natgillin/translations-raw huggingface dataset:
Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Kolloid vandfri silica Magnesiumstearat 
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Ledipasvirs farmakokinetik blev undersøgt efter en enkelt dosis af 90 mg ledipasvir hos HCV-negative patienter med svært nedsat leverfunktion (CPT klasse C). 
The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe hepatic impairment (CPT class C).
SIRIUS inkluderede patienter med kompenseret cirrose, hvor behandling med pegyleret interferon (PEG-IFN) + ribavirin først svigtede, og hvor et regime bestående af et pegyleret interferon + ribavirin + en NS3/4A proteasehæmmer dernæst svigtede. 
SIRIUS included patients with compensated cirrhosis who first failed therapy with pegylated interferon (PEG-IFN) + ribavirin, and then failed a regimen consisting of a pegylated interferon + ribavirin + an NS3/4A protease inhibitor.
Ledipasvir var fuldt aktiv over for substitutionen S282T i NS5B, som er forbundet med resistens over for sofosbuvir, mens alle substitutioner forbundet med resistens over for ledipasvir i NS5A var helt følsomme over for sofosbuvir. 
Ledipasvir was fully active against the sofosbuvir resistance-associated substitution S282T in NS5B while all ledipasvir resistance-associated substitutions in NS5A were fully susceptible to sofosbuvir.
Alle 5 patienter, der ikke opnåede SVR12, recidiverede, efter de havde et respons efter afslutning af behandlingen (se pkt. 
All 5 patients who did not achieve SVR12 relapsed after having end-of-treatment response (see section “Resistance” - “In clinical studies” above).
Tenofovirdisoproxilfumarats sikkerhed ved anvendelse af Harvoni og en farmakokinetisk forstærker er ikke klarlagt. 
The safety of tenofovir disoproxil fumarate in the setting of Harvoni and a pharmacokinetic enhancer has not been established.
Det kan være nødvendigt, at din læge giver dig et andet lægemiddel, eller justerer dosis af det lægemiddel, du tager. 
Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking.
Patienter efter levertransplantation uden cirrose eller med kompenseret cirrose 
Patients who are post-liver transplant without cirrhosis or with compensated cirrhosis
Ledipasvir/sofosbuvirs virkning er ikke blevet undersøgt hos HCV-genotype 5- og 6-inficerede patienter med dekompenseret cirrose, og/eller som venter på levertransplantation eller har gennemgået en levertransplantation. 
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.
Ledipasvir (90 mg én gang dagligt) 
Ledipasvir (90 mg once daily)
• ydre kartoner indeholdende 1 tabletbeholder med 28 filmovertrukne tabletter 
• outer cartons containing 1 bottle of 28 film-coated tablets
Virkningen af ledipasvir [LDV]/sofosbuvir [SOF] blev evalueret i tre åbne fase 3-studier med data tilgængelige hos i alt 1.950 patienter med CHC forårsaget af infektion med HCV af genotype 1. 
The efficacy of ledipasvir [LDV]/sofosbuvir [SOF] was evaluated in three open-label Phase 3 studies with data available for a total of 1,950 patients with genotype 1 CHC.
d. Interval på 70-143 %, hvor der ikke opstår farmakokinetisk interaktion. 
d Lack of pharmacokinetics interaction bounds 70-143%.
Farmakokinetikken af ledipasvir, sofosbuvir og GS-331007 hos pædiatriske patienter i alderen < 12 år er ikke klarlagt (se pkt. 
The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 have not been established in paediatric patients aged < 12 years (see section 4.2).
Antacida f.eks. Aluminium- eller magnesiumhydroxid, calciumcarbonat 
Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Hjertearytmier 
Cardiac arrhythmias
Hvid 
White
Det skal du vide, før du begynder at tage Harvoni Tag ikke Harvoni 
What you need to know before you take Harvoni Do not take Harvoni
Ud af de 8 genotype 1b-patienter, som kvalificerede for resistenstestning havde 7/8 (88 %) en eller flere NS5A-RAVs ved positionerne L31 og Y93 ved tidspunktet for svigt, mens 1/8 patienter ikke havde NS5A-RAVs, ved tidspunktet for svigt. 
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.
EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T og Y93C/F/H/N/S for genotype 1a HCV-infektion og L31I/F/M/V, P32L, P58D, A92K og Y93C/H/N/S for genotype 1b HCV-infektion). 
EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
Alle patienter var behandlingsnaive med hensyn til HCV-behandling uden cirrose, 26 % (13/50) af patienterne var naive med hensyn til hiv-antiretrovirale midler, og 74 % (37/50) af patienterne fik samtidig antiretroviral behandling mod hiv. 
therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy.
Blandt de 8 patienter, som ikke havde NS5A-RAVs ved tidspunktet for svigt, fik 7 patienter 8 ugers behandling (n = 3 med ledipasvir/sofosbuvir, n = 4 med ledipasvir/sofosbuvir + ribavirin) og 1 patient fik ledipasvir/sofosbuvir i 12 uger. 
Among the 8 patients who had no NS5A RAVs at failure, 7 patients received 8 weeks of treatment (n = 3 with ledipasvir/sofosbuvir; n = 4 with ledipasvir/sofosbuvir + ribavirin) and 1 patient received ledipasvir/sofosbuvir for 12 weeks.
Når Harvoni anvendes i kombination med ribavirin, skal der udvises ekstrem forsigtighed, så graviditet undgås hos kvindelige patienter og hos mandlige patienters kvindelige partnere. 
Women of childbearing potential / contraception in males and females When Harvoni is used in combination with ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Vejledning vedrørende dosering af ribavirin ved administration sammen med Harvoni til unge i alderen 12 til < 18 år. 
Table 3: Guidance for ribavirin dosing when administered with Harvoni to adolescents aged 12 to < 18 years.
Andelen af patienter, som seponerede behandlingen permanent på grund af bivirkninger, var 0 %, <1 % og 1 % for patienter, som fik ledipasvir/sofosbuvir i hhv. 8, 12 og 24 uger, og <1 %, 0 % og 2 % for patienter, som fik kombinationsbehandling med ledipasvir/sofosbuvir + ribavirin i hhv. 8, 12 og 24 uger. 
The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
SEDATIVER/HYPNOTIKA Midazolam (2,5 mg enkeltdosis)/ ledipasvir (90 mg enkeltdosis) 
SEDATIVES/HYPNOTICS Midazolam (2.5 mg single dose)/ ledipasvir (90 mg single dose)
b. Ikke manglende FibroTest-resultater blev kortlagt til Metavir-scores i henhold til: 0-0,31 = F0-F1, 0,32-0,58 = F2, 0,59-1,00 = F3-F4. 
b Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2; 0.59-1.00 = F3-F4.
Ingen dosisjustering af Harvoni eller ciclosporin er nødvendig ved påbegyndelse af samtidig administration. 
No dose adjustment of Harvoni or ciclosporin is required at initiation of co-administration.
Copovidon, lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid vandfri silica, magnesiumstearat 
Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
ANTIKONVULSIVA Phenytoin 
ANTICONVULSANTS Phenobarbital Phenytoin
Ved administration sammen med Harvoni skal en reduceret dosis af statiner overvejes, og der skal udføres en nøje overvågning for statinbivirkninger (se pkt. 
When co-administered with Harvoni, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 4.4).
Patienter med diabetes kan opleve forbedret blodsukkerkontrol efter påbegyndelse af HCV-behandling med direkte virkende antivirale lægemidler, hvilket potentielt kan resultere i symptomatisk hypoglykæmi. 
Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct-acting antiviral treatment.
Eksponeringen for sofosbuvirs metabolit GS-331007 var i dette studie 20 gange højere, hvilket oversteg de niveauer, hvor der blev set bivirkninger i prækliniske forsøg. 
In this setting, exposure of sofosbuvir metabolite GS331007 is 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials.
I en samlet analyse af patienter, som fik ledipasvir/sofosbuvir i fase 3-studier (ION-3, ION-1 og ION-2), kvalificerede 37 patienter (29 med genotype 1a og 8 med genotype 1b) sig til resistensanalyse på grund af virologisk svigt eller tidlig seponering af studielægemidlet, samt at de havde HCV-rna >1.000 IE/ml. 
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.
Farmakokinetikken af ledipasvir, sofosbuvir og GS-331007 blev undersøgt hos HCV-inficerede patienter med ESRD, der krævede dialyse, og som blev behandlet med ledipasvir/sofosbuvir (n=94) i 8, 12 eller 24 uger, og sammenlignet med patienter uden nedsat nyrefunktion i fase II-/III-studierne med ledipasvir/sofosbuvir. 
