FrancophonIA/ELRC3.0 huggingface dataset:
English: If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.
Danish: Hvis du har haft disse symptomer før behandlingen med lenalidomid, skal du fortælle lægen om eventuelle ændringer i symptomerne.
English: Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.
Danish: Ved ordination bør lægen nøje evaluere, hvilken dosis dexamethason der skal anvendes, under hensyntagen til patientens tilstand og sygdom.
English: • how much lenalidomide you should take
Danish: • hvor meget lenalidomid du skal tage
English: The primary efficacy endpoint in both studies was time to progression (TTP).
Danish: Det primære endepunkt i begge studier var tid til progression (TTP, Time To Progression).
English: Patients between 18 and 70 years of age with active MM requiring treatment and without prior progression after initial therapy were eligible.
Danish: Patienter mellem 18 og 70 år med aktiv behandlingskrævende MM og uden tidligere progression efter initial behandling kunne indgå.
English: • Febrile neutropenia (6.0%)
Danish: • Febril neutropeni (6,0 %)
English: Lenalidomide has minor or moderate influence on the ability to drive and use machines.
Danish: Lenalidomid påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Abnormal liver function tests were commonly reported and were generally asymptomatic and reversible upon dosing interruption.
Danish: Unormale leverfunktionsprøver blev rapporteret med en hyppighed på almindelig og var generelt asymptomatiske og reversible efter seponering.
English: Very Common Pneumonias◊,a, Neutropenic infection
Danish: Meget almindelig Pneumoni◊,a, neutropenisk infektion
English: • Previous bilateral salpingo-oophorectomy, or hysterectomy
Danish: • Tidligere bilateral salpingo-ooforektomi eller hysterektomi
English: In the event of overdose, supportive care is advised.
Danish: I tilfælde af overdosis tilrådes en understøttende behandling.
English: • You must also use effective methods of contraception (see ‘Contraception' below).
Danish: • Du skal også anvende et sikkert præventionsmiddel (se ”Prævention” nedenfor).
English: Lenalidomide is poorly metabolized as 82% of the dose is excreted unchanged in urine.
Danish: Lenalidomid metaboliseres i ringe grad, da 82 % af dosis udskilles uændret i urinen.
English: • Loss of sex drive (libido)
Danish: • Tab af sexlyst (libido)
English: However, renal impairment did not alter the oral absorption of lenalidomide.
Danish: Den nedsatte nyrefunktion ændrede dog ikke den orale optagelse af lenalidomid.
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Danish: Patienter bør rådes til at oplyse deres partner eller omsorgspersoner om behandlingen, da partneren/omsorgspersonerne måske bemærker symptomer, som patienten ikke er opmærksom på.
English: System Organ Class/Preferred Term
Danish: Systemorganklasse / foretrukken term
English: Multiple dosing does not cause marked medicinal product accumulation.
Danish: Gentagne doseringer forårsager ingen udpræget akkumulering af lægemidlet.
English: The test should ensure the patient is not pregnant when she starts treatment with lenalidomide.
Danish: Testen skal sikre, at patienten ikke er gravid, når hun indleder behandlingen med lenalidomid.
English: • Pregnancy test dates and results
Danish: • Datoerne for og resultaterne af graviditetstest
English: The MAH shall implement a pregnancy prevention programme (PPP) in each Member State.
Danish: Indehaveren af markedsføringstilladelsen skal implementere et program til svangerskabsforebyggelse (PPP, Pregnancy Prevention Programme) i hvert medlemsland.
English: Close monitoring of warfarin concentration is advised during the treatment.
Danish: Omhyggelig overvågning af warfarinkoncentrationen tilrådes under behandlingen.
English: • Increases in your blood sugar level (diabetes)
Danish: • Forhøjet sukkerniveau i blodet (sukkersyge)
English: • Medroxyprogesterone acetate depot
Danish: • Medroxyprogesteronacetat-depot
English: Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment for safe disposal.
Danish: Patienten skal instrueres i aldrig at overdrage dette lægemiddel til andre og i at aflevere eventuelt ikke anvendte kapsler til apoteket, når behandlingen er afsluttet, til sikker bortskaffelse.
