natgillin/translations-raw huggingface dataset:
When Sovaldi 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 in the Summary of Product Characteristics for ribavirin. 
Pri uporabi zdravila Sovaldi v kombinaciji z ribavirinom ali s peginterferonom alfa/ribavirinom, morajo ženske v rodni dobi ali njihovi moški partnerji med zdravljenjem in še v obdobju po zaključku zdravljenja uporabljati učinkovito kontracepcijo, kot je priporočeno v povzetku glavnih značilnosti zdravila za ribavirin.
You should not breast-feed during treatment with Sovaldi. 
Med zdravljenjem z zdravilom Sovaldi ne smete dojiti.
The intracellular metabolic activation pathway of sofosbuvir is mediated by generally low affinity and high capacity hydrolase and nucleotide phosphorylation pathways that are unlikely to be affected by concomitant medicinal products (see section 5.2). 
Pri znotrajcelični poti presnovne aktivacije sofosbuvirja posredujeta poti hidrolaze in nukleotidne fosforilacije, ki imata običajno nizko afiniteto in veliko kapaciteto, pri katerih ni verjetno, da bi nanje vplivala sočasno uporabljena zdravila (glejte poglavje 5.2).
28 out of 40 (70%) patients achieved SVR12: 22/33 (73%) with HCV genotype 1 infection, 6/6 (100%) with HCV genotype 3 infection, and 0/1 (0%) with HCV genotype 4 infection. 
28 od 40 (70 %) bolnikov je doseglo SVR12: 22/33 (73 %) bolnikov z okužbo s HCV genotipa 1, 6/6 (100 %) z okužbo s HCV genotipa 3 in 0/1
Monotherapy of Sovaldi is not recommended. 
Monoterapija z zdravilom Sovaldi se ne priporoča.
No specific antidote is available for overdose with Sovaldi. 
Specifični antidot za prevelik odmerek zdravila Sovaldi ni na voljo.
If you do miss a dose: 
Če pozabite vzeti odmerek:
Your doctor will test your blood before, during and after your treatment with Sovaldi. 
Vaš zdravnik bo pred zdravljenjem z zdravilom Sovaldi, med njim in po njem opravil krvne preiskave.
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. 
V biokemičnem testu je rekombinantna polimeraza NS5B genotipov 1b, 2a, 3a in 4a z izraženo substitucijo S282T pokazala zmanjšano dovzetnost za GS-461203 v primerjavi z nemutiranimi tipi virusa.
Special patient populations 
Posebne populacije bolnikov Starejši bolniki
Adults The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2). 
Priporočeni odmerek je ena 400-miligramska tableta peroralno enkrat na dan s hrano (glejte poglavje 5.2).
NA = not available/not applicable a. Mean ratio (90% CI) of co-administered drug pharmacokinetics with/without sofosbuvir and mean ratio of sofosbuvir and GS-331007 with/without co-administered drug. 
n/n = podatkov ni na voljo/navedba ni smiselna/potrebna a. Povprečno razmerje (90-odstotni IZ) farmakokinetike sočasno uporabljenih zdravil s sofosbuvirjem ali brez njega in povprečno razmerje sofosbuvirja in GS-331007 s sočasno uporabljenimi zdravili ali brez njih.
Table 5: Interactions between Sovaldi and other medicinal products 
Preglednica 5: Interakcije med zdravilom Sovaldi in drugimi zdravili Zdravila po terapevtskih področjih
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. 
1.000-1.200 mg na dan, uporabljen v dveh razdeljenih odmerkih, odmerek peginterferona alfa 2a pa je bil, kjer je bil uporabljen, 180 μg na teden.
Each film-coated tablet contains 400 mg of sofosbuvir. 
Ena filmsko obložena tableta vsebuje 400 mg sofosbuvirja.
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 nukleotidno predzdravilo, ki se znotraj celice presnavlja in tvori farmakološko aktivni uridinski analog trifosfat (GS-461203), ki ga polimeraza NS5B lahko vgradi v RNA HCV, in deluje kot terminator verige.
The S282T substitution in NS5B was detected in a single subject receiving Sovaldi monotherapy in a Phase 2 study. 
Substitucijo S282T so v NS5B odkrili pri eni sami osebi, ki je prejemala monoterapijo z zdravilom Sovaldi v študiji 2. faze.
Recommendation concerning co-administration with Sovaldi 
Priporočila glede sočasne uporabe z zdravilom Sovaldi
Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC. 
