natgillin/translations-raw huggingface dataset:
After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7. 
Po enem 400-miligramskem odmerku [14C]-sofosbuvirja pri zdravih osebah je bilo razmerje radioaktivnosti 14C v krvi in plazmi približno 0,7.
ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin 
ANTIKONVULZIVI Karbamazepin Fenobarbital Fenitoin
Common pyrexia, asthenia chest pain, asthenia a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa. 
pireksija pogosti pireksija, astenija bolečine v prsih, astenija a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa Druge posebne populacije
Microcrystalline cellulose (E460(i)) Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b) 
Jedro tablete manitol (E421) mikrokristalna celuloza (E460(i)) premrežen natrijev karmelozat brezvodni koloidni silicijev dioksid (E551) magnezijev stearat (E470b)
Co-administration with other direct-acting antivirals against HCV Sovaldi 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. 
Sočasno dajanje z drugimi zdravili proti HCV z direktnim delovanjem na viruse Zdravilo Sovaldi se sme dajati sočasno z drugimi zdravili z direktnim delovanjem na viruse le, če se na podlagi razpoložljivih podatkov oceni, da je korist zdravljenja večja od tveganj.
Population pharmacokinetic analysis in HCV infected subjects showed that within the age range (19 to 75 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir and GS-331007. 
Populacijska farmakokinetična analiza pri osebah, okuženih s HCV, je pokazala, da znotraj analiziranega starostnega razpona (19 do 75 let) starost ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju in GS-331007.
Patients should be instructed that if vomiting occurs within 2 hours of dosing an additional tablet should be taken. 
Bolnikom je treba naročiti, naj vzamejo dodatno tableto, če v 2 urah po odmerjanju bruhajo.
The film-coated tablet should not be chewed or crushed, due to the bitter taste of the active substance. 
Filmsko obložene tablete naj ne žvečijo in ne drobijo, saj ima zdravilna učinkovina grenak okus.
In subjects with ESRD, relative to subjects with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis. 
Pri osebah z ESRD je bila v primerjavi z osebami z normalnim delovanjem ledvic vrednost AUC0-inf sofosbuvirja za 28 % višja pri odmerjanju sofosbuvirja 1 uro pred hemodializo v primerjavi s 60 % višjo vrednostjo pri odmerjanju sofosbuvirja 1 uro po hemodializi.
Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sovaldi and another DAA when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated. 
Primeri so lahko smrtno nevarni, zato se lahko amiodaron pri bolnikih, ki prejemajo zdravilo Sovaldi in drugo zdravilo z direktnim delovanjem na viruse, uporablja samo, če drugih nadomestnih antiaritmikov ne prenašajo ali če so ti pri njih kontraindicirani.
The safety and efficacy of Sovaldi in children and adolescents aged <18 years have not yet been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Sovaldi pri otrocih in mladostnikih, starih < 18 let, še nista bili dokazani.
No dose adjustment is warranted for elderly patients (see section 5.2). 
Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5.2).
When you take Sovaldi in combination with another medicine to treat hepatitis C virus infection (including daclatasvir, simeprevir and ledipasvir) and amiodarone (a medicine used for heart problems), you may get one or more of the side effects below: 
Ko vzamete zdravilo Sovaldi v kombinaciji z drugim zdravilom za zdravljenje okužbe z virusom hepatitisa C (vključno z daklatasvirjem, simeprevirjem in ledipasvirjem) in amiodaronom (zdravilo za zdravljenje težav s srcem), se lahko pojavi en ali več neželenih učinkov, navedenih spodaj:
The virologic response rates of the 41 subjects transplanted with HCV RNA <LLOQ is described in Table 17. 
Stopnje virološkega odziva za prvih 41 oseb s presaditvijo, z RNA HCV < LLOQ, so navedene v preglednici 17.
