FrancophonIA/ELRC3.0 huggingface dataset:
English: · Chronic lymphocytic leukaemia (also called “CLL”) Gazyvaro is used in patients who have not had any treatment for CLL before and who have other illnesses which make it unlikely that they would be able to tolerate a full dose of a different medicine used to treat CLL called fludarabine.
Danish: • Kronisk lymfatisk leukæmi (også kaldet ”CLL”) - Gazyvaro bruges til patienter som ikke tidligere har været behandlet for kronisk lymfatisk leukæmi, og som har andre sygdomme, som gør, at de sandsynligvis ikke vil kunne tåle en fuld dosis af fludarabin, der er et andet lægemiddel som bruges til kronisk lymfatisk leukæmi.
English: What you need to know before you are given Gazyvaro
Danish: Det skal du vide, før du begynder at få Gazyvaro
English: Premedication to reduce the risk of IRRs is outlined in Table 1 (see also section 4.4).
Danish: Præmedicinering, der gives for at reducere risikoen for infusionsrelaterede reaktioner, er vist i tabel 1 (se også pkt.
English: Following intravenous administration, the volume of distribution of the central compartment (2.98 L in patients with CLL and 2.97 in patients with iNHL), approximates serum volume, which indicates distribution is largely restricted to plasma and interstitial fluid.
Danish: Efter intravenøs administration svarer fordelingsvolumen af det centrale kompartment (hhv. 2,98 l hos patienter med kronisk lymfatisk leukæmi og 2,97 l hos patienter med indolent non-Hodgkin lymfom) nogenlunde til serumvolumen.
English: Oral herpes, rhinitis, pharyngitis, lung infection, influenza nasopharyngitis
Danish: Oral herpes, rinitis, faryngitis, lungeinfektion, influenza, nasofaryngitis
English: The population pharmacokinetic analysis of obinutuzumab showed that creatinine clearance does not affect pharmacokinetics of obinutuzumab.
Danish: Den farmakokinetiske populationsanalyse af obinutuzumab viste, at creatininclearance ikke påvirker obinutuzumabs farmakokinetik.
English: Median observation time 34 months
Danish: 34 måneders median observationstid
English: The most frequently reported coexisting medical conditions (using a cut off of 30% or higher), in the MedDRA body systems are: Vascular disorders (73%), Cardiac disorders (46%), Gastrointestinal disorders (38%), Metabolism and nutrition disorders (40%), Renal and urinary disorders (38%), Musculoskeletal and connective tissue disorders (33%).
Danish: De hyppigst indberettede andre samtidige sygdomme (med en cut-off på 30% eller derover) i MedDRA-systemet var: Vaskulære sygdomme (73%), hjertesygdomme (46%), sygdomme i mavetarm-kanalen (38%), stofskifte- og ernæringssygdomme (40%), sygdomme i nyrer og urinveje (38%), sygdomme i knogler, led, muskler og bindevæv (33%).
English: Intravenous corticosteroid1,4 (mandatory for CLL, recommended for FL)
Danish: Intravenøst kortikosteroid1,4(obligatorisk for kronisk lymfatisk leukæmi og anbefalet for follikulært lymfom)
English: Chronic lymphocytic leukaemia (in combination with chlorambucil1)
Danish: Kronisk lymfatisk leukæmi (i kombination med chlorambucil1)
English: Cycle 1 - this will include three doses of Gazyvaro in the 28 days: · Day 1 - part of your first dose (100 mg) · Day 2 or Day 1 (continued) - remainder of first dose 900 mg · Day 8 - full dose (1,000 mg) · Day 15 - full dose (1,000 mg)
Danish: Dette vil inkludere 3 doser af Gazyvaro i løbet af 28 dage: 1. dag - første del af din 1. dosis (100 mg) 2. dag eller 1. dag (fortsat) - anden del af 1. dosis (900 mg) 8. dag - fuld dosis (1000 mg)
English: Upper respiratory tract infection, sinusitis§, , urinary tract infection, pneumonia§ ,herpes zoster§
Danish: Øvre luftvejsinfektion, sinusitis§, urinvejsinfektion, lungebetændelse§, herpes zoster§
English: · Use an effective method of contraception while being treated with Gazyvaro.
