FrancophonIA/ELRC3.0 huggingface dataset:
English: SGOT = serum glutamic oxaloacetic transaminase; AST = aspartate aminotransferase
Croatian: SGOT = serumska glutamat-oksaloacetat transaminaza; AST = aspartat aminotransferaza GGN = gornja granica normalnog raspona
English: Repeated dose toxicity studies
Croatian: Ispitivanja toksičnosti ponovljenih doza
English: Co-administration of a single 20 mg panobinostat dose with ketoconazole, a strong CYP3A inhibitor, increased the Cmax and AUC of panobinostat by 1.6- and 1.8-fold, respectively, compared to when panobinostat was given alone.
Croatian: Istodobna primjena jednokratne doze panobinostata od 20 mg s ketokonazolom, snažnim CYP3A inhibitorom, povećala je Cmax i AUC panobinostata za 1,6 odnosno 1,8 puta, u usporedbi s panobinostatom samim.
English: Resume at reduced dose
Croatian: Nastaviti u smanjenoj dozi
English: Dizziness may occur following administration of Farydak (see section 4.8).
Croatian: Može se pojaviti omaglica nakon primjene Farydaka (vidjeti dio 4.8).
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).
Croatian: Jetrenu funkciju potrebno je pratiti prije liječenja te redovito tijekom liječenja prema kliničkim indikacijama, osobito u bolesnika s oštećenjem jetre (vidjeti dio 4.4).
English: Mild hypothyroidism was reported in patients treated with panobinostat + bortezomib + dexamethasone in Study D2308; some patients required treatment (see section 4.4).
Croatian: Blagi hipotireoidizam bio je zabilježen u bolesnika liječenih panobinostatom + bortezomibom + deksametazonom u Ispitivanju D2308; neki bolesnici su trebali liječenje (vidjeti dio 4.4).
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave na lijek su prikazane od najozbiljnijih prema manje ozbiljnima.
English: Modification of panobinostat starting dose
Croatian: Modifikacija početne doze panobinostata
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%).
Croatian: Najčešći štetni događaji koji su doveli do prekida liječenja bili su proljev (4,5%), astenija i umor (2,9% svaki) te pneumonija (1,3%).
English: Platelet transfusions may be required as clinically indicated (see sections 4.2 and 4.8).
Croatian: Transfuzije trombocita mogle bi biti potrebne prema kliničkim indikacijama (vidjeti dijelove 4.2 i 4.8).
English: Regardless of events chronology, syncope was reported in 9% of patients with ST-T depression and 7.2% of patients with T wave change and 4.9% of patients with neither of these ECG abnormalities.
Croatian: Bez obzira na kronologiju događaja, sinkopa je bila prijavljena u 9% bolesnika s depresijom ST-T segmenta, u 7,2% bolesnika s promjenom u T valu te u 4,9% bolesnika s nijednom od tih abnormalnosti na EKG-u.
English: Tabulated list of adverse drug reactions from clinical studies
Croatian: Tablični popis nuspojava iz kliničkih ispitivanja
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.
Croatian: U bolesnika s trombocitopenijom 3. stupnja prema CTC-u (broj trombocita <50 x 109/l uz krvarenje) primjenu panobinostata će možda trebati privremeno prekinuti i/ili smanjiti narednu dozu.
English: Gastrointestinal
Croatian: Gastrointestinalne
English: What Farydak is used for
Croatian: Za što se Farydak koristi
English: How long to take Farydak
Croatian: Koliko dugo uzimati Farydak
English: Panobinostat is administered in combination with bortezomib and dexamethasone, as shown in Tables 1 and 2.
Croatian: Panobinostat se primjenjuje u kombinaciji s bortezomibom i deksametazonom, kako je prikazano u Tablicama 1 i 2.
English: 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).
