FrancophonIA/ELRC3.0 huggingface dataset:
English: • Rare cases of muscle breakdown (muscle pain, weakness or swelling) which can lead to kidney problems (rhabdomyolysis) have been observed, some of them when lenalidomide is administered with a statin (a type of cholesterol lowering medicines).
Slovenian: • opazili so redke primere razpadanja mišic (bolečina v mišicah, oslabelost ali otekanje mišic), ki lahko povzročijo težave z ledvicami (rabdomioliza), nekateri od njih so se pojavili, ko so dajali lenalidomid skupaj s statinom (vrsta zdravil, ki znižujejo holesterol);
English: In total 460 patients were randomised: 231 patients to lenalidomide and 229 patients to placebo.
Slovenian: Vsega skupaj je bilo v študijo vključenih 460 bolnikov, od teh je bilo 231 bolnikov randomiziranih na lenalidomid in 229 bolnikov na placebo.
English: For hematologic toxicity the dose of lenalidomide may be re-introduced to the next higher dose level (up to the starting dose) upon improvement in bone marrow function (no hematologic toxicity for at least 2 consecutive cycles: ANC ≥1,5 x 109/L with a platelet count ≥ 100 x 109/L at the beginning of a new cycle).
Slovenian: Pri hematološki toksičnosti lahko odmerek lenalidomida spet uvedemo na naslednji višji ravni odmerka (do začetnega odmerka) po izboljšanju funkcije kostnega mozga (brez hematološke toksičnosti v vsaj 2 zaporednih ciklih: ANC ≥1,5 x 109/l s številom trombocitov ≥ 100 x 109/l v začetku novega cikla).
English: • Bleeding within the skull
Slovenian: • krvavitve znotraj lobanje;
English: A medically supervised pregnancy test should be performed during the consultation, when lenalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Slovenian: Test nosečnosti pod zdravniškim nadzorom je treba opraviti med posvetom, ko se predpiše lenalidomid, ali v 3 dneh pred obiskom pri zdravniku, ki predpiše zdravilo, po tem, ko je bolnica vsaj 4 tedne že uporabljala zanesljivo kontracepcijo.
English: Your doctor may check you for changes to your skin such as red spots or rashes.
Slovenian: Zdravnik lahko pri pregledu išče kožne spremembe, na primer rdeče pege ali izpuščaje.
English: • Dry skin
Slovenian: • suha koža;
English: It is not known whether the effect will be different in the clinical use (higher lenalidomide doses and concomitant treatment with dexamethasone).
Slovenian: Ni znano, ali bi bil ta učinek pri klinični uporabi (večji odmerki lenalidomida in sočasno zdravljenje z deksametazonom) različen.
English: After initiation of lenalidomide therapy, subsequent lenalidomide dose modification in renally impaired patients should be based on individual patient treatment tolerance, as described above.
Slovenian: Po uvedbi zdravljenja z lenalidomidom se odmerek lenalidomida pri bolnikih z okvaro ledvic naknadno prilagodi glede na bolnikovo individualno prenašanje zdravljenja, kot je opisano zgoraj.
English: Do not drive or operate machines if you feel dizzy, tired, sleepy, have vertigo or blurred vision after taking lenalidomide .
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne vozite avtomobila in ne upravljajte strojev, če ste omotični, utrujeni, zaspani, imate vrtoglavico ali zamegljen vid, potem ko vzamete lenalidomid.
English: Once parameters have returned to baseline, treatment at a lower dose may be considered.
Slovenian: Ko se vrednosti parametrov vrnejo na izhodišče, morate razmisliti o zdravljenju z nižjim odmerkom.
English: In vitro (bacterial mutation, human lymphocytes, mouse lymphoma, Syrian Hamster Embryo cell transformation) and in vivo (rat micronucleus) mutagenicity studies revealed no drug related effects at either the gene or chromosomal level.
Slovenian: Študije mutagenosti in vitro (bakterijske mutacije, človeški limfociti, mišji limfom, transformacija embrionalnih celic sirijskega hrčka) in in vivo (mikronukleus pri podganah) niso pokazale nikakršnih učinkov, povezanih z zdravilom, niti na ravni gena, niti kromosoma.
