FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment at IC90 for 72 hours resulted in a 1-log10 drop in replicon RNA.
Danish: Behandling ved IC90 i 72 timer resulterede i et 1 log10-fald i replikon-RNA.
English: Blood: low potassium levels in your blood; high calcium levels in the blood
Danish: Blod: lave kalium-niveauer i blodet; høje calciumniveauer i blodet
English: Exposure to boceprevir in nursing human infants is estimated to be less than 1% of the dose.
Danish: Eksponering over for boceprevir hos diende spædbørn estimeres til at være mindre end 1 % af dosis.
English: o The duration of the tritherapy after the first 4 weeks of bitherapy should not be less than 32 weeks.
Danish: o Varigheden af tre-stofbehandlingen efter de første 4 ugers to-stofbehandling bør ikke være mindre end 32 uger.
English: The data indicate that boceprevir is eliminated primarily by the liver.
Danish: Data indikerer, at boceprevir primært bliver elimineret af leveren.
English: Victrelis does not affect your ability to drive or use tools or machines.
Danish: Victrelis påvirker ikke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
English: - if you are a man who is taking ribavirin: do not have sex with a pregnant woman unless you use a condom.
Danish: - hvis du er mand og tager ribavirin: du må ikke have samleje med en gravid kvinde, medmindre du bruger kondom.
English: Your doctor may need to increase the frequency of your blood tests to check how well your blood can
Danish: Din læge kan være nødt til hyppigere at kontrollere, hvor godt dit blod størkner.
English: • have ever had a blood problem such as neutropenia (lack of a certain type of white blood cells).
Danish: • har haft et blodproblem såsom neutropeni (mangel på visse typer af hvide blodlegemer).
English: RAVs were detected in 8% of patients at baseline by population sequencing.
Danish: RAVer blev målt hos 8 % af patienterne ved baseline efter populations-sekventering.
English: Adverse reactions are listed by System Organ Class (see Table 3).
Danish: Bivirkninger er angivet efter systemorganklasse (se tabel 3).
English: Close clinical monitoring is warranted.
Danish: Tæt klinisk monitorering er påkrævet.
English: Boceprevir was absorbed following oral administration with a median Tmax of 2 hours.
Danish: Boceprevir blev absorberet efter oral administration med en median Tmaks.
English: The frequency of severe or life threatening infections tends to be higher in boceprevir-containing arms than the control arm.
Danish: Hyppigheden af alvorlige eller livstruende infektioner har vist tendens til at være højere i boceprevirindeholdende arme end i kontrolarmen.
English: Exploratory pharmacogenomic analysis of IL28B in phase 3 studies of Victrelis
Danish: Eksplorativ farmakogenomisk analyse af IL28B i fase 3-studier af Victrelis
English: When boceprevir is administered with ritonavir alone, boceprevir concentrations are decreased.
Danish: Når boceprevir administreres med ritonavir alene, nedsættes boceprevir-koncentrationerne.
English: (postulated mechanism of
Danish: (postuleret aktionsmekanisme,
English: Within each system organ class, adverse reactions are listed under headings of frequency using the categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data).
Danish: I hver systemorganklasse er bivirkningerne opdelt efter hyppighed i kategorierne: meget almindelig (≥1/10); almindelig (≥1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: There are no data on the use of Victrelis in pregnant women.
Danish: Der er ingen data fra anvendelse af Victrelis til gravide kvinder.
English: Accumulation is minimal and pharmacokinetic steady state is achieved after approximately 1 day of three times daily dosing.
Danish: Akkumulering er minimal og farmakokinetisk steady state opnås efter cirka 1 dag med dosering
English: If therapy is initiated, a very close monitoring for signs of infections and worsening liver function is warranted.
Danish: Hvis behandling initieres, er meget tæt monitorering for tegn på infektioner og forværring af leverfunktionen påkrævet.
English: • Peel back the tab to get to the capsule - do not push the capsule through the blister since pushing the capsule through the package may break the capsule.
Danish: • Træk slippen tilbage for at komme ind til kapslen - kapslen må ikke presses gennem blisteren, da kapslen kan gå i stykker, hvis den presses gennem pakken.
English: Boceprevir has a mean apparent volume of distribution (Vd/F) of approximately 772 l at steady state.
Danish: Boceprevir har en gennemsnitlig distributionsvolumen (Vd/F) på circa 772 l i steady state.
