DBL OXALIPLATIN FOR INJECTION oxaliplatin 20mg powder for injection vial

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

oxaliplatin

Commercializzato da:

Pfizer Australia Pty Ltd

INN (Nome Internazionale):

Oxaliplatin

Stato dell'autorizzazione:

Registered

Foglio illustrativo

1
DBL
TM OXALIPLATIN FOR INJECTION &
DBL
TM OXALIPLATIN CONCENTRATE
_ _
_Oxaliplatin_ (
ox-AL-ih-pla-tin
)
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name _
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_Pharmacist Name _
_Consumer Address _
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_Pharmacist Address_
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WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL
TM
Oxaliplatin for Injection
(oxaliplatin) and DBL
TM
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 taking
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
TM
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
DBL
TM OXALIPLATIN 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
TM OXALIPLATIN
_WHEN YOU MUST NOT TAKE IT _
YOU

Scheda tecnica

Version: pfpoxala10422
Supersedes: pfpoxala10720
Page 1 of 27
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.
Version: pfpoxala10422
Supersedes: pfpoxala10720
Page 2 of 27
_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