natgillin/translations-raw huggingface dataset:
Det kan ikke udelukkes, at virkningen af perorale præventionsmidler reduceres under behandlingen.
It may not be excluded that the efficacy of oral contraceptives may be reduced during treatment.
4. 4 og 4. 6).
Effective measures to avoid pregnancy must be taken (see sections 4.4 and 4.6).
Resultater fra humane metabolismeforsøg in vitro tyder på, at lenalidomid ikke metaboliseres af cytochrom- P450- enzymer, hvilket indikerer, at administration af lenalidomid sammen med lægemidler, som hæmmer cytochrom- P450- enzymer, formentlig ikke medfører metaboliske lægemiddelinteraktioner hos mennesker.
Results from human in vitro metabolism studies indicate that lenalidomide is not metabolised by cytochrome P450 enzymes suggesting that administration of lenalidomide with drugs that inhibit cytochrome P450 enzymes is not likely to result in metabolic drug interactions in man.
In vitro- forsøg tyder på, at lenalidomid ikke har nogen hæmmende virkning på CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A.
In vitro studies indicate that lenalidomide has no inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A.
Warfarin Samtidig administration af flere doser på 10 mg lenalidomid havde ingen virkning på R - og S - warfarins enkeltdosisfarmakokinetik.
Warfarin Co-administration of multiple doses of 10 mg of len alidomide had no effect on the single dose pharmacokinetics of R- and S- warfarin.
Digoxin Samtidig administration af lenalidomid 10 mg/ dag øgede digoxins plasmaeksponering (0, 5 mg, enkeltdosis) med 14% med 90% CI (konfidensinterval) [0, 52% - 28, 2%].
Digoxin Concomitant administration with lenalidomide 10 mg/day increased the plasma exposure of digoxin (0.5 mg, single dose) by 14% with a 90% CI (confidence interval) [0.52%-28.2%].
Det vides ikke, om virkningen er anderledes i den terapeutiske situation (højere lenalidomid- doser og samtidig behandling med dexamethason).
It is not known whether the effect will be different in the therapeutic situation (higher lenalidomide doses and concomitant treatment with dexamethasone).
Digoxin- koncentrationen bør derfor overvåges under behandlingen med lenalidomid.
Therefore, monitoring of the digoxin concentration is advised during lenalidomide treatment.
4. 4) Lenalidomid er strukturelt i familie med thalidomid.
Pregnancy (see also sections 4.3 and 4.4) Lenalidomide is structurally related to thalidomide.
Hos aber førte lenalidomid til misdannelser, som ligner dem, der er beskrevet i forbindelse med thalidomid (se pkt.
Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see section 5.3).
4. 3).
Therefore, a teratogenic effect of lenalidomide is expected and lenalidomide is contraindicated during pregnancy (see section 4.3).
8 Fødedygtige kvinder skal anvende en effektiv præventionsmetode.
Women of childbearing potential should use effective method of contraception.
Derfor skal mandlige patienter, som tager lenalidomid, bruge kondomer, hvis deres partner er fødedygtig og ikke bruger prævention.
Therefore male patients taking lenalidomide should use condoms if their partner is of childbearing potential and has no contraception.
Amning Det vides ikke, om lenalidomid udskilles i human modermælk.
Lactation It is not known whether lenalidomide is excreted in human milk.
Derfor skal amning ophøre under behandlingen med lenalidomid.
Therefore breast-feeding should be discontinued during therapy with lenalidomide.
Lenalidomid påvirker muligvis i mindre eller moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
Lenalidomide may have minor or moderate influence on the ability to drive and use machines.
Træthed, svimmelhed, døsighed og sløret syn er rapporteret under brugen af lenalidomid.
Fatigue, dizziness, somnolence and blurred vision have been reported with the use of lenalidomide.
Derfor anbefales det at udvise forsigtighed under kørsel eller ved betjening af maskiner.
Therefore, caution is recommended when driving or operating machines.
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.
Gennemsnitsvarigheden af forsøgsbehandlingen var væsentligt længere (44, 0 uger) hos lenalidomid/ dexamethason- gruppen end hos placebo/ dexamethason- gruppen (23, 1 uger).
The median duration of exposure to study treatment was significantly longer (44.0 weeks) in the lenalidomide/dexamethasone group as compared to placebo/dexamethasone (23.1 weeks).
