natgillin/translations-raw huggingface dataset:
Interactions between Harvoni and other medicinal products Table 3 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined equivalence boundaries). 
V preglednici 3 je seznam ugotovljenih ali možnih klinično pomembnih interakcij med zdravili (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).
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue 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.
Table 15: Response rates (SVR12) in study SOLAR-1 LDV/SOF+RBV 12 weeks (n = 168) 
Preglednica 15: Stopnje odziva (SVR12) v študiji SOLAR-1 LDV/SOF+RBV 12 tednov (n = 168)
Harvoni + ribavirin for 12 weeks (see section 5.1). 
Zdravilo Harvoni + ribavirin 12 tednov (glejte poglavje 5.1).
The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault, median [range] CrCl 22 [17-29] mL/min). 
Farmakokinetiko ledipasvirja so preučili z enkratnim 90-miligramskim odmerkom ledipasvirja pri bolnikih, negativnih za HCV, s hudo ledvično okvaro (eGFR < 30 ml/min po metodi Cockcroft-Gault, mediana [razpon] CrCl 22 [17-29] ml/min).
Effect of baseline HCV resistance-associated variants on treatment outcome Genotype 1 
Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja
Table 17: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks 
Preglednica 17: Stopnje odziva (SVR12) pri bolnikih z okužbo z genotipom 3 (ELECTRON-2) LDV/SOF+RBV 12 tednov
Proton pump inhibitor doses comparable to omeprazole 20 mg can be administered simultaneously with Harvoni. 
Odmerke zaviralca protonske črpalke, primerljive z omeprazolom 20 mg, se lahko uporablja sočasno z zdravilom Harvoni.
Ledipasvir was not carcinogenic in the 6-month rasH2 transgenic mouse study at exposures up to 26-fold higher than human exposure. 
Ledipasvir v 6-mesečni študiji pri rasH2 transgenih miših pri izpostavljenosti, do 26-krat večji od izpostavljenosti pri človeku, ni bil kancerogen.
When used in combination with ribavirin, refer also to the Summary of Product Characteristics of ribavirin. 
Če se uporablja v kombinaciji z ribavirinom, glejte tudi povzetek glavnih značilnosti zdravila za ribavirin.
Only patients who demonstrated SVR12 or relapse were included in relapse analyses. 
V analize relapsa so bili vključeni samo bolniki, pri katerih so potrdili SVR12 ali relaps.
f. Staggered administration (12 hours apart) of atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate or darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate and Harvoni provided similar results. 
f. Uporaba z zamikom (12 ur kasneje) atazanavirja/ritonavirja + emtricitabina/dizoproksiltenofovirata fumarata ali darunavirja/ritonavirja + emtricitabina/dizoproksiltenofovirata fumarata in zdravila Harvoni je pokazala podobne rezultate.
Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin). 
Zdravila, ki so močni induktorji P-glikoproteina (P-gp) v črevesju (rifampicin, rifabutin, šentjanževka [Hypericum perforatum], karbamazepin, fenobarbital in fenitoin).
All patients were treatment-naïve to HCV therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy. 
Noben bolnik se predhodno ni zdravil zaradi HCV in noben ni imel ciroze, 26 % (13/50) bolnikov se predhodno ni zdravilo s protiretrovirusno terapijo proti HIV in 74 % (37/50) bolnikov je prejemalo sočasno protiretrovirusno terapijo proti HIV.
SVR rates for selected subgroups Patients with cirrhosis Previously treated patients with cirrhosis a. 8 patients with genotype 4 HCV infection were enrolled in the study with 8/8 achieving SVR12. 
Stopnje SVR za izbrane podskupine Bolniki s cirozo Predhodno zdravljeni bolniki s cirozo a. 8 bolnikov z okužbo HCV genotipa 4 je bilo vključenih v študijo, pri čemer jih je 8/8 doseglo SVR12.
Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis had no clinically relevant effect on the exposure to ledipasvir. 
Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza ni imela klinično pomembnega učinka na izpostavljenost ledipasvirju.
Change in MELD score: 53% (72/135) and 21% (28/135) had an improvement or no change of MELD score from baseline to post-treatment week 4, respectively; of the 35 patients whose MELD score was ≥ 15 at baseline, 63% (22/35) had a MELD score < 15 at post-treatment week 12. 
