FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomised 1:1 to receive either IMBRUVICA orally at 560 mg once daily for 21 days or temsirolimus intravenously at 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21-day cycle.
Danish: Patienterne blev randomiseret 1:1 til enten IMBRUVICA 560 mg oralt en gang dagligt i 21 dage eller 175 mg temsirolimus intravenøst på dag 1, 8 og 15 i den første serie efterfulgt af 75 mg på dag 1, 8 og 15 i hver efterfølgende 21-dages serie.
English: The safety and efficacy of IMBRUVICA in patients with relapsed or refractory MCL were evaluated in a single open-label, multi-center phase 2 study (PCYC-1104-CA) of 111 patients.
Danish: IMBRUVICAs sikkerhed og virkning hos patienter med recidiverende eller refraktær MCL blev evalueret i et enkelt åbent fase 2-multicenter-studie (PCYC-1104-CA) med 111 patienter.
English: First restart at 560 mg daily restart at 420 mg daily
Danish: Første start igen med 560 mg dagligt start igen med 420 mg dagligt
English: IMBRUVICA Film-Coated Tablets Janssen-Cilag SpA Via C. Janssen,
Danish: IMBRUVICA filmovertrukne tabletter Janssen-Cilag SpA
English: Unmutated IGHV Yes
Danish: Ikke-muteret IGHV Ja
English: Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone
Danish: Kolloid vandfri silica Croscarmellosenatrium Lactosemonohydrat Magnesiumstearat Mikrokrystallinsk cellulose Povidon
English: Use of preparations containing St. John's Wort is contraindicated in patients treated with IMBRUVICA.
Danish: Brug af præparater, som indeholder perikon, er kontraindiceret hos patienter, som behandles med IMBRUVICA.
English: Mildly decreased trabecular and cortical bone was seen in female rats administered ≥100 mg/kg/day (AUC exposure margin of 20.3-fold).
Danish: Et let tab af trabekulær og kortikal knogle blev set hos hunrotter, der fik ≥ 100 mg/kg/dag (AUC-eksponeringsmargin på 20,3 gange).
English: The patient should not take extra capsules to make up the missed dose.
Danish: Patienten må ikke tage ekstra kapsler som erstatning for den glemte dosis.
English: • Tablet core: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate (see section 2 “IMBRUVICA contains lactose”), magnesium stearate, microcrystalline cellulose, povidone, sodium lauril sulfate (E487).
Danish: • Tabletkerne: kolloid vandfri silica, croscarmellosenatrium, lactosemonohydrat (se afsnit 2, "IMBRUVICA indeholder lactose"), magnesiumstearat, mikrokrystallinsk cellulose, povidon, natriumlaurylsulfat (E487).
English: Atrial fibrillation, atrial flutter and cases of ventricular tachyarrhythmia have been reported in patients treated with IMBRUVICA.
Danish: Der er indberettet tilfælde med atrieflimren, atrieflagren og tilfælde af ventrikulær takyarytmi hos patienter i behandling med IMBRUVICA.
English: Each carton contains (30 film-coated tablets) 3 wallets.
Danish: Hver karton indeholder (30 filmovertrukne tabletter) 3 hylstre.
English: Simulations using fasted conditions suggested that the strong CYP3A4 inhibitor clarithromycin may increase the AUC of ibrutinib by a factor of 14.
Danish: Simuleringer med forsøgspersoner, der fastede, tydede på, at den potente CYP3A4-hæmmer clarithromycin kan øge AUC for ibrutinib med en faktor på 14.
English: Ibrutinib has a pH dependent solubility, with lower solubility at higher pH. A lower Cmax was observed in fasted healthy subjects administered a single 560 mg dose of ibrutinib after taking omeprazole at 40 mg once daily for 5 days (see section 5.2).
Danish: Ibrutinibs opløselighed er pH-afhængig med faldende opløselighed ved stigende pH. Der blev observeret en lavere Cmax hos fastende, raske forsøgspersoner, som fik en enkelt dosis på 560 mg ibrutinib efter at have taget 40 mg omeprazol én gang dagligt i 5 dage (se pkt.
English: CI=confidence interval; HR=hazard ratio; CR=complete response; PR=partial response.
