natgillin/translations-raw huggingface dataset:
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.
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.
If you forget to take Farydak
Če ste pozabili vzeti zdravilo Farydak
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.
Iz vnaprej opredeljene podskupine bolnikov s predhodnim zdravljenjem z bortezomibom in z imunomodulatornim zdravilom (N=193), je 76 % bolnikov prejelo vsaj dve vrsti zdravljenja.
Complete response Near complete response Partial response
[95% IZ] popolni odziv skoraj popolni odziv delni odziv
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).
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).
The panobinostat fraction metabolised through CYP3A4 is approximately 40%.
Delež panobinostata, ki se metabolizira s CYP3A4 je približno 40 %.
Thrombocytopenia rarely leads to treatment discontinuation (1.6% of patients).
Zaradi trombocitopenije je le redko treba zdravljenje prekiniti (pri 1,6 % bolnikov).
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).
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).
* Based on NCI-CTEP classification
Blaga okvara jeter po klasifikaciji NCI-CTEP
Other possible side effects If any of the side effects below becomes severe, tell your doctor, or your pharmacist.
Drugi možni neželeni učinki Če kateri od spodaj navedenih neželenih učinkov postane zelo izražen, obvestite zdravnika ali farmacevta.
The absolute oral bioavailability of panobinostat was approximately 21%.
Absolutna biološka uporabnost panobinostata po peroralnem odmerjanju je bila približno 21 %.
All 55 patients were previously treated with bortezomib and at least one IMiD (lenalidomide: 98.2%, thalidomide: 69.1%).
Vseh 55 bolnikov je predhodno prejemalo bortezomib in vsaj enega od imunomodulatornih zdravil (lenalidomid: 98,2 %, talidomid: 69,1 %).
Hard capsule (capsule).
FARMACEVTSKA OBLIKA trda kapsula (kapsula)
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.
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.
• If any QTcF value is above 500 msec, Farydak therapy should be permanently discontinued.
• Če je interval QTcF kadarkoli daljši od 500 milisekund, je treba zdravljenje z zdravilom Farydak dokončno ukiniti.
Pertinent metabolic pathways involved in the biotransformation of panobinostat are reduction, hydrolysis, oxidation and glucuronidation processes.
Presnovne poti, ki so vključene v biotransformacijo panobinostata, so procesi redukcije, hidrolize, oksidacije in glukuronidacije.
Patients should be advised to contact their physician to discuss the use of any laxative product.
Bolnikom je treba naročiti, naj se o uporabi katerega koli odvajalnega sredstva posvetujejo z zdravnikom.
Panobinostat is extensively metabolised, and a large fraction of the dose is metabolised before reaching the systemic circulation.
Biotransformacija Panobinostat se obsežno presnavlja in velik delež odmerka se presnovi preden prispe v sistemski krvni obtok.
Figure 1 Median platelet counts over time (Study D2308, Safety set, cycles 1-8)
Slika 1 Spreminjanje mediane koncentracije trombocitov s časom (študija D2308, podatki za oceno varnosti, ciklusi 1-8)
- medicines to prevent blood clotting called anti-coagulants, such as warfarin or heparin.
- zdravila za preprečevanje strjevanja krvi, ki jih imenujemo antikoagulansi, kot sta varfarin in heparin,
(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
(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
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).
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).
Your doctor will discuss with you the possible risks of taking Farydak during pregnancy.
Zdravnik vam bo pojasnil, kakšna so lahko tveganja, če jemljete zdravilo Farydak v času nosečnosti.
The recommended dose of bortezomib is 1.3 mg/m2 given as an injection.
Priporočeni odmerek bortezomiba je 1,3 mg/m2, bolnik pa ga prejema v obliki injekcije.
It is unknown whether panobinostat is excreted in human milk.
Ni znano, ali se panobinostat izloča v materino mleko.
- atomoxetine, a medicine used to treat attention deficit hyperactivity disorder.
- atomoksetin, zdravilo za zdravljenje motnje pozornosti s hiperaktivnostjo.
It is currently unknown whether panobinostat may reduce the effectiveness of hormonal contraceptives.
Hormonski kontraceptivi Zaenkrat ni znano, ali panobinostat lahko zmanjša učinkovitost hormonskih kontraceptivov.
Take Farydak once a day at the same time each day only on the scheduled days.
Zdravilo Farydak jemljite enkrat na dan ob istem času in le na tiste dni, ki so predvideni po razporedu.
Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
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.
Liver function should be monitored prior to treatment and regularly during treatment.
Delovanje jeter je treba pregledati najprej pred začetkom zdravljenja, nato pa redno med zdravljenjem.
QTc prolongation
Podaljšanje intervala QTc
Cytochrome P450 3A4 (CYP3A4) is the main oxidation enzyme, with potential minor involvement of CYP2D6 and 2C19.
Glavni encim za oksidacijo je citokrom P450 3A4 (CYP3A4), v manjši meri pa sta lahko vpletena še CYP2D6 in 2C19.
Most newly occurring severe neutropenia was grade 3 (28%), with considerably fewer cases of grade 4 (6.6%).
(28 %), precej manj pa je bilo primerov 4. stopnje (6,6 %).
Patients achieved an ORR (≥PR (partial response)) of 34.5% and 52.7% (≥MR (minimal response)).
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 %
Demographics and baseline disease characteristics were balanced and comparable between the study arms.
Demografske značilnosti bolnikov in karakteristike njihove bolezni so bile med študijskima skupinama enakomerno razporejene in primerljive.
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).
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).
Replacement intravenous fluids and electrolytes may be used as appropriate.
Bolniku je po potrebi mogoče intravensko nadomeščati tekočine in elektrolite.
Panobinostat is a P-gp substrate.
Panobinostat je substrat P-glikoproteina (P-gp).
CTC grade 3 fatigue was reported in 15.7% of the patients, and grade 4 in 1.3%.
CTC so poročali pri 15,7 % bolnikov, o utrujenosti 4. stopnje pa pri 1,3 %.
In the phase III study, thrombocytopenia typically recovered to baseline by the start of the next 21-day cycle (see Figure 1).
V študiji faze III je trombocitopenija praviloma izzvenela na izhodiščno vrednost koncentracije trombocitov do začetka naslednjega 21-dnevnega ciklusa (glejte sliko 1).
Farydak blocks the growth of cancerous plasma cells and reduces the number of cancer cells.
Zdravilo Farydak zavira rast rakavo spremenjenih plazmatk in zmanjša število rakavih celic.
Pre-existing infections should be treated prior to initiation of the therapy.
Pred začetkom zdravljenja je treba odpraviti prej prisotne okužbe.
Farydak should be used with caution in patients who already have or who are at significant risk of developing QTc prolongation.
Previdnost pri uporabi zdravila Farydak je potrebna pri bolnikih z že prisotnim podaljšanjem intervala QTc oziroma s pomembno povečanim tveganjem za razvoj te motnje.
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).
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).
The dose should not be reduced below 10 mg and the same treatment schedule (3-week treatment cycle) should be kept.
10 mg, shema odmerjanja (3-tedenski ciklus zdravljenja) pa mora ostati enaka.
Increased levels of acetylated histones were observed in xenografts from mice that were treated with panobinostat.
Zvišano koncentracijo acetiliranih histonov so opažali v heterolognih presadkih miši, ki so jim dajali panobinostat.
Prolongation of QT interval
Podaljšanje intervala QT
The median PFS (95% CI) was 12.0 months (10.3, 12.9) and 8.1 months (7.6, 9.2), respectively.
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).
Reduce bortezomib dose to 0.7 mg/m2 in the first treatment cycle.
Znižajte odmerek bortezomiba na 0,7 mg/m2 v prvem ciklusu.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči resnosti.
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.
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.
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.
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.
The most common adverse events (AEs) leading to treatment discontinuation were diarrhoea (4.5%), asthenia and fatigue (2.9% each) and pneumonia (1.3%).
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 %).
• uncontrolled shaking of the body
- neobvladano tresenje telesa,
- The active substance of Farydak is panobinostat.
- Učinkovina v zdravilu Farydak je panobinostat.
If you are a sexually active man, you should use condoms during treatment with Farydak.
Če ste spolno aktiven moški, morate v času zdravljenja z zdravilom Farydak uporabljati kondome.
- 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).
- 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),
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.
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.
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.
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.
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.
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.
Grade 3 neutropenia (<1.0-0.5 x 109/l)
nevtropenija 3. stopnje (<1,0-0,5 x 109/l)
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.
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 %.
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).
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).
Physicians and patients should be aware of the increased risk of infection with panobinostat.
Zdravniki in bolniki se morajo zavedati, da je pri zdravljenju s panobinostatom tveganje za okužbe povečano.
