FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of dexamethasone is 40 mg orally once daily on days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily on days 1 to 4 every 28 days.
Danish: Den anbefalede dosis dexamethason er 40 mg oralt én gang dagligt på dag 1 til 4, 9 til 12 og 17 til 20 af hver 28-dages cyklus i de første 4 cyklusser af behandlingen og derefter 40 mg én gang dagligt på dag 1 til 4 i hver cyklus på 28 dage.
English: Severe renal impairment (CLcr < 30 mL/min, not requiring dialysis)
Danish: Svært nedsat nyrefunktion (kreatininclearance < 30 ml/min, ikke dialysekrævende)
English: A 1.3-fold increase in incidence rate of solid tumour SPM has been observed in patients receiving lenalidomide in combination with dexamethasone until progression or for 18 months (1.58 per 100 person-years) compared to thalidomide in combination with melphalan and prednisone (1.19 per 100 person-years).
Danish: Der er observeret en 1,3-fold stigning i forekomsten af solid tumor SPM hos patienter, der fik lenalidomid i kombination med dexamethason indtil progression eller i 18 måneder (1,58 pr. 100 personår), sammenlignet med thalidomid i kombination med melphalan og prednison (1,19 pr. 100 personår).
English: Multiple myeloma: patients with at least one prior therapy
Danish: Myelomatose: patienter med mindst én tidligere behandling
English: End Stage Renal Disease (ESRD) (CLcr < 30 mL/min, requiring dialysis)
Danish: Nyresygdom i slutstadie (ESRD, End Stage Renal Disease) (kreatininclearance < 30 ml/min, dialysekrævende)
English: Tumour flare reaction
Danish: Tumor-flare-reaktion
English: • The other ingredients are: - capsule contents: lactose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Danish: • Øvrige indholdsstoffer: - kapselindhold: lactose, mikrokrystallinsk cellulose, croscarmellosenatrium, silica, kolloid vandfri, og magnesiumstearat.
English: Grade 4 febrile neutropenia episodes were consistent with the comparator arm (0.6 % in the Rd and Rd18 lenalidomide/dexamethasone-treated patients compared with 0.7% in the melphalan/prednisone/thalidomide arm, see section 4.8).
Danish: Episoder med grad 4 febril neutropeni var i overensstemmelse med den sammenlignende arm (0,6 % hos Rd- og Rd18-patienter i behandling med lenalidomid/dexamethason, sammenlignet med 0,7 % i armen med melphalan/prednison/thalidomid, se pkt.
English: Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone (see sections 4.4 and 4.8).
Danish: Erytropoietiner eller andre stoffer, som kan øge risikoen for trombose som f.eks. hormonsubstitutionsbehandling, bør anvendes med forsigtighed hos patienter med myelomatose, som får lenalidomid sammen med dexamethason (se pkt.
English: Resume lenalidomide at next lower dose level (dose level -2 or -3) once daily.
Danish: Genoptag lenalidomid ved det næste lavere dosisniveau (dosisniveau -2 eller3) én gang dagligt.
English: Vomiting, Abdominal pain upper
Danish: Almindelig Opkastning, øvre abdominalsmerter
English: Diarrhoea◊, Constipation◊, Abdominal pain◊, Nausea, Vomiting
Danish: Diarré◊, forstoppelse◊, abdominalsmerter◊, kvalme, opkastning
English: Dose level -5
Danish: Dosisniveau -5
English: These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Danish: Disse graviditetstests skal udføres enten under selve den konsultation, hvor patienten får ordineret lenalidomid eller i løbet af de sidste 3 dage inden konsultationen hos den ordinerende læge.
English: • Stroke, fainting
Danish: • Slagtilfælde, besvimelse
English: In the CALGB 100104 study, the adverse reactions observed more frequently with lenalidomide maintenance than placebo were neutropenia (79.0% [71.9% after the start of maintenance treatment]), thrombocytopenia (72.3% [61.6%]), diarrhoea (54.5% [46.4%]), rash (31.7% [25.0%]), upper respiratory tract infection (26.8% [26.8%]), fatigue (22.8% [17.9%]), leucopenia (22.8% [18.8%]) and anaemia (21.0% [13.8%]).
