natgillin/translations-raw huggingface dataset:
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
If pregnancy occurs in a woman treated with lenalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice. 
Če ženska, ki se zdravi z lenalidomidom, zanosi, je treba zdravljenje prekiniti, bolnico pa napotiti k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji zaradi ocene in svetovanja.
The Educational Healthcare Professional's Kit 
Izobraževalni paket za zdravstvene delavce
• Darkening of your skin 
• potemnitev kože;
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 . 
Možno je, da se to tveganje poveča pri zdravljenju z lenalidomidom, zato naj zdravnik skrbno oceni koristi in tveganja, ko vam predpiše lenalidomid.
T-cell type acute leukaemia◊, Basal cell carcinoma^,◊, Tumour lysis syndrome 
občasni akutna T-celična levkemija◊, bazalnocelični karcinom^,◊, sindrom tumorske lize
• Pregnancy test regime o Before commencing treatment o During treatment, every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment 
• režim testov nosečnosti: o pred začetkom zdravljenja, o vsake 4 tedne med zdravljenjem razen v primeru potrjene sterilizacije jajcevodov, o po končanem zdravljenju;
If pregnancy occurs in a partner of a male patient taking lenalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice. 
Če zanosi partnerica moškega bolnika, ki se zdravi z lenalidomidom, je priporočljivo napotiti partnerico k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji zaradi ocene in svetovanja.
Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see sections 4.6 and 5.3). 
Lenalidomid je povzročil pri opicah deformacije, ki so podobne deformacijam opisanim pri talidomidu (glejte poglavji 4.6 in 5.3).
Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide in combination therapy, and to a lesser extent in patients with multiple myeloma, taking lenalidomide monotherapy, combined oral contraceptive pills are not recommended (see also section 4.5). 
Zaradi povečanega tveganja za vensko trombembolijo pri bolnicah z diseminiranim plazmocitomom, ki jemljejo lenalidomid v okviru kombiniranega zdravljenja, in v manjšem obsegu pri bolnicah z diseminiranim plazmocitomom, ki se zdravijo z monoterapijo z lenalidomidom, uporaba kombiniranih peroralnih kontracepcijskih tablet ni priporočena (glejte tudi poglavje 4.5).
HR [95% CI]; p-value MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p Follow-up (months) Median (min, max): all patients Investigator-assessed Myeloma response n (%) CR PR Stable Disease (SD) Response Not Evaluable (NE) Investigator-assessed Duration of response (CR+PR) (months) Mediana (95% CI) 
HR [95 % IZ]; vrednost p MPR+R proti MPp+p MPR+R proti MPR+p MPR+p proti MPp +p Spremljanje (meseci) mediana (min, maks): vsi bolniki Odgovor plazmocitoma po oceni raziskovalca n (%) popolni odgovor (CR) delni odgovor (PR) stabilna bolezen (SD) odgovora ni mogoče oceniti (NE) Trajanje odgovora po oceni raziskovalca (CR+PR) (meseci) medianaa (95 % IZ)
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). 
Krvavitve so navedene pod več organskimi sistemi: bolezni krvi in limfatičnega sistema; bolezni živčevja (intrakranialna krvavitev); bolezni dihal, prsnega koša in mediastinalnega prostora (epistaksa); bolezni prebavil (krvavitve iz dlesni, krvavitve iz hemoroidov, krvavitve iz rektuma); bolezni sečil (hematurija); poškodbe, zastrupitve in zapleti pri posegih (kontuzija) in žilne bolezni (ekhimoza).
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone (see sections 4.4 and 4.8). 
Eritropoetska zdravila ali druga zdravila, ki lahko povečajo tveganje za trombozo, kot je hormonsko nadomestno zdravljenje, je treba pri bolnikih z diseminiranim plazmocitomom, ki prejemajo lenalidomid v kombinaciji z deksametazonom, uporabljati previdno (glejte poglavji 4.4 in 4.8).
A higher rate of infections was observed with lenalidomide in combination with dexamethasone than with MPT in patients with NDMM who are not eligible for transplant, and with lenalidomide maintenance compared to placebo in patients with NDMM who had undergone ASCT. 
