natgillin/translations-raw huggingface dataset:
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.
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 .
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.
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.
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).
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).
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).
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
Kapslerne må ikke åbnes eller knuses.
Capsules should not be opened or crushed.
Derfor kan det forventes, at lenalidomid har en teratogen virkning, og lenalidomid er kontraindiceret under graviditet (se pkt.
Therefore, a teratogenic effect of lenalidomide is expected and lenalidomide is contraindicated during pregnancy (see section 4.3).
Almindelig Pancytopeni◊
Common Pancytopenia◊
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.
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).
Der er rapporteret tilfælde af hypo- og hypertyroidisme.
Cases of hypothyroidism and cases of hyperthyroidism have been reported.
Lenalidomid er ikke en enzyminduktor.
Lenalidomide is not an enzyme inducer.
Da lenalidomid har antineoplastisk aktivitet, kan der optræde komplikationer i form af tumorlysesyndrom (TLS).
Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome (TLS) may occur.
De alvorligste bivirkninger, der hyppigere blev observeret med lenalidomid/dexamethason end med placebo/dexamethason-kombinationen, var:
The most serious adverse reactions observed more frequently in lenalidomide/dexamethasone than placebo/dexamethasone combination were:
Grundlaget for nedenstående tabel er data indsamlet under studier af myelomatose med kombinationsbehandling.
The following table is derived from data gathered during the multiple myeloma studies with combination therapy.
Medianf (min; maks): alle patienter Myeloma-responsg n (%)
Follow-up (months) Medianf (min, max): all patients Myeloma responseg n (%)
• 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)
• 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
• Hvis du bliver gravid under behandlingen med lenalidomid, skal du stoppe med behandlingen og omgående informere lægen.
• If you do become pregnant during your treatment with lenalidomide , you must stop the treatment and inform your doctor immediately.
Resultaterne antyder, at den samlede lenalidomidclearance falder proportionelt med faldende nyrefunktion (< 50 ml/min), hvilket medfører en stigning i AUC.
The results indicate that as renal function decreases (< 50 mL/min), the total lenalidomide clearance decreases proportionally resulting in an increase in AUC.
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.
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.
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.
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.
• Nødvendigheden af at forsyne patienterne med informationsbrochure og patientkort
• Need to provide patients with appropriate patient educational brochure and patient card
• Brug ikke lægemidlet, hvis du bemærker, at pakningen er beskadiget eller udviser tegn på at have været åbnet.
Do not use this medicine if you notice any damage or signs of tampering to the pack.
Hvis pulveret fra en knækket lenalidomid kapsel får kontakt med huden skal huden straks vaskes grundigt med sæbe og vand.
If powder from a broken lenalidomide capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
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:
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:
Afbrydelse eller seponering af lenalidomid bør overvejes ved hududslæt af grad 2 eller 3.
Lenalidomide interruption or discontinuation should be considered for grade 2 or 3 skin rash.
Myalgi, muskuloskeletale smerter
Myalgia, Musculoskeletal pain
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.
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.
• Infektion i lungerne og de øvre luftveje, åndenød
• Infection of the lung and the upper respiratory tract, breathlessness
En lægeligt monitoreret graviditetstest skal gentages hver 4. uge, inklusive 4 uger efter afslutning af behandlingen undtagen ved bekræftet æggeleder-sterilisation.
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.
• 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”).
• 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').
• hvis du har haft et hjerteanfald, tidligere har haft en blodprop, eller hvis du ryger, har højt blodtryk eller forhøjet kolesterolniveau
• 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
Du må ikke amme under behandling med lenalidomid, da det er ukendt, om lenalidomid udskilles i mælken hos mennesker.
You must not breast-feed when taking lenalidomide , as it is not known if lenalidomide passes into human milk.
Nydiagnosticeret myelomatose: patienter, der ikke er egnede til transplantation
Newly diagnosed multiple myeloma: patients who are not eligible for transplant
• Visse typer af hudsvulster
• Certain types of skin tumour
Pakningsstørrelse med 21 x 1 kapsler.
Pack size of 21x1 capsules.
