FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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
Slovenian: • 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.
English: Interrupt dose until symptoms resolve.
Slovenian: Prekinite odmerek, dokler simptomi ne izzvenijo.
English: • Brochure for women patients who are not of childbearing potential
Slovenian: • brošure za ženske, ki niso v rodni dobi,
English: Median OS time for the HD-Dex arm was 34 weeks (95% CI: 23.4, 39.9).
Slovenian: Mediana celokupnega preživetja za skupino VO-deks je bila 34 tednov (95 % IZ: 23,4; 39,9).
English: • The active substance is pomalidomide.
Slovenian: • Zdravilna učinkovina je pomalidomid.
English: Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.
Slovenian: Zdravljenje morajo začeti in nadzorovati zdravniki, izkušeni pri zdravljenju diseminiranega plazmocitoma.
English: When to take Imnovid with other medicines
Slovenian: Kdaj morate jemati zdravilo Imnovid z drugimi zdravili
English: Exposure-adjusted rates were comparable across treatment arms.
Slovenian: Pogostnost, popravljena za izpostavljenost, je bila med skupinami zdravljenja primerljiva.
English: If powder from pomalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Slovenian: Če pride prašek pomalidomida v stik s kožo, morate kožo takoj in temeljito sprati z milom in vodo.
English: 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).
Slovenian: 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).
English: In studies, pomalidomide was found to be removed by haemodialysis.
Slovenian: V študijah so ugotovili, da se pomalidomid odstrani s hemodializo.
English: Treatment with pomalidomide combined with dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
Slovenian: Zdravljanje s pomalidomidom v kombinaciji z deksametazonom naj se daje do napredovanja bolezni ali dokler ne pride do nesprejemljive toksičnosti.
English: 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.
Slovenian: 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.
English: • Verification that appropriate counselling has taken place
Slovenian: • potrditev, da je bil bolnik deležen ustreznega svetovanja,
English: 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.
Slovenian: 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.
English: • by stopping the formation of blood vessels supplying the cancer cells.
Slovenian: • ustavi nastajanje krvnih žil, ki preskrbujejo rakave celice.
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.
Slovenian: • 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,
English: Imnovid contains the active substance ‘pomalidomide'.
Slovenian: Zdravilo Imnovid vsebuje učinkovino, ki se imenuje "pomalidomid".
English: 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.
Slovenian: 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.
English: Odds ratio is for Pom+Btz+LD-Dex:Btz+LD-Dex.
Slovenian: Razmerje verjetnosti velja za Pom+Btz+NO-deks:Btz+NO-deks.
English: Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies and institute treatment as indicated.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: In patients receiving combination therapy with pomalidomide in clinical studies, thrombocytopenia occurred in 27.0-36.7% of patients.
Slovenian: Pri bolnikih, ki so v kliničnih študijah prejemali kombinirano zdravljenje s pomalidomidom, se je trombocitopenija pojavila pri 27,0-36.7 % bolnikov.
English: 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).
Slovenian: 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).
English: Dispensing of pomalidomide to women of childbearing potential should occur within 7 days of the prescription.
Slovenian: Izdaja pomalidomida ženskam v rodni dobi naj bo v roku 7 dni od izdaje recepta.
English: • Imnovid, bortezomib and dexamethasone are taken in ‘treatment cycles'.
Slovenian: • Zdravilo Imnovid, bortezomib in deksametazon se jemljejo v ‘ciklih zdravljenja'.
English: 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).
Slovenian: 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).
English: Patient Card
Slovenian: Kartica za bolnika
English: Approximately 30% of the patients experiencing peripheral neuropathy had a history of neuropathy at baseline.
Slovenian: Približno 30 % bolnikov s periferno nevropatijo je imelo anamnezo nevropatije v izhodišču.
English: In vivo, pomalidomide therapy led to reduction in the levels of Ikaros in patients with relapsed lenalidomiderefractory multiple myeloma.
Slovenian: In vivo je zdravljenje s pomalidomidom povzročilo znižanje ravni Ikarosa pri bolnikih z recidivnim diseminiranim plazmocitomom, odpornim proti zdravljenju z lenalidomidom.
