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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Rare cases of rhabdomyolysis have been observed, some of them when lenalidomide is administered with a statin.
Slovenian: Opazili so redke primere rabdomiolize, nekatere takrat, ko so lenalidomid dajali skupaj s statinom.
English: Lenalidomide may also cause blood clots in the veins (thrombosis).
Slovenian: Zdravilo Lenalidomide lahko povzroči tudi nastanek krvnih strdkov v venah (trombozo).
English: The patient card shall contain the following elements:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednje elemente:
English: If powder from a broken lenalidomide capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
Slovenian: Če prašek iz zdrobljene kapsule lenalidomida pride v stik s kožo, morate kožo takoj in temeljito sprati z milom in vodo.
English: Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide (see section 4.4).
Slovenian: Bolniki z anamnezo hudega izpuščaja, ki je povezan z zdravljenjem s talidomidom, ne smejo prejemati lenalidomida (glejte poglavje 4.4).
English: 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.
Slovenian: 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.
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).
Slovenian: 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).
English: Cataract has been reported with a higher frequency in patients receiving lenalidomide in combination with dexamethasone particularly when used for a prolonged time.
Slovenian: O kataraktah so poročali pogosteje pri bolnikih, ki so prejemali lenalidomid v kombinaciji z deksametazonom, posebno pri dolgotrajni uporabi.
English: Patients were stratified at randomisation by age ( 75 vs. > 75 years) and stage (ISS; Stages I and II vs. stage III).
Slovenian: Pri randomizaciji so bolnike stratificirali po starosti ( 75 proti > 75 let) in stadiju (ISS; stadija I in II proti stadiju III).
English: Patients were stratified at randomisation by age (≤75 versus >75 years), stage (ISS Stages I and II versus Stage III), and country.
Slovenian: Pri randomizaciji so bolnike stratificirali po starosti (≤75 proti >75 let), stadiju (ISS stadija I in II proti stadiju III), in državi.
English: In vitro studies indicate that lenalidomide has no inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A, or UGT1A1.
Slovenian: Študije in vitro kažejo, da lenalidomid nima zaviralnega učinka na CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A ali UGT1A1.
English: Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription.
Slovenian: Izdaja lenalidomida ženskam v rodni dobi naj bo v roku 7 dni od izdaje recepta.
English: ªIf the subject has not been receiving G-CSF therapy, initiate G-CSF therapy.
Slovenian: ª Če bolnik ni prejemal zdravljenja z G-CSF, uvedite zdravljenje z G-CSF.
English: What Lenalidomide Accord is and what it is used for
Slovenian: Kaj je zdravilo Lenalidomide Accord in za kaj ga uporabljamo
English: Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome (TLS) may occur.
Slovenian: Ker lenalidomid deluje antineoplastično, se lahko pojavijo zapleti v obliki sindroma tumorske lize.
English: Hydroxylenalidomide and N-acetyl-lenalidomide represent 4.59% and 1.83% of the excreted dose, respectively.
Slovenian: Hidroksi-lenalidomid predstavlja 4,59 % in N-acetil-lenalidomid predstavlja 1,83 % izločenega odmerka.
English: • 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”).
Slovenian: • 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").
English: Dose reduction steps
Slovenian: Koraki za zmanjšanje odmerka
English: Lenalidomide may be continued in patients with Grade 1 or 2 tumour flare reaction (TFR) without interruption or modification, at the physician's discretion.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • Description of the patient card and its necessity
Slovenian: • opis opozorilne kartice za bolnika in razlago, zakaj je nujna;
English: • Increase in pain, tumour size, redness around the tumour
Slovenian: • zvečanje bolečine, velikosti tumorja, rdečine okrog tumorja;
English: Not Known Acute hepatic failure^, Hepatitis toxic^
Slovenian: neznana pogostnost akutna odpoved jeter^, toksični hepatitis^
English: Lenalidomide combined therapy was less tolerated in newly diagnosed multiple myeloma patients older than 75 years of age compared to the younger population.
Slovenian: Kombinirano zdravljenje z lenalidomidom so slabše prenašali bolniki z novo diagnosticiranim diseminiranim plazmocitomom, starejši od 75 let, kot mlajša populacija.
English: Prophylactic antibiotics should be considered particularly in patients with neutropenia.
