Daklinza

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Daclatasvir dihydrochloride 66mg equivalent to daclatasvir 60mg

Beschikbaar vanaf:

Bristol-Myers Squibb (NZ) Limited

INN (Algemene Internationale Benaming):

Daclatasvir dihydrochloride 66 mg (equivalent to daclatasvir 60mg)

Dosering:

60 mg

farmaceutische vorm:

Tablet

Samenstelling:

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

Prescription-type:

Prescription

Geproduceerd door:

Swords Laboratories Limited Subsidiary of Bristol-Myers Squibb Company

therapeutische indicaties:

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).

Product samenvatting:

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

Autorisatie datum:

2015-08-31

Productkenmerken

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