Sprememba rezultata MELD: 53 % (72/135) oziroma 21 % (28/135) je imelo izboljšanje ali nobene spremembe rezultata MELD od izhodišča do 4. tedna po zdravljenju; od 35 bolnikov, ki so imeli rezultat MELD ≥ 15 ob izhodišču, jih je imelo 63 % (22/35) rezultat MELD < 15 v 12. tednu po zdravljenju.
• carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures); 
• karbamazepin, fenobarbital in fenitoin (zdravila, ki se uporabljajo za zdravljenje epilepsije in preprečevanje epileptičnih napadov).
Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV 
Predhodno zdravljenje HCV PEG-IFN+RBV Zaviralec proteaze HCV + PEG-IFN+RBV
The three Phase 3 studies included one study conducted in non-cirrhotic treatment-naïve patients (ION-3); one study in cirrhotic and non-cirrhotic treatment-naïve patients (ION-1); and one study in cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). 
Tri študije 3. faze so vključevale eno študijo, opravljeno pri predhodno nezdravljenih bolnikih brez ciroze (ION-3), eno študijo, opravljeno pri predhodno nezdravljenih bolnikih s cirozo in brez ciroze (ION-1) in eno študijo, opravljeno pri bolnikih s cirozo in brez ciroze, pri katerih predhodno zdravljenje na podlagi interferona, vključno z režimi, ki so vključevali zaviralec proteaze HCV, ni bilo uspešno (ION-2).
For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 16). 
Za okužbo z genotipom 2, 4, 5 in 6 je bilo zdravljenje sestavljeno iz ledipasvirja/sofosbuvirja brez ribavirina in dajano 12 tednov (preglednica 16).
c. Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up). 
c. Med drugo so bili vključeni bolniki, ki niso dosegli SVR in niso izpolnjevali kriterijev za virološki neuspeh (npr. izgubljeni za spremljanje).
• rifapentine (antibiotic used to treat infections, including tuberculosis); 
• rifampicin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo),
For genotype 3 infection, ledipasvir/sofosbuvir was given with or without ribavirin, also for 12 weeks (Table 17). 
Za okužbo z genotipom 3 so ledipasvir/sofosbuvir dajali z ribavirinom ali brez njega, prav tako 12 tednov (preglednica 17).
Breast-feeding It is unknown whether ledipasvir or sofosbuvir and its metabolites are excreted in human milk. 
Ni znano, ali se ledipasvir ali sofosbuvir in njegovi presnovki izločajo v materino mleko.
Table 16: Response rates (SVR12) with ledipasvir/sofosbuvir for 12 weeks in patients with genotype 2, 4, 5 and 6 HCV infection 
Preglednica 16: Stopnje odziva (SVR12) z 12-tedenskim dajanjem ledipasvirja/sofosbuvirja bolnikom z okužbo s HCV z genotipom 2, 4, 5 in 6
Table 3: Interactions between Harvoni and other medicinal products Medicinal product by therapeutic areas 
Preglednica 3: Interakcije med zdravilom Harvoniin drugimi zdravili Zdravila po terapevtskih področjih
Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow FCF aluminium lake (E110) 
Filmska obloga: polivinilalkohol, titanov dioksid, makrogol 3350, smukec, sončno rumeno FCF (E110).
The clinical data to support the use of Harvoni in patients infected with HCV genotype 2 and 6 are limited (see section 5.1). 
Klinični podatki, ki bi podprli uporabo zdravila Harvoni pri bolnikih z okužbo s HCV genotipov 2 in 6, so omejeni (glejte poglavje 5.1).
Of 169 patients with decompensated cirrhosis (pre- or post-transplant CPT B or C), those patients who achieved SVR12 and had post-treatment week 12 laboratory data available (e.g. excluding patients who died, were transplanted, or had missing data at this time-point) were assessed for changes in their MELD and CPT scores. 
Od 169 bolnikov z dekompenzirano cirozo (CPT B ali C pred presaditvijo ali po njej) so spremembe rezultatov MELD in CPT ocenili pri bolnikih, ki so dosegli SVR12 in pri katerih so bili na voljo laboratorijski podatki v 12. tednu po zdravljenju (npr. izključili so bolnike, ki so umrli, pri katerih so opravili presaditev ali ni bilo podatkov na tej časovni točki).
