FrancophonIA/ELRC3.0 huggingface dataset:
English: Vosevi is contraindicated with rifampicin (see section 4.3).
Danish: Vosevi er kontraindiceret sammen med rifampicin (se pkt.
English: Co-administration of Vosevi with ciclosporin is not recommended (see section 4.4).
Danish: Samtidig administration af Vosevi og ciclosporin frarådes (se pkt.
English: Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 3-fold higher than the human exposure at the recommended clinical dose.
Danish: I udviklingsstudiet hos rotter før og efter fødslen havde velpatasvir ingen negative virkninger på adfærd, reproduktion eller udvikling hos afkommet ved AUC-eksponeringer ca. 3 gange højere end den humane eksponering ved den anbefalede kliniske dosis.
English: Patients were randomised in a 1:1 ratio to SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks.
Danish: Patienter blev randomiseret i et forhold på 1:1 til at få SOF/VEL/VOX i 8 uger eller SOF/VEL i 12 uger.
English: In vitro, slow metabolic turnover of velpatasvir primarily by CYP2B6, CYP2C8 and CYP3A4 and of voxilaprevir primarily by CYP3A4 was observed.
Danish: In vitro blev der set langsom metabolisk omsætning af velpatasvir hovedsageligt via CYP2B6, CYP2C8 og CYP3A4 og af voxilaprevir hovedsageligt via CYP3A4.
English: ACID REDUCING AGENTS Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Danish: F.eks. aluminium- eller magnesiumhydroxid, calciumcarbonat
English: Concomitant use with rosuvastatin or dabigatran etexilate (see section 4.5).
Danish: Samtidig anvendelse med rosuvastin eller dibigatranetexilat (se pkt.
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).
Danish: Velpatasvirs farmakokinetik efter en enkelt dosis på 100 mg velpatasvir blev undersøgt hos HCV-negative patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min ved Cockcroft-Gault).
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.
Danish: Patienter med GT1-4 blev randomiseret i et forhold på 1:1 til at få SOF/VEL/VOX i 8 uger eller SOF/VEL i 12 uger.
English: Dolutegravir (50 mg once daily) + sofosbuvir/ velpatasvir (400/100 mg once daily)h
Danish: Dolutegravir (50 mg én gang dagligt) +sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)h
English: (Inhibition of OATP1B, P-gp/BCRP and CYP3A)
Danish: (Hæmning af OATP1B, P-gp/BCRP og CYP3A)
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with once daily sofosbuvir/velpatasvir 400/100 mg for
Danish: Farmakokinetikken af sofosbuvir, GS-331007 og velpatasvir blev undersøgt hos HCV inficerede patienter med ESRD, der krævede dialyse, og som blev behandlet én gang dagligt med sofosbuvir/velpatasvir 400/100 mg i 12 uger, og sammenlignet med patienter uden nedsat nyrefunktion i fase II-/III-studierne med sofosbuvir/velpatasvir.
English: Digoxin (0.25 mg single dose)e + velpatasvir (100 mg single dose)
Danish: Digoxin (0,25 mg enkeltdosis)e/velpatasvir (100 mg enkeltdosis)
English: Other medicines and Vosevi
Danish: Brug af anden medicin sammen med Vosevi
English: Median voxilaprevir EC50, nM (range)
Danish: Middelvoxilaprevir EC50, nM
English: Breast-feeding Do not breast-feed during treatment with Vosevi.
Danish: Du må ikke amme under behandlingen med Vosevi.
English: i. Administered as emtricitabine, rilpivirine, and tenofovir alafenamide fixed-dose combination.
Danish: i. Administreret som emtricitabin, rilpivirin, og tenofoviralafenamid fastdosis kombination.
English: No dose adjustment of Vosevi or elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate is required.
Danish: Dosisjustering af Vosevi eller elvitegravir/cobicistat/emtricitabin /tenofoviralafenamidfumarat er ikke nødvendig.
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
Danish: ANTIVIRALE MIDLER MOD HIV: INTEGRASEHÆMMERE Raltegravir (400 mg to gange dagligt)k + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg én gang dagligt)j+sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)f, h
English: Vosevi is contraindicated with carbamazepine (see section 4.3).
Danish: Vosevi er kontraindiceret med carbamazepin (se pkt.
