OXALIPLAN 50 oxaliplatin 50mg powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

oxaliplatin, Quantity: 50 mg

Disponível em:

Medis Pharma Pty Ltd

DCI (Denominação Comum Internacional):

Oxaliplatin

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients: mannitol

Via de administração:

Intravenous

Unidades em pacote:

1 vial

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

In combination with fluorouracil and folinic acid: adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour; and treatment of advanced colorectal cancer.

Resumo do produto:

Visual Identification: White or almost white freeze-dried powder in a vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2007-09-07

Folheto informativo - Bula

CONSUMER MEDICINE
INFORM AT ION
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Características técnicas

_Product Information:Oxaliplan (50mg and 100mg) _
_v3 September 2010 clean copy _
1
PRODUCT INFORMATION
OXALIPLAN
TM
NAME OF THE MEDICINE
Oxaliplan contains 50 or 100 mg of Oxaliplatin per vial. The
formulation also contains mannitol.
The full chemical name of Oxaliplatin is (SP-4-2)-[(1R,2R
)-Cyclohexane-1,2-diamine-κN, κN1] [ethanedioato(2-)-
κO1,κO2]platinum.
The Chemical Abstracts Name is:
[(1R,2R)-1,2-cyclohexanediamine-N,N’][oxalate(2-)O,O’]platine(II)
DESCRIPTION
Molecular formula: C
8
H
14
N
2
O
4
Pt
Molecular Weight: 397.3
CAS Number: 61825-94-3
Chemical Structure:
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
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-1-1,2- 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.
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 of Oxaliplatin at 130 mg/m2
every