FrancophonIA/ELRC3.0 huggingface dataset:
English: Velpatasvir is an inhibitor of drug transporter P-gp, BCRP, OATP1B1, OATP1B3 and OATP2B1, 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, OATP1B3 in OATP2B1, njegovo sodelovanje pri medsebojnem delovanju s temi prenašalci pa je primarno omejeno na proces absorpcije.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Vosevi 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 Vosevi, uporablja samo,
English: Table 4: Activity of sofosbuvir, velpatasvir and voxilaprevir against full-length or chimeric laboratory replicons
Slovenian: Preglednica 4: Aktivnost sofosbuvirja, velpatasvirja in voksilaprevirja proti laboratorijskim replikonom polne dolžine ali himeričnim laboratorijskim replikonom Genotip replikona
English: Get advice from a doctor or pharmacist if you take warfarin or other similar medicines called vitamin K antagonists used to thin the blood.
Slovenian: Če jemljete varfarin ali druga podobna zdravila, ki se imenujejo antagonisti vitamina K in se uporabljajo za redčenje krvi, se posvetujte z zdravnikom ali farmacevtom.
English: Vosevi has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Vosevi nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Use with strong OATP1B inhibitors
Slovenian: Uporaba z močnimi zaviralci OATP1B
English: Co-administration of Vosevi with atazanavircontaining regimens is not recommended.
Slovenian: Sočasna uporaba zdravila Vosevi z režimi, ki vključujejo atazanavir, ni priporočljiva.
English: Medicinal products that may increase plasma exposure of Vosevi Co-administration with medicinal products that inhibit P-gp or BCRP may increase sofosbuvir, velpatasvir or voxilaprevir plasma concentrations.
Slovenian: Zdravila, ki lahko povečajo izpostavljenost zdravilu Vosevi v plazmi Sočasna uporaba z zdravili, ki zavirajo P-gp ali BCRP, lahko poveča koncentracije sofosbuvirja,
English: Voxilaprevir is primarily a substrate of CYP3A4 with slow turnover.
Slovenian: Voksilaprevir je primarno substrat citokroma CYP3A4 in se presnavlja počasi.
English: Talk to your doctor or pharmacist before taking Vosevi if:
Slovenian: Pred začetkom jemanja zdravila Vosevi se posvetujte z zdravnikom ali farmacevtom, če:
English: 1.7-fold↑
Slovenian: 1,7-krat↑
English: • The active substances are sofosbuvir, velpatasvir and voxilaprevir.
Slovenian: • Učinkovine so sofosbuvir, velpatasvir in voksilaprevir.
English: The use of strong inhibitors of OATP1B (e.g. ciclosporin) with Vosevi is not recommended (see section 4.4 and Table 2).
Slovenian: Uporaba močnih zaviralcev OATP1B (npr. ciklosporina) z zdravilom Vosevi ni priporočljiva (glejte poglavje 4.4 in preglednico 2).
English: Voxilaprevir is an inhibitor of drug transporters P-gp, BCRP, OATP1B1 and OATP1B3, and its involvement in drug interactions with these transporters is primarily limited to the process of absorption.
Slovenian: Voksilaprevir 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: Interactions between Vosevi and other medicinal products
Slovenian: Interakcije med zdravilom Vosevi in drugimi zdravili
English: (Increase in gastric pH decreases velpatasvir solubility)
Slovenian: (povečanje vrednosti pH v želodcu zmanjša topnost velpatasvirja)
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose
Slovenian: Jedro tablete brezvodni koloidni silicijev dioksid kopovidon premrežen natrijev karmelozat laktoza monohidrat magnezijev stearat mikrokristalna celuloza
English: (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 bolnikov)
English: h. Administered as sofosbuvir, velpatasvir fixed-dose combination.
Slovenian: h. Uporabljeno kot fiksna kombinacija sofosbuvirja in velpatasvirja.
English: No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Slovenian: Klinično pomembnih farmakokinetičnih razlik zaradi rase ali spola za sofosbuvir, GS-331007,
English: Safety data are limited in patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] < 30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring haemodialysis.
Slovenian: Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerularne filtracije [eGFR - estimated glomerular filtration rate] < 30 ml/min/1,73 m2) in pri bolnikih z boleznijo ledvic v končni fazi (ESRD - end stage renal disease), zaradi katere je potrebna hemodializa.
English: Vosevi contains lactose • Tell your doctor if you are lactose intolerant or intolerant to other sugars.
Slovenian: • Obvestite zdravnika, če ne prenašate (imate intoleranco) laktoze ali drugih sladkorjev.
English: Titanium dioxide (E171)
Slovenian: makrogol polivinilalkohol smukec titanov dioksid (E171)
English: Edoxaban (Inhibition of OATP1B1)
Slovenian: Edoksaban (zaviranje OATP1B1)
English: The median terminal half-life of velpatasvir following administration of Vosevi was approximately 17 hours.
Slovenian: Mediani končni razpolovni čas za velpatasvir po uporabi zdravila Vosevi je bil približno 17 ur.
English: velpatasvir (400/100 mg once daily)f, h
Slovenian: velpatasvir (400/100 mg enkrat na dan)f
English: It is unknown whether sofosbuvir, metabolites of sofosbuvir, velpatasvir or voxilaprevir are excreted in human milk.
Slovenian: Ni znano, ali se sofosbuvir in njegovi presnovki, velpatasvir ali voksilaprevir izločajo v materino mleko.
English: In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Slovenian: Pri bolnikih, okuženih s HCV, s hudo ledvično okvaro, zdravljenih s sofosbuvirjem 200 mg z ribavirinom (n = 10) ali sofosbuvirjem 400 mg z ribavirinom (n = 10) 24 tednov ali ledipasvirjem/sofosbuvirjem 90/400 mg (n = 18) 12 tednov, je bila farmakokinetika sofosbuvirja in
English: The 50% effective concentration (EC50) values of sofosbuvir, velpatasvir and voxilaprevir against full-length or chimeric replicons encoding NS5B, NS5A and NS3 protease sequences from the laboratory strains are presented in Table 4.
Slovenian: Vrednosti 50-odstotne učinkovite koncentracije (EC50) za sofosbuvir, velpatasvir in voksilaprevir proti replikonom polne dolžine ali himeričnim replikonom, ki kodirajo zaporedja proteaz NS5B, NS5A in
English: In patients with genotype 1a without cirrhosis treated with Vosevi for 8 weeks, outcome was influenced by the following baseline factors: BMI ≥ 30 kg/m2, Q80K/L/R RAVs, IL28B non-CC, HCV RNA ≥ 800,000 IU/mL.
Slovenian: Pri bolnikih z genotipom 1a brez ciroze, zdravljenih z zdravilom Vosevi 8 tednov, so na izid vplivali naslednji izhodiščni dejavniki: indeks telesne mase (ITM) ≥ 30 kg/m2, RAV Q80K/L/R,
English: After a single 400 mg oral dose of [14C]-sofosbuvir, GS-331007 accounted for approximately > 90% of total systemic exposure.
Slovenian: [14C]-sofosbuvirja je GS-331007 prispeval približno > 90 % skupne sistemske izpostavljenosti.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (CPT Class A) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Slovenian: Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza (stopnja A po CPT) ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju in GS-331007.
English: Effect on amiodarone, voxilaprevir, velpatasvir, and sofosbuvir concentrations unknown.
Slovenian: Učinek na koncentracije amiodarona, voksilaprevirja, velpatasvirja in sofosbuvirja ni znan.
English: As Vosevi contains sofosbuvir, velpatasvir and voxilaprevir, any interactions that have been identified with these active substances individually may occur with Vosevi.
Slovenian: Zdravilo Vosevi vsebuje sofosbuvir, velpatasvir in voksilaprevir, zato se pri uporabi zdravila Vosevi lahko pojavijo katere koli interakcije, ki so jih opazili pri uporabi teh posameznih učinkovin.
English: Interaction only studied with voxilaprevir.
Slovenian: Preučevane so bile samo interakcije z voksilaprevirjem.
English: Of the 182 DAA-experienced patients treated with sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-4 (see Table 11), 1 of 182 (1%) patients relapsed and qualified for resistance analysis.
Slovenian: Od 182 bolnikov, ki so bili predhodno že zdravljeni z DAA in ki so prejemali 12-tedensko zdravljenje s sofosbuvirjem/velpatasvirjem/voksilaprevirjem v študiji POLARIS-4 (glejte preglednico 11), je prišlo pri 1 od 182 (1 %) bolnikov do relapsa in bolnik je bil primeren za analizo odpornosti.
English: SVR12 was achieved in all 39 patients who had baseline NS5B NI RAVs in POLARIS-2 and 2 of 3 (67%) patients in POLARIS-3.
Slovenian: V študiji POLARIS-2 je SVR12 doseglo vseh 39 bolnikov z izhodiščnimi RAV NI NS5B, v študiji POLARIS-3 pa 2 od 3 (67 %) bolnikov.
English: Protein binding of GS-331007 was minimal in human plasma.
Slovenian: GS-331007 na beljakovine minimalna.
English: Effect on sofosbuvir, velpatasvir and voxilaprevir not studied.
Slovenian: Učinka na sofosbuvir, velpatasvir in voksilaprevir niso preučevali.
English: Velpatasvir and voxilaprevir are substrates of drug transporters OATP1B1 and OATP1B3.
Slovenian: Velpatasvir in voksilaprevir sta substrata prenašalcev OATP1B1 in OATP1B3.
English: In the sofosbuvir/velpatasvir 12-week treatment group, a total of 3 of 440 (1%) patients (2 with genotype 1, 1 with genotype 4) qualified for resistance analysis due to relapse.
Slovenian: V skupini, ki je prejemala 12-tedensko zdravljenje s sofosbuvirjem/velpatasvirjem, so bili skupaj 3 od 440 (1 %) bolnikov (2 z genotipom 1, 1 z genotipom 4) primerni za analizo odpornosti zaradi relapsa.
English: Velpatasvir median peak concentrations were observed at 4 hours post-dose.
Slovenian: Mediano najvišje koncentracije velpatasvirja so zabeležili 4 ure po odmerku.
English: Voxilaprevir median peak concentrations were observed 4 hours post-dose.
Slovenian: Mediano najvišje koncentracije voksilaprevir so zabeležili 4 ure po odmerku.
English: Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir, velpatasvir and/or voxilaprevir plasma concentrations leading to reduced therapeutic effect of Vosevi.
Slovenian: Zdravila, ki so zmerni induktorji P-gp in/ali citokromov CYP (npr. efavirenz, modafinil, okskarbazepin ali rifapentin), lahko zmanjšajo koncentracije sofosbuvirja, velpatasvirja in/ali voksilaprevirja v plazmi, kar zmanjša terapevtski učinek zdravila Vosevi.
English: Voxilaprevir is not renally eliminated.
Slovenian: Voksilaprevir se ne izloča skozi ledvice.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Zdravljenje z zdravilom Vosevi v skladu s priporočenim odmerjanjem (glejte poglavje 4.2.)
English: k. Lack of pharmacokinetics interaction bounds 50-200%.
Slovenian: k. Območje 50-200 %, znotraj katerega ni farmakokinetičnih interakcij.
English: Replicons containing NS3 protease from clinical isolates
Slovenian: Replikoni, ki vsebujejo NS3 iz kliničnih izolatov
English: Iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), macrogol, polyvinyl alcohol, talc, titanium dioxide (E171)
Slovenian: Filmska obloga: črni železov oksid (E172), rdeči železov oksid (E172), rumeni železov oksid (E172), makrogol,
English: Table 13: SVR12 by HCV genotype and virologic outcome in patients who received Vosevi 8 weeks without cirrhosis or with cirrhosis in study POLARIS-2
Slovenian: Preglednica 13: SVR12 po genotipu HCV in virološki odziv pri bolnikih, ki so prejemali 8tedensko zdravljenje z zdravilom Vosevi, s cirozo ali brez, v študiji POLARIS-2
English: Alternative methods of contraception (e.g. progestin only contraception or non-hormonal methods) should be considered.
Slovenian: Razmisliti je treba o drugih kontracepcijskih metodah (npr. kontracepcija,
English: Clinically significant medicinal product interactions with Vosevi mediated by P-gp, BCRP and CYP inhibitors are not expected.
Slovenian: Klinično pomembnih medsebojnih delovanj z zdravilom Vosevi, pri katerih bi posredovali zaviralci P-gp, BCRP in CYP, se ne pričakuje; zdravilo Vosevi se lahko uporablja sočasno z zaviralci P-gp, BCRP in CYP.
English: The median time between prior DAA failure and first dose of Vosevi for patients enrolled into POLARIS-1 was 39 weeks (range: 11 to 299 weeks).
Slovenian: vključene v študijo POLARIS-1, je bila 39 tednov (razpon: 11 do 299 tednov).
English: Very common diarrhoea, nausea Common abdominal pain, decreased appetite, vomiting Skin and subcutaneous disorders: Uncommon rash
Slovenian: Pogosti bolečine v trebuhu, zmanjšan apetit, bruhanje
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Vosevi.
Slovenian: Po začetku jemanja zdravila Vosevi morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
English: Table 10: SVR12 in NS5A-inhibitor experienced patients by HCV genotype in study POLARIS-1*
Slovenian: Preglednica 10: SVR12 pri bolnikih, ki so bili predhodno že zdravljeni z zaviralci NS5A, po genotipu HCV v študiji POLARIS-1*
English: c. Lack of pharmacokinetics interaction lower bound 70%.
Slovenian: c. Območje 70 %, znotraj katerega ni farmakokinetičnih interakcij.
English: Velpatasvir is primarily a substrate of CYP2B6, CYP2C8, and CYP3A4 with slow turnover.
Slovenian: Velpatasvir je primarno substrat citokromov CYP2B6, CYP2C8 in CYP3A4 in se presnavlja počasi.
English: Close monitoring is recommended if this medicinal product is administered with Vosevi (see sections 4.4 and 4.8).
Slovenian: Kadar se to zdravilo uporablja sočasno z zdravilom Vosevi, se priporoča skrbno spremljanje (glejte poglavji 4.4 in 4.8).
English: Voxilaprevir had no adverse effects on mating and fertility.
Slovenian: Voksilaprevir nima neželenih učinkov na parjenje in plodnost.
English: Lopinavir (Inhibition of OATP1B)
Slovenian: Lopinavir (zaviranje OATP1B)
English: Co-administration of Vosevi with lopinavir-containing regimens is not recommended.
Slovenian: Sočasna uporaba zdravila Vosevi z režimi, ki vključujejo lopinavir, ni priporočljiva.
English: What Vosevi is and what it is used for What you need to know before you take Vosevi How to take Vosevi
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vosevi Kako jemati zdravilo Vosevi
English: Voxilaprevir, and to a lesser extent velpatasvir, are also substrates of OATP1B1 and OATP1B3.
Slovenian: Voksilaprevir in v manjšem obsegu tudi velpatasvir sta prav tako substrata prenašalcev OATP1B1 in
English: f. Lack of pharmacokinetics interaction bounds 70-143%.
Slovenian: f. Območje 70-143 %, znotraj katerega ni farmakokinetičnih interakcij.
English: (Induction of P-gp and CYPs)
Slovenian: (indukcija P-gp in CYP)
English: Interaction only studied with velpatasvir and voxilaprevir.
Slovenian: Preučevane so bile samo interakcije z velpatasvirjem in voksilaprevirjem.
English: Table 9: Demographics and baseline characteristics for patients enrolled into POLARIS-1, -2, -3 and -4
Slovenian: Preglednica 9: Demografske in izhodiščne značilnosti za bolnike, vključene v študije POLARIS
English: The highest documented doses of sofosbuvir, velpatasvir and voxilaprevir were single doses of 1,200 mg, 500 mg, and 900 mg, respectively.
Slovenian: Največji dokumentirani odmerki so bili enkratni odmerek 1.200 mg sofosbuvirja, enkratni odmerek 500 mg velpatasvirja in enkratni odmerek 900 mg voksilaprevirja.
English: b. One patient without cirrhosis had genotype 1 subtype other than genotype 1a or genotype 1b; the patient achieved SVR12.
Slovenian: b. En bolnik brez ciroze je imel podvrsto genotipa 1, ki ni bila genotip 1a ali genotip 1b; bolnik je dosegel SVR12.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir containing regimens are used in combination with amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5).
Slovenian: Pri uporabi režimov, ki vključujejo sofosbuvir, v kombinaciji z amiodaronom in/ali drugimi zdravili, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka (glejte poglavji 4.4
English: In vitro, slow metabolic turnover of velpatasvir primarily by CYP2B6, CYP2C8 and CYP3A4 and of voxilaprevir primarily by CYP3A4 was observed.
Slovenian: In vitro so zabeležili počasno presnovo velpatasvirja, primarno s citokromi CYP2B6, CYP2C8 in CYP3A4, ter voksilaprevirja, primarno s citokromom CYP3A4.
English: Vosevi should not affect your ability to drive or use any tools or machinery.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Vosevi ne bi smelo vplivati na vašo sposobnost upravljanja vozil ali strojev.
English: GS-331007 AUC0-inf did not change and Cmax was 19% to 35% lower when Vosevi or its components together were administered with food.
Slovenian: vrednost Cmax pa je bila za 19 % do 35 % nižja pri jemanju zdravila Vosevi ali njegovih učinkovin skupaj s hrano.
English: Efavirenz/emtricitabine/
Slovenian: Elvitegravir/kobicistat/ emtricitabin/
English: DAA-naïve patients, GT 1, 2, 4, 5, or 6, with or without cirrhosis GT 3 without cirrhosis
Slovenian: 1, 2, 4, 5 ali 6, ki predhodno še niso bili zdravljeni z DAA, s cirozo ali brez, in GT 3 brez ciroze
English: b. Four patients had genotype 1 subtypes other than genotype 1a or genotype 1b; all 4 patients achieved SVR12.
Slovenian: b. Štirje bolniki so imeli podvrste genotipa 1, ki niso bile genotip 1a ali genotip 1b; vsi 4 bolniki so dosegli SVR12.
English: Omeprazole dosed 4 hours after Vosevi
Slovenian: Omeprazol uporabljen 4 ure po zdravilu Vosevi
English: No dose adjustment of Vosevi or ketoconazole is required.
Slovenian: Odmerka zdravila Vosevi ali ketokonazola ni treba prilagajati.
English: (Inhibition of OATP1B)
Slovenian: (zaviranje OATP1B)
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Slovenian: Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) in pri bolnikih z ESRD, zaradi katere je potrebna hemodializa.
English: Population pharmacokinetic analysis in HCV-infected patients indicated that cirrhosis (CPT Class A) had no clinically relevant effect on the exposure of velpatasvir.
Slovenian: Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza (stopnja A po CPT) ni imela klinično pomembnega učinka na izpostavljenost velpatasvirju
English: Lansoprazoled Rabeprazoled Pantoprazoled Esomeprazoled
Slovenian: Pantoprazold Esomeprazold
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Vosevi.
Slovenian: Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Vosevi,
English: Observed: Darunavir
Slovenian: Darunavir
English: Digoxin (0.25 mg single dose)e + velpatasvir (100 mg single dose)
Slovenian: Digoksin (0,25 mg enkratni odmerek)e + velpatasvir (100 mg enkratni odmerek)
English: Co-administration of strong OATP1B inhibitors with Vosevi is not recommended (see section 4.5).
Slovenian: Sočasna uporaba močnih zaviralcev OATP1B z zdravilom Vosevi ni priporočljiva (glejte poglavje 4.5).
English: Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 and Cmax for sofosbuvir (n = 1038) were 1665 ng•hr/mL and 678 ng/mL, respectively; mean steady-state AUC0-24 and Cmax for GS-331007 (n = 1593) were 12834 ng•hr/mL and 744 ng/mL, respectively.
Slovenian: Na podlagi analize populacijske farmakokinetike pri bolnikih z okužbo s HCV so bile povprečne vrednosti AUC0-24 in Cmax v stanju dinamičnega ravnovesja za sofosbuvir (n = 1.038) 1.665 ng•h/ml in 678 ng/ml; povprečne vrednosti AUC0-24 in Cmax v stanju dinamičnega ravnovesja za GS331007 (n = 1.593) so bile 12.834 ng•h/ml in 744 ng/ml.
English: Based on the population pharmacokinetic analysis in HCV-infected patients mean steady-state AUC0-24 and Cmax for voxilaprevir (n = 1591) were 2577 ng•hr/mL and 192 ng/mL, respectively.
Slovenian: Na podlagi analize populacijske farmakokinetike pri bolnikih z okužbo s HCV so bile povprečne vrednosti AUC0-24 in Cmax v stanju dinamičnega ravnovesja za voksilaprevir (n = 1.591) 2.577 ng•h/ml in 192 ng/ml.
English: Interaction only studied with sofosbuvir/ velpatasvir.
Slovenian: Preučevane so bile samo interakcije s sofosbuvirjem/velpatasvirjem.
English: Liver transplant patients
Slovenian: Bolniki s presajenimi jetri
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir, voxilaprevir or Vosevi in pregnant women.
Slovenian: Podatkov o uporabi sofosbuvirja, velpatasvirja, voksilaprevirja ali zdravila Vosevi pri nosečnicah ni oziroma jih je malo (manj kot 300 izpostavljenih nosečnosti).
English: The use of such medicinal products with Vosevi is contraindicated (see section 4.3 and Table 2).
Slovenian: Uporaba takšnih zdravil skupaj z zdravilom Vosevi je kontraindicirana (glejte poglavje 4.3 in preglednico 2).
English: Table 6: SVR12 in DAA-experienced patients with or without baseline NS3 or NS5A RAVs by study sofosbuvir/velpatasvir/voxilaprevir 12 weeks POLARIS-1 (n = 260)
Slovenian: Preglednica 6: SVR12 pri bolnikih, ki so bili predhodno že zdravljeni z DAA, z izhodiščnimi RAV NS3 ali NS5A ali brez njih po študiji sofosbuvir/velpatasvir/voksilaprevir 12 tednov POLARIS-1 (n = 260)
English: Sofosbuvir and GS-331007 AUCs are near dose-proportional over the dose range of 200 mg to 1200 mg. Velpatasvir AUC increases in a greater than proportional manner from 5 to 50 mg and in a less than proportional manner from 50 to 450 mg, indicating velpatasvir absorption is solubility limited.
Slovenian: Vrednost AUC za velpatasvir se poviša več kot sorazmerno od 5 do 50 mg in manj kot sorazmerno od 50 do 450 mg, kar pomeni, da je absorpcija velpatasvirja omejena glede na topnost.
English: DAA-experienced patients (who have not received an NS5A inhibitor), GT1-6, with or without cirrhosis
Slovenian: 1-6, ki so bili predhodno že zdravljeni z DAA (vendar niso prejemali zaviralcev NS5A), s cirozo ali brez
English: Relapseb
Slovenian: Relapsd
English: Patients with GT5-6 infection were enrolled into the SOF/VEL/VOX 8 week group only.
Slovenian: Bolniki z okužbo GT 5-6 so bili vključeni samo v skupino za 8tedensko zdravljenje s SOF/VEL/VOKS.
English: Genotype 5
Slovenian: Genotip 5
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in patients with moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Slovenian: V primerjavi z bolniki z normalnim delovanjem jeter je bila vrednost AUC0-24 za sofosbuvir za 126 % višja pri bolnikih z zmerno jetrno okvaro in za 143 % višja pri bolnikih s hudo jetrno okvaro, medtem ko je bila vrednost
English: SOF/VEL/VOX 8 weeks (n = 110)
Slovenian: SOF/VEL/VOKS 8 tednov (n = 110)
English: If you are sick (vomit) after taking Vosevi it may affect the amount of Vosevi in your blood.
Slovenian: Če bruhate po uporabi zdravila Vosevi, lahko to vpliva na količino zdravila Vosevi v vaši krvi.