FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be instructed to avoid star fruit, grapefruit, grapefruit juice, pomegranates and pomegranate juice, as these are known to inhibit cytochrome P450 3A enzymes and may increase the bioavailability of panobinostat.
Slovenian: Bolnikom je treba naročiti, naj ne uživajo karambole, grenivke, soka grenivke, granatnega jabolka in soka granatnega jabolka, saj je znano, da ta živila zavirajo encime citokroma P450 3A in lahko povečajo biološko uporabnost panobinostata.
English: Amongst the patients who died of haemorrhage, one patient had thrombocytopenia grade 4, three patients had thrombocytopenia grade 3 and 1 patient had thrombocytopenia grade 1.
Slovenian: Med bolniki, ki so umrli zaradi krvavitve, je imel en bolnik trombocitopenijo 4. stopnje, trije bolniki so imeli trombocitopenijo 3. stopnje, en bolnik pa je imel trombocitopenijo 1. stopnje.
English: If your partner is able to become pregnant she should also use a highly effective method of contraception during your treatment and for six months after.
Slovenian: Če bi vaša spolna partnerka lahko zanosila, mora tudi ona uporabljati zelo učinkovito metodo kontracepcije v času vašega zdravljenja in še šest mesecev po zaključku zdravljenja.
English: Due to its cytostatic/cytotoxic mode of action, panobinostat can influence the quality of sperm formed during treatment.
Slovenian: Zaradi svojega citostatičnega/citotoksičnega načina delovanja lahko panobinostat vpliva na kakovost sperme, ki nastaja med zdravljenjem.
English: The recommended dose of dexamethasone is 20 mg taken orally on a full stomach.
Slovenian: Priporočeni odmerek deksametazona je 20 mg, bolnik ga jemlje peroralno na poln želodec.
English: Treatment with Farydak should be initiated by a physician experienced in the use of anti-cancer therapies.
Slovenian: Zdravljenje z zdravilom Farydak mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
English: The total duration of treatment is up to 16 cycles (48 weeks).
Slovenian: Skupno trajanje zdravljenja je lahko največ 16 ciklusov (48 tednov).
English: Some of these infections (e.g. pneumonia) have been severe (e.g. leading to sepsis, or respiratory or multi-organ failure) and have had fatal outcomes (see section 4.8).
Slovenian: Nekatere izmed teh okužb (na primer pljučnica) so bile hude (so se na primer razvile v sepso ali respiratorno ali večorgansko odpoved) in so povzročile smrt bolnika (glejte poglavje 4.8).
English: In vitro, panobinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells.
Slovenian: In vitro je panobinostat povzročil kopičenje acetiliranih histonov in drugih proteinov, kar je povzročilo zastoj celičnega ciklusa in/ali apoptozo nekaterih transformiranih celic.
English: If it is used during pregnancy or if the patient becomes pregnant while using it, the patient must be informed of the potential risk to the foetus.
Slovenian: Če bolnica uporablja zdravilo med nosečnostjo ali če zanosi v času uporabe zdravila, jo je treba seznaniti s potencialnim tveganjem za plod.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: 4.3 Kontraindikacije Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Contents of the pack and other information What Farydak contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Farydak
English: If you have any questions about how Farydak works or why you have been given it, ask your doctor or pharmacist.
Slovenian: Če imate kakršnokoli vprašanje o tem, kako zdravilo Farydak deluje ali zakaj so vam ga dali, se obrnite na zdravnika ali farmacevta
English: There are no clinical studies on the use of Farydak in pregnant patients.
Slovenian: O uporabi zdravila Farydak pri nosečih bolnicah niso izvedli nobene klinične študije.
English: Overall panobinostat exposure and inter-patient variability remained unchanged with or without food, whereas Cmax was reduced by <45% and Tmax prolonged by 1 to 2.5 hours with food (i.e. both normal and high-fat breakfasts).
Slovenian: Celotna izpostavljenost panobinostatu in variabilnost med bolniki se pri odmerjanju skupaj s hrano oziroma brez nje nista razlikovali, medtem ko se je Cmax pri odmerjanju s hrano znižala za <45 %, Tmax pa se je podaljšal za 1 do 2,5 ure (in sicer tako pri normalnem zajtrku kot pri zajtrku z veliko vsebnostjo maščob).