Danish: • Du skal bruge sikker prævention mens du er i behandling med Gazyvaro
English: HBVscreening should be performed in all patients before initiation of treatment with Gazyvaro.
Danish: Alle patienter bør screenes for hepatitis B, inden behandling med Gazyvaro påbegyndes.
English: · PML is a very rare and life-threatening brain infection that has been reported in very few patients having treatment with Gazyvaro.
Danish: • Progressiv multifokal leukoencefalopati er en meget sjælden, men livstruende hjernebetændelse, der er set hos meget få patienter, der har fået Gazyvaro.
English: The rates of Grade 3-4 IRRs (which occurred in relatively few patients) were similar before and after mitigation measures were implemented.
Danish: Forekomsten af grad 3-4 infusionsrelaterede reaktioner (som forekom hos relativt få patienter) var den samme, før og efter tiltagene for at dæmpe infusionsrelaterede reaktioner blev indført.
English: In nonclinical studies, obinutuzumab induces direct cell death and mediates antibody dependent cellular cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP) through recruitment of FcɣRIII positive immune effector cells.
Danish: I ikke-kliniske studier inducerer obinutuzumab direkte celledød og medierer antistofafhængig, cellulær cytotoksicitet og antistofafhængig cellulær fagocytose ved rekruttering af FcɣRIII-positive immuneffektor-celler.
English: Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).
Danish: Gazyvaro er i kombination med chlorambucil indiceret til behandling af voksne patienter med tidligere ubehandlet kronisk lymfatisk leukæmi (CLL) og med co-morbiditet, der gør dem uegnede til fludarabinbaseret behandling i fuld dosis (se pkt.
English: Tell your doctor or nurse if you notice any of the side effects listed above.
Danish: Fortæl det til lægen eller sundhedspersonalet hvis du oplever nogen af de nævnte bivirkninger.
English: In addition, there were no apparent effects of bendamustine, FC, chlorambucil or CHOP on the pharmacokinetics of Gazyvaro.
Danish: Yderligere var der ingen umiddelbare virkninger af bendamustin, FC-kemoterapi, chlorambucil eller CHOP-kemoterapi på Gazyvaros farmakokinetik.
English: Diarrhoea, constipation§
Danish: Diarré, forstoppelse§
English: Haemorrhagic events and Grade 3-5 haemorrhagic events occurred in 12% and 5% of patients, respectively.
Danish: Hæmoragiske bivirkninger og grad 3-5 hæmoragiske bivirkninger forekom hos hhv. 12 % og 5 % af patienterne.
English: Before each infusion of Gazyvaro, you will be given medicines to lessen the chance of getting infusion related reactions or tumour lysis syndrome.
Danish: Inden hver infusion af Gazyvaro, vil du få medicin, der mindsker risikoen for infusionsrelaterede reaktioner og for tumorlysesyndrom.
English: Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)
Danish: Gazyvaro er i kombination med kemoterapi efterfulgt af Gazyvaro-vedligeholdelsesbehandling hos patienter, som opnåede respons, indiceret til behandling af patienter med tidligere ubehandlet, fremskreden follikulært lymfom (FL) (se pkt.
English: 1 Chlorambucil is given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles
Danish: Chlorambucil blev givet oralt, 0,5 mg/kg kropsvægt, på 1. dag og 15. dag i alle behandlingsserierne
English: The reduction in the risk of disease progression or death seen in the iNHL population is driven by the subset of patients with FL.
Danish: Risikoreduktionen for sygdoms-progression eller død, som ses hos patienter med indolent non-Hodgkin lymfom, er drevet af subgruppen af patienter med follikulært lymfom.
English: No formal drug-drug interaction studies have been performed, although limited drug-drug interaction sub-studies have been undertaken for Gazyvaro with bendamustine, CHOP, fludarabine and cyclophosphamide (FC), and chlorambucil.
Danish: Der er udført begrænsede sub-studier for lægemiddelinteraktion mellem Gazyvaro og bendamustin, CHOP-kemoterapi, fludarabin, cyclophospamid (FC-kemoterapi) og chlorambucil.