Zdravljenje z zdravilom Sovaldi mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi bolnikov s
Common alopecia, dry skin, pruritus alopecia, dry skin 
zelo pogosti izpuščaj, pruritus pogosti alopecija, suha koža, pruritus alopecija, suha koža
Genotype 2 and 3 patients were either treatment-naïve or experienced, whereas genotype 1 patients were naïve to prior treatment. 
Bolniki z genotipom 2 in 3 bodisi predhodno še niso bili zdravljenji ali pa so bili, medtem ko bolniki z genotipom 1 predhodno še niso bili zdravljeni.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin (see section 4.4). 
Pri vseh živalskih vrstah, izpostavljenih ribavirinu, so dokazali pomembne teratogene in/ali embriocidne okvare (glejte poglavje 4.4).
Hepatobiliary disorders: Very common blood bilirubin increased blood bilirubin increased 
zelo pogosti povišana raven bilirubina v krvi povišana raven bilirubina v krvi
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). 
Bolniki so bili randomizirani v razmerju 1:1 in stratificirani 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).
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1. 
Sofosbuvir in GS-331007 nista zaviralca prenašalcev zdravil P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 in OCT1.
Dose modification in adolescents Dose reduction of Sovaldi is not recommended. 
Prilagajanje odmerka pri mladostnikih Zmanjšanje odmerka zdravila Sovaldi se ne priporoča.
Monotherapy of Sovaldi is not recommended (see section 5.1). 
Monoterapija z zdravilom Sovaldi se ne priporoča (glejte poglavje 5.1).
FUSION was a randomised, double-blinded study that evaluated 12 or 16 weeks of treatment with sofosbuvir and ribavirin in patients who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders). 
Študija FUSION je bila randomizirana, dvojno slepa študija, v kateri so ocenili 12- ali 16-tedensko zdravljenje s sofosbuvirjem in ribavirinom pri bolnikih, ki niso dosegli SVR s predhodnim zdravljenjem na podlagi interferona (bolniki z relapsom ali neodzivni bolniki).
Emtricitabinef (200 mg once daily)d 
Emtricitabinf (200 mg enkrat na dan)d
Patients were randomised in 3:1 ratio and stratified by cirrhosis (presence versus absence). 
Bolniki so bili randomizirani v razmerju 3:1 in stratificirani glede na cirozo (prisotnost v primerjavi z odsotnostjo).
Treatment-experienced 90% (37/41) Non-cirrhotic 
Predhodno nezdravljeni 97 % (31/32) Brez ciroze
Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to <18 years (see sections 4.2, 4.4 and 5.1). 
(CHC-chronic hepatitis C) pri odraslih in mladostnikih, starih 12 do < 18 let (glejte poglavja 4.2, 4.4 in 5.1).
No drug-drug interaction data exists regarding the co-administration of Sovaldi with boceprevir or telaprevir. 
Ni podatkov o interakcijah med zdravili, kar zadeva sočasno uporabo zdravila Sovaldi z boceprevirjem ali telaprevirjem.
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. 
Pri uporabi zdravila Sovaldi v kombinaciji z ribavirinom ali peginterferonom alfa/ribavirinom, je potrebna izjemna previdnost, da se prepreči nosečnost bolnic in partnerk bolnikov.
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-krat↑ 2,1-krat↑ 2,7-krat↑ 1,3-krat↑ 1,6-krat↑ ~2-krat↑ 1,9-krat↑ GS-331007 1,6-krat↑ 1,9-krat↑ 5,5-krat↑ ≥10-krat↑ ≥20-krat↑ ~7-krat↑ 21-krat ↑
If patients maintained haemoglobin levels ≥12 g/dL, ribavirin dose was increased at weeks 2, 4, and up to every 4 weeks until the appropriate weight-based dose was reached (1,000 mg daily in patients <75 kg, 1,200 mg daily in patients ≥75 kg). 
Če se je pri bolnikih ohranila raven hemoglobina ≥ 12 g/dl, so odmerek ribavirina povečali v 2. in 4. tednu in nato vsake 4 tedne, dokler ni bil dosežen ustrezen odmerek na podlagi telesne mase (1.000 mg na dan pri bolnikih < 75 kg, 1.200 mg na dan pri bolnikih ≥ 75 kg).
Eleven HCV genotype 3 patients had already completed treatment with sofosbuvir and ribavirin for 12 weeks at the time of the amendment. 
11 bolnikov s HCV genotipa 3 je v času spremembe že zaključilo 12-tedensko zdravljenje s sofosbuvirjem in ribavirinom.
Study 0154 was an open-label clinical study that evaluated the safety and efficacy of 24 weeks of treatment with sofosbuvir in combination with ribavirin in 20 genotype 1 or 3 HCV-infected patients with severe renal impairment not requiring dialysis. 
