FrancophonIA/ELRC3.0 huggingface dataset:
English: Not applicable ª Dose reduction for both medicinal products can be managed independently
Danish: Ikke relevant ª Dosereduktion for begge lægemidler kan håndteres uafhængigt
English: • Women who are pregnant.
Danish: • Gravide kvinder.
English: e Exploratory endpoint (PFS2) f The median is the univariate statistic without adjusting for censoring.
Danish: e Eksplorativt endepunkt (PFS2) f Medianen er den univariate statistik uden justering for censurering.
English: Before you start treatment, your doctor will tell you:
Danish: Før du starter behandlingen, vil din læge fortælle dig:
English: Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow.
Danish: Din læge kan kontrollere, om du har en høj total tumormængde i hele kroppen, inklusive din knoglemarv.
English: Your doctor should check whether you have ever had hepatitis B infection
Danish: Lægen bør kontrollere, om du tidligere har haft en hepatitis B-infektion
English: To remove the capsule from the blister:
Danish: Tag kapslen ud af blisteren:
English: For all indications described below:
Danish: For alle indikationer, der er beskrevet nedenfor, gælder, at:
English: Gastrointestinal perforations may lead to septic complications and may be associated with fatal outcome.
Danish: Gastrointestinal perforation kan føre til septiske komplikationer og kan være forbundet med dødeligt udfald.
English: Patients should be advised to promptly report febrile episodes.
Danish: Patienterne bør rådes til straks at rapportere febrile episoder.
English: If dose increased (15 mg) a
Danish: Hvis dosis er øget (15 mg) a
English: In IFM 2005-02, the adverse reactions were from the maintenance treatment period only.
Danish: I IFM 2005-02 stammede bivirkningerne kun fra perioden med vedligeholdelsesbehandling.
English: • if you have or have ever had previous viral infection, particularly hepatitis B infection, varicella zona, HIV.
Danish: • hvis du har eller tidligere har haft en virusinfektion, især hepatitis B-infektion, varicella zona, hiv.
English: Lenalidomide has an asymmetric carbon atom and can therefore exist as the optically active forms S(-) and R(+).
Danish: Lenalidomid har et asymmetrisk kulstofatom og kan derfor eksistere som de optisk aktive former S(-) and R(+).
English: Lenalidomide is taken on certain days over 4 weeks (28 days).
Danish: Lenalidomid tages på visse dage i løbet af 4 uger (28 dage).
English: Approximately 30% of the medicinal product in the body was removed during a single 4hour dialysis session.
Danish: Ca. 30% af lægemidlet i kroppen blev elimineret under en enkelt 4-timers dialysesession.
English: If you are newly diagnosed, your doctor may also assess your treatment based on your age and other conditions you already have.
Danish: Hvis du er nydiagnosticeret, kan din læge også vurdere din behandling på basis af din alder samt andre sygdomme, som du måske allerede har.
English: A conservative approach was applied to determine the adverse reactions from CALGB 100104.
Danish: Der blev anvendt en konservativ tilgang til at bestemme bivirkningerne fra CALGB 100104.
English: b The 95% CI about the median.
Danish: b 95% CI omkring medianen.
English: Grade ≥ 3 infections occurred within the context of neutropenia in less than one-third of the patients.
Danish: Infektioner af grad ≥ 3 forekom i sammenhæng med neutropeni hos under en tredjedel af patienterne.
English: Your doctor will advise you on appropriate methods of contraception.
Danish: Din læge vil rådgive dig om passende præventionsmetoder.
English: • Description of the patient card and its necessity
Danish: • Beskrivelse af patientkortet og dets nødvendighed
English: a The median is based on the Kaplan-Meier estimate.
Danish: a Medianen er baseret på Kaplan-Meier-estimatet.
English: Pregnancy, breast-feeding and contraception - information for women and men
Danish: Graviditet, amning og prævention - information til kvinder og mænd
English: e Exploratory endpoint (PFS2).
Danish: e Eksplorativt endepunkt (PFS2).
