FrancophonIA/ELRC3.0 huggingface dataset:
English: Haemolysis, Autoimmune haemolytic anaemia, Haemolytic anaemia
Danish: Hæmolyse, autoimmun hæmolytisk anæmi, hæmolytisk anæmi
English: In patients with multiple myeloma, the combination of lenalidomide with dexamethasone is associated with an increased risk of venous thromboembolism (predominantly deep vein thrombosis and pulmonary embolism) and was seen to a lesser extent with lenalidomide in combination with melphalan and prednisone.
Danish: Kombinationen af lenalidomid og dexamethason er forbundet med en øget risiko for venøs tromboemboli (hovedsageligt dyb venetrombose og lungeemboli ) og blev observeret i mindre grad med lenalidomid i kombination med melphalan og prednison.
English: The combination of lenalidomide with melphalan and prednisone in newly diagnosed multiple myeloma patients is associated with a higher frequency of grade 4 neutropenia (34.1% in MPR+R/MPR+p) compared with MPp+p (7.8%).
Danish: Kombinationen af lenalidomid og melphalan og prednison hos nydiagnosticerede patienter med myelomatose er forbundet med en større hyppighed af grad 4 neutropeni (34,1 % med MPR+R/MPR+p) sammenlignet med ed MPp+p (7,8 %).
English: Each capsule contains 20 mg of lenalidomide.
Danish: Hver kapsel indeholder 20 mg lenalidomid.
English: • Loss of vision
Danish: • Tab af appetit
English: • Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with lenalidomide in combination with low dose dexamethasone Grade 4 neutropenia was observed in the lenalidomide arms in combination with low dose dexamethasone to a lesser extent than in the comparator arm (8.5% in the Rd [continuous treatment] and Rd18 [treatment for 18 four-week cycles] compared with 15% in the melphalan/prednisone/thalidomide arm, see section 4.8).
Danish: Grad 4 neutropeni blev observeret i lenalidomidarmene i kombination med lavdosis dexamethason i mindre grad end i den sammenlignende arm (8,5 % i Rd [kontinuerlig behandling] og Rd18 [behandling i 18 4-ugers cyklusser], sammenlignet med 15 % i armen med melphalan/prednison/thalidomid, se pkt.
English: Return to ≥ 30 x 109/L
Danish: Vender tilbage til ≥ 30 x 109/l
English: Muscle spasms, Bone pain◊, Musculoskeletal and connective tissue pain and discomfort (including back pain◊), Arthralgia◊
Danish: Meget almindelig Muskelspasmer, knoglesmerter◊, smerter og ubehag i knogler, led, muskler og bindevæv (herunder rygsmerter◊), artralgi◊
English: Dose level -3
Danish: Dosisniveau -3
English: Overall, grade 4 neutropenia was observed at a higher frequency in the lenalidomide maintenance arms compared to the placebo maintenance arms in the 2 studies evaluating lenalidomide maintenance in NDMM patients who have undergone ASCT (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: Samlet set blev grad 4 neutropeni observeret med en højere frekvens i armene med lenalidomidvedligeholdelsesbehandling sammenlignet med armene med placebo-vedligeholdelsesbehandling i de 2 studier, der evaluerede lenalidomid-vedligeholdelsesbehandling hos NDMM-patienter, der har gennemgået ASCT (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: Resume lenalidomide at starting dose once daily
Danish: Genoptag lenalidomid ved startdosis én gang dagligt
English: There have been rare reports of TLS in patients with MM treated with lenalidomide.
Danish: Der er sjældne rapporter om TLS hos MM-patienter i behandling med lenalidomid og ingen rapporter fra MDSpatienter i behandling med lenalidomid.
English: Lenalidomide treatment must not be started if the ANC < 1.0 x 109/L, and/or platelet counts < 75 x 109/L or, dependent on bone marrow infiltration by plasma cells, platelet counts < 30 x 109/L.
Danish: Behandling med lenalidomid må ikke startes ved ANC < 1,0 x 109/´l og/eller trombocyttal < 75 x 109/l eller, afhængigt af infiltrationen af plasmaceller i knoglemarven, trombocyttal < 30 x 109/l.
