Oxaliplatin Ebewe

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxaliplatin 100mg;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Oxaliplatin 100 mg

Dosage:

100 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Oxaliplatin 100mg   Excipient: Lactose

Units in package:

Vial, glass, 60 mL Type I with butyl rubber stopper and aluminium cap, 100 mg, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Jiangsu Hengrui Medicine Co Ltd

Product summary:

Package - Contents - Shelf Life: Vial, glass, 60 mL Type I with butyl rubber stopper and aluminium cap, 100 mg - 1 dose units - 3 years from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2009-01-21

Patient Information leaflet

Oxaliplatin Ebewe
Oxaliplatin Ebewe_CMI_v2_Dec 2014
Page 1 of 3
OXALIPLATIN EBEWE
_Oxaliplatin (Ox-AL-i-PLAT-in) _
_CONSUMER MEDICINE INFORMATION _
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
Oxaliplatin Ebewe 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
Oxaliplatin Ebewe against the
benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
WHAT OXALIPLATIN EBEWE IS
USED FOR
Oxaliplatin Ebewe is used to
treat cancer of the large
intestine and rectum
(colorectal cancer). Oxaliplatin
Ebewe is used with two other
anti-cancer drugs, fluorouracil
(FU), and folinic acid. The
active ingredient in Oxaliplatin
Ebewe 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
Ebewe because they believe
that the benefit of Oxaliplatin
Ebewe 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.
Oxaliplatin Ebewe is only
available on a prescription
from your doctor.
BEFORE YOU ARE GIVEN
OXALIPLATIN EBEWE
_ _
_WHEN YOU MUST NOT RECEIVE _
_IT_
YOU SHOULD NOT BE GIVEN
OXALIPLATIN EBEWE IF YOU ARE
ALLERGIC TO THE ACTIVE
INGREDIENT OXALIPLATIN.
If you have had an allergic
reaction to oxaliplatin before,
you should not receive it
again.
YOU MUST NOT RECEIVE
OXALIPLATIN EBEWE IF YOU ARE
PREGNANT OR BREASTFEEDING.
Oxaliplatin may cause birth
defects if you are being
treated with i

Summary of Product characteristics

Page 1 of 18
DATASHEET
OXALIPLATIN EBEWE
NAME OF THE MEDICINE
Oxaliplatin Ebewe oxaliplatin 50 mg powder for injection vial
Oxaliplatin Ebewe oxaliplatin 100mg powder for injection vial
COMPOSITION
_Active. _Oxaliplatin
.
_Inactive. _Lactose
.
The empirical formula for oxaliplatin is C
8
H
14
N
2
O
4
Pt with Molecular Weight: 397.3. The
CAS Number for oxaliplatin is 61825-94-3. Oxaliplatin has the
following chemical structure:
OXALIPLATIN
Chemical name: (SP-4-2)-[(1R,2R)-Cyclohexane-1,2-diamine-kN,N’]
ethanedioato(2-)-
kO
1
,kO
2
]platinum.
DESCRIPTION
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.
PHARMACOLOGY
PHARMACODYNAMICS
Oxaliplatin is an antineoplastic medicine belonging to a new class of
platinum based
compounds in which the platinum atom is complexed with 1
,2-diaminocyclohexane (DACH)
and an oxalate group. Oxaliplatin is a single enantiomer, the
cis-[oxalato (trans-_l_-1,2- DACH)
platinum].
Oxaliplatin exhibits a wide spectrum of both _in vitro_ cytotoxicity
and _in vivo_ antitumour
activity in a variety of tumour model systems, including human
colorectal cancer models.
Oxaliplatin also demonstrates _in vitro_ and _in vivo_ activity in
various cisplatin resistant models.
A synergistic cytotoxic action has been observed in combination with
fluorouracil both _in _
_vitro _and _in vivo_.
Studies on the mechanism of action of oxaliplatin, although not
completely elucidated, show
that the aqua-derivatives resulting from the biotransformation of
oxaliplatin interact with
Page 2 of 18
DNA to form both inter- and intra-strand cross links, resulting in the
disruption of DNA
synthesis leading to cytotoxic and antitumour effects.
PHARMACOKINETICS.
The pharmacokinetics of individual active compounds have not been
determined. The
pharmacokinetics of ultrafiltrable platinum, representing a mixture of
all unbound, active and
inactive platinum species, following a two hour infusion ofoxaliplatin
at 130 m