English: • Difficulty getting an erection
Danish: • Vanskelighed ved at få erektion
English: • some medicines used to prevent pregnancy such as oral contraceptives, as they may stop working
Danish: • nogle lægemidler, der anvendes til at forhindre graviditet, såsom orale præventionsmidler, da de kan holde op med at virke
English: A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
Danish: En kvindelig patient eller en kvindelig partner til en mandlig patient betragtes som værende fertil, medmindre hun opfylder mindst et af følgende kriterier:
English: • Description of the PPP
Danish: • Beskrivelse af PPP
English: Safety advice relevant to all patients
Danish: Råd om sikkerhed, som er relevante for alle patienter
English: You should continue the cycles of treatment until your doctor tells you to stop.
Danish: Du bør fortsætte med behandlingscyklusserne, indtil lægen siger, du skal stoppe.
English: Requirements in the event of pregnancy
Danish: Krav i tilfælde af graviditet
English: • The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding
Danish: • Patienten overholder betingelserne i “Programmet til svangerskabsforebyggelse”, herunder bekræftelse af, at patienten har et passende forståelsesniveau
English: • Pneumonias (10.6%; combined term) from IFM 2005-02
Danish: • Pneumoni (10,6 %; kombineret term) fra IFM 2005-02
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Danish: Et nationalt kontrolleret udleveringssystem er implementeret i samarbejde med de nationale myndigheder.
English: Though this risk is not yet fully characterized, it should be kept in mind when considering and using lenalidomide in this setting.
Danish: Selvom denne risiko endnu ikke er fuldt beskrevet, skal man huske på den, når man overvejer at bruge lenalidomid i denne situation.
English: Key elements to be included
Danish: Nøgleelementer, der skal implementeres
English: • Depending on the day of the cycle, you will take one or more of the medicines.
Danish: • Afhængig af hvilken dag det er i cyklussen, vil du tage et eller flere af lægemidlerne.
English: • Explanation of the risk of neuropathy with long term use
Danish: • Forklaring af risikoen for neuropati ved lang tids anvendelse
English: Follow-up and end of treatment
Danish: Opfølgning og afslutning af behandling
English: Patients with known risk factors for infections should be closely monitored.
Danish: Patienter med kendte risikofaktorer for infektioner bør overvåges nøje.
English: • After completing each 28-day cycle, you should start a new ‘cycle' over the next 28 days.
Danish: • Efter du gennemfører hver 28-dages cyklus, skal du starte en ny 'cyklus' i løbet af de næste
English: Thus, lenalidomide can be administered with or without food.
Danish: Derfor kan lenalidomid indgives sammen med eller uden mad.
English: f Median follow-up post-ASCT for all surviving subjects.
Danish: f Median opfølgning efter ASCT for alle overlevende patienter.
English: You will take these other medicines at the start of treatment and then continue to take lenalidomide on its own.
Danish: Du skal tage disse andre lægemidler i begyndelsen af behandlingen og derefter fortsætte med kun at tage lenalidomid.
English: Once parameters have returned to baseline, treatment at a lower dose may be considered.
Danish: Når parametrene er vendt tilbage til baseline-værdier, kan behandling med en lavere dosis overvejes.
English: Developmental toxicity studies were previously conducted in rabbits.
Danish: Der er tidligere blevet gennemført udviklingsmæssige toksicitetsstudier med kaniner.
English: • less than 12 hours have passed - take your capsule immediately.
Danish: • der er gået mindre end 12 timer: tag kapslen omgående.
English: The capsules should be swallowed whole, preferably with water, either with or without food.
Danish: Kapslerne sluges hele, helst med vand, enten med eller uden mad.
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Danish: Hvis der er mistanke om PML, skal yderligere dosering suspenderes, indtil PML er blevet udelukket.
English: On dialysis days, the dose should be administered following dialysis.
Danish: På dialysedage skal dosis administreres efter dialysen.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til <1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Each 28 - day cycle is called a ‘treatment cycle'.
Danish: • Hver cyklus af 28 dage kaldes en 'behandlingscyklus'.
English: Safety advice for men
Danish: Sikkerhedsråd for mænd
English: • An excess of iron in the body
Danish: • Forhøjet indhold af jern i kroppen
English: If any of the above applies to you, tell your doctor before starting treatment.
Danish: Hvis noget af det ovenstående gælder for dig, skal du fortælle det til lægen før behandlingen påbegyndes.
