FrancophonIA/ELRC3.0 huggingface dataset:
English: Some combinations of substitutions in genotypes 1a and 3a (including A30K+Y93H in genotype 3a) showed reductions in susceptibility to pibrentasvir.
Slovenian: Nekatere kombinacije substitucij pri genotipih 1a in 3a (vključno z A30K+Y93H pri genotipu 3a) so zmanjšale občutljivost za pibrentasvir.
English: Table 3 provides the least-squares mean Ratio (90% Confidence Interval) effect on concentration of Maviret and some common concomitant medicinal products.
Slovenian: Preglednica 3 prikazuje povprečno razmerje učinka po metodi najmanjših kvadratov (90-odstotni interval zaupanja) na koncentracijo zdravila Maviret in nekaj pogosto sočasno uporabljenih zdravil.
English: The combination of Maviret with tacrolimus should be used with caution.
Slovenian: Pri sočasni uporabi zdravila Maviret s takrolimusom je potrebna previdnost.
English: Maternal toxicity (anorexia, lower body weight, and lower body weight gain) with some embryofoetal toxicity (increase in post-implantation loss and number of resorptions and a decrease in mean foetal body weight), precluded the ability to evaluate glecaprevir in the rabbit at clinical exposures.
Slovenian: Toksični učinki pri samicah-materah (anoreksija, manjša telesna masa in manjše pridobivanje telesne mase) ob nekaterih hkratnih embriofetalnih toksičnih učinkih (več poimplantacijskih izgub in večje število resorpcij ter zmanjšanje povprečne telesne mase plodov) so preprečili, da bi lahko glekaprevir pri kuncih ocenili ob klinični ravni izpostavljenosti.
English: For dosing recommendations with HIV antiviral agents, refer to section 4.5.
Slovenian: Za priporočila o odmerjanju s protivirusnimi zdravili proti HIV glejte poglavje 4.5.
English: Maviret is an antiviral medicine used to treat adults and adolescents (12 to less than 18 years old) with long-term (‘chronic') hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Slovenian: Zdravilo Maviret je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih bolnikov in mladostnikov (starih od 12 do <18 let) z dolgotrajnim (»kroničnim«) hepatitisom C (nalezljivo boleznijo, ki jo povzroča virus hepatitisa C in prizadene jetra).
English: P-gp and not excluded BCRP a. Median Tmax following single doses of glecaprevir and pibrentasvir in healthy subjects.
Slovenian: P-gp in BCRP ni izključen a. Mediani tmax po enkratnem odmerku glekaprevirja in pibrentasvirja pri zdravih preiskovancih.
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 zdravilom 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: c. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
Slovenian: c. Recidiv je opredeljen kot HCV RNA ≥ LLOQ po odzivu na koncu zdravljenja med bolniki, ki so dokončali zdravljenje.
English: Hypromellose 2910 (E464) Lactose monohydrate Titanium dioxide Macrogol 3350
Slovenian: Filmska obloga hipromeloza 2910 (E464) laktoza monohidrat titanov dioksid makrogol 3350
English: A 12-week treatment duration has been evaluated and is recommended in liver or kidney transplant recipients with or without cirrhosis (see section 5.1).
Slovenian: 12-tedensko zdravljenje je bilo ovrednoteno in se priporoča pri bolnikih s presajenimi jetri ali ledvicami, z ali brez ciroze (glejte poglavje 5.1).
English: Maviret is available in a pack of 84 tablets as 4 cartons, each containing 21 film-coated tablets.
Slovenian: Zdravilo Maviret je na voljo v pakiranju po 84 tablet, in sicer kot 4 škatle, vsaka vsebuje 21 filmsko obloženih tablet.
English: • your treatment has worked and you are free of the hepatitis C virus.
Slovenian: • je zdravljenje uspelo in nimate več virusa hepatitisa C.
English: Systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 63 and 102 times higher, respectively, than the exposure in humans at the recommended dose.
Slovenian: Sistemska izpostavljenost (AUC) glekaprevirju je bila približno 63-krat večja, pibrentasvirju pa približno 102-krat večja kot je izpostavljenost pri človeku ob priporočenem odmerku.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of glecaprevir or pibrentasvir in pregnant women.
