FrancophonIA/ELRC3.0 huggingface dataset:
English: At baseline, 52% had advanced clinical stage (Rai Stage III or IV), 32% of patients had bulky disease (≥5 cm), 44% with baseline anemia, 22% with baseline thrombocytopenia, 28% had a CrCL <60 mL/min, and the median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 4 (range, 0 to 12).
Danish: Ved baseline var 52 % på et fremskredent klinisk stadie (Rai-stadie III eller IV), 32 % af patienterne havde omfangsrig sygdom (≥ 5 cm), 44 % havde anæmi ved baseline, 22 % havde trombocytopeni ved baseline, 28 % havde CrCL < 60 ml/min og CIRS-G (Median Cumulative Illness Rating Score for Geriatrics) var 4 (interval: 0 til 12).
English: Co-administration of ketoconazole, a very strong CYP3A4 inhibitor, in 18 fasted healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by 29- and 24-fold, respectively.
Danish: Samtidig administration af ketoconazol, en meget potent CYP3A4-hæmmer, hos 18 fastende, raske forsøgspersoner øgede eksponering (Cmax og AUC) for ibrutinib hhv. 29 og 24 gange.
English: The updated Kaplan-Meier curve for PFS is shown in Figure 4.
Danish: Den opdaterede Kaplan-Meier-kurve for PFS er vist i figur 4.
English: Ninety-three percent of patients had a baseline ECOG performance status of 0 or 1, and 7% of patients had a baseline ECOG performance status of 2.
Danish: 93 % af patienterne havde en ECOG-performancestatus ved baseline på 0 eller 1, og 7 % af patienterne havde en ECOG-performancestatus ved baseline på 2.
English: The median investigator-assessed PFS according to IWCLL criteria was 44.1 months [95% CI (38.47, 56.18)] in the IMBRUVICA arm and 8.1 months [95% CI (7.79, 8.25)] in the ofatumumab arm, respectively; HR=0.15 [95% CI (0.11, 0.20)].
Danish: Den mediane investigatorvurderede PFS i henhold til IWCLLkriteriet var hhv. 44,1 måneder [95 % CI (38,47; 56,18)] i IMBRUVICA-gruppen og 8,1 måneder [95 % CI (7,79; 8,25)] i ofatumumab-gruppen (HR = 0,15 [95 % CI (0,11; 0,20)]).
English: Patients (n=150) were randomized 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with rituximab until disease progression or unacceptable toxicity.
Danish: Patienterne (n = 150) blev randomiseret 1:1 til at modtage enten 420 mg IMBRUVICA dagligt eller placebo i kombination med rituximab indtil sygdomsprogression eller uacceptabel toksicitet.
English: The recommended dose of IMBRUVICA is 560 mg once a day.
Danish: Den anbefalede dosis IMBRUVICA er 560 mg en gang om dagen.
English: The recommended dose for the treatment of MCL is 560 mg once daily.
Danish: Den anbefalede dosis til behandling af MCL er 560 mg en gang dagligt.
English: Median (95% CI), months
Danish: Median (95 % CI), måneder
English: Rituximab was administered at a dose of 375 mg/m2 in the first cycle,
Danish: Rituximab blev administreret med en dosis på 375 mg/m2 på dag 1 i den første serie og 500 mg/m2 på dag 1 i serie 2 til 6.
English: What you need to know before you take IMBRUVICA Do not take IMBRUVICA
Danish: Det skal du vide, før du begynder at tage IMBRUVICA Sådan skal du tage IMBRUVICA Bivirkninger
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 October 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg (three capsules) 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 (tre kapsler) en gang dagligt (for yderligere oplysninger om kombinationsregimet, se pkt.
English: CI=confidence interval; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response; NR=not reached
Danish: CI = konfidensinterval; CR = komplet respons; DOR = varighed af respons; ORR = samlet responsrate; PR = partielt respons; NR = ikke nået
English: Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001
Danish: Figur 1: Kaplan-Meier-kurver for PFS (ITT-population) i MCL3001-studiet
English: Eighty-one percent of patients had a baseline ECOG performance status of 0 or 1, and 19% had a baseline ECOG performance status of 2.
Danish: 81 % af patienterne havde en ECOG-performancestatus ved baseline på 0 eller 1, og 19 % havde en ECOG-performancestatus ved baseline på 2.
English: Leukostasis
Danish: Leukostase
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/945/001 (90 hard capsules) EU/1/14/945/002 (120 hard capsules)
Danish: EU/1/14/945/001 (90 hårde kapsler) EU/1/14/945/002 (120 hårde kapsler)
English: There are no data from the use of IMBRUVICA in pregnant women.
