FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with Grade 3 or 4 TFR, withhold treatment with lenalidomide until TFR resolves to ≤ Grade 1 and patients may be treated for management of symptoms per the guidance for treatment of Grade 1 and 2 TFR (see section 4.4).
Danish: Hos patienter med grad 3 eller 4 TFR afbrydes lenalidomidbehandlingen, indtil TFR er bedret til ≤ grad 1, og patienterne kan behandles for symptomer i henhold til retningslinjerne for behandling af grad 1 og 2 TFR (se pkt.
English: • She understands the expected teratogenic risk to the unborn child
Danish: • Kvinden er oplyst om og har indsigt i den forventede teratogene risiko for det ufødte barn
English: In patients with newly diagnosed multiple myeloma aged 75 years and older who received lenalidomide, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation.
Danish: Hos patienter med nydiagnosticeret myelomatose i alderen 75 år eller derover, som fik lenalidomid, var der en større forekomst af alvorlige bivirkninger og bivirkninger, der førte til seponering af behandlingen.
English: Myocardial infarction has been reported in patients receiving lenalidomide, particularly in those with known risk factors and within the first 12 months when used in combination with dexamethasone.
Danish: Der er rapporteret om myokardieinfarkt hos patienter, der får lenalidomid, især hos patienter med kendte risikofaktorer, og i løbet af de første 12 måneder, når det bruges i kombination med dexamethason.
English: Cataract has been reported with a higher frequency in patients receiving lenalidomide in combination with dexamethasone particularly when used for a prolonged time.
Danish: Der er blevet rapporteret katarakt med en større hyppighed hos patienter, der fik lenalidomid i kombination med dexamethason, især når det blev anvendt i længere tid.
English: Co-administration of lenalidomide does not alter the pharmacokinetics of temsirolimus.
Danish: Samtidig administration af lenalidomid ændrer ikke temsirolimus' farmakokinetik.
English: Fatal instances of TLS have been reported during treatment with lenalidomide.
Danish: Dødelige tilfælde af TLS er blevet rapporteret under behandling med lenalidomid.
English: Peripheral neuropathies (excluding motor neuropathy), Dizziness, Tremor, Dysgeusia, Headache
Danish: Meget almindelig Perifer neuropati (eksklusive motorisk neuropati), svimmelhed, tremor, dysgeusi, hovedpine
English: Resume lenalidomide and melphalan at dose level -1
Danish: Genoptag lenalidomid og melphalan ved dosisniveau -1
English: Common Dyspnoea◊
Danish: Almindelig Dyspnø◊
English: Patients should be carefully assessed for their ability to tolerate lenalidomide in combination, with consideration to age, ISS stage III, ECOG PS≤2 or CLcr<60 mL/min (see sections 4.2 and 4.8).
Danish: Patienter bør vurderes nøje for deres evne til at tolerere lenalidomid i kombination, under hensyntagen til alder, ISS trin III, ECOG PS ≤ 2 eller CrCl < 60 ml/min (se pkt.
English: A fertility study in rats with lenalidomide doses up to 500 mg/kg (approximately 200 to 500 times the human doses of 25 mg and 10 mg, respectively, based on body surface area) produced no adverse effects on fertility and no parental toxicity.
Danish: Et fertilitetsstudie hos rotter med lenalidomid-doser på op til 500 mg/kg (ca. 200 til 500 gange de humane doser på hhv. 25 mg og 10 mg, baseret på legemsoverfladearealet) fremkaldte ingen uønskede virkninger på fertiliteten og ingen toksicitet for forældregenerationen.
English: According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed for women of childbearing potential as outlined below.
Danish: I overensstemmelse med lokal praksis skal der foretages lægeligt monitorerede graviditetstests på kvinder i den fertile alder. Testene skal have en minimumfølsomhed på 25 mIE/ml og foretages som beskrevet nedenfor.
English: Common Ataxia, Balance impaired
Danish: Almindelig Ataksi, balanceforstyrrelser
English: • She understands the need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment
Danish: • Kvinden forstår nødvendigheden af en effektiv, uafbrudt prævention, 4 uger før behandlingen indledes, under hele behandlingsforløbet og 4 uger efter behandlingens afslutning
English: Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of SPM and institute treatment as indicated.
Danish: Patienterne skal omhyggeligt evalueres for forekomst af SPM før og under behandlingen ved hjælp af standard-cancerscreening og indiceret behandling iværksættes.
English: Complete response (CR), partial response (PR) and overall response (CR+PR) rates in the len/dex arm remain significantly higher than in the placebo/dex arm in both studies.
