FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 3 or 4 infusion-related reactions were observed in 1% of patients treated with IMBRUVICA+rituximab and 16% of patients treated with placebo+rituximab.
Danish: Der blev observeret grad 3 eller 4 infusionsrelaterede reaktioner hos 1 % af patienterne behandlet med IMBRUVICA + rituximab og 16 % af patienterne behandlet med placebo + rituximab.
English: Population pharmacokinetics indicated that age does not significantly influence ibrutinib clearance from the circulation.
Danish: Populationsfarmakokinetik indikerede, at alder ikke har signifikant indflydelse på ibrutinib-clearance fra kredsløbet.
English: The 4-year PFS estimate was 73.9% in the IMBRUVICA arm and 15.5% in the chlorambucil arm, respectively.
Danish: 4 års-estimeringen for PFS var hhv. 73,9 % i IMBRUVICA-gruppen og 15,5 % i chlorambucil-gruppen.
English: Population pharmacokinetics data indicated that gender does not significantly influence ibrutinib clearance from the circulation.
Danish: Populationsfarmakokinetiske data indikerede, at køn ikke har signifikant indflydelse på ibrutinibclearance fra kredsløbet.
English: Progression-free survival (PFS) was assessed by IRC according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.
Danish: Progressionsfri overlevelse (PFS) blev vurderet af IRC i henhold til de reviderede kriterier fra International Working Group (IWG) for non-Hodgkins lymfom (NHL).
English: No dose adjustment is required in combination with mild inhibitors.
Danish: Der kræves ingen dosisjustering ved brug sammen med svage hæmmere.
English: Table 2: ORR and DOR in patients with relapsed or refractory MCL (Study PCYC-1104-CA)
Danish: Tabel 2: ORR og DOR hos patienter med recidiverende eller refraktær MCL (studiet PCYC-1104-CA)
English: Tumor flare in the form of IgM increase occurred in 8.0% of subjects in the IMBRUVICA+rituximab arm and 46.7% of subjects in the placebo+rituximab arm.
Danish: Der forekom tumor-flare i form af en stigning i IgM hos 8,0 % af forsøgspersonerne i IMBRUVICA + rituximab-gruppen og 46,7 % af forsøgspersonerne i placebo + rituximab-gruppen.
English: Uncommon Cryptococcal infections Pneumocystis infections Aspergillus infections Hepatitis B reactivation
Danish: Ikke almindelig Kryptokokinfektioner* Pneumocystisinfektioner* Aspergillusinfektioner* Hepatitis B-reaktivering
English: The corresponding increase in unbound ibrutinib exposure (AUCunbound, last) is estimated to be 4.1-, 9.8-, and 13-fold in subjects with mild, moderate, and severe hepatic impairment, respectively (see section 4.2).
Danish: Den tilsvarende stigning i eksponering for ubundet ibrutinib (AUCunbound, last) anslås at være 4,1, 9,8 og 13 gange hos forsøgspersoner med hhv. let, moderat og svært nedsat leverfunktion (se pkt.
English: Black iron oxide (E172) Propylene glycol (E1520)
Danish: Sort jernoxid (E172) Propylenglycol (E1520)
English: • severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals
Danish: • alvorligt udslæt med vabler og skallende hud, især omkring munden, næsen, øjnene og kønsorganerne (Stevens-Johnsons syndrom).
English: Very common Pyrexia Oedema peripheral
Danish: Meget almindelig Pyreksi Perifert ødem
English: The safety and efficacy of IMBRUVICA in WM (IgM-excreting lymphoplasmacytic lymphoma) were evaluated in an open-label, multi-center, single-arm trial of 63 previously treated patients.
Danish: IMBRUVICAs sikkerhed og virkning ved WM (IgM-udskillende lymfoplasmacytisk lymfom) blev evalueret i et åbent, enkeltarmet multicenter-forsøg med 63 tidligere behandlede patienter.
English: • medicines to prevent nausea and vomiting associated with chemotherapy - aprepitant
Danish: • medicin mod kvalme og opkastning i forbindelse med kemoterapi - aprepitant
English: Polyvinyl chloride (PVC) laminated with polychlorotrifluoroethylene (PCTFE)/aluminium blister of 10 film-coated tablets in a cardboard wallet.
