natgillin/translations-raw huggingface dataset:
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. 
Kad se Harvoni primjenjuje u kombinaciji s ribavirinom, potreban je krajnji oprez kako bi se izbjegla trudnoća u pacijentica i partnerica muških pacijenata.
Description 
OZNAČAVANJE
What Harvoni looks like and contents of the pack The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side. 
Filmom obložene tablete narančaste su tablete u obliku dijamanta, s utisnutim “GSI” na jednoj strani i “7985” na drugoj strani.
Do not breast-feed during treatment with Harvoni. 
Nemojte dojiti tijekom liječenja lijekom Harvoni.
Patients who are post-liver transplant without cirrhosis or with compensated cirrhosis 
Pacijenti poslije transplantacije jetre bez ciroze ili s kompenziranom cirozom
If a dose is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time. 
Ako se propusti uzeti dozu, a još nije proteklo 18 sati od uobičajenog vremena uzimanja, pacijentima treba savjetovati da uzmu tabletu čim prije i zatim uzmu sljedeću dozu u uobičajeno vrijeme.
Outcome for patients without SVR On-treatment virologic failure 0/215 Relapsea 
Virološki neuspjeh uz liječenje 0/215
Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with ledipasvir/sofosbuvir. 
Plazmatske koncentracije spojeva koji su supstrati ovih enzima mogu biti snižene kad se oni primjenjuju istovremeno s ledipasvirom/sofosbuvirom.
The efficacy of Harvoni (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. 
Djelotvornost lijeka Harvoni (ledipasvir [LDV]/sofosbuvir [SOF]) bila je procijenjena u tri otvorena ispitivanja faze 3 s podacima dostupnima za ukupno 1950 pacijenata s CHC-om uzrokovanim genotipom
The clinical data to support the use of Harvoni in patients infected with HCV genotype 2 and 6 are limited (see section 5.1). 
Klinički podaci koji podupiru primjenu lijeka Harvoni u pacijenata zaraženih HCV-om genotipa 2 i 6 su ograničeni (vidjeti dio 5.1).
Harvoni + ribavirin for 12 weeks (see section 5.1). 
Harvoni s ribavirinom tijekom 12 tjedana (vidjeti dio 5.1).
Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 80 years) analysed, age did not have a clinically relevant effect on the exposure to ledipasvir, sofosbuvir or GS-331007. 
Starije osobe Analiza populacijske farmakokinetike u pacijenata zaraženih HCV-om pokazala je da unutar analiziranog raspona dobi (18 do 80 godina), dob nije imala klinički važan učinak na izloženost ledipasviru, sofosbuviru ili GS-331007.
HCV replicons with reduced susceptibility to ledipasvir have been selected in cell culture for genotype 1a and 1b. 
U staničnoj kulturi Replikoni HCV-a sa smanjenom osjetljivošću na ledipasvir odabrani su u staničnoj kulturi za genotip 1a i 1b.
The highest documented doses of ledipasvir and sofosbuvir were 120 mg twice daily for 10 days and a single dose of 1,200 mg, respectively. 
4.9 Predoziranje Najviše zabilježene doze bile su 120 mg ledipasvira dvaput na dan tijekom 10 dana i jedna doza sofosbuvira od 1200 mg.
SVR was achieved in all 24 patients (n = 20 with L159F+C316N; n = 1 with L159F; and n = 3 with N142T) who had baseline variants associated with resistance to NS5B nucleoside inhibitors. 
SVR je postignut u sva 24 pacijenta (n = 20 s L159F+C316N; n = 1 s L159F; i n = 3 s N142T) koji su na početku imali varijante povezane s rezistencijom na NS5B nukleozidne inhibitore.
Esomeprazolee 
Esomeprazole
For genotype 3 infection, ledipasvir/sofosbuvir was given with or without ribavirin, also for 12 weeks (Table 17). 
Za infekciju genotipom 3, ledipasvir/sofosbuvir davao se s ribavirinom ili bez njega također 12 tjedana (tablica 17).
The safety assessment of ledipasvir/sofosbuvir is based on pooled data from three Phase 3 clinical studies (ION-3, ION-1 and ION-2) including 215, 539 and 326 patients who received ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and 216, 328 and 328 patients who received ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively. 