Anvendelse Lenalidomide Accord anvendes hos voksne mod myelomatose.
What Lenalidomide Accord is used for Lenalidomide Accord is used in adults for multiple myeloma.
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).
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.
• 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).
• 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).
Af de 353 patienter i MM-009 og MM-010 studierne, som fik lenalidomid/dexamethason, var 45,6 % i alderen 65 år og derover.
Out of 353 patients in the MM-009 and MM-010 studies who received lenalidomide/dexamethasone, 45.6% were aged 65 or over.
De bivirkninger, som blev observeret hos patienter, der blev behandlet for myelomatose, er opført nedenfor efter systemorganklasse og hyppighed.
The adverse reactions observed in patients treated with lenalidomide are listed below by system organ class and frequency.
Patienterne blev stratificeret ved randomisering i henhold til alder (≤ 75 versus > 75 år), trin (ISS trin I og II versus trin III) og land.
Patients were stratified at randomisation by age (≤75 versus >75 years), stage (ISS Stages I and II versus Stage III), and country.
Understøttende studier af nydiagnosticeret myelomatose
Supportive newly diagnosed multiple myeloma studies
Akut myeloid leukæmi Myelomatose
Acute myeloid leukaemia Multiple myeloma
Anbefalede dosisjusteringer hos patienter med nedsat nyrefunktion er beskrevet i pkt.
Recommended dose adjustments in patients with impaired renal function are described in section 4.2.
Det skal du vide, før du begynder at tage Lenalidomide Accord 3.
What you need to know before you take Lenalidomide Accord 3.
• et antiinflammatorisk lægemiddel, der kaldes dexamethason.
• an anti-inflammatory medicine called ‘dexamethasone'
Specielle populationer
Special populations Elderly
Den bedre PFS blev observeret både i undergruppen af patienter med komplet respons (CR) og i undergruppen af patienter, som ikke havde opnået CR.
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.
CI = konfidensinterval, HR = hazard ratio, max = maksimum, min = minimum, NE = kan ikke estimeres, OS = samlet overlevelse, PFS = progressionsfri overlevelse;
CI = confidence interval; HR = hazard ratio; max = maximum; min = minimum; NE = not estimable; OS = overall survival; PFS = progression-free survival;
Der er blevet observeret sjældne tilfælde af rabdomyolyse, i nogle af disse blev lenalidomid administreret samtidigt med et statin.
Rare cases of rhabdomyolysis have been observed, some of them when lenalidomide is administered with a statin.
• Produktion af stor mængde urin samt knoglesmerter og svaghed, hvilket kan være symptomer på en nyrelidelse (Fanconis syndrom)
• Passing large amount of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
Tilfældene er generelt rapporteret hos patienter, der samtidig tog dexamethason eller tidligere havde fået anden immunsupprimerende kemoterapi.
Cases have generally been reported in patients taking concomitant dexamethasone or prior treatment with other immunosuppressive chemotherapy.
• Blødning inde i kraniet
• Bleeding within the skull
Cmax var ens mellem raske forsøgspersoner og patienter med nedsat nyrefunktion.
The Cmax was similar between healthy subjects and patients with renal impairment.
Som følge deraf bør patienter med kendte risikofaktorer, herunder tidligere trombose, monitoreres nøje.
Consequently, patients with known risk factors for thromboembolism - including prior thrombosisshould be closely monitored.
• 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.
• 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.
I to placebo-kontrollerede fase III-studier fik 353 patienter med myelomatose lenalidomid/dexamethason-kombinationen og 351 fik placebo/dexamethason-kombinationen.
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.
Patienten må ikke donere blod under behandlingen og i 1 uge efter ophør med behandling med lenalidomid.
Patients should not donate blood during therapy or for 1 week following discontinuation of lenalidomide.
Lenalidomid er blevet undersøgt i kliniske studier hos patienter på op til 91 år (se pkt.
Lenalidomide has been used in clinical trials in multiple myeloma patients up to 91 years of age (see section 5.1).
Du vil få Lenalidomide Accord af sundhedspersonale med erfaring i at behandle myelomatose.
Lenalidomide Accord must be given to you by healthcare professionals with experience in treating multiple myeloma,.
