FrancophonIA/ELRC3.0 huggingface dataset:
English: Prophylactic antithrombotic medicinal products should be recommended, especially in patients with additional thrombotic risk factors.
Danish: Profylaktiske antitrombotiske lægemidler bør anbefales, især til patienter med yderligere trombotiske risikofaktorer.
English: All patients received prophylactic anticoagulation (low molecular weight heparin, warfarin, heparin, low-dose acetylsalicylic acid during the study.
Danish: Alle patienterne fik profylaktisk antikoagulation (lavmolekylært heparin, warfarin, heparin, lavdosis acetylsalicylsyre) i løbet af studiet.
English: • if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2, ‘Pregnancy, breast-feeding and contraceptioninformation for women and men').
Danish: • hvis du kan blive gravid, medmindre du træffer alle nødvendige forholdsregler for at undgå at blive gravid (se punkt 2 “ Graviditet, amning og prævention - information til kvinder og mænd”).
English: In addition to the above adverse reactions identified from the pivotal clinical trials, the following table is derived from data gathered from post-marketing data.
Danish: I tillæg til de ovennævnte bivirkninger identificeret fra de pivotale kliniske studier er grundlaget for den følgende tabel data indsamlet efter markedsføring.
English: Lenalidomide treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Danish: Behandlingen med lenalidomid skal superviseres af en læge med erfaring i anvendelsen af behandlinger mod kræft.
English: Pre-planned interim analyses of both studies showed that len/dex was statistically significantly superior (p < 0.00001) to dexamethasone alone for the primary efficacy endpoint, TTP (median follow-up duration of 98.0 weeks).
Danish: Forud planlagte interrim-analyser af begge studier viste, at len/dex statistisk var væsentligt bedre (p<0,00001) end dexamethason alene til at nå det primære endepunkt, TTP (median opfølgningsvarighed på 98,0 uger).
English: • That Lenalidomide Accord may cause neutropenia and thrombocytopenia and the need for regular blood tests
Danish: • At Lenalidomide Accord kan forårsage neutropeni og trombocytopeni og behovet for regelmæssige blodprøver
English: The prescriber must ensure that for women of childbearing potential:
Danish: Den ordinerende læge skal for kvinder i den fertile alder sikre, at:
English: • a chemotherapy medicine called ‘melphalan' and
Danish: • et kræftlægemiddel, der kaldes melphalan, og
English: Stevens-Johnson Syndrome^, Toxic epidermal necrolysis^
Danish: Stevens-Johnsons syndrom^, toksisk epidermal nekrolyse^
English: Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding.
Danish: Implantater og spiraler, der afgiver levonorgestrel forbindes med en øget infektionsrisiko på opsætningstidspunktet og uregelmæssig vaginal blødning.
English: • Changes to the colour of your skin, sensitivity to sunlight
Danish: • Ændring af hudfarven, følsomhed over for sollys
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Danish: Patienterne bør instrueres i at søge læge, hvis de udvikler symptomer som åndenød, brystsmerter eller hævede arme eller ben.
English: • XY genotype, Turner syndrome, uterine agenesis.
Danish: • XY-genotype, Turner-syndrom, uterus-agenesi.
English: For other grade 3 or 4 toxicities judged to be related to lenalidomide, treatment should be stopped and only restarted at next lower dose level when toxicity has resolved to ≤ grade 2 depending on the physician's discretion.
Danish: For andre grad 3 eller 4 toksiciteter, der bedømmes til at være relateret til lenalidomid, bør behandlingen stoppes og kun genstartes ved det næste lavere dosisniveau, når toksiciteten er vendt tilbage til ≤ grad 2, afhængig af lægens skøn.
English: • In case of neutropenia, the use of growth factors in patient management should be considered.
Danish: • I tilfælde af neutropeni bør det overvejes at anvende vækstfaktorer til at behandle patienterne.
English: Uncommon Acquired Fanconi syndrome
Danish: Ikke almindelig Erhvervet Fanconis syndrom
English: Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the lenalidomide treatment may be restarted at the original dose dependent upon a benefit risk assessment.
Danish: Når patienten er blevet stabiliseret på antikoagulationsbehandlingen, og alle komplikationer til den tromboemboliske hændelse er blevet behandlet, kan lenalidomidbehandlingen genoptages med den oprindelige dosis baseret på en vurdering af risici i forhold til fordele.
English: Patients who had previous allergic reactions while treated with thalidomide should be monitored closely, as a possible cross-reaction between lenalidomide and thalidomide has been reported in the literature.