Danish: Blisterpakning af polyvinylklorid (PVC) lamineret med polychlortrifluorethylen (PCTFE)/aluminium med 10 filmovertrukne tabletter i et paphylster.
English: • Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called lymphocytes that also involves the lymph nodes.
Danish: • Kronisk lymfatisk leukæmi (CLL), en kræftform, der påvirker den type hvide blodlegemer, der kaldes lymfocytter, og som også involverer lymfeknuderne.
English: • If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.
Danish: • Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis du ikke er sikker på, hvornår du skal tage din næste dosis.
English: No specific studies have been conducted to date in subjects with impaired renal function.
Danish: Der er til dato ikke udført specifikke studier hos forsøgspersoner med nedsat nyrefunktion.
English: In both arms, patients received 1000 mg of obinutuzumab on Days 1, 8 and 15 of the first cycle, followed by treatment on the first day of 5 subsequent cycles (total of 6 cycles, 28 days each).
Danish: Patienterne i begge grupper modtog 1.000 mg obinutuzumab på dag 1, 8 og 15 i den første serie efterfulgt af behandling på den første dag i de næste 5 serier (6 serier i alt, på hver 28 dage).
English: IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Danish: IMBRUVICA som monoterapi er indiceret til behandling af voksne patienter med recidiverende eller refraktært mantle-celle-lymfom (MCL).
English: Polyvinyl chloride (PVC) laminated with polychlorotrifluoroethylene (PCTFE)/aluminium blister of 14 film-coated tablets in a cardboard wallet.
Danish: Blisterpakning af polyvinylklorid (PVC) lamineret med polychlortrifluorethylen (PCTFE)/aluminium med 14 filmovertrukne tabletter i et paphylster.
English: Patients previously untreated for CLL
Danish: Patienter, som ikke tidligere havde været i behandling for CLL Monoterapi
English: HDPE bottles with a child-resistant polypropylene closure.
Danish: HDPE-beholdere med børnesikret polypropylen-låg.
English: Chronic lymphocytic leukaemia (CLL)/Waldenström's macroglobulinaemia (WM) The recommended dose of IMBRUVICA is 420 mg once a day.
Danish: Kronisk lymfatisk leukæmi (CLL) / Waldenströms makroglobulinæmi (WM) Den anbefalede dosis IMBRUVICA er 420 mg en gang om dagen.
English: 90% of radioactivity was excreted within 168 hours, with the majority (80%) excreted in the faeces and <10% accounted for in urine.
Danish: C]-ibrutinib til raske forsøgspersoner blev ca. 90 % af radioaktiviteten udskilt inden for 168 timer, hvor størstedelen (80 %) blev udskilt i fæces og < 10 % i urin.
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.
Danish: Den mediane alder var 68 år (interval: 37 til 82 år), mediantid siden diagnose var 80 måneder, og medianantal af tidligere behandlinger var 4 (interval: 1 til 12 behandlinger), herunder 92,2 % med en tidligere behandling med en nukleosidanalog, 98,0 % med en tidligere behandling med rituximab, 86,3 % med en tidligere behandling med et alkylerende middel, 39,2 % med en tidligere behandling med bendamustin og 19,6 % med en tidligere behandling med ofatumumab.
English: • breaking of the nails
Danish: • neglene knækker
English: All patients had a baseline ECOG performance status of 0 or 1.
Danish: Alle patienter havde en ECOG-performancestatus ved baseline på 0 eller 1.
English: Patients should be closely monitored for signs of IMBRUVICA toxicity if a CYP3A4 inhibitor must be used (see sections 4.2 and 4.5).
Danish: Patienterne skal monitoreres nøje for tegn på IMBRUVICA-toksicitet, hvis der skal anvendes en CYP3A4-hæmmer (se pkt.
English: If you are not sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.
Danish: Hvis du er usikker, skal du tale med lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel.
English: Bendamustine was dosed at 70 mg/m2 infused IV over 30 minutes on Cycle 1, Days 2 and 3, and on Cycles 2-6, Days 1 and 2 for up to 6 cycles.