Slovenian: Podatkov o uporabi glekaprevirja in pibrentasvirja pri nosečnicah ni ali jih je malo (manj kot 300 izidov nosečnosti).
English: Substitutions important for the HCV protease inhibitor class at positions 36, 43, 54, 55, 56, 155, 166, or 170 in NS3 had no impact on glecaprevir activity.
Slovenian: Substitucije, pomembne za skupino zaviralcev proteaze HCV na položajih 36, 43, 54, 55, 56, 155, 166 ali 170 v NS3, niso vplivale na aktivnost glekaprevirja.
English: • If you notice within 18 hours of the time you usually take Maviret take the dose as soon as possible.
Slovenian: • Če to opazite v 18 urah od časa, ko običajno vzamete zdravilo Maviret, odmerek vzemite čim prej.
English: SVR12 in subjects without cirrhosis 8 weeks
Slovenian: SVR12 pri preiskovancih brez ciroze 8 tednov
English: Animal studies do not indicate harmful effects of glecaprevir or pibrentasvir on fertility at exposures higher than the exposures in humans at the recommended dose (see Section 5.3).
Slovenian: Študije na živalih niso pokazale škodljivih vplivov glekaprevirja ali pibrentasvirja na plodnost ob izpostavljenostih, ki so bile večje od izpostavljenosti pri človeku med uporabo priporočenega odmerka (glejte poglavje 5.3).
English: b. Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Slovenian: b. Opisan je vpliv atazanavirja in ritonavirja na prvi odmerek glekaprevirja in pibrentasvirja.
English: If you are not sure, talk to your doctor or pharmacist before taking Maviret.
Slovenian: Če niste prepričani, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Maviret.
English: The overall SVR12 rate was 100% (47/47).
Slovenian: Skupna stopnja SVR12 je bila 100 % (47/47).
English: If you accidentally take more than the recommended dose, contact your doctor or go to the nearest hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Maviret, kot bi smeli Če nenamerno vzamete večji odmerek od priporočenega, se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
English: The overall safety profile in HCV/HIV-1 co-infected subjects (ENDURANCE-1 and EXPEDITION2) was comparable to that observed in HCV mono-infected subjects.
Slovenian: Celoten varnostni profil pri preiskovancih, sočasno okuženih s HCV/HIV-1 (študiji ENDURANCE-1 in EXPEDITION-2), je bil primerljiv s tistim, ki so ga opazili pri preiskovancih, okuženih samo s HCV.
English: • St. John's wort (Hypericum perforatum), (herbal remedy used for mild depression).
Slovenian: • Šentjanževka (Hypericum perforatum), (zdravilo rastlinskega izvora, ki se uporablja pri blagi depresiji).
English: Glecaprevir and pibrentasvir are substrates of the efflux transporters P-gp and/or BCRP.
Slovenian: Glekaprevir in pibrentasvir sta substrata iztočnih prenašalcev P-gp in/ali BCRP.
English: In case a dose of Maviret is missed, the prescribed dose can be taken within 18 hours after the time it was supposed to be taken.
Slovenian: Če bolnik izpusti odmerek zdravila Maviret, lahko predpisani odmerek vzame v 18 urah po času, ob katerem bi moral vzeti odmerek.
English: Specifically in genotype 3a, A30K or Y93H had no impact on pibrentasvir activity.
Slovenian: Specifično pri genotipu 3a A30K oz. Y93H nista vplivala na aktivnost pibrentasvirja.
English: ANGIOTENSIN-II RECEPTOR BLOCKERS Losartan
Slovenian: BLOKATORJI RECEPTORJEV ANGIOTENZINA II losartan enkraten odmerek
English: The overall SVR12 rates were 97.2% (352/362) and 99.4% (159/160) in VOYAGE-1 and VOYAGE-2, respectively.
Slovenian: Celotni delež SVR12 je bil 97,2 % (352/362) v VOYAGE-1 oziroma 99,4 % (159/160) v VOYAGE-2.
English: Glecaprevir is also a substrate of the hepatic uptake transporters OATP1B1/3.
Slovenian: Glekaprevir je tudi substrat jetrnih privzemnih prenašalcev OATP1B1/3.
