natgillin/translations-raw huggingface dataset:
• She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation
• mora razumeti potrebo in biti pripravljena opraviti teste nosečnosti vsake 4 tedne razen v primeru potrjene sterilizacije jajcevodov;
Duration of the treatment with lenalidomide
Trajanje zdravljenja z lenalidomidom
Distribution In vitro (14C)-lenalidomide binding to plasma proteins was low with mean plasma protein binding at
Porazdelitev In vitro je bila vezava (14C)-lenalidomida na beljakovine v plazmi majhna.
Pregnancy warning
Opozorilo o nosečnosti
Therefore, monitoring of the digoxin concentration is advised during lenalidomide treatment.
Zato se med zdravljenjem z lenalidomidom priporoča spremljanje koncentracije digoksina.
Programme are met (see sections 4.4 and 4.6).
(glejte poglavji 4.4 in 4.6).
Monitoring of liver function is recommended, particularly when there is a history of or concurrent viral liver infection or when lenalidomide is combined with medicinal products known to be associated with liver dysfunction.
Priporoča se nadziranje delovanja jeter, zlasti pri anamnezi virusne okužbe jeter ali ob sočasni virusni okužbi jeter ali pri kombiniranju lenalidomida z drugimi zdravili, za katera se ve, da so povezana z motnjo delovanja jeter.
Lenalidomide has a potential for acute toxicity; minimum lethal doses after oral administration were > 2000 mg/kg/day in rodents.
Lenalidomid je lahko akutno toksičen; pri glodavcih so najmanjši smrtni odmerki po peroralni uporabi > 2.000 mg/kg/dan.
These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Te teste nosečnosti je treba opraviti na dan obiska pri zdravniku, ki predpiše zdravilo, ali v 3 dneh pred obiskom zdravnika.
System Organ Class/Preferred Term
Organski sistem / preferenčni izraz
Lenalidomide has been used in clinical trials in multiple myeloma patients up to 91 years of age (see section 5.1).
Lenalidomid so v kliničnih preskušanjih uporabljali pri bolnikih z diseminiranim plazmocitomom, starih do 91 let (glejte poglavje 5.1).
The percentage of multiple myeloma patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups.
Odstotek bolnikov z diseminiranim plazmocitomom, starih 65 let ali več, se med skupinama, ki sta prejemali lenalidomid/deksametazon in placebo/deksametazon, ni bistveno razlikoval.
• Loss of vision
• izguba vida;
• 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
• če ste imeli srčni infarkt, če ste kadarkoli imeli krvni strdek ali če kadite, imate visok krvni tlak ali zvišano raven holesterola;
Patients in the placebo/dexamethasone (placebo/dex) group took 1 placebo capsule on days 1 to 28 of each 28-day cycle.
Bolniki v skupini, ki je prejemala placebo/deksametazon (placebo/deks), so jemali eno kapsulo s placebom od 1. do 28. dne v vsakem 28-dnevnem ciklu.
Patients were randomised in a 1:1:1 ratio to one of 3 treatment arms.
Bolnike so randomizirali v razmerju 1:1:1 na eno od 3 skupin terapije.
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.
V skupini z lenalidomidom/deksametazonom v majhnem odmerku je 20 bolnikov (9,1 %) vsaj enkrat prekinilo odmerjanje, v primerjavi s 65 bolniki (29,3 %) v skupini z lenalidomidom/deksametazonom v standardnem odmerku.
Safety advice for women of childbearing potential
Varnostne nasvete za ženske v rodni dobi:
• XY genotype, Turner syndrome, uterine agenesis.
• genotip XY, Turnerjev sindrom, agenezija maternice.
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.
Lenalidomid zavira proliferacijo nekaterih hematopoetskih tumorskih celic (vključno s tumorskimi celicami MM v plazmi in celicami z delecijo v kromosomu 5), okrepi celično imunost, ki jo posredujejo celice T in naravne ubijalke (NK - Natural Killer), ter poveča število celic NKT, zavira angiogenezo, tako da blokira migracijo in adhezijo endotelijskih celic in tvorbo mikrožil, izboljša fetalno sintezo hemoglobina v hematopoetskih zarodnih celicah CD34+ in zavira sintezo proinflamatornih citokinov (npr. TNF-α in IL-6) v monocitih.
