natgillin/translations-raw huggingface dataset:
Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Znotraj vsakega organskega sistema in skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Because of the potential for adverse reactions in breastfed infants from pomalidomide, a decision must be made whether to discontinue breast-feeding or to discontinue the medicinal product, taking into account the benefit of breast-feeding for the child and the benefit of the therapy for the woman. 
Zaradi možnih neželenih učinkov pomalidomida pri dojenih otrocih se je treba odločiti med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja, pri čemer je treba upoštevati koristi dojenja za otroka in koristi zdravljenja za žensko.
Insertion of copper-releasing intrauterine devices is not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with severe neutropenia or severe thrombocytopenia. 
Vstavljanje intrauterinih vložkov, ki sproščajo baker, ni priporočljivo zaradi možnega tveganja za nastanek okužb ob času vstavitve in med menstrualno krvavitvijo, kar lahko ogrozi bolnice z resno nevtropenijo ali resno trombocitopenijo.
PFS (months) Mediana time (95% CI) b HR c (95% CI), p-valued ORR, n (%) sCR 
PFS (meseci) Mediania čas (95 % IZ)b HR c (95 % IZ), vrednost pd ORR, n (%) sCR
• Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may dispense pomalidomide receive a Direct Healthcare Professional Communication as described below. 
• pred prihodom zdravila na trg morajo vsi zdravniki, ki nameravajo predpisovati pomalidomid, in vsi farmacevti, ki bodo izdajali pomalidomid, prejeti Neposredno obvestilo za zdravstvene delavce, kot je opisano spodaj;
The MAH should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below. 
Imetnik dovoljenja za promet z zdravilom se mora s pristojnim nacionalnim organom v vsaki državi članici dogovoriti o končnem besedilu Neposrednega obvestila za zdravstvene delavce in vsebini paketa izobraževalnih gradiv za zdravnike in zagotoviti, da gradiva vsebujejo ključne elemente, kot so opisani spodaj.
Clinically relevant drug-drug interactions are not anticipated when pomalidomide is coadministered with substrates of these pathways. 
Klinično pomembnega medsebojnega delovanja med zdravili se ne pričakuje, ko se pomalidomid daje sočasno s substrati teh poti.
Patients > 75 years of age started treatment with 20 mg dexamethasone. 
Bolniki stari > 75 let so zdravljenje začeli z 20 mg deksametazona.
Pomalidomide was detected in milk of lactating rats following administration to the mother. 
Pomalidomid so zaznali v mleku podgan med laktacijo, ko so ga dali materam.
o Educational Health Care Professional's kit o Educational brochures for patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling. 
o izobraževalne brošure za bolnike, o kartice za bolnike, o povzetek glavnih značilnosti zdravila (SmPC), navodilo za uporabo in označevanje.
Uterine examination on Gestation Day 13 showed a decrease in mean number of viable embryos and an increase in postimplantation loss at all dosage levels. 
Pregled v maternici na 13. dan gestacije je pokazal zmanjšano število zarodkov, sposobnih preživetja, in višjo izgubo po ugnezditvi pri vseh ravneh odmerkov.
Complete blood counts should be monitored at baseline, weekly for the first 8 weeks and monthly thereafter. 
Prvih 8 tednov je treba celotno krvno sliko spremljati na izhodišču, tedensko, nato pa vsak mesec.
Pomalidomide was not mutagenic in bacterial and mammalian mutation assays, and did not induce chromosomal aberrations in human peripheral blood lymphocytes or micronuclei formation in polychromatic erythrocytes in bone marrow of rats administered doses up to 2000 mg/kg/day. 
Pomalidomid v preskusih mutagenosti pri bakterijah in sesalcih ni bil mutagen in ni spodbudil kromosomske aberacije v limfocitih periferne krvi pri ljudeh ali nastajanja mikronukleusov v polikromatskih eritrocitih v kostnem mozgu podgan, ki so jim dajali odmerke do 2.000 mg/kg/dan.
Frequencies for Pom+Btz+Dex (any grade) 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). 
