FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary toxicities observed in monkeys were associated with the haematopoietic/lymphoreticular systems.
Slovenian: Primarne toksičnosti, ki so jih opazili pri opicah, so bile povezane s hematopoetskim/limforetikularnim sistemom.
English: • National or other applicable specific arrangements for a prescription for pomalidomide to be dispensed
Slovenian: • nacionalne in druge ustrezne dogovore glede predpisovanja in izdajanja pomalidomida;
English: Decrease dose by one dose level.
Slovenian: Odmerek zmanjšajte za eno raven.
English: The majority of patients were male (59%) and white (79%); the median age for the overall population was 64 years (min, max: 35, 87 years).
Slovenian: Večina bolnikov je bila moških (59 %) in belcev (79 %); mediana starost celotne populacije je bila 64 let (min, maks: 35, 87 let).
English: Celgene Distribution B.V. Winthontlaan 6 N 3526 KV Utrecht Netherlands
Slovenian: Winthontlaan 6 N 3526 KV Utrecht Nizozemska
English: Based on the results of both PFS and OS endpoints, the Data Monitoring Committee established for this study recommended that the study be completed and patients in the HD-Dex arm be crossed over to the Pom + LD-Dex arm.
Slovenian: Na podlagi rezultatov obeh končnih ciljev PFS in celokupnega preživetja je Odbor za spremljanje podatkov (Data Monitoring Committee) za to študijo priporočil, da se zaključi, bolnike iz skupine VOdeks pa se priključi skupini POM + NO-deks.
English: Significant cardiac dysfunction
Slovenian: Pomembna motnja v delovanju srca
English: Date of first authorisation: 05 August 2013 Date of latest renewal: 11 July 2018
Slovenian: Datum zadnjega podaljšanja: 11. julij 2018
English: Patients with significant cardiac dysfunction (congestive heart failure [NY Heart Association Class III or IV]; myocardial infarction within 12 months of starting study; unstable or poorly controlled angina pectoris) were excluded from clinical studies with pomalidomide.
Slovenian: Bolniki s pomembno motnjo v delovanju srca (kongestivno srčno popuščanje [razred III ali IV po razvrstitvi NYHA]; miokardni infarkt v 12 mesecih od začetka študije; nestabilna ali slabo nadzirana angina pektoris) so bili iz kliničnih študij s pomalidomidom izključeni.
English: • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential)
Slovenian: • starost ≥ 50 let in naravna amenoreja ≥ 1 leto (amenoreja po zdravljenju raka ali med dojenjem ne izključuje zmožnosti zanositve),
English: Coadministration with a high-fat and high-calorie meal slows the rate of absorption, decreasing mean plasma Cmax by approximately 27%, but has minimal effect on the overall extent of absorption with an 8% decrease in mean AUC.
Slovenian: Sočasno dajanje z obrokom z visoko vsebnostjo maščob ali z visokokaloričnim obrokom upočasni hitrost absorpcije, zniža srednjo Cmax v plazmi za približno 27 %, vendar ima minimalni učinek na splošni obseg absorpcije z 8 % znižanjem srednje AUC.
English: Anticoagulation therapy (unless contraindicated) is recommended, (such as acetylsalicylic acid, warfarin, heparin or clopidogrel), especially in patients with additional thrombotic risk factors.
Slovenian: Priporoča se antikoagulacijsko zdravljenje (razen kjer je kontraindicirano) (kot so acetilsalicilna kislina, varfarin, heparin ali klopidogrel), zlasti pri bolnikih z dodatnimi dejavniki tveganja za trombozo.
English: If you notice any changes to your skin whilst taking Imnovid, tell your doctor as soon as possible.
Slovenian: Če opazite kakršne koli spremembe na koži, medtem ko jemljete zdravilo Imnovid, to čimprej povejte zdravniku;
English: The test should ensure the patient is not pregnant when she starts treatment with pomalidomide.