Slovenian: Pretehtati je treba možnost uporabe profilaktičnih antibiotikov, zlasti pri bolnicah z nevtropenijo.
English: 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.
Slovenian: 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.
English: • A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leukocytoclastic vasculitis).
Slovenian: • bolezen kože, ki jo povzroča vnetje majhnih krvnih žil, skupaj z bolečino v sklepih in zvišano telesno temperaturo (levkocitoklastični vaskulitis);
English: • Breakdown of the wall of the stomach or gut.
Slovenian: • pretrganje želodčne ali črevesne stene.
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).
Slovenian: 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).
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.
Slovenian: Zdravilo Lenalidomide Accord je v kombinaciji z deksametazonom indicirano za zdravljenje diseminiranega plazmocitoma pri odraslih bolnikih, ki so predhodno prejemali vsaj eno zdravljenje.
English: Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide.
Slovenian: Bolniki z anamnezo hudega izpuščaja, ki je povezan z zdravljenjem s talidomidom, ne smejo prejemati lenalidomida.
English: What Lenalidomide Accord is used for Lenalidomide Accord is used in adults for multiple myeloma.
Slovenian: Za kaj uporabljamo zdravilo Lenalidomide Accord Zdravilo Lenalidomide Accord se uporablja pri odraslih za zdravljenje diseminiranega plazmocitoma.
English: Patients were randomised 1:1 within 90-100 days after ASCT to receive either lenalidomide or placebo maintenance.
Slovenian: V 90-100 dneh po ASCT so bolnike randomizirali v razmerju 1:1 na vzdrževalno zdravljenje bodisi z lenalidomidom ali placebom.
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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: A possible cross-reaction between lenalidomide and thalidomide has been reported in the literature.
Slovenian: V literaturi poročajo o možnosti navzkrižnih reakcij med lenalidomidom in talidomidom.
English: 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.
Slovenian: 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.
English: Lenalidomide is present in human semen (< 0.01% of the dose) after administration of 25 mg/day and the medicinal product is undetectable in semen of a healthy subject 3 days after stopping the substance (see section 4.4).
Slovenian: Lenalidomid je prisoten v humani spermi (< 0,01 % odmerka) po jemanju 25 mg/dan, 3 dni po ukinitvi zdravila pa učinkovine v spermi zdrave osebe ni več mogoče zaznati (glejte poglavje 4.4).
English: The PFS benefit was less in the subgroup of patients with CR than in the subgroup of patients who had not achieved a CR.
Slovenian: Izboljšanje PFS je bilo v podskupini bolnikov s popolno remisijo manjše kot v podskupini bolnikov, ki niso dosegli popolne remisije.
English: The serious adverse reactions observed more frequently (≥5%) with lenalidomide maintenance than placebo were:
Slovenian: Resni neželeni učinki, ki so jih opazili pogosteje (≥5 %) pri vzdrževalnem zdravljenju z lenalidomidom kot pri placebu, so bili:
English: The Educational Health Care Professional's Kit shall contain the following elements:
Slovenian: Izobraževalni paket za zdravstvene delavce mora vsebovati naslednje elemente:
English: The lenalidomide arm was discontinued, as a proactive safety measure, after observing an imbalance of SPMs (see section 4.4).
Slovenian: Zdravljenje v skupini z lenalidomidom je bilo po ugotovitvi različne pogostnosti SPM med skupinama prekinjeno kot proaktivni varnostni ukrep (glejte poglavje 4.4).
English: • Brochure for women patients who are not of childbearing potential
Slovenian: • brošure za ženske, ki niso v rodni dobi;
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).
Slovenian: Sočasno dajanje večkratnih odmerkov močnega zaviralca P-gp kinidina (600 mg, dvakrat na dan) ali zmernega zaviralca/substrata P-gp temsirolimusa (25 mg) ni klinično pomembno vplivalo na farmakokinetiko lenalidomida (25 mg).
English: CI = confidence interval; CR = complete response; HR = Hazard Rate; M = melphalan; NE = not estimable; OS = overall survival; p = placebo; P = prednisone;
Slovenian: IZ = interval zaupanja; CR = popolni odgovor HR = razmerje ogroženosti; M = melfalan; NE = ni mogoče oceniti; OS = celokupno preživetje; p = placebo; P = prednizon;
English: Additional follow-up and evaluation may be warranted if no alternative diagnosis can be established.
