FrancophonIA/ELRC3.0 huggingface dataset:
English: leukopenia)
Danish: leukopeni)
English: Based on four individual population PK analyses (1-4) in patients receiving daratumumab monotherapy or various combination therapies (Analyses 1-4), age (range: 31-93 years) had no clinically important effect on the PK of daratumumab, and the exposure of daratumumab was similar between younger (aged <65 years, n=518) and older (aged ≥65 to <75 years n=761; aged ≥75 years, n=334) patients.
Danish: Ud fra fire individuelle farmakokinetiske populationsanalyser (1-4) hos patienter, som fik daratumumab som monoterapi eller forskellige kombinationsbehandlinger (analyse 1-4), har alder (interval: 31-93 år) ingen klinisk vigtig indvirkning på daratumumabs farmakokinetik, og eksponeringen for daratumumab var den samme hos yngre patienter (< 65 år, n = 518) og ældre patienter (≥ 65 år til < 75 år, n = 761; ≥ 75 år, n = 334).
English: 20 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of daratumumab.
Danish: 20 ml koncentrat i hætteglas af type 1 med elastomerlukke og aluminiumsforsegling med flip-off-låg indeholdende 400 mg daratumumab.
English: Pre-infusion medication
Danish: Lægemidler før infusion
English: Very Common 40
Danish: Meget almindelig 40
English: Dexamethasone was administered orally at a dose of 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each of the 8 bortezomib cycles (80 mg/week for two out of three weeks of the bortezomib cycle) or a reduced dose of 20 mg/week for patients >75 years, BMI <18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.
Danish: 4, 8 og 11) i gentagne behandlingsserier på 21 dage (3 uger) i 8 serier i alt. Dexamethason blev administreret oralt med en dosis på 20 mg på dag 1, 2, 4, 5, 8, 9, 11 og 12 i hver af de 8 bortezomibserier (80 mg/uge i to af tre uger i bortezomib-serien) eller en reduceret dosis på 20 mg/uge for patienter ≥ 75 år, med BMI < 18,5, med dårligt kontrolleret diabetes mellitus eller med tidligere intolerance over for steroidbehandling.
English: Concentrate for solution for infusion 1 vial, 100 mg/5 mL 1 vial, 400 mg/20 mL
Danish: Koncentrat til infusionsvæske, opløsning 1 hætteglas, 100 mg/5 ml 1 hætteglas, 400 mg/20 ml
English: Concentrate for solution for infusion Initiation pack: 11 vials (6 x 5 mL vials + 5 x 20 mL vials)
Danish: Koncentrat til infusionsvæske, opløsning Startpakke: 11 hætteglas (6 x 5 ml hætteglas + 5 x 20 ml hætteglas)
English: As an IgG1қ monoclonal antibody, renal excretion and hepatic enzyme-mediated metabolism of intact daratumumab are unlikely to represent major elimination routes.
Danish: Da daratumumab er et monoklonalt IgG1қ-antistof, er det ikke sandsynligt, at udskillelse i nyrerne og enzym-medieret metabolisme i leveren vil udgøre primære eliminationsveje.
English: Figure 2:
Danish: 2-test.
English: Very Common 26
Danish: Meget almindelig 26
English: The median patient age was 64 years (range 30 to 88 years) and 12% were ≥75 years.
Danish: Medianalderen var 64 år (30 til 88 år), og 12 % var ≥ 75 år.
English: What DARZALEX contains
Danish: DARZALEX indeholder
English: Weeks 1 to 9
Danish: Uge 1 til 9
English: Weeks 9 to 24
Danish: Uge 9 til 24
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 (see section 4.2).
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 (se pkt.
English: • Severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives).
Danish: • alvorlig allergisk reaktion, som kan vise sig ved hævelser af ansigtet, læberne, munden, tungen eller svælget, synke- eller vejrtrækningsbesvær eller kløende udslæt (nældefeber).