Slovenian: Test mora zagotavljati, da bolnica ob začetku zdravljenja s pomalidomidom ni noseča.
English: Strong CYP1A2 inhibitors
Slovenian: Močni zaviralci CYP1A2
English: Interrupt pomalidomide treatment for remainder of cycle.
Slovenian: Prekinite zdravljenje s pomalidomidom za preostali del cikla.
English: • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o To ensure that all appropriate measures have been performed prior to pomalidomide being dispensed
Slovenian: • za državo značilnih zahtev, po dogovoru s pristojnim nacionalnim organom, glede: o distribucije zdravila, o zagotovitve izvajanja vseh ustreznih ukrepov pred izdajanjem pomalidomida.
English: Progression free survival (PFS), N Censored, n (%)
Slovenian: Preživetje brez napredovanja (PFS), N Cenzurirano, n (%)
English: In the presence of pomalidomide in vitro, substrate proteins Aiolos and Ikaros are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.
Slovenian: V prisotnosti pomalidomida in vitro sta substratni beljakovini Aiolos in Ikaros tarči ubikvitinacije in poznejše degradacije, kar vodi v neposredne citotoksične in imunomodulatorne učinke.
English: It is important to note that patients with multiple myeloma treated with pomalidomide may develop additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed this medicine.
Slovenian: Pomembno je opomniti, da se lahko pri bolnikih z diseminiranim plazmocitomom, ki so zdravljeni s pomalidomidom, razvijejo dodatne vrste raka, zato mora zdravnik, ki zdravilo predpiše, skrbno oceniti koristi in tveganja.
English: There have also been cases of hepatitis that resulted in discontinuation of pomalidomide.
Slovenian: Prišlo je tudi do primerov hepatitisa, ki so privedli do ukinitve zdravljenja s pomalidomidom.
English: • Description of the patient card and its necessity
Slovenian: • opis kartice za bolnika in razlago, zakaj je potrebna;
English: Pomalidomide is present in human semen.
Slovenian: Pomalidomid je prisoten v spermi.
English: Pomalidomide must be discontinued for exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for these reactions.
Slovenian: Pomalidomid je treba ukiniti pri eksfoliativnem ali buloznem izpuščaju ali če posumimo na SJS, TEN ali DRESS in ga po ukinitvi zaradi teh reakcij ne smemo spet začeti dajati.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake "EXP".
English: • If your partner is pregnant or able to become pregnant, you must use condoms for the whole time you are taking treatment and for 7 days after the end of treatment.
Slovenian: • Če je vaša partnerica noseča ali lahko zanosi, morate uporabljati kondome ves čas jemanja zdravila in še 7 dni po koncu zdravljenja.
English: In vitro, CYP1A2 and CYP3A4 were identified as the primary enzymes involved in the CYP-mediated hydroxylation of pomalidomide, with additional minor contributions from CYP2C19 and CYP2D6.
Slovenian: In vitro sta bila encima CYP1A2 in CYP3A4 opredeljena kot primarna encima, ki sodelujeta v hidroksilaciji pomalidomida, ki jo posreduje encim CYP, z dodatnimi manjšimi prispevki encimov CYP2C19 in CYP2D6.
English: A total of 455 patients were enrolled in the study: 302 in the Pom+LD-Dex arm and 153 in the HD-Dex arm.
Slovenian: V študijo je bilo vključenih skupaj 455 bolnikov: 302 v skupino POM + NO-deks in 153 v skupino VO-deks.
English: Patients should be monitored for haematological adverse reactions, especially neutropenia.
Slovenian: Bolnike je treba spremljati za hematološke neželene učinke, zlasti nevtropenijo.
English: Discontinue dexamethasone from treatment regimen.
Slovenian: Izpustite deksametazon iz režima zdravljenja.
English: Close monitoring of warfarin concentration is advised during treatment.
