Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
daclatasvir dihydrochloride
Bristol-Myers Squibb Australia Pty Ltd
daclatasvir dihydrochloride
Registered
DAKLINZA ® TABLETS _Daclatasvir (dak lat as vir)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Read this leaflet carefully before taking DAKLINZA. This leaflet answers some common questions about DAKLINZA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking DAKLINZA against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT DAKLINZA IS USED FOR DAKLINZA is a trade name (manufacturer's name) for the medicine, daclatasvir. DAKLINZA is a direct acting antiviral agent (DAA) against the hepatitis C virus (HCV). DAKLINZA is an inhibitor of NS5A, which is a protein that is required to form new HCV particles. You should not take DAKLINZA alone to treat chronic (lasting a long time) hepatitis C infection in adults. DAKLINZA should only be used together with other antiviral medicines such as sofosbuvir, or asunaprevir (SUNVEPRA), or together with SUNVEPRA, peginterferon alfa, and ribavirin. _HOW DAKLINZA WORKS_ DAKLINZA (in combination with other medicines) works by stopping the HCV from multiplying and infecting liver cells. After you stop taking DAKLINZA, your doctor will monitor your blood for HCV. If HCV is still not detected in your blood at least 12 weeks after stopping treatment, you have what is called a sustained virologic response (SVR), also referred to as virologic cure. It is not known if DAKLINZA is safe and effective in children under 18 years of age. Ask your doctor if you have any questions about why DAKLINZA has been prescribed for you. DAKLINZA is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE DAKLINZA It is important that you check the information below before you take DAKLINZA. _WHEN YOU MUST NOT TAKE_ _DAKLINZA_ DAKLINZA is sometimes used with p Soma hati kamili
AU_PI_Daklinza_V8.0 1 AUSTRALIAN PRODUCT INFORMATION – DAKLINZA ® (DACLATASVIR) 1 NAME OF THE MEDICINE Daclatasvir 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DAKLINZA 30 mg daclatasvir (equivalent to 33 mg daclatasvir dihydrochloride) Excipients with known effect Each 30 mg tablet contains 58 mg of lactose DAKLINZA 60 mg daclatasvir (equivalent to 66 mg daclatasvir dihydrochloride) Excipients with known effect Each 60 mg tablet contains 116 mg of lactose Daclatasvir drug substance is white to yellow. Daclatasvir dihydrochloride is freely soluble in water. Full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM DAKLINZA daclatasvir 30 mg tablets are green biconvex pentagonal debossed with "BMS" on one side and "213" on the other side. DAKLINZA daclatasvir 60 mg tablets are light green biconvex pentagonal debossed with “BMS” on one side and “215” on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS DAKLINZA is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults [see 5.1 Pharmacodynamic properties - Clinical trials and 4.2 Dose and method of administration]. 4.2 D OSE AND METHOD OF ADMINISTRATION DAKLINZA is for oral administration and may be taken with or without food. The recommended dose of DAKLINZA is 60 mg once daily. DAKLINZA must be administered in combination with other agents [see Table 1]. For specific dose recommendations for other agents in the regimen, refer to the respective prescribing information. Dosing recommendations in Table 1 include patients co-infected with human immunodeficiency virus (HIV). For dosing recommendations with specific HIV antiviral agents, refer to INTERACTIONS WITH OTHER MEDICINES (see Table 2). AU_PI_Daklinza_V8.0 2 TABLE 1: RECOMMENDED REGIMENS WITH DAKLINZA 60 MG ONCE DAILY COMBINATION THERAPY HCV GENOTYPE PRIOR TREATMENT TREATMENT _ _ DURATION Genotype 1 or 3 a None, or failed protease inhibitor and/or peginterferon alfa/ribavirin, or failed so Soma hati kamili