FrancophonIA/ELRC3.0 huggingface dataset:
English: Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis.
Croatian: Otkriveno je da je pomalidomid teratogen i kod štakora i kod kunića kada se primjenjuje tijekom razdoblja glavne organogeneze.
English: • Pomalidomide in combination with dexamethasone The recommended starting dose of Imnovid is 4 mg orally once daily on Days 1 to 21 of repeated 28-day cycles.
Croatian: • Pomalidomid u kombinaciji s deksametazonom Preporučena početna doza Imnovida iznosi 4 mg peroralno jedanput na dan od 1. do 21. dana ponavljanih 28-dnevnih ciklusa.
English: 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%).
Croatian: U skupini koja je primala HD-Dex, medijan PFS-a bio je 8,0 tjedana (95% CI: 7,0; 9,0) uz stopu preživljenja bez događaja od 12,15% (±3,63%) na 26 tjedana.
English: • On average, Imnovid when used with dexamethasone stopped multiple myeloma from coming back for up to 4 months - compared with 2 months for those patients who used only dexamethasone.
Croatian: • kada se Imnovid primjenjivao s deksametazonom u prosjeku je zaustavio povratak multiplog mijeloma do 4 mjeseca - u usporedbi s 2 mjeseca u bolesnika koji su uzimali samo deksametazon.
English: 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).
Croatian: U bolesnika koji su u kliničkim ispitivanjima primali kombiniranu terapiju s pomalidomidom neutropeniju je razvilo do 46,8% bolesnika (41,7% 3. ili 4. stupnja).
English: • Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Croatian: • progesteronske tablete koje inhibiraju ovulaciju (tj. dezogestrel).
English: • Brochure for women patients who are not of childbearing potential
Croatian: • knjižice za bolesnice koje nisu u reproduktivnoj dobi
English: Rash = Grade 4 or blistering (including angioedema, exfoliative or bullous rash or if Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected)
Croatian: Osip = 4. stupanj ili stvaranje mjehurića (uključujući angioedem, eksfolijativni ili bulozni osip ili ako se sumnja na Stevens-Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) ili reakciju na lijek s eozinofilijom i sistemskim simptomima (DRESS))
English: ADRs reported in clinical study MM-003 in patients treated with pomalidomide in combination with dexamethasone.
Croatian: Nuspojave zabilježene u kliničkom ispitivanju MM-003 u bolesnika liječenih pomalidomidom u kombinaciji s deksametazonom
English: Approximately 30% of the patients experiencing peripheral neuropathy had a history of neuropathy at baseline.
Croatian: Približno 30% bolesnika s perifernom neuropatijom imalo je neuropatiju u anamnezi na početku ispitivanja.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po kapsuli, tj. zanemarive količine natrija.
English: Rash Rash = Grade 2-3
Croatian: Osip Osip = 2. do 3. stupnja
English: Deep vein thrombosis Hypotension Hypertension
Croatian: Često duboka venska tromboza hipotenzija hipertenzija
English: Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD.
Croatian: Kako bi se isključila IBP, potrebno je pažljivo procijeniti bolesnike s akutnom pojavom ili neobjašnjenim pogoršanjem plućnih simptoma.
English: POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.45 (0.35, 0.59) Events: POM+LD-DEX=164/302 HD-DEX=103/153
Croatian: Log-rang p-vrijednost = <0,001 (dvostrana) HR (95% CI) 0,45 (0,35; 0,59) Događaji: POM+LD-DEX = 164/302 HD-DEX = 103/153
English: In studies, pomalidomide was found to be removed by haemodialysis.
Croatian: U ispitivanjima je uočeno da se pomalidomid uklanja hemodijalizom.
English: • The other ingredients are mannitol (E421), starch, pregelatinised, and sodium stearyl fumarate.
Croatian: • Drugi sastojci su: manitol (E421), škrob, prethodno geliran i natrijev stearilfumarat.
English: Treatment with pomalidomide combined with bortezomib and dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
Croatian: Terapiju pomalidomidom u kombinaciji s bortezomibom i deksametazonom treba primjenjivati do progresije bolesti ili do pojave neprihvatljive toksičnosti.
English: • Pomalidomide in combination with dexamethasone
Croatian: • Pomalidomid u kombinaciji s deksametazonom
English: Uncommon Alanine aminotransferase increased
Croatian: Manje često povišena alanin aminotransferaza
English: • you must use effective methods of contraception for at least 4 weeks before starting treatment, for the whole time you are taking treatment, and until at least 4 weeks after stopping treatment.