English: Farydak should be administered orally once daily on scheduled days only, at the same time each day.
Slovenian: Zdravilo Farydak je treba jemati peroralno enkrat na dan in sicer samo na določene dneve po razporedu, vedno ob istem času.
English: Other medicines and Farydak
Slovenian: Druga zdravila in zdravilo Farydak
English: If vomiting occurs the patient should not take an additional dose, but should take the next usual prescribed dose.
Slovenian: Če pride do bruhanja, naj bolnik ne vzame dodatnega odmerka, vzame naj naslednji predpisani odmerek po razporedu.
English: - If it is more than 12 hours since you should have taken the medicine, skip the missed dose.
Slovenian: - Če je minilo več kot 12 ur od takrat, ko bi morali vzeti zdravilo, izpustite pozabljeni odmerek.
English: • with long QT syndrome.
Slovenian: • s sindromom dolgega intervala QT,
English: - Do not chew or crush the capsules.
Slovenian: - Kapsul ne grizite in jih ne drobite.
English: Repeated dose toxicity studies
Slovenian: Študije toksičnosti ponovljenih odmerkov
English: Instructions for dose interruptions and reductions for panobinostat are outlined in Table 5.
Slovenian: Navodila za prekinitev oziroma znižanje odmerka panobinostata so povzeta v preglednici 5.
English: This is a long-term treatment with 16 cycles (48 weeks).
Slovenian: Zdravljenje je dolgotrajno in obsega 16 ciklusov (48 tednov).
English: In addition, it is currently unknown whether panobinostat may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should additionally use a barrier method of contraception.
Slovenian: Poleg tega zaenkrat ni jasno, ali tudi panobinostat lahko zmanjšuje učinkovitost hormonskih kontraceptivov, zato morajo bolnice, ki uporabljajo hormonske kontraceptive, poleg teh uporabljati še katero od pregradnih metod kontracepcije.
English: After oral administration, panobinostat pharmacokinetics appear to be linear in the dose range 10-30 mg, but AUC increases less than proportionally with dose at higher doses.
Slovenian: Kaže , da je farmakokinetika panobinostata po peroralnem odmerjanju linearna v okviru odmerjanja 10-30 mg, njegova AUC pa se pri višjih odmerkih povečuje manj kot sorazmerno z odmerkom.
English: Farydak should only be used during pregnancy if the expected benefits outweigh the potential risks to the foetus.
Slovenian: Zdravilo Farydak se pri nosečnicah lahko uporablja samo v primeru, da pričakovane koristi presegajo potencialno tveganje za plod.
English: Patients who experience diarrhoea and nausea or vomiting may require temporary dose discontinuation or dose reduction as outlined in Table 4.
Slovenian: Pri bolnikih, pri katerih pride do diareje in navzee ali bruhanja, je lahko potrebna začasna prekinitev zdravljenja ali znižanje odmerka, kot je povzeto v preglednici 4.
English: • feeling tired (fatigue), pale skin.
Slovenian: - utrujenost, bleda koža.
English: Prior to launch of Farydak in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v vsaki državi članici s pristojno nacionalno agencijo uskladiti vsebino in obliko izobraževalnega programa, med drugim sredstva komuniciranja, načine distribucije in vse druge vidike izvajanja programa.
English: If you forget to take Farydak
Slovenian: Če ste pozabili vzeti zdravilo Farydak
English: Out of the pre-specified subgroup of patients with prior treatment with bortezomib and an immunomodulatory agent (N=193), 76% of patients had received at least two prior regimens.
Slovenian: Iz vnaprej opredeljene podskupine bolnikov s predhodnim zdravljenjem z bortezomibom in z imunomodulatornim zdravilom (N=193), je 76 % bolnikov prejelo vsaj dve vrsti zdravljenja.
English: Complete response Near complete response Partial response
Slovenian: [95% IZ] popolni odziv skoraj popolni odziv delni odziv
English: While many patients developed neutropenia, febrile neutropenia only occurred in a fraction of treated patients (1.0%, both for CTC all grades and for grades 3 and 4).
