FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to enrolment, patients had to have documented CD20+ CLL, and one or both of the following measures of coexisting medical conditions: comorbidity score (CIRS) of greater than 6 or reduced renal function as measured by CrCl < 70 mL/min.
Danish: Patienterne skulle inden inklusion have verificeret CD20+ CLL samt opfylde én eller begge af følgende mål for andre samtidige sygdomme: en co-morbiditetsscore (CIRS) på mere end 6 eller nedsat nyrefunktion svarende til CrCl <70 ml/min.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Bivirkningerne præsenteres inden for hver gruppe efter alvorlighedsgrad i faldende rækkefølge.
English: The safety of immunisation with live or attenuated viral vaccines following Gazyvaro therapy has not been studied and vaccination with live virus vaccines is not recommended during treatment and until B-cell recovery.
Danish: Sikkerhed ved immunisering med levende eller svækkede virale vacciner efter behandling med Gazyvaro er ikke undersøgt, og vaccination med levende virusvacciner frarådes under behandling og indtil B-celleniveauet er normaliseret.
English: Dysuria, urinary incontinence
Danish: Dysuri, urininkontinens
English: Following Cycles 6-8, in combination with chemotherapy, responding patients received Gazyvaro maintenance therapy every 2 months until disease progression or for up to 2 years.
Danish: Efter behandlingsserier 6-8, i kombination med kemoterapi, modtog responderende patienter Gazyvaro vedligeholdelsesbehandling hver 2. måned indtil sygdomsprogression eller i op til 2 år.
English: Two infusion bags should be prepared for the infusion on Days 1 and 2 (100 mg for Day 1 and 900 mg for Day 2).
Danish: Der skal klargøres 2 infusionsposer til infusionen 1. dag og 2. dag (100 mg til 1. dag og 900 mg til 2. dag).
English: Kaplan-Meier curves for progression-free survival (PFS) are shown in Figure 5.
Danish: Kaplan-Meier-kurver for progressionsfri overlevelse er vist i figur 5.
English: Follicular versus non-follicular was also a stratification factor for the study but is not applicable in the subgroup analysis of patients with FL. § Best response within 12 months of start of treatment
Danish: Follikulær versus non-follikulær var også en stratificeringsfaktor for studiet men er ikke en stratificeringsfaktor i subgruppe-analysen af patienter med follikulært lymfom.
English: The PFS results in the post hoc analysis are consistent with the primary analysis and its significance is unchanged and the safety profile is consistent with the primary analysis.
Danish: Resultaterne for progressionsfri overlevelse i post-hoc analysen er i overensstemmelse med den primære analyse, og signifikansen er uændret.
English: Table 3 Follicular lymphoma: Dose of Gazyvaro to be administered during induction treatment, followed by maintenance treatment
Danish: Tabel 3 Follikulært lymfom: Gazyvaro-dosis, der skal administreres under induktionsbehandling efterfulgt af vedligeholdelsesbehandling
English: The metabolism of obinutuzumab has not been directly studied.
Danish: Biotransformation Obinutuzumabs metabolisme er ikke direkte undersøgt.
English: Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype.
Danish: Obinutuzumab er et rekombinant monoklonalt, humaniseret og glycoengineered Type II anti-CD20antistof af IgG1-isotypen.
English: It is given into a vein as a drip (intravenous infusion) over several hours.
Danish: Det gives over flere timer i et drop (infusion i en vene).
English: The primary analysis based on independent Review Committee (IRC) assessment demonstrated a statistically significant - 45% reduction in the risk of disease progression or death, in patients with iNHL receiving G+B followed by Gazyvaro maintenance, compared with patients receiving bendamustine alone.
Danish: Den primære analyse baseret på vurdering fra en uafhængig komité viste en statistisk signifikant reduktion på 45% i risikoen for sygdomsprogression eller død hos patienter med indolent nonHodgkin lymfom der fik Gazyvaro plus bendamustin efterfulgt af Gazyvaro vedligeholdelsesbehandling sammenlignet med patienter, der kun fik bendamustin.
