FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment of Vosevi is required for patients with mild hepatic impairment (Child-PughTurcotte [CPT] Class A).
Danish: Dosisjustering af Vosevi er ikke nødvendig hos patienter med let nedsat leverfunktion (Child-Pugh-Turcotte [CPT] klasse A).
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)
Danish: Tabel 7: SVR12 hos DAA-behandlingsnaive patienter med og uden NS3 eller NS5A RAV'er ved baseline efter studie sofosbuvir/velpatasvir/voxilaprevir i 8 uger POLARIS-2 (n = 498)
English: c. Lack of pharmacokinetics interaction lower bound 70%.
Danish: c. Nedre grænse på 70 %, hvor der ikke er farmakokinetisk interaktion.
English: Voxilaprevir acts as a noncovalent, reversible inhibitor of the NS3/4A protease.
Danish: Voxilaprevir virker som en ikke-kovalent, reversibel hæmmer af -NS3/4A-proteasen.
English: Velpatasvir median peak concentrations were observed at 4 hours post-dose.
Danish: Velpatasvirs mediane maksimale koncentration blev observeret 4 timer efter dosering.
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.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerer, at cirrose (CPT klasse A) ikke havde nogen klinisk relevant indvirkning på eksponeringen for sofosbuvir og GS-331007.
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.
Danish: Af de 182 DAA-behandlingserfarne patienter, der blev behandlet med sofosbuvir/velpatasvir/voxilaprevir i 12 uger i POLARIS-4 (se Tabel 11), recidiverede 1 ud af 182 (1 %) patienter og kvalificerede sig til resistensanalyse.
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.
Danish: Ved klinisk relevante koncentrationer hæmmer voxilaprevir ikke levertransportørerne OCT1, de renale transportører OCT2, OAT1, OAT3, eller MATE1 eller CYP-enzymer eller UGT1A1-enzymer.
English: Co-administration of Vosevi with atazanavircontaining regimens is not recommended.
Danish: Samtidig administration af Vosevi og regimer, der indeholder atazanavir, frarådes.
English: Edoxaban (Inhibition of OATP1B1)
Danish: Edoxaban (Hæmning af OATP1B1)
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.
Danish: Volxilaprevir hæmmer lægemiddeltransportørerne P-gp, BCRP, OATP1B1 og OATP1B3, og dets involvering i lægemiddelinteraktioner med disse transportører er primært begrænset til absorptionsprocessen.
English: Use with strong OATP1B inhibitors
Danish: Anvendelse sammen med stærke OATP1B-hæmmere
English: Contents of the pack and other information What Vosevi contains
Danish: Pakningsstørrelser og yderligere oplysninger Vosevi indeholder:
English: Velpatasvir and voxilaprevir are substrates of drug transporters OATP1B1 and OATP1B3.
Danish: Velpatasvir og voxilaprevir er substrater for lægemiddeltransportørerne OATP1B1 og OATP1B3.
English: Iron oxide black (E172) Iron oxide red (E172) Iron oxide yellow (E172)
Danish: Sort jernoxid (E172) Rød jernoxid (E172) Gul jernoxid (E172) Macrogol
English: Overall SVR12a
Danish: Samlet SVR12a
English: If it is after 18 hours then patients should be instructed to wait and take the next dose of Vosevi at the usual time.
Danish: Hvis der er gået mere end 18 timer, skal de vente og tage den næste dosis Vosevi til sædvanlig tid.
English: Voxilaprevir median peak concentrations were observed 4 hours post-dose.
Danish: Median maksimal koncentration af voxilaprevir blev observeret 4 timer efter dosering.
English: Severe RI (eGFR <30 mL/min/1.73 m2)
Danish: Svært RI (eGFR < 30 ml/min/ 1,73 m2)
English: Unchanged voxilaprevir is the major species present in faeces.
Danish: Uomdannet voxilaprevir er den primære form, der er til stede i fæces.
English: b. One patient without cirrhosis had genotype 1 subtype other than genotype 1a or genotype 1b; the patient achieved SVR12.
Danish: b. En patient uden cirrose havde genotype 1-undertype anden end genotype 1a eller genotype 1b; patienten opnåede SVR12.
English: Carbamazepine (Induction of P-gp and CYPs)
Danish: Carbamazepin (Induktion af P-gp og CYP'er)
English: Vosevi may be co-administered with P-gp, BCRP and CYP inhibitors.
Danish: Vosevi kan administreres samtidig med P-gp-, BCRP- og CYP-hæmmere.
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.
