FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicinal product interactions described are based on studies conducted with either ledipasvir/sofosbuvir or ledipasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with ledipasvir/sofosbuvir.
Slovenian: Opisane interakcije med zdravili temeljijo na študijah, izvedenih z bodisi ledipasvirjem/sofosbuvirjem ali ledipasvirjem in sofosbuvirjem kot posameznimi učinkovinami ali so predvidene interakcije med zdravili, ki se lahko pojavijo z ledipasvirjem/sofosbuvirjem.
English: 264b a. Transient replicons carrying NS5A or NS5B from patient isolates.
Slovenian: 264b a. Prehodni replikoni ki nosijo NS5A ali NS5B, iz izolatov bolnikov,
English: Adolescents: for ribavirin dosing recommendations see table 3 below.
Slovenian: Mladostniki: za priporočila za odmerjanje ribavirina glejte preglednico 3 spodaj.
English: Each film-coated tablet contains 156.8 mg of lactose (as monohydrate) and 261 micrograms of sunset yellow FCF aluminium lake.
Slovenian: Ena filmsko obložena tableta vsebuje 156,8 mg laktoze (v obliki monohidrata) in 261 mikrogramov barvila sončno rumeno FCF.
English: Serum HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Slovenian: Vrednosti RNA HCV v serumu so izmerili med kliničnimi študijami s testom COBAS TaqMan za virus HCV (različica 2.0), za uporabo s sistemom High Pure System.
English: Baseline HCV RNAa HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL
Slovenian: HCV RNA < 6 milijonov i.e./ml HCV RNA ≥ 6 milijonov i.e./ml
English: It is given to treat chronic (long-term) hepatitis C virus infection in adults and adolescents 12 to less than 18 years of age.
Slovenian: Daje se za kronično (dolgotrajno) zdravljenje okužbe z virusom hepatitisa C pri odraslih in mladostnikih, starih od 12 do < 18 let.
English: The safety of Harvoni has been evaluated in a 12-week non-controlled study including 95 patients with ESRD requiring dialysis (Study 4063).
Slovenian: Varnost zdravila Harvoni so ovrednotili v 12-tedenski nenadzorovani študiji, v katero je bilo vključenih 95 bolnikov z ESRD, ki so potrebovali dializo (študija 4063).
English: 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.
Slovenian: Najvišja dokumentirana odmerka ledipasvirja in sofosbuvirja sta bila 120 mg dvakrat na dan 10 dni oz. enkratni odmerek 1.200 mg.
English: The relative efficacy of a 12-week regimen consisting of ledipasvir/sofosbuvir + ribavirin, compared to a 24-week regimen of sofosbuvir + ribavirin has not been investigated.
Slovenian: Relativna učinkovitost 12-tedenskega režima ledipasvirja/sofosbuvirja + ribavirina v primerjavi s 24-tedenskim režimom sofosbuvirja + ribavirina ni bila preučena.
English: Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome.
Slovenian: Opravili so analize, s katerimi so preučili povezavo obstoječih izhodiščnih RAV NS5A in izidom zdravljenja.
English: Ledipasvir plasma exposure (AUCinf) was similar in patients with severe hepatic impairment and control patients with normal hepatic function.
Slovenian: Izpostavljenost ledipasvirja v plazmi (AUCinf) je bila pri bolnikih s hudo jetrno okvaro podobna kot pri kontrolnih bolnikih z normalnim delovanjem jeter.
English: HCV replicons with reduced susceptibility to sofosbuvir have been selected in cell culture for multiple genotypes including 1b, 2a, 2b, 3a, 4a, 5a and 6a.
Slovenian: Replikoni HCV z zmanjšano dovzetnostjo za sofosbuvir so bili izbrani v celični kulturi za več genotipov, vključno z 1b, 2a, 2b, 3a, 4a, 5a in 6a.
