natgillin/translations-raw huggingface dataset:
Sovaldi is always taken with other medicines to treat hepatitis C (see section 1 above). 
Sovaldi se uvijek uzima s drugim lijekovima za liječenje hepatitisa C (pogledajte dio 1 gore).
This data indicate that renal clearance is the major elimination pathway for GS-331007 with a large part actively secreted. 
Ovi podaci pokazuju da je bubrežni klirens glavni put eliminacije GS­331007 s time da se veliki dio izlučuje aktivno.
Forty patients (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. 
Bilo je uključeno 40 bolesnika (33 s infekcijom HCV­om genotipa 1, 6 s infekcijom HCV­om genotipa 3 i 1 s infekcijom HCV­om genotipa 4), od kojih je 35 prethodno bilo neuspješno liječeno terapijom temeljenom na interferonu, a 16 je imalo cirozu.
If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. 
Ako bolesnik ima ozbiljnu nuspojavu potencijalno povezanu s ribavirinom, dozu ribavirina potrebno je prilagoditi ili prekinuti njegovu primjenu, ako je to primjereno, sve dok se nuspojava ne povuče ili se ne smanji težina nuspojave.
Baseline NS5B sequences were obtained for 47 patients in the Phase 2 study. 
Početne sekvence NS5B dobivene su za 47 bolesnika u ispitivanju faze 2.
In a pooled analysis of 991 patients who received sofosbuvir in Phase 3 studies, 226 patients qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA >1,000 IU/mL. 
U analizi objedinjenih podataka o 991 bolesnika koji su primali sofosbuvir u ispitivanjima faze 3, 226 bolesnika zadovoljilo je mjerila za analizu rezistencije zbog virološkog neuspjeha ili ranog prekida primjene lijeka tijekom ispitivanja i imalo je HCV RNK > 1000 IU/ml.
Peak plasma concentration of GS-331007 was observed between 2 to 4 hours post-dose. 
Vršna koncentracija GS­331007 u plazmi bila je opažena 2 do 4 sata nakon doze.
The S282T substitution in NS5B was detected in a single subject receiving Sovaldi monotherapy in a Phase 2 study. 
Supstitucija S282T u NS5B bila je otkrivena u jednog ispitanika koji je primao monoterapiju Sovaldijem u ispitivanju faze 2.
Interferon-free regimens for patients with genotype 1, 4, 5 and 6 HCV infection with Sovaldi have not been investigated in Phase 3 studies (see section 5.1). 
Režimi bez interferona za bolesnike s infekcijom HCV­om genotipa 1, 4, 5 i 6 sa Sovaldijem nisu ispitani u kliničkim ispitivanjima faze 3 (vidjeti dio 5.1).
Sovaldi should always be taken in combination with other medicinal products for use against hepatitis C. 
Sovaldi uvijek treba uzimati u kombinaciji s drugim lijekovima protiv hepatitisa C.
• Sovaldi is commonly used together with ribavirin. 
Sovaldi se obično primjenjuje zajedno s ribavirinom.
How to take Sovaldi 
Kako uzimati Sovaldi
Week 12 
12 tjedanab
Tacrolimuse (5 mg single dose) 
Takrolimuse (jedna doza od 5 mg)
Treatment-experienced (VALENCE) 
Prethodno liječeni bolesnici (VALENCE)
Patients awaiting liver transplantation 
Bolesnici koji čekaju transplantaciju jetre
Sovaldi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2). 
U tih se bolesnika Sovaldi može primjenjivati bez prilagodbe doze kada nisu dostupne nikakve druge odgovarajuće mogućnosti liječenja (vidjeti dijelove 4.4, 4.8, 5.1 i 5.2).
• Obligation to conduct post-authorisation measures 
Obveza provođenja mjera nakon davanja odobrenja
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. 
Sofosbuvir je nukleotidni predlijek iz kojeg unutarstaničnim metabolizmom nastaje farmakološki djelatan uridinu analogni trifosfat (GS­461203), koji se može ugraditi u RNK HCV­a pomoću NS5B polimeraze i djelovati kao terminator lanca.
Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes. 
Sofosbuvir i GS­331007 nisu supstrati ili inhibitori UGT1A1 ili enzima CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP2D6.
• shortness of breath or worsening of any shortness of breath you already have 
● nedostatak zraka ili pogoršanje već prisutnog nedostatka zraka
Monotherapy of Sovaldi is not recommended (see section 5.1). 
Ne preporučuje se monoterapija Sovaldijem (vidjeti dio 5.1).
Microcrystalline cellulose (E460(i)) Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b) 
Jezgra tablete manitol (E421) celuloza, mikrokristalična (E460(i)) karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni (E551) magnezijev stearat (E470b)
The ribavirin dose was weight-based at 1,000-1,200 mg daily administered in two divided doses, and the peginterferon alfa 2a dose, where applicable, was 180 μg per week. 
Doza ribavirina temeljena na tjelesnoj težini iznosila je 1000­1200 mg na dan primijenjena u dvije odvojene doze, a doza peginterferona alfa 2a, kad se primjenjivala, iznosila je 180 µg tjedno.
Sovaldi 400 mg film-coated tablets sofosbuvir 
Sovaldi 400 mg filmom obložene tablete sofosbuvir
In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50) value ranging from 0.7 to 2.6 μM. 
U biokemijskom testu, GS­461203 inhibirao je polimeraznu aktivnost rekombinantnog NS5B HCV­a genotipa 1b, 2a, 3a i 4a uz 50% inhibitorne koncentracije (IC50) u rasponu od 0,7 do 2,6 μM.
No shift in the phenotypic susceptibility to sofosbuvir or ribavirin of subject isolates with these substitutions was detected. 
Nije otkriven nikakav pomak u fenotipskoj osjetljivosti na sovosbuvir ili ribavirin u izolata ispitanika s ovim supstitucijama.
Expected: ↓ Sofosbuvir ↔ GS-331007 
↓ Sofosbuvir ↔ GS­331007
Intracellular hydrolytic prodrug cleavage catalysed by enzymes including carboxylesterase 1 and sequential phosphorylation steps catalysed by nucleotide kinases result in formation of the pharmacologically active uridine nucleoside analogue triphosphate. 
Unutarstanično hidrolitičko cijepanje predlijeka katalizirano enzimima uključujući karboksilesterazu 1, nakon kojeg slijede fosforilacijski koraci katalizirani nukleotidnim kinazama, rezultira stvaranjem farmakološki djelatnog uridinskog nukleozidnog analoga trifosfata.
Sovaldi + ribavirina for 12 weeks b 
Sovaldi + ribavirina tijekom 12 tjedana b
The safety and efficacy of Sovaldi in adolescents aged 12 to <18 years are based on data from 50 patients who were treated with Sovaldi and ribavirin for 12 weeks (genotype 2 patients) and 24 weeks (genotype 3 patients) in a Phase 2, open-label clinical trial. 
Sigurnost i djelotvornost Sovaldija u adolescenata u dobi od 12 do <18 godina temelje se na podacima 50 bolesnika liječenih Sovaldijem i ribavirinom tijekom 12 tjedana (bolesnici zaraženi genotipom 2) i tijekom 24 tjedna (bolesnici zaraženi genotipom 3) u otvorenom kliničkom ispitivanju faze 2.
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. 
Nakon jedne peroralne doze od 400 mg [14C]­sofosbuvira, sofosbuvir i GS­331007 činili su približno 4% odnosno > 90% sistemske izloženosti tvarima povezanima s lijekom (zbroj molekularnoj težini prilagođenog AUC sofosbuvira i njegovih metabolita).
Sovaldi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2). 
U tih se bolesnika Sovaldi može primjenjivati bez prilagodbe doze kada nisu dostupne nikakve druge odgovarajuće mogućnosti liječenja (vidjeti dijelove 4.8, 5.1 i 5.2).
Population pharmacokinetic analysis in HCV infected patients 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. 
