FrancophonIA/ELRC3.0 huggingface dataset:
English: • feeling or being sick (nausea or vomiting)
Danish: • en fornemmelse af at være syg (kvalme eller opkastning)
English: Treatment should continue until disease progression or no longer tolerated by the patient.
Danish: Behandlingen bør fortsættes indtil sygdomsprogression, eller indtil den ikke længere tåles af patienten.
English: Also tell your doctor if you take any of the following medicines - The effects of IMBRUVICA or other medicines may be influenced if you take IMBRUVICA together with any of the following medicines:
Danish: Fortæl det også til lægen, hvis du tager nogen af følgende lægemidler - virkningen af IMBRUVICA eller andre lægemidler kan blive påvirket, hvis du tager IMBRUVICA sammen med et eller flere af følgende lægemidler:
English: All patients received BR for a maximum of six 28-day cycles.
Danish: Alle patienter fik BR i maksimalt seks 28-dages serier.
English: Hepatitis B virus (HBV) status should be established before initiating treatment with IMBRUVICA.
Danish: Hepatitis B-virusstatus (HBV-status) skal bestemmes før iværksættelse af behandling med IMBRUVICA.
English: Do not take IMBRUVICA with grapefruit or Seville oranges (bitter oranges) - this includes eating them, drinking the juice or taking a supplement that might contain them.
Danish: Tag ikke IMBRUVICA sammen med grapefrugt eller pomeranser (bitre appelsiner) - dette betyder, at du ikke må spise dem, drikke juicen fra dem eller tage et kosttilskud, der kan indeholde dem.
English: Defined as increase of ≥2 g/dL over baseline regardless of baseline value, or an increase to >11 g/dL with a ≥0.5 g/dL improvement if baseline was ≤11 g/dL.
Danish: Defineret som en stigning på ≥ 2 g/dl over baseline uanset baseline-værdien, eller en stigning til > 11 g/dl med en ≥ 0,5 g/dl forbedring, hvis baseline var ≤ 11 g/dl.
English: a (CR+PR) P-value
Danish: a (CR +PR) P-værdi
English: Monitor patients for the appearance of non-melanoma skin cancer.
Danish: Patienterne skal monitoreres for forekomst af non-melanom hudcancer.
English: Best Overall Response (%) CR
Danish: Bedste samlede respons (%) CR
English: Your doctor or another healthcare provider may do blood tests to check for TLS.
Danish: Lægen eller sundhedspersonalet kan tage blodprøver for at analysere for TLS.
English: There are limited data on the effects of IMBRUVICA overdose.
Danish: Der findes begrænsede data om effekterne af en overdosis af IMBRUVICA.
English: No maximum tolerated dose was reached in the phase 1 study in which patients received up to 12.5 mg/kg/day (1,400 mg/day).
Danish: Der blev ikke nået en maksimal tålt dosis i fase 1-studiet, hvor patienterne fik op til 12,5 mg/kg/dag (1.400 mg/dag).
English: Warfarin or other vitamin K antagonists should not be administered concomitantly with IMBRUVICA.
Danish: Warfarin eller andre K-vitamin-antagonister bør ikke administreres samtidig med IMBRUVICA.
English: Mild inducers may be used concomitantly with IMBRUVICA, however, patients should be monitored for potential lack of efficacy.
Danish: Milde induktorer kan anvendes samtidigt med IMBRUVICA, men patienterne skal monitoreres for potentielt manglende effekt.
English: Lymphocytosis: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment.
Danish: Lymfocytose: Laboratorietest kan vise en forøgelse af hvide blodlegemer (kaldet “lymfocytter”) i dit blod i de første par uger af behandlingen.
English: • swollen hands, ankles or feet
Danish: • opsvulmede hænder, ankler eller fødder
English: Do not get pregnant while you are taking this medicine.
Danish: Du skal undgå at blive gravid, mens du tager dette lægemiddel.
