natgillin/translations-raw huggingface dataset:
HCV-ANTIVIRALE STOFFER: HCV-PROTEASEHÆMMERE Boceprevir (BOC)
HCV ANITIVIRAL AGENTS: HCV PROTEASE INHIBITORS Boceprevir (BOC)
Sovaldi er ikke blevet undersøgt i et fase III-studie hos behandlingserfarne patienter med HCV-genotype 1, 4, 5 og 6-infektion.
Sovaldi has not been studied in a Phase 3 study in treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection.
28 ud af 40 (70 %) patienter opnåede SVR12: 22/33 (73 %) med HCV-genotype 1-infektion, 6/6 (100 %) med HCV-genotype 3-infektion og 0/1 (0 %) med HCV-genotype 4-infektion.
28 out of 40 (70%) patients achieved SVR12: 22/33 (73%) with HCV genotype 1 infection, 6/6 (100%) with HCV genotype 3 infection, and 0/1 (0%) with HCV genotype 4 infection.
Rilpivirinf (25 mg én gang dagligt)
Rilpivirinef (25 mg once daily)
12 ugera, b
12 weeksa,b
I ELECTRON-studiet (N = 11) var varigheden af peginterferon alfa i intervallet fra 4-12 uger i kombination med sofosbuvir+ribavirin.
In the ELECTRON study (N = 11), the duration of peginterferon alfa ranged from 4-12 weeks in combination with sofosbuvir + ribavirin.
Den gennemsnitlige ribavirindosis var 600-800 mg dagligt ved uge 4-24.
The median ribavirin dose was 600 mg-800 mg daily at weeks 4-24.
Der blev indhentet baseline NS5B-sekvenser for 1.292 patienter fra fase III-studier ved populationssekventering, og S282T-substitutionen blev ikke detekteret hos nogen personer med en tilgængelig baselinesekvens.
Baseline NS5B sequences were obtained for 1,292 patients from Phase 3 studies by population sequencing and the S282T substitution was not detected in any subject with available baseline sequence.
Sovaldi + ribavirin Bør kun anvendes til patienter, der er uegnede eller intolerante over for peginterferon alfa (se pkt.
Sovaldi + ribavirin Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
De tilgængelige farmakokinetiske data fra dyrestudier viser, at metabolitter udskilles i mælk (se pkt.
Available pharmacokinetic data in animals have shown excretion of metabolites in milk (for details see section 5.3).
Tabel 19: Virologisk respons efter transplantation hos patienter med HCV-rna < LLOQ på tidspunktet for levertransplantationen
Table 19: Virologic response post-transplant in patients with HCV RNA <LLOQ at the time of liver transplantation
Patienter, der venter på levertransplantation
Patients awaiting liver transplantation
I forhold til fastende tilstande, sænkede administrationen af en enkelt dosis sofosbuvir sammen med et standardiseret måltid med højt fedtindhold absorptionshastigheden af sofosbuvir.
Relative to fasting conditions, the administration of a single dose of sofosbuvir with a standardised high fat meal slowed the rate of absorption of sofosbuvir.
Samtidig administration af Sovaldi og lægemidler, der hæmmer P-gp og/eller BCRP kan øge plasmakoncentrationen af sofosbuvir uden at øge plasmakoncentrationen af GS-331007, og derved kan Sovaldi administreres samtidigt med P-gp- og/eller BCRP-hæmmere.
Co-administration of Sovaldi with medicinal products that inhibit P-gp and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma concentration, thus Sovaldi may be co-administered with P-gp and/or BCRP inhibitors.
40 patienter (33 med HCV-genotype 1-infektion, 6 med HCV-genotype 3-infektion og 1 med HCVgenotype 4-infektion) indgik, hvoraf 35 havde tidligere svigt af interferonbaseret behandling, og 16 havde cirrose.
Forty patients (33 with HCV genotype 1 infection, 6 with HCV genotype 3 infection, and 1 with HCV genotype 4 infection) were enrolled, 35 of whom had previously failed interferon-based treatment, and 16 of whom had cirrhosis.
Når Sovaldi anvendes i kombination med ribavirin eller peginterferon alfa/ribavirin, skal der udvises ekstrem forsigtighed, så graviditet undgås hos kvindelige patienter og hos mandlige patienters kvindelige partnere.
When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Sofosbuvir metaboliseres i udbredt grad i leveren, så der dannes den farmakologisk aktive nukleosidanalog triphosphat GS-461203.
Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Den intracellulære metaboliske aktiveringsvej for sofosbuvir er medieret af en hydrolase med generelt lav affinitet og høj kapacitet, og nukleotid fosforyleringsveje, der sandsynligvis ikke påvirkes af samtidige lægemidler (se pkt.
The intracellular metabolic activation pathway of sofosbuvir is mediated by generally low affinity and high capacity hydrolase and nucleotide phosphorylation pathways that are unlikely to be affected by concomitant medicinal products (see section 5.2).
De mest almindelige bivirkninger, der forekom hos patienter, som fik sofosbuvir og ribavirin eller sofosbuvir, ribavirin og peginterferon alfa var træthed, hovedpine, kvalme og søvnløshed.
The most common adverse drug reactions occurring in patients receiving sofosbuvir and ribavirin or sofosbuvir, ribavirin and peginterferon alfa were fatigue, headache, nausea and insomnia.
Sofosbuvir er ikke et substrat for hepatiske optagelsestransportere, organisk aniontransporterende polypeptid (OATP) 1B1 eller 1B3, eller organisk kation-transporter (OCT) 1.
Sofosbuvir is not a substrate for hepatic uptake transporters, organic anion-transporting polypeptide (OATP) 1B1 or 1B3, and organic cation transporter (OCT) 1.
Der blev ikke detekteret skift i fænotype-følsomhed for sofosbuvir eller ribavirin i isolater fra patienter med disse substitutioner.
No shift in the phenotypic susceptibility to sofosbuvir or ribavirin of subject isolates with these substitutions was detected.
Interferonfrie behandlingsprogrammer for patienter med HCV-genotype 1, 4, 5 og 6-infektion med Sovaldi er ikke blevet undersøgt i fase III-studier (se pkt.
Interferon-free regimens for patients with genotype 1, 4, 5 and 6 HCV infection with Sovaldi have not been investigated in Phase 3 studies (see section 5.1).
Hvis en patient har en alvorlig bivirkning, som muligvis er relateret til ribavirin, skal dosis af ribavirin modificeres eller seponeres, hvis det er hensigtsmæssigt, indtil bivirkningen svinder eller reduceres i sværhedsgrad.
If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Lever og galdeveje: Meget almindelig forhøjet bilirubin i blodet forhøjet bilirubin i blodet
Hepatobiliary disorders: Very common blood bilirubin increased blood bilirubin increased
Eksponeringer for sofosbuvir og GS-331007 hos unge i alderen 12 til <18 år var lig med eksponeringer hos voksne fra fase II/III-studier efter administration af sofosbuvir (400 mg).
Sofosbuvir and GS-331007 exposures in adolescents aged 12 to <18 years were similar to those in adults from Phase 2/3 studies following administration of sofosbuvir (400 mg).
Se produktresuméet for peginterferon alfa for yderligere information om, hvordan dosis af peginterferon alfa reduceres og/eller seponeres.
Refer to the peginterferon alfa Summary of Product Characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose.
To NS5B-substitutioner, L159F og V321A, blev detekteret i recidivprøver efter behandlingen fra flere patienter med HCV-genotype 3-infektion i de kliniske fase III-studier.
Two NS5B substitutions, L159F and V321A, were detected in post-treatment relapse samples from multiple genotype 3 HCV infected patients in the Phase 3 clinical studies.
Ribavirindosis var vægtbaseret med 1.000-1.200 mg dagligt, administreret fordelt på to doser, og peginterferon alfa 2a-dosis, hvor det var relevant, var 180 μg ugentligt.
The ribavirin dose was weight-based at 1,000-1,200 mg daily administered in two divided doses, and the peginterferon alfa 2a dose, where applicable, was 180 μg per week.
Sofosbuvir bibeholdt aktivitet mod NS5B-substitutionerne L159F og L320F forbundet med resistens over for andre nuklosidhæmmere.
Sofosbuvir retained activity against the NS5B substitutions L159F and L320F associated with resistance to other nucleoside inhibitors.
• lavt antal blodplader
• low blood platelet count
Tabel 24: Virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringer (AUC) for sofosbuvir og GS-331007 sammenlignet med forsøgspersoner med normal nyrefunktion
Table 24: Effect of varying degrees of renal impairment on exposures (AUC) of sofosbuvir and GS-331007 compared to subjects with normal renal function
Behandlingsnaive (FISSION)
Treatment-naïve (FISSION)
HIV-ANTIVIRALE STOFFER: HIV-PROTEASEHÆMMERE Darunavir boostet med ritonavirf (800/100 mg én gang dagligt)
HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Darunavir boosted with ritonavirf (800/100 mg once daily)
De farmakokinetiske egenskaber for sofosbuvir og den primære cirkulerende metabolit, GS-331007, er blevet evalueret hos raske voksne personer, og hos patienter med kronisk hepatitis C. Efter oral administration blev sofosbuvir absorberet hurtigt, og den maksimale plasmakoncentration blev observeret ~0,5-2 timer efter dosering, uanset dosisniveau.
