FrancophonIA/ELRC3.0 huggingface dataset:
English: - eye problems including damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton wool spots (white deposits on the retina), - enlarged abdominal area, heartburn, trouble having bowel movement or painful bowel movement, - acute hypersensitivity reactions including urticaria (hives), bruises, intense pain in a limb, leg or thigh pain, loss of range of motion, stiffness, sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands).
Danish: sammentrækning af bronkierne og anafylaksi (en alvorlig allergisk reaktion, der rammer hele kroppen), vedvarende hoste, øjenproblemer herunder beskadigelse af nethinden, obstruktion af arterier i nethinden, inflammation af den optiske nerve, hævelse af øjet og nethinde-ekksudater (hvid aflejring på nethinden), forstørret mave, halsbrand, problemer med tarmbevægelser eller smertefulde tarmbevægelser, akutte overfølsomhedsreaktioner herunder urticaria (nældefeber), blå mærker, intens smerte i arme og/eller ben, smerter i ben eller lår, indskrænket bevægelsesområde, stivhed, sarcoidosis (en sygdom karakteriseret ved vedvarende feber, vægttab, ømme og hævede led, hudlæsion og hævede kirtler).
English: Hepatomegaly, jaundice, hyperbilirubinemia* Hepatotoxicity (including fatalities)* Skin and subcutaneous tissue disorders Alopecia, pruritus, skin dry, rash Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, night sweats, hyperhidrosis, dermatitis, acne, furuncule, erythema, urticaria, skin disorder, bruise, sweating increased, abnormal
Danish: Alopeci, pruritus, tør hud, udslæt Psoriasis, forværret psoriasis, eksem, lysoverfølsomhedsreaktion, maculopapuløst udslæt, erythematøst udslæt, nattesved, hyperhidrosis, dermatitis, akne, furunkel, erythem, urticaria, hudlidelse, blå mærker, øget svedtendens, unormal hårstruktur,
English: B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF
English: Therefore,.
Danish: Bemærk:
English: Uric acid may increase with ribavirin due to haemolysis; therefore, the potential for development of gout must be carefully monitored in pre-disposed patients.
Danish: Derfor skal muligheden for udvikling af urinsyregigt følges nøje hos prædisponerede patienter.
English: Arthritis, back pain, muscle spasms, pain in extremity
Danish: Arthritis, rygsmerter, muskelspasmer, ekstremitetssmerter
English: 6.6 Special precautions for disposal No special requirements.
Danish: 6.4 Særlige opbevaringsforhold Må ikke opbevares ved temperaturer over 25 °C.
English: Pruritus, photosensitivity reaction, maculopapular rash, eczema, hyperhidrosis, acne, skin disorder, nail disorder, skin discolouration, dry skin, erythema, bruise Pigmentation disorder, dermatitis atopic, skin exfoliation Musculoskeletal and connective tissue disorders Arthralgia, myalgia, musculoskeletal pain Pain in extremity, back pain, muscle contracture
Danish: Pruritus, lysoverfølsomhedsreaktion, maculopapuløst udslæt, eksem, hyperhidrosis, akne, hudlidelse, neglelidelse, hudmisfarvning, pruritus, tør hud, erythem, blå mærker
English: Sustained virological response in previously untreated children and adolescents Ribavirin 15 mg/kg/day interferon alfa-2b 3 MIU/m2 3 times a week a. Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during
Danish: Tabel 8 Vedvarende virologisk respons: Tidligere ubehandlede børn og unge Ribavirin 15 mg/kg/dag interferon alfa-2b 3 MIE/m2 3 gange om ugen
English: - decreases in the number of red blood cells (that may cause fatigue, shortness of breath, dizziness), decrease in neutrophils (that make you more susceptible to different infections), - decrease in thyroid gland activity (which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms), - feeling depressed or irritable, feeling sick to stomach, feeling unwell, mood swings, tired feeling, trouble falling asleep or staying asleep, virus infection, weakness, - diarrhoea, dizziness, fever, flu-like symptoms, headache, loss of or increase in appetite, loss of weight, decrease in the rate of growth (height and weight), pain on right side of ribs, pharyngitis (sore throat), shaking chills, stomach pain, vomiting, - dry skin, hair loss, irritation, pain or redness at the site of injection, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Danish: Meget almindelige rapporterede bivirkninger: fald i antallet af røde blodlegemer (som kan medføre træthed, åndenød, svimmelhed), fald i neutrofiler (der gør dig mere modtagelig for forskellige infektioner), koncentrationsbesvær, følelse af angst eller nervøsitet, humørsvingninger, følelse af nedtrykthed eller irritabilitet, følelse af søvnighed, besvær med at falde i søvn eller sove hoste, mundtørhed, pharyngitis (ondt i halsen), diarré, svimmelhed, feber, influenzalignende symptomer, hovedpine, kvalme, kulderystelser,
English: Cardiac disorders Common:
Danish: Det endokrine system Meget almindelig:
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
English: Epistaxis, respiratory disorder, respiratory tract congestion, sinus congestion, nasal congestion, rhinorrhea, increased upper airway secretion, pharyngolaryngeal pain,
Danish: Næseblod, vejrtrækningsproblemer, tilstoppede luftveje, tilstoppede bihuler, næsetæthed, næseflåd, øget sekretion i øvre luftveje, faryngolaryngeal smerter, tør
English: 6.5 Nature and contents of container
Danish: 6.3 Opbevaringstid
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare
Danish: Depression, søvnløshed, angst, emotionel labilitet,
English: Study 22
Danish: 7 d
English: Reminder: Please read the “Taking other medicines” section of the Package Leaflet for interferon alfa-2b before you begin combination treatment.
