FrancophonIA/ELRC3.0 huggingface dataset:
English: CPT A = CPT score 5-6 (compensated), CPT B = CPT score 7-9 (decompensated), CPT C = CPT score 10-12 (decompensated).
Slovenian: c. CPT = po Child-Pugh-Turcotteu, FCH = fibrozni holestatski hepatitis, CPT A = rezultat CPT 5-6 (kompenzirani), CPT B = rezultat CPT 7-9 (dekompenzirani), CPT C = rezultat CPT 10-12 (dekompenzirani).
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Harvoni when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Slovenian: Primeri so lahko smrtno nevarni, zato se lahko amiodaron pri bolnikih, ki prejemajo zdravilo Harvoni, uporablja samo, če drugih nadomestnih antiaritmikov ne prenašajo ali če so ti pri njih kontraindicirani.
English: It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human breast milk.
Slovenian: Ni znano, ali ledipasvir ali sofosbuvir, dve učinkovini v zdravilu Harvoni, prehajata v materino mleko.
English: In clinical studies - Adults-Genotype 2, 3, 4, 5 and 6
Slovenian: V kliničnih študijah - odrasli, genotip 2, 3, 4, 5 in 6
English: No human data on the effect of Harvoni on fertility are available.
Slovenian: Podatki o vplivu zdravila Harvoni na plodnost pri ljudeh niso na voljo.
English: • rifapentine (antibiotic used to treat infections, including tuberculosis);
Slovenian: • rifapentin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo),
English: The SVR12 rate was 98% overall (98% [78/80] in treatment-naïve patients and 100% [20/20] in treatment experienced patients).
Slovenian: Celokupni SVR12 je bil 98 % (98 % [78/80] pri predhodno nezdravljenih bolnikih in 100 % [20/20] pri predhodno zdravljenih bolnikih).
English: No major differences in outcomes were observed by the presence or absence of baseline NS5A RAVs.
Slovenian: Večjih razlik v izidih glede na prisotnost ali odsotnost izhodiščnih RAV NS5A niso opazili.
English: These should be taken at least 4 hours before or 4 hours after Harvoni;
Slovenian: Te je treba vzeti vsaj 4 ure pred uporabo zdravila Harvoni ali 4 ure po tem,
English: • If you notice within 18 hours of the time you usually take Harvoni, you must take the tablet as soon as possible.
Slovenian: • Če se tega spomnite v roku 18 ur od takrat, ko običajno vzamete zdravilo Harvoni, morate tableto vzeti takoj, ko je mogoče.
English: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow FCF aluminium lake (E110)
Slovenian: polivinilalkohol, titanov dioksid, makrogol 3350, smukec, sončno rumeno FCF (E110).
English: Pregnancy must be avoided if Harvoni is taken together with ribavirin.
Slovenian: Nosečnosti med jemanjem zdravila Harvoni skupaj z ribavirinom se je treba izogniti.
English: It is unknown whether ledipasvir or sofosbuvir and its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se ledipasvir ali sofosbuvir in njegovi presnovki izločajo v materino mleko.
English: Patients in the latter treatment arm received placebo (for ledipasvir/sofosbuvir and ribavirin) during the first 12 weeks, followed by active blinded therapy during the subsequent 12 weeks.
Slovenian: Bolniki v slednji skupini zdravljenja so prejemali placebo (za ledipasvir/sofosbuvir in ribavirin) v prvih 12 tednih, potem pa slepo zdravljenje z učinkovino v naslednjih 12 tednih.
English: Patients were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate, administered with efavirenz, rilpivirine or raltegravir.
Slovenian: Bolniki so prejemali stabilno protiretrovirusno zdravljenje proti HIV-1, ki je vključevalo emtricitabin/dizoproksiltenofovirat fumarat skupaj z efavirenzom, rilpivirinom ali raltegravirjem.
English: Adults-Genotype 1
Slovenian: Odrasli, genotip 1
English: The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets and outer cartons containing 84 (3 bottles of 28) film-coated tablets.
Slovenian: Na voljo so naslednje velikosti pakiranja: škatle, ki vsebujejo 1 plastenko z 28 filmsko obloženimi tabletami in škatle, ki vsebujejo 84 (3 plastenke po 28) filmsko obloženih tablet.
English: Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis (see section 5.1).
Slovenian: Varnost in učinkovitost ledipasvirja/sofosbuvirja pri bolnikih z dekompenzirano cirozo sta bili dokazani (glejte poglavje 5.1).
English: • Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110” before taking this medicine.
Slovenian: • Povejte zdravniku, če ste alergični na barvilo sončno rumeno FCF (E110) preden uporabite to zdravilo.