Pogostnejše okužbe so opazili pri lenalidomidu v kombinaciji z deksametazonom kot pri MPT (melfalan, prednizon in talidomid), pri bolnikih z NDMM, ki niso primerni za presaditev, in z vzdrževanjem lenalidomida v primerjavi s placebom pri bolnikih z NDDP, ki so bili podvrženi ASCT.
Viral infections, including herpes zoster and hepatitis B virus reactivation 
neznana pogostnost virusne okužbe, vključno z reaktivacijo virusa herpesa zostra in virusa hepatitisa B
The median duration of treatment was 44.0 weeks (min: 0.1, max: 254.9) for len/dex and 23.1 weeks (min: 0.3, max: 238.1) for placebo/dex. 
Mediana trajanja zdravljenja je bila v celoti 44,0 tednov (min: 0,1; maks: 254,9) za len/deks in 23,1 tedna (min: 0,3 maks: 238,1) za placebo/deks.
Lenalidomide maintenance in patients who have undergone autologous stem cell transplantation (ASCT) 
Novo diagnosticirani diseminirani plazmocitom (NDDP) Vzdrževalno zdravljenje z lenalidomidom pri bolnikih, pri katerih je bila opravljena avtologna presaditev matičnih celic (ASCT - autologous stem cell transplantation)
This increase was not observed in clinical trials of newly diagnosed multiple myeloma in patients taking lenalidomide in combination with low dose dexamethasone compared to thalidomide in combination with melphalan and prednisone. 
Tega zvečanja niso opazili v kliničnih preskušanjih novo diagnosticiranega diseminiranega plazmocitoma pri bolnikih, ki so jemali lenalidomid v kombinaciji z deksametazonom v majhnem odmerku, v primerjavi s talidomidom v kombinaciji z melfalanom in prednizonom.
• Numbness, tingling or burning sensation to the skin, pains in hands or feet, dizziness, tremor, 
• otrplost, mravljinčenje ali pekoč občutek na koži, bolečine v dlaneh ali stopalih, omotica,
The recommended dose of dexamethasone is 40 mg orally once daily on days 1, 8, 15 and 22 of repeated 28-day cycles. 
Priporočeni odmerek deksametazona je 40 mg peroralno enkrat na dan 1., 8., 15. in 22. dan, v ponavljajočih se 28-dnevnih ciklih.
In clinical trials in previously treated myeloma patients with lenalidomide/dexamethasone compared to controls, mainly comprising of basal cell or squamous cell skin cancers. 
*V kliničnih preskušanjih bolnikov s plazmocitomom, predhodno zdravljenih z lenalidomidom/deksametazonom, v primerjavi s kontrolnimi skupinami, ki so jih pretežno sestavljali bazalnocelični ali ploščatocelični karcinom kože.
Therefore breast-feeding should be discontinued during therapy with lenalidomide. 
Zato je treba med zdravljenjem z lenalidomidom dojenje prekiniti.
• 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 
• če partnerica zanosi, medtem ko bolnik jemlje zdravilo Lenalidomide Accord ali kmalu po prenehanju jemanja zdravila Lenalidomide Accord, mora takoj obvestiti zdravnika, ki je zdravilo predpisal;
Ask your pharmacist how to throw away medicines you no longer use. 
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.Taki ukrepi pomagajo varovati okolje.
• Wheezing, breathlessness or a dry cough, which may be symptoms caused by inflammation of the tissue in the lungs. 
• sopenje, zasoplost ali suh kašelj, ki so lahko simptomi vnetja pljučnega tkiva;
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. 
Ponavljajoča se 1-letna peroralna uporaba odmerkov 1 in 2 mg/kg/dan pri opicah je povzročila reverzibilne spremembe celularnosti kostnega mozga, rahlo zmanjšanje razmerja mieloičnih in eritroidnih celic ter atrofijo timusa.
• If you do become pregnant during your treatment with lenalidomide , you must stop the treatment and inform your doctor immediately. 
