FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the potential risk of death or malformation to the foetus, Farydak should not be taken during:
Slovenian: Zaradi tveganja za smrt zarodka ali prirojene nepravilnosti pri otroku zdravila Farydak ne smete jemati:
English: Table 7 includes adverse drug reactions that occur due to the addition of panobinostat to the bortezomib and dexamethasone combination.
Slovenian: Preglednica 7 vključuje neželene učinke do katerih je prišlo zaradi dodatka panobinostata h kombinaciji bortezomiba in deksametazona.
English: In patients with CTC grade 3 thrombocytopenia (platelet count <50 x 109/l with bleeding) panobinostat may need to be temporarily withheld and/or the subsequent dose may need to be reduced.
Slovenian: Pri bolnikih s trombocitopenijo 3. stopnje po kriterijih CTC (s koncentracijo trombocitov <50 x 109/l s krvavitvijo) je morda treba začasno prekiniti z uporabo panobinostata in/ali zdravljenje nadaljevati z nižjim odmerkom.
English: >1.0 x ULN and ≤1.5 x ULN
Slovenian: >1,0 x ZMN in ≤1,5 x ZMN
English: Table 6 Recommended starting dose modification for patients with hepatic impairment Grade of hepatic impairment*
Slovenian: Preglednica 6: Priporočila za prilagajanje začetnih odmerkov pri bolnikih z okvaro jeter stopnja okvare jeter*
English: At the first sign of abdominal cramping, loose stools or onset of diarrhoea, it is recommended that the patient be treated with an anti-diarrhoeal medicinal product (e.g. loperamide).
Slovenian: Pri prvih znakih trebušnih krčev, odvajanja redkega blata oziroma ob začetku diareje je priporočeno bolnika zdraviti z antidiaroiki (na primer z loperamidom).
English: After a single oral dose of [14C] panobinostat in patients, 29 to 51% of administered radioactivity is excreted in the urine and 44 to 77% in the faeces.
Slovenian: Po enkratnem peroralnem odmerku s [14C] označenega panobinostata se je pri bolnikih 29 do 51 %
English: Blood electrolytes, especially potassium, magnesium and phosphorus, should be measured at baseline and monitored periodically as clinically indicated, especially in patients with diarrhoea.
Slovenian: Koncentracije elektrolitov v krvi, zlasti kalija, magnezija in fosforja, je treba izmeriti pred začetkom zdravljenja, nato pa periodično spremljati v skladu s kliničnimi indikacijami, zlasti pri bolnikih z diarejo.
English: - For women taking Farydak
Slovenian: - Za ženske, ki jemljejo zdravilo Farydak
English: It is recommended to monitor patients over 65 years of age more frequently, especially for thrombocytopenia and gastrointestinal toxicity (see section 4.8 and section 4.2).
Slovenian: Pri bolnikih, ki so stari več kot 65 let, so priporočeni pogostejši pregledi, zlasti glede trombocitopenije in gastrointestinalne toksičnosti (glejte poglavje 4.8 in poglavje 4.2).
English: Likewise ischaemic heart disease (including myocardial infarction and ischaemia) were reported in 4.5% of patients with ST-T depression and 4.8% of patients with T wave change and 2.7% of patients with neither of these ECG abnormalities.
Slovenian: Podobno so tudi o koronarni bolezni (vključno z miokardnim infarktom in ishemijo) poročali pri 4,5 % bolnikov z denivelacijo segmenta ST-T, pri 4,8 % bolnikov s spremembami vala T in pri 2,7 % bolnikov, ki na EKG posnetku niso imeli navedenih sprememb.
English: Please refer to Table 1 for cycles 1 to 8 and Table 2 for cycles 9-16.
Slovenian: Za cikluse 1 do 8 glejte preglednico 1, za cikluse 9 do 16 pa preglednico 2.
English: Refractoriness to bortezomib was defined as disease progression on or within 60 days of the last bortezomib-containing line of therapy.
Slovenian: Neodzivnost na bortezomib je bila opredeljena kot napredovanje bolezni v času prejemanja sheme zdravljenja, ki je vključevala bortezomib, ali v 60 dneh po zadnji tovrstni shemi zdravljenja.
