FrancophonIA/ELRC3.0 huggingface dataset:
English: Simeprevir is extensively bound to plasma proteins (> 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein.
Danish: Simeprevir er i omfattende grad bundet til plasmaproteiner (> 99,9%), fortrinsvis til albumin og i mindre udstrækning til surt alfa-1-glykoprotein.
English: Clinical study examining QT interval
Danish: Klinisk studie med undersøgelse af QT-intervallet
English: 1 This interaction study has been performed with a dose higher than the recommended dose for simeprevir assessing the maximal effect on the co-administered drug.
Danish: 1 Dette interaktionsstudie er blevet gennemført med en højere dosis end den anbefalede dosis af simeprevir for at vurdere den maksimale virkning på det samtidigt administrerede lægemiddel.
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AE14.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk anvendelse, direkte virkende antivirale midler, ATC-kode: J05AE14.
English: Especially avoid intense or prolonged exposure to sunlight (including tanning devices).
Danish: Du skal især undgå kraftig eller længerevarende eksponering i sollyset (gælder også solarium).
English: SEDATIVES/ANXIOLYTICS Midazolam
Danish: SEDATIVA/ANXIOLYTIKA Midazolam
English: Amylase and lipase elevations were not associated with pancreatitis.
Danish: Stigningerne i amylase og lipase var ikke forbundet med pancreatitis.
English: C212 (Phase 3)
Danish: C212 (fase 3)
English: NARCOTIC ANALGESICS Methadone7
Danish: NARKOTISKE ANALGETIKA Methadon7
English: Organ transplant patients
Danish: Organtransplanterede patienter
English: No serious adverse reactions were reported.
Danish: Der blev ikke indberettet nogen alvorlige bivirkninger.
English: The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the
Danish: Pilens retning (↑ = stigning, ↓ = fald, ↔ = ingen ændring) for hver farmakokinetisk parameter er baseret på, at 90%
English: PHARMACEUTICAL FORM AND CONTENTS 7 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 7 hårde kapsler
English: - If you are a woman, you must not become pregnant during treatment and for several months afterwards.
Danish: - Hvis du er kvinde, må du ikke blive gravid under behandlingen og i flere måneder efter,
English: Ketoconazole*
Danish: Ketoconazol*
English: ANTITUSSIVE Dextromethorphan (DXM)
Danish: ANTITUSSIVA Dextromethorphan (DXM)
English: C208 - C216 (QUEST-1 and QUEST-2;
Danish: C208 - C216 (QUEST-1 og QUEST-2; fase
English: Concentrations of ledipasvir and simeprevir are increased when simeprevir is co-administered with ledipasvir.
Danish: Koncentrationerne af ledipasvir og simeprevir forhøjes, når simeprevir administreres samtidig med ledipasvir.
English: 1 May include few patients with HCV non-genotype 1a/1b.
Danish: 1 Kan omfatte nogle få patienter med HCV-non-genotype 1a/1b.
English: 4 Patient individualised dose at the discretion of the physician, according to local clinical practice.
Danish: 4 Individuelt tilpasset dosis efter lægens skøn i henhold til lokal praksis.
English: It may harm them,
Danish: Med tidligere recidiv
English: 3 Recommended duration of treatment provided that patient does not meet a stopping rule (see table 3).
Danish: 3 Anbefalet behandlingsvarighed, hvis patienten ikke er omfattet af regler for behandlingsophør (se tabel 3).
English: As simeprevir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Danish: Da simeprevir er kraftigt bundet til plasmaproteiner, er det usandsynligt, at det vil blive fjernet i betydelig grad ved dialyse.
English: Increased concentrations of cisapride may be possible.
Danish: Forhøjet koncentration af cisaprid er mulig.
English: As liver function may change during treatment with OLYSIO, close monitoring of International Normalised Ratio (INR) values is recommended.
Danish: Da leverfunktionen kan ændre sig under behandling med OLYSIO, anbefales tæt monitorering af INR (international normalised ratio).
English: In addition, tell your doctor if you take any medicines used to treat irregular heart beat or high blood pressure.
Danish: Fortæl det også til din læge, hvis du tager lægemidler til behandling af en uregelmæssig hjerterytme eller forhøjet blodtryk.
English: Based on the elimination pathway of azithromycin, no drug interactions are expected between azithromycin and simeprevir.
Danish: Baseret på elimineringsvejen for azithromycin forventes ingen lægemiddelinteraktioner mellem azithromycin og simeprevir.
English: The long-term clinical impact of the emergence or persistence of simeprevir-resistance-associated substitutions is unknown.