HCV infected subjects, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria received 400 mg sofosbuvir and 1,000-1,200 mg ribavirin daily for a maximum of 24 weeks, subsequently amended to 48 weeks, or until the time of liver transplantation, whichever occurred first. 
Osebe, okužene s HCV, neodvisno od genotpa, s hepatoceličnim karcinomom (HCC, hepatocellular carcinoma), ki so izpolnjevale kriterije po lestvici MILAN, so prejemale 400 mg sofosbuvirja in 1.000-1.200 mg ribavirina na dan za največ 24 tednov, naknadno popravljeno na 48 tednov, ali do presaditve jeter, kar je bilo prej.
12 weeks (n = 256)a 
12 tednov (n = 256)a
Genotype 4, 5 or 6 97% (34/35) Cirrhosis 
Genotip Genotip 1 Genotip 4, 5 ali 6 97 % (34/35) Ciroza Ne Da Rasa
• The active substance is sofosbuvir. 
• Zdravilna učinkovina je sofosbuvir.
Dose modification Dose reduction of Sovaldi is not recommended. 
Zmanjšanje odmerka zdravila Sovaldi se ne priporoča.
A 4-hour haemodialysis session removed approximately 18% of administered dose. 
S 4-urno hemodializo se je izločilo približno 18 % uporabljenega odmerka.
Sofosbuvir is not a substrate for hepatic uptake transporters, organic anion-transporting polypeptide (OATP) 1B1 or 1B3, and organic cation transporter (OCT) 1. 
Sofosbuvir ni substrat za jetrne privzemne prenašalce, transportni polipeptid organskih anionov (OATP, organic anion-transporting polypeptide) 1B1 ali 1B3 in prenašalca organskih kationov (OCT,
It is not known whether sofosbuvir, the active substance of Sovaldi, passes into human breast milk. 
Ni znano, ali sofosbuvir, zdravilna učinkovina v zdravilu Sovaldi, prehaja v materino mleko.
The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV infected subjects with moderate and severe hepatic impairment (CPT class B and C). 
Farmakokinetiko sofosbuvirja so proučili po 7-dnevnem odmerjanju 400 mg sofosbuvirja pri osebah, okuženih s HCV, z zmerno in hudo jetrno okvaro (stopnja B ali C po CPT).
The most common adverse drug reactions occurring in subjects receiving sofosbuvir and ribavirin or sofosbuvir, ribavirin and peginterferon alfa were fatigue, headache, nausea and insomnia. 
Najpogostejši neželeni učinki zdravila, ki so se pojavili pri osebah, ki so dobivale sofosbuvir in ribavirin ali sofosbuvir, ribavirin in peginterferon alfa, so bile utrujenost, glavobol, navzea in nespečnost.
Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 24 weeks of treatment with sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C. Eligible subjects were ≥18 years old and had undergone liver transplantation 6 to 150 months prior to screening. 
Sofosbuvir so preučili v odprti klinični študiji, v kateri so ocenjevali varnost in učinkovitost 24tedenskega zdravljenja s sofosbuvirjem in ribavirinom pri prejemnikih presajenih jeter s kroničnim hepatitisom C. Primerne osebe so bile stare ≥ 18 let in so imele presaditev jeter 6 do 150 mesecev pred presejanjem.
Forty subjects (33 with HCV genotype 1 infection, 6 with HCV genotype 3 infection, and 1 with HCV genotype 4 infection) were enrolled, 35 of whom had previously failed interferon-based treatment, and 16 of whom had cirrhosis. 
Vključenih je bilo štirideset oseb (33 z okužbo s HCV genotipa 1, 6 z okužbo s HCV genotipa 3 in 1 oseba z okužbo s HCV genotipa 4), pri čemer je bilo pri 35 osebah predhodno zdravljenje na podlagi interferona neuspešno, 16 pa jih je imelo cirozo.
Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate. 
Jedro tablete: manitol, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvodni koloidni silicijev dioksid, magnezijev stearat.
