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Antifungals & Antivirals

Sosvir

Pack size:

Box of 28 tablets. Bottle of 28 tablets.

 

Composition:

Each film-coated tablet contains Sofosbuvir 400 mg.

 

Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. 

Protect from light. Do not store above 30oC.

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Sosvir is indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

Sosvir is administered orally.

The recommended dose is one 400 mg tablet, taken orally, once daily with or without food. Sofosbuvir should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC in adults. The recommended regimen and treatment duration for sofosbuvir combination therapy is based on patient status.

  • Known hypersensitivity to any of the active substance or excipients.
  • When sofosbuvir is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies.
  • Sofosbuvir combination treatment with ribavirin or peginterferon alfa/ ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant.

Use with potent P-gp inducers: Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin). Co-administration will significantly decrease sofosbuvir plasma concentration and could result in loss of efficacy of sofosbuvir.

The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin;

Sofosbuvir + ribavirin Very common: Haemoglobin decreased, insomnia, nervous system disorders: headache; nausea; blood bilirubin increased; fatigue, irritability.

Sofosbuvir + peginterferon alfa + ribavirin Very common: Anaemia, neutropenia, lymphocyte count, decreased, platelet count decreased; decreased appetite; insomnia; dizziness, headache; dyspnoea, cough; diarrhoea, nausea, vomiting; blood bilirubin increased; rash, pruritus; arthralgia, myalgia; chills, fatigue, influenza-like illness, irritability, pain, pyrexia.

  • Sofosbuvir is not recommended for use in children and adolescents under 18 years of age.
  • When sofosbuvir is used in combination with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment as recommended.
  • Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue treatment with ribavirin-containing regimens, taking into account the importance of the therapy to the mother.
  • Sofosbuvir is not recommended for administration as monotherapy and should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection.
  • Use with caution when Sosvir is used concomitantly with another direct-acting antiviral (DAAs, including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone with or without other drugs that lower heart rate. Appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on sofosbuvir in combination with another DAA.
  • Consideration should be given to treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks.
  • Be cautious when use for treatment of patients with genotype 5 or 6 HCV infection.
  • Sofosbuvir should only be co-administered with other direct-acting antiviral medicinal products if the benefit is considered to outweigh the risks based upon available data. Concomitant use of sofosbuvir and telaprevir or boceprevir are not recommended.
  • Co-administration of medicinal products that are moderate P-gp inducers in the intestine (e. g. oxcarbazepine and modafinil) is not recommended with sofosbuvir.
  • The safety of sofosbuvir has not been assessed in patients with severe renal impairment (estimated glomerular ltration rate [eGFR] < 30 mL/min/1. 73 m2) or end stage renal disease (ESRD) requiring haemodialysis.
  • HBV screening should be performed in all patients before initiation of treatment with Sosvir, some of cases of hepatitis B virus (HBV) reactivation fatal have been reported during or after treatment with direct-acting antiviral agents.

Sofosbuvir has moderate influence on the ability to drive and use machines. Patients should be informed that fatigue and disturbance inattention, dizziness and blurred vision have been reported during treatment with sofosbuvir in combination with peginterferon alfa and ribavirin. 

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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