Danish: Der blev udført analyser for at undersøge forbindelsen mellem præeksisterende NS3 og NS5ARAV'er ved baseline og behandlingsresultatet for patienter, som tidligere var blevet behandlet med DAA-regimer, og som fik sofosbuvir/velpatasvir/voxilaprevir i 12 uger i POLARIS-1 og POLARIS-4.
English: Interaction only studied with sofosbuvir/ velpatasvir.
Danish: Interaktion kun undersøgt med sofosbuvir/velpatasvir.
English: No dose adjustment of Vosevi is required for patients with mild hepatic impairment (CPT Class A).
Danish: Dosisjustering af Vosevi er ikke nødvendig hos patienter med let nedsat leverfunktion (CPT klasse A).
English: k. Lack of pharmacokinetics interaction bounds 50-200%.
Danish: k. Interval på 50-200%, hvor der ikke er farmakokinetisk interaktion.
English: Interaction only studied with velpatasvir and voxilaprevir.
Danish: Interaktion kun undersøgt med velpatasvir og voxilaprevir.
English: In the sofosbuvir/velpatasvir 12-week treatment group, 2 of 109 (2%) patients qualified for resistance analysis due to virologic failure.
Danish: I den 12-ugers behandlingsgruppe, som fik sofosbuvir/velpapasvir, kvalificerede i alt 2 ud af 109 (2 %) patienter sig til resistensanalyse pga. virologisk svigt.
English: How to take Vosevi
Danish: Sådan skal du tage Vosevi
English: f. Lack of pharmacokinetics interaction bounds 70-143%.
Danish: f. Interval på 70-143 %, hvor der ikke er farmakokinetisk interaktion.
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.
Danish: DAA-behandlingserfarne voksne, som ikke havde fået en NS5A-hæmmer (POLARIS-4) Tabel 11 viser SVR12 efter HCV-genotype og virologisk resultat for POLARIS-4 forsøget.
English: b. Four patients had genotype 1 subtypes other than genotype 1a or genotype 1b; all 4 patients achieved SVR12.
Danish: b. Fire patienter havde genotype 1-undertyper andet end genotype 1a eller genotype 1b; alle 4 patienter opnåede SVR12.
English: No dose adjustment of Vosevi or ketoconazole is required.
Danish: Dosisjustering af Vosevi eller ketoconazol er ikke nødvendig.
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).
Danish: Der er set tilfælde af svær bradykardi og hjerteblok ved anvendelse af regimer, der indeholder sofosbuvir, i kombination med amiodaron og/eller andre lægemidler, der nedsætter hjertefrekvensen (se pkt.
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.
Danish: Ved klinisk relevante koncentrationer hæmmer velpatasvir ikke levertransportørerne BSEP, natriumtaurocholat cotransportørprotein (NTCP), OATP1A2 eller OCT1, renale transportører OCT2, OAT1, OAT3, MRP2 eller MATE1, eller CYP eller UGT1A1 enzymer.
English: Velpatasvir and voxilaprevir are inhibitors of drug transporters P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3.
Danish: Velpatasvir og voxilaprevir er hæmmere af lægemiddeltransportørerne P-gp, brystcancer-resistent protein (BCRP) samt organisk anion-transporterende polypeptid (OATP) 1B1 og OATP1B3.
English: Co-administration of Vosevi with lopinavir-containing regimens is not recommended.
Danish: Samtidig administration af Vosevi og regimer, der indeholder lopinavir, frarådes
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.
Danish: Der foreligger begrænsede sikkerhedsdata hos patienter med svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed [eGFR] < 30 ml/min/1,73 m2) og nyresygdom i slutstadiet (ESRD), der kræver hæmodialyse.
English: Velpatasvir is primarily a substrate of CYP2B6, CYP2C8, and CYP3A4 with slow turnover.
Danish: Velpatasvir er hovedsagligt et substrat for CYP2B6, CYP2C8 og CYP3A4 med langsom omsætning.
English: Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the [14C]-radioactivity was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Danish: Efter en enkeltoral 400 mg-dosis af [14C]-sofosbuvir var den gennemsnitlige totale genfinding af [14C]-radioaktivitet over 92 %, og henholdsvis ca. 80 %, 14 % og 2,5 % blev genfundet i urin, fæces og udåndingsluft.
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.
Danish: Efter en enkelt oral 100 mg-dosis af [14C]-voxilaprevir var den gennemsnitlige totale genfinding af [14C]-radioaktivitet 94 %, med al radioaktivitet målt i fæces og ingen i urinen.