Slovenian: Zato je med zdravljenjem priporočeno pozorno spremljati koncentracijo varfarina.
English: Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma cell').
Slovenian: Diseminirani plazmocitom je vrsta raka, ki prizadene določeno vrsto belih krvnih celic (imenovanih "plazmatke").
English: Physicians should observe patients for signs of bleeding including epistaxes, especially with use of concomitant medicinal products known to increase the risk of bleeding (see section 4.8).
Slovenian: Zdravniki morajo bolnike nadzirati glede znakov krvavitve, vključno z epistaksami, zlasti ob sočasni uporabi zdravil, za katera je znano, da povečujejo tveganje za krvavitve (glejte poglavje 4.8).
English: Pomalidomide was found to impact negatively on fertility and be teratogenic in animals.
Slovenian: Ugotovili so, da pomalidomid negativno vpliva na plodnost in je pri živalih teratogen.
English: Follow CBC*** weekly.
Slovenian: Tedensko spremljajte CKS***.
English: Day IMN BOR DEX
Slovenian: Dan IMN BOR deks
English: • Infections of the lungs (pneumonia and bronchitis).
Slovenian: • okužbe pljuč (pljučnica in bronhitis),
English: However, if you are over 75, the recommended starting dose is 10 mg per day.
Slovenian: Če ste starejši od 75 let, pa je priporočeni začetni odmerek 10 mg na dan.
English: Pomalidomide has a mean apparent volume of distribution (Vd/F) between 62 and 138 L at steady state.
Slovenian: Pomalidomid ima srednji navidezni volumen porazdelitve (Vd/F) med 62 in 138 l v stanju dinamičnega ravnovesja.
English: ANC** < 0.5 x 109/l or febrile neutropenia (fever ≥38.5°C and ANC <1 x 109/l)
Slovenian: • ANC** < 0,5 x 109/l ali febrilna nevtropenija (zvišana telesna temperatura ≥ 38,5 °C in ANC < 1 x 109/l)
English: • you have ever had an allergic reaction such as rash, itching, swelling, feeling dizzy or trouble breathing while taking related medicines called ‘thalidomide' or ‘lenalidomide'.
Slovenian: • ste kadar koli imeli alergijsko reakcijo, na primer izpuščaj, srbenje, oteklino, občutek vrtoglavice ali oteženo dihanje, medtem ko ste jemali sorodni zdravili, ki se imenujeta 'talidomid' ali 'lenalidomid';
English: Pack size of 14 or 21 capsules.
Slovenian: Velikost pakiranja je 14 ali 21 kapsul.
English: Refer also to the bortezomib SmPC.
Slovenian: Glejte tudi SmPC za bortezomib.
English: • Abnormal liver test.
Slovenian: • nenormalni rezultati jetrnih testov,
English: • Maximum duration of prescription o 4 weeks for women with childbearing potential o 12 weeks for men and women without childbearing potential
Slovenian: • najdaljši obdobje predpisanega zdravljenja: o 4 tedne za ženske v rodni dobi, o 12 tednov za moške in ženske, ki niso v rodni dobi,
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, objavljenem na evropskem spletnem portalu o zdravilih.
English: The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora o podrobnostih sistema nadzorovane distribucije dogovoriti s pristojnimi nacionalnimi organi in izvajati ta program na nacionalni ravni, da tako zagotovi naslednje:
English: Fatal infections (Grade 5) occurred in 2.7-4.0% of patients.
Slovenian: Smrtne okužbe (5. stopnja) so se pojavile pri 2,7-4,0 % bolnikov.
English: It is not known if Imnovid passes into human breast milk.
Slovenian: Ni znano, ali zdravilo Imnovid prehaja v materino mleko.
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants, ATC code: L04AX06
Slovenian: Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, druga zdravila za zaviranje imunske odzivnosti, oznaka ATC: L04AX06
English: In peripheral tissues, pomalidomide was preferentially taken up by tumors with apparent peripheral distribution clearance (Q/F) and apparent peripheral volume of distribution (V3/F) 3.7-fold and 8-fold higher, respectively, than that of healthy subjects.