English: • That lenalidomide is teratogenic in animals and is expected to be teratogenic in humans
Slovenian: • opozorilo, da je lenalidomid teratogen pri živalih in se pričakuje teratogenost pri človeku;
English: In patients with Grade 3 or 4 TFR, withhold treatment with lenalidomide until TFR resolves to ≤ Grade 1 and patients may be treated for management of symptoms per the guidance for treatment of Grade 1 and 2 TFR (see section 4.4).
Slovenian: Pri bolnikih s TFR 3. ali 4. stopnje prekinite zdravljenje z lenalidomidom, dokler se TFR ne zmanjša na ≤ 1. stopnjo, in bolnike lahko zdravite le za obvladovanje simptomov v skladu s smernicami za zdravljenje 1. in 2. stopnje TFR (glejte poglavje 4.4).
English: Patients with multiple myeloma are prone to develop infections including pneumonia.
Slovenian: Bolniki z diseminiranim plazmocitomom so dovzetni za razvoj okužb, vključno s pljučnico.
English: The patient should continue anticoagulation therapy during the course of lenalidomide treatment.
Slovenian: Bolnik mora v času zdravljenja z lenalidomidom še naprej prejemati antikoagulacijska zdravila.
English: The following table is derived from data gathered during NDMM studies in patients who have undergone ASCT treated with lenalidomide maintenance.
Slovenian: Naslednja preglednica vsebuje podatke, zbrane med študijami NDDP pri bolnikih, pri katerih je bila opravljena ASCT, zdravljenih z vzdrževalnim zdravljenjem z lenalidomidom.
English: In total 614 patients were randomised: 307 patients to lenalidomide and 307 patients to placebo.
Slovenian: Vsega skupaj je bilo v študijo vključenih 614 bolnikov, od teh je bilo 307 bolnikov randomiziranih na lenalidomid in 307 bolnikov na placebo.
English: • Production of much more or much less urine than usual (which may be a symptom of kidney failure), passing blood in the urine
Slovenian: • nastajanje veliko več ali veliko manj urina kot po navadi (kar je lahko simptom ledvične odpovedi), kri v urinu;
English: It may not be excluded that the efficacy of oral contraceptives may be reduced during treatment.
Slovenian: Zmanjšanje zanesljivosti peroralnih kontracepcijskih sredstev med zdravljenjem ni mogoče izključiti.
English: To remove the capsule from the blister:
Slovenian: Kapsulo odstranite iz pretisnega omota tako, da:
English: • In case of neutropenia, the use of growth factors in patient management should be considered.
Slovenian: • V primeru nevtropenije je pri obravnavi bolnika treba razmisliti o uporabi rastnih faktorjev.
English: Rare Tumour lysis syndrome
Slovenian: redki sindrom tumorske lize
English: Mild suppression of white blood cell count was observed at 1 mg/kg/day corresponding to approximately the same human dose based on AUC comparisons.
Slovenian: Opazili so rahlo supresijo števila levkocitov pri odmerku 1 mg/kg/dan, kar ustreza približno enakemu odmerku za človeka na osnovi primerjav vrednosti AUC.
English: Patients were randomised (1:1:1) to 1 of 3 treatment arms.
Slovenian: Bolnike so randomizirali (1:1:1) na 1 od 3 skupin terapije.
English: Common Deep vein thrombosis^,◊,d
Slovenian: pogosti globoka venska tromboza^,◊,d
English: For women taking lenalidomide
Slovenian: Za ženske, ki jemljejo lenalidomid
English: • Description of the PPP
Slovenian: • opis PPN;
English: • Viral infections, including herpes zoster (also known as ‘shingles', a viral disease that causes a painful skin rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-colored urine, right-sided stomach pain, fever and feeling nauseous or being sick).
