FrancophonIA/ELRC3.0 huggingface dataset:
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir.
Danish: Tilstedeværelsen af 40 % humant serum havde ingen virkning på sofosbuvirs anti-HCV-aktivitet.
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: Hyppighederne defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til
English: Interferon classification Ineligible
Danish: Interferon-klassifikation Uegnet
English: Animal studies do not indicate harmful effects on fertility.
Danish: Dyrestudier indikerer ingen skadelige virkninger på fertiliteten.
English: Treatment-experienced (LONESTAR-2b)
Danish: Behandlingserfarne (LONESTAR-2b)
English: • If you are allergic to sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: • hvis du er allergisk over for sofosbuvir eller et af de øvrige indholdsstoffer i Sovaldi (angivet i punkt 6 i denne indlægsseddel).
English: • slow or irregular heartbeat or heart rhythm problems
Danish: • langsom eller uregelmæssig hjerterytme eller problemer med hjerterytmen
English: Treatment of overdose with Sovaldi consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Danish: Behandling af en overdosis med Sovaldi består af generel støttebehandling, herunder overvågning af vitale tegn og observation af patientens kliniske status.
English: The use of Sovaldi in children under 12 years of age has not yet been studied.
Danish: Anvendelsen af Sovaldi til børn under 12 år er endnu ikke undersøgt.
English: • You or your partner must use an effective birth control method during treatment and afterwards.
Danish: • Du eller din partner skal anvende en sikker svangerskabsforebyggende metode i løbet af behandlingen og derefter.
English: • changes in your liver (as shown by increased amounts of a substance called bilirubin in the blood)
Danish: • leverændringer (der kan ses som et øget niveau af et stof, der kaldes bilirubin i blodet)
English: Effect of baseline HCV polymorphisms on treatment outcome
Danish: Virkning af baseline HCV-polymorfismer på behandlingsresultatet
English: As liver function may change during treatment with Sovaldi, a close monitoring of International Normalised Ratio (INR) values is recommended.
Danish: Da leverfunktionen kan ændre sig under behandling med Sovaldi, anbefales tæt monitorering af INR (international normaliseret ratio).
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 den, skal du ikke tage en anden tablet før din næste regelmæssigt skemalagte tablet.
English: The proportions of patients 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: Talk to your doctor about taking Sovaldi if you are taking any of the following medicines:
Danish: Tal med din læge om at tage Sovaldi, hvis du tager nogle af de følgende lægemidler:
English: Pharmacotherapeutic group: Antivirals for systemic use, direct-acting antiviral; ATC code: J05AP08
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, direkte virkende antivirale midler, ATC-kode: J05AP08
English: Assessment of adverse reactions is based on pooled data from five Phase 3 clinical studies (both controlled and uncontrolled).
Danish: Vurderingen af bivirkningerne er baseret på samlede data fra 5 kliniske fase III-studier (både kontrollerede og ikke kontrollerede).
English: Use with moderate P-gp inducers
Danish: Brug sammen med moderate P-gp-inducere
English: No effects on foetal development have been observed in rats and rabbits at the highest doses tested.
Danish: Der er ikke blevet observeret nogen virkninger på fosterudviklingen hos rotter og kaniner ved de højest testede doser.
English: Hepatitis C is a virus that infects the liver.
Danish: Hepatitis C er en virus infektion i leveren.
English: ≥2 g/dL decrease in haemoglobin during any 4 week treatment period
Danish: ≥ 2 g/dl reduktion i hæmoglobin i løbet af en 4-ugers behandlingsperiode
English: • shortness of breath or worsening of any shortness of breath you already have Tell your doctor or your pharmacist if you notice any of the above side effects during therapy.
Danish: • åndenød eller forværring af åndenød, du allerede lider af Fortæl det til lægen eller apotekspersonalet, hvis du bemærker nogen af ovenstående bivirkninger under behandlingen.
English: Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Danish: Behandling med Sovaldi bør påbegyndes og overvåges af en læge med erfaring i behandling af patienter med CHC.
