Gemcitabine Ebewe

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Gemcitabine hydrochloride 228mg equivalent to 200 mg gemcitabine;  ;  

Tilgjengelig fra:

Novartis New Zealand Ltd

INN (International Name):

Gemcitabine hydrochloride 228 mg (equivalent to 200 mg gemcitabine)

Dosering :

200 mg

Legemiddelform:

Powder for injection

Sammensetning:

Active: Gemcitabine hydrochloride 228mg equivalent to 200 mg gemcitabine     Excipient: Mannitol Nitrogen Sodium acetate as sodium acetate trihydrate Sodium hydroxide

Enheter i pakken:

Vial, glass, Ph Eur type I, halobutyl rubber stopper, 1 x 10 mL, 1 dose unit

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Dr Reddy's Laboratories Limited

Indikasjoner:

Non-Small Cell Lung Cancer: Gemcitabine Ebewe, alone or in combination with cisplatin, is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer.

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, Ph Eur type I, halobutyl rubber stopper, 1 x 10 mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, Ph Eur type I, halobutyl rubber stopper, 5 x 10 mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

2008-06-16

Informasjon til brukeren

Gemcitabine Ebewe
Gemcitabine_Ebewe_CMI_v2_Dec 2014 Page 1 of 4
GEMCITABINE EBEWE
gemcitabine hydrochlori
de
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Gemcitabine Ebewe.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits
and risks. Your doctor has
weighed the risks of you taking
gemcitabine against the
benefits this medicine is
expected to 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.
It is important to remember
that Gemcitabine Ebewe is a
PRESCRIPTION ONLY
MEDICINE.
Gemcitabine Ebewe will only
be given to you by specially
trained personnel in a hospital
environment.
WHAT GEMCITABINE EBEWE IS
USED FOR
Gemcitabine belongs to the
group of medicines called
antineoplastics or cytotoxic
medicines. It is typically used
to treat patients with lung
cancer, cancer of the pancreas,
bladder cancer, cancer of the
breast or ovarian cancer. It
works by killing cancer cells
and preventing cancer cells
from growing and multiplying.
Gemcitabine may also be used
to treat other conditions as
determined by your doctor.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
GEMCITABINE EBEWE HAS BEEN
PRESCRIBED FOR YOU.
Gemcitabine Ebewe may also
be used in combination with
other cytotoxic medicines to
treat cancer.
BEFORE YOU ARE GIVEN
GEMCITABINE EBEWE
TELL YOUR DOCTOR OR HEALTH
CARE 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 _
_THIS MEDICINE: _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE HAD AN
ALLERGIC REACTION TO
GEMCITABINE EBEWE OR TO ANY
OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET (see
PRODUCT DESCRIPTION).
Symptoms of an allergic
reaction may include rashes,
itching and redness of the skin
and swelling of the tongue or
face.
YOU MUST NOT BE GIVEN THIS
MEDICINE

Preparatomtale

Page 1 of 14
DATA SHEET
GEMCITABINE EBEWE
_GEMCITABINE (AS HYDROCHLORIDE) 200MG/20ML, 500MG/50ML AND _
_1000MG/100ML INJECTION VIALS_
NAME OF THE MEDICINE
Gemcitabine hydrochloride
DESCRIPTION
Gemcitabine hydrochloride is 2'-deoxy-2',2'-difluorocytidine
monohydrochloride (β-isomer).
The empirical formula for gemcitabine hydrochloride is C
9
H
11
F
2
N
3
0
4
·HCl. It has a molecular
weight of 299.66.
Gemcitabine is a white to off-white solid. Gemcitabine is an acidic
compound. The free base
is soluble in water, slightly soluble in methanol, and practically
insoluble in ethanol and polar
organic solvents.
Gemcitabine Ebewe is a sterile, clear, colourless, solution containing
10mg/mL gemcitabine
hydrochloride in vial containing 200mg, 500mg or 1000mg of gemcitabine
for intravenous
use.
In addition to the active ingredient gemcitabine hydrochloride,
Gemcitabine Ebewe also
contains sodium acetate, sodium hydroxide (for pH adjustment), and
water for injections.
PHARMACOLOGY
_PHARMACODYNAMICS _
Gemcitabine Ebewe is a nucleoside analogue that exhibits antitumour
activity.
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 responsible for
catalysing the reactions that generate the deoxynucleoside
triphosphates for DNA synthesis.
Inhibition
of
this
enzyme
by
dFdCDP
causes
a
reduction
in
the
concentrations
of
deoxynucleosides in general, and especially in that of dCTP. Secondly,
dFdCTP competes
with dCTP for incorporation into DNA. Likewise, a small amount of
gemcitabine may also be
incorporated into RNA. Thus, the reduction in the intracellular
concentration of dCTP
potentiates the incorporation of dFdCTP into DNA (self-potentiation).
DNA polymerase
epsilon is essentially unable to remove gemcitabine and repair the
growing DNA strands.
After g