Procjena sigurnosti ledipasvira/sofosbuvira temelji se na objedinjenim podacima iz tri klinička ispitivanja faze 3 (ION-3, ION-1 i ION-2) u koja je bilo uključeno 215, 539 odnosno 326 pacijenata koji su primali ledipasvir/sofosbuvir tijekom 8, 12 odnosno 24 tjedna; te 216, 328 odnosno 328 pacijenata koji su primali kombiniranu terapiju ledipasvirom/sofosbuvirom
No dose adjustment of Harvoni is required for patients with mild or moderate renal impairment. 
Nije potrebna prilagodba doze lijeka Harvoni u pacijenata s blagim ili umjerenim oštećenjem bubrega.
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. 
Pacijenti s dekompenziranom cirozom i/ili koji čekaju transplantaciju jetre ili poslije transplantacije jetre Djelotvornost ledipasvira/sofosbuvira u pacijenata zaraženih genotipom 5 i genotipom 6 HCV-a s dekompenziranom cirozom i/ili onih koji čekaju transplantaciju jetre ili poslije transplantacije jetre nije ispitana.
Decreases in haemoglobin to < 10 g/dL and < 8.5 g/dL during treatment were experienced by 39% and 13% of patients treated with ledipasvir/sofosbuvir with ribavirin, respectively. 
Tijekom liječenja, hemoglobin se snizio na < 10 g/dl u 39 % odnosno na < 8,5 g/dl u 13 % pacijenata liječenih ledipasvirom/sofosbuvirom s ribavirinom.
a. Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination. 
Srednja vrijednost omjera (90 % CI) farmakokinetike lijekova istovremeno primijenjenih s jednim ispitivanim lijekom ili u kombinaciji s oba ispitivana lijeka.
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. 
U analizi objedinjenih podataka pacijenata koji su primali ledipasvir/sofosbuvir u ispitivanjima faze 3 (ION-3, ION-1 i ION-2), 37 pacijenata (29 s genotipom 1a i 8 s genotipom 1b) zadovoljilo je mjerila za analizu rezistencije zbog virološkog neuspjeha ili ranog prekida primjene lijeka tijekom ispitivanja i imalo je HCV RNK > 1000 IU/ml.
Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1 
Prethodno liječeni odrasli s cirozom ili bez nje - ION-2 (ispitivanje 0109) - genotip 1
In study 1118, 44 patients with genotype 1 infection, including 12 cirrhotic patients, who had previously failed treatment with sofosbuvir + ribavirin + PEG-IFN or with sofosbuvir + ribavirin were treated with ledipasvir/sofosbuvir + ribavirin for 12 weeks; the SVR was 100% (44/44). 
U ispitivanju 1118, 44 pacijenta s infekcijom genotipom 1, uključujući 12 pacijenata s cirozom, u kojih je prethodno liječenje sofosbuvirom s ribavirinom i PEG-IFN-om ili sofosbuvirom s ribavirinom bilo neuspješno bila su liječena ledipasvirom/sofosbuvirom s ribavirinom tijekom 12 tjedana; SVR je iznosio 100 % (44/44).
Clinically significant medicinal product interactions with ledipasvir/sofosbuvir mediated by CYP450s or UGT1A1 enzymes are not expected. 
Ne očekuju se klinički značajne interakcije lijekova s ledipasvirom/sofosbuvirom posredovane enzimima CYP450 ili
The median age was 52 years (range: 26 to 72); 82% of the patients were male; 61% were white; 34% were black; 75% had genotype 1a HCV infection; 2% had genotype 4 infection; 76% had non-CC IL28B alleles (CT or TT); and 20% had compensated cirrhosis. 
Medijan dobi iznosio je 52 godine (raspon: od 26 do 72); 82 % pacijenata bili su muškarci; 61 % su bili bijelci; 34 % su bili crnci; 75 % ih je imalo infekciju genotipom 1a HCV-a; 2 % je imalo infekciju genotipom 4; 76 % je imalo ne-CC IL28B alele (CT ili TT); a 20 % je imalo kompenziranu cirozu.
The clinical data to support the use of Harvoni in patients infected with HCV genotype 3 are limited (see section 5.1). 
Klinički podaci koji podupiru primjenu lijeka Harvoni u pacijenata zaraženih HCV-om genotipa 3 su ograničeni (vidjeti dio 5.1).
- Harvoni for 8 weeks may be considered in previously untreated genotype 1-infected patients (see section 5.1, ION-3 study). 
- U pacijenata zaraženih genotipom 1 koji prethodno nisu bili liječeni može se razmotriti primjena lijeka Harvoni tijekom 8 tjedana (vidjeti dio 5.1 u ispitivanju ION-3).
