FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied rituximab doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Danish: Baseret på en populationsfarmakokinetisk undersøgelse af 298 patienter med NHL, som fik enkelte eller flere infusioner af rituximab alene eller i kombination med CHOP-kemoterapi (anvendte rituximabdoser varierede fra 100 til 500 mg/m2), vurderedes den non-specifikke clearance (CL1), den specifikke clearance (CL2), hvor B-celler eller tumor sandsynligvis bidrager, og det centrale kompartments distributionsvolumen til (V1) til at være henholdsvis 0,14 l/dag, 0,59 l/dag og 2,7 l. Den estimerede mediane terminale eliminationshalveringstid af rituximab var 22 dage (spændvidde 6, 1-52 dage).
English: Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time
Danish: Tabel 10a Førstelinjebehandling af kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for rituximab plus FC versus FC alene - median observationstid: 48,1 måneder
English: Rixathon is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Danish: Rixathon anvendes til behandling af patienter med moderat til svær pemfigus vulgaris.
English: The pharmacokinetics of rituximab were assessed following two intravenous doses of 500 mg and 1,000 mg upon re-treatment in the second course.
Danish: Farmakokinetikken for rituximab blev vurderet efter to i.v.-doser på 500 mg og 1.000 mg efter genbehandling i den anden behandlingsserie.
English: +Left ventricular failure, +supraventri cular tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia
Danish: +venstre ventrikulær t svigt, +supraventrikulær takykardi, +ventrikulæ r takykardi, +angina, +myokardie -iskæmi, bradykardi alvorlige kardielle sygdomme
English: Number of patients
Danish: Antal af patienter med større recidiv
English: 53-months p=0.029
Danish: 53-måneder p=0,029
English: In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
Danish: Ved CLL var incidensen af sygdomme fra nervesystemet af grad 3 eller 4 lav både i 1. linjestudiet (4 % R-FC, 4 % FC) og i relaps/refraktær studiet (3 % R-FC, 3 % FC).
English: Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with Rixathon.
Danish: Alle patienter bør screenes for hepatitis B-virus (HBV) før påbegyndelse af behandling med Rixathon.
English: Toxic Epidermal Necrolysis (Lyell syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Danish: Toksisk epidermal nekrolyse (Lyells syndrom) og Stevens-Johnsons syndrom, nogle med dødelig udgang, har været rapporteret meget sjældent.
English: Reactivation of hepatitis B infection has also been very rarely reported in RA patients receiving rituximab (see section 4.4).
Danish: Der er meget sjældent blevet rapporteret om reaktivering af hepatitis B-infektion hos RA-patienter, som får rituximab (se pkt.
English: Angina pectoris, atrial fibrillation, heart failure, myocardial infarction
Danish: Hjerte angina pectoris, atrieflimren , hjerteinsufficiens myokardieinfarkt atrieflagre n
English: Physicians should exercise caution when considering the use of Rixathon in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
Danish: Læger bør udvise forsigtighed, når de overvejer brugen af Rixathon til patienter, der tidligere har haft recidiverende eller kroniske infektioner eller patienter med tilgrundliggende forhold, der yderligere kan prædisponere dem til alvorlig infektion (se pkt.
English: • lower immunity - because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection
Danish: • lavt immunforsvar, fordi indholdet af antistoffer i blodet, som beskytter mod infektion, kaldet immunglobuliner (IgG), falder.
English: Patient subpopulations - rituximab combination therapy
Danish: Specielle populationer - rituximab-kombinationsterapi
English: Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Danish: Da der er begrænset viden om brug af rituximab til børn og unge, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden medicinen gives, hvis du eller dit barn er under 18 år.
English: Peripheral neuropathy , facial nerve palsy5
Danish: Dysgeusi perifer neuropati facialispare se5
English: 1 vial of 50 mL 2 vials of 50 mL
Danish: 1 hætteglas a 50 ml 2 hætteglas a 50 ml
English: Treatment with rituximab in combination with methotrexate over multiple courses resulted in sustained improvements in the clinical signs and symptoms of RA, as indicated by ACR, DAS28-ESR and EULAR responses which was evident in all patient populations studied (Figure 2).