English: Previously treated adults with cirrhosis - SIRIUS - Genotype 1
Slovenian: Predhodno zdravljeni odrasli s cirozo - SIRIUS - genotip 1
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Slovenian: Drugi neželeni učinki, ki se lahko pojavijo med zdravljenjem z zdravilom Harvoni Pogostnost naslednjih neželenih učinkov ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: Age (years): median (range)
Slovenian: Starost (v letih): mediana
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at doses which cause adverse effects was 16 times (rat) and 71 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Slovenian: Izpostavljenosti sofosbuvirju v študijah pri glodavcih ni bilo mogoče zaznati, verjetno zaradi visoke aktivnosti esteraze; vendar pa je bila izpostavljenost glavnemu presnovku GS-331007 pri odmerku, ki je povzročil neželene učinke, 16-krat (podgana) in 71-krat (pes) večja kot je klinična izpostavljenost sofosbuvirju pri odmerku 400 mg.
English: Race and gender
Slovenian: Rasa in spol
English: Sofosbuvir activity (EC50, nM)
Slovenian: Aktivnost sofosbuvirja (EC50, nM)
English: If it is after 18 hours then patients should be instructed to wait and take the next dose at the usual time.
Slovenian: Če je preteklo več kot 18 ur, bolniku naročite, naj počaka in vzame naslednji odmerek ob običajnem času.
English: (Induction of P-gp)
Slovenian: (indukcija P-gp)
English: Effect of baseline HCV resistance-associated variants on treatment outcome
Slovenian: Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja
English: No adverse effects on behaviour, reproduction or development of offspring in rat were reported.
Slovenian: Niso poročali o neželenih učinkih na vedenje, razmnoževanje ali razvoj potomcev podgan.
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203.
Slovenian: Sofosbuvir se obširno presnovi v jetrih, kjer tvori v farmakološko aktivni nukleozidni analog trifosfat GS-461203.
English: Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Harvoni.
Slovenian: Klinično spremljanje, iskanje znakov krvavitve in anemije, se priporoča, ko se dabigatran eteksilat daje sočasno z zdravilom Harvoni.
English: d Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2.
Slovenian: d. Rezultat Metavir = 4 ali rezultat Ishak ≥ 5 s pomočjo biopsije jeter ali rezultat FibroTest > 0,75 in (APRI) > 2.
English: The effects of Harvoni during pregnancy are not known.
Slovenian: Učniki zdravila Harvoni med nosečnostjo niso znani.
English: Additionally a Q30E substitution developed in genotype 1a replicons.
Slovenian: Dodatno se je v replikonih genotipa 1a razvila substitucija Q30E.
English: The active metabolite is not observed.
Slovenian: Aktivnega presnovka niso opazili.
English: In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite was approximately 5 times higher than the clinical exposure at 400 mg sofosbuvir.
Slovenian: V študijah na podganah izpostavljenosti sofosbuvirju niso mogli določiti, vendar je razpon meje izpostavljenosti na podlagi glavnega presnovka pri ljudeh približno 5-krat večji od klinične izpostavljenosti sofosbuvirju pri odmerku 400 mg.
English: • kidney problems or if you are on kidney dialysis, since Harvoni has not been fully tested in patients with severe kidney problems;
Slovenian: • težave z ledvicami ali če se zdravite z ledvično dializo, saj učinkov zdravila Harvoni pri bolnikih s hudimi težavami z ledvicami niso v celoti preučili;
English: Metavir score F0-F3 95% (94/99) CPT Ac
Slovenian: Rezultat Metavir F0-F3 95 % (94/99)
English: a Twelve patients transplanted prior to post-treatment Week 12 with HCV RNA< LLOQ at last measurement prior to transplant were excluded.
Slovenian: a. Dvanajst bolnikov, ki so opravili presaditev pred 12. tednom po zdravljenju z vrednostjo RNA HCV < LLOQ ob zadnjem merjenju pred presaditvijo, je bilo izključenih.
English: 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.
Slovenian: Učinkovitost ledipasvirja [LDV]/sofosbuvirja [SOF] so ocenili v treh odprtih študijah 3. faze, pri čemer so podatki na voljo za skupaj 1.950 bolnikov s CHC genotipa 1.
English: Table 20: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Ledipasvir Compared to Subjects with Normal Renal Function
Slovenian: Preglednica 20: Učinek različnih stopenj ledvične okvare na izpostavljenosti (AUC) sofosbuvirju, GS-331007 in ledipasvirju v primerjavi z osebami z normalnim delovanjem ledvic
English: Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered sofosbuvir dose.