4 hour haemodialysis removed 18% of administered sofosbuvir dose. 
Nakon jedne doze od 400 mg sofosbuvira, tijekom 4 sata hemodijalize uklonilo se 18 % primijenjene doze sofosbuvira.
In clinical studies, fatigue and headache were more common in patients treated with ledipasvir/sofosbuvir compared to placebo. 
U kliničkim su ispitivanjima, umor i glavobolja bili su češći u pacijenata liječenih ledipasvirom/sofosbuvirom nego placebom.
The potential risks and benefits associated with co-administration of Harvoni with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction. 
Potrebno je uzeti u obzir moguće rizike i koristi povezane s istovremenom primjenom lijeka Harvoni i tablete s fiksnom kombinacijom doza elvitegravira/kobicistata/emtricitabina/tenofovirdizoproksilfumarata ili tenofovirdizoproksilfumarata koji se daje zajedno s pojačanim inhibitorom proteaze HIV-a (npr. atazanavirom ili darunavirom), osobito u pacijenata s povećanim rizikom od poremećaja funkcije bubrega.
Patients with genotype 1, 4, 5 or 6 CHC 
Pacijenti s CHC-om uzrokovanim genotipom 1, 4, 5 ili 6
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). 
Primjena s inhibitorima HMG-CoA reduktaze Istovremena primjena lijeka Harvoni i inhibitora HMG-CoA reduktaze (statina) može značajno povećati koncentraciju statina, što povećava rizik od miopatije i rabdomiolize (vidjeti dio 4.5).
• St. John's wort (Hypericum perforatum - herbal medicine used to treat depression); 
• gospinu travu (Hypericum perforatum - biljni lijek koji se primjenjuje za liječenje depresije);
b. The chimeric replicons carrying NS5A genes from genotype 2b, 5a, 6a and 6e were used for testing ledipasvir while the chimeric replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing sofosbuvir. 
Za ispitivanje ledipasvira bili su uporabljeni kimerički replikoni koji nose NS5A gene iz genotipova 2b, 5a, 6a i 6e, dok su za ispitivanje sofosbuvira bili uporabljeni kimerički replikoni koji nose NS5B gene iz genotipova 2b, 5a ili 6a.
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 pacijenata s genotipom 1b koji su zadovoljili mjerila za provjeru rezistencije, 7/8 (88 %) nosilo je jednu ili više NS5A RAV na položajima L31 i Y93 u vrijeme virološkog neuspjeha, dok 1/8 pacijenata nije imao NS5A RAV u vrijeme virološkog neuspjeha.
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. 
Farmakokinetika sofosbuvira bila je ispitana u HCV-negativnih pacijenata s blagim (eGFR ≥ 50 i < 80 ml/min/1,73m2), umjerenim (eGFR ≥ 30 i < 50 ml/min/1,73m2), teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i pacijenata sa završnim stadijem bolesti bubrega koji su trebali hemodijalizu, nakon jedne doze od 400 mg sofosbuvira.
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). 
1. Tri ispitivanja faze 3 uključivala su jedno ispitivanje provedeno u pacijenata bez ciroze koji prethodno nisu bili liječeni (ION-3); jedno ispitivanje u pacijenata s cirozom i bez ciroze koji prethodno nisu bili liječeni (ION-1); i jedno ispitivanje u pacijenata s cirozom i bez ciroze u kojih je prethodna terapija režimom na temelju interferona bila neuspješna, uključujući režime koji su sadržavali inhibitor proteaze HCV-a (ION-2).
NS5A resistance-associated variants (RAVs) were observed in post-baseline isolates from 29/37 patients (22/29 genotype 1a and 7/8 genotype 1b) not achieving sustained virologic response (SVR). 
Varijante NS5A povezane s rezistencijom (engl. resistance-associated variants, RAV) opažene su u izolatima nakon početka ispitivanja kod 29/37 pacijenata (22/29 s genotipom 1a i 7/8 s genotipom 1b) koji nisu postigli održani virološki odgovor (SVR).
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs). 
Istovremena primjena amiodarona bila je ograničena tijekom kliničkog razvoja sofobuvira uz izravno djelujuće antivirotike.