• Če med jemanjem lenalidomida zanosite, morate takoj prekiniti zdravljenje in obvestiti zdravnika.
Lenalidomide is structurally related to thalidomide. 
Lenalidomid je strukturno soroden talidomidu.
Newly diagnosed multiple myeloma: patients who are not eligible for transplant 
Novo diagnosticirani diseminirani plazmocitom: bolniki, ki niso primerni za presaditev
Lenalidomide induced in monkey malformations similar to those described with thalidomide (see section 5.3). 
Lenalidomid je pri opicah povzročil deformacije, ki so podobne deformacijam opisanim pri talidomidu (glejte poglavje 5.3).
Ischemia, Peripheral ischemia, Intracranial venous sinus thrombosis 
pogosti vaskulitis občasni ishemija, periferna ishemija, intrakranialna venska sinusna tromboza
• Brochure for male patients 
• brošure za moške bolnike.
Lenalidomide Accord must be given to you by healthcare professionals with experience in treating multiple myeloma,. 
Zdravilo Lenalidomide Accord vam sme dati samo zdravstveni delavec, ki ima izkušnje z zdravljenjem diseminiranega plazmocitoma.
• Disposal of unwanted medicine 
• odstranjevanje odvečnega zdravila,
Grade 4 febrile neutropenia episodes were observed infrequently (1.7% in MPR+R/MPR+p treated patients compared to 0.0 % in MPp+p treated patients; see section 4.8). 
Epizode febrilne nevtropenije 4. stopnje so opazili redko (1,7 % bolnikov, zdravljenih z MPR+R/MPR+p v primerjavi z 0,0 % bolnikov, zdravljenih z MPp+p; glejte poglavje 4.8).
How to take Lenalidomide Accord 4. 
Kako jemati zdravilo Lenalidomide Accord 4.
In both studies, patients in the lenalidomide/dexamethasone (len/dex) group took 25 mg of lenalidomide orally once daily on days 1 to 21 and a matching placebo capsule once daily on days 22 to 28 of each 28-day cycle. 
V obeh študijah so bolniki v skupini, ki je prejemala lenalidomid/deksametazon (len/deks), od 1. do 21. dne enkrat na dan jemali 25 mg lenalidomida peroralno ter ustrezno kapsulo s placebom enkrat na dan od 22. do 28. dne v vsakem 28-dnevnem ciklu.
You must not breast-feed when taking lenalidomide , as it is not known if lenalidomide passes into human milk. 
Dojenje Ni znano, ali lenalidomid prehaja v materino mleko, zato med jemanjem lenalidomida ne smete dojiti.
Not Known Solid organ transplant rejection 
Bolezni imunskega sistema neznana pogostnost zavrnitev presajenega organa
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. 
Pri odmerkih 10 in 20 mg/kg/dan so opazili od odmerka odvisno odsotnost srednjega pljučnega režnja, pri odmerku 20 mg/kg/dan pa premik ledvic.
For patients older than 75 years of age treated with lenalidomide in combination with dexamethasone, the starting dose of dexamethasone is 20 mg once daily on days 1, 8, 15 and 22 of each 28-day treatment cycle. 
Pri bolnikih, starejših od 75 let, ki se zdravijo z lenalidomidom v kombinaciji z deksametazonom, je začetni odmerek deksametazona 20 mg enkrat na dan 1., 8., 15. in 22. dan v vsakem 28-dnevnem ciklu zdravljenja.
• Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection including within the bloodstream (sepsis) 
• zvišano telesno temperaturo, mrzlico, boleče grlo, kašelj, razjede v ustih ali katerekoli druge simptome okužbe, vključno v krvnem obtoku (sepsa);
5 mg (days 1-21 every 28 days) 
Raven odmerka -2 5 mg (od 1. do 21. dne vsakih 28 dni)
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). 
Podatki niso bili prilagojeni glede na daljše trajanje zdravljenja v skupinah z lenalidomidom, ki so ga dajali do napredovanja bolezni, v primerjavi s skupinami s placebom v ključnih študijah diseminiranega plazmocitoma (glejte poglavje 5.1).