English: Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate (150/150/200/10 mg once daily)l + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Danish: Elvitegravir/cobicistat/ emtricitabin/ tenofoviralafenamidfumarat (150/150/200/10 mg én gang dagligt)l+sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg én gang dagligt) + voxilaprevir (100 mg én gang dagligt)f
English: Studies in DAA-naïve patients
Danish: Studier i DAA-behandlingsnaive patienter
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
Danish: Darunavir boostet med ritonavir (800 mg + 100 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200/300 mg én gang dagligt) j /sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg én gang dagligt)f
English: Patients with GT5-6 infection were enrolled into the SOF/VEL/VOX 8 week group only.
Danish: Patienter med GT56-infektion blev kun tilmeldt til gruppen SOF/VEL/VOX i 8 uger.
English: No NS3, NS5A, or NS5B NI RAVs emerged in either of these patients.
Danish: Ingen NS3, NS5A eller NS5B-NI-RAV'er udviklede sig hos nogen af disse patienter.
English: ANTICOAGULANTS Dabigatran etexilate (75 mg single dose) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg single dose) + voxilaprevir (100 mg single dose)f
Danish: ANTIKOAGULANTIA Dabigatranetexilat (75 mg enkeltdosis) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg enkeltdosis) + voxilaprevir (100 mg enkeltdosis)f
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.
Danish: Voxilaprevir var ikke genotoksisk i et arsenal af in vitro- eller in vivo-analyser, herunder bakteriel mutagenicitet, kromosomafvigelse ved brug af humane lymfocytter fra perifert blod og in vivomikronukleus-analyser hos rotter.
English: Rifampicin (600 mg once daily) + sofosbuvir (400 mg single dose)f
Danish: Rifampicin (600 mg én gang dagligt) +sofosbuvir (400 mg enkeltdosis)f
English: Close monitoring is recommended if this medicinal product is administered with Vosevi (see sections 4.4 and 4.8).
Danish: Tæt overvågning anbefales, hvis amiodaron administreres med Vosevi (se pkt.
English: No dose adjustment of Vosevi, darunavir (ritonavir boosted) or emtricitabine/tenofovir disoproxil fumarate is required.
Danish: Dosisjustering af Vosevi, darunavir (ritonavir-boostet) eller emtricitabin/tenofovirdisoproxilf umarat er ikke nødvendig.
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.
Danish: Efter en enkelt 100 mg-dosis af [14C]-velpatasvir hos raske personer var forholdet af [14C]-radioaktivitet mellem blod og plasma fra 0,5 til 0,7.
English: Co-administration of Vosevi with modafinil is not recommended (see section 4.4).
Danish: Samtidig administration af Vosevi med modafinil anbefales ikke (se pkt.
English: Ketoconazole (200 mg twice daily) + velpatasvir (100 mg single dose)f
Danish: Ketoconazol (200 mg to gange dagligt) +velpatasvir (100 mg enkeltdosis)f
English: In healthy volunteer studies with sofosbuvir and velpatasvir, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups.
Danish: De højeste dokumenterede doser af sofosbuvir, velpatasvir og voxilaprevir var henholdsvis enkeltdoser på 1.200 mg, 500 mg og 900 mg. I studier med sofosbuvir og velpatasvir hos raske frivillige blev der ikke set nogen uønskede virkninger ved disse dosisniveauer, og bivirkningerne var sammenlignelige i frekvens og sværhedsgrad med dem, der blev rapporteret i placebogrupperne.
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).
Danish: Voxilaprevirs farmakokinetik efter en enkelt dosis på 100 mg voxilaprevir blev undersøgt hos HCV-negative patienter med moderat og svært nedsat leverfunktion (CPT klasse B og C).
English: Studies with DAA-experienced Patients
Danish: Studier med DAA-behandlingserfarne patienter
English: Voriconazole (200 mg twice daily) + voxilaprevir (100 mg single dose)f
Danish: Voriconazol (200 mg to gange dagligt) + voxilaprevir (100 mg enkeltdosis)f
English: Effect on velpatasvir or voxilaprevir exposure not studied.
Danish: Virkning på velpatasvir- eller voxilaprevireksponering ikke undersøgt.
English: (Inhibition of OATP1B, P-gp and CYP3A)
Danish: (Hæmning af OATP1B, P-gp og CYP3A)
English: Emtricitabine/rilpivirine/ tenofovir alafenamide (200/25/25 mg once daily)i + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Danish: Emtricitabin/rilpivirin/ tenofoviralafenamid (200/25/25 mg én gang dagligt)i+sofosbuvir/ velpatasvir (400/100/ 100 mg én gang dagligt) +voxilaprevir (100 mg én gang dagligt)f
English: SOF/VEL 12 weeks (n = 151)
Danish: SOF/VEL i 12 uger (n = 151)
English: tenofovir disoproxil fumarate (600/200/300 mg once daily)g + sofosbuvir/
Danish: (600/200/300 mg én gang dagligt) g + sofosbuvir/
English: Patients with GT2-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Danish: Patienter med GT2-6-infektion blev kun tilmeldt til gruppen SOF/VEL/VOX i 12 uger.