Rd vs MPT Rd vs Rd18 Rd18 vs MPT PFS2e (months) Mediana PFS2 time, months (95% CI)b HR [95% CI]c; p-valued
Rd proti MPT Rd proti Rd18 Rd18 proti MPT PFS2e (meseci) Medianaa časa PFS2, meseci (95 % IZ)b HR [95 % IZ]c; vrednost pd
• Dose reduction steps
• Koraki za zmanjšanje odmerka
In an in vitro study with human hepatocytes, lenalidomide, at various concentrations tested did not induce CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4/5.
V študiji in vitro s humanimi hepatociti lenalidomid ob različnih koncentracijah, na katerih je bil testiran, ni spodbujal CYP1A2, CYP2B6, CYP2C9, CYP2C19 in CYP3A4/5.
Pre-planned interim analyses of both studies showed that len/dex was statistically significantly superior (p < 0.00001) to dexamethasone alone for the primary efficacy endpoint, TTP (median follow-up duration of 98.0 weeks).
Vnaprej načrtovana vmesna analiza obeh študij je pokazala, da je pri primarnem cilju za dokaz učinkovitosti, TTP (mediana trajanja spremljanja 98,0 tednov), len/deks statistično pomembno učinkovitejši (p < 0,00001) od deksametazona samega.
Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of SPM and institute treatment as indicated.
Zdravniki naj pred zdravljenjem in med njim s standardnimi pregledi za rakava obolenja pri bolnikih skrbno ocenjujejo pojav SPM in uvedejo zdravljenje, kot je indicirano.
• Hives, rashes, swelling of eyes, mouth or face, difficulty breathing, or itching, which may be symptoms of an allergic reaction
• koprivnica, izpuščaji, otekanje oči, ust ali obraza, oteženo dihanje ali srbenje, ki so lahko simptomi alergijske reakcije .
Abnormal liver function tests were commonly reported and were generally asymptomatic and reversible upon dosing interruption.
Pogosto so poročali o nenormalnih rezultatih testov delovanja jeter, ki so bili na splošno asimptomatski in po prenehanju uporabe zdravila reverzibilni.
• Sore inflamed mouth, dry mouth, difficulty swallowing
• vneta usta, suha usta, težave s požiranjem;
Concomitant administration with lenalidomide 10 mg once daily increased the plasma exposure of digoxin (0.5 mg, single dose) by 14% with a 90% CI (confidence interval) [0.52%-28.2%].
Sočasna uporaba z lenalidomidom v odmerku 10 mg enkrat na dan je povečala izpostavljenost digoksina v plazmi (0,5 mg, enkratni odmerek) za 14 % z 90-odstotnim IZ (interval zaupanja) [0,5228,2 %].
An open-label, randomised, multicenter, phase III study (ECOG E4A03) was conducted in 445 patients with newly diagnosed multiple myeloma; 222 patients were randomised to the lenalidomide/low dose dexamethasone arm, and 223 were randomised to the lenalidomide/standard dose dexamethasone arm.
Odprto, randomizirano, multicentrično študijo faze III (ECOG E4A03) so opravili pri 445 bolnikih z novo diagnosticiranim diseminiranim plazmocitomom; 222 bolnikov so randomizirali na skupino lenalidomida/deksametazona v majhnem odmerku, 223 pa so jih randomizirali na skupino lenalidomida/deksametazona v standardnem odmerku.
If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
Pri jemanju lenalidomida med nosečnostjo se pričakuje teratogeni učinek pri človeku.
• Cloudy vision (cataract)
• zamegljen vid (katarakta);
Follow-up (months) Medianf (min, max): all patients Myeloma responseg n (%)
Spremljanje (meseci) Medianaf (min, maks): vsi bolniki Odgovor plazmocitomag n (%)
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
Lenalidomid se veže neposredno na cereblon, ki je sestavni del encimskega kompleksa kulin-RING E3 ubikvitinske ligaze, ki vključuje beljakovino 1, ki se veže na poškodbe deoksiribonukleinske kisline (DNA) (DDB1- DNA damage-binding protein 1), kulin 4 (CUL4) in kulinski regulator 1 (Roc1regulator of cullins 1).
Multiple myeloma generally cannot be cured.
Diseminiranega plazmocitoma na splošno ne moremo ozdraviti.
• Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials
• opis in obvladovanje nevtropenije in trombocitopenije, vključno s stopnjami pojavnosti v kliničnih preskušanjih,
• Infection of the lung and the upper respiratory tract, breathlessness
• okužba pljuč in zgornjih dihal, zasoplost;
Common Hypotension◊, Hypertension, Ecchymosis^
pogosti hipotenzija◊, hipertenzija, ekhimoza^
The study compared lenalidomide in combination with melphalan and prednisone (MPR) with or without lenalidomide maintenance therapy until disease progression, to that of melphalan and prednisone for a maximum of 9 cycles.