Danish: anvendelse af IMBRUVICA til gravide kvinder.
English: The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily.
Danish: Den anbefalede dosis til behandling af MCL er 560 mg (fire kapsler) en gang dagligt.
English: If the toxicity reoccurs, the once daily dose should be reduced by 140 mg. A second reduction of dose by 140 mg may be considered as needed.
Danish: Hvis toksiciteten forekommer igen, skal dosis en gang dagligt reduceres med 140 mg.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med IMBRUVICA Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: 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 (two capsules) 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 (to kapsler) i det tidsrum, hæmmeren anvendes.
English: Yellow-green to green round (9 mm) tablets, written with “ibr” on one side and “140” on the other side.
Danish: Gulliggrønne til grønne runde tabletter (9 mm) med påskriften ”ibr” på den ene side og ”140” på den anden side.
English: Cases of leukostasis have been reported in patients treated with IMBRUVICA.
Danish: Der er blevet indberettet tilfælde af leukostase hos patienter i behandling med IMBRUVICA.
English: The median age was 73 years (range, 65 to 90 years), 63% were male, and 91% were Caucasian.
Danish: Medianalderen var 73 år (interval 65 til 90 år), 63 % var mænd, og 91 % var kaukasiere.
English: PFS Median (95% CI), months
Danish: PFS Median (95 % CI), måneder
English: Monitor patients for pulmonary symptoms indicative of ILD.
Danish: Patienterne skal monitoreres for lungesymptomer, der kan tyde på ILS.
English: The safety and efficacy of IMBRUVICA in patients previously treated for CLL were further evaluated in a randomised, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with BR versus placebo+BR (Study CLL3001).
Danish: IMBRUVICAs sikkerhed og virkning hos patienter med tidligere behandling for CLL blev evalueret yderligere i et randomiseret dobbeltblindt fase 3-multicenterstudie af IMBRUVICA i kombination med BR versus placebo + BR (CLL3001-studiet).
English: The safety and efficacy of IMBRUVICA in WM were further evaluated in patients with treatmentnaïve or previously treated WM in a randomized, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with rituximab versus placebo in combination with rituximab (PCYC-1127-CA).
Danish: IMBRUVICAs sikkerhed og virkning ved WM blev yderligere evalueret hos patienter med ubehandlet eller tidligere behandlet WM i et randomiseret, dobbeltblindet fase 3 multicenterstudie med IMBRUVICA i kombination med rituximab versus placebo i kombination med rituximab (PCYC-1127-CA).
English: Patients (n=229) were randomized 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity or chlorambucil at a dose of 0.5 mg/kg on Days 1 and 15 of each 28-day cycle for 6 cycles.
Danish: Patienterne (n = 229) blev randomiseret 1:1 til at modtage enten 420 mg IMBRUVICA dagligt indtil sygdomsprogression eller uacceptabel toksicitet eller chlorambucil ved en dosis på 0,5 mg/kg på dag 1 og 15 i hver 28-dages serie, i 6 på hinanden følgende serier.
English: Refractory disease to purine analog Yes
Danish: Alle forsøgspersoner Del17P Ja Nej Refraktær sygdom til purin analog Ja Nej Alder
English: At baseline, 45% had advanced clinical stage (Rai Stage III or IV), 35% of patients had at least one tumor ≥5 cm, 39% with baseline anemia, 23% with baseline thrombocytopenia, 65% had elevated β2 microglobulin >3500 mcg/L, 47% had a CrCL <60 mL/min, 20% of patients presented with del11q, 6% of patients presented with del17p/tumor protein 53 (TP53) mutation, and 44% of patients presented with unmutated immunoglobulin heavy chain variable region (IGHV).
Danish: Ved baseline var 45 % på et fremskredent klinisk stadie (Rai-stadie III eller IV), 35 % af patienterne havde mindst én tumor ≥ 5 cm, 39 % havde anæmi ved baseline, 23 % havde trombocytopeni ved baseline, 65 % havde forhøjet β2-mikroglobulin > 3500 mikrog/l, 47 % havde CrCl < 60 ml/min, 20 % af patienterne havde del11q, 6 % af patienterne havde del17p/tumorprotein 53 (TP53)-mutation, og 44 % af patienterne havde ikke-muterede gener i den variable region af den tunge kæde af immunglobulinet (IGHV).
English: The safety and efficacy of IMBRUVICA in patients with treatment naïve CLL/SLL were further evaluated in a randomized, multi-center, open-label, Phase 3 study (PCYC-1130-CA) of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab.