Pogostnosti za Pom+Btz+deks (vse stopnje) so opredeljene v skladu z veljavnimi smernicami kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
Stop taking Imnovid and see a doctor straight away if you notice any of the serious side effects listed above - you may need urgent medical treatment. 
Takoj prenehajte jemati zdravilo Imnovid in pojdite k zdravniku, če opazite kakega od zgoraj navedenih resnih neželenih učinkov - mogoče bo potrebno nujno medicinsko zdravljenje.
• She understands the need to commence the treatment as soon as pomalidomide is dispensed following a negative pregnancy test 
• mora razumeti potrebo, da prične z zdravljenjem, brž ko je izdan pomalidomid po negativnem testu nosečnosti,
Do not take Imnovid: 
Ne jemljite zdravila Imnovid:
These patients should be closely monitored for signs and symptoms of active HBV infection throughout therapy. 
Te bolnike morate ves čas zdravljenja skrbno spremljati glede znakov in simptomov aktivne infekcije s HBV.
Interrupt dose until muscle weakness ≤ Grade 1. 
Prekinite odmerek, dokler ni oslabelost mišic ≤ 1. stopnje.
Stop dexamethasone dosing until the adverse event resolves to ≤ Grade 2. 
Prenehajte dajati deksametazon, dokler se neželeni učinki ne zmanjšajo na ≤ 2. stopnjo.
Based on in vitro data, pomalidomide is not an inhibitor or inducer of cytochrome P-450 isoenzymes, and does not inhibit any drug transporters that were studied. 
Na podlagi podatkov in vitro pomalidomid ni zaviralec ali spodbujevalec izoencimov citokroma P-450 in ne zavira nobenega od prenašalcev zdravil, ki so jih proučevali.
Pomalidomide is absorbed with a maximum plasma concentration (Cmax) occurring between 2 and 3 hours and is at least 73% absorbed following administration of single oral dose. 
Ko se pomalidomid absorbira, so največje koncentracije v plazmi (Cmax) dosežene po 2 do 3 urah in vsaj 73 % se absorbira po uporabi enega peroralnega odmerka.
Patients with a prior history of serious allergic reactions associated with thalidomide or lenalidomide were excluded from clinical studies. 
Bolniki s predhodnimi resnimi alergijskimi reakcijami med zdravljenjem s talidomidom ali lenalidomidom so bili izključeni iz kliničnih študij.
PFS is summarised in Table 11 for the ITT population. 
PFS je povzeto v preglednici 11 za populacijo ITT.
Overall Survival (week) 
Celokupno preživetje (tedni)
The patient card shall contain the following elements: 
Kartica za bolnika mora vsebovati naslednje elemente:
Maintain dose and treat with histamine (H2) blockers or equivalent. 
Ohranite odmerek in zdravite z antagonisti histaminskih receptorjev (H2) ali enakovrednim zdravilom.
Peripheral neuropathy led to discontinuation of bortezomib in approximately 12.9% of patients, pomalidomide in 1.8% and dexamethasone in 2.2 - 8.9% of patients, respectively. 
Periferna nevropatija je povzročila ukinitev bortezomiba pri približno 12,9 % bolnikov, pomalidomida pri 1,8 % in deksametazona pri 2,2-8,9 % bolnikov.
• Urinary tract infection, which may cause a burning sensation when passing urine, or a need to pass urine more often. 
• okužbe sečil, ki lahko povzročijo pekoč občutek pri odvajanju urina ali potrebo po pogostnejšem odvajanju urina,
This includes vasectomised males who should wear a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential as seminal fluid may still contain pomalidomide in the absence of spermatozoa. 
To vključuje tudi moške, ki so imeli vazektomijo, ki morajo uporabljati kondom, če spolno občujejo z nosečnico ali žensko v rodni dobi, ker lahko semenska tekočina v odsotnosti semenčic še vedno vsebuje pomalidomid;
The most frequently reported adverse reaction was peripheral sensory neuropathy (47.8%). 
Neželeni učinek, o katerem so najpogosteje poročali, je bila periferna senzorična nevropatija (47,8 %).
95% confidence interval about the median progression free survival time. 
