Oxaliplatin Actavis
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
28-05-2024
Summary of Product characteristics
(SPC)
28-05-2024
Active ingredient:
Oxaliplatin
Available from:
Actavis Australia Pty Ltd
Class:
Medicine Registered
Patient Information leaflet
OXALIPLATIN ACTAVIS 50
OXALIPLATIN
ACTAVIS
100
VERSION
2
PRODUCT INFORMATION
Actavis Australia Pty Ltd
1
PRODUCT INFORMATION
NAME OF THE MEDICINE
OXALIPLATIN ACTAVIS 50 oxaliplatin 50mg powder for injection vial
OXALIPLATIN ACTAVIS 100 oxaliplatin 100mg powder for injection
vial
_Active._ Oxaliplatin.
_Inactive._ Lactose
OXALIPLATIN
DESCRIPTION
Chemical name: [SP-4-2]-(1R,2R)- (cyclohexane-1,2-diamine- k
2
N,N'(oxalato (2-)-
k
2
O
1
,O
2
) platinum (II). Molecular formula: C
8
H
14
N
2
O
4
Pt. MW: 397.3. CAS: 61825-
94-3.
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 drug 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-λ-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 DNA to form both inter and intra strand
cross links, resulting
in the disruption of DNA synthesis leading to cytotoxic and
antitumour effects.
OXALIPLATIN ACTAVIS 50
OXALIPLATIN
ACTAVIS
100
VERSION
2
PRODUCT INFORMATION
Actavis Australia
Read the complete document
Summary of Product characteristics
Oxaliplatin Actavis
PRODUCT INFORMATION
NAME OF THE MEDICINE
OXALIPLATIN ACTAVIS 50 oxaliplatin 50mg powder for injection
vial
OXALIPLATIN ACTAVIS 100 oxaliplatin 100mg powder for
injection vial
_Active._ Oxaliplatin.
_Inactive._ Lactose
Oxaliplatin
DESCRIPTION
Chemical name: [SP-4-2]-(1R,2R)- (cyclohexane-1,2-diamine- k
2
N,N'(oxalato (2-)-k
2
O
1
,O
2
) platinum
(II). Molecular formula: C
8
H
14
N
2
O
4
Pt. MW: 397.3. CAS: 61825-94-3.
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 drug 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-λ-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 DNA to form
both inter and intra strand cross links, resulting in the
disruption of DNA synthesis leading to
cytotoxic and antitumour effects.
OXALIPLATIN ACTAVIS – Product information
Page 2 of 17
PHARMACOKINETICS
The pharmacokinetics of individual active compounds have not
been determined. The
pharmaco
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