Croatian: • Morate koristiti učinkovite metode kontracepcije tijekom najmanje 4 tjedna prije početka liječenja, čitavo vrijeme trajanja liječenja i tijekom najmanje 4 tjedna nakon prestanka liječenja.
English: A medically supervised pregnancy test should be repeated at least every 4 weeks, including at least 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
Croatian: Test na trudnoću pod liječničkim nadzorom treba ponavljati najmanje svaka 4 tjedna, uključujući najmanje 4 tjedna nakon završetka liječenja, osim u slučaju potvrđenog podvezivanja jajovoda.
English: Co-administration of the strong CYP1A2 inhibitor fluvoxamine with pomalidomide in the presence of ketoconazole, increased mean exposure to pomalidomide by 107% with a 90% confidence interval [91% to 124%] compared to pomalidomide plus ketoconazole.
Croatian: Istodobna primjena jakog inhibitora CYP1A2 fluvoksamina s pomalidomidom u prisutnosti ketokonazola, povećala je srednju vrijednost izloženosti pomalidomidu za 107% uz 90%-tni interval pouzdanosti [91% do 124%] u usporedbi s pomalidomidom s ketokonazolom.
English: For each subsequent drop < 0.5 x 109/l
Croatian: Kod svakog sljedećeg pada na <0,5 x 109/l
English: • 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.
Croatian: • s dva druga lijeka od kojih se jedan naziva bortezomib (vrsta lijeka za kemoterapiju), a drugi deksametazon (lijek protiv upala); to vrijedi za bolesnike koji su prije liječeni bar jednom drugom terapijom - uključujući lenalidomid ili
English: Patients at greatest risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Croatian: Rizik od lize tumora najveći je u onih bolesnika koji imaju veliku tumorsku masu prije početka liječenja.
English: Minimal or mild bile duct proliferation with associated increases in ALP and GGT were also observed at 1 mg/kg/day.
Croatian: Pri dozi od 1 mg/kg na dan također se javila minimalna ili blaga proliferacija žučovoda povezana s povećanjem vrijednosti ALP i GGT.
English: • Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
Croatian: • niska razina fosfata u krvi (hipofosfatemija) što može prouzročiti slabost u mišićima i razdražljivost ili smetenost
English: • Low red blood cells, which may cause anaemia leading to tiredness and weakness.
Croatian: • mali broj crvenih krvnih stanica što može prouzročiti slabokrvnost (anemiju) koja dovodi do umora i slabosti
English: • 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
Croatian: • potreba za uporabom prezervativa ako je partnerica trudna ili u reproduktivnoj dobi i bez kontracepcije (čak i ako se muški partner podvrgnuo vazektomiji) o tijekom liječenja pomalidomidom (uključujući privremene prekide liječenja) o još 7 dana nakon zadnje doze
English: Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake klasifikacije organskog sustava i skupine učestalosti, nuspojave su navedene prema opadajućoj ozbiljnosti.
English: If pomalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Croatian: Ako pomalidomid dođe u kontakt sa sluznicama, temeljito isperite vodom.
English: This can result in kidney problems.
Croatian: To može dovesti do tegoba s bubrezima
English: • Post-authorisation efficacy study (PAES) MM-007: In order to further investigate the efficacy of pomalidomide in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide, the MAH should submit the final analysis of OS from the phase 3, randomized, open label study MM-007.
Croatian: • Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES) MM-007: u svrhu daljnjeg ispitivanja djelotvornosti pomalidomida u kombinaciji s bortezomibom i deksametazonom u liječenju odraslih bolesnika s multiplim mijelomom koji su prije primili barem jednu liniju liječenja koja je uključivala lenalidomid, nositelj odobrenja dostavit će konačnu analizu ukupnog preživljenja iz randomiziranog, otvorenog ispitivanja faze III MM-007.
English: IMN: Imnovid; BOR: Bortezomib; DEX: Dexamethasone
Croatian: • IMN: Imnovid; BOR: bortezomib; DEKS: deksametazon Od 1. do 8. ciklusa
English: • For Cycles 9 and onwards: 10 mg once daily on Days 1, 2, 8 and 9 of each 21-day cycle.