The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level.
HCV-replikoner, der udtrykker substitutionen S282T, som er forbundet med resistens over for sofosbuvir, var helt følsomme over for andre klasser af anti-HCV-stoffer.
HCV replicons expressing the sofosbuvir-associated resistance substitution S282T were fully susceptible to other classes of anti-HCV agents.
Der blev ikke identificeret nogen klinisk relevante farmakokinetiske forskelle, der skyldes køn eller race, for sofosbuvir og GS-331007.
No clinically relevant pharmacokinetic differences due to gender or race have been identified for sofosbuvir and GS-331007.
Sovaldi 400 mg filmovertrukne tabletter sofosbuvir
Sovaldi 400 mg film-coated tablets sofosbuvir
Behandlingsnaive (QUANTUMb og 11-1-0258b) SOF+RBV 24 uger
Treatment-naïve (QUANTUMb and 11-1-0258b) SOF+RBV 24 weeks
NS5B-sekvenser ved baseline blev opnået hos 47 patienter i fase II-studiet.
Baseline NS5B sequences were obtained for 47 patients in the Phase 2 study.
Efter en enkelt 400 mg dosis af [14C]-sofosbuvir hos raske personer, var forholdet af 14C-radioaktivitet mellem blod og plasma ca. 0,7.
After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7.
Sikkerheden og effekten af 12 ugers behandling med ledipasvir/sofosbuvir hos 18 genotype 1 HCV-inficerede patienter med svært nedsat nyrefunktion, som ikke krævede dialyse, blev også undersøgt i Studie 0154.
The safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir in 18 genotype 1 HCV-infected patients with severe renal impairment not requiring dialysis was also studied in Study 0154.
I forhold til raske personer (n = 284) var sofosbuvir og GS-331007 AUC0-24 hhv. 57 % højere og 39 % lavere hos HCV-inficerede patienter.
Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected patients.
Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af regimer, der indeholder sofosbuvir, i kombination med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler.
Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Ingen patienter havde virologisk svigt eller recidiverede under behandling.
No patient experienced on-treatment virologic failure or relapse.
Patienter i studiet med HCV-genotype 2- eller 3-infektion blev behandlet med sofosbuvir med ribavirin i henholdsvis 12 eller 24 uger.
Patients with HCV genotype 2 or 3 infection in the trial were treated with sofosbuvir with ribavirin for 12 or 24 weeks, respectively.
Patienterne blev randomiseret i forholdet 1:1 og stratificeret efter cirrose (til stede versus ikke til stede), HCV-genotype (2 versus 3) og baseline HCV-rna-niveau (< 6 log10 IE/ml versus ≥ 6 log10 IE/ml).
Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level (<6 log10 IU/mL versus ≥6 log10 IU/mL).
Dosis af ribavirin, når det anvendes i kombination med Sovaldi, er vægtbaseret (< 75 kg = 1.000 mg og ≥ 75 kg = 1.200 mg) og administreres oralt fordelt på 2 doser sammen med mad.
The dose of ribavirin, when used in combination with Sovaldi is weight-based (<75 kg = 1,000 mg and ≥75 kg = 1,200 mg) and administered orally in two divided doses with food.
I biokemiske analyser viste rekombinant NS5Bpolymerase fra genotype 1b, 2a, 3a og 4a, der udtrykte S282T-substitutionen, reduceret følsomhed over for GS-461203, sammenlignet med de tilhørende vildtyper.
In biochemical assays, recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution showed reduced susceptibility to GS-461203 compared to respective wild-types.
Dosislinearitet for sofosbuvir og den primære metabolit, GS-331007, blev evalueret hos fastende, raske personer.
The dose linearity of sofosbuvir and its primary metabolite, GS-331007, was evaluated in fasted healthy subjects.
Psykiske forstyrrelser: Meget almindelig søvnløshed
Psychiatric disorders: Very common insomnia insomnia
Det skal du vide, før du begynder at tage Sovaldi Tag ikke Sovaldi
What you need to know before you take Sovaldi Do not take Sovaldi
Det er ukendt, om sofosbuvir, det aktive stof i Sovaldi, udskilles i modermælken.
It is not known whether sofosbuvir, the active substance of Sovaldi, passes into human breast milk.
