Eloxatin

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Oxaliplatin 5 mg/mL

Tilgjengelig fra:

sanofi-aventis new zealand limited

INN (International Name):

Oxaliplatin 5 mg/mL

Dosering :

5 mg/mL

Legemiddelform:

Concentrate for infusion

Sammensetning:

Active: Oxaliplatin 5 mg/mL Excipient: Water for injection

Enheter i pakken:

Vial, glass, single dose, Type 1 clear glass, 50mg in 10mL pack, 10 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Johnson Matthey Pharmaceutical Materials

Indikasjoner:

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.

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, single dose, Type 1 clear glass, 50mg in 10mL pack - 10 mL - 36 months from date of manufacture stored at or below 25°C. Do not freeze. - Vial, glass, single dose, Type 1 clear glass, 100mg in 20mL pack - 20 mL - 36 months from date of manufacture stored at or below 25°C. Do not freeze. - Vial, glass, single dose, Type 1 clear glass, 200mg in 40mL pack - 40 mL - 36 months from date of manufacture stored at or below 25°C. Do not freeze

Autorisasjon dato:

2004-06-14

Informasjon til brukeren

ELOXATIN
Page 1 of 4
_ _
ELOXATIN
®
_Oxaliplatin concentrated solution for injection _
_CONSUMER MEDICINE INFORMATION _
PLEASE READ THIS LEAFLET BEFORE YOU ARE GIVEN THIS MEDICINE.
WHAT IS IN THIS
LEAFLET?
This leaflet answers some
common questions about Eloxatin
injection.
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 ELOXATIN IS
USED FOR
Eloxatin is used to treat cancer of
the large intestine and rectum
(colorectal cancer). Eloxatin is
used with two other anti-cancer
drugs, fluorouracil (FU), and
folinic acid. The active ingredient
in Eloxatin 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 Eloxatin because
they believe that the benefit of
Eloxatin 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.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR OR PHARMACIST
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 IT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN
ELOXATIN IF YOU ARE ALLERGIC TO
THE ACTIVE INGREDIENT
OXALIPLATIN.
If you have had an allergic
reaction to oxaliplatin before

Preparatomtale

Page | 1
eloxatin-conc-ccdsv15-dsv7-18jun20
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Eloxatin 5mg/mL concentrated solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Eloxatin concentrate for injection is available in the following
strengths:
•
Oxaliplatin 50 mg
•
Oxaliplatin 100 mg
•
Oxaliplatin 200 mg
For the full list of excipients, see section 6.1.
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.
3
PHARMACEUTICAL FORM
Powder for injection: White to off-white freeze-dried powder in a
clear glass vial
Concentrated solution for injection: A liquid contained in a clear
glass vial
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
Page | 2
eloxatin-conc-ccdsv15-dsv7-18jun20
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
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,
or
130mg/m
2
repeated every three 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 eg 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 dail