FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not stop taking Vosevi
Danish: Du må ikke holde op med at tage Vosevi
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Danish: Størstedelen af den sofosbuvirdosis, der blev genfundet i urinen, var GS-331007 (78 %), mens 3,5 % blev genfundet som sofosbuvir.
English: Additional study details
Danish: Yderligere oplysninger om studie
English: Talk to your doctor or pharmacist before taking Vosevi if:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Vosevi, hvis:
English: The difference in SVR12 was driven by a lower response rate in patients with genotype 1a infection and/or cirrhosis.
Danish: Forskellen i SVR12 var forårsaget af en lavere responsrate hos patienter med genotype 1a-infektion og/eller cirrose.
English: The safety and efficacy of Vosevi in children and adolescents aged less than 18 years have not yet been established.
Danish: Vosevis sikkerhed og virkning hos børn og unge i alderen under 18 år er endnu ikke klarlagt.
English: Demographics and baseline characteristics for all studies are detailed in Table 9.
Danish: Demografi og karakteristika ved baseline er beskrevet i tabel 9.
English: If you forget to take Vosevi
Danish: Hvis du har glemt at tage Vosevi
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.
Danish: • Få rådgivning fra en læge eller apotekspersonalet, hvis du tager warfarin eller andre lignende lægemidler, såkaldte vitamin K-antagonister, der anvendes til fortynding af blodet.
English: Each bottle contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets.
Danish: Hver beholder indeholder et silicageltørremiddel, som skal blive i beholderen for at hjælpe med at beskytte tabletterne.
English: GT = genotype * The most common prior NS5A inhibitors were ledipasvir (LDV) (51%), daclatasvir (27%), and ombitasvir (11%).
Danish: GT = genotype * De mest almindelige tidligere NS5A-hæmmere var ledipasvir (LDV) (51 %), daclatasvir (27 %), og ombitasvir (11 %).
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Vosevi.
Danish: Lægen kan være nødt til nøje at overvåge disse andre lægemidler, som du tager, og foretage dosisjusteringer efter påbegyndelse af Vosevi.
English: • modafinil, used to treat sleep disorders;
Danish: • modafinil, som anvendes til at behandle søvnforstyrrelser
English: Co-administration of Vosevi with digoxin may increase the concentration of digoxin.
Danish: Samtidig administration af Vosevi og digoxin kan øge koncentrationen af digoxin.
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Silicageltørremidlet kommer i et separat brev eller hylster og må ikke sluges.
English: The film-coated tablets are beige, capsule-shaped tablets debossed with “GSI” on one side and “3” on the other side.
Danish: De filmovertrukne tabletter er beige, kapselformede tabletter, præget med ”GSI” på den ene side og med ”3” på den anden side.
English: HBV screening should be performed in all patients before initiation of treatment.
Danish: Alle patienter bør derfor screenes for HBV inden start af behandling.
English: Animal studies have shown a possible link to reproductive toxicity (see section 5.3).
Danish: Dyrestudier har vist en mulig forbindelse til reproduktionstoksicitet (se pkt.
English: • rosuvastatin (a medicine used to treat high blood cholesterol or decrease the risk of certain cardiovascular events);
Danish: • rosuvastatin (medicin, der anvendes til at behandle førhøjet blodkolesterol eller nedsætte risikoen for visse hjerte/karhændelser)
English: Taking Vosevi with any of these may stop your medicines from working properly, or make any side effects worse:
Danish: At tage Vosevi med nogen af disse kan stoppe din medicin med at virke korrekt, eller forværre bivirkningerne:
English: Some of the active substances of Vosevi may pass into human breast milk.
Danish: Nogle aktive stoffer i Vosevi, kan udskilles i modermælken hos mennesker.
English: The use of Vosevi in children and adolescents has not yet been studied.
Danish: Vosevi er endnu ikke undersøgt hos børn og unge.
English: It is given to adults of 18 years and older to treat a chronic (long-term) viral infection of the liver called hepatitis C.
Danish: Det gives til behandling af voksne i alderen 18 år og derover med en kronisk (langvarig) virusinfektion i leveren, der kaldes hepatitis C.
English: Patients should be instructed that if vomiting occurs within 4 hours of dosing an additional tablet of Vosevi should be taken.
Danish: Patienter skal informeres om, at hvis de kaster op inden for 4 timer efter dosering, skal de tage en ekstra tablet af Vosevi.
