ZOVIRAX 800mg tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Toote omadused (SPC)
01-12-2017
Laadi alla Avaliku hindamisaruande (PAR)
14-05-2019

Toimeaine:

aciclovir

Saadav alates:

GlaxoSmithKline Australia Pty Ltd

Volitamisolek:

Registered

Toote omadused

                                1
ZOVIRAX
®
TABLETS AND ZOVIRAX
®
DISPERSIBLE TABLETS
NAME OF THE DRUG:
Aciclovir
_Chemical name:_ 9-((2-hydroxyethoxy)methyl)guanine
_Chemical Structure _
N
HN
N
N
O
H
2
N
O
HO
_ _
_CAS Number_: 59277-89-3
DESCRIPTION:
Aciclovir is a synthetic acyclic purine nucleoside analogue. It is a
white crystalline powder slightly
soluble in water and practically insoluble in most organic solvents.
The chemical structure of
aciclovir is:
Each Zovirax tablet contains 200 mg, 400 mg or 800 mg of aciclovir.
Zovirax Dispersible Tablets (200 mg, 400 mg and 800 mg) contain the
excipients cellulose-
microcrystalline, aluminium magnesium silicate, sodium starch
glycollate, povidone, magnesium
stearate, Opadry Complete film coating system White Y-1-7000 and
macrogol 8000.
Zovirax 200 mg Tablets contain the excipients
cellulose-microcrystalline, lactose monohydrate,
magnesium stearate, povidone and sodium starch glycollate.
Zovirax 400 mg and 800 mg Tablets contain the excipients
cellulose-microcrystalline, magnesium
stearate, povidone and sodium starch glycollate.
PHARMACOLOGY:
MICROBIOLOGY:
Aciclovir is an antiviral agent which is active _in vitro_ against
_Herpes simplex_ virus (HSV) types I
and II
and
_Varicella _
_zoster_
virus (VZV),
the
latter
being
considerably
less sensitive.
The
relationship between the level of _ in vitro_ sensitivity of herpes
viruses to aciclovir and clinical
response to therapy has not been adequately established. Development
of resistance by HSV to
aciclovir has been documented. Aciclovir needs to be phosphorylated to
the active compound,
aciclovir triphosphate, in order to become active against the virus.
Such conversion is very limited
in normal cells and in addition cellular DNA polymerase is not very
sensitive to the active
compound. However,
in infected cells HSV or VZV-coded thymidine kinase facilitates the
conversion
of
aciclovir
to
aciclovir
monophosphate
which
is
then
converted
to
aciclovir
2
triphosphate by cellular enzymes. Aciclovir triphosphate acts as an
inhibitor of, and substrate for
                                
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