FrancophonIA/ELRC3.0 huggingface dataset:
English: Patient population (including HIV co-infected patients)
Danish: Patientpopulation (herunder patienter med samtidig hiv-infektion)
English: The combination should be used with caution with frequent renal monitoring, if other alternatives are not available (see section 4.4).
Danish: Kombinationen skal anvendes med forsigtighed med hyppig nyreovervågning, hvis andre alternativer ikke er tilgængelige (se pkt.
English: Swallow the tablet whole with or without food.
Danish: Slug tabletten hel sammen med eller uden mad.
English: If you take Harvoni you may get one or more of the side effects below:
Danish: Hvis du tager Harvoni, kan du få en eller flere af de nedenstående bivirkninger:
English: 7% of liver transplant recipients had a modification of their immunosuppressive agents.
Danish: 7 % af de levertransplantaterede patienter fik modificeret deres immunsupprimerende lægemidler.
English: • The other ingredients are
Danish: • Øvrige indholdsstoffer:
English: In genotype 4, 5 and 6 infection, only small numbers of patients have been evaluated (total of 5 patients with failure).
Danish: Hos genotype 4-, 5- og 6-inficerede patienter er kun et lille antal blevet evalueret (i alt 5 patienter med svigt).
English: Study 0122 (ELECTRON-2) 6 25 0% (0/25)
Danish: Studie 0122 (ELECTRON-2) 6 25 0 % (0/25)
English: Harvoni can be administered without regard to food.
Danish: Harvoni kan administreres uden hensynstagen til mad.
English: Patients who are identified as being high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Danish: Patienter med kendt høj risiko for bradyarytmi bør overvåges kontinuerligt i 48 timer i passende kliniske omgivelser.
English: Of the 155 patients enrolled, 1 patient discontinued treatment whilst on placebo.
Danish: Ud af de 155 patienter, der indgik, seponerede 1 patient behandlingen, mens patienten fik placebo.
English: Patients should be instructed to swallow the tablet whole with or without food.
Danish: Patienterne skal instrueres i at sluge tabletten hel sammen med eller uden mad.
English: Interaction not studied.
Danish: Interaktion ikke undersøgt.
English: Your liver function may change with treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.).
Danish: Din leverfunktion kan ændre sig med behandlingen af hepatitis C og kan derfor påvirke andre lægemidler (f.eks. lægemidler, der anvendes til at hæmme dit immunsystem osv.).
English: These should be taken at least 4 hours before or 4 hours after Harvoni;
Danish: Disse bør tages mindst 4 timer før eller 4 timer efter Harvoni.
English: The marketing authorisation holder shall submit the first PSURs for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for 6 måneder efter godkendelsen.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Danish: Der er blevet vist signifikante teratogene og/eller embryocidale virkninger hos alle dyrearter, der blev eksponeret for ribavirin.
English: Subsequently, the marketing authorisation holder (MAH) shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal derefter fremsende PSUR i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Treatment of overdose with Harvoni 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 Harvoni består af generel støttebehandling, herunder overvågning af vitale tegn og observation af patientens kliniske status.
English: These data suggest that biliary excretion of unchanged ledipasvir is a major route of elimination with renal excretion being a minor pathway (approximately 1%).
Danish: Disse data tyder på, at galdeudskillelsen af uændret ledipasvir er en primær eliminationsvej, og nyreudskillelse er en mindre vej (ca. 1 %).
English: Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed (see section 5.2).
Danish: Grundet den bitre smag anbefales det, at den filmovertrukne tablet ikke tygges eller knuses (se pkt.
English: If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice.
Danish: Hvis du utilsigtet har taget mere end den anbefalede dosis, skal du straks kontakte lægen eller den nærmeste skadestue for rådgivning.
English: Clinical studies of ledipasvir/sofosbuvir included 235 patients (8.6% of total number of patients) aged 65 years and over.
Danish: Kliniske studier af ledipasvir/sofosbuvir omfattede 235 patienter (8,6 % af det totale antal patienter) i alderen 65 år og derover.
English: Limited data indicate that such NS5A mutations do not revert on long-term follow-up.
Danish: Begrænsede data indikerer, at sådanne NS5A-mutationer ikke reverterer ved langvarig opfølgning.