Danish: Bendamustin blev doseret med 70 mg/m2 som i.v.-infusion over 30 minutter på dag 2 og 3 i serie 1 og på dag 1 og 2 i serie 2-6 i op til 6 serier.
English: Ibrutinib did not show meaningful inhibition of platelet aggregation using other agonists of platelet aggregation.
Danish: Ibrutinib udviste ikke en betydningsfuld hæmning af blodpladeaggregationen med andre agonister til blodpladeaggregation.
English: Includes multiple adverse reaction terms.
Danish: * Omfatter flere bivirkningstermer.
English: In fasted healthy subjects administered a single 560 mg dose of ibrutinib after taking omeprazole at 40 mg once daily for 5 days, compared to ibrutinib alone, geometric mean ratios (90% CI) were 83% (68-102%), 92% (78-110%), and 38% (26-53%) for AUC0-24, AUClast, and Cmax, respectively.
Danish: 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, var de geometriske middelværdier (90 % CI) 83 % (68-102 %), 92 % (78-110 %) og 38 % (26-53 %) for hhv. AUC0-24, AUClast og Cmax sammenlignet med ibrutinib alene.
English: Interstitial Lung Disease (ILD)
Danish: Interstitiel lungesygdom (ILS)
English: A hepatic impairment trial was performed in non-cancer subjects administered a single dose of 140 mg of medicinal product under fasting conditions.
Danish: Der blev udført et forsøg hos fastende patienter med nedsat leverfunktion, som ikke havde cancer, og som fik en enkelt dosis på 140 mg af lægemidlet.
English: • fast heart rate, missed heart beats, weak or uneven pulse, lightheadedness, shortness of breath,
Danish: • hurtig puls, hjerteslag, der springes over, svag eller uregelmæssig puls, ørhed, kortåndethed,
English: A smaller proportion of patients treated with ibrutinib experienced a clinically meaningful worsening of lymphoma symptoms versus temsirolimus (27% versus 52%) and time to worsening of symptoms occurred more slowly with ibrutinib versus temsirolimus (HR 0.27, p<0.0001).
Danish: En mindre andel af patienterne i ibrutinib-gruppen end i temsirolimus-gruppen oplevede en klinisk betydningsfuld forværring af lymfom-symptomerne (henholdsvis 27 % og 52 %), og tiden til forværring af symptomerne var længere med ibrutinib end med temsirolimus (HR 0,27; p < 0,0001).
English: Not reached HR=0.203 [95% CI: 0.150, 0.276]
Danish: Ikke nået HR = 0,203 [95 % CI: 0,150; 0,276]
English: Co-administration of strong or moderate CYP3A4 inhibitors with IMBRUVICA may lead to increased ibrutinib exposure and consequently a higher risk for toxicity.
Danish: Co-administration af potente eller moderate CYP3A4-hæmmere sammen med IMBRUVICA kan føre til forhøjet ibrutinib-eksponering med deraf følgende øget risiko for toksicitet.
English: 8.1 months HR=0.215 [95% CI: 0.146; 0.317]
Danish: 8,1 måneder HR = 0,215 [95 % CI: 0,146; 0,317]
English: With a median follow-up time on study of 48 months in Study PCYC-1115-CA and its extension study, an 86% reduction in the risk of death or progression by investigator assessment was observed for patients in the IMBRUVICA arm.
Danish: Med en median opfølgningstid i studiet på 48 måneder i PCYC-1115-CA-studiet og dets forlængelsesstudie blev der gennem investigatorvurdering observeret en reduktion på 86 % i risikoen for død eller progression hos patienter i IMBRUVICA-gruppen.
English: In a hepatic impairment study, data showed an increase in ibrutinib exposure (see section 5.2).
Danish: Data fra et studie hos patienter med nedsat leverfunktion viste en øget eksponering for ibrutinib (se pkt.
English: Agents that may decrease ibrutinib plasma concentrations Administration of IMBRUVICA with inducers of CYP3A4 can decrease ibrutinib plasma concentrations.
