FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of daratumumab on the QTc interval was evaluated in an open-label study for 83 patients (Study GEN501) with relapsed and refractory multiple myeloma following daratumumab infusions (4 to 24 mg/kg).
Danish: Daratumumabs indvirkning på QTc-intervallet blev evalueret i et åbent studie (studiet GEN501) med 83 patienter med recidiverende og refraktær myelomatose efter infusion af daratumumab (4 til 24 mg/kg).
English: The most frequent adverse reactions (≥ 20%) were infusion reactions, fatigue, nausea, diarrhoea, constipation, pyrexia, dyspnoea, cough, neutropenia, thrombocytopenia, anaemia, oedema peripheral, asthenia, peripheral sensory neuropathy and upper respiratory tract infection.
Danish: De hyppigst rapporterede bivirkninger (≥ 20 %) var infusionsrelaterede reaktioner, træthed, kvalme, diarré, forstoppelse, pyrexi, dyspnø, hoste, neutropeni, trombocytopeni, anæmi, perifert ødem, asteni, perifer sensorisk neuropati og infektion i øvre luftveje.
English: At baseline, 97% of patients were refractory to the last line of treatment, 95% were refractory to both, a proteasome inhibitor (PI) and immunomodulatory agent (IMiD), 77% were refractory to alkylating agents, 63% were refractory to pomalidomide and 48% of patients were refractory to carfilzomib.
Danish: Ved baseline var 97 % af patienterne resistente over for den sidste behandlingslinje, 95 % var resistente over for både en proteasomhæmmer (PI) og et immunmodulerende middel (IMiD), 77 % var resistente over for alkylerende midler, 63 % var resistente over for pomalidomid, og 48 % af patienterne var resistente over for carfilzomib.
English: The majority were white (92%), male (52%), 34% had an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 49.5% had an ECOG performance score of 1 and 17% had an ECOG performance score of ≥2.
Danish: Størstedelen var hvide (92 %), mænd (52 %), 34 % havde en ECOG-performancescore (Eastern Cooperative Oncology Group) på 0, 49,5% havde en ECOG-performancescore på 1, og 17 % havde en ECOG-performancescore på ≥ 2.
English: p-value from Cochran Mantel-Haenszel Chi-Squared test.
Danish: p-værdi fra Cochran Mantel-Haenszel Chi
English: DARZALEX 20 mg/mL concentrate for solution for infusion daratumumab
Danish: DARZALEX 20 mg/ml koncentrat til infusionsvæske, opløsning daratumumab
English: Patients treated with daratumumab monotherapy (n=199) and combination therapy (n=1051) were evaluated for anti-therapeutic antibody responses to daratumumab at multiple time points during treatment and up to 8 weeks following the end of treatment.
Danish: Patienter, behandlet med daratumumab som monoterapi (n = 199) og kombinationsterapi (n = 1.051), blev evalueret for antiterapeutisk antistofrespons på daratumumab på flere forskellige tidspunkter under behandlingen og i op til 8 uger efter afsluttet behandling.
English: With an overall median follow-up of 13.5 months, the hazard ratio for OS was 0.64 (95% CI: 0.40, 1.01; p=0.0534).
Danish: Med en samlet median opfølgning på 13,5 måneder var hazard ratio for OS 0,64 (95 % CI: 0,40; 1,01; p = 0,0534).
English: However, if a background regimen-specific corticosteroid (e.g. dexamethasone, prednisone) is administered the day after the DARZALEX infusion, additional post-infusion medications may not be needed (see section 5.1).
Danish: Hvis der som del af baggrundsbehandlingen administreres et kortikosteroid (f.eks. dexamethason, prednison) dagen efter infusion af DARZALEX, vil det dog muligvis ikke være nødvendigt med yderligere lægemidler efter infusionen (se pkt.
English: Results of a PFS analysis by censoring patients who were randomized to daratumumab maintenance in the second randomization, at the date of the second randomization showed HR=0.50; 95% CI: 0.34, 0.75; p=0.0005.