English: 18.7 months median observation time g
Danish: 18,7 måneders medianobservationstidg
English: R-Chemo: Rituximab plus chemotherapy, G-Chemo: Gazyvaro plus chemotherapy, HR: hazard ratio, CI: confidence interval
Danish: R-Kemo: Rituximab plus kemoterapi, G-Kemo: Gazyvaro plus kemoterapi
English: In case of exposure during pregnancy, depletion of B-cells may be expected in infants due to the pharmacological properties of the product.
Danish: På grund af produktets farmakologiske egenskaber er B-celledepletering forventelig hos spædbørn, der har været eksponeret under graviditeten.
English: The observed HRs by chemotherapy subgroup were as follows; CHOP (n = 398): HR 0.77 (95% CI: 0.50, 1.20), CVP (n = 118): HR 0.63 (95% CI: 0.32, 1.21), and bendamustine (n = 686): HR 0.61 (95% CI: 0.43, 0.86).
Danish: 0,50, 1,20), CVP (n = 118): hazard ratio 0,63 (95% konfidensinterval: 0,32, 1,21), og bendamustin (n = 686): hazard ratio 0,61 (95 % konfidensinterval: 0,43, 0,86).
English: Women of childbearing potential must use effective contraception during and for 18 months after treatment with Gazyvaro.
Danish: Fertile kvinder skal anvende sikker prævention under behandling og i 18 måneder efter behandling med Gazyvaro.
English: Only the highest frequency observed in the trials is reported (based on studies BO21004/previously untreated CLL, BO21223/previously untreated advanced iNHL and GAO4753g/rituximab refractory iNHL)
Danish: Kun den højeste observerede frekvens i de kliniske forsøg er rapportet (baseret på studie BO21004/ tidligere ubehandlet kronisk lymfatisk leukæmi, BO21223/tidligere ubehandlet fremskreden indolent non-Hodgkin lymfom og GAO4753g/rituximab refraktær indolent non-Hodgkin lymfom).
English: Infusion can be continued upon resolution of symptoms and, if the patient does not experience any IRR symptoms, the infusion rate escalation can resume at the increments and intervals as appropriate for the treatment dose (see Tables 4 and 5).
Danish: Når symptomerne er forsvundet, og hvis patienten ikke oplever symptomer på infusionsrelaterede reaktioner, kan infusionshastigheden fortsætte med de trinvise øgninger og intervaller, der gælder for denne dosis (se tabel 4 og 5).
English: Cases of prolonged neutropenia (2% in the Gazyvaro plus chlorambucil arm and 4% in the rituximab plus chlorambucil arm) and late onset neutropenia (16% in the Gazyvaro plus chlorambucil arm and 12% in the rituximab plus chlorambucil arm) were also reported (see section 4.4).
Danish: Der er også indberettet tilfælde af forlænget neutropeni (2% i Gazyvaro plus chlorambucil-armen og 4% i rituximab plus chlorambucil-armen) og sent forekommende neutropeni (16% i Gazyvaro plus chlorambucil-arm og 12% i rituximab plus chlorambucil-armen) (se pkt.
English: No studies have been conducted to investigate the pharmacokinetics of obinutuzumab in paediatric patients.
Danish: Pædiatrisk population Der er ikke gennemført studier vedrørende obinutuzumabs farmakokinetik hos pædiatriske patienter.
English: Efficacy results for patients with previously untreated CLL are summarised in Table 7.
Danish: Effektresultaterne hos patienter med tidligere ubehandlet kronisk lymfatisk leukæmi er opsummeret i tabel 7.
English: Obinutuzumab, as a glycoengineered antibody, is characterised by enhanced ADCC and ADCP compared to non-glycoengineered antibodies at an equivalent dose.
Danish: Obinutuzumab, som er glycoengineered antistof, er karakteriseret ved forstærket antistofafhængig cellulær cytotoksicitet og fagocytose sammenlignet med de non-glycoengineered antistoffer i ækvivalent dosis.
English: Postponing vaccination with live vaccines should be considered for infants born to mothers who have been exposed to Gazyvaro during pregnancy until the infant's B-cell levels are within normal ranges (see section 4.4).
Danish: Vaccination med levende virusvacciner bør udsættes hos spædbørn, hvis mødre er behandlet med obinutuzumab under graviditeten indtil spædbarnets B-celletal er inden for normalområdet (se pkt.