English: The recommended dose of dexamethasone is 20 mg orally once daily, on the days shown in Table 1.
Slovenian: Priporočeni odmerek deksametazona je 20 mg peroralno enkrat na dan, na dneve, ki so prikazani v preglednici 1.
English: OR (95% CI) e, p-valuef DoR (months) Mediana time (95% CI) b HRc (95% CI)
Slovenian: OR (95 % IZ)e, vrednost pf DoR (meseci) Mediania čas (95 % IZ)b HR
English: See section 4.2 for dosing information.
Slovenian: Za podatke o odmerjanju glejte poglavje 4.2.
English: What Imnovid is used for Imnovid is used to treat adults with a type of cancer called ‘multiple myeloma'.
Slovenian: Zdravilo Imnovid se uporablja za zdravljenje odraslih bolnikov z vrsto raka, ki ga imenujemo "diseminirani plazmocitom ".
English: 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).
Slovenian: Ugotovili so, da je pomalidomid teratogen pri podganah in kuncih, če se daje v obdobju glavne organogeneze (glejte poglavji 4.6 in 5.3).
English: • Chest pain, or leg pain and swelling, especially in your lower leg or calves (caused by blood clots).
Slovenian: • bolečine v prsnem košu ali bolečine oz. otekline v nogah, zlasti v spodnjih delih nog oz. mečih (zaradi krvnih strdkov);
English: Specifically, pomalidomide inhibits proliferation and induces apoptosis of haematopoietic tumour cells.
Slovenian: Bolj natančno pomalidomid zavira proliferacijo in spodbuja apoptozo hematopoetskih tumorskih celic.
English: • Low red blood cells, which may cause anaemia leading to tiredness and weakness.
Slovenian: • zmanjšanje števila rdečih krvničk, ki lahko povzroči anemijo, ki privede do utrujenosti in šibkosti,
English: Btz+LD-Dex (N = 278)
Slovenian: Btz+NO-deks (N = 278)
English: In particular, tell your doctor, pharmacist or nurse before taking Imnovid if you are taking any of the following medicines:
Slovenian: Zdravniku, farmacevtu ali medicinski sestri še zlasti povejte, če jemljete katero od naslednjih zdravil:
English: Treatment with pomalidomide combined with bortezomib and dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
Slovenian: Zdravljenje s pomalidomidom v kombinaciji z bortezomibom in deksametazonom naj se daje do napredovanja bolezni ali dokler ne pride do nesprejemljive toksičnosti.
English: The most commonly reported serious adverse reaction was pneumonia (9.3%).
Slovenian: Resni neželeni učinek, o katerem so poročali najpogosteje, je bila pljučnica (9,3 %).
English: The Educational Health Care Professional's Kit shall contain the following elements:
Slovenian: Paket izobraževalnih gradiv za zdravstvene delavce mora vsebovati naslednje elemente:
English: 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).
Slovenian: 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).
English: Patients with ongoing ≥ Grade 2 peripheral neuropathy were excluded from clinical studies with pomalidomide.
Slovenian: Bolniki, ki imajo periferno nevropatijo ≥ 2. stopnje, so bili izključeni iz kliničnih študij s pomalidomidom.
English: Psychiatric disorders Common Confusional state
Slovenian: Psihiatrične motnje pogosti stanje zmedenosti pogosti stanje zmedenosti
English: • That pomalidomide is teratogenic in animals and is expected to be teratogenic in humans
Slovenian: • opozorilo, da je pomalidomid teratogen pri živalih in se pričakuje teratogenost pri človeku;
English: Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis.
Slovenian: Ugotovili so, da je pomalidomid teratogen pri podganah in kuncih, če se daje v obdobju glavne organogeneze.
English: • The breakdown of cancer cells resulting in the release of toxic compounds into the bloodstream
Slovenian: • razgradnja rakavih celic, ki ima za posledico sproščanje toksičnih spojin v krvni obtok (sindrom tumorske lize).
