FrancophonIA/ELRC3.0 huggingface dataset:
English: Previously treated adults with or without cirrhosis - ION-2 (study 0109) - Genotype 1 ION-2 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin (randomised 1:1:1:1) in genotype 1 HCV-infected patients with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Slovenian: Študija ION-2 je bila randomizirana, odprta študija, v kateri so ocenjevali 12- in 24-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem z ribavirinom ali brez njega (randomizirane v razmerju 1:1:1:1) pri bolnikih, okuženih s HCV genotipa 1 s cirozo ali brez nje, pri katerih predhodno zdravljenje na podlagi interferona, vključno z režimi, ki so vključevali zaviralca proteaze HCV, ni bilo uspešno.
English: • rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
Slovenian: • rifampicin in rifabutin (antibiotika, ki se uporabljata za zdravljenje okužb, vključno s tuberkulozo),
English: 12 weeks (n = 214)
Slovenian: 12 tednov (n = 214)
English: Table 9: Response rates in study ION-3 LDV/SOF
Slovenian: Preglednica 9: Stopnje odziva v študiji ION-3 LDV/SOF
English: ≥50 and mL/min/1.
Slovenian: < 50 ml/min/
English: Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Slovenian: Z ritonavirjem okrepljeni atazanavir (300 mg/ 100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirat fumarat (200 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/
English: HCV protease inhibitor + PEG-IFN+RBV
Slovenian: Zaviralec proteaze HCV +
English: No new adverse drug reactions were detected among patients with decompensated cirrhosis and/or who were post-liver transplant and who received ledipasvir/sofosbuvir with ribavirin.
Slovenian: Pri bolnikih z dekompenzirano cirozo in/ali po presaditvi jeter, ki so prejemali ledipasvir/sofosbuvir z ribavirinom niso opazili nobenih novih neželenih učinkov zdravila.
English: Gilead Sciences Ltd. Tel: + 44 (0) 8000 113700
Slovenian: Tel: + 44 (0) 8000 113700
English: No target organs of toxicity were identified in rat and dog studies with ledipasvir at AUC exposures approximately 7 times the human exposure at the recommended clinical dose.
Slovenian: V študijah ledipasvirja na podganah in psih z izpostavljenostjo AUC, ki je bila približno 7-krat večja od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, niso opredelili ciljnih organov za toksičnost.
English: LDV/SOF 24 weeks (n = 109)
Slovenian: LDV/SOF 24 tednov (n = 109)
English: No dose adjustment of Harvoni or abacavir/ lamivudine is required.
Slovenian: Odmerka zdravila Harvoni ali abakavirja/
English: Harvoni [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Harvoni [samo zunanja ovojnina]
English: Polyvinyl alcohol
Slovenian: Etinilestradiol
English: ERADICATE was an open-label study to evaluate 12 weeks of treatment with ledipasvir/sofosbuvir in 50 patients with genotype 1 CHC co-infected with HIV.
Slovenian: Odrasli s sočasno okužbo HCV/HIV - ERADICATE ERADICATE je bila odprta študija, v kateri so ocenjevali 12-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem pri 50 bolnikih z okužbo CHC genotipa 1 in sočasno okužbo s HIV.
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45)
Slovenian: Sofosbuvir ↑ Cmax 2,54 (1,87; 3,45) ↑ AUC 4,53 (3,26; 6,30)
English: Co-administration of Harvoni with rifapentine is expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect of Harvoni.
Slovenian: Harvoni z rifapentinom zmanjšalo koncentracije ledipasvirja in sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Harvoni.
English: Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + ribavirin ± PEG-IFN.
Slovenian: Pri predhodno zdravljenih bolnikih je bilo predhodno zdravljenje s PEG-IFN + ribavirinom ± zaviralcem proteaze
English: Genotype 6a
Slovenian: 15b genotip 6a
English: The following adverse drug reactions have been identified with Harvoni (Table 6).
Slovenian: Pri uporabi zdravila Harvoni so ugotovili naslednje neželene učinke zdravila (preglednica 6).
English: Table 12: Response rates in study ION-1 LDV/SOF
Slovenian: Preglednica 12: Stopnje odziva v študiji ION-1 LDV/SOF
English: Cirrhosisd
Slovenian: Ciklosporin
English: Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Slovenian: Rifampicin (600 mg enkrat na dan)/ sofosbuvir
English: How to store Harvoni
Slovenian: Shranjevanje zdravila Harvoni
English: Co-administration with such medicinal products is not recommended with Harvoni (see section 4.4).
