natgillin/translations-raw huggingface dataset:
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.
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.
Zdravilo Imnovid v kombinaciji z deksametazonom je indicirano za zdravljenje ponovljenega in na zdravljenje odpornega diseminiranega plazmocitoma pri odraslih bolnikih, ki so predhodno prejemali vsaj dve zdravljenji, vključno z lenalidomidom in bortezomibom, in pri katerih je bilo po zadnjem zdravljenju dokazano napredovanje bolezni.
• Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for effective contraception (even if woman has amenorrhoea) and definition of effective contraception
• varnostne nasvete za ženske v rodni dobi: o potrebo po izogibanju fetalni izpostavljenosti, o opis PPN, o potrebo po zanesljivi kontracepciji (tudi, če ima ženska amenorejo) in opredelitev zanesljive kontracepcije, ▪ režim testov nosečnosti, ▪ svetovanje o ustreznih testih, ▪ pred začetkom zdravljenja,
Pomalidomide dose reduction∞ Dose level
Zmanjševanje odmerka pomalidomida∞ Raven odmerka
Mean normalised AUC exposure to pomalidomide was 100.2% with a 90% confidence interval [79.7% to 127.0%] in severe renal impairment patients not requiring dialysis (CrCl <30 or eGFR <30 mL/minute/1.73 m2) compared to patients with normal renal function.
Srednja normalizirana AUC izpostavljenost pomalidomidu je bila 100,2 % z 90% intervalom zaupanja [79,7 % do 127,0 %] pri bolnikih s hudo okvaro ledvic, pri katerih hemodializa ni bila potrebna (CrCl <30 ali eGFR <30 ml/minuto/1,73 m2) v primerjavi z bolniki z normalno funkcijo ledvic.
• The recommended starting dose of dexamethasone is 20 mg per day.
• Priporočeni začetni odmerek deksametazona je 20 mg na dan.
Dexamethasone dose modification instructions Toxicity
Navodila za prilagajanje odmerka deksametazona Toksičnost
What Imnovid contains
Kaj vsebuje zdravilo Imnovid
• See the leaflets that come with bortezomib and dexamethasone for further information on their use and effects.
• Za informacije o uporabi in učinkih bortezomiba in deksametazona glejte navodila za njuno uporabo.
Slight reduction in maternal body weight gain, significant reduction in triglycerides, and significant dec rease in absolute and relative spleen weights were observed at 100 and 250 mg/kg/day.
Pri odmerkih 100 in 250 mg/kg/dan so opazili zmanjšano pridobivanje telesne mase matere, znatno znižanje trigliceridov in znatno znižanje absolutne in relativne mase vranice.
To initiate a new cycle of pomalidomide, the neutrophil count must be  1 x 109/l and the platelet count must be  50 x 109/l.
Prilagajanje ali prekinitev odmerka pomalidomida Nov cikel pomalidomida lahko uvedete, ko je število nevtrofilcev  1 x 109/l in število trombocitov  50 x 10
Dose Level
- 2. stopnje
You should not donate semen or sperm during treatment and for 7 days after the end of treatment.
Med zdravljenjem in še 7 dni po koncu zdravljenja ne smete darovati semena ali sperme.
• Disposal of unwanted medicine
• napotke za odstranjevanje odvečnega zdravila;
In patients who received 1 prior antimyeloma line, median PFS time was 20.73 months (95% CI: 15.11, 27.99) in the Pom + Btz + LD-Dex arm and 11.63 months (95% CI: 7.52, 15.74) in the Btz + LD-Dex arm. A 46% risk reduction was observed with Pom + Btz + LD-Dex treatment (HR = 0.54, 95% CI: 0.36,
Pri bolnikih, ki so prejeli eno predhodno vrsto zdravljenja proti diseminiranemu plazmocitomu, je bil mediani čas PFS 20,73 meseca (95 % IZ: 15,11; 27,99) v skupini Pom + Btz + NO-deks in 11,63 meseca (95 % IZ: 7,52; 15,74) v skupini Btz + NO-deks.
