natgillin/translations-raw huggingface dataset:
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). 
Kod prvog znaka grčeva u abdomenu, meke stolice ili nastupa proljeva, preporučuje se liječiti bolesnika antidijaroikom (npr. loperamidom).
Anti-emetic medicinal products with a known risk of QT prolongation such as dolasetron, granisetron, ondansetron and tropisetron should be used with caution (see section 4.4). 
Antiemetici s poznatim rizikom od produljenja QT-a kao što su dolasetron, granisetron, ondansetron i tropisetron moraju se koristiti oprezno (vidjeti dio 4.4).
Adjustment of bortezomib dose should also be considered (see bortezomib SmPC and Table 6). 
Prilagođavanje doze bortezomiba također treba razmotriti (vidjeti Sažetak opisa svojstava lijeka za bortezomib i Tablicu 6).
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. 
Očekuje se da snažni induktori imaju veće učinke te mogu smanjiti djelotvornost panobinostata, stoga je potrebno izbjegavati istodobnu primjenu snažnih CYP3A4 induktora uključujući, između ostalih, karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin i gospinu travu (Hypericum perforatum).
How to take Farydak 
Kako uzimati Farydak
Farydak 10 mg hard capsules Farydak 15 mg hard capsules Farydak 20 mg hard capsules 
Farydak 10 mg tvrde kapsule Farydak 15 mg tvrde kapsule Farydak 20 mg tvrde kapsule
In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, including, but not limited to, ketoconazole, itraconazole, voriconazole, ritonavir, saquinavir, telithromycin, posaconazole and nefazodone, the dose of panobinostat should be reduced to 10 mg (see section 4.5). 
U bolesnika koji istodobno uzimaju lijekove koji su snažni CYP3A i/ili Pgp inhibitori, uključujući, između ostalih, ketokonazol, itrakonazol, vorikonazol, ritonavir, sakvinavir, telitromicin, posakonazol i nefazodon, dozu panobinostata treba smanjiti na 10 mg (vidjeti dio 4.5).
• CTC grade 2 toxicity recurrence or CTC grades 3 and 4 - omit the dose until recovery to CTC 
• Ponovna pojava toksičnosti 2. stupnja prema CTC-u ili pojava toksičnosti 3. ili 4. stupnja prema
Additionally, dose adjustment of bortezomib may be considered (see bortezomib SmPC and Table 3). 
Uz to, može se razmotriti prilagođavanje doze bortezomiba (vidjeti Sažetak opisa svojstava lijeka za bortezomib i Tablicu 3).
Table 8 Progression-free survival in patients who received at least two prior regimens including bortezomib and an immunomodulating agent 
Tablica 8 Preživljenje bez progresije u bolesnika koji su primili najmanje dva prethodna režima uključujući bortezomib i imunomodulator
o Patient information leaflet o A patient compliance card 
Informativni paket za bolesnika treba sadržavati: o uputu o lijeku o karticu za praćenje suradljivosti bolesnika
Progression-free survival Median, months [95% CI] Hazard ratio [95% CI]1 
Omjer hazarda [95% CI]1
Patients with moderate hepatic impairment should be started on panobinostat at a reduced dose of 10 mg during the first treatment cycle. 
U bolesnika s umjerenim oštećenjem jetre treba početi s primjenom panobinostata u smanjenoj dozi od 10 mg tijekom prvog ciklusa liječenja.
Anti-emetic medicinal products with a known risk of QT prolongation such as dolasetron, granisetron, ondansetron and tropisetron should be used with caution (see section 4.5). 
Antiemetici s poznatim rizikom od produljenja QT-a, kao što su dolasetron, granisetron, ondansetron i tropisetron, moraju se oprezno koristiti (vidjeti dio 4.5).
In particular tell your doctor or pharmacist if you are taking any of the following medicines: - medicines used to treat infections, including fungal infections (such as ketoconazole, 
Svakako se obratite liječniku ili ljekarniku ako uzimate bilo koji od sljedećih lijekova: - lijekove koji se koriste za liječenje infekcija, uključujući gljivične infekcije (kao što su ketokonazol, itrakonazol, vorikonazol ili posakonazol) i neke bakterijske infekcije (kao što su antibiotici poput klaritromicina ili telitromicina).
