natgillin/translations-raw huggingface dataset:
Der er konstateret tilfælde af progressiv multifokal leukoencefalopati hos patienter med John Cunningham (JC)-virus og som har andre risikofaktorer (fx patientpopulation, polyterapi med immunosupprimerende midler) behandlet med anti-CD20 antistoffer og andre multipel sclerose-behandlinger.
A risk of PML cannot be ruled-out since John Cunningham (JC) virus infection resulting in PML has been observed in patients treated with anti-CD20 antibodies and other MS therapies, and associated with risk factors (e.g. patient population, polytherapy with immunosuppressants).
• Præmedicinering for infusionsrelaterede reaktioner Følgende to slags præmedicinering skal gives inden hver Ocrevus-infusion med henblik på at reducere hyppighed og sværhedsgrad af infusionsrelaterede reaktioner: 100 mg intravenøs methylprednisolon (eller tilsvarende) ca. 30 minutter inden hver Ocrevus-infusion antihistamin ca. 30-60 minutter inden hver Ocrevus-infusion
The two following premedications must be administered prior to each Ocrevus infusion to reduce the frequency and severity of IRRs: -100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each Ocrevus infusion; -antihistamine approximately 30-60 minutes prior to each Ocrevus infusion; In addition, premedication with an antipyretic (e.g. paracetamol) may also be considered approximately 30-60 minutes prior to each Ocrevus infusion.
• Patienter behandlet med Ocrevus skal observeres i mindst en time efter infusionen er afsluttet for symptomer på infusionsrelaterede reaktioner.
· Patients treated with Ocrevus should be observed for at least one hour after the completion of the infusion for any symptom of an IRR.
Patienten bør monitoreres under infusionen og i mindst en time efter infusionen er afsluttet (se pkt.
Patients should be monitored during the infusion and for at least one hour after the completion of the infusion (see section 4.4).
Hætteglassene skal opbevares i den ydre karton for at beskytte mod lys.
Keep the vials in the outer carton in order to protect from light.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Ocrevus 300 mg koncentrat til infusionsvæske, opløsning ocrelizumab
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ocrevus 300 mg concentrate for solution for infusion ocrelizumab
Hvis en patient oplever en svær infusionsrelateret reaktion (såsom dyspnø) eller et kompleks bestående af rødme, feber og halssmerter, skal infusionen straks afbrydes, og patienten modtage symptomatisk behandling.
If a patient experiences a severe IRR (such as dyspnea) or a complex of flushing, fever, and throat pain symptoms, the infusion should be interrupted immediately and the patient should receive symptomatic treatment.
Hos patienter behandlet med ocrelizumab øgede en booster vaccine (13-valent pneumokok konjugeret vaccine, 13-PCV) givet 4 uger efter indgivelse af en 23-valent pneumokok polysakkaridvaccine (23PPV) ikke mærkbart responset på 12 serotyper sammenlignet med 23-valent pneumokok polysakkaridvaccine (23-PPV) alene.
In patients treated with ocrelizumab a booster vaccine (13-PCV) given 4 weeks after 23-PPV did not markedly enhance the response to 12 serotypes
Fald i blod- immunglobulin M Fald i blod- immunglobulin G
Blood immunoglobulin G decreased
Præspecificeret subgruppeanalyse, som ikke har nok styrke, af det primære endepunkt antyder, at patienter, der er yngre (≤ 45 år) eller med Gd-opladende T1-læsioner ved baseline, får en større fordel af behandlingen (Hazard ratio 0,64 [0,45, 0, 92]), end patienter, der er ældre (> 45 år) eller uden Gdopladende T1-læsioner (Hazard ratio 0,88 [0,62, 1,26]).
Pre-specified non-powered subgroup analysis of the the primary endpoint suggests that patients who are younger or those with T1 Gd-enhancing lesions at baseline receive a greater treatment benefit than patients who are older or without T1 Gd-enhancing lesions (≤ 45 years: HR 0.64 [0.45, 0.92], >45 years: HR 0.88 [0.62, 1.26]; with T1 Gd-enhancing lesions at baseline: HR 0.65 [0.40-1.06], without T1 Gd-enhancing lesions at baseline: HR 0.84 [0.62-1.13]).
