natgillin/translations-raw huggingface dataset:
In clinical studies with axitinib for the treatment of patients with RCC, cardiac failure events (including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular failure) were reported (see section 4.8).
V kliničnih študijah z aksitinibom pri zdravljenju bolnikov z RCC so poročali o dogodkih srčnega popuščanja (vključno s srčnim popuščanjem, kongestivnim srčnim popuščanjem, kardiopulmonalno odpovedjo, disfunkcijo levega prekata, zmanjšanim iztisnim deležem in popuščanjem desnega prekata) (glejte poglavje 4.8).
In clinical studies with axitinib for the treatment of patients with RCC, events of hypothyroidism and, to a lesser extent, hyperthyroidism, were reported (see section 4.8).
V kliničnih študijah z aksitinibom pri zdravljenju bolnikov z RCC so poročali o primerih hipotiroidizma in, v manjšem obsegu, hipertiroidizma (glejte poglavje 4.8).
In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported (see section 4.8).
V kliničnih študijah z aksitinibom pri zdravljenju bolnikov z RCC so o hipertenziji poročali zelo pogosto (glejte poglavje 4.8).
In clinical studies with axitinib for the treatment of patients with RCC, patients with serum creatinine > 1.5 times the ULN or calculated creatinine clearance < 60 mL/min were excluded.
V klinične študije z aksitinibom pri zdravljenju bolnikov z RCC niso bili vključeni bolniki, pri katerih je raven serumskega kreatinina presegala 1,5-kratnik ZMN oziroma je izračunani očistek kreatinina znašal < 60 ml/min.
In clinical studies with axitinib, arterial embolic and thrombotic events (including transient ischemic attack, myocardial infarction, cerebrovascular accident and retinal artery occlusion) were reported (see section 4.8).
V kliničnih študijah z aksitinibom so poročali o arterijskih emboličnih in trombotičnih dogodkih (vključno s prehodno možgansko ishemijo, miokardnim infarktom, cerebrovaskularnim insultom in zaporo mrežnične arterije) (glejte poglavje 4.8).
In clinical studies with axitinib, events of gastrointestinal perforation and fistulas were reported (see section 4.8).
V kliničnih študijah z aksitinibom so poročali o pojavu perforacij prebavil in fistul (glejte poglavje 4.8).
In clinical studies with axitinib, events of PRES were reported (see section 4.8).
V kliničnih študijah z aksitinibom so poročali o primerih sindroma posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome) (glejte poglavje 4.8).
In clinical studies with axitinib, haemorrhagic events were reported (see section 4.8).
V kliničnih študijah z aksitinibom so poročali o pojavu krvavitev (glejte poglavje 4.8).
In clinical studies with axitinib, the systemic exposure to axitinib was approximately two-fold higher in subjects with moderate hepatic impairment (Child-Pugh class B) compared to subjects with normal hepatic function.
V kliničnih študijah z aksitinibom je bila sistemska izpostavljenost aksitinibu pri osebah z zmerno okvaro jeter (razred B po Child-Pughu) približno dvakrat večja kot pri osebah z normalnim delovanjem jeter.
In clinical studies with axitinib, venous embolic and thrombotic events (including pulmonary embolism, deep vein thrombosis, and retinal vein occlusion/thrombosis) were reported (see section 4.8).
V kliničnih študijah z aksitinibom so poročali o venskih emboličnih in trombotičnih dogodkih (vključno s pljučno embolijo, globoko vensko trombozo in zaporo/trombozo mrežnične vene) (glejte poglavje 4.8).