English: Summary of results of efficacy analyses as of cut-off date for extended follow-uppooled studies MM-009 and MM-010 (cut-offs 23 July 2008 and 2 March 2008, respectively)
Danish: Oversigt over resultater for effektanalyser på skæringsdatoen for den forlængede opfølgning - Poolede MM-009 og MM-010 studier (skæringsdatoer hhv. den 23. juli 2008 og 2. marts 2008)
English: • Lung infection (9.4% [9.4% after the start of maintenance treatment]) from CALGB 100104
Danish: • Lungeinfektion (9,4% [9,4% efter påbegyndelse af vedligeholdelsesbehandling]) fra CALGB
English: Lenalidomide can stop the signs and symptoms of multiple myeloma getting worse.
Danish: Lenalidomide Accord kan forhindre, at tegn og symptomer fra myelomatose bliver værre.
English: However with a longer follow-up, the difference in overall survival in favour of lenalidomide/ low dose dexamethasone tends to decrease.
Danish: Med en længere opfølgning har forskellen i samlet overlevelse, der favoriserer lenalidomid/ lavdosis dexamethason, imidlertid en tendens til at falde.
English: • Increased blood pressure or a fall in blood pressure, slow, fast or irregular heart beat
Danish: • Forhøjet blodtryk eller blodtryksfald, langsom eller hurtig eller uregelmæssig hjerterytme
English: Treatment with lenalidomide may cause virus to become active again, in patients who carry the virus, resulting in a recurrence of the infection.
Danish: Behandling med lenalidomid kan føre til, at virus igen bliver aktiv hos patienter, der er bærere af virus, og dermed få infektionen til at vende tilbage.
English: On day 1 of next cycle, continue G-CSF as needed and maintain dose of lenalidomide if neutropenia was the only DLT.
Danish: På dag 1 af den næste cyklus fortsættes G-CSF efter behov, og dosis af lenalidomid opretholdes, hvis neutropeni var den eneste DLT.
English: • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans Obligations of the health care professional in relation to the prescribing of Lenalidomide Accord
Danish: • Nødvendigheden af at undgå føtal eksponering pga. lenalidomids teratogenicitet hos dyr og den forventede teratogene effekt af lenalidomid hos mennesker Sundhedspersonalets forpligtelser i forbindelse med ordinationen af Lenalidomide Accord
English: Enhanced clinical and laboratory monitoring is warranted notably during the first weeks of treatment.
Danish: Øget klinisk og laboratoriemæssig overvågning er påkrævet, især i de første behandlingsuger.
English: The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
Danish: Betingelserne i “Programmet til svangerskabsforebyggelse” skal overholdes af alle patienter, medmindre der er pålidelige beviser for, at patienten ikke er fertil.
English: • Infections of all types
Danish: • Alle slags infektioner
English: Hard capsule (capsule)
Danish: Hård kapsel (kapsel).
English: Tests and checks
Danish: Undersøgelser og kontroller
English: • Local contact details for reporting of any suspected pregnancy
Danish: • Lokale kontaktinformationer for rapportering af ethvert tilfælde om mistænkt graviditet
English: Patients with multiple myeloma are prone to develop infections including pneumonia.
Danish: Patienter med myelomatose har tendens til at udvikle infektioner, herunder pneumoni.
English: Therefore, lenalidomide is unlikely to cause any clinically relevant medicinal product interactions when co-administered with substrates of these enzymes.
Danish: Det er derfor ikke sandsynligt, at lenalidomid forårsager klinisk relevante lægemiddelinteraktioner, når det administreres sammen med substrater for disse enzymer.
English: However, dexamethasone is known to be a weak to moderate inducer of CYP3A4 and is likely to also affect other enzymes as well as transporters.
Danish: Dexamethason er imidlertid kendt som en svag til moderat induktor af CYP3A4 og påvirker sandsynligvis også andre enzymer samt transportproteiner.
English: Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell.
Danish: Myelomatose er en kræfttype, der påvirker en bestemt type af hvide blodlegemer, der kaldes plasmaceller.
English: Viral infections, including herpes zoster and hepatitis B virus reactivation
Danish: Virusinfektioner, herunder herpes zoster og reaktivering af hepatitis B-virus
English: Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Danish: Ideelt bør graviditetstest, ordination og udlevering foregå samme dag.
English: The renal clearance of lenalidomide exceeds the glomerular filtration rate and therefore is at least actively secreted to some extent.