English: Carcinogenicity studies in mice and rats do not indicate any carcinogenicity potential of sofosbuvir administered at doses up to 600 mg/kg/day in mouse and 750 mg/kg/day in rat.
Slovenian: Študije kancerogenosti pri miših in podganah niso pokazale kancerogenega potenciala sofosbuvirja ki so ga miši dobivale v odmerkih do 600 mg/kg/dan in podgane 750 mg/kg/dan.
English: b Two patients who did not have decompensated cirrhosis and had also not received a liver transplant were excluded due to failure to meet the inclusion criteria for any of the treatment groups.
Slovenian: b. Dva bolnika, ki nista imela dekompenzirane ciroze in ki nista opravila presaditve, sta bila izključena, ker nista ustrezala kriterijem za vključitev v nobeno od skupin zdravljenja.
English: Medicinal product by therapeutic areas
Slovenian: Zdravila po terapevtskih področjih
English: All 5 patients who did not achieve SVR12 relapsed after having end-of-treatment response (see section “Resistance” - “In clinical studies” above).
Slovenian: Pri vseh 5 bolnikih, ki niso dosegli SVR12, je prišlo po odzivu ob koncu zdravljenja do relapsa (glejte zgornje poglavje »Odpornost« - »V kliničnih študijah«).
English: Harvoni + ribavirinA for 12 weeks or
Slovenian: Zdravilo Harvoni + ribavirinA 12 tednov ali
English: When administered to lactating rats, ledipasvir was detected in plasma of suckling rats likely due to excretion of ledipasvir via milk.
Slovenian: Pri dajanju podganam v laktaciji, so ledipasvir odkrili v plazmi dojenih podgan, verjetno kot posledico izločanja ledipasvirja v mleko.
English: Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir in a single tablet.
Slovenian: Zdravilo Harvoni je zdravilo, ki vsebuje učinkovini ledipasvir in sofosbuvir v eni sami tableti.
English: Table 7: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons
Slovenian: Preglednica 7: Aktivnost ledipasvirja in sofosbuvirja proti himeričnim replikonom Genotip replikonov
English: Clinically significant medicinal product interactions with ledipasvir/sofosbuvir mediated by CYP450s or UGT1A1 enzymes are not expected.
Slovenian: Klinično pomembnih medsebojnih delovanj z ledipasvirjem/sofosbuvirjem, pri katerih bi posredovali encimi CYP450 ali UGT1A1, se ne pričakuje.
English: Patients treated with vitamin K antagonists
Slovenian: Bolniki, ki se zdravijo z antagonisti vitamina K
English: * - If a more normalized dose of ribavirin (by weight and renal function) cannot be reached for reasons of tolerability, 24 weeks of Harvoni + ribavirin should be considered in order to minimize the risk for relapse.
Slovenian: * - Če bolj normaliziranega odmerka ribavirina (glede na telesno maso in ledvično funkcijo) ni mogoče doseči zaradi slabega prenašanja zdravila, je treba razmisliti o 24 tednih zdravila Harvoni + ribavirina, da se zmanjša tveganje za relaps.
English: ANTIARRHYTHMICS Amiodarone
Slovenian: ANTIARITMIKI Amiodaron
English: Such co-administration is not recommended.
Slovenian: Taka sočasna uporaba ni priporočljiva.
English: A total of 80 patients (80%) were treatment-naïve, while 20 patients (20%) were treatment-experienced.
Slovenian: Skupaj 80 bolnikov (80 %) še ni bilo predhodno zdravljenih, medtem ko se je 20 bolnikov (20 %) že predhodno zdravljenih.
English: SVR was the primary endpoint to determine the HCV cure rate which was defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment.
Slovenian: SVR je bil primarni opazovani dogodek za ugotovitev stopnje ozdravljenja HCV, ki je bil opredeljen kot RNA HCV manj kot LLOQ 12 tednov po koncu zdravljenja.
