VALGANCICLOVIR AN valganciclovir (as hydrochloride) 450 mg film coated tablet bottle

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

valganciclovir hydrochloride

Доступна с:

Juno Pharmaceuticals Pty Ltd

ИНН (Международная Имя):

Valganciclovir hydrochloride

Статус Авторизация:

Registered

тонкая брошюра

Valganciclovir AN CMI v2.0
1
VALGANICLOVIR AN
_TABLETS_
Pronounced
_val gan SYE kloh veer_
_contains the active ingredient valganciclovir hydrochloride_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VALGANICLOVIR
AN 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
VALGANICLOVIR AN 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 VALGANICLOVIR
AN IS USED FOR
VALGANICLOVIR AN contains the
active ingredient valganciclovir. In the
body valganciclovir rapidly changes
to ganciclovir.
VALGANICLOVIR AN belongs to a
class of medicines used to prevent the
growth of viruses.
VALGANICLOVIR AN 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.
VALGANICLOVIR AN 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.
VALGANICLOVIR AN is not
effective against any underlying
HIV infection.
VALGANICLOVIR AN is also used
to prevent CMV infection in patients
following organ transplantation.
Your doctor, however, may have
prescribed VALGANICLOVIR AN
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
VALGANICLOVIR
AN
HAS
BEEN PRESCRIBED FOR YOU.
VALGANICLOVIR AN is not
addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
VALGANICLOVIR AN
Animal and other laboratory studies
have shown VALGANICLOVIR AN
causes infertility, birth defects and
cancer. It i

Характеристики продукта

PRODUCT INFORMATION
VALGANCICLOVIR AN
VALGANCICLOVIR HYDROCHLORIDE 450 MG TABLET
NAME OF THE MEDICINE
The name of the medicine is 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 C
14
H
22
N
6
O
5
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.
VALGANCICLOVIR AN is available as a 450 mg tablet for oral
administration. Each tablet contains 496.3
mg
valganciclovir HCl (corresponding to 450 mg valganciclovir), and
inactive ingredients:
microcrystalline
cellulose, povidone, crospovidone, and stearic acid. The film-coat
applied to the tablets contains Opadry
Pink
®
which consists of hypromellose, titanium dioxide, macrogol 400, and
Allura Red AC aluminium lake.
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
initially
phosphorylated
to
ganciclovir
monophosphate by the viral protein kinase, UL97. Further
phosphorylat