FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
Dutch: Voor patiënten met een lichte leverinsufficiëntie (Child-Pugh klasse A), is de aanbevolen dosis 280 mg per dag.
English: The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian.
Dutch: De mediane leeftijd was 64 jaar (bereik: 31 tot 86 jaar), 66% was man en 91% was blank.
English: Patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Dutch: Patiënten met een hoge tumorlast voorafgaand aan de behandeling hebben een verhoogd risico op het tumorlysissyndroom.
English: The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian.
Dutch: De mediane leeftijd was 67 jaar (bereik: 30 tot 88 jaar), 68% was man en 90% was blank.
English: INFORMATION IN BRAILLE Imbruvica 420 mg
Dutch: Imbruvica 420 mg
English: The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian.
Dutch: De mediane leeftijd was 68 jaar (bereik: 40 tot 84 jaar), 77% was man en 92% was blank.
English: The median time since diagnosis was 74 months, and the median number of prior treatments was 2 (range: 1 to 11 treatments).
Dutch: De mediane tijd sinds de diagnose was 74 maanden en het mediane aantal eerdere behandelingen was 2 (bereik: 1 tot 11 behandelingen).
English: All subjects
Dutch: Alle proefpersonen
English: IMBRUVICA 140 mg film-coated tablets and IMBRUVICA 420 mg film-coated tablets Macrogol
Dutch: IMBRUVICA 140 mg filmomhulde tabletten en IMBRUVICA 420 mg filmomhulde tabletten Macrogol
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
Dutch: IMBRUVICA 140 mg filmomhulde tabletten IMBRUVICA 280 mg filmomhulde tabletten IMBRUVICA 420 mg filmomhulde tabletten IMBRUVICA 560 mg filmomhulde tabletten
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
Dutch: IMBRUVICA 140 mg filmomhulde tabletten IMBRUVICA 280 mg filmomhulde tabletten IMBRUVICA 420 mg filmomhulde tabletten IMBRUVICA 560 mg filmomhulde tabletten ibrutinib
English: Fatigue, dizziness and asthenia have been reported in some patients taking IMBRUVICA and should be considered when assessing a patient's ability to drive or operate machines.
Dutch: Hiermee dient rekening te worden gehouden bij de beoordeling van de rijvaardigheid van een patiënt en zijn/haar vermogen om machines te bedienen.
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.
Dutch: De dosis van ibrutinib dient te worden verlaagd tot 140 mg eenmaal daags of gedurende maximaal 7 dagen te worden onderbroken bij gelijktijdig gebruik met sterke CYP3A4-remmers.
English: IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
Dutch: IMBRUVICA 140 mg filmomhulde tabletten: elke tablet bevat 140 mg ibrutinib.
English: IMBRUVICA 560 mg film-coated tablets Macrogol
Dutch: IMBRUVICA 560 mg filmomhulde tabletten Macrogol
English: HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response
Dutch: HR = hazard ratio; BI = betrouwbaarheidsinterval; ORR = algeheel responspercentage (overall response rate); OS = algehele overleving (overall survival); PFS = progressievrije overleving (progression free survival); PR = partiële respons
English: Cases of progressive multifocal leukoencephalopathy (PML) including fatal ones have been reported following the use of ibrutinib within the context of a prior or concomitant immunosuppressive therapy.
Dutch: Na gebruik van ibrutinib binnen de context van een eerdere of gelijktijdig toegepaste immunosuppressieve therapie zijn er gevallen gemeld van progressieve multifocale leuko-encefalopathie (PML), waaronder gevallen met een fatale afloop.
English: INFORMATION IN BRAILLE Imbruvica 140 mg
Dutch: Imbruvica 140 mg
English: Figure 7: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1112-CA at Final Analysis with 65 months Follow-up
Dutch: Figuur 7: Kaplan-Meier-curve van de PFS (ITT-populatie) in studie PCYC-1112-CA bij eindanalyse met 65 maanden follow-up
English: NE=not estimable; HR=hazard ratio; CI=confidence interval; ORR=overall response rate; PFS=progression-free survival IRC evaluated.
Dutch: NE = niet te schatten (not estimable); HR = hazard ratio; BI = betrouwbaarheidsinterval; ORR = algeheel responspercentage (overall response rate); PFS = progressievrije overleving (progression free survival) beoordeeld door de IRC.