English: As no clinical data are available on this interaction, it cannot be excluded that ibrutinib could inhibit intestinal P-gp and BCRP after a therapeutic dose.
Danish: Eftersom der ikke foreligger kliniske data vedrørende denne interaktion, kan det ikke udelukkes, at ibrutinib kan hæmme intestinal P-gp og BCRP efter en terapeutisk dosis.
English: • an increase in the number or proportion of white blood cells shown in blood tests
Danish: • en stigning i antallet eller andelen af hvide blodlegemer påvist i blodprøver
English: • low white blood cell counts with fever (febrile neutropenia)
Danish: • lavt antal hvide blodlegemer sammen med feber (febril neutropeni)
English: If PML is suspected then appropriate diagnostic evaluations should be undertaken and treatment suspended until PML is excluded.
Danish: Hvis der er mistanke om PML, skal passende diagnostiske undersøgelser iværksættes og behandlingen afbrydes, indtil PML er udelukket.
English: Date of latest renewal: 25 June 2019
Danish: Dato for første markedsføringstilladelse: 21. oktober 2014 Dato for seneste fornyelse: 25. juni 2019
English: Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.
Danish: Overvej profylakse ifølge standardbehandlingen hos patienter, der er i forhøjet risiko for opportunistiske infektioner.
English: The ORR including PR with lymphocytosis was 70.6%.
Danish: ORR inklusive PR med lymfocytose var 70,6 %.
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 <1/1,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden 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 < 1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Take IMBRUVICA tablet by mouth, at about the same time each day, with a glass of water.
Danish: Tag IMBRUVICA tabletten gennem munden, på omtrent samme tidspunkt hver dag, sammen med et glas vand.
English: • supplements that may increase your risk of bleeding such as fish oil, vitamin E or flaxseed.
Danish: • kosttilskud, der kan øge din risiko for blødning såsom fiskeolie, E-vitamin eller hørfrø.
English: The efficacy was similar across all of the subgroups examined, including in patients with and without deletion 17p, a pre-specified stratification factor (Table 8).
Danish: Effekten var ens på tværs af alle undersøgte undergrupper, inklusive patienter med og uden deletion 17p, en på forhånd angivet stratifikationsfaktor (tabel 8).
English: Co-administration with transport substrates/inhibitors In vitro studies indicated that ibrutinib is not a substrate of P-gp, nor other major transporters, except OCT2.
Danish: Co-administration sammen med transportsubstrater/hæmmere In vitro-studier pegede på, at ibrutinib ikke er substrat for P-gp eller for andre væsentlige transportører med undtagelse af OCT2.
English: The overall response to IMBRUVICA was independent of prior treatment including bortezomib and lenalidomide or underlying risk/prognostic factors, bulky disease, gender or age.
Danish: Samlet respons på IMBRUVICA var uafhængig af tidligere behandlinger, herunder behandling med bortezomib og lenalidomid, eller underliggende risiko/prognose-faktorer, omfangsrig sygdom, køn eller alder.
English: • The active substance is ibrutinib.
Danish: • Aktivt stof: ibrutinib.
English: Table 1: Adverse reactions reported in clinical studies or during post marketing surveillance in patients with B-cell malignancies
Danish: Tabel 1: Bivirkninger rapporteret i kliniske studier eller under overvågning efter markedsføringen hos patienter med B-celle-maligniteter
English: IMBRUVICA should not be used during pregnancy.
Danish: IMBRUVICA må ikke anvendes under graviditeten.
English: In MCL, CLL and WM, IMBRUVICA works by blocking Bruton's tyrosine kinase, a protein in the body that helps these cancer cells grow and survive.
Danish: Ved MCL, CLL og WM virker IMBRUVICA ved at blokere Brutons tyrosinkinase, et protein i kroppen, som hjælper disse kræftceller med at leve og vokse.
English: • Take the capsules about the same time each day.
Danish: • Tag kapslerne på omtrent samme tidspunkt hver dag.