Danish: Den renale clearance af lenalidomid overskrider den glomerulære filtrationshastighed, og lenalidomid secerneres derfor i det mindste i nogen grad aktivt.
English: • Changes to a protein in the blood that can cause swelling of the arteries (vasculitis)
Danish: • Ændringer af et protein i blodet, der kan få dine arterier til at hæve (vaskulitis)
English: Patients aged < 65 years at diagnosis who had undergone ASCT and had achieved at least a stable disease response at the time of hematologic recovery were eligible.
Danish: Patienter < 65 år ved diagnosticering, der havde gennemgået ASCT og opnået en mindst stabil sygdomsrespons på tidspunktet for hæmatologisk restitution, kunne indgå.
English: • Renal failure (including acute) (6.3%)
Danish: • Nyresvigt (herunder akut) (6,3 %)
English: • Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception
Danish: • Selv hvis en kvinde i den fertile alder har amenorre, skal hun følge alle rådene om effektiv prævention
English: Optimal control of co-morbid conditions influencing thyroid function is recommended before start of treatment.
Danish: Optimal kontrol af komorbide tilstande, der påvirker thyreoideafunktionen, anbefales før behandlingen påbegyndes.
English: Cases of allergic reaction/hypersensitivity reactions have been reported.
Danish: Der er rapporteret om tilfælde af allergiske reaktioner/overfølsomhedsreaktioner.
English: Lenalidomide is rapidly absorbed following oral administration in healthy volunteers, under fasting conditions, with maximum plasma concentrations occurring between 0.5 and 2 hours post-dose.
Danish: Lenalidomid absorberes hurtigt efter oral administration hos raske frivillige under faste, med maksimale plasmakoncentrationer mellem 0,5 og 2 timer efter indtagelse.
English: Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Danish: Detaljerne i dette program, herunder iværksættelsen af nationale tiltag til vurdering af programmets effektivitet og overholdelsen af programmet, skal aftales med den relevante nationale myndighed i hvert enkelt medlemsland og være på plads, inden produktet lanceres på markedet.
English: Both patient populations presented a median age of 63 years, with a comparable male to female ratio.
Danish: Begge patientpopulationer havde en gennemsnitsalder på 63 år, og der var lige fordeling mellem mænd og kvinder.
English: In this study, two methods were used to classify renal function: the urinary creatinine clearance measured over 24 hours and the creatinine clearance estimated by CockcroftGault formula.
Danish: I dette studie blev der anvendt to metoder til at klassificere nyrefunktionen: kreatininclearance i urinen målt over 24 timer, og den kreatininclearance, der blev estimeret ud fra Cockcroft-Gault-ligningen.
English: • Rejection of solid organ transplant (such as kidney, heart).
Danish: • Afstødning af transplanterede solide organer (såsom nyre eller hjerte).
English: Also, some other medicines can affect the way lenalidomide works.
Danish: Andre lægemidler kan også påvirke den måde, lenalidomid virker på.
English: • Brief background on lenalidomide and its licensed indication
Danish: • Kort baggrundsinformation angående lenalidomid og den godkendte indikation
English: • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
Danish: • Kvinden har fået information om og forstår de potentielle følger af graviditet og nødvendigheden af omgående at søge læge, hvis der er risiko for graviditet
English: Do not use this medicine after the expiry date, which is stated on the carton and blister after ‘EXP'.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisteren efter EXP.
English: Injury, Poisoning and Procedural Complications
Danish: Traumer, forgiftninger og behandlingskomplikationer
English: Do not use while pregnant or breastfeeding.
Danish: Må ikke bruges under graviditet eller amning.
English: • how much of the other medicines you should take in combination with lenalidomide , if any
Danish: • hvor meget du evt. skal tage af de andre lægemidler i kombination med lenalidomid
English: • Serious allergic reaction that may begin as rash in one area but spread with extensive loss of skin over the whole body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
Danish: • Alvorlige overfølsomhedsreaktioner, der kan starte som udslæt i ét område, men som breder sig med udbredt tab af hud over hele kroppen til følge (Stevens-Johnsons syndrom og/eller toksisk epidermal nekrolyse)
English: Table 4: Summary of overall efficacy data
Danish: Tabel 4: Oversigt over samlede data for virkning
English: Starting dose (10 mg)
Danish: Startdosis (10 mg)
English: • by stopping the cancer cells developing
Danish: • ved at stoppe kræftcellernes udvikling
English: • Sudden, or mild but worsening pain in the upper stomach and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse.
