natgillin/translations-raw huggingface dataset:
Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups, stratified by age (≤75 vs >75),diseases population (refractory to both lenalidomide and bortezomib vs not refractory to both active substances), and prior number of anti myeloma therapy (=2 vs >2).
Na podlagi modela sorazmernih ogroženosti po Coxu s primerjavo funkcij tveganja, povezanih z zdravljenimi skupinami, stratificiranimi po starosti (≤ 75 v primerjavi z > 75), bolezni prebivalstva (neodzivni na lenalidomid in bortezomib v primerjavi z odzivnimi na obe učinkovini) in predhodnim številom terapij proti plazmocitomu (= 2 v primerjavi z > 2).
In patients receiving combination therapy with pomalidomide in clinical studies, infection occurred in 55.0-80.2% of patients (24.0-30.9% Grade 3 or 4).
Pri bolnikih, ki so v kliničnih študijah prejemali kombinirano zdravljenje s pomalidomidom, so se okužbe pojavile pri 55,0-80,2 % bolnikov (pri 24,0-30,9 % 3. ali 4. stopnje).
• Brief background on pomalidomide and its licensed indication
• povzetek podatkov o pomalidomidu in indikaciji, za katero je odobren;
This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na kapsulo, kar v bistvu pomeni "brez natrija".
Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD.
Pri bolnikih z akutnim nastopom ali nepojasnjenim poslabšanjem pljučnih simptomov je treba opraviti skrbno presojo in izključiti možnost IPB.
Pomalidomide doses as high as 50 mg as a single dose in healthy volunteers, and 10 mg as once-daily multiple doses in multiple myeloma patients have been studied without reported serious adverse reactions related to overdose.
Preučili so enkratne odmerke pomalidomida do 50 mg pri zdravih prostovoljcih in 10 mg večkratni odmerek enkrat na dan pri bolnikih z diseminiranim plazmocitomom brez poročil o resnih neželenih učinkih, povezanih s prevelikim odmerjanjem.
Regular monitoring of liver function is recommended for the first 6 months of treatment with pomalidomide and as clinically indicated thereafter.
Priporočamo, da prvih 6 mesecev zdravljenja s pomalidomidom redno spremljate delovanje jeter, nato pa skladno s kliničnimi indikacijami.
During the treatment with Imnovid you have an increased risk of getting blood clots in your veins and arteries.
Med zdravljenjem z zdravilom Imnovid je tveganje za pojav krvnih strdkov v venah in arterijah večje.
Two sided 95% CIb
Dvostranski 95 % IZb
A medically supervised pregnancy test should be performed during the consultation, when pomalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Test nosečnosti pod zdravniškim nadzorom je treba opraviti med posvetom, ko se predpiše pomalidomid, ali v 3 dneh pred obiskom pri zdravniku, ki predpiše zdravilo, po tem ko je bolnica vsaj 4 tedne že uporabljala zanesljivo kontracepcijo.
The median is based on the Kaplan-Meier estimate.
Mediana temelji na oceni Kaplan-Meier.
• Requirements in the event of pregnancy o Instructions to stop pomalidomide immediately upon suspicion of pregnancy if female patients o Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice o Local contact details for reporting of any suspected pregnancy o Pregnancy reporting form
• zahteve v primeru nosečnosti: o navodila za takojšnjo prekinitev zdravljenja s pomalidomidom v primeru suma na nosečnost pri bolnicah, o potrebo po napotitvi k zdravniku specialistu za teratologijo ali z izkušnjami na področju teratologije in njeni diagnostiki zaradi ocene in svetovanja, o kontaktne podatke za poročanje kakršnegakoli suma na nosečnost, o obrazec za poročanje o nosečnosti.
• For Cycles 9 and onwards: 10 mg once daily on Days 1, 2, 8 and 9 of each 21-day cycle.
• za cikel 9 in naprej: 10 mg enkrat na dan na 1., 2., 8. in 9. dan vsakega 21-dnevnega cikla.
If you take more Imnovid than you should, talk to a doctor or go to a hospital straight away.