Croatian: • od 9. ciklusa nadalje: 10 mg jedanput na dan 1., 2., 8. i 9. dana svakog 21-dnevnog ciklusa.
English: Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Croatian: Imnovid u kombinaciji s deksametazonom indiciran je u liječenju odraslih bolesnika s relapsnim i refraktornim oblikom multiplog mijeloma koji su prije toga primili barem dvije linije liječenja, uključujući i lenalidomid i bortezomib, a kod kojih je bolest napredovala tijekom zadnje terapije.
English: • That pomalidomide is teratogenic in animals and is expected to be teratogenic in humans
Croatian: • da je pomalidomid teratogen za životinje te se očekuje da će biti teratogen i za ljude
English: • 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.
Croatian: • Pomalidomid u kombinaciji s bortezomibom i deksametazonom Bolesnici u kojih je u 14 dana prije randomizacije bila prisutna periferna neuropatija ≥2. stupnja s bolovima bili su isključeni iz kliničkih ispitivanja.
English: For instructions on dose interruptions or reductions for bortezomib related adverse reactions, physicians should refer to bortezomib Summary of Product Characteristics (SmPC).
Croatian: Upute za prekid primjene ili smanjenje doze zbog nuspojava povezanih s bortezomibom liječnik treba pogledati u sažetku opisa svojstava lijeka za bortezomib.
English: Common Depressed level of consciousness
Croatian: Često snižena razina svijesti
English: Pomalidomide dose modification instructions Toxicity
Croatian: Upute za prilagodbu doze pomalidomida Toksičnost
English: For each subsequent drop < 25 x 109/l
Croatian: Kod svakog sljedećeg pada na <25 x 109/l
English: How Imnovid works
Croatian: Kako Imnovid djeluje
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje često (mogu se pojaviti u do 1 na 100 osoba):
English: Markedly elevated levels of alanine aminotransferase and bilirubin have been observed in patients treated with pomalidomide (see section 4.8).
Croatian: U bolesnika liječenih pomalidomidom opažene su izrazito povišene razine alanin aminotransferaze i bilirubina (vidjeti dio 4.8).
English: In patients receiving combination therapy with pomalidomide in clinical studies, thrombocytopenia occurred in 27.0-36.7% of patients.
Croatian: U bolesnika koji su u kliničkim ispitivanjima primali kombiniranu terapiju s pomalidomidom trombocitopenija se pojavila u 27,0 - 36,7% bolesnika.
English: • Pregnancy test regime o Before commencing treatment o During treatment (including dose interruptions), at least every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment
Croatian: • režim testiranja na trudnoću o prije početka liječenja o tijekom liječenja (uključujući privremene prekide liječenja) najmanje svaka 4 tjedna, osim u slučaju potvrđenog podvezivanja jajovoda o nakon završetka liječenja
English: The recommended dose of dexamethasone is 20 mg orally once daily, on the days shown in Table 1.
Croatian: Preporučena doza deksametazona je 20 mg peroralno jedanput na dan, a primjenjuje se na dane kako je označeno u tablici 1.
English: See section 4.2 for dosing information.
Croatian: Podatke o doziranju vidjeti u dijelu 4.2.
English: Other serious adverse reactions reported included febrile neutropenia (4.0%), neutropenia (2.0%), thrombocytopenia (1.7%) and VTE adverse reactions (1.7 %).
Croatian: Ostale ozbiljne nuspojave uključivale su febrilnu neutropeniju (4,0%), neutropeniju (2,0%), trombocitopeniju (1,7%) i VTE (1,7%).
English: Patients in the Pom+Btz+LD-Dex arm were administered 4 mg pomalidomide orally on Days 1 to 14 of each 21-day cycle.
Croatian: Bolesnici u skupini Pom+Btz+LD-Dex primali su peroralno 4 mg pomalidomida od 1. do 14. dana svakog 21-dnevnog ciklusa.
English: For the HD-Dex arm, dexamethasone (40 mg) was administered once per day on days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle.
Croatian: U skupini koja je primala HD-Dex, deksametazon (40 mg) se primjenjivao jedanput na dan od 1. do 4. dana, od 9. do 12. dana te od 17. do 20. dana 28-dnevnog ciklusa.
English: The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28day treatment cycle.
Croatian: Preporučena doza deksametazona iznosi 40 mg peroralno jedanput na dan 1., 8., 15. i 22. dana svakog 28-dnevnog terapijskog ciklusa.
