FrancophonIA/ELRC3.0 huggingface dataset:
English: Nonafact contains human coagulation factor IX, a protein extracted and purified from human plasma (the liquid part of the blood).
Danish: Nonafact indeholder human koagulationsfaktor IX, som er udvundet af humant plasma (den flydende del af blodet) og renset.
English: The full EPAR for Nonafact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Nonafact findes på EMA's websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Hvis du ønsker yderligere oplysninger om behandling med Nonafact, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why has Nonafact been approved?
Danish: Hvorfor er Nonafact godkendt?
English: What is Nonafact used for?
Danish: Hvad anvendes Nonafact til?
English: What is Nonafact?
Danish: Hvad er Nonafact?
English: The medicine can only be obtained with a prescription.
Danish: Lægemidlet Nonafact udleveres kun efter recept.
English: How has Nonafact been studied?
Danish: Hvordan blev Nonafact undersøgt?
English: How is Nonafact used?
Danish: Hvordan anvendes Nonafact?
English: What benefit has Nonafact shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Nonafact?
English: How does Nonafact work?
Danish: Hvordan virker Nonafact?
English: It will not work on its own.
Danish: Det vil ikke virke alene.
English: It is therefore very important that you (or your partner) do not become pregnant during this therapy.
Danish: Derfor er det meget vigtigt, at du (eller din partner) ikke bliver gravide i løbet af denne behandling.
English: Eight subjects (20%) received epoetin and/or a blood product.
Danish: Otte personer (20 %) fik epoetin og/eller et blodprodukt.
English: If you forget to take Sovaldi It is important not to miss a dose of this medicine.
Danish: Hvis du har glemt at tage Sovaldi Det er vigtigt ikke at glemme en dosis af dette lægemiddel.
English: Furthermore, the appropriate dose has not been established.
Danish: Desuden er en passende dosis ikke blevet klarlagt.
English: The film-coated tablet is for oral use.
Danish: Den filmovertrukne tablet er til oral anvendelse.
English: • Ribavirin, or
Danish: • Ribavirin eller
English: In 5 subjects (12.5%), study drugs were discontinued, modified or interrupted due to adverse events.
Danish: Hos 5 personer (12,5 %) blev studielægemidlerne seponeret, modificeret eller afbrudt som følge af bivirkninger.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gennemførte graviditeter) fra anvendelse af sofosbuvir til gravide kvinder.
English: Most subjects had no prior HCV treatment (81.3%).
Danish: De fleste patienter havde ingen tidligere HCV-behandling (81,3 %).
English: In particular, do not take Sovaldi if you are taking any of the following medicines:
Danish: Du må især ikke tage Sovaldi, hvis du tager nogle af de følgende lægemidler:
English: Response rates for selected subgroups are presented in Table 6.
Danish: Responsrater for udvalgte undergrupper vises i tabel 6.
English: • If you or your partner become pregnant during Sovaldi treatment or in the months that follow, you must contact your doctor immediately.
Danish: • Hvis du eller din partner bliver gravide under behandling med Sovaldi, eller i de efterfølgende måneder, skal du straks kontakte lægen.
English: Until liver transplantation c
Danish: Indtil levertransplantation c
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2014
Danish: Dato for første markedsføringstilladelse: 16 januar 2014
English: Subjects in these studies had compensated liver disease including cirrhosis.
Danish: Patienterne i disse studier havde kompenseret leversygdom, herunder cirrose.
English: INFORMATION IN BRAILLE Sovaldi [Outer packaging only]
Danish: INFORMATION I BRAILLESKRIFT Sovaldi [Kun på den ydre emballage]
English: The proportions of subjects who were interferon intolerant, ineligible, or unwilling were 9%, 44%, and 47%, respectively.
Danish: Andelen afpatienter, som var interferon-intolerante, -uegnede eller -uvillige var hhv. 9 %, 44 % og 47 %.
English: The response rates observed for subjects over 65 years of age were similar to that of younger subjects across treatment groups.
Danish: De observerede responsrater for personer over 65 år var sammenlignelige med raterne for yngre personer i alle behandlingsgrupperne.
English: • Have kidney problems.
Danish: • Har nyreproblemer.
English: Preliminary SVR12 data are available for 210 subjects.
Danish: Foreløbige data for SVR12 er tilgængelige for 210 patienter.