English: · Continue to use effective contraception for 18 months after stopping treatment with Gazyvaro.
Danish: • Du skal fortsætte med at bruge sikker prævention i 18 måneder, efter du har stoppet behandlingen med Gazyvaro.
English: Neutropenia§, thrombocytopenia, anaemia, leukopenia
Danish: Neutropeni§, trombocytopeni, anæmi, leukopeni
English: The incidence of haemorrhagic events was similar across all treatment arms.
Danish: Incidensen af hæmoragiske bivirkninger var ens på tværs af alle behandlingsarme.
English: A total of 781 patients were randomised 2:2:1 to receive Gazyvaro plus chlorambucil, rituximab plus chlorambucil or chlorambucil alone.
Danish: Ialt 781 patienter randomiseredes i forholdet 2:2:1 til behandling med Gazyvaro plus chlorambucil, rituximab plus chlorambucil og chlorambucil alene.
English: No Grade 3-5 IRRs were reported beyond the first 1,000 mg infusions of Cycle 1.
Danish: Der er ikke indberettet infusionsrelaterede reaktioner af grad 3-5 efter den første infusion af 1000 mg i 1. behandlingsserie.
English: Depression, anxiety
Danish: Depression, angst
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Danish: Hvis du har spørgsmål til hvordan denne medicin bruges, skal du kontakte lægen eller sundhedspersonalet.
English: Follicular lymphoma (FL)
Danish: Follikulært lymfom (FL)
English: Hypotension may occur during Gazyvaro intravenous infusions.
Danish: Der kan forekomme hypotension under intravenøs infusion af Gazyvaro.
English: Four percent of patients treated with Gazyvaro plus chlorambucil experienced acute thrombocytopenia (occurring within 24 hours after the Gazyvaro infusion) (see section 4.4).
Danish: Fire procent af patienterne behandlet med Gazyvaro plus chlorambucil oplevede akut trombocytopeni (forekom inden for 24 timer efter infusion af Gazyvaro) (se pkt.
English: For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.
Danish: Ved behandling af tumorlysesyndrom korrigeres elektrolytafvigelser, nyrefunktionen og væskebalancen monitoreres og understøttende behandling initieres hvis indiceret, inklusive dialyse.
English: Patients who experience neutropenia should be closely monitored with regular laboratory tests until resolution.
Danish: Patienter der oplever neutropeni skal overvåges omhyggeligt med jævnlige blodprøver indtil neutropenien forsvinder.
English: Completed at least 1 hour prior to Gazyvaro infusion
Danish: Afsluttet mindst 1 time inden infusion af Gazyvaro
English: * Chemotherapy: Chlorambucil in CLL; bendamustine, CHOP, CVP in iNHL including FL § observed also during maintenance treatment with at least 2% higher incidence in Gazyvaro arm (BO21223)
Danish: * Kemoterapi: chlorambucil i kronisk lymfatisk leukæmi; bendamustin, CHOP, CVP i indolent non-Hodgikin lymfom herunder follikulært lymfom § Også observeret under vedligeholdelsesbehandlingen med mindst 2 % højere incidens i Gazyvaro-armen (BO21223)
English: The patient should be referred to a neurologist for the evaluation and treatment of PML.
Danish: Patienten bør henvises til neurolog for udredning og behandling af progressiv multifokal leukoencefalopati.
English: Efficacy results for patients with previously untreated FL are summarised in Table 8.
Danish: Effektresultater for patienter med tidligere ubehandlet follikulært lymfom er opsummerede i tabel 8.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,000 mg/40 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1000 mg/40 ml
English: · Six 28-day cycles in combination with bendamustine2 or,
Danish: • Seks 28-dages behandlingsserier i kombination med bendamustin2 eller,
English: The European Medicines Agency has waived the obligation to submit the results of studies with Gazyvaro in all subsets of the paediatric population in CLLand FL (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Gazyvaro i alle subgrupper af den pædiatriske population ved kronisk lymfatisk leukæmi og follikulært lymfom (se pkt.