Danish: Stoffer, der kan mindske koncentrationen af ibrutinib i plasma Administration af IMBRUVICA sammen med CYP3A4-induktorer kan mindske koncentrationen af ibrutinib i plasma.
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 (HED 16 mg/kg/day).
Danish: Der blev ikke observeret virkning på fertilitet eller reproduktionsevne hos han- eller hunrotter op til den maksimalt testede dosis, 100 mg/kg/dag (HED 16 mg/kg/dag).
English: Progression Free Survival Number of events (%) Median (95% CI), months
Danish: Progressionsfri overlevelse Antal hændelser (%) Median (95 % CI), måneder
English: What you need to know before you take IMBRUVICA
Danish: Det skal du vide, før du begynder at tage IMBRUVICA
English: Ibrutinib has a pH dependent solubility, with lower solubility at higher pH.
Danish: Ibrutinibs opløselighed er pH-afhængig med faldende opløselighed ved stigende pH.
English: Strong inhibitors of CYP3A4 (e.g., ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazodon, cobicistat, voriconazole and posaconazole) should be avoided.
Danish: Potente hæmmere af CYP3A4 (f.eks. ketoconazol, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazol, nefazodon, cobicistat, voriconazol og posaconazol) bør undgås.
English: A randomised, multi-center, open-label phase 3 study of IMBRUVICA versus ofatumumab (PCYC-1112-CA) was conducted in patients with relapsed or refractory CLL.
Danish: Et randomiseret, åbent fase 3 multicenterstudie med IMBRUVICA kontra ofatumumab (PCYC-1112-CA) blev udført med patienter med recidiverende eller refraktær CLL.
English: Median duration of overall response, months (range)
Danish: Median varighed af samlet respons, måneder (interval)
English: In pregnant rats, ibrutinib at a dose of 80 mg/kg/day was associated with increased post-implantation loss and increased visceral (heart and major vessels) malformations and skeletal variations with an exposure margin 14 times the AUC found in patients at a daily dose of 560 mg. At a dose of ≥40 mg/kg/day, ibrutinib was associated with decreased foetal weights (AUC ratio of ≥5.6 as compared to daily dose of 560 mg in patients).
Danish: Hos gravide rotter blev ibrutinib ved en dosis på 80 mg/kg/dag associeret med øget tab efter implantation og en stigning i viscerale (hjerte og store kar) misdannelser og skeletrelaterede variationer med en eksponeringsmargin på 14 gange den AUC, der fandtes i patienter med en daglig dosis på 560 mg. Ved en dosis på ≥ 40 mg/kg/dag blev ibrutinib associeret med nedsat fostervægt (AUC-forhold på ≥ 5,6 i forhold til den daglige dosis på 560 mg til patienter).
English: The investigator-assessed ORR was 91.2% in the IMBRUVICA arm versus 36.8% in the chlorambucil arm.
Danish: Den investigatorvurderede ORR var 91,2 % i IMBRUVICA-gruppen versus 36,8 % i chlorambucil-gruppen.
English: With a median follow-up time on study of 65 months in Study PCYC-1112-CA, an 85% reduction in the risk of death or progression by investigator assessment was observed for patients in the IMBRUVICA arm.
Danish: Med en median opfølgningstid i studiet på 65 måneder i PCYC-1112-CA-studiet blev der gennem investigatorvurdering observeret en reduktion på 85 % i risikoen for død eller progression hos patienter i IMBRUVICA-gruppen.
English: IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Danish: IMBRUVICA som monoterapi eller i kombination med bendamustin og rituximab (BR) er indiceret til behandling af voksne patienter med CLL, som har fået mindst én tidligere behandling.
English: IMBRUVICA must not be taken with grapefruit juice or Seville oranges (see section 4.5).
Danish: IMBRUVICA må ikke indtages sammen med grapefrugtjuice eller pomeranser (se pkt.
English: Third restart at 280 mg daily restart at 140 mg daily
Danish: Tredje start igen med 280 mg dagligt start igen med 140 mg dagligt
English: Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og beholderens etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The most commonly occurring adverse reactions (≥20%) were diarrhoea, rash, haemorrhage (e.g., bruising), neutropenia, musculoskeletal pain, nausea, and thrombocytopenia.