Slovenian: V perifernih tkivih so pomalidomid najraje privzemali tumorji z navideznim perifernim porazdelitvenim očistkom (Q/F) in navideznim perifernim volumnom porazdelitve (V3/F), ki sta bila 3,7krat oziroma 8-krat večja kot pri zdravih osebah.
English: • The need to avoid foetal exposure due to teratogenicity of pomalidomide in animals and the expected teratogenic effect of pomalidomide in humans
Slovenian: • potrebo po izogibanju fetalni izpostavljenosti zaradi teratogenosti pomalidomida pri živalih in pričakovanega teratogenega učinka pomalidomida na človeka;
English: Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Slovenian: Bolnikom je treba naročiti, da nikoli ne dajo svojega zdravila drugim in da po koncu zdravljenja vrnejo neporabljene kapsule farmacevtu.
English: Your doctor may need to reduce the dose of Imnovid, bortezomib or dexamethasone or stop one or more of these medicines based on the results of your blood tests, your general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if you experience side effects (especially rash or swelling) from treatment.
Slovenian: Zdravnik lahko zmanjša vaš odmerek zdravila Imnovid, bortezomiba ali deksametazona ali ukine eno ali več teh zdravil na podlagi rezultatov vaših krvnih preiskav, splošnega stanja, drugih zdravil, ki jih mogoče jemljete (npr. ciprofloksacin, enoksacin in fluvoksamin), in če imate zaradi zdravljenja neželene učinke (posebno izpuščaj ali otekanje).
English: E3 ubiquitin ligases are responsible for the poly-ubiquitination of a variety of substrate proteins, and may partially explain the pleiotropic cellular effects observed with pomalidomide treatment.
Slovenian: Ubikvitin ligaze E3 so odgovorne za poli-ubikvitinacijo različnih substratnih beljakovin in lahko deloma razložijo pleiotropne celične učinke, ki jih ugotavljamo pri zdravljenju s pomalidomidom.
English: In addition, findings consistent with acute myelogenous leukemia led to euthanasia of 1 monkey; clinical observations and clinical pathology and/or bone marrow alterations observed in this animal were consistent with immunosuppression.
Slovenian: Poleg tega so izsledki, ki so kazali na akutno mielogeno levkemijo, povzročili evtanazijo 1 opice; klinična opazovanja in klinična patologija in/ali spremembe kostnega mozga, ki so jih pri tej živali opazili, so kazali na imunosupresijo.
English: For women of childbearing potential, pomalidomide is contraindicated unless all of the following are met:
Slovenian: Za ženske v rodni dobi je pomalidomid kontraindiciran, razen če so izpolnjeni vsi navedeni pogoji:
English: • Women of childbearing potential, unless all the conditions of the pregnancy prevention programme are met (see sections 4.4 and 4.6).
Slovenian: • ženske v rodni dobi, če ne izpolnjujejo vseh pogojev programa za preprečevanje nosečnosti (glejte poglavji 4.4 in 4.6),
English: The capsules are packaged in Polyvinyl chloride (PVC)/ polychlorotrifluoroethylene (PCTFE) blisters with push through aluminium foil.
Slovenian: Kapsule so pakirane v pretisne omote iz polivinilklorida (PVC)/poliklorotrifluoroetilena (PCTFE)/aluminijeve folije.
English: Interrupt dose until symptoms are controlled.
Slovenian: Prekinite odmerek, dokler simptomi niso pod nadzorom.
English: Administration of pomalidomide in smokers, with smoking tobacco known to induce the CYP1A2 isoform, had no clinically relevant effect on exposure to pomalidomide compared to that exposure to pomalidomide observed in non-smokers.