English: • Low blood pressure, which may cause dizziness or fainting.
Croatian: • nizak krvni tlak što može prouzročiti omaglicu ili nesvjesticu
English: • Chest pain, or leg pain and swelling, especially in your lower leg or calves (caused by blood clots).
Croatian: • bol u prsnom košu ili bolnost i oticanje nogu, osobito potkoljenica ili listova (prouzročeno krvnim ugrušcima)
English: 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%.
Croatian: Prema nedavno provedenoj interim analizi ukupnog preživljenja (OS), s datumom prestanka prikupljanja podataka od 15. rujna 2018. (medijan razdoblja praćenja 26,2 mjeseca), medijan ukupnog preživljenja na temelju Kaplan-Meierove procjene bio je 40,5 mjeseci u skupini Pom+Btz+LD-Dex i 30,5 mjeseci u skupini Btz+LD-Dex, HR = 0,91; 95% CI: 0,70; 1,18, s ukupnom stopom događaja od
English: • Pomalidomide in combination with bortezomib and dexamethasone The efficacy and safety of pomalidomide in combination with bortezomib and low -dose dexamethasone (Pom+Btz+LD-Dex) was compared with bortezomib and low-dose dexamethasone (Btz+LD-Dex) in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-007), in previously treated adult patients with multiple myeloma, who had received at least one prior regimen, including lenalidomide and have demonstrated disease progression on or after the last therapy.
Croatian: • Pomalidomid u kombinaciji s bortezomibom i deksametazonom Djelotvornost i sigurnost pomalidomida u kombinaciji s bortezomibom i niskom dozom deksametazona (Pom+Btz+LD-Dex) uspoređene su s bortezomibom i niskom dozom deksametazona (Btz+LD-Dex) u multicentričnom, randomiziranom, otvorenom ispitivanju faze III (CC-4047-MM-007) u prethodno liječenih odraslih bolesnika s multiplim mijelomom, koji su prethodno liječeni najmanje jednom linijom terapije, uključujući lenalidomid, i u kojih je bolest napredovala tijekom ili nakon posljednje terapije.
English: The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and /or dispensing controls, and the collection of detailed data relating to the indication in order to monitor the off-label use within the national territory.
Croatian: Kako bi se na nacionalnom teritoriju nadzirala uporaba izvan odobrenih indikacija, taj sustav kontrolirane distribucije uključuje upotrebu kartica za bolesnika i/ili njezinog ekvivalenta za kontrolu propisivanja ili izdavanja lijeka i prikupljanje detaljnih podataka u vezi s indikacijom.
English: **ANC - Absolute Neutrophil Count; ***CBC - Complete Blood Count.
Croatian: *U slučaju neutropenije, liječnik treba razmotriti primjenu čimbenika rasta; **ABN - apsolutni broj neutrofila; ***KKS - kompletna krvna slika.
English: If pregnancy occurs in a partner of a male patient taking pomalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Croatian: Ako partnerica bolesnika koji uzima pomalidomid zatrudni, preporučuje se uputiti je liječniku specijaliziranom ili iskusnom u teratologiji na pregled i savjetovanje.
English: • 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.
Croatian: U randomiziranom ispitivanju CC-4047-MM-003, 302 bolesnika s relapsnim i refraktornim multiplim mijelomom primalo je pomalidomid u dozi od 4 mg jedanput na dan tijekom 21 dana svakog 28-dnevnog ciklusa u kombinaciji s niskom dozom deksametazona jednom tjedno.
English: If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50%.
Croatian: Ako se jaki inhibitori CYP1A2 (npr. ciprofloksacin, enoksacin i fluvoksamin) primjenjuju istodobno s pomalidomidom, dozu pomalidomida smanjite za 50%.
English: • 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
Croatian: • od 1. do 8. ciklusa: 10 mg jedanput na dan 1., 2., 4., 5., 8., 9., 11. i 12. dana svakog 21-dnevnog ciklusa
English: Oral pomalidomide dose
Croatian: Peroralna doza pomalidomida
English: Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
Croatian: Imnovid u kombinaciji s bortezomibom i deksametazonom indiciran je u liječenju odraslih bolesnika s multiplim mijelomom koji su prije toga primili barem jednu liniju liječenja koja uključuje lenalidomid.