English: Population pharmacokinetic analysis in HCV-infected subjects showed that within the age range (12 to 88 years) analysed, age did not have a clinically relevant effect on the exposure to glecaprevir or pibrentasvir.
Slovenian: Populacijska farmakokinetična analiza pri preiskovancih, okuženih s HCV, je pokazala, da v analiziranem razponu starosti (od 12 do 88 let) starost ni klinično pomembno vplivala na izpostavljenost glekaprevirju ali pibrentasvirju.
English: 16 weeks (GT3 TE only) (n=3)
Slovenian: 16 tednov (samo GT3 TE) (n=3)
English: Genotype 2 Genotype 4 Genotype 5 Genotype 6
Slovenian: Genotip 4 Genotip 5 Genotip 6
English: General disorders and administration site conditions Very common fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti utrujenost pogosti astenija
English: Elevations in total bilirubin of at least 2x upper limit normal (ULN) were observed in 1.3% of subjects related to glecaprevir-mediated inhibition of bilirubin transporters and metabolism.
Slovenian: Zvišanje celokupnega bilirubina na vsaj 2-kratno zgornjo normalno mejo (ULN - upper limit normal) so opazili pri 1,3 % preiskovancev, kar je povezano z zavrtjem bilirubinskih prenašalcev in presnove zaradi glekaprevirja.
English: MAGELLAN-2 Maviret for 12 weeks (n=100) Adolescent subjects (12 to <18 years) GT1-6
Slovenian: MAGELLAN-2 Zdravilo Maviret 12 tednov (n = 100) Mladostniki (stari od 12 do <18 let) GT1-6
English: Substitutions at amino acid position 168 in NS3 had no impact in genotype 2, while some substitutions at position 168 reduced glecaprevir susceptibility by up to 55-fold (genotypes 1, 3, 4), or reduced susceptibility by > 100-fold (genotype 6).
Slovenian: Substitucije na aminokislinskem položaju 168 v NS3 niso vplivale pri genotipu 2, nekatere substitucije na položaju 168 pa so zmanjšale občutljivost za glekaprevir do 55-krat (genotip 1, 3, 4) ali več kot 100-krat (genotip 6).
English: Both glecaprevir and pibrentasvir were fully active against substitutions associated with resistance to NS5B nucleotide and non-nucleotide inhibitors.
Slovenian: Tako glekaprevir kot pibrentasvir sta bila popolnoma aktivna proti substitucijam, povezanim z odpornostjo proti NS5B nukleotidnim in nenukleotidnim zaviralcem.
English: Glecaprevir EC50, nM Pibrentasvir EC50, nM
Slovenian: EC50 glekaprevirja, nM EC50 pibrentasvirja, nM
English: ENDURANCE-2 Maviret (n=202) or Placebo (n=100) for 12 weeks SURVEYOR-2b
Slovenian: ENDURANCE-2 Zdravilo Maviret (n = 202) ali placebo (n = 100) 12 tednov SURVEYOR-2b
English: SVR12 in subjects with cirrhosis 12 weeks
Slovenian: SVR12 pri preiskovancih s cirozo 12 tednov
English: No dose adjustment of Maviret is required in elderly patients.
Slovenian: Starejši Prilagoditev odmerka zdravila Maviret pri starejših bolnikih ni potrebna.
English: The overall prevalence of A30K and Y93H at baseline was 6.5% and 4.9%, respectively.
Slovenian: Celotna izhodiščna prevalenca A30K je bila 6,5 % in Y93H 4,9 %.
English: Glecaprevir was fully active against resistance-associated substitutions in NS5A, while pibrentasvir was fully active against resistance-associated substitutions in NS3.
Slovenian: Glekaprevir je bil popolnoma aktiven proti substitucijam v NS5A, povezanim z odpornostjo, pibrentasvir pa je bil popolnoma aktiven proti substitucijam v NS3, povezanim z odpornostjo.
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years (see sections 4.2, 4.4. and 5.1).
Slovenian: Zdravilo Maviret je indicirano za zdravljenje kronične okužbe z virusom hepatitisa C (HCV) pri odraslih in mladostnikih, starih od 12 do <18 let (glejte poglavja 4.2, 4.4 in 5.1).
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Maviret.
Slovenian: Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Maviret, nizke ravni sladkorja v krvi (hipoglikemija).
