natgillin/translations-raw huggingface dataset:
• two other medicines - called ‘bortezomib' (a type of chemotherapy medicine) and ‘dexamethasone' (an anti-inflammatory medicine) in people who have had at least one other treatment - including lenalidomide. 
• dvema drugima zdraviloma - imenujeta se ‘bortezomib' (vrsta kemoterapevtskega zdravila) in ‘deksametazon' (protivnetno zdravilo) - pri ljudeh, ki so že imeli vsaj eno drugo zdravljenjevključno z lenalidomidom,
Imnovid contains the active substance ‘pomalidomide'. 
Zdravilo Imnovid vsebuje učinkovino, ki se imenuje "pomalidomid".
In a fertility and early embryonic development study in rats, pomalidomide was administered to males and females at dosages of 25, 250, and 1000 mg/kg/day. 
V študiji plodnosti in zgodnjega razvoja zarodka pri podganah so pomalidomid dajali samcem in samicam v odmerkih 25, 250 in 1.000 mg/kg/dan.
Odds ratio is for Pom+Btz+LD-Dex:Btz+LD-Dex. 
Razmerje verjetnosti velja za Pom+Btz+NO-deks:Btz+NO-deks.
Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies and institute treatment as indicated. 
Zdravniki naj pred zdravljenjem in med njim s standardnimi pregledi za rakava obolenja pri bolnikih skrbno ocenjujejo pojav drugih primarnih malignosti in uvedejo zdravljenje, kot je indicirano.
Additionally, pomalidomide inhibits the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergises with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumour cell apoptosis. 
Pomalidomid dodatno zavira proliferacijo celičnih vrst diseminiranega plazmocitoma, odpornih na lenalidomid, in v sinergiji z deksametazonom povzroči apoptozo tumorskih celic celičnih linij, občutljivih na lenalidomid in odpornih na lenalidomid.
In patients receiving combination therapy with pomalidomide in clinical studies, thrombocytopenia occurred in 27.0-36.7% of patients. 
Pri bolnikih, ki so v kliničnih študijah prejemali kombinirano zdravljenje s pomalidomidom, se je trombocitopenija pojavila pri 27,0-36.7 % bolnikov.
The No Observed Adverse Effect Level (NOAEL) was 0.1 mg/kg/day (0.5-fold exposure ratio relative to a 4 mg clinical dose). 
Raven brez opaženih neželenih učinkov (NOAEL, No Observed Adverse Effect Level) je bila 0,1 mg/kg/dan (0,5-kratnik izpostavljenosti glede na 4 mg klinični odmerek).
Dispensing of pomalidomide to women of childbearing potential should occur within 7 days of the prescription. 
Izdaja pomalidomida ženskam v rodni dobi naj bo v roku 7 dni od izdaje recepta.
• Imnovid, bortezomib and dexamethasone are taken in ‘treatment cycles'. 
• Zdravilo Imnovid, bortezomib in deksametazon se jemljejo v ‘ciklih zdravljenja'.
The p-value is based on a CMH test, stratified by age (<=75 vs >75), Prior number of antimyeloma regimens (1 vs >1), and Beta-2 microglobulin at screening (< 3.5 mg/L versus ≥ 3.5 mg/L - ≤ 5.5 mg/L versus > 5.5 mg/L). 
Vrednost p temelji na testu CMH, stratificiranem po starosti (< = 75 proti > 75), predhodnem številu zdravljenj proti diseminiranemu plazmocitomu (1 proti > 1) in mikroglobulinu beta-2 ob presejanju (< 3,5 mg/l proti ≥ 3,5 mg/l - ≤ 5,5 mg/l proti > 5,5 mg/l).
Patient Card 
Kartica za bolnika
Approximately 30% of the patients experiencing peripheral neuropathy had a history of neuropathy at baseline. 
Približno 30 % bolnikov s periferno nevropatijo je imelo anamnezo nevropatije v izhodišču.
In vivo, pomalidomide therapy led to reduction in the levels of Ikaros in patients with relapsed lenalidomiderefractory multiple myeloma. 
In vivo je zdravljenje s pomalidomidom povzročilo znižanje ravni Ikarosa pri bolnikih z recidivnim diseminiranim plazmocitomom, odpornim proti zdravljenju z lenalidomidom.
The recommended dose of dexamethasone is 20 mg orally once daily, on the days shown in Table 1. 