The recommended starting dose is lenalidomide 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles for up to 9 cycles, melphalan 0.18 mg/kg orally on days 1 to 4 of repeated 28-day cycles, prednisone 2 mg/kg orally on days 1 to 4 of repeated 28-day cycles. 
Priporočeni začetni odmerek lenalidomida je 10 mg peroralno enkrat na dan od 1. do 21. dne, v ponavljajočih se 28-dnevnih ciklih, do 9 ciklov; melfalan 0,18 mg/kg peroralno od 1. do 4. dne, v ponavljajočih se 28-dnevnih ciklih, prednizon 2 mg/kg peroralno od 1. do 4. dne, v ponavljajočih se 28-dnevnih ciklih.
The results of PFS at unblinding, following a preplanned interim analysis, using a cut-off of 17 December 2009 (15.5 months follow up) showed a 62% reduction in risk of disease progression or death favoring lenalidomide (HR = 0.38; 95% CI 0.27, 0.54; p <0.001). 
Rezultati PFS ob prekinitvi dvojno slepega zdravljenja po vnaprej načrtovani vmesni analizi, z datumom zaključka zbiranja podatkov 17. december 2009 (15,5 meseca sledenja), so pokazali 62 % zmanjšanje tveganja napredovanja bolezni ali smrti v prid lenalidomidu (HR = 0,38; 95 % IZ 0,27; 0,54; p <0,001).
The data were not adjusted according to the longer duration of treatment in the lenalidomide-containing arms continued until disease progression versus the comparator arms in the pivotal multiple myeloma studies (see section 5.1). 
Podatki niso bili prilagojeni glede na daljše trajanje zdravljenja v skupinah z lenalidomidom, ki so ga dajali do napredovanja bolezni, v primerjavi s primerjalnimi skupinami v ključnih študijah diseminiranega plazmocitoma (glejte poglavje 5.1).
Supportive newly diagnosed multiple myeloma studies 
Podporne študije novo diagnosticiranega diseminiranega plazmocitoma
Tabulated summary for combination therapy in MM 
Povzetek za kombinirano zdravljenje DP v obliki preglednice
Interruption or discontinuation of lenalidomide should be considered for other forms of skin reaction depending on severity. 
Pri drugih oblikah kožnih reakcij pride v poštev prekinitev dajanja lenalidomida ali njegova ukinitev, odvisno od njihove izraženosti.
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. 
Pri bolnikih, zdravljenih z lenalidomidom v kombinirani terapiji, so poročali o odpovedi jeter, vključno s smrtnimi primeri: poročali so o akutni odpovedi jeter, toksičnem hepatitisu, citolitičnem hepatitisu, holestatskem hepatitisu in mešanem citolitičnem/holestatskem hepatitisu.
In this pooled extended follow-up analysis, the median TTP was 60.1 weeks (95% CI: 44.3, 73.1) in patients treated with len/dex (N = 353) versus 20.1 weeks (95% CI: 17.7, 20.3) in patients treated with placebo/dex (N = 351). 
V tej zbrani podaljšani sledilni analizi je bila mediana TTP 60,1 tedna (95 % IZ: 44,3; 73,1) pri bolnikih, ki so prejemali len/deks (n = 353) v primerjavi z 20,1 tedna (95 % IZ: 17,7; 20,3) pri bolnikih, ki so prejemali placebo/deks (n = 351).
• Educational Health Care Professional's kit 
• izobraževalni paket za zdravstvene delavce,
The recommended dose of dexamethasone is 40 mg orally once daily on days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily on days 1 to 4 every 28 days. 
Priporočeni odmerek deksametazona je 40 mg peroralno enkrat na dan od 1. do 4. dne, od 9. do 12. dne in od 17. do 20. dne v 28-dnevnih ciklih v prvih štirih ciklih zdravljenja, nato pa 40 mg enkrat na dan od 1. do 4. dne vsakih 28 dni.
It has also been shown to delay multiple myeloma from coming back following treatment. 