Slovenian: • virusne okužbe, vključno s herpesom zostrom (ki je znan tudi pod imenom ‘pasovec', virusna bolezen, ki povzroča boleč kožni izpuščaj z mehurji), in ponovitev okužbe z virusom hepatitisa B (ki lahko povzroči porumenitev kože in oči, temno rjavo obarvan urin, bolečino v desni strani trebuha, vročino in siljenje na bruhanje ali bruhanje);
English: • Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
Slovenian: • opredelitev žensk v rodni dobi (ŽRD), in ukrepov, ki jih morajo zdravniki izvajati, kadar niso prepričani;
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.
Slovenian: Študije in vitro kažejo, da lenalidomid ni substrat humanega proteina odpornosti proti raku dojke (BCRP - breast cancer resistant protein), prenašalcev (MRP - multidrug resistance protein) MRP1, MRP2 ali MRP3, prenašalcev organskih anionov (OAT - organic anion transporter) OAT1 in OAT3, polipeptidnega prenašalca organskih anionov 1B1 (OATP1B1 - organic anion transporting polypeptide 1B1), prenašalcev organskih kationov (OCT - organic cation transporters) OCT1 in OCT2, proteina MATE1 (MATE - multidrug and toxin extrusion protein) in prenašalcev organskih kationov (OCTNorganic cation transporters novel) OCTN1 in OCTN2.
English: • Description and management of cutaneous reactions
Slovenian: • opis in obvladovanje kožnih reakcij,
English: placebo/dex(N=351)
Slovenian: placebo/deks (n=351)
English: • Pregnancy test regime o Advice on suitable tests o Before commencing treatment o During treatment based on method of contraception o After finishing treatment
Slovenian: • režim testov nosečnosti: o svetovanje o ustreznih testih, o pred začetkom zdravljenja, o med zdravljenjem, glede na kontracepcijsko metodo, o po končanem zdravljenju;
English: Your doctor will advise you on appropriate methods of contraception.
Slovenian: O ustreznih kontracepcijskih metodah se posvetujte z zdravnikom.
English: • Passing large amount of urine with bone pain and weakness, which may be symptoms of a kidney disorder (Fanconi syndrome)
Slovenian: • izločanje velike količine urina z bolečinami v kosteh in oslabelostjo, kar so lahko simptomi bolezni ledvic (Fanconijevega sindroma);
English: • Verification that appropriate counselling has taken place
Slovenian: • potrditev, da je bil bolnik deležen ustreznega svetovanja;
English: Pack size of 7x1 or 21x1 capsules.
Slovenian: Pakiranje s po 7x1 ali 21x1 kapsulo.
English: 5 mg (days 1-21 every 28 days) Do not dose below 5 mg (days 1-21 every 28 days)
Slovenian: 5 mg (od 1. do 21. dne vsakih 28 dni) Odmerek naj ne bo manjši od 5 mg (od 1. do 21. dne vsakih 28 dni)
English: See also section 2.
Slovenian: Glejte tudi poglavje 2;
English: • She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation
Slovenian: • mora razumeti potrebo in biti pripravljena opraviti teste nosečnosti vsake 4 tedne razen v primeru potrjene sterilizacije jajcevodov;
English: Duration of the treatment with lenalidomide
Slovenian: Trajanje zdravljenja z lenalidomidom
English: Distribution In vitro (14C)-lenalidomide binding to plasma proteins was low with mean plasma protein binding at
Slovenian: Porazdelitev In vitro je bila vezava (14C)-lenalidomida na beljakovine v plazmi majhna.
English: Pregnancy warning
Slovenian: Opozorilo o nosečnosti
English: Therefore, monitoring of the digoxin concentration is advised during lenalidomide treatment.
Slovenian: Zato se med zdravljenjem z lenalidomidom priporoča spremljanje koncentracije digoksina.
English: Programme are met (see sections 4.4 and 4.6).
Slovenian: (glejte poglavji 4.4 in 4.6).
English: Monitoring of liver function is recommended, particularly when there is a history of or concurrent viral liver infection or when lenalidomide is combined with medicinal products known to be associated with liver dysfunction.