• hvis du tidligere har oplevet en kombination af nogen af følgende symptomer: udslæt i ansigtet eller udbredt udslæt, hudrødme, høj feber, influenzalignende symptomer, forstørrede lymfeknuder (tegn på en alvorlig hudreaktion, der kaldes lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS), se også punkt 4 “Bivirkninger”).
• if you have experienced in the past a combination of any of the following symptoms: rash on face or extended rash, red skin, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), see also section 4 “Possible side effects”).
Alle bivirkninger/hyppighed
All ADRs/Frequency
Gentagen oral administration af 4 og 6 mg/kg/dag til aber i op til 20 uger forårsagede dødelighed og væsentlig toksicitet (udpræget vægttab, reduktion af røde og hvide blodlegemer og trombocyttal, blødning fra flere organer, inflammation af mavetarmkanalen, lymfom- og knoglemarvsatrofi).
Repeated oral administration of 4 and 6 mg/kg/day to monkeys for up to 20 weeks produced mortality and significant toxicity (marked weight loss, reduced red and white blood cell and platelet counts, multiple organ haemorrhage, gastrointestinal tract inflammation, lymphoid, and bone marrow atrophy).
Infektion◊, urinvejsinfektion◊,*, nedre luftvejsinfektion, lungeinfektion◊
Infection◊, Urinary tract infection◊,*, Lower respiratory tract infection, Lung infection◊
Hyperkoagulation, koagulopati
Uncommon Hypercoagulation, Coagulopathy
Hvis du har taget for mange lenalidomid kapsler Hvis du har taget flere lenalidomid kapsler, end du bør ifølge recepten, skal du straks fortælle det til lægen.
If you take more lenalidomide than you should If you take more lenalidomide than was prescribed, tell your doctor immediately.
Fortæl det til lægen, hvis du får svære mavesmerter, feber, kvalme, opkastning, blod i afføringen eller ændret afføringsmønster.
Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Hvis pulveret med lenalidomid får kontakt med huden, skal huden straks vaskes grundigt med sæbe og vand.
If powder from lenalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
• Nedbrydning af mave- eller tarmvæggen.
• Breakdown of the wall of the stomach or gut.
De alvorlige bivirkninger, som blev observeret hyppigere (≥ 5 %) med lenalidomidvedligeholdelsesbehandling end med placebo, var:
The serious adverse reactions observed more frequently (≥5%) with lenalidomide maintenance than placebo were:
Der er i litteraturen rapporteret om en mulig krydsreaktion mellem lenalidomid og thalidomid.
A possible cross-reaction between lenalidomide and thalidomide has been reported in the literature.
• Hvis din partner bliver gravid, mens du tager lenalidomid, skal du omgående informere lægen.
• If your partner becomes pregnant whilst you are taking lenalidomide , you should inform your doctor immediately.
Lenalidomids primære, dosisbegrænsende toksiciteter er neutropeni og trombocytopeni.
The major dose limiting toxicities (DLT )of lenalidomide include neutropenia and thrombocytopenia.
• Anvendelse hos patienter med nedsat lever- og/eller nyrefunktion
• Use in patients with hepatic and/or renal impairment
I disse studier fik kaninerne lenalidomid oralt i doser på 3, 10 og 20 mg/kg/dag.
In these studies, rabbits were administered 3, 10 and 20 mg/kg/day orally.
Præventionssteroiders virkning kan muligvis være nedsat ved samtidig behandling med dexamethason (se pkt.
The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone (see section 4.5).
• En sygdom, som påvirker huden og forårsages af en betændelseslignende reaktion i de små blodkar, sammen med smerter i leddene og feber (leukocytoklastisk vaskulitis).
• A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leukocytoclastic vasculitis).
I gruppen med lenalidomid/Lavdosis dexamethason gennemgik 20 patienter (9,1 %) mindst én dosisafbrydelse, sammenlignet med 65 patienter (29,3 %) i armen med lenalidomid/standarddosis dexamethason.
In the lenalidomide/low dose dexamethasone group, 20 patients (9.1%) underwent at least one dose interruption compared to 65 patients (29.3%) in the lenalidomide/standard dose dexamethasone arm.