English: Push tablet through from other side.
Danish: Åbn pakningen, og tryk en tablet ud på den anden side.
English: The first dose of obinutuzumab was divided between day 1 (100 mg) and day 2 (900 mg).
Danish: Den første dosis obinutuzumab blev opdelt mellem dag 1 (100 mg) og dag 2 (900 mg).
English: Overall Response Rate (CR, VGPR, PR, MR)
Danish: Samlet responsrate (CR, VGPR, PR, MR)
English: Absolute bioavailability in fasted condition (n=8) was 2.9% (90% CI=2.1 - 3.9) and doubled when combined with a meal.
Danish: Absolut biotilgængelighed i fastende tilstand (n = 8) var 2,9 % (90 % CI = 2,1 - 3,9) og fordobledes ved indtagelse i forbindelse med et måltid.
English: If these toxicities persist or recur following two dose reductions, discontinue the medicinal product.
Danish: Hvis toksiciteten varer ved eller opstår igen efter to reduktioner af dosis, skal brugen af lægemidlet seponeres.
English: Do not open, break or chew them.
Danish: Du må ikke åbne, knække eller tygge dem.
English: Although ibrutinib is a sensitive CYP3A4 substrate, it does not have a clinically relevant effect on its own exposure.
Danish: Selv om ibrutinib er et sensitivt CYP3A4-substrat, har det ikke nogen klinisk relevant virkning på dets egen eksponering.
English: The safety profile is based on pooled data from 1200 patients treated with IMBRUVICA in three phase 2 clinical studies and six randomised phase 3 studies and from post-marketing experience.
Danish: Sikkerhedsprofilen er baseret på puljede data fra 1.200 patienter, som blev behandlet med IMBRUVICA i tre kliniske fase 2-studier og seks randomiserede fase 3-studier og fra rapporter efter markedsføringen.
English: When administering IMBRUVICA in combination with anti-CD20 therapies, it is recommended to administer IMBRUVICA prior to rituximab or obinutuzumab when given on the same day.
Danish: Ved administration af IMBRUVICA i kombination med anti-CD20-terapier anbefales det at administrere IMBRUVICA før rituximab eller obinutuzumab, når de gives samme dag.
English: There is no specific antidote for IMBRUVICA.
Danish: Der findes intet specifikt antidot til IMBRUVICA.
English: • nose bleeds, small red or purple spots caused by bleeding under the skin
Danish: • næseblod, små røde eller lilla pletter, der skyldes blødning under huden
English: This effect has also been observed in about one third of patients with relapsed or refractory MCL treated with IMBRUVICA.
Danish: Denne effekt er også blevet observeret i omkring en tredjedel af patienterne med recidiverende eller refraktær MCL i behandling med IMBRUVICA.
English: • if you have liver or kidney problems
Danish: • hvis du har problemer med leveren eller nyrerne
English: IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib.
Danish: IMBRUVICA er en kræftmedicin, som indeholder det aktive stof ibrutinib.
English: IMBRUVICA should be administered orally once daily with a glass of water approximately at the same time each day.
Danish: IMBRUVICA skal indtages oralt en gang dagligt med et glas vand på omtrent samme tidspunkt på dagen.
English: The Kaplan-Meier landmark estimate for OS at 48-months was 85.5% in the IMBRUVICA arm.
Danish: Den vigtige Kaplan-Meier-estimering for OS ved 48 måneder var 85,5 % i IMBRUVICA-gruppen.
English: Population pharmacokinetics data indicated that body weight (range: 41-146 kg; mean [SD]: 83 [19 kg]) had a negligible effect on ibrutinib clearance.
Danish: Populationsfarmakokinetiske data indikerede, at legemsvægt (område: 41-146 kg; middel [SD]: 83 [19 kg] havde en ubetydelig effekt på ibrutinib-clearance.
English: Pharmacokinetics of ibrutinib does not significantly differ in patients with different B-cell malignancies.