In clinical studies with Azomyr, the following side effects were reported as: Children
V kliničnih študijah z zdravilom Azomyr so poročali o naslednjih neželenih učinkih: Otroci
In clinical studies with Azomyr, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
V kliničnih študijah z zdravilom Azomyr so poročali o naslednjih neželenih učinkih: Pogosti: naslednji se lahko pojavijo pri največ 1 od 10 bolnikov
In clinical studies with desloratadine, the following side effects were reported as: Common (the following may affect up to 1 in 10 people):
V kliničnih študijah z desloratadinom so poročali o naslednjih neželenih učinkih: Pogosti: naslednji se lahko pojavijo pri največ 1 od 10 bolnikov
In clinical studies with desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
V kliničnih študijah z desloratadinom so poročali o naslednjih neželenih učinkih: Pogosti: naslednji se lahko pojavijo pri največ 1 od 10 bolnikov
In clinical studies with desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
V kliničnih študijah z zdravilom Desloratadin ratiopharm so poročali o naslednjih neželenih učinkih: Pogosti: naslednji se lahko pojavijo pri največ 1 od 10 bolnikov
In clinical studies with desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
V kliničnih študijah z zdravilom Desloratadin Teva so poročali o naslednjih neželenih učinkih: Pogosti: naslednji se lahko pojavijo pri največ 1 od 10 bolnikov
In clinical studies with doses up to 700 mg/m2 given every 2 weeks the safety profile was consistent with that described in section 4.8.
V kliničnih študijah z odmerki do 700 mg/m², ki so se dajali vsaka dva tedna, je bil varnostni profil skladen s profilom, opisanim v poglavju 4.8.
In clinical studies with filgrastim administration to HIV patients, the only adverse effects consistently considered to be related to filgrastim administration were musculoskeletal pain, bone pain and myalgia.
V kliničnih študijah, kjer so filgrastim prejemali bolniki s HIV, so bili edini neželeni učinki, za katere so utemeljeno menili, da so povezani z uporabo filgrastima, mišično-skeletna bolečina, bolečina v kosteh in mialgija.
In clinical studies with infliximab in which 5,780 patients were treated, representing 5,494 patient years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no lymphomas and 1 non-lymphoma malignancy in 1,600 placebo-treated patients representing
V kliničnih študijah z infliksimabom, v katerih je bilo zdravljenih 5780 bolnikov, to pomeni skupaj 5494 bolnikov x let, so odkrili 5 primerov limfoma in 26 nelimfomskih rakavih bolezni, pri 1600 s placebom zdravljenih bolnikih, to pomeni skupaj 941 bolnikih x letih, pa nič limfomov in
In clinical studies with Kyprolis, cardiac failure was reported in approximately 7% of subjects (< 5% of subjects had grade ≥ 3 events), myocardial infarction was reported in approximately 2% of subjects (< 1.5% of subjects had grade ≥ 3 events) and myocardial ischaemia was reported in approximately 1% of subjects (< 1% of subjects had grade ≥ 3 events).
V kliničnih študijah z zdravilom Kyprolis so poročali o srčnem popuščanju pri približno 7 % bolnikov (pri < 5 % bolnikov je bilo ≥ 3. stopnje), miokardnem infarktu pri približno 2 % bolnikov (pri < 1,5 % bolnikov je bil ≥ 3. stopnje) in ishemiji miokarda pri približno 1 % bolnikov (pri < 1 % bolnikov je bila ≥ 3. stopnje).
In clinical studies with lamivudine-refractory patients, 4% had ALT elevations > 3 times baseline, and
V kliničnih študijah pri bolnikih, ki se niso odzivali na zdravljenje z lamivudinom, so bile pri 4% bolnikov vrednosti ALT > 3 krat večje od izhodiščnih vrednosti.
In clinical studies with Neoclarityn, the following side effects were reported as: Children
V kliničnih študijah z zdravilom Neoclarityn so poročali o naslednjih neželenih učinkih: Otroci
In clinical studies with Neoclarityn, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
V kliničnih študijah z zdravilom Neoclarityn so poročali o naslednjih neželenih učinkih: Pogosti: naslednji se lahko pojavijo pri največ 1 od 10 bolnikov
In clinical studies with patients with resistance or intolerance to prior imatinib therapy, it was recommended that treatment with imatinib be discontinued at least 7 days before starting treatment with SPRYCEL.