Forklaringen på dette var en lavere ophørsfrekvens i forsøgsbehandlingen pga. lavere sygdomsprogression hos patienter, som fik lenalidomid/ dexamethason (39, 7%) end hos patienter, som fik placebo/ dexamethason (70, 4%).
The difference was accounted for by a lower rate of discontinuation from study treatment due to lower progression of disease in patients exposed to lenalidomide/dexamethasone (39.7%) than in placebo/dexamethasone patients (70.4%).
325 (92%) af patienterne i lenalidomid/ dexamethason- gruppen fik mindst én bivirkning sammenlignet med 288 (82%) af patienterne i placebo/ dexamethason- gruppen.
325 (92%) of the patients in the lenalidomide/dexamethasone group experienced at least one adverse reaction compared to 288 (82%) in the placebo/dexamethasone group.
4. 4)
The most serious adverse reactions were: • Venous thromboembolism (deep vein thrombosis, pulmonary embolism) (see section 4.4) • Grade 4 neutropenia (see section 4.4).
De hyppigst observerede bivirkninger, som var væsentligt hyppigere hos lenalidomid/ dexamethason - gruppen sammenlignet med placebo/ dexamethason- gruppen, var: neutropeni (39, 4%), træthed (27, 2%), asteni (17, 6%), forstoppelse (23, 5%), muskelkrampe (20, 1%), trombocytopeni (18, 4%), anæmi (17, 0%), diarré (14, 2%) og udslæt (10, 2%).
The most frequently observed adverse reactions which occurred significantly more frequently in the lenalidomide/dexamethasone group compared to the placebo/dexamethasone group were neutropenia (39.4%), fatigue (27.2%), asthenia (17.6%), constipation (23.5%), muscle cramp (20.1%), thrombocytopenia (18.4%), anaemia (17.0%), diarrhoea (14.2%) and rash (10.2%).
De bivirkninger, som blev observeret hos patienter, der blev behandlet med lenalidomid/ dexamethason, er opført nedenfor efter systemorganklasse og hyppighed.
The adverse reactions observed in patients treated with lenalidomide/dexamethasone are listed below by system organ class and frequency.
Hyppigheden defineres som:
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 including isolated reports).
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, herunder enkeltstående indberetninger.) I størstedelen af tilfældene var der ingen væsentlig forskel i forekomsten af specifikke bivirkninger mellem de to behandlingsarme.
In the majority of cases, there was no significant difference in the incidence of specific adverse events between the two treatment arms.
Kun de bivirkninger, som er markeret med * forekom væsentligt hyppigere hos lenalidomid/ dexamethason - armen sammenlignet med placebo/ dexamethason- armen.
Only those adverse reactions marked with * occurred significantly more frequently in the lenalidomide/dexamethasone arm compared to the placebo/dexamethasone arm.
9 Følgende bivirkninger er blevet observeret i kliniske forsøg og efter påbegyndelse af markedsføringen. † Bivirkninger, der er indberettet efter påbegyndelse af markedsføringen, er markeret med
The following adverse reactions have been observed in clinical trials and postmarketing experience: † Reports from post-marketing experience are marked with
Pneumoni *, infektion i de nedre luftveje, Herpes Zoster, Herpes simplex urinvejsinfektion, infektion i de øvre luftveje, sinusitis, oral candidiasis, oral svampeinfektion.
Pneumonia*, lower respiratory tract infection, Herpes Zoster, Herpes Simplex, urinary tract infection, upper respiratory tract infection, sinusitis, oral candidiasis, oral fungal infection
Septisk shock, meningitis, neutropenisk sepsis, sepsis, Escherichia- sepsis, Clostridium difficile- sepsis, Enterobacter- bakteræmi, subakut endocarditis, bronkopneumoni, betændelse i lungelappen, bakteriel pneunomi, pneumokok - pneumoni, Pneumocystis carinii- pneumoni, primær atypisk pneumoni, akut bronkitis, luftvejsinfektion, zoster ophthalmicus, neuralgia postherpetica, prostatainfektion, paranasal sinusitis med bronkitis, øsofagal candidiasis, smitsom bursitis, erysipelas, cellulitis, tandbylder, kronisk sinusitis, bylder, pustuløst udslæt, øreinfektion, svampeinfektion, genital candidiasis, candidainfektion, influenza, tinea, fodsvampinfektion, vorter ved endetarmsåbningen.