English: Renal function (CLcr)
Danish: Nyrefunktion (kreatininclearance)
English: Lenalidomide Accord 2.5 mg hard capsules Lenalidomide Accord 5 mg hard capsules Lenalidomide Accord 7.5 mg hard capsules Lenalidomide Accord 10 mg hard capsules Lenalidomide Accord 15 mg hard capsules Lenalidomide Accord 20 mg hard capsules Lenalidomide Accord 25 mg hard capsules
Danish: Lenalidomide Accord 2,5 mg hårde kapsler Lenalidomide Accord 5 mg hårde kapsler Lenalidomide Accord 7,5 mg hårde kapsler Lenalidomide Accord 10 mg hårde kapsler Lenalidomide Accord 15 mg hårde kapsler Lenalidomide Accord 20 mg hårde kapsler Lenalidomide Accord 25 mg hårde kapsler
English: The safety and efficacy of lenalidomide was assessed in a phase III, multicenter, randomised, openlabel, 3-arm study (MM-020) of patients who were at least 65 years of age or older or, if younger than 65 years of age, were not candidates for stem cell transplantation because they declined to undergo stem cell transplantation or stem cell transplantation is not available to the patient due to cost or other reason.The study (MM-020) compared lenalidomide and dexamethasone (Rd) given for 2 different durations of time (i.e., until progressive disease [Arm Rd] or for up to eighteen 28-day cycles [72 weeks, Arm Rd18]) to melphalan, prednisone and thalidomide (MPT) for a maximum of twelve 42-day cycles (72 weeks).
Danish: Lenalidomids sikkerhed og virkning blev vurderet i et fase III, multicenter, randomiseret, open-label, studie (MM-020) med tre arme hos patienter, der var mindst 65 år eller ældre eller, hvis de var yngre end 65 år, ikke var kandidater til stamcelletransplantation, da de afslog at gennemgå en stamcelletransplantation, eller stamcelletransplantationen ikke var tilgængelig for patienten på grund af omkostninger eller andre årsager.
English: Very Common Neutropenia^,◊, Thrombocytopenia^,◊,
Danish: Meget almindelig Neutropeni^,◊, febril neutropeni^,◊, trombocytopeni^,◊,
English: The combination of lenalidomide with dexamethasone in multiple myeloma patients 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).
Danish: Kombination af lenalidomid og dexamethason hos patienter med myelomatose 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).
English: • She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation
Danish: • Kvinden forstår nødvendigheden af og accepterer at få foretaget graviditetstest hver 4. uge,
English: Very Common Depression, Insomnia Uncommon Loss of libido
Danish: Psykiske forstyrrelser Meget almindelig Depression, insomni
English: Grade 3 or 4 thrombocytopenia was observed at a higher frequency in the lenalidomide maintenance arms compared to the placebo maintenance arms in studies evaluating lenalidomide maintenance in NDMM patients who have undergone ASCT (37.5% vs 30.3% [17.9% vs 4.1% after the start of maintenance treatment] in CALGB 100104 and 13.0% vs 2.9% in IFM 2005-02, respectively).
Danish: Grad 3 og 4 trombocytopeni blev observeret med en højere forekomst i armene med lenalidomidvedligeholdelsesbehandling sammenlignet med armene med placebo-vedligeholdelsesbehandling i studier, der evaluerede lenalidomid-vedligeholdelsesbehandling hos NDMM-patienter, der havde gennemgået ASCT (37,5 % vs 30,3 % [17,9% vs 4,1% efter påbegyndelse af vedligeholdelsesbehandling] i CALGB 100104 og 13,0 % vs 2,9 % i IFM 2005-02).
English: • Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with lenalidomide in combination with melphalan and prednisone The combination of lenalidomide with melphalan and prednisone in clinical trials of newly diagnosed multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (34.1% in melphalan, prednisone and lenalidomide arm followed by lenalidomide [MPR+R] and melphalan, prednisone and lenalidomide followed by placebo [MPR+p] treated patients compared with 7.8% in MPp+p-treated patients; see section 4.8).