English: Induction (in combination with chemotherapy2) Gazyvaro should be administered with chemotherapy as follows:
Danish: Induktionsbehandling (i kombination med kemoterapi2) Gazyvaro bør administreres med kemoterapi som følger:
English: Overall Survival (not yet mature) No. (%) of patients with event Median time to event (months)
Danish: Samlet overlevelse (data er endnu ikke fuldstændige) Antal (%) patienter med hændelse Mediantid til hændelse (måneder)
English: Patients with no IRR during the previous infusion
Danish: Patienter uden infusionsrelateret reaktion under den forudgående infusion
English: · CLL and FL are types of cancer that affect white blood cells called “B-lymphocytes”.
Danish: • Kronisk lymfatisk leukæmi og follikulært lymfom er begge kræfttyper i blodet, der påvirker den type hvide blodlegemer, der hedder B lymfocytter.
English: Pharmacokinetics of obinutuzumab in patients with mild creatinine clearance (CrCl 50-89 mL/min, n=464) or moderate (CrCl 30 to 49 mL/min, n=106) renal impairment were similar to those in patients with normal renal function (CrCl ³ 90 mL/min, n=383).
Danish: Obinutuzumabs farmakokinetik hos patienter med let (CrCl 5089 ml/min, n=464) eller middelsvær (CrCl 30 to 49 ml/min, n=106) nedsat nyrefunktion svarede til den hos patienter med normal nyrefunktion (CrCl ≥90 ml/min, n=383).
English: The incidences presented in the following sections if referring to iNHL are the highest incidence of that ADR reported from either pivotal study (BO21223/GALLIUM, GAO4753g/GADOLIN).
Danish: Incidenserne præsenteret i de følgende afsnit, hvis der henvises til indolent non-Hodgkin lymfom er den højeste incidens af den specifikke bivirkning rapporteret fra et af de 2 pivotale studier (BO21223/GALLIUM, GAO4753g / GADOLIN).
English: Gazyvaro + Bendamustine followed by Gazyvaro maintenance N=155
Danish: Gazyvaro + bendamustin efterfulgt af Gazyvaro vedligeholdelsesbehandling N=155
English: Patients who experience overdose should have immediate interruption or reduction of their infusion and be closely supervised.
Danish: Ved overdosering, bør infusionen straks afbrydes eller reduceres, og patienten overvåges nøje.
English: Concentrations in infant serum on day 28 post-partum were in the range of concentrations in maternal serum, whereas concentrations in milk on the same day were very low (less than 0.5% of the corresponding maternal serum levels) suggesting that exposure of infants must have occurred in utero.
Danish: Serumkoncentrationer hos nyfødte på 28. dag postpartum lå inden for samme område som de maternelle serumkoncentrationer, hvorimod koncentrationer i mælken samme dag var meget lave (mindre end 0,5% af de tilsvarende maternelle serumkoncentrationer).
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejersken eller apoteket.
English: The incidence and severity of infusion related symptoms decreased substantially after the first 1,000 mg was infused, with most patients having no IRRs during subsequent administrations of Gazyvaro (see section 4.8).
Danish: Forekomst og sværhedsgrad af infusionsrelaterede reaktioner faldt betydeligt efter de første 1000 mg var infunderet, og de fleste patienter oplevede ikke infusionsrelaterede reaktioner under efterfølgende infusioner af Gazyvaro (se pkt.
English: Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain magnetic resonance imaging (MRI), and lumbar puncture (cerebrospinal fluid testing for John Cunningham viral DNA).
Danish: Evaluering af progressiv multifokal leukoencefalopati inkluderer, men er ikke begrænset til, vurdering af en neurolog, MR (magnetisk resonans)-skanning af hjernen og lumbalpunktur (cerebrospinalvæskeanalyse for John Cunningham virus-DNA).
English: · Tell your doctor or nurse if you are pregnant, think you might be pregnant or are planning to have a baby.