Danish: • Pludselig eller mild, men forværret smerte i den øvre del af maven og/eller ryg, som varer ved i nogle dage, eventuelt ledsaget af kvalme, opkastning, feber og hurtig puls.
English: • You must not become pregnant while taking lenalidomide.
Danish: • Du må ikke blive gravid, mens du tager lenalidomid.
English: • That the patient should tell their doctor about any adverse events
Danish: • At patienten skal oplyse lægen om enhver bivirkning
English: A second analysis identified events that occurred after the start of maintenance treatment.
Danish: En anden analyse identificerede bivirkninger, der forekom efter påbegyndelse af vedligeholdelsesbehandling.
English: • some medicines used to thin the blood - such as warfarin
Danish: • nogle lægemidler, der anvendes til at fortynde blodet - såsom warfarin
English: If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this confirmation.
Danish: Hvis du kan blive gravid, vil din læge notere at alle nødvendige forholdsregler er blevet truffet og vil bekræfte dette over for dig, hver gang du får ordineret medicin.
English: Currently available pharmacokinetic data are described in section 5.2.
Danish: De aktuelt tilgængelige farmakokinetiske data er beskrevet i pkt.
English: Any unused product or waste material should be returned to the pharmacist for safe disposal in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal returneres til apotekspersonalet til sikker bortskaffelse i henhold til lokale retningslinjer.
English: a: Two-tailed log rank test comparing survival curves between treatment groups.
Danish: a: Two-tailed log rank test med sammenligning af overlevelseskurverne mellem behandlingsgrupperne.
English: Hepatitis B virus status should be established before initiating treatment with lenalidomide.
Danish: Hepatitis B-virusstatus bør klarlægges før behandling med lenalidomid påbegyndes.
English: Non-invasive SPM comprise basal cell or squamous cell skin cancers.
Danish: Ikke-invasiv SPM omfatter basalcelle- eller planocellulær hudcancer.
English: All patients should be advised to seek medical attention promptly at the first sign of infection (eg, cough, fever, etc) thereby allowing for early management to reduce severity.
Danish: Alle patienter bør rådes til straks at søge lægehjælp ved det første infektionstegn (f.eks. hoste, feber osv.), og derved gøre en tidlig behandling mulig for at reducere sværhedsgraden.
English: • Anaemia (5.3%)
Danish: • Anæmi (5,3 %)
English: • the capsules can be taken either with or without food.
Danish: • Du kan tage kapslerne med eller uden mad.
English: • Premature ovarian failure confirmed by a specialist gynaecologist
Danish: • Tidlig menopause bekræftet af en speciallæge i gynækologi
English: Blood donation You should not donate blood during treatment and for 1 week after the end of treatment.
Danish: Bloddonation Du må ikke donere blod under behandlingen og i 1 uge efter behandlingsophør.
English: Regular monitoring of visual ability is recommended.
Danish: Det anbefales at overvåge synsevnen regelmæssigt.
English: In an analysis of PFS, PFS2, OS using a cut-off of April 2013 where the median follow up time for all surviving subjects was 62.4 months, the results of the study are presented in Table 6:
Danish: I en analyse af PFS, PFS2, OS ved anvendelse af en afskæringsdato i april 2013, hvor den mediane opfølgningstid for alle overlevende personer var 62,4 måneder, vises resultaterne af studiet i tabel 6:
English: If a patient is currently using combined oral contraception the patient should switch to one of the effective methods listed above.
Danish: Hvis en patient aktuelt anvender p-piller af kombinationstypen, skal patienten skifte til én af de ovenstående effektive metoder.
English: However, in the main multiple myeloma registration trials where the efficacy and safety were established for lenalidomide, the medicinal product was administered without regard to food intake.
Danish: I de primære registreringsstudier af myelomatose, hvor sikkerhed og virkning blev klarlagt for lenalidomid, blev lægemidlet imidlertid indgivet uden hensyntagen til fødeindtagelse.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption bør ikke tage dette lægemiddel.
