Valcivir 450mg Film Coated Tablet

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

VALGANCICLOVIR HYDROCHLORIDE

Disponible depuis:

CIPLA MALAYSIA SDN BHD

DCI (Dénomination commune internationale):

VALGANCICLOVIR HYDROCHLORIDE

Unités en paquet:

1 x 60 Tablets

Fabriqué par:

Cipla Limited

Notice patient

_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
VALCIVIR 450 MG FILM COATED TABLET
_Valganciclovir (450mg) _
1
WHAT IS IN THIS LEAFLET
1.
What Valcivir is used for
2.
How Valcivir works
3.
Before you use Valcivir
4.
How to use Valcivir
5.
While you are using Valcivir
6.
Side effects
7.
Storage and disposal of Valcivir
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
10.11.
Serial Number
WHAT VALCIVIR IS USED FOR
Valcivir 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.
Valcivir 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 Valcivir has
been prescribed for you.
Valcivir is not addictive.
Valcivir is available only with a
doctor’s prescription
HOW VALCIVIR WORKS
Valcivir contains the active
ingredient valganciclovir
hydrochloride.
Valcivir belongs to a class of
medicines used to prevent the growth
of viruses.
Valcivir 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.
BEFORE YOU USE VALCIVIR
_ _
_When you must not use it _
_ _
_ _
Do not use Valcivir 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),
neutrophils (a type of white blood
cell used as defence against

Résumé des caractéristiques du produit

1
_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR for _
_Specialist Use only _
VALCIVIR 450 MG TABLET
Valganciclovir 450 mg USP tablets
COMPOSITION
Each film coated tablet contains
Valganciclovir Hydrochloride USP equivalent to
Valganciclovir …………………………… 450 mg
Colour: Titanium Dioxide, Red Oxide of Iron
DOSAGE FORM
Film coated tablet
PRODUCT DESCRIPTION
Pink coloured, capsule shaped biconvex film coated tablet plain on
both sides.
PHARMACOLOGY
_ _
_PHARMACODYNAMICS _
Mechanism of action
Valganciclovir is a L-valyl ester (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-6, 7 and 8
(HHV-6, HHV-7, HHV-
8), Epstein-Barr virus (EBV), varicella zoster virus (VZV) and
hepatitis B virus.
In CMV-infected cells ganciclovir is initially phosphorylated to
ganciclovir monophosphate
by the viral protein kinase, UL97. Further phosphorylation occurs by
cellular kinases to
produce ganciclovir triphosphate, which is then slowly metabolised
intracellularly. This has
been shown to occur in HSV- and HCMV- infected cells with half-lives
of 18 and between 6
and 24 hours respectively after 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
2
termination of, or very limited further viral DNA elongation. Typical
anti-viral IC
50
against
CMV
_in