natgillin/translations-raw huggingface dataset:
Hvis der opstår lysfølsomhedsreaktioner, bør seponering af OLYSIO overvejes, og patienten skal monitoreres, indtil reaktionerne er forsvundet. 
If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the reaction has resolved.
Typen af mad har ingen betydning for eksponeringen for simeprevir. 
The type of food does not affect exposure to simeprevir.
Pædiatrisk population Simeprevirs farmakokinetik er ikke blevet undersøgt hos børn under 18 år. 
Paediatric population The pharmacokinetics of simeprevir in children aged below 18 years have not been investigated.
Kapslen skal sluges hel. 
The capsule should be swallowed as a whole.
OLYSIOs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt. 
The safety and efficacy of OLYSIO in children aged below 18 years have not yet been established.
Studie HPC3007: Inkluderer 5 simeprevir-behandlede patienter, der fik recidiv efter SVR12. 
Study HPC3007: includes 5 simeprevir-treated patients who experienced relapse after SVR12.
Luftveje, thorax og mediastinum: meget almindelig dyspnø* 
Respiratory, thoracic and mediastinal disorders: very common dyspnoea*
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. 
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.
STIMULANTIA Methylphenidat 
STIMULANTS Methylphenidate
Patienter med cirrose1 
Patients with cirrhosis1
I studie HPC3017 deltog patienter uden cirrose; i studie HPC3018 deltog patienter med cirrose (tabel 12). 
In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis were enrolled (table 12).
Miljørisikovurdering Simeprevir er klassificeret som PBT-stof (persistent, bioakkumulerbart og toksisk) (se pkt. 
Environmental Risk Assessment (ERA) Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Disopyramid Flecainid Mexiletin Propafenon Quinidin 
Disopyramide Flecainide Mexiletine Propafenone Quinidine
SVR12-raterne var henholdsvis 96%, 94%, 100% og 68% hos disse patienter. 
In these patients the SVR12 rates were 96%, 94%, 100% and 68%, respectively.
Gennemsnitlig (SE) ændring i HCV-RNA på dag 7/8 (log10 IE/ml) 
Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL)
Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/. 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
12 uger N = 286 
12 weeks N = 286
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Janssen-Cilag International NV 
NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag International NV
C206 (ASPIRE; fase 
C206 (ASPIRE; Phase 2)
Alle HCV-genotyper N = 197 % (n) 
All HCV genotypes N = 197 % (n)
repræsenterer flere aminosyrer. 
X represents multiple amino acids.
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. 
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.
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). 
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).
Alder (år) median (interval) % over 65 år Mand Race Hvid Sort/afroamerikansk Asiatisk Latinamerikansk 
Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Asian Hispanic
positionerne 80, 122, 155 og/eller 168. 
122, 155 and/or 168.
Varigheden af simeprevir-resistente NS3-aminosyresubstitutioner blev undersøgt efter manglende behandlingseffekt. 
The persistence of simeprevir-resistant NS3 amino acid substitutions was assessed following treatment failure.
En in vitro-kombination af simeprevir med interferon, ribavirin, NS5A- eller NS5B-hæmmere medførte additive eller synergistiske effekter. 
In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic effects.
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. 
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.
Simeprevir er kraftigt proteinbundet, og det er derfor usandsynligt, at dialyse vil medføre signifikant fjernelse af simeprevir (se pkt. 
Simeprevir is highly protein bound, therefore dialysis is unlikely to result in significant removal of simeprevir (see section 5.2).
SVR12 uden cirrose med cirrose 
SVR12 without cirrhosis with cirrhosis
* darunavir/ritonavir + 50 mg simeprevir sammenlignet med 150 mg simeprevir alene. 
* darunavir/ritonavir + 50 mg simeprevir compared to 150 mg simeprevir alone.
1 Dobbeltblindt, randomiseret, placebokontrolleret, bortset fra studierne C212 og HPC3011, der var åbne med en enkelt behandlingsarm. 