Izkazalo se je tudi, da zdravilo Lenalidomide odloži ponovitev diseminiranega plazmocitoma po zdravljenju.
Severe renal impairment (CLcr < 30 mL/min, not requiring dialysis) 
Huda okvara ledvic (CLcr < 30 ml/min, dializa ni potrebna)
The following table is derived from data gathered during the multiple myeloma studies with combination therapy. 
Naslednja preglednica vsebuje podatke, zbrane med študijami diseminiranega plazmocitoma s kombiniranim zdravljenjem.
Tabulated summary of post-marketing adverse reactions 
Povzetek neželenih učinkov v obdobju trženja v obliki preglednice
Hypokalaemia◊, Hyperglycaemia, Hypocalcaemia◊, Diabetes mellitus◊, Hypophosphataemia, Hyponatraemia◊, Hyperuricaemia, Gout, Decreased appetite, Weight decreased 
pogosti hipokaliemija◊, hiperglikemija◊, hipokalciemija◊, sladkorna bolezen◊, hipofosfatemija, hiponatriemija◊, hiperurikemija, protin, zmanjšan apetit, zmanjšanje telesne mase
Overall survival (months) Mediana OS time, months (95% CI)b 
Celokupno preživetje (meseci) Medianaa časa OS, meseci (95 % IZ)b
• you must use effective methods of contraception for 4 weeks before starting treatment, during treatment, and until 4 weeks after stopping treatment. 
• 4 tedne pred začetkom zdravljenja, med zdravljenjem in 4 tedne po koncu zdravljenja morate uporabljati zanesljivo kontracepcijsko metodo.
Congestive cardiac failure◊, Tachycardia, Cardiac failure◊, Myocardial ischemia◊ 
atrijska fibrilacija◊, kongestivno srčno popuščanje◊, tahikardija, srčno popuščanje◊, ishemija miokarda◊
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. 
Varnost in učinkovitost lenalidomida so ocenili v petih študijah faze III pri novo diagnosticiranem diseminiranem plazmocitomu in v dveh študijah faze III pri ponovljenem, na zdravljenje neodzivnem diseminiranem plazmocitomu, kot je opisano v nadaljevanju.
The demographic and disease-related characteristics were balanced across both arms. 
Demografske značilnosti in z boleznijo povezane značilnosti bolnikov so bile v obeh skupinah primerljive.
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. 
Bolnike z znanimi dejavniki tveganja, vključno s predhodnimi trombozami, je potrebno skrbno spremljati in z ustreznimi ukrepi poskusiti zmanjšati tiste dejavnike tveganja, na katere lahko vplivamo (npr. kajenje, hipertenzija in hiperlipidemija).
• an anti-inflammatory medicine called ‘dexamethasone' 
• s protivnetnim zdravilom, ki se imenuje ‘deksametazon';
Acute hepatic failure^, Hepatitis toxic^, Cytolytic hepatitis^, Cholestatic hepatitis^, Mixed cytolytic/cholestatic hepatitis^ 
Bolezni jeter, žolčnika in žolčevodov neznana pogostnost akutna odpoved jeter^, toksični hepatitis^, citolitični hepatitis^, holestatični hepatitis^, mešani citolitični/holestatični hepatitis^
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 
• obrazec za poročanje nosečnosti; Kontrolni seznam za zdravnike, ki zagotavlja, da je bil bolnik deležen ustreznega svetovanja o zdravljenju, kontracepcijskih metodah in preprečevanju nosečnosti, ki ustreza spolu in statusu zmožnosti zanositve; Obrazce za poročanje o neželenih učinkih.
Cholestasis◊, Abnormal liver function tests◊ 
pogosti holestaza◊, nenormalni testi delovanja jeter◊
No dose adjustment is proposed for patients older than 75 years who are treated with lenalidomide in combination with melphalan and prednisone. 
Za bolnike, starejše od 75 let, zdravljene z lenalidomidom v kombinaciji z melfalanom in prednizonom, ne predlagajo prilagajanja odmerka.
