin for
Injection (oxaliplatin) and DBL
Oxaliplatin Concentrate (oxaliplatin).
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using oxaliplatin
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.
You may need to read it again.
WHAT DBL OXALIPLATIN
IS USED FOR
Oxaliplatin belongs to a group of
medicines called antineoplastic or
cytotoxic medicines. You may also
hear of these being called
chemotherapy medicines.
This medicine is used to treat cancers
of the colon and rectum (colorectal
cancer or bowel cancer).
It is often used in combination with
other medicines (such as fluorouracil
and folinic acid) to treat cancer.
Oxaliplatin works by killing cancer
cells and/or stopping cancer cells
from growing and multiplying.
Because cancer cells are similar to
normal cells, anti cancer drugs often
have side effects on normal cells.
Many side effects from anti cancer
drugs are predictable and can be
prevented or lessened. Your doctor
will take all the precautions need to
reduce the side effects of treatment.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Oxaliplatin is not addictive.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU ARE GIVEN
DBL OXALIPLATIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN DBL
OXALIPLATIN IF YOU HAVE HAD A
REACTION TO ANY OTHER PLATINUM
COMPOUND.
YOU SHOULD NOT BE GIVEN DBL
OXALIPLATIN IF YOU HAVE AN ALLERGY
TO OXALIPLATIN OR ANY O

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™ OXALIPLATIN FOR INJECTION, DBL
™
OXALIPLATIN CONCENTRATE (OXALIPLATIN)
1.
NAME OF THE MEDICINE
Oxaliplatin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of DBL Oxaliplatin for Injection contains 20 mg, 50 mg or
100 mg of oxaliplatin and
lactose.
Each vial of DBL Oxaliplatin Concentrate contains 50 mg/10 mL or 100
mg/20 mL of
oxaliplatin as well as tartaric acid, sodium hydroxide and water for
injections.
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
DBL Oxaliplatin for Injection is a freeze dried powder for injection.
DBL Oxaliplatin Concentrate is an injection for intravenous infusion.
4.
CLINICAL PARTICULARS
4.1
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
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
In combination with fluorouracil and folinic acid the recommended dose
for the treatment of
advanced colorectal cancer is either 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.
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Supersedes: pfpoxala10720
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_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 i