HOSPIRA DOCETAXEL docetaxel 80mg/4mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

docetaxel

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Docetaxel

Authorization status:

Registered

Summary of Product characteristics

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PRODUCT INFORMATION
HOSPIRA
TM DOCETAXEL CONCENTRATED INJECTION
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Docetaxel
O
NH
O
O
O
OH
HO
O
OH
O
OH
O
O
H
H
O
O
3H
2
O
Molecular Formula:
C
43
H
53
NO
14
.3H
2
O
Molecular Weight: 861.9
Chemical Name: (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl
ester, 13-ester with
5β, 20 epoxy 1, 2α , 4, 7β, 10β, 13α -hexahydroxytax-11-en-9-one
4-acetate 2-benzoate,
trihydrate
Chemical name: (2
_R_
,3
_S_
)-
_N_
-carboxy-3-phenylisoserine,
_N_
-
_tert_
-butyl ester, 13-ester
with 5β, 20-epoxy-1,2α,4,7β,10β,13α -hexahydroxytax-11-en-9-one
4-acetate 2-benzoate,
trihydrate.
CAS REGISTRY NUMBER
148408-66-6
DESCRIPTION
Docetaxel is a white to almost white powder. It is highly lipophilic
and practically insoluble
in water.
Single-dose vials of HOSPIRA
TM
Docetaxel concentrated injection containing 20 or 80 or
120mg of docetaxel per 1.0 or 4.0 or 6.0mL, respectively, in 50/50
(v/v) polysorbate
80/ethanol (anhydrous). The sterile pyrogen-free viscous solution
contains 20mg/mL
docetaxel (anhydrous).
In each
HOSPIRA
TM
Docetaxel
20mg/1ml concentrate vial, the absolute ethanol amount is 395
mg.
In each
HOSPIRA
TM
Docetaxel
80mg/4ml concentrate vial, the absolute ethanol amount is
1.58 g.
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In each
HOSPIRA
TM
Docetaxel
120mg/6ml concentrate vial, the absolute ethanol amount is
2.37 g.
PHARMACOLOGY
CLASS
Docetaxel is an antineoplastic agent which acts by promoting the
assembly of tubulin into
stable microtubules and inhibits their disassembly which leads to a
marked decrease of free
tubulin. The binding of docetaxel to microtubules does not alter the
number of
protofilaments.
PHARMACODYNAMICS
MECHANISM OF ACTION
Docetaxel has been shown in vitro to disrupt the microtubular network
in cells which is
essential for vital mitotic and interphase cellular functions.
_PRECLINICAL DATA _
Docetaxel was found to be cytotoxic in vitro against various murine
and human tumour cell
lines and against freshly excised human tumour cells in clonogenic
assays. Do