Slovenian: Do nevtropenije je sicer prišlo pri številnih bolnikih, do febrilne nevtropenije pa le pri majhnem deležu zdravljenih bolnikov (pri 1,0 %, kar velja tako za vse stopnje po CTC skupaj kot za 3. in 4. stopnjo).
English: The panobinostat fraction metabolised through CYP3A4 is approximately 40%.
Slovenian: Delež panobinostata, ki se metabolizira s CYP3A4 je približno 40 %.
English: Thrombocytopenia rarely leads to treatment discontinuation (1.6% of patients).
Slovenian: Zaradi trombocitopenije je le redko treba zdravljenje prekiniti (pri 1,6 % bolnikov).
English: If this is unavoidable, patients should be closely monitored and further dose reduction or discontinuation may be considered as clinically indicated (see section 4.5).
Slovenian: Če se temu ni mogoče izogniti, je treba bolnike skrbno spremljati in jim dodatno znižati odmerek ali ukiniti zdravilo, če je to klinično indicirano (glejte poglavje 4.5).
English: * Based on NCI-CTEP classification
Slovenian: Blaga okvara jeter po klasifikaciji NCI-CTEP
English: Other possible side effects If any of the side effects below becomes severe, tell your doctor, or your pharmacist.
Slovenian: Drugi možni neželeni učinki Če kateri od spodaj navedenih neželenih učinkov postane zelo izražen, obvestite zdravnika ali farmacevta.
English: The absolute oral bioavailability of panobinostat was approximately 21%.
Slovenian: Absolutna biološka uporabnost panobinostata po peroralnem odmerjanju je bila približno 21 %.
English: All 55 patients were previously treated with bortezomib and at least one IMiD (lenalidomide: 98.2%, thalidomide: 69.1%).
Slovenian: Vseh 55 bolnikov je predhodno prejemalo bortezomib in vsaj enega od imunomodulatornih zdravil (lenalidomid: 98,2 %, talidomid: 69,1 %).
English: Hard capsule (capsule).
Slovenian: FARMACEVTSKA OBLIKA trda kapsula (kapsula)
English: In the event of grade 3 nausea or grade 3 or 4 vomiting despite administration of an anti-emetic, panobinostat should be temporarily discontinued and resumed at a reduced dose on recovery to grade 1.
Slovenian: V primeru navzee 3. stopnje ali bruhanja 3. ali 4. stopnje kljub uporabi antiemetikov je treba jemanje panobinostata začasno prekiniti in ga ponovno uvesti z nižjim odmerkom po izboljšanju do 1. stopnje.
English: Secura Bio Limited 32 Molesworth Street Dublin 2
Slovenian: 32 Molesworth Street
English: • If any QTcF value is above 500 msec, Farydak therapy should be permanently discontinued.
Slovenian: • Če je interval QTcF kadarkoli daljši od 500 milisekund, je treba zdravljenje z zdravilom Farydak dokončno ukiniti.
English: Pertinent metabolic pathways involved in the biotransformation of panobinostat are reduction, hydrolysis, oxidation and glucuronidation processes.
Slovenian: Presnovne poti, ki so vključene v biotransformacijo panobinostata, so procesi redukcije, hidrolize, oksidacije in glukuronidacije.
English: Patients should be advised to contact their physician to discuss the use of any laxative product.
Slovenian: Bolnikom je treba naročiti, naj se o uporabi katerega koli odvajalnega sredstva posvetujejo z zdravnikom.
English: Panobinostat is extensively metabolised, and a large fraction of the dose is metabolised before reaching the systemic circulation.
Slovenian: Biotransformacija Panobinostat se obsežno presnavlja in velik delež odmerka se presnovi preden prispe v sistemski krvni obtok.
English: Figure 1 Median platelet counts over time (Study D2308, Safety set, cycles 1-8)
Slovenian: Slika 1 Spreminjanje mediane koncentracije trombocitov s časom (študija D2308, podatki za oceno varnosti, ciklusi 1-8)
English: - medicines to prevent blood clotting called anti-coagulants, such as warfarin or heparin.