The pharmacokinetics of ledipasvir, 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, and compared to patients without renal impairment in the ledipasvir/sofosbuvir Phase 2/3 trials.
In vitro resistensudvælgelse og krydsresistensstudier indikerer, at ledipasvirs virkningsmåde er målrettet mod ledipasvir. 
In vitro resistance selection and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action.
Hos HCV-inficerede patienter med svært nedsat nyrefunktion, behandlet med ledipasvir/sofosbuvir i 12 uger (n=18), var farmakokinetiken for ledipasvir, sofosbuvir og GS-331007 i overensstemmelse med, hvad der blev observeret hos HCV-negative patienter med svært nedsat nyrefunktion. 
In HCV-infected patients with severe renal impairment treated with ledipasvir/sofosbuvir for 12 weeks (n = 18), the pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Ved genotype 2-, 4-, 5- og 6-infektion bestod behandlingen af ledipasvir/sofosbuvir uden ribavirin i 12 uger (tabel 18). 
For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 18).
Tenofovirdisoproxilfumarats sikkerhed ved anvendelse af Harvoni og en farmakokinetisk forstærker (f.eks. ritonavir eller cobicistat) er ikke klarlagt. 
The safety of tenofovir disoproxil fumarate in the setting of Harvoni and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
De kliniske data, der støtter brug af Harvoni hos voksne inficeret med HCV-genotype 3 er begrænsede (se pkt. 
The clinical data to support the use of Harvoni in adults infected with HCV genotype 3 are limited (see section 5.1).
Hos patienter, hvor behandlingen med ledipasvir/sofosbuvir svigter, ses der i de fleste tilfælde en udvælgelse af NS5A-resistensmutationer, der reducerer følsomheden over for ledipasvir betragteligt (se pkt. 
In patients who fail treatment with ledipasvir/sofosbuvir, selection of NS5A resistance mutations that substantially reduce the susceptibility to ledipasvir is seen in the majority of cases (see section 5.1).
I ALT (n = 440) 
TOTAL (n = 440)
Ingen dosisjustering af Harvoni eller tacrolimus er nødvendig ved påbegyndelse af samtidig administration. 
No dose adjustment of Harvoni or tacrolimus is required at initiation of co-administration.
Hvis du er i tvivl med hensyn til at tage andre lægemidler, skal du kontakte lægen eller apotekspersonalet. 
If you are not sure about taking any other medicines, talk to your doctor or pharmacist.
Hæmoglobin hos patienter med tidligere stabil hjertesygdom 
Haemoglobin in patients with history of stable cardiac disease
Harvoni er kontraindiceret sammen med phenobarbital og phenytoin (se pkt. 
Harvoni is contraindicated with phenobarbital and phenytoin (see section 4.3).
Blandt levertransplanterede patienter med kompenseret leversygdom eller patienter med dekompenseret leversygdom enten før eller efter transplantation (studierne SOLAR-1 og SOLAR-2) var recidiv forbundet med detektion af en eller flere af følgende NS5A RAV'er: K24R, M28T, Q30R/H/K, L31V, H58D og Y93H/C hos 12/14 genotype 1a-patienter, og L31M, Y93H/N hos 6/6 genotype 1b-patienter. 
Among post-transplant patients with compensated liver disease or patients with decompensated liver disease either pre- or post-transplant (SOLAR-1 and SOLAR-2 studies), relapse was associated with the detection of one or more of the following NS5A RAVs: K24R, M28T, Q30R/H/K, L31V, H58D and Y93H/C in 12/14 genotype 1a patients, and L31M, Y93H/N in 6/6 genotype 1b patients.
Patienter med kompenseret cirrose 
Patients with compensated cirrhosis
Sunset yellow FCF aluminiumpigment (E110) 
Sunset yellow FCF aluminium lake (E110)
Der rådes til forsigtighed, samt overvågning af terapeutiske koncentrationer af digoxin ved administration sammen med Harvoni. 
Caution is warranted and therapeutic concentration monitoring of digoxin is recommended when co-administered with Harvoni.