Danish: Den langsigtede kliniske betydning af fremkomst eller varighed af substitutioner, der er forbundet med simeprevir-resistens, kendes ikke.
English: 30-150 mg once daily, individualised dose
Danish: 30-150 mg én gang dagligt; individuelt tilpasset dosis
English: Buprenorphine Naloxone
Danish: Buprenorphin Naloxon
English: Excipient with known effect: each capsule contains 78.4 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder 78,4 mg lactose (som monohydrat).
English: 2 SVR: SVR12 for study HPC3007 and SVR24 for study C206.
Danish: 2 SVR: SVR12 for studie HPC3007 og SVR24 for studie C206.
English: 3 Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80,
Danish: 3 Substitutioner, der kun blev observeret i kombinationer med andre opståede substitutioner ved en eller flere af NS3
English: The days of the week are printed on the blister strip.
Danish: Ugedagene er trykt på blisterkortet.
English: Budesonide Fluticasone Methylprednisolone Prednisone
Danish: Budesonid Fluticason Methylprednisolon Prednison
English: SVR12 rates for selected subgroups METAVIR fibrosis score F0-2
Danish: SVR12-rater for udvalgte undergrupper METAVIR-fibrose-score F0-2
English: H2-receptor antagonists Cimetidine
Danish: H2-receptor-antagonister Cimetidin
English: Following a single oral administration of 200 mg 14C-simeprevir to healthy subjects, the majority of the radioactivity in plasma (up to 98%) was accounted for by unchanged drug and a small part of the radioactivity in plasma was related to metabolites (none being major metabolites).
Danish: Efter en enkelt oral administration af 200 mg 14C-simeprevir til raske personer kunne størstedelen af radioaktiviteten i plasma (op til 98%) tilskrives uomdannet lægemiddel, og en lille del af radioaktiviteten i plasma var bundet til metabolitter (hvoraf ingen er vigtige metabolitter).
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on OLYSIO combination treatment with sofosbuvir when other alternative antiarrhythmic treatments are not tolerated or are contraindicated.
Danish: Tilfælde er potentielt livstruende, og amiodaron bør derfor kun anvendes til patienter, der er i kombinationsbehandling med OLYSIO og sofosbuvir, når andre alternative behandlinger med antiarytmika ikke tolereres eller er kontraindicerede.
English: HIV PRODUCTS Antiretroviral - CCR5 antagonist Maraviroc
Danish: PRÆPARATER MOD HIV Antiretrovirale midler - CCR5-antagonist Maraviroc
English: This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite - confusion.
Danish: Dette er især vigtigt, hvis disse symptomer opstår samtidig med nogen af de følgende symptomer: - hvis du får kvalme, kaster op eller mister appetitten - hvis du lettere bliver forvirret
English: Table 4: Interactions and dose recommendation with other medicinal products Medicinal products by therapeutic areas
Danish: Tabel 4: Interaktioner med andre lægemidler og anbefalinger til dosering Lægemiddel inddelt efter terapeutisk område
English: Unchanged simeprevir in faeces accounted for on average 31% of the administered dose.
Danish: Uomdannet simeprevir i fæces udgjorde gennemsnitligt 31% af den administrerede dosis.
English: WHO toxicity range1
Danish: WHO's toksicitetsinterval1
English: No effects on fertility were observed in animal studies (see section 5.3).
Danish: Der er ikke observeret nogen effekter på fertiliteten i dyrestudier (se pkt.
English: GLUCOCORTICOIDS Dexamethasone (systemic)
Danish: GLUKOKORTIKOIDER Dexamethason (systemisk)
English: EU/1/14/924/002 (28 capsules)
Danish: EU/1/14/924/002 (28 kapsler)
English: HORMONAL CONTRACEPTIVES Ethinylestradiol and norethindrone
Danish: HORMONEL ANTIKONCEPTION Ethinylestradiol og norethindron
English: OLYSIO must be taken orally once a day with food (see section 5.2).
Danish: Administration OLYSIO skal tages oralt én gang dagligt sammen med mad (se pkt.
English: ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Danish: ANTIKONVULSIVA Carbamazepin Oxcarbazepin Phenobarbital Phenytoin
English: Treatment with OLYSIO should be initiated and monitored by a physician experienced in the management of CHC.
Danish: Behandling med OLYSIO skal iværksættes og superviseres af en læge med erfaring i behandling af CHC.
