FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of viral reactivation have been reported in patients receiving lenalidomide, including serious cases of herpes zoster or hepatitis B virus (HBV) reactivation.
Croatian: U bolesnika koji su primali lenalidomid zabilježeni su slučajevi reaktivacije virusa, uključujući ozbiljne slučajeve reaktivacije virusa herpes zostera ili hepatitisa B (HBV).
English: Myocardial infarction has been reported in patients receiving lenalidomide, particularly in those with known risk factors and within the first 12 months when used in combination with dexamethasone.
Croatian: Infarkt miokarda prijavljen je u bolesnika koji su primali lenalidomid, posebice u onih s prethodno utvrđenim čimbenicima rizika i u prvih 12 mjeseci kada se primjenjivao u kombinaciji s deksametazonom.
English: Co-administration of multiple doses of the strong P-gp inhibitor quinidine (600 mg, twice daily) or the moderate P-gp inhibitor/substrate temsirolimus (25 mg) has no clinically relevant effect on the pharmacokinetics of lenalidomide (25 mg).
Croatian: Istodobna primjena ponovljenih doza jakog inhibitora P-gp-a kinidina (600 mg, dvaput dnevno) ili umjerenog inhibitora/supstrata P-gp-a temsirolimusa (25 mg) nema klinički značajan učinak na farmakokinetiku lenalidomida (25 mg).
English: The primary efficacy endpoint in both studies was time to progression (TTP).
Croatian: Primarni ishod u oba ispitivanja bilo je vrijeme do napredovanja bolesti.
English: In an updated analysis of PFS, PFS2 and OS using a cut off of 3 March 2014 where the median follow-up time for all surviving subjects was 45.5 months, the results of the study are presented in Table 5:
Croatian: U tablici 5 prikazani su podaci za PFS, PFS2 i ukupno preživljenje (OS) do zaključnog datuma 3. ožujka 2014., dobiveni u obnovljenoj analizi u kojoj je medijan vremena praćenja za sve preživjele ispitanike bio 45,5 mjeseci.
English: The maintenance dose was 10 mg once daily on days 1-28 of repeated 28-day cycles (increased up to 15 mg once daily after 3 months in the absence of dose-limiting toxicity), and treatment was continued until disease progression.
Croatian: Doza održavanja iznosila je 10 mg jednom dnevno od 1. do 28. dana ponavljajućih 28-dnevnih ciklusa (s povećanjem do 15 mg jednom dnevno nakon 3 mjeseca ako nije postojala toksičnost koja ograničava dozu), a liječenje je trajalo bez prekida sve do progresije bolesti.
English: Gastrointestinal perforations have been reported during treatment with lenalidomide.
Croatian: Gastrointestinalne perforacije zabilježene su tijekom liječenja lenalidomidom.
English: Educational Brochures for patients
Croatian: Edukacijske knjižice za bolesnike
English: Patient Card
Croatian: Kartica za bolesnika
English: If lenalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Croatian: Ako lenalidomid dođe u kontakt sa sluznicama, treba ih temeljito isprati vodom.
English: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it would be prudent to monitor renal function.
Croatian: Budući da je u starijih bolesnika veća vjerojatnost da imaju smanjenu funkciju bubrega, treba voditi brigu o odabiru doze te je razborito nadzirati funkciju bubrega.
English: Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide (see section 4.4).
Croatian: Bolesnici s anamnezom teškog osipa koji je povezan s liječenjem talidomidom ne smiju primati lenalidomid (vidjeti dio 4.4).
English: Return to ≥ 0.5 x 109/L when neutropenia is the only observed toxicity
Croatian: Vrati se na ≥ 0,5 x 109/L, a neutropenija je jedina primijećena toksičnost
English: Pack size of 21x1 capsules.
Croatian: Veličina pakiranja od 21x1 kapsula.
English: After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
Croatian: Nakon 3 ciklusa terapije održavanja lenalidomidom, dozu se može povećati na 15 mg peroralno jednom dnevno, ako je bolesnik podnosi.