Agents whose plasma exposure can be decreased by panobinostat 
Tvari čiju izloženost u plazmi panobinostat može smanjiti
Adverse reaction 
Kompletan odgovor
In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, including, but not limited to, ketoconazole, itraconazole, voriconazole, ritonavir, saquinavir, telithromycin, posaconazole and nefazodone, the dose of panobinostat should be reduced (see section 4.2). 
U bolesnika koji istodobno uzimaju druge lijekove koji su snažni inhibitori CYP3A i/ili P-gp-a, uključujući, između ostaloga, ketokonazol, itrakonazol, vorikonazol, ritonavir, sakvinavir, telitromicin, posakonazol i nefazodon, dozu panobinostata treba smanjiti (vidjeti dio 4.2).
It is recommended to monitor patients over 65 years of age more frequently, especially for thrombocytopenia and gastrointestinal toxicity (see sections 4.4 and 
Preporučuje se motriti bolesnike starije od 65 godina učestalije, osobito radi otkrivanja trombocitopenije i gastrointestinalne toksičnosti (vidjeti dijelove 4.4 i 4.8).
- medicines used to treat irregular heartbeat, such as amiodarone, disopyramide, procainamide, 
- lijekove koji se koriste za liječenje nepravilnih otkucaja srca, kao što su amiodaron,
Strong inducers 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 (see section 4.5). 
Snažni induktori mogu smanjiti djelotvornost panobinostata, stoga treba izbjegavati istodobnu primjenu snažnih CYP3A4 induktora uključujući, između ostaloga, karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin i gospinu travu (Hypericum perforatum) (vidjeti dio 4.5).
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. 
U toj podskupni bolesnika (N=147), medijan trajanja liječenja bio je 4,5 mjeseci u skupini koja je primala panobinostat + bortezomib
Patients with mild hepatic impairment should be started on panobinostat at a reduced dose of 15 mg during the first treatment cycle. 
U bolesnika s blagim oštećenjem jetre treba započeti primjenu panobinostata u smanjenoj dozi od 15 mg tijekom prvog ciklusa liječenja.
Renal failure, haematuria, urinary incontinence 
Zatajenje bubrega, hematurija, urinarna inkontinencija
Grade 3 despite anti-diarrhoeal medicinal product 
3. stupanj usprkos antidijaroiku
• swelling of the legs or arms 
• oticanje nogu ili ruku
Chills, malaise 
Zimica, malaksalost
• new or worsening symptoms such as cough with or without mucus, fever, difficult or painful breathing, wheezing, pain in chest when breathing, shortness of breath or, difficulty breathing, 
• novi ili pogoršavajući simptomi kao što su kašalj sa sluzi ili bez nje, vrućica, otežano ili bolno disanje, piskanje, bol u grudima kod disanja, nedostatak zraka ili poteškoće s disanjem, bol ili osjećaj peckanja kod mokrenja, prekomjerni osjećaj potrebe za mokrenjem, krv u mokraći (znakovi infekcije u plućima ili mokraćnom sustavu)
Other possible side effects If any of the side effects below becomes severe, tell your doctor, or your pharmacist. 
Ako bilo koja od nuspojava navedenih u nastavku postane teška, obratite se svom liječniku ili ljekarniku.
Treatment-emergent haematological toxicities included thrombocytopenia, anaemia, neutropenia and lymphopenia. 
Hematološke toksičnosti koje su se pojavile tijekom liječenja uključivale su trombocitopeniju, anemiju, neutropeniju i limfopeniju.
Figure 2 Kaplan-Meier plot of progression-free survival in patients with multiple myeloma who received at least two prior regimens including bortezomib and an immunomodulatory agent 
Slika 2 Kaplan-Meierov dijagram preživljenja bez progresije u bolesnika s multiplim mijelomom koji su primili najmanje dva prethodna režima uključujući bortezomib i imunomodulator
Consider dose escalation up to 20 mg in subsequent cycles based on patient tolerability. 
Razmotriti povećanje doze do 20 mg u naknadnim ciklusima na temelju bolesnikove podnošljivosti.
Week 1 Days 
1. tjedan
Grade 4 despite anti-diarrhoeal medicinal product 
4. stupanj usprkos antidijaroiku
1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate. 