English: The pharmacokinetics of sofosbuvir was studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT Class B and C).
Danish: Sofosbuvirs farmakokinetik blev undersøgt efter 7 dages dosering med 400 mg sofosbuvir hos HCV-inficerede patienter med moderat og svært nedsat leverfunktion (CPT klasse B og C).
English: Table 10: SVR12 in NS5A-inhibitor experienced patients by HCV genotype in study POLARIS-1*
Danish: Tabel 10: SVR12 hos NS5A-hæmmer-behandlingserfarne patienter efter HCV-genotype i forsøget POLARIS-1*
English: b. Two patients had genotype 1 subtypes other than genotype 1a or genotype 1b; both patients achieved SVR12.
Danish: b. To patienter havde genotype 1-undertyper andet end genotype 1a eller genotype 1b; begge patienter opnåede SVR12.
English: (may affect more than 1 in 10 people) • headache
Danish: (kan påvirke mere end 1 ud af 10 personer)
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.
Danish: Der blev udført analyser for at undersøge forbindelsen mellem præeksisterende NS3 og NS5A RAV'er ved baseline og behandlingsresultatet for patienter, der ikke tidligere var blevet behandlet med DAAregimer, og som fik sofosbuvir/velpatasvir/voxilaprevir i 8 uger i POLARIS-2 og POLARIS-3.
English: Othere a. Two patients without cirrhosis with undetermined genotype in the SOF/VEL/VOX group achieved SVR12.
Danish: Andete a. To patienter uden cirrose med ubestemt genotype i gruppen, som blev behandlet med SOF/VEL/VOX, opnåede SRV12.
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.
Danish: Der blev ikke observeret nogen teratogene virkninger i studier af udviklingstoksicitet hos rotter og kaniner med voxilaprevir ved AUC-eksponeringer ca. hhv. 141 og 4 gange højere end den humane eksponering ved den anbefalede kliniske dosis.
English: Co-administration with Vosevi is not recommended.
Danish: Samtidig administration med Vosevi frarådes.
English: DAA naïve patients without cirrhosis
Danish: DAA-behandlingsnaive patienter uden cirrose
English: Methadone (Methadone maintenance therapy [30 to 130 mg daily]) + sofosbuvir (400 mg once daily)f
Danish: Methadon (Methadon vedligeholdelsesbehandling [30-130 mg dagligt]) + sofosbuvir (400 mg én gang dagligt)f
English: Interaction only studied with velpatasvir.
Danish: Interaktion er kun undersøgt med velpatasvir.
English: Potential for other medicinal products to affect Vosevi
Danish: Potentialet for andre lægemidlers påvirkning af Vosevi
English: Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Danish: Vosevi er indiceret til behandling af kronisk hepatitis C-virus- (HCV-) infektion hos voksne (se pkt.
English: (Inhibition of OATP1B and BCRP)
Danish: (Hæmning af OATP1B og BCRP)
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.
Danish: Lægemidler der kan reducere eksponeringen for Vosevi i plasma Lægemidler, der er stærke induktorer af P-gp og/eller stærke induktorer af CYP2B6, CYP2C8 eller CYP3A4 (f.eks. carbamazepin, phenobarbital, phenytoin, rifampicin, rifabutin og perikon) kan nedsætte plasmakoncentrationen af sofosbuvir, velpatasvir og/eller voxilaprevir, hvilket fører til en nedsat terapeutisk virkning af Vosevi.
English: Rifapentine (Induction of P-gp and CYPs)
Danish: Rifapentin (Induktion af P-gp og CYP'er)
English: Both of these patients had virus with emergent NS5A RAV Y93H at failure.
Danish: Begge disse patienter havde virus med begyndende NS5ARAV Y93H for svigt.
English: Other statins (Inhibition of OATP1B)
Danish: Andre statiner (Hæmning af OATP1B)
English: Observed: Ciclosporin ↔ ↔
Danish: Observeret: Ciclosporin
English: Atorvastatin may be administered with Vosevi at a dose that does not exceed atorvastatin 20 mg.
Danish: Atorvastatin kan administreres sammen med Vosevi ved en dosis af atorvastatin, som ikke overstiger 20 mg.
English: Table 11: SVR12 by HCV genotype and virologic outcome in study POLARIS-4
Danish: Tabel 11: SVR12 efter HCV-genotype og virologisk resultat i POLARIS-4 forsøget
English: g. Administered as efavirenz, emtricitabine and tenofovir DF fixed-dose combination.