• This includes any possible side effects not listed in this leaflet.
- Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 95% CI c
Razmerje tveganja (POM + NO-deks: VO-deks) 2-stranski 95 % IZ
Instructions for dose reduction for dexamethasone related adverse reactions are outlined in Table 6 below.
Navodila za zmanjševanje odmerka zaradi neželenih učinkov, povezanih z deksametazonom, so opisana v preglednici 6 v nadaljevanju.
C] -pomalidomide (2 mg) to healthy subjects, approximately 73% and 15% of the radioactive dose was eliminated in urine and faeces, respectively, with approximately 2% and 8% of the dosed radiocarbon eliminated as pomalidomide in urine and faeces.
73 % in v blatu približno 15 % radioaktivnega odmerka, s približno 2 % odmerjenega radiokarbona kot pomalidomida v seču in 8% kot pomalidomida v blatu.
What Imnovid is
Kaj je zdravilo Imnovid
ILD and related events, including cases of pneumonitis, have been observed with pomalidomide.
Pri zdravljenju s pomalidomidom so opazili IPB in sorodne dogodke, vključno s primeri pnevmonitisa.
Caution should be exercised when pomalidomide in combination with dexamethasone is used in patients previously infected with HBV, including patients who are anti-HBc positive but HBsAg negative.
Pri bolnikih, pri katerih je test na infekcijo s HBV pozitiven, je priporočljiv posvet z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B. Kadar pomalidomid v kombinaciji z deksametazonom uporabljate pri bolnikih, ki so bili predhodno okuženi s HBV, vključno z bolniki, ki so anti-HBc pozitivni, a HBsAg negativni, je potrebna previdnost.
• 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
o med zdravljenjem (vključno s prekinitvami odmerjanja) vsaj vsake 4 tedne, razen v primeru potrjene sterilizacije jajcevodov, o po končanem zdravljenju;
Unused medicinal product should be returned to the pharmacist.
Neuporabljeno zdravilo morate vrniti v lekarno.
• Numbness, itching, and a feeling of pins and needles on your skin (paraesthesia).
• odrevenelost, srbenje in občutek mravljinčenja v koži (parestezije),
LD-Dex (40 mg) was administered once per day on days 1, 8, 15 and 22 of a 28-day cycle.
NO-deks (40 mg) so dajali enkrat na dan 1., 8., 15. in 22. dan 28-dnevnega cikla.
Instructions on dose interruptions or reductions for pomalidomide related adverse reactions are outlined in the Table 2 and dose levels are defined in Table 3 below:
Navodila za prekinitev ali zmanjšanje odmerka zaradi neželenih učinkov, povezanih s pomalidomidom, so opisana v preglednici 2, ravni odmerkov pa so opredeljene v preglednici 3 spodaj: Preglednica 2: Navodila za prilagajanje odmerka pomalidomida Toksičnost
Name and address of the manufacturer responsible for batch release
IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Celgene Distribution B.V.
Hyperglycaemia ≥ Grade 3
Hiperglikemija ≥ 3. stopnje
Ammonium hydroxide (E527)
(E1520) in amonijev hidroksid (E527).
No adverse findings were noted up to 1000 mg/kg/day (175-fold exposure ratio relative to a 4 mg clinical dose).
Pri odmerkih do 1.000 mg/kg/dan (175-kratnik izpostavljenosti glede na 4 mg klinični odmerek) niso prišli do neželenih izsledkov.
> 75 years old Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21-day cycle Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day cycle)
> 75 let stari Odmerek (cikel 1-8: 1., 2., 4., 5., 8., 9., 11., 12. dan 21-dnevnega cikla Cikel ≥ 9: 1., 2., 8., 9. dan 21-dnevnega cikla)
If pregnancy occurs in a woman treated with pomalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Če ženska, ki se zdravi s pomalidomidom, zanosi, je treba zdravljenje nemudoma prekiniti in bolnico napotiti k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
Progression Free Survival Based on IRAC Review of Response by IMWG Criteria (Stratified Log Rank Test) (ITT Population).