Danish: Resultaterne af en PFS-analyse, der censurerede patienter, som blev randomiseret til daratumumab vedligeholdelse i den anden randomisering, viste HR = 0,50; 95 % CI: 0,34; 0,75; p = 0,0005 på datoen for den anden randomisering.
English: Following dilution the DARZALEX infusion should be intravenously administered at the initial infusion rate presented in Table 5 below.
Danish: Efter fortynding skal DARZALEX-infusionsvæske administreres intravenøst med den initiale infusionshastighed, der er anført i tabel 5 nedenfor.
English: The median time to response was 1 (range: 0.5 to 3.2) month.
Danish: Mediantiden til respons var 1 (0,5 til 3,2) måned.
English: Management of IRRs may further require reduction in the rate of infusion, or treatment discontinuation of DARZALEX as outlined below (see section 4.4).
Danish: Håndtering af IRR'er kan desuden nødvendiggøre, at infusionshastigheden nedsættes, eller at behandling med DARZALEX afbrydes, som anført nedenfor (se pkt.
English: The median time to onset of a reaction was 1.8 hours (range: 0.1 to 5.4 hours).
Danish: Mediantiden til indtræden af en reaktion var 1,8 timer (interval: 0,1 til 5,4 timer).
English: Twenty-seven percent had International Staging System (ISS) Stage I, 43% had ISS Stage II and 29% had ISS Stage III disease.
Danish: Syvogtyve procent havde ISS (International Staging System) stadie I, 43 % havde ISS stadie II, og 29 % havde ISS stadie III.
English: DARZALEX may increase neutropenia and thrombocytopenia induced by background therapy (see section 4.8).
Danish: DARZALEX kan potensere neutropeni og trombocytopeni induceret af baggrundsterapien (se pkt.
English: Medicines given during treatment with DARZALEX You may be given medicines to lower the chance of getting shingles.
Danish: Lægemidler, der gives under behandling med DARZALEX Du kan få andre lægemidler for at nedsætte risikoen for at få helvedesild.
English: No data are available to determine potential effects of daratumumab on fertility in males or females (see section 5.3).
Danish: Der foreligger ingen data, som kan fastlægge de potentielle virkninger af daratumumab på hanlig og hunlig fertilitet (se pkt.
English: Each 5 mL and 20 mL vial of DARZALEX contains 0.4 mmol and 1.6 mmol (9.3 mg and 37.3 mg) sodium, respectively.
Danish: Hvert hætteglas med 5 ml og 20 ml DARZALEX indeholder henholdsvis 0,4 mmol (9,3 mg) og 1,6 mmol (37,3 mg) natrium.
English: Weeks 9 to 16
Danish: Uge 9 til 16
English: The pharmacokinetics (PK) of daratumumab following intravenous administration of daratumumab monotherapy were evaluated in patients with relapsed and refractory multiple myeloma at dose levels from 0.1 mg/kg to 24 mg/kg.
Danish: Daratumumabs farmakokinetiske egenskaber efter intravenøs administration af daratumumab som monoterapi blev evalueret hos patienter med recidiverende og refraktær myelomatose ved dosisniveauer fra 0,1 mg/kg til 24 mg/kg.
English: Hrvatska Johnson & Johnson S.E.
Danish: Johnson & Johnson S.E.
English: For information concerning medicinal products given in combination with DARZALEX, see corresponding Summary of Product Characteristics.
Danish: For oplysninger om lægemidler, der gives i kombination med DARZALEX, henvises til de relevante produktresuméer.
English: • low number of a type of blood cell called platelets which help to clot blood (thrombocytopenia)
Danish: • lavt antal blodplader, en type blodlegemer, som hjælper blodet med at størkne (trombocytopeni)
English: Combination therapy:
Danish: Kombinationsterapi:
English: A total of 498 patients were randomised; 251 to the DVd arm and 247 to the Vd arm.
Danish: I alt 498 patienter blev randomiseret; 251 til DVd-armen og 247 til Vd-armen.
English: Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
Danish: Daratumumab er et humant monoklonalt IgG1κ-antistof mod CD38-antigen, fremstillet i pattedyrsceller (ovarieceller fra kinesiske hamstere [CHO]) med rekombinant DNA-teknologi.