The pharmacokinetics of sofosbuvir and GS-331007 in paediatric subjects have not been established (see section 4.2). 
Pediatrična populacija Farmakokinetike sofosbuvirja in GS-331007 pri pediatričnih osebah niso ugotavljali (glejte poglavje 4.2).
Subjects were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1 
Osebe bodisi niso prejemale protiretrovirusne terapije s številom celic CD4+ > 500 celic/mm3 ali so imele
Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4) 
Uporablja se samo za bolnike, ki za zdravljenje peginterferonom alfa niso primerni ali ga ne prenašajo (glejte poglavje 4.4)
Treatment-naïve (ELECTRONb and 
Predhodno nezdravljeni (ELECTRONb in
Sofosbuvir is a nucleotide prodrug that is extensively metabolised. 
Sofosbuvir je nukleotidno predzdravilo, ki se obsežno presnavlja.
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenzf (600 mg once daily)d 
PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI REVERZNE TRANSKRIPTAZE Efavirenzf (600 mg enkrat na dan)d
The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level. 
Farmakokinetične lastnosti sofosbuvirja in prevladujočega cirkulirajočega presnovka GS-331007 so ocenili pri zdravih odraslih osebah in pri osebah s kroničnim hepatitisom C. Po peroralni uporabi se je sofosbuvir hitro absorbiral in dosegel najvišje koncentracije v plazmi ~0,5-2 uri po odmerku,
Effect of baseline HCV polymorphisms on treatment outcome Baseline NS5B sequences were obtained for 1,292 subjects from Phase 3 studies by population sequencing and the S282T substitution was not detected in any subject with available baseline sequence. 
Učinki izhodiščnega polimorfizma HCV na izid zdravljenja Izhodiščna zaporedja NS5B so pridobili za 1.292 oseb iz študij 3. faze z določanjem populacijskega zaporedja genoma, pri čemer substitucije S282T niso odkrili pri nobeni osebi, za katero je bilo na voljo izhodiščno zaporedje.
Sofosbuvir was studied in HCV infected subjects prior to undergoing liver transplantation in an open-label clinical study evaluating the safety and efficacy of sofosbuvir and ribavirin administered pre-transplant to prevent post-transplant HCV reinfection. 
Sofosbuvir so preučili pri osebah, okuženih z virusom HCV, pred načrtovano transplantacijo jeter v odprti klinični študiji, v kateri so ocenjevali varnost in učinkovitost sofosbuvirja in ribavirina, ki so ga dajali pred presaditvijo, da se prepreči ponovna okužba s HCV po presaditvi.
with a CD4+ cell count >200 cells/mm3. 
HIV-1 z virološko supresijo s številom celic CD4+ > 200 celic/mm3.
The safety of Sovaldi has not been assessed in subjects with severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD requiring haemodialysis. 
Varnosti zdravila Sovaldi niso ocenili pri osebah s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) ali ESRD, zaradi katere bolnik potrebuje hemodializo.
Table 13: Response rates in study VALENCE Genotype 2 
Preglednica 13: Stopnje odziva v študiji VALENCE Genotip 2
During treatment with sofosbuvir in combination with ribavirin or with peginterferon alfa and ribavirin, the most frequently reported adverse drug reactions were consistent with the expected safety profile of ribavirin and peginterferon alfa treatment, without increasing the frequency or severity of the expected adverse drug reactions. 
Povzetek varnostnega profila Med zdravljenjem s sofosbuvirjem v kombinaciji z ribavirinom ali s peginterferonom alfa in ribavirinom so bili neželeni učinki zdravila, o katerih so najpogosteje poročali, skladni s pričakovanim profilom varnosti zdravljenja z ribavirinom in peginterferonom alfa, brez povečanja pogostnosti ali resnosti pričakovanih neželenih učinkov zdravila.
Subjects were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level (<6 log10 IU/mL versus ≥6 log10 IU/mL). 