Danish: Frekvenserne for fuldstændig respons (CR, Complete Response), delvis respons (PR, Partial Response) og samlet respons (CR+PR) i len/dex-armen forbliver væsentligt højere end i placebo/dex-armen i begge studier.
English: Concomitant administration with lenalidomide 10 mg once daily increased the plasma exposure of digoxin (0.5 mg, single dose) by 14% with a 90% CI (confidence interval) [0.52%-28.2%].
Danish: Samtidig administration af lenalidomid 10 mg én gang dagligt øgede digoxins plasmaeksponering (0,5 mg, enkeltdosis) med 14 % med 90 % CI (konfidensinterval) [0,52 %-28,2 %].
English: Fatigue, dizziness, somnolence, vertigo and blurred vision have been reported with the use of lenalidomide.
Danish: Træthed, svimmelhed, døsighed, vertigo og sløret syn er rapporteret under behandling med lenalidomid.
English: Pack size of 7x1 or 21x1 capsules.
Danish: Pakningsstørrelser med 7 x 1 eller 21 x 1 kapsler.
English: • Bleeding or bruising in the absence of injury
Danish: • Blødning eller blå mærker, uden at der har været skader
English: The following dose adjustments are recommended at the start of therapy and throughout treatment for patients with moderate or severe impaired renal function or end stage renal disease.
Danish: Følgende dosisjusteringer anbefales ved behandlingsstart og i løbet af behandlingen hos patienter med moderat til svært nedsat nyrefunktion eller nyresygdom i sidste stadium.
English: Common Cataract Uncommon Blindness
Danish: Almindelig Katarakt Ikke almindelig Blindhed
English: For hematologic toxicity the dose of lenalidomide may be re-introduced to the next higher dose level (up to the starting dose) upon improvement in bone marrow function (no hematologic toxicity for at least 2 consecutive cycles: ANC ≥1,5 x 109/L with a platelet count ≥ 100 x 109/L at the beginning of a new cycle).
Danish: Ved hæmatologisk toksicitet kan dosis af lenalidomid igen introduceres til det næste, højere dosisniveau (op til startdosis) ved forbedret knoglemarvsfunktion (ingen hæmatologisk toksicitet i mindst 2 på hinanden følgende cyklusser: ANC ≥ 1,5 x 109/l med et trombocyttal på ≥ 100 x 109/l ved begyndelsen af en ny cyklus).
English: Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription.
Danish: Udlevering af lenalidomid til kvinder i den fertile alder bør ske inden 7 dage efter ordination.
English: Common Respiratory distress◊, Dyspnoea◊
Danish: Almindelig Respirationsbesvær◊, dyspnø◊
English: It is important to note that a small number of patients may develop additional types of cancer, and it is possible that this risk may be increased with lenalidomide treatment, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed lenalidomide .
Danish: Det er vigtigt at bemærke, at et lille antal patienter kan udvikle andre former for kræft, og det er muligt, at behandling med lenalidomid kan øge denne risiko.
English: An absence of the intermediate lobe of the lung was observed at 10 and 20 mg/kg/day with dose dependence and displaced kidneys were observed at 20 mg/kg/day.
Danish: En manglende mellemlap i lungerne blev observeret ved 10 og 20 mg/kg/dag afhængig af dosis, og fejlplacerede nyrer blev observeret ved 20 mg/kg/dag.
English: Despite the fact that 170 out of the 351 patients randomised to placebo/dex received lenalidomide after disease progression or after the studies were unblinded, the pooled analysis of overall survival demonstrated a statistically significant survival advantage for len/dex relative to placebo/dex (HR = 0.833, 95% CI = [0.687, 1.009], p=0.045).
Danish: Selvom 170 ud af 351 patienter, som blev randomiseret til placebo/dex, fik behandling med lenalidomid, efter at sygdommen progredierede, eller efter at studierne var blevet afblindet, viste den poolede analyse af den samlede overlevelse en statistisk signifikant forbedret overlevelse for len/dex sammenlignet med placebo/dex (HR = 0,833, 95 % konfidensinterval = [0,687; 1,009], p = 0,045).
English: Lenalidomide binds directly to cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4
Danish: Lenalidomid binder direkte til cereblon, en komponent af et cullin-ring E3 ubiquitinligase enzymkompleks, der omfatter deoxyribonukleinsyre (DNA) damage-binding protein 1(DDB1), cullin 4 (CUL4) og regulator for cullin 1 (Roc1).
English: Capsules should not be opened or crushed.
