Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Daclatasvir dihydrochloride 33mg equivalent to daclatasvir 30mg
Bristol-Myers Squibb (NZ) Limited
Daclatasvir dihydrochloride 33 mg (equivalent to daclatasvir 30mg)
30 mg
Tablet
Active: Daclatasvir dihydrochloride 33mg equivalent to daclatasvir 30mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose Opadry Green
Prescription
Swords Laboratories Limited Subsidiary of Bristol-Myers Squibb Company
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).
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
2015-08-31
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 Prečítajte si celý dokument