English: Daily doses of 3,600 mg have been taken by healthy volunteers for 5 days without untoward symptomatic effects.
Danish: Raske frivillige har taget daglige doser på op til 3.600 mg i 5 dage uden ubehagelige symptomatiske
English: For additional information on use of Victrelis in patients with advanced
Danish: For yderligere information om brugen af Victrelis hos patienter med fremskreden
English: No carcinomas or adenomas were observed in rats.
Danish: Der sås ingen karcinomer eller adenomer hos rotter.
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: Multipack: 336 (4 packs of 84) hard capsules
Danish: Multipakning: 336 (4 pakker af 84) hårde kapsler
English: Effects on fertility and Sertoli cells have been observed in rats but not in mice and monkeys.
Danish: Virkning på fertilitet og Sertoliceller er blevet observeret hos rotter, men ikke hos mus og aber.
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjælden (kan berøre op til 1 ud af 1.000)
English: The results of this retrospective subgroup analysis should be viewed with caution because of the small sample size and potential differences of the sub-study population relative to the overall trial
Danish: Resultatet af denne retrospektive sub-gruppeanalyse bør fortolkes med forsigtighed på grund af det lille udsnit og potentielle forskelle af populationen i substudiepopulationen i forhold til den samlede forsøgspopulation.
English: Boceprevir is not eliminated by dialysis.
Danish: Boceprevir elimineres ikke ved dialyse.
English: Other clinical experience has not identified differences in responses between the older and younger patients (see section 5.2).
Danish: Anden klinisk erfaring har ikke identificeret forskelle i respons mellem ældre og yngre patienter (se pkt.
English: *Please see section 5.1 clinical trial descriptions for each treatment arm.
Danish: 5.1 for beskrivelser af kliniske forsøg for hver behandlings-arm.
English: Hypoalbuminemia and low platelet count, as well as severe infections, have been identified as predictive factors of severe complications of liver disease.
Danish: Hypoalbuminæmi og lavt trombocyttal samt svære infektioner er blevet identificeret som prædiktive faktorer for svære komplikationer ved leversygdom.
English: Clinical studies of boceprevir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Danish: Kliniske studier med boceprevir omfattede ikke et tilstrækkeligt antal af forsøgspersoner i alderen 65 og derover til at fastslå, om disse patienter responderer anderledes end yngre forsøgspersoner.
English: Medicinal products by therapeutic areas
Danish: Lægemidler fordelt på terapeutiske områder
English: • have a current or previous infection with the hepatitis B virus, since your doctor may want to
Danish: • har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere
English: The recommended dose of Victrelis is 4 capsules three times a day (a total of 12 capsules a day).
Danish: Den anbefalede dosis Victrelis er 4 kapsler tre gange dagligt (i alt 12 kapsler om dagen).
English: Table 4
Danish: Tabel 6
English: Clear polychlorotrifluoroethylene /PVC/aluminium blisters containing 4 hard capsules per blister cavity.
Danish: Klare polychlortrifluoronethylen/PVC/aluminiumblisterkort, der indeholder 4 hårde kapsler per blisterrum.
English: The SVR rates for subjects who received at least one dose of any study medication (Intent-to-Treat population) are shown in Table 9.
Danish: SVR-rater for de forsøgspersoner, som fik mindst en dosis studiemedicin (Intent-to-Treat population), er vist i tabel 9.
English: • have ever had a blood problem such as anaemia (when you lack enough healthy red blood cells, which transport oxygen around your body)
Danish: • har haft et blodproblem såsom anæmi (hvis du mangler tilstrækkeligt antal raske røde blodlegemer, som transporterer ilten rundt i din krop)
English: Boceprevir concentrations are not likely to be affected by maraviroc co-administration (based on elimination pathway of boceprevir).
Danish: Koncentrationen af boceprevir vil sandsynligvis ikke blive påvirket af samtidig administration af maraviroc (baseret på eliminationsvejen for boceprevir).
English: Boceprevir is eliminated with a mean plasma half-life (t½) of approximately 3.4 hours.
Danish: Boceprevir bliver elimineret med en gennemsnitlig plasma-halveringstid (t½) på cirka 3,4 timer.
English: The percent change and arrows (↑ = increase, ↓ = decrease, ↔ = no change) are used to show the magnitude and direction of change in mean ratio estimate for each pharmacokinetic parameter.
