FrancophonIA/ELRC3.0 huggingface dataset:
English: 1.5-fold↑
Slovenian: 1,5-krat↑
English:  If this applies to you, do not take Epclusa and tell your doctor immediately.
Slovenian: Če to velja za vas, ne jemljite zdravila Epclusa in se takoj posvetujte z zdravnikom.
English: Treatment of overdose with Epclusa consists of general supportive measures including monitoring of vital signs, as well as observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerka z zdravilom Epclusa je sestavljeno iz splošnih podpornih ukrepov, ki vključujejo spremljanje vitalnih znakov in opazovanje kliničnega stanja bolnika.
English: Overall SVR12 83% (75/90) Genotype 1
Slovenian: Celokupni SVR12 83 % (75/90) Genotip 1
English: Pharmacotherapeutic group: Direct acting antiviral, ATC code: J05AP55
Slovenian: Farmakoterapevtska skupina: zdravila z direktnim delovanjem na viruse, oznaka ATC: J05AP55
English: Observed: Rosuvastatin ↑
Slovenian: Rosuvastatin ↑
English: 1.4-fold↑
Slovenian: 1,4-krat↑
English: • H2-receptor antagonists (such as famotidine, cimetidine, nizatidine or ranitidine).
Slovenian: • antagoniste receptorjev H2 (kot so famotidin, cimetidin, nizatidin ali ranitidin).
English: • a wide spread severe rash with peeling skin which may be accompanied by fever, flu like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens Johnson syndrome).
Slovenian: • zelo razširjen hud izpuščaj z luščenjem kože, ki ga lahko spremljajo vročina, gripi podobni simptomi ter mehurji v ustih, očeh in/ali genitalijah (Stevens-Johnsonov sindrom).
English: Unchanged velpatasvir is the major species present in faeces.
Slovenian: Nespremenjeni velpatasvir je glavna vrsta, prisotna v blatu.
English: Combinations of these variants often showed greater reductions in susceptibility to velpatasvir than single RAVs alone.
Slovenian: Kombinacije teh različic so pogosto pokazale večje zmanjšanje dovzetnosti za velpatasvir kot posamezne RAV.
English: • are taking treatment for human immunodeficiency virus (HIV) infection, since your doctor may want to monitor you more closely.
Slovenian: • se zdravite za okužbo z virusom humane imunske pomanjkljivosti (HIV), ker vas bo morda zdravnik spremljal bolj skrbno.
English: Pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Slovenian: Farmakokinetični podatki za tega bolnika so bili v skladu z neupoštevanjem zdravljenja.
English: It is given to treat a chronic (long-term) viral infection of the liver called hepatitis C in adults of 18 years and older.
Slovenian: Daje se za zdravljenje kronične (dolgotrajne) okužbe jeter, imenovane hepatitis C, pri odraslih, starih 18 let in več.
English: Tell your doctor or pharmacist if you are taking any of the medicines below:
Slovenian: Zdravnika ali farmacevta obvestite, če jemljete katero koli od spodaj navedenih zdravil:
English: Observed: Pravastatin ↑
Slovenian: Pravastatin ↑
English: In these healthy volunteer studies, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups.
Slovenian: V tej študiji z zdravimi prostovoljci ob teh ravneh odmerkov niso opazili neugodnih učinkov, neželeni učinki pa so bili po pogostnosti in resnosti podobni tistim, ki so jih poročali v skupinah, ki so prejemale placebo.
English: No individual substitutions tested in genotypes 2a, 4a, or 5a conferred a > 100-fold reduction in velpatasvir susceptibility.
Slovenian: Nobene posamezne substitucije, testirane v genotipih 2a, 4a ali 5a, niso doprinesle k > 100-kratnemu zmanjšanju dovzetnosti za velpatasvir.
English: Co-administration of Epclusa with medicinal products that are substrates of these transporters may increase the exposure of such medicinal products.
Slovenian: Sočasna uporaba zdravila Epclusa z zdravili, ki so substrati teh prenašalcev, lahko poveča izpostavljenost takšnim zdravilom.
English: The response rates observed for patients ≥ 65 years of age were similar to that of patients < 65 years of age, across treatment groups.
Slovenian: starih ≥ 65 let, so bile podobne kot pri bolnikih, starih < 65 let, v vseh skupinah zdravljenja.
