Gemcitabine Ebewe

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Gemcitabine hydrochloride 1140mg equivalent to 1000 mg gemcitabine;  ;  

Inapatikana kutoka:

Novartis New Zealand Ltd

INN (Jina la Kimataifa):

Gemcitabine hydrochloride 1140 mg (equivalent to 1000 mg gemcitabine)

Kipimo:

1000 mg

Dawa fomu:

Powder for injection

Tungo:

Active: Gemcitabine hydrochloride 1140mg equivalent to 1000 mg gemcitabine     Excipient: Mannitol Nitrogen Sodium acetate as sodium acetate trihydrate Sodium hydroxide

Vitengo katika mfuko:

Vial, glass, Ph Eur type I glass vial, halobutyl rubber stopper, 1 x 50 mL, 1 dose unit

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Dr Reddy's Laboratories Limited

Matibabu dalili:

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.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Vial, glass, Ph Eur type I glass vial, halobutyl rubber stopper, 1 x 50 mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C

Idhini ya tarehe:

2008-06-16

Tabia za bidhaa

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