Slovenian: Po enkratnem 400-miligramskem odmerku sofosbuvirja se je s 4-urno hemodializo izločilo približno 18 % uporabljenega odmerka sofosbuvirja.
English: If you forget to take Harvoni
Slovenian: Če ste pozabili vzeti zdravilo Harvoni
English: Animal studies do not indicate direct harmful effects with respect to reproductive toxicity.
Slovenian: Študije na živalih ne kažejo neposrednih škodljivih učinkov na sposobnost razmnoževanja.
English: Ledipasvir, sofosbuvir, and GS-331007 exposures in adolescents aged 12 to < 18 years were similar to those in adults from Phase 2/3 studies, following administration of ledipasvir/sofosbuvir (90 mg/400 mg).
Slovenian: Izpostavljenosti ledipasvirju, sofosbuvirju in GS-331007 pri mladostnikih, starih od 12 do < 18 let, so bile podobne kot pri odraslih v študijah faze 2/3, po dajanju ledipasvirja/sofosbuvirja (90 mg/400 mg).
English: Ledipasvir was not carcinogenic in the 26-week rasH2 transgenic mouse and the 2-year rat carcinogenicity studies at exposures up to 26-times in mice and 8-times in rats higher than human exposure.
Slovenian: Ledipasvir v 26-tedenski študiji kancerogenosti pri rasH2 transgenih miših in v 2-letni študiji kancerogenosti pri podganah pri izpostavljenosti, ki je bila pri miših do 26-krat večja, pri podganah pa 8-krat večja od izpostavljenosti pri človeku, ni bil kancerogen.
English: HMG-CoA REDUCTASE INHIBITORS Rosuvastating
Slovenian: ZAVIRALCI REDUKTAZE HMG-CoA Rosuvastating
English: Clinical efficacy and safety in genotype 2, 3, 4, 5 and 6 (see also section 4.4) Ledipasvir/sofosbuvir has been evaluated for the treatment of non-genotype 1 infection in small Phase 2 studies, as summarised below.
Slovenian: Klinična učinkovitost in varnost pri genotipu 2, 3, 4, 5 in 6 (glejte tudi poglavje 4.4) Ledipasvir/sofosbuvir so ovrednotili za zdravljenje okužb, razen z genotipom 1, v majhnih študijah
English: There were no effects on survival, physical and behavioural development and reproductive performance in the offspring at maternal exposures similar to the exposure in humans at the recommended clinical dose.
Slovenian: Učinkov na preživetje, telesni in vedenjski razvoj ali na sposobnost razmnoževanja pri potomcih mater, izpostavljenih odmerku, ki je bil podoben priporočenemu kliničnemu odmerku pri človeku, ni bilo.
English: Changes in MELD and CPT score from baseline to post-treatment Week 12 were analyzed for all patients with decompensated cirrhosis (pre- or post-transplant) who achieved SVR12 and for whom data were available (n = 123) to assess the effect of SVR12 on hepatic function.
Slovenian: Spremembe rezultatov MELD in CPT od izhodišča do 12. tedna po zdravljenju so analizirali pri vseh bolnikih z dekompenzirano cirozo (pred presaditvijo ali po njej), ki so dosegli SVR12 in pri katerih so bili na voljo podatki (n = 123) za oceno učinka SVR12 na jetrno funkcijo.
English: Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%.
Slovenian: Hemodializa lahko učinkovito odstrani prevladujoči cirkulirajoči presnovek sofosbuvirja, GS-331007, z ekstrakcijskim razmerjem 53 %.
English: Within ledipasvir/sofosbuvir, GS-331007 accounts for approximately 85% of total systemic exposure.
Slovenian: Pri ledipasvirju/sofosbuvirju prispeva GS-331007 približno 85 % skupne sistemske izpostavljenosti.
English: • dabigatran used to thin the blood;
Slovenian: • dabigatran, ki se uporablja za redčenje krvi,
English: The E237G substitution showed a 1.3-fold reduction in susceptibility to sofosbuvir in the genotype 1a replicon assay.
Slovenian: Substitucija E237G je pokazala za 1,3-krat zmanjšano dovzetnost za sofosbuvir pri replikonski analizi genotipa 1a.
English: Harvoni (administered alone or in combination with ribavirin) has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Harvoni (uporabljeno samo ali v kombinaciji z ribavirinom) nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: In this setting, exposure of sofosbuvir metabolite GS331007 is 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials.
Slovenian: V teh pogojih se je izpostavljenost presnovku sofosbuvirja GS-331007 povečala za 20-krat, kar je preseglo ravni, pri katerih so v predkliničnih preskušanjih opazili neželene učinke.
