FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of erythropoietic agents or previous history of thromboembolic events may also increase thrombotic risk in these patients.
Slovenian: Sočasna uporaba eritropoetskih zdravil ali trombembolični dogodki v anamnezi lahko pri teh bolnikih tudi povečajo tveganje za trombozo.
English: Repeated oral administration of 4 and 6 mg/kg/day to monkeys for up to 20 weeks produced mortality and significant toxicity (marked weight loss, reduced red and white blood cell and platelet counts, multiple organ haemorrhage, gastrointestinal tract inflammation, lymphoid, and bone marrow atrophy).
Slovenian: Do 20 tednov trajajoča ponavljajoča se peroralna uporaba odmerkov 4 in 6 mg/kg/dan je pri opicah povzročila umrljivost in pomembno toksičnost (precejšnjo izgubo telesne mase, zmanjšanje števila eritrocitov, limfocitov in trombocitov, krvavitve v več organih, vnetje prebavil, limfno atrofijo in atrofijo kostnega mozga).
English: Lenalidomide can stop the signs and symptoms of multiple myeloma getting worse.
Slovenian: Zdravilo Lenalidomide lahko zaustavi slabšanje znakov in simptomov diseminiranega plazmocitoma.
English: • Leg pain (which could be a symptom of thrombosis), chest pain or breathlessness (which may be a symptom of blood clots in the lungs, called pulmonary embolism)
Slovenian: • bolečina v nogah (kar je lahko znak tromboze), bolečina v prsnem košu ali zasoplost (kar je lahko znak krvnih strdkov v pljučih, to stanje imenujemo pljučna embolija);
English: 7x1 hard capsules
Slovenian: 7x1 trda kapsula
English: Endpoint len/dex (N=353)
Slovenian: Končni cilj len/deks (n=353)
English: Co-administration of a single 25 mg dose of warfarin had no effect on the pharmacokinetics of lenalidomide.
Slovenian: Sočasna uporaba enkratnega 25 mg odmerka varfarina ni imela učinka na farmakokinetiko lenalidomida.
English: • by stopping blood vessels growing in the cancer
Slovenian: • ustavi rast krvnih žil v raku,
English: • Understand the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception (even if the man has had a vasectomy), during treatment and for 1 week after dose interruptions and/or cessation of treatment.
Slovenian: • morajo razumeti potrebo po uporabi kondoma, če spolno občujejo z nosečnico ali žensko v rodni dobi, ki ne uporablja zanesljive kontracepcije (tudi če je moški imel vazektomijo), med zdravljenjem in 1 teden po prekinitvah odmerjanja in/ali prenehanju zdravljenja;
English: How much Lenalidomide to take
Slovenian: Koliko zdravila Lenalidomide jemati
English: • Thirst
Slovenian: • žeja;
English: Common Myelodysplastic syndrome◊,*
Slovenian: pogosti mielodisplastični sindrom◊,*
English: • Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Slovenian: • razširjen izpuščaj, visoka telesna temperatura, zvišanje jetrnih encimov, krvne motnje (eozinofilija), povečane bezgavke in vključenost drugih telesnih organov (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, znana tudi kot DRESS ali sindrom preobčutljivosti za zdravilo).
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.
Slovenian: Novo diagnosticirani diseminirani plazmocitom - pri bolnikih, ki so jim presadili kostni mozeg Zdravilo Lenalidomide Accord se samostojno uporablja za vzdrževalno zdravljenje, potem ko bolniki primerno okrevajo po presaditvi kostnega mozga.
English: Overall response: CR, VGPR, or PR Duration of response (months) Mediana (95% CI)b
Slovenian: PR celokupni odgovor: CR, VGPR, ali PR 402 (75,1) Trajanje odgovora (meseci) Medianaa (95 % IZ)b
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).
Slovenian: Za moške bolnike, ki jemljejo lenalidomid, so farmakokinetični podatki pokazali, da je lenalidomid med zdravljenjem prisoten v humani spermi v izredno nizkih koncentracijah, 3 dni po ukinitvi zdravila pa učinkovine v spermi zdrave osebe ni več mogoče zaznati (glejte poglavje 5.2).
