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dhiraj@gjpharmaceutical.com -
+91-9167369755
Daclatasvir Dihydrochloride Tablets Exporter
| Business Type | Manufacturer, Exporter, Supplier |
| Dose | 60mg |
| Pack Size | Single Vial |
| Brand Name | GJ |
| Click to view more | |
Preferred Buyer From
| Location | All Countries Except India |
Product Details
Packaging Size
10 tablets per strip
Storage
Store in cool and dry place
Best Before
24 months from Manufacture date
Drug Description
Description
DAKLINZA (daclatasvir) is an inhibitor of HCV nonstructural protein 5A (NS5A). The chemical name for drug substance daclatasvir dihydrochloride is carbamic acid, N,N'-[[1,1'biphenyl]-4,4'-diylbis[1H-imidazole-5,2-diyl-(2S)-2,1-pyrrolidinediyl[(1S)-1-(1-methylethyl)-2oxo-2,1-ethanediyl]]]bis-,C,C'-dimethyl ester, hydrochloride (1:2). Its molecular formula is C40H50N8O6•2HCl, and its molecular weight is 738.88 (free base)
Indications & Dosage
Indication : DAKLINZA is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection [see DOSAGE AND ADMINISTRATION and Clinical Studies].
Limitations Of Use
- Sustained virologic response (SVR12) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving DAKLINZA in combination with sofosbuvir for 12 weeks
Dosage and Administration:
Testing Prior To Initiation Of Therapy
NS5A Resistance Testing In HCV Genotype 1a-Infected Patients With Cirrhosis Consider screening for the presence of NS5A polymorphisms at amino acid positions M28, Q30, L31, and Y93 in patients with cirrhosis who are infected with HCV genotype 1a prior to the initiation of treatment with DAKLINZA and sofosbuvir with or without ribavirin
Dosage Forms And Strengths
Tablets:
- 60 mg: 60 mg of daclatasvir (equivalent to 66 mg daclatasvir dihydrochloride), light green, biconvex, pentagonal, and debossed with “BMS” on one side and “215” on the other side.
- 30 mg: 30 mg of daclatasvir (equivalent to 33 mg daclatasvir dihydrochloride), green, biconvex, pentagonal, and debossed with “BMS” on one side and “213” on the other side.
- 90 mg: 90 mg of daclatasvir (equivalent to 99 mg daclatasvir dihydrochloride), light green, biconvex, round, and embossed with “BMS” on one side and “011” on the other side.
- If DAKLINZA and sofosbuvir are administered with ribavirin, refer to the prescribing information for ribavirin regarding ribavirin-associated adverse reactions.
- The following serious adverse reaction is described below and elsewhere in the labeling:
- Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone
