FrancophonIA/ELRC3.0 huggingface dataset:
English: Breast-feeding Do not breast-feed during treatment with Vosevi.
Slovenian: Dojenje Med zdravljenjem z zdravilom Vosevi ne smete dojiti.
English: b. Two patients had genotype 1 subtypes other than genotype 1a or genotype 1b; both patients achieved SVR12.
Slovenian: b. Dva bolnika sta imela podvrsto genotipa 1, ki ni bila genotip 1a ali genotip 1b; oba bolnika sta dosegla SVR12
English: No dose adjustment of Vosevi or tacrolimus is required at initiation of co-administration.
Slovenian: Odmerka zdravila Vosevi ali takrolimusa ob uvedbi sočasnega dajanja ni treba prilagajati.
English: Following a single dose of 100 mg [14C]-voxilaprevir, the majority (approximately 91%) of radioactivity in plasma was parent drug.
Slovenian: Po enkratnem 100-miligramskem odmerku [14C]-voksilaprevirja je večina (približno 91 %) radioaktivnosti v plazmi posledica izhodiščne spojine.
English: (Inhibition of P-gp and CYP3A)
Slovenian: (zaviranje P-gp in CYP3A)
English: The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir/voxilaprevir, its components (sofosbuvir, velpatasvir, and/or voxilaprevir), or are predicted medicinal product interactions that may occur with Vosevi.
Slovenian: Opisane interakcije med zdravili temeljijo na študijah, izvedenih z bodisi sofosbuvirjem/velpatasvirjem/voksilaprevirjem, njegovimi učinkovinami
English: Medicinal products that may decrease plasma exposure of Vosevi Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir, velpatasvir and/or voxilaprevir leading to reduced therapeutic effect of Vosevi.
Slovenian: Zdravila, ki so močni induktorji P-gp in/ali citokromov CYP2B6, CYP2C8 ali CYP3A4 (npr. karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin in šentjanževka), lahko zmanjšajo koncentracije sofosbuvirja, velpatasvirja in/ali voksilaprevirja v plazmi, kar zmanjša terapevtski učinek zdravila Vosevi.
English: Ciclosporin (600 mg single dose)f +
Slovenian: Ciklosporin (600 mg enkratni odmerek)f +
English: Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with DAAs.
Slovenian: Med zdravljenjem z zdravili z DAA in po njem so poročali o primerih reaktivacije virusa HBV, tudi takih s smrtnim izidom.
English: Rifapentine (Induction of P-gp and CYPs)
Slovenian: Rifapentin (indukcija P-gp in CYP)
English: Both of these patients had virus with emergent NS5A RAV Y93H at failure.
Slovenian: Oba bolnika sta imela virus, pri katerem je prišlo do NS5A RAV Y93H
English: Adults previously treated with sofosbuvir/velpatasvir-containing regimens Vosevi for 12 weeks was evaluated in patients who were previously treated with a sofosbuvir/velpatasvir-containing regimen.
Slovenian: 12-tedensko zdravljenje z zdravilom Vosevi so ocenili pri bolnikih, ki so predhodno prejemali zdravljenje z režimom na osnovi sofosbuvirja/velpatasvirja.
English: Otherd
Slovenian: Drugoe
English: Potential for Vosevi to affect other medicinal products
Slovenian: Farmakokinetične interakcije Možnost vpliva zdravila Vosevi na druga zdravila
English: Following a single 100 mg oral dose of [14C]-voxilaprevir, mean total recovery of the [14C]-radioactivity was 94%, with all radioactivity measured in the faeces and none in the urine.
Slovenian: Po enkratnem 100-miligramskem peroralnem odmerku [14C]-voksilaprevirja je bil povprečni skupni delež [14C]-radioaktivnosti, ki so jo izolirali, višji kot 94 %, pri čemer je bila vsa radioaktivnost izmerjena v blatu in nobene v urinu.
English: POLARIS-1 (randomised double blind)
Slovenian: (randomizirana, dvojno slepa)
English: Table 7: SVR12 in DAA-naïve patients with or without baseline NS3 or NS5A RAVs by study sofosbuvir/velpatasvir/voxilaprevir 8 weeks POLARIS-2 (n = 498)
Slovenian: Preglednica 7: SVR12 pri bolnikih, ki predhodno še niso bili zdravljeni z DAA, z izhodiščnimi RAV NS3 ali NS5A ali brez njih po študiji sofosbuvir/velpatasvir/voksilaprevir 8 tednov POLARIS-2 (n = 498)
English: Additionally, the pharmacokinetics of voxilaprevir were studied with a single dose of 100 mg voxilaprevir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Slovenian: Dodatno so farmakokinetiko voksilaprevirja preučili z enkratnim 100-miligramskim odmerkom voksilaprevirja pri bolnikih, negativnih za HCV, s hudo ledvično okvaro (eGFR < 30 ml/min po metodi Cockcroft-Gault).
English: Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 400 mg sofosbuvirja, 100 mg velpatasvirja in 100 mg voksilaprevirja.
English: P-gp or BCRP)
Slovenian: BCRP)
English: Vosevi 400 mg/100 mg/100 mg film-coated tablets sofosbuvir/velpatasvir/voxilaprevir
Slovenian: Navodilo za uporabo Vosevi 400 mg/100 mg/100 mg filmsko obložene tablete sofosbuvir/velpatasvir/voksilaprevir
English: Based on the population pharmacokinetic analysis in HCV-infected patients mean steady-state AUC0-24 and Cmax for velpatasvir (n = 1595) were 4041 ng•hr/mL and 311 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 velpatasvir (n = 1.595) 4.041 ng•h/ml in 311 ng/ml.
English: Famotidine dosed simultaneously with Vosevi
Slovenian: Famotidin uporabljen sočasno z zdravilom Vosevi Cimetidind Nizatidind
English: (Inhibition of OATP1B, P-gp and CYP3A)
Slovenian: (zaviranje prenašalcev OATP1B, P-gp in CYP3A)
English: With Cirrhosis
Slovenian: S cirozo
English: In the POLARIS-3 sofosbuvir/velpatasvir/voxilaprevir 8-week treatment group (see Table 14), 2 of 110 (2%) patients (genotype 3) qualified for resistance analysis due to relapse.
Slovenian: V študiji POLARIS-3 sta bila v skupini, ki je prejemala 8-tedensko zdravljenje s sofosbuvirjem/velpatasvirjem/voksilaprevirjem (glejte preglednico 14), 2 od 110 (2 %) bolnikov (genotip 3) primerna za analizo odpornosti zaradi relapsa.
English: SOF/VEL 12 weeks (n = 151)
Slovenian: SOF/VEL 12 tednov (n = 151)
English: How to store Vosevi
Slovenian: Shranjevanje zdravila Vosevi
English: ↔ Velpatasvir ↔ Voxilaprevir
Slovenian: ↔ Velpatasvir ↔ Voksilaprevir
English: Studies with DAA-experienced Patients
Slovenian: Študije pri bolniki, ki so bili predhodno zdravljeni z DAA
English: Patients with GT4-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Slovenian: Bolniki z okužbo GT 46 so bili vključeni samo v skupino za 12tedensko zdravljenje s SOF/VEL/VOKS.
English: SOF/VEL/VOX 12 weeks (n = 263)
Slovenian: SOF/VEL/VOKS 12 tednov (n = 263)
English: No teratogenic effects were observed in the rat and rabbit developmental toxicity studies with voxilaprevir at AUC exposures approximately 141- and 4-times higher, respectively, than the human exposure at the recommended clinical dose.
Slovenian: V študijah razvojne toksičnosti z voksilaprevirjem pri izpostavljenostih na podlagi AUC, ki so bile približno 141-krat večje pri podganah in 4-krat večje pri kuncih od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, niso zabeležili nobenih teratogenih učinkov.
English: Darunavir boosted with ritonavir (800 + 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/300 mg once daily)j + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Slovenian: Darunavir, okrepljen z ritonavirjem (800 + 100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirijev fumarat (200/300 mg enkrat na dan)j +
English: Pravastatin may be administered with Vosevi at a dose that does not exceed pravastatin 40 mg.
Slovenian: Pravastatin se lahko daje z zdravilom Vosevi v odmerku, ki ne presega odmerka pravastatina 40 mg.
English: Biliary excretion of parent drug was the major route of elimination for voxilaprevir.
Slovenian: Glavna pot izločanja voksilaprevirja je bilo izločanje izhodiščne spojine skozi žolč.
English: Omeprazole dosed 2 hours prior to Vosevi
Slovenian: Omeprazol uporabljen 2 uri pred zdravilom Vosevi Lansoprazold
English: No dose adjustment of Vosevi or methadone is required.
Slovenian: Odmerka zdravila Vosevi ali metadona ni treba prilagajati.
English: Genotype 4
Slovenian: Genotip 4
English: Co-administration of such medicinal products with Vosevi is not recommended (see section 4.5).
Slovenian: Sočasna uporaba teh zdravil z zdravilom Vosevi ni priporočljiva (glejte poglavje 4.5).
English: SOF/VEL 12 weeks (n = 440)
Slovenian: SOF/VEL 12 tednov (n = 440)
English: ACID REDUCING AGENTS Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Slovenian: Antacidi npr. aluminijev hidroksid ali magnezijev hidroksid;
English: Musculoskeletal and connective tissue disorders: Common myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva:
English: sofosbuvir (400 mg single dose)e
Slovenian: sofosbuvir (400 mg enkratni odmerek)f
English: Genotype 6
Slovenian: Genotip 6
English: Voxilaprevir ↔ ↔ ↔
Slovenian: R-metadon ↔ ↔ ↔ S-metadon ↔ ↔ ↔
English: SOF/VEL 12 weeks (n = 109)
Slovenian: SOF/VEL 12 tednov (n = 109)
English: Table 12: SVR12 by HCV genotype and virologic outcome in study POLARIS-2*
Slovenian: Preglednica 12: SVR12 po genotipu HCV in virološki izid v študiji POLARIS-2* SOF/VEL/VOKS
English: No dose adjustment of Vosevi, raltegravir or emtricitabine/tenofovir disoproxil fumarate is required.
Slovenian: Odmerka zdravila Vosevi, raltegravirja ali emtricitabina/dizoproksil tenofovirijevega fumarata ni treba prilagajati.
English: The pharmacokinetics of velpatasvir were studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Slovenian: Farmakokinetiko velpatasvirja so preučili z enkratnim 100-miligramskim odmerkom velpatasvirja pri bolnikih, negativnih za HCV, s hudo ledvično okvaro (eGFR < 30 ml/min po metodi CockcroftGault).
English: Median sofosbuvir EC50, nM (range)
Slovenian: Sofosbuvir EC50, nMa
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Slovenian: Pri uporabi režimov, ki vključujejo sofosbuvir, v kombinaciji z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
English: Median voxilaprevir EC50, nM (range)
Slovenian: Povprečna vrednost EC50 za voksilaprevir, nM (razpon)
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Tenofovir disoproxil fumarate
Slovenian: ZDRAVILA ZA ZDRAVLJENJE OKUŽBE Z VIRUSOM HIV: ZAVIRALCI REVERZNE TRANSKRIPTAZE
English: NS5A inhibitorexperienced patients, GT1-6, with or without cirrhosis
Slovenian: 1-6, ki so bili predhodno že zdravljeni z zaviralci NS5A, s cirozo ali brez
English: • The other ingredients are
Slovenian: • Druge sestavine zdravila so Jedro tablete:
English: The median time between prior DAA failure and first dose of Vosevi or sofosbuvir/velpatasvir for patients enrolled into POLARIS-4 was 76 weeks (range: 10 to 549 weeks).
Slovenian: Mediana časa med predhodnim neuspehom zdravljenja z DAA in prvim odmerkom zdravila Vosevi ali sofosbuvirja/velpatasvirja za bolnike, vključene v študijo POLARIS-4, je bila
English: No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 23- and 4-fold higher, respectively, than the human exposure at the recommended clinical dose.
Slovenian: V študijah razvojne toksičnosti z velpatasvirjem pri izpostavljenostih na podlagi AUC, ki so bile približno 23-krat večje pri miših in 4-krat večje pri podganah od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, niso zabeležili nobenih teratogenih učinkov.
English: Rifampicin (600 mg once daily) + sofosbuvir (400 mg single dose)f
Slovenian: Rifampicin (600 mg enkrat na dan) + sofosbuvir (400 mg enkratni odmerek)f
English: Ketoconazole (200 mg twice daily) + velpatasvir (100 mg single dose)f
Slovenian: Ketokonazol (200 mg dvakrat na dan) + velpatasvir (100 mg enkratni odmerek)f
English: Patients with GT1-4 were randomised in a 1:1 ratio to SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks.
Slovenian: Bolniki z okužbo GT 1-4 so bili randomizirani v razmerju 1 : 1 za 8tedensko zdravljenje s SOF/VEL/VOKS
English: At clinically relevant concentrations, voxilaprevir is not an inhibitor of hepatic transporters OCT1, renal transporters OCT2, OAT1, OAT3 or MATE1, or CYP or UGT1A1 enzymes.
Slovenian: V klinično pomembnih koncentracijah voksilaprevir ni zaviralec jetrnih prenašalcev OCT1, ledvičnih prenašalcev
English: Severe RI (eGFR <30 mL/min/1.73 m2)
Slovenian: ≥ 50 in < 80 ml/mi n/1,73 m2)
English: No dose adjustment of Vosevi or voriconazole is required.
Slovenian: Odmerka zdravila Vosevi ali vorikonazola ni treba prilagajati.
English: Analyses were conducted to explore the association between pre-existing baseline NS3 and NS5A RAVs and treatment outcome for patients that had not previously been treated with DAA regimens and received sofosbuvir/velpatasvir/voxilaprevir for 8 weeks in POLARIS-2 and POLARIS-3.
Slovenian: V študijah POLARIS-2 in POLARIS-3 so opravili analize, da bi raziskali povezavo med predhodno obstoječimi izhodiščnimi RAV NS3 in NS5A in izidom zdravljenja pri bolnikih, ki predhodno še niso bili zdravljeni z režimi, ki vsebujejo DAA, in ki so prejemali 8-tedensko zdravljenje s sofosbuvirjem/velpatasvirjem/voksilaprevirjem.
English: Analyses were conducted to explore the association between pre-existing baseline NS3 and NS5A RAVs and treatment outcome for patients that had previously been treated with DAA regimens and received sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-1 and POLARIS-4.
Slovenian: V študijah POLARIS-1 in POLARIS-4 so opravili analize, da bi raziskali povezavo med predhodno obstoječimi izhodiščnimi RAV NS3 in NS5A in izidom zdravljenja pri bolnikih, ki so bili predhodno že zdravljeni z režimi, ki vsebujejo DAA, in ki so prejemali 12-tedensko zdravljenje s sofosbuvirjem/velpatasvirjem/voksilaprevirjem.
English: ↔ Voxilaprevir
Slovenian: ↔ voksilaprevir
English: ANTIMYCOBACTERIALS Rifampicin (single dose)
Slovenian: ZDRAVILA ZA ZDRAVLJENJE OKUŽB Z MIKOBAKTERIJAMI Rifampicin (enkratni odmerek) (zaviranje OATP1B)
English: mL/min/1.
Slovenian: ml/min/1,7 3m2)
English: No dose adjustment of Vosevi or elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate is required.
Slovenian: Odmerka zdravila Vosevi ali elvitegravirja/kobicistata/ emtricitabina/ tenofoviralafenamidijevega fumarata ni treba prilagajati.
English: ↔ Lopinavir ↔ Sofosbuvir ↔ Velpatasvir ↑ Voxilaprevir
Slovenian: ↔ Lopinavir ↔ Sofosbuvir ↔ Velpatasvir ↑ Voksilaprevir
English: Sofosbuvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study.
Slovenian: V študiji razvoja pri podganah pred kotitvijo in po njej sofosbuvir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
English: Norgestrel Ethinyl estradiol
Slovenian: Norgestimat/etinilestradiol (norgestimat
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol (norgestimate 0.180 mg/0.215 mg/0.25 m g/ethinyl estradiol 0.025 mg) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Slovenian: 0,180 mg/0,215 mg/0,25 mg/ etinilestradiol 0,025 mg) +
English: Patient disposition
Slovenian: Razporeditev bolnikov
English: After a single 100 mg dose of [14C]-velpatasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.5 and 0.7.
Slovenian: Po enkratnem 100-miligramskem odmerku [14C]-velpatasvirja pri zdravih osebah je bilo razmerje radioaktivnosti [14C] v krvi in plazmi 0,5-0,7.
English: Voxilaprevir
Slovenian: Voksilaprevir
English: l. Administered as elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide fixed-dose combination.
Slovenian: l.Uporabljeno kot fiksna kombinacija elvitegravirja, kobicistata, emtricitabina in tenofoviralafenamida.
English: Genotype 1b
Slovenian: Genotip 1b Genotip 2
English: Co-administration with such medicinal products is not recommended with Vosevi (see section 4.4 and Table 2).
Slovenian: Sočasna uporaba teh zdravil z zdravilom Vosevi ni priporočljiva (glejte poglavje 4.4 in preglednico 2).
English: The safety assessment of Vosevi was based on data from Phase 2 and 3 clinical trials in which 1383 patients received sofosbuvir/velpatasvir/voxilaprevir or sofosbuvir/velpatasvir + voxilaprevir for 8 or 12 weeks.
Slovenian: 1.383 bolniki, ki so prejemali sofosbuvir/velpatasvir/voksilaprevir ali sofosbuvir/velpatasvir +
English: No dose adjustment of Vosevi, darunavir (ritonavir boosted) or emtricitabine/tenofovir disoproxil fumarate is required.
Slovenian: darunavirja (okrepljenega z ritonavirjem) ali emtricitabina/dizoproksil tenofovirijevega fumarata ni treba prilagajati.
English: The pharmacokinetics of voxilaprevir were studied with a single dose of 100 mg voxilaprevir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Slovenian: Farmakokinetiko voksilaprevirja so proučili z enkratnim 100-miligramskim odmerkom voksilaprevirja pri bolnikih, negativnih za HCV, z zmerno in hudo jetrno okvaro (stopnja B in C po CPT).
English: The pharmacokinetics of velpatasvir were studied with a single dose of 100 mg velpatasvir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Slovenian: Farmakokinetiko velpatasvirja so proučili z enkratnim 100-miligramskim odmerkom velpatasvirja pri bolnikih, negativnih za HCV, z zmerno in hudo jetrno okvaro (stopnja B in C po CPT).
English: No dose adjustment of Vosevi or dolutegravir is required.
Slovenian: Odmerka zdravila Vosevi ali dolutegravirja ni treba prilagajati.
English: The physician in charge of the diabetic care of the patient should be informed when DAA therapy is initiated.
Slovenian: O začetku zdravljenja z neposredno delujočim protivirusnim zdravilom je treba obvestiti zdravnika, odgovornega za zdravljenje sladkorne bolezni pri zadevnem bolniku.
English: Impact of DAA therapy on drugs metabolized by the liver
Slovenian: Vpliv zdravil z direktnim delovanjem na viruse (DAA - direct-acting antivirals) na zdravila, ki se presnavljajo prek jeter
English: No NS3, NS5A, or NS5B NI RAVs emerged in this patient infected with genotype 1a HCV.
Slovenian: Pri tem bolniku, okuženim z virusom HCV genotipa 1a, ni prišlo do nobenih RAV NI NS3, NS5A ali NS5B.
English: a. Two patients with undetermined genotype in the SOF/VEL/VOX group achieved SVR12.
Slovenian: a. V skupini SOF/VEL/VOKS sta SVR12 dosegla dva bolnika z nedoločenim genotipom.
English: Ciclosporin ↔ ↔ Voxilaprevir ↑
Slovenian: Ciklosporin ↔ ↔ Voksilaprevir
English: Observed: Dabigatran ↑
Slovenian: Dabigatran ↑
English: i. Administered as emtricitabine, rilpivirine, and tenofovir alafenamide fixed-dose combination.
Slovenian: i. Uporabljeno kot fiksna kombinacija emtricitabina, rilpivirina in tenofoviralafenamida.
English: Voxilaprevir was 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 rat micronucleus assays.
Slovenian: Voksilaprevir v nizu raziskav in vitro ali in vivo ni bil genotoksičen, vključno z bakterijskim testom mutagenosti, testom kromosomske aberacije z uporabo limfocitov humane periferne krvi in in vivo v testu mikronukleusa pri miših.
English: No NS3, NS5A, or NS5B NI RAVs emerged in either of these patients.
Slovenian: Pri nobenem od teh bolnikov ni prišlo do nobenih RAV NI NS3, NS5A ali NS5B.
English: Of these 3 patients, 1 patient (33%) had virus with emergent NS5A RAV Y93N at failure.
Slovenian: (33 %) virus, pri katerem je prišlo do RAV NS5A Y93N ob neuspehu.
English: g. Administered as efavirenz, emtricitabine and tenofovir DF fixed-dose combination.
Slovenian: g. Uporabljeno kot fiksna kombinacija efavirenza, emtricitabina in dizoproksiltenofovirijevega fumarata.
English: The most common adverse reactions in patients receiving voxilaprevir 900 mg were diarrhoea (34%), nausea (17%) and headache
Slovenian: so bili diareja (34 %), navzea (17 %) in glavobol (9 %).
English: Voriconazole (200 mg twice daily) + voxilaprevir (100 mg single dose)f
Slovenian: Vorikonazol (200 mg dvakrat na dan) + voksilaprevir (100 mg enkratni odmerek)f
English: Not applicable.
Slovenian: ob neuspehu.
English: • St. John's wort (a herbal medicine used to treat depression);
Slovenian: • šentjanževko (zdravilo rastlinskega izvora, ki se uporablja za zdravljenje depresije);
English: It is recommended to separate antacid and Vosevi administration by 4 hours.
Slovenian: Priporoča se, da med uporabo antacida in zdravila Vosevi minejo 4 ure.
English: Co-administration of Vosevi with ciclosporin is not recommended (see section 4.4).
Slovenian: Vosevi s ciklosporinom ni priporočljiva (glejte poglavje
English: hr After Dialysis
Slovenian: 1 uro pred dializo
English: ↔ Sofosbuvir ↔ Voxilaprevir
Slovenian: ↔ Sofosbuvir ↔ Voksilaprevir
English: At clinically relevant concentrations, velpatasvir is not an inhibitor of hepatic transporters BSEP, sodium taurocholate cotransporter protein (NTCP), OATP1A2 or OCT1, renal transporters OCT2, OAT1, OAT3, MRP2 or MATE1, or CYP or UGT1A1 enzymes.
Slovenian: OATP1A2 ali OCT1, ledvičnih prenašalcev OCT2, OAT1, OAT3, MRP2 ali MATE1 ali encimov
English: Vosevi is contraindicated with ethinylestradiol-containing medicinal products (see section 4.3).
Slovenian: Uporaba zdravila Vosevi v kombinaciji z zdravili, ki vsebujejo etinilestradiol, je kontraindicirana (glejte poglavje 4.3).
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)k + emtricitabine/ tenofovir disoproxil fumarate (200/300 mg once daily)j + sofosbuvir/ velpatasvir (400/100 mg once daily)f, h
Slovenian: Raltegravir (400 mg dvakrat na dan)k + emtricitabin/ dizoproksiltenofovirijev fumarat (200/300 mg enkrat na dan)j +
English: After a single 100 mg dose of [14C]-voxilaprevir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.5 and 0.8.
Slovenian: 100-miligramskem odmerku [14C]-voksilaprevirja pri zdravih osebah je bilo razmerje radioaktivnosti [14C] v krvi in plazmi 0,5-0,8.
English: Patient population
Slovenian: Starejši bolniki
English: Ciclosporin (600 mg single dose)e + velpatasvir (100 mg single dose)f
Slovenian: Ciklosporin (600 mg enkratni odmerek)e + velpatasvir (100 mg enkratni odmerek)f
English: DAA-experienced adults who had not received an NS5A inhibitor (POLARIS-4) Table 11 presents the SVR12 by HCV genotype and virologic outcome for the POLARIS-4 trial.
Slovenian: Klinične študije pri bolnikih, ki so bili predhodno že zdravljeni z DAA Odrasli bolniki, ki so bili predhodno že zdravljeni z zaviralci NS5A (POLARIS-1) V preglednici 10 je predstavljen SVR12 po genotipu HCV za preskušanje POLARIS-1.
English: Vosevi is contraindicated with rifabutin (see section 4.3).
Slovenian: Uporaba zdravila Vosevi v kombinaciji z rifabutinom je kontraindicirana (glejte poglavje 4.3).
English: DAA-naïve adults with genotype 3 HCV infection and compensated cirrhosis (POLARIS-3) Table 14 presents the SVR12 and virologic outcome for the POLARIS-3 study.
Slovenian: Odrasli bolniki z okužbo z virusom HCV genotipa 3 in kompenzirano cirozo, ki predhodno še niso bili zdravljeni z DAA (POLARIS-3)
English: j. Administered as emtricitabine, tenofovir disoproxil fumarate fixed-dose combination.
Slovenian: j. Uporabljeno kot fiksna kombinacija emtricitabina in dizoproksiltenofovirijevega fumarata.
English: Outcome for patients without SVR On-treatment virologic failure
Slovenian: Virološki neuspeh med zdravljenjemc
English: Rifampicin (600 mg once daily) + velpatasvir (100 mg single dose)f
Slovenian: Rifampicin (600 mg enkrat na dan) + velpatasvir (100 mg enkratni odmerek)f