Priporočeni odmerek deksametazona je 20 mg peroralno enkrat na dan, na dneve, ki so prikazani v preglednici 1.
OR (95% CI) e, p-valuef DoR (months) Mediana time (95% CI) b HRc (95% CI) 
OR (95 % IZ)e, vrednost pf DoR (meseci) Mediania čas (95 % IZ)b HR
See section 4.2 for dosing information. 
Za podatke o odmerjanju glejte poglavje 4.2.
What Imnovid is used for Imnovid is used to treat adults with a type of cancer called ‘multiple myeloma'. 
Zdravilo Imnovid se uporablja za zdravljenje odraslih bolnikov z vrsto raka, ki ga imenujemo "diseminirani plazmocitom ".
Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis (see sections 4.6 and 5.3). 
Ugotovili so, da je pomalidomid teratogen pri podganah in kuncih, če se daje v obdobju glavne organogeneze (glejte poglavji 4.6 in 5.3).
• Chest pain, or leg pain and swelling, especially in your lower leg or calves (caused by blood clots). 
• bolečine v prsnem košu ali bolečine oz. otekline v nogah, zlasti v spodnjih delih nog oz. mečih (zaradi krvnih strdkov);
Specifically, pomalidomide inhibits proliferation and induces apoptosis of haematopoietic tumour cells. 
Bolj natančno pomalidomid zavira proliferacijo in spodbuja apoptozo hematopoetskih tumorskih celic.
• Low red blood cells, which may cause anaemia leading to tiredness and weakness. 
• zmanjšanje števila rdečih krvničk, ki lahko povzroči anemijo, ki privede do utrujenosti in šibkosti,
Btz+LD-Dex (N = 278) 
Btz+NO-deks (N = 278)
In particular, tell your doctor, pharmacist or nurse before taking Imnovid if you are taking any of the following medicines: 
Zdravniku, farmacevtu ali medicinski sestri še zlasti povejte, če jemljete katero od naslednjih zdravil:
Treatment with pomalidomide combined with bortezomib and dexamethasone should be given until disease progression or until unacceptable toxicity occurs. 
Zdravljenje s pomalidomidom v kombinaciji z bortezomibom in deksametazonom naj se daje do napredovanja bolezni ali dokler ne pride do nesprejemljive toksičnosti.
The most commonly reported serious adverse reaction was pneumonia (9.3%). 
Resni neželeni učinek, o katerem so poročali najpogosteje, je bila pljučnica (9,3 %).
The Educational Health Care Professional's Kit shall contain the following elements: 
Paket izobraževalnih gradiv za zdravstvene delavce mora vsebovati naslednje elemente:
In patients receiving combination therapy with pomalidomide in clinical studies, venous thromboembolic events (VTE) occurred in 3.3-11.5% of patients (1.3-5.4% Grade 3 or 4). 
Pri bolnikih, ki so v kliničnih študijah prejemali kombinirano zdravljenje s pomalidomidom, so se venski trombembolični dogodki (VTE) pojavili pri 3,3-11,5 % bolnikov (pri 1,3-5,4 % 3. ali 4. stopnje).
Patients with ongoing ≥ Grade 2 peripheral neuropathy were excluded from clinical studies with pomalidomide. 
Bolniki, ki imajo periferno nevropatijo ≥ 2. stopnje, so bili izključeni iz kliničnih študij s pomalidomidom.
Psychiatric disorders Common Confusional state 
Psihiatrične motnje pogosti stanje zmedenosti pogosti stanje zmedenosti
• That pomalidomide is teratogenic in animals and is expected to be teratogenic in humans 
• opozorilo, da je pomalidomid teratogen pri živalih in se pričakuje teratogenost pri človeku;
Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis. 
Ugotovili so, da je pomalidomid teratogen pri podganah in kuncih, če se daje v obdobju glavne organogeneze.
• The breakdown of cancer cells resulting in the release of toxic compounds into the bloodstream 
• razgradnja rakavih celic, ki ima za posledico sproščanje toksičnih spojin v krvni obtok (sindrom tumorske lize).
HD-Dex (N=153) 
VO-deks (N=153)
Co-administration of pomalidomide with the strong CYP3A4/5 and P-gp inhibitor ketoconazole, or the strong CYP3A4/5 inducer carbamazepine, had no clinically relevant effect on exposure to pomalidomide. 