1 Double-blind, randomised, placebo-controlled, except for studies C212 and HPC3011 which were open-label, single arm.
Alder (år) median (interval) % over 65 år Mand Race hvid sort/afroamerikansk Latinamerikansk 
Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Hispanic
HPC2002 (COSMOS; fase 2) 
HPC2002 (COSMOS; Phase 2)
Samtidig infektion med hepatitis B-virus (HBV) 
Hepatitis B virus (HBV) co-infection
Patienter coinficerede med HIV-1 
Patients co-infected with HIV-1
Anbefaling ved samtidig administration 
Recommendation for co-administration
6 Sammenligning baseret på historiske kontroller. 
6 Comparison based on historic controls.
1 HCV/HIV 1-coinficerede patienter. 
1 HCV/HIV-1 co-infected patients.
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. 
Following a single oral administration of 200 mg 14C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces.
Antimykotika (systemisk administration) Itraconazol 
Antifungals (systemic administration) Itraconazole
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. 
Read the package leaflets for the other medicines used for treating your hepatitis C infection for side effects reported with these medicines.
5 Sammenligning baseret på historiske kontroller. 
5 Comparison based on historic controls.
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. 
Note, substitutions at NS3 position 43 and 156 associated with reduced simeprevir activity in vitro were not observed at time of failure.
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. 
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.
Antimykobakterielle midler Bedaquilin 
Antimycobacterials Bedaquiline
Virkning på lægemiddelniveauer ratioer fundet ved mindste kvadraters metode (90%CI) 
Effect on drug levels Least Squares Mean Ratio (90%CI)
Seponering af behandlingen hos patienter med utilstrækkeligt virologisk respons OLYSIO i kombination med sofosbuvir 
Treatment discontinuation in patients with inadequate on-treatment virologic response OLYSIO in combination with sofosbuvir
Seponér peginterferon alfa og ribavirin (behandlingen med OLYSIO er afsluttet i uge 12) 
Discontinue peginterferon alfa and ribavirin (treatment with OLYSIO is complete at week 12)
konfidensintervallet for ratioerne af middelværdierne er inden for (↔), under (↓) eller over (↑) intervallet 0,80-1,25. 
90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 0.80 - 1.25 range.
Let forhøjet koncentration af triazolam kan forventes. 
Mild increases in concentrations of triazolam may be expected.
Antal inkluderede patienter 
Number of patients enrolled
SVR12-rater for udvalgte undergrupper Tidligere behandling behandlingsnaiv behandlingserfaren4 
SVR12 rates for selected subgroups Prior treatment history treatment-naïve treatment-experienced4
3 Den samlede varighed af behandling med peg-IFN-alfa og RBV var responsafhængig. 
3 Overall treatment duration with peg-IFN-alfa and RBV was response-guided.
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. 
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.
Posaconazol 
Posaconazole
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). 
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).
- 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. 
- If you are a man, your female partner must not become pregnant during your treatment and for several months afterwards.
Enhver substitution ved NS3-position 43, 80, 122, 155, 156 eller1682 
Any substitution at NS3 position 43, 80, 122, 155, 156, or 1682
Andre NNRTI'er (delavirdin, etravirin, nevirapin) 
Other NNRTIs (Delavirdine, Etravirine, Nevirapine)
Effekten hos voksne med HCV-genotype 4 
Efficacy in adults with HCV genotype 4
almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til 
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).
OLYSIO må ikke indgives som monoterapi, men skal ordineres i kombination med andre lægemidler til behandling af CHC. 
OLYSIO must not be administered as monotherapy and must be prescribed in combination with other medicinal products for the treatment of CHC.
Perikon (Hypericum perforatum) 
St John's wort (Hypericum perforatum)
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. 
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.
Lipase Grad 1 
Lipase Grade 1
Simeprevir hæmmer ikke OCT2 in vitro. 
Simeprevir does not inhibit OCT2 in vitro.
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. 
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.
Let forhøjede koncentrationer af disse antihistaminer kan forventes. 