HCV-proteasehæmmer + PEG-IFN+RBV 
HCV protease inhibitor + PEG-IFN+RBV
Patienter, der får Harvoni administreret sammen med elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat eller med tenofovirdisoproxilfumarat og en boostet hiv proteasehæmmer, bør overvåges for tenofovirassocierede bivirkninger. 
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.
Efter en enkelt 90 mg dosis af [14C]-ledipasvir hos raske personer, var forholdet af [14C]-radioaktivitet mellem blod og plasma fra 0,51 til 0,66. 
After a single 90 mg dose of [14C]-ledipasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.51 and 0.66.
Efter en enkelt 90 mg oral dosis af [14C]-ledipasvir, var den gennemsnitlige totale genfinding af [14C]-radioaktivitet i fæces og urin 87 %, hvoraf størstedelen af den radioaktive dosis blev genfundet i fæces (86 %). 
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%).
b. Ikke manglende FibroTest-resultater blev kortlagt til Metavir-scores i henhold til: 0-0,31 = F0-F1, 0,32-0,58 = F2, 
b Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2;
AUC og Cmax for ledipasvir var hhv. 77 % og 58 % højere hos kvinder end hos mænd. 
AUC and Cmax of ledipasvir were 77% and 58% higher, respectively, in females than males; however, the relationship between gender and ledipasvir exposures was not considered clinically relevant.
Oxcarbazepin 
Oxcarbazepine
Alder (år): median (interval) 52 (18-75) Køn: Mand Race: Sort/amerikaner med afrikansk herkomst Hvid Genotype 1aa IL28CC-genotype FibroTest-bestemt Metavir-scoreb F0-F1 F2 F3-F4 Kan ikke fortolkes a. To patienter i behandlingsarmen med 12-ugers LDV/SOF, en patient i behandlingsarmen med 12-ugers LDV/SOV + RBV, to patienter i behandlingsarmen med 24-ugers LDV/SOF og to patienter i behandlingsarmen med 24-ugers LDV/SOF+RBV havde ikke en bekræftet genotype 1-undertype. 
Age (years): median (range) Male gender Race: Black/ African American White Genotype 1aa IL28CC genotype FibroTest-Determined Metavir scoreb F0-F1 F2 F3-F4 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.
Hæmoglobin hos patienter uden hjertesygdom 
Haemoglobin in patients with no cardiac disease
Harvoni er indiceret til behandling af kronisk hepatitis C (CHC) hos voksne og unge i alderen 12 til < 18 år (se pkt. 
Harvoni is indicated 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).
Administration af Harvoni sammen med HMG-CoA reductasehæmmere (statiner) kan forhøje koncentrationen af statin signifikant, hvilket øger risikoen for myopati og rhabdomyolyse (se pkt. 
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).
Substitutionen S282T, som er forbundet med resistens over for sofosbuvir, blev ikke detekteret i baseline-NS5B-sekvensen hos nogen af patienterne i fase 3-studier ved populationssekventering eller dyb sekventering. 
The sofosbuvir resistance-associated substitution S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies by population or deep sequencing.
Ud af de 29 genotype 1apatienter, som kvalificerede for resistenstestning havde 22/29 (76 %) patienter en eller flere NS5A-RAVs ved positionerne K24, M28, Q30, L31, S38 og Y93 ved tidspunktet for svigt, mens de resterende 7/29 patienter ikke havde NS5A-RAVs, der kunne detekteres ved tidspunktet for svigt. 
Of the 29 genotype 1a patients who qualified for resistance testing, 22/29 (76%) patients harboured one or more NS5A RAVs at positions K24, M28, Q30, L31, S38 and Y93 at failure, while the remaining 7/29 patients had no NS5A RAVs detected at failure.
Harvonis sikkerhed og virkning hos unge i alderen 12 til <18 år er baseret på data fra et fase 2, ikkeblindet klinisk studie (Studie 1116), der inkluderede 100 patienter med genotype 1 HCV-infektion, som blev behandlet med ledipasvir/sofosbuvir i 12 uger. 
The safety and efficacy of Harvoni in adolescents aged 12 to < 18 years is based on data from a Phase 2, open-label clinical study (Study 1116) that enrolled 100 patients with genotype 1 HCV infection who were treated with ledipasvir/sofosbuvir for 12 weeks.
Administration af Harvoni sammen med rosuvastatin kan forhøje koncentrationen af rosuvastatin signifikant (AUC mange gange større), hvilket er forbundet med en øget risiko for myopati, herunder rhabdomyolyse. 