Danish: CI = konfidensinterval; HR = hazard ratio; CR = komplet respons; PR = partielt respons.
English: What IMBRUVICA is and what it is used for
Danish: Hvad IMBRUVICA anvendes til
English: Women of childbearing potential must use a highly effective method of contraception while taking IMBRUVICA (see section 4.6).
Danish: Fertile kvinder skal anvende en yderst effektiv præventionsmetode, mens de tager IMBRUVICA (se pkt.
English: At baseline, the median serum IgM value was 3.2 g/dL (range, 0.6 to 8.3 g/dL), 63% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L) and MYD88 L265P mutations were present in 77% of patients, absent in 13% of patients, and 9% of patients were not evaluable for mutation status.
Danish: Ved baseline var medianværdien for serum-IgM 3,2 g/dl (interval: 0,6 til 8,3 g/dl), 63 % af patienterne havde anæmi (hæmoglobin ≤ 11 g/dl eller 6,8 mmol/l), og MYD88 L265P-mutationer var til stede hos 77 % af patienterne og ikke til stede hos 13 % af patienterne, og 9 % af patienterne kunne ikke evalueres for mutationsstatus.
English: IMBRUVICA contains sodium
Danish: IMBRUVICA indeholder natrium
English: The recommended dose for the treatment of WM is 420 mg once daily.
Danish: Den anbefalede dosis til behandling af WM er 420 mg en gang dagligt.
English: Treatment-emergent grade 3 or 4 cytopenias (neutropenia, thrombocytopenia and anaemia) were reported in patients treated with IMBRUVICA.
Danish: Der er blevet indberettet cytopenier af grad 3 eller 4 (neutropeni, trombocytopeni og anæmi), der er opstået efter behandlingsstart, hos patienter i behandling med IMBRUVICA.
English: The treatment effect of ibrutinib was consistent across the high-risk CLL/SLL population (del17p/TP53 mutation, del11q, or unmutated IGHV), with a PFS HR of 0.15 [95% CI (0.09, 0.27)], as shown in Table 6.
Danish: Ibrutinibs behandlingsvirkning var sammenlignelig på tværs af højrisiko CLL/SLL-populationen (del17p/TP53-mutation, del11q eller ikke-muteret IGHV), med en PFS HR på 0,15 [95 % CI (0,09; 0,27)], som vist i tabel 6.
English: Atrial fibrillation Uncommon Ventricular tachyarrhythmia
Danish: Atrieflimren Ikke almindelig Ventrikulær takyarytmi
English: If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Danish: Hvis fordelene opvejer risikoen, og der skal anvendes en potent CYP3A4-hæmmer, skal dosis af IMBRUVICA reduceres til 140 mg i det tidsrum, hæmmeren anvendes, eller også skal IMBRUVICA midlertidigt tilbageholdes (i 7 dage eller derunder).
English: In vitro platelet aggregation
Danish: Blodpladeaggregation in vitro
English: Capsule content Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Sodium lauril sulfate (E487)
Danish: Kapslens indhold Croscarmellosenatrium Magnesiumstearat Mikrokrystallinsk cellulose Natriumlaurylsulfat (E487)
English: If symptoms develop, interrupt IMBRUVICA and manage ILD appropriately.
Danish: Hvis der udvikles symptomer, skal behandling med IMBRUVICA afbrydes og relevant behandling af ILS iværksættes.
English: Non-melanoma skin cancer Basal cell carcinoma Squamous cell carcinoma
Danish: Non-melanom hudcancer* Basalcellekarcinom Pladecellekarcinom
English: No effects on fertility or reproductive capacities were observed in male or female rats up to the maximum dose tested, 100 mg/kg/day (Human Equivalent Dose [HED] 16 mg/kg/day) (see section 5.3).
Danish: Der blev ikke observeret virkninger på fertilitet eller reproduktionsevne hos han- og hunrotter op til den maksimalt testede dosis, 100 mg/kg/dag (HED [humanækvivalent dosis] 16 mg/kg/dag) (se pkt.
English: Simulations using fasted conditions suggested that the mild CYP3A4 inhibitors azithromycin and fluvoxamine may increase the AUC of ibrutinib by <2-fold.
Danish: Simuleringer med patienter under fastende omstændigheder tydede på, at de svage CYP3A4-hæmmere azithromycin og fluvoxamin kan øge AUC for ibrutinib med < 2 gange.