Sočasno dajanje s ketokonazolom, ki je močan zaviralec encima CYP3A4/5 in P-gp, ali karbamazepinom, ki je močan induktor CYP3A4/5, ni imelo klinično pomembnega učinka na izpostavljenost pomalidomidu.
ADRs reported in clinical study MM-003 in patients treated with pomalidomide in combination with dexamethasone. 
NUZ, opaženi v klinični študiji MM-003 pri bolnikih, zdravljenih s pomalidomidom v kombinaciji z deksametazonom
• one other medicine - called ‘dexamethasone' in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib. 
• enim drugim zdravilom - imenuje se ‘deksametazon' -pri ljudeh, pri katerih se je plazmocitom poslabšal kljub temu, da so že bili vsaj dvakrat zdravljeni, vključno z zdraviloma lenalidomid in bortezomib.
• High blood levels of potassium, which may cause abnormal heart rhythm. 
• visoke ravni kalija v krvi, ki lahko povzročijo nenormalni srčni ritem,
Pom+LD-Dex (N=302) 
POM+NO-deks (N=302)
• He understands the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception, throughout treatment duration, during dose interruption and for 7 days after dose interruptions and/or cessation of treatment. 
• mora razumeti potrebo po uporabi kondoma, če spolno občuje z nosečnico ali žensko v rodni dobi, ki ne uporablja zanesljive metode kontracepcije, ves čas zdravljenja, ob prekinitvi odmerjanja in še 7 dni po prekinitvi odmerjanja in/ali prenehanju zdravljenja.
• Pomalidomide in combination with dexamethasone In randomised study CC-4047-MM-003, 302 patients with relapsed and refractory multiple myeloma were exposed to 4 mg pomalidomide administered once daily for 21 days of each 28-day cycle in combination with a weekly low dose of dexamethasone. 
• Pomalidomid v kombinaciji z deksametazonom V randomizirani študiji CC-4047-MM-003 sta bila 302 bolnika z recidivnim in refraktarnim diseminiranim plazmocitomom izpostavljena 4 mg pomalidomida, ki sta jih prejemala enkrat na dan 21 dni vsakega 28-dnevnega cikla v kombinaciji s tedenskim majhnim odmerkom deksametazona.
In rats, chronic administration of pomalidomide at doses of 50, 250, and 1000 mg/kg/day for 6 months was well tolerated. 
Podgane so kronično 6-mesečno dajanje pomalidomida v odmerkih 50, 250 in 1.000 mg/kg/dan dobro prenašale.
For instructions on dose interruptions or reductions for bortezomib related adverse reactions, physicians should refer to bortezomib Summary of Product Characteristics (SmPC). 
Prilagajanje ali prekinitev odmerjanja bortezomiba Za navodila o prekinitvah ali zmanjšanjih odmerkov zaradi neželenih učinkov, povezanih z bortezomibom, naj se zdravniki obračajo na povzetek glavnih značilnosti zdravila (SmPC - Summary of Product Characteristics) za bortezomib.
Therefore, the NOAEL for these observed effects was < 25 mg/kg/day (AUC 24h was 39960 ng•h/mL (nanogram•hour/millilitres) at this lowest dose tested, and the exposure ratio was 99-fold relative to a 4 mg clinical dose). 
Zato je bila NOAEL za te opazovane učinke < 25 mg/kg/dan (AUC24h je bila 39.960 ng•h/ml (nanogram•ura/mililitri) pri tem najnižjem testiranem odmerku, razmerje izpostavljenosti pa je bilo 99-kratnik glede na 4 mg klinični odmerek).
Pomalidomide is also a substrate of P-glycoprotein in vitro. 
In vitro je pomalidomid tudi substrat P-glikoproteina.
Doses were reduced and treatment was temporarily interrupted or stopped as needed to manage toxicity (see section 
Po potrebi so zaradi nadziranja toksičnosti zmanjševali odmerke in začasno prekinili zdravljenje ali prenehali z njim (see glejte poglavje 4.2).
• Pomalidomide in combination with bortezomib and dexamethasone Patients with ongoing peripheral neuropathy ≥ Grade 2 with pain within 14 days prior to randomisation were excluded from clinical trials. 
• Pomalidomid v kombinaciji z bortezomibom in deksametazonom Bolniki s potekajočo periferno nevropatijo ≥ 2. stopnje z bolečinami v 14 dneh pred randomizacijo so bili izključeni iz kliničnih preskušanj.