Danish: I CALGB 100104-studiet var de bivirkninger, der blev observeret hyppigere med lenalidomidvedligeholdelsesbehandling end med placebo, neutropeni (79,0 % [71,9% efter påbegyndelse af vedligeholdelsesbehandling]), trombocytopeni (72,3 % [61,6%]), diarré (54,5% [46,4%]), udslæt (31,7 % [25,0%]), øvre luftvejsinfektion (26,8 % [26,8%], træthed (22,8 % [17,9%]), leukopeni (22,8 % [18,8%]) og anæmi (21,0 % [13,8%]).
English: In this pooled extended follow-up analysis, the median TTP was 60.1 weeks (95% CI: 44.3, 73.1) in patients treated with len/dex (N = 353) versus 20.1 weeks (95% CI: 17.7, 20.3) in patients treated with placebo/dex (N = 351).
Danish: I denne poolede, forlængede opfølgningsanalyse var den mediane TTP 60,1 uger (95 % konfidensinterval: 44,3; 73,1) hos de patienter, der fik behandling med len/dex (N = 353), mens gennemsnitstiden for TTP var 20,1 uger (95 % konfidensinterval: 17,7; 20,3) i placebo/dexpatientgruppen (N = 351).
English: (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide)
Danish: (E172), gul jernoxid (E172), titandioxid (E171), indigokarmin (E132) og kaliumhydroxid).
English: How much Lenalidomide to take
Danish: Hvor meget lenalidomid skal der tages?
English: The observed adverse reactions which occurred more frequently with lenalidomide and dexamethasone than placebo and dexamethasone in pooled multiple myeloma clinical trials (MM-009 and MM-010) were fatigue (43.9%), neutropenia (42.2%), constipation (40.5%), diarrhoea (38.5%), muscle cramp (33.4%), anaemia (31.4%), thrombocytopenia (21.5%), and rash (21.2%).
Danish: De observerede bivirkninger, som opstod hyppigere med lenalidomid og dexamethason end med placebo og dexamethason i en samlet oversigt af kliniske studier med myelomatose (MM-009 og MM010) var træthed (43,9 %), neutropeni (42,2 %), forstoppelse (40,5 %), diarré (38,5 %), muskelkrampe (33,4 %), anæmi (31,4 %), trombocytopeni (21,5 %), og udslæt (21,2 %).
English: • Brochure for male patients
Danish: Brochure til mandlige patienter
English: bone pain, joint pain, tiredness, generalised swelling including swelling of your arms and legs
Danish: knoglesmerter, ledsmerter, træthed, hævelser i hele kroppen, herunder af arme og ben
English: Lenalidomide in combination with melphalan and prednisone followed by maintenance therapy in patients who are not eligible for transplant
Danish: Lenalidomid i kombination med melphalan og prednison efterfulgt af vedligeholdelsesbehandling hos patienter, der ikke er egnede til transplantation
English: The median overall PFS was 33.9 months (95% CI NE, NE) in the lenalidomide arm versus 19.0 months (95% CI 16.2, 25.6) in the placebo arm.
Danish: Den mediane samlede PFS var 33,9 måneder (95% CI NE; NE) i lenalidomid-armen vs 19,0 måneder (95% CI 16,2-25,6) i placebo-armen.
English: • Dose reduction steps
Danish: • Dosisreduktionstrin
English: Lenalidomide in combination with melphalan and prednisone followed by lenalidomide maintenance in patients who are not eligible for transplant
Danish: Lenalidomid i kombination med melphalan og prednison, efterfulgt af lenalidomidvedligeholdelsesbehandling hos patienter, der ikke er egnede til transplantation
English: Resume lenalidomide at dose level -1 once daily
Danish: Genoptag lenalidomid ved dosisniveau -1 én gang dagligt
English: An increased risk of DVT and PE is associated with the use of the combination of lenalidomide with dexamethasone in patients with multiple myeloma, and to a lesser extent in patients treated with lenalidomide in combination with melphalan and prednisone or in patients with multiple myeloma, treated with lenalidomide monotherapy (see section 4.5).
Danish: Der er en øget risiko for DVT og lungeemboli forbundet med anvendelse af kombinationen lenalidomid plus dexamethason og i mindre grad med anvendelse af lenalidomid i kombination med melphalan og prednison hos patienter med myelomatose eller anvendelse af lenalidomid-monoterapi hos patienter med myelomatose (se pkt.