Croatian: Kompletnu krvnu sliku treba učestalo pratiti tijekom liječenja (osobito prije svake injekcije bortezomiba, tj. 1., 4., 8. i 11. dana 1. do 8. ciklusa te 1. i 8. dana od 9. do 16. ciklusa), osobito radi otkrivanja trombocitopenije (vidjeti dio 4.4).
English: Plasma exposure of panobinostat is not altered in cancer patients with mild to severe renal impairment.
Croatian: Izloženost panobinostata u plazmi ne mijenja se u bolesnika oboljelih od raka s blagim do teškim oštećenjem bubrega.
English: • generally feeling unwell
Croatian: • opće loše osjećanje
English: • increased blood levels of the liver enzymes alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP).
Croatian: • povećane razine jetrenih enzima alanin aminotransferaze (ALT), aspartat aminotransferaze
English: Clinical judgement on how to continue the treatment should be exercised when a patient experiences an adverse drug reaction.
Croatian: Potrebno je upotrijebiti kliničku prosudbu o načinu nastavka liječenja kada u bolesnika dođe do nuspojave na lijek.
English: • oral thrush (yeast infection of the mouth)
Croatian: • oralna kandidijaza (gljivična infekcija ustiju)
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.
Croatian: Također, ishemijska bolest srca (uključujući infarkt miokarda i ishemiju) bila je prijavljena u 4,5 % bolesnika s depresijom ST-T segmenta, u 4,8% bolesnika s promjenom u T valu te u 2,7% bolesnika s nijednom od tih abnormalnosti na EKG-u.
English: Panobinostat has not been studied in patients with end-stage renal disease (ESRD) or patients on dialysis (see section 5.2).
Croatian: Panobinostat nije bio ispitivan u bolesnika sa završnom fazom bubrežne bolesti (eng. end-stage renal disease, ESRD) ili u bolesnika na dijalizi (vidjeti dio 5.2).
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.
Croatian: Farydak, u kombinaciji s bortezomibom i deksametazonom, indiciran je za liječenje odraslih bolesnika s recidivirajućim i/ili refraktornim multiplim mijelomom koji su primili najmanje dva prethodna režima uključujući bortezomib i imunomodulator.
English: In the event of grade 3 or 4 neutropenia, physicians should consider the use of growth factors (e.g.
Croatian: U slučaju neutropenije 3. ili 4. stupnja, liječnici trebaju razmotriti primjenu čimbenika rasta (npr. G-CSF) u skladu s lokalnim smjernicama.
English: • difficulty in breathing or swallowing, swelling of the face, lips, tongue or throat, severe itching of the skin, with a red rash or raised bumps (potential signs of an allergic reaction)
Croatian: • poteškoće u disanju ili gutanju, oticanje lica, usana, jezika ili grla, teški svrbež kože, s crvenim osipom ili izdignutim kvržicama (potencijalni znakovi alergijske reakcije)
English: Modification of bortezomib starting dose
Croatian: Modifikacija početne doze bortezomiba
English: Very common Decreased appetite, hypophosphataemia a, hyponatraemia a, hypokalaemia a
Croatian: Smanjeni apetit, hipofosfatemija a, hiponatrijemija a, hipokalijemija a
English: Paediatric population Panobinostat was not evaluated in multiple myeloma patients under 18 years of age.
Croatian: Pedijatrijska populacija Panobinostat nije ispitivan u bolesnika s multiplim mijelomom mlađih od 18 godina.
English: Severe nausea, diarrhoea, constipation and vomiting, sometimes requiring the use of anti-emetic and anti-diarrhoeal medicinal products, have been reported in patients treated with Farydak (see section 4.8).
Croatian: Gastrointestinalni poremećaji Teška mučnina, proljev, konstipacija i povraćanje, koji ponekad zahtijevaju primjenu antiemetika i antidijaroika, prijavljeni su u bolesnika liječenih Farydakom (vidjeti dio 4.8).
English: When panobinostat is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of hormonal contraceptives needs to be considered.