Patients with compensated cirrhosis 
Pacijenti s kompenziranom cirozom
Omeprazole dosed simultaneously with Harvoni 
Omeprazol primijenjen istovremeno s lijekom Harvoni
• Your doctor can confirm that your treatment has worked and you are free of the hepatitis C 
• Vaš liječnik može odlučiti trebate li uzimati Harvoni i koliko dugo; • Vaš liječnik može potvrditi da Vam liječenje djeluje i da više nemate virus hepatitisa C.
Relapse b 
Relaps b
Refer to the Summary of Product Characteristics for ribavirin for additional information. 
Pročitajte Sažetak opisa svojstava lijeka za ribavirin zbog dodatnih informacija.
HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL 
HCV RNK < 6 milijuna IU/ml 2 % (2/121) HCV RNK > 6 milijuna IU/ml 10 % (9/92)
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). 
Farmakokinetika ledipasvira bila je ispitana u HCV-negativnih pacijenata s teškim oštećenjem bubrega (eGFR < 30 ml/min prema Cockcroft-Gaultu, medijan [raspon] CrCl 22 [17-29] ml/mm)
The safety and efficacy of sofosbuvir have not been established in patients with severe renal impairment or ESRD. 
Sigurnost i djelotvornost sofosbuvira nisu ustanovljene u pacijenata s teškim oštećenjem bubrega ili završnim stadijem bolesti bubrega.
Breast-feeding It is unknown whether ledipasvir or sofosbuvir and its metabolites are excreted in human milk. 
Nije poznato izlučuju li se ledipasvir ili sofosbuvir i njihovi metaboliti u majčino mlijeko.
↔ GS-331007 (Induction of P-gp) 
↔GS-331007 (Indukcija P-gp)
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. 
Među 169 pacijenata s dekompenziranom cirozom (CPT B ili C prije ili poslije transplantacije), promjene MELD (model for end stage liver disease) i CPT rezultata procijenjene su u onih pacijenata koji su postigli SVR12 i za koje su bili dostupni laboratorijski podaci iz 12. tjedna nakon liječenja (npr. bili su isključeni pacijenti koji su umrli, kojima je transplantiran organ ili za koje nisu postojali podaci u ovoj vremenskoj točki).
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). 
Interakcije između lijeka Harvoni i drugih lijekova U tablici 3 prikazan je popis ustanovljenih ili potencijalno klinički značajnih interakcija lijekova (gdje je 90 % interval pouzdanosti [CI] omjera geometrijske srednje vrijednosti najmanjih kvadrata [GLSM]
Among patients with a baseline HCV RNA < 6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of ledipasvir/sofosbuvir and 96% (126/131) with 12-week treatment of ledipasvir/sofosbuvir. 
< 6 milijuna IU/ml, SVR je bio 97 % (119/123) uz osmotjedno liječenje ledipasvirom/sofosbuvirom i 96 % (126/131) uz 12-tjedno liječenje ledipasvirom/sofosbuvirom.
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. 
Od 8 pacijenata koji nisu imali NS5A RAV u vrijeme virološkog neuspjeha, 7 pacijenata primalo je liječenje tijekom 8 tjedana (n = 3 ledipasvirom/sofosbuvirom; n = 4 ledipasvirom/sofosbuvirom +ribavirinom), a 1 je pacijent primao ledipasvir/sofosbuvir tijekom
Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed (see section 5.2). 
preporučuje se ne žvakati niti drobiti filmom obloženu tabletu (vidjeti dio 5.2).
BOTTLE AND CARTON LABELLING 
NALJEPNICA BOCE I KUTIJE
Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant The safety profile of ledipasvir/sofosbuvir with ribavirin for 12 or 24 weeks in patients with decompensated liver disease and/or those post-liver transplant was assessed in an open-label study (SOLAR-1). 
Pacijenti s dekompenziranom cirozom i/ili koji čekaju transplantaciju jetre ili poslije transplantacije jetre Sigurnosni profil ledipasvira/sofosbuvira s ribavirinom tijekom 12 ili 24 tjedna u pacijenata s dekompenziranom bolešću jetre i/ili onih poslije transplantacije jetre bio je procijenjen u otvorenom ispitivanju (SOLAR-1).
In study ION-4, 13 HCV/HIV-1 co-infected patients with genotype 1, including 1 cirrhotic patient, who had failed a sofosbuvir + ribavirin regimen were enrolled; the SVR was 100% (13/13) after 12 weeks of treatment with ledipasvir/sofosbuvir. 