English: Patients received panobinostat (20 mg taken orally once a day, three times per week, on a 2 weeks on and 1 week off dosing regimen), in combination with bortezomib (1.3 mg/m2 injected intravenously) and dexamethasone (20 mg).
Slovenian: Bolniki so prejemali panobinostat (20 mg peroralno enkrat na dan trikrat na teden po shemi zdravljenja, po kateri so zdravila prejemali 2 tedna, nato pa je sledil 1 teden premora) v kombinaciji z bortezomibom (1,3 mg/m2 intravensko) in deksametazonom (20 mg).
English: Fatigue and asthenia were reported in 41.2% and 22.0% of patients, respectively.
Slovenian: Utrujenost in astenija O utrujenosti so poročali pri 41,2 % bolnikov, o asteniji pa pri 22,0 %.
English: Panobinostat shows more cytotoxicity towards tumour cells compared to normal cells.
Slovenian: Na tumorske celice deluje panobinostat bolj citotoksično kot na normalne celice.
English: Patients had to be exposed to an IMiD (lenalidomide or thalidomide).
Slovenian: Pogoj za vključitev je bila tudi predhodna izpostavljenost enemu od imunomodulatornih zdravil (IMiD) (lenalidomidu ali talidomidu).
English: Number of patients at risk
Slovenian: število ogroženih bolnikov čas (meseci)
English: Limited experience with overdose has been reported during clinical studies.
Slovenian: Iz kliničnih študij so poročali le o malo izkušnjah s prevelikim odmerjanjem.
English: Agents that may increase panobinostat plasma concentrations
Slovenian: Zdravila, ki lahko zvišajo koncentracijo panobinostata v plazmi
English: Fluid and electrolyte blood levels, especially potassium, magnesium and phosphate, should be monitored periodically during therapy and corrected as clinically indicated to prevent potential dehydration and electrolyte disturbances (see section 4.2).
Slovenian: Med zdravljenjem je treba periodično spremljati volumen tekočin in koncentracije elektrolitov v krvi, zlasti koncentracije kalija, magnezija in fosfata, in jih korigirati, če je to klinično indicirano, da bi preprečili potencialno dehidracijo in neravnovesje elektrolitov (glejte poglavje 4.2).
English: Treatment of tumour cells with panobinostat resulted in a dose-dependent increase in acetylation of histones H3 and H4 both in vitro and in xenograft animal pre-clinical models, demonstrating target inhibition.
Slovenian: Pri izpostavljanju tumorskih celic panobinostatu je prišlo do od odmerka odvisnega povečanja deleža acetiliranih histonov H3 in H4 tako in vitro kot pri predkliničnih modelih heterolognih tumorskih presadkov (ksenograftov) na živalih, kar dokazuje, da gre za zaviranje tarčnih molekul.
English: Abnormal values should be corrected as clinically indicated (see section 4.4).
Slovenian: Patološke vrednosti je treba odpraviti v skladu s kliničnimi indikacijami (glejte poglavje 4.4).
English: In the event of grade 3 or 4 neutropenia, physicians should consider the use of growth factors (e.g.
Slovenian: V primeru nevtropenije 3. ali 4. stopnje naj zdravnik razmisli o uporabi rastnih dejavnikov (na primer dejavnikov rasti kolonij granulocitov, G-CSF) v skladu z lokalno sprejetimi smernicami.
English: Liver function tests
Slovenian: Testi delovanja jeter
English: Panobinostat may prolong cardiac ventricular repolarisation (QT interval).
Slovenian: Panobinostat lahko podaljša trajanje repolarizacije prekatov srčne mišice (interval QT).
English: ECG (electrocardiogram) abnormalities have been reported in patients treated with panobinostat + bortezomib + dexamethasone, mainly involving ST-T depression (21.7%) and T wave changes (39.6%).
Slovenian: Pri bolnikih, ki so prejemali kombinacijo panobinostata, bortezomiba in deksametazona, so poročali o nepravilnostih na EKG posnetku (elektrokardiogramu), ki so večinoma vključevale denivelacijo segmenta ST-T (21,7 %) in spremembe vala T (39,6 %).
English: Farydak is always used together with two other medicines: bortezomib and dexamethasone.
Slovenian: Zdravilo Farydak vedno uporabljamo skupaj z dvema drugima zdraviloma, z bortezomibom in deksametazonom.
