EPIRUBICIN KABI epirubicin hydrochloride 200 mg/100 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

epirubicin hydrochloride, Quantity: 2 mg/mL

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

epirubicin hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride

Administration route:

Intravesical, Intravenous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Epirubicin hydrochloride has produced responses in a wide spectrum of neoplastic diseases and is indicated for the treatment of:,? breast cancer,? gastric cancer,? ovarian cancer,? small cell lung cancer,? lymphoma (non-Hodgkin?s lymphoma),? advanced/metastatic soft tissue sarcoma,? superficial bladder cancer (Tis; Ta).,In bladder cancer, epirubicin hydrochloride is also indicated in the prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage Ta multifocal papillary cancers (Grade 2 and 3).

Product summary:

Visual Identification: Clear red coloured solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-11-21

Patient Information leaflet

CMI for Epirubicin Kabi
November, 2011
Filename: EpiCMI011111
Page 1 of 3
EPIRUBICIN KABI INJECTION
Epirubicin hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Epirubicin Kabi.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the risks of you using Epirubicin
Kabi
against
the
benefits
they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT EPIRUBICIN KABI IS
USED FOR
Epirubicin
Kabi
is
used
in
the
treatment
of
various
types
of
cancer. It may be used alone or
with other medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY EPIRUBICIN
KABI
HAS
BEEN
PRESCRIBED
FOR
YOU.
Your doctor may have prescribed it
for another purpose.
Epirubicin
Kabi
is
only
available
with a doctor's prescription. It is not
addictive.
BEFORE
YOU
ARE
GIVEN
EPIRUBICIN KABI
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT USE EPIRUBICIN KABI IF YOU
HAVE
EVER
HAD
AN
ALLERGIC
REACTION TO EPIRUBICIN (THE ACTIVE
INGREDIENT
IN
EPIRUBICIN
KABI),
OTHER MEDICINES TO TREAT CANCER
OR ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing
or
difficulty
breathing;
swelling of the face, lips, tongue or
other
parts
of
the
body;
rash,
itching or hives on the skin.
DO
NOT
USE
THE
MEDICINE
FOR
INJECTION INTO A VEIN IF YOU HAVE:
a low number of red blood cells,
white blood cells or platelets in
your blood
sore, red mouth from previous
treatment or radiation therapy
an infection
severe liver problems
heart
problems
or
have
ever
had heart problems
already
received
the
highest
dose
allowed
for
medicines
such
as
mitozantrone,
mitomycin
C,
doxorubicin
or
daunorubicin
DO
NOT
USE
THE
MEDICINE
FOR
INJECTION INTO THE BLADDER IF YOU
HAVE:
cancer that has gone into the
bladder wall
kidn

Summary of Product characteristics

Filename: EpiPI011111
Page 1 of 14
PRODUCT INFORMATION
NAME OF MEDICINE
Epirubicin Kabi Solution for Injection
DESCRIPTION
Structurally, epirubicin hydrochloride differs from doxorubicin
hydrochloride only in the
orientation of the hydroxyl group at the 4 position on the
aminoglycoside ring. The
chemical name of epirubicin hydrochloride is (8S,
10S)-10-(3-amino-2,3,6-trideoxy-α-L-
arabinohexopyranosyloxy)-8-glycolloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1
methoxynaphthacene-5,12-dione hydrochloride.
The structural formula is:
Empirical formula:
C
27
H
29
NO
11
·HCl
Molecular weight:
579.99
CAS number:
56390-09-1
Epirubicin
hydrochloride
is
a
red-orange,
almost
odourless,
hygroscopic
powder,
sparingly soluble in water and dilute alcohol.
Epirubicin
hydrochloride
is
available
as
a
ready-to-use
solution
(Epirubicin
Kabi).
Epirubicin Kabi is a clear red coloured solution of epirubicin
hydrochloride and sodium
chloride in Water for Injections. Hydrochloric acid is added as
necessary to adjust the
pH. The solution is available as a 2 mg/mL solution in 10 mg/5 mL, 50
mg/25 mL and
200 mg/100 mL presentations.
PHARMACOLOGY
The mechanism of action of epirubicin hydrochloride has not been fully
elucidated but is
probably
related
to
its
ability
to
bind
DNA.
Cell
culture
studies
have
shown
cell
penetration, localisation in the nucleus and inhibition of nucleic
acid synthesis and
mitosis. Epirubicin hydrochloride has proved to be active on the
following experimental
tumours: L 1210 ascites and P388 leukaemias, sarcoma SA 180 (solid and
ascitic
forms),
melanoma
B
16,
mammary
carcinoma,
Lewis
lung
carcinoma
and
colon
carcinoma 38.
The specificity of epirubicin hydrochloride toxicity appears to be
related primarily to
proliferative activity of normal tissue. Thus, bone marrow,
gastrointestinal tract, lymphoid
Filename: EpiPI011111
Page 2 of 14
organs
and
the
gonads
are
the
main
normal
tissues
damaged.
Degenerative
or
functional
alterations
in
liver
and
kidneys
were
also
seen
in
animals
dosed
with
epirubicin hydrochloride.
Lik