Septic shock, meningitis, neutropenic sepsis, sepsis, Escherichia sepsis, Clostridium difficile sepsis, Enterobacter bacteraemia, subacute endocarditis, bronchopneumonia, lobar pneumonia, bacterial pneumonia, pneumococcal pneumonia, Pneumocystis carinii pneumonia, primary atypical pneumonia, acute bronchitis, respiratory tract infection, herpes zoster ophthalmic, post-herpetic neuralgia, prostate infection, sinobronchitis, oesophageal candidiasis, infective bursitis, erysipelas, cellulitis, tooth abscess, chronic sinusitis, furuncle, pustular rash, ear infection, fungal infection, genital candidiasis, candida infection, influenza, tinea, fungal foot infection, anal warts
Basalcelle- karcinom, glioblastoma multiforme
Basal cell carcinoma, glioblastoma multiforme
Anæmi *, neutropeni *, trombocytopeni *, blødningsforstyrrelser Almindelig:
9 Blood and lymphatic system disorders Very Common:
Febril neutropeni, pancytopeni, leukopeni *, lymfopeni *
Anaemia*, neutropenia*, thrombocytopenia*, haemorrhagic disorder Common:
Granolocytopeni, hæmolytisk anæmi, autoimmun hæmolytisk anæmi, hæmolyse, hyperkoagulation, koagulationsdefekt, monocytopeni, leukocytose, lymfadenopati
Febrile neutropenia, pancytopenia, leucopenia*, lymphopenia* Granulocytopenia, haemolytic anaemia, autoimmune haemolytic anaemia, haemolysis, hypercoagulation, coagulopathy, monocytopenia, leucocytosis, lymphadenopathy
Erhvervet hypogammaglobulinæmi
Acquired hypogammaglobulinaemia
Binyrehæmning, binyreinsufficiens, erhvervet hypothyroidisme, øget og nedsat mængde thyroidstimulerende hormon, hirsutisme
Cushingoid-like symptoms Adrenal suppression, adrenal insufficiency, acquired hypothyroidism, increased and decreased thyroid stimulating hormone, hirsutism
Hyperglykæmi, anoreksi, hypocalcæmi, hypokalæmi, dehydrering, hypomagnesæmi, væskeretention
Hyperglycaemia, anorexia, hypocalcaemia, hypokalaemia, dehydration, hypomagnesaemia, fluid retention
Metabolsk acidose, diabetes mellitus, hyponatræmi, hypercalcæmi, hyperurikæmi, hypoalbuminæmi, kakeksi, manglende trivsel, podagra, hypofosfatæmi, hyperfosfatæmi, øget appetit
Metabolic acidosis, diabetes mellitus, hyponatraemia, hypercalcaemia, hyperuricaemia, hypoalbuminaemia, cachexia, failure to thrive, gout, hypophosphataemia, hyperphosphataemia, increased appetite
Psykiske forstyrrelser Meget almindelig:
Psychiatric disorders Very Common:
Søvnløshed Almindelig:
Insomnia Common:
Forvirring, hallucinationer, depression, aggression, agitation, humørskift, angst, nervøsitet, irritabilitet, humørsvingninger
Confusional state, hallucinations, depression, aggression, agitation, mood alteration, anxiety, nervousness, irritability, mood swings
Psykotiske forstyrrelser, hypomani, vrangforestillinger, ændringer i mental status, søvnforstyrrelse, unormale drømme, nedtrykt sindsstemning, affektlabilitet, apati, nedsat libido, mareridt, personlighedsforandring, panikanfald, rastløshed.
Psychotic disorder, hypomania, delusion, mental status changes, sleep disorder, abnormal dreams, depressed mood, affect lability, listless, loss of libido, nightmare, personality change, panic attack, restlessness.