English: Package leaflet: Information for the user Sovaldi 400 mg film-coated tablets sofosbuvir This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Sovaldi 400 mg filmovertrukne tabletter sofosbuvir Dette lægemiddel er underlagt supplerende overvågning.
English: If you are sick (vomit) less than 2 hours after taking Sovaldi, take another tablet.
Danish: Hvis du er syg (kaster op) mindre end 2 timer efter du har taget Sovaldi, skal du tage en anden tablet.
English: Treatment duration was fixed in each study and was not guided by patients' 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: 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: Sovaldi må kun administreres sammen med andre direkte virkende antivirale lægemidler, hvis fordelen anses for at opveje risici baseret på tilgængelige data.
English: Sofosbuvir is approximately 85% bound to human plasma proteins (ex vivo data) and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
Danish: Sofosbuvir er ca. 85 % bundet til humane plasmaproteiner (ex vivo-data), og bindingen er uafhængig af lægemiddelkoncentrationen i intervallet fra 1 μg/ml til 20 μg/ml.
English: Vomiting and missed doses
Danish: Opkastning og glemte doser
English: You can also report any side effects directly to the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Once ribavirin has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily.
Danish: Efter ribavirin er blevet tilbageholdt, enten på grund af en laboratorieabnormalitet eller klinisk manifestation, kan der gøres et forsøg på at genstarte ribavirin med 600 mg dagligt, og yderligere øge dosis til 800 mg dagligt.
English: Among these, one patient was found to have a NS5B RAV substitution (F289L).
Danish: Blandt dem havde én patient en NS5B RAV-substitution (F289L).
English: Cmin (NA) (Induction of P-gp)
Danish: Cmin (NA) (Induktion af P-gp)
English: The predominant (>90%) metabolite, GS-331007, is inactive.
Danish: Den primære (> 90 %) metabolit, GS-331007, er inaktiv.
English: This is because they may make Sovaldi work less well.
Danish: Det skyldes, at disse lægemidler kan forårsage, at Sovaldi virker mindre godt.
English: Table 2 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration and cardiac status.
Danish: Tabel 2 giver retningslinjer for dosismodifikationer og seponering baseret på patientens hæmoglobinkoncentration og kardielle status.
English: Adult patients awaiting liver transplantation - Study 2025
Danish: Voksne patienter, der venter på levertransplantation - studie 2025
English: Recommendation concerning co-administration with Sovaldi
Danish: Anbefalinger vedrørende administration sammen med Sovaldi
English: Sovaldi has moderate influence on the ability to drive and use machines.
Danish: Sovaldi påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: RBV daily dose* 15 mg/kg/day 600 mg/day 800 mg/day 1000 mg/day 1200 mg/day
Danish: RBV daglig dosis* 15 mg/kg/dag 600 mg/dag 800 mg/dag 1000 mg/dag 1200 mg/dag
English: Patient population*
Danish: Patientpopulation*
English: • Currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine);
Danish: • Får eller inden for de seneste måneder har fået lægemidlet amiodaron mod uregelmæssig hjerterytme (lægen kan overveje andre behandlinger, hvis du har taget dette lægemiddel)
English: Talk to your doctor or pharmacist before taking this medicine if you:
Danish: Kontakt lægen eller apotekspersonalet, før du tager dette lægemiddel, hvis du:
English: Outcome for patients without SVR12
Danish: Resultat for patienter uden SVR12
English: EU/1/13/894/001 28 film-coated tablets EU/1/13/894/002 84 (3 bottles of 28) film-coated tablets
Danish: EU/1/13/894/001 28 filmovertrukne tabletter EU/1/13/894/002 84 (3 tabletbeholdere med 28) filmovertrukne tabletter
English: Sovaldi [Outer packaging only]
Danish: Sovaldi [Kun på den ydre emballage]
English: The SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed sofosbuvir with velpatasvir treatment and relapsed.