Of the 8 genotype 1b patients who qualified for resistance testing, 7/8 (88%) harboured one or more NS5A RAVs at positions L31 and Y93 at failure, while 1/8 patients had no NS5A RAVs at failure. 
Od 8 bolnikov z genotipom 1b, ki so bili primerni za testiranje odpornosti, jih je bilo 7 od 8 (88 %) nosilcev enega ali več RAV NS5A na položajih L31 in Y93 ob neuspehu, medtem ko 1 od 8 bolnikov ob neuspehu ni imelo nobene RAV NS5A.
Co-administration of Harvoni with rosuvastatin may significantly increase the concentration of rosuvastatin (several fold-increase in AUC) which is associated with increased risk of myopathy, including rhabdomyolysis. 
Sočasno dajanje zdravila Harvoni z rosuvastatinom lahko značilno poveča koncentracijo rosuvastatina (večkrtano povečanje AUC), kar je povezano z večjim tveganjem za miopatijo, vključno z rabdomiolizo.
Harvoni contains the azo colouring agent sunset yellow FCF aluminium lake (E110), which may cause allergic reactions. 
Zdravilo Harvonivsebuje azobarvilo sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
Co-administration of Harvoni and HMG-CoA reductase inhibitors (statins) can significantly increase the concentration of the statin, which increases the risk of myopathy and rhabdomyolysis (see section 4.5). 
Sočasno dajanje zdravila Harvoniin zaviralcev reduktaze HMG-CoA (statinov) lahko značilno poveča koncentracijo statina, kar poveča tveganje za miopatijo in rabdomiolizo (glejte poglavje 4.5).
Patients with genotype 3 CHC Patients with compensated cirrhosis and/or prior treatment failure 
Bolniki s kompenzirano cirozo in/ali predhodno neuspešnim zdravljenjem
Relative to patients 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 bolniki z normalnim delovanjem ledvic (eGFR > 80 ml/min/1,73 m2) je bila vrednost AUC0-inf za sofosbuvir za 61 % višja pri bolnikih z blago, za 107 % pri bolnikih 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 %.
Median peak plasma concentration of GS-331007 was observed at 4 hours post-dose. 
Mediano najvišje koncentracije GS-331007 v plazmi so opazili 4 ure po odmerku.
The clinical data to support the use of Harvoni in patients infected with HCV genotype 3 are limited (see section 5.1). 
Klinični podatki, ki bi podprli uporabo zdravila Harvoni pri bolnikih z okužbo s HCV genotipa 3, so omejeni (glejte poglavje 5.1).
The medicinal product interactions described are based on studies conducted with either ledipasvir/sofosbuvir or ledipasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with ledipasvir/sofosbuvir. 
izvedenih z bodisi ledipasvirjem/sofosbuvirjem ali ledipasvirjem in sofosbuvirjem kot posameznimi učinkovinami ali so predvidene interakcije med zdravili, ki se lahko pojavijo z ledipasvirjem/sofosbuvirjem.
- Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks should be considered for previously treated patients with uncertain subsequent retreatment options (see section 4.4). 
- O 12 tednih zdravila Harvoni + ribavirina ali 24 tednih zdravila Harvoni (brez ribavirina) je treba razmisliti pri predhodno zdravljenih bolnikih z negotovo možnostjo za naknadno ponovno zdravljenje (glejte poglavje 4.4).
NS5B transient replicons Median (range) 
Stabilni replikoni prehodni replikoni NS5B mediana (razpon)
NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets 
IME ZDRAVILA Harvoni 90 mg/400 mg filmsko obložene tablete
When ledipasvir/sofosbuvir was studied with ribavirin, the most frequent adverse drug reactions to ledipasvir/sofosbuvir + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions. 
Ko so ledipasvir/sofosbuvir preučevali z ribavirinom, so bili najpogostejši neželeni učinki kombinirane terapije ledipasvirja/sofosbuvirja + ribavirina skladni z znanim profilom varnosti zdravljenja z ribavirinom,
Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat). 
Pokazalo se je, da zdravilo Harvoni poveča izpostavljenost tenofovirju, zlasti, če se uporablja skupaj z režimom proti HIV, ki vsebuje dizoproksiltenofovirat fumarat in farmakokinetični ojačevalec
In a pooled analysis of patients who received ledipasvir/sofosbuvir in Phase 3 studies (ION-3, ION-1 and ION-2), 37 patients (29 with genotype 1a and 8 with genotype 1b) qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA > 1,000 IU/mL. 