Danish: Farmakokinetikken for ibrutinib er ikke væsentlig forskellig hos patienter med forskellige B-cellesygdomme.
English: The capsules should be swallowed whole with water and should not be opened, broken, or chewed.
Danish: Kapslerne skal synkes hele med vand og må ikke åbnes, deles eller tygges.
English: Take the capsules and this leaflet with you.
Danish: Tag kapslerne og denne indlægsseddel med dig.
English: ORR including PR with lymphocytosis d (%)
Danish: ORR inklusive PR med lymfocytose d (%)
English: The steady state AUC observed in patients at 560 mg is (mean ± standard deviation) 953 ± 705 ng h/mL.
Danish: Den observerede steady state-AUC hos patienter ved 560 mg er (middel ± standardafvigelse) 953 ± 705 ng∙h/ml.
English: Consider temporarily withholding IMBRUVICA.
Danish: Overvej at tilbageholde IMBRUVICA midlertidigt.
English: • acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or naproxen
Danish: • acetylsalicylsyre og non-steroide anti-inflammatoriske midler (NSAID'er) såsom ibuprofen eller naproxen
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter faldende sværhedsgrad.
English: Reversible binding of ibrutinib to human plasma protein in vitro was 97.3% with no concentration dependence in the range of 50 to 1,000 ng/mL.
Danish: Reversibel binding af ibrutinib til humant plasmaprotein in vitro var 97,3 % uden koncentrationsafhængighed i intervallet 50 til 1.000 ng/ml.
English: Peripheral neuropathy
Danish: Perifer neuropati*
English: • if you are allergic to ibrutinib or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for ibrutinib eller et af de øvrige indholdsstoffer i IMBRUVICA (angivet i punkt 6).
English: Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioral signs or symptoms.
Danish: Lægen bør overveje PML som differentialdiagnose hos patienter med nyopståede neurologiske, kognitive eller adfærdsrelaterede symptomer eller forværring af sådanne.
English: Once the symptoms of the toxicity have resolved to grade 1 or baseline (recovery), IMBRUVICA therapy may be reinitiated at the starting dose.
Danish: Når toksicitetssymptomerne er mildnet til grad 1 eller baseline (bedring), kan behandling med IMBRUVICA genoptages ved startdosis.
English: Unchanged ibrutinib accounted for approximately 1% of the radiolabeled excretion product in faeces and none in urine.
Danish: Uomdannet ibrutinib udgjorde ca. 1 % af det radioaktivt mærkede udskillelsesprodukt i fæces og intet i urin.
English: • if you have ever had unusual bruising or bleeding or are on any medicines or supplements that increase your risk of bleeding (see section “Other medicines and IMBRUVICA”)
Danish: • hvis du nogensinde har fået usædvanlige blå mærker eller blødning, eller hvis du tager medicin eller kosttilskud, der øger din risiko for blødning (se punktet “Brug af anden medicin sammen med IMBRUVICA”)
English: Administer supportive care including hydration and/or cytoreduction as indicated.
Danish: Administrer støttebehandling, herunder hydrering og/eller cytoreduktion efter behov.
English: There is no evidence that the lower Cmax would have clinical significance, and medicinal products that increase stomach pH (e.g., proton pump inhibitors) have been used without restrictions in the pivotal clinical studies.
Danish: Der er ingen evidens for, at den lavere Cmax vil have klinisk signifikans, og lægemidler, som øger mavens pH (f.eks. protonpumpehæmmere) har været anvendt uden begrænsninger i de pivotale kliniske studier.
English: • temporary episode of neurologic dysfunction caused by loss of blood flow, stroke.
Danish: • forbigående episode med neurologisk dysfunktion forårsaget af tab af blodgennemstrømning, slagtilfælde.
English: If a dose is not taken at the scheduled time, it can be taken as soon as possible on the same day with a return to the normal schedule the following day.