V kliničnih študijah pri bolnikih, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali, je veljalo priporočilo, da se zdravljenje z imatinibom prekine vsaj 7 dni pred uvedbo zdravljenja z zdravilom SPRYCEL.
In clinical studies with pazopanib, events of QT prolongation and Torsade de Pointes have occurred (see section 4.8).
V kliničnih študijah s pazopanibom so poročali o pojavu podaljšanja intervala Q-T in tahikardiji torsade de pointes (glejte poglavje 4.8).
In clinical studies with pazopanib, myocardial infarction, ischemic stroke, and transient ischemic attack were observed (see section 4.8).
V kliničnih študijah s pazopanibom so poročali o pojavu miokardnega infarkta, ishemične kapi in tranzitorne ishemične atake (glejte poglavje 4.8).
In clinical studies with psoriasis patients, dimethyl fumarate affected lymphocyte phenotypes through a down-regulation of pro- inflammatory cytokine profiles (TH1, TH17), and biased towards anti-inflammatory production (TH2).
V kliničnih študijah pri bolnikih s psoriazo je dimetilfumarat vplival na fenotipe limfocitov z zmanjšanjem profilov provnetnih citokinov (TH1, TH17), s čimer zavira protivnetni odziv (TH2).
In clinical studies with tocilizumab, rapid decreases in CRP, erythrocyte sedimentation rate (ESR) and serum amyloid A (SAA) were observed.
V kliničnih študijah s tocilizumabom so opažali hitro znižanje CRP, hitrosti sedimentacije eritrocitov (SR) in serumskega amiloida A (SAA).
In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/dl.
Med kliničnimi študijami zdravljenja raka materničnega vratu je bilo zdravljenje s topotekanom v kombinaciji s cisplatinom uvedeno le pri bolnicah, ki so imele vrednost serumskega kreatinina manjšo ali enako 1,5 mg/dl.
In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 132 μmol/l.
V kliničnih študijah uporabe topotekana v kombinaciji s cisplatinom za zdravljenje raka materničnega vratu je bilo zdravljenje uvedeno le pri tistih bolnicah, ki so imele vrednost kreatinina v serumu ≤
In clinical studies with Ultibro Breezhaler, paradoxical bronchospasm was not observed.
V kliničnih študijah z zdravilom Ultibro Breezhaler niso opažali paradoksnega bronhospazma, opažali pa so ga pri uporabi drugih inhalacijskih zdravil.
In clinical studies with Ulunar Breezhaler, paradoxical bronchospasm was not observed.
V kliničnih študijah z zdravilom Ulunar Breezhaler niso opažali paradoksnega bronhospazma, opažali pa so ga pri uporabi drugih inhalacijskih zdravil.
In clinical studies with Xoterna Breezhaler, paradoxical bronchospasm was not observed.
V kliničnih študijah z zdravilom Xoterna Breezhaler niso opažali paradoksnega bronhospazma, opažali pa so ga pri uporabi drugih inhalacijskih zdravil.
In clinical studies – Genotype 1
V kliničnih študijah – genotip 1
In clinical studies – Genotype 2, 3, 4, 5 and 6
V kliničnih študijah – genotip 2, 3, 4, 5 in 6
In clinical studies, 0.1% of patients (7 out of 4846 patients with primary hyperlipidaemia and mixed dyslipidaemia and 0 out of 80 patients with homozygous familial hypercholesterolaemia) treated with at least one dose of Repatha tested positive for binding antibody development (4 of these patients had transient antibodies).
V kliničnih študijah je imela 0,1 % bolnikov (7 od 4.846 bolnikov s primarno hiperlipidemijo in mešano dislipidemijo ter 0 od 80 bolnikov s homozigotno družinsko hiperholesterolemijo), ki so prejeli vsaj en odmerek zdravila Repatha, pozitiven izvid testiranja za ne-nevtralizacijska protitelesa (4 od teh bolnikov so imeli prehodna protitelesa).