English: Amino acid substitutions in NS3 or NS5A selected in cell culture or important for the inhibitor class were phenotypically characterized in replicons.
Slovenian: V celični kulturi Substitucije aminokislin v NS3 ali NS5A, izbrane v celični kulturi oziroma substitucije pomembne za skupino zaviralcev, so bile fenotipsko opredeljene v replikonih.
English: The overall safety profile in transplant recipients was comparable to that observed in subjects in the Phase 2 and 3 studies.
Slovenian: Celoten varnostni profil pri prejemnikih presadka je bil primerljiv s tistim, ki so ga opazili pri preiskovancih v kliničnih študijah 2.
English: Phenytoin, phenobarbital, primidone
Slovenian: ↓ pibrentasvir fenitoin, fenobarbital, primidon
English: VF=virologic failure a. Percent of subjects with prior treatment experience to PRS is 26%, 14%, 24%, 0%, and 13% for genotypes 1, 2, 4, 5, and 6, respectively.
Slovenian: VN=virusna neodzivnost a. Odstotki preiskovancev, predhodno že zdravljenih s PRS, po genotipih so 26 %, 14 %, 24 %, 0 % in 13 % z genotipom 1, 2, 4, 5 ali 6, v tem zaporedju.
English: The safety assessment of Maviret in subjects treated for 8, 12 or 16 weeks with compensated liver disease (with or without cirrhosis) was based on registrational Phase 2 and 3 studies which evaluated approximately 2,300 subjects.
Slovenian: Ocena varnosti zdravila Maviret pri preiskovancih s kompenzirano boleznijo jeter (s cirozo ali brez nje), zdravljenih 8, 12 ali 16 tednov, je temeljila na registracijskih študijah 2. in 3. faze, v katerih so ocenili približno 2.300 bolnikov.
English: Glecaprevir and pibrentasvir were not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rodent micronucleus assays.
Slovenian: Glekaprevir in pibrentasvir nista bila genotoksična v skupini preizkusov in vitro ali in vivo, vključno s preizkusom mutagenosti pri bakterijah, preizkusom kromosomskih aberacij na humanih limfocitih iz periferne krvi in v mikrojedrnem preizkusu in vivo pri glodalcih.
English: Pibrentasvir was the only component observed in the milk of lactating rats without effect on nursing pups.
Slovenian: Pibrentasvir je bil edina snov v mleku doječih podgan, brez vpliva na dojene mladiče.
English: Co-administration of such medicinal products with Maviret is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba takšnih zdravil z zdravilom Maviret je kontraindicirana (glejte poglavje 4.3).
English: Overall, the changes in exposures of Maviret in HCV-infected subjects with renal impairment with or without dialysis were not clinically significant.
Slovenian: V celoti spremembe izpostavljenosti zdravilu Maviret pri preiskovancih, ki so bili okuženi s HCV in so imeli okvaro ledvic (z dializo ali brez nje), ni bila klinično pomembna.
English: Unchanged glecaprevir was the main component observed in the milk of lactating rats without effect on nursing pups.
Slovenian: Nespremenjeni glekaprevir je bil glavna snov v mleku doječih podgan, brez vpliva na dojene mladiče.
English: b. Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
Slovenian: b. Vključuje bolnike, ki so zdravljenje prenehali zaradi neželenega učinka, so se izgubili spremljanju ali so se umaknili iz študije.
English: The safety of Maviret in HCV GT1-6 infected adolescents is based on data from a Phase 2/3 openlabel study in 47 subjects aged 12 years to <18 years treated with Maviret for 8 to 16 weeks (DORAPart 1).
Slovenian: Varnost zdravila Maviret pri mladostnikih, okuženih s HCV GT1-6, temelji na podatkih iz faze 2/3 odprte študije pri 47 preiskovancih, starih od 12 let do <18 let, ki so se zdravili z zdravilom Maviret 8
English: Potential for Maviret to affect other medicinal products
Slovenian: Možen vpliv zdravila Maviret na druga zdravila
English: d. Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
Slovenian: d. Vključuje bolnike, ki so zdravljenje prenehali zaradi neželenega učinka, so se izgubili spremljanju ali so se umaknili iz študije.