V študiji so primerjali lenalidomid v kombinaciji z melfalanom in prednizonom (MPR) z vzdrževalno terapijo z lenalidomidom do napredovanja bolezni ali brez nje, z melfalanom in prednizonom za največ 9 ciklov.
• Bleeding or bruising in the absence of injury
• krvavitve ali modrice, ki niso posledica poškodbe;
Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Ženske v rodni dobi morajo 4 tedne pred začetkom zdravljenja, med zdravljenjem in 4 tedne po zdravljenju z lenalidomidom in celo med morebitnimi prekinitvami odmerjanja uporabljati eno zanesljivo kontracepcijsko metodo, razen če se zavežejo popolni in neprekinjeni abstinenci, ki se potrjuje vsak mesec.
• 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.
• nenadna ali blaga, naraščajoča bolečina v zgornjem delu želodca in/ali hrbta, ki traja nekaj dni, lahko jo spremljajo slabost s siljenjem na bruhanje, bruhanje, zvišana telesna temperatura in pospešen srčni utrip.
• 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
• boste opravili test nosečnosti pod zdravnikovim nadzorom (pred vsakim zdravljenjem, vsake 4 tedne med zdravljenjem in 4 tedne po koncu zdravljenja), razen če je bilo potrjeno, da sta bila jajcevoda zvezana, tako da jajčeca ne dosežejo maternice (sterilizacija jajcevodov)
• 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
• potrebo po izogibanju fetalni izpostavljenosti zaradi teratogenosti lenalidomida pri živalih in pričakovanega teratogenega učinka lenalidomida pri človeku;
Due to the teratogenic potential, lenalidomide must be prescribed under a Pregnancy Prevention Programme (see section 4.4) unless there is reliable evidence that the patient does not have childbearing potential.
Zaradi teratogenega potenciala je treba lenalidomid predpisovati v skladu s programom za preprečevanje nosečnosti, razen če obstajajo zanesljivi dokazi, da bolnica ne more zanositi.
Basal cell carcinoma^,◊, Squamous skin cancer^,◊,*
občasni bazalnocelični karcinom^,◊, ploščatocelični karcinom kože^,◊,*
Cases of viral reactivation have been reported in patients receiving lenalidomide, including serious cases of herpes zoster or hepatitis B virus (HBV) reactivation.
Pri bolnikih, ki so prejemali lenalidomid, so poročali o primerih virusne reaktivacije, vključno z resnimi primeri reaktivacije virusa herpesa zostra ali virusa hepatitisa B (HBV).
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.
Varnost in učinkovitost lenalidomida so ocenili v multicentrični, randomizirani, dvojno slepi študiji faze III s 3 skupinami (MM-015) pri bolnikih, ki so bili stari vsaj 65 let in so imeli serumski kreatinin < 2,5 mg/dl.
Rare cases of rhabdomyolysis have been observed, some of them when lenalidomide is administered with a statin.
Opazili so redke primere rabdomiolize, nekatere takrat, ko so lenalidomid dajali skupaj s statinom.
Lenalidomide may also cause blood clots in the veins (thrombosis).
Zdravilo Lenalidomide lahko povzroči tudi nastanek krvnih strdkov v venah (trombozo).
The patient card shall contain the following elements:
Opozorilna kartica za bolnika mora vsebovati naslednje elemente:
If powder from a broken lenalidomide capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
Če prašek iz zdrobljene kapsule lenalidomida pride v stik s kožo, morate kožo takoj in temeljito sprati z milom in vodo.
Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide (see section 4.4).
Bolniki z anamnezo hudega izpuščaja, ki je povezan z zdravljenjem s talidomidom, ne smejo prejemati lenalidomida (glejte poglavje 4.4).
Complete response (CR), partial response (PR) and overall response (CR+PR) rates in the len/dex arm remain significantly higher than in the placebo/dex arm in both studies.
Pogostnost popolnega odgovora (CR - complete response), delnega odgovora (PRpartial response) in celokupnega odgovora (CR+PR) je bila še naprej v skupini, ki je prejemala len/deks, v obeh študijah pomembno večja kot v skupini, ki je prejemala placebo/deks.
Co-administration of single or multiple doses of dexamethasone (40 mg once daily) has no clinically relevant effect on the multiple dose pharmacokinetics of lenalidomide (25 mg once daily).