Analiza populacijske farmakokinetike u bolesnika zaraženih HCV­om pokazala je da unutar analiziranog raspona dobi (19 do 75 godina), dob nije imala klinički važan učinak na izloženost sofosbuviru i GS­331007.
The pharmacokinetics of sofosbuvir and GS-331007 have not been established in paediatric patients < 12 years of age. 
Farmakokinetika sofosbuvira i GS­331007 nije ustanovljena u pedijatrijskih bolesnika mlađih od 12 godina.
Patients with genotype 2 CHC Sovaldi + ribavirin 
Bolesnici s CHC­om uzrokovanim genotipom 2 Sovaldi + ribavirin
However, based on emerging data, the study was unblinded and all HCV genotype 2 patients continued to receive sofosbuvir and ribavirin for 12 weeks, whilst treatment for HCV genotype 3 patients was extended to 24 weeks. 
Međutim, na temelju podataka koji su se pojavili, uklonilo se maskiranje u ispitivanju i svi bolesnici s genotipom 2 HCV­a nastavili su primati sofosbuvir i ribavirin tijekom 12 tjedana, dok je liječenje bolesnika s genotipom 3 HCV­a bilo produljeno na 24 tjedna.
• The active substance is sofosbuvir. 
Djelatna tvar je sofosbuvir.
Sovaldi has not been studied in a Phase 3 study in treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection. 
Sovaldi nije ispitan u kliničkom ispitivanju faze 3 u liječenju prethodno liječenih bolesnika s infekcijom HCV­om genotipa 1, 4, 5 i 6.
• low red blood cell count (anaemia); the signs may include feeling tired, headaches, shortness of breath when exercising 
● smanjen broj crvenih krvnih stanica (anemija); znakovi mogu uključivati umor, glavobolje,
HCV replicons expressing the sofosbuvir-associated resistance substitution S282T were fully susceptible to other classes of anti-HCV agents. 
Replikoni HCV­a s S282T supstitucijom povezanom s rezistencijom na sofosbuvir bili su potpuno osjetljivi na druge skupine lijekova protiv HCV­a.
Renal impairment No dose adjustment of Sovaldi is required for patients with mild or moderate renal impairment. 
Nije potrebna prilagodba doze Sovaldija u bolesnika s blagim ili umjerenim oštećenjem bubrega.
The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets and 84 (3 bottles of 28) film-coated tablets. 
Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bočicu s 28 filmom obloženih tableta i 84 (3 bočice s 28) filmom obloženih tableta.
Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected patients. 
U odnosu na zdrave ispitanike (n = 284), AUC0­24 sofosbuvira bio je 57% viši, a GS­331007 39% niži u bolesnika zaraženih HCV­om.
Hepatobiliary disorders: Very common blood bilirubin increased blood bilirubin increased 
Vrlo često povišen bilirubin u krvi povišen bilirubin u krvi
In HCV replicon assays, the effective concentration (EC50) values of sofosbuvir against full-length replicons from genotype 1a, 1b, 2a, 3a and 4a were 0.04, 0.11, 0.05, 0.05 and 0.04 μM, respectively, and EC50 values of sofosbuvir against chimeric 1b replicons encoding NS5B from genotype 2b, 5a or 6a were 0.014 to 0.015 μM. 
U testu s replikonima HCV­a, vrijednosti učinkovite koncentracije (EC50) sofosbuvira protiv replikona pune duljine iz genotipova 1a, 1b, 2a, 3a i 4a bile su 0,04, 0,11, 0,05, 0,05 odnosno 0,04 μM, a vrijednosti EC50 sofosbuvira protiv kimeričnih replikonia 1b koji kodiraju NS5B iz genotipova 2b, 5a ili 6a bile su 0,014 do 0,015 μM.
Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate. 
Jezgra tablete: manitol, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid, magnezijev stearat.
There are no data to support the co-administration of Sovaldi and telaprevir or boceprevir. 
Nema podataka koji podupiru istodobnu primjenu Sovaldija i telaprevira ili boceprevira.