Študija 0154 je bila odprta klinična študija, v kateri so ocenili varnost in učinkovitost 24-tedenskega zdravljenja s sofosbuvirjem v kombinaciji z ribavirinom pri 20 bolnikih, okuženih s HCV genotipa 1 ali 3 s hudo okvaro ledvic, zaradi katere ni potrebna dializa.
Common depression depression, anxiety, agitation 
zelo pogosti nespečnost nespečnost pogosti depresija depresija, anksioznost, agitacija
Medicinal products that are moderate P-gp inducers in the intestine (e.g. modafinil, oxcarbazepine and rifapentine) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi. 
Zdravila, ki so zmerni induktorji P-gp v črevesju (npr. modafinil, okskarbazepin in rifapentin), lahko zmanjšajo koncentracije sofosbuvirja v plazmi, kar zmanjša terapevtski učinek zdravila Sovaldi.
For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. 
Za aktivnost, specifično za genotip virusa hepatitisa C (HCV), glejte poglavji 4.4 in 5.1. 4.2 Odmerjanje in način uporabe
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 pri bolnikih, okuženih s HCV, je pokazala, da ciroza ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju in GS-331007.
• shortness of breath or worsening of any shortness of breath you already have 
• zasoplost ali poslabšanje že obstoječe zasoplosti
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. 
Na voljo so naslednje velikosti pakiranja: škatle, ki vsebujejo 1 plastenko z 28 filmsko obloženimi tabletami in škatle s 84 (3 plastenke po 28) filmsko obloženimi tabletami.
c. Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up). 
c. Med drugo so bili vključeni bolniki, ki niso dosegli SVR12 in niso izpolnjevali kriterijev za virološki neuspeh (npr. izgubljeni za spremljanje).
Sovaldi 400 mg film-coated tablets sofosbuvir 
Sovaldi 400 mg filmsko obložene tablete sofosbuvir
The recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy are provided in Table 1. 
Priporočeno(a) zdravilo(a), ki se daje(jo) sočasno in trajanje zdravljenja s kombinirano terapijo z zdravilom Sovaldi so razvidni iz preglednice 1.
b. Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up). 
b. Med drugo so bili vključeni bolniki, ki niso dosegli SVR12 in niso izpolnjevali kriterijev za virološki neuspeh (npr. izgubljeni za spremljanje).
Peak plasma concentration of GS-331007 was observed between 2 to 4 hours post-dose. 
Najvišje koncentracije GS-331007 v plazmi so opazili med 2 in 4 urami po odmerku.
When you take Sovaldi with ribavirin or both peginterferon alfa and ribavirin, you may get one or more of the side effects below: 
Pri jemanju zdravila Sovaldi z ribavirinom ali tako s peginterferonom alfa kot z ribavirinom se lahko pojavi en ali več od spodaj navedenih neželenih učinkov:
Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30) Cmin (NA) 
↑ Cmax 2,54 (1,87; 3,45) ↑ AUC 4,53 (3,26; 6,30) Cmin (n/n)
Sofosbuvir is a nucleotide prodrug. 
Sofosbuvir je nukleotidno predzdravilo.
Sovaldi is always taken with other medicines to treat hepatitis C (see section 1 above). 
Zdravilo Sovaldi se vedno jemlje z drugimi zdravili za zdravljenje hepatitisa C (glejte poglavje 1
Table 17 presents the response rates by genotype and exposure to prior HCV treatment. 
V preglednici 17 so predstavljene stopnje odziva po genotipu in izpostavljenost predhodnemu zdravljenju HCV.
A single subject with genotype 5 and all 6 patients with genotype 6 HCV infection in this study achieved SVR12. 
genotipa 5 in vseh 6 bolnikov z okužbo s HCV genotipa 6 doseglo SVR12.
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). 
a. Za predhodno zdravljene bolnike z okužbo s HCV genotipa 1 ni podatkov za kombinacijo zdravila Sovaldi, ribavirina in peginterferona alfa (glejte poglavje 4.4).
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). 
Zdravila, ki so močni induktorji P-gp v črevesju (karbamazepin, fenobarbital, fenitoin, rifampicin in šentjanževka), lahko močno zmanjšajo koncentracije sofosbuvirja v plazmi, kar zmanjša terapevtski učinek zdravila Sovaldi, zato je njihova uporaba z zdravilom Sovaldi kontraindicirana (glejte poglavje 4.3).
The median terminal half-lives of sofosbuvir and GS-331007 were 0.4 and 27 hours respectively. 
Mediani končni razpolovni čas za sofosbuvir je bil 0,4 ure, za GS-331007 pa 27 ur.