Danish: De hyppigste bivirkninger (≥ 20 %) var diarré, udslæt, blødning (f.eks. blå mærker), neutropeni, muskuloskeletale smerter, kvalme og trombocytopeni.
English: The safety and efficacy of IMBRUVICA were demonstrated in a randomised phase 3, open-label, multicenter study including 280 patients with MCL who received at least one prior therapy (Study MCL3001).
Danish: IMBRUVICAs sikkerhed og virkning blev påvist i et randomiseret åbent fase 3-multicenterstudie hos 280 patienter med MCL, der havde fået mindst en tidligere behandling (MCL3001-studiet).
English: Chronic lymphocytic leukaemia (CLL)/Waldenström's macroglobulinaemia (WM) The recommended dose of IMBRUVICA is three capsules (420 mg) once a day.
Danish: Kronisk lymfatisk leukæmi (CLL) / Waldenströms makroglobulinæmi (WM) Den anbefalede dosis IMBRUVICA er tre kapsler (420 mg) en gang om dagen.
English: Ibrutinib is metabolised in the liver.
Danish: Ibrutinib metaboliseres i leveren.
English: • The other ingredients are: capsule content: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sodium lauril sulfate (E487) capsule shell: gelatin and titanium dioxide (E171) printing ink: shellac, black iron oxide (E172), and propylene glycol (E1520).
Danish: • Øvrige indholdsstoffer: Kapslens indhold: croscarmellosenatrium, magnesiumstearat, mikrokrystallinsk cellulose og natriumlaurylsulfat (E487) Kapselskal: gelatine og titandioxid (E171) Trykfarve: shellac, sort jernoxid (E172) og propylenglycol (E1520).
English: In rats, moderate pancreatic acinar cell atrophy (considered adverse) was observed at doses of ≥100 mg/kg in male rats (AUC exposure margin of 2.6-fold) and not observed in females at doses up to 300 mg/kg/day (AUC exposure margin of 21.3-fold).
Danish: Hos rotter observeredes moderat pankreatisk acinær celleatrofi (hvilket anses som en bivirkning) ved doser på ≥ 100 mg/kg hos hanrotter (AUCeksponeringsmargin på 2,6 gange), men dette observeredes ikke hos hunrotter ved doser på op til 300 mg/kg/dag (AUC-eksponeringsmargin på 21,3 gange).
English: IMBRUVICA was administered orally at 560 mg once daily until disease progression or unacceptable toxicity.
Danish: IMBRUVICA blev administreret oralt med 560 mg en gang dagligt indtil sygdomsprogression eller uacceptabel toksicitet.
English: Tumour response was assessed according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.
Danish: Tumorrespons blev vurderet i henhold til de reviderede NHL-kriterier (non-Hodgkins lymfom) fra International Working Group (IWG).
English: Ibrutinib caused malformations in rabbits at a dose of 15 mg/kg/day (approximately 2.0 times the exposure (AUC) in patients with MCL administered ibrutinib 560 mg daily and 2.8 times the exposure in patients with CLL or WM receiving ibrutinib dose 420 mg per day).
Danish: Ibrutinib forårsagede misdannelser hos kaniner ved en dosis på 15 mg/kg/dag (ca. 2,0 gange eksponeringen (AUC) hos patienter med MCL, som får 560 mg ibrutinib dagligt, og 2,8 gange eksponeringen hos patienter med CLL eller WM, som får 420 mg ibrutinib dagligt).
English: Based on mean exposure (AUC) at the 560 mg/day clinical dose, AUC ratios were 2.6 and 21 at the NOAEL in male and female rats, and 0.4 and 1.8 at the NOAEL in male and female dogs, respectively.
Danish: Baseret på middeleksponering (AUC) med den kliniske dosis på 560 mg/dag var AUCforholdet hhv. 2,6 og 21 ved NOAEL hos han- og hunrotter, og 0,4 og 1,8 ved NOAEL hos han- og hunhunde.
English: IMBRUVICA was administered orally at 420 mg once daily until disease progression or unacceptable toxicity.
Danish: IMBRUVICA blev administreret oralt med 420 mg en gang dagligt indtil sygdomsprogression eller uacceptabel toksicitet.