English: The following information should also be provided in the appropriate brochure:
Danish: De følgende informationer skal også findes i de tilsvarende brochurer:
English: If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.
Danish: Hvis der er gået mere end 12 timer efter en glemt dosis, må patienten ikke tage dosen, men skal tage den næste dosis på det normale tidspunkt den efterfølgende dag.
English: • if you have had blood clots in the past - you have an increased risk of developing blood clots in the veins and arteries during treatment
Danish: • hvis du tidligere har haft blodpropper - du har en øget risiko for at udvikle blodpropper i dine vener og arterier under behandlingen
English: • on what days of your treatment cycle to take each medicine.
Danish: • på hvilke dage af din behandlingscyklus, du skal tage hvert lægemiddel.
English: • you should take lenalidomide at about the same time on the scheduled days.
Danish: • Du bør tage lenalidomid på nogenlunde samme tidspunkt på de planlagte dage.
English: • more than 12 hours have passed - do not take your capsule.
Danish: • der er gået mere end 12 timer: du må ikke tage kapslen.
English: • before treatment
Danish: • før behandlingen
English: In both studies, treatment was to continue until disease progression.
Danish: I begge studier skulle behandlingen fortsætte indtil sygdomsprogression.
English: 08039 Barcelona, Spain
Danish: 08039 Barcelona,
English: • That the patient should not give Lenalidomide Accord to any other person
Danish: • At patienten ikke må give Lenalidomide Accord til andre personer
English: In particular, tell your doctor or nurse if you are taking any of the following medicines:
Danish: Du skal især fortælle det til lægen eller sundhedspersonalet, hvis du tager nogle af de følgende lægemidler:
English: These patients should be closely monitored for signs and symptoms of active HBV infection throughout therapy.
Danish: Disse patienter bør overvåges nøje for tegn og symptomer på aktiv HBV-infektion under hele behandlingen.
English: PML was reported several months to several years after starting the treatment with lenalidomide.
Danish: PML blev rapporteret adskillige måneder til adskillige år efter påbegyndelse af behandlingen med lenalidomid.
English: Children and adolescents Lenalidomide is not recommended for use in children and adolescents under 18 years.
Danish: Børn og unge Lenalidomid anbefales ikke til børn og unge under 18 år.
English: No overall difference in safety or efficacy was observed between these patients and younger patients, but greater pre-disposition of older individuals cannot be ruled out.
Danish: Der blev ikke observeret nogen generel forskel i sikkerhed og virkning imellem patienter på 65 år og ældre og yngre patienter, men en større prædisposition hos ældre personer kan ikke udelukkes.
English: This is because lenalidomide can affect the way some other medicines work.
Danish: Dette skyldes, at lenalidomid kan påvirke den måde, nogle af de andre lægemidler virker på.
English: This can damage the bones and kidneys.
Danish: Dette kan beskadige knogler og nyrer.
English: Prescriptions for women of childbearing potential can be for a maximum duration of 4 weeks, and prescriptions for all other patients can be for a maximum duration of 12 weeks.
Danish: Ordinationer til fertile kvinder kan være af en maksimal varighed på 4 uger, og ordinationer til alle andre patienter kan være af en maksimal varighed på 12 uger.
English: OTHER SPECIAL WARNING(S), IF NECESSARY WARNING: Risk of severe birth defects.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER ADVARSEL: Risiko for svære fødselsdefekter.
English: Treatment cycle
Danish: Behandlingscyklus
English: • Ringing in the ears (tinnitus)
Danish: • Ringen for ørerne (tinnitus)
English: Adverse reactions have been included under the appropriate category in the table below according to the highest frequency observed in any of the main clinical trials.
Danish: Bivirkningerne er inkluderet i passende kategorier i tabellen nedenunder i henhold til den største observerede hyppighed i alle de primære kliniske studier.
English: Not Known Interstitial pneumonitis
Danish: Ikke kendt Interstitiel pneumonitis
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: If you are taking lenalidomide in combination with other medicines, you should refer to the package leaflets for these medicines for further information on their use and effects.
Danish: Hvis du tager lenalidomid i kombination med andre lægemidler, bør du læse indlægssedlerne for disse lægemidler for yderligere information om deres anvendelse og virkning.
