Daklinza

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Daclatasvir dihydrochloride 66mg equivalent to daclatasvir 60mg

थमां उपलब्ध:

Bristol-Myers Squibb (NZ) Limited

INN (इंटरनेशनल नाम):

Daclatasvir dihydrochloride 66 mg (equivalent to daclatasvir 60mg)

डोज़:

60 mg

फार्मास्यूटिकल फॉर्म:

Tablet

रचना:

Active: Daclatasvir dihydrochloride 66mg equivalent to daclatasvir 60mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose Opadry Green

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Swords Laboratories Limited Subsidiary of Bristol-Myers Squibb Company

चिकित्सीय संकेत:

Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults with compensated liver disease (including cirrhosis).

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Blister pack, Polyvinyl Chloride/Aclar(PVC/Aclar) clear blister - 28 tablets - 24 months from date of manufacture stored at or below 30°C. Store in original container

प्राधिकरण की तारीख:

2015-08-31

उत्पाद विशेषताएं

NZ_DAKLINZA V2.0_2 November_ 2016
1(27)
NEW ZEALAND DATA SHEET
DAKLINZA
®
daclatasvir
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).
_ _
Opadry green contains hypromellose, titanium dioxide, Macrogol 400,
indigo carmine
aluminum lake, and iron oxide yellow.
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
NZ_DAKLINZA V2.0_2 November_ 2016
2(27)
replication and virion assembly.
_In vitro_
and computer modelling data indicate that
daclatasvir interacts with the N-terminus within Domain 1 of the
protein, which may cause
structural distortions that interfere with NS5A functions.
_ANTIVIRAL ACTIVITY