English: • 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: No patients in the placebo group achieved SVR12.
Slovenian: V skupini, ki je prejemala placebo, noben bolnik ni dosegel SVR12.
English: No patient had HIV-1 rebound during the study, and CD4+ counts were stable during treatment.
Slovenian: Med študijo ni pri nobenem bolniku prišlo do povrnitve HIV-1, vrednosti CD4+ pa so bile med zdravljenjem stabilne.
English: County Cork
Slovenian: County Cork IRSKA
English: Evaluation of sofosbuvir in combination with velpatasvir showed no antagonistic effect in reducing HCV RNA levels in replicon cells.
Slovenian: Ocena sofosbuvirja v kombinaciji z velpatasvirjem ni pokazala antagonističnega učinka pri zmanjšanju ravni HCV RNK v celicah replikonov.
English: If vomiting occurs more than 3 hours after dosing, no further dose of Epclusa is needed (see section 5.1).
Slovenian: Če se bruhanje pojavi več kot 3 ure po odmerjanju, dodaten odmerek zdravila Epclusa ni potreben (glejte poglavje 5.1).
English: Your liver function may change with treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.).
Slovenian: Zaradi zdravljenja hepatitisa C se delovanje vaših jeter lahko spremeni, kar lahko vpliva na druga zdravila (npr. zdravila za zaviranje imunskega sistema itd.).
English: SVR12 was achieved by 19/19 patients with cirrhosis.
Slovenian: SVR12 je doseglo vseh 19/19 bolnikov s cirozo.
English: Table 1: Recommended treatment and duration for all HCV genotypes
Slovenian: Preglednica 1: Priporočeno zdravljenje in trajanje zdravljenja za vse genotipe HCV Populacija bolnikova
English: As liver function may change during treatment with Epclusa, a close monitoring of International Normalised Ratio (INR) values is recommended.
Slovenian: Ker se delovanje jeter v času zdravljenja z zdravilom Epclusa lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR).
English: Patients should be instructed not to take a double dose of Epclusa.
Slovenian: Bolniku je treba naročiti, naj ne vzame dvojnega odmerka zdravila Epclusa.
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 s sofosbuvirjem: Pogostnost naslednjih neželenih učinkov ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Epclusa.
Slovenian: Zaradi dolge razpolovne dobe amiodarona je treba ustrezno spremljati tudi bolnike, ki so prekinili zdravljenje z amiodaronom v zadnjih nekaj mesecih in bodo začeli zdravljenje z zdravilom Epclusa.
English: The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets.
Slovenian: Na voljo so naslednje velikosti pakiranja: škatle, ki vsebujejo 1 plastenko z 28 filmsko obloženimi tabletami.
English: Changes in the parameters found in the CPT score system in patients achieving SVR12 in ASTRAL-4 (all 3 regimens) are shown in Table 16.
Slovenian: Spremembe v parametrih rezultatov CPT pri bolnikih, ki so dosegli SVR12 v študiji ASTRAL-4 (vsi trije režimi), so prikazane v preglednici 16.
English: ↔ Ketoconazole
Slovenian: ↔ Ketokonazol
English: Clinical studies of Epclusa included 156 patients aged 65 and over (12% of total number of patients in the Phase 3 clinical studies).
Slovenian: V klinične študije zdravila Epclusa je bilo vključenih 156 bolnikov, starih 65 let ali več (12 % skupnega števila bolnikov v kliničnih študijah 3. faze).
English: Rosuvastatin, at a dose that does not exceed 10 mg, may be administered with Epclusa.
Slovenian: Rosuvastatin v odmerku, ki ne presega 10 mg, se lahko uporablja z zdravilom Epclusa.
English: The recommended dose of Epclusa is one tablet, taken orally, once daily with or without food (see section 5.2).
Slovenian: Priporočeni odmerek zdravila Epclusa je ena tableta peroralno enkrat na dan s hrano ali brez nje (glejte poglavje 5.2).
English: This may make Epclusa work less well.
Slovenian: Zaradi tega bo morda zdravilo Epclusa slabše delovalo.
English: The overall mean CD4+ count was 598 cells/µL (range: 183−1513 cells/µL).
