ZAVEDOS SOLUTION FOR INJECTION 5 mg5 ml

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

IDARUBICIN HCl

Beschikbaar vanaf:

PFIZER PRIVATE LIMITED

ATC-code:

L01DB06

Dosering:

5 mg/5 ml

farmaceutische vorm:

INJECTION

Samenstelling:

IDARUBICIN HCl 5 mg/5 ml

Toedieningsweg:

INTRAVENOUS

Prescription-type:

Prescription Only

Geproduceerd door:

Bridgewest Perth Pharma Pty Ltd

Autorisatie-status:

ACTIVE

Autorisatie datum:

2003-10-29

Bijsluiter

ZAVEDOS
®
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
_ _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 13
ZAVEDOS

Idarubicin Hydrochloride Injection
PRODUCT INFORMATION
Zavedos

(Idarubicin Hydrochloride), Solution for Injection (5 mg/5 mL & 10
mg/10 mL)
NAME OF THE MEDICINE
NON-PROPRIETARY NAME:
Idarubicin Hydrochloride
The structural formula of idarubicin hydrochloride is shown below:
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-

-L-lyxo-hexopyranosyl)-5,12-
naphthacenedione hydrochloride
CAS REGISTRY NUMBER:
57852-57-0
DESCRIPTION
Idarubicin hydrochloride is an odourless red-orange powder, slightly
soluble in water, with a
melting point of 173°C-174°C. The molecular formula is C
26
H
27
NO
9
·HCl and the molecular
weight is 533.95.
Zavedos solution for injection consists of idarubicin hydrochloride as
a red-orange, clear,
mobile solution, free from particles.
PHARMACOLOGY
PHARMACODYNAMICS
Zavedos is a semi synthetic antineoplastic anthracycline for
intravenous use.
Mechanism of action
Page 2 of 13
Idarubicin 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.
Pharmacodynamic effects
Idarubicin has been shown to have a higher potency with respect to
daunorubicin and to be an
effective agent against murine leukaemia and lymphomas. Studies
_in vitro_
on human and
murine 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 anti-tumour activities in
experimental models
both
_in vi

Productkenmerken

ZAVEDOS
 CS
Idarubicin Hydrochloride Injection
PRODUCT INFORMATION
Zavedos

CS (Idarubicin Hydrochloride), Solution for Injection (5 mg/5 mL & 10
mg/10 mL)
NAME OF THE MEDICINE
NON-PROPRIETARY NAME:
Idarubicin Hydrochloride
The structural formula of idarubicin hydrochloride is shown below:
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-

-L-lyxo-hexopyranosyl)-5,12-
naphthacenedione hydrochloride
CAS REGISTRY NUMBER:
57852-57-0
DESCRIPTION
Idarubicin hydrochloride is an odourless red-orange powder, slightly
soluble in water, with a
melting point of 173°C-174°C. The molecular formula is C
26
H
27
NO
9
·HCl and the molecular
weight is 533.95.
Zavedos solution for injection consists of idarubicin hydrochloride as
a red-orange, clear,
mobile solution, free from particles.
PHARMACOLOGY
PHARMACODYNAMICS
Zavedos is a semi synthetic antineoplastic anthracycline for
intravenous use.
Mechanism of action
Idarubicin 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.
Pharmacodynamic effects
Idarubicin has been shown to have a higher potency with respect to
daunorubicin and to be an
effective agent against murine leukaemia and lymphomas. Studies
_in vitro_
on human and
murine 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 anti-tumour activities in
experimental models
both
_in vitro_
and
_in vivo_
. In the rat, idarubicinol, administered at the same doses as the
parent
drug, is less cardiotoxic than idarubicin.
PHARMACOKINETICS
After intravenous administration of i