Slovenian: Priporoča se nadziranje delovanja jeter, zlasti pri anamnezi virusne okužbe jeter ali ob sočasni virusni okužbi jeter ali pri kombiniranju lenalidomida z drugimi zdravili, za katera se ve, da so povezana z motnjo delovanja jeter.
English: Lenalidomide has a potential for acute toxicity; minimum lethal doses after oral administration were > 2000 mg/kg/day in rodents.
Slovenian: Lenalidomid je lahko akutno toksičen; pri glodavcih so najmanjši smrtni odmerki po peroralni uporabi > 2.000 mg/kg/dan.
English: These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Slovenian: Te teste nosečnosti je treba opraviti na dan obiska pri zdravniku, ki predpiše zdravilo, ali v 3 dneh pred obiskom zdravnika.
English: System Organ Class/Preferred Term
Slovenian: Organski sistem / preferenčni izraz
English: Lenalidomide has been used in clinical trials in multiple myeloma patients up to 91 years of age (see section 5.1).
Slovenian: Lenalidomid so v kliničnih preskušanjih uporabljali pri bolnikih z diseminiranim plazmocitomom, starih do 91 let (glejte poglavje 5.1).
English: The percentage of multiple myeloma patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups.
Slovenian: Odstotek bolnikov z diseminiranim plazmocitomom, starih 65 let ali več, se med skupinama, ki sta prejemali lenalidomid/deksametazon in placebo/deksametazon, ni bistveno razlikoval.
English: • Loss of vision
Slovenian: • izguba vida;
English: • if you have kidney problems - your doctor may adjust your dose of lenalidomide if you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or raised cholesterol levels
Slovenian: • če ste imeli srčni infarkt, če ste kadarkoli imeli krvni strdek ali če kadite, imate visok krvni tlak ali zvišano raven holesterola;
English: Patients in the placebo/dexamethasone (placebo/dex) group took 1 placebo capsule on days 1 to 28 of each 28-day cycle.
Slovenian: Bolniki v skupini, ki je prejemala placebo/deksametazon (placebo/deks), so jemali eno kapsulo s placebom od 1. do 28. dne v vsakem 28-dnevnem ciklu.
English: Patients were randomised in a 1:1:1 ratio to one of 3 treatment arms.
Slovenian: Bolnike so randomizirali v razmerju 1:1:1 na eno od 3 skupin terapije.
English: In the lenalidomide/low dose dexamethasone group, 20 patients (9.1%) underwent at least one dose interruption compared to 65 patients (29.3%) in the lenalidomide/standard dose dexamethasone arm.
Slovenian: V skupini z lenalidomidom/deksametazonom v majhnem odmerku je 20 bolnikov (9,1 %) vsaj enkrat prekinilo odmerjanje, v primerjavi s 65 bolniki (29,3 %) v skupini z lenalidomidom/deksametazonom v standardnem odmerku.
English: Safety advice for women of childbearing potential
Slovenian: Varnostne nasvete za ženske v rodni dobi:
English: • XY genotype, Turner syndrome, uterine agenesis.
Slovenian: • genotip XY, Turnerjev sindrom, agenezija maternice.
English: Specifically, lenalidomide inhibits proliferation of certain haematopoietic tumour cells (including MM plasma tumour cells and those with deletions of chromosome 5), enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases the number of NK T cells, inhibits angiogenesis by blocking the migration and adhesion of endothelial cells and the formation of microvessels, augments foetal haemoglobin production by CD34+ haematopoietic stem cells, and inhibits production of pro-inflammatory cytokines (e.g., TNF-αand IL-6) by monocytes.
Slovenian: Lenalidomid zavira proliferacijo nekaterih hematopoetskih tumorskih celic (vključno s tumorskimi celicami MM v plazmi in celicami z delecijo v kromosomu 5), okrepi celično imunost, ki jo posredujejo celice T in naravne ubijalke (NK - Natural Killer), ter poveča število celic NKT, zavira angiogenezo, tako da blokira migracijo in adhezijo endotelijskih celic in tvorbo mikrožil, izboljša fetalno sintezo hemoglobina v hematopoetskih zarodnih celicah CD34+ in zavira sintezo proinflamatornih citokinov (npr. TNF-α in IL-6) v monocitih.