English: It may not be excluded that the efficacy of oral contraceptives may be reduced during treatment.
Danish: Det kan ikke udelukkes, at virkningen af orale præventionsmidler reduceres under behandlingen.
English: This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Danish: Dette krav omfatter kvinder i den fertile alder, som praktiserer absolut og vedvarende seksuel afholdenhed.
English: • Description and management of hypersensitivity and angioedema
Danish: • Beskrivelse og håndtering af hypersensitivitet og angioødem
English: Your doctor may check you for changes to your skin such as red spots or rashes.
Danish: Lægen kan kontrollere din hud for ændringer for dig, såsom røde pletter eller udslæt.
English: The lenalidomide arm was discontinued, as a proactive safety measure, after observing an imbalance of SPMs (see section 4.4).
Danish: Lenalidomid-armen blev stoppet som en proaktiv sikkerhedsforanstaltning efter observation af en ubalance i SPM'er (se pkt.
English: Other intrinsic factors
Danish: Andre intrinsiske faktorer
English: Most of the invasive SPMs were solid tumour malignancies.
Danish: De fleste invasive SPM'er var maligniteter med solide tumorer.
English: Physicians should monitor patients at regular intervals and should consider PML in the differential diagnosis in patients with new or worsening neurological symptoms, cognitive or behavioural signs or symptoms.
Danish: Læger bør monitorere patienter regelmæssigt og bør overveje PML i differentialdiagnosen hos patienter med nye eller forværrede neurologiske symptomer, kognitive eller adfærdsmæssige tegn eller symptomer.
English: Lenalidomide Accord hard capsules should be taken orally at about the same time on the scheduled days.
Danish: Lenalidomide Accord hårde kapsler bør indtages oralt på cirka samme tidspunkt på de planlagte dage.
English: Treatment was to be continued until disease progression.
Danish: Behandlingen skulle fortsætte indtil sygdomsprogression.
English: 2 In countries where the 7.5 mg capsule is available.
Danish: 2 I lande, hvor kapslen på 7,5 mg er tilgængelig.
English: Not Known Solid organ transplant rejection
Danish: Ikke kendt Afstødning af transplanterede solide organer
English: A second analysis that identified events that occurred after the start of maintenance treatment suggests that the frequencies described in Table 1 may be higher than actually observed during the maintenance treatment period.
Danish: En anden analyse, der identificerede hændelser, der forekom efter påbegyndelse af vedligeholdelsesbehandling, tyder på, at de hyppigheder, der er anført i tabel 1, kan være højere end dem, der rent faktisk blev observeret i perioden med vedligeholdelsesbehandling.
English: Some of the cases of viral reactivation had a fatal outcome.
Danish: Nogle af tilfældene af viral reaktivering var dødelige.
English: The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors.
Danish: Beslutningen om antitrombotiske, profylaktiske forholdsregler bør træffes efter omhyggelig vurdering af den individuelle patients underliggende risikofaktorer.
English: • some medicines used for heart problems - such as digoxin
Danish: • nogle lægemidler, der anvendes til hjerteproblemer - såsom digoxin
English: Action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Danish: Der bør træffes foranstaltninger til at forsøge at minimere alle de risikofaktorer, som kan ændres (f.eks. rygning, hypertension og hyperlipidæmi).
English: Lenalidomide works by affecting the body's immune system and directly attacking the cancer.
Danish: Lenalidomide Accord virker ved at påvirke kroppens immunsystem og direkte angribe kræften.
English: Lenalidomide is produced as a racemic mixture.
Danish: Lenalidomid produceres som en racemisk blanding.
English: These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Danish: Hvert af disse symptomer kan være tegn på en alvorlig og potentielt dødelig hjernesygdom, der kaldes progressiv multifokal leukoencefalopati (PML).
English: • by stimulating part of the immune system to attack the cancer cells.
Danish: • ved at stimulere en del af immunsystemet, så kræftcellerne angribes.
English: • do not put pressure on the center of the capsule, as this can cause it to break.
Danish: • tryk ikke midt på kapslen, da det kan forårsage, at den knækker.