Če ste vzeli večji odmerek zdravila Imnovid, kot bi smeli Če ste vzeli večji odmerek zdravila Imnovid, kot bi smeli, se pogovorite z zdravnikom ali pojdite takoj v bolnišnico.
There is no relevant use of pomalidomide in children aged 0-17 years for the indication of multiple myeloma.
Uporaba pomalidomida pri otrocih, starih 0 do 17 let, za indikacijo diseminiranega plazmocitoma ni primerna.
• Swelling caused by fluid.
• otekanje, ki ga povzroča tekočina,
Other serious adverse reactions reported included pyrexia (4.0%), lower respiratory tract infection (2.9%), pulmonary embolism (2.9%), influenza (2.9%), and acute kidney injury (2.9%).
Med drugimi resnimi neželenimi učinki, o katerih so poročali, so bili pireksija (4,0 %), infekcije spodnjih dihal (2,9 %), pljučna embolija (2,9 %), gripa (2,9 %) in akutna okvara ledvic (2,9 %).
• Pomalidomide in combination with dexamethasone
• Pomalidomid v kombinaciji z deksametazonom
Patients should not adjust the dose to make up for a missing dose on previous days.
Bolnik ne sme prilagajati odmerka, da bi nadomestil odmerek, zamujen prejšnji dan.
Cycle 9 and onwards
9. cikel in naprej
ANC return to ≥ 1 x 109/l
• ANC se vrne na ≥1 x 109/l
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).
Primarni cilj študije za dokaz učinkovitosti je bilo preživetje brez napredovanja (PFS - progression free survival), ki ga je ocenjeval neodvisni presojevalni odbor (IRAC - Independent Response Adjudication Committee) po kriterijih IMWG z uporabo populacije z namenom zdravljenja (ITT - Intention to Treat -).
The 1-year event free rate was 52.6% (± 5.72%) for the Pom + LD-Dex arm and 28.4% (± 7.51%) for the HD-Dex arm.
Enoletna stopnja brez dogodkov je bila 52,6 % (± 5,72 %) za skupino POM + NO-deks in 28,4 % (± 7,51 %) za skupino VO-deks.
Co-administration of multiple doses of up to 4 mg pomalidomide with 20 mg to 40 mg dexamethasone (a weak to moderate inducer of several CYP enzymes including CYP3A) to patients with multiple myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered alone.
Sočasno dajanje več odmerkov do 4 mg pomalidomida z 20 mg do 40 mg deksametazona (šibek do zmeren spodbujevalec številnih encimov CYP, vključno s CYP3A) bolnikom z diseminiranim plazmocitomom ni imelo vpliva na farmakokinetiko pomalidomida v primerjavi z dajanjem samega pomalidomida.
For each subsequent drop < 0.5 x 109/l
• Pri vsakem nadaljnjem zmanjšanju < 0,5 x 109/l
• Low blood levels of magnesium (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability and may result in low blood levels of calcium (hypocalcaemia), which may cause numbness and, or tingling of hands, feet, or lips, muscle cramps, muscle weakness, light-headedness, confusion.
• nizka raven magnezija v krvi (hipomagneziemija), ki lahko povzroča utrujenost, splošno šibkost, mišične krče, razdražljivost in lahko povzroči nizko raven kalcija v krvi (hipokalciemija), ki lahko povzroči odrevenelost in/ali mravljinčenje dlani, stopal ali ustnic, mišične krče, mišično šibkost, vrtoglavost, zmedenost,
ADRs reported in post-marketing use in patients treated with pomalidomide.
NUZ, o katerih so poročali pri uporabi po začetku trženja zdravila pri bolnikih, zdravljenih s pomalidomidom.