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
Slovenian: Rd proti MPT Rd proti Rd18 Rd18 proti MPT PFS2e (meseci) Medianaa časa PFS2, meseci (95 % IZ)b HR [95 % IZ]c; vrednost pd
English: • Dose reduction steps
Slovenian: • Koraki za zmanjšanje odmerka
English: In an in vitro study with human hepatocytes, lenalidomide, at various concentrations tested did not induce CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4/5.
Slovenian: V študiji in vitro s humanimi hepatociti lenalidomid ob različnih koncentracijah, na katerih je bil testiran, ni spodbujal CYP1A2, CYP2B6, CYP2C9, CYP2C19 in CYP3A4/5.
English: Pre-planned interim analyses of both studies showed that len/dex was statistically significantly superior (p < 0.00001) to dexamethasone alone for the primary efficacy endpoint, TTP (median follow-up duration of 98.0 weeks).
Slovenian: Vnaprej načrtovana vmesna analiza obeh študij je pokazala, da je pri primarnem cilju za dokaz učinkovitosti, TTP (mediana trajanja spremljanja 98,0 tednov), len/deks statistično pomembno učinkovitejši (p < 0,00001) od deksametazona samega.
English: Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of SPM and institute treatment as indicated.
Slovenian: Zdravniki naj pred zdravljenjem in med njim s standardnimi pregledi za rakava obolenja pri bolnikih skrbno ocenjujejo pojav SPM in uvedejo zdravljenje, kot je indicirano.
English: • Hives, rashes, swelling of eyes, mouth or face, difficulty breathing, or itching, which may be symptoms of an allergic reaction
Slovenian: • koprivnica, izpuščaji, otekanje oči, ust ali obraza, oteženo dihanje ali srbenje, ki so lahko simptomi alergijske reakcije .
English: Abnormal liver function tests were commonly reported and were generally asymptomatic and reversible upon dosing interruption.
Slovenian: Pogosto so poročali o nenormalnih rezultatih testov delovanja jeter, ki so bili na splošno asimptomatski in po prenehanju uporabe zdravila reverzibilni.
English: • Sore inflamed mouth, dry mouth, difficulty swallowing
Slovenian: • vneta usta, suha usta, težave s požiranjem;
English: Concomitant administration with lenalidomide 10 mg once daily increased the plasma exposure of digoxin (0.5 mg, single dose) by 14% with a 90% CI (confidence interval) [0.52%-28.2%].
Slovenian: Sočasna uporaba z lenalidomidom v odmerku 10 mg enkrat na dan je povečala izpostavljenost digoksina v plazmi (0,5 mg, enkratni odmerek) za 14 % z 90-odstotnim IZ (interval zaupanja) [0,5228,2 %].
English: An open-label, randomised, multicenter, phase III study (ECOG E4A03) was conducted in 445 patients with newly diagnosed multiple myeloma; 222 patients were randomised to the lenalidomide/low dose dexamethasone arm, and 223 were randomised to the lenalidomide/standard dose dexamethasone arm.
Slovenian: Odprto, randomizirano, multicentrično študijo faze III (ECOG E4A03) so opravili pri 445 bolnikih z novo diagnosticiranim diseminiranim plazmocitomom; 222 bolnikov so randomizirali na skupino lenalidomida/deksametazona v majhnem odmerku, 223 pa so jih randomizirali na skupino lenalidomida/deksametazona v standardnem odmerku.
English: If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
Slovenian: Pri jemanju lenalidomida med nosečnostjo se pričakuje teratogeni učinek pri človeku.