English: All Adverse Reactions (ADRs) reported in clinical trial MM-007 in patients treated with pomalidomide in combination with bortezomib and dexamethasone.
Croatian: Sve nuspojave zabilježene u kliničkom ispitivanju MM-007 u bolesnika liječenih pomalidomidom u kombinaciji s bortezomibom i deksametazonom
English: Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis (see section 5.3).
Croatian: Otkriveno je da je pomalidomid teratogen u štakora i kunića kad se primjenuje tijekom razdoblja glavne organogeneze (vidjeti dio 5.3).
English: • Pomalidomide in combination with bortezomib and dexamethasone In randomised study CC-4047-MM-007, 278 patients received pomalidomide, bortezomib and dexamethasone (Pom+Btz+Dex arm).
Croatian: U randomiziranom ispitivanju CC-4047-MM-007, 278 bolesnika primalo je pomalidomid, bortezomib i deksametazon (skupina Pom+Btz+Dex).
English: 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).
Croatian: Tako je NOAEL za majke iznosio 1000 mg/kg na dan, a NOAEL za razvojnu toksičnost <25 mg/kg na dan (AUC24h je bio 34340 ng•h/ml 17. dana gestacije pri ovoj najnižoj ispitanoj dozi, a omjer izloženosti bio je 85 puta veći u odnosu na kliničku dozu od 4 mg).
English: Any unused medicine should be returned to the pharmacist at the end of treatment.
Croatian: Sav neupotrijebljeni lijek trebate vratiti ljekarniku na kraju liječenja.
English: • Adverse event reporting forms
Croatian: • Obrasci za prijavljivanje štetnog događaja.
English: The efficacy and safety of pomalidomide in combination with dexamethasone were evaluated in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-003), where pomalidomide plus low-dose dexamethasone therapy (Pom+LD-Dex) was compared to high-dose dexamethasone alone (HD-Dex) in previously treated adult patients with relapsed and refractory multiple myeloma, who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Croatian: Djelotvornost i sigurnost pomalidomida u kombinaciji s deksametazonom procijenjene su u multicentričnom, randomiziranom, otvorenom ispitivanju faze III (CC-4047-MM-003), u kojem je terapija pomalidomidom s niskom dozom deksametazona (Pom+LD-Dex) bila uspoređena s monoterapijom visokim dozama deksametazona (HD-Dex) u prethodno liječenih odraslih bolesnika s relapsnim i refraktornim oblikom multiplog mijeloma, koji su prethodno liječeni s najmanje dvije linije terapije, uključujući lenalidomid i bortezomib, i kod kojih je bolest progredirala tijekom zadnje terapije.
English: 4.6 Fertility, pregnancy and lactation Women of childbearing potential / Contraception in males and females
Croatian: Žene reproduktivne dobi / kontracepcija u muškaraca i žena
English: • Description of the PPP and categorisation of patients based on sex and childbearing potential o Algorithm for implementation of PPP o Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
Croatian: • Opis Programa prevencije trudnoće i kategorizacija bolesnika na temelju spola i reproduktivne dobi o algoritam za primjenu Programa prevencije trudnoće o definicija žena u reproduktivnoj dobi i mjera koje liječnik treba poduzeti ako reproduktivni status bolesnice nije jasan.
English: The primary efficacy endpoint was Progression Free Survival (PFS) assessed by an Independent Response Adjudication Committee (IRAC) according to the IMWG criteria using the intent to treat population (ITT).
Croatian: Primarna mjera ishoda djelotvornosti bila je preživljenje bez progresije bolesti (PFS) u populaciji predviđenoj za liječenje (ITT) prema procjeni neovisnog povjerenstva za ocjenu odgovora (engl.
English: A teratogenic effect of pomalidomide in humans is expected.
Croatian: Očekuje se da će pomalidomid imati teratogni učinak u ljudi.
English: Other ≥ Grade 3 dexamethasone-related adverse events
Croatian: Drugi štetni događaji ≥3. stupnja povezani s deksametazonom
English: Resume pomalidomide treatment at one dose level lower than the previous dose.
Croatian: Nastaviti liječenje pomalidomidom u dozi koja je za jednu razinu niža od prethodne.
English: Sepsis
Croatian: • osipi
English: Recommended dosing scheme for Imnovid in combination with bortezomib and dexamethasone
Croatian: Preporučena shema doziranja Imnovida u kombinaciji s bortezomibom i deksametazonom