English: Therefore, caution is recommended when driving or operating machines.
Danish: Det anbefales derfor at udvise forsigtighed, når der føres motorkøretøj eller betjenes maskiner.
English: The ECOG performance status was comparable between both groups, as was the number and type of prior therapies.
Danish: ECOG-(Eastern Cooperative Oncology Group)performance-status var næsten ens for begge grupper, hvilket også gjaldt for antallet og typen af tidligere behandlinger.
English: Stop using lenalidomide if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge lenalidomid, hvis du udvikler disse symptomer, og kontakt straks lægen, eller søg lægehjælp.
English: Description of the PPP and categorisation of patients based on sex and childbearing potential
Danish: Beskrivelse af PPP og kategorisering af patienter på basis af køn og fødedygtighed
English: • You must not take lenalidomide if you are pregnant, as it is expected to be harmful to an unborn baby.
Danish: • Du må ikke tage lenalidomid, hvis du er gravid, da det forventes at være skadeligt for det ufødte barn.
English: The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and/or dispensing controls, and the collecting of detailed data relating to the indication in order to monitor closely the off-label use within the national territory.
Danish: Det kontrollerede distributionssystem omfatter anvendelse af et patientkort og/eller tilsvarende redskab for kontrol af ordination og udlevering samt indsamling af detaljerede data i relation til indikationen for nøje at monitorere off label-anvendelse i det pågældende land.
English: Lenalidomide is generally more soluble in organic solvents but exhibits the greatest solubility in 0.1N HCl buffer.
Danish: Lenalidomid er generelt mere opløselig i organiske opløsningsmidler, men udviser den største opløselighed i 0,1N HCl-buffer.
English: Data cut-off dates: 17 Dec 2009 and 01 Feb 2016
Danish: Datoer for data-cut-off: 17. december 2009 og 1. februar 2016
English: Therefore you must tell your doctor immediately if you experience:
Danish: Derfor skal du omgående fortælle det til lægen, hvis du får:
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Danish: Thalidomid er et kendt humanteratogent aktivt stof, som forårsager svære livstruende fødselsdefekter.
English: • She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide.
Danish: • Kvinden bekræfter, at hun forstår risikoen og de nødvendige sikkerhedsforanstaltninger, som er forbundet med brugen af lenalidomid.
English: • Tumour lysis syndrome - metabolic complications that can occur during treatment of cancer and sometimes even without treatment.
Danish: • Tumorlysesyndrom - metaboliske komplikationer, der kan forekomme under cancerbehandling og nogle gange endda uden behandling.
English: There is no specific experience in the management of lenalidomide overdose in patients, although in dose-ranging studies some patients were exposed to up to 150 mg, and in single-dose studies, some patients were exposed to up to 400 mg.
Danish: Der er ingen specifik erfaring med håndtering af overdosis af lenalidomid hos patienter, selvom nogle patienter i dosisstudier blev udsat for op til 150 mg, og i enkeltdosisstudier blev nogle patienter eksponeret for op til 400 mg.
English: • Description and management of cutaneous reactions
Danish: • Beskrivelse og håndtering af kutane reaktioner
English: Very Common Renal failure (including acute)◊
Danish: Meget almindelig Nyresvigt (herunder akut)◊
English: It has also been shown to delay multiple myeloma from coming back following treatment.
Danish: Det har også vist sig at kunne forsinke myelomatose fra at vende tilbage efter behandlingen.
English: Patients should be advised of the signs and symptoms of these reactions by their prescribers and should be told to seek medical attention immediately if they develop these symptoms.
Danish: Patienter skal underrettes om tegn og symptomer på disse reaktioner af dem, der ordinerer medicinen, og bør instrueres i straks at søge lægehjælp, hvis de udvikler disse symptomer.
English: Your doctor may adjust your dose of lenalidomide or stop your treatment based on the results of your blood tests and on your general condition.
Danish: Lægen kan justere dosis af lenalidomid eller standse behandlingen på basis af resultaterne fra blodprøverne og din generelle tilstand.
English: In both studies, dose adjustments were allowed based on clinical and laboratory finding.
Danish: I begge studier var dosisjusteringer baseret på kliniske og laboratoriemæssige parametre tilladt.