English: HD-Dex (N=153)
Slovenian: VO-deks (N=153)
English: 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.
Slovenian: 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.
English: ADRs reported in clinical study MM-003 in patients treated with pomalidomide in combination with dexamethasone.
Slovenian: NUZ, opaženi v klinični študiji MM-003 pri bolnikih, zdravljenih s pomalidomidom v kombinaciji z deksametazonom
English: • one other medicine - called ‘dexamethasone' in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib.
Slovenian: • 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.
English: • High blood levels of potassium, which may cause abnormal heart rhythm.
Slovenian: • visoke ravni kalija v krvi, ki lahko povzročijo nenormalni srčni ritem,
English: Pom+LD-Dex (N=302)
Slovenian: POM+NO-deks (N=302)
English: • 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.
Slovenian: • 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.
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.
Slovenian: • 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.
English: In rats, chronic administration of pomalidomide at doses of 50, 250, and 1000 mg/kg/day for 6 months was well tolerated.
Slovenian: Podgane so kronično 6-mesečno dajanje pomalidomida v odmerkih 50, 250 in 1.000 mg/kg/dan dobro prenašale.
English: For instructions on dose interruptions or reductions for bortezomib related adverse reactions, physicians should refer to bortezomib Summary of Product Characteristics (SmPC).
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Pomalidomide is also a substrate of P-glycoprotein in vitro.
Slovenian: In vitro je pomalidomid tudi substrat P-glikoproteina.
English: Doses were reduced and treatment was temporarily interrupted or stopped as needed to manage toxicity (see section
Slovenian: Po potrebi so zaradi nadziranja toksičnosti zmanjševali odmerke in začasno prekinili zdravljenje ali prenehali z njim (see glejte poglavje 4.2).
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.
Slovenian: • 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.
English: • High blood levels of uric acid, which may cause a form of arthritis called gout.
Slovenian: • visoke ravni sečne kisline v krvi, ki lahko povzročijo obliko artritisa, ki se imenuje protin,
English: POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.53 (0.37, 0.74) KM median: POM+LD-DEX=NE [48.1, NE] KM median: HD-DEX = 34.0[23.4, 39.9] Events: POM+LD-DEX=75/284 HD-DEX=56/139
Slovenian: POM+NO-deks vs VO-deks Log-rank vrednost p = < 0,001 (2-stranska) HR (95 % IZ) 0,53 (0,37; 0,74) Mediana KM: POM+NO-deks = NE [48,1 NE] Mediana KM: VO-deks = 34,0 [23,4; 39,9] Dogodki: POM+NO-deks = 75/284 VO-deks = 56/139
English: Peripheral neuropathy adverse reactions were reported in 12.3% of patients and venous embolic or thrombotic (VTE) adverse reactions were reported in 3.3% of patients.
Slovenian: O periferni nevropatiji kot neželenem učinku so poročali pri 12,3 % bolnikov, o venski emboliji ali trombozi (VTE) kot neželenem učinku pa pri 3,3 % bolnikov.
English: In a second study to evaluate the contribution of a CYP1A2 inhibitor alone to metabolism changes, co-administration of fluvoxamine alone with pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% to 157%] compared to pomalidomide alone.
Slovenian: V drugi študiji, v kateri so ocenjevali prispevek zaviralca CYP1A2 samega k spremembam presnove, je sočasno dajanje fluvoksamina samega s pomalidomidom zvečalo srednjo izpostavljenost pomalidomidu za 125 % z 90 % intervalom zaupanja [98 % do 157 %] v primerjavi s pomalidomidom samim.
English: • Shortness of breath (from serious chest infection, inflammation of the lung, heart failure or blood clot).
Slovenian: • zasoplost (zaradi hude okužbe v prsih, vnetja pljuč, srčnega popuščanja ali krvnega strdka);
English: • The need to contact their doctor immediately upon suspicion of pregnancy
Slovenian: • potrebo po takojšnjem obveščanju zdravnika pri sumu na nosečnost.