Mild increases in concentrations of these antihistamines may be expected.
Lever- og galdeveje: almindelig forhøjet blodbilirubin* forhøjet blodbilirubin* forhøjet blodbilirubin* Hud og subkutane væv: meget almindelig udslæt* 
Hepatobiliary disorders: common blood bilirubin increased* blood bilirubin increased* blood bilirubin increased* Skin and subcutaneous tissue disorders: very common rash*
Tabel 21: SVR12-raterne for udvalgte undergrupper (studie HPC3007) Undergruppe simeprevir + peginterferon + ribavirin % (n/N) 
Table 21: SVR12 rates for selected subgroups (study HPC3007) Subgroup simeprevir + peginterferon + ribavirin % (n/N)
HPC2014 (OSIRIS; fase 
HPC2014 (OSIRIS; Phase 2)
12 eller 24 ugers SMV + sofosbuvir med eller uden ribavirin4 
12 or 24 weeks SMV + sofosbuvir, with or without ribavirin4
CALCIUMANTAGONISTER (oral administration) Amlodipin 
CALCIUM CHANNEL BLOCKERS (oral administration) Amlodipine
Denne effekt blev observeret ved højere systemisk eksponering (11 gange) end hos mennesker ved den anbefalede dosis på 150 mg én gang dagligt. 
This effect was observed at higher systemic exposures (11-fold) than those in humans at the recommended dose of 150 mg once daily.
OLYSIO indeholder lactose 
OLYSIO contains lactose
I tilfælde af alvorligt udslæt skal OLYSIO og anden samtidig medicin til behandling af CHC seponeres, og patienten skal monitoreres, indtil symptomerne er forsvundet. 
In case of severe rash, OLYSIO and other co-administered medicinal products for the treatment of CHC should be discontinued and the patients should be monitored until the symptoms have resolved.
Samtidig administration af OLYSIO og ciclosporin anbefales ikke, da dette giver signifikant højere eksponering for simeprevir baseret på foreløbige data fra et igangværende fase 2-studie med HCVinficerede levertransplanterede patienter (se pkt. 
Co-administration of OLYSIO with ciclosporin is not recommended as this leads to significantly higher exposure of simeprevir based on interim data from an ongoing phase 2 study in HCV infected post-liver transplant patients (see section 4.5).
Tacrolimus 2 mg individuelt tilpasset dosis4 
Tacrolimus 2 mg patient individualised dose4
7 Interaktionen mellem simeprevir og lægemidlet blev undersøgt i et farmakokinetisk studie med opioidafhængige voksne i stabil vedligeholdelsesbehandling med methadon. 
7 The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic study in opioid-dependent adults on stable methadone maintenance therapy.
1 Reevaluering af HCV-RNA anbefales, hvis HCV-RNA ≥ 25 IE/ml efter tidligere udetekterbart HCV-RNA for at bekræfte HCV-RNA-niveauet inden seponering af HCV-behandlingen. 
1 Re-evaluation of HCV RNA is recommended in case of HCV RNA ≥ 25 IU/ml after previous undetectable HCV RNA to confirm HCV RNA levels prior to discontinuing HCV treatment.
- Øvrige indholdsstoffer: natriumlaurilsulphat, magnesiumstearat, kolloid vandfri silica, croscarmellosenatrium, lactosemonohydrat, gelatine, titandioxid (E 171), sort jernoxid (E 172) og shellac (E 904). 
- The other ingredients are sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black (E172) and shellac (E904).
1 Sværeste toksicitetsgrader 1 til 4 iht. 
1 WHO worst toxicity grades 1 to 4.
Meget almindelig: Kan ramme flere end 1 ud af 10 personer: - kvalme - hudkløe - hududslæt - stakåndethed 
Very common: may affect more than 1 in 10 people: - feeling sick (nausea) - itching of the skin - skin rash - being short of breath.