Danish: Kapslerne må ikke åbnes eller knuses.
English: Therefore, a teratogenic effect of lenalidomide is expected and lenalidomide is contraindicated during pregnancy (see section 4.3).
Danish: Derfor kan det forventes, at lenalidomid har en teratogen virkning, og lenalidomid er kontraindiceret under graviditet (se pkt.
English: Common Pancytopenia◊
Danish: Almindelig Pancytopeni◊
English: The European Medicines Agency has waived the obligation to submit the results of studies with lenalidomide in all subsets of the paediatric population in multiple myeloma, (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med lenalidomid i alle undergrupper af den pædiatriske population med myelomatose (se pkt.
English: Cases of hypothyroidism and cases of hyperthyroidism have been reported.
Danish: Der er rapporteret tilfælde af hypo- og hypertyroidisme.
English: Lenalidomide is not an enzyme inducer.
Danish: Lenalidomid er ikke en enzyminduktor.
English: Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome (TLS) may occur.
Danish: Da lenalidomid har antineoplastisk aktivitet, kan der optræde komplikationer i form af tumorlysesyndrom (TLS).
English: The most serious adverse reactions observed more frequently in lenalidomide/dexamethasone than placebo/dexamethasone combination were:
Danish: De alvorligste bivirkninger, der hyppigere blev observeret med lenalidomid/dexamethason end med placebo/dexamethason-kombinationen, var:
English: The following table is derived from data gathered during the multiple myeloma studies with combination therapy.
Danish: Grundlaget for nedenstående tabel er data indsamlet under studier af myelomatose med kombinationsbehandling.
English: Follow-up (months) Medianf (min, max): all patients Myeloma responseg n (%)
Danish: Medianf (min; maks): alle patienter Myeloma-responsg n (%)
English: • you will have pregnancy tests under the supervision of your doctor (before every treatment, every 4 weeks during treatment, and 4 weeks after the treatment has finished) except where it has been confirmed that the fallopian tubes have been severed and sealed, to stop eggs from reaching the uterus (tubal sterilisation) AND
Danish: • vil du få udført graviditetstest, som lægen overvåger (før hver behandling, hver 4. uge under behandlingen og 4 uger efter behandlingen er gennemført), medmindre det er blevet bekræftet, at dine æggeledere er blevet gennemskåret og afsnøret, så æggene ikke kan nå frem til livmoderen (tubar sterilisation)
English: • If you do become pregnant during your treatment with lenalidomide , you must stop the treatment and inform your doctor immediately.
Danish: • Hvis du bliver gravid under behandlingen med lenalidomid, skal du stoppe med behandlingen og omgående informere lægen.
English: The results indicate that as renal function decreases (< 50 mL/min), the total lenalidomide clearance decreases proportionally resulting in an increase in AUC.
Danish: Resultaterne antyder, at den samlede lenalidomidclearance falder proportionelt med faldende nyrefunktion (< 50 ml/min), hvilket medfører en stigning i AUC.
English: Repeated oral administration of 1 and 2 mg/kg/day to monkeys for up to 1 year produced reversible changes in bone marrow cellularity, a slight decrease in myeloid/erythroid cell ratio and thymic atrophy.
Danish: Gentagen oral administration af 1 og 2 mg/kg/dag til aber i op til 1 år fremkaldte reversible ændringer i knoglemarvens cellularitet, et let fald i forholdet mellem myeloide/erytroide celler og thymusatrofi.
English: In a post-hoc analysis, lower mortality was observed in the lenalidomide/low dose dexamethasone arm 6.8% (15/220) compared to the lenalidomide/standard dose dexamethasone arm 19.3% (43/223), in the newly diagnosed multiple myeloma patient population, with a median follow up of 72.3 weeks.
Danish: I en post-hoc-analyse blev der observeret en lavere mortalitet i armen med lenalidomid/Lavdosis dexamethason 6,8 % (15/220), sammenlignet med armen med lenalidomid/standarddosis dexamethason 19,3 % (43/223) i patientpopulation med nydiagnosticeret myelomatose, med en median opfølgning på op til 72,3 uger.
English: • Need to provide patients with appropriate patient educational brochure and patient card
Danish: • Nødvendigheden af at forsyne patienterne med informationsbrochure og patientkort
English: Do not use this medicine if you notice any damage or signs of tampering to the pack.
Danish: • Brug ikke lægemidlet, hvis du bemærker, at pakningen er beskadiget eller udviser tegn på at have været åbnet.