English: The SVR rates for the 8, 12, and 24 week ledipasvir/sofosbuvir treatment groups were 93% (42/45), 100% (31/31), and 79% (15/19), respectively.
Slovenian: Stopnje SVR za skupine z ledipasvirjem/sofosbuvirjem za 8, 12 in 24 tednov so bile 93 % (42/45), 100 % (31/31) oz. 79 % (15/19).
English: Relapsea
Slovenian: Relapsa
English: Elderly No dose adjustment is warranted for elderly patients (see section 5.2).
Slovenian: Starejši bolniki Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Table 5: Interactions between Harvoni and other medicinal products Medicinal product by therapeutic areas
Slovenian: Preglednica 5: Interakcije med zdravilom Harvoni in drugimi zdravili Zdravila po terapevtskih področjih
English: Relative to fasting conditions, the administration of a single dose of ledipasvir/sofosbuvir with a moderate fat or high fat meal increased the sofosbuvir AUC0-inf by approximately 2-fold, but did not significantly affect the sofosbuvir Cmax.
Slovenian: V primerjavi s pogoji na tešče je dajanje enkratnega odmerka ledipasvirja/sofosbuvirja z obrokom z zmerno vsebnostjo maščobe ali visoko vsebnostjo maščobe vrednost AUC0-inf sofosbuvirja povečalo za približno 2-krat, na vrednost Cmax sofosbuvirja pa ni pomembno vplivalo.
English: NARCOTIC ANALGESICS Methadone
Slovenian: NARKOTIČNI ANALGETIKI
English: No specific antidote is available for overdose with Harvoni.
Slovenian: Specifični antidot za prevelik odmerek zdravila Harvoni ni na voljo.
English: GS-331007 is efficiently removed by haemodialysis with an extraction coefficient of approximately 53%.
Slovenian: GS-331007 se s hemodializo učinkovito odstrani z ekstrakcijskim razmerjem približno 53 %.
English: Biochemical confirmation of NS5A inhibition by ledipasvir is not currently possible as NS5A has no enzymatic function.
Slovenian: Trenutno ni mogoče biokemično potrditi, da ledipasvir zavira NS5A, saj NS5A nima encimske funkcije.
English: Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Slovenian: Defosforilacija povzroči nastanek nukleozidnega presnovka GS-331007, ki ga ni mogoče učinkovito ponovno refosforilati in ki in vitro ni aktiven proti HCV.
English: For the combination of tenofovir/emtricitabine + atazanavir/ritonavir, please see below.
Slovenian: Za kombinacijo tenofovirja/emtricitabina + atazanavirja/ritonavirja glejte spodaj.
English: Glucose levels of diabetic patients initiating direct-acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Slovenian: Pri sladkornih bolnikih, ki so se začeli zdraviti z neposredno delujočim protivirusnim zdravilom, je treba zlasti v prvih treh mesecih skrbno spremljati ravni krvnega sladkorja ter po potrebi prilagoditi zdravilo za zdravljenje sladkorne bolezni.
English: In genotype 3 infected patients experiencing virologic failure, development of NS5A RAVs (including enrichment of RAVs present at baseline) was typically not detected at the time of failure (n = 17).
Slovenian: Pri bolnikih, okuženih z genotipom 3, ki so doživeli virološki neuspeh, razvoja RAV NS5A (vključno z obogatitvijo RAV, prisotno ob izhodišču) v času neuspeha običajno niso odkrili (n = 17).
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of ledipasvir/sofosbuvir were 0.5 and 27 hours, respectively.
Slovenian: Mediana končna razpolovna časa za sofosbuvir in GS-331007 po uporabi ledipasvirja/sofosbuvirja sta bila 0,5 ure oz. 27 ur.
English: 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.
Slovenian: 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 (MRP-multidrug resistance protein) 2 ali MRP4.
English: 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
Slovenian: 1.000 mg na dan pri bolnikih s telesno maso < 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg
English: In vitro potential for ledipasvir/sofosbuvir to affect other medicinal products
Slovenian: Možnost vpliva ledipasvirja/sofosbuvirja na druga zdravila in vitro
English: In cirrhotic patients relapses occurred with both regimens, and in the absence and presence of baseline NS5A RAVs.
Slovenian: Pri bolnikih s cirozo so se relapsi pojavili z obema režimoma zdravljenja in v odsotnosti ali prisotnosti izhodiščnih RAV NS5A.
English: Sofosbuvir-derived material was transferred through the placenta in pregnant rats and into the milk of lactating rats.
Slovenian: Derivat sofosbuvirja je prehajal skozi placento pri nosečih podganah in v mleko doječih podgan.