English: Grade 3−4 ADRs/Frequency
Slovenian: Neželeni učinki 3.-4. stopnje / pogostnost
English: The most serious adverse reactions observed more frequently in lenalidomide/dexamethasone than placebo/dexamethasone combination were:
Slovenian: Najresnejši neželeni učinki, ki so jih opazili pogosteje pri kombinaciji lenalidomida in deksametazona kot pri kombinaciji placeba in deksametazona, so bili:
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.
Slovenian: Vzdrževalni odmerek je bil 10 mg enkrat na dan od 1. do 28. dne v ponavljajočih se 28-dnevnih ciklih (zvečan na do 15 mg enkrat na dan po 3 mesecih, če ni bilo toksičnosti, ki bi omejevala odmerek), zdravljenje se je nadaljevalo do napredovanja bolezni.
English: Various visceral effects (discoloration, red foci at different organs, small colourless mass above atrioventricular valve, small gall bladder, malformed diaphragm) were also observed in single foetuses.
Slovenian: Pri posameznih plodovih so opazili tudi različne visceralne učinke (spremenjeno barvo, rdeča žarišča v različnih organih, majhno brezbarvno gmoto nad atrioventrikularno zaklopko, majhen žolčnik, malformirano diafragmo).
English: Lenalidomide Accord hard capsules contain lactose.
Slovenian: Trde kapsule Lenalidomide Accord vsebujejo laktozo.
English: There was a higher rate of intolerance (grade 3 or 4 adverse events, serious adverse events, discontinuation) in patients with age > 75 years, ISS stage III, ECOG PS≤2 or CLcr<60 mL/min when lenalidomide is given in combination.
Slovenian: • Bolniki z novo diagnosticiranim diseminiranim plazmocitomom Intoleranca (neželeni dogodki 3. ali 4. stopnje, resni neželeni dogodki, prekinitev zdravljenja) se je pogosteje pojavljala pri bolnikih, starejših od 75 let, s stadijem III ISS, ECOG PS≤2 ali CLcr<60 ml/min, kadar so prejemali lenalidomid v kombinaciji.
English: Lenalidomide Accord hard capsules are available in OPA AL PVC/Aluminium foil perforated unit dose blister.
Slovenian: Lenalidomide Accord trde kapsule so na voljo v perforiranem pretisnem omotu za enkratni odmerek iz OPA AL PVC/aluminijaste folije.
English: In a post-hoc analysis, lower mortality was observed in the lenalidomide/low dose dexamethasone arm 6.8% (15/220) compared to the lenalidomide/standard dose dexamethasone arm 19.3% (43/223), in the newly diagnosed multiple myeloma patient population, with a median follow up of 72.3 weeks.
Slovenian: V naknadni (post hoc) analizi so v populaciji bolnikov z novo diagnosticiranim diseminiranim plazmocitomom ugotovili manjšo smrtnost v skupini z lenalidomidom/deksametazonom v majhnem odmerku (6,8 % (15/220) v primerjavi s skupino z lenalidomidom/deksametazonom v standardnem odmerku (19,3 % (43/223), z mediano spremljanja 72,3 tedna.
English: Non-invasive SPM comprise basal cell or squamous cell skin cancers.
Slovenian: Neinvazivne druge primarne malignosti so sestavljali bazalnocelični ali ploščatocelični karcinom kože.
English: • Passing much more or much less urine than usual, which may be a symptom of a type of kidney problem (called renal tubular necrosis)
Slovenian: • izločanje mnogo večjih ali manjših količin urina kot navadno, kar je lahko simptom vrste ledvičnih težav (imenuje se nekroza ledvičnih tubulov);
English: Lenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
Slovenian: Zdravilo Lenalidomide Accord je v monoterapiji indicirano za vzdrževalno zdravljenje odraslih bolnikov z novo diagnosticiranim diseminiranim plazmocitomom, pri katerih je bila opravljena avtologna presaditev matičnih celic.