English: Combination treatment with bortezomib, melphalan and prednisone (VMP) in patients ineligible for autologous stem cell transplant:
Danish: Kombinationsbehandling med bortezomib, melphalan og prednison (VMP) hos patienter, som ikke er kandidater til autolog stamcelletransplantation:
English: In some cases you may have a severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives).
Danish: I visse tilfælde kan den allergiske reaktion være alvorlig og omfatte hævelser af ansigtet, læberne, munden, tungen eller svælget, synke- eller vejrtrækningsbesvær eller kløende udslæt (nældefeber).
English: What DARZALEX is and what it is used for What you need to know before you are given DARZALEX How DARZALEX is given
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får DARZALEX Sådan får du DARZALEX Bivirkninger
English: Combination treatment with lenalidomide and dexamethasone in patients ineligible for autologous stem cell transplant:
Danish: Kombinationsbehandling med lenalidomid og dexamethason hos patienter, som ikke er kandidater til autolog stamcelletransplantation:
English: In this subgroup, median PFS was not reached in the DVMP group and was 17.9 months in the VMP group (HR=0.56; 95% CI: 0.42, 0.75); p<0.0001).
Danish: I denne undergruppe blev median PFS ikke nået i D-VMP-gruppen, og den var 17,9 måneder i VMP-gruppen (HR = 0,56; 95 % CI: 0,42, 0,75; p < 0,0001).
English: A Chi-Squared estimate of the common odds ratio is used.
Danish: 2-estimat af den fælles oddsratio anvendes.
English: Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus and hypotension (see section 4.8).
Danish: Mindre hyppige symptomer var hvæsende vejrtrækning, allergisk rhinitis, pyrexi, ubehag i brystkassen, pruritus og hypotension (se pkt.
English: Part 1 compared induction and consolidation treatment with DARZALEX 16 mg/kg in combination with bortezomib, thalidomide and dexamethasone (D-VTd) to treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients with newly diagnosed multiple myeloma eligible for ASCT.
Danish: Del 1 sammenlignede induktions- og konsolideringsbehandling med 16 mg/kg DARZALEX i kombination med bortezomib, thalidomid og dexamethason (D-VTd) med behandling med bortezomib, thalidomid og dexamethason (VTd) hos patienter med nydiagnosticeret myelomatose, som var kandidater til ASCT.
English: Four individual population PK analyses were performed in patients receiving daratumumab monotherapy or various combination therapies (Analyses 1-4), and included a total of 1404 patients with normal hepatic function (total bilirubin [TB] and aspartate aminotransferase [AST] ≤ upper limit of normal [ULN]), 189 with mild hepatic impairment (TB 1.0 x to 1.5 x ULN or AST >ULN) and 8 patients with moderate (TB > 1.5 x to 3.0 x ULN; n=7), or severe (TB > 3.0 x ULN; n=1) hepatic impairment.
Danish: Der blev udført fire individuelle farmakokinetiske populationsanalyser hos patienter, som fik daratumumab som monoterapi eller forskellige kombinationsbehandlinger (analyse 1-4) med i alt 1.404 patienter med normal leverfunktion (total-bilirubin [TB] og aspartataminotransferase [ASAT] ≤ øvre grænse for normal [ULN]), 189 med let nedsat leverfunktion (TB 1,0 x til 1,5 x ULN eller ASAT > ULN) og 8 patienter med moderat (TB > 1,5 x til 3,0 x ULN; n = 7) eller svært (TB > 3,0 x ULN; n = 1) nedsat leverfunktion.
English: Driving and using machines You may feel tired after taking DARZALEX which may affect your ability to drive or use machines.
Danish: Du kan føle dig træt, når du har fået DARZALEX, og det kan påvirke din evne til at færdes i trafikken og din arbejdssikkerhed.
English: Dosing schedule in combination with lenalidomide (4-week cycle regimen) and for monotherapy: The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 1.