• High blood levels of uric acid, which may cause a form of arthritis called gout. 
• visoke ravni sečne kisline v krvi, ki lahko povzročijo obliko artritisa, ki se imenuje protin,
POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.53 (0.37, 0.74) KM median: POM+LD-DEX=NE [48.1, NE] KM median: HD-DEX = 34.0[23.4, 39.9] Events: POM+LD-DEX=75/284 HD-DEX=56/139 
POM+NO-deks vs VO-deks Log-rank vrednost p = < 0,001 (2-stranska) HR (95 % IZ) 0,53 (0,37; 0,74) Mediana KM: POM+NO-deks = NE [48,1 NE] Mediana KM: VO-deks = 34,0 [23,4; 39,9] Dogodki: POM+NO-deks = 75/284 VO-deks = 56/139
Peripheral neuropathy adverse reactions were reported in 12.3% of patients and venous embolic or thrombotic (VTE) adverse reactions were reported in 3.3% of patients. 
O periferni nevropatiji kot neželenem učinku so poročali pri 12,3 % bolnikov, o venski emboliji ali trombozi (VTE) kot neželenem učinku pa pri 3,3 % bolnikov.
In a second study to evaluate the contribution of a CYP1A2 inhibitor alone to metabolism changes, co-administration of fluvoxamine alone with pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% to 157%] compared to pomalidomide alone. 
V drugi študiji, v kateri so ocenjevali prispevek zaviralca CYP1A2 samega k spremembam presnove, je sočasno dajanje fluvoksamina samega s pomalidomidom zvečalo srednjo izpostavljenost pomalidomidu za 125 % z 90 % intervalom zaupanja [98 % do 157 %] v primerjavi s pomalidomidom samim.
• Shortness of breath (from serious chest infection, inflammation of the lung, heart failure or blood clot). 
• zasoplost (zaradi hude okužbe v prsih, vnetja pljuč, srčnega popuščanja ali krvnega strdka);
• The need to contact their doctor immediately upon suspicion of pregnancy 
• potrebo po takojšnjem obveščanju zdravnika pri sumu na nosečnost.
Markedly elevated levels of alanine aminotransferase and bilirubin have been observed in patients treated with pomalidomide (see section 4.8). 
Pri bolnikih, zdravljenih s pomalidomidom, so opazili znatno zvišane ravni alanin aminotransferaze in bilirubina (glejte poglavje 4.8).
Imnovid works in a number of different ways: 
Kako zdravilo Imnovid deluje Zdravilo Imnovid deluje na več različnih načinov:
Minimal or mild bile duct proliferation with associated increases in ALP and GGT were also observed at 1 mg/kg/day. 
Pri odmerku 1 mg/kg/dan so opazili tudi minimalno ali blago proliferacijo žolčevoda s povezanim zvišanjem ALP in GGT.
Haemorrhagic events have included epistaxis, intracranial haemorrhage and gastrointestinal haemorrhage. 
Hemoragični dogodki vključujejo epistakso, znotrajlobanjske krvavitve in gastrointestinalne krvavitve.
• The other ingredients are mannitol (E421), starch, pregelatinised, and sodium stearyl fumarate. 
• Druge sestavine zdravila so manitol (E421), škrob, predgelirani, in natrijev stearilfumarat.
Consider dose interruption or discontinuation of pomalidomide treatment. 
V poštev pride prekinitev odmerjanja ali prekinitev zdravljenja s pomalidomidom.
• Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark browncoloured urine, right-sided abdominal pain, fever and feeling nauseous or being sick. 
• Ponovitev okužbe z virusom hepatitisa B, ki lahko povzroči porumenitev kože in oči, temno rjavo obarvan urin, bolečine v desni strani trebuha, zvišano telesno temperaturo, občutek slabosti (navzeo) ali bruhanje.
The maternal NOAEL was 10 mg/kg/day, and the developmental NOAEL was <10 mg/kg/day (AUC24h was 418 ng•h/mL on Gestation Day 19 at this lowest dose tested, which was similar to that obtained from a 4 mg clinical dose). 
NOAEL za mater je bila 10 mg/kg/dan in razvojna NOAEL < 10 mg/kg/dan (AUC24h je bila 418 ng•h/ml na 19. dan gestacije pri tem najnižjem testiranem odmerku, kar je podobno kot pri 4 mg kliničnem odmerku).