English: Treatment difference -1.2%; 95% confidence interval (-5.6% to 3.1%) Treatment difference -0.4%; 97.5% confidence interval (-5.4% to 4.6%) Outcome for subjects without SVR12 On-treatment VF Relapsea Otherb a. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
Slovenian: Razlika zdravljenj -1,2 %; 95 % interval zaupanja (-5,6 % do 3,1 %) Razlika zdravljenj -0,4 %; 97,5 % interval zaupanja (-5,4 % do 4,6 %) Izid pri preiskovancih brez SVR12 VN med zdravljenjem Recidiva Drugob a. Recidiv je opredeljen kot HCV RNA ≥ LLOQ po odzivu na koncu zdravljenja med bolniki, ki so dokončali zdravljenje.
English: Subjects with genotype 3b infection
Slovenian: Preiskovanci z okužbo z genotipom 3b
English: P-gp, BCRP, and OATP1B1/3
Slovenian: P-gp, BCRP in OATP1B1/3
English: The mechanism for the differences between glecaprevir exposure in chronic Hepatitis C patients with or without cirrhosis is unknown.
Slovenian: Mehanizem razlike v izpostavljenosti glekaprevirju pri bolnikih s kroničnim hepatitisom C s cirozo in brez nje ni znan.
English: If you do miss a dose, work out how long it is since you should have last taken Maviret:
Slovenian: Če odmerek pozabite vzeti, preračunajte, koliko časa je minilo, od kar ste nazadnje vzeli zdravilo
English: No effects on mating, female or male fertility, or early embryonic development were observed in rodents at up to the highest dose tested.
Slovenian: Pri glodalcih niso opazili učinkov na parjenje, plodnost samic ali samcev, ali na embrionalni razvoj vse do največjega testiranega odmerka.
English: Glecaprevir and pibrentasvir are not significantly removed by haemodialysis.
Slovenian: Glekaprevir in pibrentasvir se s hemodializo ne odstranita v pomembni meri.
English: No re-treatment data is available for patients infected with genotypes 2, 3, 5 or 6.
Slovenian: Za bolnike, ki so okuženi z genotipom 2, 3, 5 ali 6, podatkov o ponovnem zdravljenju ni na voljo.
English: Patients treated with vitamin K antagonists
Slovenian: Bolniki, zdravljeni z antagonisti vitamina K
English: % Bound to human plasma proteins Blood-to-plasma ratio
Slovenian: % vezave na beljakovine v humani plazmi
English: Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘NXT'.
Slovenian: Rožnata, podolgovata, bikonveksna filmsko obložena tableta velikosti 18,8 mm x 10,0 mm, z vtisnjeno oznako "NXT" na eni strani.
English: Maviret 12 weeks N=233
Slovenian: Zdravilo Maviret 12 tednov N = 233
English: There was one relapse and no on-treatment virologic failure.
Slovenian: Pojavil se je en recidiv, med zdravljenjem pa ni prišlo do virusne neodzivnosti.
English: What Maviret looks like and contents of the pack
Slovenian: Izgled zdravila Maviret in vsebina pakiranja
English: 16 weeks
Slovenian: 16 tednov
English: • If you notice 18 hours or more after the time you usually take Maviret, wait and take the next dose at your usual time.
Slovenian: • Če to opazite 18 ur ali več od časa, ko običajno vzamete zdravilo Maviret, počakajte in zdravilo vzemite ob običajni uri.
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, AUC, and Cmin) in glecaprevir, pibrentasvir, and the coadministered medicinal product (↑ = increase (more than 25%), ↓ = decrease (more than 20%), ↔ = no change (equal to or less than 20% decrease or 25% increase)).
Slovenian: Smer puščice kaže smer spremembe izpostavljenosti (Cmax, AUC in Cmin) glekaprevirju, pibrentasvirju in sočasno uporabljenemu zdravilu (↑ = povečanje za več kot 25 %, ↓ = zmanjšanje za več kot 20 %,
English: ENDURANCE-5,6 Maviret for 12 weeks (n=9)
Slovenian: ENDURANCE-5,6 Zdravilo Maviret 12 tednov (n=9)
English: The overall SVR12 rate was 97% (98/101).
Slovenian: Skupna stopnja SVR12T je bila 97% (98/101).