English: Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide in combination therapy, and to a lesser extent in patients with multiple myeloma, taking lenalidomide monotherapy, combined oral contraceptive pills are not recommended (see also section 4.5).
Danish: På grund af den øgede risiko for venøs tromboemboli hos patienter med myelomatose, som tager lenalidomid i kombinationsbehandling, og i mindre grad hos patienter med myelomatose, der tager lenalidomid som monoterapi, bør patienten ikke bruge p-piller af kombinationstypen (se også pkt.
English: A medically supervised pregnancy test should be performed during the consultation, when lenalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Danish: En lægeligt monitoreret graviditetstest skal udføres enten under selve den konsultation, hvor patienten får ordineret lenalidomid, eller i løbet af de sidste 3 dage inden konsultationen hos den ordinerende læge.
English: The median overall PFS was 40.1 months (95% CI 35.7, 42.4) in the lenalidomide arm versus 22.8 months (95% CI 20.7, 27.4) in the placebo arm.
Danish: Den mediane samlede PFS var 40,1 måneder (95% CI 35,7-42,4) i lenalidomid-armen sammenlignet med 22,8 måneder (95% CI 20,7-27,4) i placebo-armen.
English: Hypokalaemia◊, Hyperglycaemia, Hypocalcaemia◊, Decreased appetite, Weight decreased
Danish: Meget almindelig Hypokaliæmi◊, hyperglykæmi, hypokalcæmi◊, nedsat appetit, vægttab
English: Lenalidomide Accord 2.5 mg, Lenalidomide Accord 5 mg, Lenalidomide Accord 10 mg and Lenalidomide Accord 15 mg hard capsules
Danish: Lenalidomide Accord 2,5 mg, Lenalidomide Accord 5 mg, Lenalidomide Accord 10 mg og Lenalidomide Accord 15 mg hårde kapsler
English: Lenalidomide Accord as combination therapy (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Danish: 4.2) er indiceret til behandling af voksne patienter med tidligere ubehandlet myelomatose, hvis de ikke er egnede til transplantation.
English: A majority of lenalidomide is eliminated through urinary excretion.
Danish: Størstedelen af lenalidomid udskilles via nyrerne.
English: Lenalidomide is excreted by the kidneys.
Danish: Lenalidomid udskilles af nyrerne.
English: ^see section 4.8 description of selected adverse reactions
Danish: 4.8 Beskrivelse af udvalgte bivirkningers
English: Caution should be exercised when lenalidomide is used in patients previously infected with HBV, including patients who are anti-HBc positive but HBsAg negative.
Danish: For patienter, der tester positive for HBV-infektion, anbefales det at konsultere en læge med erfaring i at behandle hepatitis B. Der bør udvises forsigtighed, når lenalidomid anvendes til patienter, der tidligere har været inficeret med HBV, herunder patienter, som er anti-HBc-positive, men HBsAg-negative.
English: TLS and tumour flare reaction (TFR) have commonly been observed in patients with chronic lymphocytic leukemia (CLL), and uncommonly in patients with lymphomas, who were treated with lenalidomide.
Danish: I forbindelse med lenalidomidbehandling er TLS og tumor-flare-reaktion (TFR) observeret med frekvensen ”almindelig” hos patienter med kronisk lymfocytisk leukæmi (CLL) og med frekvensen ”ikke almindelig” hos patienter med lymfomer.
English: • Sore inflamed mouth, dry mouth, difficulty swallowing
Danish: • Øm og betændt mund, mundtørhed, synkebesvær
English: • Rare cases of muscle breakdown (muscle pain, weakness or swelling) which can lead to kidney problems (rhabdomyolysis) have been observed, some of them when lenalidomide is administered with a statin (a type of cholesterol lowering medicines).
Danish: • Sjældne tilfælde af muskelnedbrydning (muskelsmerter, svaghed eller hævelse), hvilket kan føre til nyreproblemer (rabdomyolyse), er blevet observeret.
English: ADRs reported in clinical studies in patients with multiple myeloma treated with lenalidomide in combination with dexamethasone, or with melphalan and prednisone System Organ
Danish: Bivirkninger indberettet i kliniske studier hos patienter med myelomatose, der blev behandlet med lenalidomid i kombination med dexamethason, eller med melphalan og prednison
English: Dose reduction steps
Danish: Dosisreduktionstrin
English: How and when to take lenalidomide swallow the capsules whole, preferably with water.