Danish: g. Administreret som efavirenz, emtricitabin og tenofovir DF fastdosis kombination.
English: In vitro potential for sofosbuvir/velpatasvir/voxilaprevir drug-drug interactions
Danish: In vitro-potentialet for lægemiddelinteraktioner mellem sofosbuvir/velpatasvir/voxilaprevir
English: No NS3, NS5A, or NS5B nucleoside inhibitor (NI) RAVs emerged in the other 5 patients who relapsed.
Danish: NS5A eller NS5B-nukleosidhæmmer- (NI) RAV'er udviklede sig hos de andre 5 patienter, som recidiverede.
English: Co-administration of Vosevi with efavirenz/emtricitabine/tenofovir disoproxil fumarate is not recommended (see section 4.4).
Danish: Samtidig administration af Vosevi og efavirenz/emtricitabin/ tenofovirdisoproxilfumarat frarådes (se pkt.
English: With Cirrhosis
Danish: Med cirrose
English: DAA-naïve adults with genotype 1, 2, 3, 4, 5, or 6 HCV infection (POLARIS-2) Table 12 presents the SVR12 by HCV genotype and virologic outcome for the POLARIS-2 trial.
Danish: Kliniske studier hos DAA-behandlingsnaive patienter DAA-behandlingsnaive voksne med genotype 1, 2, 3, 4, 5, eller 6 HCV-infektion (POLARIS-2) Tabel 12 viser SVR12 efter HCV-genotype og virologisk resultat for POLARIS-2-forsøget.
English: Table 13 presents the SVR12 by HCV genotype by cirrhosis status for the POLARIS-2 trial.
Danish: Tabel 13 viser SVR12 efter HCV-genotype efter cirrose-status for POLARIS-2-forsøget.
English: In the POLARIS-2 sofosbuvir/velpatasvir/voxilaprevir 8-week treatment group (see Table 12), a total of 21 of 501 (4%) patients (16 with genotype 1, 2 with genotype 2, 2 with genotype 4, and 1 with genotype 5) qualified for resistance analysis due to relapse.
Danish: I POLARIS-2 behandlingsgruppen, som fik sofosbuvir/velpatasvir/voxilaprevir i 8 uger (se tabel 12), kvalificerede i alt 21 ud af 501 (4 %) patienter (16 med genotype 1, 2 med genotype 2, 2 med genotype 4, og 1 med genotype 5) sig til resistensanalyse pga. recidiv.
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.
Danish: I den 12-ugers behandlingsgruppe, som fik sofosbuvir/velpapasvir, kvalificerede i alt 3 ud af 440 (1 %) patienter (2 med genotype 1, 1 med genotype 4) sig til resistensanalyse pga. recidiv.
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.
Danish: Baseret på den populationsfarmakokinetiske analyse hos HCV-inficerede patienter var middel-AUC0-24 i Steady-state og Cmax for velpatasvir (n = 1595) hhv. 4041 ng•time/ml og 311 ng/ml.
English: Vosevi is contraindicated with ethinylestradiol-containing medicinal products (see section 4.3).
Danish: ↔ ↔ ↔ Vosevi er kontraindiceret med ethinylestradiol-indholdende lægemidler (se pkt.
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.
Danish: Baseret på den populationsfarmakokinetiske analyse hos HCV-inficerede patienter var middel-AUC0-24 i Steady-state og Cmax for voxilaprevir (n = 1591) hhv. 2577 ng•time/ml og 192 ng/ml.
English: The use of strong inhibitors of OATP1B (e.g. ciclosporin) with Vosevi is not recommended (see section 4.4 and Table 2).
Danish: Anvendelsen af stærke hæmmere af OATP1B (f.eks. ciclosporin) sammen med Vosevi frarådes (se pkt.
English: Tacrolimus (5 mg single dose)e + sofosbuvir (400 mg single dose)f
Danish: Tacrolimus (5 mg enkeltdosis)e +sofosbuvir (400 mg enkeltdosis)f
English: Co-administration of strong OATP1B inhibitors with Vosevi is not recommended (see section 4.5).
Danish: Samtidig administration af OATP1B-hæmmere og Vosevi frarådes (se pkt.4.5).
English: For velpatasvir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were L31I/V and Y93H.
Danish: For velpatasvir var NS5A-resistensforbundne substitutioner, der blev selekteret i replikoner fra genotype 1-6 , L31I/V og Y93H.
English: Following a single dose of 100 mg [14C]-voxilaprevir, the majority (approximately 91%) of radioactivity in plasma was parent drug.