English: Photosensitivity
Danish: Fotosensibilitet
English: INFORMATION IN BRAILLE olysio 150 mg
Danish: INFORMATION I BRAILLESKRIFT olysio 150 mg
English: Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the treatment of CHC
Danish: Justering af dosis eller seponering af lægemidler, der bruges i kombination med OLYSIO til behandling af CHC
English: Patients treated with vitamin K antagonists
Danish: Patienter i behandling med vitamin K-antagonister:
English: How to remove capsule Press either edge of the pocket to push the capsule through the foil, as shown.
Danish: Sådan tages en kapsel ud Tryk på den ene kant af lommen, så kapslen skubbes gennem folien som vist.
English: METAVIR fibrosis score
Danish: METAVIR-fibrose-score
English: Discontinuation of simeprevir due to ‘blood bilirubin increased' was rare (0.1%; n = 1).
Danish: Seponering af simeprevir på grund af forhøjet blodbilirubin forekom sjældent (0,1%; n = 1).
English: Hyperbilirubinemia Grade 1
Danish: Hyperbilirubinæmi Grad 1
English: All grades Grade 3
Danish: Alle grader Grad 3
English: Alkaline phosphatase
Danish: Alkalisk fosfatase
English: If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the reaction has resolved.
Danish: Hvis der opstår lysfølsomhedsreaktioner, bør seponering af OLYSIO overvejes, og patienten skal monitoreres, indtil reaktionerne er forsvundet.
English: The type of food does not affect exposure to simeprevir.
Danish: Typen af mad har ingen betydning for eksponeringen for simeprevir.
English: Paediatric population The pharmacokinetics of simeprevir in children aged below 18 years have not been investigated.
Danish: Pædiatrisk population Simeprevirs farmakokinetik er ikke blevet undersøgt hos børn under 18 år.
English: The capsule should be swallowed as a whole.
Danish: Kapslen skal sluges hel.
English: The safety and efficacy of OLYSIO in children aged below 18 years have not yet been established.
Danish: OLYSIOs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Study HPC3007: includes 5 simeprevir-treated patients who experienced relapse after SVR12.
Danish: Studie HPC3007: Inkluderer 5 simeprevir-behandlede patienter, der fik recidiv efter SVR12.
English: Respiratory, thoracic and mediastinal disorders: very common dyspnoea*
Danish: Luftveje, thorax og mediastinum: meget almindelig dyspnø*
English: All patients receiving OLYSIO combination treatment with sofosbuvir in combination with amiodarone with or without other drugs 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, der får kombinationsbehandling med OLYSIO og sofosbuvir i kombination med amiodaron med eller uden andre lægemidler, der sænker hjertefrekvensen, skal desuden advares om symptomerne på bradykardi og hjerteblok og skal tilrådes straks at søge læge, hvis de får disse symptomer.
English: Dexlansoprazole Esomeprazole Lansoprazole Pantoprazole Rabeprazole
Danish: Dexlansoprazol Esomeprazol Lansoprazol Pantoprazol Rabeprazol
English: STIMULANTS Methylphenidate
Danish: STIMULANTIA Methylphenidat
English: Patients with cirrhosis1
Danish: Patienter med cirrose1
English: In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis were enrolled (table 12).
Danish: I studie HPC3017 deltog patienter uden cirrose; i studie HPC3018 deltog patienter med cirrose (tabel 12).
English: Environmental Risk Assessment (ERA) Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Danish: Miljørisikovurdering Simeprevir er klassificeret som PBT-stof (persistent, bioakkumulerbart og toksisk) (se pkt.
English: Disopyramide Flecainide Mexiletine Propafenone Quinidine
Danish: Disopyramid Flecainid Mexiletin Propafenon Quinidin
English: In these patients the SVR12 rates were 96%, 94%, 100% and 68%, respectively.
Danish: SVR12-raterne var henholdsvis 96%, 94%, 100% og 68% hos disse patienter.
English: Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL)
Danish: Gennemsnitlig (SE) ændring i HCV-RNA på dag 7/8 (log10 IE/ml)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: 12 weeks N = 286
Danish: 12 uger N = 286
English: NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag International NV
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Janssen-Cilag International NV
English: C206 (ASPIRE; Phase 2)
Danish: C206 (ASPIRE; fase
English: All HCV genotypes N = 197 % (n)
Danish: Alle HCV-genotyper N = 197 % (n)
English: X represents multiple amino acids.
Danish: repræsenterer flere aminosyrer.
English: No meaningful changes in QTc interval were observed with either the recommended dose of 150 mg once daily or the supratherapeutic dose of 350 mg once daily.