Slovenian: Skupno povprečno število CD4+ je bilo 598 celic/μl (razpon: 183−1.513 celic/μl).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Epclusa in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Epclusa za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The use of Epclusa in children and adolescents has not yet been studied.
Slovenian: Uporabe zdravila Epclusa pri otrocih in mladostnikih niso preučevali.
English: H2-receptor antagonists may be administered simultaneously with or staggered from Epclusa at a dose that does not exceed doses comparable to famotidine 40 mg twice daily.
Slovenian: Antagoniste receptorjev H2 se lahko uporablja sočasno z zdravilom Epclusa ali s časovnim zamikom, v odmerku, ki ne presega odmerkov, primerljivih s famotidinom 40 mg dvakrat na dan.
English: Sustained virologic response (SVR12), defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment, was the primary endpoint to determine the HCV cure rate.
Slovenian: Trajni virološki odziv (SVR12), opredeljen kot HCV RNK, ki je nižji od LLOQ v 12. tednu po prenehanju zdravljenja, je bil primarni opazovani dogodek za ugotovitev stopnje ozdravljenja HCV.
English: Genotype 1a 6% (3/50)
Slovenian: Genotip 1a 6 % (3/50)
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.8-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 18-fold↑ Velpatasvir
Slovenian: 1,6-krat↑ 2,1-krat↑ 2,7-krat↑ 1,3-krat↑ 1,6-krat↑ ~2-krat↑ 1,8-krat↑ GS-331007 1,6-krat↑ 1,9-krat↑ 5,5-krat↑ ≥10-krat↑ ≥20-krat↑ ~7-krat↑ 18-krat↑
English: If the starting dose is not well tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels
Slovenian: Če bolnik začetnega odmerka ne prenaša dobro, je treba odmerek zmanjšati, kot je klinično indicirano, na podlagi vrednosti hemoglobina.
English: As a precautionary measure, Epclusa use is not recommended during pregnancy.
Slovenian: Kot previdnostni ukrep uporaba zdravila Epclusa ni priporočljiva med nosečnostjo.
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity and exposure to the major metabolite GS-331007 was instead used to estimate exposure margins.
Slovenian: Izpostavljenost sofosbuvirju v študijah pri glodavcih ni bilo mogoče zaznati, verjetno zaradi visoke aktivnosti esteraze in izpostavljenosti glavnemu presnovku GS-331007, ki je bil namesto tega uporabljen za ocenitev meja izpostavljenosti.
English: The resistance associated variants (RAVs) selected in 2 or more genotypes were F28S, L31I/V and Y93H.
Slovenian: Z odpornostjo povezane različice (RAV, resistance-associated variant), izbrane v 2 ali več genotipih, so bile F28S, L31I/V in Y93H.
English: Patients should be instructed to swallow the tablet whole with or without food (see section 5.2).
Slovenian: Bolnikom je treba naročiti, naj pogoltnejo celo tableto s hrano ali brez nje (glejte poglavje 5.2).
English: If you need high doses of these medicines your doctor may give you a different medicine instead or adjust the dose of the medicine you are taking.
Slovenian: Če potrebujete velike odmerke teh zdravil, vam lahko vaš zdravnik predpiše drugo zdravilo ali prilagodi odmerek zdravila, ki ga že jemljete.
English: The moderate or high fat meal increased sofosbuvir AUC0-inf by 60% and 78%, respectively, but did not substantially affect the sofosbuvir Cmax.
Slovenian: Obrok z zmerno ali visoko vsebnostjo maščobe je povečal vrednost AUC0-inf za sofosbuvir za 60 % in 78 %, vendar ni imel večjega vpliva na vrednost Cmax za sofosbuvir.
English: In vitro data suggests that the majority of NS5A RAVs that confer resistance to ledipasvir and daclatasvir remained susceptible to velpatasvir.
Slovenian: In vitro podatki nakazujejo, da je večina RAV NS5A, ki doprinesejo k odpornosti na ledipasvir in daklatasvir, ostala dovzetna za velpatasvir.
English: Interactions between Epclusa 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 interaction boundaries).
Slovenian: Interakcije med zdravilom Epclusa in drugimi zdravili V preglednici 3 je seznam ugotovljenih ali možnih klinično pomembnih interakcij med zdravili (pri čemer je bil 90-odstotni interval zaupanja [IZ] povprečnega razmerja (geometrično povprečje po metodi najmanjših kvadratov [GLSM, geometric least-squares mean]) znotraj „↔“, razširjen nad „↑“ ali razširjen pod „↓“ vnaprej določene meje interakcij).