English: IMBRUVICA Hard Capsules Janssen Pharmaceutica NV Turnhoutseweg 30
Danish: IMBRUVICA hårde kapsler Janssen Pharmaceutica NV Turnhoutseweg 30
English: Agents that may increase ibrutinib plasma concentrations Concomitant use of IMBRUVICA and medicinal products that strongly or moderately inhibit CYP3A4 can increase ibrutinib exposure and strong CYP3A4 inhibitors should be avoided.
Danish: Stoffer, der kan øge koncentrationen af ibrutinib i plasma Samtidig brug af IMBRUVICA og lægemidler, som hæmmer CYP3A4 i kraftig eller moderat grad, kan øge eksponering for ibrutinib, og potente CYP3A4-hæmmere bør undgås.
English: What IMBRUVICA looks like and contents of the pack IMBRUVICA are white opaque, hard capsules marked with “ibr 140 mg” in black ink on one side.
Danish: IMBRUVICA er hvide, uigennemsigtige, hårde kapsler mærket med “ibr 140 mg” med sort på den ene side.
English: The 2-year PFS rate estimates for the high-risk CLL/SLL population were 78.8% [95% CI (67.3, 86.7)] and 15.5% [95% CI (8.1, 25.2)] in the IMBRUVICA+obinutuzumab and chlorambucil+obinutuzumab arms, respectively.
Danish: Estimeringerne for 2 års PFS-raten for højrisiko CLL/SLL-populationen var hhv. 78,8 % [95 % CI (67,3; 86,7)] og 15,5 % [95 % CI (8,1; 25, 2)] i IMBRUVICA + obinutuzumabgruppen og chlorambucil + obinutuzumab-gruppen.
English: The patient should not take extra tablets to make up the missed dose.
Danish: Patienten må ikke tage ekstra tabletter som erstatning for den glemte dosis.
English: Transient ischaemic attack Ischaemic stroke a, #
Danish: Transitorisk iskæmisk attak Iskæmisk slagtilfælde a,#
English: Always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: If the benefit outweighs the risk and a strong or moderate CYP3A4 inducer must be used, monitor patient closely for lack of efficacy (see sections 4.3 and 4.4).
Danish: Hvis fordelen opvejer risikoen, og det er nødvendigt at anvende en potent eller moderat CYP3A4-induktor, skal patienten monitoreres nøje for manglende effekt (se pkt.
English: Women of childbearing age must use a highly effective method of birth control during and up to three months after receiving IMBRUVICA, to avoid becoming pregnant while being treated with IMBRUVICA.
Danish: Kvinder i den fødedygtige alder skal anvende en yderst effektiv form for prævention, mens de får IMBRUVICA, og i op til tre måneder efter, at de har fået IMBRUVICA, for at undgå at blive gravide, mens de er i behandling med IMBRUVICA.
English: Grade 3 or higher or serious infusion-related reactions were observed in 3% of patients treated with IMBRUVICA+obinutuzumab and 9% of patients treated with chlorambucil+obinutuzumab.
Danish: Der blev observeret grad 3 eller højere eller alvorlige infusionsrelaterede reaktioner hos 3 % af patienterne behandlet med IMBRUVICA + obinutuzumab og 9 % af patienterne behandlet med chlorambucil + obinutuzumab.
English: Each carton contains (28 film-coated tablets) 2 wallets.
Danish: Hver karton indeholder (28 filmovertrukne tabletter) 2 hylstre.
English: Tests and check-ups before and during treatment Tumour lysis syndrome (TLS): Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment.
Danish: Tumorlysesyndrom (TLS): Der er forekommet tilfælde af unormale niveauer i blodet af stoffer fra tumorhenfald, forårsaget af den hurtige nedbrydning af kræftceller under behandling af kræft og i visse tilfælde endda uden behandling.
English: At baseline, the median serum IgM value was 3.5 g/dL, and 60% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L).
Danish: Ved baseline var medianværdien for serum-IgM 35 g/l, og 60 % af patienterne var anæmiske (hæmoglobin ≤ 110 g/l [6,82 mmol/l]).