FrancophonIA/ELRC3.0 huggingface dataset:
English: In POLARIS-4, a total of 14 patients had virus with NS5B NI RAVs at baseline and all achieved SVR12.
Danish: I POLARIS-4 havde i alt 14 patienter virus med NS5B NI RAV'er ved baseline, og de opnåede alle SVR12.
English: Site directed mutagenesis of NS5A resistance associated variants (RAVs) showed that substitutions conferring a > 100-fold reduction in velpatasvir susceptibility are M28G, A92K and Y93H/N/R/W in genotype 1a, A92K in genotype 1b, C92T and Y93H/N in genotype 2b, Y93H in genotype 3, and L31V and P32A/L/Q/R in genotype 6.
Danish: Site-directed mutagenese af kendte NS5A-RAV'er viste, at substitutioner, der gav > 100 gange nedsat følsomhed for velpatasvir, er M28G, A92K og Y93H/N/R/W i genotype 1a, A92K i genotype 1b, C92T og Y93H/N i genotype 2b, Y93H i genotype 3 samt L31V og P32A/L/Q/R i genotype 6.
English: Site directed mutagenesis of known NS3 RAVs showed that substitutions conferring a > 100-fold reduction in voxilaprevir susceptibility are A156V, A156T or A156L in genotype 1a, 1b, 2a, 3a and 4.
Danish: Site-directed mutagenese af kendte NS3 RAV'er viste, at substitutioner, der gav > 100 gange nedsat følsomhed for voxilaprevir, er A156V, A156T eller A156L i genotype 1a, 1b, 2a, 3a og 4.
English: Colloidal anhydrous silica, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose
Danish: Vandfrit siliciumdioxid, copovidon, croscarmellosenatrium, laktosemonohydrat, magnesiumstearat, mikrokrystallinsk cellulose
English: When administered to lactating rats, voxilaprevir was detected in the plasma of nursing pups.
Danish: Ved administration til rotter, der gav die, blev voxilaprevir detekteret i plasma hos diende unger.
English: Interaction only studied with voxilaprevir.
Danish: Interaktion kun undersøgt med voxilaprevir.
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).
Danish: Gennemsnitstiden mellem før-DAA-svigt og første dosis Vosevi eller sofosbuvir/velpatasvir til patienter inkluderet i POLARIS-4 var 76 uger (interval: 10 til 549 uger).
English: Table 5: Activity of sofosbuvir, velpatasvir and voxilaprevir against transient replicons containing NS5A, NS5B or NS3 protease from clinical isolates
Danish: Tabel 5: Aktivitet af sofosbuvir, velpatasvir og voxilaprevir mod transiente replikoner, der indeholder NS5A, NS5B eller NS3-protease fra kliniske isolater
English: The unbound fraction of voxilaprevir was approximately 2-fold higher in severe hepatic impairment compared with moderate hepatic impairment or normal hepatic function.
Danish: Den ubundne fraktion af voxilaprevir var cirka dobbelt så høj hos patienter med svært nedsat leverfunktion sammenlignet med moderat nedsat leverfunktion eller normal leverfunktion.
English: Relative to healthy subjects (n = 63), voxilaprevir AUC0-24 and Cmax were both 260% higher in HCV-infected patients.
Danish: I forhold til raske personer (n = 63) var AUC0-24 og Cmax for voxilaprevir begge 260 % højere hos HCV-inficerede patienter.
English: NARCOTIC ANALGESICS Methadone
Danish: OPIOID-ANALGETIKA Methadon
English: Observed: Tacrolimus ↓
Danish: Observeret: Tacrolimus
English: Relative to healthy subjects (n = 137), velpatasvir AUC0-24 and Cmax were 41% lower and 39% lower, respectively, in HCV-infected patients.
Danish: I forhold til raske personer (n = 137) var velpatasvir AUC0-24 og Cmax hhv. 41 % lavere og 39 % lavere hos HCV-inficerede patienter.