English: Grade 4 neutropenia (<0.5 x 109/l) or febrile neutropenia (<1.0 x 109/l and fever ≥38.5°C)
Slovenian: (<0,5 x 109/l) ali febrilna nevtropenija (<1,0 x 109/l z zvišano telesno temperaturo ≥38,5°C)
English: Push the Farydak capsule through the pocket on days 1, 3 and 5 of week 1 and days 8, 10 and 12 of week 2.
Slovenian: Kapsulo zdravila Farydak potisnite iz ležišča na 1., 3. in 5. dan prvega tedna ter na 8., 10. in 12. dan drugega tedna.
English: • Patient information pack
Slovenian: • Izobraževalni komplet za bolnike
English: Panobinostat is rapidly and almost completely absorbed with Tmax reached within 2 hours of oral administration in patients with advanced cancer.
Slovenian: Absorpcija Panobinostat se hitro in skoraj v celoti absorbira in pri bolnikih z napredovalim rakom doseže najvišjo koncentracijo v plazmi v 2 urah (Tmax) po peroralnem odmerjanju.
English: Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
Slovenian: Zdravilo Farydak je v kombinaciji z bortezomibom in deksametazonom indicirano za zdravljenje odraslih bolnikov z neodzivno obliko ali recidivom diseminiranega plazmocitoma, ki so predhodno že prejemali vsaj dve vrsti zdravljenja, ki je vključevalo bortezomib in imunomodulatorno zdravilo.
English: No patient had an absolute QTcF >500 msec.
Slovenian: Pri nobenem bolniku ni prišlo do absolutne vrednosti trajanja intervala QTcF, ki bi presegala 500 milisekund.
English: - medicines used to treat breast cancer, such as tamoxifen.
Slovenian: - zdravila za zdravljenje raka dojke, kot je tamoksifen,
English: Caucasians comprised 65.0% of the study population, Asians 30.2% and blacks 2.9%.
Slovenian: 30,2 % in pripadniki črne rase 2,9 % študijske populacije.
English: CTC grade 3 or 4 haemorrhage was reported in 4.2% of patients, mostly commonly involving gastrointestinal haemorrhage.
Slovenian: krvavitvi 3. ali 4. stopnje po CTC so poročali pri 4,2 % bolnikov, večinoma pa je šlo za gastrointestinalno krvavitev.
English: The effect of renal impairment on the pharmacokinetics of panobinostat was assessed in a phase I study in 37 patients with advanced solid tumours with varying degrees of renal function.
Slovenian: Vpliv okvare ledvic na farmakokinetiko panobinostata so ocenjevali v študiji faze I pri 37 bolnikih s solidnimi tumorji in različnimi stopnjami okvare ledvic.
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis or candidiasis, and viral infections including hepatitis B virus and herpes simplex, have been reported in patients taking panobinostat.
Slovenian: Pri bolnikih, ki so jemali panobinostat, so poročali o lokaliziranih in sistemskih okužbah, med drugim o pljučnici, drugih bakterijskih okužbah, invazivnih glivičnih okužbah, kot sta aspergiloza in kandidoza, ter o virusnih okužbah, vključno z okužbo z virusom hepatitisa B in z virusom herpesa simpleksa.
English: Mild, moderate and severe renal impairment based on baseline urinary creatinine clearance did not increase the panobinostat plasma exposure in mild, moderate and severe groups.
Slovenian: Okvara ledvic, tako blaga, zmerna kot huda glede na izhodiščno vrednost očistka kreatinina, pridobljeno pri preiskavi urina, ni povečala izpostavljenosti panobinostatu v plazmi v posameznih skupinah bolnikov.
English: Reduce panobinostat dose to 10 mg in the first treatment cycle.
Slovenian: Znižajte odmerek panobinostata na 10 mg v prvem ciklusu.
English: CTC grade 3 or 4 thrombocytopenia occurred in 256 patients, with a median onset time of one month.
Slovenian: Do trombocitopenije 3. ali 4. stopnje po CTC je prišlo pri 256 bolnikih, pri čemer je bila mediana časa do pojava trombocitopenije en mesec.
English: Tell your doctor or pharmacist straight away during treatment with Farydak: - if you notice any signs of a gastrointestinal problem.