English: 319 Pinner Road
Slovenian: 319 Pinner Road North Harrow Middlesex
English: • Educational brochures for Patients
Slovenian: • izobraževalne brošure za bolnike,
English: 10 mg once daily1
Slovenian: 10 mg enkrat na dan1
English: Lenalidomide maintenance should be initiated after adequate haematologic recovery following ASCT in patients without evidence of progression.
Slovenian: Vzdrževalno zdravljenje z lenalidomidom se mora pri bolnikih brez dokazanega napredovanja bolezni začeti po ustreznem hematološkem okrevanju po ASCT.
English: • If your partner becomes pregnant whilst you are taking lenalidomide , you should inform your doctor immediately.
Slovenian: • Če vaša partnerica zanosi med tem, ko vi jemljete lenalidomid, nemudoma obvestite svojega zdravnika.
English: Treatment-emergent AEs of neutropenia leading to lenalidomide discontinuation were reported in 2.2% of patients in CALGB 100104 and 2.4% of patients in IFM 2005-02, respectively.
Slovenian: O nevtropeniji kot neželenem dogodku zaradi zdravljenja, ki je povzročila prekinitev zdravljenja z lenalidomidom, so poročali pri 2,2 % bolnikov v CALGB 100104 oziroma pri 2,4 % bolnikov v IFM 2005-02.
English: Therefore, 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.
Slovenian: Zato je treba eritropoetska zdravila ali druga zdravila, ki lahko povečajo tveganje za trombozo, kot je hormonsko nadomestno zdravljenje, pri bolnikih z diseminiranim plazmocitomom, ki prejemajo lenalidomid v kombinaciji z deksametazonom, uporabljati previdno.
English: The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
Slovenian: Priporočeni začetni odmerek lenalidomida je 25 mg peroralno enkrat na dan od 1. do 21. dne, v ponavljajočih se 28-dnevnih ciklih.
English: Acute myeloid leukaemia◊, Myelodysplastic syndrome◊, Squamous cell carcinoma of skin^,◊,**
Slovenian: pogosti akutna mieloična levkemija◊, mielodisplastični sindromi◊, ploščatocelični karcinom kože^,◊,**
English: Stop using lenalidomide if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Če se vam pojavijo ti simptomi, prenehajte uporabljati lenalidomid in se posvetujte z zdravnikom oziroma poiščite zdravniško pomoč.
English: There was a higher frequency of grade 4 febrile neutropenia observed (1.7% in MPR+R/MPR+p compared to 0.0% in MPp+p).
Slovenian: Opazili so večjo pogostnost febrilne nevtropenije 4. stopnje (1,7 % pri MPR+R/MPR+p v primerjavi z 0,0 % pri MPp+p).
English: The adverse reactions described in Table 1 included events reported post-HDM/ASCT as well as events from the maintenance treatment period.
Slovenian: Neželeni učinki, opisani v preglednici 1, so obsegali učinke po velikih odmerkih melfalana in ASCT ter dogodke iz obdobja vzdrževalnega zdravljenja.
English: The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone (see section 4.5).
Slovenian: Pri sočasnem zdravljenju z deksametazonom se lahko zanesljivost kontracepcijskih steroidov zmanjša (glejte poglavje 4.5).
English: • Levonorgestrel-releasing intrauterine system (IUS)
Slovenian: • intrauterini sistem (IUS), ki sprošča levonorgestrel;
English: Caution should be practiced when introducing these patients to lenalidomide.
Slovenian: Pri začetku zdravljenja z lenalidomidom pri teh bolnikih je potrebna previdnost.