Danish: Læs afsnittet ”Brug af anden medicin” i Indlægssedlen for interferon alfa-2b, for du
English: Interferon medicine that is used in combination with Ribavirin BioPartners may cause unusual tiredness; if you are injecting this medicine yourself or giving it to a child, use it at bedtime.
Danish: Interferon-medicin, der bliver brugt i kombination med Ribavirin BioPartners, kan forårsage usædvanlig træthed.
English: Respiratory, thoracic and mediastinal disorders Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhoea, sneezing, pharyngolaryngeal
Danish: Dyspnø, tachypnoea, næseblod, hoste, næsetæthed, næseirritation, næseflåd, nysen, pharyngealis smerte Hiven efter vejret, nasal ubehag
English: Conjunctival haemorrhage, eye pruritus, keratitis, vision
Danish: Colitis ulcerosa٭ Rodbetændelse, tandlidelse
English: Skin and subcutaneous tissue disorders
Danish: cyster og polypper) Uspecificerede svulster
English: Patients treated with ribavirin and zidovudine are at increased risk of developing anaemia; therefore, the concomitant use of ribavirin with zidovudine is not recommended (see section 4.5).
Danish: Patienter, der er blevet behandlet med ribavirin og zidovudin, har en øget risiko for at udvikle anæmi.
English: Concentrate: 1.5ml Solvent: 4.5 ml
Danish: Koncentrat: 1,5ml Solvens: 4,5 ml
English: EU/1/11/676/001Jevtana 60 mg Concentrate and solvent for solution for infusion
Danish: EU/1/11/676/001 Jevtana
English: (Invented) name
Danish: EU nummer Særnavn
English: Intravenous use Concentrate: vial (glass) Solvent: vial (glass)
Danish: Solvens: Hætteglas (glas)
English: Packaging
Danish: Intravenøs anvendelse
English: • you have diabetes.
Danish: • du har diabetes.
English: d. These are medicinal products within class where similar interactions could be predicted.
Danish: d. Dette er lægemidler inden for en klasse, hvor lignende interaktioner kunne forventes.
English: Date of first authorisation: 26 July 2017
Danish: Dato for første markedsføringstilladelse: 26 juli 2017
English: Total (all
Danish: I alt (alle
English: No effect = 1.00. b. All interaction studies conducted in healthy volunteers.
Danish: Ingen virkning = 1,00. b. Alle interaktionsstudier blev udført hos raske frivillige.
English: • Your doctor can decide if you should take Vosevi and for how long;
Danish: • Din læge kan beslutte, om du skal tage Vosevi og hvor længe
English: The final study report shall be submitted by:
Danish: Den endelige undersøgelsesrapport skal indsendes senest i:
English: The following pack size is available:
Danish: Følgende pakningsstørrelse er tilgængelig:
English: The overall SVR12 rate was 100% (31/31).
Danish: Den samlede SVR12 rate var 100 % (31/31).
English: • decreased appetite
Danish: • mindsket appetit
English: Your doctor will test your blood before, during and after your treatment with Vosevi.
Danish: Din læge vil undersøge dit blod før, under og efter din behandling med Vosevi.
English: STIMULANTS Modafinil
Danish: STIMULANSER Modafinil
English: The adverse reactions are listed below by system organ class and frequency.
Danish: Bivirkningerne er angivet nedenfor efter system-organklasse og hyppighed.