Sočasna uporaba z enkratnimi ali večkratnimi odmerki deksametazona (40 mg enkrat na dan) ni klinično pomembno vplivala na farmakokinetiko večkratnih odmerkov lenalidomida (25 mg enkrat na dan).
Cataract has been reported with a higher frequency in patients receiving lenalidomide in combination with dexamethasone particularly when used for a prolonged time.
O kataraktah so poročali pogosteje pri bolnikih, ki so prejemali lenalidomid v kombinaciji z deksametazonom, posebno pri dolgotrajni uporabi.
Patients were stratified at randomisation by age ( 75 vs. > 75 years) and stage (ISS; Stages I and II vs. stage III).
Pri randomizaciji so bolnike stratificirali po starosti ( 75 proti > 75 let) in stadiju (ISS; stadija I in II proti stadiju III).
Patients were stratified at randomisation by age (≤75 versus >75 years), stage (ISS Stages I and II versus Stage III), and country.
Pri randomizaciji so bolnike stratificirali po starosti (≤75 proti >75 let), stadiju (ISS stadija I in II proti stadiju III), in državi.
In vitro studies indicate that lenalidomide has no inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A, or UGT1A1.
Študije in vitro kažejo, da lenalidomid nima zaviralnega učinka na CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A ali UGT1A1.
Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription.
Izdaja lenalidomida ženskam v rodni dobi naj bo v roku 7 dni od izdaje recepta.
ªIf the subject has not been receiving G-CSF therapy, initiate G-CSF therapy.
ª Če bolnik ni prejemal zdravljenja z G-CSF, uvedite zdravljenje z G-CSF.
What Lenalidomide Accord is and what it is used for
Kaj je zdravilo Lenalidomide Accord in za kaj ga uporabljamo
Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome (TLS) may occur.
Ker lenalidomid deluje antineoplastično, se lahko pojavijo zapleti v obliki sindroma tumorske lize.
Hydroxylenalidomide and N-acetyl-lenalidomide represent 4.59% and 1.83% of the excreted dose, respectively.
Hidroksi-lenalidomid predstavlja 4,59 % in N-acetil-lenalidomid predstavlja 1,83 % izločenega odmerka.
• 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”).
• če ste v preteklosti imeli kombinacijo katerih izmed naslednjih simptomov: izpuščaj na obrazu ali razširjen izpuščaj, pordelo kožo, močno povišano telesno temperaturo, gripi podobne simptome, povečane bezgavke (znake hude kožne reakcije, imenovane reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms), glejte tudi poglavje 4 "Možni neželeni učinki").
Dose reduction steps
Koraki za zmanjšanje odmerka
Lenalidomide may be continued in patients with Grade 1 or 2 tumour flare reaction (TFR) without interruption or modification, at the physician's discretion.
Pri bolnikih z z zdravljenjem povzročenim zagonom rakave bolezni prehodne narave (TFR - tumour flare reaction) 1. ali 2. stopnje lahko nadaljujete z lenalidomidom brez prekinitve ali prilagajanja, po presoji zdravnika.
Educational materials, prescribing and dispensing restrictions In order to assist patients in avoiding foetal exposure to lenalidomide, the marketing authorisation holder will provide educational material to health care professionals to reinforce the warnings about the expected teratogenicity of lenalidomide, to provide advice on contraception before therapy is started, and to provide guidance on the need for pregnancy testing.
Izobraževalna gradiva, omejitve predpisovanja in izdajanja zdravila Da bi bolnikom pomagali preprečiti izpostavitev ploda lenalidomidu, bo imetnik dovoljenja za promet z zdravilom priskrbel izobraževalno gradivo za zdravnike, v katerem bodo poudarjena opozorila o pričakovani teratogenosti lenalidomida.
• Description of the patient card and its necessity
• opis opozorilne kartice za bolnika in razlago, zakaj je nujna;
• Increase in pain, tumour size, redness around the tumour
• zvečanje bolečine, velikosti tumorja, rdečine okrog tumorja;
Not Known Acute hepatic failure^, Hepatitis toxic^
neznana pogostnost akutna odpoved jeter^, toksični hepatitis^
Lenalidomide combined therapy was less tolerated in newly diagnosed multiple myeloma patients older than 75 years of age compared to the younger population.
Kombinirano zdravljenje z lenalidomidom so slabše prenašali bolniki z novo diagnosticiranim diseminiranim plazmocitomom, starejši od 75 let, kot mlajša populacija.
Prophylactic antibiotics should be considered particularly in patients with neutropenia.