English: Dose adjustments for bortezomib, thalidomide and dexamethasone were applied according to manufacturer's prescribing information.
Danish: Dosis af bortezomib, thalidomid og dexamethason blev justeret i henhold til producentens ordinationsoplysninger.
English: • as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
Danish: • som monoterapi til behandling af voksne patienter med recidiverende og refraktær myelomatose, som tidligere har fået behandling med en proteasomhæmmer og et immunmodulerende middel, og som har vist sygdomsprogression under den sidste behandling.
English: The median patient age was 64 years (range, 44 to 76 years), 64% were male and 76% were Caucasian.
Danish: Medianalderen var 64 år (44 til 76 år), 64 % var mænd, og 76 % var kaukasere.
English: Table 10: IRC assessed efficacy results for study MMY2002 Efficacy endpoint
Danish: Tabel 10: IRC-vurderede effektresultater for studiet MMY2002
English: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using DARZALEX (daratumumab), and that this treatment is associated with the Important Identified Risk of Interference for blood typing (minor antigen) (Positive Indirect Coombs' test), which might persist for up to 6 months after the last product's infusion, and a clear reference that the patient should continue to carry this card until 6 months after the treatment has ended; o Contact details of the DARZALEX (daratumumab) prescriber; o Reference to the need to consult the Package Leaflet (PL).
Danish: o En advarsel til sundhedspersonale, der på et givet tidspunkt har patienten i behandling, herunder i akutsituationer, om at patienten er i behandling med DARZALEX (daratumumab), og at denne behandling er forbundet med en vigtig identificeret risiko for interferens med blodtypebestemmelse (minor antigener) (positiv indirekte Coombs test), som kan vare ved i op til 6 måneder efter den sidste infusion af lægemidlet, samt en klar anbefaling af, at patienten bliver ved med at have patientkortet på sig indtil 6 måneder efter, behandlingen er afsluttet.
English: The majority were white (85%), female (54%), 25% had an ECOG performance score of 0, 50% had an ECOG performance score of 1 and 25% had an ECOG performance score of 2.
Danish: Størstedelen var hvide (85 %), 54 % var kvinder, 25 % havde en ECOG-performancescore på 0, 50 % havde en ECOGperformancescore på 1 og 25 % havde en ECOG-performancescore på 2.
English: Results of an updated PFS analysis approximately 4 months after the original clinical cutoff, continued to show an improvement in PFS for patients in the D-VMP arm compared with the VMP arm.
Danish: Resultaterne af en opdateret PFSanalyse cirka 4 måneder efter den oprindelige kliniske cutoff viste fortsat en forbedring i PFS for patienter i D-VMP-armen sammenlignet med VMP-armen.
English: Weeks 10 to 24
Danish: Uge 10 til 24
English: In Study MMY2002, 106 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
Danish: I studiet MMY2002 fik 106 patienter med recidiverende og refraktær myelomatose 16 mg/kg DARZALEX indtil sygdomsprogression.
English: Relapsed/refractory patient studies: DVd: 21%, Vd: 19%; DRd: 27%, Rd: 23%; DPd: 28% Newly diagnosed patient studies: D-VMP: 23%, VMP: 15%; DRd: 32%, Rd: 23%; D-VTd: 22%, VTd: 20%.
Danish: Studier med nydiagnosticerede patienter: D-VMP: 23 %, VMP: 15 %, DRd: 32 %, Rd: 23 %, D-VTd: 22 %, VTd: 20 %.
English: A total of 706 patients were randomised: 350 to the D-VMP arm and 356 to the VMP arm.
Danish: I alt 706 patienter blev randomiseret: 350 til D-VMP-armen og 356 til VMP-armen.
English: • irregular heart beat (atrial fibrillation)
Danish: • uregelmæssig hjerterytme (atrieflimren)
English: First dose of the every-2-week dosing schedule is given at Week 9 First dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following ASCT
Danish: Første dosis i doseringsskemaet for hver 2. uge gives i uge 9 Første dosis i doseringsskemaet for hver 2. uge gives i uge 1 efter genopstart af behandlingen efter ASCT
English: A total of 1085 patients were randomized: 543 to the D-VTd arm and 542 to the VTd arm.