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Dutch: 28 filmomhulde tabletten 30 filmomhulde tabletten
English: Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Dutch: Tabel 11: Werkzaamheidsresultaten in studie PCYC-1127-CA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE
Dutch: ETIKET OP FLES 140 MG CAPSULE
English: Mild CYP3A4 inhibitors
Dutch: Lichte CYP3A4-remmers
English: The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
Dutch: De mediane leeftijd was 69 jaar (bereik 36 tot 89 jaar), 66% was man en 79% was blank.
English: IMBRUVICA 280 mg film-coated tablets Macrogol
Dutch: IMBRUVICA 280 mg filmomhulde tabletten Macrogol
English: IMBRUVICA 420 mg film-coated tablets
Dutch: IMBRUVICA 420 mg filmomhulde tabletten
English: IMBRUVICA 140 mg film-coated tablets
Dutch: IMBRUVICA 140 mg filmomhulde tabletten
English: The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian.
Dutch: De mediane leeftijd was 63 jaar (bereik: 44 tot 86 jaar), 76% was man en 95% was blank.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking IMBRUVICA:
Dutch: Neem contact op met uw arts, apotheker of verpleegkundige voordat u dit middel gebruikt:
English: Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate.
Dutch: Hulpstoffen met bekend effect Elke filmomhulde tablet van 560 mg bevat 112 mg lactosemonohydraat.
English: Non-melanoma skin cancer Basal cell carcinoma Squamous cell carcinoma
Dutch: Niet-melanome huidkanker* Basaalcelcarcinoom Plaveiselcelcarcinoom
English: The median age was 68 years (range: 37 to 82 years), median time since diagnosis was 80 months, and median number of prior treatments was 4 (range: 1 to 12 treatments), including 92.2% with a prior nucleoside analog, 98.0% with prior rituximab, 86.3% with a prior alkylator, 39.2% with prior bendamustine and 19.6% with prior ofatumumab.
Dutch: Hiervan werd 92,2% eerder behandeld met een nucleoside-analoog, 98,0% met rituximab, 86,3% met een alkylerend middel, 39,2% met bendamustine en 19,6% met ofatumumab.
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
Dutch: De progressievrije overleving (PFS), beoordeeld door een IRC op basis van de IWCLL-criteria, gaf een statistisch significante afname aan van 77% van het risico op overlijden of progressie in de
English: Moderate CYP3A4 inhibitors
Dutch: Matige CYP3A4-remmers
English: IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib.
Dutch: IMBRUVICA 560 mg filmomhulde tabletten Elke filmomhulde tablet bevat 560 mg ibrutinib.
English: IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg of ibrutinib.
Dutch: IMBRUVICA 560 mg filmomhulde tabletten: elke tablet bevat 560 mg ibrutinib.
English: • inflammation of the fatty tissue underneath the skin
Dutch: • ontsteking van het onderhuidse vetweefsel
English: Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Dutch: Figuur 5: Kaplan-Meier-curve van de PFS (ITT-populatie) in studie PCYC-1130-CA
English: The median time since diagnosis was 6 years and the median number of prior treatments was 2 (range, 1 to 11 treatments).
Dutch: De mediane tijd vanaf diagnose was 6 jaar en het mediane aantal eerdere behandelingen was 2 (bereik: 1 tot 11 behandelingen).
English: Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
Dutch: Hulpstoffen met bekend effect Elke filmomhulde tablet van 140 mg bevat 28 mg lactosemonohydraat.
English: Very common Pyrexia Oedema peripheral
Dutch: Pyrexie Perifeer oedeem
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
Dutch: WALLET 560 MG TABLET (28 dagen)
English: IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg of ibrutinib.
Dutch: IMBRUVICA 420 mg filmomhulde tabletten: elke tablet bevat 420 mg ibrutinib.
English: Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate.
Dutch: Hulpstoffen met bekend effect Elke filmomhulde tablet van 420 mg bevat 84 mg lactosemonohydraat.
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.
Dutch: Gele tot oranje langwerpige tabletten (19 mm lang en 8,1 mm breed), met op de ene kant ‘ibr' en op de andere kant ‘560'.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
Dutch: WALLET 560 MG TABLET (30 dagen)
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.
Dutch: De progressievrije overleving (progression free survival, PFS), zoals beoordeeld door de IRC op basis van de IWCLL-criteria, gaf voor patiënten in de IMBRUVICA-arm een statistisch significante afname aan van 78% in het risico op overlijden of op progressie.
English: Fertility
Dutch: Hartaritmie
English: Purple oblong tablets (15 mm in length and 7 mm in width), debossed with “ibr” on one side and “280” on the other side.
Dutch: Paarse langwerpige tabletten (15 mm lang en 7 mm breed), met op de ene kant ‘ibr' en op de andere kant ‘280'.