English: The EC50 values of sofosbuvir, velpatasvir and voxilaprevir against clinical isolates are presented in Table 5.
Danish: EC50-værdierne for sofosbuvir, velpatasvir og voxilaprevir i forhold til kliniske isolater er vist i tabel 5.
English: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication.
Danish: Sofosbuvir er en pan-genotypisk hæmmer af HCV-NS5B-RNA-afhængig RNA-polymerase, som er påkrævet for viral replikation.
English: No NS3 or NS5A RAVs Any NS3 or NS5A RAV NS3 only NS5A only NS3 and NS5A RAVs not determined for both NS3 and NS5Aa a. Patients with NS3 and/or NS5A gene sequencing failure.
Danish: Ingen NS3 eller NS5A RAV'er Enhver NS3 eller NS5A RAV Kun NS3 Kun NS5A NS3 og NS5A RAV'er ikke bestemt for både NS3 og NS5Aa a. Patienter med svigt af NS3- og/eller NS5A-gensekventering.
English: No NS3, NS5A, or NS5B NI RAVs emerged in this patient infected with genotype 1a HCV.
Danish: Ingen NS3, NS5A, eller NS5B NI RAV'er udviklede sig hos denne patient inficeret med genotype 1a HCV.
English: (Induction of CYPs)
Danish: (Induktion af CYP'er)
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.
Danish: H2-receptorantagonister kan administreres samtidig med eller forskudt i forhold til Vosevi ved en dosis, der ikke overstiger svarende til famotidin 40 mg to gange dagligt.
English: Therefore, Vosevi should not be used during breast-feeding.
Danish: Derfor bør Vosevi ikke anvendes under amning.
English: • Placebo 12 weeks (N=152)
Danish: • Placebo i 12 uger (N=152)
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.
Danish: 50 % effektive koncentrationsværdier (EC50) for sofosbuvir, velpatasvir og voxilaprevir mod replikoner af fuld længde eller kimære replikoner, der koder for NS5B-, NS5A- og NS3proteasesekvenser, fra laboratoriestammer er vist i tabel 4.
English: Observed: Norelgestro min
Danish: Observeret: Norelgestromin
English: DAA experienced patients* without cirrhosis or with compensated cirrhosis
Danish: DAA-behandlingserfarne patienter* uden cirrose eller patienter med kompenseret cirrose.
English: Concomitant use with ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (see section 4.5).
Danish: Samtidig anvendelse med ethinylestradiol-indholdende lægemidler såsom såsom p-piller eller svangerskabsforebyggende vaginalring (se pkt.
English: • oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
Danish: • oxcarbazepin (lægemiddel der anvendes til at behandle epilepsi og forebygge krampeanfald)
English: Replicons containing NS3 protease from clinical isolates
Danish: Replikoner, der indeholder NS3-protease fra kliniske isolater
English: Sofosbuvir EC50, nMa Velpatasvir EC50, nMa Voxilaprevir EC50, nMa
Danish: Replikongenotype Sofosbuvir EC50, nMa Velpatasvir EC50, nMa Voxilaprevir EC50, nMa 1a
English: Potential for Vosevi to affect other medicinal products
Danish: Vosevis potentiale til at påvirke andre lægemidler
English: Vosevi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Danish: Vosevi er kontraindiceret sammen med phenobarbital og phenytoin (se pkt.
English: Patient disposition
Danish: Patientdisposition
English: The patient with genotype 1a and virologic breakthrough developed the NS5A RAVs L31M and Y93H.
Danish: Patienten med genotype 1a og virologisk gennembrud udviklede NS5A-RAV'er L31M og Y93H.
English: Close monitoring of INR is recommended when Vosevi is co-administered with all vitamin K antagonists.
Danish: Tæt monitorering af INR anbefales ved alle vitamin Kantagonister ved samtidig behandling med Vosevi.