Danish: Skema for dosering i kombination med lenalidomid (regime med 4-ugers serier) og for monoterapi: Den anbefalede dosis er 16 mg DARZALEX pr. kg legemsvægt administreret som en intravenøs infusion i henhold til doseringsskemaet i tabel 1.
English: Median Duration of Response [months (95% CI)]
Danish: Mediantid til respons [måneder (interval)] Median responsvarighed [måneder (95 % CI)]
English: every three weeks (total of 16 doses)
Danish: hver tredje uge (i alt 16 doser)
English: • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Danish: • i kombination med lenalidomid og dexamethason eller bortezomib og dexamethason til behandling af voksne patienter med myelomatose, som tidligere har fået mindst én behandling.
English: No formal studies of daratumumab in patients with renal impairment have been conducted.
Danish: Der er ikke udført formelle studier af daratumumab hos patienter med nedsat leverfunktion.
English: Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose dexamethasone at 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or BMI <18.5).
Danish: Lenalidomid (25 mg oralt en gang dagligt på dag 1-21 i gentagne serier på 28 dage [4 uger]) blev givet sammen med 40 mg/uge lavdosis-dexamethason (eller en reduceret dosis på 20 mg/uge for patienter > 75 år eller med BMI < 18,5).
English: Post-infusion medication
Danish: Lægemidler efter infusion
English: DARZALEX can affect the results of this blood test. Tell the person doing the test that you are using DARZALEX.
Danish: Fortæl det til den person, der tager blodprøven, at du får DARZALEX.
English: 500 mL 50 mL/hour 50 mL/hour every hour
Danish: 50 ml/time hver time
English: 95% CI (%) Odds ratio with 95% CI
Danish: 95 % CI (%) Oddsratio med 95 % CI
English: The median age was 71 (range: 40-93) years, with 30% of the patients ≥75 years of age.
Danish: Medianalderen var 71 år (interval: 40 til 93 år), og 30 % af patienterne var ≥ 75 år.
English: One mL of concentrate contains 20 mg daratumumab.
Danish: En ml koncentrat indeholder 20 mg daratumumab.
English: Bortezomib was administered by subcutaneous (SC) injection at a dose of 1.3 mg/m2 body surface area twice weekly at
Danish: Bortezomib blev administreret som subkutan injektion eller intravenøs infusion i en dosis på 1,3 mg/m2 to gange om ugen i to uger (dag 1,
English: every three weeks (total of 5 doses)
Danish: hver tredje uge (i alt 5 doser)
English: Serious adverse reactions were pneumonia, bronchitis, upper respiratory tract infection, pulmonary oedema, influenza, pyrexia, dehydration, diarrhoea and atrial fibrillation.
Danish: Alvorlige bivirkninger var pneumoni, bronchitis, infektion i øvre luftveje, pulmonalt ødem, influenza, pyrexi, dehydrering, diarré og atrieflimren.
English: On DARZALEX infusion days, 20 mg of the dexamethasone dose was given as a pre-infusion medication and the remainder given the day after the infusion.
Danish: På dagene med infusion af DARZALEX blev 20 mg af dexamethasondosen givet før infusionen, og resten blev givet dagen efter infusionen.
English: Median OS was not reached for either treatment group.With an overall median follow-up of 7.4 months (95% CI: 0.0, 14.9), the hazard ratio for OS was 0.77 (95% CI: 0.47, 1.26; p=0.2975).
Danish: Med en samlet median opfølgning på 7,4 måneder (95 % CI: 0,0; 14,9) var hazard ratio for OS 0,77 (95 % CI: 0,47; 1,26; p = 0,2975).
English: Very Common 10
Danish: Meget almindelig 10
English: Dosing schedule in combination with bortezomib, thalidomide and dexamethasone (4-week cycle regimens) for treatment of newly diagnosed patients eligible for autologous stem cell transplant (ASCT):
Danish: Skema for dosering i kombination med med bortezomib, thalidomid og dexamethason (regime med 4-ugers serier) til behandling af nydiagnosticerede patienter, som er kandidater til autolog stamcelletransplantation (ASCT):
English: Very Common 16
Danish: Meget almindelig 16
English: Interference with determination of Complete Response Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both, the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein (see section 4.5).