95 % interval zaupanja pri mediani časa preživetja brez napredovanja.
• That the patient should tell their doctor about any adverse events 
• opozorilo, da mora bolnik zdravniku poročati o kakršnihkoli neželenih učinkih.
CYP dependent metabolites account for approximately 43% of the total excreted radioactivity, while nonCYP dependent hydrolytic metabolites account for 25%, and excretion of unchanged pomalidomide accounted for 10% (2% in urine and 8% in faeces). 
Od CYP odvisni presnovki predstavljajo približno 43 % skupne izločene radioaktivnosti, hidrolitični presnovki, ki niso odvisni od CYP, predstavljajo 25 %, nespremenjenega pomalidomida pa se izloči 10 % (2 % v urinu in 8 % v blatu).
• Swallow the capsules whole, preferably with water. 
• Kapsule zaužijte cele, po možnosti z vodo.
• A fast and irregular heartbeat (atrial fibrillation). 
• hiter in nereden srčni utrip (atrijska fibrilacija),
Pomalidomide enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. 
Pomalidomid okrepi celično imunost, ki jo posredujejo celice T in naravne ubijalke (NK - Natural Killer), ter zavira nastajanje proinflamatornih citokinov (npr. TNF-α in IL-6) z monociti.
Do not increase the number of capsules you take to make up for not taking Imnovid the previous day. 
Ne povečajte števila kapsul, da bi nadomestili kapsulo zdravila Imnovid, ki ste jo prejšnji dan izpustili.
st relapse and approximately 73% of patients received bortezomib as prior treatment. 
Približno 40 % bolnikov je imelo prvi recidiv, približno 73 % bolnikov pa je kot predhodno zdravljenje prejemalo bortezomib.
• Severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile. 
• močna, trdovratna ali krvava driska (lahko z bolečinami v želodcu ali zvišano telesno temperaturo), ki jo povzročajo bakterije, ki se imenujejo Clostridium difficile;
The median duration of treatment was 8.8 months (12 treatment cycles) in the Pom+Btz+LD-Dex arm and 4.9 months (7 treament cycles) in the Btz+LD-Dex arm. 
Mediano trajanje zdravljenja je bilo 8,8 meseca (12 ciklov zdravljenja) v skupini Pom+Btz+NO-deks in 4,9 meseca (7 ciklov zdravljenja) v skupini Btz+NO-deks.
Resume at one dose level lower than previous dose at next cycle (adverse event must be resolved or improved to ≤ Grade 2 before restarting dosing). 
V naslednjem ciklu nadaljujte zdravljenje z odmerkom, za eno raven manjšim od predhodnega odmerka (pred ponovnim začetkom odmerjanja mora neželeni učinek izzveneti ali se ublažiti na ≤ 2. stopnjo).
No peripheral neuropathy reactions were reported as serious, and peripheral neuropathy led to dose discontinuation in 0.3% of patients (see section 4.4). 
O resnih reakcijah periferne nevropatije niso poročali, periferna nevropatija pa je povzročila ukinitev odmerjanja pri 0,3 % bolnikov (glejte poglavje 4.4).
However, patients with hepatic impairment should be carefully monitored for adverse reactions and dose reduction or interruption of pomalidomide should be used as needed. 
Vendar je treba bolnike z okvaro jeter skrbno spremljati glede neželenih učinkov in po potrebi zmanjšati odmerek ali prekiniti uporabo pomalidomida.
Patients receiving pomalidomide either in combination with bortezomib and dexamethasone or in combination with dexamethasone have developed venous thromboembolic events (predominantly deep vein thrombosis and pulmonary embolism) and arterial thrombotic events (myocardial infarction and cerebrovascular accident). 
Pri bolnikih, ki so prejemali pomalidomid bodisi v kombinaciji z bortezomibom in deksametazonom ali v kombinaciji z deksametazonom, so se razvili venski trombembolični dogodki (zlasti globoka venska tromboza in pljučna embolija) in arterijski trombotični dogodki (miokardni infarkt in cerebrovaskularni dogodek).