Panobinostat je povećao Cmax i AUC dekstrometorfana (supstrata CYP2D6) 1,8 odnosno 1,6 puta, a ne može se isključiti mogućnost da bi učinak mogao biti veći na osjetljiviji CYP2D6 supstrat.
Patients who experience diarrhoea and nausea or vomiting may require temporary dose discontinuation or dose reduction as outlined in Table 4. 
Bolesnicima u kojih se pojavi proljev i mučnina ili povraćanje mogao bi biti potreban privremeni prekid doziranja ili smanjenje doze kako je navedeno u Tablici 4. Tablica 4 Preporučena prilagođavanja doze kod gastrointestinalne toksičnosti Nuspojava Stupanj na dan liječenja
Table 5 Recommended dose modifications for neutropenia Neutropenia grade on day of treatment 
Tablica 5 Preporučene modifikacije doze kod neutropenije
- Each Farydak 20 mg hard capsule contains 20 mg panobinostat. 
- Svaka Farydak 20 mg tvrda kapsula sadrži 20 mg panobinostata.
More than half (57.2%) of the patients had undergone prior stem cell transplantation and 62.8% of the patients were relapsed after previous anti-neoplastic therapies (e.g. melphalan 79.6%, dexamethasone 81.1%, thalidomide 51.2%, cyclophosphamide 45.3%, bortezomib 43.0%, combined bortezomib and dexamethasone 37.8%, lenalidomide 20.4%). 
deksametazon 81,1%, talidomid 51,2%, ciklofosfamid 45,3%, bortezomib 43,0%, kombinirani bortezomib i deksametazon 37,8%, lenalidomid 20,4%).
Capsule content 
6 kapsula
• feeling dizzy, tired or weak 
• osjećaj omaglice, umora ili slabosti
Agents whose plasma concentrations may be increased by panobinostat 
Tvari čije koncentracije u plazmi panobinostat može povećati
Bortezomib dose on recovery to grade 2 neutropenia 
Doza bortezomiba nakon oporavka do neutropenije 2. stupnja
Very common Pancytopenia, thrombocytopenia, anaemia, leukopenia, neutropenia, lymphopenia 
Pancitopenija, trombocitopenija, anemija, leukopenija, neutropenija, limfopenija
• severely decreased urine output, swelling of the legs (signs of a kidney problem) 
• jako smanjena proizvodnja mokraće, oticanje nogu (znakovi problema s bubrezima)
- Each Farydak 15 mg hard capsule contains 15 mg panobinostat. 
- Svaka Farydak 15 mg tvrda kapsula sadrži 15 mg panobinostata.
Reduce panobinostat dose to 10 mg in the first treatment cycle. 
Bilo koja Smanjiti dozu panobinostata na 10 mg u prvom ciklusu liječenja.
Table 9 Response rates in patients with multiple myeloma who received at least two prior regimens including bortezomib and an immunomodulatory agent 
Tablica 9 Stope odgovora u bolesnika s multiplim mijelomom koji su primili najmanje dva prethodna režima uključujući bortezomib i imunomodulator
Consider dose escalation up to 15 mg in subsequent cycles based on patient tolerability. 
Razmotriti povećanje doze do 15 mg u naknadnim ciklusima na temelju bolesnikove podnošljivosti.
- Breast-feeding You should not take Farydak if you are breast-feeding. 
Ne smijete uzimati Farydak ako dojite.
Pulmonary haemorrhage, haemoptysis 
Krvarenje u plućima, hemoptiza
Bortezomib dose on recovery to ≤ grade 1 
Doza bortezomiba nakon oporavka do ≤1. stupnja
Week 1 Week 2 Week 3 Day 1 
1. tjedan 2. tjedan 3. tjedan 1. dan 2. dan 3. dan 4. dan 5. dan 6. dan 7. dan 8. dan 9. dan
- Each Farydak 10 mg hard capsule contains 10 mg panobinostat. 
- Svaka Farydak 10 mg tvrda kapsula sadrži 10 mg panobinostata.
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. 