English: Figure 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA
Dutch: Figuur 8: Kaplan-Meier-curve van de PFS (ITT-populatie) in studie PCYC-1127-CA
English: IMBRUVICA 560 mg film-coated tablets
Dutch: IMBRUVICA 560 mg filmomhulde tabletten
English: IMBRUVICA 280 mg film-coated tablets: Each tablet contains 280 mg of ibrutinib.
Dutch: IMBRUVICA 280 mg filmomhulde tabletten: elke tablet bevat 280 mg ibrutinib.
English: The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian.
Dutch: De mediane leeftijd was 68 jaar (bereik: 34 tot 88 jaar), 74% was man en 87% was blank.
English: IMBRUVICA 420 mg film-coated tablets Each film-coated tablet contains 420 mg of ibrutinib.
Dutch: IMBRUVICA 420 mg filmomhulde tabletten Elke filmomhulde tablet bevat 420 mg ibrutinib.
English: IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib.
Dutch: IMBRUVICA 280 mg filmomhulde tabletten Elke filmomhulde tablet bevat 280 mg ibrutinib.
English: IMBRUVICA 280 mg film-coated tablets
Dutch: IMBRUVICA 280 mg filmomhulde tabletten
English: Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), debossed with “ibr” on one side and “420” on the other side.
Dutch: Geelgroene tot groene langwerpige tabletten (17,5 mm lang en 7,4 mm breed), met op de ene kant ‘ibr' en op de andere kant ‘420'.
English: Tumour lysis syndrome has been reported with IMBRUVICA therapy.
Dutch: Bij behandeling met IMBRUVICA is melding gemaakt van het tumorlysissyndroom.
English: Immune system disorders
Dutch: Immuunsysteemaandoeningen Vaak
English: • liver failure
Dutch: • misselijkheid of braken
English: Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Dutch: Hulpstoffen met bekend effect Elke filmomhulde tablet van 280 mg bevat 56 mg lactosemonohydraat.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
Dutch: WALLET 420 MG TABLET (30 dagen)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (28 days)
Dutch: WALLET 280 MG TABLET (28 dagen)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg tablets ibrutinib
Dutch: IMBRUVICA 140 mg tabletten ibrutinib
English: CI=confidence interval; HR=hazard ratio; ORR=overall response rate; OS=overall survival; PFS=progression-free survival IRC evaluated.
Dutch: BI = betrouwbaarheidsinterval; HR = hazard ratio; ORR = algeheel responspercentage (overall response rate); OS = algehele overleving (overall survival); PFS = progressievrije overleving (progression free survival) Beoordeeld door de IRC.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
Dutch: IMBRUVICA 140 mg harde capsules
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (30 days)
Dutch: WALLET 280 MG TABLET (30 dagen)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
Dutch: IMBRUVICA 420 mg tabletten ibrutinib
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
Dutch: IMBRUVICA 560 mg tabletten ibrutinib
English: Posology
Dutch: Printinkt
English: Very common Pneumonia Upper respiratory tract infection
Dutch: Bovenste luchtweginfectie Huidinfectie*
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
Dutch: WALLET 420 MG TABLET (28 dagen)
English: Figure 3: Kaplan-Meier curve of OS (ITT Population) in Study PCYC-1115-CA
Dutch: Figuur 3: Kaplan-Meier-curve van de OS (ITT-populatie) in studie PCYC-1115-CA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (28 days)
Dutch: WALLET 140 MG TABLET (28 dagen)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (30 days)
Dutch: WALLET 140 MG TABLET (30 dagen)
English: Patients with mild or moderate renal impairment were treated in IMBRUVICA clinical studies.
Dutch: In de klinische studies met IMBRUVICA zijn patiënten met lichte of matig ernstige nierinsufficiëntie behandeld.
English: Film-coat
Dutch: Filmomhulling
English: Urticaria
Dutch: Leverfalen
English: Analysis of OS demonstrated a 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA arm. Efficacy results for Study PCYC-1112-CA are shown in Table 7.
Dutch: Analyse van de OS toonde een statistisch significante afname van 57% in het risico op overlijden voor patiënten in de IMBRUVICA-arm.
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.
Dutch: Bij baseline was de mediane waarde voor serum-IgM 3,2 g/dl (bereik 0,6 tot 8,3 g/dl), 63% van de patiënten was anemisch (hemoglobine ≤ 11 g/dl of
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.