Danish: • Hvis du er gravid, har mistanke om at du er gravid eller planlægger at blive gravid, skal du kontakt lægen eller sundhedspersonalet.
English: No post-baseline HAHA (Human Anti-Human Antibody) were observed in patients with iNHL treated in study GAO4753g/GADOLIN.
Danish: Der blev ikke observeret post-baseline Human Anti-Human Antibody (HAHA) hos patienter med indolent non-Hodgkin lymfom behandlet i studie GAO4753g / GADOLIN.
English: No Grade 5 events of thrombocytopenia were reported.
Danish: Der var ikke rapporteret trombocytopeni af grad 5.
English: · Follicular lymphoma (also called “FL”) Gazyvaro is used in patients who have not had any treatment for FL Gazyvaro is used in patients who have had at least one treatment with a medicine called rituximab before and whose FL has come back or got worse during or after this treatment.
Danish: • Follikulært lymfom (også kaldet ”FL”) - Gazyvaro bruges til patienter, som ikke tidligere har været behandlet for follikulært lymfom - Gazyvaro bruges til patienter, som tidligere har fået mindst en behandling med et andet lægemiddel, kaldet rituximab, og hvor sygdommen er kommet igen eller blevet værre under eller efter behandlingen.
English: However, in patients with FL the addition of Gazyvaro to bendamustine delayed the time to worsening of health-related quality of life as measured by the FACT-Lym TOI score by 2.2 months (median 5.6 versus 7.8 months for B and G+B respectively HR = 0.83; 95% CI: 0.60, 1.13).
Danish: Hos patienterne med follikulært lymfom forsinkede tillæg af Gazyvaro til bendamustin dog tiden til forværring af helbredsrelateret livskvalitet målt med FACT-Lym med en Trial Outcome Index score på 2,2 måneder (mediantid på 5,6 måned versus 7,8 måned for henholdsvis bendamustin og Gazyvaro plus bendamustin, hazard ratio = 0,83; 95% konfidensinterval 0,60; 1,13).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,000 mg/40 mL
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1000 mg/40 ml
English: Kaplan-Meier curves for progression-free survival (PFS) and Overall Survival (OS) are shown in Figures 1-4.
Danish: Kaplan-Meyer kurver for progressionsfri overlevelse og samlet overlevelse er vist i figur 1-4.
English: Co-administration with Gazyvaro had no effect on the pharmacokinetics of bendamustine, FC, chlorambucil or the individual components of CHOP.
Danish: Administration sammen med Gazyvaro havde ingen effekt på farmakokinetikken af bendamustin, FCkemoterapi, chlorambucil eller de enkelte komponenter i CHOP-kemoterapi.
English: In addition, in vivo, obinutuzumab mediates a low degree of complement dependent cytotoxicity (CDC).
Danish: Derudover medierer obinutuzumab in-vivo en mild grad af komplementafhængig cytotoksicitet.
English: Patients were randomised 1:1 to receive either bendamustine (B) alone (n = 202) or Gazyvaro in combination with bendamustine (G+B) (n = 194) for 6 cycles, each of 28 days duration.
Danish: Patienterne blev randomiseret 1:1 til at få enten bendamustin alene (n=202) eller Gazyvaro i kombination med bendamustin (n=194) i seks behandlingsserier, hver af 28 dages varighed.
English: If you had any of these symptoms before treatment with Gazyvaro, tell your doctor straight away if you notice any changes in them.
Danish: Hvis du har haft nogen af disse symptomer inden behandlingen med Gazyvaro, skal du straks kontakte lægen, hvis de ændrer sig.
English: The rates of Grade 3-4 IRRs (which were based on a relatively small number of patients) were similar before and after mitigation measures were implemented.
Danish: Forekomst af infusionsrelaterede reaktioner af grad 3-4 (baseret på et relativt lille antal patienter) var ensartet før og efter at tiltagene initieredes.
English: The incidence of infection was 81% in the Gazyvaro plus chemotherapy arm (with Grade 3-5 events reported in 22% of patients and fatal events reported in 3% of patients).