English: Body weight kg
Danish: Legemsvægt kg
English: In vitro potential for ledipasvir/sofosbuvir to affect other medicinal products
Danish: Ledipasvir/sofosbuvirs potentiale in vitro for at påvirke andre lægemidler
English: Medicinal product by therapeutic areas
Danish: Lægemiddel i henhold til terapeutiske områder
English: Each bottle contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets.
Danish: Hver tabletbeholder indeholder et tørremiddel af silicagel, der skal opbevares i flasken for at hjælpe med at beskytte dine tabletter.
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Danish: HBV/HCV co-inficerede patienter har risiko for reaktivering af HBV og bør derfor monitoreres og behandles i henhold til gældende kliniske vejledninger.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of ledipasvir, sofosbuvir or Harvoni in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gennemførte graviditeter) fra anvendelse af ledipasvir, sofosbuvir eller Harvoni til gravide kvinder.
English: • statins used to treat high cholesterol;
Danish: • statiner, anvendes til at behandle højt kolesterol;
English: The effects of Harvoni during pregnancy are not known.
Danish: Virkningen af Harvoni under graviditet er ukendt.
English: Talk to your doctor or pharmacist before taking Harvoni if:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Harvoni, hvis:
English: Harvoni for 12 weeks.
Danish: Harvoni i 12 uger.
English: ↔ indicates no clinically relevant change in the exposure of Ledipasvir.
Danish: ↔ angiver ingen klinisk relevant ændring i eksponering for ledipasvir.
English: • you 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: • du 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: A total of 2 out of 100 patients (2%), both treatment- naïve, did not achieve SVR12 (due to loss to follow-up).
Danish: I alt 2 ud af 100 patienter (2 %), begge behandlingsnaive, opnåede ikke SVR12 (på grund af tab af opfølgning).
English: (may affect up to 1 in 10 people) • rash
Danish: (kan forekomme hos op til 1 ud af 10 personer) • udslæt
English: Treatment with Harvoni should be guided by an assessment of the potential benefits and risks for the individual patient.
Danish: Behandling med Harvoni skal foregå på baggrund af en vurdering af de mulige fordele og risici for den enkelte patient.
English: As Harvoni contains ledipasvir and sofosbuvir, any interactions that have been identified with these active substances individually may occur with Harvoni.
Danish: Da Harvoni indeholder ledipasvir og sofosbuvir kan alle interaktioner, der er blevet identificeret med disse aktive stoffer individuelt, forekomme med Harvoni.
English: Protein binding of GS-331007 was minimal in human plasma.
Danish: Proteinbinding af GS-331007 var minimal i humant plasma.
English: Warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Danish: Warfarin og lignende lægemidler, såkaldte vitamin K-antagonister, der anvendes til fortynding af blodet.
English: (Induction of P-gp)
Danish: (Induktion af P-gp)
English: Hepatitis C is a virus that infects the liver.
Danish: Hepatitis C er en virusinfektion i leveren.
English: H2-receptor antagonists may be administered simultaneously with or staggered from Harvoni at a dose that does not exceed doses comparable to famotidine 40 mg twice daily.
Danish: H2-receptorantagonister kan administreres sammen med eller adskilt fra Harvoni ved en dosis, der ikke overskrider doser, der er sammenlignelige med famotidin 40 mg to gange dagligt.
English: Patients were enrolled in one of the seven groups based on liver transplantation status and severity of hepatic impairment (see Table 17).
Danish: Patienterne indgik i en ud af de syv grupper baseret på levertransplantationsstatus og sværhedsgraden af nedsat leverfunktion (se tabel 17).
English: Other effects that may be seen during treatment with sofosbuvir:
Danish: Andre virkninger, der kan ses under behandling med sofosbuvir:
English: Clinical and biochemical control is recommended in these patients and a dose adjustment may be needed (see section 4.4).
Danish: Klinisk og biokemisk kontrol anbefales til disse patienter, og en dosisjustering kan være nødvendig (se pkt.
English: As liver function may change during treatment with Harvoni, a close monitoring of International Normalised Ratio (INR) values is recommended.
Danish: Da leverfunktionen kan ændre sig under behandling med Harvoni, anbefales tæt monitorering af INR (international normaliseret ratio).
