OLIPLAT FOR INJECTION 100 mg

Šalis: Malaizija

kalba: anglų

Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Veiklioji medžiaga:

OXALIPLATIN

Prieinama:

MYLAN HEALTHCARE SDN. BHD.

INN (Tarptautinis Pavadinimas):

OXALIPLATIN

Vienetai pakuotėje:

1vial Vials

Pagaminta:

Onco Therapies Limited

Pakuotės lapelis

Not Applicable

Prekės savybės

FRONT SIDE
PRODUCT DESCRIPTION
Oliplat for Injection 50 mg is a white lyophilized powder or plug.
After
reconstitution with 5% w/v Dextrose injection, the reconstituted
solution is a
clear colorless solution.
Oliplat for Injection 100 mg is a white lyophilized powder or plug.
After
reconstitution with 5% w/v Dextrose injection, the reconstituted
solution is a
clear colorless solution.
COMPOSITION
Each vial of Oliplat for Injection 50 mg contains sterile lyophilized
powder of
Oxaliplatin 50 mg.
Each vial of Oliplat for Injection 100 mg contains sterile lyophilized
powder of
Oxaliplatin 100 mg.
PHARMACOLOGY
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.
Oxaliplatin exhibits a wide spectrum of both _in vitro_ cytotoxicity
and _in vivo_
antitumor activity in a variety of tumor models. Oxaliplatin also
demonstrates
in _in vitro_ and _in vivo_ activity in various cisplatin resistant
models.
A synergistic cytotoxic action has been observed in combination with
5-fluorouracil both _in vitro_ and _in vivo_.
Studies on the mechanism of action of oxaliplatin, even if this one is
not
completely understood, support the concept that biotransformed,
aquated
products of oxaliplatin interact with DNA to form intra and
interstrand
crosslinks, resulting in disruption of DNA synthesis leading to
cytotoxicity and
antitumor effects.
PHARMACOKINETICS
The pharmacokinetics of platinum in plasma, ultrafiltered plasma and
red
blood cells following a 2-hr oxaliplatin infusion of 130 mg/m
2
every 3 weeks
for 1-5 cycles, are as follows:
C
end
(mcg/
ml)
C
max
(mcg/
ml)
T
max
(hr)
AUC
0-48
(mcg/
ml.hr)
AUC
0-∞
(mcg/
ml.hr)
t
1/2
α
(hr)
t
1/2ß
(hr)
t
1/2
γ
(hr)
V
ss
(L)
Cl
(L/hr)
Ultrafiltrated
Plasma
Mean SD
1.21
0.10
1.21
0.10
2
8.2
2.4
11.9
4.6
0.28
0.06
16.3
2.9
273
19
582
261
10.1
3.07
Mean AUC
0-48
, C
end
and C
max
values were calculated on Cycle 5
Mean AUC
0