Danish: IMBRUVICAs sikkerhed og virkning hos patienter med ubehandlet CLL/SLL blev yderligere vurderet i et randomiseret, åbent fase 3 multicenterstudie (PCYC-1130-CA) med IMBRUVICA i kombination med obinutuzumab versus chlorambucil i kombination med obinutuzumab.
English: The median time since diagnosis was 91 months and the median number of prior treatments was 2 (range: 1 to 13 treatments).
Danish: Mediantiden efter diagnose var 91 måneder, og medianantallet af tidligere behandlinger var 2 (interval: 1 til 13 behandlinger).
English: Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA arm.
Danish: Progressionsfri overlevelse (PFS), som vurderet af en IRC i henhold til kriterierne fra IWCLL, indikerede en statistisk signifikant reduktion på 78 % af risikoen for død eller progression for patienter i IMBRUVICA-gruppen.
English: Moderate CYP3A4 inhibitors
Danish: Moderate CYP3A4-hæmmere
English: The median age was 71 years (range, 40 to 87 years), 64% were male, and 96% were Caucasian.
Danish: Medianalderen var 71 år (interval: 40 til 87 år), 64 % var mænd, og 96 % var kaukasiere.
English: Cases of ILD have been reported in patients treated with IMBRUVICA.
Danish: Der er rapporteret tilfælde af ILS hos patienter i behandling med IMBRUVICA.
English: The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Danish: Dosis af ibrutinib skal reduceres til 280 mg en gang dagligt ved brug samtidig med moderate CYP3A4-hæmmere.
English: Patients (n=578) were randomised 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with BR until disease progression, or unacceptable toxicity.
Danish: Patienterne (n = 578) blev randomiseret 1:1 til at få enten 420 mg IMBRUVICA dagligt + BR eller placebo + BR indtil sygdomsprogression eller uacceptabel toksicitet.
English: Table 5: Efficacy results in Study PCYC-1130-CA
Danish: Tabel 5: Effektresultater i PCYC-1130-CA-studiet
English: The dose of ibrutinib should be reduced to 140 mg once daily (one capsule) or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Danish: Dosis af ibrutinib skal reduceres til 140 mg en gang dagligt (én kapsel) eller indstilles i op til 7 dage ved brug samtidig med potente CYP3A4-hæmmere.
English: The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Danish: Dosis af ibrutinib skal reduceres til 280 mg en gang dagligt (to kapsler) ved brug samtidig med moderate CYP3A4-hæmmere.
English: Interstitial lung disease
Danish: Interstitiel lungesygdom*
English: In this same study, a concentration dependent shortening in the QTc interval was observed (-5.3 ms [90% CI: -9.4, -1.1] at a Cmax of 719 ng/mL following the supratherapeutic dose of 1,680 mg).
Danish: Den højeste øvre grænse af det tosidede 90 % CI for den baseline-justerede gennemsnitsforskel mellem ibrutinib og placebo var under 10 ms. I det samme studie sås en koncentrationsafhængig forkortelse af QTc-intervallet (-5,3 ms [90 % CI: -9,4; -1,1] ved en Cmax på 719 nanogram/ml efter den supraterapeutiske dosis på 1.680 mg).
English: Figure 4: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1115-CA with 48 Months Follow-up
Danish: Figur 4: Kaplan-Meier-kurve for PFS (ITT-population) PCYC-1115-CA-studiet med 48 måneders opfølgning
English: INFORMATION IN BRAILLE Imbruvica 560 mg
Danish: Imbruvica 560 mg
English: The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian.
Danish: Medianalderen var 64 år (31 til 86 år), 66 % var mænd, og 91 % var kaukasiere.
English: The median time since diagnosis was 74 months, and the median number of prior treatments was 2 (range: 1 to 11 treatments).
Danish: Mediantiden efter diagnose var 74 måneder, og medianantallet af tidligere behandlinger var 2 (interval 1 til 11 behandlinger).
English: The dose of ibrutinib should be reduced to 140 mg once daily or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Danish: Dosis af ibrutinib skal reduceres til 140 mg en gang dagligt eller indstilles i op til 7 dage ved brug samtidig med potente CYP3A4-hæmmere.
English: • infections of the urinary tract
Danish: • urinvejsinfektioner
English: Figure 7: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1112-CA at Final Analysis with 65 Months Follow-up
Danish: Figur 7: Kaplan-Meier-kurve for PFS (ITT-population) PCYC-1112-CA-studiet ved den endelige analyse med 65 måneders opfølgning
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily.