After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7. 
[14C]-sofosbuvirja pri zdravih osebah je bilo razmerje radioaktivnosti 14C v krvi in plazmi približno 0,7.
b. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment. 
b. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
The starting dose of ribavirin was 400 mg given in a divided daily dose. 
Začetni odmerek ribavirina je bil 400 mg v dveh razdeljenih dnevnih odmerkih.
However, it has not been possible to fully estimate exposure margins achieved for sofosbuvir in the rat relative to the exposure in humans at the recommended clinical dose (see section 5.3). 
Vendar pa ni bilo povsem oceniti mogoče meja izpostavljenosti pri podganah, doseženih pri sofosbuvirju, glede na izpostavljenost pri ljudeh, ki so prejemali priporočeni klinični odmerek
Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence) and HCV genotype (2 versus 3). 
Bolniki so bili randomizirani v razmerju 1:1 in stratificirani glede na cirozo (prisotnost v primerjavi z odsotnostjo) in genotip HCV (2 v primerjavi s 3).
a. For previously treated patients with genotype 1 HCV infection, no data exists with the combination of sofosbuvir, peginterferon alfa and ribavirin. 
a. Za predhodno zdravljene bolnike z okužbo HCV genotipa 1 ni podatkov za kombinacijo sofosbuvirja, peginterferona alfa in ribavarina.
Common disturbance in attention migraine, memory impairment, disturbance in attention 
zelo pogosti glavobol omotičnost, glavobol pogosti motnje pozornosti migrena, motnje spomina, motnje pozornosti
Table 4: Recommended dosing for ribavirin in combination therapy with Sovaldi in adolescents aged 12 to < 18 years 
Preglednica 4: Priporočeni režim odmerjanja ribavirina pri kombinirani terapiji z zdravilom Sovaldi pri mladostnikih, starih 12 do < 18 let
Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring haemodialysis. 
Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerularne filtracije [eGFR-estimated glomerular filtration rate] < 30 ml/min/1,73 m2) in pri bolnikih z boleznijo ledvic v končni fazi (ESRD-end stage renal disease), zaradi katere je potrebna hemodializa.
Treatment of patients with genotype 5 or 6 HCV infection 
Zdravljenje bolnikov z okužbo s HCV genotipa 5 ali 6
12 weeksb 
12 tednovb
What Sovaldi is and what it is used for 
Kaj vsebuje navodilo Kaj je zdravilo Sovaldi in za kaj ga uporabljamo
Cirrhosis n = number of patients with SVR12 response; N = total number of patients per group. 
Brez ciroze Ciroza n = število bolnikov z odzivom SVR12; N = skupno število bolnikov v skupini.
Sofosbuvir and GS-331007 exposures in adolescents aged 12 to <18 years were similar to those in adults from Phase 2/3 studies following administration of sofosbuvir (400 mg). 
Izpostavljenosti sofosbuvirju in GS-331007 pri mladostnikih, starih 12 do < 18 let, so bile podobne kot pri odraslih iz študij 2./3.
HCV genotype 3 
HCV genotipa 3
HIV/HCV co-infection 
Sočasna okužba z virusoma HIV in HCV
Patients with genotype 2 CHC 
Bolniki z genotipom 2 CHC
Common abdominal discomfort, constipation, dyspepsia constipation, dry mouth, gastroesophageal reflux 
dispepsija konstipacija, suha usta, gastroezofagealni refluks
Patients with HCV genotype 2 or 3 infection in the trial were treated with sofosbuvir with ribavirin for 12 or 24 weeks, respectively. 
Bolniki z okužbo s HCV genotipa 2 ali 3 v preskušanju so bili zdravljeni s sofosbuvirjem in ribavirinom 12 oz. 24 tednov.
Common pyrexia, asthenia chest pain, asthenia a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa. 
zelo pogosti utrujenost, razdražljivost mrzlica, utrujenost, gripi podobna bolezen, razdražljivost, bolečine, pireksija pogosti pireksija, astenija bolečine v prsih, astenija a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa
Treatment duration was 12 weeks in treatment-naïve patients with genotype 2 or 3 HCV infection, and 24 weeks in treatment-experienced patients with genotype 3 HCV infection, as well as patients with genotype 1 HCV infection. 
Zdravljenje je trajalo 12 tednov pri predhodno nezdravljenih bolnikih z okužbo s HCV genotipa 2 ali 3 in 24 tednov pri predhodno zdravljenih bolnikih z okužbo s HCV genotipa 3 in bolnikih z okužbo s HCV genotipa 1.
Sovaldi has been studied in combination with ribavirin, with or without peginterferon alfa. 