Danish: Gentagne behandlingsserier med rituximab i kombination med methotrexat resulterede i vedvarende forbedringer af kliniske symptomer på RA angivet ved ACR-DAS28-ESR-og EULAR-respons.
English: Serum ickness-like reaction
Danish: serumsyge -lignende reaktion
English: Response rate and CR rates analysed using Chi-squared Test. NR: not reached; n.a.: not applicable *: only applicable to patients achieving a CR, nPR, PR **: only applicable to patients achieving a CR
Danish: *: gælder kun for patienter, som opnåede CR, nPR eller PR; NR: ikke nået; n.a.: ikke relevant **: gælder kun for patienter, som opnåede CR
English: • short term increase in the amount of some types of anti-bodies in the blood (called
Danish: • kortvarig stigning i antallet af bestemte antistoffer kaldet immunglobuliner i blodet (IgM),
English: Patients randomised to the standard-dose prednisone group received an initial 1 mg/kg/day oral prednisone tapered off over 12 months if they had moderate disease or 1.5 mg/kg/day oral prednisone tapered off over 18 months if they had severe disease.
Danish: Patienter med første større recidiv i procent dosis på 1 mg/kg/dag oral prednison nedtitreret over 12 måneder, hvis de havde moderat sygdom, eller 1,5 mg/kg/dag oral prednison nedtitreret over 18 måneder, hvis de havde svær sygdom.
English: The 10 mL vial contains 100 mg of rituximab (10 mg/mL).
Danish: Hætteglasset med 10 ml indeholder 100 mg rituximab (10 mg/ml).
English: Median EFS: 36 Not reached p < 0.0001
Danish: Median EFS: Ikke opnået p < 0,0001
English: • Infections such as bronchial tube inflammation (bronchitis)
Danish: • infektioner som f.eks. inflammation i bronkierne (bronkitis)
English: Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.
Danish: Rødme, ofte forbundet med blærer, kan forekomme på hud og slimhinder, såsom på indersiden af munden, kønsdele eller øjenlåg og kan være ledsaget af feber.
English: Adverse drug reaction rituximab + low-dose prednisone (n = 38)
Danish: Bivirkning rituximab + lavdosis prednison (n = 38)
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Danish: Vedligeholdelsesbehandling med rituximab resulterede i en klinisk relevant og statistisk signifikant forbedring af det primære endepunkt investigatorbedømt progressionsfri overlevelse, sammenlignet med observation hos patienter med tidligere ubehandlet follikulært lymfom (tabel 7).
English: Neutropenia1
Danish: Bivirkninger1
English: Immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
Danish: kemiske forstyrrelser i blodet forårsaget af nedbrydningen af døende kræftceller
English: 10 mL vial: Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Danish: 10 ml hætteglas: Hætteglas, af klart type I glas med butylgummiprop, indeholdende 100 mg rituximab i 10 ml.
English: • swelling of the hands or ankles
Danish: • hævede hænder eller ankler.
English: A course of Rixathon consists of two 1,000 mg intravenous infusions.
Danish: En behandlingsserie med Rixathon består af to intravenøse infusioner a 1.000 mg.
English: Rixathon in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia.
Danish: Rixathon er i kombination med kemoterapi indiceret til behandling af kronisk lymfatisk leukæmi (CLL) hos patienter, som ikke tidligere er behandlet, og til patienter med relaps/refraktær kronisk lymfatisk leukæmi.
English: • Periodic safety update reports (PSUR)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: 50 mL vial: Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Danish: 50 ml hætteglas: Hætteglas, af klart type I glas med butylgummiprop, indeholdende 500 mg rituximab i 50 ml.
English: Mean terminal elimination half-life ranged from 15 to 16 days for the 2 x 500 mg dose group and 17 to 21 days for the 2 x 1,000 mg dose group.
Danish: Den gennemsnitlige terminale halveringstid for elimination varierede fra 15 til 16 dage for doseringsgruppen 2 x 500 mg og fra 17 til 21 dage for doseringsgruppen 2 x 1.000 mg.