Danish: I alt 1.085 patienter blev randomiseret: 543 til D-VTd-armen og 542 til VTd-armen.
English: When dexamethasone is the background-regimen specific corticosteroid, the dexamethasone treatment dose will instead serve as pre-medication on DARZALEX infusion days (see section 5.1).
Danish: Når dexamethason er det specifikke kortikosteroid i baggrundsbehandlingen, fungerer behandlingsdosen af dexamethason i stedet som præmedicinering på dage med infusion af DARZALEX (se pkt.
English: The median patient age was 63.5 years (range, 31 to 84 years), 11% of patients were ≥75 years of age, 49% were male and 79% were Caucasian.
Danish: Medianalderen var 63,5 år (31 til 84 år), 11 % af patienterne var ≥ 75 år, 49 % var mænd, og 79 % var kaukasere.
English: A Mantel-Haenszel estimate of the common odds ratio for stratified tables is used.
Danish: Et Mantel-Haenszel-estimat af den fælles oddsratio for stratificerede tabeller er anvendt.
English: The baseline demographic and disease characteristics were similar between the two treatment groups.
Danish: Demografi og sygdomskarakteristika ved baseline var ens i de to behandlingsgrupper.
English: In Study GEN501, 42 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
Danish: I studiet GEN501 fik 42 patienter med recidiverende og refraktær myelomatose 16 mg/kg DARZALEX indtil sygdomsprogression.
English: In responders, the median time to response was 0.79 months (range: 0.4 to 15.5 months) in the D-VMP group and 0.82 months (range: 0.7 to 12.6 months) in the VMP group.
Danish: Hos patienter med respons var mediantiden til respons 0,79 måneder (interval: 0,4 til 15,5 måneder) i D-VMP-gruppen og 0,82 måneder (interval: 0,7 til 12,6 måneder) i VMP-gruppen.
English: Phenotyping may be considered prior to starting daratumumab treatment as per local practice.
Danish: Fænotypebestemmelse kan overvejes i henhold til lokal praksis, før behandling med daratumumab indledes.
English: Do not use if visibly opaque particles, discolouration or foreign particles are observed.
Danish: Infusionsvæsken må ikke bruges, hvis den indeholder synlige, uigennemsigtige partikler, er misfarvet, eller hvis der ses fremmedlegemer.
English: Dexamethasone (oral or intravenous) was administered at 40 mg on Days 1, 2, 8, 9, 15, 16, 22 and 23 of Cycles 1 and 2, and at 40 mg on Days 1-2 and 20 mg on subsequent dosing days (Days 8, 9, 15, 16) of Cycles 3-4.
Danish: Dexamethason (oralt eller intravenøst) blev administreret med en dosis på 40 mg på dag 1, 2, 8, 9, 15, 16, 22 og 23 i serie 1 og 2 og med en dosis på 40 mg på dag 1-2 samt 20 mg på de efterfølgende doseringsdage (dag 8, 9, 15 og 16) i serie 3-4.
English: Based on population pharmacokinetic (PK) analyses no dosage adjustment is necessary for patients with renal impairment (see section 5.2).
Danish: Baseret på farmakokinetiske populationsanalyser er det ikke nødvendigt at justere dosis hos patienter med nedsat leverfunktion (se pkt.
English: Paraesthesia Headache
Danish: Paræstesi Hovedpine
English: Hepatitis B Virus reactivation
Danish: Influenza Reaktivering af hepatitis B-virus
English: Key: D=daratumumab; Vd=bortezomib-dexamethasone; Rd=lenalidomide-dexamethasone; Pd=pomalidomidedexamethasone; VMP=bortezomib-melphalan-prednisone; VTd=bortezomib-thalidomide-dexamethasone.
Danish: Forklaring: D = daratumumab, Vd = bortezomib-dexamethason, Rd = lenalidomid-dexamethason, Pd = pomalidomiddexamethason, VMP = bortezomib-melphalan-prednison, VTd = bortezomib-thalidomid-dexamethason.
