Idarubicin Ebewe

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Idarubicin hydrochloride 1 mg/mL;  

Available from:

Sandoz New Zealand Limited

INN (International Name):

Idarubicin hydrochloride 1 mg/mL

Dosage:

1 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Idarubicin hydrochloride 1 mg/mL   Excipient: Glycerol Hydrochloric acid Sodium hydroxide Water for injection

Units in package:

Vial, glass, single dose, Type 1 clear glass 5 ml vial, coated chlorobutyl closure, al crimp seal in printed carton, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sicor (Societa Italiana Corticosteroidi) Srl

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:

Package - Contents - Shelf Life: Vial, glass, single dose, Type 1 clear glass 5 ml vial, coated chlorobutyl closure, al crimp seal in printed carton - 5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, Type 1 clear glass 10 ml vial, coated chlorobutyl closure, al crimp seal in printed carto - 10 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, Type 1 clear glass 20 ml vial, coated chlorobutyl closure, al crimp seal in printed carton - 20 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, 5 x Type 1 clear glass 5 ml vial, coated chlorobutyl closure, al crimp seal in printed carton - 25 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, 5 x Type 1 clear glass 10 ml vial, coated chlorobutyl closure, al crimp seal in printed carton - 50 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, 5 x Type 1 clear glass 20 ml vial, coated chlorobutyl closure, al crimp seal in printed carto - 100 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2010-12-20

Summary of Product characteristics

Page 1 of 12
DATASHEET
IDARUBICIN EBEWE 1 MG/ML 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
.
HCl
_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
both
by
intravenous
and
oral
routes.
Studies
_in _
_vitro_
on
human
and
murine
Page 2 of 12
anthracycline-resistant
cells
have
shown
a
lower
degree
of
cross-resistance
for
idarubicin compared with doxorubicin and daunorubicin. Cardiotoxicity
studies in
animals
have
indicated
that
idarubicin
has
a
better
therapeutic
index
than
daunorubicin
and
doxorubicin.
The
main
metabolite
idarubicinol,
has
shown
antitumour activities in experimental models both _ in vitro_ and _ in
vivo_. In the rat,
idarubicinol, administered the same doses as the parent drug, is less
cardiotoxic than
idarubicin.
PHARMACOKINETICS
After intravenous administration of idarubicin, there is triphasic
disposition in plasma.
Estimates of the plasma half-life for the parent compound range from
10 to 35 hours.
Idarubicin i