English: If powder from a broken lenalidomide capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
Danish: Hvis pulveret fra en knækket lenalidomid kapsel får kontakt med huden skal huden straks vaskes grundigt med sæbe og vand.
English: The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Danish: Indehaveren af markedsføringstilladelsen skal sammen med den relevante nationale myndighed i hvert land aftale detaljerne omkring et kontrolleret distributionssystem og implementere sådanne programmer nationalt for at sikre at:
English: Lenalidomide interruption or discontinuation should be considered for grade 2 or 3 skin rash.
Danish: Afbrydelse eller seponering af lenalidomid bør overvejes ved hududslæt af grad 2 eller 3.
English: Myalgia, Musculoskeletal pain
Danish: Myalgi, muskuloskeletale smerter
English: The safety and efficacy of lenalidomide was assessed in a phase III multicenter, randomised double blind 3 arm study (MM-015) of patients who were 65 years or older and had a serum creatinine < 2.5 mg/dL.
Danish: Lenalidomids sikkerhed og virkning blev vurderet i et fase III randomiseret, dobbeltblindet multicenterstudie med tre arme (MM-015) hos patienter i alderen 65 år eller ældre, der havde serumkreatinin < 2,5 mg/dl.
English: • Infection of the lung and the upper respiratory tract, breathlessness
Danish: • Infektion i lungerne og de øvre luftveje, åndenød
English: A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
Danish: En lægeligt monitoreret graviditetstest skal gentages hver 4. uge, inklusive 4 uger efter afslutning af behandlingen undtagen ved bekræftet æggeleder-sterilisation.
English: • When lenalidomide is used to treat multiple myeloma in patients who cannot have a bone marrow transplant or have had other treatments before, it is taken with other medicines (see section 1 ‘What lenalidomide is used for').
Danish: • Når lenalidomid anvendes til behandling af myelomatose hos patienter, som ikke kan gennemgå en knoglemarvstransplantation, eller som tidligere har fået andre behandlinger, tages det sammen med andre lægemidler (se punkt 1 ”Virkning og anvendelse”).
English: • if you have kidney problems - your doctor may adjust your dose of lenalidomide if you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or raised cholesterol levels
Danish: • hvis du har haft et hjerteanfald, tidligere har haft en blodprop, eller hvis du ryger, har højt blodtryk eller forhøjet kolesterolniveau
English: You must not breast-feed when taking lenalidomide , as it is not known if lenalidomide passes into human milk.
Danish: Du må ikke amme under behandling med lenalidomid, da det er ukendt, om lenalidomid udskilles i mælken hos mennesker.
English: Newly diagnosed multiple myeloma: patients who are not eligible for transplant
Danish: Nydiagnosticeret myelomatose: patienter, der ikke er egnede til transplantation
English: • Certain types of skin tumour
Danish: • Visse typer af hudsvulster
English: Pack size of 21x1 capsules.
Danish: Pakningsstørrelse med 21 x 1 kapsler.
English: What Lenalidomide Accord is used for Lenalidomide Accord is used in adults for multiple myeloma.
Danish: Anvendelse Lenalidomide Accord anvendes hos voksne mod myelomatose.
English: If your female partner is pregnant or able to become pregnant, and she does not use effective methods of contraception, you must use condoms during treatment and 1 week after the end of treatment, even if you have had a vasectomy.
Danish: Hvis din kvindelige partner er eller kan blive gravid, og hun ikke benytter en effektiv præventionsmetode, skal du benytte kondom under og 1 uge efter behandlingsophør, selv hvis du er vasektomeret (steriliseret).
English: • Viral infections, including herpes zoster (also known as ‘shingles', a viral disease that causes a painful skin rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-colored urine, right-sided stomach pain, fever and feeling nauseous or being sick).
Danish: • Virusinfektioner, herunder herpes zoster (som også kaldes 'helvedesild', en virussygdom, der giver et smertefuldt hududslæt med blærer) og en tilbagevendende hepatitis B-infektion (som kan give en gulfarvning af hud og øjne, mørkebrun urin, højresidige mavesmerter, feber og kvalme eller opkastning).
English: Out of 353 patients in the MM-009 and MM-010 studies who received lenalidomide/dexamethasone, 45.6% were aged 65 or over.
Danish: Af de 353 patienter i MM-009 og MM-010 studierne, som fik lenalidomid/dexamethason, var 45,6 % i alderen 65 år og derover.
English: The adverse reactions observed in patients treated with lenalidomide are listed below by system organ class and frequency.