• De mest almindelige bivirkninger ved behandling med Ocrevus er infusionsrelaterede reaktioner.
· Infusion-related reactions are the most common side effect of Ocrevus treatment.
Der har været inkluderet patienter med let nedsat leverfunktion i de kliniske studier, og der blev ikke set ændringer i Ocrevus' farmakokinetik hos disse patienter.
Patients with mild hepatic impairment were included in clinical trials, and no change in the pharmacokinetics was observed in those patients.
I de kontrollerede attakvis multipel sclerose-studier med aktiv komparator forekom infektioner hos 58,5% af patienterne behandlet med Ocrevus versus 52,5% af patienterne behandlet med interferon beta 1a.
In the active-controlled studies in RMS, infections occurred in 58.5% of patients receiving Ocrevus vs 52.5% of patients receiving interferon beta 1a.
I det placebokontrollerede kliniske studie (primær progressiv multipel sclerose), var infusionsrelaterede reaktioner den hyppigste bivirkning blandt patienter behandlet med Ocrevus, med en overordnet incidens på 40,1 % sammenlignet med en incidens på 25,5 % i placebogruppen.
In the placebo-controlled (PPMS) clinical trial, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 40.1% compared with an incidence of 25.5% in the placebo group.
• Hvis du springer en Ocrevus-infusion over, skal du så hurtigt som muligt aftale med lægen hvornår du kan få den. Du skal ikke vente til næste planlagte infusion.
If an infusion of Ocrevus is missed, it should be administered as soon as possible; do not wait until the next planned dose.
• Efter fortynding administreres Ocrevus som intravenøs infusion gennem separat anlagt intravenøs adgang.
· After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line.
Pædiatrisk
Paediatrics
I den den aktivt kontrollerede behandlingsperiode (attakvis multipel sclerose) sås fald i neutrofilocytter <laveste referencegrænse hos 14,7% af de Ocrevus-behandlede patienter sammenlignet med 40,9% af de interferon-beta-1a-behandlede patienter.
In the active-controlled (RMS) treatment period, a decrease in neutrophils < LNN was observed in 14.7% of Ocrevus patients compared with 40.9% of patients treated with interferon beta-1a.
Den første dosis på 600 mg administreres som to, separate intravenøse infusioner; først som infusion af 300 mg efterfulgt to uger senere af endnu en infusion af 300 mg (Tabel 1).
The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion (Table 1).
Hvert hætteglas indeholder 300 mg ocrelizumab i 10 ml ved en koncentration på 30 mg/ml.
Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30mg/mL.
Ocrevus indeholder:
What Ocrevus contains
21,7% og 10,1% af de Ocrevusbehandlede patienter oplevede hhv. milde og moderate infusionsrelaterede reaktioner; 2,4% oplevede svære infusionsrelaterede reaktioner og 0,1% oplevede livstruende infusionsrelaterede reaktioner (se pkt.
21,7% and 10.1% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 2.4% experienced severe IRRs and 0.1% experienced lifethreatening IRRs.
Det er for at holde øje med, om du får nogle bivirkninger, fx. infusionsrelaterede reaktioner.
This is in case you have any side effects such as infusion-related reactions.
Den første dosis på 600 mg administreres som to, separate intravenøse infusioner; først som en infusion á 300 mg efterfulgt, 2 uger senere, af endnu en infusion á 300 mg.
The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion.
Patienter behandlet med Ocrevus (Gruppe A) fik 600 mg hver 6. måned (Dosis 1: 2 x 300 mg intravenøs infusion, administreret med to ugers mellemrum.
Patients receiving Ocrevus (Group A) were given 600 mg every 6 months (Dose 1 as 2 x 300 mg intravenous infusions, administered 2 weeks apart, and subsequent doses were administered as a single 600 mg intravenous infusion).
