natgillin/translations-raw huggingface dataset:
The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib and dexamethasone are listed in Table 7 by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions. 
Neželeni učinki, ki so jih opazili pri bolnikih, zdravljenih s pomalidomidom v kombinaciji z bortezomibom in deksametazonom, so našteti v preglednici 7 po organskih sistemih in pogostnosti za vse neželene učinke in za neželene učinke 3. ali 4. stopnje.
• Ovulation inhibitory progesterone-only pills (i.e. desogestrel) 
• tablete za zaviranje ovulacije le s progesteronom (t. j. dezogestrel).
• you experience or have experienced in the past a combination of any of the following symptoms: rash on face or extended rash, red skin, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis (TEN) or Stevens-Johnson Syndrome (SJS). 
• imate ali ste v preteklosti imeli kombinacijo katerih izmed naslednjih simptomov: izpuščaj na obrazu ali razširjen izpuščaj, pordelo kožo, močno povišano telesno temperaturo, gripi podobne simptome, povečane bezgavke (znake hude kožne reakcije, imenovane reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms) ali sindrom preobčutljivosti za zdravilo, toksično epidermalno nekrolizo (TEN) ali Stevens-Johnsonov sindrom (SJS).
The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28day treatment cycle. 
Priporočeni začetni odmerek deksametazona je 40 mg peroralno enkrat na dan na 1., 8., 15. in 22. dan vsakega 28-dnevnega cikla zdravljenja.
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 
Log-rank vrednost p = < 0,001 (2-stranska) HR (95 % IZ) 0,45 (0,35; 0,59) Dogodki: POM+NO-deks = 164/302 VO-deks = 103/153
Medicine name 
IME ZDRAVILA
Increased cardiac anomalies were seen at all doses with significant increases at 250 mg/kg/day. 
Pri vseh odmerkih z močnim zvišanjem pri 250 mg/kg/dan so opazili zvišanje srčnih anomalij.
IMN: Imnovid; BOR: Bortezomib; DEX: Dexamethasone 
• IMN: Imnovid; BOR: bortezomib; deks: deksametazon 1. do 8. cikel
The benefit of using Imnovid with bortezomib and dexamethasone When Imnovid is used with bortezomib and dexamethasone, in people who have had at least one other treatment, it can stop multiple myeloma getting worse: 
Koristni učinki uporabe zdravila Imnovid z bortezomibom in deksametazonom Ko se zdravilo Imnovid uporablja skupaj z bortezomibom in deksametazonom pri ljudeh, ki so že imeli vsaj eno drugo zdravljenje, lahko ustavi slabšanje diseminiranega plazmocitoma:
Propotion of Patients 
Delež bolnikov
In order to assist patients in avoiding foetal exposure to pomalidomide, the Marketing Authorisation Holder will provide educational material to health care professionals to reinforce the warnings about the expected teratogenicity of pomalidomide, to provide advice on contraception before therapy is started, and to provide guidance on the need for pregnancy testing. 
Da bi bolnikom pomagali preprečiti izpostavitev ploda pomalidomidu, bo imetnik dovoljenja za promet z zdravilom priskrbel izobraževalno gradivo za zdravnike, v katerem bodo poudarjena opozorila o pričakovani teratogenosti pomalidomida.
Multiple myeloma generally cannot be cured. 
Diseminirani plazmocitom na splošno ni ozdravljiv.
• Chest pain, chest infection. 
• bolečina v prsih, okužba v prsnem košu,
Progression Free Survival (weeks) 
Preživetje brez napredovanja (tedni)
• Weight loss. 
• izguba teka,
The efficacy of contraceptive steroids may be reduced during cotreatment with dexamethasone (see section 4.5). 
Pri sočasnem zdravljenju z deksametazonom se lahko zanesljivost kontracepcijskih steroidov zmanjša (glejte poglavje 4.5).
If powder from a broken Imnovid capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water. 
Če pride prašek pomalidomida v stik s kožo, kožo takoj in temeljito sperite z milom in vodo.
• Pomalidomide in combination with dexamethasone No dose adjustment is required for pomalidomide. 
• Pomalidomid v kombinaciji z deksametazonom Odmerka pomalidomida ni treba prilagajati.
Tell your doctor if you are breast-feeding or intend to breast-feed. 
Povejte zdravniku, če dojite ali nameravate dojiti.
Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin 
občasni bazalnocelični karcinom kože ploščatocelični karcinom kože občasni bazalnocelični karcinom kože ploščatocelični karcinom kože
Oral pomalidomide dose 
Peroralni odmerek pomalidomida
Other serious adverse reactions reported included febrile neutropenia (4.0%), neutropenia (2.0%), thrombocytopenia (1.7%) and VTE adverse reactions (1.7 %). 