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Slovenian: Silikagelsko sušilno sredstvo je v posebni vrečici ali vsebniku, ki ga ne smete zaužiti.
English: ESRD Requiring Dialysis
Slovenian: ESRD, zaradi katere je potrebna dializa
English: Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir.
Slovenian: Zdravila Harvoni se ne sme dati sočasno z drugimi zdravili, ki vsebujejo sofosbuvir.
English: In rabbit studies exposure to sofosbuvir was 6 times the expected clinical exposure.
Slovenian: V študijah na kuncih je bila izpostavljenost sofosbuvirju 6-krat večja od pričakovane klinične izpostavljenosti.
English: B For ribavirin dosing recommendations in patients with decompensated cirrhosis, see table 2 below.
Slovenian: B Za priporočila za odmerjanje ribavirina pri bolnikih z dekompenzirano cirozo glejte preglednico 2 spodaj.
English: f One patient who achieved a viral load < LLOQ at end of treatment had missing baseline NS5A data and was excluded from the analysis.
Slovenian: f. En bolnik, ki je dosegel virusno obremenitev < LLOQ ob koncu zdravljenja, ni imel izhodiščnih podatkov za NS5A in je bil iz analize izključen.
English: This is due to liver function changes during treatment with Harvoni.
Slovenian: Razlog za to so spremembe delovanja jeter pri zdravljenju z zdravilom Harvoni.
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Harvoni compared to subjects with normal renal function, as described in the text below, are provided in Table 20.
Slovenian: Ledvična okvara Povzetek učinka različnih stopenj ledvične okvare na izpostavljenost sestavinam zdravila Harvoni v primerjavi z osebami z normalnim delovanjem ledvic, kot je opisano spodaj, so na voljo v preglednici 20.
English: 1200 mg/day
Slovenian: 1.200 mg/dan
English: • antacids (such as aluminium/magnesium hydroxide or calcium carbonate).
Slovenian: • antacide (kot so aluminijev/magnezijev hidroksid ali kalcijev karbonat).
English: In this limited clinical safety data set, the rate of adverse events and deaths was not clearly elevated from what is expected in ESRD patients.
Slovenian: V tem omejenem naboru podatkov klinične varnosti, stopnja neželenih učinkov in smrti ni bila očitno večja od tiste, ki je pričakovana pri bolnikih z ESRD.
English: In genotype 3-infection, the use of Harvoni (always in combination with ribavirin) should only be considered for patients who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
Slovenian: Pri okužbi z genotipom 3 smemo o uporabi zdravila Harvoni (vedno v kombinaciji z ribavirinom) razmišljati le pri bolnikih, ki veljajo za visoko tvegane z vidika kliničnega napredovanja bolezni in pri katerih ni na voljo drugačnih možnosti zdravljenja.
English: HCV replicons with reduced susceptibility to ledipasvir have been selected in cell culture for genotype 1a and 1b.
Slovenian: Replikoni HCV z zmanjšano dovzetnostjo za ledipasvir so bili izbrani v celični kulturi za genotipa 1a in 1b.
English: Concerning genotype-specific virological and clinical activity, see section 5.1.
Slovenian: Glede virološke in klinične aktivnosti, specifične za genotip, glejte poglavje 5.1.
English: Film-coating:
Slovenian: Filmska obloga:
English: The median terminal half-life of ledipasvir in healthy volunteers following administration of ledipasvir/sofosbuvir in the fasted state was 47 hours.
Slovenian: Mediani končni razpolovni čas za ledipasvir pri zdravih prostovoljcih po uporabi ledipasvirja/sofosbuvirja na tešče je bil 47 ur.
English: Table 5 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).
Slovenian: V preglednici 5 je seznam ugotovljenih ali možnih klinično pomembnih interakcij med zdravili (pri čemer je bil 90-odstotni interval zaupanja [IZ] razmerja geometričnega povprečja najmanjših kvadratov [GLSM-geometric least-squares mean] znotraj "↔", razširjenimi nad "↑" ali razširjenimi pod "↓" vnaprej določenih mej ekvivalentnosti).