English: • Appetite lostLow levels of potassium in the blood
Slovenian: • nizke ravni kalija v krvi;
English: Pneumonia◊, Bacterial, viral and fungal infections (including opportunistic infections)◊, Cellulitis◊, Sepsis◊, Bronchitis◊
Slovenian: pogosti pljučnica◊, bakterijska, virusna in glivična okužba (vključno z oportunističnimi okužbami) ◊, celulitis◊, sepsa◊, bronhitis◊
English: • Skin eruptions, skin cracking, flaking or peeling skin
Slovenian: • kožni izpuščaji, razpokana koža, luskavost ali luščenje kože;
English: The adverse reactions from CALGB 100104 included events reported post-high dose melphalan and ASCT (HDM/ASCT) as well as events from the maintenance treatment period.
Slovenian: zdravljeni z vzdrževalnim zdravljenjem z lenalidomidom Neželeni učinki v študiji CALGB 100104 so obsegali učinke po velikih odmerkih melfalana in ASCT (HDM/ASCT - high dose melphalan/autologous stem cell transplantation) ter dogodke iz obdobja vzdrževalnega zdravljenja.
English: • When lenalidomide is used to treat multiple myeloma in patients who have had a bone marrow transplant.
Slovenian: • Ko se lenalidomid uporablja za zdravljenje diseminiranega plazmocitoma pri bolnikih, ki so jim presadili kostni mozeg.
English: Pack size of 21x1 capsules.
Slovenian: Pakiranje s po 21x1 kapsulo.
English: What Lenalidomide Accord looks like and contents of the pack
Slovenian: Izgled zdravila Lenalidomide Accord in vsebina pakiranja
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.
Slovenian: AMT = terapija proti plazmocitomu; IZ = interval zaupanja; CR = popolni odgovor; d = deksametazon v majhnem odmerku; HR = razmerje ogroženosti; IMWG = Mednarodna delovna skupina za plazmocitom; IRAC = neodvisni odbor za presojo odzivov; M = melfalan; maks = maksimum; min = minimum; NE = ni mogoče oceniti; OS = celokupno preživetje; P = prednizon; PFS = obdobje brez napredovanja bolezni; PR = delni odgovor; R = lenalidomid; Rd = Rd se daje, dokler ni dokumentirano napredovanje bolezni;
English: ª The median is based on the Kaplan-Meier estimate ¤PFS2 (an exploratory endpoint) was defined for all patients (ITT) as time from randomisation to start of 3rd line antimyeloma therapy (AMT) or death for all randomised patients
Slovenian: ¤ PFS2 (končni cilj raziskave) je bilo definirano za vse bolnike (ITT) kot čas od randomizacije do začetka 3. linije zdravljenja plazmocitoma
English: After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
Slovenian: Po 3 ciklih vzdrževalnega zdravljenja z lenalidomidom se lahko odmerek zveča na 15 mg peroralno enkrat na dan, če ga bolnik prenaša.
English: • do not break, open or chew the capsules.
Slovenian: • Kapsul ne drobite, odprite ali žvečite.
English: The serious adverse reactions observed more frequently (≥5%) with lenalidomide in combination with low dose dexamethasone (Rd and Rd18) than with melphalan, prednisone and thalidomide (MPT) were:
Slovenian: Resna neželena učinka, ki so ju opazili pogosteje (≥ 5 %) pri lenalidomidu v kombinaciji z deksametazonom v majhnem odmerku (Rd in Rd18) kot pri melfalanu, prednizonu in talidomidu (MPT), sta bila:
English: Overall survival Median [95% CI], weeks 1-year Overall survival rate
Slovenian: Mediana celokupnega preživetja [95 % IZ], tedni 1-letna stopnja celokupnega preživetja p = 0,045
English: • an immunosuppressant medicine called ‘prednisone'.
Slovenian: • zdravilom za zaviranje imunske odzivnosti, ki se imenuje ‘prednizon'.
English: This study investigated the use of combination therapy of MPR (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; and lenalidomide 10 mg/day orally on days 1 to 21 of repeated 28-day cycles) for induction therapy, up to 9 cycles.