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Epclusa compared to subjects with normal renal function, as described in the text below, are provided in Table 18.
Slovenian: Ledvična okvara Povzetek učinka različnih stopenj ledvične okvare na izpostavljenost sestavinam zdravila Epclusa v primerjavi z osebami z normalnim delovanjem ledvic, kot je opisano spodaj, so na voljo v preglednici 18.
English: Randomisation was stratified by the presence or absence of cirrhosis and prior treatment experience (treatment-naïve versus treatment-experienced).
Slovenian: Randomizacija je bila stratificirana glede na prisotnost ali odsotnost ciroze in izkušnje s predhodnim zdravljenjem (predhodno nezdravljene osebe v primerjavi s predhodno zdravljenimi).
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Epclusa 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 Epclusa, uporablja samo, če drugih nadomestnih antiaritmikov ne prenašajo ali če so ti pri njih kontraindicirani.
English: • tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
Slovenian: • dizoproksiltenofovirijev fumarat ali katero koli zdravilo, ki vsebuje dizoproksiltenofovirijev fumarat, ki se uporablja za zdravljenje okužbe z virusom HIV;
English: Epclusa is sometimes taken with another medicine, ribavirin.
Slovenian: Zdravilo Epclusa se včasih jemlje s še enim zdravilom, ribavirinom.
English: 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: Ni bilo mogoče povsem oceniti meja izpostavljenosti pri podganah, doseženih pri sofosbuvirju, glede na izpostavljenost pri ljudeh, ki prejemajo priporočeni klinični odmerek (glejte poglavje 5.3).
English: The response rates in Phase 3 studies were similar in HCV-infected patients who received Epclusa with food or without food.
Slovenian: Stopnje odziva v študijah 3. faze so bile podobne pri bolnikih z okužbo s HCV, ki so zdravilo Epclusa prejemali s hrano ali brez nje.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Epclusa, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Slovenian: Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom Epclusa, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
English: Taking Epclusa with any of these may stop your medicines from working properly, or make any side effects worse.
Slovenian: Jemanje zdravila Epclusa s katerim koli od teh zdravil lahko povzroči, da vaša zdravila morda ne bodo pravilno delovala ali pa se bodo neželeni učinki okrepili.
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 Epclusa.
English: In the pooled analysis of the Phase 3 studies, 380/1,023 (37%) patients' virus had baseline NS5A RAVs.
Slovenian: V združeni analizi študij 3. faze je imelo 380/1.023 (37 %) virusov pri bolnikih izhodiščne RAV NS5A.
English: What Epclusa is and what it is used for
Slovenian: Kaj je zdravilo Epclusa in za kaj ga uporabljamo
English: You must read the “Pregnancy” section in the ribavirin package leaflet very carefully.
Slovenian: Natančno preberite poglavje „Nosečnost“ v navodilu za uporabo ribavirina.
English: If you forget to take Epclusa
Slovenian: Če ste pozabili vzeti zdravilo Epclusa
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Slovenian: Sofosbuvir se obširno presnovi v jetrih, kjer tvori v farmakološko aktivni nukleozidni analog trifosfat GS-461203.
English: If you are sick (vomit) after taking Epclusa it may affect the amount of Epclusa in your blood.
Slovenian: Če bruhate po uporabi zdravila Epclusa, lahko to vpliva na količino zdravila Epclusa v vaši krvi.
English: The film-coated tablets are pink, diamond-shaped tablets debossed with “GSI” on one side and “7916” on the other side.
Slovenian: Filmsko obložene tablete so rožnate tablete v obliki romba, z vtisnjeno oznako „GSI“ na eni in „7916“ na drugi strani.
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 polimeraz DNK in RNK pri človeku niti ne zavira mitohondrijske polimeraze RNK.
English: • efavirenz used to treat HIV infection;
Slovenian: • efavirenz, ki se uporablja se za zdravljenje okužbe z virusom HIV;
English: Site-directed mutagenesis of the S282T substitution in replicons of genotype 1 to 6 conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the replication viral capacity by 89% to 99% compared to the corresponding wild-type.