Danish: Kombinationen af lenalidomid sammen med melphalan og prednison i kliniske studier hos patienter med nydiagnosticeret myelomatose er forbundet med en større forekomst af grad 4 neutropeni (34,1 % i armen med melphalan, prednison og lenalidomid, efterfulgt af lenalidomid [MPR+R] og melphalan, prednison og lenalidomid, efterfulgt af patienter i behandling med placebo [MPR+p], sammenlignet med 7,8 % hos patienter i behandling med MPp+p.
English: Medianf (min, max), months: all surviving patients
Danish: ), måneder: alle overlevende patienter
English: Grade 4 febrile neutropenia was reported at similar frequencies in the lenalidomide maintenance arms compared to placebo maintenance arms in both studies (0.4% vs 0.5% [0.4% vs 0.5% after the start of maintenance treatment] in CALGB 100104 and 0.3% vs 0% in IFM 2005-02, respectively).
Danish: Grad 4 febril neutropeni blev rapporteret med sammenlignelige hyppigheder i armene med lenalidomid-vedligeholdelsesbehandling og placebo-vedligeholdelsesbehandling i de to studier (0,4 % vs 0,5 % [0,4% vs 0,5% efter påbegyndelse af vedligeholdelsesbehandling] i CALGB 100104 og 0,3 % vs 0 % i IFM 2005-02).
English: Lenalidomide treatment must not be started if the ANC is < 1.5 x 109/L, and/or platelet counts are < 75 x 109/L.
Danish: Lenalidomid-behandlingen må ikke startes, hvis ANC er < 1,5 x 109/l, og/eller trombocyttallet er < 75 x 109/l.
English: Iron oxide black (E172) Titanium dioxide (E171)
Danish: Sort jernoxid (E172) Titandioxid (E171)
English: Each capsule contains 7.5 mg of lenalidomide.
Danish: Hver kapsel indeholder 7,5 mg lenalidomid.
English: • Weight loss
Danish: • Hævelse af led
English: Specifically, lenalidomide inhibits proliferation of certain haematopoietic tumour cells (including MM plasma tumour cells and those with deletions of chromosome 5), enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases the number of NK T cells, inhibits angiogenesis by blocking the migration and adhesion of endothelial cells and the formation of microvessels, augments foetal haemoglobin production by CD34+ haematopoietic stem cells, and inhibits production of pro-inflammatory cytokines (e.g., TNF-αand IL-6) by monocytes.
Danish: Det øger føtal hæmoglobin-produktion af CD34+-hæmatopoietiske stamceller og hæmmer monocytters produktion af pro-inflammatoriske cytokiner (f.eks. TNF-α og IL-6).
English: • Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless,
Danish: • Smerter i brystet, der spreder sig ud til arme, hals, kæbe, ryg eller mave, en følelse af at være svedig og kortåndet, kvalme eller opkastning (hvilket kan være symptomer på hjerteanfald/myokardieinfarkt)
English: Myocardial infarction (including acute)^,◊, Atrial fibrillation◊,
Danish: Myokardieinfarkt (herunder akut)^,◊, atrieflimren◊, kongestiv hjerteinsufficiens◊, takykardi, hjerteinsufficiens◊,
English: First fall to < 25 x 109/L
Danish: Først falder til < 25 x 109/l
English: Lenalidomide is primarily excreted by the kidney; patients with greater degrees of renal impairment can have impaired treatment tolerance (see section 4.4).
Danish: Patienter med sværere grader af nedsat nyrefunktion kan i højere grad have en reduceret tolerance over for behandlingen (se pkt.
English: As a precaution, and taking into account special populations with prolonged elimination time such as renal impairment, all male patients taking lenalidomide should use condoms throughout treatment duration, during dose interruption and for 1 week after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception.
Danish: benytte kondom under hele behandlingen, under dosisafbrydelse og i 1 uge efter behandlingsophør, hvis deres partner er gravid eller i den fertile alder og ikke bruger kontraception.