As per an interim analysis for Overall Survival (OS), using a cut-off of 15 September 2018 (median follow-up period of 26.2 months), median OS time from Kaplan-Meier estimates was 40.5 months for the Pom + Btz + LD-Dex arm and 30.5 months for the Btz + LD-Dex arm; HR = 0.91, 95% CI: 0.70, 1.18, with an overall event rate of 43.3%. 
V skladu z nedavno vmesno analizo celokupnega preživetja (OS), z upoštevanjem datuma zaključka zbiranja podatkov 15. september 2018 (mediana obdobja spremljanja 26,2 meseca), je bil mediani čas OS po Kaplan-Meierjevi oceni 40,5 meseca za skupino Pom + Btz + NO-deks in 30,5 meseca za skupino Btz + NO-deks; HR = 0,91; 95 % IZ: 0,70; 1,18, s celokupno pogostnostjo dogodkov 43,3 %.
• your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished. 
• bo zdravnik pred vsakim zdravljenjem, vsaj vsake 4 tedne med zdravljenjem in vsaj 4 tedne po koncu zdravljenja naročil test nosečnosti.
• Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and irritability or confusion. 
• nizko raven fosfatov v krvi (hipofosfatemija), ki lahko povzroča mišično šibkost in razdražljivost ali zmedenost,
• The need to use condoms if sexual partner is pregnant or a WCBP and has no contraception (even if man has had vasectomy) o During pomalidomide treatment (including dose interruptions) o For 7 days following final dose 
• potrebo po uporabi kondomov, če je spolna partnerica noseča ali ŽRD in ne uporablja kontracepcije (tudi, če je moški imel vazektomijo) o med zdravljenjem s pomalidomidom (vključno s prekinitvami odmerjanja) o še 7 dni po zadnjem odmerku;
• Pomalidomide in combination with bortezomib and dexamethasone The most commonly reported blood and lymphatic system disorders were neutropenia (46.8%), thrombocytopenia (36.7%) and anaemia (28.4%). 
• Pomalidomid v kombinaciji z bortezomibom in deksametazonom Bolezni krvi in limfatičnega sistema, o katerih so najpogosteje poročali, so bile nevtropenija (46,8 %), trombocitopenija (36,7 %) in anemija (28,4 %).
Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma tumour cell growth. 
Pomalidomid deluje tumoricidno neposredno proti plazmocitomu, ima imunomodulatorno aktivnost ter zavira podporo stromalnih celic za celično rast tumorja diseminiranega plazmocitoma.
• Levonorgestrel-releasing intrauterine system 
• intrauterini sistem, ki sprošča levonorgestrel,
• Numbness, tingling or burning sensation to the skin, pains in hands or feet (peripheral sensory neuropathy). 
• odrevenelost, mravljinčenje ali pekoč občutek na koži, bolečine v dlaneh ali stopalih (periferna senzorična nevropatija),
For each subsequent drop < 25 x 109/l 
• Pri vsakem nadaljnjem zmanjšanju < 25 x 109/l
• He understands that if his female partner becomes pregnant whilst he is taking pomalidomide or 7 days after he has stopped taking pomalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice. 
• mora razumeti, da mora takoj obvestiti lečečega zdravnika, če njegova partnerica zanosi v času, ko on jemlje pomalidomid ali 7 dni po prenehanju jemanja pomalidomida, in da je priporočljivo, da partnerico takoj napoti k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
Always take your medicines exactly as your doctor has told you. 
Pri jemanju zdravil vedno natančno upoštevajte navodila zdravnika.
• High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal muscle weaknesses. 
• visoko raven kalcija v krvi (hiperkalciemija), ki lahko povzroči upočasnitev refleksov in oslabelost skeletnih mišic,
In the HD-Dex arm, median PFS time was 8.0 weeks (95% CI: 7.0, 9.0); the estimated 26-week event-free survival rate was 12.15% (±3.63%). 
V skupini VO-deks je bil mediani čas PFS 8,0 tednov (95 % IZ: 7,0; 9,0); ocenjena 26-tedenska stopnja preživetja brez dogodkov je bila 12,15 %
For the intention to treat (ITT) population, median PFS time by Independent Review Adjudication Committee (IRAC) review based on IMWG criteria was 15.7 weeks (95% CI: 13.0, 20.1) in the Pom + LD-Dex arm; the estimated 26-week event-free survival rate was 35.99% (±3.46%). 