Slovenian: Sočasna uporaba teh zdravil z zdravilom Harvoni ni priporočljiva (glejte poglavje 4.4).
English: 12 weeks (n = 217)
Slovenian: 12 tednov (n = 217)
English: Harvoni is contraindicated with carbamazepine (see section 4.3).
Slovenian: Zdravilo Harvoni je kontraindicirano s karbamazepinom (glejte poglavje 4.3).
English: Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62)
Slovenian: Sofosbuvir ↓ Cmax 0,52 (0,43; 0,62) ↓ AUC 0,52 (0,46; 0,59)
English: Harvoni is contraindicated with rifabutin (see section 4.3).
Slovenian: Zdravilo Harvoni je kontraindicirano z rifabutinom (glejte poglavje 4.3).
English: Other effects that may be seen during treatment with Harvoni
Slovenian: Možni neželeni učinki Shranjevanje zdravila Harvoni
English: When given with lopinavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Slovenian: Pri sočasni uporabi z lopinavirjem/ritonavirjem v povezavi z dizoproksiltenofoviratom fumaratom se pričakuje, da zdravilo Harvoni poveča koncentracijo tenofovirja.
English: LDV/SOF+RBV 8 weeks (n = 216)
Slovenian: LDV/SOF+RBV 8 tednov (n = 216)
English: LDV/SOF 12 weeks (n = 335)
Slovenian: LDV/SOF 12 tednov (n = 335)
English: Impact of DAA therapy on drugs metabolized by the liver
Slovenian: Vpliv zdravljenja z neposredno delujočim protivirusnim zdravilom na zdravila, ki se presnavljajo v jetrih
English: LDV/SOF+RBV 8 weeks (n = 210)
Slovenian: LDV/SOF+RBV 8 tednov (n = 210)
English: Norelgestromin ↔ Cmax 1.02 (0.89, 1.16)
Slovenian: Norelgestromin ↔ Cmax 1,02 (0,89; 1,16) ↔ AUC 1,03 (0,90; 1,18)
English: Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
Slovenian: (1.000 mg pri bolnikih s telesno maso < 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg), če bolnik zdravilo dobro prenaša.
English: LDV/SOF 8 weeks (n = 215)
Slovenian: LDV/SOF 8 tednov (n = 215)
English: When given with darunavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni increased the concentration of tenofovir.
Slovenian: Pri sočasni uporabi z darunavirjem/ritonavirjem v povezavi z dizoproksiltenofoviratom fumaratom je zdravilo Harvoni povečalo koncentracijo tenofovirja.
English: The exposures to GS-331007 and ledipasvir were not altered in the presence of either meal type.
Slovenian: Prisotnost nobene vrste obroka ni spremenila izpostavljenosti presnovku GS-331007 in ledipasvirju.
English: Recommendation concerning co-administration with Harvoni
Slovenian: Priporočila glede sočasne uporabe z zdravilom Harvoni
English: Table 14: Response rates in study ION-2 LDV/SOF
Slovenian: Preglednica 14: Stopnje odziva v študiji ION-2 LDV/SOF
English: 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.
Slovenian: Po 12 tednih zdravljenja z ledipasvirjem/sofosbuvirjem + ribavirinom pri bolnikih s kompenzirano jetrno boleznijo po presaditvi (študiji SOLAR-1 in SOLAR-2) pri bolnikih z izhodiščnimi RAV NS5A (n = 23) ni prišlo do relapsa.
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)d
Slovenian: 0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/
English: Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Slovenian: Famotidin (40 mg enkratni odmerek)/ ledipasvir (90 mg enkratni odmerek)c/ sofosbuvir
English: Reduced susceptibility to ledipasvir was associated with the primary NS5A substitution Y93H in both genotype 1a and 1b.
Slovenian: Zmanjšana dovzetnost za ledipasvir je bila povezana s primarno substitucijo Y93H v polimerazi
English: Renal impairment No dose adjustment of Harvoni is required for patients with mild or moderate renal impairment.
Slovenian: Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro odmerka zdravila Harvoni ni treba prilagajati.