Osebe so bile randomizirane v razmerju 1:1 in stratificirane glede na cirozo (prisotnost v primerjavi z odsotnostjo), genotip HCV (2 v primerjavi s 3) in raven RNA HCV ob izhodišču (< 6 log10 i.e./ml v primerjavi z ≥ 6 log10 i.e./ml).
Eleven HCV genotype 3 subjects had already completed treatment with sofosbuvir and ribavirin for 12 weeks at the time of the amendment. 
11 oseb s HCV genotipa 3 je v času spremembe že zaključilo 12-tedensko zdravljenje s sofosbuvirjem in ribavirinjem.
If you vomit more than 2 hours after taking it you do not need to take another tablet until your next regularly scheduled tablet. 
2 uri po uporabi zdravila, ne vzemite še ene tablete do naslednje načrtovane tablete.
Table 17: Virologic response post-transplant in subjects with HCV RNA <LLOQ at the time of liver transplantation 
Preglednica 17: Virološki odziv po presaditvi pri osebah s RNA HCV < LLOQ v času presaditve jeter
Table 15: Response rates in study PHOTON-1 Genotype 2/3 treatment-naïve 
Preglednica 15: Stopnje odziva v študiji PHOTON-1 Genotip 2/3 predhodno nezdravljeni
Sovaldi is always taken with other medicines (see section 1 above). 
Opozorila in previdnostni ukrepi Zdravilo Sovaldi se vedno jemlje z drugimi zdravili (glejte poglavje 1 zgoraj).
Genotype 1bc No cirrhosisc Cirrhosisc n = number of subjects with SVR12 response; N = total number of subjects per group. 
Skupajc Genotip 1ac Genotip 1bc Brez cirozec Cirozac n = število oseb z odzivom SVR12; N = skupno število oseb v skupini.
Women of childbearing potential / contraception in males and females When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Pri uporabi zdravila Sovaldi v kombinaciji z ribavirinom ali s peginterferonom alfa/ribavirinom, je potrebna izjemna previdnost, da se prepreči nosečnost bolnic in partnerk bolnikov.
Relative to subjects with normal renal function (eGFR >80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively. 
V primerjavi z osebami z normalnim delovanjem ledvic (eGFR > 80 ml/min/1,73 m2) je bila vrednost AUC0-inf za sofosbuvir za 61 % višja pri osebah z blago, za 107 % pri osebah z zmerno in za 171 % s hudo ledvično okvaro, medtem ko je bila vrednost AUC0-inf za GS-331007 višja za 55 %, 88 % oz. za 451 %.
Metabolism and nutrition disorders: Very common decreased appetite 
Presnovne in prehranske motnje: zelo pogosti zmanjšan apetit pogosti zmanjšanje telesne mase
Treatment-naïve (FISSION) 
Predhodno nezdravljeni (FISSION)
• Have kidney problems. 
• imate težave z ledvicami.
Response rates for subjects with cirrhosis at baseline are presented in Table 8 by HCV genotype. 
Stopnje odziva za osebe s cirozo ob izhodišču so predstavljene v preglednici 8 po genotipu HCV.
Subjects were randomised in 3:1 ratio and stratified by cirrhosis (presence versus absence). 
Osebe so bile randomizirane v razmerju 3:1 in stratificirane glede na cirozo (prisotnost v primerjavi z odsotnostjo).
General disorders and administration site conditions: Very common fatigue, irritability chills, fatigue, influenza-like illness, irritability, pain, pyrexia 
Splošne težave in spremembe na mestu aplikacije: zelo pogosti utrujenost, razdražljivost mrzlica, utrujenost, gripi podobna bolezen, razdražljivost, bolečine,
• St. John's wort (Hypericum perforatum - herbal medicine used to treat depression); 
• šentjanževka (Hypericum perforatum - zdravilo rastlinskega izvora, ki se uporablja za zdravljenje depresije);
Treatment-experienced (VALENCE) 
Predhodno zdravljeni (VALENCE)
Overall SVR12 Outcome for subjects without SVR12 On-treatment virologic failure Relapsea Otherb a. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment. 
