GEMACCORD gemcitabine (as hydrochloride) 1000 mg powder for injection vial

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

gemcitabine hydrochloride (Equivalent: gemcitabine, Qty 1 g)

Beszerezhető a:

Accord Healthcare Pty Ltd

INN (nemzetközi neve):

Gemcitabine hydrochloride

Gyógyszerészeti forma:

Injection, powder for

Összetétel:

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

Az alkalmazás módja:

Intravenous

db csomag:

1 x 50 mL vial

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

Treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Treatment of patients with 5-FU refractory pancreatic cancer. Treatment of patients with bladder cancer, alone or in combination with cisplatin. Treatment, in combination with paclitaxel, 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. Treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed > six months following platinum based therapy.

Termék összefoglaló:

Visual Identification: White to off white lyophilised powder in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2011-03-25

Betegtájékoztató

GEMACCORD GEMCITABINE (AS HYDROCHLORIDE) 200 MG AND 1 GM POWDER FOR
INJECTION VIAL
CONSUMER MEDICINE INFORMATION
Version-1.0
2011
Page 1 of 4
GEMACCORD (GEMCITABINE) FOR INJECTION 200 MG/VIAL AND 1 G/VIAL
Gemcitabine Hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
is
designed
to
provide
you
with
answers
to
some common questions about
this
medicine.
It
does
not
contain
all
the
available
information and does not take
the place of talking with your
doctor.
All
medicines
have
risks
and
benefits.
Your
doctor
has
more
information about this medicine
than is contained in this leaflet.
Also, your doctor has had the
benefit
of
taking
a
full
and
detailed history from you and is
in the best position to make an
expert judgment to meet your
individual needs.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
BEING
GIVEN
THIS
MEDICINE, TALK TO YOUR DOCTOR
OR HEALTH CARE PROFESSIONAL.
KEEP
THIS
LEAFLET
WITH
THIS
MEDICINE.
YOU
MAY
NEED
TO
READ IT AGAIN.
WHAT
GEMCITABINE
FOR INJECTION IS
USED FOR
GEMCITABINE FOR
INJECTION is used to treat
patients with:
•
Lung cancer
•
Cancer of the pancreas
•
Bladder cancer
•
Breast cancer
•
Ovarian cancer.
GEMCITABINE
FOR
INJECTION
works
by
killing
cancer
cells
and
preventing
cancer cells from growing and
multiplying.
GEMCITABINE FOR
INJECTION belongs to a group
of medicines called
antineoplastic or cytotoxic
medicines. You may also hear
of these being called
chemotherapy medicines.
Your
doctor
may
have
prescribed
GEMCITABINE
FOR
INJECTION
for
another
reason.
ASK
YOUR
DOCTOR
OR
HEALTH CARE PROFESSIONAL IF YOU
HAVE ANY QUESTIONS ABOUT WHY
GEMCITABINE
FOR
INJECTION
HAS
BEEN
PRESCRIBED FOR YOU.
GEMCITABINE
FOR
INJECTION
may
be
used
in
combination
with
other
cytotoxic
medicines
to
treat
cancer.
BEFORE YOU ARE GIVEN
GEMCITABINE
FOR INJECTION
TELL
YOUR
DOCTOR
OR
HEALTH
PROFESSIONAL IF YOU HAVE ANY OF
THE FOLLOWING CONDITIONS OR IF
YOU HAVE EVER EXPERIENCED ANY
OF THESE CONDITIONS.
_WHEN _
_YOU _
_MUST _
_NOT _
_BE _
_GIVEN _
_GEMCITABINE _
_FOR INJECTION _
YOU
MUST
NOT
BE
GIVEN

Termékjellemzők

GEMACCORD gemcitabine (as hydrochloride)
200 mg and 1 gm powder for injection vial Version-1.0
2011 Page 1 of 19
PRODUCT INFORMATION
GEMACCORD (GEMCITABINE) POWDER FOR INJECTION 200 MG/VIAL AND 1G/VIAL
NAME OF MEDICINE
Gemcitabine hydrochloride
Chemical name
:4-Amino-1-(2-deoxy-2,2-difluoro-
β
-D-
_erythro_
-
pentofuranosyl)pyrimidin-2(1
_H_
)-one hydrochloride
Molecular formula
: C
9
H
11
F
2
N
3
O
4
.
HCl
Molecular Weight
: 299.66
C.A.S. No.
: 122111-03-09
Actions
: Antimetabolite
INACTIVE INGREDIENTS
Mannitol, sodium acetate trihydrate, sodium hydroxide, hydrochloric
acid.
DESCRIPTION
Gemcitabine
is
a
white
to
off
white
lyophilised
powder
to
be
reconstituted
for
intravenous use. Soluble in water, slightly soluble in methanol,
practically insoluble in
acetone.
PHARMACOLOGY
Gemcitabine exhibits significant cytotoxic activity against a variety
of cultured murine
and
human
tumour
cells.
It
exhibits
cell
phase
specificity,
primarily
killing
cells
undergoing
deoxyribonucleic
acid
(DNA)
synthesis
(S-phase)
and
under
certain
conditions blocking progression of cells through the GI/S-phase
boundary. In vitro, the
cytotoxic action of gemcitabine is both concentration and time
dependent.
In animal tumour models, the antitumour activity of gemcitabine is
schedule dependent.
When administered daily gemcitabine causes death in animals with
minimal antitumour
GEMACCORD gemcitabine (as hydrochloride)
200 mg and 1 gm powder for injection vial Version-1.0
2011 Page 2 of 19
activity.
However,
when
an
every
third
or
fourth
day
dosing
schedule
is
used,
gemcitabine can be given at nonlethal doses and have excellent
antitumour activity
against a broad range of mouse tumours.
MECHANISM OF ACTION
Gemcitabine (dFdC) is metabolised intracellularly by nucleoside
kinases to the active
diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. The
cytotoxic action of
gemcitabine appears to be due to inhibition of DNA synthesis by two
actions of dFdCDP
and
dFdCTP.
First,
dFdCDP
inhibits
ribonucleotide
reductase,
which
is
uniquely
responsib