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
Danish: Tabel 13: SVR12 efter HCV-genotype og virologisk resultat hos patienter, som fik Vosevi i 8 uger uden cirrose eller med cirrose i POLARIS-2 forsøget
English: POLARIS-1 (randomised double blind)
Danish: POLARIS-1 (randomiseret, dobbeltblindet)
English: Table 3: Adverse drug reactions identified with Vosevi Frequency
Danish: Tabel 3: Bivirkninger identificeret med Vosevi
English: c. SVR12 is 89% in genotype 1a patients enrolled at sites in the US and 97% in genotype 1a patients enrolled at sites outside the US d. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
Danish: c. SVR12 er 89 % hos patienter med genotype 1a, som er tilmeldt forsøget på centre i USA, og 97 % hos patienter med genotype 1a, som er tilmeldt på centre uden for USA.
English: Table 14: SVR12 and virologic outcome in study POLARIS-3 (HCV genotype 3 with compensated cirrhosis)*
Danish: Tabel 14: SVR12 og virologisk resultat i POLARIS-3 forsøget (HCV-genotype 3 med kompenseret cirrose)*
English: NS5A inhibitorexperienced patients, GT1-6, with or without cirrhosis
Danish: NS5A-hæmmerbehandlingserfarne patienter, GT1-6, med eller uden cirrose
English: Of these 3 patients, 1 patient (33%) had virus with emergent NS5A RAV Y93N at failure.
Danish: Ud af disse 3 patienter, havde 1 patient (33 %) virus med begyndende NS5A-RAV Y93N for svigt.
English: 1.7-fold↑
Danish: 1,7 gange↑
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.
Danish: SVR12 blev opnået hos alle 39 patienter, der havde NS5B-NI-RAV'er ved baseline i POLARIS-2, og hos 2 ud af 3 (67 %) i POLARIS-3.
English: Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Danish: Vosevi kan anvendes hos disse patienter uden dosisjustering, når ingen andre relevante behandlingsmuligheder er tilgængelige (se pkt.
English: S-methadone ↔ ↔ ↔ Sofosbuvir
Danish: S-methadon ↔ ↔ ↔ Sofosbuvir
English: Medicinal products that inhibit OATP1B, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentrations of velpatasvir or voxilaprevir.
Danish: Lægemidler, der hæmmer OATP1B, CYP2B6, CYP2C8 eller CYP3A4, kan øge plasmakoncentrationen af velpatasvir eller voxilaprevir.
English: Co-administration of Vosevi with edoxaban is not recommended.
Danish: Samtidig administration af Vosevi og edoxaban frarådes.
English: Sofosbuvir, velpatasvir and voxilaprevir are substrates of drug transporters P-gp and BCRP.
Danish: Sofosbuvir, velpatasvir og voxilaprevir er substrater for lægemiddeltransportørerne P-gp og BCRP.
English: Population pharmacokinetic analysis in HCV-infected patients indicated that patients with cirrhosis (CPT Class A) had 73% higher exposure of voxilaprevir than those without cirrhosis (see section 4.2).
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerede, at patienter med cirrose (CPT klasse A) havde 73 % højere eksponering for voxilaprevir end patienter uden cirrose (se pkt.
English: DAA-naïve patients with GT 3 and cirrhosis
Danish: DAAbehandlingsnaive patienter med GT 3 og cirrose
English: Unchanged voxilaprevir was the major species in faeces accounting for a mean of 40% of the administered dose.
Danish: Uomdannet voxilaprevir var den form, der primært var til stede i fæces, hvor den i gennemsnit udgjorde 40 % af den administrerede dosis.
English: The pharmacokinetics of sofosbuvir was studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir,relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Danish: Sofosbuvirs farmakokinetik efter en enkelt dosis på 400 mg blev undersøgt hos HCV-negative patienter med let (eGFR ≥ 50 og < 80 ml/min/1,73 m2), moderat (eGFR ≥ 30 og < 50 ml/min/1,73 m2) eller svært nedsat nyrefunktion (eGFR < 30 ml/min/1,73 m2) og hos patienter med ESRD, der krævede hæmodialyse i forhold til patienter med normal nyrefunktion (eGFR > 80 ml/min/1,73 m2).