English: IRRs may be clinically indistinguishable from immunoglobulin E (IgE) mediated allergic reactions (e.g. anaphylaxis).
Danish: Infusionsrelaterede reaktioner kan være svære at skelne klinisk fra immunglobulin E (IgE)-medierede allergiske reaktioner (fx anafylaksi).
English: Compared to Type I antibodies, obinutuzumab, a Type II antibody, is characterised by an enhanced direct cell death induction with a concomitant reduction in CDC at an equivalent dose.
Danish: Obinutuzumab, et Type II-antistof, sammenlignet med Type I antistoffer i ækvivalent dosis, er karakteriseret ved øget induktion af direkte celledød med samtidig reduktion af komplementafhængig cytotoksicitet.
English: The clearance of obinutuzumab was approximately 0.11 L/day in CLL patients and 0.08 L/day in iNHL patients with a median elimination t½ of 26.4 days in CLL patients and 36.8 days in iNHL patients.
Danish: Clearance af obinutuzumab var ca. 0,11 l/dag hos patienter med kronisk lymfatisk leukæmi og 0,08 l/dag hos patienter med indolent non-Hodgkin lymfom med en median halveringstid på 26,4 dage hos patienter med kronisk lymfatisk leukæmi og 36,8 dage hos patienter med indolent non-Hodgkin lymfom.
English: 3 e.g. 50 mg diphenhydramine
Danish: fx 1000 mg paracetamol 3 fx 50 mg diphenhydramin
English: These patients experienced more serious adverse events, adverse events leading to death and adverse events leading to treatment withdrawal than patients with a CrCl ≥ 50 mL/min (see section 4.2 and 5.2).
Danish: Disse patienter oplevede flere alvorlige bivirkninger, dødelige bivirkninger og bivirkninger som førte til seponering end patienter med CrCl ≥ 50 ml/min (se pkt.
English: Dyspepsia, colitis, haemorrhoids Diarrhoea, colitis
Danish: Dyspepsi, colitis, hæmorider
English: Table 7 Summary of efficacy from BO21004/CLL11 study Stage 1a
Danish: Tabel 7 Resumé af effektresultater i studie BO21004/CLL11
English: A clear relationship between thrombocytopenia and haemorrhagic events has not been established.
Danish: Der er ikke etableret klar sammenhæng mellem trombocytopeni og hæmorrhagiske bivirkninger.
English: In total, six cycles of Gazyvaro (every 28 days) were given in combination with six cycles of bendamustine, and a total of eight cycles of Gazyvaro (every 21 days) were given in combination with six cycles of CHOP or eight cycles of CVP.
Danish: I alt blev seks behandlingsserier med Gazyvaro (hver 28. dag) givet i kombination med seks behandlingsserier af bendamustin, og i alt otte behandlingsserier af Gazyvaro (hver 21. dag) blev givet i kombination med seks behandlingsserier af CHOP eller otte behandlingsserier af CVP.
English: The population pharmacokinetic analysis of obinutuzumab showed that age did not affect the pharmacokinetics of obinutuzumab.
Danish: Den farmakokinetiske populationsanalyse af obinutuzumab viste, at alder ikke påvirker obinutuzumabs farmakokinetik.
English: Rate of infusion
Danish: Infusionshastighed
English: Other medicines and Gazyvaro
Danish: Brug af anden medicin sammen med Gazyvaro
English: · If you become pregnant during treatment with Gazyvaro, tell your doctor or nurse as soon as possible.
Danish: • Hvis du bliver gravid under din behandling med Gazyvaro, skal du kontakte lægen eller sundhedspersonalet hurtigst muligt, da behandling med Gazyvaro kan påvirke dit og barnets helbred.
English: Hypotension, as a symptom of IRRs, may occur during Gazyvaro intravenous infusions.
Danish: Der kan, som et symptom på infusionsrelaterede reaktioner, opstå hypotension under intravenøs infusion af Gazyvaro.
English: Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen (study GAO4753g/GADOLIN).
Danish: Patienter med follikulært lymfom, som ikke responderede eller som fik sygdomsprogression under eller op til 6 måneder efter behandling med rituximab eller en behandling indeholdende rituximab (studie GAO4753g/GADOLIN)
English: The incidence of infection was 38% in the Gazyvaro plus chlorambucil arm and 37% in the rituximab plus chlorambucil arm (with Grade 3-5 events reported in 12% and 14%, respectively and fatal events reported in < 1% in both treatment arms).