Izgurajte Farydak kapsulu iz džepića 1., 3. i 5. dana 1. tjedna te
Diarrhoea Grade 2 despite anti-diarrhoeal medicinal product 
Proljev 2. stupanj usprkos antidijaroiku
o How to use the compliance card: this section provides a general overview on how to use the compliance card. o How to take medication according to the prescription: this section provides guidance on how to fill in the compliance card. o Recommendation to bring compliance card to each visit: this section reminds the patient to bring the compliance card to the HCP at each visit. 
o Preporuka da se donese kartica za praćenje suradljivosti na svaki posjet: taj dio podsjeća bolesnika da donese karticu za praćenje suradljivosti liječniku prilikom svakog posjeta.
Week 2 Days 
2. tjedan Dani
Cycles 9-16 (3-week cycles) 
9.-16. ciklus
When Farydak is co-administered with sensitive CYP2D6 substrates (e.g. atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine and pimozide), dose titrate individual CYP2D6 substrates based on tolerability and frequently monitor patients for adverse reactions. 
Kada se Farydak istodobno primjenjuje s osjetljivim supstratima CYP2D6 (npr. atomoksetinom, dekstrometorfanom, metoprololom, nebivololom,
Table 4 Recommended dose modifications for gastrointestinal toxicity Adverse drug reaction 
Tablica 3 Preporučene modifikacije doze kod trombocitopenije
• diarrhoea, abdominal pain, fever (signs of an inflamed colon) 
• proljev, bol u trbuhu, vrućica (znakovi upale debelog crijeva)
How to store Farydak 
Kako čuvati Farydak
• abdominal pain, diarrhoea, swelling or bloating of the abdomen (signs of inflamed stomach lining) 
• bol u trbuhu, proljev, oticanje ili nadutost trbuha (znakovi upaljene ovojnice želuca)
Haemorrhage intracranial, syncope, tremor, dysgeusia 
Intrakranijalno krvarenje, sinkopa, tremor, poremećaj osjeta okusa
A dose escalation from 15 mg to 20 mg may be considered based on patient tolerability. 
Može se razmotriti povećanje doze s 15 mg na 20 mg na temelju bolesnikove podnošljivosti.
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. 
Srčani događaji (najučestaliji fibrilacija atrija, tahikardija, palpitacija i sinusna tahikardija) bili su prijavljeni u 17,6% bolesnika liječenih panobinostatom + bortezomibom
A total of 768 patients were randomised in a 1:1 ratio to either the panobinostat + bortezomib + dexamethasone (n=387) or the placebo + bortezomib + dexamethasone (n=381) arm, stratified by prior use of bortezomib [Yes (n=336 (43.8%)), No (n=432 (56.3%))] and number of prior lines of anti-myeloma therapy [1 prior line (n=352 (45.8%)), 2 to 3 prior lines (n=416 (54.2%))]. 
[Da (n=336 (43,8%)), Ne (n=432 (56,3%))] i broju prethodnih linija antimijelomske terapije [1 prethodna linija (n=352 (45,8%)), 2 do 3 prethodne linije (n=416 (54,2%))]. Demografske karakteristike i karakteristike bolesti na početku bile su uravnotežene i usporedive između terapijskih skupina.
If you have any questions about how Farydak works or why you have been given it, ask your doctor or pharmacist. 
Ako imate ikakvih pitanja o tome kako Farydak djeluje ili zašto
Farydak 15 mg hard capsules 
Farydak 15 mg tvrde kapsule
Decrease in blood cell count 
Smanjenje razina krvnih stanica
The median PFS (95% CI) was 12.5 months (7.26, 14.03) in the panobinostat + bortezomib + dexamethasone arm and 4.7 months (3.71, 6.05) in the placebo + bortezomib + and dexamethasone arm [HR: 0.47 (0.31, 0.72)]. 
Medijan PFS-a (95% CI) bio je 12,5 mjeseci (7,26, 14,03) u skupini koja je primala panobinostat + bortezomib
The median duration of follow-up was 28.75 months in the panobinostat + bortezomib + dexamethasone arm and 29.04 months in the placebo + bortezomib + dexamethasone arm. 
Medijan trajanja praćenja bio je 28,75 mjeseci u skupini koja je primala panobinostat + bortezomib
33.3% patients in the panobinostat + bortezomib + dexamethasone arm and 10.3% patients in the placebo + bortezomib + dexamethasone arm received platelet transfusions during treatment. 