Slovenian: Če ni mogoče postaviti drugačne diagnoze, sta morda potrebna nadaljnje spremljanje in vrednotenje.
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.
Slovenian: Starejši bolniki imajo večjo verjetnost za zmanjšano delovanje ledvic, zato je potrebna previdnost pri izbiri odmerka in priporočljivo je spremljanje ledvičnega delovanja.
English: Gastrointestinal perforations may lead to septic complications and may be associated with fatal outcome.
Slovenian: Med zdravljenjem z lenalidomidom so poročali o perforacijah prebavil, kar lahko vodi v septične zaplete in je lahko povezano s smrtnim izidom.
English: In plasma, the relative exposures of the S- and Renantiomers of lenalidomide are approximately 56% and 44%, respectively.
Slovenian: V plazmi je relativna izpostavitev S-enantiomera lenalidomida približno 56 % in Renantiomera približno 44 %.
English: Co-administration of multiple 10 mg doses of lenalidomide had no effect on the single dose pharmacokinetics of R- and S- warfarin.
Slovenian: Sočasna uporaba večkratnih 10-miligramskih odmerkov lenalidomida ni imela učinka na farmakokinetiko enkratnih odmerkov R- in S-varfarina.
English: • if you have had an allergic reaction whilst taking thalidomide (another medicine used to treat multiple myeloma) such as rash, itching, swelling, dizziness or difficulty breathing
Slovenian: • če ste med jemanjem talidomida (drugo zdravilo, ki se uporablja za zdravljenje diseminiranega plazmocitoma) imeli alergijsko reakcijo, na primer izpuščaj, srbenje, otekline, omotico ali oteženo dihanje;
English: All ADRs/Frequency
Slovenian: Vsi neželeni učinki/pogostnost
English: If powder from lenalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Slovenian: Če pride prašek z lenalidomidom v stik s kožo, morate kožo takoj in temeljito sprati z milom in vodo.
English: There are no data available for patients with moderate to severe hepatic impairment.
Slovenian: Za bolnike z zmernimi do hudimi okvarami jeter podatkov ni na voljo.
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).
Slovenian: Posodobljena vrednost PFS, z datumom zaključka zbiranja podatkov 1. februar 2016 (96,7 meseca spremljanja), še vedno kaže prednost pri PFS: HR = 0,57 (95 % IZ 0,47; 0,68; p < 0,001).
English: 8-year survival rate, % (SE) HR [95% CI]c ; p-valued
Slovenian: Stopnja 8-letnega preživetja, % (SE) HR [95 % IZ]c ; vrednost pd
English: 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.
Slovenian: V dveh s placebom nadzorovanih študijah faze III je 353 bolnikov z diseminiranim plazmocitomom prejemalo kombinacijo lenalidomida in deksametazona, 351 bolnikov pa kombinacijo placeba in deksametazona.
English: In vitro studies indicate that lenalidomide has no inhibitory effect on human bile salt export pump (BSEP), BCRP, MRP2, OAT1, OAT3, OATP1B1, OATP1B3, and OCT2.
Slovenian: Študije in vitro kažejo, da lenalidomid nima zaviralnega učinka na eksportno črpalko humanih žolčnih soli (BSEP), BCRP, MRP2, OAT1, OAT3, OATP1B1, OATP1B3 in OCT2.
English: Grade 4 febrile neutropenia was observed infrequently (0.6% in Rd and Rd18 compared with 0.7% in MPT).
Slovenian: Febrilno nevtropenijo 4. stopnje so redko opazili (0,6 % pri Rd in Rd18 v primerjavi z 0,7 % pri MPT).
English: Care should be taken in dose selection and monitoring of renal function is advised.
Slovenian: Pri izbiri odmerka je potrebna previdnost, priporočeno pa je tudi spremljanje delovanja ledvic.
English: 21x1 hard capsules
Slovenian: 21x1 trda kapsula
English: Venous thromboembolic events, predominantly deep vein thrombosis and pulmonary embolism^,◊
Slovenian: zelo pogosti venski trombembolični dogodki, pretežno globoka venska tromboza in pljučna embolija^,◊
English: • She understands the need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment
Slovenian: • razume potrebo po zanesljivi kontracepciji, brez prekinitve, 4 tedne pred začetkom zdravljenja,
English: • Women who are pregnant.