Fatigue, dizziness, somnolence, vertigo and blurred vision have been reported with the use of lenalidomide. 
Pri uporabi lenalidomida so poročali o utrujenosti, omotici, somnolenci, vrtoglavici in zamegljenem vidu.
Not Known 
ni navedbe
A majority of lenalidomide is eliminated through urinary excretion. 
Večina lenalidomida se izloči preko ledvic.
• Abnormal liver test results 
• nenormalni rezultati delovanja jeter;
The results of PFS at unblinding, following a preplanned interim analysis, using a cut-off of 7 July 2010 (31.4 months follow up) showed a 48% reduction in risk of disease progression or death favoring lenalidomide (HR = 0.52; 95% CI 0.41, 0.66; p <0.001). 
Rezultati PFS ob prekinitvi dvojno slepega zdravljenja po vnaprej načrtovani vmesni analizi, z datumom zaključka zbiranja podatkov 7. julij 2010 (31,4 meseca spremljanja), so pokazali 48% zmanjšanje tveganja napredovanja bolezni ali smrti v prid lenalidomidu (HR = 0,52; 95 % IZ 0,41; 0,66; p <0,001).
The primary efficacy endpoint in the study was progression free survival (PFS). 
Primarni cilj študije za dokaz učinkovitosti je bilo obdobje brez napredovanja bolezni (PFSprogression free survival ).
Decrease by one dose level when dosing resumed at next cycle ª If Dose limiting toxicity (DLT) occurs on > day15 of a cycle, lenalidomide dosing will be interrupted for at least the remainder of the current 28-day cycle. 
Priporočen potek zdravljenja zmanjša na < 25 x 109/l prekinite zdravljenje z lenalidomidom za preostali del ciklaª vrne na ≥ 50 x 109/l ko nadaljujete zdravljenje v naslednjem ciklu, zmanjšajte odmerek za eno raven odmerka ª Če toksičnost, ki omejuje odmerek (DLT - dose limiting toxicity), nastopi po 15. dnevu cikla, prekinite zdravljenje z lenalidomidom vsaj za preostanek trenutnega 28-dnevnega cikla.
Common Deafness (Including Hypoacusis), Tinnitus 
Ušesne bolezni, vključno z motnjami labirinta pogosti gluhost (vključno s hipoakuzo), tinitus
◊ Adverse reactions reported as serious in clinical trials in patients with NDMM who had undergone ASCT * Applies to serious adverse drug reactions only ^ See section 4.8 description of selected adverse reactions a “Pneumonias” combined AE term includes the following PTs: Bronchopneumonia, Lobar pneumonia, Pneumocystis jiroveci pneumonia, Pneumonia, Pneumonia klebsiella, Pneumonia legionella, Pneumonia mycoplasmal, Pneumonia pneumococcal, Pneumonia streptococcal, Pneumonia viral, Lung disorder, Pneumonitis b “Sepsis” combined AE term includes the following PTs: Bacterial sepsis, Pneumococcal sepsis, Septic shock, Staphylococcal sepsis c “Peripheral neuropathy” combined AE term includes the following preferred terms (PTs): Neuropathy peripheral, Peripheral sensory neuropathy, Polyneuropathy d “Deep vein thrombosis” combined AE term includes the following PTs: Deep vein thrombosis, Thrombosis, Venous thrombosis 
◊ Neželeni učinki, za katere v kliničnih preskušanjih pri bolnikih z NDDP, pri katerih je bila opravljena ASCT, poročajo, da so resni * Se nanaša samo na resne neželene učinke ^ Glejte poglavje 4.8 opis izbranih neželenih učinkov a “Pljučnice”, kombiniran izraz za neželene dogodke, vključuje naslednje preferenčne izraze (PT - preferred terms): bronhopnevmonija, lobarna pnevmonija, pnevmonija Pneumocystis jiroveci, pnevmonija, pnevmonija klebsiela, pnevmonija legionela, mikoplazmatska pnevmonija, pnevmokokna pnevmonija, streptokokna pnevmonija, virusna pnevmonija, pljučna bolezen, pnevmonitis.