Med drugimi resnimi neželenimi učinki, o katerih so poročali, so bili febrilna nevtropenija (4,0 %), nevtropenija (2,0 %), trombocitopenija (1,7 %) in VTE (1,7 %).
• That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment 
• opozorilo, da ne sme darovati semena ali sperme med zdravljenjem (vključno s prekinitvami odmerjanja) in še 7 dni po končanem zdravljenju s pomalidomidom.
Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis (see section 5.3). 
Pomalidomid je teratogen pri podganah in kuncih, če se daje v obdobju glavne organogeneze (glejte poglavje 5.3).
• Widespread rash, high body temperature, enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis or Stevens-Johnson Syndrome). 
• razširjen izpuščaj, visoka telesna temperatura, povečane bezgavke in vključenost drugih telesnih organov (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, znana tudi kot DRESS ali sindrom preobčutljivosti za zdravilo, toksična epidermalna nekroliza ali Stevens-Johnsonov sindrom).
Thalidomide is a known human teratogen that causes severe life-threatening birth defects. 
Talidomid je za človeka znana teratogena učinkovina, ki povzroča hude, smrtno nevarne okvare ploda.
For information on bortezomib given in combination with Imnovid, refer to the respective current SmPC. 
Za informacije o bortezomibu, ki ga dajete v kombinaciji z zdravilom Imnovid, glejte zadevni veljavni SmPC.
However, dose interruption or resumption decisions are at the physician's discretion per Summary of Product Characteristics (SmPC). 
Vendar pa so odločitve o prekinitvi ali ponovnem začetku odmerjanja prepuščene zdravnikovi presoji ob upoštevanju povzetka glavnih značilnosti zdravila (SmPC).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 5. avgust 2013
Data cutoff: 26 Oct 2017 
Datum zaključka zbiranja podatkov: 26. oktober 2017.
> 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle 
> 75 let stari 1., 8., 15. in 22. dan vsakega 28-dnevnega cikla zdravljenja
• Look at the chart below to see what to take on each day of the 4-week cycle: o Each day, look down the chart and find the correct day to see which medicines to take. 
• Poglejte spodnjo preglednico in si oglejte, kaj morate vzeti ob vsakem dnevu 4-tedenskega cikla: o vsak dan poglejte po razpredelnici navzdol in poiščite pravilni dan, da boste videli, kateri zdravili morate vzeti; o nekatere dni boste vzeli obe zdravili, nekatere dni samo eno zdravilo, nekatere dni pa sploh nobenega.
Dose reduction in this table is applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone. 
Zmanjšanje odmerka v tej preglednici se lahko uporablja za pomalidomid v kombinaciji z bortezomibom in deksametazonom in za pomalidomid v kombinaciji z deksametazonom.
Dyspepsia = Grade 1-2 
Izpuščaj Izpuščaj = 2.-3. stopnje
The frequencies of adverse reactions are those reported in the pomalidomide plus dexamethasone arm of study CC-4047-MM-003 (n = 302). 
Pogostnosti neželenih učinkov izhajajo iz poročil v skupini študije CC-4047-MM-003 (n = 302) za pomalidomid in deksametazon.
Muscle weakness ≥ Grade 2 
Mišična oslabelost ≥ 2. stopnje
The adverse reactions observed in patients treated with pomalidomide plus dexamethasone are listed below in Table 8 by system organ class (SOC) and frequency for all adverse reactions (ADRs) and for Grade 3 or 4 adverse reactions. 
Neželeni učinki, ki so jih opazili pri bolnikih, zdravljenih s pomalidomidom in deksametazonom, so našteti spodaj v preglednici 8 po organskih sistemih in pogostnosti za vse neželene učinke zdravila (NUZ) in za neželene učinke 3. ali 4. stopnje.
Dexamethasone dose reduction 
Zmanjševanje odmerka deksametazona
You should not donate blood during treatment and for 7 days after the end of treatment. 
Med zdravljenjem in še 7 dni po koncu zdravljenja ne smete darovati krvi.
Men Imnovid passes into human semen. 
Moški Zdravilo Imnovid prehaja v spermo pri ljudeh.
Upper respiratory tract infection and pneumonia were the most frequently occurring infections. 
Najpogostnejši okužbi sta bili okužba zgornjih dihal in pljučnica.