Za populacijo z namenom zdravljenja (ITT - Intention to Treat) je bil mediani čas PFS po pregledu Neodvisnega presojevalnega odbora (IRAC - Independent Review Adjudication Committee) na podlagi kriterijev IMWG 15,7 tednov (95 % IZ: 13,0; 20,1) v skupini POM + NO-deks; ocenjena 26-tedenska stopnja preživetja brez dogodkov je bila 35,99 % (± 3,46 %).
Angioedema and severe dermatologic reactions including SJS, TEN and DRESS have been reported with the use of pomalidomide (see section 4.8). 
Pri uporabi pomalidomida so poročali so o angioedemu in hudih dermatoloških reakcijah, vključno s SJS, TEN in DRESS (glejte poglavje 4.8).
Therefore, the maternal NOAEL was 1000 mg/kg/day, and the NOAEL for developmental toxicity was < 25 mg/kg/day (AUC24h was 34340 ng•h/mL on Gestation Day 17 at this lowest dose tested, and the exposure ratio was 85-fold relative to a 4 mg clinical dose). 
Zato je bila NOAEL za mater 1.000 mg/kg/dan in NOAEL za razvojno toksičnost < 25 mg/kg/dan (AUC24h je bila 34.340 ng•h/ml na 17. dan gestacije pri tem najnižjem testiranem odmerku, razmerje izpostavljenosti pa je bilo 85-kratnik glede na 4 mg klinični odmerek).
On haemodialysis days, patients should take their pomalidomide dose following haemodialysis. 
Tiste dni, ko imajo bolniki hemodializo, naj svoj odmerek pomalidomida vzamejo po hemodializi.
Interstitial lung disease (ILD) 
Intersticijska pljučna bolezen (IPB)
Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1. 
Pomalidomid se uporablja v kombinaciji z bortezomibom in deksametazonom, kot je prikazano v preglednici 1.
In addition to the above adverse reactions identified from the pivotal clinical trials, the following Table 9 is derived from data gathered from post-marketing surveillance. 
Seznam neželenih učinkov po začetku trženja zdravila v obliki preglednice Poleg zgornjih neželenih učinkov, ugotovljenih v ključnih kliničnih preskušanjih, naslednja preglednica 9 navaja podatke, zbrane v obdobju spremljanja zdravila po začetku trženja.
How to take Imnovid Imnovid must be given to you by a doctor with experience in treating multiple myeloma. 
Zdravilo Imnovid vam sme dati samo zdravnik, ki ima izkušnje z zdravljenjem diseminiranega plazmocitoma.
• The need to stop pomalidomide immediately upon suspicion of pregnancy 
• potrebo po takojšnji prekinitvi zdravljenja s pomalidomidom pri sumu na nosečnost,
Haematological events Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia. 
Nevtropenija je bil najpogosteje poročani hematološki neželeni učinek 3. ali 4. stopnje pri bolnikih s ponovljenim/na zdravljenje odpornim diseminiranim plazmocitomom, sledili sta anemija in trombocitopenija.
• For Cycles 1 to 8: 10 mg once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle 
• za cikle 1 do 8: 10 mg enkrat na dan na 1., 2., 4., 5., 8., 9., 11. in 12. dan vsakega 21-dnevnega cikla,
All Adverse Reactions (ADRs) reported in clinical trial MM-007 in patients treated with pomalidomide in combination with bortezomib and dexamethasone. 
Vsi neželeni učinki (NUZ), o katerih so poročali v kliničnem preskušanju MM-007 pri bolnikih, zdravljenih s pomalidomidom v kombinaciji z bortezomibom in deksametazonom.
Kaplan-Meier curve for PFS for the ITT population is provided in Figure 2. 
Krivulja po Kaplan-Meier za PFS za populacijo ITT je na sliki 2.
In patients receiving combination therapy with pomalidomide in clinical studies, neutropenia occurred in up to 46.8% of patients (41.7% Grade 3 or 4). 
Pri bolnikih, ki so v kliničnih študijah prejemali kombinirano zdravljenje s pomalidomidom, se je nevtropenija pojavila pri največ 46,8 % bolnikov (pri 41,7 % 3. ali 4. stopnje).