English: Contact your doctor or nearest emergency department immediately for advice.
Danish: Kontakt straks lægen eller den nærmeste skadestue for rådgivning.
English: If this applies to you, do not take Vosevi and tell your doctor immediately.
Danish:  Hvis dette gælder for dig, må du ikke tage Vosevi, og du skal straks fortælle det til lægen.
English: Use with certain HIV antiretroviral regimens
Danish: Anvendelse sammen med visse hiv-antiretrovirale regimer
English: • Your doctor can confirm that your treatment has worked and you are free of the hepatitis C virus.
Danish: • Din læge kan bekræfte, at behandlingen har virket, og at du ikke længere har hepatitis C-virus.
English: e. Bioequivalence/Equivalence boundary 80-125%.
Danish: e. Bioækvivalens/ækvivalensgrænse 80-125 %.
English: The median time to re-treatment was 414 days (range 1981271).
Danish: Gennemsnitstiden til genbehandling var 414 dage (interval 198-1271).
English: Observed: atorvastatin
Danish: Observeret: atorvastatin
English: These medicines can decrease the amount of Vosevi in your blood.
Danish: Disse lægemidler kan nedsætte mængden af Vosevi i blodet.
English: The SVR12 was 98% among those with two or fewer factors and 81% among those with three or four factors.
Danish: SVR12 var 98 % blandt dem med to eller færre faktorer og 81 % blandt dem med tre eller fire faktorer.
English: If you do miss a dose, work out how long it is since you last took your Vosevi:
Danish: Hvis du glemmer en dosis, skal du regne ud, hvor lang tid der er gået, siden du sidst tog Vosevi:
English: Vosevi should not be used if you have moderate or severe liver problems.
Danish: Vosevi bør ikke anvendes, hvis du har moderate eller alvorlige leverproblemer.
English: Recommended dose The recommended dose is one tablet once a day for 8 or 12 weeks.
Danish: Anbefalet dosis Den anbefalede dosis er én tablet én gang om dagen i 8 eller 12 uger.
English: f. Data obtained from transiently transfected replicons.
Danish: f. Data indhentet fra transiente, transficerede replikoner .
English: • abnormality in a laboratory test of liver function (total bilirubin)
Danish: • unormalitet i laboratorieundersøgelser af leverfunktion (total bilirubin)
English: The active substances in this medicine work together by blocking three different proteins that the hepatitis C virus needs to grow and reproduce itself, causing the infection to be eliminated from the body.
Danish: De aktive stoffer i dette lægemiddel arbejder sammen ved at blokere tre forskellige proteiner, som hepatitis C-virusset skal bruge til at vokse og formere sig, og forårsager derved at infektionen udryddes i kroppen.
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); or uncommon (≥ 1/1000 to < 1/100).
Danish: Hyppighed defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100til < 1/10), eller ikke almindelig (≥ 1/1000 til
English: This may make Vosevi work less well.
Danish: Dette kan få Vosevi til at virke mindre effektivt.
English: Alternative methods of contraception (e.g. progestin only contraception or non-hormonal methods) should be considered.
Danish: Andre former for antikonception (f.eks. kun progestin eller metoder uden hormoner) bør overvejes.
English: • if you have had a liver transplant.
Danish: • hvis du har gennemgået en levertransplantation
English: Vitamin K antagonists (Liver function changes during treatment with Vosevi).
Danish: Vitamin K-antagonister (ændringer i leverfunktion under behandling med Vosevi).
English: Swallow the tablet whole with food.
Danish: Slug tabletten hel med mad.
English: No patients in the placebo group achieved SVR4.
Danish: Ingen patienter i placebogruppen opnåede SVR4.
English: Study arms and duration (Number of patients treated)
Danish: Studiearme og -varighed (antal patienter behandlet)
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 at tage hyppigere blodprøver for at kontrollere, hvor godt dit blod størkner.
English: Treatment of overdose with Vosevi 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 Vosevi-overdosis består af generelt understøttende behandling, herunder overvågning af vitale tegn og observation af patientens kliniske status.
English: As liver function may change during treatment with Vosevi, close monitoring of International Normalised Ratio (INR) values is recommended.
Danish: Da leverfunktionen kan ændre sig under behandling med Vosevi, anbefales tæt monitorering af INR (international normaliseret ratio).
English: Table 8: Studies conducted with Vosevi
Danish: Tabel 8: Studier udført med Vosevi
English: Efavirenz/emtricitabine/
Danish: Efavirenz/emtricitabin/
English: For both velpatasvir and voxilaprevir, combinations of RAVs often showed greater reductions in susceptibility than individual RAVs alone.