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) 
Izpuščaj = 4. stopnja ali nastajanje mehurjev (vključno z angioedemom, eksfoliativnim ali buloznim izpuščajem ali če domnevamo, da bi lahko šlo za Stevens-Johnsonov sindrom (SJS), toksično epidermalno nekrolizo (TEN) ali reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms).
Treatment with Imnovid may cause the hepatitis B virus to become active again in patients who carry the virus, resulting in a recurrence of the infection. 
• imate ali ste kdaj imeli okužbo s hepatitisom B. Zdravljenje z zdravilom Imnovid lahko pri bolnikih, ki so nosilci virusa, povzroči ponovno aktivacijo virusa hepatitisa B in s tem ponovitev okužbe.
Therefore, pomalidomide can be administered without regard to food intake. 
Zato se lahko pomalidomid daje s hrano ali brez nje.
• Low blood pressure, which may cause dizziness or fainting. 
• nizek krvni tlak, ki lahko povzroči omotico ali omedlevico,
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. 
Zdravilo Imnovid v kombinaciji z bortezomibom in deksametazonom je indicirano za zdravljenje diseminiranega plazmocitoma pri odraslih bolnikih, ki so predhodno prejeli vsaj eno zdravljenje, vključno z lenalidomidom.
The most commonly reported Grade 3 or 4 adverse reactions were in the blood and lymphatic system disorders including neutropenia (41.7%), anaemia (27%) and thrombocytopenia (20.7%); in infections and infestations including pneumonia (9%); and in general disorders and administration site conditions including fatigue (4.7%), pyrexia (3%) and oedema peripheral (1.3%). 
Neželeni učinki 3. ali 4. stopnje, o katerih so najpogosteje poročali, so bile bolezni krvi in limfatičnega sistema, vključno z nevtropenijo (41,7 %), anemijo (27 %) in trombocitopenijo (20,7 %); infekcijske in parazitske bolezni, vključno s pljučnico (9 %); splošne težave in spremembe na mestu aplikacije, vključno z utrujenostjo (4,7 %), pireksijo (3 %) in perifernim edemom (1,3 %).
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. 
Učinkovitost in varnost pomalidomida v kombinaciji z deksametazonom so ocenili v multicentrični, randomizirani, odprti študiji faze III (CC-4047-MM-003), v kateri so zdravljenje s pomalidomidom in nizkoodmernim deksametazonom (POM + NO-deks) primerjali s samo visokoodmernim deksametazonom (VO-deks) pri predhodno zdravljenih odraslih bolnikih s ponovljenim in na zdravljenje odpornim diseminiranim plazmocitomom, ki so predhodno prejemali vsaj dva režima zdravljenja, vključno z lenalidomidom in bortezomibom, in pri katerih je bilo po zadnjem zdravljenju dokazano napredovanje bolezni.
4.6 Fertility, pregnancy and lactation Women of childbearing potential / Contraception in males and females 
Ženske v rodni dobi/kontracepcija pri moških in ženskah
≤ 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle 
≤ 75 let stari 1., 8., 15. in 22. dan vsakega 28-dnevnega cikla zdravljenja
Patients in the Pom+Btz+LD-Dex arm were administered 4 mg pomalidomide orally on Days 1 to 14 of each 21-day cycle. 
Bolnikom v skupini Pom+Btz+NO-deks so dajali 4 mg pomalidomida peroralno na 1. do 14. dan vsakega 21-dnevnega cikla.
KaplanMeier curve for PFS for the ITT population is provided in Figure 1. 
Kaplan-Meierjeva krivulja za PFS za populacijo ITT je na sliki 1.
Recommended dosing scheme for Imnovid in combination with bortezomib and dexamethasone 
Priporočena shema odmerjanja za zdravilo Imnovid v kombinaciji z bortezomibom in deksametazonom
• 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. 
• Pomalidomid v kombinaciji z bortezomibom in deksametazonom Učinkovitost in varnost pomalidomida v kombinaciji z bortezomibom in nizkoodmernim deksametazonom (Pom+Btz+NO-deks) so primerjali z bortezomibom in nizkoodmernim deksametazonom (Btz+NO-deks) v multicentrični, randomizirani, odprti študiji faze III (CC-4047-MM007) pri predhodno zdravljenih odraslih bolnikih z diseminiranim plazmocitomom, ki so prejeli vsaj en predhoden režim zdravljenja, vključno z lenalidomidom, in pri katerih je bilo dokazano napredovanje bolezni ob ali po zadnjem zdravljenju.
• Look at the chart below to see what to take on each day of the 3-week cycle: o Each day, look down the chart and find the correct day to see which medicines to take. 