Danish: De bivirkninger, som blev observeret hos patienter, der blev behandlet for myelomatose, er opført nedenfor efter systemorganklasse og hyppighed.
English: Patients were stratified at randomisation by age (≤75 versus >75 years), stage (ISS Stages I and II versus Stage III), and country.
Danish: Patienterne blev stratificeret ved randomisering i henhold til alder (≤ 75 versus > 75 år), trin (ISS trin I og II versus trin III) og land.
English: Supportive newly diagnosed multiple myeloma studies
Danish: Understøttende studier af nydiagnosticeret myelomatose
English: Acute myeloid leukaemia Multiple myeloma
Danish: Akut myeloid leukæmi Myelomatose
English: Recommended dose adjustments in patients with impaired renal function are described in section 4.2.
Danish: Anbefalede dosisjusteringer hos patienter med nedsat nyrefunktion er beskrevet i pkt.
English: What you need to know before you take Lenalidomide Accord 3.
Danish: Det skal du vide, før du begynder at tage Lenalidomide Accord 3.
English: • an anti-inflammatory medicine called ‘dexamethasone'
Danish: • et antiinflammatorisk lægemiddel, der kaldes dexamethason.
English: Special populations Elderly
Danish: Specielle populationer
English: The PFS benefit was observed both in the subgroup of patients with CR and in the subgroup of patients who had not achieved a CR.
Danish: Den bedre PFS blev observeret både i undergruppen af patienter med komplet respons (CR) og i undergruppen af patienter, som ikke havde opnået CR.
English: CI = confidence interval; HR = hazard ratio; max = maximum; min = minimum; NE = not estimable; OS = overall survival; PFS = progression-free survival;
Danish: CI = konfidensinterval, HR = hazard ratio, max = maksimum, min = minimum, NE = kan ikke estimeres, OS = samlet overlevelse, PFS = progressionsfri overlevelse;
English: Rare cases of rhabdomyolysis have been observed, some of them when lenalidomide is administered with a statin.
Danish: Der er blevet observeret sjældne tilfælde af rabdomyolyse, i nogle af disse blev lenalidomid administreret samtidigt med et statin.
English: • Passing large amount of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
Danish: • Produktion af stor mængde urin samt knoglesmerter og svaghed, hvilket kan være symptomer på en nyrelidelse (Fanconis syndrom)
English: Cases have generally been reported in patients taking concomitant dexamethasone or prior treatment with other immunosuppressive chemotherapy.
Danish: Tilfældene er generelt rapporteret hos patienter, der samtidig tog dexamethason eller tidligere havde fået anden immunsupprimerende kemoterapi.
English: • Bleeding within the skull
Danish: • Blødning inde i kraniet
English: The Cmax was similar between healthy subjects and patients with renal impairment.
Danish: Cmax var ens mellem raske forsøgspersoner og patienter med nedsat nyrefunktion.
English: Consequently, patients with known risk factors for thromboembolism - including prior thrombosisshould be closely monitored.
Danish: Som følge deraf bør patienter med kendte risikofaktorer, herunder tidligere trombose, monitoreres nøje.
English: • Understand that if his female partner becomes pregnant whilst he is taking lenalidomide or shortly after he has stopped taking lenalidomide , he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Danish: • Forstå, at hvis hans kvindelige partner bliver gravid, mens han tager lenalidomid eller kort efter, han er holdt op med at tage lenalidomid, skal han straks informere sin behandlende læge, og at det anbefales at henvise den kvindelige partner til en læge med speciale eller erfaring i teratologi for evaluering og rådgivning.
English: In two phase III placebo-controlled studies, 353 patients with multiple myeloma were exposed to the lenalidomide/dexamethasone combination and 351 to the placebo/dexamethasone combination.
Danish: I to placebo-kontrollerede fase III-studier fik 353 patienter med myelomatose lenalidomid/dexamethason-kombinationen og 351 fik placebo/dexamethason-kombinationen.
English: Patients should not donate blood during therapy or for 1 week following discontinuation of lenalidomide.
Danish: Patienten må ikke donere blod under behandlingen og i 1 uge efter ophør med behandling med lenalidomid.
English: Lenalidomide has been used in clinical trials in multiple myeloma patients up to 91 years of age (see section 5.1).
Danish: Lenalidomid er blevet undersøgt i kliniske studier hos patienter på op til 91 år (se pkt.
English: Lenalidomide Accord must be given to you by healthcare professionals with experience in treating multiple myeloma,.
Danish: Du vil få Lenalidomide Accord af sundhedspersonale med erfaring i at behandle myelomatose.