Danish: Ændring i procent og pile (↑ = stigning, ↓ = fald, ↔ = ingen ændring) er brugt til at vise omfang og ændringsretning i estimeret gennemsnitsratio for hver farmakokinetisk parameter.
English: At steady-state, the exposure ratio for the two diastereomers is approximately 2:1, with the predominant diastereomer being pharmacologically active.
Danish: Ved steady-state var eksponeringsforholdet for de to diastereomere ca. 2:1, hvor den dominerende diastereomer var farmakologisk aktiv.
English: Victrelis contains lactose (a type of sugar).
Danish: Victrelis indeholder lactose (en slags sukker).
English: It should be noted that retrospective analyses bridging the data between the two pivotal studies have led to a recommended posology that differs from the regimen studied in some patient subgroups.
Danish: Det skal bemærkes, at retrospektive analyser af data fra de to pivotale undersøgelser har ført til dosisrekommandationer, der adskiller sig fra det undersøgte regime hos enkelte patient-sub-grupper.
English: There is potential for inhibitors of these transporters to increase concentrations of boceprevir; the clinical implications of these interactions are not known.
Danish: Hæmmere af disse transportere kan potentielt øge koncentrationen af boceprevir; den kliniske relevans af disse interaktioner er ukendt.
English: Treatment with Victrelis should be initiated and monitored by a physician experienced in the
Danish: Behandling med Victrelis skal initieres og monitoreres af en læge med erfaring i behandling af
English: In a study of patients with varying degrees of stable chronic liver impairment (mild, moderate and severe), no clinically significant differences in pharmacokinetic parameters were found, and no dose adjustment is recommended.
Danish: I et studie med patienter med forskellige grader af stabil, kronisk nedsat leverfunktion (let, moderat og alvorlig) blev der ikke fundet klinisk signifikante forskelle i farmakokinetiske parametre, og der kræves ingen dosisjustering.
English: Treatment of overdose with Victrelis should consist of general supportive measures, including monitoring of vital signs, and observation of the patient's clinical status.
Danish: Behandling af overdosering med Victrelis bør bestå af generel understøttende behandling, herunder monitorering af livstegn og observation af patientens kliniske status.
English: The absolute bioavailability of Victrelis has not been studied.
Danish: Victrelis' absolutte biotilgængelighed er ikke undersøgt.
English: There is no specific antidote for overdose with Victrelis.
Danish: Der findes ingen specifik antidot mod overdosering af Victrelis.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Victrelis in one or more subsets of the paediatric population in chronic viral hepatitis C (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har fremsat kravet om fremlæggelse af resultaterne af studier med Victrelis hos en eller flere undergrupper af den pædiatriske population ved kronisk viral hepatitis C (se pkt 4.2 for information om pædiatrisk anvendelse).
English: Clinical data (semen analyses and inhibin B levels - [a glycoprotein produced by Sertoli cells - used as a surrogate marker of testicular function]) showed no evidence of altered testicular function.
Danish: Kliniske data (sædanalyser og inhibin-B-niveauer - [et glykoprotein produceret af Sertoliceller - anvendt som surrogatmarkør for testikelfunktionen]) viste ikke tegn på ændret testikelfunktion.
English: C-boceprevir, approximately 79% and 9% of the dose was excreted in faeces and urine, respectively, with approximately 8% and 3% of the dosed radiocarbon eliminated as boceprevir in faeces and urine.
Danish: C-boceprevir blev cirka 79 % og 9 % af dosis udskilt i henholdsvis fæces og urin, og cirka 8 % og 3 % af det doserede radioaktive-kulstof blev elimineret som boceprevir i fæces og urin.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan berøre op til 1 ud af 10)
English: Sustained Virologic Response (SVR)
Danish: Vedvarende virologisk respons (SVR)
English: The bioavailability of boceprevir is regardless of meal type (e.g., high-fat vs. low-fat) or whether taken 5 minutes prior to eating, during a meal, or immediately following completion of the meal.
Danish: Biotilgængeligheden af boceprevir er uafhængig af typen af måltid (f.eks. højt fedtindhold vs. lavt fedtindhold) eller om det bliver indtaget 5 minutter før et måltid, under et måltid
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Victrelis are provided with a healthcare professional educational pack containing the following at
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som kan forventes at udskrive eller anvende Victrelis, ved lanceringen får en uddannelsespakke til sundhedspersonale, som indeholder
English: As liver function may change during treatment with Victrelis, a close monitoring of International Normalised Ratio (INR) values is recommended in patients treated with vitamin K antagonists.
