CYTOVENE - CAP 250MG CAPSULE

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

GANCICLOVIR

Tillgänglig från:

HOFFMANN-LA ROCHE LIMITED

ATC-kod:

J05AB06

INN (International namn):

GANCICLOVIR

Dos:

250MG

Läkemedelsform:

CAPSULE

Sammansättning:

GANCICLOVIR 250MG

Administreringssätt:

ORAL

Enheter i paketet:

84

Receptbelagda typ:

Prescription

Terapiområde:

NUCLEOSIDES AND NUCLEOTIDES

Produktsammanfattning:

Active ingredient group (AIG) number: 0128037001; AHFS:

Bemyndigande status:

CANCELLED POST MARKET

Tillstånd datum:

2007-08-02

Produktens egenskaper

PRODUCT MONOGRAPH
CYTOVENE ®
ganciclovir capsules
ganciclovir sodium for injection (sterile powder)
Antiviral Agent
Hoffmann-La Roche Limited
Date of Preparation:
2455 Meadowpine Boulevard
April
26, 1995
Mississauga, Ontario
L5N 6L7
Date of Revision:
July 18, 2003
Control # 082238
® Registered Trademark
© Copyright 1999 - 2003
CDS Version 1.2 (vials) and Version 1.2 (capsules)
CYTOVENE®
ganciclovir capsules
ganciclovir sodium for injection (sterile powder)
THERAPEUTIC CLASSIFICATION
Antiviral Agent
ACTIONS
CYTOVENE
(ganciclovir
and
ganciclovir
sodium)
is
a
synthetic
nucleoside
analogue
of
guanine which inhibits the replication of herpes viruses both_ in
vitro_ and_ in vivo._
Intracellular
ganciclovir
is
phosphorylated
to
ganciclovir
monophosphate
by
a
cellular
deoxyguanosine kinase. Further phosphorylation occurs by several
cellular kinases to produce
ganciclovir triphosphate. It has been shown _in vitro_ that the levels
of ganciclovir triphosphate
are as much as 100-fold greater in CMV-infected cells than
non-infected cells. Thus, there is
a preferential phosphorylation of ganciclovir in virus-infected cells.
In virus-infected cells,
ganciclovir triphosphate is metabolized slowly, with 60 to 70%
remaining intracellularly 18
hours after removal of ganciclovir from the extracellular fluid. The
antiviral activity of
ganciclovir is the result of inhibition of viral DNA synthesis by two
modes: (1) ganciclovir
triphosphate competitively inhibits dGTP incorporation into DNA by DNA
polymerase and (2)
incorporation of ganciclovir triphosphate into viral DNA causes
subsequent termination or very
limited viral DNA elongation.
Ganciclovir
inhibits
mammalian
cell
proliferation_ _
_in _
_vitro_
at
concentrations
from
10
to
60 µg/mL, with bone marrow colony forming cells being most sensitive
(IC
50
of 10 µg/mL).
The pharmacokinetics of CYTOVENE (ganciclovir sodium for injection)
have been evaluated
in immunocompromised patients with serious CMV disease. In patients
with normal renal
- 2 -
function,
the
plasma
half-life
w