Slovenian: Uporaba pomalidomida pri kadilcih, pri čemer je znano, da kajenje tobaka inducira izoobliko CYP1A2, ni klinično pomembno vplivalo na izpostavljenost pomalidomidu v primerjavi s to izpostavljenostjo pri nekadilcih.
English: • Bleeding within the skull.
Slovenian: • krvavitve znotraj lobanje,
English: Based on population PK analysis using a two-compartment model, healthy subjects and MM patients had comparable apparent clearance (CL/F) and apparent central volume of distribution (V2/F).
Slovenian: Na podlagi analize populacijske farmakokinetike, z uporabo dvoprostornega modela, so imele zdrave osebe in bolniki z DP primerljiv navidezni očistek (CL/F) in navidezni centralni volumen porazdelitve (V2/F).
English: Pomalidomide is eliminated with a median plasma half-life of approximately 9.5 hours in healthy subjects and approximately 7.5 hours in patients with multiple myeloma.
Slovenian: Pomalidomid se izloča z mediano razpolovnega časa v plazmi približno 9,5 ur pri zdravih osebah in približno 7,5 ur pri bolnikih z diseminiranim plazmocitomom.
English: • Even if a woman of childbearing potential has amenorrhoea she must follow all the advice on effective contraception
Slovenian: • tudi če ima ženska v rodni dobi amenorejo, mora upoštevati vsa navodila za zanesljivo kontracepcijo,
English: Population Pharmacokinetics (PK)
Slovenian: Populacijska farmakokinetika (FK)
English: • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are provided with a physician information pack containing the following:
Slovenian: • pred predpisovanjem (kjer je ustrezno in v dogovoru s pristojnim nacionalnim organom, pred izdajanjem) morajo vsi zdravstveni delavci, ki nameravajo predpisovati (in izdajati) pomalidomid, prejeti paket izobraževalnih gradiv za zdravnike, ki vsebuje naslednje: o paket izobraževalnih gradiv za zdravstvene delavce,
English: Overall survival is summarised in Table 12 for the ITT population.
Slovenian: Celokupno preživetje je povzeto v preglednici 12 za populacijo ITT.
English: Frequencies are defined in accordance with current guidance, as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); and uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Njihova pogostnost je določena v skladu s trenutnimi smernicami kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
English: Pomalidomide is contraindicated during pregnancy and in women of childbearing potential, except when all the conditions for pregnancy prevention have been met, see section 4.3 and section 4.4.
Slovenian: Pomalidomid je med nosečnostjo in pri ženskah v rodni dobi kontraindiciran, razen če so izpolnjeni vsi pogoji za preprečevanje nosečnosti, glejte poglavje 4.3 in poglavje 4.4.
English: The 3 predominant metabolites in urine (formed via hydrolysis or hydroxylation with subsequent glucuronidation) account for approximately 23%, 17%, and 12%, respectively, of the dose in the urine.
Slovenian: Trije prevladujoči presnovki v urinu (nastanejo s hidrolizo ali hidroksilacijo, ki ji sledi glukuronidacija) predstavljajo 23 % oz. 17 % oz. 12 % odmerka v urinu.
English: • Decreased number of lymphocytes (one type of white blood cells) often caused by infection (lymphopenia).
Slovenian: • zmanjšano število limfocitov (vrsta belih krvničk), ki ga pogosto povzroči okužba (limfopenija),
English: • by stimulating the immune system to attack the cancer cells
Slovenian: • spodbuja imunski sistem, da napada rakave celice,
English: Infections led to pomalidomide discontinuation in 2.0-2.9% of patients.
Slovenian: Okužbe so povzročile ukinitev pomalidomida pri 2,0-2,9 % bolnikov.
English: The potential for such drug-drug interactions, including the potential impact of pomalidomide on the pharmacokinetics of combined oral contraceptives, has not been evaluated clinically (see section 4.4 Teratogenicity).
