DAKLINZA daclatasvir (as dihyrochloride) 90 mg tablet blister

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

daclatasvir dihydrochloride

थमां उपलब्ध:

Bristol-Myers Squibb Australia Pty Ltd

INN (इंटरनेशनल नाम):

daclatasvir dihydrochloride

उत्पाद विशेषताएं

AU_DAKLINZA V6.0_13 January 2017
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DAKLINZA
®
daclatasvir
PRODUCT INFORMATION
NAME OF THE MEDICINE
DAKLINZA (daclatasvir), is a highly selective inhibitor of HCV
nonstructural protein 5A
(NS5A)
replication
complex.
The
chemical
name
for
daclatasvir
dihydrochloride
is
carbamic
acid,
_N,N'_
-[[1,1'-biphenyl]-4,4'-diylbis[1
_H_
-imidazole-5,2-diyl-(2
_S_
)-
2,1-
pyrrolidinediyl[(1
_S_
)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl]]]bis-,
_C,C'_
-dimethyl
ester,
hydrochloride (1:2). Daclatasvir dihydrochloride has the following
structural formula:
CAS number: 1009119-65-6
Molecular formula: C
40
H
50
N
8
O
6
.2HCl
Molecular weight: 738.88 (free base); 811.80 (dihydrochloride salt)
DESCRIPTION
Daclatasvir drug substance is white to yellow. Daclatasvir
dihydrochloride is freely soluble
in water.
DAKLINZA 60 mg tablets contain the inactive ingredients anhydrous
lactose (116 mg),
microcrystalline cellulose, croscarmellose sodium, silicon dioxide,
magnesium stearate,
and
_ _
OPADRY complete film coating system 03B110007 Green (proprietary
ingredient
number109448).
_ _
DAKLINZA 30 mg tablets contain the inactive ingredients anhydrous
lactose (58 mg),
microcrystalline cellulose, croscarmellose sodium, silicon dioxide,
magnesium stearate,
and OPADRY complete film coating system 03B110005 Green (proprietary
ingredient
number109451).
DAKLINZA 90 mg tablets contain the inactive ingredients anhydrous
lactose (173 mg),
microcrystalline cellulose, croscarmellose sodium, silicon dioxide,
magnesium stearate,
and OPADRY complete film coating system 03B110005 Green (proprietary
ingredient
number 109451).
Opadry green contains hypromellose, titanium dioxide, Macrogol 400,
indigo carmine
aluminum lake, and iron oxide yellow.
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PHARMACOLOGY
MECHANISM OF ACTION
Daclatasvir
is
a
direct
acting
antiviral
agent
(DAA)
against
the
hepatitis
C
virus.
Daclatasvir
is
an
inhibitor
of
NS5A,
a
multifunctional
protein
that
is
an
essential
component
of
the
HCV
replication
complex.
Daclatasvir
inhibits
both
viral
RNA