Danish: • Slug kapslerne hele, helst med vand.
English: Multiple myeloma with at least one prior therapy
Danish: Myelomatose med mindst én tidligere behandling
English: Patients randomised to the lenalidomide/standard dose dexamethasone arm received lenalidomide 25 mg/day, days 1 to 21 every 28 days plus dexamethasone 40 mg/day on days 1 to 4, 9 to 12, and 17 to 20 every 28 days for the first four cycles.
Danish: Patienter randomiseret til armen med lenalidomid/standarddosis dexamethason fik lenalidomid 25 mg/dag, dag 1 til 21, cyklus på 28 dage plus dexamethason 40 mg/dag på dag 1 til 4, 9 til 12 og 17 til 20, cyklus på 28 dage i de første fire cyklusser.
English: Patients were stratified at randomisation by age ( 75 vs. > 75 years) and stage (ISS; Stages I and II vs. stage III).
Danish: Patienterne blev randomiseret til 1 ud af 3 behandlingsarme i et forhold på 1:1:1: Patienterne blev stratificeret i forhold til alder ved randomisering ( 75 vs. > 75 og) og trin (ISS, trin I og II vs. trin III).
English: • Brochure for women patients who are not of childbearing potential
Danish: • En brochure til ikke-fertile kvinder
English: Common Muscular weakness, Joint swelling, Myalgia
Danish: Muskelsvaghed, hævelse af led, myalgi
English: Common Rashes
Danish: Almindelig Udslæt
English: The study was unblinded upon the recommendations of the data monitoring committee after surpassing the threshold for a preplanned interim analysis of PFS. After unblinding, patients in the placebo arm were allowed to cross over to receive lenalidomide before disease progression.
Danish: Studiet blev afblindet efter anbefaling fra datamonitoreringskomitéen efter overskridelse af tærsklen for en forud planlagt interimanalyse af PFS.
English: The median progression free survival was 48.1 weeks (95% CI: 36.4, 62.1) in patients treated with len/dex versus 20.0 weeks (95% CI: 16.1, 20.1) in patients treated with placebo/dex.
Danish: Medianen for progressionsfri overlevelse var 48,1 uger (95 % konfideninterval: 36,4; 62,1) hos de patienter, der fik behandling med len/dex, mens den var på 20,0 uger (95 % konfidensinterval: 16,1; 20,1) i placebo/dex-patientgruppen.
English: Overall survival (months) Mediana OS time, months (95% CI)b
Danish: Samlet overlevelse (måneder) Mediana OS-tid, måneder (95 % CI)b
English: - capsule contents: lactose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Danish: - kapselindhold: lactose, mikrokrystallinsk cellulose, croscarmellosenatrium, silica, kolloid vandfri, og magnesiumstearat
English: 5 mg (days 1-21 every 28 days)
Danish: Dosisniveau -2 5 mg dag 1-21 i 28 dages cyklus
English: • Patient cards
Danish: • Patientkort
English: Gastrointestinal haemorrhage (including rectal haemorrhage, haemorrhoidal haemorrhage, peptic ulcer haemorrhage and gingival bleeding)^, Dry mouth, Stomatitis, Dysphagia
Danish: Gastrointestinal blødning (herunder rektalblødning, hæmorideblødning, blødende mavesår og gingivalblødning)^, mundtørhed, stomatitis, dysfagi
English: Lenalidomide Accord 7.5 mg, Lenalidomide Accord 20 mg and Lenalidomide Accord 25 mg hard capsules
Danish: Lenalidomide Accord 7,5 mg, Lenalidomide Accord 20 mg og Lenalidomide Accord 25 mg hårde kapsler
English: Lenalidomide Accord 20 mg hard capsules Each hard capsule contains 20 mg of lenalidomide.
Danish: Lenalidomide Accord 20 mg hårde kapsler Hver hård kapsel indeholder 20 mg lenalidomid.
English: The Educational Healthcare Professional's Kit
Danish: Sættet med oplysningsmateriale til sundhedspersonale
English: Newly diagnosed multiple myelomaLenalidomide maintenance in patients who have undergone ASCT
Danish: Nydiagnosticeret myelomatose Vedligeholdelsesbehandling med lenalidomid hos patienter, der har gennemgået ASCT
English: • you must use effective methods of contraception for 4 weeks before starting treatment, during treatment, and until 4 weeks after stopping treatment.