English: Ciclosporin (600 mg single dose)e + voxilaprevir (100 mg single dose)f
Danish: Ciclosporin (600 mg enkeltdosis)e +voxilaprevir (100 mg enkeltdosis)f
English: • SOF/VEL 12 weeks (N=151)
Danish: • SOF/VEL i 12 uger (N=151)
English: Atorvastatin (40 mg single dose) + sofosbuvir/ velpatasvir (400/100 mg once daily)f
Danish: Atorvastatin (40 mg enkelt dosis) + sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)f
English: Patients with GT4-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Danish: Patienter med GT4-6infektion blev kun tilmeldt til gruppen SOF/VEL/VOX i 12 uger.
English: H2-receptor antagonists Famotidine (40 mg single dose) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/100 mg single dose)c
Danish: H2-receptorantagonister Famotidin (40 mg enkeltdosis) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg enkeltdosis)c
English: Uncommon muscle spasm Laboratory investigations: Common total bilirubin increased
Danish: Muskelspasme Laboratorieundersøgelser: Almindelig
English: SOF/VEL 12 weeks (n = 440)
Danish: SOF/VEL i 12 uger (n = 440)
English: SOF/VEL 12 weeks (n = 109)
Danish: SOF/VEL i 12 uger (n = 109)
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).
Danish: Velpatasvirs farmakokinetik efter en enkelt dosis på 100 mg velpatasvir blev undersøgt hos HCV-negative patienter med moderat og svært nedsat leverfunktion (CPT klasse B og C).
English: Lopinavir (Inhibition of OATP1B)
Danish: Lopinavir (Hæmning af OATP1B)
English: • SOF/VEL 12 weeks (N=440)
Danish: • SOF/VEL i 12 uger (N=440)
English: • palpitations;
Danish: • mavesmerter
English: As a precautionary measure, Vosevi use is not recommended during pregnancy.
Danish: For en sikkerheds skyld frarådes Vosevi under graviditet.
English: Co-administration of Vosevi with rifapentine is not recommended (see section 4.4).
Danish: Samtidig administration af Vosevi og rifapentin frarådes (se pkt.
English: • SOF/VEL 12 weeks (N=109)
Danish: • SOF/VEL i 12 uger (N=109)
English: POLARIS-4 (open label)
Danish: POLARIS-4 (ublindet)
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 + 100 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg single dose)f
Danish: ANTIVIRALE MIDLER MOD HIV: PROTEASEHÆMMERE Atazanavir boostet med ritonavir (300 mg +100 mg én gang dagligt) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg én gang dagligt)f
English: Ciclosporin (600 mg single dose)e + velpatasvir (100 mg single dose)f
Danish: Ciclosporin (600 mg enkeltdosis)e+velpatasvir (100 mg enkeltdosis)f
English: Rifampicin (600 mg once daily) + voxilaprevir (100 mg single dose)f
Danish: Rifampicin (600 mg én gang dagligt) + voxilaprevir (100 mg enkeltdosis)f
English: Sofosbuvir, velpatasvir and voxilaprevir are substrates of drug transporters P-gp and BCRP while GS-331007 is not.
Danish: Sofosbuvir, velpatasvir og voxilaprevir er substrater for lægemiddeltransportørerne P-gp og BCRP, hvorimod GS-331007 ikke er det. Velpatasvir og i mindre grad velpatasvir er også substrater for OATP1B og OATP1B3.
English: Pravastatin (40 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Danish: Pravastatin (40 mg enkeltdosis) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg én gang dagligt) + voxilaprevir (100 mg én gang dagligt)f
English: Rosuvastatin (10 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Danish: Rosuvastatin (10 mg enkeltdosis) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg én gang dagligt) + voxilaprevir (100 mg én gang dagligt)d
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.
Danish: Efter en enkelt 100 mg-dosis af [14C]voxilaprevir hos raske personer var forholdet af [14C]-radioaktivitet mellem blod og plasma fra 0,5 til
English: Liver transplant patients
Danish: Patienter, der har gennemgået en levertransplantation
English: Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 and Cmax for sofosbuvir (n = 1038) were 1665 ng•hr/mL and 678 ng/mL, respectively; mean steady-state AUC0-24 and Cmax for GS-331007 (n = 1593) were 12834 ng•hr/mL and 744 ng/mL, respectively.