English: Body weight did not have a significant effect on sofosbuvir exposure according to a population pharmacokinetic analysis.
Danish: Legemsvægt havde ikke en signifikant virkning på eksponeringen over for sofosbuvir i henhold til en populationsfarmakokinetisk analyse.
English: ESRD Requiring Dialysis
Danish: ESRD, der krævede dialyse
English: Harvoni is sometimes taken with another medicine, ribavirin.
Danish: Harvoni tages nogle gange med et andet lægemiddel, ribavirin.
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP51
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale midler, ATC-kode: J05AP51
English: • Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers, heartburn or acid reflux.
Danish: • Få rådgivning fra en læge eller apotekspersonalet, hvis du tager lægemidler, der anvendes til at behandle mavesår, halsbrand eller sure opstød.
English: At the time of the interim analysis 40 patients have reached 12 weeks post treatment and SVR12 was 98% (39/40).
Danish: På tidspunktet for interimanalysen var 40 patienter nået til 12 uger efter behandlingen, og SVR12 var 98 % (39/40).
English: Harvoni treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Danish: Behandling med Harvoni bør påbegyndes og overvåges af en læge med erfaring i behandling af patienter med CHC.
English: • If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: • Hvis du er allergisk over for ledipasvir, sofosbuvir eller et af de øvrige indholdsstoffer i Harvoni (angivet i punkt 6 i denne indlægsseddel).
English: A coagulation test helps to identify patients with an increased bleeding risk due to increased dabigatran exposure.
Danish: En koagulationstest hjælper med at identificere patienter med en øget blødningsrisiko, der skyldes øget eksponering over for dabigatran.
English: • dabigatran used to thin the blood;
Danish: • dabigatran, anvendes til at fortynde blodet;
English: Harvoni (without ribavirin) for 24 weeks.
Danish: Harvoni (uden ribavirin) i 24 uger.
English: Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 µg/mL to 20 µg/mL.
Danish: Sofosbuvir er ca. 61-65 % bundet til humane plasmaproteiner, og bindingen er uafhængig af lægemiddelkoncentrationen i intervallet fra 1 μg/ml til 20 μg/ml.
English: CPT A = CPT score 5-6 (compensated), CPT B = CPT score 7-9 (decompensated), CPT C = CPT score 10-12 (decompensated).
Danish: CPT A = CPT-score 5-6 (kompenseret), CPT B = CPT-score 7-9 (dekompenseret), CPT C = CPT-score 10-12 (dekompenseret).
English: The most common variants were Q30R, Y93H and L31M.
Danish: De mest almindelige varianter var Q30R, Y93H og L31M.
English: Table 4 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration and cardiac status.
Danish: Tabel 4 giver retningslinjer for dosismodifikationer og seponering baseret på patientens hæmoglobinkoncentration og kardielle status.
English: EU/1/14/958/001 28 film-coated tablets EU/1/14/958/002 84 (3 bottles of 28) film-coated tablets
Danish: EU/1/14/958/001 28 filmovertrukne tabletter EU/1/14/958/002 84 (3 tabletbeholdere med 28) filmovertrukne tabletter
English: These should be taken at the same time as Harvoni.
Danish: Disse bør tages på samme tidspunkt som Harvoni.
English: * Ribavirin administered orally in two divided doses with food.
Danish: * Ribavirin administreret oralt fordelt på 2 doser sammen med mad.
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 studie på at genstarte ribavirin med 600 mg dagligt, og yderligere øge dosis til 800 mg dagligt.
English: Taking Harvoni with any of these may stop your medicines from working properly, or make any side effects worse.
Danish: Hvis du tager Harvoni sammen med nogle af disse lægemidler, kan det forhindre, at dine lægemidler virker korrekt, eller det kan gøre bivirkninger værre.
English: Lansoprazolee Rabeprazolee Pantoprazolee Esomeprazolee
Danish: Lansoprazole Rabeprazole Pantoprazole Esomeprazole
English: • Tell your doctor or pharmacist if you are taking any of the medicines below:
Danish: • Fortæl altid lægen eller apotekspersonalet, hvis du tager nogle af lægemidlerne nedenfor:
English: It is recommended to separate antacid and Harvoni administration by 4 hours.