English: All subjects who achieved SVR12 achieved SVR24 and SVR48.
Danish: Alle personer, der opnåede SVR12, opnåede SVR24 og SVR48.
English: Clinical studies of sofosbuvir included 65 subjects aged 65 and over.
Danish: Kliniske studier af sofosbuvir omfattede 65 personer i alderen 65 år og derover.
English: Virologic response in evaluable subjectsa a. Evaluable subjects are defined as those who have reached the specified time point at the time of the interim analysis.
Danish: Virologisk respons hos evaluerbare patientera a. Evaluerbare patienter er defineret som depatienter, som har nået det specificerede tidspunkt på tidspunktet for interimanalysen.
English: Animal studies do not indicate harmful effects on fertility.
Danish: Dyreforsøg indikerer ingen skadelige virkninger på fertiliteten.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet.
English: IMMUNOSUPPRESSANTS Ciclosporine
Danish: IMMUNOSUPPRIMERENDE MIDLER Ciclosporine
English: Pharmacotherapeutic group: Direct-acting antiviral; ATC code: J05AX15
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale midler, ATC-kode: J05AX15
English: If you vomit more than 2 hours after taking it you do not need to take another tablet until your next regularly scheduled tablet.
Danish: Hvis du kaster op mere end 2 timer efter du har taget det, skal du ikke tage en anden tablet før din næste regelmæssigt skemalagte tablet.
English: Interferon classification Ineligible Intolerant Unwilling
Danish: Interferonklassifikation Uegnet Intolerant Uvillig
English: Table 3: Interactions between Sovaldi and other medicinal products Medicinal product by therapeutic areas
Danish: Tabel 3: Interaktioner mellem Sovaldi og andre lægemidler Lægemiddel i henhold til terapeutiske områder
English: Patients awaiting liver transplantation - Study 2025
Danish: Patienter, der venter på levertransplantation - studie 2025
English: However, it is not recommended that ribavirin be increased to the original assigned dose (1,000 mg to 1,200 mg daily).
Danish: Det anbefales dog ikke, at ribavirin øges til den oprindeligt tildelte dosis (1.000 mg til 1.200 mg dagligt).
English: Tell your doctor if you take any of the following medicines: • amiodarone, used to treat irregular heartbeats.
Danish: Fortæl det til lægen, hvis du tager nogen af følgende lægemidler: • Amiodaron mod uregelmæssig hjerterytme.
English: SVR12 rate % (n/N)
Danish: Undergruppe SVR12-rate % (n/N)
English: If you are sick (vomit) less than 2 hours after taking Sovaldi, take another tablet.
Danish: Hvis du er syg (kaster op) mindre en 2 timer efter du har taget Sovaldi, skal du tage en anden tablet.
English: The use of Sovaldi in children and adolescents has not yet been studied.
Danish: Anvendelsen af Sovaldi hos børn og unge er endnu ikke undersøgt.
English: If vomiting occurs more than 2 hours after dosing, no further dose is needed.
Danish: Hvis de kaster op mere end 2 timer efter dosering, er der ikke behov for en yderligere dosis.
English: Sovaldi is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this population.
Danish: Sovaldi bør ikke anvendes til børn og unge under 18 år, da sikkerhed og virkning ikke er klarlagt for denne population.
English: ≥2 g/dL decrease in haemoglobin during any 4 week treatment period
Danish: ≥ 2 g/dl reduktion i hæmoglobin i løbet af en 4ugers behandlingsperiode
English: Cirrhosis No Yes Response to prior HCV treatment Relapser Nonresponder 70% (7/10)
Danish: Cirrose Nej Ja Respons på tidligere HCVbehandling Recidiv Ingen respons 70 % (7/10)
English: • Modafinil (a medicine to treat people with narcolepsy to help them stay awake).
Danish: • Modafinil (medicin til personer med narkolepsi for at hjælpe dem med at holde sig vågne).
English: • Peginterferon alfa and ribavirin
Danish: • Peginterferon alfa og ribavirin
English: 130 mg/daily])
Danish: 130 mg/dagligt])
English: (600 mg single dose)
Danish: (600 mg enkeltdosis)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/894/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/894/001
English: Talk to your doctor or pharmacist if you have severe kidney problems or if you are on kidney dialysis as the effects of Sovaldi on patients with severe kidney problems have not been fully tested.