English: In patients with multiple myeloma, , treatment with lenalidomide monotherapy was associated with a lower risk of venous thromboembolism (predominantly deep vein thrombosis and pulmonary embolism) than in patients with multiple myeloma treated with lenalidomide in combination therapy (see sections 4.5 and 4.8).
Danish: Hos patienter med myelomatose var behandling med lenalidomid-monoterapi forbundet med en lavere risiko for venøs tromboemboli (hovedsageligt dyb venetrombose og lungeemboli) end hos patienter med myelomatose, som blev behandlet med lenalidomid i kombinationsbehandling (se pkt.
English: Distribution In vitro (14C)-lenalidomide binding to plasma proteins was low with mean plasma protein binding at
Danish: Fordeling (14C)-lenalidomids binding til plasmaproteiner in vitro var lav med gennemsnitlig plasmaproteinbinding på 23 % og 29 % hos henholdsvis patienter med myelomatose og raske forsøgspersoner.
English: Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with lenalidomide in combination with low dose dexamethasone
Danish: Patienter med nydiagnosticeret myelomatose, som ikke er egnede til transplantation, og som er i behandling med lenalidomid i kombination med lavdosis dexamethason
English: Lenalidomide Accord 5 mg and Lenalidomide Accord 25 mg hard capsules Gelatin
Danish: Lenalidomide Accord 5 mg og Lenalidomide Accord 25 mg hårde kapsler
English: • Kidney problems
Danish: • Nyreproblemer
English: When platelets
Danish: Når trombocytter
English: The median overall PFS2 was 69.9 months (95% CI 58.1, 80.0) in the lenalidomide arm versus 58.4 months (95% CI 51.1, 65.0) in the placebo arm. For OS, the observed HR was 0.90: (95% CI 0.72, 1.13; p = 0.355) for lenalidomide versus placebo.
Danish: Den mediane samlede PFS2 var 69,9 måneder (95% CI 58,1-80,0) i lenalidomid-armen versus 58,4 måneder (95% CI 51,1-65,0) i placebo-armen.
English: Mediana PFS2 time, months (95% CI) b HR [95% CI]c ; p-valued
Danish: Mediana PFS2-tid, måneder (95% CI)b HR [95% CI]c ; p-værdid
English: The combination of lenalidomide with low dose dexamethasone in newly diagnosed multiple myeloma patients is associated with a lower frequency of grade 3 and 4 thrombocytopenia (8.1% in Rd and Rd18) compared with MPT (11%).
Danish: Kombinationen af lenalidomid og lavdosis dexamethason hos nydiagnosticerede patienter med myelomatose er forbundet med en lavere hyppighed af grad 3 og 4 neutropeni (8,1 % med Rd og Rd18), sammenlignet med MPT (11 %).
English: Lenalidomide Accord 7.5 mg hard capsules Each hard capsule contains 7.5 mg of lenalidomide.
Danish: Lenalidomide Accord 7,5 mg hårde kapsler Hver hård kapsel indeholder 7,5 mg lenalidomid.
English: Progression free survival Median [95% CI], weeks
Danish: Progressionsfri overlevelse, median [95 %konfidensinterval], uger p < 0,001
English: Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with lenalidomide in combination with melphalan and prednisone
Danish: Nydiagnosticeret myelomatose hos patienter, der ikke er egnede til transplantation, og som er i behandling med lenalidomid i kombination med melphalan og prednison.
English: Propylene glycol Iron oxide black (E172) Iron oxide yellow (E172) Potassium hydroxide Titanium dioxide (E171) Indigo carmine (E132)
Danish: Propylenglycol Sort jernoxid (E172) Gul jernoxid (E172) Kaliumhydroxid Titanidioxid (E171) Indigokarmin (E132)
English: Lenalidomide is taken in treatment cycles, each cycle lasting 28 days (see above ‘Treatment cycle').
Danish: Varighed af behandlingen med lenalidomid Lenalidomid tages i behandlingscyklusser på hver 28 dage.