Slovenian: V času zdravljenja z zdravilom Farydak morate takoj obvestiti zdravnika ali farmacevta: - če opazite kakršnekoli prebavne težave, - če opazite kakršnekoli znake težav z jetri, - če opazite kakršnekoli znake okužbe, - če opazite kakršnekoli težave s srcem.
English: PAN=panobinostat BTZ= bortezomib Dex = dexamethasone
Slovenian: PAN = panobinostat BTZ = bortezomib Dex = deksametazon PBO = placebo
English: The parent substance is deemed to be responsible for the overall pharmacological activity of panobinostat.
Slovenian: Domnevajo, da je za celotno farmakološko aktivnost panobinostata odgovorna samo matična učinkovina.
English: Monitoring recommendations
Slovenian: Priporočila za spremljanje bolnika
English: Based on findings in animals, the likelihood of panobinostat increasing the risk of both foetal death and developmental skeletal abnormalities when administered to pregnant women is predicted to be high.
Slovenian: Glede na ugotovitve pri živalih je zelo verjetno, da panobinostat povečuje tveganje za smrt ploda in nepravilnosti v razvoju skeleta, ča ga jemjejo nosečnice.
English: Description of selected adverse drug reactions
Slovenian: Opis izbranih neželenih učinkov
English: Due to the nature of multiple myeloma and the known haematotoxicity for panobinostat and its combination agent bortezomib, thrombocytopenia, often severe, has been frequently observed.
Slovenian: Zaradi narave diseminiranega plazmocitoma in znane hematotoksičnosti panobinostata in bortezomiba, ki ga bolniki prejemajo v kombinaciji s panobinostatom, so pri bolnikih pogosto opažali trombocitopenijo, mnogokrat v hudi obliki.
English: Panobinostat should not be administered in patients with severe hepatic impairment due to lack of experience and safety data in this population.
Slovenian: Bolniki s hudo okvaro jeter panobinostata ne smejo prejemati, saj ni na voljo dovolj izkušenj in podatkov o varnosti pri uporabi zdravila v tej skupini bolnikov.
English: • reduced blood level of phosphate or sodium
Slovenian: - znižana koncentracija fosfatov ali natrija v krvi.
English: If you accidentally take more capsules than you should, or if someone else accidentally takes your medicine, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Farydak, kot bi smeli Če pomotoma vzamete več kapsul, kot bi jih morali, ali če kdo drug pomotoma vzame vaše zdravilo,
English: A complete blood cell count must be performed before initiating treatment with panobinostat.
Slovenian: Bolniku je treba pred začetkom zdravljenja s panobinostatom določiti celotno krvno sliko.
English: - medicines that may have an unwanted effect on the heart (called QT prolongation), such as chloroquine, halofantrine, methadone, moxifloxacin, bepridil or pimozide.
Slovenian: - zdravila, ki imajo lahko neželen učinek na srce (ki ga imenujemo podaljšanje intervala QT), kot so klorokin, halofantrin, metadon, moksifloksacin, bepridil ali pimozid, - zdravila za zdravljenje hipertenzije, kot sta metoprolol ali nebivolol,
English: • clicking, rattling or crackling noise made by the lungs when breathing
Slovenian: - tleski, hropenje ali poki, slišni nad pljuči pri dihanju,
English: In the subgroup of patients who had received at least two prior regimens including bortezomib and an immunomodulatory agent (n=147), the overall response rate using modified EBMT criteria was 59% in the panobinostat + bortezomib + dexamethasone arm and 39% in the placebo + bortezomib + dexamethasone arm.
Slovenian: V podskupini bolnikov, ki so predhodno prejemali vsaj dve vrsti zdravljenja, ki je vključevalo bortezomib in imunomodulatorno zdravilo (n=147), je bila skupna stopnja odziva po modificiranih kriterijih EBMT v skupini s kombinacijo panobinostata, bortezomiba in deksametazona 59 %, v skupini s kombinacijo placeba, bortezomiba in deksametazona pa 39 %.
English: Only 0.3% of the patients were discontinued from the treatment due to neutropenia.
Slovenian: Zaradi nevtropenije je bilo zdravljenje prekinjeno pri samo 0,3 % bolnikov.
English: - if you have heart or heartbeat problems, such as irregular heartbeat or a condition called long
Slovenian: - če imate težave s srcem ali s srčnim ritmom, kot so motnje srčnega ritma ali bolezen, ki jo imenujemo sindrom dolgega intervala QT,
English: Additional analysis suggests that the risk of QTc prolongation does not increase over time (see section 4.2).