Celokupni SVR12 Izid za osebe brez SVR12 Virološki neuspeh med zdravljenjem Relapsa Drugob a. Denominator za relaps je število oseb z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
Sovaldi should be used in combination with other medicinal products. 
Zdravilo Sovaldi se uporablja v kombinaciji z drugimi zdravili.
Subjects were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence) and HCV genotype (2 versus 3). 
Osebe so bile randomizirane v razmerju 1:1 in stratificirane glede na cirozo (prisotnost v primerjavi z odsotnostjo) in genotip HCV (2 v primerjavi s 3).
A single subject with genotype 5 and all 6 subjects with genotype 6 HCV infection in this study achieved SVR12. 
V tej študiji je ena sama oseba z okužbo s HCV genotipa 5 in vseh 6 oseb z okužbo s HCV genotipa 6 doseglo SVR12.
NAME OF THE MEDICINAL PRODUCT Sovaldi 400 mg film-coated tablets 
IME ZDRAVILA Sovaldi 400 mg filmsko obložene tablete
Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine and modafinil) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi. 
Zdravila, ki so zmerni induktorji P-gp v črevesju (npr. okskarbazepin in modafinil), lahko zmanjšajo koncentracije sofosbuvirja v plazmi, kar zmanjša terapevtski učinek zdravila Sovaldi.
Elimination Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively. 
Po enkratnem 400-miligramskem peroralnem odmerku [14C]-sofosbuvirja je bil povprečni skupni delež odmerka, ki so ga izolirali, višji kot 92 %, pri čemer ga je bilo 80 % izoliranega v urinu, 14 % v blatu in 2,5 % v izdihanemu zraku.
Sovaldi should always be taken in combination with other medicinal products for use against hepatitis C. 
Zdravilo Sovaldi vedno jemljite v kombinaciji z drugimi zdravili proti hepatitisu C.
Treatment-naïve (NEUTRINO) 
Predhodno nezdravljenia (NEUTRINO)
Genotype 2 and 3 subjects were either treatment-naïve or experienced, whereas genotype 1 subjects were naïve to prior treatment. 
Osebe z genotipom 2 in 3 bodisi predhodno še niso bile zdravljenje ali pa so bile, medtem ko osebe z genotipom 1 predhodno še niso bile zdravljene.
After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively. 
Po enkratnem 400-miligramskem peroralnem odmerku [14C]-sofosbuvirja je sofosbuvir prispeval približno 4 % sistemske izpostavljenosti z zdravilom povezanega materiala (vsota vrednosti AUC sofosbuvirja in njegovih presnovkov, prilagojenih glede na molekulsko maso), GS-331007 pa > 90 %.
In biochemical assays, recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution showed reduced susceptibility to GS-461203 compared to respective wild-types. 
NS5B genotipov 1b, 2a, 3a in 4a z izraženo substitucijo S282T pokazala zmanjšano dovzetnost za GS-461203 v primerjavi z nemutiranimi tipi virusa.
Treatment-naïve and previously treated adults - VALENCE (study 133) VALENCE was a Phase 3 study that evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects with compensated cirrhosis. 
Predhodno nezdravljeni in predhodno zdravljeni odrasli - VALENCE (študija 133) VALENCE je bila študija 3. faze, v kateri so ocenili sofosbuvir v kombinaciji z ribavirinom na podlagi telesne mase za zdravljenje okužbe s HCV genotipa 2 ali 3 pri predhodno nezdravljenih osebah ali pri osebah, ki niso dosegle SVR s predhodnim zdravljenjem na podlagi interferona, vključno z osebami s kompenzirano cirozo.