Danish: Incidensen af infektioner var 81 % i Gazyvaro plus kemoterapi-armen (grad 3-5 reaktioner blev rapporteret hos hhv. 22% af patienterne og dødelige reaktioner blev rapporteret hos 3% af patienterne.
English: Some signs/symptoms regarded as “cortical” (e.g. aphasia or visual-spatial disorientation) may occur.
Danish: Symptomer, der anses for kortikale (fx afasi eller visuelrumlig desorientering) kan forekomme.
English: No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance [CrCl] 30-89 mL/min) (see section 5.2).
Danish: Dosisjustering er ikke nødvendig til patienter med mild til moderat nedsat nyrefunktion (creatininclearance [CrCl] 30 - 89 ml/min) (se pkt.
English: Most frequently reported (≥ 5%) symptoms associated with an IRR were nausea, vomiting, diarrhoea, headache, dizziness, fatigue, chills, pyrexia, hypotension, flushing, hypertension, tachycardia, dyspnoea, and chest discomfort.
Danish: De hyppigst indrapporterede symptomer (≥ 5%) associeret med en infusionsrelateret reaktion var kvalme, opkastning, diarre, hovedpine, svimmelhed, træthed, kulderystelser, pyreksi, hypotension, ansigtsrødme, hypertension, takykardi,dyspnø og ubehag i brystet.
English: Rituximab + Chemotherapy followed by rituximab maintenance N=601
Danish: Rituximab + Kemoterapi efterfulgt af rituximab vedligeholdelsesbehandling N=601
English: The most common Grade 3-5 adverse reactions were neutropenia (10%), and anaemia, febrile neutropenia, thrombocytopenia, sepsis, upper respiratory tract infection, and urinary tract infection (all at 1%).
Danish: De hyppigste grad 3-5 bivirkninger var neutropeni (10%) samt anæmi, febril neutropeni, trombocytopeni, sepsis, øvre luftvejsinfektioner og urinvejsinfektioner (alle på 1%).
English: · Six 28-day cycles in combination with bendamustine2 or
Danish: • Seks 28-dages behandlingsserier i kombination med bendamustin2 eller
English: A Phase III international, multicentre, open label, randomised, two-stage, three-arm clinical study (BO21004/CLL11) investigating the efficacy and safety of Gazyvaro plus chlorambucil (GClb) compared to rituximab plus chlorambucil (RClb) or chlorambucil (Clb) alone was conducted in patients with previously untreated CLL with comorbidities.
Danish: Der er gennemført et fase III, internationalt klinisk multicenterstudie, ublindet, randomiseret, trearmet, 2 stadier (BO21004/CLL11) for at undersøge virkning og sikkerhed af Gazyvaro plus chlorambucil (GClb) sammenlignet med rituximab plus chlorambucil (RClb) eller chlorambucil alene (Clb).
English: It should be given as an intravenous infusion through a dedicated line after dilution.
Danish: Det skal gives som intravenøs infusion i separat infusionsslange efter fortynding.
English: The observed improvement in OS seen with G+B was supported by a stratified HR for OS of 0.62 (95% CI: 0.39, 0.98) in this post hoc analysis.
Danish: Den observerede forbedring i samlet overlevelse, set med Gazyvaro + bendamustin blev supporteret af en stratificeret hazard-ratio for den samlede overlevelse på 0,62 (95% konfidensinterval 0,39; 0,98) i denne post-hoc analyse.
English: Serum concentrations of obinutuzumab in offspring were similar to those in the mothers on day 28 post-partum, whereas concentrations in milk on the same day were very low, suggesting that obinutuzumab crosses the placenta (see section 5.3).
Danish: Serumkoncentrationen af obinutuzumab hos afkommet svarede til de værdier, der sås hos deres mødre på 28. dagen efter fødslen, hvorimod koncentrationen i mælk på den samme dag var meget lave, hvilket tyder på, at obinutuzumab passerer blod-placenta-barrien (se pkt.