Danish: Daratumumab er et humant monoklonalt IgG kappa-antistof, som kan påvises med såvel SPE-analyser (serumproteinelektroforese) som IFE-analyser (immunfiksering), der anvendes til klinisk monitorering af endogent M-protein (se pkt.
English: Subsequent (Week 3 onwards, 16 mg/kg) infusions
Danish: Efterfølgende infusioner (uge 3 og derefter, 16 mg/kg)
English: Four individual population PK analyses were performed based on pre-existing renal function data in patients receiving daratumumab monotherapy, or various combination therapies (Analyses 1-4), and included a total of 441 patients with normal renal function (creatinine clearance [CRCL] ≥90 mL/min), 621 with mild renal impairment (CRCL <90 and ≥60 mL/min), 523 with moderate renal impairment (CRCL <60 and ≥30 mL/min), and 27 with severe renal impairment or end stage renal disease
Danish: Der blev udført fire individuelle farmakokinetiske populationsanalyser på grundlag af eksisterende data for nyrefunktionen hos patienter, der fik daratumumab som monoterapi eller forskellige kombinationsbehandlinger (analyse 1-4), som omfattede i alt 441 patienter med normal nyrefunktion (kreatinin-clearance [CrCl] ≥ 90 ml/min), 621 patienter med let nedsat nyrefunktion (CrCl < 90 og ≥ 60 ml/min), 523 patienter med moderat nedsat nyrefunktion (CrCl <60 og ≥ 30 ml/min) og 27 patienter med svært nedsat nyrefunktion eller nyresygdom i terminalstadiet (CrCl < 30 ml/min) indgik i analysen.
English: VGPR or better (sCR + CR + VGPR) p-value
Danish: VGPR eller bedre (sCR + CR + VGPR) p-værdi
English: Table 1: DARZALEX dosing schedule in combination with lenalidomide (4-week cycle dosing regimen) and monotherapy
Danish: Tabel 1: Skema for dosering af DARZALEX i kombination med lenalidomid (doseringsregime med 4-ugers serier) og monoterapi
English: Table 6: Adverse reactions in multiple myeloma patients treated with DARZALEX
Danish: Tabel 6: Bivirkninger hos patienter med myelomatose behandlet med DARZALEX 16 mg/kg
English: The incidence of infusion modifications due to reactions was 36%.
Danish: I 36 % af tilfældene blev infusionen ændret som følge af en reaktion.
English: Bortezomib was administered by SC injection or IV injection at a dose of 1.3 mg/m2 body surface area twice weekly for two weeks (Days 1, 4, 8, and 11) of repeated 28 day (4-week) induction treatment cycles (Cycles 1-4) and two consolidation cycles (Cycles 5 and 6) following ASCT after Cycle 4.
Danish: injektion med en dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger (dag 1, 4, 8 og 11) i gentagne serier på 28 dage (4 uger) med induktionsbehandling (serie 1-4) og to konsolideringsserier (serie 5 og 6) efter ASCT efter serie 4.
English: Combination treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients eligible for autologous stem cell transplant (ASCT):
Danish: Kombinationsbehandling med bortezomib, thalidomid og dexamethason (VTd) hos patienter, som er kandidater til autolog stamcelletransplantation (ASCT):
English: Very Common 25
Danish: Meget almindelig 25
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjældne symptomer (kan forekomme hos op til 1 ud af 1.000 patienter):
English: Median PFS was not reached in the DRd arm and was 33.8 months in the Rd arm (HR=0.56; 95% CI: 0.44, 0.71; p<0.0001).
Danish: Den mediane PFS blev ikke nået i DRd-armen og var 33,8 måneder i Rd-armen (HR = 0,56; 95 % CI: 0,44; 0,71; p < 0,0001).
English: The median age was 73 (range: 45-90) years, with 44% of the patients ≥75 years of age.