English: Fourth discontinue IMBRUVICA
Danish: Fjerde seponer IMBRUVICA
English: If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg (one capsule) for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Danish: Hvis fordelene opvejer risikoen, og der skal anvendes en potent CYP3A4-hæmmer, skal dosis af IMBRUVICA reduceres til 140 mg (én kapsel) i det tidsrum, hæmmeren anvendes, eller også skal IMBRUVICA midlertidigt tilbageholdes (i 7 dage eller derunder).
English: In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the strong CYP3A4 inhibitor voriconazole increased Cmax by 6.7-fold and AUC by 5.7-fold.
Danish: Hos patienter med B-celle-maligniteter, der tog IMBRUVICA sammen med mad, forøgede samtidig administration af den potente CYP3A4-hæmmer voriconazol Cmax 6,7 gange og AUC 5,7 gange.
English: IMBRUVICA as a single agent or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).
Danish: IMBRUVICA som monoterapi eller i kombination med obinutuzumab er indiceret til voksne patienter med tidligere ubehandlet kronisk lymfatisk leukæmi (CLL) (se pkt.
English: Hypertension has occurred in patients treated with IMBRUVICA (see section 4.8).
Danish: Der er forekommet tilfælde af hypertension hos patienter behandlet med IMBRUVICA (se pkt.
English: Median DOR months (range)
Danish: Median DOR i måneder (interval)
English: The median time since diagnosis was 42 months, and median number of prior treatments was 3 (range: 1 to 5 treatments), including 35% with prior high-dose chemotherapy, 43% with prior bortezomib, 24% with prior lenalidomide, and 11% with prior autologous or allogeneic stem cell transplant.
Danish: Mediantiden siden diagnose var 42 måneder, og medianantallet af tidligere behandlinger var 3 (interval: 1 til 5 behandlinger), herunder 35 % med tidligere behandling med højdosis-kemoterapi, 43 % med tidligere behandling med bortezomib, 24 % med tidligere behandling med lenalidomid samt 11 % med tidligere autolog eller allogen stamcelletransplantation.
English: • Swallow the tablets whole.
Danish: • Tabletterne skal synkes hele.
English: Consequently the foetal NOAEL was 5 mg/kg/day (approximately 0.7 times the AUC of ibrutinib at a dose of 560 mg daily) (see section 4.6).
Danish: Heraf følger, at NOAEL for fostre var 5 mg/kg/dag (ca. 0,7 gange AUC for ibrutinib ved en dosis på 560 mg dagligt) (se pkt.
English: Consequently the foetal NOAEL was 10 mg/kg/day (approximately 1.3 times the AUC of ibrutinib at a dose of 560 mg daily) (see section 4.6).
Danish: Heraf følger, at foster-NOAEL var 10 mg/kg/dag (ca. 1,3 gange AUC for ibrutinib ved en dosis på 560 mg dagligt) (se pkt.
English: Ibrutinib is primarily metabolised by cytochrome P450 enzyme 3A4 (CYP3A4).
Danish: Ibrutinib metaboliseres primært af CYP3A4.
English: Very common Pneumonia Upper respiratory tract infection
Danish: Meget almindelig Pneumoni* Infektion i øvre luftveje Hudinfektion*
English: The median investigator-assessed PFS was not reached in the IMBRUVICA arm and was 15 months [95% CI (10.22, 19.35)] in the chlorambucil arm; (HR=0.14 [95% CI (0.09, 0.21)]).
Danish: Den mediane investigatorvurderede PFS blev ikke nået i IMBRUVICA-gruppen og var 15 måneder [95 % CI (10,22; 19,35)] i chlorambucil-gruppen (HR = 0,14 [95 % CI (0,09; 0,21)]).
English: At baseline, 58% of patients had at least one tumour ≥5 cm. Thirty-two percent of patients had deletion 17p (with 50% of patients having deletion 17p/TP53 mutation), 24% had 11q deletion, and 47% of patients had unmutated IGHV.
Danish: Ved baseline havde 58 % af patienterne mindst én tumor ≥ 5 cm. 32 % af patienterne havde deletion 17p (med 50 % af patienterne med deletion 17p/TP53-mutation), 24 % havde 11q-deletion og 47 % af patienterne havde ikke-muteret IGHV.