Tabel 11: Studier udført med simeprevir + sofosbuvir: population og resumé af studiedesign Studie1 
Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design
Andre NRTI'er (abacavir, didanosin, emtricitabin, lamivudin, stavudin, zidovudin) 
Other NRTIs (Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Zidovudine)
De fleste tilfælde af udslæt og kløe hos simeprevir-behandlede patienter var lette eller moderate i styrke (grad 1 eller 2). 
Most of the rash and pruritus events in simeprevir-treated patients were of mild or moderate severity (grade 1 or 2).
Antiretrovirale midler - proteasehæmmere (PI'er) Darunavir/ritonavir3 
Antiretroviral - protease inhibitors (PIs) Darunavir/ritonavir3
(Hæmning af P-gp-transportør.) 
(inhibition of P-gp transporter)
Cobicistat-holdige lægemidler 
Cobicistat-containing medicinal products
1 Den ene patient med manglende effekt under behandlingen afbrød behandlingen før det planlagte tidspunkt på grund af en bivirkning. 
1 The one patient with on-treatment failure discontinued treatment early due to an adverse event.
Sværeste toksicitetsgrader 1 til 4 iht. 
WHO worst toxicity grades 1 to 4.
Sammenlignet med raske personer med normal leverfunktion var den gennemsnitlige AUC for simeprevir ved steady state 2,4 gange højere hos ikke-HCV-inficerede personer med moderat leverinsufficiens (Child-Pugh-klasse B) og 5,2 gange højere hos ikke-HCV-inficerede personer med svær leverinsufficiens (Child-Pugh-klasse C). 
Compared to healthy subjects with normal hepatic function, the mean steady-state AUC of simeprevir was 2.4-fold higher in non-HCV infected subjects with moderate hepatic impairment (Child-Pugh class B) and 5.2-fold higher in non-HCV infected subjects with severe hepatic impairment (Child-Pugh class C).
Simeprevirs sikkerhed og virkning er ikke blevet fastlagt hos HCV-inficerede patienter med moderat eller svær leverinsufficiens (Child-Pugh klasse B eller C). 
The safety and efficacy of simeprevir have not been established in HCV infected patients with moderate or severe hepatic impairment (Child-Pugh class B or C).
Andre ritonavir-forstærkede eller uforstærkede HIV-PI'er (atazanavir, (fos)amprenavir, lopinavir, indinavir, nelfinavir, saquinavir, tipranavir) 
Other ritonavir-boosted or unboosted HIV PIs (Atazanavir, (Fos)amprenavir, Lopinavir, Indinavir, Nelfinavir, Saquinavir, Tipranavir)
HPC3011 (RESTORE; fase 3) 
HPC3011 (RESTORE; Phase 3)
Følgende bivirkninger kan optræde, når du tager OLYSIO sammen med sofosbuvir: Almindelig: Kan ramme op til 1 ud af 10 personer: - hudkløe - hududslæt* - forstoppelse - øget følsomhed for sollys (fotosensibilitet) - for meget bilirubin i blodet (bilirubin er et farvestof, der dannes i leveren) * Hududslæt kan ramme flere end 1 ud af 10 personer (meget almindelig bivirkning), hvis 
The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people: - itching of the skin - skin rash* - constipation - being sensitive to sunlight (photosensitivity) - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver).
Inkluderer 4 simeprevir-behandlede patienter, der fik recidiv efter SVR12. 
4 simeprevir-treated patients who experienced relapse after SVR12.
2 Den daglige dosis af ribavirin er vægtbaseret (< 75 kg: 1.000 mg; ≥ 75 kg: 1.200 mg) og administreres oralt fordelt på to doser sammen med mad. 
2 The daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food; also refer to the Summary of Product Characteristics of ribavirin.
Det er OLYSIO - OLYSIO indeholder det aktive stof simeprevir. 
What OLYSIO is - OLYSIO contains the active substance ‘simeprevir'.