Danish: Patienter, der tidligere har haft allergiske reaktioner under behandling med thalidomid, skal følges tæt, da der i litteraturen er rapporteret om en mulig krydsreaktion mellem lenalidomid og thalidomid.
English: Therefore, induction leading to reduced efficacy of medicinal products, including hormonal contraceptives, is not expected if lenalidomide is administered alone.
Danish: Derfor forventes der ingen induktion, som fører til reduceret virkning af lægemidler, herunder hormonelle præventionsmidler, hvis lenalidomid administreres alene.
English: Lenalidomide is structurally related to thalidomide, which is known to induce severe peripheral neuropathy.
Danish: Lenalidomid er strukturelt i familie med thalidomid, som er kendt for at forårsage svær perifer neuropati.
English: Patients should be advised to promptly report febrile episodes, a treatment interruption and/or dose reductions may be required (see section 4.2).
Danish: Patienterne skal informeres om straks at rapportere febrile episoder, og behandlingsafbrydelse og/eller dosisreduktion kan være nødvendig (se pkt.
English: The mechanisms of severe drug-induced hepatotoxicity remain unknown although, in some cases, pre-existing viral liver disease, elevated baseline liver enzymes, and possibly treatment with antibiotics might be risk factors.
Danish: Mekanismen for svær lægemiddelinduceret hepatotoksicitet er stadig ukendt, selvom eksisterende viral leversygdom, forhøjede leverenzymer ved baseline og muligvis behandling med antibiotika i nogle tilfælde kan være risikofaktorer.
English: If you forget to take lenalidomideIf you forget to take lenalidomide at your regular time and
Danish: Hvis du har glemt at tage lenalidomid på det normale tidspunkt og
English: • Need for adequate contraception and definition of adequate contraception
Danish: • Nødvendigheden af effektiv prævention og definition af effektiv prævention
English: Lenalidomide has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.
Danish: Lenalidomid er ikke formelt undersøgt hos patienter med nedsat leverfunktion, og der er ingen specifikke dosisanbefalinger.
English: c Based on Cox proportional hazards model comparing the hazard functions associated with the indicated treatment arms.
Danish: c Baseret på Cox proportionale risikomodel, der sammenligner risikofunktioner associeret med de indikerede behandlingsarme.
English: In an updated analysis of PFS, PFS2 and OS using a cut off of 3 March 2014 where the median follow-up time for all surviving subjects was 45.5 months, the results of the study are presented in Table 5:
Danish: I en opdateret analyse af PFS, PFS2 og OS med 3. marts 2014 som afskæringsdato, hvor den mediane opfølgningstid for alle overlevende personer var 45,5 måneder, vises resultaterne af studiet i tabel 5:
English: At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis du på noget tidspunkt under eller efter behandlingen: oplever sløret syn, synstab eller dobbeltsyn, talebesvær, svaghed i en arm eller et ben, ændringer i måden, du går på, eller balanceproblemer, vedvarende følelsesløshed, nedsættelse eller tab af følesans, hukommelsestab eller forvirring.
English: When neutrophils
Danish: Når neutrofiler
English: At doses of 5 to 25 mg/day, half-life in plasma is approximately 3 hours in healthy volunteers and ranges from 3 to 5 hours in patients with multiple myeloma,.
Danish: Ved doser på 5-25 mg/dag er halveringstiden i plasma ca. 3 timer hos raske frivillige og varierer fra 3 til 5 timer hos patienter med myelomatose.
English: Common Depression, Insomnia
Danish: Almindelig Depression, insomni
English: Prior to starting treatment
Danish: Før behandling indledes
English: The MAH should agree the final text of the healthcare profesional's information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Danish: Indehaveren af markedsføringstilladelsen skal aftale den endelige tekst i informationspakken til sundhedspersonale med den relevante nationale myndighed i hvert enkelt medlemsland og sikre, at materialet indeholder de nøgleelementer, der er beskrevet nedenfor.
English: If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
Danish: Hvis patienten ikke benytter effektiv prævention, skal han/hun henvises til relevant uddannet sundhedspersonale for at få rådgivning om prævention, således at præventionen kan påbegyndes.
English: The prescriber must inform male and female patients about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme and provide patients with appropriate patient educational brochure, patient card and/or equivalent tool in accordance to the national implemented patient card system.