English: 42-months p=0.029
Danish: 42-måneder p=0,029
English: • infections, such as chest infections, urinary tract infections (pain on passing water), colds and herpes infections
Danish: • infektioner som f.eks. luftvejsinfektioner, urinvejsinfektion (smerter ved vandladning),
English: If you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
Danish: Hvis du har reumatoid artrit, granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris fortæl da også din læge
English: The ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Danish: Den samlede responsrate var 57 % (95 % konfidensinterval: 41 %-73 %; CR 14 % og PR 43 %) med en median tid indtil progression, for responderende patienter, på 19,4 måneder (interval: 5,3-38,9 måneder).
English: • Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica,
Danish: • unormal fornemmelse i huden, såsom følelsesløshed, snurren, prikken eller brænden, iskias,
English: Only the highest frequency observed in the trials is reported 1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
Danish: Frekvens er baseret på R-FC regime ved relaps/refraktær CLL 2 se også afsnittet om infektioner herunder
English: e) Pemphigus vulgaris
Danish: e) Pemfigus vulgaris
English: Sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
Danish: Infektioner og parasitære sygdomme bakterielle og virale infektioner +bronkitis sepsis, +pneumoni, +febril infektion, +herpes zoster, +luftvejsinfektion er, svampeinfektione r, infektioner af ukendt ætiologi, +akut bronkitis, +sinusitis, hepatitis B1
English: You might get infections more easily during your treatment with Rixathon.
Danish: Risikoen for infektioner kan øges under behandling med Rixathon.
English: • Inflammation, irritation and / or tightness of the lungs, and throat, coughing
Danish: • vævsirritation, irritation og/eller tæthed i lunger og hals, hoste
English: For the 60 re-treatments on study, the ORR was 38% (CI95% 26% - 51%; CR 10%, PR 28%) with a projected median TTP for responding patients of 17.8 months (range 5.4-26.6).
Danish: Den samlede responsrate for de 60 genbehandlinger i studiet var 38 % (95 % konfidensinterval: 26 %-51 %, CR 10 % og PR 28 %) med en median tid indtil progression, for responderende patienter, på 17,8 måneder (spændvidde: 5,4 måneder-26,6 måneder).
English: This is because Rixathon can affect the way some other medicines work.
Danish: Det er vigtigt, da Rixathon kan påvirke virkningen af anden medicin, og anden medicin kan påvirke virkningen af Rixathon.
English: • Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth
Danish: • fordøjelsesbesvær, diarré, sure opstød, irritation og/eller sårdannelse i halsen og munden
English: albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95
Danish: I alle patientundergrupper (køn, alder, aldersjusteret IPI, Ann Arbor stadie, ECOG, β2-mikrobuglobulin, LD, albumin, B-symptomer, udbredt sygdom, ekstranodale lymfomer, knoglemarvspåvirkning) var risikoratioen for hændelsesfri overlevelse og samlet overlevelse (R-CHOP sammenlignet med CHOP) mindre end henholdsvis 0,83 og 0,95.
English: The recommended dosage of Rixathon for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Danish: Den anbefalede dosis af Rixathon til behandling af PV er 1.000 mg administreret som en intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion 2 uger senere i kombination med nedtitrerende glukokortikoider.
English: The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared to younger patients (< 65 years).
Danish: Hyppigheden af bivirkninger, uanset sværhedsgrad, og hyppigheden af grad 3/4 bivirkninger var ens hos ældre, sammenlignet med yngre (< 65 år).
English: • Pain in the tummy, back, muscles and/or joints
Danish: • smerter i maven, ryg, muskler og/eller led.
English: The recommended dosage of Rixathon in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Danish: Den anbefalede dosis af Rixathon i kombination med kemoterapi til tidligere ubehandlede patienter og til relaps/refraktære patienter er 375 mg/m2 legemsoverflade, som gives på dag 0 af første behandlingsserie, efterfulgt af 500 mg/m2 legemsoverflade på dag 1 af hver af de følgende serier, i alt 6 serier.