English: Prophylaxis and premedication for infusion related reactions (IRRs)
Danish: Profylakse og præmedicinering for infusionsrelaterede reaktioner
English: Median observation time 35 months
Danish: 35 måneders median observationstid
English: Day of treatment
Danish: Behandlingsdag
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Roche Pharma AG
English: For management of symptomatic adverse events (including IRRs), see paragraph below (Management of IRRs or section 4.4).
Danish: For håndtering af symptomatiske bivirkninger (inklusiv infusionsrelaterede reaktioner), se afsnittet nedenfor (håndtering af infusionsrelaterede reaktioner eller pkt.
English: Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of Gazyvaro as outlined below (see also section 4.4).
Danish: Håndtering af infusionsrelaterede reaktioner kan kræve midlertidig afbrydelse, nedsættelse af infusionshastighed eller seponering af Gazyvaro, som beskrevet nedenfor (se også pkt.
English: The number of fatal haemorrhagic events was balanced between the treatment arms; however, all of the events in patients treated with Gazyvaro were reported in Cycle 1.
Danish: Antallet af dødelige hæmorrhagiske bivirkninger balancerede behandlingsgrupperne imellem, dog rapporteredes alle bivirkninger i Gazyvaro-armen i 1. behandlingsserie.
English: · Grade 4 (life threatening): Infusion must be stopped and therapy must be permanently discontinued.
Danish: • Grad 4 (livstruende): Infusionen skal afbrydes og behandlingen permanent seponeres.
English: Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Danish: Gazyvaro er i kombination med bendamustin efterfulgt af Gazyvaro-vedligeholdelsesbehandling indiceret til behandling af patienter med follikulært lymfom, som ikke havde responderet på eller som progredierede under eller op til 6 måneder efter behandling med rituximab eller et behandlingsregime indeholdende rituximab.
English: Cycles 2-6 or 2-8
Danish: Efterfølgende behandlingsserier - 2-6 eller 2-8.
English: No renal toxicity with a causal relationship to obinutuzumab has been observed in humans.
Danish: Der er ikke observeret nyretoksicitet med årsagssammenhæng med obinutuzumab hos mennesker.
English: Forty-two percent of patients enrolled had both a CrCl < 70 mL/min and a comorbidity score of > 6.
Danish: 42% af patienterne havde både en CrCl <70 ml/min og en co-morbiditetsscore over 6.
English: Anti-histaminic medicine3
Danish: Antihistamin3
English: Pruritus, night sweats
Danish: Kløe, nattesved
English: A population pharmacokinetic (PK) model was developed to analyse the PK data in 469 iNHL, 342 CLL and 130 diffuse large B-cell lymphoma (DLBCL) patients from Phase I, Phase II and Phase III studies who received obinutuzumab alone or in combination with chemotherapy.
Danish: Der er udviklet en farmakokinetisk populationsmodel til at analysere farmakokinetiske data fra 469 patienter med indolent non-Hodgkin lymfom, 342 patienter med kronisk lymfatisk leukæmi og 130 patienter med diffust storcellet B-celle lymfom fra fase I-, fase II- og fase III-studier, som har været behandlet med obinutuzumab alene eller i kombination med kemoterapi.
English: · If you had any of these symptoms before treatment with Gazyvaro, tell your doctor straight away if you notice any changes in them.
Danish: • Hvis du har haft nogen af disse symptomer inden behandlingen med Gazyvaro, skal du straks kontakte lægen hvis symptomerne ændrer sig.
English: Fatal haemorrhagic events have also been reported in Cycle 1 in patients treated with Gazyvaro.
Danish: Der er også rapporteret dødelige hæmoragiske bivirkninger under 1. behandlingsserie hos patienter behandlet med Gazyvaro.
English: The infusion rate may be escalated provided that the patient can tolerate it. For management IRRs that occur during the infusion, refer to “Management of IRRs”.
Danish: Infusionshastigheden kan øges forudsat patienten kan tolerere dette For håndtering af infusionsrelateret reaktion, der opstår under infusionen, se "Håndtering af infusionsrelaterede reaktioner".