English: HCV/HBV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Danish: Patienter med samtidig infektion med HCV/HBV har risiko for HBVreaktivering, og de skal derfor nøje overvåges og behandles ifølge gældende kliniske retningslinjer.
English: Table 2: Interactions between Vosevi and other medicinal products
Danish: Tabel 2: Interaktioner mellem Vosevi og andre lægemidler
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of velpatasvir and voxilaprevir by 13- and 6.8-fold, respectively, against genotype 1a HCV replicons.
Danish: Tilstedeværelse af 40 % humant serum havde ingen virkning på sofosbuvirs anti-HCV-aktivitet, men reducerede anti-HCV-aktiviteten af velpatasvir og voxilaprevir henholdsvis 13 gange og 6,8 gange mod genotype 1a-HCV-replikoner.
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Vosevi compared to subjects with normal renal function, as described in the text below, are provided in Table 15.
Danish: Et resumé af virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringen for indholdsstofferne i Vosevi sammenlignet med forsøgspersoner med normal nyrefunktion, som beskrevet nedenfor, vises i tabel 15.
English: There are no data on the use of Vosevi in patients with HCV/hepatitis B virus (HBV) co-infection.
Danish: Der foreligger ingen data om anvendelse af Vosevi hos patienter med samtidig infektion med HCV/hepatitis B-virus (HBV).
English: Use with moderate P-gp inducers or moderate CYP inducers
Danish: Anvendelse sammen med moderate P-gp-induktorer eller moderate CYP-induktorer
English: Co-administration of Vosevi with atazanavir is expected to increase the concentration of voxilaprevir.
Danish: Samtidig administration af Vosevi og atazanavir forventes at øge koncentrationen af voxilaprevir.
English: All patients receiving Vosevi in combination with amiodarone with or without other medicinal products that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Danish: Alle patienter, som får Vosevi i kombination med amiodaron med eller uden andre lægemidler, der nedsætter hjertefrekvensen, skal advares om symptomerne på bradykardi og hjerteblok og informeres om øjeblikkeligt at søge lægehjælp, hvis symptomerne opstår.
English: Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm, debossed with “GSI” on one side and “3” on the other side.
Danish: Beige, kapselformet, filmovertrukket tablet med dimensionerne 10 mm x 20 mm, præget med ”GSI” på den ene side og med ”3” på den anden side.
English: Most subjects had genotype 1 (61% (19/31) [1a, 48% (15/31); 1b, 13% (4/31)]) or genotype 3 (26% (8/31)) HCV infection.
Danish: De fleste forsøgspersoner havde genotype 1 (61 % (19/31) [1a, 48 % (15/31); 1b, 13 % (4/31)]) eller genotype 3 (26 % (8/31)) HCV-infektion.
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.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af sofosbuvir, velpatasvir, voxilaprevir eller Vosevi til gravide kvinder.
English: If you are lactose intolerant, or if you have been told that you have an intolerance to other sugars, talk to your doctor before taking this medicine.
Danish: Hvis du lider af laktoseintolerans eller har fået at vide, at du ikke tåler andre sukkerarter, skal du tale med din læge, inden du tager lægemidlet.
English: Lansoprazoled Rabeprazoled Pantoprazoled Esomeprazoled
Danish: Lansoprazold Rabeprazold Pantoprazold Esomeprazold
English: Biliary excretion of parent drug was the major route of elimination for voxilaprevir.
Danish: Galdeudskillelse af moderstoffet var den primære eliminationsvej for voxilaprevir.
English: In the Phase 3 trials increases in total bilirubin less than or equal to 1.5 x the upper limit of normal were observed in 4% of patients without cirrhosis and 10% of patients with compensated cirrhosis, due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir.
Danish: I fase III-forsøgene blev der set stigninger i total bilirubin på mindre end eller svarende til 1,5 gange den øvre normalgrænse hos 4 % af patienterne uden cirrose og hos 10 % af patienterne med kompenseret cirrose på grund af voxilaprevirs hæmning af OATP1B1 og OATP1B3.
English: * 29% of patients enrolled into POLARIS-3 had received prior treatment with an interferon-based regimen.
Danish: * 29 % af patienter tilmeldt POLARIS-3 havde fået tidligere behandling med et regime baseret på interferon.
English: The hydrolysed and dehydrogenated voxilaprevir were the major metabolites identified in human plasma.
Danish: Den hydrolyserede og dehydrerede voxilaprevir var de primære metabolitter, der blev identificeret i humant plasma.