Croatian: Kada se panobinostat primjenjuje zajedno s deksametazonom, za koji je poznato da je slabi do umjereni induktor CYP3A4 kao i drugih enzima i transportera, mora se uzeti u obzir rizik od smanjene djelotvornosti hormonskih kontraceptiva.
English: Patients should be advised to contact their physician to discuss the use of any laxative product.
Croatian: Bolesnike treba uputiti da se obrate svom liječniku i razgovaraju o primjeni laksativa.
English: In addition, when panobinostat is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of contraceptives needs to be considered.
Croatian: Uz to, kada se panobinostat primjenjuje zajedno s deksametazonom, za koji se zna da je slab do umjeren induktor CYP3A4 kao i drugih enzima i transportera, rizik od smanjenja djelotvornosti kontraceptiva treba uzeti u obzir.
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.
Croatian: Zbog prirode multiplog mijeloma i poznate hematotoksičnosti za panobinostat i tvar s kojom se kombinira, bortezomib, trombocitopenija, često teška, bila je učestalo uočena.
English: For adverse drug reactions that are related to bortezomib or dexamethasone treatment, please refer to the relevant SmPC.
Croatian: Za nuspojave koje su povezane s liječenjem bortezomibom ili deksametazonom, molimo pogledajte odgovarajući Sažetak opisa svojstava lijeka.
English: - if you notice any signs of a heart problem.
Croatian: - ako primijetite bilo kakve znakove problema s jetrom. - ako primijetite bilo kakve znakove infekcije. - ako primijetite bilo kakve znakove srčanih problema.
English: • fast breathing, feeling dizzy
Croatian: • ubrzano disanje, osjećaj omaglice
English: In patients with platelet count <50 x 109/l (complicated by bleeding) or <25 x 109/l, Farydak therapy should be withheld and resumed at a reduced dose upon recovery to platelet count ≥50 x 109/l.
Croatian: U bolesnika s brojem trombocita <50 x 109/l (zakomplicirano krvarenjem) ili <25 x 109/l, terapiju Farydakom treba privremeno prekinuti te nastaviti smanjenom dozom nakon oporavka do broja trombocita ≥50 x 109/l.
English: Platelet counts should be monitored prior to each dose of bortezomib (i.e. on days 1, 4, 8 and 11 of cycles 1-8, see Table 1, and on days 1 and 8 of cycles 9-16, see Table 2).
Croatian: Broj trombocita potrebno je pratiti prije svake doze bortezomiba (tj. 1., 4., 8. i 11. dana 1.-8. ciklusa, vidjeti Tablicu 1, te 1. i 8. dana 9.-16. ciklusa, vidjeti Tablicu 2).
English: Petechiae
Croatian: Petehije
English: CTC grade 3 or 4 haemorrhage was reported in 4.2% of patients, including cases of gastrointestinal and pulmonary haemorrhage with fatal outcomes.
Croatian: Krvarenje 3. ili 4. stupnja prema CTC-u prijavljeno je u 4,2% bolesnika, uključujući slučajeve gastrointestinalnog i plućnog krvarenja sa smrtnim ishodima.
English: ≤1.0 x ULN >ULN Reduce panobinostat dose to 15 mg in the first treatment cycle.
Croatian: ≤1,0 x GGN >GGN Smanjiti dozu panobinostata na 15 mg u prvom ciklusu liječenja.
English: Agents that are predicted to decrease panobinostat concentrations
Croatian: Tvari za koje se predviđa da smanjuju koncentracije panobinostata
English: >1.0 x ULN and ≤1.5 x ULN
Croatian: >1,0 x GGN i ≤1,5 x GGN
English: • inflamed ear, nose bleed or bleeding in the white of the eye, bruising, inflamed skin caused by infection (rash, red skin, which is also known as erythema)
Croatian: • upaljeno uho, krvarenje iz nosa ili krvarenje u bjeloočnici, stvaranje modrica, upaljena koža uzrokovana infekcijom (osip, crvenilo kože, što se naziva eritem)
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).