Slovenian: - zdravila za preprečevanje strjevanja krvi, ki jih imenujemo antikoagulansi, kot sta varfarin in heparin,
English: (BL) 1:4 1:8 1:11 2:1 2:4 2:8 2:11 3:1 3:4 3:8 3:11 4:1 4:4 4:8 4:11 5:1 5:4 5:8 5:11 6:1 6:4 6:8 6:11 7:1 7:4 7:8 7:11 8:1 8:4 8:8 8:11
Slovenian: (Izh) 1:4 1:8 1:11 2:1 2:4 2:8 2:11 3:1 3:4 3:8 3:11 4:1 4:4 4:8 4:11 5:1 5:4 5:8 5:11 6:1 6:4 6:8 6:11 7:1 7:4 7:8 7:11 8:1 8:4 8:8 8:11
English: In case of concomitant use of agents that may increase panobinostat plasma concentrations, such as strong CYP3A4 inhibitors, dose adjustment is required (see sections 4.5 and 4.2).
Slovenian: V primeru sočasne uporabe zdravil, ki lahko povzročijo zvišanje koncentracije panobinostata v plazmi, kot so močni zaviralci CYP3A4, je potrebna prilagoditev odmerka (glejte poglavji 4.5 in 4.2).
English: Your doctor will discuss with you the possible risks of taking Farydak during pregnancy.
Slovenian: Zdravnik vam bo pojasnil, kakšna so lahko tveganja, če jemljete zdravilo Farydak v času nosečnosti.
English: The recommended dose of bortezomib is 1.3 mg/m2 given as an injection.
Slovenian: Priporočeni odmerek bortezomiba je 1,3 mg/m2, bolnik pa ga prejema v obliki injekcije.
English: It is unknown whether panobinostat is excreted in human milk.
Slovenian: Ni znano, ali se panobinostat izloča v materino mleko.
English: - atomoxetine, a medicine used to treat attention deficit hyperactivity disorder.
Slovenian: - atomoksetin, zdravilo za zdravljenje motnje pozornosti s hiperaktivnostjo.
English: It is currently unknown whether panobinostat may reduce the effectiveness of hormonal contraceptives.
Slovenian: Hormonski kontraceptivi Zaenkrat ni znano, ali panobinostat lahko zmanjša učinkovitost hormonskih kontraceptivov.
English: Take Farydak once a day at the same time each day only on the scheduled days.
Slovenian: Zdravilo Farydak jemljite enkrat na dan ob istem času in le na tiste dni, ki so predvideni po razporedu.
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Slovenian: Razmislite o zvišanju odmerka na 1,0 mg/m2 ali nadaljnjem znižanju odmerka na 0,5 mg/m2 v naslednjih ciklusih glede na to, kako bolnik zdravilo prenaša.
English: Liver function should be monitored prior to treatment and regularly during treatment.
Slovenian: Delovanje jeter je treba pregledati najprej pred začetkom zdravljenja, nato pa redno med zdravljenjem.
English: QTc prolongation
Slovenian: Podaljšanje intervala QTc
English: Cytochrome P450 3A4 (CYP3A4) is the main oxidation enzyme, with potential minor involvement of CYP2D6 and 2C19.
Slovenian: Glavni encim za oksidacijo je citokrom P450 3A4 (CYP3A4), v manjši meri pa sta lahko vpletena še CYP2D6 in 2C19.
English: Most newly occurring severe neutropenia was grade 3 (28%), with considerably fewer cases of grade 4 (6.6%).
Slovenian: (28 %), precej manj pa je bilo primerov 4. stopnje (6,6 %).
English: Patients achieved an ORR (≥PR (partial response)) of 34.5% and 52.7% (≥MR (minimal response)).
Slovenian: Skupna stopnja odziva (ORR) pri bolnikih je obsegala vsaj delni odziv (partial response, PR) pri 34,5 % bolnikov in vsaj minimalni odziv (minimal response, MR) pri 52,7 %
English: Demographics and baseline disease characteristics were balanced and comparable between the study arms.
Slovenian: Demografske značilnosti bolnikov in karakteristike njihove bolezni so bile med študijskima skupinama enakomerno razporejene in primerljive.
English: However, thrombocytopenia is reversible (median time to recovery of 12 days) and can usually be managed by dose adjustment and interruption with or without platelet transfusion (see section 4.4).
Slovenian: Trombocitopenija je reverzibilna (z mediano časa do izboljšanja 12 dni) in jo je običajno mogoče nadzirati s prilagajanjem odmerka in prekinitvijo zdravljenja, skupaj s transfuzijo trombocitov ali brez nje (glejte poglavje 4.4).