Slovenian: V tej študiji so raziskovali uporabo kombinirane terapije z MPR (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; in lenalidomid 10 mg/dan peroralno od 1. do 21. dne v ponavljajočih se 28-dnevnih ciklih) za indukcijsko zdravljenje, do največ 9 ciklov.
English: Patients who complete 9 cycles or who are unable to complete the combination therapy due to intolerance are treated with lenalidomide monotherapy as follows: 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles given until disease progression.
Slovenian: Bolniki, ki dokončajo 9 ciklov ali ki niso sposobni dokončati kombiniranega zdravljenja zaradi intolerance, naj se zdravijo z monoterapijo z lenalidomidom, in sicer takole: 10 mg peroralno enkrat na dan od 1. do 21. dne, v ponavljajočih se 28-dnevnih ciklih, ki ga dajemo do napredovanja bolezni.
English: The incidence rate of hematologic malignancies, most notably AML, MDS and B-cell malignancies (including Hodgkin's lymphoma), was 1.31 per 100 person-years for the lenalidomide arms and 0.58 per 100 person-years for the placebo arms (1.02 per 100 person-years for patients exposed to lenalidomide after ASCT and 0.60 per 100 person-years for patients not-exposed to lenalidomide after ASCT).
Slovenian: Stopnja incidence hematoloških malignosti, predvsem AML, MDS in malignosti celic B (vključno s Hodgkinovim limfomom), je bila 1,31 na 100 oseb-let v skupinah z lenalidomidom in 0,58 na 100 oseb-let v skupinah s placebom (1,02 na 100 oseb-let pri bolnikih, izpostavljenih lenalidomidu po ASCT, in 0,60 oseb-let pri bolnikih, neizpostavljenih lenalidomidu po ASCT).
English: Multiple myeloma - in patients who have had treatment before Lenalidomide Accord is taken together with an anti-inflammatory medicine called ‘dexamethasone'.
Slovenian: Diseminirani plazmocitom - pri bolnikih, ki so se že prej zdravili Zdravilo Lenalidomide Accord se jemlje skupaj s protivnetnim zdravilom, ki se imenuje ‘deksametazon'.
English: There is an increased risk of rhabdomyolysis when statins are administered with lenalidomide, which may be simply additive.
Slovenian: Kadar se statini dajejo skupaj z lenalidomidom, obstaja povečano tveganje za rabdomiolizo, ki se lahko enostavno prišteva.
English: Cases of AML have been observed in clinical trials of newly diagnosed multiple myeloma in patients taking lenalidomide treatment in combination with melphalan or immediately following HDM/ASCT (see section 4.4).
Slovenian: V kliničnih preskušanjih novo diagnosticiranega diseminiranega plazmocitoma so pri bolnikih, ki so se zdravili z lenalidomidom v kombinaciji z melfalanom ali takoj po HDM/ASCT, opazili primere AML (glejte poglavje 4.4).
English: Patients should not donate blood during therapy or for 1 week following discontinuation of lenalidomide.
Slovenian: Bolniki med zdravljenjem z lenalidomidom ali en teden po prekinitvi zdravljenja ne smejo darovati krvi.
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Slovenian: Talidomid je znana za človeka teratogena učinkovina, ki povzroča hude, smrtno nevarne okvare ploda.
English: There are no phase III trial experiences with End Stage Renal Disease (ESRD) (CLcr < 30 mL/min, requiring dialysis).
Slovenian: Ni izkušenj iz preskušanj faze III pri končni ledvični odpovedi (ESRD - End Stage Renal Disease) (CLcr < 30 ml/min, dializa je potrebna).
English: Co-administration of lenalidomide with other myelosuppressive agents should be undertaken with caution.
Slovenian: Pri sočasni uporabi lenalidomida in drugih mielosupresivnih zdravil moramo biti previdni.
English: Cases of allergic reaction/hypersensitivity reactions have been reported in patients treated with lenalidomide (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z lenalidomidom, so poročali o primerih alergijskih reakcij/preobčutljivostnih reakcij (glejte poglavje 4.8).