Croatian: Bolesnici su primali panobinostat (20 mg peroralno jedanput na dan, triput na tjedan, u režimu doziranja s 2 tjedna primanja terapije i 1 tjednom bez), u kombinaciji s bortezomibom (1,3 mg/m2 injicirano intravenski) i deksametazonom (20 mg).
English: Hyperglycaemia, dehydration, hypoalbuminaemia, fluid retention, hyperuricaemia, hypocalcaemia, hypomagnesaemia
Croatian: Hiperglikemija, dehidracija, hipoalbuminemija, zadržavanje tekućine, hiperurikemija, hipokalcijemija, hipomagnezijemija
English: quinidine, propafenone or sotalol.
Croatian: disopiramid, prokainamid, kvinidin, propafenon ili sotalol.
English: PAN= panobinostat PBO= placebo BTZ= bortezomib Dex = dexamethasone
Croatian: PAN= panobinostat PBO= placebo BTZ= bortezomib Dex = deksametazon
English: Clinical efficacy in patients with bortezomib-refractory multiple myeloma (Study DUS71Panorama 2)
Croatian: Klinička djelotvornost u bolesnika s multiplim mijelomom refraktornim na bortezomib (Ispitivanje DUS71 - Panorama 2)
English: Septic shock, urinary tract infection, viral infection, oral herpes, Clostridium difficile colitis, otitis media, cellulitis, sepsis, gastroenteritis, lower respiratory tract infection, candidiasis
Croatian: Septički šok, infekcija mokraćnog sustava, virusna infekcija, oralni herpes, Clostridium difficile kolitis, upala srednjeg uha, celulitis, sepsa, gastroenteritis, infekcija donjeg dijela dišnog sustava, kandidijaza
English: The safety data of panobinostat have been assessed from a total of 451 patients with multiple myeloma treated with panobinostat in combination with bortezomib and dexamethasone and from a total of 278 patients treated with panobinostat as a single agent.
Croatian: Sigurnosni podaci o panobinostatu procijenjeni su na ukupno 451 bolesniku s multiplim mijelomom liječenom panobinostatom u kombinaciji s bortezomibom i deksametazonom te na ukupno 278 bolesnika liječenih samim panobinostatom.
English: Study DUS71 was a two-stage, single-arm, open-label multicentre phase II study of oral panobinostat (20 mg) in combination with bortezomib (1.3 mg/m2) and dexamethasone (20 mg) in 55 patients with relapsed and refractory multiple myeloma, who were bortezomib-refractory and had received at least two prior lines of therapy.
Croatian: Ispitivanje DUS71 bilo multicentrično, otvoreno ispitivanje faze II u dvije etape i s jednom skupinom, u kojem se ispitivao oralni panobinostat (20 mg) u kombinaciji s bortezomibom (1,3 mg/m2) i deksametazonom (20 mg) u 55 bolesnika s rekurentnim i refraktornim multiplim mijelomom, koji su bili refraktorni na bortezomib i primili najmanje dvije prethodne linije terapije.
English: • sudden bleeding or bruising underneath the skin (signs of low level of blood platelets)
Croatian: • iznenadno krvarenje ili podljevi ispod kože (znakovi niske razine trombocita u krvi)
English: Women using hormonal contraceptives should additionally use a barrier method of contraception.
Croatian: Žene koje koriste hormonske kontraceptive trebaju uz to koristiti kontracepcijsku metodu barijere.
English: Haematological adverse drug reactions, including severe thrombocytopenia, neutropenia and anaemia (CTC grade 3 to 4) were reported in patients treated with panobinostat.
Croatian: Hematološke nuspojave, uključujući tešku trombocitopeniju, neutropeniju i anemiju (3. do 4. stupnja prema CTC-u) prijavljene su u bolesnika liječenih panobinostatom.