Danish: Efter en enkelt dosis på 100 mg [14C]-velpatasvir var størstedelen (cirka 91 %) af radioaktiviteten i plasma moderstof.
English: Method of administration
Danish: Anbefaling vedrørende administration sammen med
English: No dose adjustment of Vosevi or methadone is required.
Danish: Dosisjustering af Vosevi eller methadon er ikke nødvendig.
English: Table 12: SVR12 by HCV genotype and virologic outcome in study POLARIS-2*
Danish: Tabel 12: SVR12 efter HCV-genotype og virologisk resultat i forsøget POLARIS-2*
English: Vosevi is contraindicated with rosuvastatin (see section 4.3).
Danish: Vosevi er kontraindiceret med rosuvastatin (se pkt.
English: Proton pump inhibitors may be administered with Vosevi at a dose that does not exceed doses comparable with omeprazole 20 mg.
Danish: Protonpumpehæmmere kan administreres samtidig med Vosevi ved en dosis, som ikke må overstige en dosis svarende til omeprazol 20 mg.
English: No NS3 and NS5B NI RAVs emerged in any of these 21 patients at failure.
Danish: Ingen NS3 og NS5B NI RAV'er udviklede sig hos nogen af disse 21 patienter på tidspunktet for svigt.
English: Interaction only studied with sofosbuvir/velpatasvir Expected:
Danish: Interaktion kun undersøgt med sofosbuvir/velpatasvir Forventet:
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.
Danish: Der blev ikke observeret nogen teratogene virkninger i studier af udviklingstoksicitet hos mus og rotter med velpatasvir ved AUCeksponeringer ca. hhv. 23 og 4 gange højere end den humane eksponering ved den anbefalede kliniske dosis.
English: l. Administered as elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide fixed-dose combination.
Danish: l. Administreret som elvitegravir, cobicistat, emtricitabin og tenofoviralafenamid fastdosis kombination.
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).
Danish: Endvidere blev voxilaprevirs farmakokinetik efter en enkelt dosis på 100 mg voxilaprevir undersøgt hos HCV-negative patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min ved Cockcroft-Gault).
English: The use of such medicinal products with Vosevi is contraindicated (see section 4.3 and Table 2).
Danish: Anvendelse af sådanne lægemidler sammen med Vosevi er kontraindiceret (se pkt.
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
Danish: ORALE KONTRACEPTIVA Norgestimat/ ethinylestradiol (norgestimat 0,180 mg/0,215 mg/0,25 mg/ ethinylestradiol 0,025 mg) +sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg én gang dagligt) + voxilaprevir (100 mg once)f
English: Pravastatin may be administered with Vosevi at a dose that does not exceed pravastatin 40 mg.
Danish: Pravastatin kan administreres sammen med Vosevi ved en dosis af pravastatin, som ikke overstiger 40 mg.
English: No dose adjustment of Vosevi or dolutegravir is required.
Danish: Dosisjustering af Vosevi eller dolutegravir er ikke nødvendig.
English: Vosevi is contraindicated with rifabutin (see section 4.3).
Danish: Vosevi er kontraindiceret sammen med rifabutin (se pkt.
English: (Inhibition of P-gp and CYP3A)
Danish: (Hæmning af P-gp og CYP3A)
English: GTs)a (n = 263)
Danish: GT'er) (n = 263)
English: If you take more Vosevi than you should
Danish: Hvis du har taget for meget Vosevi
English: Voxilaprevir is not renally eliminated.
Danish: Voxilaprevir udskilles ikke gennem nyrerne.
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.
Danish: I POLARIS-3 behandlingsgruppen, som fik sofosbuvir/velpatasvir/voxilaprevir i 8 uger (se tabel 14), kvalificerede 2 ud af 110 (2 %) patienter (genotype 3) sig til resistensanalyse pga. recidiv.
English: Patients with GT1-3 infection were randomised in a 1:1 ratio to SOF/VEL/VOX or SOF/VEL for 12 weeks.
Danish: Patienter med GT1-3infektion blev randomiseret i et forhold på 1:1 til at få SOF/VEL/VOX eller SOF/VEL i 12 uger.
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.
Danish: Lægemidler, der er moderate P-gp-induktorer og/eller moderate CYP-induktorer (f.eks. efavirenz, modafinil, oxcarbazepin eller rifapentin), kan nedsætte plasmakoncentrationen af sofosbuvir, velpatasvir og/eller voxilaprevir og medføre reduceret terapeutisk virkning af Vosevi.