V združeni analizi bolnikov, ki so prejeli ledipasvir/sofosbuvir v študijah 3. faze (ION-3, ION-1 in ION-2), je bilo 37 bolnikov (29 z genotipom 1a in 8 z genotipom 1b) primernih za analizo odpornosti zaradi virološkega neuspeha ali predčasne prekinitve uporabe preiskovanega zdravila in zaradi
Otherb 
Drugoc
• Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110” 
• Povejte zdravniku, če ste alergični na barvilo sončno rumeno FCF (E110) preden uporabite to zdravilo.
Taking Harvoni with any of these may make Harvoni work less well or make any side effects of the medicines worse. 
Jemanje zdravila Harvoni s katerim koli od teh zdravil lahko povzroči, da bo morda zdravilo Harvoni slabše delovalo ali pa se bodo kateri od neželenih učinkov zdravila okrepili.
Concentrations of ledipasvir, sofosbuvir and simeprevir are increased when simeprevir is co-administered with Harvoni. 
Koncentracije ledipasvirja, sofosbuvirja in simeprevirja se povečajo pri sočasnem dajanju simeprevirja z zdravilom Harvoni.
24% (4/17)e a. These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms. 
Da e a. Ti 4 bolniki brez ciroze z relapsom so imeli izhodiščne z odpornostjo povezane polimorfizme NS5A.
There are presently no data to support the effectiveness of retreatment of patients who have failed ledipasvir/sofosbuvir with a subsequent regimen that contains an NS5A inhibitor. 
Trenutno ni na voljo podatkov, ki bi podprli učinkovitost ponovnega zdravljenja z naknadnim režimom, ki vključuje zaviralca NS5A, pri bolnikih,
Genotype Genotype 1a Genotype 1b a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment. 
Genotip Genotip 1a Genotip 1b a. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
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. 
Farmakokinetiko sofosbuvirja so preučili pri bolnikih, negativnih za HCV, z blago (eGFR ≥ 50 in < 80 ml/min/1,73 m2), zmerno (eGFR ≥ 30 in < 50 ml/min/1,73m2) in hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) ter pri bolnikih z ESRD, zaradi katere bolnik potrebuje hemodializo, po enkratnem 400-miligramskem odmerku sofosbuvirja.
No dose adjustment of Harvoni or abacavir/ lamivudine is required. 
Odmerka zdravila Harvoni ali abakavirja/ lamivudina ni treba prilagajati.
Similarly, there are presently no data to support the effectiveness of NS3/4A protease inhibitors in patients who previously failed prior therapy that included an NS3/4A protease inhibitor. 
Podobno trenutno ni na voljo podatkov, ki bi podprli učinkovitost zaviralcev proteaze NS3/4A pri bolnikih, pri katerih zdravljenje,
Change in CPT: 59% (79/133) and 34% (45/133) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 39 patients who had CPT C cirrhosis at baseline, 56% (22/39) had CPT B cirrhosis at post-treatment week 12; of the 99 patients who had CPT B cirrhosis at baseline, 29% (27/92) had CPT A cirrhosis at post-treatment week 12. 
Sprememba rezultata CPT: 59 % (79/133) oziroma 34 % (45/133) je imelo izboljšanje ali nobene spremembe rezultatov CPT od izhodišča do 12. tedna po zdravljenju; od 39 bolnikov s cirozo CPT C ob izhodišču jih je imelo 56 % (22/39) cirozo CPT B v 12. tednu po zdravljenju; od 99 bolnikov s cirozo CPT B ob izhodišču jih je imelo 29 % (27/92) cirozo CPT A v 12. tednu po zdravljenju.
Clinically significant medicinal product interactions with ledipasvir/sofosbuvir mediated by CYP450s or UGT1A1 enzymes are not expected. 
Klinično pomembnih medsebojnih delovanj z ledipasvirjem/sofosbuvirjem, pri katerih bi posredovali encimi CYP450 ali
• St. John's wort (Hypericum perforatum - herbal medicine used to treat depression); 
• šentjanževka (Hypericum perforatum - zdravilo rastlinskega izvora, ki se uporablja za zdravljenje depresije),
Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate 
Jedro tablete: kopovidon, laktoza monohidrat, mikrokristalna celuloza, premrežen natrijev karmelozat, koloidni brezvodni silicijev dioksid, magnezijev stearat.