Danish: Tal med lægen eller apotekspersonalet, hvis du har alvorlige nyreproblemer, eller hvis du er i nyredialyse, da virkningerne af Sovaldi på patienter med alvorlige nyreproblemer ikke er helt undersøgt.
English: Treatment duration was fixed in each study and was not guided by subjects' HCV RNA levels (no response guided algorithm).
Danish: Behandlingsvarigheden var fikseret i hvert studie, og den var ikke guidet af patienternes HCV-rna-niveauer (ingen responsguidet algoritme).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/894/001 28 film-coated tablets EU/1/13/894/002 84 (3 bottles of 28) film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/894/001 28 filmovertrukne tabletter EU/1/13/894/002 84 (3 tabletbeholdere med 28) filmovertrukne tabletter
English: Overview of outcomes by therapeutic regimen and treatment duration, a comparison across studies The following tables (Table 18 to Table 21) present data from Phase 2 and Phase 3 studies relevant to the dosing to help clinicians determine the best regimen for individual patients.
Danish: Oversigt over resultater for behandlingsprogram og behandlingsvarighed, en sammenligning af studier De følgende tabeller (tabel 18 til tabel 21) viser data fra fase II- og fase III-studier, relevante for doseringen, for at hjælpe klinikerne med at bestemme det bedste behandlingsprogram for individuelle patienter.
English: Co-administration with other direct-acting antivirals against HCV Sovaldi should only be co-administered with other direct-acting antiviral medicinal products if the benefit is considered to outweigh the risks based upon available data.
Danish: Samtidig administration af andre direkte virkende antivirale midler mod HCV Sovaldi må kun administreres sammen med andre direkte virkende antivirale lægemidler, hvis fordelen anses for at opveje risici baseret på tilgængelige data.
English: Genotype 4, 5 or 6 97% (34/35) Cirrhosis
Danish: Genotype 4, 5 eller 6 97 % (34/35) Cirrose
English: ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Danish: ANTIKONVULSIVA Carbamazepin Phenobarbital Phenytoin
English: Liver transplant recipients - Study 0126
Danish: Patienter, der har gennemgået en levertransplantation - studie 0126
English: SVR12 rates were similarly high in subjects with baseline IL28B C/C allele [94/95 (99%)] and non-C/C (C/T or T/T) allele [202/232 (87%)].
Danish: SVR12-rater var sammenligneligt høje hos patienter med baseline IL28B C/Callel [94/95 (99 %)] og non-C/C (C/T eller T/T)-allel [202/232 (87 %)].
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol
Danish: ORALE ANTIKONTRACEPTIVA Norgestimat/ethinylestrad iol
English: Use with moderate P-gp inducers
Danish: Brug sammen med moderate P-gp-induktorer
English: Do not stop taking Sovaldi
Danish: Du må ikke holde op med at tage Sovaldi
English: The safety and efficacy of Sovaldi in children and adolescents aged <18 years have not yet been established.
Danish: Sovaldis sikkerhed og virkning hos børn og unge i alderen < 18 år er endnu ikke klarlagt.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sovaldi and another DAA when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Danish: Da disse tilfælde er potentielt livstruende, bør amiodaron kun anvendes hos patienter i behandling med Sovaldi og et andet DAA, når andre antiarytmika ikke tolereres eller er kontraindiceret.
English: Post-baseline NS5B sequences were available for 225 of the 226 subjects, with deep sequencing data (assay cutoff of 1%) from 221 of these subjects.
Danish: NS5B-sekvenser efter baseline var tilgængelige for 225 ud af de 226 patienter, med dybe sekvensdata (afskæring for analyse på 1 %) for 221 af disse patienter.
English: • Rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
Danish: • Rifampicin og rifabutin (antibiotika, der anvendes til behandling af infektioner, herunder tuberkulose)
English: Use with potent P-gp inducers
Danish: Brug sammen med potente P-gp-induktorer
English: Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults of 18 years and older.
Danish: Sovaldi indeholder det aktive stof sofosbuvir, som gives til behandling af infektion med hepatitis Cvirus hos voksne i alderen 18 år og derover.
English: Treatment-experienced 90% (37/41) Non-cirrhotic
Danish: Behandlingserfarne 90 % (37/41) Uden cirrose
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus DAAs.