English: 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.
Croatian: Lenalidomid Accord je u kombinaciji s deksametazonom indiciran u liječenju multiplog mijeloma u odraslih bolesnika koji su prethodno primili barem jednu liniju liječenja.
English: 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).
Croatian: Analize populacijske farmakokinetike uključile su bolesnike s blagim oštećenjem funkcije jetre (N = 16, ukupni bilirubin > 1 do ≤ 1,5 x GGN ili AST > GGN) i ukazuju da blago oštećenje funkcije jetre ne utječe na klirens lenalidomida (izloženost u plazmi).
English: Close monitoring of warfarin concentration is advised during the treatment.
Croatian: Tijekom liječenja preporučuje se pomno praćenje koncentracije varfarina.
English: The following table is derived from data gathered during the multiple myeloma studies with combination therapy.
Croatian: Sljedeća tablica dobivena je iz podataka prikupljenih tijekom ispitivanja u kojima je multipli mijelom liječen kombiniranom terapijom.
English: Patients were stratified at randomisation by age ( 75 vs. > 75 years) and stage (ISS; Stages I and II vs. stage III).
Croatian: Bolesnici su bili stratificirani prema dobi ( 75 naspram > 75 godina) i stadiju bolesti (ISS; stupnjevi I i II naspram stupnja III).
English: • by stopping blood vessels growing in the cancer
Croatian: • zaustavljanjem rasta krvnih žila raka
English: Lenalidomide efficacy and safety have been evaluated in five phase III studies in newly diagnosed multiple myeloma, two phase III studies in relapsed refractory multiple myelomaas described below.
Croatian: Sigurnost i djelotvornost lenalidomida je procijenjena u pet ispitivanja faze III kod novodijagnosticiranog multiplog mijeloma, dva ispitivanja faze III kod relapsa refraktornog multiplog mijeloma, kao što je opisano u nastavku.
English: Melphalan
Croatian: Melfalan
English: • A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leukocytoclastic vasculitis).
Croatian: • stanje koje zahvaća kožu, a uzrokovano je upalom malih krvnih žila i praćeno bolom u zglobovima te vrućicom (leukocitoklastični vaskulitis)
English: Acute hepatic failure^, Hepatitis toxic^, Cytolytic hepatitis^, Cholestatic hepatitis^, Mixed cytolytic/cholestatic hepatitis^
Croatian: Nepoznato akutno zatajenje jetre^, toksični hepatitis^, citolitički hepatitis^, kolestatski hepatitis^, mješoviti citolitički/kolestatski hepatitis^
English: Grade 4 febrile neutropenia was observed infrequently (0.6% in Rd and Rd18 compared with 0.7% in MPT).
Croatian: Febrilna neutropenija 4. stupnja opažena je rijetko (0,6 % u Rd i Rd18 u usporedbi s 0,7 % za MPT).
English: Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription.
Croatian: Do izdavanja lenalidomida ženama u reproduktivnoj dobi treba doći unutar 7 dana od propisivanja.
English: Lenalidomide
Croatian: Lenalidomid
English: Lenalidomide Accord contains the active substance ‘lenalidomide'.
Croatian: Lenalidomid Accord sadrži djelatnu tvar zvanu „lenalidomid“.
English: 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.
Croatian: U ispitivanju se usporedila terapija lenalidomidom u kombinaciji s melfalanom i prednizonom (MPR), s terapijom održavanja lenalidomidom ili bez nje do napredovanja bolesti, s terapijom melfalanom i prednizonom tijekom najviše 9 ciklusa.
English: • In case of neutropenia, the use of growth factors in patient management should be considered.
Croatian: • U slučaju neutropenije, potrebno je razmotriti primjenu čimbenika rasta u zbrinjavanju bolesnika.