Day 10 Day 11 Day 12 Day 13 Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20 Day 21
1. teden 2. teden 3. teden 1. dan 2. dan 3. dan 4. dan 5. dan 6. dan 7. dan 8. dan 9. dan 10. dan 11. dan 12. dan 13. dan
Potential contributing factors may include prior history of chemotherapy, stem cell transplant, the nature of the disease and neutropenia or lymphopenia associated with Farydak treatment.
Med možnimi dejavniki, ki prispevajo k povečanju tveganja, so predhodna kemoterapija, presaditev krvotvornih matičnih celic, sama narava bolezni in nevtropenija ali limfopenija zaradi zdravljenja z zdravilom Farydak.
Panobinostat may be started at a dose of 15 mg, and if tolerated in the first cycle escalated to 20 mg in the second cycle.
Zdravljenje s panobinostatom se lahko začne z odmerkom 15 mg in se, v primeru dobrega prenašanja tega odmerka v prvem ciklusu, odmerek zviša na 20 mg v drugem ciklusu.
In patients with hepatic impairment receiving concomitant medicinal products which are strong CYP3A4 inhibitors, treatment with panobinostat should be avoided due to lack of experience and safety data in this patient population.
Pri bolnikih, ki imajo okvaro jeter in sočasno jemljejo zdravila, ki so močni zaviralci CYP3A4, se je treba uporabi panobinostata izogniti, saj za to skupino bolnikov ni na voljo dovolj izkušenj in podatkov o varnosti.
Patients with neutropenia are prone to infection, mostly upper respiratory tract infection or pneumonia.
Bolniki z nevtropenijo so bolj dovzetni za okužbe, največkrat pride do okužbe zgornjih dihal ali pljučnice.
Never take a missed dose of Farydak on one of the “off” days when no Farydak dose is planned.
Pozabljenega odmerka zdravila Farydak nikoli ne vzemite v dneh, ko imate premor in ni predvideno, da bi jemali zdravilo Farydak.
• If QT prolongation is resolved within 7 days, resume treatment at prior dose for initial occurrence or at reduced dose if QT prolongation is recurrent.
• Če podaljšanje intervala QT izzveni v 7 dneh, je treba zdravljenje ponovno uvesti z enakim odmerkom kot prej, če je bilo to prvo podaljšanje intervala QT, oziroma z nižjim odmerkom, če je šlo za ponovno podaljšanje intervala QT. • Če podaljšanje intervala QT ne izzveni v 7 dneh, je treba zdravljenje ukiniti.
At the first sign of abdominal cramping, loose stools or onset of diarrhoea, it is recommended that the patient be treated with anti-diarrhoeal medicinal product (e.g. loperamide) or any additional treatment in accordance with local treatment guidelines.
Pri prvih znakih trebušnih krčev, odvajanja redkega blata oziroma ob začetku diareje je priporočeno bolnika zdraviti z antidiaroiki (na primer z loperamidom) ali z drugimi dodatnimi zdravili v skladu z lokalno sprejetimi smernicami zdravljenja.
Five patients (1.3%) died of events associated with haemorrhage.
Zaradi dogodkov v povezavi s krvavitvami je umrlo 5 bolnikov (1,3 %).
Complete blood counts should be frequently monitored during treatment (in particular before each injection of bortezomib, i.e. on days 1, 4, 8 and 11 of cycles 1 to 8 and on days 1 and 8 of cycles 9 to 16), especially for thrombocytopenia (see section 4.4).
Med zdravljenjem je treba pogosto pregledovati celotno krvno sliko (zlasti pred vsako injekcijo bortezomiba, torej na 1., 4., 8. in 11. dan ciklusov 1 do 8 in na 1. in 8. dan ciklusov 9 do 16) s posebno pozornostjo glede pojava trombocitopenije (glejte poglavje 4.4).
Week 2 Days
2. teden dnevi
Oxidative metabolism of panobinostat played a less prominent role, with approximately 40% of the dose eliminated by this pathway.
Oksidativni metabolizem je pri panobinostatu nekoliko manj pomemben, saj se po tej presnovni poti izloči približno 40 % danega odmerka.
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If a diagnosis of invasive systemic fungal infection is made, panobinostat should be discontinued and appropriate anti-fungal therapy instituted.
Ob postavitvi diagnoze invazivne sistemske glivične okužbe je treba uporabo panobinostata ukiniti in uvesti ustrezno antimikotično zdravljenje.