English: Placebo-controlled study in which patients with GT1 infection were randomised in a 1:1 ratio to SOF/VEL/VOX or placebo for 12 weeks.
Danish: Placebokontrolleret studie hvori patienter med GT1infektion var randomiseret i et forhold på 1:1 til SOF/VEL/VOX eller placebo i 12 uger.
English: Effect on amiodarone, voxilaprevir, velpatasvir, and sofosbuvir concentrations unknown.
Danish: Virkning på amiodaron-, voxilaprevir-, velpatasvir- og sofosbuvirkoncentrationer ukendt.
English: The physician in charge of the diabetic care of the patient should be informed when DAA therapy is initiated.
Danish: Den læge, der er ansvarlig for patientens diabetesbehandling, bør informeres, når behandling med direkte virkende antivirale lægemidler påbegyndes.
English: Very common diarrhoea, nausea Common abdominal pain, decreased appetite, vomiting Skin and subcutaneous disorders: Uncommon rash
Danish: Almindelig mavesmerter, tab af appetit, opkastning Hud- og subkutane lidelser:
English: One patient with genotype 4d who relapsed developed the NS5A RAV Y93H.
Danish: En patient med genotype 4d, som recidiverede, udviklede NS5A RAV Y93H.
English: • tenofovir disoproxil fumarate, or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
Danish: • tenofovirdisoproxilfumarat eller et hvilket som helst lægemiddel, der indeholder tenofovirdisoproxilfumarat, (lægemiddel der anvendes til at behandle hiv-infektion)
English: Vosevi 400 mg/100 mg/100 mg film-coated tablets sofosbuvir/velpatasvir/voxilaprevir
Danish: Vosevi 400 mg/100 mg/100 mg filmovertrukne tabletter sofosbuvir/velpatasvir/voxilaprevir
English: Pack size: outer carton containing 1 bottle of 28 film-coated tablets.
Danish: Pakningsstørrelse: Kartonæske indeholdende 1 beholder med 28 filmovertrukne tabletter.
English: Although exposures of the fixed-dose combination sofosbuvir, GS-331007, velpatasvir, and voxilaprevir were not directly evaluated in HCV-infected patients with ESRD requiring dialysis after administration of Vosevi, the exposures of sofosbuvir, GS-331007, and velpatasvir are expected to be similar to those observed after administration of sofosbuvir/velpatasvir 400/100 mg in HCV-infected patients with ESRD requiring dialysis.
Danish: Selvom eksponeringerne for den faste dosiskombination af sofosbuvir, GS-331007, velpatasvir og voxilaprevir ikke blev direkte evalueret hos HCV-inficerede patienter med ESRD, der kræver dialyse, efter administration af Vosevi, forventes eksponeringerne for sofosbuvir, GS-331007 og velpatasvir at svare til dem, som blev set efter administration af 400/100 mg sofosbuvir/velpatasvir hos HCVinficerede patienter med ESRD, som krævede dialyse.
English: • If you are sick (vomit) less than 4 hours after taking Vosevi, take another tablet.
Danish: • Hvis du kaster op mindre end 4 timer efter, du har taget Vosevi skal du tage en ny tablet.
English: Norgestrel Ethinyl estradiol
Danish: Norgestrel Ethinylestradiol ↔ ↔ ↔
English: Table 2 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined interaction boundaries).
Danish: Tabel 2 viser en liste over påviste eller potentielt klinisk signifikante lægemiddelinteraktioner (hvor 90 % konfidensintervallet [KI] for middelratio beregnet ved mindste kvadraters metode var inden for
English: Treatment with Vosevi, in accordance with the recommended posology (see section 4.2), should be guided by an assessment of the potential benefits and risks for the individual patient.
Danish: 4.2) skal ledsages af en vurdering af de mulige fordele og risici for den enkelte patient.
English: If you are sick (vomit) after taking Vosevi it may affect the amount of Vosevi in your blood.