Preživetje brez napredovanja na podlagi IRAC-ovega pregleda odzivov na podlagi kriterijev IMWG (stratificirani test Log Rank) (populacija ITT).
Thrombocytopenia Platelet count < 25 x 10
Trombocitopenija • Število trombocitov < 25 x 109/l
• Heart attack (chest pain spreading to the arms, neck, jaw, feeling sweaty and breathless, feeling sick or vomiting).
• srčna kap (bolečina v prsih, ki se širi v roki, vrat, čeljust; občutek potenja in kratke sape,
Uncommon Bronchitis Herpes zoster
• srbeča koža, • pasovec (herpes zoster),
• if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see “Pregnancy, contraception and breast-feeding - information for women and men”).
• če lahko zanosite, razen če upoštevate nujne ukrepe za preprečevanje nosečnosti (glejte "Nosečnost, kontracepcija in dojenje - informacije za ženske in moške"); če lahko zanosite, bo zdravnik ob vsakem receptu preveril, ali upoštevate nujne ukrepe, in bo priložil potrdilo;
• The printing ink contains: shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) and ammonium hydroxide (E527) (white ink) and shellac, iron oxide black (E172), propylene glycol (E1520) and ammonium hydroxide (E527) (black ink).
• Tiskarsko črnilo vsebuje: šelak, titanov dioksid (E171), simetikon, propilenglikol (E1520) in amonijev hidroksid (E527) (belo črnilo) in šelak, črni železov oksid (E172), propilenglikol (E1520) in amonijev hidroksid (E527) (črno črnilo).
• Pomalidomide in combination with dexamethasone The most commonly reported adverse reactions in clinical studies have been blood and lymphatic system disorders including anaemia (45.7%), neutropenia (45.3%) and thrombocytopenia (27%); in general disorders and administration site conditions including fatigue (28.3%), pyrexia (21%) and oedema peripheral (13%); and in infections and infestations including pneumonia (10.7%).
Neželeni učinki, o katerih so v kliničnih študijah najpogosteje poročali, so bile bolezni krvi in limfatičnega sistema, vključno z anemijo (45,7 %), nevtropenijo (45,3 %) in trombocitopenijo (27 %); od splošnih težav in sprememb na mestu aplikacije so poročali o utrujenosti (28,3 %), pireksiji (21 %) in perifernem edemu (13 %); infekcijske in parazitske bolezni so vključevale pljučnico (10,7 %).
Mean exposure to pomalidomide increased by 51% with a 90% confidence interval [9% to 110%] in mildly hepatically impaired patients compared to healthy subjects.
Pri bolnikih z blago okvaro jeter se je v primerjavi z zdravimi osebami srednja izpostavljenost pomalidomidu zvečala za 51 % z 90 % intervalom zaupanja [9 % do 110 %].
Other ≥ Grade 3 pomalidomide-related adverse events
Drugi neželeni učinki ≥ 3. stopnje, povezani s pomalidomidom.
• See the leaflet that comes with dexamethasone for further information on its use and effects.
• Za informacije o uporabi in učinkih deksametazona glejte navodila za njegovo uporabo.
Some people feel tired, dizzy, faint, confused or less alert when taking Imnovid.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri ljudje so pri jemanju zdravila Imnovid utrujeni, omotični, omedlevajo, so zmedeni ali imajo zmanjšano pozornost.
After a median follow-up of 15.9 months, median PFS time was 11.20 months (95% CI: 9.66, 13.73) in the Pom+Btz+LD-Dex arm.
Po medianem času spremljanja 15,9 meseca je bil v skupini Pom+Btz+NO-deks mediani čas PFS 11,20 meseca (95 % IZ: 9,66; 13,73).
• Bone pain, back pain.
• bolečine v kosteh, bolečine v hrbtu,
Cycle 9 onwards
Od 9. cikla naprej
• The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) and ammonium hydroxide (E527).
• Tiskarsko črnilo vsebuje: belo črnilo - šelak, titanov dioksid (E171), simetikon, propilenglikol (E1520) in amonijev hidroksid (E527).