English: Markedly elevated levels of alanine aminotransferase and bilirubin have been observed in patients treated with pomalidomide (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih s pomalidomidom, so opazili znatno zvišane ravni alanin aminotransferaze in bilirubina (glejte poglavje 4.8).
English: Imnovid works in a number of different ways:
Slovenian: Kako zdravilo Imnovid deluje Zdravilo Imnovid deluje na več različnih načinov:
English: Minimal or mild bile duct proliferation with associated increases in ALP and GGT were also observed at 1 mg/kg/day.
Slovenian: Pri odmerku 1 mg/kg/dan so opazili tudi minimalno ali blago proliferacijo žolčevoda s povezanim zvišanjem ALP in GGT.
English: Haemorrhagic events have included epistaxis, intracranial haemorrhage and gastrointestinal haemorrhage.
Slovenian: Hemoragični dogodki vključujejo epistakso, znotrajlobanjske krvavitve in gastrointestinalne krvavitve.
English: • The other ingredients are mannitol (E421), starch, pregelatinised, and sodium stearyl fumarate.
Slovenian: • Druge sestavine zdravila so manitol (E421), škrob, predgelirani, in natrijev stearilfumarat.
English: Consider dose interruption or discontinuation of pomalidomide treatment.
Slovenian: V poštev pride prekinitev odmerjanja ali prekinitev zdravljenja s pomalidomidom.
English: • Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark browncoloured urine, right-sided abdominal pain, fever and feeling nauseous or being sick.
Slovenian: • Ponovitev okužbe z virusom hepatitisa B, ki lahko povzroči porumenitev kože in oči, temno rjavo obarvan urin, bolečine v desni strani trebuha, zvišano telesno temperaturo, občutek slabosti (navzeo) ali bruhanje.
English: The maternal NOAEL was 10 mg/kg/day, and the developmental NOAEL was <10 mg/kg/day (AUC24h was 418 ng•h/mL on Gestation Day 19 at this lowest dose tested, which was similar to that obtained from a 4 mg clinical dose).
Slovenian: NOAEL za mater je bila 10 mg/kg/dan in razvojna NOAEL < 10 mg/kg/dan (AUC24h je bila 418 ng•h/ml na 19. dan gestacije pri tem najnižjem testiranem odmerku, kar je podobno kot pri 4 mg kliničnem odmerku).
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%.
Slovenian: V skladu z nedavno vmesno analizo celokupnega preživetja (OS), z upoštevanjem datuma zaključka zbiranja podatkov 15. september 2018 (mediana obdobja spremljanja 26,2 meseca), je bil mediani čas OS po Kaplan-Meierjevi oceni 40,5 meseca za skupino Pom + Btz + NO-deks in 30,5 meseca za skupino Btz + NO-deks; HR = 0,91; 95 % IZ: 0,70; 1,18, s celokupno pogostnostjo dogodkov 43,3 %.
English: • your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished.
Slovenian: • bo zdravnik pred vsakim zdravljenjem, vsaj vsake 4 tedne med zdravljenjem in vsaj 4 tedne po koncu zdravljenja naročil test nosečnosti.
English: • Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
Slovenian: • nizko raven fosfatov v krvi (hipofosfatemija), ki lahko povzroča mišično šibkost in razdražljivost ali zmedenost,
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
Slovenian: • potrebo po uporabi kondomov, če je spolna partnerica noseča ali ŽRD in ne uporablja kontracepcije (tudi, če je moški imel vazektomijo) o med zdravljenjem s pomalidomidom (vključno s prekinitvami odmerjanja) o še 7 dni po zadnjem odmerku;
English: • Pomalidomide in combination with bortezomib and dexamethasone The most commonly reported blood and lymphatic system disorders were neutropenia (46.8%), thrombocytopenia (36.7%) and anaemia (28.4%).
Slovenian: • Pomalidomid v kombinaciji z bortezomibom in deksametazonom Bolezni krvi in limfatičnega sistema, o katerih so najpogosteje poročali, so bile nevtropenija (46,8 %), trombocitopenija (36,7 %) in anemija (28,4 %).