English: Uncommon Hypersensitivity^
Danish: Overfølsomhed^
English: Fall to < 25 x 109/L
Danish: Falder til < 25 x 109/l
English: The combination of lenalidomide with melphalan and prednisone in newly diagnosed multiple myeloma patients is associated with a higher frequency of grade 3 and grade 4 thrombocytopenia (40.4% in MPR+R/MPR+p) compared with MPp+p (13.7%).
Danish: Kombinationen af lenalidomid sammen med melphalan og prednison hos nydiagnosticerede patienter med myelomatose er forbundet med en større hyppighed af grad 3 og grad 4 trombocytopeni (40,4 % hos patienter i behandling med MPR+R/MPR+p, sammenlignet med MPp+p (13,7 %)).
English: Lenalidomide Accord 10 mg hard capsules Each hard capsule contains 10 mg of lenalidomide.
Danish: Lenalidomide Accord 10 mg hårde kapsler Hver hård kapsel indeholder 10 mg lenalidomid.
English: Excipient with known effect Each hard capsule contains 33 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 33 mg lactose.
English: Baseline and ongoing monitoring of thyroid function is recommended.
Danish: Overvågning af thyreoideafunktionen anbefales ved behandlingsstart og fortløbende.
English: Each capsule contains 2.5 mg of lenalidomide.
Danish: Hver kapsel indeholder 2,5 mg lenalidomid.
English: Due to the teratogenic potential, lenalidomide must be prescribed under a Pregnancy Prevention Programme (see section 4.4) unless there is reliable evidence that the patient does not have childbearing potential.
Danish: På grund af lenalidomids teratogene potentiale skal det ordineres under et program til svangerskabsforebyggelse (se pkt.
English: Very Common Cough
Danish: Meget almindelig Hoste
English: Lenalidomide Accord 20 mg hard capsules
Danish: Lenalidomide Accord 20 mg hårde kapsler
English: The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients).
Danish: Hos patienter med myelomatose er kombination af lenalidomid og dexamethason forbundet med en højere forekomst af grad 3- og grad 4-trombocytopeni (henholdsvis 9,9 % og 1,4 % hos patienter, som blev behandlet med lenalidomid/dexamethason, sammenlignet med 2,3 % og 0,0 % hos patienter, som blev behandlet med placebo/dexamethason).
English: ADRs reported in clinical trials in patients with multiple myeloma treated with lenalidomide maintenance therapy
Danish: Bivirkninger rapporteret i kliniske studier hos patienter med myelomatose, der blev behandlet med lenalidomid-vedligeholdelsesbehandling Systemorganklasse / foretrukken term
English: Lenalidomide Accord 10 mg hard capsules:
Danish: Lenalidomide Accord 10 mg hårde kapsler:
English: Each capsule contains 25 mg of lenalidomide.
Danish: Hver kapsel indeholder 25 mg lenalidomid.
English: • Newly diagnosed multiple myeloma: patients who have undergone ASCT treated with lenalidomide maintenance
Danish: • Nydiagnosticeret myelomatose hos patienter, der har gennemgået ASCT og er i vedligeholdelsesbehandling med lenalidomid
English: • Abnormal liver test results
Danish: • Unormale prøver for leverfunktionen
English: • That if his partner becomes pregnant whilst he is taking Lenalidomide Accord or shortly after he has stopped taking Lenalidomide Accord he should inform his treating doctor immediately
Danish: • At han skal informere den behandlende læge omgående, hvis hans partner bliver gravid, imens han tager, eller kort tid efter, at han er ophørt med Lenalidomide Accord
English: Lenalidomide must not be started if the Absolute Neutrophil Count (ANC) is < 1.0 x 109/L, and/or platelet counts are < 75 x 109/L.
Danish: Lenalidomid-behandlingen må ikke startes, hvis det absolutte neutrofiltal (ANC) er < 1,0 x 109/l og/eller trombocyttallet er < 75 x 109/l.
English: Lenalidomide Accord 25 mg hard capsules Each hard capsule contains 25 mg of lenalidomide.