English: Following the first four infusions, if the patient experiences no major IRRs, these inhaled post-infusion medications may be discontinued at the discretion of the physician.
Danish: Hvis patienten ikke oplever væsentlige IRR'er, kan disse inhalationslægemidler efter infusion seponeres efter de første fire infusioner efter lægens skøn.
English: DARZALEX is for intravenous use.
Danish: DARZALEX skal administreres intravenøst.
English: Response assessment Day 100 posttransplant Stringent Complete Response (sCR) 157 (28.9%) CR or better (sCR+CR) Very Good Partial Response or better (sCR+CR+VGPR) MRD negativity c, d n(%)
Danish: Responsvurdering på dag 100 efter transplantation Stringent komplet respons (sCR) CR eller bedre (sCR+CR) Meget godt delvist respons eller bedre (sCR+CR+VGPR) MRD-negativitet c, d n (%)
English: Additional background regimen specific corticosteroids (e.g. prednisone) should not be taken on DARZALEX infusion days when patients have received dexamethasone as a pre-medication.
Danish: Der bør ikke tages andre specifikke kortikosteroider som en del af baggrundsbehandlingen (f.eks. prednison) på dage med infusion af DARZALEX, hvis patienten har fået dexamethason som præmedicinering.
English: MRD negative rate (95% CI)
Danish: Forekomst af negativ MRD (95 % CI)
English: These reactions are very common (may affect more than 1 in 10 people):
Danish: Disse reaktioner er meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter):
English: Interference with Serum Protein Electrophoresis and Immunofixation Tests Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein).
Danish: Interferens med serumproteinelektroforese- og immunfikseringstest Daratumumab kan detekteres i SPE-analyser (serumproteinelektroforese) og IFE-analyser (immunfiksering), som anvendes til at monitorere monoklonale sygdomsimmunglobuliner (Mprotein).
English: What DARZALEX is
Danish: Hvad er DARZALEX
English: • Do not infuse DARZALEX concomitantly in the same intravenous line with other agents.
Danish: • DARZALEX må ikke infunderes sammen med andre midler i den samme intravenøse slange.
English: Weeks 1 to 8
Danish: Uge 1 til 8
English: Fertility No animal studies have been performed to determine potential effects on fertility in males or females.
Danish: Der er ikke udført dyrestudier for at fastlægge de potentielle virkninger på fertilitet hos hanner og hunner.
English: The majority were male (59%), 48% had an ECOG performance score of 0, 42% had an ECOG performance score of 1 and 10% had an ECOG performance score of 2.
Danish: Størstedelen var mænd (59 %), 48 % havde en ECOG-performancescore på 0, 42 % havde en ECOG-performancescore på 1, og 10 % havde en ECOG-performancescore på 2.
English: Based on four individual population PK analyses in patients receiving either daratumumab monotherapy or various combination therapies (Analyses 1-4), the exposure to daratumumab was similar between white (n=1371) and non-white subjects (n=242).
Danish: På baggrund af fire individuelle farmakokinetiske populationsanalyser hos patienter, som enten fik daratumumab som monoterapi eller forskellige kombinationsbehandlinger (analyse 1-4), var eksponeringen for daratumumab den samme hos hvide (n = 1.371) og ikke-hvide (n = 242) forsøgspersoner.
English: Significant increases in CD4+ and CD8+ T cell absolute counts, and percentages of lymphocytes, were observed with daratumumab treatment in peripheral whole blood and bone marrow.
Danish: Ved behandling med daratumumab blev der observeret væsentlige stigninger i det absolutte antal CD4+- og CD8+-T-celler samt procentdelen af lymfocytter i perifert fuldblod og knoglemarv.
English: A total of 737 patients were randomized: 368 to the DRd arm and 369 to the Rd arm.
Danish: I alt 737 patienter blev randomiseret: 368 til DRd-armen, og 369 til Rd-armen.
English: The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.
Danish: 36 % af patienterne oplevede infusionsrelaterede reaktioner på dag 1 i uge 1, 4 % på dag 2 i uge 1 og 8 % ved efterfølgende infusioner.
English: A total of 569 patients were randomised; 286 to the DRd arm and 283 to the Rd arm.