English: * 23% of patients enrolled into POLARIS-2 had received prior treatment with an interferon-based regimen.
Danish: * 23 % af patienter tilmeldt til POLARIS-2 havde fået tidligere behandling med et regime baseret på interferon.
English: The recommended dose of Vosevi is one tablet, taken orally, once daily with food (see section 5.2).
Danish: Den anbefalede dosis Vosevi er én tablet oralt én gang dagligt sammen med mad (se pkt.
English: DAA: direct-acting antiviral; GT: genotype; SOF: sofosbuvir; VEL: velpatasvir; VOX: voxilaprevir
Danish: DAA: direkte virkende antiviralt middel; GT: genotype; SOF: sofosbuvir; VEL: velpatasvir; VOX: voxilaprevir
English: Treatment with Vosevi for 8 weeks in POLARIS-2 did not demonstrate noninferiority to treatment with sofosbuvir/velpatasvir for 12 weeks with a prespecified margin of -5%.
Danish: Behandling med Vosevi i 8 uger i POLARIS-2 viste ikke non-inferioritet i forhold til behandling med sofosbuvir/velpatasvir i 12 uger med en på forhånd specificeret margin på -5 %.
English: • atorvastatin, pravastatin, or other statins, used to treat high cholesterol;
Danish: • atorvastatin, pravastatin eller andre statiner, der anvendes til at behandle forhøjet kolesterol
English: Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
Danish: Sofosbuvir er ca. 61-65 % bundet til humane plasmaproteiner, og bindingen er uafhængig af lægemiddelkoncentrationen i intervallet fra 1 μg/ml til 20 μg/ml.
English: Interactions between Vosevi and other medicinal products
Danish: Interaktioner mellem Vosevi og andre lægemidler
English: Overall SVR12a Genotype 1b
Danish: Samlet SVR12a Genotype 1b
English: Voxilaprevir (studied under fed conditions) AUC increases in a greater than doseproportional manner over the dose range of 100 to 900 mg.
Danish: AUC for voxilaprevir (undersøgt efter indtagelse af mad) steg mere end proportionalt over doseringsintervallet fra 100 til 900 mg.
English: Following a single 400 mg dose of sofosbuvir, a 4-hour haemodialysis removed 18% of administered dose.
Danish: Efter en enkelt dosis på 400 mg sofosbuvir fjernede en 4-timers hæmodialysesession 18 % af den administrerede sofosbuvir-dosis.
English: Concomitant use with ethinylestradiol-containing medicinal products may increase the risk of alanine aminotransferase (ALT) elevations and is contraindicated (see section 4.3 and Table 2).
Danish: Samtidig anvendelse med ethinylestradiol-indholdende lægemidler kan øge risikoen for forhøjelse af alanin-aminotransferase (ALT) og er kontraindiceret (se pkt.
English: The most common adverse reactions in patients receiving voxilaprevir 900 mg were diarrhoea (34%), nausea (17%) and headache
Danish: De mest almindelige bivirkninger hos patienter, som fik voxilaprevir 900 mg var diarré (34 %), kvalme (17 %) og hovedpine (9 %).
English: These are shown in Table 6.
Danish: Disse vises i tabel 6.
English: Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne, arvelige problemer med galaktosæmi, Lapplaktasemangel eller glukose-galaktose-malabsorption må ikke tage lægemidlet.
English: If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Vosevi.
Danish: Hvis du tager et syreneutraliserende middel, skal du tage det mindst 4 timer før eller mindst 4 timer efter Vosevi.
English: Caution is warranted and therapeutic concentration monitoring of digoxin is recommended.
Danish: Der skal udvises forsigtighed, og det tilrådes at monitorere digoxinkoncentrationen.
English: The safety and efficacy of Vosevi in the treatment of HCV infection in patients who are post-liver transplant have not been assessed.
Danish: Vosevis sikkerhed og virkning til behandling af HCV-infektion hos patienter, der har gennemgået en levertransplantation, er ikke blevet vurderet.
English: There was an increase in tenofovir exposure (AUC and Cmax) of around 40% during co-treatment with Vosevi and darunavir + ritonavir + tenofovir disoproxil fumarate/emtricitabine.
Danish: Der sås en stigning i tenofovireksponeringen (AUC og Cmax) på ca. 40 % under samtidig behandling med Vosevi og darunavir+ritonavir + tenofovirdisoproxilfumarat/emtricitabin.