Danish: Samtidig anvendelse af amiodaron blev begrænset ved den kliniske udvikling af sofosbuvir plus DAA'er.
English: The virologic response rates of the 41 subjects transplanted with HCV RNA <LLOQ is described in Table 17.
Danish: De virologiske responsrater for de første 41 patienter, der blev transplanteret med HCV-rna < LLOQ er beskrevet i tabel 17.
English: All patients receiving Sovaldi and another DAA 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, som får Sovaldi og et andet DAA i kombination med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler, skal ligeledes advares om symptomerne på bradykardi og hjerteblok og tilrådes at søge øjeblikkelig lægehjælp, hvis de kommer ud for dem.
English: In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 subjects) experiencing a decline in haemoglobin to <10 g/dL, 1 of whom also had a decline to <8.5 g/dL.
Danish: I studie 0126 var fald i hæmoglobin i løbet af behandlingen meget almindelig, og 32,5 % (13/40 personer) oplevede et fald i hæmoglobin til < 10 g/dl, hvoraf 1 havde et fald til < 8,5 g/dl.
English: A single subject with genotype 5 and all 6 subjects with genotype 6 HCV infection in this study achieved SVR12.
Danish: En enkelt person med genotype 5 og alle 6 personer med genotype 6 HCV-infektion i dette studie opnåede SVR12.
English: Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Danish: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til
English: Common pyrexia, asthenia chest pain, asthenia a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
Danish: Almindelig Pyreksi, asteni brystsmerter, asteni a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Sovaldi and another DAA.
Danish: Hvis samtidig brug af amiodaron findes nødvendig, anbefales tæt overvågning af patienterne ved initiering af behandlingen med Sovaldi og et andet DAA.
English: Cirrhosis n = number of subjects with SVR12 response; N = total number of subjects per group.
Danish: Cirrose n = antal patienter med SVR12-respons; N = totalt antal patienter pr. gruppe.
English: If sofosbuvir is used in combination with peginterferon alfa, and a patient has a serious adverse reaction potentially related to this drug, the peginterferon alfa dose should be reduced or discontinued.
Danish: Hvis sofosbuvir anvendes i kombination med peginterferon alfa, og en patient har en alvorlig bivirkning, som muligvis er relateret til dette lægemiddel, skal dosis af peginterferon alfa reduceres eller seponeres.
English: Sovaldi has mainly been studied in combination with ribavirin, with or without peginterferon alfa.
Danish: Sovaldi er primært blevet undersøgt i kombination med ribavirin, sammen med eller uden peginterferon alfa.
English: Treatment-naïve (QUANTUMb and
Danish: Behandlingsnaive (QUANTUMb og
English: However, based on emerging data, the study was unblinded and all HCV genotype 2 subjects continued to receive sofosbuvir and ribavirin for 12 weeks, whilst treatment for HCV genotype 3 subjects was extended to 24 weeks.
Danish: Baseret på opdukkende data blev studiet imidlertid afblindet, og alle HCV-genotype 2-patienter fortsatte med at få sofosbuvir og ribavirin i 12 uger, mens behandlingen for HCV-genotype 3-patienter blev forlænget til 24 uger.
English: Breast-feeding It is unknown whether sofosbuvir and its metabolites are excreted in human milk.
Danish: Amning Det er ukendt, om sofosbuvir og dets metabolitter udskilles i human mælk.
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Sovaldi in combination with another DAA.
Danish: På grund af amiodarons lange halveringstid skal der desuden foretages passende overvågning af patienter, som inden for de seneste måneder har fået seponeret amiodaron og skal sættes i behandling med Sovaldi i kombination med et andet DAA.
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 1.4% for subjects receiving placebo, 0.5% for subjects receiving sofosbuvir + ribavirin for 12 weeks, 0% for subjects receiving sofosbuvir + ribavirin for 16 weeks, 11.1% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2.4% for subjects receiving sofosbuvir + peginterferon alfa + ribavirin for 12 weeks.
Danish: Andelen af personer, som seponerede behandlingen permanent på grund af bivirkninger, var 1,4 % for personer, som fik placebo, 0,5 % for personer, som fik sofosbuvir + ribavirin i 12 uger, 0 % for personer, som fik sofosbuvir + ribavirin i 16 uger, 11,1 % for personer, som fik peginterferon alfa + ribavirin i 24 uger og 2,4 % for personer, som fik sofosbuvir + peginterferon alfa + ribavirin i 12 uger.