Zdravilo Sovaldi so proučili v kombinaciji z ribavirinom, s peginterferonom alfa ali brez njega.
If the other medicinal products used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued (see section 4.2). 
Ob trajni ukinitvi drugih zdravil, ki se uporabljajo v kombinaciji z zdravilom Sovaldi, je treba ukiniti tudi uporabo zdravila Sovaldi (glejte poglavje 4.4).
Based on population pharmacokinetic analysis in patients with genotypes 1 to 6 HCV infection (n = 986), steady-state AUC0-24 for sofosbuvir and GS-331007 was 1,010 ng•h/mL and 7,200 ng•h/mL, respectively. 
Na podlagi analize populacijske farmakokinetike pri bolnikih z okužbo s HCV genotipa 1 do 6 (n = 986) je bila vrednost AUC0-24 za sofosbuvir v stanju dinamičnega ravnovesja 1.010 ng•h/ml, za GS-331007 pa 7.200 ng•h/ml.
Patients should be informed that fatigue and disturbance in attention, dizziness and blurred vision have been reported during treatment with sofosbuvir in combination with peginterferon alfa and ribavirin (see section 4.8). 
Bolnikom je treba povedati, da so med zdravljenjem s sofosbuvirjem v kombinaciji s peginterferonom alfa in ribavirinom poročali o utrujenosti in motnji pozornosti, omotičnosti in zamegljenem vidu (glejte poglavje 4.8).
Sovaldi + ribavirin a for 24 weeks 
Sovaldi + ribavirin a 24 tednov
Sovaldi + ribavirin 
Zdravilo Sovaldi + ribavirin
• stomach discomfort, constipation, dry mouth, indigestion, acid reflux 
• nelagodje v trebuhu, zaprtost, suha usta, težave s prebavo, refluks kisline
Overall No cirrhosis Cirrhosis n = number of patients with SVR12 response; N = total number of patients per group. 
Brez cirozec Cirozac n = število bolnikov z odzivom SVR12; N = skupno število bolnikov v skupini.
HCV genotype 2 
HCV genotipa 2
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). 
Farmakokinetiko sofosbuvirja in GS-331007 so preučili pri bolnikih, okuženih s HCV, z ESRD, zaradi katere je potrebna dializa, zdravljenih z ledipasvirjem/sofosbuvirjem (n = 94) 8, 12 ali 24 tednov ali sofosbuvirjem/velpatasvirjem (n = 59) 12 tednov in primerjali z bolniki brez ledvične okvare v preskušanjih 2./3.
ANTIMYCOBACTERIALS Rifampicinf (600 mg single dose) 
Rifampicinf (600 mg enkratni odmerek)
Table 6: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin 
Preglednica 6: Neželeni učinki zdravila, identificirani pri sofosbuvirju v kombinaciji z ribavirinom ali s peginterferonom alfa in ribavirinom Pogostnost
Close monitoring is recommended if this medicinal product is administered with Sovaldi (see sections 4.4 and 4.8). 
Kadar se to zdravilo uporablja sočasno z zdravilom Sovaldi, se priporoča skrbno spremljanje (glejte poglavji 4.4 in 4.8).
Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes. 
UGT1A1 ali encimov CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in CYP2D6.
At baseline, two patients had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0-39.6). 
Ob izhodišču sta imela dva bolnika cirozo, povprečni eGFR pa je bil 24,9 ml/min
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). 
Bolniki so prejeli 400 mg sofosbuvirja in odmerek ribavirina na podlagi telesne mase (1.000 mg za bolnike s telesno maso < 75 kg ali 1.200 mg za bolnike s telesno maso ≥ 75 kg).
Table 1: Recommended co-administered medicinal product(s) and treatment duration for adults treated with Sovaldi combination therapy 
Preglednica 1: Priporočeno(a) zdravilo(a), ki se daje(jo) sočasno, in trajanje zdravljenja za odrasle, zdravljene s kombinirano terapijo z zdravilom Sovaldi Populacija bolnikov* Zdravljenje
Drug interaction information for Sovaldi with potential concomitant medicinal products is summarised in Table 5 below (where 90% confidence interval (CI) of the geometric least-squares mean (GLSM) 
Informacije o interakcijah med zdravili za zdravilo Sovaldi z možnimi sočasnimi zdravili so povzete v spodnji preglednici 5 (pri čemer je bil 90-odstotni interval zaupanja (IZ) razmerja geometričnega povprečja najmanjših kvadratov (GLSM-geometric least-squares mean) znotraj "↔", razširjenimi nad "↑" ali razširjenimi pod "↓" vnaprej določenih mej ekvivalentnosti).