DASVIR 30 (DACLATASVIR TABLETS 30 MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

daclatasvir dihydrochloride

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

daclatasvir dihydrochloride

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

DASVIR 30/60
Daclatasvir 30mg and 60mg (as dihydrochloride) Tablet
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What Dasvir is used for
2.
How Dasvir works
3.
Before you use Dasvir
4.
How to use Dasvir
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Dasvir
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
1.WHAT DASVIR IS USED FOR
It is used to treat adults with hepatitis C,
an infectious disease that affects the liver,
caused by the hepatitis C virus
2.HOW DASVIR WORKS
This medicine works by stopping the
hepatitis C virus from multiplying and
infecting new cells. This lowers the
amount of hepatitis C virus in your body
and removes the virus from your blood
over a period of time.
3.
BEFORE YOU USE DASVIR
_-When you must not use it _
• Allergic to daclatasvir or any of the
other ingredients of this medicine
_Pregnancy and lactation _
Do not use Dasvir if you are pregnant,
trying to get pregnant or think you may be
pregnant.
Do not use Dasvir if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_-Before you start to use it _
Tell your doctor if any of the following
applies:
•
you currently take, or have taken in
the last few months, the medicine
amiodarone to treat irregular heartbeats
(your doctor may consider alternative
treatments if you have taken this
medicine)
•
you have a current or previous
infection with the hepatitis B virus, since
your doctor may want to monitor you
more closely
•
your liver is damaged and not
functioning properly (decompensated
liver disease)
Tell your doctor immediately if you are
taking any medicines for heart problems
and during treatment you experience:
•
Shortness of breath
•
Light-headedness
•
Palpitations
•
Faintings
-
_Taking other medicines_
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop. This is because Dasvir may af

Ciri produk

DASVIR 30/60
(DACLATASVIR TABLETS 30 MG & 60 MG)
HETERO
NAME AND STRENGTH OF ACTIVE INGREDIENT
_Dasvir 30mg _
Each film coated Tablet contains Daclatasvir dihydrochloride
equivalent to Daclatasvir 30mg
_Dasvir 60 mg _
Each film coated Tablet contains Daclatasvir dihydrochloride
equivalent to Daclatasvir 60mg
PRODUCT DESCRIPTION
_Dasvir 30mg _
Yellow round; bevel edged, biconvex, film coated tablets debossed with
'D 14' on one side and 'H' on the other side.
_Dasvir 60 mg _
Light yellow, round, bevel edged, biconvex film coated tablets
debossed with ‘D 19’ on one side and ‘H’ on other
side.
DOSAGE FORM
Film coated Tablets
PHARMACODYNAMICS
Pharmacotherapeutic group: Direct-acting antiviral ATC code, J05AP07
Mechanism of action
Daclatasvir is an inhibitor of nonstructural protein 5A (NS5A), a
multifunctional protein that is an essential
component of the HCV replication complex. Daclatasvir inhibits both
viral RNA replication and virion
assembly.
Antiviral activity in cell culture
Daclatasvir is an inhibitor of HCV genotypes 1a and 1b replication in
cell-based replicon assays with
effective
concentration (50% reduction, EC
50
) values of 0.003-0.050 and 0.001-0.009 nM, respectively, depending on
the
assay method. The daclatasvir EC
50
values in the replicon system were
0.003-1.25 nM for genotypes 3a, 4a, 5a
and 6a, and 0.034-19 nM for genotype 2a as well as 0.020 nM for
infectious genotype 2a (JFH-1) virus.
Daclatasvir showed additive to synergistic interactions with
interferon alfa, HCV nonstructural protein 3
(NS3) PIs, HCV nonstructural protein 5B (NS5B) non-nucleoside
inhibitors, and HCV NS5B nucleoside
analogues in combination studies using the cell-based HCV replicon
system. No antagonism of antiviral
activity was observed.
No clinically relevant antiviral activity was observed against a
variety of RNA and DNA viruses, including
HIV, confirming that daclatasvir, which inhibits a HCV-specific
target, is highly selective for HCV.
Resistance in cell culture
Substitutions conferring daclatasvir resistance i