VALGANCICLOVIR JUNO valganciclovir (as hydrochloride) 450 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valganciclovir hydrochloride

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Valganciclovir hydrochloride

Authorization status:

Registered

Patient Information leaflet

Valganciclovir Juno Consumer Medicine Information
Juno Pharmaceuticals Pty Ltd
39 xxxxx
1
VALGANCICLOVIR JUNO
_VALGANCICLOVIR HYDROCHLORIDE 450MG TABLETS_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
VALGANCICLOVIR
JUNO
tablets.
It
does
not
contain
all
the
available information.
It does not take the place of
talking
to
your
doctor
or
pharmacist.
All medicines have risks and
benefits.
Your
doctor
has
weighed the risks of you taking
VALGANCICLOVIR
JUNO
against the benefits they expect
it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
VALGANCICLOVIR
JUNO IS USED FOR
VALGANCICLOVIR
JUNO
contains the active ingredient
valganciclovir.
In
the
body
valganciclovir rapidly changes
to ganciclovir.
VALGANCICLOVIR
JUNO
belongs to a class of medicines
used to prevent the growth of
viruses.
VALGANCICLOVIR
JUNO
acts
against
a
virus
called
cytomegalovirus
or
CMV
(a
type
of
herpes
virus).
It
prevents this virus from
growing and multiplying in the
body. CMV causes infections,
mainly
in
people
with
poor
immunity. Poor immunity can
be caused by HIV/AIDS or by
medications
taken
after
an
organ transplant.
VALGANCICLOVIR JUNO is
used
to
treat
CMV
eye
infections
(known
as
CMV
retinitis)
in
AIDS
patients,
which,
if
left
untreated
can
cause blindness. It is not a cure
for CMV eye infections.
VALGANCICLOVIR JUNO is
not
effective
against
any
underlying HIV infection.
VALGANCICLOVIR JUNO is
also
used
to
prevent
CMV
infection in patients following
organ transplantation.
Your
doctor,
however,
may
have
prescribed
VALGANCICLOVIR
JUNO
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
VALGANCICLOVIR JUNO
HAS BEEN PRESCRIBED FOR YOU.
VALGANCICLOVIR JUNO is
not addictive.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE
VALGANCICLOVIR
JUNO
Animal
and
other
laboratory
studies
have
shown
VALGANCICLOVIR
JUNO
causes

Summary of Product characteristics

Valganciclovir Juno PI Juno Pharmaceuticals Pty Ltd
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VALGANCICLOVIR JUNO VALGANCICLOVIR HYDROCHLORIDE 450MG FILM COATED TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Valganciclovir hydrochloride
CAS:
175865-59-5
The chemical name for valganciclovir hydrochloride is L-valine,
2-[(2-amino-1, 6-dihydro-6-oxo-9H-
purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride.
The molecular formula is C14H22N6O5 HCl and molecular weight is
390.83.
DESCRIPTION
Valganciclovir
hydrochloride
(valganciclovir
HCl)
is
the
hydrochloride
salt
of
the
L-valyl
ester
of
ganciclovir. Ganciclovir is a synthetic nucleoside analogue of
guanine.
Valganciclovir HCl is a white to off-white crystalline powder.
Valganciclovir HCl is a polar hydrophilic compound with a solubility
of 70 mg/mL in water at 25°C at a pH
of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH
7.0. The pKa for valganciclovir is 7.6.
Each tablet contains 496.3 mg valganciclovir HCl (corresponding to 450
mg valganciclovir), and inactive
ingredients: microcrystalline cellulose, crospovidone, povidone, and
stearic acid. The film- coat applied
Valganciclovir Juno PI Juno Pharmaceuticals Pty Ltd
Doc ID: xxxxx Page 2 of 29
to the tablets contains OPADRY complete film coating system 04F54165
PINK which consists of
hypromellose, titanium dioxide, macrogol 6000 and iron oxide red.
PHARMACOLOGY
MECHANISM OF ACTION
Valganciclovir is an L-valyl ester salt (prodrug) of ganciclovir
which, after oral administration, is rapidly
converted to ganciclovir by intestinal and hepatic esterases.
Ganciclovir is a synthetic analogue of 2’-
deoxyguanosine, which inhibits replication of herpes viruses in vitro
and in vivo. Sensitive human viruses
include human cytomegalovirus (HCMV), herpes -simplex virus-1 and -2
(HSV-1 and HSV-2), human
herpes virus type 6, 7 and 8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus
(EBV), varicella- zoster virus
(VZV) and hepatitis B virus.
In
cytomegalovirus
(CMV)-infected
cells,
ganciclovir
is
i