Danish: Hvis du kaster op, efter du har taget Vosevi, kan det påvirke mængden af Vosevi i blodet.
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose
Danish: Croscarmellosenatrium Laktosemonohydrat Magnesiumstearat Mikrokrystallinsk cellulose
English: Vosevi contains lactose monohydrate.
Danish: Vosevi indeholder laktosemonohydrat.
English: Rifampicin (multiple dose) (Induction of P-gp and CYPs)
Danish: Rifampicin (flere doser) (Induktion af P-gp og CYP'er)
English: Velpatasvir is a pan-genotypic HCV inhibitor targeting the HCV NS5A protein, which is required for viral replication.
Danish: Velpatasvir er en pan-genotypisk HCV-hæmmer, der er målrettet mod HCV-NS5A-protein, som er påkrævet for virusreplikation.
English: There were no patients receiving sofosbuvir/velpatasvir/voxilaprevir for 12 weeks who permanently discontinued treatment due to adverse reactions.
Danish: Ingen af de patienter, som fik sofosbuvir/velpatasvir/voxilaprevir i 12 uger, stoppede permanent behandling på grund af bivirkninger.
English: Dabigatran etexilate (P-gp substrate) and rosuvastatin (OATP1B and BCRP substrate) are contraindicated (see section 4.3 and Table 2).
Danish: Dabigatranetexilat (P-gp-substrat) og rosuvastatin (OATP1B og BCRP-substrat) er kontraindiceret (se pkt.
English: • outer cartons containing 1 bottle of 28 film-coated tablets
Danish: • kartonæske indeholdende 1 tabletbeholder med 28 filmovertrukne tabletter
English: Voxilaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease.
Danish: Voxilaprevir er en pan-genotypisk hæmmer af HCV-NS3/4A-protease.
English: Table 4: Activity of sofosbuvir, velpatasvir and voxilaprevir against full-length or chimeric laboratory replicons
Danish: Tabel 4: Aktivitet af sofosbuvir, velpatasvir og voxilaprevir mod laboratoriereplikoner af fuld længde eller kimære laboratoriereplikoner
English: Omeprazole dosed 2 hours prior to Vosevi
Danish: Omeprazol doseret 2 timer inden Vosevi
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.
Danish: Hos HCV-inficerede patienter med svært nedsat nyrefunktion, som blev behandlet med en dosis på 200 mg sofosbuvir med ribavirin (n=10) eller 400 mg sofosbuvir med ribavirin (n=10) i 24 uger, eller med 90/400 mg ledipasvir/sofosbuvir (n=18) i 12 uger, var farmakokinetikken af sofosbuvir og GS-331007 i overensstemmelse med farmakokinetikken, som blev set hos HCV-negative patienter med svært nedsat nyrefunktion.
English: Totalb (n = 150)
Danish: I altb (n = 150)
English: Patients receiving Vosevi concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions.
Danish: Patienter, der får Vosevi sammen med elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat eller med tenofovirdisoproxilfumarat plus en boostet hiv-proteasehæmmer, bør overvåges for bivirkninger forbundet med tenofovir.
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, multidrug resistanceassociated protein 2 (MRP2), bile salt export pump (BSEP), OATP1B1, OATP1B3 and organic cation transporter (OCT) 1 and GS-331007 is not an inhibitor of OAT1, OAT3, OCT2, and multidrug and toxin extrusion protein (MATE) 1.
Danish: Sofosbuvir og GS-331007 hæmmer ikke lægemiddeltransportørerne P-gp, BCRP, MRP2 (multidrug resistance-associated protein 2), BSEP (galdesalt-eksportpumpe), OATP1B1, OATP1B3 og OCT (organisk kationtransportør) 1 og GS-331007 hæmmer ikke OAT1, OCT3, OCT2 og MATE1 (multidrug and toxin extrusion protein) -enzymer.
English: SOF/VEL/VOX 8 weeks
Danish: SOF/VEL/VOX i 8 uger
English: Concomitant use with medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) (see section 4.5).