Dexamethasona
Dexamethasonea
• Venøs tromboemboli (dyb venetrombose (DVT), lungeemboli) (se pkt.
• Venous thromboembolism (deep vein thrombosis, pulmonary embolism) (see section 4.4)
Meget almindelig Udslæt, pruritus
Very Common Rashes, Pruritus
Vender tilbage til ≥ 1 x 109/l, når neutropeni er den eneste observerede toksicitet
Return to ≥ 1 x 109/L when neutropenia is the only observed toxicity
Tjekliste til læger for at sikre at patienter modtager passende rådgivning angående behandlingen, præventionsmetoder og beskyttelse mod graviditet i overensstemmelse med køn og fertilitet Formularer til rapportering af bivirkninger
Check list for physicians ensuring that patients receive the appropriate counselling concerning the treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing status
0,25 mg/kg ª Hvis neutropeni er den eneste toksicitet for et af dosisniveauerne, tilføjes granulocyt-kolonistimulerende faktor (G-CSF), og dosisniveauet for lenalidomid opretholdes
0.25 mg/kg ª If neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide
Farmakoterapeutisk klassifikation: Immunsuppressiva.
Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants.
• Neutropeni
• Neutropenia
Ingen dosisjustering foreslås for patienter over 75 år, som behandles med lenalidomid i kombination med melphalan og prednison.
No dose adjustment is proposed for patients older than 75 years who are treated with lenalidomide in combination with melphalan and prednisone.
Oplysningsbrochurer til patienter
Educational Brochures for patients
Udlevering af lenalidomid til kvinder i den fertile alder bør finde sted inden for 7 dage efter ordinationen, og efter en sundhedsperson har konstateret en negativ graviditetstest.
Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result.
Hypotension◊, hypertension, ekkymose^
Common Hypotension◊, Hypertension, Ecchymosis^
Grundlaget for nedenstående tabel er data indsamlet under NDMM-studier hos patienter, der har gennemgået ASCT og er i vedligeholdelsesbehandling med lenalidomid.
The following table is derived from data gathered during NDMM studies in patients who have undergone ASCT treated with lenalidomide maintenance.
Frekvenserne for fuldstændig respons og samlet respons i len/dexarmen var væsentligt højere end i placebo/dex-armen i begge studier.
Complete response and overall response rates in the len/dex arm were also significantly higher than the placebo/dex arm in both studies.
Du skal følge ”Programmet til svangerskabsforebyggelse” for lenalidomid.
You must follow the Lenalidomide Pregnancy Prevention Programme
Patienter med kendte risikofaktorer, herunder tidligere trombose, bør monitoreres nøje, og der bør træffes foranstaltninger til at forsøge at minimere alle de risikofaktorer, som kan ændres (f.eks. rygning, hypertension og hyperlipidæmi).
Patients with known risk factors - including prior thrombosis - should be closely monitored, and action should be taken to try to minimize all modifiable risk factors (eg.
Ikke almindelig Angioødem
Uncommon Angioedema
• Smerter i brystet eller benene
• Chest pain or leg pain
Variationer i bløddele og skeletter hos fostre sås ved 10 og 20 mg/kg/dag.
Soft tissue and skeletal variations in the foetuses were also observed at 10 and 20 mg/kg/day.
Almindelig Febril neutropeni^,◊, pancytopeni◊
Common Febrile neutropenia^,◊, Pancytopenia◊
• Følelsesløshed, prikkende eller brændende fornemmelse i huden, smerter i hænder eller fødder,
• Numbness, tingling or burning sensation to the skin, pains in hands or feet, dizziness, tremor,
svimmelhed, rysten, ændringer i den måde, mad smager på
changes in the way things taste
Der skal tages effektive forholdsregler for at undgå graviditet (se pkt.
Effective measures to avoid pregnancy must be taken (see sections 4.4 and 4.6).
Samlet respons: CR, VGPR eller PR Varighed af respons - (måneder) Mediana (95 % CI)b
Overall response: CR, VGPR, or PR Duration of response (months) Mediana (95% CI)b