Slovenian: Rezultati dodatne analize kažejo, da se tveganje za podaljšanje intervala QTc s časom ne povečuje
English: Adverse drug reactions from the phase III study (Panorama 1) are shown in Table 7.
Slovenian: Tabelaričen prikaz neželenih učinkov iz kliničnih študij V preglednici 7 so navedeni neželeni učinki zdravila iz študije faze III (Panorama 1).
English: Decrease in blood cell count
Slovenian: Znižane koncentracije krvnih celic
English: If a dose reduction is required, the dose of panobinostat should be reduced by decrements of 5 mg (i.e. from 20 mg to 15 mg or from 15 mg to 10 mg).
Slovenian: 5 mg (kar pomeni z 20 mg na 15 mg ali s 15 mg na 10 mg).
English: The safety data reported below are based on the phase III clinical study (Panorama 1) in 381 patients with multiple myeloma treated with 20 mg panobinostat once a day three times per week, on a 2 weeks on and 1 week off dosing regimen in combination with bortezomib and dexamethasone.
Slovenian: Spodaj navedeni podatki izhajajo iz klinične študije faze III (študije Panorama 1) s 381 bolniki z diseminiranim plazmocitomom, ki so jih zdravili z odmerkom 20 mg panobinostata enkrat na dan, trikrat na teden, po shemi zdravljenja v kombinaciji z bortezomibom in deksametazonom, kjer so zdravila prejemali 2 tedna, nato pa je sledil 1 teden premora.
English: System Organ Class
Slovenian: Organski sistem Pogostnost
English: In this subset of patients (N=147), the median duration of treatment was 4.5 months in the panobinostat + bortezomib + dexamethasone arm and 4.8 months in the placebo + bortezomib + dexamethasone arm.
Slovenian: V tej podskupini bolnikov (N=147) je bilo mediano trajanje zdravljenja 4,5 meseca v skupini, ki je prejemala kombinacijo panobinostata, bortezomiba in deksametazona in 4,8 meseca v skupini, ki je prejemala kombinacijo placeba, bortezomiba in deksametazona.
English: Platelet transfusions may be required as clinically indicated (see sections 4.2 and 4.8).
Slovenian: Glede na klinične indikacije lahko bolnik potrebuje transfuzije trombocitov (glejte poglavji 4.2 in 4.8).
English: Clinical efficacy in patients with bortezomib-refractory multiple myeloma (Study DUS71Panorama 2)
Slovenian: Klinična učinkovitost pri bolnikih z diseminiranim plazmocitomom, ki se ne odziva na zdravljenje z bortezomibom (študija DUS71 - Panorama 2)
English: Treatment-emergent haematological toxicities included thrombocytopenia, anaemia, neutropenia and lymphopenia.
Slovenian: Hematološko toksično delovanje zdravila je vključevalo trombocitopenijo, anemijo, nevtropenijo in limfopenijo.
English: Moderate >1.5 x ULN and ≤3.0 x ULN
Slovenian: >1,5 x ZMN in ≤3,0 x ZMN
English: It is recommended to monitor patients over 65 years of age more frequently, especially for thrombocytopenia and gastrointestinal toxicity (see sections 4.4 and
Slovenian: Pri bolnikih, ki so stari več kot 65 let, so priporočeni pogostejši pregledi, zlasti glede trombocitopenije in gastrointestinalne toksičnosti (glejte poglavji 4.4 in 4.8).
English: 20.7% of patients experienced haemorrhage, most frequently epistaxis (4.7%), haematoma (2.6%), and conjunctival haemorrhage (2.1%).
Slovenian: Do krvavitve je prišlo pri 20,7 % bolnikov, največkrat do krvavitve iz nosu (pri 4,7 %), hematoma (pri 2,6 %) in krvavitve pod veznico (2,1 %).
English: In the overall patient population PFS based on the full analysis set (FAS) was statistically significantly different between the treatment arms (stratified Log-rank test p<0.0001, with an estimated 37% risk reduction in the panobinostat + bortezomib + dexamethasone arm compared to the placebo + bortezomib + dexamethasone arm (Hazard ratio: 0.63 (95% CI: 0.52, 0.76)).