English: Monitor patients for signs of IMBRUVICA toxicity and follow dose modification guidance as needed.
Danish: Monitorer patienterne for tegn på IMBRUVICA-toksicitet, og følg vejledningen vedr.
English: What IMBRUVICA is
Danish: Hvad er IMBRUVICA
English: Second restart at 420 mg daily restart at 280 mg daily
Danish: Anden start igen med 420 mg dagligt start igen med 280 mg dagligt
English: The median investigator-assessed PFS2 (time from randomisation until PFS event after first subsequent anti-neoplastic therapy) according to IWCLL criteria was 65.4 months [95% CI (51.61, not estimable)] in the IMBRUVICA arm and 38.5 months [95% CI (19.98, 47.24)] in the ofatumumab arm, respectively; HR=0.54 [95% CI (0.41, 0.71)].
Danish: Den mediane investigatorvurderede PFS2 (tid fra randomisering indtil PFS-hændelse efter første efterfølgende antineoplastiske behandling) i henhold til IWCLL-kriterierne var henholdsvis 65,4 måneder [95 % CI (51,61; kan ikke estimeres)] i IMBRUVICA-gruppen og 38,5 måneder [95 % CI (19,98; 47,24)] i ofatumumab-gruppen; HR = 0,54 [95 % CI (0,41; 0,71)].
English: The treatment effect of ibrutinib in Study PCYC-1112-CA was consistent across high-risk patients with deletion 17p/TP53 mutation, deletion 11q, and/or unmutated IGHV.
Danish: Ibrutinibs behandlingsvirkning i PCYC-1112-CA-studiet var konsekvent på tværs af højrisikopatienter med deletion 17p/TP53-mutation, deletion 11q og/eller ikke-muteret IGHV.
English: Any grade infusion-related reactions were observed in 25% of patients treated with IMBRUVICA+obinutuzumab and 58% of patients treated with chlorambucil+obinutuzumab.
Danish: Der blev observeret infusionsrelaterede reaktioner af alle grader hos 25 % af patienterne behandlet med IMBRUVICA + obinutuzumab og 58 % af patienterne behandlet med chlorambucil + obinutuzumab.
English: The recommended dose for the treatment of WM is 420 mg (three capsules) once daily.
Danish: Den anbefalede dosis til behandling af WM er 420 mg (tre kapsler) en gang dagligt.
English: • bruising or increased tendency of bruising.
Danish: • blå mærker eller en øget tendens til blå mærker
English: Among previously treated patients, the median number of prior treatments was 2 (range, 1 to 6 treatments).
Danish: Blandt tidligere behandlede patienter var medianantallet af tidligere behandlinger 2 (interval: 1 til 6 behandlinger).
English: Table 6: Subgroup Analysis of PFS (Study PCYC-1130-CA) N Hazard Ratio
Danish: Tabel 6: Undergruppeanalyse af PFS (PCYC-1130-CA-studiet) N Hazard Ratio
English: CI=confidence interval; CR=complete response; HR=hazard ratio; MR=minor response; NE=not estimable; PR=partial response; R=Rituximab; TTnT=time to next treatment; VGPR=very good partial response IRC evaluated.
Danish: CI = konfidensinterval; CR = komplet respons; HR = hazard ratio; MR = mindre respons; NE = ikke estimerbar; PR = partielt respons; R = Rituximab; TTnT = tid til næste behandling; VGPR = meget godt partielt respons IRC-vurderet.
English: There are no data in patients with severe renal impairment or patients on dialysis (see section 5.2).
Danish: patienter med svært nedsat nyrefunktion eller patienter i dialyse (se pkt.
English: In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the CYP3A4 inhibitor erythromycin increased Cmax by 3.4-fold and AUC by 3.0-fold.
Danish: Hos patienter med B-celle-maligniteter, der tog IMBRUVICA sammen med mad, forøgede samtidig administration af CYP3A4-hæmmeren erythromycin Cmax 3,4 gange og AUC 3,0 gange.
English: At baseline, 65% of patients presented with CLL/SLL with high risk factors (del17p/TP53 mutation [18%], del11q [15%], or unmutated IGHV [54%]).