• Der kan, som symptom på infusionsrelaterede reaktioner, opstå hypotension under Ocrevusinfusioner.
· Hypotension, as a symptom of IRR, may occur during Ocrevus infusions.
Hvis der er mistanke om progressiv multifokal leukoencefalopati, skal behandling med Ocrevus tilbageholdes.
If PML is suspected, dosing with Ocrevus must be withheld.
Forekomsten lå dog inden for hvad, der kan forventes for en multipel sclerose-population.
However, the incidence was within the background rate expected for an MS population.
Du vil altid få Ocrevus som intravenøs infusion.
You will always be given Ocrevus as a drip (intra-venous infusion)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1231/001 pakning med 1 hætteglas
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1231/001 1-vial pack EU/1/17/1231/002 2-vials pack
Hvad er Ocrevus?
What Ocrevus is
I attakvis multipel sclerose blev der observeret et fald i lymfocytter < laveste referencegrænse hos 20,7% af Ocrevus-behandlede patienter sammenlignet med 32,6% af patienterne behandlet med interferon-beta-1a.
In RMS, a decrease in lymphocyte < LLN was observed in 20.7% of Ocrevus patients compared with 32.6% of patients treated with interferon beta-1a.
Den procentvise andel af patienter med serum-beskyttende titer mod fem influenzastammer varierede henholdsvis fra 20,0 - 60,0 % og fra 16,7 - 43,8 % før vaccination.
The percentage of patients with seroprotective titers against five influenza strains ranged from 20.0-60.0% and 16.7-43.8% pre-vaccination and at 4 weeks post vaccination from 55.6-80.0% in patients treated with ocrelizumab and 75.0-97.0% in the control group , respectively.
(CDP) og MRI-aktivitet (enten Gd-opladende T1-læsioner eller nye eller forstørrende T2-læsioner) i løbet af hele 96-ugers behandlingsperioden.
NEDA defined as absence of protocol defined relapses, 12-week Confirmed Disability Progression (CDP), and any MRI activity (either Gd-enhancing T1 lesions, or new or enlarging T2 lesions) during the whole 96-week treatment.
• leveres som koncentrat til infusionsvæske, opløsning.
· It is supplied as a concentrate for solution for infusion.
Vejledning til fortynding
Instructions for dilution
Under infusionen
During the infusion
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Tyskland
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Germany
I de kontrollerede kliniske studier (attakvis multipel sclerose) med aktiv komparator, var infusionsrelaterede reaktioner den hyppigste bivirkning hos patienter behandlet med Ocrevus, med en overordnet incidens på 34,3% sammenlignet med en incidens på 9,9% i interferon-beta-1abehandlingsgruppen (samt placeboinfusion).
In active-controlled (RMS) clinical trials, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 34.3% compared with an incidence of 9.9% in the interferon beta-1a treatment group (placebo infusion).
Præmedicinering for at reducere infusionsrelaterede reaktioner
Premedication for infusion-related reactions
Der er tilgængelige data vedrørende effekt af vaccination hos patienter i behandling med Ocrevus for følgende vacciner: stivkrampe, 23-valent pneumokok polysakkarid (23-PPV), keyhole limpet hæmocyanin neoantigen samt sæsonbetonede influenzavacciner .
Data are available on the effects of tetanus toxoid, 23-valent pneumococcal polysaccharide, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines in patients receiving Ocrevus.
• du tidligere har taget, aktuelt tager eller planlægger at tage medicin der påvirker immunsystemet - fx kemoterapi, immunsupprimerende midler eller anden medicin mod multipel sclerose.
In particular tell your doctor if: · you have ever taken, are taking or are planning to take medicines that affect the immune system - such as chemotherapy, immunosuppressants or other medicines used to treat MS.
I primær progressiv multipel sclerose blev der observeret et fald i lymfocytter < laveste referencegrænse hos 26,3% af Ocrevus-behandlede patienter versus 11,7% af de placebobehandlede patienter.