Danish: Den ordinerende læge skal informere mandlige og kvindelige patienter om den forventede teratogene risiko og de strenge krav til at forebygge graviditet, som specificeret i "Programmet til svangerskabsforebyggelse", og give patienterne hensigtsmæssigt informationsmateriale, patientkort og/eller tilsvarende redskaber i overensstemmelse med de nationalt implementerede retningslinjer.
English: These patients discontinued at a higher rate due to intolerance (Grade 3 or 4 adverse events and serious adverse events), when compared to patients < 75 years.
Danish: Disse patienter seponerede behandlingen med en større hyppighed på grund af intolerans (grad 3 eller 4 uønskede hændelser og alvorlige uønskede hændelser), sammenlignet med patienter < 75 år.
English: ªIf the subject has not been receiving G-CSF therapy, initiate G-CSF therapy.
Danish: ªHvis personen ikke har fået behandling med G-CSF, påbegyndes behandlingen med G-CSF.
English: Carcinogenicity studies with lenalidomide have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med lenalidomid.
English: • A fall in the number of red blood cells which may cause anaemia leading to tiredness and weakness
Danish: • Et fald i antallet af røde blodlegemer, hvilket kan føre til blodmangel og forårsage træthed og svækkelse
English: Endpoint len/dex (N=353)
Danish: Endepunkt len/dex (N=353)
English: • if you have had an allergic reaction whilst taking thalidomide (another medicine used to treat multiple myeloma) such as rash, itching, swelling, dizziness or difficulty breathing
Danish: • hvis du har haft en allergisk reaktion, mens du tog thalidomid (et andet lægemiddel til behandling af myelomatose), såsom ud slæt, kløe, hævelse, svimmelhed eller vejrtrækningsbesvær
English: • Changes to blood thyroid hormone, low levels of calcium, phosphate or magnesium in the blood
Danish: • Ændringer i blodets indhold af stofskiftehormon, lavt niveau af kalcium, fosfat eller magnesium i blodet
English: • She should be capable of complying with effective contraceptive measures
Danish: • Kvinden skal være i stand til at overholde effektive præventionsmetoder
English: • Circulatory problems
Danish: • Kredsløbsproblemer
English: Common Sepsis◊, Sinusitis◊
Danish: Almindelig Sepsis◊, sinuitis◊
English: The DLT in these studies was essentially haematological.
Danish: Den dosisbegrænsende toksicitet i disse studier var primært hæmatologisk.
English: Lenalidomide (N = 231)
Danish: Lenalidomid (N = 231)
English: Uncommon Renal tubular necrosis
Danish: Ikke almindelig Renal tubulær nekrose
English: Very Common Dyspnoea◊, Epistaxis^
Danish: Meget almindelig Dyspnø◊, epistaxis^
English: Taking this medicine
Danish: Sådan tages dette lægemiddel
English: Common Erectile dysfunction
Danish: Almindelig Erektil dysfunction
English: • That Lenalidomide Accord may cause venous and arterial thromboembolism
Danish: • At Lenalidomide Accord kan forårsage venøs og arteriel tromboembolisme
English: Prophylactic antibiotics should be considered particularly in patients with neutropenia.
Danish: Det bør overvejes at give antibiotika profylaktisk især til patienter med neutropeni.
English: No interaction study has been performed with oral contraceptives.
Danish: Der er ikke udført interaktionsstudier med orale præventionsmidler.
English: Decrease by one dose level when dosing resumed at next cycle ª If Dose limiting toxicity (DLT) occurs on > day15 of a cycle, lenalidomide dosing will be interrupted for at least the remainder of the current 28-day cycle.
Danish: Nedsæt med et dosisniveau, når doseringen genoptages i den næste cyklus ª Hvis der opstår dosisbegrænsende toksictet (dose limiting toksicitet, DLT) på > dag 15 af en cyklus, vil lenalidomid-dosering blive afbrudt i mindst resten af den aktuelle 28-dages cyklus.
English: The adverse reactions described in Table 1 included events reported post-HDM/ASCT as well as events from the maintenance treatment period.
Danish: Bivirkningerne, der er beskrevet i tabel 1, omfatter hændelser, der blev rapporteret efter HDM/ASCT, samt hændelser fra perioden med vedligeholdelsesbehandling.
English: This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure (this condition is called ‘Tumour Lysis Syndrome').
Danish: Dette kan føre til en tilstand, hvor tumorerne nedbrydes, og forårsager usædvanlige niveauer af kemikalier i blodet, hvilket kan føre til nyresvigt (denne tilstand kaldes 'Tumorlysesyndrom')
English: In patients, as well as in healthy volunteers, the maximum concentration (Cmax) and area-under-theconcentration time curve (AUC) increase proportionally with increases in dose.
