GEMCITABINE KABI gemcitabine (as hydrochloride) 200 mg powder for injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

gemcitabine hydrochloride, Quantity: 227.72 mg (Equivalent: gemcitabine, Qty 200 mg)

Tilgjengelig fra:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients: mannitol; sodium acetate; hydrochloric acid; sodium hydroxide

Administreringsrute:

Intravenous Infusion

Enheter i pakken:

1 X 10 mL vial

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Gemcitabine Kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. Treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine is also indicated for patients with 5-FU refractory pancreatic cancer. Alone or in combination with cisplatin, for the treatment of patients with bladder cancer. In combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. In combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

Produkt oppsummering:

Visual Identification: White to off-white lyophilised powder or cake; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2010-09-30

Informasjon til brukeren

CMI for Gemcitabine Kabi
May, 2013
Page 1 of 4
GEMCITABINE KABI
Gemcitabine hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Gemcitabine Kabi
Injection. It does not contain all the
available information. It does not
take the place of talking to your
doctor.
All
medicines
have
benefits
and
risks. Your doctor has weighed the
risks
of
using
Gemcitabine
Kabi
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
HEALTH
CARE
PROFESSIONAL.
KEEP THIS LEAFLET. You may need to
read it again.
WHAT GEMCITABINE KABI
IS USED FOR
Gemcitabine Kabi is used to treat
patients with:
•
lung cancer
•
cancer of the pancreas
•
bladder cancer
•
breast cancer
•
ovarian cancer
Gemcitabine
Kabi
belongs
to
a
group of anticancer drugs known
as
antineoplastic
or
cytotoxic
medicines.
It
works
by
killing
cancer cells and preventing cancer
cells from growing and multiplying,
and is used for different types of
cancer. The active ingredient in
Gemcitabine
Kabi
is
gemcitabine
hydrochloride.
Your doctor will be able to tell you
about
the
specific
condition
for
which
you
have been
prescribed
Gemcitabine Kabi. Ask your doctor
or health care professional if you
have
any
questions
why
it
has
been
prescribed
for
you.
Gemcitabine is only available on a
prescription from your doctor.
Your doctors have decided to treat
you with Gemcitabine because they
believe
that
the
benefit
of
Gemcitabine
treatment
will
be
greater
than
any
unwanted
side
effects.
Many of the side effects from anti
cancer drugs are predictable and
can
be
prevented
or
lessened.
Your doctor and other staff will take
all
of
the
precautions
needed
to
reduce
the
unwanted
effects
of
treatment.
BEFORE
YOU
ARE
GIVEN
GEMCITABINE KABI
_WHEN YOU MUST NOT RECEIVE IT _
DO NOT USE GEMCITABINE KABI IF:
•
you
have
an
allergy
to
Gemcitabine
or
any
of
the
ingredients listed at the end of
this leaflet
•
you
have
kidney
disease
or
poor kidney function
•
you

Preparatomtale

Page 1 of 21
PRODUCT INFORMATION
Product Name: GEMCITABINE KABI
NAME OF THE MEDICINE
Gemcitabine hydrochloride
Gemcitabine is an antineoplastic agent that inhibits ribonucleotide
reductase.
Gemcitabine
is
described
chemically
as
2'-deoxy-2',
2'
-
difluorocytidine
monohydrochloride (ß-isomer).
Gemcitabine hydrochloride has the following chemical structure:
Empirical formula:
C
9
H
11
F
2
N
3
O
4
.HCl
Molecular weight:
299.7
CAS Number:
122111-03-9
DESCRIPTION
Gemcitabine hydrochloride is a white to off-white lyophilised powder
soluble in
water, slightly soluble in methanol and practically insoluble in
ethanol and
polar organic solvents.
Gemcitabine
Kabi
38
mg/mL
concentrated
injection
contains
38
mg/mL
gemcitabine
(as
the
hydrochloride)
as
well
as
the
excipients
sodium
hydroxide, hydrochloric acid and water for injections.
Gemcitabine Kabi 200 mg, 1000 mg and 2000 mg powder for injection
contains gemcitabine hydrochloride as well as the excipients mannitol,
sodium
acetate, hydrochloric acid and sodium hydroxide.
PHARMACOLOGY
Pharmacodynamics
Cytotoxic activity in cell cultures
Gemcitabine exhibits significant cytotoxic effects against a variety
of cultured
murine
and
human
tumour
cells.
Its
action
is
phase
specific
such
that
gemcitabine primarily kills cells that are undergoing DNA synthesis
(S-phase)
and, under certain circumstances, blocks the progression of cells
through the
GI/S-phase boundary. _In vitro _the cytotoxic action of gemcitabine is
dependent
on both concentration and time.
Page 2 of 21
Antitumoral activity in preclinical models
In animal tumour models, the antitumour activity of gemcitabine is
schedule-
dependent. When gemcitabine is administered daily, high mortality
among the
animals but minimal antitumour activity is observed. If, however,
gemcitabine
is given every third or fourth day, it can be administered in
non-lethal doses
with substantial antitumoural activity against a broad spectrum of
mouse
tumours.
Mechanism of Action:
Gemcitabine (dFdC), which is a pyrimidine antimetabolite, is
meta