English: The adverse reactions observed were consistent with those observed in clinical studies of ledipasvir/sofosbuvir in adults (see Table 6).
Slovenian: Neželeni učinki, ki so jih opazili, so bili skladni s tistimi, ki so jih opazili v kliničnih študijah z ledipasvirjem/sofosbuvirjem pri odraslih (glejte preglednico 6).
English: The safety assessment of Harvoni was mainly based on pooled Phase 3 clinical studies, without a control, in 1952 patients who received Harvoni for 8, 12 or 24 weeks, including 872 patients who received Harvoni in combination with ribavirin.
Slovenian: Ocena varnosti zdravila Harvoni večinoma temelji na združenih podatkih iz kliničnih študij 3. faze brez kontrolne skupine pri 1952 bolnikih, ki so zdravilo Harvoni prejemali 8, 12 ali 24 tednov, vključno z 872 bolniki, ki so zdravilo Harvoni prejemali v kombinaciji z ribavirinom.
English: • Do not take any other medicine that contains sofosbuvir, one of the active substances in
Slovenian: • Ne jemljite nobenih drugih zdravil, ki vsebujejo sofosbuvir, ki je ena od učinkovin v zdravilu Harvoni.
English: Unchanged ledipasvir excreted in faeces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose.
Slovenian: Nespremenjeni ledipasvir, ki se je izločil v blatu, je predstavljal povprečno 70 % uporabljenega odmerka, oksidativni presnovek M19 pa je predstavljal 2,2 % odmerka.
English: The use of Harvoni in children has not yet been studied.
Slovenian: Uporabe zdravila Harvoni pri otrocih niso preučili.
English: Animal studies do not indicate harmful effects of ledipasvir or sofosbuvir on fertility.
Slovenian: Študije na živalih ne kažejo škodljivih učinkov ledipasvirja ali sofosbuvirja na plodnost.
English: • if you are awaiting a liver transplant; • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Slovenian: • če imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal;
English: Patients with decompensated cirrhosis irrespective of transplant status
Slovenian: Bolniki z dekompenzirano cirozo ne glede na presaditev
English: If you are taking a proton pump inhibitor, take it at the same time as Harvoni.
Slovenian: Če jemljete zaviralec protonske črpalke, ga vzemite sočasno z zdravilom Harvoni.
English: Sofosbuvir was absorbed quickly and the median peak plasma concentrations were observed ~ 1 hour post-dose.
Slovenian: Sofosbuvir se je hitro absorbiral in dosegel najvišjo mediano koncentracije v plazmi ~ 1 uro po odmerku.
English: GS-461203 (the active metabolite of sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Slovenian: GS-461203 (aktivni presnovek sofosbuvirja) ni niti zaviralec DNA in RNA polimeraz pri človeku niti ne zavira mitohondrijske RNA polimeraze.
English: These will be considered before treatment with Harvoni is started.
Slovenian: To bo upošteval pred pričetkom zdravljenja z zdravilom Harvoni.
English: When ledipasvir/sofosbuvir was studied with ribavirin, the most frequent adverse drug reactions to ledipasvir/sofosbuvir + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions.
Slovenian: Ko so ledipasvir/sofosbuvir preučevali z ribavirinom, so bili najpogostejši neželeni učinki kombinirane terapije ledipasvirja/sofosbuvirja + ribavirina skladni z znanim profilom varnosti zdravljenja z ribavirinom, brez povečanja pogostnosti ali resnosti pričakovanih neželenih učinkov zdravila.
English: Each bottle contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets.
Slovenian: Vsaka plastenka vsebuje sušilno sredstvo iz silikagela, ki ga morate hraniti v plastenki za zaščito tablet.