Monotherapy of Sovaldi is not recommended. 
Ne preporučuje se monoterapija Sovaldijem.
The dose of ribavirin, when used in combination with Sovaldi is weight-based (<75 kg = 1,000 mg and ≥75 kg = 1,200 mg) and administered orally in two divided doses with food. 
Doza ribavirina, kad se primjenjuje u kombinaciji sa Sovaldijem, temelji se na tjelesnoj težini (< 75 kg = 1000 mg i ≥ 75 kg = 1200 mg) i primjenjuje se peroralno, raspodijeljeno u dvije doze, s hranom.
No patient experienced on-treatment virologic failure or relapse. 
3. Nijedan bolesnik nije imao virološki neuspjeh ili relaps tijekom liječenja.
Genotype 2 
Genotip 2
General disorders and administration site conditions: Very common fatigue, irritability chills, fatigue, influenza-like illness, irritability, pain, pyrexia 
Vrlo često umor, razdražljivost zimica, umor, bolest nalik gripi, razdražljivost, bol, pireksija
Medicinal products that are strong P-gp inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin and St. John's wort) may significantly decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi and thus are contraindicated with Sovaldi (see section 4.3). 
Lijekovi koji su jaki induktori P­gp­a u crijevima (karbamazepin, fenobarbital, fenitoin, rifampicin i gospina trava) mogu značajno smanjiti koncentracije sofosbuvira u plazmi i tako dovesti do smanjenog terapijskog učinka Sovaldija te su stoga kontraindicirani sa Sovaldijem (vidjeti dio 4.3).
The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV. 
Na farmakokinetiku lijekova koji se metaboliziraju putem jetre (npr. imunosupresivi, kao što su inhibitori kalcineurina) mogu utjecati promjene u funkciji jetre nastale tijekom terapije direktno djelujućim antiviroticima, a koje su povezane s klirensom HCV­a.
If the other medicinal products used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued (see section 4.2). 
Ako se trajno prekine primjena drugih lijekova koji se primjenjuju u kombinaciji sa Sovaldijem, potrebno je također prekinuti primjenu Sovaldija (vidjeti dio 4.2).
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. 
Sofosbuvir je pan­genotipski inhibitor HCV NS5B RNK­ovisne RNK polimeraze, koja je neophodna za umnažanje virusa.
The pharmacokinetics of sofosbuvir were studied in HCV negative patients with mild (eGFR ≥50 and <80 mL/min/1.73 m2), moderate (eGFR ≥30 and <50 mL/min/1.73 m2), severe renal impairment (eGFR <30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir, relative to patients with normal renal function (eGFR >80 mL/min/1.73 m2). 
Farmakokinetika sofosbuvira bila je ispitana u HCV­negativnih bolesnika s blagim (eGFR ≥ 50 i < 80 ml/min/1,73m2), umjerenim (eGFR ≥ 30 i < 50 ml/min/1,73 m2), teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i bolesnika sa završnim stadijem bolesti bubrega koji su trebali hemodijalizu, nakon jedne doze od 400 mg sofosbuvira u odnosu na bolesnike s normalnom funkcijom bubrega (eGFR > 80 ml/min/1,73 m2).
Table 3: Recommended treatment regimen and durations for adolescents aged 12 to < 18 years treated with Sovaldi 
Tablica 3. Preporučeni režim i trajanje liječenja za adolescente u dobi od 12 do < 18 godina liječene Sovaldijem
Sofosbuvir was studied in HCV infected patients 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 je bio ispitan u bolesnika zaraženih HCV­om prije transplantacije jetre u otvorenom kliničkom ispitivanju u kojem se ocjenjivala sigurnost i djelotvornost sofosbuvira i ribavirina primijenjenih prije transplantacije kako bi se spriječila ponovna infekcija HCV­om nakon transplantacije.
Emtricitabinef (200 mg once daily)d 
Emtricitabinf (200 mg jedanput na dan)d
The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets and outer cartons containing 84 (3 bottles of 28) film-coated tablets. 
Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bočicu s 28 filmom obloženih tableta i kutije koje sadrže 84 (3 bočice s 28) filmom obloženih tableta.
The virologic response rates of the 41 patients transplanted with HCV RNA <LLOQ is described in Table 19. 
Stope virološkog odgovora u 41 bolesnika s transplantiranom jetrom i HCV RNK < donje granice kvantifikacije opisane su u tablici 19.
Consult the Summary of Product Characteristics for co-prescribed medicinal products before starting therapy with Sovaldi. 
Pročitajte sažetke opisa svojstava lijeka za lijekove koji se propisuju zajedno sa Sovaldijem prije početka liječenja Sovaldijem.
Table 4: Recommended dosing for ribavirin in combination therapy with Sovaldi in adolescents aged 12 to < 18 years 
Tablica 4: Preporučena doza za ribavirin u kombiranoj terapiji sa Sovaldijem u adolescenata u dobi od 12 do < 18 godina
The median terminal half-lives of sofosbuvir and GS-331007 were 0.4 and 27 hours respectively. 
Medijan terminalnog poluvijeka sofosbuvira iznosio je 0,4 sata, a GS­331007 27 sati.
Such co-administration is not recommended. 
Ne preporučuje se njihova istodobna primjena.
Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with Sovaldi. 
Pročitajte također sažetak opisa svojstava lijeka za lijekove koji se primjenjuju u kombinaciji sa Sovaldijem.
Population pharmacokinetics analysis in HCV infected patients indicated that cirrhosis had no clinically relevant effect on the exposure to sofosbuvir and GS-331007. 
Analiza populacijske farmakokinetike u bolesnika zaraženih HCV­om pokazala je da ciroza nije imala klinički važan utjecaj na izloženost sofosbuviru i GS­331007.
Sovaldi has been studied in combination with ribavirin, with or without peginterferon alfa. 
Sovaldi je ispitan u kombinaciji s ribavirinom, s peginterferonom alfa ili bez njega.
Patients were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1 with a CD4+ cell count >200 cells/mm3. 
Bolesnici ili nisu primali antiretrovirusnu terapiju i imali su broj CD4+ stanica > 500 stanica/mm3 ili su imali virološki potisnut HIV­1 i broj CD4+
Sovaldi is always taken with other medicines to treat hepatitis C. It will not work on its own. 
Sovaldi se uvijek uzima s drugim lijekovima za liječenje hepatitisa C jer sam neće djelovati.
The efficacy of sofosbuvir in HCV-infected patients aged 12 to <18 years was evaluated in a Phase 2, open label clinical trial that enrolled 50 patients with genotype 2 (n = 13) or genotype 3 (n = 37) chronic HCV infection. 
Djelotvornost sofosbuvira u bolesnika zaraženih HCV­om u dobi od 12 do <18 godina procijenjena je u otvorenom kliničkom ispitivanju faze 2 u koje je bilo uključeno 50 bolesnika s kroničnom infekcijom HCV­om genotipa 2 (n = 13) ili genotipa 3 (n = 37).
• low blood platelet count 
● smanjen broj krvnih pločica
A starting ribavirin dose of 400 mg administered orally in two divided doses with food is recommended. 
Preporučuje se početna doza ribavirina od 400 mg, koja se primjenjuje peroralno, podijeljeno u dvije doze, s hranom.
Dose modification in adults Dose reduction of Sovaldi is not recommended. 
Prilagodba doze u odraslih Ne preporučuje se sniženje doze Sovaldija.
Each film-coated tablet contains 400 mg of sofosbuvir. 
Jedna filmom obložena tableta sadrži 400 mg sofosbuvira.
The mean ± SD EC50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and 0.085 ± 0.034 μM for genotype 3a (n = 106). 