Danish: Lenalidomide Accord 25 mg hårde kapsler Hver hård kapsel indeholder 25 mg lenalidomid.
English: Each capsule contains 10 mg of lenalidomide.
Danish: Hver kapsel indeholder 10 mg lenalidomid.
English: • Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection including within the bloodstream (sepsis)
Danish: • Feber, kulderystelser, ondt i halsen, hoste, sår i munden eller andre symptomer på infektion
English: Common Abnormal liver function tests◊
Danish: Lever og galdeveje Almindelig Unormale leverfunktionstest◊
English: Lenalidomide Accord 2.5 mg hard capsules Each hard capsule contains 2.5 mg of lenalidomide.
Danish: Lenalidomide Accord 2,5 mg hårde kapsler Hver hård kapsel indeholder 2,5 mg lenalidomid.
English: Return to ≥ 25 x 109/L
Danish: Vender tilbage til ≥ 25 x 109/l
English: What Lenalidomide Accord contains
Danish: Lenalidomide Accord indeholder:
English: For men taking lenalidomide lenalidomide passes into human semen.
Danish: Lenalidomid udskilles i sæd fra mennesker.
English: First fall to < 0.5 x 109/L
Danish: Først falder til < 0,5 x 109/l
English: Lenalidomide Accord 10 mg hard capsules
Danish: Lenalidomide Accord 10 mg hårde kapsler
English: An open-label, randomised, multicenter, phase III study (ECOG E4A03) was conducted in 445 patients with newly diagnosed multiple myeloma; 222 patients were randomised to the lenalidomide/low dose dexamethasone arm, and 223 were randomised to the lenalidomide/standard dose dexamethasone arm.
Danish: 222 patienter blev randomiseret til armen med lenalidomid/Lavdosis dexamethason, og 223 blev randomiseret til armen med lenalidomid/standarddosis dexamethason.
English: Excipient with known effect Each hard capsule contains 36 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 36 mg lactose.
English: Excipient with known effect Each hard capsule contains134 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 134 mg lactose.
English: Lenalidomide Accord 15 mg hard capsules:
Danish: Lenalidomide Accord 15 mg hårde kapsler:
English: Lenalidomide Accord 10 mg and Lenalidomide Accord 20 mg hard capsules Gelatin
Danish: Lenalidomide Accord 10 mg hårde kapsler og Lenalidomide Accord 20 mg hårde kapsler
English: Rare Tumour lysis syndrome
Danish: Sjælden Tumorlysesyndrom
English: Each capsule contains 15 mg of lenalidomide.
Danish: Hver kapsel indeholder 15 mg lenalidomid.
English: The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients; see section 4.8).
Danish: Hos patienter med myelomatose er kombination af lenalidomid sammen med dexamethason forbundet med en højere forekomst af grad 3- og grad 4-trombocytopeni (henholdsvis 9,9 % og 1,4 % hos patienter, som blev behandlet med lenalidomid/dexamethason, sammenlignet med 2,3 % og 0,0 % hos patienter, som blev behandlet med placebo/dexamethason se pkt.
English: In patients with multiple myeloma, the combination of lenalidomide with dexamethasone is associated with an increased risk of arterial thromboembolism (predominantly myocardial infarction and cerebrovascular event) and was seen to a lesser extent with lenalidomide in combination with melphalan and prednisone.
Danish: Hos patienter med myelomatose er kombination af lenalidomid og dexamethason forbundet med en øget risiko for arteriel tromboemboli (hovedsageligt myokardieinfarkt og cerebrovaskulær hændelse).
English: How to take Lenalidomide Accord
Danish: Sådan skal du tage Lenalidomide Accord
English: Lenalidomide Accord 7.5 mg hard capsules
Danish: Lenalidomide Accord 7,5 mg hårde kapsler
English: Lactose
Danish: Dosering
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; see section 4.8).
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, se pkt.
English: Lenalidomide Accord 5 mg hard capsules Each hard capsule contains 5 mg of lenalidomide.
Danish: Lenalidomide Accord 5 mg hårde kapsler Hver hård kapsel indeholder 5 mg lenalidomid.