Slovenian: • nosečnice;
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:
Slovenian: Resna neželena učinka, ki so ju opazili pogosteje (≥ 5 %) pri melfalanu, prednizonu in lenalidomidu, ki jim je sledil vzdrževalni odmerek lenalidomida (MPR+R), ali pri melfalanu, prednizonu in lenalidomidu, ki jim je sledil placebo (MPR+p), kot pri melfalanu, prednizonu in placebu, ki jim je sledil placebo (MPp+p), sta bila:
English: When neutrophils
Slovenian: Ko se število nevtrofilcev
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking lenalidomide
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja lenalidomida se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Some of the cases of viral reactivation had a fatal outcome.
Slovenian: Nekateri primeri virusne reaktivacije so se končali s smrtjo bolnika.
English: Repeated oral administration of 75, 150 and 300 mg/kg/day to rats for up to 26 weeks produced a reversible treatment-related increase in kidney pelvis mineralisation in all 3 doses, most notably in females.
Slovenian: Pri podganah je ponavljajoča se 26-tedenska peroralna uporaba odmerkov 75, 150 in 300 mg/kg/dan pri vseh treh odmerkih povzročila reverzibilno, od zdravljenja odvisno povečanje mineralizacije pielona, zlasti pri samicah.
English: • by stopping the cancer cells developing
Slovenian: • ustavi razvoj rakavih celic,
English: Despite the fact that 170 out of the 351 patients randomised to placebo/dex received lenalidomide after disease progression or after the studies were unblinded, the pooled analysis of overall survival demonstrated a statistically significant survival advantage for len/dex relative to placebo/dex (HR = 0.833, 95% CI = [0.687, 1.009], p=0.045).
Slovenian: Čeprav je 170 od 351 bolnikov, ki so jih naključno razporedili v skupino, ki je prejemala placebo/deks, prejemalo lenalidomid po napredovanju bolezni ali po tem, ko so razkrili podatke študij, je zbrana analiza celokupnega preživetja pokazala statistično pomembno večje preživetje v skupini, ki je prejemala len/deks, kot pri skupini, ki je prejemala placebo/deks (HR = 0,833; 95 % IZ = [0,687; 1,009], p = 0,045).
English: • Confusion
Slovenian: • zmedenost;
English: • Brief background on lenalidomide and its licensed indication
Slovenian: • povzetek podatkov o lenalidomidu in indikacijah, za katere je odobren;
English: The recommended starting dose is lenalidomide 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance.
Slovenian: Priporočeni začetni odmerek lenalidomida je 10 mg peroralno enkrat na dan neprekinjeno (od 1. do 28. dne v ponavljajočih se 28-dnevnih ciklih) do napredovanja bolezni ali intolerance.
English: Multiple myeloma: patients with at least one prior therapy
Slovenian: Diseminirani plazmocitom: bolniki z vsaj eno predhodno terapijo
English: Moderate renal impairment (30  CLcr < 50 mL/min)
Slovenian: Zmerna okvara ledvic (30 ≤ CLcr < 50 ml/min)
English: • Yellow pigmentation to the skin, mucus membrane or eyes (jaundice), pale coloured stools, dark coloured urine, itchy skin, rash, pain or swelling of the stomach -these may be symptoms of injury to the liver (hepatic disorder).
Slovenian: • rumeno obarvanje kože, sluznice ali oči (zlatenica), blato blede barve, urin temne barve, srbeča koža, izpuščaj, bolečina ali oteklina želodca so lahko simptomi poškodbe jeter (bolezen jeter);
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.
Slovenian: Primarni cilj študije za dokaz učinkovitosti je bilo obdobje brez napredovanja bolezni (PFSprogression free survival) od randomizacije do datuma napredovanja bolezni ali smrti, kar se je zgodilo prej; moč študije je bila premajhna za dosego končnega cilja celokupnega preživetja.
English: Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported with lenalidomide.
Slovenian: Pri uporabi lenalidomida so poročali o primerih progresivne multifokalne levkoencefalopatije (PML), vključno s smrtnimi primeri.
English: Close monitoring of warfarin concentration is advised during the treatment.
Slovenian: Zato je med zdravljenjem priporočeno pozorno spremljati koncentracijo varfarina.