English: 8 weeks may be considered in genotype 3 infected patients (see section 5.1)
Danish: 12 uger 8 uger kan overevejes hos genotype 3-inficerede patienter (se pkt.
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203.
Danish: Sofosbuvir metaboliseres i udstrakt grad i leveren under dannelse af den farmakologisk aktive nukleosid-analog triphosphat GS-461203.
English: Age (years) median (range) Male Gender Race Black/African American 14% (60) White Hispanic/Latino Genotype Genotype 1a Genotype 1b Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 IL28B CC HCV RNA ≥ 800,000 IU/mL 74% (306) Compensated cirrhosis Site US Non-US
Danish: Gennemsnitsalder (år) (interval) Køn - Mænd Race Sort/Afroamerikansk Hvid Spansk/Latin-amerikansk 6 % (25) Genotype Genotype 1a Genotype 1b Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 IL28B CC HCV RNA ≥ 800.000 IE/mL 74 % (306) Kompenseret cirrose Center USA Uden for USA
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Vosevi, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS): For at kunne vurdere tilbagevenden af hepatocellulær karcinom forbundet med Vosevi, skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne af en prospektiv sikkerhedsundersøgelse ved hjælp af data udledt fra en kohorte af en gruppe veldefinerede patienter, baseret på en aftalt protokol.
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.
Danish: AUC0-inf for GS-331007 ændrede sig ikke, og Cmax var 19 % til 35 % lavere ved administration af Vosevi eller dets indholdsstoffer sammen med mad.
English: For sofosbuvir, the NS5B substitution S282T was selected in genotype 1-6 replicons and was associated with 2- to 18-fold reduced susceptibility to sofosbuvir.
Danish: For sofosbuvir blev NS5B-substitution S282T selekteret i replikoner fra genotype 1-6 og gav 2 til 18 gange nedsat følsomhed for sofosbuvir.
English: Table 15: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of SOF, GS331007, Velpatasvir and Voxilaprevir Compared to Subjects with Normal Renal Function
Danish: Tabel 15: Virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringer (AUC) for SOF, GS-331007, velpatasvir og voxilaprevir sammenlignet med forsøgspersoner med normal nyrefunktion
English: Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
Danish: Indberetning af bivirkninger Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: The MAH shall complete, within the stated timeframe, the below measures:
Danish: Indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Voxilaprevir metabolites also identified in faeces included des[methylcyclopropylsulphonamide]-voxilaprevir (22.1%), which is formed intestinally, dehydrovoxilaprevir (7.5%), and two des-[methylcyclopropylsulphonamide]-oxy-voxilaprevir metabolites (5.4% and 3.9%).
Danish: Metabolitter af voxilaprevir til stede i fæces inkluderede des[methylcyclopropylsulfonamid]-voxilaprevir (22,1 %), som dannes i tarmen, dehydro-voxilaprevir (7,5 %), og to des-[methylcyclopropylsulfonamid]-oxy-voxilaprevir metabolitter (5,4 % og 3,9 %).
English: Among subjects with genotype 1a in POLARIS-2, SVR12 was 87% (53/61) for those with Q80K/L/R RAVs and 94% (99/105) for those without Q80K/L/R RAVs.
Danish: Blandt forsøgspersoner med genotype 1a i POLARIS-2, var SVR12 87 % (53/61) for dem med Q80K/L/R RAV'er og 94 % (99/105) for dem uden Q80K/L/R RAV'er.
English: NA: Not available a. Mean value from multiple experiments of same laboratory replicon.
Danish: a. Middelværdi fra adskillige eksperimenter med samme laboratoriereplikon.
English: Serum HCV RNA values were measured during the clinical studies using the COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of 15 IU per mL.
Danish: Serum-HCV-RNA blev målt i løbet af de kliniske studier vha. COBAS AmpliPrep/COBAS Taqman HCV-test (version 2.0) med en nedre kvantificeringsgrænse (LLOQ) på 15 IE per ml.
English: Sofosbuvir, velpatasvir, and voxilaprevir were fully active against substitutions associated with resistance to other classes of DAAs with different mechanisms of actions, e.g. voxilaprevir was fully active against NS5A and NS5B NI RAVs.
Danish: Sofosbuvir, velpatasvir og voxilaprevir var fuldt aktive mod substitutioner, der var forbundet med resistens over for andre klasser af DAA'er med forskellige virkningsmekanismer, f.eks. var voxilaprevir fuldt aktiv mod NS5A og NS5B NI RAV'er.