English: Patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.4, and 5.2).
Slovenian: Bolniki s hudo okvaro jeter (Child-Pugh C) (glejte poglavje 4.2, 4.4 in 5.2).
English: This may make Maviret work less well.
Slovenian: To lahko poslabša delovanje zdravila Maviret.
English: Pibrentasvir AUC increased in a greater than dose-proportional manner at doses up to 120 mg, (over 10-fold exposure increase at 120 mg QD compared to 30 mg QD), but exhibited linear pharmacokinetics at doses ≥ 120 mg.
Slovenian: AUC pibrentasvirja se je ob odmerkih do 120 mg povečevala več kot sorazmerno odmerku (več kot 10-krat večja izpostavljenost po odmerku 120 mg na dan kot po 30 mg na dan), ob odmerkih ≥ 120 mg pa je bila njena farmakokinetika linearna.
English: film-coated tablets 84 (4 x 21) film-coated tablets
Slovenian: filmsko obložena tableta 84 (4 x 21) filmsko obloženih tablet
English: Accumulating double class resistance was a general finding for patients who failed re-treatment with glecaprevir/pibrentasvir in MAGELLAN-1.
Slovenian: Prisotnost odpornosti na obe skupini je bila splošna ugotovitev za bolnike, pri katerih ponovno zdravljenje z glekaprevirjem/pibrentasvirjem v študiji MAGELLAN-1 ni bilo uspešno.
English: As a precautionary measure, Maviret use is not recommended in pregnancy.
Slovenian: Zaradi previdnosti je priporočljivo, da se zdravila Maviret med nosečnostjo ne uporablja.
English: Co-administration with Maviret may increase plasma concentrations of medicinal products that are substrates of P-gp (e.g. dabigatran etexilate, digoxin), BCRP (e.g. rosuvastatin), or OATP1B1/3 (e.g. atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin).
Slovenian: Sočasna uporaba z zdravilom Maviret lahko poveča plazemske koncentracije zdravil, ki so substrati P-gp (npr. dabigatran eteksilat, digoksin), BCRP (npr. rosuvastatin) ali OATP1B1/3 (npr. atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin).
English: Glecaprevir AUC increased in a greater than dose-proportional manner (1200 mg QD had 516-fold higher exposure than 200 mg QD) which may be related to saturation of uptake and efflux transporters.
Slovenian: AUC glekaprevirja se je povečevala več kot sorazmerno odmerku (izpostavljenost po odmerku 1200 mg na dan je bila 516-krat večja kot po odmerku 200 mg enkrat na dan); to je morda povezano z zasičenjem sprejema in iztočnih prenašalcev.
English: Activity of glecaprevir and pibrentasvir against HCV genotypes 1-6 replicon cell lines
Slovenian: Aktivnost glekaprevirja in pibrentasvirja proti replikonom celičnih linij HCV genotipov 1-6
English: Of the genotype 3-infected subjects with end stage renal disease enrolled in EXPEDITION-4, 100% (11/11) achieved SVR12.
Slovenian: Med preiskovanci, okuženimi z genotipom 3, ki so imeli končno odpoved ledvic in so bili vključeni v študijo EXPEDITION-4, jih je SVR12 doseglo 100 % (11/11).
English: Studies VOYAGE-1 and VOYAGE-2 were conducted in China, Singapore, and South Korea in HCV genotype 1-6 subjects without cirrhosis (VOYAGE-1) or with compensated cirrhosis (VOYAGE-2) that were treatmentnaïve (TN) or treatment-experienced to combinations of interferon, peg-interferon, ribavirin and/or sofosbuvir (TE-PRS).
Slovenian: Študiji VOYAGE-1 in VOYAGE-2 sta bili izvedeni na Kitajskem, v Singapurju in Južni Koreji pri preiskovancih s HCV genotipom 1-6 brez ciroze (VOYAGE-1) ali s kompenzirano cirozo (VOYAGE2), ki predhodno še niso bili zdravljeni (TN) ali so bili zdravljeni s kombinacijo interferona, peginterferona, ribavirina in/ali sofosbuvirja (TE-PRS).
English: • current or previous infection with the hepatitis B virus
Slovenian: • imate ali ste imeli okužbo z virusom hepatitisa B,