Gemcitabine Actavis
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
05-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
Gemcitabine hydrochloride
Available from:
Actavis Australia Pty Ltd
Class:
Medicine Registered
Summary of Product characteristics
Gemcitabine Actavis
POWDER FOR INJECTION
PRODUCT INFORMATION
NAME OF THE MEDICINE
Gemcitabine (as hydrochloride).
The chemical name for gemcitabine hydrochloride is 4-Amino-1-
(2-Deoxy-2,2-difluoro-ß-D-_erythro_-pentofuranosyl)pyrimidin-2(1_H_)-one hydrochloride. Its
structural formula is:
C
9
H
11
F
2
N
3
O
4
.HCl
Molecular weight: 299.7
CAS No.: 122111-03-9.
DESCRIPTION
Gemcitabine hydrochloride is a white or almost white powder, which
is soluble in water. The pH
value is 2 to 3 in aqueous solution at 10 mg/mL, and the pKa
is 3.6.
GEMCITABINE ACTAVIS comes in three strengths of powder for
injection and contains either 200
mg, 1000 mg or 2000 mg of gemcitabine (as hydrochloride).
It also contains mannitol, sodium
acetate and sodium hydroxide may be added to adjust pH 3.0 ±
0.2.
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 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 activity.
However, when an every third or fourth day dosing schedule is
used, gemcitabine can be given at
non-lethal doses and have
excellent antitumour activity against a broad range of mouse
tumours.
Mechanism of Action: Gemcitabine (dFdC) is
metabolised intracellularly by nucleoside kinase to
the active diphosphate (dFdCDP) and triphosphate
(dFdCTP) nucleosides. The cytotoxic action of
gemcitabine appears to be due to inhibition of
Read the complete document