English: However, the NS5B S282T substitution in combination with NS5A substitutions L31M, Y93H and Q30L were detected in one patient at failure following 8 weeks of treatment with ledipasvir/sofosbuvir from a Phase 2 study (LONESTAR).
Slovenian: Vendar pa so pri enem bolniku ob neuspehu po 8-tedenskem zdravljenju z ledipasvirjem/sofosbuvirjem v študiji 2. faze (LONESTAR) odkrili substitucijo S282T v polimerazi NS5B v kombinaciji s substitucijami L31M, Y93H in Q30L v polimerazi NS5A.
English: Harvoni is contraindicated with rifampicin (see section 4.3).
Slovenian: Zdravilo Harvoni je kontraindicirano z rifampicinom (glejte poglavje 4.3).
English: Emtricitabine ↔ Cmax 1.02 (0.98, 1.06)
Slovenian: Emtricitabin ↔ Cmax 0,98 (0,94; 1,02)
English: LDV/SOF 24 weeks (n = 217)
Slovenian: LDV/SOF 24 tednov (n = 217)
English: ANTICOAGULANTS Dabigatran etexilate
Slovenian: ANTIKOAGULANTI
English: virus.
Slovenian: bolnikov.
English: Hepatic impairment
Slovenian: Huda ledvična okvara
English: 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.
Slovenian: 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. b. Nemanjkajoči rezultati FibroTest so kartirani v rezultate Metavir glede na: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,59
English: Darunavir ↔ Cmax 1.01 (0.96, 1.06)
Slovenian: Darunavir ↔ Cmax 1,01 (0,96; 1,06) ↔ AUC 1,04 (0,99; 1,08)
English: Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)h
Slovenian: Ciklosporin (600 mg enkratni odmerek)/ sofosbuvir
English: Darunavir ↔ Cmax 1.02 (0.88, 1.19)
Slovenian: ↔ Cmax 1,02 (0,88; 1,19)
English: As Harvoni contains ledipasvir and sofosbuvir, any interactions that have been identified with these active substances individually may occur with Harvoni.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravilo Harvoni vsebuje ledipasvir in sofosbuvir, zato se pri uporabi zdravila Harvoni lahko pojavijo katere koli interakcije, ki so jih opazili pri uporabi teh posameznih učinkovin.
English: ↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir
Slovenian: ↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir ↔ GS-331007
English: Sofosbuvir ↑ Cmax 1.15 (0.88, 1.50)
Slovenian: Sofosbuvir ↑ Cmax 1,15 (0,88; 1,50) ↔ AUC 1,11 (1,00; 1,24)
English: Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Slovenian: Za priporočila o spremljanju ledvic glejte povzetke glavnih značilnosti zdravila za dizoproksiltenofovirat fumarat, emtricitabin/dizoproksiltenofovirat fumarat ali elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirat fumarat.
English: Dosed 1 hr Before Dialysis
Slovenian: 1 uro pred dializo
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone with or without other drugs that lower heart rate.
Slovenian: Pri uporabi zdravila Harvoni z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
English: ↔ Cmin 1.12 (1.03, 1.21) Tenofovir ↔ Cmax 1.32 (1.25, 1.39)
Slovenian: ↔ Cmin 1,12 (1,03; 1,21) Tenofovir
English: Genotype
Slovenian: Genotip
English: Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni.
Slovenian: Harvoni z okskarbazepinom zmanjšalo koncentracije ledipasvirja in sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Harvoni.
English: For the combination of tenofovir/emtricitabine + darunavir/ritonavir, please see below.
Slovenian: darunavirja/ritonavirja glejte spodaj.
English: LDV/SOF 12 weeks (n = 216)
Slovenian: LDV/SOF 12 tednov (n = 216)
English: No dose adjustment of Harvoni or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Slovenian: rilpivirina/ dizoproksiltenofovirat fumarata ni treba prilagajati.
English: Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)d
Slovenian: Raltegravir (400 mg dvakrat na dan)/ ledipasvir (90 mg enkrat na dan)d
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c
Slovenian: Omeprazol (20 mg enkrat na dan)/ ledipasvir (90 mg enkratni odmerek)c/ sofosbuvir
English: GS 331007 ↔ Cmax 1.15 (1.03, 1.27)
Slovenian: GS 331007 ↔ Cmax 1,15 (1,03; 1,27) ↔ AUC 1,03 (0,95; 1,12)
English: Do not take it before Harvoni.