Kapselindhold Natriumlaurilsulfat Magnesiumstearat Kolloid vandfri silica Croscarmellosenatrium Lactosemonohydrat 
Capsule content Sodium lauryl sulfate Magnesium stearate Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate
Mindre stigninger i koncentrationerne af disse antiarytmika kan forventes, hvis disse lægemidler indgives oralt. 
Mild increases in concentrations of these antiarrhythmics may be expected when these medicinal products are administered orally.
Den planlagte samlede varighed af HCV-behandling var 24 uger, hvis følgende protokoldefinerede kriterier for responsafhængig behandling var opfyldt under behandlingen: HCV-RNA < 25 IE/ml detekterbart eller ikke-detekterbart i uge 4 OG ikke-detekterbart HCVRNA i uge 12. 
treatment was 24 weeks if the following on-treatment protocol-defined response-guided therapy criteria were met: HCV RNA < 25 IU/ml detectable or undetectable at week 4 AND undetectable HCV RNA at week 12.
Eksperimenter in vitro med humane Caco-2-celler indikerede, at simeprevir er substrat for P-glykoprotein (P-gp). 
In vitro experiments with human Caco-2 cells indicated that simeprevir is a substrate of P-gp.
Hvis en dosis af OLYSIO glemmes i mere end 12 timer efter det sædvanlige doseringstidspunkt, må patienten ikke tage den manglende dosis, men skal genoptage doseringen af OLYSIO sammen med mad på det sædvanlige, planlagte tidspunkt. 
If a dose of OLYSIO is missed by more than 12 hours after the usual dosing time, the patient should not take the missed dose of OLYSIO and should resume dosing of OLYSIO with food at the regularly scheduled time.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/924/001 (7 kapsler) 
MARKETING AUTHORISATION NUMBER(S) EU/1/14/924/001 (7 capsules)
infektion (studie C212) 
(study C212)
Tabel 9: Antiviral aktivitet af monoterapi med simeprevir 200 mg (studie C201 og C202) Genotype 
Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Genotype
ANTIHISTAMINER Astemizol 
ANTIHISTAMINES Astemizole Terfenadine
HPC3007 (PROMISE; fase 3) 
HPC3007 (PROMISE; Phase 3)
Kvindelige, fertile patienter samt mandlige patienter og deres kvindelige fertile partnere skal bruge en sikker antikonceptionsmetode under behandlingen med ribavirin, og efter behandlingen med ribavirin er afsluttet i den periode, der er angivet i produktresumeet for ribavirin. 
Female patients of childbearing potential and male patients with female partners of childbearing potential must use an effective form of contraception during treatment with ribavirin and after completion of ribavirin treatment for a duration as specified in the Summary of Product Characteristics for ribavirin.
De fleste lysfølsomhedsreaktioner hos simeprevir-behandlede patienter var af let eller moderat sværhedsgrad (grad 1 eller grad 2); 0,3% af de simeprevir-behandlede patienter havde alvorlige reaktioner førende til hospitalisering (se pkt. 
Most photosensitivity reactions in simeprevir-treated patients were of mild or moderate severity (grade 1 or 2); 0.3% of the simeprevir-treated patients experienced serious reactions leading to hospitalisation (see section 4.4).
Hos patienter > 45 år blev der indberettet dyspnø hos 16,4% af de simeprevir-behandlede patienter sammenlignet med hos 9,1% i placebo-gruppen (alle grader; puljede fase 3-studier). 
In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated patients (all grades; pooled phase 3).
Der kan forekomme let forhøjet eller reduceret plasmakoncentration af sirolimus. 
Mild increased or decreased plasma concentrations of sirolimus may occur.
Samtidig administration af OLYSIO og stoffer, der i moderat eller kraftig grad inducerer eller hæmmer cytokrom P450 3 A (CYP3A4), anbefales ikke, da dette i signifikant grad kan henholdsvis reducere eller øge eksponeringen af simeprevir. 
Co-administration of OLYSIO with substances that moderately or strongly induce or inhibit cytochrome P450 3A (CYP3A4) is not recommended as this may lead to significantly lower or higher exposure of simeprevir, respectively.