• Safety advice for men o The need to avoid foetal exposure o The need to use condoms if sexual partner is pregnant or a WCBP and has no contraception (even if man has had a vasectomy) ▪ During pomalidomide treatment ▪ For one week following final dose o That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment o That if his partner becomes pregnant whilst he is taking pomalidomide or shortly after he has stopped taking pomalidomide he should inform his treating doctor immediately
• varnostne nasvete za moške: o potrebo po izogibanju fetalni izpostavljenosti, o potrebo po uporabi kondomov, če je spolna partnerica noseča ali ŽRD in ne uporablja kontracepcije (tudi, če je moški imel vazektomijo) ▪ med zdravljenjem s pomalidomidom, ▪ še en teden po zadnjem odmerku; o da ne sme darovati semena ali sperme med zdravljenjem (vključno s prekinitvami odmerjanja) in še 7 dni po končanem zdravljenju s pomalidomidom; o da mora v primeru zanositve partnerice, medtem ko bolnik jemlje pomalidomid ali kmalu po prenehanju jemanja pomalidomida, takoj obvestiti zdravnika, ki je zdravilo predpisal.
Interrupt dose until symptoms resolve.
Prekinite odmerek, dokler simptomi ne izzvenijo.
• Brochure for women patients who are not of childbearing potential
• brošure za ženske, ki niso v rodni dobi,
Median OS time for the HD-Dex arm was 34 weeks (95% CI: 23.4, 39.9).
Mediana celokupnega preživetja za skupino VO-deks je bila 34 tednov (95 % IZ: 23,4; 39,9).
• The active substance is pomalidomide.
• Zdravilna učinkovina je pomalidomid.
Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.
Zdravljenje morajo začeti in nadzorovati zdravniki, izkušeni pri zdravljenju diseminiranega plazmocitoma.
When to take Imnovid with other medicines
Kdaj morate jemati zdravilo Imnovid z drugimi zdravili
Exposure-adjusted rates were comparable across treatment arms.
Pogostnost, popravljena za izpostavljenost, je bila med skupinami zdravljenja primerljiva.
If powder from pomalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Če pride prašek pomalidomida v stik s kožo, morate kožo takoj in temeljito sprati z milom in vodo.
In the rat embryofoetal developmental toxicity study, malformations of absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (central and/or neural arches) were observed at all dosage levels (25, 250, and 1000 mg/kg/day).
V študiji embriofetalne razvojne toksičnosti pri podganah so ugotovili deformacije kot npr. odsotnost sečnega mehurja, odsotnost ščitnice in združitev ter neporavnanost ledvenih in prsnih elementov hrbtenice (osrednji in/ali nevralni lok) pri vseh ravneh odmerkov (25, 250 in 1.000 mg/kg/dan).
In studies, pomalidomide was found to be removed by haemodialysis.
V študijah so ugotovili, da se pomalidomid odstrani s hemodializo.
Treatment with pomalidomide combined with dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
Zdravljanje s pomalidomidom v kombinaciji z deksametazonom naj se daje do napredovanja bolezni ali dokler ne pride do nesprejemljive toksičnosti.
Women of childbearing potential must use at least one effective method of contraception for at least 4 weeks before therapy, during therapy, and until at least 4 weeks after pomalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Ženske v rodni dobi morajo vsaj 4 tedne pred začetkom zdravljenja, med zdravljenjem in vsaj 4 tedne po zdravljenju s pomalidomidom in celo med morebitnimi prekinitvami odmerjanja uporabljati vsaj eno zanesljivo kontracepcijsko metodo, razen če se zavežejo popolni in neprekinjeni abstinenci, ki se potrjuje vsak mesec.
• Verification that appropriate counselling has taken place
• potrditev, da je bil bolnik deležen ustreznega svetovanja,
Bortezomib (1.3 mg/m2/dose) was administered to patients in both study arms on Days 1, 4, 8 and 11 of a 21-day cycle for Cycles 1 to 8; and on Days 1 and 8 of a 21-day cycle for Cycles 9 and onwards.
Bortezomib (1,3 mg/m2/odmerek) so dajali bolnikom v obeh skupinah študije na 1., 4., 8. in 11. dan 21-dnevnega cikla v 1. do 8. ciklu; in na 1. in 8. dan 21-dnevnega cikla v 9. ciklu in naprej.
• by stopping the formation of blood vessels supplying the cancer cells.
• ustavi nastajanje krvnih žil, ki preskrbujejo rakave celice.
• 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,