Danish: Såvel hos patienter som hos raske frivillige øges den maksimale koncentration (Cmax) og arealet under kurven (AUC) for koncentration versus tid proportionalt med stigende dosis.
English: • Understand the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential
Danish: • Forstå den forventede teratogene risiko ved seksuelt samvær med en gravid kvinde eller en kvinde i den fertile alder
English: Table 7 summarises the results of the follow-up efficacy analyses - pooled studies MM-009 and MM-010.
Danish: Tabel 7 giver en oversigt over de poolede resultater af opfølgningsanalyserne af effekten for MM-009og MM-010-studierne.
English: It is not known whether lenalidomide is excreted in human milk.
Danish: Det er ukendt, om lenalidomid udskilles i human mælk.
English: • National or other applicable specific arrangements for a prescription for Lenalidomide Accord to be dispensed
Danish: • Nationale eller andre specifikke foranstaltninger, der finder anvendelse, for at en recept på Lenalidomide Accord, kan blive udleveret
English: • if you are pregnant, think you may be pregnant or are planning to become pregnant, as lenalidomide is expected to be harmful to an unborn child (see section 2, ‘Pregnancy, breastfeeding and contraception - information for women and men').
Danish: • hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid, da lenalidomid forventes at være skadeligt for det ufødte barn (se punkt 2, “Graviditet, amning og præventioninformation til kvinder og mænd”).
English: See also section 2.
Danish: Se også punkt 2.
English: An embryofoetal development study has been conducted in monkeys administered lenalidomide at doses from 0.5 and up to 4 mg/kg/day.
Danish: Der er blevet udført et studie angående embryoføtal udvikling hos aber, som fik lenalidomid i doser fra 0,5 og op til 4 mg/kg/dag.
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Danish: Patienter og læger rådes til at holde øje med tegn og symptomer på tromboemboli.
English: The results for the study, using a cut-off of 1 February 2016, are presented in Table 4
Danish: Resultatet af studiet, hvor man bruger 1. februar 2016 som cut-off dato, kan ses i tabel 4.
English: The primary efficacy endpoint in the study was progression free survival (PFS).
Danish: Det primære endepunkt for virkning i studiet var progressionsfri overlevelse (progression free survival, PFS).
English: • Grade 4 neutropenia (see section 4.4).
Danish: • Grad 4 neutropeni (se pkt.
English: All patient brochures should contain the following elements:
Danish: Alle patientbrochurer skal indeholde følgende elementer:
English: Patients were randomised 1:1 within 90-100 days after ASCT to receive either lenalidomide or placebo maintenance.
Danish: Patienterne blev inden for 90-100 dage efter ASCT randomiseret 1:1 til at få vedligeholdelsesbehandling med enten lenalidomid eller placebo.
English: In total 460 patients were randomised: 231 patients to lenalidomide and 229 patients to placebo.
Danish: I alt 460 patienter blev randomiseret: 231 patienter til lenalidomid og 229 patient til placebo.
English: PD = progressive disease; PR = partial response; R = lenalidomide; SD = stable disease; VGPR = very good partial response.
Danish: PD = progressiv sygdom, PR = delvist respons, R = lenalidomid, SD = stabil sygdom, VGPR = meget godt delvist respons.
English: The evaluation for PML should be based on neurological examination, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Danish: Evalueringen for PML skal baseres på en neurologisk undersøgelse, MR-scanning af hjernen, analyse af cerebrospinalvæske for JC-viral (JCV) DNA ved polymerase-kædereaktion (PCR) eller en hjernebiopsi med testing for JCV.
English: Patients were randomised (1:1:1) to 1 of 3 treatment arms.
Danish: Patienterne blev randomiseret i forholdet (1:1:1) til 1 ud af 3 behandlingsarme.
English: The patient should continue anticoagulation therapy during the course of lenalidomide treatment.
Danish: Patienten bør fortsætte med antikoagulationsbehandlingen under lenalidomidbehandlingen.
English: If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Danish: Hvis patienten får en tromboembolisk hændelse, skal behandlingen seponeres, og standard antikoagulationsbehandling iværksættes.
English: • Dose adjustments, during treatment and restart of treatment, are recommended to manage grade 3 or 4 thrombocytopenia, neutropenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
Danish: • Dosisjustering under behandling og ved genstart på behandling anbefales ved håndtering af grad 3 eller 4 trombocytopeni, neutropeni eller anden grad 3 eller 4 toksicitet, der vurderes som værende relateret til lenalidomid.