Danish: Hvis en dosis ikke tages på det planlagte tidspunkt, kan den tages snarest muligt samme dag, og den normale plan kan følges fra den efterfølgende dag.
English: Median follow-up time on study=9 months
Danish: Median opfølgningstid i studiet = 9 måneder
English: ORR was assessed according to the 2008 IWCLL criteria by investigators and IRC.
Danish: ORR blev vurderet i henhold til kriterierne fra 2008 IWCLL af investigatorer og ICR.
English: The clinical relevance is not known, but the exposure to substrates of CYP2B6 (such as efavirenz and bupropion) and of co-regulated enzymes may be reduced upon co-administration with ibrutinib.
Danish: Den kliniske relevans af dette kendes ikke, men eksponeringen for CYP2B6-substrater (som f.eks. efavirenz og bupropion) og co-regulerede enzymer kan blive reduceret ved samtidig administration af ibrutinib.
English: At a supratherapeutic dose of 1,680 mg, ibrutinib did not prolong the QTc interval to any clinically relevant extent.
Danish: Ved en supraterapeutisk dosis på 1.680 mg forlængede ibrutinib ikke QTc-intervallet i klinisk relevant grad.
English: The safety and efficacy of IMBRUVICA in patients with CLL were demonstrated in one uncontrolled study and one randomised, controlled study.
Danish: IMBRUVICAs sikkerhed og virkning hos patienter med CLL blev påvist i ét ikke-kontrolleret studie og ét randomiseret, kontrolleret studie.
English: In a separate study, one healthy subject who received a dose of 1,680 mg experienced reversible grade 4 hepatic enzyme increases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)].
Danish: I et separat studie oplevede én rask forsøgsperson, som fik en dosis på 1.680 mg, reversibel grad 4 forhøjede leverenzymer [aspartat-aminotransferase (ASAT) og alanin-aminotransferase (ALAT)].
English: • weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral neuropathy).
Danish: • svaghed, følelsesløshed, snurren eller smerter i hænder, fødder eller andre kropsdele (perifer neuropati).
English: The prevalence for Grade 3 or greater hypertension was 4% (year 0-1), 6% (year 1-2), 8% (year 2-3), 9% (year 3-4), and 9% (year 4-5).
Danish: Prævalensen af hypertension af grad 3 eller derover var 4 % (år 0-1), 6 % (år 1-2), 8 % (år 2-3), 9 % (år 3-4) og 9 % (år 4-5).
English: The median time to response was 1.0 month (range: 0.7-13.4 months).
Danish: Mediantiden til respons var 1,0 måned (interval 0,7-13,4 måneder).
English: ECOG per CRF
Danish: ECOG pr. CRF
English: Mantle cell lymphoma (MCL)
Danish: Mantle-celle-lymfom (MCL)
English: In both disease types, lymphocytosis typically occurs during the first month of IMBRUVICA therapy and typically resolves within a median of 8.0 weeks in patients with MCL and 14 weeks in patients with CLL.
Danish: I begge sygdomstyper optræder lymfocytose typisk i løbet af den første behandlingsmåned med IMBRUVICA og bedres typisk inden for en median på 8,0 uger hos patienter med MCL og 14 uger hos patienter med CLL.
English: This includes medicines obtained without a prescription, herbal medicines and supplements.
Danish: Dette gælder også medicin, som ikke er købt på recept, naturlægemidler og kosttilskud.
English: It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy.
Danish: Det anvendes til patienter, som ikke tidligere har været i behandling for WM, eller hvis sygdommen er vendt tilbage, eller patienten ikke har reageret på behandling, eller hos patienter for hvem kemoterapi givet sammen med et antistof ikke er en egnet behandling.
English: Patients with congenital bleeding diathesis have not been studied.
Danish: Patienter med kongenit blødningsdiatese er ikke blevet undersøgt.