Slovenian: Zdravila ne jemljite pred zdravilom Harvoni.
English: 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.
Slovenian: ESRD, zaradi katere so potrebovali dializo, zdravljenih z ledipasvirjem/sofosbuvirjem (n = 94) 8, 12 ali 24 tednov, in primerjali s farmakokinetiko pri bolnikih brez ledvične okvare v preskušanjih 2./3.
English: This patient was subsequently retreated with ledipasvir/sofosbuvir + ribavirin for 24 weeks and achieved SVR following retreatment.
Slovenian: Ta bolnik se je nato 24 tednov ponovno zdravil z ledipasvirjem/sofosbivirjem +
English: Genotype 1b 0.004 Genotype 2a
Slovenian: Genotip 1a Genotip 1b
English: ↑ Cmin 1.53 (1.47, 1.59)
Slovenian: ↑ AUC 1,44 (1,41; 1,48) ↑ Cmin 1,53 (1,47; 1,59)
English: LDV/SOF 12 weeks (n = 211)
Slovenian: LDV/SOF 12 tednov (n = 211)
English: NS
Slovenian: V
English: Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29)
Slovenian: ↓ Cmax 0,23 (0,19; 0,29)
English: LDV/SOF 12 weeks (n = 214)
Slovenian: LDV/SOF 12 tednov (n = 214)
English: CPT C
Slovenian: ↔ AUC
English: GS-331007 ↔ Cmax 1.17 (1.12, 1.23)
Slovenian: GS-331007 ↔ Cmax 1,17 (1,12; 1,23) ↔ AUC 1,31 (1,25; 1,36)
English: FibroTest-Determined Metavir scoreb F0-F1
Slovenian: F0-F1 F2 F3-F4
English: ↑ Cmin 1.63 (1.45, 1.84) Ritonavir ↔ Cmax 0.86 (0.79, 0.93)
Slovenian: ↑ Cmax 1,40 (1,18; 1,66) ↔ AUC 1,20 (1,04; 1,39) ↔ Cmin 0,98 (0,79; 1,22)
English: ↔ Cmin 1.04 (0.98, 1.11) Tenofovir ↑ Cmax 1.79 (1.56, 2.04)
Slovenian: ↔ Cmin 1,04 (0,98; 1,11) Tenofovir
English: However, it is not recommended that ribavirin be increased to the originally assigned dose (1,000 mg to 1,200 mg daily).
Slovenian: Prilagajanje odmerka ribavirina pri odraslih, ki jemljejo 1.000-1.200 mg na dan
English: GS 331007 ↔ Cmax 1.04 (0.97, 1.11)
Slovenian: GS 331007 ↔ Cmax 1,04 (0,97; 1,11) ↔ AUC 0,99 (0,94; 1,04)
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43)
Slovenian: Sofosbuvir ↓ Cmax 0,97 (0,65; 1,43) ↑ AUC 1,13 (0,81; 1,57)
English: Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77)
Slovenian: Sofosbuvir ↓ Cmax 0,64 (0,53; 0,77) ↓ AUC 0,76 (0,63; 0,91)
English: Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Slovenian: (600 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Slovenian: 100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirat fumarat (200 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/
English: LDV/SOF+RBV 24-week treatment arm as both patients were infected with genotype 4 CHC.
Slovenian: LDV/SOF+RBV sta bila izključena, ker sta bila okužena s CHC genotipa 4. b. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
English: Fertility
Slovenian: Nizatidine
English: Prior HCV therapy
Slovenian: Predhodno zdravljenje HCV
English: 84 (3 bottles of 28) film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet 84 (3 plastenke po 28) filmsko obloženih tablet
English: When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Slovenian: emtricitabinom/ dizoproksiltenofovirat fumaratom se pričakuje, da bo zdravilo Harvoni povečalo koncentracijo tenofovirja.