Danish: Da leverfunktionen kan ændre sig under behandling med Victrelis, anbefales tæt monitorering af INR (international normaliseret ratio) hos patienter i behandling med vitamin K-antagonister.
English: The mean decreases in haemoglobin values from baseline were larger in previously treated patients compared to patients who had never received prior therapy.
Danish: Det gennemsnitlige fald i hæmoglobinværdierne i forhold til baseline var større hos tidligere behandlede patienter end hos patienter, der ikke tidligere havde været i behandling.
English: Boceprevir is primarily metabolized by aldoketo reductase (AKR).
Danish: Boceprevir bliver primært metaboliseret af aldoketo-reduktase (AKR).
English: Boceprevir/medicine derived material was shown to be transferred into the milk of lactating rats.
Danish: Boceprevir/lægemiddelderiveret materiale blev overført til mælken hos lakterende rotter.
English: If such reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted
Danish: Hvis sådanne reaktioner opstår, skal kombinationsbehandlingen seponeres og passende behandling påbegyndes omgående (se
English: If you have been told by your doctor that you cannot tolerate or digest some sugars (you have an intolerance to some sugars), such as Lapp lactase deficiency, or glucose-galactose malabsorption, talk to your doctor before taking this medicine.
Danish: Hvis du har fået at vide af din læge, at du ikke kan tåle eller fordøje visse sukkerarter (du er intolerant over for nogle sukkerarter) såsom en særlig form for arvelig lactasemangel (Lapp lactase-mangel) eller forstyrrelser i glucose-galactose-optagelsen, skal du tale med din læge, før du tager denne medicin.
English: (effect on P-gp transport in the
Danish: (virkning på P-gp-transport i
English: In an in vitro dog Purkinje fiber study, boceprevir prolonged the action potential duration with inverse frequency dependence; the clinical relevance remains uncertain.
Danish: I et in vitro-studie med hunde-Purkinje-fibre forlængede boceprevir varigheden af aktionspotentialet med invers frekvensafhængighed; den kliniske relevans er fortsat uvis.
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current
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: The PEM should contain the following key elements:
Danish: Uddannelsesmateriale til lægen skal indeholde følgende hovedelementer:
English: • pimozide or lurasidone - used for mental health problems
Danish: • pimozid eller lurasidon - bruges til behandling af psykiske problemer
English: Sarcoidosis*, porphyria non-acute
Danish: Sarcoidose*, ikke-akut porfyri
English: The last available value in the period at and after FW 24.
Danish: Den sidst tilgængelige værdi i perioden op til og efter FW 24.
English: Treatment duration = 48 weeks
Danish: Behandlingsvarighed = 48 uger 1.
English: In 2-year carcinogenicity studies, no carcinogenicity was observed, but there was an increased incidence of hepatocellular adenomas in mice, which was not statistically significant, at systemic exposures 5.7-fold higher than those in humans at the recommended therapeutic dose.
Danish: I 2-årige karcinogenicitetsstudier sås ingen karcinogenicitet, men der var øget incidens af hepatocellulære adenomer hos mus, hvilket ikke var statistisk signifikant, ved systemiske eksponeringer, der var 5,7 gange højere end hos mennesker ved den anbefalede terapeutiske dosis.
English: A 3-year follow-up study of subjects who achieved SVR with a Victrelis-based regimen showed that > 99% (693/696) of patients maintained their SVR (no relapse) through the available follow-up period
Danish: Et 3-års opfølgningsstudie med forsøgspersoner, som opnåede SVR med et Victrelis-baseret regime, viste, at >99% (693/696) af patienterne opretholdt deres SVR (intet tilbagefald) i hele den tilgængelige opfølgningsperiode (gennemsnitsvarighed 3,4 år).
English: † in previously untreated subjects with HIV co-infection
Danish: † hos tidligere ubehandlede forsøgspersoner med hiv co-infektion
English: The clinical outcome of this observed reduction of Victrelis trough concentrations has not been directly assessed.
Danish: Den kliniske konsekvens af denne reduktion er ikke blevet vurderet direkte.
English: If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Danish: Hvis din kvindelige partner ikke er gravid, men er i den fødedygtige alder, skal hun testes for graviditet hver måned under behandlingen og i 7 måneder efter ophørt behandling.