Slovenian: Potencial takega medsebojnega delovanja med zdravili, vključno z možnim vplivom pomalidomida na farmakokinetiko kombiniranih peroralnih kontraceptivov, ni bil klinično ocenjen (glejte poglavje 4.4., Teratogenost).
English: • Infections of the nose, sinuses and throat, caused by bacteria or viruses.
Slovenian: • okužbe nosu, obnosnih votlin (sinusov) in žrela, ki jih povzročijo bakterije ali virusi,
English: Log-Rank Test Two sided P-Value d
Slovenian: Test log-rank dvostranska vrednost p d
English: According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed for women of childbearing potential as outlined below.
Slovenian: V skladu z lokalno prakso je treba pri ženskah v rodni dobi opraviti test nosečnosti pod zdravniškim nadzorom, z občutljivostjo vsaj 25 m i.e./ml, kot je opisano spodaj.
English: • Medroxyprogesterone acetate depot
Slovenian: • depo medroksiprogesteronacetat,
English: The prescriber must inform the patient about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme and provide patients with appropriate patient educational brochure, patient card and/or equivalent tool in accordance with the national implemented patient card system.
Slovenian: Zdravniki, ki zdravilo predpisujejo, morajo bolnikom dati vse informacije o pričakovanem teratogenem tveganju in strogih ukrepih za preprečevanje nosečnosti, ki so določeni v programu za preprečevanje nosečnosti, in bolnikom izročiti ustrezno izobraževalno brošuro za bolnika, kartico bolnika in/ali enakovredno sredstvo v skladu z nacionalno uvedenim sistemom kartic za bolnika.
English: The recommended starting dose of bortezomib is 1.3 mg/m2 intravenous or subcutaneous once daily, on the days shown in Table 1.
Slovenian: Priporočeni začetni odmerek bortezomiba je 1,3 mg/m2 intravensko ali subkutano enkrat na dan, na dneve ki so prikazani v preglednici 1.
English: • Swelling of the body, including swelling of the arms or legs.
Slovenian: • oteklost telesa, vključno z otekanjem rok in nog.
English: The use of erythropoietic agents carries a risk of thrombotic events including thromboembolism.
Slovenian: Z uporabo eritropoetskih zdravil je povezano tveganje trombotičnih dogodkov, vključno z trombembolijo.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B.
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B.
English: If the patient forgets to take a dose of pomalidomide on one day, then the patient should take the normal prescribed dose as scheduled on the next day.
Slovenian: Če bolnik en dan pozabi vzeti odmerek pomalidomida, mora naslednji dan vzeti običajni predpisani odmerek.
English: These immunosuppressive effects resulted in early euthanasia of 4 monkeys due to poor health condition (watery stool, inappetence, reduced food intake, and weight loss); histopathologic evaluation of these animals showed chronic inflammation of the large intestine and villous atrophy of the small intestine.
Slovenian: Ti imunosupresivni učinki so povzročili zgodnjo evtanazijo 4 opic zaradi slabega zdravja (vodeno blato, neješčost, manjše uživanje hrane in izguba telesne mase); histopatološka ocena teh živali je pokazala kronično vnetje debelega črevesa in atrofijo črevesnih resic tankega črevesa.
English: • Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of your skin or growths on your skin.
Slovenian: • Nekatere vrste kožnega raka (ploščatocelični karcinom in bazalnocelični karcinom), ki lahko povzročijo spremembe videza kože ali rašče na koži.
English: The mean changes in exposure to pomalidomide in each of these renal impairment groups are not of a magnitude that requires dosage adjustments.
Slovenian: Srednje spremembe izpostavljenosti pomalidomidu v nobeni od teh skupin z okvaro ledvic niso tako velike, da bi bile potrebne prilagoditve odmerjanja.
English: This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure.
Slovenian: To lahko povzroči razkroj tumorjev in posledično neobičajno visoke ravni kemikalij v krvi, ki lahko povzročijo ledvično odpoved.