In PPMS, a decrease in lymphocytes <LLN was observed in 26.3% of Ocrevus treated patients vs 11.7% of placebo-treated patients.
• Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du får Ocrevus.
· Tell your doctor before being given Ocrevus if you are pregnant, think that you might be pregnant or are planning to have a baby.
Disse reaktioner kan vise sig som kløende hud, udslæt, nældefeber, rødme af huden, irritation eller smerter i halsen, åndenød, ødem i svælget eller strubehovedet, rødme, lavt blodtryk, feber, træthed, hovedpine, svimmelhed, kvalme og hjertebanken (se pkt.
These reactions may present as pruritus, rash, urticaria, erythema, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea and tachycardia (see section 4.8).
Infusion af 600 mg i studierne med attakvis multipel sclerose og infusion af 2 x 300 mg i studierne med primær progressiv multipel sclerose viste samme farmakokinetiske/farmakodynamiske profiler.
The 600 mg infusions in RMS and the 2 x 300 mg infusions in PPMS demonstrated consistent PK/PD profiles.
Primær progressiv multipel sclerose
Primary Progressive MS
Procentdel ændring i ganghastighed, 25 fod målt på tid, fra baseline til Uge 120
Percentage change in Timed 25-Foot Walk from baseline to Week 120 Relative reduction in progression rate of walking time
Virkning og sikkerhed af Ocrevus er også evalueret i et randomiseret, dobbeltblændet, placebokontrolleret, klinisk studie med patienter med primær progressiv multipel sclerose (Studie WA25046) som var tidligt i deres sygdomsforløb i henhold til de vigtigste inklusionskriterier, dvs. i alderen fra 18 til og med 55 år.
Efficacy and safety of Ocrevus were also evaluated in a randomised, double-blind, placebo-controlled clinical trial in patients with primary progressive MS (Study WA25046) who were early in their disease course according to the main inclusion criteria, i.e. ages 18-55 years, inclusive; EDSS at screening from 3.0 to 6.5 points; disease duration from the onset of MS symptoms less than 10 years in patients with an EDSS at screening ≤5.0 or less than 15 years in patients with an EDSS at screening
Medicin du skal tage inden du får Ocrevus
What you need to know before you are given Ocrevus
Hvis patienten oplever en mild til moderate infusionsrelateret reaktion (fx hovedpine), infusionshastigheden reduceres til det halve af infusionshastigheden ved hændelsens indtræden.
If a patient experiences a mild to moderate IRR (e.g. headache), the infusion rate should be reduced to half the rate at the onset of the event.
Vaccination af nyfødte og spædbørn med levende eller svækkede levende vacciner efter eksponering for Ocrevus i livmoderen
Exposure in utero to ocrelizumab and vaccination of neonates and infants with live or live attenuated vaccines
Relativ reduktion i progression af ganghastighed
Relative reduction in rate of brain volume loss
Det kan være umuligt klinisk at skelne mellem type 1 akutte overfølsomhedsreaktioner (IgE-medierede) og infusionsrelaterede reaktioner.
Type 1 acute hypersensitivity reactions (IgE-mediated) may be clinically indistinguishable from IRR symptoms.
• For at mindske risikoen for infusionsrelaterede reaktioner, vil lægen muligvis give dig anden medicin før hver infusion med Ocrevus (se pkt.
· To reduce the risk of infusion-related reaction, your doctor will give you other medicines before each infusion of Ocrevus (see section 3) and you will be closely monitored during the infusion and for at least one hour after the infusion has been given.
Efter fortynding administreres Ocrevus som intravenøs infusion gennem separat anlagt intravenøs adgang.
After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line.
Hvis progressiv multifokal leukoencefalopati bekræftes, skal behandlingen seponeres permanent.
If PML is confirmed, treatment must be discontinued permanently.