Tenofovir disoproxil fumaratef (300 mg once daily)d 
Dizoproksiltenofovirat fumaratf (300 mg enkrat na dan)d
If the other medicinal products used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued (see section 4.4). 
Ob trajni ukinitvi drugih zdravil, ki se uporabljajo v kombinaciji z zdravilom Sovaldi, je treba ukiniti tudi uporabo zdravila Sovaldi (glejte poglavje 4.4).
Discontinuation of dosing 
Ukinitev odmerjanja
Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) ↓ AUC 0.28 (0.24, 0.32) Cmin (NA) 
Sofosbuvir ↓ Cmax 0,23 (0,19; 0,29) ↓ AUC 0,28 (0,24; 0,32) Cmin (n/n)
Interferon intolerant, ineligible or unwilling adults - POSITRON (study 107) POSITRON was a randomised, double-blinded, placebo-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared to placebo (n = 71) in subjects who are interferon intolerant, ineligible or unwilling. 
Odrasli, ki niso prenašali interferona, niso bili primerni ali voljni - POSITRON (študija 107) Študija POSITRON je bila randomizirana, dvojno slepa, s placebom kontrolirana študija, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem in ribavirinom (n = 207) v primerjavi s placebom (n = 71) pri osebah, ki interferona ne prenašajo oz. niso primerne ali voljne.
Treatment duration was 12 weeks in treatment-naïve subjects with genotype 2 or 3 HCV infection, and 24 weeks in treatment-experienced subjects with genotype 3 HCV infection, as well as subjects with genotype 1 HCV infection. 
Zdravljenje je trajalo 12 tednov pri predhodno nezdravljenih osebah z okužbo s HCV genotipa 2 ali 3 in 24 tednov pri predhodno zdravljenih osebah z okužbo s HCV genotipa 3 in osebah z okužbo s HCV genotipa 1.
Breast-feeding It is unknown whether sofosbuvir and its metabolites are excreted in human milk. 
Ni znano, ali se sofosbuvir in njegovi presnovki izločajo v materino mleko.
Sovaldi has moderate influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Sovaldi ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Treatment of patients with genotype 5 or 6 HCV infection The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1). 
Klinični podatki, ki bi podprli uporabo zdravila Sovaldi pri bolnikih z okužbo s HCV genotipa 5 in 6, so zelo omejeni (glejte poglavje 5.1).
How to take Sovaldi 
Kako jemati zdravilo Sovaldi
• feeling tired and irritable 
• nespečnost (insomnija) • občutek utrujenosti in razdražljivosti
12 weeks (n = 68) 
12 tednov (n = 68)
Table 15 presents the response rates by genotype and exposure to prior HCV treatment. 
V preglednici 15 so predstavljene stopnje odziva po genotipu in izpostavljenost predhodnemu zdravljenju HCV.
Patients with genotype 3 CHC 
Bolniki s CHC genotipa 3
Cmin (NA) Norgestrel ↔ Cmax 1.18 (0.99, 
Cmin (n/n) Norgestrel ↔ Cmax 1,18 (0,99;
b. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment. 
b. Denominator za relaps je število oseb z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
Film-coated tablet. 
FARMACEVTSKA OBLIKA filmsko obložena tableta.
12 weeks (n = 327) 
12 tednov (n = 327)
Previously treated adults - FUSION (study 108) 
Odrasli, ki se predhodno še niso zdravili - FISSION (študija 1231)
Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a,b 
(90-odstotni interval zaupanja) za AUC,
Overview of outcomes by therapeutic regimen and treatment duration, a comparison across studies The following tables (Table 18 to Table 21) present data from Phase 2 and Phase 3 studies relevant to the dosing to help clinicians determine the best regimen for individual patients. 
Pregled izidov zdravljenja glede na režime in trajanje zdravljenja, primerjava med študijami V naslednjih preglednicah (preglednica 18 do preglednice 21) so predstavljeni podatki študij 2. faze in