English: Eleven HCV genotype 3 subjects had already completed treatment with sofosbuvir and ribavirin for 12 weeks at the time of the amendment.
Danish: Elleve HCV-genotype 3-patienter havde allerede gennemført behandlingen med sofosbuvir og ribavirin i 12 uger på ændringstidspunktet.
English: Table 15: Response rates in study PHOTON-1 Genotype 2/3 treatment-naïve
Danish: Tabel 15: Responsrater i PHOTON-1-studiet Genotype 2/3 behandlingsnaive
English: Available pharmacokinetic data in animals has shown excretion of metabolites in milk (for details see section 5.3).
Danish: De tilgængelige farmakokinetiske data fra dyreforsøg viser, at metabolitter udskilles i mælk (se pkt.
English: Elimination Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Danish: Elimination Efter en enkelt 400 mg oral dosis af [14C]-sofosbuvir, var den gennemsnitlige totale genfinding af dosis over 92 %, og bestod af ca. 80 %, 14 % og 2,5 %, som blev genfundet i hhv. urin, fæces og udåndingsluft.
English: When you take Sovaldi in combination with another medicine to treat hepatitis C virus infection (including daclatasvir, simeprevir and ledipasvir) and amiodarone (a medicine used for heart problems), you may get one or more of the side effects below:
Danish: Når du tager Sovaldi sammen med et andet lægemiddel til behandling af infektion med hepatitis C (herunder daclatasvir, simeprevir og ledispavir) og amiodaron (et lægemiddel, der bruges mod hjerteproblemer), kan du få en eller flere af nedenstående bivirkninger:
English: (400 mg twice daily)
Danish: (400 mg to gange dagligt)
English: ANTIMYCOBACTERIALS Rifampicinf
Danish: ANTIMYKOBAKTERIELLE MIDLER Rifampicinf
English: Metabolism and nutrition disorders: Very common decreased appetite
Danish: Almindelig anæmi Metabolisme og ernæring: Meget almindelig nedsat appetit
English: 28 out of 40 (70%) subjects 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.
Danish: 28 ud af 40 (70 %) personer 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.
English: A 4-hour haemodialysis session removed approximately 18% of administered dose.
Danish: En 4-timers hæmodialysesession fjernede ca. 18 % af den administrerede dosis.
English: Treatment-naïve (ELECTRONb and
Danish: Behandlingsnaive (ELECTRONb og
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b) Yellow iron oxide (E172)
Danish: Filmovertræk Polyvinylalkohol (E1203) Titandioxid (E171) Macrogol 3350 (E1521) Talcum (E553b) Gul jernoxid (E172)
English: Dose modification Dose reduction of Sovaldi is not recommended.
Danish: Dosismodifikation Dosisreduktion af Sovaldi bør ikke anvendes.
English: Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a,b
Danish: Gennemsnitligt forhold konfidensinterval) AUC, Cmax, Cmin a,b
English: Genotype 2 and 3 subjects were either treatment-naïve or experienced, whereas genotype 1 subjects were naïve to prior treatment.
Danish: Patienter med genotype 2 og 3 var enten behandlingsnaive eller -erfarne, hvorimod patienter med genotype 1 var naive før behandlingen.
English: It is not known whether sofosbuvir, the active substance of Sovaldi, passes into human breast milk.
Danish: Det er ukendt, om sofosbuvir, det aktive stof i Sovaldi, udskilles i human mælk.
English: In subjects with ESRD, relative to subjects with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis.
Danish: Hos personer med ESRD, i forhold til personer med normal nyrefunktion, var sofosbuvir AUC0-inf 28 % højere, når sofosbuvir blev doseret 1 time før hæmodialyse, sammenlignet med 60 % højere, når sofosbuvir blev doseret 1 time efter hæmodialyse.
English: Posology The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2).
Danish: Den anbefalede dosis er en 400 mg tablet, der tages oralt, én gang dagligt sammen med mad (se pkt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with sofosbuvir in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med sofosbuvir i en eller flere undergrupper af den pædiatriske population ved behandling af kronisk hepatitis C (se pkt.
English: No dose adjustment is warranted for elderly patients (see section 5.2).
Danish: Ingen dosisjustering er nødvendig hos ældre patienter (se pkt.