English: In vitro studies indicate that lenalidomide is not a substrate of human breast cancer resistance protein (BCRP), multidrug resistance protein (MRP) transporters MRP1, MRP2, or MRP3, organic anion transporters (OAT) OAT1 and OAT3, organic anion transporting polypeptide 1B1 (OATP1B1), organic cation transporters (OCT) OCT1 and OCT2, multidrug and toxin extrusion protein (MATE) MATE1, and organic cation transporters novel (OCTN) OCTN1 and OCTN2.
Croatian: (MRP, od engl. multidrug resistance protein) MRP1, MRP2 ili MRP3, transportera organskog aniona (OAT, od engl. organic anion transporter) OAT1 i OAT3, polipeptidnog transportera organskog aniona 1B1 (OATP1B1, od engl. organic anion transporting polypeptide 1B1), transportera organskog kationa (OCT, od engl. organic cation transporter) OCT1 i OCT2, proteina za izbacivanje više lijekova i toksina (MATE, od engl. multidrug and toxin extrusion) MATE1 i novih transportera organskog kationa (OCTN, od engl. organic cation transporters novel) OCTN1 i OCTN2.
English: Rd vs MPT Rd vs Rd18 Rd18 vs MPT PFS2e (months) Mediana PFS2 time, months (95% CI)b HR [95% CI]c; p-valued
Croatian: Rd vs MPT Rd vs Rd18 Rd18 vs MPT PFS2e (mjeseci) Medijana trajanja PFS2-a, mjeseci (95 % CI)b HR [95 % CI]c; p-vrijednostd
English: Haemorrhagic disorders are listed under several system organ classes: 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).
Croatian: Hemoragijski poremećaji navedeni su pod nekoliko klasifikacija organskih sustava: poremećaji krvi i limfnog sustava; poremećaji živčanog sustava (intrakranijalno krvarenje); poremećaji dišnog sustava, prsišta i sredoprsja (epistaksa); poremećaji probavnog sustava (krvarenje iz desni, krvarenje iz hemoroida, rektalno krvarenje); poremećaji bubrega i mokraćnog sustava (hematurija); ozljede, trovanja i proceduralne komplikacije (kontuzija) i krvožilni poremećaji (ekhimoze).
English: • Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection including within the bloodstream (sepsis)
Croatian: • Vrućicu, zimicu, bolno grlo, kašalj, čireve u ustima ili bilo koje druge simptome infekcije uključujući onu u krvotoku (tzv. sepsu)
English: For male patients taking lenalidomide, pharmacokinetic data has demonstrated that lenalidomide is present in human semen at extremely low levels during treatment and is undetectable in human semen 3 days after stopping the substance in the healthy subject (see section 5.2).
Croatian: Za muške bolesnike koji uzimaju lenalidomid, farmakokinetički podaci su pokazali da je lenalidomid prisutan u ljudskoj spermi u iznimno niskim koncentracijama tijekom liječenja te se ne može detektirati u ljudskoj spermi 3 dana nakon prekida uzimanja tvari u zdravih ispitanika (vidjeti dio 5.2).
English: Time to progression Median [95% CI], weeks
Croatian: Vrijeme do napredovanja bolesti Medijan [95 % CI], tjedni
English: Co-administration of multiple 10 mg doses of lenalidomide had no effect on the single dose pharmacokinetics of R- and S- warfarin.
Croatian: Istodobna primjena ponovljenih doza od 10 mg lenalidomida nije imala učinka na farmakokinetiku pojedinačne doze R- i S- varfarina.
English: The updated PFS, using a cut-off of 1 February 2016 (96.7 months follow up) continues to show a PFS advantage: HR = 0.57 (95% CI 0.47, 0.68; p < 0.001).
Croatian: Ažurirani PFS, do zaključnog datuma podataka 1. veljače 2016. (96,7 mjeseci praćenja) i dalje pokazuje prednost PFS-a: HR = 0,57 (95 % CI 0,47; 0,68; p <0,001).
English: • That Lenalidomide Accord may cause neutropenia and thrombocytopenia and the need for regular blood tests
Croatian: • da Lenalidomid Accord može izazvati neutropeniju i trombocitopeniju te da je neophodno redovito obavljanje krvnih pretraga
English: The results indicate that as renal function decreases (< 50 mL/min), the total lenalidomide clearance decreases proportionally resulting in an increase in AUC.