Dutch: Hiervan werd 35% eerder behandeld met een hogedosis-chemotherapie, 43% met bortezomib, 24% met lenalidomide, en 11% met autologe of allogene stamceltransplantie.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg tablets ibrutinib
Dutch: IMBRUVICA 280 mg tabletten ibrutinib
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Dutch: 14 filmomhulde tabletten
English: Chronic lymphocytic leukaemia (CLL)/Waldenström's macroglobulinaemia (WM) The recommended dose of IMBRUVICA is 420 mg once a day.
Dutch: Chronische lymfatische leukemie (CLL)/ziekte van Waldenström (macroglobulinemie - WM)
English: Figure 2: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1115-CA
Dutch: Figuur 2: Kaplan-Meier-curve van de PFS (ITT-populatie) in studie PCYC-1115-CA
English: Hepatic failure
Dutch: Ernstige hartziekte
English: Toxicity occurrence
Dutch: Aantal keer optreden van toxiciteit
English: Cases of ILD have been reported in patients treated with IMBRUVICA.
Dutch: Bij patiënten behandeld met IMBRUVICA zijn gevallen van ILD gemeld.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg capsules ibrutinib
Dutch: IMBRUVICA 140 mg capsules ibrutinib
English: Table 8: Subgroup analysis of PFS (Study PCYC-1112-CA)
Dutch: Tabel 8: Subgroepanalyse van PFS (studie PCYC-1112-CA) Hazard ratio
English: Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
Dutch: Figuur 6: Kaplan-Meier-curve voor PFS (ITT-populatie) in studie PCYC-1112-CA
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg film-coated tablets ibrutinib
Dutch: IMBRUVICA 140 mg filmomhulde tabletten ibrutinib
English: How IMBRUVICA works
Dutch: Hoe werkt IMBRUVICA?
English: • skin rash
Dutch: Rash*
English: • fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath - these could be signs of an infection (viral, bacterial or fungal).
Dutch: • koorts, rillingen, pijn in het lichaam, vermoeidheid, verschijnselen van verkoudheid of griep,
English: Mildly decreased trabecular and cortical bone was seen in female rats administered ≥100 mg/kg/day (AUC exposure margin of 20.3-fold).
Dutch: Bij vrouwtjesratten die > 100 mg/kg/dag kregen (20,3-voudige verhoging van de AUC-blootstellingsmarge) werd een lichte afname gezien van trabeculair en corticaal bot.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg film-coated tablets ibrutinib
Dutch: IMBRUVICA 420 mg filmomhulde tabletten ibrutinib
English: Very common Haemorrhage Bruising Hypertension
Dutch: Blauwe plek* Hypertensie*
English: QUALITATIVE AND QUANTITATIVE COMPOSITION IMBRUVICA 140 mg film-coated tablets Each film-coated tablet contains 140 mg of ibrutinib.
Dutch: IMBRUVICA 140 mg filmomhulde tabletten Elke filmomhulde tablet bevat 140 mg ibrutinib.
English: Response Rate (CR, VGPR, PR) Median duration of response, months (range)
Dutch: Responspercentage (CR, VGPR, PR)
English: The CR rate according to IWCLL criteria was 16.2% in the IMBRUVICA arm versus 3.0% in the chlorambucil arm. At the time of long-term follow-up, a total of 73 subjects (54.9%) originally randomized to the chlorambucil arm subsequently received ibrutinib as cross-over treatment.