Danish: SVR-raten var 95 % (56/59); ud af de tre patienter, som ikke opnåede SVR12, havde én afsluttet behandling med sofosbuvir med velpatasvir og oplevet recidiv.
English: • shortness of breath or worsening of any shortness of breath you already have
Danish: • Åndenød eller forværring af åndenød, du allerede lider af
English: * Includes patients co-infected with human immunodeficiency virus (HIV).
Danish: * Omfatter patienter med samtidig infektion med humant immundefektvirus (hiv).
English: Each film-coated tablet contains 400 mg of sofosbuvir.
Danish: Hver filmovertrukket tablet indeholder 400 mg sofosbuvir.
English: Non-Black
Danish: Ikke sort
English: If vomiting occurs more than 2 hours after dosing, no further dose is needed.
Danish: Hvis patienterne kaster op mere end 2 timer efter dosering, er der ikke behov for en yderligere dosis.
English: This patient achieved SVR12.
Danish: Denne patient opnåede SVR12.
English: All patients who achieved SVR12 achieved SVR24 and SVR48.
Danish: Alle patienter, der opnåede SVR12, opnåede SVR24 og SVR48.
English: • Sovaldi is commonly used together with ribavirin.
Danish: • Sovaldi anvendes normalt sammen med ribavirin.
English: The study was designed as a direct comparison of sofosbuvir and ribavirin versus placebo for 12 weeks.
Danish: Studiet blev designet som en direkte sammenligning af sofosbuvir og ribavirin versus placebo i 12 uger.
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Danish: Andre virkninger, der kan ses under behandling med sofosbuvir: Hyppigheden af følgende bivirkninger er ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: Metabolism and nutrition disorders: Very common decreased appetite
Danish: Metabolisme og ernæring: Meget almindelig nedsat appetit
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Sovaldi.
Danish: Nogle patienter med diabetes har oplevet lavt blodsukker (hypoglykæmi) efter påbegyndelse af behandling med lægemidler som Sovaldi.
English: Sofosbuvir was administered at a dose of 400 mg once daily.
Danish: Sofosbuvir blev administreret ved en dosis på 400 mg én gang dagligt.
English: When you take Sovaldi in combination with 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 amiodaron (et lægemiddel, der bruges mod hjerteproblemer), kan du få en eller flere af nedenstående bivirkninger:
English: The S282T substitution reverted to wild-type over the next 8 weeks and was no longer detectable by deep sequencing at 12 weeks post-treatment.
Danish: S282T-substitutionen vendte tilbage til vildtypen i løbet af de næste 8 uger, og kunne ikke længere detekteres med dybe sekvensdata 12 uger efter behandlingen.
English: In an analysis evaluating the effect of baseline polymorphisms on treatment outcome, no statistically significant association was observed between the presence of any HCV NS5B variant at baseline and treatment outcome.
Danish: I en analyse, som evaluerede virkningen af baseline polymorfismer på behandlingens resultat, blev der ikke observeret nogen statistisk signifikant forbindelse mellem tilstedeværelsen af en HCV NS5B-variant ved baseline og behandlingsresultatet.
English: The safety and efficacy of Sovaldi have not been established in patients with decompensated cirrhosis.
Danish: Sovaldis sikkerhed og virkning er ikke klarlagt hos patienter med dekompenseret cirrose.
English: • trouble sleeping (insomnia)
Danish: • søvnbesvær (søvnløshed)
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: Placebo recipients are not included in the tables since none achieved SVR12.
Danish: Patienterne, der fik placebo, er ikke inkluderet i disse tabeller, da ingen af dem opnåede SVR12.
English: Plasma HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Danish: Plasma HCV-rna-værdier blev i de kliniske studier målt ved hjælp af COBAS TaqMan HCV-test (version 2.0) til brug med 'High Pure System'.
English: This is due to liver function changes during treatment with Sovaldi.
Danish: Dette skyldes, at leverfunktionen kan ændre sig under behandling med Sovaldi.