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.
40 patienter med genotype 4 CHC indgik i studierne SOLAR-1 og SOLAR-2, SVR 12 var 92 % (11/12) og 100 % (10/10) hos levertransplanterede patienter uden dekompenseret cirrose og 60 % (6/10) og 75 % (6/8) hos patienter med dekompenseret cirrose (før og efter levertransplantation) behandlet i hhv. 12 eller 24 uger. 
Forty patients with genotype 4 CHC were enrolled in SOLAR-1 and SOLAR-2 studies, SVR12 were 92% (11/12) and 100% (10/10) in post-transplant patients without decompensated cirrhosis and 60% (6/10) and 75% (6/8) in patients with decompensated cirrhosis (pre- and post-liver transplantation) treated for 12 or 24 weeks, respectively.
Blandt levertransplanterede patienter med kompenseret leversygdom (studierne SOLAR-1 og SOLAR-2) forekom der ikke recidiv hos patienter med baseline-NS5A RAV'er (n = 23) efter 12 ugers behandling med ledipasvir/sofosbuvir + ribavirin. 
Among post-transplant patients with compensated liver disease (SOLAR-1 and SOLAR-2 studies), no relapse occurred in patients with baseline NS5A RAVs (n = 23) following 12 weeks of treatment with ledipasvir/sofosbuvir + ribavirin.
Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerer, at cirrose (inklusive dekompenseret cirrose) ikke havde nogen klinisk relevant virkning på eksponeringen for sofosbuvir og GS-331007. 
Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Der er ikke blevet observeret nogen signifikante virkninger med ledipasvir eller sofosbuvir på fosterudviklingen hos rotter og kaniner. 
No significant effects on foetal development have been observed with ledipasvir or sofosbuvir in rats and rabbits.
Patienter med cirrose 
Patients with cirrhosis
Ingen dosisjustering er nødvendig. 
No dose adjustment required.
Virkningen af ledipasvir/sofosbuvir hos HCV-inficerede unge i alderen 12 til < 18 år blev vurderet i et fase 2, ikke-blindet klinisk studie, der inkluderede 100 patienter med genotype 1 CHC (Studie 1116). 
The efficacy of ledipasvir/sofosbuvir in HCV infected adolescents aged 12 to < 18 years was evaluated in a Phase 2, open label clinical study that enrolled 100 patients with genotype 1 CHC (Study 1116).
↔ Ciclosporin 
↑ Ledipasvir ↔ Ciclosporin
Ledipasvir var ikke genotoksisk i et arsenal af in vitro- eller in vivo-analyser, herunder bakteriel mutagenicitet, kromosomafvigelse med lymfocytter fra humant perifert blod og in vivo mikronukleusanalyser hos rotter. 
Ledipasvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Demografi og baselinekarakteristika var afbalanceret på tværs af behandlingsgrupperne. 
Demographics and baseline characteristics were balanced across the treatment groups.
Derfor må Harvoni ikke anvendes under amning. 
Therefore, Harvoni should not be used during breast-feeding.
• ydre kartoner indeholdende 3 tabletbeholdere med 28 (84) filmovertrukne tabletter. 
• outer cartons containing 3 bottles of 28 (84) film-coated tablets.
Sofosbuvir var ikke genotoksisk i et arsenal af in vitro- eller in vivo-analyser, herunder bakteriel mutagenicitet, kromosomafvigelse med lymfocytter fra humant perifert blod og in vivo mikronukleusanalyser hos mus. 
Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Der blev ikke identificeret nogen klinisk relevante farmakokinetiske forskelle, der skyldes race, for ledipasvir, sofosbuvir eller GS-331007. 
No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007.
(Øget pH-værdi i maven) 
(Increase in gastric pH)
Tidligere HCV-behandling PEG-IFN+RBV HCV-proteasehæmmer + PEG-IFN+RBV 
Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV
Harvoni kan anvendes hos disse patienter uden dosisjustering, når ingen andre relevante behandlingsmuligheder er tilgængelige (se pkt. 
Harvoni 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).
Administration af Harvoni sammen med rosuvastatin er kontraindiceret (se pkt. 
Co-administration of Harvoni with rosuvastatin is contraindicated (see section 4.3).