Overall response [95% CI]
razmerje ogroženosti [95%
These medicines should be used with care or may need to be avoided during your treatment with Farydak.
Navedena zdravila je treba v času zdravljenja z zdravilom Farydak uporabljati previdno ali pa se jim je treba izogibati.
The efficacy and safety of panobinostat in combination with bortezomib and dexamethasone were evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III study in patients with relapsed or relapsed and refractory multiple myeloma who had received 1-3 prior lines of therapies.
Učinkovitost in varnost panobinostata v kombinaciji z bortezomibom in deksametazonom so ocenjevali v randomizirani, dvojno slepi, s placebom kontrolirani multicentrični študiji faze III pri bolnikih z recidivom oziroma z recidivno in neodzivno obliko diseminiranega plazmocitoma, ki so predhodno že prejemali 1-3 vrste zdravljenja.
Week 1 Days
1. teden dnevi
Farydak is a histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar concentrations.
Zdravilo Farydak je zaviralec histonske deacetilaze (angl. histone deacetylase inhibitor, HDAC) in zavira encimsko aktivnost histonske deacetilaze v nanomolarnih koncentracijah.
The most common non-haematological adverse reactions were diarrhoea, fatigue, nausea and vomiting.
Najpogostejši nehematološki neželeni učinki so bili diareja, utrujenost, navzea in bruhanje.
If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Farydak.
Če jemljete katero od navedenih zdravil, vam bo zdravnik za čas zdravljenja z zdravilom Farydak morda predpisal drugo zdravilo.
QTc prolongation was observed and was mostly mild in degree: QTcF interval >450 msec and ≤480 msec was reported in 10.8% of patients, with maximum increase from baseline >30 msec and ≤60 msec in 14.5% of patients.
Opažali so podaljšanje intervala QTc, ki je bilo večinoma blago: o trajanju intervala QTcF >450 milisekund in ≤480 milisekund so poročali pri 10,8 % bolnikov, pri čemer je do največjega podaljšanja za >30 milisekund in ≤60 milisekund od izhodiščne vrednosti prišlo pri 14,5 % bolnikov.
ECOG performance status was 0-1 in 93% of patients.
(Eastern Cooperative Oncology Group) 0-1 je imelo 93 % bolnikov.
For patients experiencing severe adverse drug reactions other than thrombocytopenia, gastrointestinal toxicity, neutropenia or QTc prolongation, the recommendation is the following:
Za bolnike, pri katerih pride do hudih neželenih učinkov, ki niso trombocitopenija, gastrointestinalna toksičnost, nevtropenija ali podaljšanje intervala QTc, veljajo naslednja priporočila:
In addition, increased expression of the tumour suppressor gene p21CDKNIA (cyclin dependent kinase inhibitor 1/p21) gene, a key mediator of G1 arrest and differentiation, was triggered with panobinostat exposure.
Poleg tega je izpostavljenost panobinostatu povečala izražanje tumor supresorskega gena p21CDKNIA (zaviralec od ciklinov odvisne kinaze 1/p21), ki je ključni mediator ustavitve celičnega ciklusa v fazi G1 in diferenciacije celic.
Discontinuation of treatment may be considered if neutropenia does not improve despite the dose modifications and/or despite the addition of granulocyte colony stimulating factor therapy according to local medical practice and treatment guidelines, and/or in the event of severe secondary infections.
Če se nevtropenija ne izboljša kljub prilagoditvi odmerka in/ali dodatnemu zdravljenju z dejavnikom rasti kolonij granulocitov v skladu z lokalno zdravstveno prakso in smernicami zdravljenja in/ali če pride do hudih sekundarnih okužb, je treba razmisliti o ukinitvi zdravljenja.
- Store in the original package in order to protect from moisture.
- Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
HDACs catalyse the removal of acetyl groups from the lysine residues of histones and some non-histone proteins.
Histonska deacetilaza katalizira odcepitev acetilne skupine z lizinskih ostankov histonov in nekaterih nehistonskih proteinov.
Take Farydak on days 1, 3 and 5 and on days 8, 10 and 12.
Zdravilo Farydak vzemite na 1., 3. in 5. dan ter na 8., 10. in 12. dan.
PAN= panobinostat PBO= placebo BTZ= bortezomib Dex = dexamethasone
PAN = panobinostat PBO = placebo BTZ = bortezomib Dex = deksametazon