Croatian: Rezultati pokazuju da se ukupni klirens lenalidomida smanjuje proporcionalno smanjenju bubrežne funkcije (< 50 mL/min), što rezultira porastom u AUC-u.
English: The most serious adverse reactions observed more frequently in lenalidomide/dexamethasone than placebo/dexamethasone combination were:
Croatian: Najozbiljnije nuspojave, češće opažene u kombinaciji lenalidomid/deksametazon nego placebo/deksametazon, bile su:
English: • Passing large amount of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
Croatian: • prekomjerno mokrenje s bolom u kostima i slabošću, što mogu biti simptomi poremećaja bubrega (Fanconijev sindrom)
English: Newly diagnosed multiple myeloma - in patients who have had a bone marrow transplant Lenalidomide Accord is used on its own as maintenance therapy after patients have recovered enough following a bone marrow transplant.
Croatian: Novodijagnosticirani multipli mijelom - u bolesnika u kojih je provedena transplantacija koštane srži Lenalidomid Accord se primjenjuje samostalno kao terapija održavanja nakon odgovarajućeg oporavka poslije transplantacije koštane srži.
English: AMT = antimyeloma therapy; CI = confidence interval; CR = complete response; d = low-dose dexamethasone; HR = hazard ratio; IMWG = International Myeloma Working Group; IRAC = Independent Response Adjudication Committee; M = melphalan; max = maximum; min = minimum; NE = not estimable; OS = overall survival; P = prednisone; PFS = progression-free survival; PR = partial response; R = lenalidomide; Rd = Rd given until documentation of progressive disease; Rd18 = Rd given for 18 cycles; SE = standard error; T = thalidomide; VGPR = very good partial response; vs = versus.
Croatian: Independent Response Adjudication Committee); M = melfalan; maks = maksimum; min = minimum; NP = nije procjenjivo; OS = ukupno preživljenje (engl. overall survival); P = prednizon; PFS = preživljenje bez napredovanja bolesti (engl. progression-free survival); PR = djelomični odgovor (engl. partial response); R = lenalidomid; Rd = Rd davan do dokumentirane progresivne bolesti; Rd18 = Rd davan 18 ciklusa; SE = standardna greška (engl. standard error); T = talidomid; VGPR = vrlo dobar djelomični odgovor (engl. very good partial response); vs = naspram (engl. versus)
English: • Brochure for women patients who are not of childbearing potential
Croatian: • Knjižice za bolesnice koje nisu u reproduktivnoj dobi
English: 7x1 hard capsules
Croatian: 7x1 tvrda kapsula
English: Anaemia ◊, Haemorrhagic disorder^, Leucopenias
Croatian: anemija◊, hemoragijski poremećaj^, leukopenije
English: The major dose limiting toxicities (DLT )of lenalidomide include neutropenia and thrombocytopenia.
Croatian: Glavne toksičnosti koje ograničavaju dozu lenalidomida uključuju neutropeniju i trombocitopeniju.
English: • That if his partner becomes pregnant whilst he is taking Lenalidomide Accord or shortly after he has stopped taking Lenalidomide Accord he should inform his treating doctor immediately
Croatian: • ako njegova partnerica zatrudni dok on uzima Lenalidomid Accord ili ubrzo nakon prestanka uzimanja lijeka Lenalidomid Accord, odmah treba obavijestiti svog liječnika.
English: The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
Croatian: Preporučena početna doza lenalidomida iznosi 25 mg peroralno jednom dnevno od 1. do 21. dana u ponavljajućim 28-dnevnim ciklusima.
English: The pharmacokinetics of lenalidomide was studied in subjects with renal impairment due to nonmalignant conditions.
Croatian: Farmakokinetika lenalidomida ispitana je u ispitanika s funkcijom bubrega oštećenom zbog stanja koja nisu bila zloćudne naravi.