• Poglejte spodnjo preglednico in si oglejte, kaj morate vzeti ob vsakem dnevu 3-tedenskega cikla: o vsak dan poglejte po razpredelnici navzdol in poiščite pravilni dan, da boste videli, katera zdravila morate vzeti; o nekatere dni boste vzeli vsa tri zdravila, nekatere dni samo dve zdravili ali eno zdravilo, nekatere dni pa sploh nobenega.
Women and men taking Imnovid must not become pregnant or father a child. 
Ženske, ki jemljejo zdravilo Imnovid, ne smejo zanositi, moški, ki jemljejo zdravilo Imnovid, pa ne smejo zaploditi otroka.
Mean normalised AUC exposure to pomalidomide was 98.2% with a 90% confidence interval [77.4% to 120.6%] in moderate renal impairment patients (eGFR ≥30 to ≤45 mL/minute/1.73 m2) compared to patients with normal renal function. 
Srednja normalizirana AUC izpostavljenost pomalidomidu je bila 98,2 % z 90% intervalom zaupanja [77,4 % do 120,6 %] pri bolnikih z zmerno okvaro ledvic (eGFR ≥30 do ≤45 ml/minuto/1,73 m2) v primerjavi z bolniki z normalno funkcijo ledvic.
Fatigue, depressed level of consciousness, confusion, and dizziness have been reported with the use of pomalidomide. 
Pri uporabi pomalidomida so poročali o utrujenosti, zmanjšani stopnji zavesti, zmedenosti in omotici.
• 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. 
• morate vsaj 4 tedne pred začetkom zdravljenja, ves čas jemanja zdravila in vsaj 4 tedne po koncu zdravljenja uporabljati zanesljivo kontracepcijsko metodo.
Dose modification instructions in this table are applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone. 
Navodila za prilagajanje odmerka v tej razpredelnici se lahko uporabljajo za pomalidomid v kombinaciji z bortezomibom in deksametazonom in za pomalidomid v kombinaciji z deksametazonom.
• She understands the need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment 
• razume potrebo po zanesljivi kontracepciji, brez prekinitve, vsaj 4 tedne pred začetkom zdravljenja,
• 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. 
• Pomalidomid v kombinaciji z deksametazonom Priporočeni začetni odmerek zdravila Imnovid je 4 mg peroralno enkrat na dan na 1.-21. dan ponavljajočih se 28-dnevnih ciklov.
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. 
Če zanosi partnerica moškega, ki uporablja pomalidomid, se priporoča, da se ženska partnerica napoti k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji, da oceni stanje in ji ustrezno svetuje.
However, dose interruption / resumption decisions are at physician's discretion per the current Summary of Product Characteristics (SmPC). 
Vendar pa so odločitve o prekinitvi / ponovnem začetku odmerjanja prepuščene zdravnikovi presoji ob upoštevanju povzetka glavnih značilnosti zdravila (SmPC).
Pomalidomide is the major circulating component (approximately 70% of plasma radioactivity) in vivo in healthy subjects who received a single oral dose of [14C]-pomalidomide (2 mg). 
Pomalidomid je pri zdravih osebah, ki so prejele en peroralni odmerek [14C]-pomalidomid (2 mg) in vivo glavna cirkulirajoča sestavina (približno 70 % radioaktivnosti v plazmi).
If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50% (see sections 4.5 and 5.2). 
Pri sočasnem dajanju močnih zaviralcev encima CYP1A2 (npr. ciprofloksacina, enoksacina in fluvoksamina) s pomalidomidom zmanjšajte odmerek pomalidomida za 50 % (glejte poglavji 4.5 in 5.2).
Imnovid with bortezomib and dexamethasone 
Zdravilo Imnovid z bortezomibom in deksametazonom
• On average, Imnovid when used with bortezomib and dexamethasone stopped multiple myeloma from coming back for up to 11 months - compared with 7 months for those patients who only used bortezomib and dexamethasone. 
• Ko se zdravilo Imnovid uporablja skupaj z bortezomibom in deksametazonom, v povprečju prepreči ponovitev diseminiranega plazmocitoma za do 11 mesecev v primerjavi s 7 meseci pri bolnikih, ki uporabljajo samo bortezomib in deksametazon.
Talk to your doctor about the best method of contraception for you. 
O ustrezni kontracepcijski metodi se posvetujte z zdravnikom;
Low-dose dexamethasone (20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old]) was administered to patients in both study arms on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle for Cycles 1 to 8; and on Days 1, 2, 8 and 9 of each subsequent 21-day cycle from Cycles 9 onwards. 