English: Replacement intravenous fluids and electrolytes may be used as appropriate.
Slovenian: Bolniku je po potrebi mogoče intravensko nadomeščati tekočine in elektrolite.
English: Panobinostat is a P-gp substrate.
Slovenian: Panobinostat je substrat P-glikoproteina (P-gp).
English: CTC grade 3 fatigue was reported in 15.7% of the patients, and grade 4 in 1.3%.
Slovenian: CTC so poročali pri 15,7 % bolnikov, o utrujenosti 4. stopnje pa pri 1,3 %.
English: In the phase III study, thrombocytopenia typically recovered to baseline by the start of the next 21-day cycle (see Figure 1).
Slovenian: V študiji faze III je trombocitopenija praviloma izzvenela na izhodiščno vrednost koncentracije trombocitov do začetka naslednjega 21-dnevnega ciklusa (glejte sliko 1).
English: Farydak blocks the growth of cancerous plasma cells and reduces the number of cancer cells.
Slovenian: Zdravilo Farydak zavira rast rakavo spremenjenih plazmatk in zmanjša število rakavih celic.
English: Pre-existing infections should be treated prior to initiation of the therapy.
Slovenian: Pred začetkom zdravljenja je treba odpraviti prej prisotne okužbe.
English: Farydak should be used with caution in patients who already have or who are at significant risk of developing QTc prolongation.
Slovenian: Previdnost pri uporabi zdravila Farydak je potrebna pri bolnikih z že prisotnim podaljšanjem intervala QTc oziroma s pomembno povečanim tveganjem za razvoj te motnje.
English: Of note, whereas grade 3 and grade 4 neutropenia were observed in 28% and 7% of patients, respectively, febrile neutropenia was observed in 1% of patients (see section 4.8).
Slovenian: Omeniti velja, da je do nevtropenije 3. stopnje prišlo pri 28 % bolnikov in do nevtropenije 4. stopnje pri 7 % bolnikov, febrilno nevtropenijo pa so opažali pri 1 % bolnikov (glejte poglavje 4.8).
English: The dose should not be reduced below 10 mg and the same treatment schedule (3-week treatment cycle) should be kept.
Slovenian: 10 mg, shema odmerjanja (3-tedenski ciklus zdravljenja) pa mora ostati enaka.
English: Increased levels of acetylated histones were observed in xenografts from mice that were treated with panobinostat.
Slovenian: Zvišano koncentracijo acetiliranih histonov so opažali v heterolognih presadkih miši, ki so jim dajali panobinostat.
English: Prolongation of QT interval
Slovenian: Podaljšanje intervala QT
English: The median PFS (95% CI) was 12.0 months (10.3, 12.9) and 8.1 months (7.6, 9.2), respectively.
Slovenian: Mediano preživetje brez napredovanja bolezni (v oklepaju 95-odstotni IZ) je znašalo 12,0 meseca (10,3, 12,9) oziroma 8,1 meseca (7,6, 9,2).
English: Reduce bortezomib dose to 0.7 mg/m2 in the first treatment cycle.
Slovenian: Znižajte odmerek bortezomiba na 0,7 mg/m2 v prvem ciklusu.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: In clinical studies in multiple myeloma, the exposure of panobinostat was decreased by approximately 20% by the concomitant use of dexamethasone, which is a dose-dependent mild/moderate CYP3A4 inducer.
Slovenian: V kliničnih študijah diseminiranega plazmocitoma se je izpostavljenost panobinostatu zmanjšala za približno 20 % pri sočasni uporabi deksametazona, ki je od odmerka odvisen šibak/zmeren induktor CYP3A4.
English: You should not eat star fruit, pomegranate or grapefruit or drink pomegranate or grapefruit juice during your treatment with Farydak, as they may increase the amount of the medicine that passes into your blood.
Slovenian: V času zdravljenja z zdravilom Farydak ne smete uživati karambole, granatnega jabolka ali grenivke in ne smete piti soka granatnega jabolka ali grenivke, saj bi ta živila lahko povečala količino zdravila, ki preide v kri.