English: Some of the cases of herpes zoster reactivation resulted in disseminated herpes zoster, meningitis herpes zoster or ophthalmic herpes zoster requiring a temporary hold or permanent discontinuation of the treatment with lenalidomide and adequate antiviral treatment.
Danish: Nogle af tilfældene af herpes zoster-reaktivering førte til dissemineret herpes zoster, meningitis herpes zoster eller oftalmisk herpes zoster, der krævede en midlertidig afbrydelse eller en permanent seponering af behandlingen med lenalidomid og passende antiviral behandling.
English: It is important to dose adjust patients with renal impairment in order to avoid plasma levels which may increase the risk for higher haematological adverse reactions or hepatotoxicity.
Danish: Det er vigtigt at justere dosis hos patienter med nedsat nyrefunktion, så der undgås plasmaniveauer, der kan øge risikoen for hæmatologiske bivirkninger eller hepatotoksicitet.
English: In general, study subjects had advanced-stage disease: of the total study population, 41% had ISS stage III, 9% had severe renal insufficiency (creatinine clearance [CLcr] < 30 mL/min).
Danish: Generelt havde studiepersonerne sygdom i et fremskredent stadie: ud af hele studiepopulationen havde 41 % ISS trin III, 9 % havde svært nedsat nyrefunktion (kreatininclearance [CrCl] < 30 ml/min).
English: Common Myelodysplastic syndrome◊,*
Danish: Almindelig Myelodysplastisk syndrom◊,*
English: Lenalidomide may also cause blood clots in the veins (thrombosis).
Danish: Lenalidomid kan ligeledes forårsage blodpropper i årerne (trombose).
English: However, it is not known whether there is an interaction during clinical use (concomitant treatment with dexamethasone).
Danish: Det vides imidlertid ikke, om der er en interaktion ved klinisk anvendelse (samtidig behandling med dexamethason).
English: Co-administration of lenalidomide with other myelosuppressive agents should be undertaken with caution.
Danish: Samtidig administration af lenalidomid og andre myelosuppressive stoffer bør ske med forsigtighed.
English: Dose adjustment (days 1 to 21 of repeated 28-day cycles)
Danish: Dosisjustering (Dag 1 til 21 i gentagne cyklusser på 28 dage)
English: Blood and Lymphatic System Disorders
Danish: Blod og lymfesystem
English: Common Deafness (Including Hypoacusis), Tinnitus
Danish: Døvhed (herunder hypakusi), tinnitus
English: • Dose is modified based upon clinical and laboratory findings (see section 4.4).
Danish: • Dosis skal justeres på basis af kliniske og laboratoriemæssige parametre (se pkt.
English: Findings from this study indicate that lenalidomide produced external malformations including non-patent anus and malformations of upper and lower extremities (bent, shortened, malformed, malrotated and/or absent part of the extremities, oligo and/or polydactyly) in the offspring of female monkeys who received the active substance during pregnancy.
Danish: Fund fra dette studie tyder på, at lenalidomid forårsager ydre misdannelser, herunder ikke-åben anus og og misdannede øvre og nedre ekstremiteter (bøjede, forkortede, vanskabte, forkert drejede og/eller manglende dele af ekstremiteter, oligo- og/eller polydaktyli) hos afkom af hunaber, som har fået det aktive stof under graviditeten.
English: Of the 704 patients evaluated in the MM-009 and MM-010 studies, 44.6% were aged 65 or over.
Danish: Af de 704 patienter, som blev vurderet i MM-009 og MM-010 studierne, var 44,6 % i alderen 65 år og derover.
English: The PFS benefit was less in the subgroup of patients with CR than in the subgroup of patients who had not achieved a CR.
Danish: PFS-fordelen var mindre i undergruppen af patienter med CR end i undergruppen af patienter, som ikke havde opnået CR.
English: Stop lenalidomide dosing for remainder of cycleª
Danish: Stop lenalidomiddosis i resten af cyklussenª
English: • some medicines used to treat raised cholesterol - such as statins
Danish: • nogle lægemidler, der anvendes til behandling af forhøjet kolesterol - såsom statiner
English: • Need for adequate contraception (even if woman has amenorrhoea) and definition of adequate contraception
Danish: • Nødvendigheden af effektiv prævention (også selvom kvinden har amenorre) og definition af effektiv prævention