FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products that are strong OATP1B inhibitors (e.g. ciclosporin) may substantially increase voxilaprevir plasma concentrations, the safety of which has not been established.
Slovenian: Zdravila, ki so močni zaviralci OATP1B (npr. ciklosporin) lahko znatno povečajo koncentracije voksilaprevirja v plazmi, varnost tega pa ni bila ugotovljena.
English: These should be taken at least 4 hours before or 4 hours after Vosevi;
Slovenian: Te je treba vzeti vsaj 4 ure pred uporabo zdravila Vosevi ali 4 ure po tem;
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: Table 15: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of SOF, GS331007, Velpatasvir and Voxilaprevir Compared to Subjects with Normal Renal Function
Slovenian: Preglednica 15: Učinek različnih stopenj ledvične okvare na izpostavljenosti (AUC) SOF, GS-331007, velpatasvirju in voksilaprevirju v primerjavi z osebami z normalnim delovanjem ledvic
English: No specific antidote is available for overdose with Vosevi.
Slovenian: Specifični antidot za prevelik odmerek zdravila Vosevi ni na voljo.
English: No human data on the effect of Vosevi on fertility are available.
Slovenian: Podatki o vplivu zdravila Vosevi na plodnost pri ljudeh niso na voljo.
English: Effect on fluvastatin, lovastatin, pitavastatin and simvastatin not studied.
Slovenian: Učinka na fluvastatin, lovastatin, pitavastatin in simvastatin niso preučevali.
English: The NS5B NI RAV S282T was not detected in any patient in POLARIS-2 and POLARIS-3 studies.
Slovenian: RAV NI NS5B S282T niso zaznali pri nobenem bolniku v študijah POLARIS-2 in POLARIS-3.
English: Your doctor will test your blood before, during and after your treatment with Vosevi.
Slovenian: Zdravnik vam bo pred zdravljenjem z zdravilom Vosevi, med njim in po njem opravil krvne preiskave.
English: Haemodialysis is unlikely to result in significant removal of velpatasvir or voxilaprevir since velpatasvir and voxilaprevir are highly bound to plasma proteins.
Slovenian: Ni verjetno, da bi hemodializa pomembno odstranila velpatasvir ali voksilaprevir, saj se velpatasvir in voksilaprevir v veliki meri vežeta na beljakovine v plazmi.
English: The film-coated tablets are beige, capsule-shaped tablets debossed with “GSI” on one side and “3” on the other side.
Slovenian: Filmsko obložene tablete so bež tablete v obliki kapsule, z vtisnjeno oznako „GSI“ na eni in „3“ na drugi strani.
English: For voxilaprevir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were Q41H, A156V/T/L and D168E/H/Y.
Slovenian: Za voksilaprevir v replikonih genotipa 1-6 so bile z odpornostjo povezane substitucije, selekcionirane v 2 ali več genotipih, Q41H, A156V/T/L in D168E/H/Y.
English: Of the 31 patients enrolled, 74% (23/31) were male, 81% (25/31) were white, 71% (22/31) had a baseline body mass index < 30 kg/m2, 48% (15/31) had compensated cirrhosis, 58% (18/31) had previously received sofosbuvir, velpatasvir and voxilaprevir, and 42% (13/31) had previously received sofosbuvir and velpatasvir.
Slovenian: Od 31 vključenih bolnikov je bilo 74 % (23/31) moških, 81 % (25/31) belcev, 71 % (22/31) jih je imelo izhodiščni indeks telesne mase < 30 kg/m2, 48 % (15/31) jih je imelo kompenzirano cirozo, 58 % (18/31) jih je predhodno prejemalo sofosbuvir, velpatasvir in voksilaprevir in 42 % (13/31) jih je predhodno prejemalo sofosbuvir in velpatasvir.
English: However, a possible teratogenic effect was indicated in rabbits where an increase in total visceral malformations was seen in exposed animals at AUC exposures up to 0.5 fold the human exposure at recommended clinical dose.
Slovenian: Vendar pa je bil nakazan morebiten teratogeni učinek pri kuncih, kjer je bilo pri izpostavljenih živalih z do 0,5-kratno izpostavljenostjo na podlagi AUC kot pri človeški izpostavljenosti pri priporočenem kliničnem odmerku opaženo zvečanje celokupnega števila visceralnih malformacij.
English: Vosevi is a medicine that contains the active substances sofosbuvir, velpatasvir and voxilaprevir in a single tablet.
Slovenian: Zdravilo Vosevi je zdravilo, ki vsebuje učinkovine sofosbuvir, velpatasvir in voksilaprevir v eni sami tableti.
English: • If you notice within 18 hours of the time you usually take Vosevi, you must take the tablet as soon as possible.
Slovenian: • Če se tega spomnite v roku 18 ur od takrat, ko običajno vzamete zdravilo Vosevi, morate tableto vzeti takoj, ko je mogoče.
English: The adverse reactions are listed below by system organ class and frequency.
Slovenian: V nadaljevanju so navedeni neželeni učinki po organskih sistemih in pogostnosti.
English: Other medicines and Vosevi
Slovenian: Druga zdravila in zdravilo Vosevi
English: c. Data from various strains of full length NS5A replicons or chimeric NS5A replicons carrying full-length NS5A genes that contain L31 or M31 polymorphisms.
Slovenian: c. Podatki iz različnih sevov replikonov NS5A polne dolžine ali himeričnih replikonov NS5A, ki vsebujejo gene NS5A polne dolžine, ki vsebujejo polimorfizme L31 ali M31.
English: Mean ratio (90% confidence interval)a,b Recommendation concerning co-administration with Vosevi
Slovenian: Povprečno razmerje (90-odstotni interval zaupanja)a, b
English: ↑ Voxilaprevir
Slovenian: ↑ Voksilaprevir
English: • modafinil, used to treat sleep disorders;
Slovenian: • modafinil, ki se uporablja za zdravljenje motenj spanja;
English: Most subjects had genotype 1 (61% (19/31) [1a, 48% (15/31); 1b, 13% (4/31)]) or genotype 3 (26% (8/31)) HCV infection.
Slovenian: Večina oseb je imela okužbo s HCV genotipa 1 (61 % (19/31) [1a, 48 % (15/31); 1b, 13 % (4/31)]) ali genotipa 3 (26 % (8/31)).
English: Famotidine dosed 12 hours prior to Vosevi
Slovenian: Famotidin uporabljen 12 ur pred zdravilom Vosevi
English: • atazanavir, efavirenz or lopinavir, used to treat HIV infection;
Slovenian: • atazanavir, efavirenz ali lopinavir, ki se uporabljajo se za zdravljenje okužbe z virusom HIV;
English: Dabigatran etexilate (P-gp substrate) and rosuvastatin (OATP1B and BCRP substrate) are contraindicated (see section 4.3 and Table 2).
Slovenian: Dabigatran eteksilat (substrat P-gp) in rosuvastatin (substrat OATP1B in BCRP) sta kontraindicirana (glejte poglavje 4.3 in preglednico 2).
English: Velpatasvir was not carcinogenic in the 26-week transgenic mouse and 2-year rat carcinogenicity studies at exposures up to 67- and 5-times higher than human exposure, respectively.
Slovenian: Velpatasvir ni bil kancerogen v 26-tedenski študiji pri transgenskih miših in 2-letni študiji kancerogenosti pri podganah ob izpostavljenostih, ki so bile do 67-krat in 5-krat večje od izpostavljenosti pri človeku.
English: In the Phase 3 trials increases in total bilirubin less than or equal to 1.5 x the upper limit of normal were observed in 4% of patients without cirrhosis and 10% of patients with compensated cirrhosis, due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir.
Slovenian: Celokupni bilirubin V preskušanjih faze 3 so opazili povečanja celokupnega bilirubina za 1,5 x zgornje meje normalne vrednosti ali manj pri 4 % bolnikov brez ciroze in 10 % pri bolnikih s kompenzirano cirozo, ker voksilaprevir zavira OATP1B1 in OATP1B3.
English: Concomitant use with ethinylestradiol-containing medicinal products may increase the risk of alanine aminotransferase (ALT) elevations and is contraindicated (see section 4.3 and Table 2).
Slovenian: Sočasna uporaba z zdravili, ki vsebujejo etinilestradiol, lahko poveča tveganje za zvišanje vrednosti alanin aminotransferaze (ALT), zato je kontraindicirana (glejte poglavje 4.3 in preglednico 2).
English: If you accidentally take more than the recommended dose of Vosevi you may be at increased risk of side effects with this medicine (see section 4 Possible side effects).
Slovenian: Če ste vzeli večji odmerek zdravila Vosevi, kot bi smeli Če ste pomotoma vzeli večji odmerek zdravila Vosevi od priporočenega, lahko pri vas obstaja večje tveganje za neželene učinke, povezane s tem zdravilom (glejte poglavje 4, Neželeni učinki).
English: Vitamin K antagonists (Liver function changes during treatment with Vosevi).
Slovenian: Antagonisti vitamina K (med zdravljenjem z zdravilom Vosevi prihaja do sprememb delovanja jeter)
English: The tablets are packed in plastic bottles with child resistant caps.
Slovenian: Tablete so pakirane v plastenke z za otroke varno zaporko.
English: When administered to lactating rats, voxilaprevir was detected in the plasma of nursing pups.
Slovenian: Pri dajanju doječim podganam so voksilaprevir zaznali v plazmi dojenih mladičev.
English: The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Slovenian: Na farmakokinetiko zdravil, ki se presnavljajo prek jeter (npr. imunosupresivna zdravila, kot so zaviralci kalcinevrina), lahko vplivajo spremembe delovanja jeter med zdravljenjem z DAA, ki so povezane z odstranitvijo virusa HCV.
English: Following a single 400 mg dose of sofosbuvir, a 4-hour haemodialysis removed 18% of administered dose.
Slovenian: Po enkratnem 400-miligramskem odmerku sofosbuvirja se je s 4-urno hemodializo izločilo približno 18 % uporabljenega odmerka.
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) 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 (CatA) ali karboksilesteraza 1 (CES1), in cepitev fosforamidata z nukleotid-vezajočo beljakovino s histidinsko triado 1 (HINT1, histidine triad nucleotide-binding protein 1), čemur sledi fosforilacija po biosintezni poti pirimidinskih nukleotidov.
English: Additionally, velpatasvir is active in vitro against most of the NS5A RAVs that confer resistance to ledipasvir and daclatasvir.
Slovenian: Poleg tega velpatasvir deluje in vitro proti večini RAV NS5A, ki doprinesejo k odpornosti na ledipasvir in daklatasvir.
English: The EC50 values of sofosbuvir, velpatasvir and voxilaprevir against clinical isolates are presented in Table 5.
Slovenian: Vrednosti EC50 za sofosbuvir, velpatasvir in voksilaprevir proti kliničnim izolatom so prikazane v preglednici 5.
English: Iron oxide black (E172) Iron oxide red (E172) Iron oxide yellow (E172)
Slovenian: Filmska obloga črni železov oksid (E172) rdeči železov oksid (E172) rumeni železov oksid (E172)
English: Pack size: outer carton containing 1 bottle of 28 film-coated tablets.
Slovenian: Velikosti pakiranja: škatla, ki vsebuje 1 plastenko z 28 filmsko obloženimi tabletami.
English: • muscle pain (myalgia)
Slovenian: • bruhanje • bolečine v mišicah (mialgija)
English: Concomitant use with ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (see section 4.5).
Slovenian: Sočasna uporaba z zdravili, ki vsebujejo etinilestradiol, kot so kombinirani peroralni kontraceptivi ali kontracepcijski vaginalni obročki (glejte poglavje 4.5).
English: Following oral administration of Vosevi, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 2 hours post-dose.
Slovenian: Po peroralni uporabi zdravila Vosevi se je sofosbuvir hitro absorbiral in dosegel najvišje koncentracije v plazmi 2 uri po odmerku.
English: H2-receptor antagonists may be administered simultaneously with or staggered from Vosevi at a dose that does not exceed doses comparable with famotidine 40 mg twice daily.
Slovenian: Antagoniste receptorjev H2 se lahko uporablja sočasno z zdravilom Vosevi ali s časovnim zamikom, v odmerku, ki ne presega odmerkov, primerljivih s famotidinom 40 mg dvakrat na dan.
English: There are no data on the use of Vosevi in patients with HCV/hepatitis B virus (HBV) co-infection.
Slovenian: Podatkov o uporabi zdravila Vosevi pri bolnikih s sočasno okužbo s HCV in virusom hepatitisa B (HBV) ni.
English: Table 2: Interactions between Vosevi and other medicinal products
Slovenian: Preglednica 2: Interakcije med zdravilom Vosevi in drugimi zdravili
English: Vosevi should not be used if you have moderate or severe liver problems.
Slovenian: Zdravilo Vosevi se ne sme uporabljati pri bolnikih z zmernimi ali hudimi težavami z jetri.
English: Animal studies do not indicate harmful effects of sofosbuvir, velpatasvir or voxilaprevir on fertility.
Slovenian: Študije na živalih ne kažejo škodljivih učinkov sofosbuvirja, velpatasvirja ali voksilaprevirja na plodnost.
English: Sofosbuvir was not carcinogenic in the 2-year mouse and rat carcinogenicity studies at GS-331007 exposures up to 17 and 10-times higher, respectively than human exposure.
Slovenian: Sofosbuvir ni bil kancerogen v 2-letnih študijah kancerogenosti pri miših in podganah ob izpostavljenostih GS-331007, ki so bile do 17-krat oz. 10-krat večje od izpostavljenosti pri človeku.
English: Vosevi has been shown to increase tenofovir exposure when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Slovenian: Pokazalo se je, da zdravilo Vosevi poveča izpostavljenost tenofovirju, če se uporablja skupaj z režimom proti HIV, ki vsebuje dizoproksiltenofovirijev fumarat in farmakokinetični ojačevalec (ritonavir ali kobicistat).
English: It is given to adults of 18 years and older to treat a chronic (long-term) viral infection of the liver called hepatitis C.
Slovenian: Daje se odraslim, starim 18 let in več, za zdravljenje kronične (dolgotrajne) okužbe jeter,
English: These are shown in Table 7.
Slovenian: Analize so prikazane v preglednici 7.
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of velpatasvir and voxilaprevir by 13- and 6.8-fold, respectively, against genotype 1a HCV replicons.
Slovenian: NA = podatkov ni na voljo Prisotnost 40-odstotnega humanega seruma ni vplivala na aktivnost sofosbuvirja proti HCV, je pa aktivnost velpatasvirja in voksilaprevirja proti HCV zmanjšala za 13-krat oz. 6,8-krat proti replikonom HCV genotipa 1a.
English: No individual RAV tested in genotypes 2a, 4a or 5a conferred a > 100-fold reduction in velpatasvir susceptibility.
Slovenian: Nobene posamezne RAV, testirane v genotipih 2a, 4a ali 5a, niso doprinesle k > 100kratnemu zmanjšanju dovzetnosti za velpatasvir.
English: In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a, and 4a.
Slovenian: Na biokemičnem testu je GS-461203 zaviral aktivnost polimeraze rekombinantne NS5B virusa HCV genotipov 1b, 2a, 3a in 4a.
English: • dabigatran (a medicine used to prevent blood clots);
Slovenian: • dabigatran (zdravilo, ki se uporablja za preprečevanje strjevanja krvi);
English: • If you are sick (vomit) more than 4 hours after taking Vosevi, you do not need to take another tablet until your next scheduled tablet.
Slovenian: • Če bruhate več kot 4 ure po uporabi zdravila Vosevi, ne vzemite še ene tablete do naslednje načrtovane tablete.
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Vosevi.
Slovenian: Zdravnik bo morda moral skrbno spremljati druga zdravila, ki jih jemljete, in po uvedbi zdravila Vosevi prilagoditi njihov odmerek.
English: • Placebo 12 weeks (N=152)
Slovenian: • Placebo 12 tednov (N = 152)
English: Serum HCV RNA values were measured during the clinical studies using the COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of 15 IU per mL.