Dutch: Gedurende de langdurige follow-up ontvingen in totaal 73 proefpersonen (54,9%) die oorspronkelijk gerandomiseerd waren naar de chloorambucil-arm, vervolgens ibrutinib als cross-over-behandeling.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg film-coated tablets ibrutinib
Dutch: IMBRUVICA 560 mg filmomhulde tabletten ibrutinib
English: Angioedema Panniculitis
Dutch: Neutropenie Trombocytopenie
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg film-coated tablets ibrutinib
Dutch: IMBRUVICA 280 mg filmomhulde tabletten ibrutinib
English: EU/1/14/945/007 - 28 tablets (2 wallet packs of 14) EU/1/14/945/008 - 30 tablets (3 wallet packs of 10)
Dutch: EU/1/14/945/007 (28 tabletten) EU/1/14/945/008 (30 tabletten)
English: EU/1/14/945/009 - 28 tablets (2 wallet packs of 14) EU/1/14/945/010 - 30 tablets (3 wallet packs of 10)
Dutch: EU/1/14/945/009 (28 tabletten) EU/1/14/945/010 (30 tabletten)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 140 MG CAPSULE
Dutch: KARTONNEN OMDOOS 140 MG CAPSULE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 280 MG TABLET
Dutch: KARTONNEN OMDOOS 280 MG TABLET
English: EU/1/14/945/012 - 28 tablets (2 wallet packs of 14) EU/1/14/945/006 - 30 tablets (3 wallet packs of 10)
Dutch: EU/1/14/945/012 (28 tabletten) EU/1/14/945/006 (30 tabletten)
English: EU/1/14/945/011 - 28 tablets (2 wallet packs of 14) EU/1/14/945/005 - 30 tablets (3 wallet packs of 10)
Dutch: EU/1/14/945/011 (28 tabletten) EU/1/14/945/005 (30 tabletten)
English: Constipation
Dutch: Duizeligheid
English: Musculoskeletal pain
Dutch: Spierspasmen Skeletspierstelselpijn*
English: • feeling or being sick (nausea or vomiting)
Dutch: moeite met slikken of ademhalen, jeukende huiduitslag (galbulten)
English: Hazard Ratio
Dutch: Hazard ratio op basis van niet-gestratificeerde analyse
English: • feeling dizzy
Dutch: • rugpijn of gewrichtspijn
English: Uncommon Angioedema Panniculitis
Dutch: Angio-oedeem Panniculitis*
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 560 mg of ibrutinib
Dutch: Elke filmomhulde tablet bevat 560 mg ibrutinib
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Dutch: Gebruikt u naast IMBRUVICA nog andere geneesmiddelen, heeft u dat kort geleden gedaan of bestaat de mogelijkheid dat u in de nabije toekomst andere geneesmiddelen gaat gebruiken?
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 280 MG TABLET
Dutch: BLISTERVERPAKKING 280 MG TABLET
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 280 mg of ibrutinib
Dutch: Elke filmomhulde tablet bevat 280 mg ibrutinib
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 140 MG TABLET
Dutch: KARTONNEN OMDOOS 140 MG TABLET
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 420 MG TABLET
Dutch: KARTONNEN OMDOOS 420 MG TABLET
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 420 MG TABLET
Dutch: BLISTERVERPAKKING 420 MG TABLET
English: Leukostasis syndrome
Dutch: Tumorlysissyndroom
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 560 MG TABLET
Dutch: BLISTERVERPAKKING 560 MG TABLET
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 420 mg of ibrutinib
Dutch: Elke filmomhulde tablet bevat 420 mg ibrutinib
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg of ibrutinib
Dutch: Elke filmomhulde tablet bevat 140 mg ibrutinib
English: Breast-feeding
Dutch: Leukostasesyndroom
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 140 MG TABLET
Dutch: BLISTERVERPAKKING 140 MG TABLET
English: Number of prior lines
Dutch: Aantal eerdere behandelingen
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.
Dutch: BI = betrouwbaarheidsinterval; HR = hazard ratio; CR = complete respons; ORR = algeheel responspercentage (overall response rate); OS = algehele overleving (overall survival); PFS = progressievrije overleving (progression free survival); PR = partiële respons
English: Taking this medicine
Dutch: Hoe neemt u dit middel in?
English: EU/1/14/945/006 (30 tablets)
Dutch: EU/1/14/945/006
English: EU/1/14/945/005 (30 tablets)
Dutch: EU/1/14/945/005
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/12/763/001 Ecansya
Dutch: (Fantasie)naam Sterkte Farmaceutische vorm Toedieningsweg Primaire Verpakking
English: 1 bottle + 1 oral syringe 10 ml
Dutch: 1 fles + 1 orale spuit 10 ml
English: Strength Pharmaceutical Form
Dutch: Naam Sterkte Farmaceutische vorm
English: This overview was last updated in 07-2018.
Dutch: Dit overzicht is voor het laatst bijgewerkt in 07-2018.
English: A cycle lasts 3 weeks.
Dutch: Een cyclus duurt 3 weken.
English: Ceplene has been authorised under ‘exceptional circumstances'.
Dutch: Ceplene is goedgekeurd ‘onder uitzonderlijke omstandigheden'.
English: Ceplene received a marketing authorisation valid throughout the EU on 7 October 2008.
Dutch: Ceplene heeft op 7 oktober 2008 een in de hele EU geldige vergunning voor het in de handel brengen gekregen.
English: It is used during the patients' first ‘remission' (a period without symptoms of the disease after the first course of treatment).
Dutch: Het middel wordt gebruikt tijdens de eerste ‘remissie' van de patiënt (een periode zonder symptomen van de ziekte na de eerste behandelingskuur).
English: Histamine is a substance occurring naturally in the body that is involved in many processes.
Dutch: Histamine is een van nature in het lichaam voorkomende stof die bij veel processen is betrokken.