Danish: Der blev ikke observeret nogen betydningsfulde ændringer i QTc-intervallet hverken ved den anbefalede dosis på 150 mg én gang dagligt eller den supraterapeutiske dosis på 350 mg én gang dagligt.
English: The median baseline CD4+ cell count in patients on highly active antiretroviral therapy (HAART) was 561 x 106 cells/ml (range: 275-1,407 x 106 cells/ml).
Danish: De mediane CD4+ tal ved baseline hos patienter, der fik højaktiv antiretroviral behandling (HAART), var 561 x 106 celler/ml (275-1.407 x 106 celler/ml).
English: Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Asian Hispanic
Danish: Alder (år) median (interval) % over 65 år Mand Race Hvid Sort/afroamerikansk Asiatisk Latinamerikansk
English: 122, 155 and/or 168.
Danish: positionerne 80, 122, 155 og/eller 168.
English: The persistence of simeprevir-resistant NS3 amino acid substitutions was assessed following treatment failure.
Danish: Varigheden af simeprevir-resistente NS3-aminosyresubstitutioner blev undersøgt efter manglende behandlingseffekt.
English: In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic effects.
Danish: En in vitro-kombination af simeprevir med interferon, ribavirin, NS5A- eller NS5B-hæmmere medførte additive eller synergistiske effekter.
English: 3 The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Danish: 3 Dosis af simeprevir i dette interaktionsstudie var 50 mg, når det blev administreret i kombination med darunavir/ritonavir, og sammenlignet med 150 mg i behandlingsgruppen på simeprevir alene.
English: Simeprevir is highly protein bound, therefore dialysis is unlikely to result in significant removal of simeprevir (see section 5.2).
Danish: Simeprevir er kraftigt proteinbundet, og det er derfor usandsynligt, at dialyse vil medføre signifikant fjernelse af simeprevir (se pkt.
English: SVR12 without cirrhosis with cirrhosis
Danish: SVR12 uden cirrose med cirrose
English: * darunavir/ritonavir + 50 mg simeprevir compared to 150 mg simeprevir alone.
Danish: * darunavir/ritonavir + 50 mg simeprevir sammenlignet med 150 mg simeprevir alene.
English: 1 Double-blind, randomised, placebo-controlled, except for studies C212 and HPC3011 which were open-label, single arm.
Danish: 1 Dobbeltblindt, randomiseret, placebokontrolleret, bortset fra studierne C212 og HPC3011, der var åbne med en enkelt behandlingsarm.
English: Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Hispanic
Danish: Alder (år) median (interval) % over 65 år Mand Race hvid sort/afroamerikansk Latinamerikansk
English: HPC2002 (COSMOS; Phase 2)
Danish: HPC2002 (COSMOS; fase 2)
English: Hepatitis B virus (HBV) co-infection
Danish: Samtidig infektion med hepatitis B-virus (HBV)
English: Patients co-infected with HIV-1
Danish: Patienter coinficerede med HIV-1
English: Recommendation for co-administration
Danish: Anbefaling ved samtidig administration
English: 6 Comparison based on historic controls.
Danish: 6 Sammenligning baseret på historiske kontroller.
English: 1 HCV/HIV-1 co-infected patients.
Danish: 1 HCV/HIV 1-coinficerede patienter.
English: Following a single oral administration of 200 mg 14C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces.
Danish: Efter administration af en enkelt oral dosis på 200 mg 14C-simeprevir til raske personer blev gennemsnitligt 91% af den samlede radioaktivitet påvist i fæces.
English: Antifungals (systemic administration) Itraconazole
Danish: Antimykotika (systemisk administration) Itraconazol
English: Read the package leaflets for the other medicines used for treating your hepatitis C infection for side effects reported with these medicines.
Danish: Læs indlægssedlerne til de andre lægemidler, som du tager til behandling af din hepatitis C-infektion, med information om de bivirkninger, der er indberettet for disse lægemidler.
English: 5 Comparison based on historic controls.
Danish: 5 Sammenligning baseret på historiske kontroller.
English: Note, substitutions at NS3 position 43 and 156 associated with reduced simeprevir activity in vitro were not observed at time of failure.
Danish: Bemærk, at substitutioner ved NS3-position 43 og 156, forbundet med nedsat aktivitet af simeprevir in vitro, blev ikke observeret på tidspunktet for manglende behandlingseffekt.
English: Tell your doctor immediately if you are taking OLYSIO with sofosbuvir and any medicines for heart problems, and during treatment you experience: - shortness of breath - light-headedness - palpitations - fainting.