Slovenian: Med kliničnimi študijami so izmerili vrednosti RNK HCV v serumu s testom COBAS AmpliPrep/COBAS Taqman za virus HCV (različica 2.0), s spodnjo mejo kvantifikacije (LLOQ, lower limit of quantification) 15 i.e. na ml.
English: When Vosevi or its components taken together were administered with food, sofosbuvir AUC0-inf and Cmax were 64% to 144% and 9% to 76% higher, respectively; velpatasvir AUC0-inf and Cmax were 40% to 166% and 37% to 187% higher, respectively; and voxilaprevir AUC0-inf and Cmax were 112% to 435% and 147% to 680% higher, respectively.
Slovenian: Pri jemanju zdravila Vosevi ali njegovih učinkovin skupaj s hrano sta bili vrednosti AUC0-24 in Cmax za sofosbuvir za 64 % do 144 % oz. 9 % do 76 % višji; vrednosti AUC0-24 in Cmax za velpatasvir sta bili za 40 % do 166 % oz. 37 % do 187 % višji; in vrednosti AUC0-24 in Cmax za voksilaprevir sta bili za 112 % do 435 % oz. 147 % do 680 % višji.
English: Paediatric population The pharmacokinetics of Vosevi in paediatric patients have not been established (see section 4.2).
Slovenian: Pediatrična populacija Farmakokinetike zdravila Vosevi pri pediatričnih bolnikih niso ugotavljali (glejte poglavje 4.2).
English: • If you are sick (vomit) less than 4 hours after taking Vosevi, take another tablet.
Slovenian: • Če bruhate manj kot 4 ure po uporabi zdravila Vosevi, vzemite še eno tableto.
English: HMG-CoA REDUCTASE INHIBITORS Atorvastatin
Slovenian: ZAVIRALCI REDUKTAZE HMG-CoA
English: d. Data from a chimeric NS5A replicon carrying NS5A amino acids 9-184. e. Stable cell lines expressing Renilla luciferase-encoding replicons.
Slovenian: d. Podatki iz himeričnega replikona NS5A, ki prenaša aminokisline NS5A 9-184. e. Stabilne celične linije, ki izražajo replikone, ki kodirajo Renilla luciferazo.
English: Effect on atazanavir and ritonavir exposure not studied.
Slovenian: Učinka na izpostavljenost atazanavirju in ritonavirju niso preučevali.
English: The safety of tenofovir disoproxil fumarate in the setting of Vosevi and a pharmacokinetic enhancer has not been established.
Slovenian: Varnost dizoproksiltenofovirijevega fumarata z zdravilom Vosevi in farmakokinetičnim ojačevalcem ni bila dokazana.
English: There was an increase in tenofovir exposure (AUC and Cmax) of around 40% during co-treatment with Vosevi and darunavir + ritonavir + tenofovir disoproxil fumarate/emtricitabine.
Slovenian: Zvečanje izpostavljenosti tenofovirju (AUC in Cmax) je bilo med sočasnim zdravljenjem z zdravilom Vosevi in darunavirjem + ritonavirjem + dizoproksiltenofovirijevim fumaratom/emtricitabinom približno 40 %.
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 85 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Slovenian: Populacijska farmakokinetična analiza pri bolnikih, okuženih s HCV, je pokazala, da znotraj analiziranega starostnega razpona (18-85 let) starost ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju, GS-331007, velpatasvirju ali voksilaprevirju.
English: The unbound fraction of voxilaprevir was approximately 2-fold higher in severe hepatic impairment compared with moderate hepatic impairment or normal hepatic function.
Slovenian: Nevezani del voksilaprevirja je bil približno 2-krat večji pri bolnikih s hudo jetrno okvaro kot pri bolnikih z zmerno jetrno okvaro ali z normalnim delovanjem jeter.
English: Velpatasvir is > 99% bound to human plasma proteins and binding is independent of drug concentration over the range of 0.09 μg/mL to 1.8 μg/mL.
Slovenian: Velpatasvir se > 99-odstotno veže na humane beljakovine v plazmi, kar ni odvisno od koncentracije zdravila v razponu 0,09-1,8 μg/ml.