English: • oral midazolam or oral triazolam - a sedative, given by mouth
Danish: • oral midazolam eller oral triazolam - beroligende medicin, der gives via munden
English: Use in patients having HCV genotypes other than genotype 1
Danish: Anvendelse hos patienter med hcv-genotyper ud over genotype 1
English: No dose adjustment is required in these patients and in patients with any degree of renal impairment.
Danish: Der kræves ingen dosisjustering hos disse patienter eller hos patienter med nogen grad af nedsat
English: Patients should be monitored for signs of opiate toxicity associated with buprenorphine.
Danish: Patienterne skal monitoreres for tegn på opiattoksicitet i forbindelse med buprenorphin.
English: • have ever had a blood problem such as pancytopenia (a combination of low platelet, red and
Danish: • har haft et blodproblem såsom pancytopeni (en kombination af lavt antal blodplader, hvide og
English: The D168V single substitution did not reduce sensitivity to boceprevir.
Danish: Enkeltsubstitutionen D168V reducerede ikke følsomheden over for boceprevir.
English: • have or anyone in your family has an irregular heartbeat, especially a condition called “QT
Danish: • selv har eller har et familiemedlem med uregelmæssig hjerterytme, især en tilstand, der hedder
English: In a genotype 1a replicon, the IC50 and IC90 values for boceprevir were 900 nM and 1,400 nM, respectively.
Danish: I et genotype 1a-replikon var IC50- og IC90-værdierne for boceprevir henholdsvis 900 nM og 1.400 nM.
English: Individual patients may require additional titration of their methadone dosage when Victrelis is started or stopped to ensure clinical effect of methadone.
Danish: For enkelte patienter kan ekstra titrering af methadondosis være nødvendig, når Victrelis startes op eller seponeres for at sikre klinisk virkning af methadon.
English: Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur:
Danish: Derfor skal du og din partner tage særlige forholdsregler i forbindelse med seksuel
English: What you need to know before you take Victrelis
Danish: Det skal du vide, før du begynder at tage Victrelis
English: No gender-related pharmacokinetic differences in the phase III studies have been observed in adult patients.
Danish: Der er ikke observeret kønsrelaterede farmakokinetiske forskelle hos voksne patienter i fase III
English: Follow-up analysis of boceprevir-treated subjects who did not achieve SVR showed that the population of wild-type virus increased and the majority of boceprevir-resistant variants became undetectable over time after the end of boceprevir treatment.
Danish: En opfølgningsanalyse af boceprevir-behandlede forsøgspersoner, som ikke opnåede SVR, viste at populationen af vildtype virus steg, og størstedelen af de boceprevir-resistente varianter blev ikkedetekterbare over tid efter afsluttet boceprevir-behandling.
English: This is due to liver function changes during treatment with Victrelis.
Danish: Dette skyldes, at leverfunktionen kan ændre sig under behandling med Victrelis.
English: For most of these subjects (n=54), the lowest dose of ribavirin received for at least 14 days was ≥ 600mg/day.
Danish: For de fleste af forsøgspersonerne (n=54) var den laveste ribavirin-dosis i mindst 14 dage ≥600 mg/dag.
English: Concomitant administration of Victrelis and quetiapine may increase plasma concentrations of quetiapine leading to quetiapine-related toxicity, including coma.
Danish: Samtidig administration af Victrelis og quetiapin kan øge plasmakoncentrationen af quetiapin og medføre quetiapin-relateret toksicitet, herunder koma.
English: Maraviroc 150 mg twice daily when co-administered with boceprevir.
Danish: Maraviroc 150 mg to gange dagligt ved samtidig anvendelse af boceprevir.
English: Human plasma protein binding is approximately 75% following a single dose of Victrelis 800 mg. Boceprevir is administered as an approximately equal mixture of two diastereomers which rapidly interconvert in plasma.
Danish: Bindingen til humane plasmaproteiner er cirka 75 % efter en enkeltdosis af Victrelis på 800 mg. Boceprevir administreres som en omtrent ligelig blanding af to diastereomere, der hurtigt interkonverterer i plasma.
English: The median time for all RAVs to become undetectable was 1.17 years for genotype 1a.
Danish: Mediantiden, før alle RAVer blev ikke-detekterbare, var 1,17 år for genotype 1a.
English: • medicine used to treat symptoms of an enlarged prostate - doxazosin and tamsulosin
Danish: • medicin til behandling af symptomer på forstørret prostata - doxazosin og tamsulosin