Slovenian: V celotni populaciji bolnikov se je preživetje brez napredovanja bolezni po podatkih bolnikov za celotno analizo (angl. full analysis set, FAS) statistično značilno razlikovalo med obema študijskima skupinama (p<0,0001 za stratificiran test log-rank) z ocenjenim 37-odstotnim zmanjšanjem tveganja v skupini s kombinacijo panobinostata, bortezomiba in deksametazona v primerjavi s skupino s kombinacijo placeba, bortezomiba in deksametazona (razmerje ogroženosti HR: 0,63 (95-odstotni IZ: 0,52, 0,76)).
English: Agents that are predicted to decrease panobinostat concentrations
Slovenian: Zdravila, ki predvidoma znižajo koncentracijo panobinostata
English: Farydak 10 mg hard capsules Farydak 15 mg hard capsules Farydak 20 mg hard capsules
Slovenian: Farydak 10 mg trde kapsule Farydak 15 mg trde kapsule Farydak 20 mg trde kapsule
English: • CTC grade 3 or 4 toxicity recurrence - a further dose reduction may be considered once the adverse event has resolved to CTC grade <1.
Slovenian: • ponovitev neželenega učinka 3. ali 4. stopnje po CTC - po izboljšanju neželenega učinka do najmanj 1. stopnje po CTC je mogoče razmisliti o ponovni uvedbi zdravljenja z dodatno znižanim odmerkom.
English: Omit dose
Slovenian: PRETISNI OMOTI
English: Mild hypothyroidism was reported in patients treated with panobinostat + bortezomib + dexamethasone in Study D2308; some patients required treatment (see section 4.4).
Slovenian: V študiji D2308 so o blagem hipotiroidizmu poročali pri bolnikih, ki so prejemali kombinacijo panobinostata, bortezomiba in deksametazona; nekateri bolniki so potrebovali zdravljenje (glejte poglavje 4.4).
English: Keep taking Farydak for as long as your doctor tells you.
Slovenian: Kako dolgo je treba jemati zdravilo Farydak Zdravilo Farydak jemljite tako dolgo, kot vam je naročil zdravnik.
English: The effects of panobinostat on labour and post-natal growth and maturation were not evaluated in animal studies.
Slovenian: V študijah na živalih niso ocenjevali vpliva panobinostata na porod in rast ter razvoj mladičev po porodu.
English: Dose adjustments
Slovenian: Prilagajanje odmerjanja
English: Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation and sinus tachycardia) were reported in 17.6% of panobinostat + bortezomib + dexamethasone-treated patients versus 9.8% of placebo + bortezomib + dexamethasone-treated patients and syncope events were reported in 6.0% versus 2.4%, respectively.
Slovenian: O dogodkih, povezanih s srcem (najpogosteje o atrijski fibrilaciji, tahikardiji, palpitacijah in sinusni tahikardiji) so poročali pri 17,6 % bolnikov, ki so prejemali kombinacijo panobinostata, bortezomiba in deksametazona, v primerjavi z 9,8 % bolnikov, ki so prejemali kombinacijo placeba, bortezomiba in deksametazona.
English: Strong inducers are expected to have greater effects, and may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided.
Slovenian: Pri močnih induktorjih je mogoče pričakovati še večji vpliv in lahko zmanjšajo učinkovitost panobinostata, zato se je treba izogibati sočasni uporabi močnih induktorjev CYP3A4, med katerimi so med drugim karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin in šentjanževka (Hypericum perforatum).
English: The treatment was discontinued in 2.9% of patients due to fatigue and asthenia.
Slovenian: Zaradi utrujenosti in astenije so zdravljenje prekinili pri 2,9 % bolnikov.
English: Strong CYP3A inhibitors should not be started in patients who have already received a reduced dose of panobinostat due to adverse events.
Slovenian: Bolnikom, ki zaradi neželenih dogodkov že prejemajo znižane odmerke panobinostata, se ne sme uvajati močnih zaviralcev CYP3A.
English: Based on animal data, the likelihood of panobinostat increasing the risk of foetal death and developmental skeletal abnormalities is predicted to be high.
Slovenian: Glede na podatke pri živalih je zelo verjetno, da panobinostat povečuje tveganje za smrt ploda in nepravilnosti v razvoju skeleta.