Danish: For både velpatasvir og voxilaprevir gav kombinationer af RAV'er ofte større reduktioner i følsomhed end individuelle RAV'er alene.
English: Vosevi contains lactose • Tell your doctor if you are lactose intolerant or intolerant to other sugars.
Danish: Vosevi indeholder laktose • Fortæl lægen, hvis du er intolerant over for laktose eller ikke tåler andre sukkerarter.
English: Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with DAAs.
Danish: Der er blevet rapporteret tilfælde af HBV-reaktivering, hvoraf nogle var dødelige, under og efter behandling med DAA'er.
English: Medicinal products that are sensitive substrates of these transporters and for which elevated plasma levels are associated with serious events are contraindicated (see Table 2).
Danish: Lægemidler, som er følsommer substrater af disse transportere og for hvilke forhøjede plasmaniveauer er forbundet med alvorlige hændelser er kontraindiceret (se tabel 2).
English: Observed: Raltegravir
Danish: Observeret: Raltegravir
English: Co-administration of Vosevi with medicinal products that are substrates of these transporters may increase the exposure of such medicinal products.
Danish: Samtidig administration af Vosevi og lægemidler, der er substrater for disse transportører, kan øge eksponeringen for sådanne lægemidler.
English: Patients should be instructed not to take a double dose of Vosevi.
Danish: Patienterne skal informeres om ikke at tage en dobbelt dosis Vosevi.
English: a. Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Danish: a. Middelratio (90 % CI) af farmakokinetikken af samtidigt administreret forsøgsmedicin alene eller i kombination.
English: Voxilaprevir is approximately > 99% bound to human plasma proteins.
Danish: Voxilaprevir er ca. > 99 % bundet til humane plasmaproteiner.
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 under behandling for hepatitis C, og kan derfor påvirke anden medicin (f.eks. medicin brugt til at undertrykke dit immunsystem osv.).
English: Clinical studies of Vosevi included 189 patients aged 65 and over (17% of total number of patients in the Phase 2 and 3 clinical studies).
Danish: Kliniske studier med Vosevi inkluderede 189 patienter i alderen 65 år og derover (17 % af det samlede antal patienter i kliniske fase II og III- studier).
English: Cross resistance in cell culture
Danish: Krydsresistens i cellekultur
English: These are shown in Table 7.
Danish: Disse er vist i tabel 7.
English: Polyvinyl alcohol Talc
Danish: Polyvinylalkohol Talcum
English: NA: Not available
Danish: IT = Ikke tilgængelig
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP56
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale midler, ATC-kode: J05AP56
English: Tell your doctor if you have kidney problems or if you are on kidney dialysis, since Vosevi has not been fully tested in patients with severe kidney problems.
Danish: Fortæl lægen, hvis du har nyreproblemer, eller hvis du får dialyse, da Vosevi ikke er blevet fuldt undersøgt hos patienter med svære nyreproblemer.
English: • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Danish: • hvis du har eller tidligere har haft en infektion med hepatitis B-virussen, da din læge kan ønske at overvåge dig nøjere
English: Following oral administration of Vosevi, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 2 hours post-dose.
Danish: Efter oral administration af Vosevi blev sofosbuvir absorberet hurtigt, og median maksimal plasmakoncentration blev observeret 2 timer efter dosering.
English: Should direct Xa inhibitor use be deemed necessary, apixaban or rivaroxaban may be considered.
Danish: Skulle direkte anvendelse af Xahæmmer skønnes nødvendig, bør apixaban eller rivaroxaban overvejes.
English: • are taking treatment for human immunodeficiency virus (HIV) infection, since your doctor may want to monitor you more closely.
Danish: • er i behandling for hiv-infektion, da din læge kan ønske at overvåge dig nøjere.
English: Some medicines must not be taken with Vosevi.
Danish: Nogle lægemidler må ikke tages sammen med Vosevi.
English: The recommended durations of treatment applicable to all HCV genotypes are shown in Table 1.
Danish: Den anbefalede behandlingsvarighed for anvendelse til alle HCV-genotyper vises i Tabel 1.
English: Each film-coated tablet contains 117 mg of lactose (as lactose monohydrate).
Danish: Hver filmovertrukket tablet indeholder 117 mg laktose (som laktosemonohydrat).
English: Otherc a. The majority (85%) of patients previously failed a regimen containing sofosbuvir.
