IDARUBICIN EBEWE idarubicin hydrochloride 10mg/10mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

idarubicin hydrochloride, Quantity: 1 mg/mL

Available from:

Sandoz Pty Ltd

INN (International Name):

idarubicin hydrochloride

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; dilute hydrochloric acid; glycerol

Administration route:

Intravenous

Units in package:

10mg/10mL in a 10mL vial x 1, 10mg/10mL in a 10mL vial x 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Idarubicin Ebewe is indicated for use in acute myelogenous leukaemia (AML) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. Idarubicin Ebewe may be used in combination chemotherapy regimens involving other cytotoxic agents.

Product summary:

Visual Identification: Idarubicin Ebewe is a clear, red-orange solution supplied in a clear glass,vial with a fluoropolymer coated halobutyl rubber stopper.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-10-21

Summary of Product characteristics

_Product information _
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_Idarubcin Ebewe 5mg/5mL, 10mg/10mL, 20mg/20mL solution for injection
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_03/2016 _
_Sandoz Pty Ltd _
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_PRODUCT INFORMATION _
IDARUBICIN EBEWE
® 5MG/5ML, 10MG/10ML, 20MG/20ML
INJECTION
NAME OF THE MEDICINE
idarubicin hydrochloride
_Chemical name: _(7_S_, 9_S_) -9-acetyl-7, 8, 9,
10-tetrahydro-6,7,9,11- tetrahydroxy-7-_O_-
(2, 3, 6-trideoxy-3-amino-α-L-lyxo- hexopyranosyl)-5,
12-naphthacenedione
hydrochloride
_Molecular formula:_ C
26
H
27
NO
9
.
HCI
_Molecular weight:_ 533.95
_CAS No:_ 57852-57-0
DESCRIPTION
Idarubicin Ebewe is a semi synthetic antineoplastic anthracycline for
intravenous use.
Idarubicin Ebewe solution for injection is a sterile, pyrogen free,
clear, red to orange,
mobile solution in vials for intravenous administration and consists
of idarubicin
hydrochloride. The excipients included are glycerol, dilute
hydrochloric acid, sodium
hydroxide and water for injections.
PHARMACOLOGY
Idarubicin hydrochloride is a cytotoxic agent. It is a DNA
intercalating agent which
reacts with topoisomerase II and has an inhibitory effect on nucleic
acid synthesis.
The compound has a high lipophilicity which results in an increased
rate of cellular
uptake compared with doxorubicin and daunorubicin.
Idarubicin hydrochloride has been shown to have a higher potency with
respect to
daunorubicin and to be an effective agent against murine leukaemia and
lymphomas
_Product information _
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_ Page 2 _
_Idarubcin Ebewe 5mg/5mL, 10mg/10mL, 20mg/20mL solution for injection
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_03/2016 _
_Sandoz Pty Ltd _
_ _
_ _
both
by
intravenous
and
oral
routes.
Studies
in
vitro
on
human
and
murine
anthracycline-resistant
cells
have
shown
a
lower
degree
of
cross-resistance
for
idarubicin
hydrochloride
compared
with
doxorubicin
and
daunorubicin.
Cardiotoxicity studies in animals have indicated that idarubicin
hydrochloride has a
better therapeutic index than daunorubicin and doxorubicin. The main
metabolite
idarubicinol, has shown antitumour activities in experimental models
both _in vitro_ and
_