English: • feeling restless, problems falling asleep
Danish: • rastløshed, søvnproblemer
English: The ORR was 36% (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Danish: Den samlede responsrate var 36 % (95 % konfidensinterval: 21 %-51 %; CR 3 % og PR 33 % med en median tid indtil progression, for responderende patienter, på 9,6 måneder (interval: 4,5-26,8 måneder).
English: For retreatment with Rixathon monotherapy for patients who have responded to previous treatment with rituximab monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks (see section 5.1).
Danish: Til genbehandling med Rixathon monoterapi til patienter, som har responderet på tidligere behandling med rituximab monoterapi for recidiveret/refraktært follikulært lymfom, er den anbefalede dosis: 375 mg/m2 legemsoverfladeareal, givet som en intravenøs infusion én gang ugentligt i 4 uger (se pkt.
English: Preparation should be: - performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Danish: - udføres under aseptiske forhold af uddannet personale i henhold til regler om god praksis, særligt med hensyn til den aseptiske tilberedning af parenterale lægemidler - tilberedes i et aftræksskab med laminært airflow eller i et biologisk sikkerhedsskab, idet der tages forholdsregler for sikker håndtering af intravenøse midler.
English: Packs of 2 or 3 vials.
Danish: Pakninger med 2 eller 3 hætteglas.
English: Rixathon can be given alone or with other medicines called “chemotherapy”.
Danish: Rixathon kan anvendes alene eller sammen med kemoterapi.
English: Respirator y failure4
Danish: respirations -svigt4
English: All patients Newly diagnosed Relapsing n=99 n=48 n=51
Danish: Nyligt diagnosticerede n=48
English: The recommended dose of Rixathon in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Danish: Den anbefalede dosis af Rixathon i kombination med kemoterapi til induktionsbehandling hos tidligere ubehandlede patienter eller patienter med recidiveret/ refraktært follikulært lymfom er 375 mg/m2 legemsoverfladeareal pr. behandlingsserie i op til 8 serier.
English: In a multi-centre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of rituximab, were re-treated with 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Danish: I et enkelt-arms multicenterstudie blev 58 patienter med recidiveret elle kemoterapi-resistent lavmalignt eller follikulært B-celle NHL, som havde opnået et objektivt klinisk respons efter en tidligere serie med rituximab, genbehandlet med 375 mg/m2 rituximab som intravenøs infusion ugentligt i fire doser.
English: Rituximab maintenance treatment consisted of a single infusion of rituximab at 375 mg/m2 body surface area given every 2 months until disease progression or for a maximum period of two years.
Danish: rituximab-vedligeholdelsesbehandling bestod af en enkelt rituximabinfusion på 375 mg/m2 legemsoverfladeareal hver 2. måned indtil sygdomsprogression eller i maksimalt 2 år.
English: migraine, dizziness
Danish: migræne, svimmelhed
English: This variability in V1 (27.1% and 19.0%) contributed by the range in BSA (1.53 to 2.32 m2) and concurrent CHOP therapy, respectively, were relatively small.
Danish: Forskellen i kroppens overfladeareal (1,53-2,32 m2 ) og samtidig behandling med CHOP kemoterapi, bidrog til den relativt ringe variation i V1 (27,1 % og 19,0 %).
English: Dyspepsia, diarrhoea, gastrooesophageal reflux, mouth ulceration, upper abdominal pain
Danish: Mave-tarm-kanalen dyspepsi, diarré, gastroøsofage al refluks, ulceration i munden, smerter i øvre del af abdomen
English: Toxic Epidermal Necrolysis (Lyell's syndrome), StevensJohnson syndrome5
Danish: Hud og subkutane væv alopeci toksisk epidermal nekrolyse (Lyells syndrom), StevensJohnsons syndrom5
English: GLSG'00 CHOP, 205 R-CHOP, 223 18
Danish: CHOP, 205 R-CHOP,
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is < 1% of patients by the eighth cycle of rituximab (containing) treatment.