Danish: Baseret på den populationsfarmakokinetiske analyse hos HCV-inficerede patienter var middel-AUC0-24 i Steady-state og Cmax for sofosbuvir (n = 1038) hhv. 1665 ng•time/ml og 678 ng/ml.
English: • SOF/VEL/VOX 12 weeks (N=263)
Danish: • SOF/VEL/VOX i 12 uger (N=263)
English: Studies with DAA-naïve Patients
Danish: Studier med DAA-behandlingsnaive patienter
English: No dose adjustment of Vosevi, raltegravir or emtricitabine/tenofovir disoproxil fumarate is required.
Danish: Dosisjustering af Vosevi, raltegravir eller emtricitabin/tenofovirdisoproxilf umarat er ikke nødvendig.
English: Famotidine (40 mg single dose) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg single dose)c
Danish: Famotidin (40 mg enkeltdosis)/ sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg enkeltdosis)c
English: SOF/VEL/VOX 12 weeks (n = 263)
Danish: SOF/VEL/VOX i 12 uger (n = 263)
English: Outcome for patients without SVR Ontreatment virologic failurec
Danish: Resultat for patienter uden SVR Virologisk svigt under behandling 0/110 Recidiva
English: • SOF/VEL/VOX 8 weeks (N=110)
Danish: • SOF/VEL/VOX i 8 uger (N=110)
English: SOF/VEL/VOX 8 weeks (n = 501)
Danish: SOF/VEL/VOX i 8 uger (n = 501)
English: • SOF/VEL/VOX 8 weeks (N=501)
Danish: • SOF/VEL/VOX i 8 uger (N=501)
English: • SOF/VEL/VOX 12 weeks (N=182)
Danish: • SOF/VEL/VOX i 12 uger (N=182)
English: SOF/VEL/VOX 8 weeks (n = 110)
Danish: SOF/VEL/VOX i 8 uger (n = 110)
English: SOF/VEL/VOX 12 weeks (n = 182)
Danish: SOF/VEL/VOX i 12 uger (n = 182)
English: Omeprazole (20 mg once daily) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg single dose)c
Danish: Omeprazol (20 mg en gang dagligt)/ sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg enkeltdosis)c
English: POLARIS-3 (open label)
Danish: POLARIS-3 (ublindet)
English: Rifampicin (600 mg once daily) + velpatasvir (100 mg single dose)f
Danish: Rifampicin (600 mg én gang dagligt) +velpatasvir (100 mg enkeltdosis) f
English: Rifampicin (600 mg single dose) + velpatasvir (100 mg single dose)f
Danish: Rifampicin (600 mg enkeltdosis) + velpatasvir (100 mg enkeltdosis)f
English: Co-administration of such medicinal products with Vosevi is not recommended (see section 4.5).
Danish: Samtidig administration af sådanne lægemidler og Vosevi frarådes (se pkt.
English: NS3 and NS5A
Danish: Ingen NS3,
English: See leaflet for further information.
Danish: Indeholder laktose: Læs indlægssedlen for yderligere information.
English: POLARIS-2 (open label)
Danish: POLARIS-2 (ublindet)
English: The proportion of patients who permanently discontinued treatment due to adverse reactions was 0.1% for patients receiving sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.
Danish: 0,1 % af patienterne, der fik sofosbuvir/velpatasvir/voxilaprevir i 8 uger, seponerede behandlingen permanent pga. bivirkninger.
English: No NS3 and NS5B NI RAVs emerged in any of these 3 patients.
Danish: Ingen NS3 og NS5B-NIRAVøer udviklede sig hos nogle af disse 3 patienter.
English: Outcome for patients without SVR On-treatment virologic failure
Danish: Resultat for patienter, der ikke opnåede SVR Virologisk svigt under behandling 0/411 Recidivd
English: No NS3 or NS5B NI RAVs emerged in either of these patients.
Danish: Ingen NS3 eller NS5B-NI-RAV'er udviklede sig hos nogen af disse patienter.
English: No dose adjustment of Vosevi or emtricitabine/rilpivirine/tenofovi r alafenamide is required.
Danish: ↔ ↔ ↔ Dosisjustering af Vosevi eller emtricitabin/rilpivirin/tenofoviral afenamid er ikke nødvendig.