In clinical studies, 2,011 subjects received Cubicin.
V kliničnih študijah je več kot 2.011 oseb prejemalo zdravilo Cubicin.
In clinical studies, 23.8% of subjects receiving naltrexone / bupropion and 11.9% of subjects receiving placebo discontinued treatment due to an adverse event.
V kliničnih študijah je bilo pri 23,8 % preiskovancev, ki so prejemali naltrekson/bupropion, in 11,9 % preiskovancev, ki so prejemali placebo, zdravljenje prekinjeno zaradi neželenega učinka.
In clinical studies, 60.2% of women aged 16 through 26 years who received Gardasil 9 used hormonal contraceptives during the vaccination period of the clinical studies.
V kliničnih študijah je 60,2 % žensk, starih od 16 do 26 let, ki so prejele cepivo Gardasil 9, v obdobju cepljenja uporabljalo hormonske kontraceptive.
In clinical studies, 88.9% (8/9) of patients with late first relapse as defined in the individual studies achieved CR/CRh* within the first 2 treatment cycles with 62.5% (6/9) achieving MRD response and 37.5 % (3/9) undergoing allogeneic HSCT after treatment with BLINCYTO.
V kliničnih študijah je 88,9 % (8/9) bolnikov s poznim prvim recidivom, kot je definiran v individualnih študijah, doseglo CR/CRh* med prvima 2 ciklusoma zdravljenja, 62,5 % (6/9) jih je doseglo odziv minimalne rezidualne bolezni, in 37,5 % (3/9) jih je po zdravljenju z zdravilom BLINCYTO opravilo alogensko presaditev krvotvornih matičnih celic.
In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 2.4 MU/kg/day (24 micrograms/kg/day).
V kliničnih preskušanjih so pri 97% bolnikov, ki so se odzivali, dosegli popoln odziv z odmerki ≤ 2,4 M e./kg/dan (24 mikrogramov/kg/dan).
In clinical studies, > 90 % of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
V kliničnih preskušanjih se je več kot 90 % bolnikov odzvalo na te odmerke, tako da so za ustavitev napredovanja nevtropenije v povprečju potrebovali 2 dni.
In clinical studies, a small number of patients fainted.
V kliničnih študijah se je omedlevica pojavila pri nizkem številu bolnikov.
In clinical studies, about one quarter of the patients required more than 3 leukapheresis procedures in order to receive 3 infusions of Provenge.
V kliničnih študijah so bili pri približno eni četrtini bolnikov potrebni več kot 3 postopki levkafereze za prejem 3 infuzij zdravila Provenge.
In clinical studies, Activyl was co-administered with deltamethrin collars impregnated with up to 4% deltamethrin without evidence of associated adverse reactions.
V kliničnih študijah so dajali zdravilo Activyl skupaj z ovratnicami, ki so bile impregnirane z do 4% deltametrina in niso ugotovili s tem povezanih stranskih učinkov.
In clinical studies, after over 3 years (40 months) of treatment arterial and venous occlusive adverse events (clots or blockages in the arteries or veins) occurred in 23% of patients, with serious adverse events occurring in 18% of patients.
V kliničnih študijah so se po več kot treh letih (40 mesecih) zdravljenja pri 23 % bolnikov pojavili neželeni arterijski in venski okluzivni dogodki (strdki ali zapore v arterijah ali venah), od tega so se resni neželeni dogodki pojavili pri 18 % bolnikov.
In clinical studies, antibodies that cross- react with human insulin and insulin glargine were observed with the same frequency in both NPH- insulin and insulin glargine treatment groups.
V kliničnih raziskavah so protitelesa, ki navzkrižno reagirajo s človeškim insulinom in insulinom glargin, enako pogosto ugotavljali med prejemniki insulina NPH in insulina glargin.
In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups.
V kliničnih raziskavah so protitelesa, ki navzkrižno reagirajo s človeškim insulinom in insulinom glargin, enako pogosto ugotavljali med prejemniki insulina NPH in insulina glargin.