English: If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice.
Slovenian: Če ste vzeli večji odmerek zdravila Harvoni, kot bi smeli Če ste pomotoma vzeli večji odmerek od priporočenega, se takoj posvetujte z zdravnikom ali pojdite na najbližji oddelek nujne pomoči.
English: Cimetidinee Nizatidinee Ranitidinee
Slovenian: Starost (v letih):
English: Both sofosbuvir and ledipasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
Slovenian: Tako sofosbuvir kot ledipasvir sta bila povsem aktivna pri substitucijah, povezanih z odpornostjo na druga zdravila z direktnim delovanjem na viruse z različnimi mehanizmi delovanja, kot so nenukleozidni zaviralci NS5B in zaviralci proteaze NS3.
English: • proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole).
Slovenian: • zaviralci protonske črpalke (kot so omeprazol, lansoprazol, rabeprazol, pantoprazol in esomeprazol).
English: Afterwards, close monitoring and potential dose adjustment of ciclosporin may be required.
Slovenian: Kasneje bo morda potrebno natančno spremljanje in prilagoditev odmerka ciklosporina.
English: Use with strong P-gp inducers
Slovenian: Uporaba z močnimi induktorji P-gp
English: NS5B RAVs: The NS5B substitution S282T emerged in the HCV of 1/17 genotype 3-failures, and in the HCV of 1/3, 1/1 and 1/1 of genotype 4-, 5- and 6-failures, respectively.
Slovenian: RAV NS5B: Substitucija S282T v polimerazi NS5B se je pojavila pri 1/17 neuspehov pri HCV genotipa 3 ter pri 1/3, 1/1 oz. 1/1 neuspehov pri HCV genotipa 4, 5 oz. 6.
English: Such co-administration is not recommended (see section 4.4).
Slovenian: Taka sočasna uporaba ni priporočljiva (glejte poglavje 4.4).
English: • If you are sick (vomit) less than 5 hours after taking Harvoni, take another tablet.
Slovenian: • Če bruhate manj kot 5 ur po uporabi zdravila Harvoni, vzemite še eno tableto.
English: 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.
Slovenian: V analizah fenotipov so po izhodišču izolati bolnikov, nosilcev RAV NS5A ob neuspehu, kazali 20- do vsaj 243-krat (največji preskušeni odmerek) zmanjšano dovzetnost za ledipasvir.
English: Demographics and baseline characteristics were balanced across the treatment groups.
Slovenian: Demografske in izhodiščne značilnosti so bile uravnotežene v vseh skupinah zdravljenja.
English: • digoxin used to treat heart conditions;
Slovenian: • digoksin, ki se uporablja za zdravljenje bolezni srca,
English: Patients were randomised in a 1:1:1 ratio to one of the three treatment groups and stratified by HCV genotype (1a versus 1b).
Slovenian: Bolniki so bili randomizirane v razmerju 1:1:1 v eno od treh skupin zdravljenja in stratificirane glede na genotip HCV (1a v primerjavi z 1b).
English: The NS5A substitution Y93C emerged in the HCV of 1 patient (genotype 4), while NS5A RAVs present at baseline were observed at the time of failure in all patients.
Slovenian: Substitucija Y93C v polimerazi NS5A se je pojavila pri HCV pri 1 bolniku (genotip 4), medtem ko so RAV NS5A, prisotne ob izhodišču, opazili v času neuspeha pri vseh bolnikih.
English: The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 7.
Slovenian: Vrednosti EC50 za ledipasvir in sofosbuvir proti replikonom polne dolžine ali himeričnim replikonom, ki kodirajo zaporedje NS5A in NS5B iz kliničnih izolatov, so prikazane v preglednici 7.
English: a HCV RNA values were determined using the Roche TaqMan Assay; a patient's HCV RNA may vary from visit to visit.
Slovenian: a. Vrednosti HCV RNA so bile ugotovljene s pomočjo testa Roche TaqMan; vrednost HCV RNA bolnika se lahko med obiski razlikuje.
English: Ledipasvir solubility decreases as pH increases.
Slovenian: Topnost ledipasvirja se z večanjem vrednosti pH manjša.
English: Outcome for patients without SVR On-treatment virologic failure 0/215 Relapsea
Slovenian: Virološki neuspeh med zdravljenjem 0/215
English: • If you are sick (vomit) more than 5 hours after taking Harvoni, you do not need to take another tablet until your next scheduled tablet.
Slovenian: • Če bruhate več kot 5 ur po uporabi zdravila Harvoni, ne vzemite še ene tablete do naslednje načrtovane tablete.