English: Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps)
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
English: Grade 3 or 4 thrombocytopenia was observed to a lesser extent in the Rd and Rd18 arms than in the comparator arm (8.1% vs 11.1%, respectively).
Slovenian: Trombocitopenijo 3. ali 4. stopnje so opazili v manjši meri v skupinah z Rd in Rd18 kot v skupini s primerjalnim zdravilom (8,1 % v primerjavi z 11,1 %).
English: • Local country specific arrangements for a prescription for Lenalidomide Accord to be dispensed
Slovenian: • lokalne, za državo značilne dogovore glede predpisovanja in izdajanja zdravila Lenalidomide
English: Complete response and overall response rates in the len/dex arm were also significantly higher than the placebo/dex arm in both studies.
Slovenian: Pogostnost popolnega odgovora in celokupnega odgovora je bila v skupini len/deks v obeh študijah pomembno večja kot v skupini placebo/deks.
English: In total, 353 patients were evaluated in the MM-009 study; 177 in the len/dex group and 176 in the placebo/dex group and, in total, 351 patients were evaluated in the MM-010 study; 176 in the len/dex group and 175 in the placebo/dex group.
Slovenian: V študiji MM-009 so skupno ocenili 353 bolnikov; 177 v skupini len/deks in 176 v skupini placebo/deks.
English: • Understand that if his female partner becomes pregnant whilst he is taking lenalidomide or shortly after he has stopped taking lenalidomide , he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Slovenian: • morajo razumeti, da je treba takoj obvestiti lečečega zdravnika, če njegova partnerica zanosi, medtem ko on jemlje lenalidomid ali kratek čas po tistem, ko preneha jemati lenalidomid, in da je priporočljivo napotiti partnerico k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji, zaradi ocene in svetovanja.
English: The following post-marketing adverse reactions have been reported (frequency unknown): acute hepatic failure and cholestasis (both potentially fatal), toxic hepatitis, cytolytic hepatitis, mixed cytolytic/cholestatic hepatitis.
Slovenian: Poročali so o naslednjih neželenih učinkih v obdobju trženja (z neznano pogostnostjo): akutna odpoved jeter in holestaza (oboje potencialno smrtno), toksični hepatitis, citolitični hepatitis in mešani citolitični/holestatski hepatitis.
English: The efficacy and safety of lenalidomide maintenance was assessed in two phase 3 multicenter, randomised, double-blind 2-arm, parallel group, placebo-controlled studies: CALGB 100104 and IFM
Slovenian: Učinkovitost in varnost vzdrževalnega zdravljenja z lenalidomidom so ocenili v dveh multicentričnih randomiziranih dvojno slepih študijah faze III z dvema skupinama in paralelnimi skupinami, kontroliranih s placebom: CALGB 100104 in IFM 2005-02.
English: The incidence rate of solid tumour SPMs was 1.36 per 100 person-years for the lenalidomide arms and 1.05 per 100 person-years for the placebo arms (1.26 per 100 person-years for patients exposed to lenalidomide after ASCT and 0.60 per 100 person-years for patients not-exposed to lenalidomide after ASCT).
Slovenian: Stopnja incidence SPM s čvrstimi tumorji je bila 1,36 na 100 oseb-let v skupinah z lenalidomidom in 1,05 na 100 oseb-let v skupinah s placebom (1,26 na 100 oseb-let pri bolnikih, izpostavljenih lenalidomidu po ASCT, in 0,60 oseb-let pri bolnikih, neizpostavljenih lenalidomidu po ASCT).
English: • Chest pain or leg pain
Slovenian: • bolečine v prsnem košu ali v nogah;
English: • That Lenalidomide Accord may cause venous and arterial thromboembolism
Slovenian: • opozorilo, da lahko zdravilo Lenalidomide Accord povzroči vensko ali arterijsko trombembolijo;
English: Lenalidomide Accord contains the active substance ‘lenalidomide'.
Slovenian: Zdravilo Lenalidomide Accord vsebuje učinkovino, ki se imenuje "lenalidomid".