Danish: Det anbefales, at administration af antacida og Harvoni finder sted med 4 timers mellemrum.
English: Pregnancy must be avoided if Harvoni is taken together with ribavirin.
Danish: En graviditet skal undgås, hvis Harvoni tages sammen med ribavirin.
English: • If you or your partner become pregnant during Harvoni and ribavirin treatment or in the months that follow, you must contact your doctor immediately.
Danish: • Hvis du eller din partner bliver gravide under behandling med Harvoni og ribavirin, eller i de efterfølgende måneder, skal du straks kontakte lægen.
English: If the starting dose is not well tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels
Danish: Hvis startdosis ikke er veltolereret, bør dosis reduceres efter klinisk indikation baseret på hæmoglobinniveauer.
English: • kidney problems or if you are on kidney dialysis, since Harvoni has not been fully tested in patients with severe kidney problems;
Danish: • nyreproblemer eller hvis du er i dialyse, da Harvoni ikke er helt undersøgt hos patienter med svære nyreproblemer;
English: Tipranavir boosted with ritonavir
Danish: Tipranavir boostet med ritonavir
English: Harvoni (administered alone or in combination with ribavirin) has no or negligible influence on the ability to drive and use machines.
Danish: Harvoni (administreret alene eller i kombination med ribavirin) påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Fifty-five percent (55%) of the patients were treatment-experienced.
Danish: 55 % af patienterne var behandlingserfarne.
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir.
Danish: Samtidig anvendelse af amiodaron var begrænset gennem den kliniske udvikling af sofosbuvir.
English: Due to the limited size of studies, the impact of baseline NS5A RAVs on treatment outcome for patients with genotype 2, 3, 4, 5 or 6 CHC has not been fully evaluated.
Danish: Som følge af studiernes begrænsede omfang er indvirkningen af baseline-NS5A-RAVs på behandlingsresultaterne hos patienter med genotype 2-, 3-, 4-, 5- eller 6-CHC ikke blevet evalueret fuldt ud.
English: This includes:
Danish: Dette omfatter:
English: The use of Harvoni in children has not yet been studied.
Danish: Anvendelsen af Harvoni hos børn er endnu ikke undersøgt.
English: Unchanged ledipasvir is also the major species present in faeces.
Danish: Uændret ledipasvir er også den primære form, der er til stede i fæces.
English: Famotidine dosed 12 hours prior to Harvonid
Danish: Famotidin doseret 12 timer før Harvonid
English: ≥ 2 g/dL decrease in haemoglobin during any 4-week treatment period
Danish: ≥2 g/dl reduktion i hæmoglobin i løbet af en periode med 4 ugers behandling
English: Posology The recommended dose of Harvoni is one tablet once daily with or without food (see section 5.2).
Danish: Den anbefalede dosis af Harvoni er en tablet én gang dagligt sammen med eller uden mad (se pkt.
English: c Administered as Harvoni.
Danish: c. Administreret som Harvoni.
English: Observed:
Danish: Observeret:
English: Treatment-naïve adults without cirrhosis - ION-3 (study 0108) - Genotype 1
Danish: Behandlingsnaive voksne uden cirrose - ION-3 (studie 0108) - genotype 1
English: Sofosbuvir was absorbed quickly and the median peak plasma concentrations were observed ~ 1 hour post-dose.
Danish: Sofosbuvir blev absorberet hurtigt, og de mediane maksimale plasmakoncentrationer blev observeret ~ 1 time efter dosering.
English: Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir in a single tablet.
Danish: Harvoni er et lægemiddel, der indeholder de aktive stoffer, ledipasvir og sofosbuvir i en enkel tablet.
English: d 3/3 of these patients had cirrhosis.
Danish: d. 3/3 af disse patienter havde cirrose.
English: • H2-receptor antagonists (such as famotidine, cimetidine, nizatidine or ranitidine).
Danish: • H2-receptorantagonister (såsom famotidin, cimetidin, nizatidin eller ranitidin).
English: The improvement in MELD scores observed was driven largely by improvements in total bilirubin.
Danish: Forbedringen i de observerede MELD-scores skyldtes i høj grad forbedringer i total-bilirubin.