Danish: Incidensen af infektion var 38% i Gazyvaro plus chlorambucil-armen og 37% i rituximab plus chlorambucil-armen (bivirkninger af grad 3-5 indberettet for henholdsvis 12% og 14%, og dødelige bivirkninger for <1% i begge behandlingsarme).
English: In the pivotal BO21004/CLL11 study, 27% (90 out of 336) of patients treated with Gazyvaro plus chlorambucil had moderate renal impairment (CrCl < 50 mL/min).
Danish: I det pivotale BO21004/CLL11-studie havde 27% (90 ud af 336) af patienterne behandlet med Gazyvaro plus chlorambucil moderat nedsat nyrefunktion (CrCl <50 ml/min).
English: The profile of adverse reactions in patients with FL was consistent with the overall iNHL population in both studies.
Danish: Bivirkningsprofilen hos patienter med follikulært lymfom var i overensstemmelse med bivirkningsprofilen hos den samlede population med indolent non-Hodgkin lymfom i begge studier.
English: Severe and life-threatening thrombocytopenia including acute thrombocytopenia (occurring within 24 hours after the infusion) has been observed during treatment with Gazyvaro.
Danish: Der er set svær og livstruende trombocytopeni, inklusive akut trombocytopeni (opstået inden for 24 timer efter infusionen) ved behandling med Gazyvaro.
English: Overall, 7% of patients experienced an IRR leading to discontinuation of Gazyvaro.
Danish: Ialt oplevede 7% af patienterne en infusionsrelateret reaktion, der medførte seponering af Gazyvaro.
English: Patients with a CrCl < 30 mL/min were excluded from the study (see section 5.1).
Danish: Patienter med CrCl <30 ml/min blev ekskluderet fra studiet (se pkt.
English: What Gazyvaro is
Danish: Hvad er Gazyvaro?
English: Cases of gastro-intestinal perforation have been reported in patients receiving Gazyvaro, mainly in iNHL.
Danish: Der er indberettet tilfælde af gastrointestinal perforation hos patienter behandlet med Gazyvaro, hovedsageligt hos patienter med indolent non-Hodgkin lymfom.
English: Therapy with Gazyvaro should be withheld during the investigation of potential PML and permanently discontinued in case of confirmed PML.
Danish: Behandling med Gazyvaro bør afbrydes under udredning af eventuel progressiv multifokal leukoencefalopati og permanent seponeres, hvis progressiv multifokal leukoencefalopati bekræftes.
English: In the non-FL population the HR for IRC-assessed PFS was 0.94 [95% CI: 0.49, 1.90].
Danish: I gruppen af ikke-follikulært lymfom patienter var hazard ratio for progressionsfri overlevelse, vurderet af en uafhængig komité, 0,94 (95% konfidensinterval, 0,49; 1,90).
English: Night sweats, eczema
Danish: Almindelig nattesved, eksem
English: Respiratory, thoracic and mediastinal disorders Very common
Danish: Luftveje, thorax og mediastinum Meget almindelig
English: Less frequently reported: · irregular heartbeat · swelling of the throat or airway · wheezing, difficulty breathing, tight chest or throat irritation
Danish: Indberettet mindre ofte: uregelmæssigt hjerteslag (puls) hævelse af svælg eller luftveje hvæsende vejrtrækning, vejrtrækningsbesvær, trykken for brystet eller irritation i svælget
English: Hazard ratio (95% CI) p-value (Log-Rank test, stratified b)
Danish: Hazard ratio (95% konfidensinterval) p-værdi (stratificeret log-rank testb)
English: The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered over Day 1 and Day 2 (or Day 1 continued), and on Day 8 and Day 15 of the first 28 day treatment cycle.
Danish: Den anbefalede dosis af Gazyvaro i kombination med chlorambucil er 1000 mg administreret på 1. og 2. dag (eller fortsat på 1. dag), 8. dag og 15. dag i den første 28-dages behandlingsserie.