English: chest discomfort (symptoms of heart rhythm problems)
Danish: ubehag i brystet (symptomer på problemer med hjerterytmen)
English: MCL dose modification after recovery CLL/WM dose modification after recovery
Danish: Ændring af MCL-dosis efter bedring Ændring af CLL-/WM-dosis efter bedring
English: Includes 1 patient in the IMBRUVICA+obinutuzumab arm with a complete response with incomplete marrow recovery (CRi).
Danish: Inkluderer 1 patient i IMBRUVICA + obinutuzumab-gruppen med et komplet respons med ukomplet generhvervelse af knoglemarvsfunktionen (CRi).
English: What IMBRUVICA is used for It is used to treat the following blood cancers in adults:
Danish: Lægemidlet anvendes til behandling af følgende former for blodkræft hos voksne:
English: The incidence for the 5-year period was 11%.
Danish: Forekomsten for 5-års perioden var
English: No dose adjustment is needed for patients with mild or moderate renal impairment (greater than 30 mL/min creatinine clearance).
Danish: Der er ikke behov for dosisjustering til patienter med let eller moderat nedsat nyrefunktion (kreatininclearance over 30 ml/min.).
English: Take the tablets and this leaflet with you.
Danish: Tag tabletterne og denne indlægsseddel med dig.
English: Race There are insufficient data to evaluate the potential effect of race on ibrutinib pharmacokinetics.
Danish: Der foreligger ikke tilstrækkelige data til at evaluere den potentielle effekt af race på ibrutinibs farmakokinetik.
English: Adverse reactions in patients treated with ibrutinib for B-cell malignancies and post-marketing adverse reactions are listed below by system organ class and frequency grouping.
Danish: Bivirkninger hos patienter behandlet med ibrutinib for B-celle-maligniteter og bivirkninger rapporteret efter markedsføringen er anført nedenfor efter systemorganklasse og hyppighedsgruppe.
English: • Take the tablets about the same time each day.
Danish: • Tabletterne skal tages på omtrent samme tidspunkt hver dag.
English: Ibrutinib may also inhibit BCRP in the liver and increase the exposure of medicinal products that undergo BCRP-mediated hepatic efflux, such as rosuvastatin.
Danish: Ibrutinib kan også hæmme BCRP i leveren og øge eksponeringen af lægemidler, der undergår BCRP-medieret hepatisk effluks som f.eks. rosuvastatin.
English: The tablets should be swallowed whole with water and should not be broken or chewed.
Danish: Tabletterne skal synkes hele med vand og må ikke deles eller tygges.
English: It is not recommended to administer IMBRUVICA to patients with severe hepatic impairment (Child-Pugh class C).
Danish: Det frarådes at administrere IMBRUVICA til patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: Treatment on both arms continued until disease progression or unacceptable toxicity.
Danish: Behandling i begge grupper fortsatte indtil sygdomsprogression eller uacceptabel toksicitet.
English: Manufacturer Janssen-Cilag SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina, Italy
Danish: Fremstiller Janssen-Cilag SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina, Italien
English: Patients should be monitored for fever, neutropenia and infections and appropriate anti-infective therapy should be instituted as indicated.
Danish: Patienterne skal monitoreres for feber, neutropeni og infektioner, og relevant infektionsbekæmpende behandling skal igangsættes efter behov.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking IMBRUVICA:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager IMBRUVICA:
English: • heart medicines/anti-arrhythmics - amiodarone or dronedarone
Danish: • hjertemedicin/antiarytmika - amiodaron eller dronedaron
English: Ninety patients randomised to placebo+BR crossed over to receive IMBRUVICA following IRC confirmed progression.
Danish: 90 patienter randomiseret til placebo + BR krydsede over til at få IMBRUVICA efter IRC-bekræftet progression.
English: IMBRUVICA is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to treatment.
Danish: IMBRUVICA anvendes til patienter, som ikke tidligere har været i behandling for CLL, eller hvis sygdommen er vendt tilbage, eller patienten ikke har reageret på behandling.