English: - a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Danish: Et udbredt, alvorligt udslæt, hvor huden skaller af, og som kan være ledsaget af feber, influenzalignende symptomer, blærer i munden, øjnene og/eller på kønsorganerne (Stevens-Johnson syndrom).
English: It is unknown whether ledipasvir or sofosbuvir and its metabolites are excreted in human milk.
Danish: Det er ukendt, om ledipasvir eller sofosbuvir og dets metabolitter udskilles i human mælk.
English: In vitro, no detectable metabolism of ledipasvir was observed by human CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Danish: In vitro blev der ikke observeret nogen detekterbar metabolisme af ledipasvir via humant CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4.
English: These will be considered before treatment with Harvoni is started.
Danish: Disse vil blive overvejet, før behandling med Harvoni startes:
English: Treatment of patients with prior exposure to HCV direct-acting antivirals
Danish: Behandling af patienter med tidligere eksponering over for HCV direkte virkende antivirale midler
English: Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir.
Danish: Harvoni må ikke administreres sammen med andre lægemidler, der indeholder sofosbuvir.
English: No dose adjustment of oral contraceptives is required.
Danish: Ingen dosisjustering af orale antikontraceptiva er nødvendig.
English: If a dose is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time.
Danish: Hvis en dosis glemmes, og det er inden for 18 timer fra det normale tidspunkt, skal patienterne instrueres i at tage tabletten så snart som muligt, og patienterne skal så tage den næste dosis på den sædvanlige tid.
English: All three Phase 3 studies evaluated the efficacy of ledipasvir/sofosbuvir with or without ribavirin.
Danish: Alle tre fase 3-studier evaluerede virkningen af ledipasvir/sofosbuvir med eller uden ribavirin.
English: This data indicate that renal clearance is the major elimination pathway for GS-331007 with a large part actively secreted.
Danish: Disse data indikerer, at nyreclearance er den største eliminationsvej for GS-331007, hvor en stor del sekreteres aktivt.
English: Interactions cannot be excluded with other HMG-CoA reductase inhibitors.
Danish: Interaktioner med andre HMG-CoA reductasehæmmere kan ikke udelukkes.
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of ledipasvir by 12-fold against genotype 1a HCV replicons.
Danish: Tilstedeværelsen af 40 % humant serum havde ingen virkning på sofosbuvirs anti-HCV-aktivitet, men reducerede anti-HCV-aktiviteten af ledipasvir 12 gange mod genotype 1a HCV-replikoner.
English: Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Danish: Din læge kan være nødt til hyppigere at kontrollere, hvor godt dit blod størkner.
English: The assay had a lower limit of quantification (LLOQ) of 25 IU/mL.
Danish: Analysen havde et nedre kvantificeringsniveau (lower limit of quantification, LLOQ) på 25 IE/ml.
English: Harvoni is not recommended for use in paediatric patients aged < 12 years because the safety and efficacy have not been established in this population.
Danish: Harvoni bør ikke anvendes til pædiatriske patienter i alderen <12 år, da sikkerhed og virkning ikke er klarlagt for denne population.
English: The improvement in CPT scores observed was driven largely by improvements in total bilirubin and albumin.
Danish: Forbedringen i CPT-scores skyldtes i høj grad forbedringer i total-bilirubin og albumin.
English: The median terminal half-life of ledipasvir in healthy volunteers following administration of ledipasvir/sofosbuvir in the fasted state was 47 hours.
Danish: Den mediane terminale halveringstid for ledipasvir hos raske frivillige efter administration af ledipasvir/sofosbuvir i den fastende tilstand var 47 timer.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Harvoni.
Danish: Nogle patienter med diabetes har oplevet lavt blodsukker (hypoglykæmi) efter påbegyndelse af behandling med lægemidler som Harvoni.
English: Haemodialysis is unlikely to result in significant removal of ledipasvir as ledipasvir is highly bound to plasma protein.
Danish: Det er ikke sandsynligt, at hæmodialyse fører til, at ledipasvir fjernes i signifikant grad, da ledipasvir i høj grad er bundet til plasmaprotein.
English: Ledipasvir activity (EC50, nM)
Danish: Ledipasvir-aktivitet (EC50, nM)