English: The serious adverse reactions observed more frequently (≥5%) with melphalan, prednisone and lenalidomide followed by lenalidomide maintenance (MPR+R) or melphalan, prednisone and lenalidomide followed by placebo (MPR+p) than melphalan, prednisone and placebo followed by placebo (MPp+p) were:
Croatian: Ozbiljne nuspojave opažene su češće (≥ 5 %) uz melfalan, prednizon i lenalidomid nakon čega je slijedila terapija održavanja lenalidomidom (MPR+R) ili uz melfalan, prednizon i lenalidomid nakon čega je slijedio placebo (MPR+p), nego uz melfalan, prednizon i placebo nakon čega je slijedio placebo (MPp+p), a bile su:
English: 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).
Croatian: Istodobna primjena pojedinačne doze ili ponovljenih doza deksametazona (40 mg jedanput na dan) nije imala klinički značajan učinak na farmakokinetiku ponovljenih doza lenalidomida (25 mg jedanput na dan).
English: Common Erectile dysfunction
Croatian: Često erektilna disfunkcija
English: • you should take lenalidomide at about the same time on the scheduled days.
Croatian: • Lenalidomid treba uzimati otprilike u isto vrijeme svakoga dana određenog za uzimanje lijeka.
English: CI = confidence interval; CR = complete response; HR = Hazard Rate; M = melphalan; NE = not estimable; OS = overall survival; p = placebo; P = prednisone;
Croatian: CI = interval pouzdanosti; CR = potpuni odgovor; HR = omjer hazarda; M = melfalan; NE = nije procjenjivo; OS = ukupno preživljenje; p = placebo; P = prednizon;
English: Common Febrile neutropenia^,◊,
Croatian: Često febrilna neutropenija^,◊,
English: Pneumonia◊, Bacterial, viral and fungal infections (including opportunistic infections)◊, Cellulitis◊, Sepsis◊, Bronchitis◊
Croatian: Često pneumonija◊, bakterijske, virusne i gljivične infekcije (uključujući oportunističke infekcije)◊, celulitis◊, sepsa◊, bronhitis◊
English: Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see sections 4.6 and 5.3).
Croatian: Lenalidomid je u majmuna inducirao malformacije slične onima opisanim s talidomidom (vidjeti dijelove 4.6 i 5.3).
English: Common Pulmonary embolism◊,*
Croatian: Često plućna embolija◊,*
English: The demographics and disease-related baseline characteristics of the patients were well balanced in all 3 arms.
Croatian: Demografski podaci i uz bolest povezane karakteristike bolesnika prije ispitivanja bili su dobro ujednačeni u sve 3 skupine.
English: 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.
Croatian: Test na trudnoću pod liječničkim nadzorom treba ponavljati svaka 4 tjedna, uključujući 4 tjedna nakon završetka liječenja, osim u slučaju potvrđenog podvezivanja jajovoda.
English: Interrupt lenalidomide treatment
Croatian: Privremeno prekinuti liječenje lenalidomidom
English: Leukocytoclastic vasculitis, Drug Reaction with Eosinophilia and Systemic Symptoms^
Croatian: Nepoznato leukocitoklastični vaskulitis, reakcija na lijek s eozinofilijom i sistemskim simptomima^
English: • Description of the patient card and its necessity
Croatian: • opis kartice za bolesnika te zašto je ona potrebna
English: Fatigue◊, Oedema (including peripheral oedema), Pyrexia◊, Asthenia, Influenza like illness syndrome (including pyrexia, cough, myalgia, musculoskeletal pain, headache and rigors)
Croatian: Vrlo često umor◊, edem, (uključujući periferni edem), pireksija◊, astenija, sindrom bolesti nalik gripi (uključujući pireksiju, kašalj, mialgiju, mišićnokoštanu bol, glavobolju i tresavicu)
English: 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.
Croatian: Bolesnici koji su završili 9 ciklusa ili nisu mogli završiti 9 ciklusa zbog nepodnošenja, nastavili su s terapijom održavanja počevši s lenalidomidom 10 mg peroralno od 1. do 21. dana u ponavljajućim 28-dnevnim ciklusima do progresije bolesti.