Danish: Fortæl det straks til din læge, hvis du tager OLYSIO sammen med sofosbuvir og et hvilket som helst lægemiddel mod hjerteproblemer, og du under behandlingen oplever: - stakåndethed - svimmelhed - hjertebanken - besvimelse.
English: Antimycobacterials Bedaquiline
Danish: Antimykobakterielle midler Bedaquilin
English: Effect on drug levels Least Squares Mean Ratio (90%CI)
Danish: Virkning på lægemiddelniveauer ratioer fundet ved mindste kvadraters metode (90%CI)
English: Treatment discontinuation in patients with inadequate on-treatment virologic response OLYSIO in combination with sofosbuvir
Danish: Seponering af behandlingen hos patienter med utilstrækkeligt virologisk respons OLYSIO i kombination med sofosbuvir
English: Discontinue peginterferon alfa and ribavirin (treatment with OLYSIO is complete at week 12)
Danish: Seponér peginterferon alfa og ribavirin (behandlingen med OLYSIO er afsluttet i uge 12)
English: 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 0.80 - 1.25 range.
Danish: konfidensintervallet for ratioerne af middelværdierne er inden for (↔), under (↓) eller over (↑) intervallet 0,80-1,25.
English: Mild increases in concentrations of triazolam may be expected.
Danish: Let forhøjet koncentration af triazolam kan forventes.
English: Number of patients enrolled
Danish: Antal inkluderede patienter
English: SVR12 rates for selected subgroups Prior treatment history treatment-naïve treatment-experienced4
Danish: SVR12-rater for udvalgte undergrupper Tidligere behandling behandlingsnaiv behandlingserfaren4
English: 3 Overall treatment duration with peg-IFN-alfa and RBV was response-guided.
Danish: 3 Den samlede varighed af behandling med peg-IFN-alfa og RBV var responsafhængig.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from OLYSIO therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Danish: Det skal besluttes, om amning eller behandling med OLYSIO skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til den terapeutiske fordel for moderen.
English: Posaconazole
Danish: Posaconazol
English: Data from an ongoing, long-term follow-up study (study HPC3002) in patients who did not achieve SVR with a simeprevir-based regimen in a previous phase 2 study showed that in 70% (16/23) of these patients emerging mutations were no longer detected after a median follow-up of 88 weeks (range 47-147 weeks).
Danish: Data fra et igangværende langvarigt opfølgningsstudie (studie HPC3002) med patienter, der ikke opnåede SVR med et simeprevir-baseret regime i et tidligere fase 2-studie, viste, at hos 70% (16/23) af disse patienter kunne de opståede mutationer ikke længere påvises efter en median opfølgningtid på 88 uger (intervallet 47-147 uger).
English: - If you are a man, your female partner must not become pregnant during your treatment and for several months afterwards.
Danish: - Hvis du er mand, må din kvindelige partner ikke blive gravid, så længe du er i behandling og i flere måneder efter, behandlingen er stoppet.
English: Any substitution at NS3 position 43, 80, 122, 155, 156, or 1682
Danish: Enhver substitution ved NS3-position 43, 80, 122, 155, 156 eller1682
English: Other NNRTIs (Delavirdine, Etravirine, Nevirapine)
Danish: Andre NNRTI'er (delavirdin, etravirin, nevirapin)
English: Efficacy in adults with HCV genotype 4
Danish: Effekten hos voksne med HCV-genotype 4
English: The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Danish: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til
English: OLYSIO must not be administered as monotherapy and must be prescribed in combination with other medicinal products for the treatment of CHC.
Danish: OLYSIO må ikke indgives som monoterapi, men skal ordineres i kombination med andre lægemidler til behandling af CHC.
English: St John's wort (Hypericum perforatum)
Danish: Perikon (Hypericum perforatum)
English: During administration of simeprevir with peginterferon alfa and ribavirin, the elevations in direct and indirect bilirubin were generally not associated with elevations in liver transaminases and normalised after end of treatment.
Danish: Under administration af simeprevir sammen med peginterferon alfa og ribavirin var stigningerne i direkte og indirekte bilirubin generelt ikke forbundet med stigninger i leveraminotransferaser og blev normaliseret efter afslutning af behandlingen.
English: Lipase Grade 1
Danish: Lipase Grad 1
English: Simeprevir does not inhibit OCT2 in vitro.
Danish: Simeprevir hæmmer ikke OCT2 in vitro.
English: 2 Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event.
Danish: 2 Af de 3 patienter, der udviste manglende effekt under behandlingen, havde 2 patienter viralt gennembrud, og en patient afbrød behandlingen før det planlagte tidspunkt på grund af en bivirkning.