Not Known Hepatitis B reactivation 
neznana pogostnost reaktivacija hepatitisa B
PFS was evaluated in several relevant subgroups: gender, race, ECOG performance status, stratification factors (age, disease population, prior anti-myeloma therapies [2, > 2]), selected parameters of prognostic significance (baseline beta-2 microglobulin level, baseline albumin levels, baseline renal impairment, and cytogenetic risk), and exposure and refractoriness to prior anti-myeloma therapies. 
PFS je bilo ocenjeno v številnih pomembnih podskupinah: spol, rasa, status zmogljivosti po ECOG, stratifikacijski dejavniki (starost, populacija bolezni, predhodne terapije proti plazmocitomu [2, > 2]), izbrani parametri prognostične pomembnosti (raven beta-2 mikroglobulina ob izhodišču, ravni albumina ob izhodišču, okvara ledvic ob izhodišču in citogenetsko tveganje) in izpostavljenost in odpornost na predhodna zdravljenja proti plazmocitomu.
These cells grow out of control and accumulate in the bone marrow. 
Te celice začnejo nenadzorovano rasti in se kopičiti v kostnem mozgu.
Hepatic impairment has a modest effect on the pharmacokinetics of pomalidomide (see section 5.2). 
Okvara jeter zmerno vpliva na farmakokinetiko pomalidomida (glejte poglavje 5.2).
It is unknown whether pomalidomide is excreted in human milk. 
Ni znano, ali se pomalidomid izloča v materino mleko.
You and your partner should use effective methods of contraception while taking this medicine. 
Med jemanjem tega zdravila morate vi in vaš partner uporabljati zanesljivo metodo kontracepcije.
• Documentation of childbearing potential status 
• dokumentacijo o statusu zmožnosti zanositve,
Therefore, erythropoietic agents, as well as other agents that may increase the risk of thromboembolic events, should be used with caution. 
Zato je treba eritropoetska zdravila ali druga zdravila, ki lahko povečajo tveganje za trombozo, uporabljati previdno.
If you are uncertain whether any of the conditions above apply to you, talk to your doctor, pharmacist or nurse before taking Imnovid. 
Če ste negotovi, ali kateri od zgornjih pogojev velja za vas, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete zdravilo Imnovid.
Haemorrhagic disorders have been reported with pomalidomide, especially in patients with risk factors such as concomitant medicinal products that increase susceptibility to bleeding. 
Pri uporabi pomalidomida so poročali o krvavitvah, posebno pri bolnikih z dejavniki tveganja, kot so sočasna zdravila, ki zvečajo dovzetnost za krvavitve.
Kaplan-Meier Curve of Overall Survival (ITT Population) 
Krivulja celokupnega preživetja po lestvici Kaplan-Meier (populacija ITT)
This condition is called tumour lysis syndrome. 
To stanje se imenuje sindrom tumorske lize;
6.6 Special precautions for disposal and other handling Capsules should not be opened or crushed. 
6.6 Posebni varnostni ukrepi za odstranjevanje Kapsul ne odpirajte in ne drobite.
Pomalidomide has a mean total body clearance (CL/F) of approximately 7-10 L/hr. 
Pomalidomid ima povprečen skupni telesni očistek (CL/F) približno 7-10 l/uro.
Febrile neutropenia (FN) was reported in 3.2-6.7% of patients and was serious in 1.8-4.0% of patients (see section 4.2 and 4.4). 
O febrilni nevtropeniji (FN) so poročali pri 3,2- 6,7 % bolnikov, resna je bila pri 1,8- 4,0 % bolnikov (glejte poglavji 4.2 in 4.4).
Your doctor should ask you to have a blood test: 
Zdravnik bo opravil krvno preiskavo:
Cardiac events, including congestive cardiac failure, pulmonary oedema and atrial fibrillation (see section 4.8), have been reported, mainly in patients with pre-existing cardiac disease or cardiac risk factors. 
Poročali so o dogodkih, povezanih s srcem, vključno s kongestivnim popuščanjem srca, pljučnim edemom in atrijsko fibrilacijo (glejte poglavje 4.8), predvsem pri bolnikih s predhodnimi boleznimi srca ali dejavniki tveganja za srce.
