VALGAN 450 (Valganciclovir Tablets 450 mg)

Ülke: Malezya

Dil: İngilizce

Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktif bileşen:

VALGANCICLOVIR HYDROCHLORIDE

Mevcut itibaren:

CAMBER LABORATORIES SDN. BHD.

INN (International Adı):

VALGANCICLOVIR HYDROCHLORIDE

Paketteki üniteler:

10x10'stablet Tablets; 60tablet Tablets

Tarafından üretildi:

Hetero Labs Limited

Bilgilendirme broşürü

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
VALGAN 450 (VALGANCICLOVIR TABLETS 450MG)
Valganciclovir (450mg)_ _
WHAT IS IN THIS LEAFLET
1.
What _VALGAN 450_ is used for
2.
How _VALGAN 450_ works
3.
Before you take _VALGAN 450_
4.
How to use _VALGAN 450_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _VALGAN 450_
8.
Product Description
9.
Manufacturer and
Product
Registration
Holder
10.
Date of Revision
11.
Serial Number
1. WHAT _VALGAN 450_ IS USED FOR.
_VALGAN 450_ is used to treat
cytomegalovirus (CMV) retinitis (an eye
infection caused by a type of herpes virus)
in acquired immunodeficiency syndrome
(AIDS) patients as it can cause blindness
if untreated.
_VALGAN 450_ is also used to prevent CMV
disease in patients who are not infected
with CMV but received organ
transplantation from a CMV infected
donor.
Ask your doctor if you have any questions
about why _VALGAN 450_ has been
prescribed for you. _VALGAN 450_ is not
addictive.
_VALGAN 450_ is available only with a
doctor’s prescription.
2. HOW _VALGAN 450_ WORKS.
VALGAN 450 contains the active
ingredient valganciclovir hydrochloride.
VALGAN 450 belongs to a class of
medicines used to prevent the growth of
viruses.
VALGAN 450 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.
3. BEFORE YOU USE _VALGAN 450 _
_ _
When you must not use it
Do not use VALGAN 450 if:
1.
You are allergic to:
- valganciclovir, acyclovir,
ganciclovir, valaciclovir or any of
the ingredients listed at the end of
this leaflet.
Some of the symptoms of an
allergic reaction may include:
- shortness of breath
- wheezing or difficulty in
breathing
- swelling of the face, lips, tongue
or other parts of the body
- rashes, itching, hives on the skin
2.
You have very low blood counts
for platelets (used for clotting),
neutro

Ürün özellikleri

1
HETERO
NAME OF THE PRODUCT
VALGAN 450 (Valganciclovir Tablets 450 mg)
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each film coated tablet contains 496.3 mg of valganciclovir
hydrochloride equivalent to
450 mg of Valganciclovir.
PRODUCT DESCRIPTION
Pink, oval, biconvex, film-coated tablets, debossed with ‘J’ on
one side and ‘156’ on the
other side
PHARMACODYNAMICS/PHARMACOKINETICS
PHARMACODYNAMICS:
MECHANISM OF ACTION:
Valganciclovir is an L-valyl ester (prodrug) of ganciclovir. After
oral administration,
valganciclovir is rapidly and extensively metabolised to ganciclovir
by intestinal and
hepatic
esterases.
It
was
reported
that
ganciclovir
is
a
synthetic
analogue
of
2'-
deoxyguanosine and 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 -6, -7 and -8 (HHV-6, HHV-7,
HHV8), Epstein-
Barr virus (EBV), varicella-zoster virus (VZV) and hepatitis B virus
(HBV).
In
CMV-infected
cells,
ganciclovir
is
initially
phosphorylated
to
ganciclovir
monophosphate by the viral protein kinase, pUL97. Further
phosphorylation occurs by
cellular kinases to produce ganciclovir triphosphate, which is then
slowly metabolised
intracellularly. Triphosphate metabolism has been shown to occur in
HSV- and HCMV-
infected cells with half-lives of 18 and between 6 and 24 hours
respectively, after the
2
HETERO
removal of extracellular ganciclovir. As the phosphorylation is
largely dependent on the
viral kinase, phosphorylation of ganciclovir occurs preferentially in
virus-infected cells.
The virustatic activity of ganciclovir is due to inhibition of viral
DNA synthesis by: (a)
competitive inhibition of incorporation of deoxyguanosine-triphosphate
into DNA by viral
DNA polymerase, and (b) incorporation of ganciclovir triphosphate into
viral DNA causing
termination of, or very limited, further viral DNA elongation.
PHARMACOKINETICS
Absorption
Valganciclovir is a prodrug of ganciclovir. It is well a