English: Sofosbuvir is a nucleotide prodrug.
Danish: Sofosbuvir er et nukleotid prodrug.
English: ANTICONVULSANTS Phenobarbital Phenytoin
Danish: ANTIKONVULSIVA Phenobarbital Phenytoin
English: In rabbit studies exposure to sofosbuvir was 9 times the expected clinical exposure.
Danish: I studier med kaniner var eksponeringen for sofosbuvir 9 gange den forventede kliniske eksponering.
English: No specific antidote is available for overdose with Sovaldi.
Danish: Der findes ingen specifik antidot for en overdosis af Sovaldi.
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Sovaldi.
Danish: Din læge kan være nødt til nøje at overvåge de andre lægemidler, du tager, samt foretage justeringer, efter du begynder at tage Sovaldi.
English: In that study, there were no untoward effects observed at this dose level, and adverse reactions were similar in frequency and severity to those reported in the placebo and sofosbuvir 400 mg treatment groups.
Danish: I dette studie blev der ikke dokumenteret nogen uønskede virkninger ved dette dosisniveau, og bivirkningerne var sammenlignelige med hensyn til hyppighed og sværhedsgrad med dem, der blev rapporteret i behandlingsgrupperne med placebo og sofosbuvir 400 mg.
English: No effect = 1.00 b. All interaction studies conducted in healthy volunteers c. Comparison based on historical control d. Administered as Atripla e. Bioequivalence boundary 80%-125% f. Equivalence boundary 70%-143%
Danish: Ingen virkning = 1,00 b. Alle interaktionsstudier blev udført hos raske frivillige forsøgspersoner c. Sammenligning baseret på tidligere kontrol d. Administreret som Atripla e. Bioækvivalensgrænse 80 %-125 % f. Ækvivalensgrænse 70 %-143 %
English: When taking Sovaldi together with other medicines for the treatment of hepatitis C infection, patients have reported tiredness, dizziness, blurred vision and reduced attention.
Danish: Når Sovaldi tages sammen med andre lægemidler til behandling af hepatitis C-infektion, har patienterne rapporteret træthed, svimmelhed, sløret syn og koncentrationsbesvær.
English: It is unknown whether sofosbuvir and its metabolites are excreted in human milk.
Danish: Det er ukendt, om sofosbuvir og dets metabolitter udskilles i human mælk.
English: The film-coated tablet should not be chewed or crushed, due to the bitter taste of the active substance.
Danish: Den filmovertrukne tablet må ikke tygges eller knuses, da det aktive stof har en bitter smag.
English: No liver or heart findings were observed in chronic toxicity studies at exposures 9 times (rat) and 27 times (dog) higher than the clinical exposure.
Danish: Der blev ikke observeret nogen fund i lever og hjerte i kroniske toksicitetsstudier ved eksponeringer, der var 9 gange (rotter) og 27 gange (hunde) højere end den kliniske eksponering.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin (see section 4.4).
Danish: Der er blevet vist signifikante teratogene og/eller embryocidale virkninger hos alle dyrearter, der blev eksponeret for ribavirin (se pkt.
English: Special patient populations
Danish: Specielle patientpopulationer
English: Patient population* Treatment
Danish: Patientpopulation* Behandling
English: The SVR12 rate was 100% (13/13) in genotype 2 patients and 97% (36/37) in genotype 3 patients.
Danish: SVR12-raten var 100 % (13/13) i genotype 2-patienter og 97 % (36/37) i genotype 3-patienter.
English: All patients receiving Sovaldi in combination with amiodarone with or without other medicinal products 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 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: Do not stop taking this medicine unless your doctor tells you to.
Danish: Du må ikke holde op med at tage Sovaldi Du må ikke holde op med at tage dette lægemiddel, medmindre lægen fortæller dig det.
English: If you are not sure of what medicines can be taken with Sovaldi, talk to your doctor or pharmacist.
Danish: Er du i tvivl om, hvilken medicin der må tages sammen med Sovaldi, så tal med lægen eller apotekspersonalet.