Srednja vrijednost ± SD EC50 sofosbuvira za kimerične replikone koji kodiraju sekvence NS5B iz kliničkih izolata iznosila je 0,068 ± 0,024 μM za genotip 1a (n = 67), 0,11 ± 0,029 μM za genotip 1b (n = 29), 0,035 ± 0,018 μM za genotip 2 (n = 15) i 0,085 ± 0,034 μM
Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0 
Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890­0
Sofosbuvir in a fixed dose combination with ledipasvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154). 
Sofosbuvir u fiksnoj kombinaciji s ledipasvirom primjenjivan je tijekom 12 tjedana u 18 bolesnika s CHC­om uzrokovanim genotipom 1 i s teškim oštećenjem bubrega u otvorenom ispitivanju (ispitivanje 0154).
Safety data are limited in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) and ESRD requiring haemodialysis. 
Podaci o sigurnosti primjene ograničeni su u bolesnika s teškim oštećenjem bubrega (eGFR< 30 ml/min/1,73 m2) i ESRD­om koji zahtijeva hemodijalizu.
Patients 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). 
Bolesnici su bili randomizirani u omjeru 1:1 i stratificirani prema cirozi (prisutna naspram odsutna), genotipu HCV­a (2 naspram 3) i početnoj razini HCV RNK (< 6 log10 IU/ml naspram ≥ 6 log10 IU/ml).
Dosed 1 hr After Dialysis Sofosbuvir 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 21-fold↑ 
Sofosbuvir 1,6 puta↑ 2,1 puta↑ 2,7 puta↑ 1,3 puta↑ 1,6 puta↑ ~2 puta↑ 1,9 puta↑ GS­331007 1,6 puta↑ 1,9 puta↑ 5,5 puta↑ ≥ 10 puta↑ ≥ 20 puta↑ ~7 puta↑ 21 put↑
The safety and efficacy of Sovaldi in children and adolescents aged <12 years have not yet been established. 
Sigurnost i djelotvornost Sovaldija u djece i adolescenata u dobi
Common abdominal discomfort, constipation, dyspepsia constipation, dry mouth, gastroesophageal reflux 
Često nelagoda u abdomenu, konstipacija, dispepsija konstipacija, suha usta, gastroezofagealni refluks
Patients received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for patients weighing <75 kg or 1,200 mg for patients weighing ≥75 kg). 
Bolesnici su primali 400 mg sofosbuvira i ribavirin na temelju tjelesne težine (1000 mg za bolesnike tjelesne težine < 75 kg ili 1200 mg za bolesnike tjelesne težine ≥ 75 kg).
a. For previously treated patients with HCV genotype 1 infection, no data exists with the combination of Sovaldi, ribavirin and peginterferon alfa (see section 4.4). 
Za prethodno liječene bolesnike s infekcijom HCV-om genotipa 1 ne postoje podaci za kombinaciju Sovaldija, ribavirina i peginterferona alfa (vidjeti dio 4.4).
A summary of the effect of varying degrees of renal impairment (RI) on the exposures of sofosbuvir and GS-331007 compared to subjects with normal renal function, as described in the text below, are provided in Table 24. 
Sažeti prikaz utjecaja različitih stupnjeva oštećenja bubrega na izloženost sofosbuviru i GS­331007 u usporedbi s ispitanicima s normalnom funkcijom bubrega, kako je opisano u nastavku, prikazan je u tablici 24.
The pharmacokinetics of sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n = 94) for 8, 12, or 24 weeks or sofosbuvir/velpatasvir (n = 59) for 12 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir and sofosbuvir/velpatasvir Phase 2/3 trials (see section 4.4). 
Farmakokinetika sofosbuvira i GS­331007 ispitana je u bolesnika zaraženih HCV­om s ESRD­om koji je zahtijevao dijalizu liječenih ledipasvirom/sofosbuvirom (n = 94) tijekom 8, 12 ili 24 tjedna ili sofosbuvirom/velpatasvirom (n = 59) tijekom 12 tjedana i uspoređenih s bolesnicima bez oštećenja bubrega u ispitivanjima ledipasvira/sofosbuvira i sofosbuvira/velpatasvira faze 2/3 (vidjeti dio 4.4).