Not interpretable a. Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype. 
Razlaga ni mogoča a. Dva bolnika v skupini 12-tedenskega zdravljenja z LDV/SOF, en bolnik v skupini 12-tedenskega zdravljenja z LDV/SOF+RBV, dva bolnika v skupini 24-tedenskega zdravljenja z LDV/SOF in dva bolnika v skupini 24-tedenskega zdravljenja z LDV/SOF+RBV niso imeli potrjenega podtipa genotipa 1.
including those with cirrhosis (randomised 1:1:1:1). 
CHC genotipa 1, vključno s tistimi s cirozo (randomiziranih v razmerju 1:1:1:1).
In the SOLAR-1 study (see “Clinical efficacy and safety”, below) 13 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with ribavirin. 
V študiji SOLAR-1 (glejte spodnje poglavje »Klinična učinkovitost in varnost«) so pri 13 bolnikih z okužbo genotipa 1 opazili relaps po zdravljenju z ledipasvirjem/sofosbuvirjem z ribavirinom.
Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant The efficacy of ledipasvir/sofosbuvir in genotype 5 and genotype 6 HCV-infected patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant has not been investigated. 
Učinkovitosti ledipasvirja/sofosbuvirja pri bolnikih, okuženih s HCV genotipa 5 in genotipa 6 z dekompenzirano cirozo, in/ali pri bolnikih, ki čakajo na presaditev jeter ali bolnikih po presaditvi jeter, niso preučevali.
In vitro potential for ledipasvir/sofosbuvir to affect other medicinal products At concentrations achieved in the clinic, ledipasvir is not an inhibitor of hepatic transporters including the OATP 1B1 or 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug and toxic compound extrusion (MATE) 1 transporter, multidrug resistance protein (MRP) 2 or MRP4. 
V klinično doseženih koncentracijah ledipasvir ni zaviralec jetrnih prenašalcev, vključno z OATP 1B1 ali 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, prenašalca za ekstruzijo več zdravil in toksičnih spojin (MATE-multidrug and toxic compound extrusion) 1, beljakovine z odpornostjo proti več zdravilom
Skin and subcutaneous tissue disorders: Common rash 
Bolezni kože in podkožja: pogosti izpuščaj
Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions. 
Ledipasvir je zaviralec HCV, ki deluje na beljakovino HCV NS5A, ki je bistvena za replikacijo RNA
Ledipasvir AUC is dose proportional over the dose range of 3 to 100 mg. Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg. 
Vrednosti AUC za sofosbuvir in GS-331007 sta skoraj sorazmerni z odmerkom v razponu odmerka od 200 mg do 400 mg.
Elimination Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%). 
Po enkratnem 90-miligramskem peroralnem odmerku [14C]-ledipasvirja je bil povprečni skupni delež [14C]-radioaktivnosti, ki so jo izolirali v blatu in urinu, 87 %, pri čemer so večino radioaktivnega odmerka izolirali v blatu (86 %).
Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1 
Predhodno nezdravljeni odrasli s cirozo ali brez nje - ION-1 (študija 0102) - genotip 1
In vitro ledipasvir inhibits intestinal CYP3A4 and UGT1A1. 
CYP3A4 in UGT1A1 v črevesju.
For the combination of tenofovir/emtricitabine + darunavir/ritonavir, please see below. 
Za kombinacijo tenofovirja/emtricitabina + darunavirja/ritonavirja glejte spodaj.
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.
GT n TE 
GT n PZa
Patients receiving Harvoni concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovirassociated adverse reactions. 
Bolnike, ki prejemajo zdravilo Harvonisočasno z elvitegravirjem/kobicistatom/emtricitabinom/dizoproksiltenofovirat fumaratomali s dizoproksiltenofoviratom fumaratom in okrepljenim zaviralcem proteaze HIV, je treba spremljati za pojav s tenofovirjem povezanih neželenih učinkov.
Dose modification of ribavirin in patients taking 1,000-1,200 mg daily If Harvoni is used in combination with ribavirin and 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. 
Če se zdravilo Harvoni uporablja v kombinaciji z ribavirinom in ima bolnik resne neželene učinke, ki so morebiti povezani z ribavirinom, je treba odmerek ribavirina prilagoditi ali ukiniti, kakor je ustrezno, dokler ni neželeni učinek odpravljen ali postane manj resen.