10 Nervesystemet Almindelig:
Nervous system disorders Common:
Cerebrovaskulært tilfælde, synkope, perifer neuropati, neuropati, perifer sensorisk neuropati, svimmelhed, ageusi, dysgeusi, paræstesi, hovedpine, tremor *, hypoæstesi *, døsighed, hukommelsessvækkelse
Cerebrovascular accident, syncope, peripheral neuropathy, neuropathy, peripheral sensory neuropathy, dizziness, ageusia, dysgeusia, paraesthesia, headache, tremor*, hypoaesthesia*, somnolence, memory impairment
Intrakranial blødning, intrakranial venøs sinustrombose, slagtilfælde pga. blodprop, cerebral iskæmi, forbigående iskæmisk anfald, leukoencephalopati, neurotoksicitet, polyneuropati, perifer motorisk neuropati, sanseforstyrrelser, afoni, taleforstyrrelse, forstyrrelse i opmærksomhed, ataksi, nedsat balance, postural svimmelhed, brændende fornemmelse, smerter ved cervikale rødder, dyskinesi, hyperæstesi, motorisk dysfunktion, myastent syndrom, oral paræstesi, psykomotorisk hyperaktivitet, anosmi
Intracranial haemorrhage, intracranial venous sinus thrombosis, thrombotic stroke, cerebral ischaemia, transient ischaemic attack, leukoencephalopathy, neurotoxicity, polyneuropathy, peripheral motor neuropathy, dysaesthesia, aphonia, dysphonia, disturbance in attention, ataxia, balance impaired, postural dizziness, burning sensation, cervical root pain, dyskinesia, hyperaesthesia, motor dysfunction, myasthenic syndrome, oral paraesthesia, psychomotor hyperactivity, anosmia
Sløret syn, grå stær, nedsat synsstyrke og øget tåreflåd Blindhed, arteriosclerose i nethinden, venetrombose i nethinden, hornhindebetændelse, synsforstyrrelse, øjenlågsødem, konjunktivitis, øjenkløe, røde øjne, øjenirritation, tørre øjne
Blurred vision, cataract, reduced visual acuity, lacrimation increased Blindness, retinal arteriosclerosis, retinal vein thrombosis, keratitis, visual disturbance, eyelid oedema, conjunctivitis, eye pruritus, eye redness, eye irritation, dry eye
Vertigo Døvhed, hypoakusi, tinnitus, øresmerter, ørekløe
Vertigo Deafness, hypoacusia, tinnitus, ear pain, ear pruritus
Atrieflimren, palpitationer Kongestiv hjerteinsufficiens, lungeødem, hjerteklapinsufficiens, atrieflagren, arytmi, ventrikulær trigemini, bradykardi og takykardi, forlænget QT, sinus takykardi
Atrial fibrillation, palpitations Congestive cardiac failure, pulmonary oedema, heart valve insufficiency, atrial flutter, arrhythmia, ventricular trigeminy, bradycardia, tachycardia, QT prolongation, sinus tachycardia
Dyb venetrombose *, venøs trombose i ekstremiteter, hypotension *, hypertension, ortostatisk hypotension, rødme, ecchymosis
Deep vein thrombosis*, limb venous thrombosis, hypotension*, hypertension, orthostatic hypotension, flushing, ecchymosis
Kredsløbskollaps, trombose, iskæmi, perifer iskæmi, claudicatio intermittens, flebitis, bleghed, petecchier, hæmatom, post- flebitis- syndrom, tromboflebitis, overfladisk tromboflebitis
Circulatory collapse, thrombosis, ischaemia, peripheral ischaemia, intermittent claudication, phlebitis, pallor, petechiae, haematoma, postphlebitic syndrome, thrombophlebitis, superficial thrombophlebitis
Luftveje, thorax Almindelig:
Respiratory, thoracic and mediastinal disorders Common:
og mediastinum Lungeemboli, dyspnø *, anstrengelsesudløst dyspnø, bronkitis, hoste, pharyngitis, nasopharyngitis, hæshed, hikke, epistaxis
Pulmonary embolism, dyspnoea*, exertional dyspnoea, bronchitis, cough, pharyngitis, nasopharyngitis, hoarseness, hiccups, epistaxis
Bronkopneumopati, astma, åndedrætsbesvær, pulmonær kongestion, pleural smerte, tilstoppet næse, øget halssekretion, laryngitis, tilstoppede bihuler, smerter i bihulerne, rhinorrhoea, tør hals
Bronchopneumopathy, asthma, respiratory distress, pulmonary congestion, pleuritic pain, nasal congestion, throat secretion increased, laryngitis, sinus congestion, sinus pain, rhinorrhoea, dry throat
Mave- tarm- kanalen Meget almindelig:
Gastrointestinal disorders Very Common:
Forstoppelse, diarré, kvalme, øget og nedsat vægt Almindelig:
Constipation, diarrhoea, nausea, increase and decrease in weight Common:
Opkastning, dyspepsi, smerte i mellemgulvet, gastritis, udspilet mave, mavesmerter, stomatitis, mundtørhed, flatulens, rektalblødning
Vomiting, dyspepsia, upper abdominal pain, gastritis, abdominal distension, abdominal pain, stomatitis, dry mouth, flatulence, rectal haemorrhage
Gingivalblødning, gastrointestinal blødning, hæmorideblødning, blødende mavesår, øsofagitis, gastro- øsofagal refluks- sygdom, kolitis, caecitis, gastroduodenitis, reduceret spytsekretion, proktit, gastroenteritis, smerte i øsofagus, dysfagi, odynofagi, epigastrisk ubehag, aftøs stomatitis, cheilitis, glossodyni, gingivitis, læbeblødning, tungeblødning, smerter i munden, tandpine, følsomme tænder, oral hypoæsthesi, læbesmerter, belagt tunge
Gingival bleeding, gastrointestinal haemorrhage, haemorrhoidal haemorrhage, peptic ulcer haemorrhage, oesophagitis, gastro-oesophageal reflux disease, colitis, caecitis, gastroduodenitis, aptyalism, proctitis, gastroenteritis, oesophageal pain, dysphagia, odynophagia, epigastric discomfort, aphthous stomatitis, cheilitis, glossodynia, gingivitis, lip ulceration, tongue ulceration, oral pain, toothache, sensitivity of teeth, oral hypoaesthesia, lip pain, coated tongue
11 Lever og galdeveje Ikke almindelig:
Hepatobiliary disorders Uncommon:
Unormale leverfunktionstal, øget alanin- aminotransferase, øget aspartat - aminotransferase, øget blodbilirubin
Abnormal liver function tests, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin
Udslæt * Almindelig:
Common:
Ansigts- ødem, tør hud, pruritus *, erytem, follikulitis, hyperpigmentering i huden, exantem, øget svedafsondring, nattesved, alopeci †
Rash* Face oedema, dry skin, pruritus*, erythema, folliculitis, skin hyperpigmentation, exanthema, increased sweating, night sweats, alopecia †
†
Erythema nodosum, urticaria, angioedema, eczema, erythrosis, erythematous rash, pruritic rash, papular rash, hyperkeratosis, skin fissures, acne, dermatitis acneiforme, lichen sclerosus, decubitus ulcer, pigmentation lip, prurigo, rosacea, photosensitivity reaction, seborroeic dermatitis, skin burning sensation, skin desquamation, skin discolouration † †
†
Rare:
Stevens- Johnsons syndrom, toksisk epidermal nekrolyse
Stevens-Johnson syndrome, toxic epidermal necrolysis
Knogler, led, muskler og bindevæv Meget almindelig:
Musculoskeletal and connective tissue disorders Very Common:
Muskelkrampe *, muskelsvaghed Almindelig:
Muscle cramp*, muscle weakness Common:
Steroid myopati, myopati, myalgi, artralgi, rygsmerter, smerter i knogler, smerter i lemmer, smerte i brystvæggen, perifer hævelse,
Steroid myopathy, myopathy, myalgia, arthralgia, back pain, bone pain, pain in limb, chest wall pain, peripheral swelling
Knoglenekrose, muskelatrofi, amyotrofi, smerte i foden, muskelkramper, muskuloskeletale smerter, nattekrampe, lyskensmerter, smerte i kæben, nakkesmerter, spondylitis, ledstivhed, hævede led, muskuloskeletal stivhed, smerter i lemmer, tådeformiteter, lokal hævelse
Osteonecrosis, muscle atrophy, amyotrophy, pain in foot, muscle spasms, musculoskeletal pain, night cramps, groin pain, pain in jaw, neck pain, spondylitis, joint stiffness, joint swelling, musculoskeletal stiffness, limb discomfort, toe deformities, local swelling
Nyresvigt, hæmaturi
Renal and urinary Common:
Akut nyresvigt, hyppig vandladning, renal tubulær nekrose, cystitis, urinretention, dysuri, erhvervet Fanconis syndrom, urininkontinens, polyuri, øget blodurea, øget blodkreatinin, nykturi
disorders Renal failure, haematuria Acute renal failure, urinary frequency, renal tubular necrosis, cystitis, urinary retention, dysuria, acquired Fanconi Syndrome, urinary incontinence, polyuria, increased blood urea, increased blood creatinine, nocturia
Det reproduktive system og mammae Almindelig:
11 Reproductive system and breast disorders Common:
Erektil dysfunktion, gynækomasti, metroragi, smerter i brystvorterne
Erectile dysfunction, gynaecomastia, metrorrhagia, nipple pain
Medfødte, familiære og genetiske sygdomme Ikke almindelig:
Congenital, familial and genetic disorders Uncommon:
Kromosomabnormitet
Chromosome abnormality
Træthed *, asteni *, perifert ødem Almindelig:
General disorders and administration site conditions Very Common:
Pyreksi, stivhed, inflammation i slimhinder, ødem, letargi, utilpashed
Uncommon:
Ikke almindelig: hyperpyrexi, brystsmerter, tæthedsfornemmelse i brystet, smerter, besvær med at gå, unormal gang, tørst, trykken for brystet, kuldskærhed, nervøs fornemmelse, influenza- lignende sygdom, submandibulær masse, fald, nedsat ophelingsevne
Pyrexia, rigors, mucosal inflammation, oedema, lethargy, malaise Hyperpyrexia, chest pain, chest tightness, pain, difficulty in walking, abnormal gait, thirst, chest pressure sensation, feeling cold, feeling jittery, influenza-like illness, submandibular mass, fall, impaired healing
Undersøgelser Ikke almindelig:
Uncommon:
Forlænget PT, forlænget APTT, øget INR, øget AP, øget LDH, øget C- reaktivt protein, positiv CMV- antistof
Prolonged prothrombin time, prolonged activated partial thromboplastin time, increased International Normalised Ratio, increased blood alkaline phosphatase, increased blood lactate dehydrogenase, increased C-Reactive Protein, Cytomegalovirus antibody positive
Sårkomplikation
Contusion Wound complication
Blødningsforstyrrelser Blødningsforstyrrelser er anført under flere systemorganklasser: blod og lymfesystem, nervesystemet (intrakraniel blødning), luftveje, thorax og mediastinum (epistaxis), mave- tarm- kanalen (gingivalblødning, hæmorideblødning, rektalblødning), nyrer og urinveje (hæmaturi), traumer, forgiftninger og behandlingskomplikationer (kontusion) og vaskulære sygdomme (ecchymosis).
Blood and lymphatic system disorders; nervous system disorders (intracranial haemorrhage); respiratory, thoracic and mediastinal disorders (epistaxis); gastrointestinal disorders (gingival bleeding, haemorrhoidal haemorrhage, rectal haemorrhage); renal and urinary disorders (haematuria); Injury, poisoning and procedural complications (contusion) and vascular disorders (ecchymosis).
12 4. 9 Overdosering
4.9 Overdose
Der er ingen specifik erfaring med håndtering af overdosis af lenalidomid hos patienter med myelomatose, selvom nogle patienter i dosisstudier blev udsat for op til 50 mg.
There is no specific experience in the management of lenalidomide over dose in multiple myeloma patients, although in dose-ranging studies some patients were exposed to up to 50 mg.
Immunmodulerende stof.
Immunomodulating agent.
Lenalidomids virkningsmekanisme inkluderer anti- neoplastiske, anti- angiogene, pro- erythropoietiske og immunmodulerende egenskaber.
The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory properties.
TNF- α og IL- 6).
Specifically, lenalidomide inhibits proliferation of certain haematopoietic tumour cells (including MM plasma tumour cells and those with deletions of chromosome 5), enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases the number of NK T cells, inhibits angiogenesis by blocking the migration and adhesion of endothelial cells and the formation of microvessels, augments foetal haemoglobin production by CD34+ haematopoietic stem cells, and inhibits production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.
I disse studier blev behandling med lenalidomid plus dexamethason sammenlignet med behandling med dexamethason alene hos patienter med multipelt myelom, som tidligere havde fået behandling.
Clinical trials The efficacy and safety of lenalidomide were evaluated in two Phase III multi-centre, randomised, double-blind, placebo-controlled, parallel-group controlled studies (MM-009 and MM-010) of lenalidomide plus dexamethasone therapy versus dexamethasone alone in previously treated patients
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.