English: • feeling thirsty, low urine output, weight loss, dry flushed skin, irritability (signs of dehydration)
Croatian: • osjećaj žeđi, mala proizvodnja mokraće, gubitak tjelesne težine, suha užarena koža, razdražljivost (znakovi dehidracije)
English: Hypertension, haematoma, orthostatic hypotension
Croatian: Hipertenzija, hematom, ortostatska hipotenzija
English: The effect of hepatic impairment on the pharmacokinetics of panobinostat was evaluated in a phase I study, in 24 patients with solid tumours and with varying degrees of hepatic impairment.
Croatian: Učinak oštećenja jetre na farmakokinetiku panobinostata ocijenjen je u ispitivanju faze I, u 24 bolesnika sa solidnim tumorima i s različitim stupnjevima oštećenja jetre.
English: Thyroid and pituitary function should be monitored by measuring hormone levels (e.g. free T4 and TSH) as clinically indicated.
Croatian: Funkciju štitnjače i hipofize treba pratiti mjerenjem razina hormona (npr. slobodnog T4 i TSH-a) prema kliničkim indikacijama.
English: - For women taking Farydak
Croatian: • Za žene koje uzimaju Farydak
English: The most common non-haematological adverse reactions were diarrhoea, fatigue, nausea and vomiting.
Croatian: Najčešće ne-hematološke nuspojave bile su proljev, umor, mučnina i povraćanje.
English: Due to the potential risk of death or malformation to the foetus, Farydak should not be taken during:
Croatian: Trudnoća i dojenje Zbog potencijalnog rizika od smrti ili anomalije fetusa Farydak se ne smije uzimati tijekom:
English: On-treatment deaths not due to the study indication (multiple myeloma) were reported in 6.8% of panobinostat + bortezomib + dexamethasone-treated patients versus 3.2% of placebo + bortezomib + dexamethasone-treated patients.
Croatian: Smrt tijekom liječenja koja nije bila uzrokovana ispitivanom indikacijom (multiplim mijelomom) bila je prijavljena u 6,8% bolesnika liječenih panobinostatom + bortezomibom + deksametazonom u usporedbi s 3,2% bolesnika liječenih placebom + bortezomibom + deksametazonom.
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.
Croatian: Na temelju nalaza u životinja, predviđa se da je velika vjerojatnost da će panobinostat povećati rizik od fetalne smrti i razvojnih skeletalnih poremećaja kada se primjenjuje u trudnica.
English: The platelet count should be ≥100 x 109/l and the absolute neutrophil count ≥1.0 x 109/l prior to initiation of treatment.
Croatian: Broj trombocita treba biti ≥100 x 109/l, a apsolutni broj neutrofila ≥1,0 x 109/l prije početka liječenja.
English: Figure 1 Median platelet counts over time (Study D2308, Safety set, cycles 1-8)
Croatian: Slika 1 Medijan broja trombocita tijekom vremena (Ispitivanje D2308, Sigurnosna skupina,
English: • feeling tired (fatigue), pale skin.
Croatian: • osjećaj umora, blijeda koža.
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).
Croatian: Preporučuje se učestalije pratiti bolesnike starije od 65 godina, osobito radi trombocitopenije i gastrointestinalne toksičnosti (vidjeti dio 4.8 i dio 4.2).
English: • coughing up blood, oozing of bloody fluid from the nose (signs of bleeding in the lungs)
Croatian: • iskašljavanje krvi, curenje tjelesnih tekućina iz nosa (znakovi krvarenja u plućima)
English: • increased blood level of uric acid
Croatian: • povećana razina mokraćne kiseline u krvi
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.
Croatian: Sigurnosni podaci navedeni u nastavku temelje se na kliničkom ispitivanju faze III (Panorama 1) na 381 bolesniku s multiplim mijelomom liječenom s 20 mg panobinostata jedanput na dan tri puta tjedno, prema režimu doziranja 2 tjedna primanja terapije, 1 tjedan bez terapije, u kombinaciji s bortezomibom i deksametazonom.