In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups.
V kliničnih študijah so protitelesa, ki navzkrižno reagirajo s humanim insulinom in insulinom glargin, enako pogosto ugotavljali med prejemniki insulina NPH in insulina glargin.
In clinical studies, approximately 60% of women who received Cervarix used hormonal contraceptives.
Hormonske kontraceptive je v kliničnih študijah uporabljalo približno 60 % žensk, ki so bile cepljene s cepivom Cervarix.
In clinical studies, approximately 78 patients were evaluated with elotuzumab at 20 mg/kg without apparent toxic effects.
V kliničnih študijah so pri približno 78 bolnikih vrednotili uporabo elotuzumaba v odmerku 20 mg/kg brez pojava neželenih učinkov.
In clinical studies, apremilast has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and saliycyilic acid scalp preparations) and UVB phototherapy.
V kliničnih študijah so dajali apremilast sočasno z lokalno terapijo (vključno s kortikosteroidi, šamponom s premogovim katranom in pripravki za lasišče s salicilno kislino) in s fototerapijo z UVB.
In clinical studies, cancers were observed in patients receiving Isentress at a rate similar to that observed in the patients receiving other HIV treatment that doesn’t contain Isentress.
V kliničnih študijah so pri bolnikih, ki so prejemali zdravilo Isentress, rakava obolenja opazili v podobnem odstotku kot pri bolnikih, ki so prejemali druga zdravila proti HIV, ki niso vsebovala zdravila Isentress.
In clinical studies, cangrelor has been co-administered with bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors (abciximab, eptifibatide, tirofiban) with no apparent effect upon the pharmacokinetics or pharmacodynamics of cangrelor.
V kliničnih študijah so kangrelor dajali sočasno z bivalirudinom, nizkomolekularnim heparinom, fondaparinuksom in zaviralci GP Iib/IIIa (abciksimab, eptifibatid, tirofiban) brez opaznega učinka na farmakokinetiko ali farmakodinamiko kangrelorja.
In clinical studies, CAPS patients who have uncontrolled over-production of IL-1 beta show a rapid response to therapy with canakinumab, i.e. laboratory parameters such as high C-reactive protein (CRP) and serum amyloid A (SAA), high neutrophil and platelet counts, and leukocytosis rapidly returned to normal.
V kliničnih študijah je pri bolnikih, ki so imeli katerega od s kriopirinom povezanih periodičnih sindromov (CAPS) in nenadzorovano prekomerno tvorbo IL-1 beta, prišlo do hitrega odziva na zdravljenje s kanakinumabom, kar pomeni, da so se pri njih laboratorijski parametri, kot so koncentracije C-reaktivnega proteina (CRP), serumskega amiloida A (SAA) in zvišano število nevtrofilcev ter trombocitov in levkocitoza hitro vrnili na normalne vrednosti.
In clinical studies, CAPS patients who have uncontrolled over-production of IL-1β show a rapid response to therapy with rilonacept, i.e. laboratory parameters such as C-reactive protein (CRP) and serum amyloid A (SAA) levels, leukocytosis, and high platelet count rapidly returned to normal.
V kliničnih študijah se bolniki s CAPS, ki imajo nenadzorovano hiperprodukcijo IL-1βhitro odzovejo na zdravljenje z rilonaceptom, t.j., laboratorijski parameteri, na primer koncentracije C-reaktivnega proteina (CRP) in serumskega amiloida A (SAA), levkocitoza in zvišana koncentracija trombocitov, se hitro vrnejo na normalne vrednosti.
In clinical studies, colestilan had no effect on serum calcium levels over a period of up to one year.
V kliničnih študijah kolestilan ni vplival na ravni kalcija v serumu v obdobju do enega leta.
In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events.
V kliničnih študijah je sočasna uporaba abatacepta in zdravila Enbrel zvečala incidenco resnih neželenih učinkov.