English: Oral analgesic/anti-pyretic2
Danish: Oralt analgetikum/antipyretikum2
English: Package leaflet: Information for the patient Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab
Danish: Indlægsseddel: Information til patienten Gazyvaro 1000 mg koncentrat til opløsning til infusion obinutuzumab
English: Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Gazyvaro infusion and for the first hour after administration (see section 4.4).
Danish: Det bør derfor overvejes at standse antihypertensiv behandling i 12 timer inden og under hver infusion af Gazyvaro samt i en time efter administration (se pkt.
English: Tumour lysis syndrome, hyperuricaemia, hypokalaemia
Danish: Tumorlysesyndrom, hyperuricæmi, hypokaliæmi
English: Urinary tract infection, pneumonia, lung infection, upper respiratory tract infection, sinusitis, herpes zoster
Danish: Urinvejsinfektion, lungebetændelse, lungeinfektion, øvre luftvejsinfektion, sinusitis, herpes zoster
English: Patients with a CrCl < 40 mL/min were excluded from the studies (see section 5.1).
Danish: Patienter med CrCl <40 ml/min blev ekskluderet fra studierne (se pkt.
English: Pharmacokinetic/pharmacodynamic relationship(s)
Danish: Farmakokinetiske/farmakodynamiske-forhold
English: In the pivotal BO21004/CLL11 study, 46% (156 out of 336) of patients with CLL treated with Gazyvaro plus chlorambucil were 75 years or older (median age was 74 years).
Danish: I det pivotale studie, BO21004/CLL11 var 46% (156 ud af 336) af patienterne med kronisk lymfatisk leukæmi, der blev behandlet med Gazyvaro plus chlorambucil 75 år eller derover (medianalder var 74 år).
English: Table 2 Dose of Gazyvaro to be administered during 6 treatment cycles each of 28 days duration for patients with CLL
Danish: Tabel 2 Gazyvaro-dosis der skal administreres i 6 behandlingsserier, hver af 28 dages varighed hos patienter med kronisk lymfatisk leukæmi
English: · changes in blood tests: anaemia (low levels of red blood cells) low levels of all types of white blood cell (combined) low levels of neutrophils (a type of white blood cell) low level of platelets (a type of blood cell that helps your blood to clot)
Danish: • urinvejsinfektion, næse og svælg inflammation, helvedesild ændringer i blodprøve-resultater: - blodmangel (lavt antal af røde blodlegemer ) - lavt antal af lle typer hvide blodlegmer (kombineret) - lavt antal af neutrofilocytter (en type hvide blodlegemer) - lavt antal af blodplader (som hjælper blodet med at størkne) infektion i de øvre luftveje (næse, svælg, strube og bihuler), hoste
English: Do not use other diluents such as glucose (5%) solution.
Danish: Andre fortyndingsmidler, fx glucose (5%) injektionsvæske må ikke bruges.
English: NR (22.5,-)
Danish: 4.2 og 5.2).
English: Day 1 (100 mg)
Danish: 1. dag (100 mg)
English: Corticosteroid premedication is recommended for patients with FL and mandatory for CLL patients in the first cycle (see Table 1).
Danish: Præmedicinering med kortikosteroider i den første behandlingsserie anbefales til patienter med follikulært lymfom og er obligatorisk til patienter med kronisk lymfatisk leukæmi (se tabel 1).
English: Pack size of 1 vial.
Danish: Pakningsstørrelse med 1 hætteglas
English: Tell your doctor or nurse straight away if you get any signs of infection during and after your Gazyvaro treatment.
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du under og efter en behandling med Gazyvaro oplever tegn på infektion.
English: Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro.
Danish: Bendamustin blev administreret intravenøst på dag 1 og 2 for alle behandlingsserier (behandlingsserier 1-6) ved 90 mg/m2/dag, når administreret i kombination med Gazyvaro.
English: What Gazyvaro is used for
Danish: Hvad bruges Gazyvaro til?
English: Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro or 120 mg/m2/day when given alone.
Danish: Bendamustin blev givet intravenøst på dag 1og 2 for alle behandlingsserier (serie 1-6) i en dosis på 90 mg/m2/dag, når det blev indgivet i kombination med Gazyvaro, og i en dosis på 120 mg/m2/dag, når det blev indgivet alene.