Danish: Ved baseline havde 65 % af patienterne CLL/SLL med høje risikofaktorer (del17p/TP53-mutation [18 %], del11q [15 %], eller ikke-muteret IGHV [54 %]).
English: Administration of ibrutinib in fasted condition resulted in approximately 60% of exposure (AUClast) as compared to either 30 minutes before, 30 minutes after (fed condition) or 2 hours after a high fat breakfast.
Danish: (AUClast) sammenlignet med enten 30 minutter før, 30 minutter efter (dvs. i forbindelse med et måltid) eller 2 timer efter et morgenmåltid med højt fedtindhold.
English: The median number of prior treatments was 4 (range, 1 to 7 treatments).
Danish: Medianantallet af tidligere behandlinger var 4 (interval: 1 til 7 behandlinger).
English: CI=confidence interval; DOR=duration of response; NR=not reached; MR=minor response; PR=partial response; VGPR=very good partial response; ORR=MR+PR+VGPR Median follow-up time on study=14.8 months
Danish: CI = konfidensinterval; DOR = varighed af respons; NR = ikke nået; MR = mindre respons; PR = partielt respons; VGPR = meget godt partielt respons; ORR = MR+PR+VGPR Median opfølgningstid i studiet = 14,8 måneder.
English: Co-administration of rifampicin, a strong CYP3A4 inducer, in 18 fasted healthy subjects, decreased exposure (Cmax and AUC) of ibrutinib by 92 and 90%, respectively.
Danish: Samtidig administration af rifampicin, en potent CYP3A4-induktor, hos 18 fastende, raske forsøgspersoner mindskede eksponering (Cmax og AUC) for ibrutinib med hhv. 92 og 90 %.
English: Monitor patient closely for toxicity and follow dose modification guidance as needed.
Danish: Monitorer patienten nøje for toksicitet, og følg vejledningen vedr.
English: In pregnant rabbits, ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal malformations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased post-implantation loss.
Danish: Hos drægtige kaniner associeredes ibrutinib med misdannelser i skelettet (sammenvoksede sternebrae) ved en dosis på 15 mg/kg/dag og med øget tab efter implantation ved en dosis på 45 mg/kg/dag.
English: Gastrointestinal disorders Very common Diarrhoea Vomiting
Danish: Mave-tarm-kanalen Meget almindelig Diarré Opkastning
English: 120 hard capsules
Danish: 90 hårde kapsler 120 hårde kapsler
English: Manufacturer Janssen Pharmaceutica NV Turnhoutseweg 30
Danish: Janssen Pharmaceutica NV Turnhoutseweg 30
English: The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.
Danish: Den anbefalede dosis IMBRUVICA er fire kapsler (560 mg) en gang om dagen.
English: Each hard capsule contains 140 mg of ibrutinib.
Danish: Hver hård kapsel indeholder 140 mg ibrutinib.
English: Discontinuation and dose reduction due to adverse reactions Of the 1200 patients treated with IMBRUVICA for B-cell malignancies, 5% discontinued treatment primarily due to adverse reactions.
Danish: Behandlingsafbrydelse og dosisreduktion på grund af bivirkninger Af de 1.200 patienter, som blev behandlet med IMBRUVICA for B-celle-maligniteter, afbrød 5 % behandlingen primært som følge af bivirkninger, bl.a. pneumoni, atrieflimren, blødning og trombocytopeni.
English: A large increase in the number of circulating lymphocytes (e.g., >400,000/mcL) has been observed in some patients.
Danish: Der er blevet observeret en stor stigning i antallet af cirkulerende lymfocytter (f.eks. > 400 x 10
English: Table 7: Efficacy results in patients with CLL (Study PCYC-1112-CA) Endpoint
Danish: Tabel 7: Effektresultaterne hos patienter med CLL (studiet PCYC-1112-CA) Endepunkt
English: The treatment effect of ibrutinib in Study PCYC-1115-CA was consistent across high-risk patients with del17p/TP53 mutation, del11q, and/or unmutated IGHV.
Danish: Ibrutinibs behandlingsvirkning i PCYC-1115-CA-studiet var konsekvent på tværs af højrisikopatienter med del17p/TP53-mutation, del11q og/eller ikke-muteret IGHV.