English: Studies in DAA-experienced patients
Danish: Studier med DAAbehandlingserfarne patienter
English: (may affect up to 1 in 100 people)
Danish: (kan påvirke op til 1 i 100 personer) muskelspasmer udslæt
English: • St. John's wort (a herbal medicine used to treat depression);
Danish: • perikon (et naturlægemiddel, der anvendes mod depression)
English: Proton pump inhibitors Omeprazole (20 mg once daily) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg single dose)c
Danish: Protonpumpehæmmere Omeprazol (20 mg én gang dagligt) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg enkeltdosis)c
English: Musculoskeletal and connective tissue disorders: Common myalgia
Danish: Knogler, led, muskler og bindevæv: Almindelig
English: Otherd
Danish: Andetd
English: Effect on sofosbuvir, velpatasvir and voxilaprevir concentrations not studied Expected:
Danish: Effekt på sofusbuvir-, velpatasvir- og voxilaprevir-koncentrationerne er ikke undersøgt.
English: IMMUNOSUPPRESSANTS
Danish: • besvimelsesanfald
English: Table 6: SVR12 in DAA-experienced patients with or without baseline NS3 or NS5A RAVs by study sofosbuvir/velpatasvir/voxilaprevir 12 weeks POLARIS-1 (n = 260)
Danish: Tabel 6: SVR12 hos DAA-behandlingserfarne patienter med eller uden NS3 eller NS5A-RAV'er ved baseline efter studie.
English: Vosevi is contraindicated with dabigatran etexilate (see section 4.3).
Danish: Vosevi er kontraindiceret med dabigatranetexilat (se pkt.
English: Taking Vosevi with any of these may stop your medicines from working properly, or make any side effects worse.
Danish: • ciclosporin, der anvendes til suppression af immunssystemet Hvis du tager Vosevi sammen med nogle af disse lægemidler, kan det forhindre, at lægemidlerne virker korrekt, eller det kan gøre bivirkninger mere udtalte.
English: c. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Danish: c. Andet omfatter patienter med manglende data og patienter, som stoppede behandling inden virologisk suppression.
English: e. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Danish: e. Andet omfatter patienter med manglende data, og patienter som stoppede behandling inden virologisk suppression.
English: a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Danish: a. Nævneren for recidiv er antallet af patienter med HCV RNA < LLOQ ved deres seneste vurdering under behandling.
English: Effect on velpatasvir exposure not studied Expected:
Danish: Virkning på velpatasvir-eksponering er ikke undersøgt
English: c. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
Danish: c. Nævneren for recidiv er antallet af patienter med HCV RNA < LLOQ ved deres seneste vurdering under behandling.
English: b. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Danish: b. Nævneren for recidiv er antallet af patienter med HCV RNA < LLOQ ved deres seneste vurdering under behandling.
English: Othere
Danish: Vosevi
English: d. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Danish: d. Nævneren for recidiv er antallet af patienter med HCV RNA < LLOQ ved deres seneste vurdering under behandling.
English: d. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Danish: d. Andet omfatter patienter med manglende data, og patienter som stoppede behandling inden virologisk suppression.
English: What Vosevi is and what it is used for What you need to know before you take Vosevi How to take Vosevi
Danish: Det skal du vide, før du begynder at tage Vosevi Sådan skal du tage Vosevi Bivirkninger
English: j. Administered as emtricitabine, tenofovir disoproxil fumarate fixed-dose combination.
Danish: j. Administreret som emtricitabin, tenofovirdisoproxilfumarat fastdosis kombination.
English: b. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Danish: b Andet omfatter patienter med manglende data, og patienter som stoppede behandling inden virologisk suppression.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: Dette betyder, at selv om der ikke er tilstrækkelig dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og der er dokumentation for, at har været anvendt sikkert på denne måde i mindst 30 år (herunder mindst 15 år inden for EU).
English: If symptoms last longer than two weeks during treatment, a doctor or a qualified healthcare practitioner should be consulted.
Danish: Hvis symptomer varer længere end to uger under behandling, bør en læge eller kvalificeret sundhedsperson kontaktes.
English: The plant is cultivated or gathered when flowering to obtain the above-ground parts for medicinal use.
Danish: Planten dyrkes eller indsamles ved blomstring for høste de overjordiske dele til medicinsk anvendelse.
English: California poppy preparations should only be used in adults.
Danish: Californisk guldvalmue bør kun anvendes til voksne.
English: California poppy EMA/HMPC/334023/2015
Danish: Californisk guldvalmue EMA/HMPC/334023/2015
English: In its assessment, the HMPC also considered a few available clinical studies, including a study in patients suffering from sleep disorders, which suggested a positive effect on sleep.
Danish: I HMPC's vurdering indgår også nogle få tilgængelige kliniske studier, som tydede på en positiv virkning på søvn - herunder et studie med patienter, der led af søvnforstyrrelser.,.