In clinical studies, dopaminergic adverse reactions, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
V kliničnih raziskavah so bili neželeni dopaminergični učinki (npr. diskinezija) pogostejši pri bolnikih, ki so prejemali entakapon in agoniste dopamina (kot je bromokriptin), selegilin ali amantadin, kot pa pri tistih, ki so prejemali to kombinacijo s placebom.
In clinical studies, dopaminergic adverse reactions, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
V kliničnih raziskavah so bili neželeni dopaminergični učinki, npr. diskinezija, pogostejši pri bolnikih, ki so prejemali entakapon in agoniste dopamina (kot je bromokriptin), selegilin ali amantadin, kot pa pri tistih, ki so prejemali to kombinacijo s placebom.
In clinical studies, for patients treated with pegvisomant (n=550), the majority of adverse reactions to pegvisomant were of mild to moderate intensity, of limited duration and did not require discontinuation of treatment.
V kliničnih študijah je bila večina neželenih učinkov pri bolnikih, zdravljenih s pegvisomantom (n = 550), blagih do zmernih, omejenega trajanja in zaradi njih zdravljenja ni bilo treba prekiniti.
In clinical studies, haemorrhages were the most commonly reported reaction.
V kliničnih študijah so bile krvavitve najpogosteje opisan neželeni učinek.
In clinical studies, Helixate NexGen has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated paediatric patients (MTPs, defined as having ≤4 exposure days) with residual FVIII:C < 2 IU/dl.
V kliničnih študijah so zdravilo Helixate NexGen uporabili za zdravljenje krvavitev pri 37 predhodno nezdravljenih bolnikih in 23 minimalno zdravljenih pediatričnih bolnikih (MTP – minimally treated patient, kar pomeni, da so bili izpostavljeni 4 dni ali manj) z rezidualnim faktorjem VIII: c < 2 i.e./dl.
In clinical studies, hypertension adverse events occurred in approximately 20% of subjects and approximately 6% of subjects had grade ≥ 3 hypertension events, but hypertensive crises occurred in < 0.5% of subjects.
V kliničnih študijah se je hipertenzija kot neželen učinek pojavila pri približno 20 % preiskovancev; približno 6 % bolnikov je imelo hipertenzivne dogodke ≥ 3. stopnje, toda hipertenzivne krize so se pojavile pri < 0,5 % preiskovancev.
In clinical studies, Ilaris has been safely administered with ULT.
V kliničnih študijah je bila sočasna uporaba zdravila Ilaris in zdravil za zmanjševanje količine urata varna.
In clinical studies, inadequate response to treatment was seen in 10–15% of the dogs.
V kliničnih študijah je bil neustrezen odgovor na zdravljenje viden pri 10 - 15 % psov.
In clinical studies, infections have been observed in patients receiving Cosentyx (see section 4.8).
V kliničnih študijah so pri bolnikih, ki so prejemali zdravilo Cosentyx, opažali pojavljanje okužb (glejte poglavje 4.8).
In clinical studies, luteal phase support was given according to study centres’ practice or according to the clinical protocol.
V kliničnih študijah so dajali podporo lutealne faze glede na prakso raziskovalnega centra ali glede na klinični protokol.
In clinical studies, more than 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
V kliničnih študijah se je več kot 90% bolnikov odzvalo na te odmerke in za dosego preobrata nevtropenije so v povprečju potrebovali 2 dni.
In clinical studies, neutralising antibodies have not been observed for Prolia.
V kliničnih študijah niso ugotovili nevtralizirajočih protiteles proti zdravilu Prolia.
In clinical studies, neutralising antibodies have not been observed for XGEVA.
V kliničnih študijah niso ugotovili nevtralizirajočih protiteles proti zdravilu XGEVA.
In clinical studies, no dosage adjustment was required in elderly (> 65 years) patients exposed to pomalidomide.
V kliničnih študijah pri starejših bolnikih (> 65 let), izpostavljenih pomalidomidu, prilagoditev odmerka ni bila potrebna.