English: Results of these analyses subsequently led to an unblinding in both studies, in order to allow patients in the placebo/dex group to receive treatment with the len/dex combination.
Danish: Resultaterne fra disse analyser førte derefter til en afblinding i begge studier for at gøre det muligt for patienter i placebo/dex-gruppen at modtage behandling med len/dex-kombinationen.
English: • Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Danish: • Produktresume (SmPC), indlægsseddel og etikettering.
English: The MAH should agree on the implementation of the patient card system in each Member State.
Danish: Indehaveren af markedsføringstilladelsen skal give samtykke til implementering af patientkortsystemet i hvert enkelt medlemsland.
English: Dexamethasone is a weak to moderate enzyme inducer and its effect on warfarin is unknown.
Danish: Dexamethason er en svag til moderat enzyminduktor, og dens effekt på warfarin kendes ikke.
English: These symptoms may be due to inflammation of the pancreas.
Danish: Disse symptomer kan skyldes betændelse i bugspytkirtlen.
English: The increased risk of secondary primary malignancies associated with lenalidomide is relevant also in the context of NDMM after stem cell transplantation.
Danish: Den øgede risiko for sekundær primær malignitet forbundet med lenalidomid er relevant også i forbindelse med NDMM efter stamcelletransplantation.
English: b: Two-tailed continuity-corrected chi-square test.
Danish: b: Two-tailed kontinuitetskorrigeret chi i anden test.
English: Additional precautions
Danish: Yderligere sikkerhedsforanstaltninger
English: The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory properties.
Danish: Lenalidomids virkningsmekanisme inkluderer anti-neoplastiske, anti-angiogene, pro-erytropoietiske og immunmodulerende egenskaber.
English: • Pneumonia (9.8%)
Danish: • Lungebetændelse (9,8 %)
English: The no observed adverse effect level (NOAEL) was considered to be less than 75 mg/kg/day, and is approximately 25-fold greater than the human daily exposure based on AUC exposure.
Danish: Niveauet uden observerede negative effekter (No observed adverse effect level, NOAEL) blev vurderet til at være mindre end 75 mg/kg/dag og er cirka 25 gange større end den humane, daglige eksponering baseret på AUC-eksponeringen.
English: 1 The dose may be escalated to 15 mg once daily after 2 cycles if patient is not responding to treatment and is tolerating the treatment.
Danish: 1 Dosis kan øges til 15 mg/dag efter 2 cyklusser, hvis patienten ikke reagerer på behandlingen, og behandlingen tåles.
English: ª The median is based on the Kaplan-Meier estimate ¤PFS2 (an exploratory endpoint) was defined for all patients (ITT) as time from randomisation to start of 3rd line antimyeloma therapy (AMT) or death for all randomised patients
Danish: ª Medianen er baseret på Kaplan-Meier-estimatet ¤PFS2 (et eksploratorisk endepunkt) blev for alle patienter (ITT) defineret som tidspunktet fra randomisering til start på tredjevalgs antimyelomabehandlingen (antimyeloma therapy, AMT) eller dødsfald for alle randomiserede patienter
English: Other special warnings and precautions for use
Danish: Andre særlige advarsler og forsigtighedsregler vedrørende brugen
English: • an immunosuppressant medicine called ‘prednisone'.
Danish: • et immunundertrykkende lægemiddel, der kaldes prednison.
English: • if you are allergic to lenalidomide or any of the other ingredients of this medicine listed in section 6.
Danish: • hvis du er allergisk over for lenalidomid eller et af de øvrige indholdsstoffer i Lenalidomide Accord angivet i punkt 6.
English: If you are aged 75 years or older or have moderate to severe kidney problems - your doctor will check you carefully before starting treatment.
Danish: Hvis du er 75 år eller derover, eller hvis du har moderate til svære nyreproblemer, vil din læge undersøge dig grundigt, før du starter behandlingen.
English: Patients may continue lenalidomide and dexamethasone therapy until disease progression or intolerance.
Danish: Patienterne kan fortsætte behandlingen med lenalidomid og dexamethason indtil sygdomsprogression eller intolerans.
English: In case of neutropenia, the physician should consider the use of growth factors in patient management.
Danish: I tilfælde af neutropeni bør lægen overveje at anvende vækstfaktorer i behandlingen af patienten.