English: The most common adverse events (AEs) leading to treatment discontinuation were diarrhoea (4.5%), asthenia and fatigue (2.9% each) and pneumonia (1.3%).
Slovenian: Najpogostejši neželeni dogodki, zaradi katerih so bolniki prekinili zdravljenje, so bili diareja (4,5 %), astenija in utrujenost (vsaka posebej 2,9 %) in pljučnica (1,3 %).
English: • uncontrolled shaking of the body
Slovenian: - neobvladano tresenje telesa,
English: - The active substance of Farydak is panobinostat.
Slovenian: - Učinkovina v zdravilu Farydak je panobinostat.
English: If you are a sexually active man, you should use condoms during treatment with Farydak.
Slovenian: Če ste spolno aktiven moški, morate v času zdravljenja z zdravilom Farydak uporabljati kondome.
English: - medicines used to treat nausea and vomiting such as dolasetron, granisetron, ondansetron or tropisetron; these may also have an unwanted effect on the heart (QT prolongation).
Slovenian: - zdravila za zdravljenje slabosti in bruhanja, kot so dolasetron, granisetron, ondansetron in tropisetron: ta zdravila imajo lahko tudi neželen učinek na srce (podaljšanje intervala QT),
English: Panobinostat has demonstrated mutagenic potential in the Ames assay, endo-reduplication effects in human peripheral blood lymphocytes in vitro, and DNA damage in an in vivo COMET study in mouse lymphoma L5178Y cells, that are attributed to the pharmacological mode of action.
Slovenian: Pri panobinostatu so dokazali mutageni potencial z Amesovim testom, in vitro povzročanje endoreduplikacije v človeških limfocitih iz periferne krvi in povzročanje poškodb na DNA v in vivo študiji COMET na celicah L5178Y mišjega limfoma, kar vse pripisujejo farmakološkemu mehanizmu delovanja panobinostata.
English: If continuous treatment with a strong CYP3A4 inhibitor is required, a dose escalation from 10 mg to 15 mg panobinostat may be considered based on patient tolerability.
Slovenian: Če bolnik potrebuje dolgotrajno zdravljenje z močnim zaviralcem CYP3A4, je treba razmisliti o zvišanju odmerka panobinostata z 10 mg na 15 mg glede na to, kako bolnik zdravilo prenaša.
English: Concomitant use of anti-arrhythmic medicinal products (including, but not limited to, amiodarone, disopyramide, procainamide, quinidine and sotalol) and other substances that are known to prolong the QT interval (including, but not limited to, chloroquine, halofantrine, clarithromycin, methadone, moxifloxacin, bepridil and pimozide) is not recommended.
Slovenian: Sočasna uporaba antiaritmičnih zdravil (med katere med drugim sodijo amiodaron, dizopiramid, prokainamid, kinidin in sotalol) in drugih snovi, za katere je znano, da podaljšujejo interval QT (med katerimi so med drugim klorokin, halofantrin, klaritromicin, metadon, moksifloksacin, bepridil in pimozid) ni priporočena.
English: Grade 3 neutropenia (<1.0-0.5 x 109/l)
Slovenian: nevtropenija 3. stopnje (<1,0-0,5 x 109/l)
English: Pooled clinical data from over 500 patients treated with panobinostat alone in multiple indications and at different dose levels have shown that the incidence of CTC grade 3 QTc prolongation (QTcF >500 msec) was approximately 1% overall and 5% or more at a dose of 60 mg or higher; no episodes of torsades de pointes were observed.
Slovenian: Združeni klinični podatki več kot 500 bolnikov, ki so jih zdravili samo s panobinostatom za več indikacij in z različno visokimi odmerki, so pokazali, da je pogostnost podaljšanja intervala QTc 3. stopnje po CTC (s trajanjem intervala QTcF >500 milisekund) pri vseh odmerkih približno 1 % in pri odmerkih 60 mg ali več 5 %.
English: Liver function should be monitored prior to treatment and regularly during treatment as clinically indicated, especially in patients with hepatic impairment (see section 4.4).
Slovenian: Delovanje jeter je treba preveriti pred začetkom zdravljenja, in ga nato redno spremljati tekom zdravljenja v skladu s kliničnimi indikacijami, zlasti pri bolnikih z okvaro jeter (glejte poglavje 4.4).