Danish: Kvinder i den fertile alder skal benytte en effektiv præventionsmetode i 4 uger før behandlingen, under behandlingen, og indtil 4 uger efter lenalidomid-behandlingen.
English: MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p PFS2 (months) ¤ Mediana PFS2 time, months (95% CI)
Danish: HR [95 % CI], p-værdi MPR+R vs. MPp+p MPR+R vs. MPR+p MPR+p vs. MPp+p PFS2 (måneder) ¤ Mediana PFS2-tid, måneder (95 % CI)
English: In the IFM 2005-02 study, the adverse reactions observed more frequently with lenalidomide maintenance than placebo were neutropenia (60.8%), bronchitis (47.4%), diarrhoea (38.9%), nasopharyngitis (34.8%), muscle spasms (33.4%), leucopenia (31.7%), asthenia (29.7%), cough (27.3%), thrombocytopenia (23.5%), gastroenteritis (22.5%) and pyrexia (20.5%).
Danish: I IFM 2005-02-studiet var de bivirkninger, der blev observeret hyppigere med lenalidomidvedligeholdelsesbehandling end med placebo, neutropeni (60,8 %), bronkitis (47,4 %), diarré (38,9 %), nasofaryngitis (34,8 %), muskelspasmer (33,4 %), leukopeni (31,7 %), asteni (29,7 %), hoste (27,3 %), trombocytopeni (23,5 %), gastroenteritis (22,5 %) og pyreksi (20,5 %).
English: The adverse reactions observed more frequently with MPR+R or MPR+p than MPp+p were: neutropenia (83.3%), anaemia (70.7%), thrombocytopenia (70.0%), leukopenia (38.8%), constipation (34.0%), diarrhoea (33.3%), rash (28.9%), pyrexia (27.0%), peripheral oedema (25.0%), cough (24.0%), decreased appetite (23.7%), and asthenia (22.0%).
Danish: De bivirkninger, der hyppigere blev observeret med MPR+R eller MPR+ p end med MPp+p var: neutropeni (83,3 %), anæmi (70,7 %), trombocytopeni (70,0 %), leukopeni (38,8 %), forstoppelse (34,0 %), diarré (33,3 %), udslæt (28,9 %), pyreksi (27,0 %), perifert ødem (25,0 %), hoste (24,0 %), nedsat appetit (23,7 %) og asteni (22,0 %).
English: Lenalidomide maintenance after ASCT is associated with a higher frequency of grade 4 neutropenia compared to placebo maintenance (32.1% vs 26.7% [16.1% vs 1.8% after the start of maintenance treatment] in CALGB 100104 and 16.4% vs 0.7% in IFM 2005-02, respectively).
Danish: Vedligeholdelsesbehandling med lenalidomid efter ASCT er forbundet med en højere forekomst af grad 4 neutropeni sammenlignet med placebo-vedligeholdelsesbehandling (32,1 % vs 26,7 % [16,1% vs 1,8% efter påbegyndelse af vedligeholdelsesbehandling] i CALGB 100104 og 16,4 % vs 0,7 % i IFM 2005-02).
English: • Wheezing, breathlessness or a dry cough, which may be symptoms caused by inflammation of the tissue in the lungs.
Danish: • Hiven efter vejret, åndenød eller tør hoste − disse symptomer kan skyldes betændelse i lungevævet.
English: Overall survival Mediana OS time, months (95% CI)b
Danish: Samlet overlevelse Mediana OS-tid, måneder (95% CI)b
English: The combination of lenalidomide with low dose dexamethasone in newly diagnosed multiple myeloma patients is associated with a lower frequency of grade 4 neutropenia (8.5% in Rd and Rd18, compared with MPT (15%).
Danish: Kombinationen af lenalidomid og lavdosis dexamethason hos nydiagnosticerede patienter med myelomatose er forbundet med en lavere hyppighed af grad 4 neutropeni (8,5 % med Rd og Rd18, sammenlignet med 15 % med MPT).
