Examples of using Sofosbuvir in English and their translations into Croatian
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The parent sofosbuvir accounts for approximately 4% of drug-related material systemic exposure see section 5.2.
Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir+ sofosbuvir, with or without ribavirin study HPC2002.
The pharmacokinetics of ledipasvir, sofosbuvir and GS-331007 in paediatric patients have not been established see section 4.2.
The most common adverse drug reactions occurring in subjects receiving sofosbuvir and ribavirin or sofosbuvir, ribavirin and peginterferon alfa were fatigue,
limited amount of data(less than 300 pregnancy outcomes) from the use of ledipasvir, sofosbuvir or Harvoni in pregnant women.
Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni.
Epclusa is available as tablets which contain 400 mg sofosbuvir and 100 mg velpatasvir.
For previously treated patients with genotype 1 HCV infection, no data exists with the combination of sofosbuvir, peginterferon alfa and ribavirin.
of co-administered drug pharmacokinetics with/without sofosbuvir and mean ratio of sofosbuvir and GS-331007 with/without co-administered drug.
daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3.
Among patients who achieved SVR12 with daclatasvir and sofosbuvir(± ribavirin) with a median duration of post-SVR12 follow-up of 15 months,
Co-administration will significantly decrease ledipasvir and sofosbuvir plasma concentrations and could result in loss of efficacy of Harvoni see section 4.5.
The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient infected with genotype 3.
Co-administration will significantly decrease sofosbuvir or velpatasvir plasma concentrations
The sofosbuvir resistance-associated substitution S282T in NS5B was not detected in any virologic failure isolate from the Phase 3 studies.
Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered dose see section 4.2.
The clinical data to support the use of Daklinza and sofosbuvir in patients infected with HCV genotypes 4
Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis see section 5.1.
Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects
Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.