• Patient confirmation form ensuring that patients receive the appropriate counselling concerning the treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing status 
• obrazec potrditve bolnika, ki zagotavlja, da so bili bolniki deležni ustreznega svetovanja o zdravljenju, kontracepcijskih metodah in preprečevanju nosečnosti, ki ustreza spolu in statusu zmožnosti zanositve,
For information on other medicinal products given in combination with Imnovid, refer to the respective current SmPC. 
Za informacije o drugih zdravilih, ki jih dajete v kombinaciji z zdravilom Imnovid, glejte zadevni veljavni SmPC.
Adverse reactions tended to occur more frequently within the first 2 cycles of treatment with pomalidomide. 
Neželeni učinki so bili pogostejši v prvih 2 ciklih zdravljenja s pomalidomidom.
• She understands the need and accepts to undergo pregnancy testing at least every 4 weeks except in case of confirmed tubal sterilisation 
• mora razumeti potrebo in biti pripravljena opraviti teste nosečnosti vsaj vsake 4 tedne, razen v primeru potrjene sterilizacije jajcevodov,
• He understands the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential 
• mora razumeti pričakovano tveganje za teratogene učinke, če spolno občuje z nosečnico ali žensko v rodni dobi;
4.5 Interaction with other medicinal products and other forms of interaction Effect of pomalidomide on other medicinal products 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Imnovid is either used with: 
Zdravilo Imnovid se uporablja bodisi z:
As a precaution, all male patients taking pomalidomide should use condoms throughout treatment duration, during dose interruption and for 7 days after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception (see sections 4.3 and 4.4). 
Zato morajo zaradi previdnosti vsi moški, ki se zdravijo s pomalidomidom, med zdravljenjem, prekinitvami odmerjanja in 7 dni po koncu zdravljenja uporabljati kondome, če je njihova partnerica v rodni dobi, in če ne uporablja zanesljive kontracepcije (glejte poglavje 4.3 in 4.4).
In clinical studies, no dose adjustment was required in elderly (> 65 years) patients exposed to pomalidomide (see section 4.2). 
V kliničnih študijah pri starejših bolnikih (> 65 let), izpostavljenih pomalidomidu, prilagoditev odmerka ni bila potrebna (glejte poglavje 4.2).
Dispensing of pomalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result. 
Ženski v rodni dobi je dovoljeno pomalidomid izdati v roku 7 dni od izdaje recepta in zdravstveno nadzorovanega negativnega rezultata testa nosečnosti.
Based on population pharmacokinetic analyses in healthy subjects and multiple myeloma patients, no significant influence of age (19-83 years) on oral clearance of pomalidomide was observed. 
Na podlagi analiz populacijske farmakokinetike pri zdravih preskušancih in bolnikih z diseminiranim plazmocitomom niso ugotovili pomembnega vpliva starosti (19-83 let) na peroralni očistek pomalidomida.
Repeat-dose toxicology studies 
Toksikološke študije pri ponavljajočem odmerku
Pomalidomide should be interrupted pending investigation of these symptoms and if ILD is confirmed, appropriate treatment should be initiated. 
Do zaključka preiskave teh simptomov je treba zdravljenje s pomalidomidom prekiniti in, če je IPB potrjena, uvesti ustrezno zdravljenje.
The p-value is based on a stratified log-rank test. 
Vrednost p temelji na stratificiranem testu log-rank.
In the 9-month study in monkeys with doses of 0.05, 0.1, and 1 mg/kg/day, morbidity and early euthanasia of 6 animals were observed at the dose of 1 mg/kg/day and were attributed to immunosuppressive effects (staphylococcal infection, decreased peripheral blood lymphocytes, chronic inflammation of the large intestine, histologic lymphoid depletion, and hypocellularity of bone marrow) at high exposures of pomalidomide (15-fold exposure ratio relative to a 4 mg clinical dose). 