English: ↑ Cmin 1.91 (1.76, 2.08) Sofosbuvir ↑ Cmax 1.33 (1.14, 1.56)
Slovenian: Sofosbuvir ↑ Cmax 1,33 (1,14; 1,56) ↑ AUC 1,36 (1,21; 1,52)
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Slovenian: Z ritonavirjem okrepljeni atazanavir (300 mg/ 100 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir
English: GS-331007 ↔ Cmax 1.00 (0.94, 1.07)
Slovenian: GS-331007 ↔ Cmax 1,00 (0,94; 1,07) ↔ AUC 1,05 (1,01; 1,09)
English: ↑ Cmin 1.59 (1.49, 1.70) Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
Slovenian: ↑ Cmax 1,64 (1,54; 1,74) ↑ AUC 1,50 (1,42; 1,59) ↑ Cmin 1,59 (1,49; 1,70)
English: Male
Slovenian: Odmerjeno
English: GS-331007 ↔ Cmax 1.13 (1.07, 1.20)
Slovenian: GS-331007 ↔ Cmax 1,13 (1,07; 1,20) ↔ AUC 1,06 (1,01; 1,12)
English: ↔ Cmin 1.07 (0.89, 1.28) Norgestrel ↔ Cmax 1.18 (0.99, 1.41)
Slovenian: Norgestrel ↔ Cmax 1,03 (0,87; 1,23) ↔ AUC 0,99 (0,82; 1,20)
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c
Slovenian: Elvitegravir/ kobicistat/emtricitabin/ dizoproksiltenofovirat fumarat (150 mg/ 150 mg/ 200 mg/
English: Package leaflet: Information for the user Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Harvoni 90 mg/400 mg filmsko obložene tablete ledipasvir/sofosbuvir
English: Sofosbuvir ↔ Cmax 1.12 (0.88, 1.42)
Slovenian: ↔ Cmax 1,12 (0,88; 1,42)
English: ↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Slovenian: Ledipasvir ↔ Cmax 1,10 (1,01; 1,19)
English: ↑ Digoxin ↔ Ledipasvir
Slovenian: Abakavir/ lamivudin
English: SVR Outcome for patients without SVR On-treatment virologic failure Relapsea Otherb SVR rates for selected subgroups Genotype Genotype 1a Genotype 1b Cirrhosis No
Slovenian: Stabilni replikoni prehodni replikoni NS5B mediana (razpon)a genotip 1a genotip 1b genotip 2a genotip 2b
English: Titanium dioxide
Slovenian: Norgestimat/ etinilestradiol
English: Excipients
Slovenian: Emtricitabin
English: GS-331007 ↔ Cmax 1.06 (0.97, 1.14)
Slovenian: GS-331007 ↔ Cmax 1,06 (0,97; 1,14) ↔ AUC 1,06 (1,02; 1,11)
English: Atazanavir ↔ Cmax 1.07 (0.99, 1.14)
Slovenian: Ledipasvir ↔ Cmax 1,11 (0,99; 1,24)
English: ↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, 1.13)
Slovenian: ↔ Cmax 0,95 (0,79; 1,13) ↔ AUC 0,95 (0,77; 1,17) ↔ Cmin 0,95 (0,74; 1,22)
English: ↔ Cmin 0.91 (0.83, 0.99) Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
Slovenian: ↓ Cmax 0,83 (0,69; 1,00) ↔ AUC 0,98 (0,80; 1,20)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAČEVANJE NA NALEPKI PLASTENKE IN ŠKATLI
English: Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)h
Slovenian: sofosbuvir (400 mg enkratni odmerek)h
English: ↔ Cmin 1.08 (0.98, 1.20) Ritonavir ↔ Cmax 1.17 (1.01, 1.35)
Slovenian: ↔ Cmin 1,08 (0,98; 1,20) Ritonavir
English: ↔ Cmin 0.97 (0.86, 1.10) Ledipasvir ↑ Cmax 1.45 (1.34, 1.56)
Slovenian: Sofosbuvir ↑ Cmax 1,45 (1,10; 1,92) ↑ AUC 1,34 (1,12; 1,59)
English: GS-331007 ↑ Cmax 1.33 (1.22, 1.44)
Slovenian: ↑ Cmax 1,33 (1,22; 1,44)
English: Skin and subcutaneous tissue disorders: Common rash
Slovenian: Bolezni kože in podkožja:
English: ↔ Cmin 1.07 (1.02, 1.13)
Slovenian: ↔ Cmax 1,14 (1,01; 1,29)
English: Norelgestromin ↔ Cmax 1.07 (0.94, 1.22)
Slovenian: Norelgestromin ↔ Cmax 1,07 (0,94; 1,22) ↔ AUC 1,06 (0,92; 1,21) ↔ Cmin 1,07 (0,89; 1,28)
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: (vzdrževalna terapija z metadonom [30 do
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ sofosbuvir (400 mg once daily)
Slovenian: (800 mg/ 100 mg enkrat na dan)/ sofosbuvir (400 mg enkrat na dan)
English: Ledipasvir ↓ Cmax 0.89 (0.61, 1.30)
Slovenian: ↓ Cmax 0,89 (0,61; 1,30) ↓ AUC 0,96 (0,66; 1,39)
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
Slovenian: Sofosbuvir ↓ Cmax 0,63 (0,52; 0,75) ↓ AUC 0,73 (0,65; 0,82)
English: Treatment-naïve Patients without cirrhosis 100% (20/20) Patients with cirrhosis Treatment-experienced
Slovenian: Predhodno nezdravljeni Bolniki brez ciroze Bolniki s cirozo Predhodno zdravljeni
English: ↔ Cmin 1.16 (1.08, 1.25) Sofosbuvir ↔ Cmax 1.05 (0.93, 1.20)
Slovenian: Sofosbuvir ↔ Cmax 1,08 (0,85; 1,35) ↔ AUC 1,21 (1,09; 1,35)
English: ↑ Cmin 2.18 (1.91, 2.50) Sofosbuvir ↔ Cmax 1.01 (0.88, 1.15)
Slovenian: Sofosbuvir ↔ Cmax 1,01 (0,88; 1,15) ↔ AUC 1,11 (1,02; 1,21)
English: used to treat HIV infection;
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI PROTEAZE HIV
English: Ledipasvir ↓ Cmax 0.65 (0.56, 0.76)
Slovenian: ↓ Cmax 0,66 (0,59; 0,75) ↓ AUC 0,66 (0,59; 0,75) ↓ Cmin 0,66 (0,57; 0,76)
English: ↔ Cmin 0.95 (0.81, 1.12) Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08)
Slovenian: Sofosbuvir ↔ Cmax 0,96 (0,88; 1,05) ↔ AUC 1,08 (1,02; 1,15)
English: Copovidone
Slovenian: Okskarbazepin
English: GS-331007 ↔ Cmax 1.06 (1.01, 1.11)
Slovenian: GS-331007 ↔ Cmax 1,06 (1,01; 1,11) ↔ AUC 1,15 (1,11; 1,19)
English: Moderate RI
Slovenian: Zmerna ledvična okvara
English: Ledipasvir ↓ Cmax 0.80 (0.69, 0.93)
Slovenian: ↓ Cmax 0,80 (0,69; 0,93) ↔ AUC 0,89 (0,76; 1,06)
English: ↔ Cmin 1.06 (0.97, 1.15) Rilpivirine ↔ Cmax 0.97 (0.88, 1.07)
Slovenian: ↔ Cmax 1,02 (0,98; 1,06) ↔ AUC 1,05 (1,02; 1,08) ↔ Cmin 1,06 (0,97; 1,15)
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14)
Slovenian: GS-331007 ↓ Cmax 0,73 (0,65; 0,83) ↔ AUC 1,04 (0,89; 1,22)
English: ↔ Cmin 1.26 (1.17, 1.36) Sofosbuvir ↔ Cmax 1.08 (0.85, 1.35)
Slovenian: Sofosbuvir ↔ Cmax 1,00 (0,76; 1,32) ↔ AUC 0,95 (0,82; 1,10)
English: ↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
Slovenian: ↔ Cmax 1,25 (1,18; 1,32) ↑ AUC 1,59 (1,49; 1,70) ↑ Cmin 4,25 (3,47; 5,22)
English: Abacavir ↔ Cmax 0.92 (0.87, 0.97)
Slovenian: ↔ Cmax 0,92 (0,87; 0,97) ↔ AUC 0,90 (0,85; 0,94)
English: ↑ Cmin 1.91 (1.74, 2.10) Ledipasvir ↔ Cmax 1.01 (0.95, 1.07)
Slovenian: ↑ Cmax 1,68 (1,54; 1,84) ↑ AUC 1,96 (1,74; 2,21) ↑ Cmin 2,18 (1,91; 2,50)
English: GS-331007 ↔ Cmax 0.97 (0.90, 1.05)
Slovenian: GS-331007 ↔ Cmax 0,97 (0,90; 1,05) ↔ AUC 1,24 (1,18; 1,30)
English: No dose adjustment of Harvoni or efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is required.
Slovenian: Odmerka zdravila Harvoni ali emtricitabina/