GS-331007 er ikke hæmmer af OAT1, OCT2 eller MATE1.
GS-331007 is not an inhibitor of OAT1, OCT2, and MATE1.
• Oxcarbazepin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald)
• Oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
Efter en enkelt dosis på 400 mg sofosbuvir, fjernede en 4-timers hæmodialysesession ca. 18 % af den administrerede dosis.
Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered sofosbuvir dose.
Samlet Uden cirrose Cirrose n = antal patienter med SVR12-respons; N = totalt antal patienter pr. gruppe.
Cirrhosis n = number of patients with SVR12 response; N = total number of patients per group.
Sofosbuvirs farmakokinetik blev undersøgt hos HCV-negative patienter med let (eGFR ≥ 50 og < 80 ml/min/1,73m2), moderat (eGFR ≥ 30 og < 50 ml/min/1,73m2), svært nedsat nyrefunktion (eGFR < 30 ml/min/1,73 m2) og patienter med ESRD, der krævede hæmodialyse efter en enkelt 400 mg dosis sofosbuvir i forhold til patienter med normal nyrefunktion (eGFR > 80 ml/min/1,73 m2).
The pharmacokinetics of sofosbuvir were studied in HCV negative patients with mild (eGFR ≥50 and <80 mL/min/1.73 m2), moderate (eGFR ≥30 and <50 mL/min/1.73 m2), severe renal impairment (eGFR <30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir, relative to patients with normal renal function (eGFR >80 mL/min/1.73 m2).
Baseret på populationsfarmakokinetisk analyse hos patienter med HCV-infektion af genotype 1 til 6 (n = 986) var steady-state AUC0-24 for sofosbuvir og GS-331007 hhv. 1.010 ng•t/ml og 7.200 ng•t/ml.
Based on population pharmacokinetic analysis in patients with genotypes 1 to 6 HCV infection (n = 986), steady-state AUC0-24 for sofosbuvir and GS-331007 was 1,010 ng•h/mL and 7,200 ng•h/mL, respectively.
Patienterne blev randomiseret i forholdet 3:1, og stratificeret efter cirrose (til stede versus ikke til stede).
Patients were randomised in 3:1 ratio and stratified by cirrhosis (presence versus absence).
Sovaldi + ribavirin a i 24 uger
Sovaldi + ribavirin a for 24 weeks
Et resumé af virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringen for indholdsstofferne i sofosbuvir og GS-331007 sammenlignet med forsøgspersoner med normal nyrefunktion, som beskrevet nedenfor, vises i tabel 24.
A summary of the effect of varying degrees of renal impairment (RI) on the exposures of sofosbuvir and GS-331007 compared to subjects with normal renal function, as described in the text below, are provided in Table 24.
Farmakokinetikken hos lægemidler, der metaboliseres i leveren (f.eks. immunsuppressive midler såsom calcineurinhæmmere), kan påvirkes af ændringer i leverfunktionen under DAA-behandling, relateret til clearance af hepatitis C-virus.
The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Behandlingsvarigheden var 12 uger hos behandlingsnaive patienter med HCV-genotype 2 eller 3-infektion, og 24 uger hos behandlingserfarne patienter med HCV-genotype 3-infektion, samt hos patienter med genotype 1 HCV-infektion.
Treatment duration was 12 weeks in treatment-naïve patients with genotype 2 or 3 HCV infection, and 24 weeks in treatment-experienced patients with genotype 3 HCV infection, as well as patients with genotype 1 HCV infection.
Hovedparten af patienterne havde HCV-genotype 1, 44 patienter havde CPT klasse A og 17 patienter havde CPT klasse B. Ud af disse 61 patienter gennemgik 44 patienter levertransplantation efter op til 48 ugers behandling med sofosbuvir og ribavirin, 41 havde HCV-rna < LLOQ på tidspunktet for transplantationen.
An interim analysis was conducted on 61 patients who received sofosbuvir and ribavirin; the majority of patients had HCV genotype 1, 44 patients were CPT class A and 17 patients were CPT class B. Of these 61 patients, 44 patients underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA <LLOQ at the time of transplantation.
Når Sovaldi anvendes i kombination med ribavirin eller peginterferon alfa/ribavirin, henvises der også til produktresuméet for ribavirin for patienter med kreatininclearance (CrCl) < 50 ml/min (se også pkt.
When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) <50 mL/min (see also section 5.2).
Patienterne bør informeres om, at der er blevet rapporteret om træthed og koncentrationsbesvær, svimmelhed og sløret syn under behandling med sofosbuvir i kombination med peginterferon alfa og ribavirin (se pkt.