Danish: Andetc a. Størstedelen (85 %) af patienter, hvis tidligere behandling med et regime indeholdende sofosbuvir mislykkedes.
English: The tablets are packed in plastic bottles with child resistant caps.
Danish: Tabletterne er pakket i plastbeholdere med børnesikret låg.
English: • ethinylestradiol containing medicines, including many contraceptives.
Danish: • ethinylestradiol-indholdende lægemidler, herunder mange kontraceptiva
English: Vosevi [Outer packaging only]
Danish: Vosevi [Kun ydre emballage]
English: (may affect up to 1 in 10 people)
Danish: (kan påvirke op til 1 ud af 10 personer)
English: Patients treated with ethinylestradiol-containing medicinal products
Danish: Patienter behandlet med ethinylestradiol-indholdende lægemidler
English: Laboratory abnormalities
Danish: Laboratorie abnormaliteter
English: Observed: Darunavir
Danish: Observeret: Darunavir
English: Table 9: Demographics and baseline characteristics for patients enrolled into POLARIS-1, -2, -3 and -4
Danish: Tabel 9: Demografi og baseline-karakteristika for patienter tilmeldt til POLARIS-1, -2, -3 og -4
English: As Vosevi contains sofosbuvir, velpatasvir and voxilaprevir, any interactions that have been identified with these active substances individually may occur with Vosevi.
Danish: Da Vosevi indeholder sofosbuvir, velpatasvir og voxilaprevir, kan alle interaktioner, der er blevet identificeret med disse aktive stoffer individuelt, forekomme med Vosevi.
English: If you are pregnant, think you may be pregnant, are breast-feeding your baby, or are planning to have a baby ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, ammer, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Vosevi treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Danish: Behandling med Vosevi bør påbegyndes og monitoreres af en læge med erfaring i behandling af patienter med HCV-infektion.
English: Carcinogenicity studies for voxilaprevir have not been conducted.
Danish: Der er ikke blevet udført karcinogenicitetsstudier for voxilaprevir.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Vosevi when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Danish: Da disse tilfælde er potentielt livstruende, bør amiodaron kun anvendes til patienter i behandling med Vosevi, når andre antiarytmika ikke tolereres eller er kontraindicerede.
English: Effect of baseline HCV resistance-associated variants on treatment outcome
Danish: Virkning af HCV-resistensassocierede varianter ved baseline på behandlingsresultatet
English: Patients should be instructed to swallow the tablet whole with food (see section 5.2).
Danish: Patienterne skal informeres om at sluge tabletten hel sammen med mad (se pkt.
English: Vosevi should not affect your ability to drive or use any tools or machinery.
Danish: Vosevi vil ikke påvirke din evne til at føre køretøjer eller anvende værktøj eller maskiner.
English: No specific antidote is available for overdose with Vosevi.
Danish: Der findes ingen specifik antidot for en overdosis af Vosevi.
English: Total bilirubin levels decreased after completing Vosevi treatment.
Danish: Niveauerne af total bilirubin aftog efter fuldførelse af behandlingen med Vosevi.
English: If you accidentally take more than the recommended dose of Vosevi you may be at increased risk of side effects with this medicine (see section 4 Possible side effects).
Danish: Hvis du utilsigtet har taget mere end den anbefalede dosis Vosevi, kan du have større risiko for at få bivirkninger af lægemidlet (se punkt 4, Bivirkninger).
English: Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Vosevi.
Danish: Hvis samtidig brug af amiodaron findes nødvendig, anbefales nøje monitorering af patienterne ved initiering af behandlingen med Vosevi.
English: These should be taken at least 4 hours before or 4 hours after Vosevi;
Danish: Disse lægemidler skal tages mindst 4 timer før eller 4 timer efter Vosevi.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Vosevi.
Danish: Nogle patienter med diabetes har oplevet lavt blodsukker (hypoglykæmi) efter påbegyndelse af behandling med lægemidler som Vosevi.
English: Table 1: Recommended treatment durations for Vosevi for all HCV genotypes
Danish: Tabel 1: Anbefalet behandlingsvarighed for Vosevi til alle HCV-genotyper
English: In the 13 patients aged 75 to 84 years with available pharmacokinetic data, mean exposure to voxilaprevir was 93% higher than the mean exposure observed in patients aged 18 to 64 years.
Danish: Hos de 13 patienter i alderen 75 til 84 år med tilgængelige farmakokinetiske data, var middeleksponeringen til voxilaprevir 93 % højere end middeleksponeringen observeret hos patienter i alderen 18 til 64 år.