V 9-mesečni študiji pri opicah z odmerki 0,05, 0,1 in 1 mg/kg/dan so opazili obolevnost in zgodnjo evtanazijo 6 živali pri odmerku 1 mg/kg/dan, kar so pripisali imunosupresivnim učinkom (stafilokokne okužbe, znižanje limfocitov v periferni krvi, kronično vnetje debelega črevesa, histološko limfoidno izčrpavanje in hipocelularnost kostnega mozga) pri visoki izpostavljenosti pomalidomidu (15-kratnik izpostavljenosti glede na 4 mg klinični odmerek).
The primary efficacy endpoint was progression free survival by International Myeloma Working Group (IMWG criteria). 
Primarni cilj študije za dokaz učinkovitosti je bilo preživetje brez napredovanja po kriterijih Mednarodne delovne skupine za plazmocitom (IMWG - International Myeloma Working Group).
• Obligations of the health care professional in relation to the prescribing of pomalidomide o Need to provide comprehensive advice and counselling to patients o That patients should be capable of complying with the requirements for the safe use of pomalidomide o Need to provide patients with appropriate patient educational brochure and patient card 
• obveznosti, ki jih morajo zdravstveni delavci upoštevati pri predpisovanju pomalidomida: o potrebo po obsežnem posvetu in svetovanju bolnikom, o bolniki morajo biti sposobni upoštevati zahteve za varno uporabo pomalidomida, o bolnikom je treba izročiti ustrezno izobraževalno brošuro in kartico za bolnika;
Approximately 70% of patients were refractory to lenalidomide (71.2% in Pom+Btz+LD-Dex, 68.7 % in Btz+LD-Dex). 
Približno 70 % bolnikov je bilo odpornih proti lenalidomidu (71,2 % v Pom+Btz+NO-deks, 68,7 % v Btz+NO-deks).
Peripheral neuropathy occurred in 55.4 % of patients (10.8% Grade 3; 0.7% Grade 4). 
Periferna nevropatija se je pojavila pri 55,4 % bolnikov (pri 10,8 % 3. stopnje; pri 0,7 % 4. stopnje).
At the end of the treatment you should return all unused capsules to the pharmacist. 
Na koncu zdravljenja morate vse neporabljene kapsule vrniti farmacevtu.
Direct Healthcare Professional Communications (Prior to Launch) 
Ključni elementi, ki morajo biti vsebovani Neposredno obvestilo za zdravstvene delavce (pred prihodom zdravila na trg)
No data are available on administration of pomalidomide to paediatric patients (< 18 years of age). 
Podatki o dajanju pomalidomida pediatričnim bolnikom (< 18 let starosti) niso na voljo.
As a result of these tests, your doctor may change your dose of Imnovid or stop your treatment. 
Zdravnik lahko na podlagi rezultatov preiskav spremeni vaš odmerek zdravila Imnovid ali prekine zdravljenje.
• Brochure for women patients of childbearing potential and their partners 
• brošure za ženske v rodni dobi in njihove partnerje,
Stop taking Imnovid and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: 
Takoj prenehajte jemati zdravilo Imnovid in pojdite takoj k zdravniku, če opazite katerega od naslednjih neželenih učinkov - morda potrebujete nujno zdravniško pomoč:
All Adverse Reactions /Frequency 
Vsi neželeni učinki /pogostnost
In the Btz+LD-Dex arm, median PFS time was 7.1 months (95% CI: 5.88, 8.48). 
V skupini Btz+NO-deks je bil mediani čas PFS 7,1 meseca (95 % IZ: 5,88; 8,48).
If pomalidomide is taken during pregnancy, a teratogenic effect of pomalidomide in humans is expected (see section 4.4). 
Pri jemanju pomalidomida med nosečnostjo se pri ljudeh pričakuje teratogeni učinek (glejte poglavje 4.4).
Dexamethasone should be discontinued if the patient is unable to tolerate 10 mg if ≤ 75 years old or 8 mg if > 75 years old. 
Deksametazon je treba ukiniti, če bolnik ne more prenašati odmerka 10 mg pri starosti ≤ 75 let ali 8 mg pri starosti > 75 let.