Patients should be informed that fatigue and disturbance in attention, dizziness and blurred vision have been reported during treatment with sofosbuvir in combination with peginterferon alfa and ribavirin (see section 4.8).
Sovaldi bør altid tages i kombination med andre lægemidler, der anvendes mod hepatitis C.
Sovaldi should always be taken in combination with other medicinal products for use against hepatitis C.
Sovaldis sikkerhed og virkning hos børn og unge i alderen 12 til <18 år er baseret på data fra 50 patienter, som blev behandlet med Sovaldi og ribavirin i 12 uger (genotype 2-patienter) og 24 uger (genotype 3-patienter) i et fase II, ublindet klinisk studie.
The safety and efficacy of Sovaldi in adolescents aged 12 to <18 years are based on data from 50 patients who were treated with Sovaldi and ribavirin for 12 weeks (genotype 2 patients) and 24 weeks (genotype 3 patients) in a Phase 2, open-label clinical trial.
c. Andet omfatter patienter, der ikke opnåede SVR12 og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
c. Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Sofosbuvir og GS-331007 er ikke substrater for eller hæmmere af UGT1A1 eller CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP2D6.
Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
Sofosbuvirs farmakokinetik blev undersøgt efter 7 dages dosering med 400 mg sofosbuvir hos HCVinficerede patienter med moderat og svært nedsat leverfunktion (CPT klasse B og C).
The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV infected patients with moderate and severe hepatic impairment (CPT class B and C).
Patienterne skal instrueres i at tage en ekstra tablet, hvis de kaster op inden for 2 timer efter dosering.
Patients should be instructed that if vomiting occurs within 2 hours of dosing an additional tablet should be taken.
Emtricitabinf (200 mg én gang dagligt)d
Emtricitabinef (200 mg once daily)d
Efter en enkelt 400 mg oral dosis af [14C]-sofosbuvir udgjorde sofosbuvir og GS-331007 ca. hhv. 4 % og > 90 % af det lægemiddelrelaterede materiale (summen af molekylvægt-justeret AUC for sofosbuvir og metabolitterne herfra) systemisk eksponering.
After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively.
Tabel 17: Responsrater i PHOTON-1-studiet
Table 17: Response rates in study PHOTON-1
Sovaldi + ribavirina i 12 uger b
Sovaldi + ribavirina for 12 weeks b
Angående samtidig administration af andre direkte virkende antivirale midler mod HCV, se pkt.
Concerning co-administration with other direct-acting antivirals against HCV, see section 4.4.
Farmakokinetikken af sofosbuvir og GS-331007 hos pædiatriske patienter <12 år er ikke klarlagt.
The pharmacokinetics of sofosbuvir and GS-331007 have not been established in paediatric patients < 12 years of age.
Intracellulær hydrolytisk prodrugkløvning katalyseret af enzymer, herunder carboxylesterase 1 og sekventiel fosforyleringstrinkatalyseret af nukleotidkinaser fører til dannelsen af det farmakologisk aktive uridinnukleosidanalog-triphosphat.
Intracellular hydrolytic prodrug cleavage catalysed by enzymes including carboxylesterase 1 and sequential phosphorylation steps catalysed by nucleotide kinases result in formation of the pharmacologically active uridine nucleoside analogue triphosphate.
Tabel 4: Anbefalet dosering af ribavirin i kombinationsbehandling med Sovaldi hos unge i alderen 12 til <18 år
Table 4: Recommended dosing for ribavirin in combination therapy with Sovaldi in adolescents aged 12 to < 18 years
Almindelig anæmi
Common anaemia
IMMUNOSUPPRIMERENDE MIDLER Ciclosporine (600 mg enkeltdosis)
IMMUNOSUPPRESSANTS Ciclosporine (600 mg single dose)
b. Andet omfatter patienter, der ikke opnåede SVR12 og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
b. Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Selvom det gennemgår aktiv tubulær sekretion er GS-331007 ikke et substrat for renale transportere, herunder organisk aniontransporter (OAT) 1 eller 3, OCT 2, MRP2, P-gp, BCRP og MATE1.
While subject to active tubular secretion, GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or 3, OCT2, MRP2, P-gp, BCRP or MATE1.
Når Sovaldi anvendes i kombination med ribavirin eller peginterferon alfa/ribavirin, skal kvinder i den fertile alder eller deres mandlige partnere anvende en sikker kontraceptionsmetode i løbet af behandlingen og i en tidsperiode efter behandlingen, som anbefalet i produktresuméet for ribavirin.
When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment as recommended in the Summary of Product Characteristics for ribavirin.