Opløsninger af Ocrevus til intravenøs infusion forberedes ved at lægemidlet fortyndes i en infusionspose med 0,9% natriumchlorid, til en endelig koncentration på ca. 1,2 mg/ml.
Solutions of Ocrevus for intravenous infusion are prepared by dilution of the medicinal product into an infusion bag containing 0.9% sodium chloride, to a final concentration of approximately 1.2 mg/mL.For instructions on dilution of the medicinal product before administration see section 6.6.
Lægen kan beslutte at udskyde din behandling med Ocrevus eller, ikke at behandle dig med Ocrevus, hvis:
Your doctor may decide to delay your treatment with Ocrevus, or may decide you cannot receive Ocrevus if: · you have an infection.
Klar til let opaliserende og farveløs til lysebrun opløsning.
Clear to slightly opalescent, and colourless to pale brown solution.
Hvis der er tegn på livstruende eller invaliderende infusionsrelaterede reaktioner under en infusion, fx akut overfølsomhed eller akut lungesvigt, skal infusionen straks stoppes, og patienten skal modtage relevant behandling.
If there are signs of a life threatening or disabling IRR during an infusion, such as acute hypersensitivity or acute respiratory distress syndrome, the infusion must be stopped immediately and the patient should receive appropriate treatment.
4.4 og 4.5.
See sections 4.4 and 4.5.
Det er vigtigt på grund af den meget sjældne og livstruende hjerneinfektion, progressiv multifokal leukoencefalopati (PML), som kan give symptomer, der minder om multipel sclerose-symptomer.
This is because of a very rare and life-threatening brain infection, called ‘progressive multifocal leukoencephalopathy' (PML), which can cause symptoms similar to those of MS. PML can occur in patients taking medicines like Ocrevus, and other medicines used for treating MS. Tell your partner or carer about your Ocrevus treatment.
LÆGEMIDLETS NAVN Ocrevus 300 mg koncentrat til infusionsvæske, opløsning
NAME OF THE MEDICINAL PRODUCT Ocrevus 300 mg concentrate for solution for infusion
9,8% Ocrevus vs. 15,2% Interferon-beta-1a 40% (p=0,0006)7 43% (p=0,0139)7
9.8% Ocrevus vs 15.2% IFN 40% (p=0.0006)7
Ocrevus opbevares af sundhedspersonalet på hospitalet under følgende forhold:
Ocrevus will be stored by the healthcare professionals at the hospital or clinic under the following conditions: · This medicine is to be kept out of the sight and reach of children.
Infusionsvejledning
Infusion instructions
Der er påvist fald i Bcelle-niveauet i livmoderen.
B-cell depletion in utero was detected.
bihulebetændelse bronkitis herpes (forkølelsessår eller helvedesild).
Common: may affect up to 1 in 10 people sinus infection bronchitis (bronchial tube inflammation) herpes infection (cold sore or shingles).
Desuden antyder post-hoc-analyser, at der er en bedre behandlingseffekt for yngre patienter med Gdopladende T1-læsioner ved baseline ≤ 45 år: (Hazard ratio 0,52 [0,27-1,00]); ≤ 46 år (medianalder i WA25046 studiet); (Hazard ratio 0,48 [0,25-0,92]); <51 år: (Hazard ratio 0,53 [0,31-0,89]).
Moreover, post-hoc analyses suggested that younger patients with T1 Gd-enhancing lesions at baseline have the better treatment effect (≤ 45 years: HR 0.52 [0.27-1.00]; ≤ 46 years [median age of the
Laboratorieafvigelser
Laboratory Abnormalities
4.4 og 5.1.
See section 4.4 and 5.1.
Det blev undersøgt for stivkrampevaccine, 23-valent pneumokok polysakkaridvaccine (PPV-23) med eller uden en booster, keyhole limpet hæmocyanin neoantigen samt sæsonbetonede influenzavacciner.
In a randomized open-label study, RMS patients were able to mount humoral responses, although decreased, to tetanus toxoid, 23-valent pneumococcal polysaccharide with or without a booster vaccine, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines.