Danish: I alt 569 patienter blev randomiseret: 286 til DRd-armen og 283 til Rd-armen.
English: Do not use if opaque particles, discolouration or other foreign particles are present.
Danish: Koncentratet må ikke bruges, hvis det indeholder uigennemsigtige partikler, er misfarvet, eller hvis det indeholder andre fremmedlegemer.
English: Mantel-Haenszel estimate of the odds ratio for un-stratified tables is used.
Danish: Mantel-Haenszel-estimat af oddsratio for ikke-stratificerede tabeller er anvendt.
English: Resumption of DARZALEX treatment in patients whose HBV reactivation is adequately controlled should be discussed with physicians with expertise in managing HBV.
Danish: Hos patienter med tilstrækkeligt velkontrolleret reaktivering af HBV skal genopstart af behandlingen med DARZALEX drøftes med læger med ekspertise i behandling af HBV.
English: • Withdraw the necessary amount of DARZALEX solution and dilute to the appropriate volume by adding to an infusion bag/container containing 0.9% Sodium Chloride.
Danish: • Træk det nødvendige volumen DARZALEX-koncentrat op og fortynd det til det ønskede volumen ved at tilsætte det til en infusionspose/-beholder med 0,9 % natriumchlorid.
English: Since the Kell Blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs.
Danish: Da Kell-blodtypesystemet også er følsomt for DDT-behandling, skal Kell-negative portioner leveres efter udelukkelse eller identifikation af allo-antistoffer vha. DDT-behandlede erytrocytter.
English: Four population PK analyses were performed to describe the PK characteristics of daratumumab and to evaluate the influence of covariates on the disposition of daratumumab in patients with multiple myeloma; Analysis 1 (n=223) in patients receiving DARZALEX monotherapy while Analysis 2 (n=694), Analysis 3 (n=352) and Analysis 4 (n=355) were conducted in patients with multiple myeloma that received daratumumab combination therapies.
Danish: Der blev gennemført fire farmakokinetiske populationsanalyser for at beskrive daratumumabs farmakokinetiske egenskaber og evaluere indflydelsen af kovariater på fordelingen af daratumumab hos patienter med myelomatose: analyse 1 (n = 223) omfattede patienter, som fik DARZALEX som monoterapi, og analyse 2 (n = 694), analyse 3 (n = 352) og analyse 4 (n = 355) omfattede patienter med myelomatose, som fik kombinationsbehandling med daratumumab.
English: Weeks 1 to 6
Danish: Uge 1 til 6
English: 5 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of daratumumab.
Danish: 5 ml koncentrat i hætteglas af type 1 med elastomerlukke og aluminiumsforsegling med flip-off-låg indeholdende 100 mg daratumumab.
English: DARZALEX 20 mg/mL concentrate for solution for infusion.
Danish: DARZALEX 20 mg/ml koncentrat til infusionsvæske, opløsning.
English: Table 6 summarises the adverse drug reactions that occurred in patients receiving DARZALEX.
Danish: Tabel 6 giver en oversigt over de bivirkninger, der forekom hos patienter i behandling med DARZALEX.
English: No clinically important differences in exposure to daratumumab were observed between patients with renal impairment and those with normal renal function.
Danish: Der blev ikke observeret klinisk betydningsfulde forskelle i eksponeringen for daratumumab mellem patienter med nedsat leverfunktion og patienter med normal leverfunktion.
English: Very Common 32
Danish: Meget almindelig 32
English: Infections and infestations Pneumonia
Danish: Infektioner og parasitære sygdomme
English: Additionally the use of post-infusion medications (e.g. inhaled corticosteroids, short and long acting bronchodilators) should be considered for patients with a history of chronic obstructive pulmonary disease to manage respiratory complications should they occur (see section 4.2).
Danish: Desuden skal det overvejes at give patienter med kronisk obstruktiv lungesygdom i anamnesen lægemidler efter infusionen (f.eks. inhalationskortikosteroider, bronkodilatorer med kort og lang virkningstid) for at håndtere respiratoriske komplikationer, hvis sådanne opstår (se pkt.