English: Congestive cardiac failure◊, Tachycardia, Cardiac failure◊, Myocardial ischemia◊
Croatian: kongestivno zatajenje srca◊, tahikardija, zatajenje srca◊, ishemija miokarda◊
English: The primary efficacy endpoint in the study was progression free survival (PFS) from randomisation to the date of progression or death, whichever occurred first; the study was not powered for the overall survival endpoint.
Croatian: U ispitivanju, mjera primarnog ishoda djelotvornosti bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS) od randomizacije do datuma progresije bolesti ili smrti, štogod se dogodilo prije; ispitivanje nije omogućilo ishod ukupnog preživljenja.
English: Psychiatric Disorders
Croatian: Psihijatrijski poremećaji
English: • Chest pain or leg pain
Croatian: • Bol u prsnom košu ili nogama
English: It is not known whether lenalidomide is excreted in human milk.
Croatian: Nije poznato izlučuje li se lenalidomid u majčino mlijeko.
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:
Croatian: U tablici 6 prikazani su podaci ispitivanja u kojem su se analizirali podaci za PFS, PFS2 i OS do zaključnog datuma podataka u travnju 2013., gdje je medijan vremena praćenja za sve preživjele ispitanike iznosio 62,4 mjeseca.
English: • Levonorgestrel-releasing intrauterine system (IUS)
Croatian: • intrauterini uložak za otpuštanje levonorgestrela
English: Multiple myeloma - in patients who have had treatment before Lenalidomide Accord is taken together with an anti-inflammatory medicine called ‘dexamethasone'.
Croatian: Multipli mijelom - u bolesnika koji su prethodno liječeni Lenalidomid Accord se uzima zajedno s protuupalnim lijekom pod nazivom ‘deksametazon'
English: Lenalidomide induced in monkey malformations similar to those described with thalidomide (see section 5.3).
Croatian: Lenalidomid je u majmuna prouzročio malformacije slične onima opisanim s talidomidom (vidjeti dio 5.3).
English: • If your partner becomes pregnant whilst you are taking lenalidomide , you should inform your doctor immediately.
Croatian: • Ako Vaša partnerica zatrudni dok Vi uzimate lenalidomid, odmah obavijestite svog liječnika.
English: The data were not adjusted according to the longer duration of treatment in the lenalidomide-containing arms continued until disease progression versus the placebo arms in the pivotal multiple myeloma studies (see section 5.1).
Croatian: Podaci nisu bili prilagođeni za dulje trajanje liječenja u skupinama koje su primale lenalidomid do progresije bolesti naspram skupina koje su primale placebo u ključnim ispitivanjima multiplog mijeloma (vidjeti dio 5.1).
English: In total 460 patients were randomised: 231 patients to lenalidomide and 229 patients to placebo.
Croatian: bolesnika: 231 bolesnik u skupinu lenalidomida i 229 bolesnika u skupinu placeba.
English: Lenalidomide treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Croatian: Liječenje lenalidomidom treba nadzirati liječnik iskusan u primjeni protutumorske terapije.
English: Hepatic failure, including fatal cases, has been reported in patients treated with lenalidomide in combination therapy: acute hepatic failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, and mixed cytolytic/cholestatic hepatitis have been reported.
Croatian: Zatajenje jetre, uključujući smrtne slučajeve, prijavljeno je u bolesnika liječenih lenalidomidom u kombiniranoj terapiji: prijavljeno je akutno zatajenje jetre, toksični hepatitis, citolitički hepatitis, kolestatski hepatitis i mješoviti citolitički/kolestatski hepatitis.
English: Muscular weakness, Bone pain◊, Musculoskeletal and connective tissue pain and discomfort (including back pain◊)
Croatian: Često mišićna slabost, bol u kostima◊, bol i nelagoda u mišićnokoštanom i vezivnom tkivu (uključujući bol u leđima◊)