English: • fever, chest pain, increased heart rate, decreased blood pressure, shortness of breath or rapid breathing (signs of blood poisoning, which is also known as sepsis)
Croatian: • vrućica, bol u grudima, povećana srčana frekvencija, sniženi krvni tlak, nedostatak zraka ili ubrzano disanje (znakovi trovanja krvi, koje se naziva i sepsa)
English: Possible side effects
Croatian: Druge moguće nuspojave
English: • fast weight gain, swelling of hands, ankles, feet or face (signs of water retention)
Croatian: • brzi porast tjelesne težine, oticanje šaka, gležnjeva, stopala ili lica (znakovi zadržavanja tekućine)
English: Table 7 Panobinostat adverse drug reactions observed in multiple myeloma patients in the phase III study
Croatian: Tablica 7 Nuspojave na panobinostat uočene u bolesnika s multiplim mijelomom u ispitivanju faze III
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: Platelet transfusions may be required, if clinically indicated (see section 4.4).
Croatian: Mogle bi biti potrebne transfuzije trombocita, ako je to klinički indicirano (vidjeti dio 4.4).
English: Grade 3
Croatian: Neutropenija 3. stupnja
English: • fever, sore throat, or mouth ulcers due to infections (signs of a low level of white blood cells)
Croatian: • vrućica, grlobolja ili čirevi u ustima uzrokovani infekcijama (znakovi niske razine bijelih krvnih stanica)
English: - medicines used to treat cough, such as dextromethorphan.
Croatian: - lijekove koji se koriste za liječenje kašlja, kao što je dekstrometorfan.
English: Grade 3-4 events more frequently observed in patients included the following (percentages presented for patients <65 years, 65-75 years and ≥75 years of age, respectively): thrombocytopenia (60%, 74%, and 91%), anaemia (16%, 17% and 29%), diarrhoea (21%, 27% and 47%), and fatigue (18%, 28% and 47%).
Croatian: <65 godina, 65-75 godina i ≥75 godina): trombocitopenija (60%, 74% i 91%), anemija (16%, 17% i
English: • muscle weakness, muscle spasms, unusual heartbeat (signs of changes in the level of potassium in the blood)
Croatian: • slabost mišića, grčevi u mišićima, neuobičajeni otkucaji srca (znakovi promjena u razini kalija u krvi)
English: • rash of small fluid-filled blisters, appearing on reddened skin, mouth or gums (signs of a potentially severe viral infection)
Croatian: • osip s malim mjehurićima ispunjenim tekućinom, koji se javljaju na crvenoj koži, ustima ili desnima (znakovi potencijalno teške virusne infekcije)
English: - If it is less than 12 hours since you should have taken the medicine, take the missed dose as soon as you remember.
Croatian: Ako ste zaboravili uzeti Farydak - Ako je prošlo manje od 12 sati otkad ste trebali uzeti lijek, uzmite propuštenu dozu čim se sjetite.
English: Appropriate monitoring of electrolytes (e.g. potassium, magnesium and phosphorus) and ECG should be performed at baseline and periodically during treatment, particularly in patients with severe gastrointestinal adverse drug reaction (see section 4.2).
Croatian: Potrebno je provesti odgovarajuće praćenje elektrolita (npr. kalija, magnezija i fosfora) te EKG-a na početku te periodički tijekom liječenja, osobito u bolesnika s teškom gastrointestinalnom nuspojavom na lijek (vidjeti dio 4.2).
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.
Croatian: Učinak oštećenja bubrega na farmakokinetiku panobinostata procjenjivao se u ispitivanju faze I u 37 bolesnika s uznapredovalim solidnim tumorima s različitim stupnjevima bubrežne funkcije.
English: It is unknown whether panobinostat is excreted in human milk.
Croatian: Nije poznato izlučuje li se panobinostat u majčino mlijeko.