English: - Harvoni (without ribavirin) for 12 weeks may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see section 4.4).
Slovenian: - O 12 tednih zdravila Harvoni (brez ribavirina) je možno razmisliti pri bolnikih, za katere je bilo ocenjeno, da imajo nizko tveganje za klinično napredovanje bolezni in imajo možnost za naknadno ponovno zdravljenje (glejte poglavje 4.4)
English: EU/1/14/958/001 28 film-coated tablets EU/1/14/958/002 84 (3 bottles of 28) film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/958/001 28 filmsko obloženih tablet EU/1/14/958/002 84 (3 plastenke po 28) filmsko obloženih tablet
English: Demographics and baseline characteristics were balanced across the two treatment groups.
Slovenian: Demografske in izhodiščne značilnosti so bile uravnotežene pri obeh skupinah zdravljenja.
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~6-fold↑ 23-fold↑ Ledipasvir
Slovenian: 1,6-krat↑ 2,1-krat↑ 2,7-krat↑ 1,3-krat↑ 1,6-krat↑ ~2-krat↑ 1,9-krat↑ GS-331007 1,6- krat↑ 1,9- krat↑ 5,5- krat↑ ≥10-krat↑ ≥20- krat↑ ~6-krat↑ 23-krat↑
English: Exposure to GS-331007 in these studies was up to 17 times (mouse) and 9 times (rat) higher than the clinical exposure at 400 mg sofosbuvir.
Slovenian: Izpostavljenost GS-331007 v teh študijah je bila do 17-krat (miši) in 9-krat (podgane) večja, kot je klinična izpostavljenost sofosbuvirju pri odmerku 400 mg.
English: In vitro resistance selection and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action.
Slovenian: Študije selekcije odpornosti in navzkrižne odpornosti in vitro kažejo, da ledipasvir cilja NS5A kot njegov način delovanja.
English: Patients should be instructed that if vomiting occurs within 5 hours of dosing an additional tablet should be taken.
Slovenian: Bolnikom je treba naročiti, naj vzamejo dodatno tableto, če v 5 urah po odmerjanju bruhajo.
English: When Harvoni is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
Slovenian: Če se zdravilo Harvoni uporablja v kombinaciji z ribavirinom, glejte tudi povzetek glavnih značilnosti za ribavirin za bolnike z očistkom kreatinina (CrCl-creatinine clearance) < 50 ml/min (glejte poglavje 5.2).
English: 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.
Slovenian: b. Himerični replikoni, ki nosijo gene NS5A genotipov 2b, 5a, 6a in 6e, so bili uporabljeni za preskušanje ledipasvirja, himerični replikoni, ki nosijo gene NS5B genotipov 2b, 5a ali 6a so bili uporabljeni za preskušanje sofosbuvirja.
English: Treatment of patients with prior exposure to HCV direct-acting antivirals
Slovenian: Zdravljenje bolnikov s predhodno izpostavljenostjo zdravilom z direktnim delovanjem na viruse za zdravljenje HCV
English: All patients receiving Harvoni in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Slovenian: Vse bolnike, ki prejemajo zdravilo Harvoni v kombinaciji z amiodaronom in drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, je treba prav tako opozoriti na simptome bradikardije in srčnega bloka ter jim svetovati, naj ob pojavu simptomov takoj poiščejo zdravniško pomoč.
English: All patients in the study were treated with ledipasvir/sofosbuvir for 12 weeks.
Slovenian: Vsi bolniki v študiji so bili z ledipasvirjem/sofosbuvirjem zdravljeni 12 tednov.
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Slovenian: Večina odmerka sofosbuvirja, izoliranega v urinu, je bila GS-331007 (78 %), medtem ko je bilo 3,5 % izoliranega kot sofosbuvir.
English: Harvoni for 12 weeks.
Slovenian: Zdravilo Harvoni 12 tednov.
English: Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 µg/mL to 20 µg/mL.