Danish: Medianalderen var 73 (interval: 45-90 år), og 44 % af patienterne var ≥ 75 år.
English: Severe infusion-related reactions included bronchospasm, dyspnoea, laryngeal oedema, pulmonary oedema, hypoxia, and hypertension.
Danish: Alvorlige infusionsrelaterede reaktioner inkluderede bronkospasme, dyspnø, larynxødem, lungeødem, hypoxi og hypertension.
English: weekly (total of 9 doses)
Danish: ugentligt (i alt 9 doser)
English: Very Common 19
Danish: Meget almindelig 19
English: • in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Danish: • i kombination med lenalidomid og dexamethason eller med bortezomib, melphalan og prednison til behandling af voksne patienter med nydiagnosticeret myelomatose, som ikke er kandidater til autolog stamcelletransplantation.
English: • in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Danish: • i kombination med bortezomib, thalidomid og dexamethason til behandling af voksne patienter med nydiagnosticeret myelomatose, som er kandidater til autolog stamcelletransplantation.
English: Very Common 45
Danish: Meget almindelig 45
English: Other common symptoms (affecting up to 1 in 10 people) are:
Danish: Andre almindelige symptomer (kan forekomme hos op til 1 ud af 10 patienter):
English: The median patient age was 65 years (range 34 to 89 years) and 11% were ≥75 years.
Danish: Medianalderen var 65 år (34-89 år), og 11 % var ≥ 75 år.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med DARZALEX Fortæl det altid til lægen eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: Other adverse infusion-related reactions included nasal congestion, cough, chills, throat irritation, vomiting and nausea (see section 4.4).
Danish: Andre infusionsrelaterede bivirkninger omfattede tilstoppet næse, hoste, kulderystelser, irritation i svælget, opkastning og kvalme (se pkt.
English: Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose oral or intravenous dexamethasone 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or body mass index [BMI] <18.5).
Danish: Lenalidomid (25 mg en gang dagligt administreret oralt på dag 1-21 i gentagne serier på 28 dage [4 uger]) blev administreret sammen med oral eller intravenøs lavdosis dexamethason 40 mg/uge (eller en reduceret dosis på 20 mg/uge for patienter > 75 år eller med et BMI < 18,5).
English: Your doctor will work out your dose and schedule of DARZALEX.
Danish: Lægen fastsætter den rette dosis DARZALEX og en doseringsplan.
English: Median PFS was not reached in the D-VMP arm and was 19.3 months in the VMP arm (HR=0.46; 95% CI: 0.36, 0.60; p<0.0001).
Danish: Median PFS blev ikke nået i D-VMParmen og var 19,3 måneder i VMP-armen (HR = 0,46; 95 % CI: 0,36, 0,60; p < 0,0001).
English: Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension, laryngeal oedema and pulmonary oedema.
Danish: Alvorlige reaktioner, herunder bronkospasme, hypoxi, dyspnø, hypertension, larynxødem og lungeødem er forekommet.
English: Symptoms predominantly included nasal congestion, cough, throat irritation, chills, vomiting and nausea.
Danish: Symptomerne omfattede fortrinsvis tilstoppet næse, hoste, irritation i svælget, kulderystelser, opkastning og kvalme.
English: Infusion rates
Danish: Infusionshastigheder
English: Table 4: DARZALEX dosing schedule in combination with bortezomib (3-week cycle dosing regimen)
Danish: Tabel 4: Skema for dosering af DARZALEX i kombination med bortezomib (doseringsregime med 3-ugers serier)
English: Stringent complete response (sCR) [n (%)] Complete response (CR) [n] Very good partial response (VGPR) [n (%)] Partial response (PR) [n (%)] Clinical Benefit Rate (ORR+MR) [n (%)]
Danish: Stringent komplet respons (sCR) [n(%)] Komplet respons (CR) [n(%)] Meget godt delvist respons (VGPR) [n(%)] Delvist respons (PR) [n(%)] MRD-negativitetsrate (95% CI)
English: On the days of DARZALEX infusion, the dexamethasone dose was administered intravenously as a pre-infusion medication.