Nizkoodmerni deksametazon (20 mg/dan [≤ 75 let starosti] ali 10 mg/dan [> 75 let starosti]) so dajali bolnikom v obeh skupinah študije na 1., 2., 4., 5., 8., 9., 11. in 12. dan 21-dnevnega cikla v 1. do 8. ciklu; in na 1., 2., 8. in 9. dan vsakega naslednjega 21-dnevnega cikla od 9. cikla naprej.
Dexamethasone (20 mg) * • • * For patients > 75 years of age, see Special populations. 
pomalidomid (4 mg) bortezomib (1,3 mg/m2) deksametazon (20 mg) * • • * Glede bolnikov, starih > 75 let, glejte Posebne skupine bolnikov.
Patients in the Pom+LD-Dex arm were administered 4 mg pomalidomide orally on days 1 to 21 of each 28-day cycle. 
Bolnikom v skupini POM + NO-deks so dajali 4 mg pomalidomida peroralno od 1. do 21. dne vsakega 28-dnevnega cikla.
How to take Imnovid 
Kako jemati zdravilo Imnovid
• Pain in the pelvis. 
• bolečina v medenici,
Oedema ≥ Grade 3 
Edem ≥ 3. stopnje
ANC return to ≥ 1 x 10 
• ANC se vrne na ≥ 1 x 10 9/l
Mean normalised AUC exposure to pomalidomide increased by 35.8% with a 90% CI [7.5% to 70.0%] in severe renal impairment patients requiring dialysis (CrCl <30mL/minute requiring dialysis) compared to patients with normal renal function. 
Srednja normalizirana AUC izpostavljenost pomalidomidu se je zvečala za 35,8 % z 90% IZ [7,5 % do 70,0 %] pri bolnikih s hudo okvaro ledvic, pri katerih je bila potrebna dializa (CrCl <30 ml/minuto, pri katerem je bila potrebna dializa) v primerjavi z bolniki z normalno funkcijo ledvic.
• Muscle spasm, muscle weakness. 
• mišični spazmi, mišična šibkost,
Other ≥ Grade 3 dexamethasone-related adverse events 
Drugi neželeni učinki ≥ 3. stopnje, povezani z deksametazonom
Instructions for dose interruptions or reductions for pomalidomide related adverse reactions are outlined in Table 2 and 3. 
Prilagajanje ali prekinitev odmerjanja pomalidomida Navodila za prekinitve ali zmanjšanja pomalidomida povezanih z neželenimi učinki so opisana v preglednici 2 in 3.
• Pomalidomide in combination with bortezomib and dexamethasone No dose adjustment is required for pomalidomide. 
• Pomalidomid v kombinaciji z bortezomibom in deksametazonom Za pomalidomid prilagajanje odmerka ni potrebno.
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. 
Sočasno dajanje fluvoksamina, ki je močan zaviralec encima CYP1A2, s pomalidomidom v prisotnosti ketokonazola je povečalo srednjo izpostavljenost pomalidomidu za 107 % z 90 % intervalom zaupanja [91 % do 124 %] v primerjavi s kombinacijo pomalidomida in ketokonazola.
• by stopping the myeloma cells developing 
• ustavi razvoj plazmocitomskih celic,
Progression Free Survival Time (weeks) Median a 
Napredovanje/umrli, n (%) Čas preživetja brez napredovanja (tedni) Mediana a
• if you are pregnant or think you may be pregnant or are planning to become pregnant - this is because Imnovid is expected to be harmful to an unborn child. (Men and women taking this medicine must read the section “Pregnancy, contraception and breast-feeding - information for women and men” below). 
• če ste noseči, ali mislite, da bi lahko bili noseči, ali načrtujete zanositev - ker se pričakuje, da je zdravilo Imnovid škodljivo za nerojenega otroka.
Note: CI=Confidence interval. 
Opomba: IZ = interval zaupanja; NE = ni mogoče oceniti.
• Pomalidomide in combination with bortezomib and dexamethasone The recommended starting dose of Imnovid is 4 mg orally once daily on Days 1 to 14 of repeated 21-day cycles. 
• Pomalidomid v kombinaciji z bortezomibom in deksametazonom Priporočeni začetni odmerek zdravila Imnovid je 4 mg peroralno enkrat na dan na 1. do 14. dan v ponavljajočih se 21-dnevnih ciklih
• 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. 
• Ko se zdravilo Imnovid uporablja skupaj z deksametazonom, v povprečju prepreči ponovitev diseminiranega plazmocitoma za do¸4 mesece v primerjavi z 2 mesecema pri bolnikih, ki uporabljajo samo deksametazon.