Slovenian: Vezava sofosbuvirja na humane beljakovine v plazmi je približno 61- do 65-odstotna, ni pa odvisna od koncentracije zdravila v razponu od 1 μg/ml do 20 μg/ml.
English: Available pharmacokinetic data in animals has shown excretion of ledipasvir and metabolites of sofosbuvir in milk (see section 5.3).
Slovenian: Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje ledipasvirja in presnovkov sofosbuvirja v mleko (glejte poglavje 5.3).
English: At baseline, two patients had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0-39.6).
Slovenian: Ob izhodišču sta imela dva bolnika cirozo in povprečna vrednost eGFR je bila 24,9 ml/min (razpon: 9,0-39,6).
English: In repeat dose toxicology studies in rat and dog, high doses of the 1:1 diastereomeric mixture caused adverse liver (dog) and heart (rat) effects and gastrointestinal reactions (dog).
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih pri podganah in psih so veliki odmerki diastereomeričnih mešanic v razmerju 1:1 povzročili neželene učinke na jetra (psi) in srce (podgane) in reakcije v prebavilih (psi).
English: ANTICONVULSANTS Phenobarbital Phenytoin
Slovenian: ANTIKONVULZANTI Fenobarbital Fenitoin
English: SVR12 was achieved in 18/18 patients.
Slovenian: SVR12 je doseglo 18 od
English: Treatment-naïve adults without cirrhosis - ION-3 (study 0108) - Genotype 1
Slovenian: Predhodno nezdravljeni odrasli brez ciroze - ION-3 (študija 0108) - genotip 1
English: However, it has not been possible to fully estimate exposure margins achieved for sofosbuvir in the rat relative to the exposure in humans at the recommended clinical dose (see section 5.3).
Slovenian: Vendar pa ni bilo mogoče povsem oceniti meja izpostavljenosti pri podganah, doseženih pri sofosbuvirju, glede na izpostavljenost pri ljudeh, ki so prejemali priporočeni klinični odmerek (glejte poglavje 5.3).
English: 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.
Slovenian: Če bolnik izpusti odmerek in je preteklo manj kot 18 ur od običajnega časa za jemanje zdravila, bolniku naročite, naj tableto vzame takoj, ko je mogoče, nato pa naj naslednji odmerek vzame ob običajnem času.
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A or carboxylesterase 1 and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Slovenian: Pot presnovne aktivacije vključuje sekvenčno hidrolizo karboksil-esternega dela, ki jo katalizira humani katepsin A ali karboksilesteraza 1 in cepitev fosforamidata z nukleotid-vezajočo beljakovino s histidinsko triado 1, čemur sledi fosforilacija po biosintezni poti pirimidinskih nukleotidov.
English: In this limited clinical safety data set, the rate of adverse events was not clearly elevated from what is expected in patients with severe renal impairment.
Slovenian: V tem omejenem naboru podatkov klinične varnosti stopnja neželenih učinkov ni bila očitno večja od tiste, ki je pričakovana pri bolnikih s hudo ledvično okvaro.
English: NS5A RAVs: No genotype 2 infected patients experienced relapse in the clinical study and therefore there are no data regarding NS5A RAVs at the time of failure.
Slovenian: RAV NS5A: V klinični študiji ni noben bolnik, okužen z genotipom 2, doživel relapsa, zato ni podatkov o RAV NS5A v času neuspeha.
English: 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).
Slovenian: Zdravilo Harvoni je indicirano za zdravljenje kroničnega hepatitisa C (CHC-chronic hepatitis C) pri odraslih in mladostnikih, starih od 12 do < 18 let (glejte poglavja 4.2, 4.4 in 5.1).
English: The improvement in MELD scores observed was driven largely by improvements in total bilirubin.
Slovenian: Izboljšanje rezultatov MELD je bilo večinoma posledica izboljšanja skupne ravni bilirubina.