VIRPAS - Ledipasvir & Sofosbuvir Tablets 90mg400mg

Country: Malasja

Lingwa: Ingliż

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

Ingredjent attiv:

Ledipasvir; Sofosbuvir

Disponibbli minn:

UNIMED SDN BHD

INN (Isem Internazzjonali):

Ledipasvir; Sofosbuvir

Unitajiet fil-pakkett:

28 Tablets

Manifatturat minn:

Strides Shasun Limited

Fuljett ta 'informazzjoni

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
VIRPAS - LEDIPASVIR & SOFOSBUVIR
TABLETS 90MG/400MG
Ledipasvir/Sofosbuvir (90/400 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Virpas is used for
2.
How Virpas works
3.
Before you use
Virpas
4.
How to use
Virpas
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_ _
Virpas
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
VIRPAS IS USED FOR
Virpas is used for the treatment of chronic
Hepatitis C (CHC) in adults. It is also used
for Hepatitis C virus (HCV) genotype-
specific activity.
HOW
VIRPAS WORKS
Hepatitis C is a virus that infects the liver.
This medicine works by blocking two
different
proteins
that
the
Hepatitis
C
virus needs to grow and reproduce itself.
BEFORE YOU USE VIRPAS
-
_When you must not use it _
Do not take Virpas if:
- You are allergic (hypersensitive) to
sofosbuvir, ledipasvir or to any one
of the ingredients of this medicine.
- You are taking any of the following
medicine:
•
Other
medicinal
product
containing sofosbuvir
•
Rosuvastatin (a medicine used to
treat high cholesterol).
•
Rifampicin
and
rifabutin
(antibiotics
used
to
treat
infections,
including
tuberculosis)
•
St.
John’s
wort
(Hypericum
perforatum
–
herbal
medicine
used to treat depression)
•
Carbamazepine,
phenytoin,
phenobarbital (medicines used to
treat
epilepsy
and
prevent
seizures).
_ _
_ _
_ _
_ _
_Pregnancy and lactation _
When Virpas is used in combination with
ribavirin, extreme care must be taken to
avoid pregnancy in female patients and in
female partners of male patients. Women
of childbearing potential or their male
partners must use an effective form of
contraception during treatment and for a
period of time after the treatment has
concluded.
Do
not
take
this
medicine
if
you
are
pregnant. The effects during pregnancy
are not known. If you are thinking you
may be pregnant or are planning to get
pregnant,
ask
your
doctor
for
advice
before taking this medicine.
Do not breast-feed during treatment with
V

Karatteristiċi tal-prodott

VIRPAS - LEDIPASVIR & SOFOSBUVIR TABLETS 90MG/400MG
COMPOSITION
Ledipasvir & Sofosbuvir Tablets 90mg/400mg
Each tablet contains:-
Ledipasvir…………90 mg
Sofosbuvir……….400 mg
DOSAGE FORM
Oral film-coated tablet
PRODUCT DESCRIPTION
VIRPAS (Ledipasvir & Sofosbuvir 90mg/400mg) is Brown coloured oval
shaped bevelled edge film coated
tablets debossed with “SL” on one side and plain on other side.
Each film coated tablet contains 90mg of Ledipasvir and 400mg of
Sofosbuvir.
PHARMACODYNAMICS
Pharmacotherapeutic group: Direct-acting antiviral,
ATC code: J05AX65
MECHANISM OF ACTION:
Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is
essential for both RNA
replication and the assembly of HCV virions. Biochemical confirmation
of NS5A inhibition by
Ledipasvir is not currently possible as NS5A has no enzymatic
function. _In vitro_ resistance
selection and cross-resistance studies indicate Ledipasvir targets
NS5A as its mode of action.
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent
RNA polymerase,
which is essential for viral replication. Sofosbuvir is a nucleotide
prodrug that undergoes
intracellular metabolism to form the pharmacologically active uridine
analogue triphosphate
(GS-461203), which can be incorporated into HCV RNA by the NS5B
polymerase and acts as a
chain terminator. GS-461203 (the active metabolite of Sofosbuvir) is
neither an inhibitor of
human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA
polymerase.
Antiviral activity The EC50 values of ledipasvir and sofosbuvir
against full-length or chimeric
replicons encoding NS5A and NS5B sequences from clinical isolates are
detailed in below table.
The presence of 40% human serum had no effect on the anti-HCV activity
of sofosbuvir but
reduced the anti-HCV activity of ledipasvir by 12-fold against
genotype 1a HCV replicons.
Activity of ledipasvir and sofosbuvir against chimeric replicons
Genotype replicons Ledipasvir activity (EC50, nM)
Sofosbuvir activity (EC50, nM)
Stable replicons
NS5A transient