English: Table 3: Adverse drug reactions identified with Vosevi Frequency
Slovenian: Preglednica 3: Neželeni učinki, ki so jih zabeležili pri zdravilu Vosevi Pogostnost
English: Co-administration of Vosevi with edoxaban is not recommended.
Slovenian: Vosevi z edoksabanom ni priporočljiva.
English: These are shown in Table 6.
Slovenian: Analize so prikazane v preglednici 6.
English: • digoxin, used to treat heart conditions;
Slovenian: • digoksin, ki se uporablja za zdravljenje bolezni srca;
English: Vosevi has been shown to increase tenofovir exposure (P-gp inhibition).
Slovenian: Pokazalo se je, da zdravilo Vosevi poveča izpostavljenost tenofovirju (zaviranje P-gp).
English: • rifapentine (an antibiotic used to treat infections, including tuberculosis);
Slovenian: • rifapentin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo);
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 61-65 %, ni pa odvisna od koncentracije zdravila v razponu 1-20 μg/ml.
English: Some medicines must not be taken with Vosevi.
Slovenian: Nekaterih zdravil ne smete uporabljati sočasno z zdravilom Vosevi.
English: If a dose of Vosevi 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 zdravila Vosevi 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: Colloidal anhydrous silica, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose
Slovenian: brezvodni koloidni silicijev dioksid, kopovidon, premrežen natrijev karmelozat, laktoza monohidrat, magnezijev stearat, mikrokristalna celuloza.
English: Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Slovenian: Zdravilo Vosevi se sme pri teh bolnikih uporabljati brez prilagajanja odmerka, ko druge ustrezne možnosti zdravljenja niso na voljo (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
English: Vosevi 400 mg/100 mg/100 mg film-coated tablets
Slovenian: Vosevi 400 mg/100 mg/100 mg filmsko obložene tablete
English: Sofosbuvir, velpatasvir and voxilaprevir are substrates of drug transporters P-gp and BCRP while GS-331007 is not.
Slovenian: Sofosbuvir, velpatasvir in voksilaprevir so substrati prenašalcev P-gp in BCRP, GS-331007 pa ni.
English: The patient with genotype 1a and virologic breakthrough developed the NS5A RAVs L31M and Y93H.
Slovenian: Bolnik z genotipom 1a in virološkim prebojem je razvil RAV NS5A L31M in Y93H.
English: • amiodarone, used to treat irregular heartbeats;
Slovenian: • amiodaron, ki se uporablja za zdravljenje nerednega srčnega utripa;
English: Vosevi is not recommended during pregnancy.
Slovenian: Zdravilo Vosevi se med nosečnostjo ne priporoča.
English: No individual RAV tested in genotypes 2b, 5a or 6a conferred a > 100-fold reduction in voxilaprevir susceptibility.
Slovenian: Nobene posamezne RAV, testirane v genotipih 2b, 5a ali 6a, niso doprinesle k > 100-kratnemu zmanjšanju dovzetnosti za voksilaprevir.
English: Vosevi has not been studied in patients with ESRD requiring dialysis.
Slovenian: Zdravila Vosevi niso preučevali pri bolnikih z ESRD, zaradi katere je potrebna dializa.
English: and <50 mL/min/1.73 m2)
Slovenian: in < 50 ml/min/1,73 m2)
English: Table 14: SVR12 and virologic outcome in study POLARIS-3 (HCV genotype 3 with compensated cirrhosis)*
Slovenian: Preglednica 14: SVR12 in virološki odziv v študiji POLARIS-3 (HCV genotipa 3 s kompenzirano cirozo)*
English: Of these 21 patients, 1 patient had virus with emergent NS5A RAVs Q30R and L31M at failure.
Slovenian: Od teh 21 bolnikov je imel 1 bolnik virus, pri katerem je prišlo do RAV NS5A Q30R in L31M ob neuspehu.
English: SOF/VEL/VOX 8 weeks
Slovenian: SOF/VEL/VOKS 8 tednov
English: Potential for other medicinal products to affect Vosevi
Slovenian: Možnost vpliva drugih zdravil na zdravilo Vosevi