English: Of the 31 patients enrolled, 74% (23/31) were male, 81% (25/31) were white, 71% (22/31) had a baseline body mass index < 30 kg/m2, 48% (15/31) had compensated cirrhosis, 58% (18/31) had previously received sofosbuvir, velpatasvir and voxilaprevir, and 42% (13/31) had previously received sofosbuvir and velpatasvir.
Danish: Af de 31 indskrevne patienter var 74 % (23/31) mænd, 81 % (25/31) var hvide, 71 % (22/31) havde et body mass index < 30 kg/m2 ved baseline, 48 % (15/31) havde kompenseret cirrose, 58 % (18/31) havde tidligere modtaget sofosbuvir, velpatasvir og voxilaprevir, og 42 % (13/31) havde tidligere modtaget sofosbuvir og velpatasvir.
English: Velpatasvir is > 99% bound to human plasma proteins and binding is independent of drug concentration over the range of 0.09 μg/mL to 1.8 μg/mL.
Danish: Velpatasvir er > 99 % bundet til humane plasmaproteiner, og bindingen er uafhængig af lægemiddelkoncentrationen i intervallet fra 0,09 μg/ml til 1,8 μg/ml.
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of Vosevi were 0.5 and 29 hours, respectively.
Danish: De mediane terminale halveringstider for sofosbuvir og GS-331007 efter administration af Vosevi var hhv. 0,5 og 29 timer.
English: Vosevi has been shown to increase tenofovir exposure when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Danish: Det er vist, at Vosevi øger tenofovir-eksponeringen, når det anvendes sammen med et hiv-regime, der indeholder tenofovirdisoproxilfumarat og en farmakokinetisk forstærker (ritonavir eller cobicistat).
English: GS-461203 is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Danish: GS-461203 hæmmer hverken humane DNA- og RNA-polymeraser eller mitokondriel RNA-polymerase.
English: These data indicate that biliary excretion of parent drug was a major route of elimination for velpatasvir.
Danish: Disse data indikerer, at galdeudskillelse af moderstoffet var en primær eliminationsvej for velpatasvir.
English: Iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), macrogol, polyvinyl alcohol, talc, titanium dioxide (E171)
Danish: Sort jernoxid (E172), rød jernoxid (E172), gul jernoxid (E172), macrogol, polyvinylalkohol, talcum, titandioxid (E171).
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Vosevi.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med Vosevi.
English: What you need to know before you take Vosevi Do not take Vosevi
Danish: Det skal du vide, før du begynder at tage Vosevi Tag ikke Vosevi
English: Vosevi has not been studied in patients with ESRD requiring dialysis.
Danish: Vosevi er ikke undersøgt hos patienter med ESRD, der kræver dialyse.
English: Vosevi has no or negligible influence on the ability to drive and use machines.
Danish: Vosevi påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If a dose of Vosevi is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time.
Danish: Hvis en dosis af Vosevi glemmes, og der er gået mindre end 18 timer fra det normale tidspunkt, skal patienterne informeres om at tage tabletten så hurtigt som muligt, hvorefter de skal tage den næste dosis til sædvanlig tid.
English: Vosevi contains lactose.
Danish: Vosevi indeholder laktose.
English: • If you are allergic to sofosbuvir, velpatasvir, voxilaprevir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: • Hvis du er allergisk over for sofosbuvir, velpatasvir, voxilaprevir eller et af de øvrige indholdsstoffer i Vosevi (angivet i punkt 6).
English: Additionally, velpatasvir is active in vitro against most of the NS5A RAVs that confer resistance to ledipasvir and daclatasvir.
Danish: Endvidere er velpatasvir aktiv in vitro mod størstedelen af NS5A-RAV'er med resistens over for ledipasvir og daclatasvir.
English: Cimetidined Nizatidined Ranitidined
Danish: Cimetidind Nizatidind Ranitidind
English: Vosevi 400 mg/100 mg/100 mg film-coated tablets
Danish: Vosevi 400 mg/100 mg/100 mg filmovertrukne tabletter
English: Vosevi is a medicine that contains the active substances sofosbuvir, velpatasvir and voxilaprevir in a single tablet.
Danish: Vosevi er et lægemiddel, der indeholder de aktive stoffer sofosbuvir, velpatasvir og voxilaprevir i den samme tablet.
English: Median peak plasma concentration of GS-331007 was observed 4 hours post-dose.
Danish: Median maksimal plasmakoncentration af GS-331007 blev observeret 4 timer efter dosering.