Danish: For patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) er den anbefalede daglige dosis 140 mg dagligt.
English: The investigator-assessed ORR in the IMBRUVICA arm was 87.7% versus 22.4% in the ofatumumab arm. At the time of final analysis, 133 (67.9%) of the 196 subjects originally randomized to the ofatumumab treatment arm had crossed over to ibrutinib treatment.
Danish: På tidspunktet for den endelige analyse var 133 (67,9 %) af de 196 forsøgspersoner, der oprindeligt blev randomiseret til ofatumumabbehandlingsgruppen, skiftet over til ibrutinib-behandling.
English: Therefore, women of child-bearing potential must use highly effective contraceptive measures while taking IMBRUVICA and for three months after stopping treatment.
Danish: Derfor skal fertile kvinder anvende en meget sikker form for prævention, mens de tager IMBRUVICA, og i op til 3 måneder efter behandlingens afslutning.
English: IMBRUVICA 140 mg film-coated tablets and IMBRUVICA 420 mg film-coated tablets Macrogol
Danish: IMBRUVICA 140 mg filmovertrukne tabletter og IMBRUVICA 420 mg filmovertrukne tabletter Macrogol
English: INFORMATION IN BRAILLE Imbruvica 280 mg
Danish: Imbruvica 280 mg
English: Ninety one percent of patients had a baseline ECOG performance status of 0 or 1 and 9% had an ECOG performance status of 2.
Danish: 91 % af patienterne havde en ECOG-performancestatus ved baseline på 0 eller 1, og 9 % havde en ECOGperformancestatus på 2.
English: Upon initiation of treatment, a reversible increase in lymphocyte counts (i.e., ≥50% increase from baseline and an absolute count >5,000/mcL), often associated with reduction of lymphadenopathy, has been observed in about three fourths of patients with CLL treated with IMBRUVICA.
Danish: Efter indledning af behandlingen er der blevet observeret en reversibel stigning i lymfocyttallet (dvs. ≥ 50 % stigning fra baseline og et absolut tal på > 5 x 10
English: HR (95% CI) Overall Response Rate CR
Danish: HR (95 % CI) Samlet responsrate a (%)
English: The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian.
Danish: Medianalderen var 67 år (interval: 30 til 88 år), 68 % var mænd og 90 % var kaukasiere.
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily (one capsule).
Danish: For patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) er den anbefalede daglige dosis 140 mg dagligt (én kapsel).
English: Table 4: Efficacy results in Study PCYC-1115-CA Endpoint
Danish: Tabel 4: Effektresultater i PCYC-1115-CA-studiet Endepunkt
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules).
Danish: For patienter med let nedsat leverfunktion (Child-Pugh klasse A) er den anbefalede daglige dosis 280 mg dagligt (to kapsler).
English: IMBRUVICA 140 mg hard capsules ibrutinib
Danish: IMBRUVICA 140 mg hårde kapsler ibrutinib
English: At baseline, 39% of patients had bulky disease (≥5 cm), 49% had high-risk score by Simplified MCL International Prognostic Index (MIPI), and 72% had advanced disease (extranodal and/or bone marrow involvement) at screening.
Danish: Simplified MCL International Prognostic Index (MIPI), og 72 % havde fremskreden sygdom (ekstranodal involvering og/eller involvering af knoglemarv) ved screening.
English: The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian.
Danish: Medianalderen var 68 år (interval: 40 til 84 år), 77 % var mænd, og 92 % var kaukasiere.
English: A high number of circulating lymphocytes (>400,000/mcL) may confer increased risk.
Danish: Et højt antal cirkulerende lymfocytter (> 400 x 10
English: IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
Danish: IMBRUVICA 140 mg filmovertrukne tabletter: Hver tablet indeholder 140 mg ibrutinib.
English: IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets ibrutinib
Danish: IMBRUVICA 140 mg filmovertrukne tabletter IMBRUVICA 280 mg filmovertrukne tabletter IMBRUVICA 420 mg filmovertrukne tabletter IMBRUVICA 560 mg filmovertrukne tabletter ibrutinib
English: IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets
Danish: IMBRUVICA 140 mg filmovertrukne tabletter IMBRUVICA 280 mg filmovertrukne tabletter IMBRUVICA 420 mg filmovertrukne tabletter IMBRUVICA 560 mg filmovertrukne tabletter
English: INFORMATION IN BRAILLE Imbruvica 420 mg
Danish: Imbruvica 420 mg
English: Check with your doctor, pharmacist or nurse if you are not sure.