U ispitivanje ION-4 bilo je uključeno 13 pacijenata istovremeno zaraženih virusima HCV genotipa 1/HIV-1, uključujući 1 pacijenta s cirozom, u kojih je liječenje režimom sofosbuvira s ribavirinom bilo neuspješno; SVR je iznosio 100 % (13/13) nakon 12 tjedana liječenja ledipasvirom/sofosbuvirom.
virus. 
HIV-infekcijom.
In the SIRIUS study (see “Clinical efficacy and safety”, below) 5 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with or without ribavirin. 
U ispitivanju SIRIUS (vidjeti niže „Klinička djelotvornost i sigurnost“), 5 pacijenata zaraženih genotipom 1 imalo je relaps nakon liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega.
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 pacijenata zaraženih HCV-om pokazala je da ciroza nije imala klinički važan utjecaj na izloženost sofosbuviru i GS-331007.
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. 
Od 29 pacijenata s genotipom 1a koji su zadovoljili mjerila za provjeru rezistencije, 22/29 (76 %) pacijenata nosilo je jednu ili više NS5A RAV na položajima K24, M28, Q30, L31, S38 i Y93 u vrijeme virološkog neuspjeha, dok se u preostalih
Table 14: Response rates in study ION-4 
Tablica 14: Stope odgovora u ispitivanju ION-4.
Not interpretable a. One patient in the LDV/SOF 8-week treatment arm did not have a confirmed genotype 1 subtype. 
U jednog pacijenta u terapijskoj skupini liječenoj 8 tjedana LDV/SOF-om nije bila potvrđena podvrsta genotipa 1.
Concentrations of ledipasvir, sofosbuvir and simeprevir are increased when simeprevir is co-administered with Harvoni. 
Koncentracije ledipasvira, sofosbuvira i simeprevira povećane su kad se simeprevir primjenjuje istovremeno s lijekom Harvoni.
Do not take Harvoni 
Nemojte uzimati Harvoni
Other b 
Ostalo b
Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Harvoni. 
Preporučuje se kliničko praćenje, u kojem se traže znakovi krvarenja i anemije, kada se dabigatran eteksilat primjenjuje istovremeno s lijekom
When used in combination with ribavirin, refer also to the Summary of Product Characteristics of ribavirin. 
Kad se primjenjuje u kombinaciji s ribavirinom, pročitajte također Sažetak opisa svojstava lijeka za ribavirin.
Nizatidinee Ranitidine e 
Nizatidine Ranitidin e
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 90 mg ledipasvira i 400 mg sofosbuvira.
NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets 
NAZIV LIJEKA Harvoni 90 mg/400 mg filmom obložene tablete
In phenotypic analyses, post-baseline isolates from patients who harboured NS5A RAVs at failure showed 20- to at least a 243-fold (the highest dose tested) reduced susceptibility to ledipasvir. 
NS5A RAV u vrijeme virološkog neuspjeha pokazali su 20 do najmanje 243 puta (najviša ispitana doza) smanjenu osjetljivost na ledipasvir.
Previously treated adults who have failed on sofosbuvir + ribavirin ± PEG-IFN The efficacy of ledipasvir/sofosbuvir in patients who had previously failed treatment with sofosbuvir + ribavirin ± PEG-IFN is supported by two clinical studies. 
Prethodno liječeni odrasli u kojih je liječenje sofosbuvirom s ribavirinom ± PEG-IFN bilo neuspješno Djelotvornost ledipasvira/sofosbuvira u pacijenata u kojih je prethodno liječenje sofosbuvirom s ribavirinom ± PEG-IFN bilo neuspješno potkrijepljena je u dva klinička ispitivanja.
Medicinal products that are potent P-gp inducers (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3). 
Lijekovi koji su jaki induktori P-gp (rifampicin, rifabutin, gospina trava, karbamazepin, fenobarbital i fenitoin) mogu značajno smanjiti koncentracije ledipasvira i sofosbuvira u plazmi i tako dovesti do smanjenog terapijskog učinka ledipasvira/sofosbuvira te su stoga kontraindicirani s lijekom Harvoni
H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose) 
Antagonisti H2-receptora Famotidin (jedna doza od 40 mg)/ ledipasvir (jedna doza od 90 mg)
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. 
U ispitivanju SOLAR-1 (vidjeti niže „Klinička djelotvornost i sigurnost“) 13 pacijenata zaraženih genotipom 1 imalo je relaps nakon liječenja ledipasvirom/sofosbuvirom s ribavirinom.
Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV 
Prethodna terapija HCV-a PEG-IFN+RBV Inhibitor proteaze HCV-a +