Danish: Hyppigheden af infusionsrelaterede bivirkninger aftog væsentligt med de efterfølgende infusioner og var under 1 % efter den ottende behandlingsserie med rituximab.
English: How to store Rixathon
Danish: Sådan gives Rixathon
English: Rixathon 100 mg concentrate for solution for infusion Each 10 mL vial contains 100 mg of rituximab.
Danish: Rixathon 100 mg koncentrat til infusionsvæske, opløsning Hvert 10 ml hætteglas indeholder 100 mg rituximab.
English: In a non-randomised study, patients with relapsed low-grade NHL who received rituximab monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for > 2-fold increase in antibody titer).
Danish: Patienterne havde en lavere responsrate over for vaccination med tetanus recall antigen (16 % versus 81 %) og Keyhole Limet Haemocyanin (KLH) neoantigen (4 % versus 76 %, når vurderet for > 2-fold stigning i antistof -titeren).
English: Hyperglycaemia, weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Danish: Metabolisme og ernæring hyperglykæmi, vægttab, perifert ødem, ansigtsødem, øget LD, hypocalcæmi
English: Infusionrelated reactions3 (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
Danish: Immunsystemet infusionsrelaterede reaktioner3 (hypertension, kvalme, udslæt, pyreksi, kløe, urticaria, halsirritation, hedeture, hypotension, rhinitis, kulderystelser, takykardi, træthed, orofaryngeale smerter, perifert ødem, erytem)
English: Data from extended follow up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of rituximab maintenance therapy in terms of PFS, EFS, TNLT, and TNCT (Table 7).
Danish: Resultaterne af forlænget opfølgning af patienterne i studiet (median observationstid 9 år) bekræftede langtidseffekterne af rituximab-vedligeholdelsesbehandling i forhold til progressionsfri overlevelse, hændelsesfri overlevelse, tid til næste anti-lymfom-behandling og tid til næste kemoterapibehandling (tabel 7).
English: Rixathon is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Danish: Rixathon er, i kombination med CHOP-kemoterapi (cyclophosphamid, doxorubicin, vincristin og prednisolon), indiceret til behandling af patienter med CD20 positivt, diffust storcellet B-celle non-Hodgkin-lymfom.
English: c) Rheumatoid arthritis
Danish: c) Reumatoid artrit
English: Rixathon 500 mg concentrate for solution for infusion Each 50 mL vial contains 500 mg of rituximab.
Danish: Rixathon 500 mg koncentrat til infusionsvæske, opløsning Hvert 50 ml hætteglas indeholder 500 mg rituximab.
English: • muscle problems - such as tight muscles, joint or muscle pain, back and neck pain
Danish: • muskelproblemer, f.eks. muskelkramper, led- eller muskelsmerter, ryg- og nakkesmerter
English: Mild or moderate infusion-related reactions (IRR) (section 4.8) usually respond to a reduction in the rate of infusion.
Danish: 4.8) responderer sædvanligvis på en reduktion af infusionshastigheden.
English: b) Chronic lymphocytic leukaemia
Danish: b) Kronisk lymfatisk leukæmi
English: Median PFS: 28.8 Not reached p < 0.0001
Danish: Median PFS: Ikke opnået p < 0,0001
English: 3 Reactions occurring during or within 24 hours of infusion.
Danish: 2 Hyppigheden stammer fra data efter markedsføring 3 Reaktioner, som forekommer inden for 24 timer efter infusion.
English: Rixathon 100 mg sterile concentrate rituximab
Danish: Rixathon 100 mg sterilt koncentrat rituximab
English: p-value Risk reduction1)
Danish: Risikoreduktion1
English: Infusionrelated reactions3 (generalised oedema, bronchospas m, wheezing, laryngeal oedema, angioneuroti c oedema, generalised pruritus, anaphylaxis, anaphylactoi d reaction)
Danish: infusionsrelaterede reaktioner3 (generelt ødem, bronkospasm e, hiven efter vejret, larynxødem angioødem, generaliseret kløe, anafylaksi, anafylaktoide reaktioner)