Danish: På dage med infusion af DARZALEX blev dexamethason-dosen administreret intravenøst som en præ-infusionsmedicinering.
English: Table 3: DARZALEX dosing schedule in combination with bortezomib, thalidomide and dexamethasone ([VTd]; 4-week cycle dosing regimen)
Danish: Tabel 3: Skema for dosering af DARZALEX i kombination med bortezomib, thalidomid og dexamethason ([VTd]; doseringsregime med 4-ugers serier) Behandlingsfase
English: Interference with Indirect Antiglobulin Test (Indirect Coombs Test) Daratumumab binds to CD38 found at low levels on red blood cells (RBCs) and may result in a positive indirect Coombs test. Daratumumab-mediated positive indirect Coombs test may persist for up to 6 months after the last daratumumab infusion.
Danish: Interferens med indirekte antiglobulintest (indirekte Coombs test) Daratumumab binder til CD38, der findes i lavt niveau på erytrocytter, hvilket kan medføre en positiv indirekte Coombs test.
English: every two weeks (total of 4 doses)
Danish: hver anden uge (i alt 4 doser)
English: • feeling very tired
Danish: • udpræget træthedsfølelse
English: The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 3.
Danish: Den anbefalede dosis er 16 mg DARZALEX pr. kg legemsvægt administreret som intravenøs infusion i henhold til doseringsskemaet i tabel 3.
English: weekly (total of 6 doses)
Danish: ugentligt (i alt 6 doser)
English: Week and subsequent infusions were approximately 7, 4 and 3 hours respectively.
Danish: Den mediane infusionsvarighed for 16 mg/kg infusioner i uge 1 og uge 2 og efterfølgende infusioner var henholdsvis ca. 7, 4 og 3 timer.
English: Median Time to Response [months (95% CI)] 1.0 (1.0, 1.1) Median Duration of Response [months (95% CI)]
Danish: Mediantid til respons [måneder (95 % CI)] Median responsvarighed [måneder (95 % CI)]
English: 95% CI (%) Odds ratio with 95% CI p-value
Danish: 95 % CI (%) Oddsratio med 95 % CI p-værdi
English: weekly (total of 8 doses)
Danish: ugentligt (i alt 8 doser)
English: DVd=daratumumab- bortezomib-dexamethasone; Vd=bortezomib-dexamethasone; MRD=minimal residual disease; CI=confidence interval; NE=not estimable.
Danish: DVd = daratumumab- bortezomib-dexamethason; Vd = bortezomib-dexamethason; MRD = minimal restsygdom; CI = konfidensinterval; NE = kan ikke estimeres.
English: Dosing schedule in combination with bortezomib, melphalan and prednisone (6-week cycle regimens): The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 2.
Danish: Skema for dosering i kombination med bortezomib (regime med 3-ugers serier): Den anbefalede dosis er 16 mg DARZALEX pr. kg legemsvægt administreret som intravenøs infusion i henhold til doseringsskemaet i tabel 4.
English: Table 8: Additional efficacy results from Study MMY3007
Danish: Tabel 8: Yderligere effektresultater fra studie MMY3007
English: every two weeks (total of 8 doses)
Danish: hver anden uge (i alt 8 doser)
English: Week 2 (16 mg/kg)infusion
Danish: Infusion i uge 2 (16 mg/kg)
English: If an anaphylactic reaction or life-threatening (Grade 4) infusion reaction occurs, appropriate emergency resuscitation should be initiated immediately.
Danish: (grad 4), skal der straks iværksættes passende livreddende behandling.
English: Talk to your doctor or nurse before you are given DARZALEX if you are pregnant, think you might be pregnant or are planning to have a baby.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du får DARZALEX.
English: Table 7: Additional efficacy results from Study MMY3008
Danish: Tabel 7: Yderligere effektresultater fra studie MMY3008