English: For each subsequent drop below < 0.5 x 109/L
Danish: For hvert efterfølgende fald til under < 0,5 x 109/l
English: • The need to contact their doctor immediately upon suspicion of pregnancy Brochure for male patients
Danish: • Nødvendigheden af omgående at oplyse det til lægen, hvis der er mistanke om graviditet
English: HR [95% CI], p-value a
Danish: HR [95 % CI]c, p-værdid
English: • Multiple myeloma: patients with at least one prior therapy The combination of lenalidomide with dexamethasone in multiple myeloma patients with at least one prior therapy is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients; see section 4.8).
Danish: • Myelomatose hos patienter, der har fået mindst én tidligere behandling Kombination af lenalidomid sammen med dexamethason hos patienter med myelomatose med mindst én tidligere behandling er forbundet med en højere forekomst af grad 4-neutropeni (5,1 % hos patienter, som blev behandlet med lenalidomid/dexamethason, sammenlignet med 0,6 % hos patienter, som blev behandlet med placebo/dexamethason, se pkt.
English: The adverse reactions observed more frequently with Rd or Rd18 than MPT were: diarrhoea (45.5%), fatigue (32.8%), back pain (32.0%), asthenia (28.2%), insomnia (27.6%), rash (24.3%), decreased appetite (23.1%), cough (22.7%), pyrexia (21.4%), and muscle spasms (20.5%).
Danish: De bivirkninger, der hyppigere blev observeret med Rd eller Rd18 end med MPT, var: diarré (45,5 %), træthed (32,8 %), rygsmerter (32,0 %), asteni (28,2 %), insomni (27,6 %), udslæt (24,3 %), nedsat appetit (23,1 %), hoste (22,7 %), pyreksi (21,4 %) og muskelspasmer (20,5 %).
English: Patients randomised to the lenalidomide/low dose dexamethasone arm received lenalidomide 25 mg/day, days 1 to 21 every 28 days plus low dose dexamethasone - 40 mg/day on days 1, 8, 15, and 22 every 28 days.
Danish: Patienter randomiseret til armen med lenalidomid/Lavdosis dexamethason fik lenalidomid 25 mg/dag, dag 1 til 21, cyklus på 28 dage plus lavdosis dexamethason - 40 mg/dag på dag 1, 8, 15 og 22, cyklus på 28 dage.
English: Prior to prescribing (and where appropriate, and in agreement with the National Competent Authority, prior to dispensing) all healthcare professionals who intend to prescribe (and dispense) Lenalidomide Accord are provided with a physician information pack containing the following:
Danish: • Alt sundhedspersonale, som har til hensigt at ordinere (og udlevere) Lenalidomide Accord, modtager en informationspakke til læger, inden produktet lanceres på markedet (og hvor det er hensigtsmæssigt og med samtykke fra den relevante nationale myndighed, inden udleveringen).
English: Dose level -2
Danish: Dosisniveau -2
English: • Educational Health Care Professional's kit
Danish: • Sæt med oplysningsmateriale til sundhedspersonale
English: Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients).
Danish: Episoder af grad 4 febril neutropeni blev observeret mindre hyppigt (0,6 % hos patienter, som blev behandlet med lenalidomid/dexamethason, sammenlignet med 0,0 % hos patienter, som blev behandlet med placebo/dexamethason).
English: Newly diagnosed multiple myeloma: patients who have undergone ASCT treated with lenalidomide maintenance
Danish: Nyligt diagnosticeret myelomatose: patienter, der har gennemgået ASCT og er i vedligeholdelsesbehandling med lenalidomid
English: Grade 4 febrile neutropenia episodes were observed infrequently (1.7% in MPR+R/MPR+p treated patients compared to 0.0 % in MPp+p treated patients; see section 4.8).
Danish: Episoder med grad 4 febril neutropeni blev ikke observeret hyppigt (1,7 % hos patienter i behandling med MPR+R/MPR+p, sammenlignet med 0,0 % hos patienter i behandling med MPp+p.
English: Time to progression Median [95% CI], weeks
Danish: Tid til progression, median [95 %konfidensinterval], uger p < 0,001
English: Fall to < 30 x 109/L
Danish: Falder til < 30 x 109/l
English: Muscular weakness, Bone pain◊, Musculoskeletal and connective tissue pain and discomfort (including back pain◊)
Danish: Muskelsvaghed, knoglesmerter◊, smerter og ubehag i knogler, led, muskler og bindevæv (herunder rygsmerter◊)