Pretehtati je treba možnost uporabe profilaktičnih antibiotikov, zlasti pri bolnicah z nevtropenijo.
Lenalidomide Accord as combination therapy (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Zdravilo Lenalidomide Accord je v kombinirani terapiji (glejte poglavje 4.2) indicirano za zdravljenje odraslih bolnikov s predhodno nezdravljenim diseminiranim plazmocitomom, ki niso primerni za presaditev.
• A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leukocytoclastic vasculitis).
• bolezen kože, ki jo povzroča vnetje majhnih krvnih žil, skupaj z bolečino v sklepih in zvišano telesno temperaturo (levkocitoklastični vaskulitis);
• Breakdown of the wall of the stomach or gut.
• pretrganje želodčne ali črevesne stene.
Population pharmacokinetic analyses included patients with mild hepatic impairment (N=16, total bilirubin >1 to ≤1.5 x ULN or AST > ULN) and indicate that mild hepatic impairment does not influence lenalidomide clearance (exposure in plasma).
Analize populacijske farmakokinetike so zajele bolnike z blagimi okvarami jeter (N=16, celotni bilirubin >1 do ≤1,5 x ULN ali AST > ULN) in kažejo, da blage okvare jeter ne vplivajo na očistek lenalidomida (izpostavljenost v plazmi).
Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Zdravilo Lenalidomide Accord je v kombinaciji z deksametazonom indicirano za zdravljenje diseminiranega plazmocitoma pri odraslih bolnikih, ki so predhodno prejemali vsaj eno zdravljenje.
Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide.
Bolniki z anamnezo hudega izpuščaja, ki je povezan z zdravljenjem s talidomidom, ne smejo prejemati lenalidomida.
What Lenalidomide Accord is used for Lenalidomide Accord is used in adults for multiple myeloma.
Za kaj uporabljamo zdravilo Lenalidomide Accord Zdravilo Lenalidomide Accord se uporablja pri odraslih za zdravljenje diseminiranega plazmocitoma.
Patients were randomised 1:1 within 90-100 days after ASCT to receive either lenalidomide or placebo maintenance.
V 90-100 dneh po ASCT so bolnike randomizirali v razmerju 1:1 na vzdrževalno zdravljenje bodisi z lenalidomidom ali placebom.
Patients who completed 9 cycles or who were unable to complete 9 cycles due to intolerance proceeded to maintenance therapy starting with lenalidomide 10 mg orally on days 1 to 21 of repeated 28-day cycles until disease progression.
Bolniki, ki so dokončali 9 ciklov ali ki niso mogli dokončati 9 ciklov zaradi intolerance, so nadaljevali z vzdrževalno terapijo z lenalidomidom 10 mg peroralno od 1. do 21. dne v ponavljajočih se 28-dnevnih ciklih do napredovanja bolezni.
A fertility study in rats with lenalidomide doses up to 500 mg/kg (approximately 200 to 500 times the human doses of 25 mg and 10 mg, respectively, based on body surface area) produced no adverse effects on fertility and no parental toxicity.
Študija vpliva na sposobnost razmnoževanja pri podganah z odmerki lenalidomida do 500 mg/kg (približno 200-krat do 500-krat več kot odmerka pri človeku, ki sta 25 mg oziroma 10 mg na telesno površino) ni pokazala neželenih učinkov na plodnost ali parentalno toksičnost.
Lenalidomide must be discontinued for angioedema, grade 4 rash, exfoliative or bullous rash, or if Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspectedand should not be resumed following discontinuation from these reactions.
Lenalidomid morate ukiniti pri angioedemu, izpuščaju 4. stopnje, eksfoliativnem ali buloznem izpuščaju ali če posumite na Stevens-Johnsonov sindrom (SJS), toksično epidermalno nekrolizo (TEN - toxic epidermal necrolysis) ali reakcijo na zdravilo z eozinofilijo in sistemskimi sindromi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms), in po ukinitvi zdravila zaradi teh reakcij se ne sme več začeti zdravljenja s tem zdravilom.
A possible cross-reaction between lenalidomide and thalidomide has been reported in the literature.
V literaturi poročajo o možnosti navzkrižnih reakcij med lenalidomidom in talidomidom.
The primary endpoint was PFS defined from randomisation to the date of progression or death, whichever occurred first; the study was not powered for the overall survival endpoint.
Primarni cilj študije je bil PFS, opredeljen od randomizacije do napredovanja bolezni ali smrti, kar se je zgodilo prej; moč študije je bila premajhna za dosego končnega cilja celokupnega preživetja.