Slovenian: Usmerjena mutageneza substitucije S282T v replikonih genotipov 1 do 6 je doprinesla k 2- do 18-krat zmanjšani dovzetnosti za sofosbuvir in zmanjšala replikacijsko sposobnost virusa za 89 % do 99 % v primerjavi z ustreznim nemutiranim tipom virusa.
English: When Epclusa is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance < 50 mL/min (see section 5.2).
Slovenian: Če se zdravilo Epclusa uporablja v kombinaciji z ribavirinom, glejte tudi povzetek glavnih značilnosti za ribavirin za bolnike z očistkom kreatinina < 50 ml/min (glejte poglavje 5.2).
English: The adverse events observed were consistent with expected clinical sequelae of decompensated liver disease, or the known toxicity profile of ribavirin for patients receiving Epclusa in combination with ribavirin.
Slovenian: Opaženi neželeni učinki so bili skladni s pričakovanimi kliničnimi posledicami dekompenzirane bolezni jeter ali pa so bili v skladu z znanim toksikološkim profilom ribavirina za bolnike, ki so prejemali zdravilo Epclusa v kombinaciji z ribavirinom.
English: Interaction only studied with velpatasvir.
Slovenian: Preučevane so bile samo interakcije z velpatasvirjem.
English: Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Slovenian: Zdravilo Epclusa je indicirano za zdravljenje kronične okužbe z virusom hepatitisa C (HCV) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
English: SVR without Y93H 95% CI
Slovenian: SVR brez Y93H 95 % IZ
English: Animal studies do not indicate harmful effects of sofosbuvir or velpatasvir on fertility.
Slovenian: Študije na živalih ne kažejo škodljivih učinkov sofosbuvirja ali velpatasvirja na plodnost.
English: Co-administration of Epclusa with digoxin may increase the concentration of digoxin.
Slovenian: Sočasno dajanje zdravila Epclusa z digoksinom lahko poveča koncentracijo digoksina.
English: The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir or velpatasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with sofosbuvir/velpatasvir.
Slovenian: Opisane interakcije med zdravili temeljijo na študijah, izvedenih z bodisi sofosbuvirjem/velpatasvirjem ali velpatasvirjem in sofosbuvirjem kot posameznimi učinkovinami ali so predvidene interakcije med zdravili, ki se lahko pojavijo s sofosbuvirjem/velpatasvirjem.
English: • fainting.
Slovenian: • omedlevico.
English: In this setting, exposure of sofosbuvir metabolite GS331007 was 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: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Epclusa.
Slovenian: Zdravnik bo morda moral skrbno spremljati druga zdravila, ki jih jemljete, in po uvedbi zdravila Epclusa prilagoditi njihov odmerek.
English: This is due to liver function changes during treatment with Epclusa.
Slovenian: Razlog za to so spremembe delovanja jeter pri zdravljenju z zdravilom Epclusa.
English: Velpatasvir is an inhibitor of drug transporter P-gp, BCRP, OATP1B1 and OATP1B3 and its involvement in drug interactions with these transporters is primarily limited to the process of absorption.
Slovenian: Velpatasvir je zaviralec prenašalcev P-gp, BCRP, OATP1B1 in OATP1B3, njegovo sodelovanje pri medsebojnem delovanju s temi prenašalci pa je primarno omejeno na proces absorpcije.
English: If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Epclusa.
Slovenian: Če jemljete antacid, ga vzemite vsaj 4 ure pred zdravilom Epclusa ali najmanj 4 ure po tem.
English: Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Slovenian: Zdravljenje z zdravilom Epclusa mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi bolnikov z okužbo s HCV.
English: Haemodialysis is unlikely to result in significant removal of velpatasvir, since velpatasvir is highly bound to plasma protein.
Slovenian: Ni verjetno, da bi hemodializa pomembno odstranila velpatasvir, saj se velpatasvir v veliki meri veže na beljakovine v plazmi.
English: Table 18: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Velpatasvir Compared to Subjects with Normal Renal Function
Slovenian: Preglednica 18: Učinek različnih stopenj ledvične okvare na izpostavljenosti (AUC) sofosbuvirju, GS-331007 in velpatasvirju v primerjavi z osebami z normalnim delovanjem ledvic