Studiedesign og baselinekarakteristika for forsøgspopulationen opsummeres i Tabel
Study design and baseline characteristics of the study population are summarised in Table 3.
Infusionsjusteringer i tilfælde af infusionsrelaterede reaktioner
Infusion Adjustments in case of IRRs
5.2), er det ikke nødvendigt at justere dosis hos patienter over 55 år.
Based on the limited data available (see section 5.1 and section 5.2), no posology adjustment is needed in patients over 55 years of age.
4.2) for at reducere det samlede antal infusioner (og tilsvarende eksponering for profylaktisk methylprednisolon og antihistamin) og de relaterede infusionsrelaterede reaktioner.
Therefore, after Dose 1 it is recommended to administer Ocrevus in a 600 mg single infusion (see section 4.2) to reduce the total number of infusions (with concurrent exposure to prophylactic methylprednisolone and an antihistamine) and the related infusion reactions).
Profilerne for infusionsrelaterede reaktion svarede også til hinanden, uafhængigt af, om 600 mg blev administreret som enkeltdosis infusion eller som 2 x 300 mg infusioner med 2 ugers mellemrum (se pkt.
IRR profiles per infusion were also similar, independent of whether the 600 mg dose was administered as a single 600 mg infusion or as two 300 mg infusions separated by two weeks (see sections 4.8 and 5.2), but due to overall more infusions with the 2 x 300 mg regimen, the total number of IRRs were higher.
På tværs af attakvis multipel sclerose- og primær progressiv multipel sclerose-studierne omfattede symptomer i forbindelse med infusionsrelaterede reaktioner bl.a.: kløende hud, udslæt, nældefeber, rødme af huden, irritation eller smerter i halsen, åndenød, ødem i svælget eller strubehovedet, rødme, lavt blodtryk, feber, træthed, hovedpine, svimmelhed, kvalme og hjertebanken.
Across the RMS and PPMS trials, symptoms associated with IRRs included, but are not limited to: pruritus, rash, urticaria, erythema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, nausea, tachycardia.
Der er ingen erfaring med patienter med moderat og svær nedsat nyrefunktion.
There is no experience in patients with moderate and severe renal impairment.
• Din risiko for at få infektioner stiger, når du får Ocrevus.
· You might get infections more easily with Ocrevus.
Risikoreduktion (poolet analyse1) Risikoreduktion (individuelle studier2)
Proportion of patients with 24 week Confirmed Disability Progression Risk Reduction (Pooled Analysis Risk Reduction (Individual Studies2)
Gennemsnitlig/median varighed af sygdom siden siden diagnose af primær progressiv multipel sclerose (år)
Mean/Median disease duration since diagnosis (years) Patients naive to previous DMT
• Patienter i en svær immunkompromitteret tilstand (se pkt.
· Current active infection (see section 4.4) · Patients in a severely immunocompromised state (see section 4.4 ).
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use after dilution Do not shake the vial
På grund af muligt fald i B-celleniveauet hos spædbørn, hvis mødre har fået Ocrevus under graviditeten, anbefales det, at vaccination med levende eller svækkede levende vacciner bør udskydes indtil B-celleniveauet er normaliseret.
Due to the potential depletion of B cells in infants of mothers who have been exposed to Ocrevus during pregnancy, it is recommended that vaccination with live or live-attenuated vaccines should be delayed until B-cell levels have recovered; therefore, measuring CD19-positive B-cell levels, in neonates and infants, prior to vaccination is recommended It is recommended that all vaccinations other than live or live-attenuated should follow the local immunisation schedule and measurement of vaccine-induced response titers should be considered to check whether individuals have mounted a protective immune response because the efficacy of the vaccination may be decreased.
Patienter med kendt aktiv malignitet må ikke behandles med Ocrevus (se pkt.
Patients with a known active malignancy should not be treated with
Håndtering af infusionsrelaterede reaktioner inden infusion
Management of IRRs before the infusion