English: Overview of outcomes by therapeutic regimen and treatment duration, a comparison across studies The following tables (Table 20 to Table 23) 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 20 til tabel 23) 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: If you do miss a dose:
Danish: Hvis du glemmer en dosis:
English: In these assays, the in vitro antiviral activity of sofosbuvir against the less common genotypes 4, 5 and 6 was similar to that observed for genotypes 1, 2 and 3.
Danish: I disse analyser var den antivirale aktivitet af sofosbuvir in vitro mod de mindre almindelige genotyper 4, 5 og 6 sammenlignelige med aktiviteterne, der blev observeret for genotyper 1, 2 og 3.
English: Virologic response in evaluable patientsa a. Evaluable patients are defined as those who have reached the specified time point at the time of the interim analysis.
Danish: a. Evaluerbare patienter er defineret som depatienter, som har nået det specificerede tidspunkt på tidspunktet for interimanalysen.
English: ↔ GS-331007 (TPV or BOC)
Danish: ↔ GS-331007 (TPV eller BOC)
English: On-treatment virologic failure < 1% (1/256) Relapseb
Danish: Virologisk svigt under behandling < 1 % (1/256) Recidivb
English: The extent of absorption of sofosbuvir was increased approximately 1.8-fold, with little effect on peak concentration.
Danish: Absorptionsgraden af sofosbuvir blev forhøjet ca. 1,8 gange, uden en betydelig virkning på den maksimale plasmakoncentration.
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Tørremidlet med silicagel findes i et separat brev eller en beholder, og må ikke sluges.
English: If it is after 18 hours then patients should be instructed to wait and take the next dose at the usual time.
Danish: Hvis der er gået over 18 timer, skal patienterne instrueres i at vente og tage den næste dosis til sædvanlig tid.
English: • The active substance is sofosbuvir.
Danish: • Aktivt stof: sofosbuvir.
English: A 4-hour haemodialysis session removed 18% of the administered dose.
Danish: En 4 timers hæmodialysesession fjernede 18 % af den administrerede dosis.
English: In this context, no adverse drug reactions specific to sofosbuvir have been identified.
Danish: I denne sammenhæng er der ikke identificeret bivirkninger, som er specifikke for sofosbuvir.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sovaldi 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, når andre antiarytmika ikke tolereres eller er kontraindiceret.
English: SVR12 rates were similarly high in patients 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: The highest documented dose of sofosbuvir was a single supratherapeutic dose of sofosbuvir 1,200 mg administered to 59 healthy subjects.
Danish: Den højeste dokumenterede dosis af sofosbuvir var en enkelt, supraterapeutisk dosis af sofosbuvir 1.200 mg administreret til 59 raske personer.
English: Such regimens should only be used for patients that are intolerant to or ineligible for interferon therapy, and are in urgent need of treatment.
Danish: Sådanne behandlingsprogrammer må kun anvendes til patienter, der er intolerante over for eller uegnede til behandling med interferon, og med et akut behandlingsbehov.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Sovaldi, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Danish: For at vurdere recidiv af hepatocellulært karcinom associeret med Sovaldi skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne fra et prospektivt sikkerhedsstudie baseret på en vedtagen protokol med brug af data fra en kohorte af en veldefineret gruppe patienter.
English: The film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with “GSI” and “7977” on the other side.
Danish: De filmovertrukne tabletter er gule, kapselformede tabletter, præget på den ene side med ”GSI” og med ”7977” på den anden side.
English: No human data on the effect of Sovaldi on fertility are available.
Danish: Der foreligger ingen data fra mennesker om Sovaldis indvirkning på fertiliteten.
English: The SVR12 rate in the sofosbuvir + ribavirin treatment group was statistically significant when compared to placebo (p <0.001).
Danish: SVR12-raten i behandlingsgruppen med sofosbuvir + ribavirin var statistisk signifikant, sammenlignet med placebo (p < 0,001).