English: • Cloudy vision (cataract)
Slovenian: • zamegljen vid (katarakta);
English: Follow-up (months) Medianf (min, max): all patients Myeloma responseg n (%)
Slovenian: Spremljanje (meseci) Medianaf (min, maks): vsi bolniki Odgovor plazmocitomag n (%)
English: Lenalidomide binds directly to cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4
Slovenian: Lenalidomid se veže neposredno na cereblon, ki je sestavni del encimskega kompleksa kulin-RING E3 ubikvitinske ligaze, ki vključuje beljakovino 1, ki se veže na poškodbe deoksiribonukleinske kisline (DNA) (DDB1- DNA damage-binding protein 1), kulin 4 (CUL4) in kulinski regulator 1 (Roc1regulator of cullins 1).
English: Multiple myeloma generally cannot be cured.
Slovenian: Diseminiranega plazmocitoma na splošno ne moremo ozdraviti.
English: • Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials
Slovenian: • opis in obvladovanje nevtropenije in trombocitopenije, vključno s stopnjami pojavnosti v kliničnih preskušanjih,
English: • Infection of the lung and the upper respiratory tract, breathlessness
Slovenian: • okužba pljuč in zgornjih dihal, zasoplost;
English: Common Hypotension◊, Hypertension, Ecchymosis^
Slovenian: pogosti hipotenzija◊, hipertenzija, ekhimoza^
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.
Slovenian: V študiji so primerjali lenalidomid v kombinaciji z melfalanom in prednizonom (MPR) z vzdrževalno terapijo z lenalidomidom do napredovanja bolezni ali brez nje, z melfalanom in prednizonom za največ 9 ciklov.
English: • Bleeding or bruising in the absence of injury
Slovenian: • krvavitve ali modrice, ki niso posledica poškodbe;
English: Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Slovenian: Ženske v rodni dobi morajo 4 tedne pred začetkom zdravljenja, med zdravljenjem in 4 tedne po zdravljenju z lenalidomidom in celo med morebitnimi prekinitvami odmerjanja uporabljati eno zanesljivo kontracepcijsko metodo, razen če se zavežejo popolni in neprekinjeni abstinenci, ki se potrjuje vsak mesec.
English: • Sudden, or mild but worsening pain in the upper stomach and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse.
Slovenian: • nenadna ali blaga, naraščajoča bolečina v zgornjem delu želodca in/ali hrbta, ki traja nekaj dni, lahko jo spremljajo slabost s siljenjem na bruhanje, bruhanje, zvišana telesna temperatura in pospešen srčni utrip.
English: • you will have pregnancy tests under the supervision of your doctor (before every treatment, every 4 weeks during treatment, and 4 weeks after the treatment has finished) except where it has been confirmed that the fallopian tubes have been severed and sealed, to stop eggs from reaching the uterus (tubal sterilisation) AND
Slovenian: • boste opravili test nosečnosti pod zdravnikovim nadzorom (pred vsakim zdravljenjem, vsake 4 tedne med zdravljenjem in 4 tedne po koncu zdravljenja), razen če je bilo potrjeno, da sta bila jajcevoda zvezana, tako da jajčeca ne dosežejo maternice (sterilizacija jajcevodov)
English: • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans Obligations of the health care professional in relation to the prescribing of Lenalidomide Accord
Slovenian: • potrebo po izogibanju fetalni izpostavljenosti zaradi teratogenosti lenalidomida pri živalih in pričakovanega teratogenega učinka lenalidomida pri človeku;
English: Due to the teratogenic potential, lenalidomide must be prescribed under a Pregnancy Prevention Programme (see section 4.4) unless there is reliable evidence that the patient does not have childbearing potential.
Slovenian: Zaradi teratogenega potenciala je treba lenalidomid predpisovati v skladu s programom za preprečevanje nosečnosti, razen če obstajajo zanesljivi dokazi, da bolnica ne more zanositi.
English: Basal cell carcinoma^,◊, Squamous skin cancer^,◊,*
Slovenian: občasni bazalnocelični karcinom^,◊, ploščatocelični karcinom kože^,◊,*
English: 58.9 (56.0, NE) 56.7 (50.1, NE) 48.5 (44.2, 52.0)
Slovenian: 56,7 (50,1; NE) 48,5 (44,2; 52,0)