Danish: Samtidig anvendelse med lægemidler, der er stærke induktorer af P-glykoprotein (P-gp) og/eller af cytochrom 450 (CYP) (f.eks. carbamazepin, phenobarbital, phenytoin, rifampicin, rifabutin og perikon) (se pkt.
English: Omeprazole dosed 4 hours after Vosevi
Danish: Omeprazol doseret 4 timer efter Vosevi
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.
Danish: DAA-behandlingsnaive voksne med genotype 3 HCV-infektion og kompenseret cirrose (POLARIS-3) Tabel 14 viser SVR12 og det virologiske resultat for POLARIS-3-studiet.
English: DAA naïve patients with compensated cirrhosis
Danish: DAA-behandlingsnaive patienter med kompenseret cirrose
English: Of the 263 NS5A inhibitor-experienced patients treated with sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-1 (see Table 10), 7 of 263 (3%) patients (2 with genotype 1, 4 with genotype 3, and 1 with genotype 4) did not achieve sustained virologic response (SVR12) and qualified for resistance analysis; 6 relapsed and 1 experienced virologic breakthrough with pharmacokinetic data consistent with nonadherence.
Danish: Af de 263 patienter, som havde behandlingserfaring med en NS5A-hæmmer, der blev behandlet med sofosbuvir/velpatasvir/voxilaprevir i 12 uger i POLARIS-1 (se Tabel 10) opnåede 7 ud af de 263 patienter (3 %) (2 med genotype 1, 4 med genotype 3 og 1 med genotype 4) ikke vedvarende virologisk respons (SVR12) og kvalificerede sig til resistensanalyse; 6 recidiverede og 1 opnåede virologisk gennembrud med farmakokinetiske data, der var forenelige med manglende overholdelse af behandling.
English: Of these 21 patients, 1 patient had virus with emergent NS5A RAVs Q30R and L31M at failure.
Danish: Ud af disse 21 patienter, havde 1 patient virus med begyndende NS5A RAV'er Q30R og L31M på tidspunktet for svigt.
English: Vosevi is not recommended during pregnancy.
Danish: Vosevi frarådes under graviditet.
English: a. Two patients with undetermined genotype in the SOF/VEL/VOX group achieved SVR12.
Danish: a. To patienter med ubestemt genotype i SOF/VEL/VOX gruppen opnåede SVR12.
English: c. Pharmacokinetic data for the 1 patient with on-treatment virologic failure was consistent with non-adherence.
Danish: Farmakokinetiske data fra denne patient var forenelige med manglende overholdelse af behandlingen.
English: No dose adjustment of Vosevi or voriconazole is required.
Danish: Ingen dosisjustering af Vosevi eller voriconazol er nødvendig.
English: Population pharmacokinetic analysis in HCV-infected patients indicated that cirrhosis (CPT Class A) had no clinically relevant effect on the exposure of velpatasvir.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerer, at cirrose (CPT klasse A) ikke havde nogen klinisk relevant indvirkning på eksponeringen for velpatasvir.
English: Without Cirrhosis
Danish: Uden cirrose
English: Effect on sofosbuvir, velpatasvir and voxilaprevir not studied.
Danish: Virkning på sofosbuvir, velpatasvir og voxilaprevir ikke undersøgt.
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.
Danish: Lægemidler, der er stærke OATP1B-hæmmere (f.eks. ciclosporin), kan øge plasmakoncentrationerne betydeligt af voxilaprevir.
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.
Danish: Velpatasvir hæmmer lægemiddeltransportørerne P-gp, BCRP, OATP1B1, OATP1B3 og OATP2B1, og dets involvering i lægemiddelinteraktioner med disse transportører er primært begrænset til absorptionsprocessen.
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.
Danish: Lægemidler der kan øge eksponeringen for Vosevi i plasma Samtidig administration af lægemidler, der hæmmer P-gp eller BCRP, kan øge plasmakoncentrationen af sofosbuvir, velpatasvir eller voxilaprevir.