English: The median time since diagnosis was 43 months, and median number of prior treatments was 2 (range: 1 to 9 treatments), including 51% with prior high-dose chemotherapy, 18% with prior bortezomib, 5% with prior lenalidomide, and 24% with prior stem cell transplant.
Danish: Mediantiden efter diagnosticering var 43 måneder, og det mediane antal tidligere behandlinger var 2 (1 til 9 behandlinger), herunder 51 % med tidligere højdosis-kemoterapi, 18 % med tidligere behandling med bortezomib, 5 % med tidligere behandling med lenalidomid og 24 % med tidligere stamcelletransplantation.
English: Number of events (%) Median (95% CI), months
Danish: Antal hændelser (%) Median (95 % CI), måneder
English: Uncommon Angioedema Panniculitis
Danish: Ikke almindelig Angioødem Panniculitis*
English: Dose adjustments Moderate and strong CYP3A4 inhibitors increase the exposure of ibrutinib (see sections 4.4 and 4.5).
Danish: Dosisjusteringer Moderate og potente CYP3A4-hæmmere øger eksponeringen for ibrutinib (se pkt.
English: If a moderate CYP3A4 inhibitor (e.g., fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone and dronedarone) is indicated, reduce IMBRUVICA dose to 280 mg for the duration of the inhibitor use.
Danish: Hvis en moderat CYP3A4-hæmmer (f.eks. fluconazol, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodaron og dronedaron) er indiceret, skal IMBRUVICA-dosis reduceres til 280 mg i det tidsrum, hæmmeren anvendes.
English: Table 3: Efficacy Results in patients with relapsed or refractory MCL (Study MCL3001) Endpoint
Danish: Tabel 3: Effektresultater hos patienter med recidiverende eller refraktær MCL (MCL3001-studiet)
English: Breast-feeding should be discontinued during treatment with IMBRUVICA.
Danish: Amning skal ophøre under behandling med IMBRUVICA.
English: sinus or throat (upper respiratory tract infection), or lung, or skin.
Danish: Det kan være infektioner i næsen, bihulerne eller svælget (de øvre luftveje), i lungerne eller i huden.
English: CI=confidence interval; HR=hazard ratio; CR=complete response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response IRC evaluated, median follow-up 18.4 months.
Danish: CI = konfidensinterval; HR = hazard ratio; CR = komplet respons; ORR = samlet responsrate; OS = samlet overlevelse; PFS = progressionsfri overlevelse; PR = partielt respons IRC-vurderet, median opfølgning 18,4 måneder.
English: The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg once daily (for details of the combination regimen, see section 5.1).
Danish: Den anbefalede dosis til behandling af CLL, enten som monoterapi eller som kombinationsbehandling, er 420 mg en gang dagligt (for yderligere oplysninger om kombinationsregimet, se pkt.
English: • medicines called antibiotics to treat bacterial infections - clarithromycin, telithromycin,
Danish: • medicin, der kaldes antibiotika, som anvendes til at behandle bakterieinfektioner clarithromycin, telithromycin, ciprofloxacin, erythromycin eller rifampicin
English: 30 film-coated tablets
Danish: 10 filmovertrukne tabletter
English: Co-administration of grapefruit juice, containing CYP3A4 inhibitors, in eight healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by approximately 4- and 2-fold, respectively.
Danish: Samtidig administration af grapefrugtjuice, som indeholder CYP3A4-hæmmere, hos otte raske forsøgspersoner øgede eksponering (Cmax og AUC) for ibrutinib hhv. ca. 4 og 2 gange.
English: Patients (n=391) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or ofatumumab for up to 12 doses (300/2,000 mg).
Danish: Patienterne (n = 391) blev randomiseret 1:1 til at modtage enten 420 mg IMBRUVICA dagligt indtil sygdomsprogression eller uacceptabel toksicitet eller op til 12 doser ofatumumab (300/2.000 mg).
English: The Kaplan-Meier curve for PFS is shown in Figure 6.
Danish: Kaplan-Meier-kurven for PFS er vist i figur 6.
English: The updated Kaplan-Meier curve for PFS is shown in Figure 7.
Danish: Den opdaterede Kaplan-Meier-kurve for PFS er vist i figur 7.