Danish: - Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
Danish: Medianalderen var 69 år (interval: 36 til 89 år), 66 % var mænd, og 79 % var kaukasiere.
English: HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response
Danish: HR = hazard ratio; CI = konfidensinterval; ORR = samlet responsrate; OS = samlet overlevelse; PFS = progressionsfri overlevelse; PR = partielt respons
English: Cardiac arrhythmia
Danish: Alvorlig hjertesygdom
English: At a median duration follow up of 16.4 months, the ORR by IRC for the 51 relapsed or refractory patients was 64.7% (95% CI: 50.1%; 77.6%), all PRs.
Danish: ICR 64,7 % (95 % CI: 50,1 %; 77,6 %), alle PR'er.
English: IMBRUVICA 560 mg film-coated tablets Macrogol
Danish: IMBRUVICA 560 mg filmovertrukne tabletter Macrogol
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Danish: 28 filmovertrukne tabletter 30 filmovertrukne tabletter
English: Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Danish: Tabel 11: Effektresultater i PCYC-1127-CA-studiet
English: The median time since diagnosis was 6 years and the median number of prior treatments was 2 (range, 1 to 11 treatments).
Danish: Mediantiden efter diagnosticering var 6 år, og det mediane antal tidligere behandlinger var 2 (1 til 11 behandlinger).
English: IMBRUVICA 140 mg film-coated tablets
Danish: IMBRUVICA 140 mg filmovertrukne tabletter
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
Danish: For patienter med let nedsat leverfunktion (Child-Pugh klasse A) er den anbefalede daglige dosis 280 mg dagligt.
English: IMBRUVICA 280 mg film-coated tablets Macrogol
Danish: IMBRUVICA 280 mg filmovertrukne tabletter Macrogol
English: The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian.
Danish: Medianalderen var 63 år (interval 44 til 86 år), 76 % var mænd, og 95 % var kaukasiere.
English: Janssen-Cilag B.V. Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Danish: Tel: +31 76 711 1111 janssen@jacnl.jnj.com
English: IMBRUVICA 420 mg film-coated tablets
Danish: IMBRUVICA 420 mg filmovertrukne tabletter
English: At baseline, 53% of patients had bulky disease (≥5 cm), 21% had high-risk score by Simplified MIPI, 60% had extranodal disease and 54% had bone marrow involvement at screening.
Danish: Ved baseline havde 53 % af patienterne bulky disease (≥ 5 cm), 21 % havde højrisiko-score iht.
English: IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib.
Danish: IMBRUVICA 560 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 560 mg ibrutinib.
English: The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian.
Danish: Medianalderen var 68 år (34 til 88 år), 74 % var mænd, og 87 % var kaukasiere.
English: Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), written with “ibr” on one side and “560” on the other side.
Danish: Gule til orange aflange tabletter (19 mm i længen og 8,1 mm i bredden) med påskriften ”ibr” på den ene side og ”560” på den anden side.
English: IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg of ibrutinib.
Danish: IMBRUVICA 560 mg filmovertrukne tabletter: Hver tablet indeholder 560 mg ibrutinib.
English: IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg of ibrutinib.
Danish: IMBRUVICA 420 mg filmovertrukne tabletter: Hver tablet indeholder 420 mg ibrutinib.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
Danish: HYLSTER 560 MG TABLET (30 dage)
English: Patients (n=269) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or chlorambucil at a starting dose of 0.5 mg/kg on days 1 and 15 of each 28-day cycle for a maximum of 12 cycles, with an allowance for intrapatient dose increases up to 0.8 mg/kg based on tolerability.
Danish: Patienterne (n = 269) blev randomiseret 1:1 til enten IMBRUVICA 420 mg dagligt indtil sygdomsprogression eller uacceptabel toksicitet eller chlorambucil med en startdosis på 0,5 mg/kg på dag 1 og 15 i hver 28-dages serie i maksimalt 12 serier.
English: Drug-drug interactions
Danish: Lægemiddelinteraktioner
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
Danish: HYLSTER 560 MG TABLET (28 dage)
English: IMBRUVICA 280 mg film-coated tablets: Each tablet contains 280 mg of ibrutinib.
Danish: IMBRUVICA 280 mg filmovertrukne tabletter: Hver tablet indeholder 280 mg ibrutinib.
English: INFORMATION IN BRAILLE Imbruvica 140 mg
Danish: Imbruvica 140 mg
English: IMBRUVICA 280 mg film-coated tablets
Danish: IMBRUVICA 280 mg filmovertrukne tabletter