+ deksametazon i 10,3% bolesnika koji su primali placebo + bortezomib
• flatulence 
• vjetrovi
Omit dose Resume at same dose 
Propustiti dozu Nastaviti u istoj dozi
Cardiac monitoring and assessment of electrolytes and platelet counts should be undertaken and supportive care given as necessary in the event of overdose. 
U slučaju predoziranja potrebno je provesti praćenje rada srca, pretrage elektrolita i broja trombocita te prema potrebi pružiti suportivnu skrb.
Kaplan Meier medians PAN+BTZ+Dex: 12.48 months PBO+BTZ+Dex: 4.70 months 
95% CI [0,31; 0,72] Logrank p-vrijednost=0,0003 Kaplan Meierovi medijani PAN+BTZ+Dex: 12,48 mjeseci PBO+BTZ+Dex: 4,70 mjeseci
Farydak 10 mg hard capsules 
Farydak 10 mg tvrde kapsule
- For men taking Farydak 
• Za muškarce koji uzimaju Farydak
Farydak 20 mg hard capsules 
Farydak 20 mg tvrde kapsule
Infections and infestations Very common Upper respiratory tract infection, pneumonia 
Infekcija gornjeg dijela dišnog sustava, pneumonija
Panobinostat dose on recovery to grade 2 neutropenia 
Doza panobinostata nakon oporavka do neutropenije 2. stupnja
Panobinostat dose on recovery to ≤ grade 1 
Doza panobinostata nakon oporavka do ≤1. stupnja
Table 1 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 1-8) 
Tablica 1 Preporučeni raspored uzimanja Farydaka u kombinaciji s bortezomibom i deksametazonom (1.-8. ciklus)
Fatigue and asthenia 
Infekcije i infestacije
The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze. 
Drugi sastojci su: magnezijev stearat, manitol, mikrokristalična celuloza, prethodno geliran škrob, želatina, titanijev dioksid (E171), briljantno plava FCF (E133), žuti željezov oksid (E172), crni željezov oksid (E172), propilenglikol (E1520), glazura šelaka.
Omit dose Resume at reduced dose 
Propustiti dozu Nastaviti u smanjenoj dozi
Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172) 
željezov oksid, žuti (E172) Farydak 15 mg tvrde kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
Very common Weight decreased Common 
Smanjena tjelesna težina
• stomach or abdominal pain, nausea, diarrhoea, vomiting, black or bloody stools, constipation, 
• bol u želucu ili trbuhu, mučnina, proljev, povraćanje, crna ili krvava stolica, zatvor, žgaravica, oticanje ili nadutost trbuha (znakovi želučano-crijevnog problema)
QT prolongation and ECG abnormalities 
Produljenje QT-a i poremećaji EKG-a
Microcrystalline cellulose Pregelatinised starch (maize) 
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Sadržaj kapsule magnezijev stearat manitol celuloza, mikrokristalična škrob, prethodno geliran (kukuruzni)
Rest period 
ROK VALJANOSTI
The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze. 
Drugi sastojci su: magnezijev stearat, manitol, mikrokristalična celuloza, prethodno geliran škrob, želatina, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172), propilenglikol (E1520), glazura šelaka.
Package leaflet: Information for the patient Farydak 10 mg hard capsules 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Farydak 10 mg tvrde kapsule
Table 1 Recommended dosing schedule of panobinostat in combination with bortezomib and dexamethasone (cycles 1-8) 
Tablica 1 Preporučeni raspored doziranja panobinostata u kombinaciji s bortezomibom i deksametazonom (1.-8. ciklus)
- if you have heart or heartbeat problems, such as irregular heartbeat or a condition called long 
- ako imate problema sa srcem ili otkucajima srca, kao što su neredoviti otkucaji ili stanje koje se naziva sindrom dugog QT-a. - ako imate bakterijsku, virusnu ili gljivičnu infekciju. - ako imate želučano-crijevne tegobe kao što su proljev, mučnina ili povraćanje.
grade ≤1 and resume treatment at a reduced dose. 
CTC-u - propustiti dozu do oporavka do ≤1. stupnja prema CTC-u te nastaviti liječenje u smanjenoj dozi.
The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze. 
Drugi sastojci su: magnezijev stearat, manitol, mikrokristalična celuloza, prethodno geliran škrob, želatina, titanijev dioksid (E171), crveni željezov oksid (E172), crni željezov oksid (E172), propilenglikol (E1520), glazura šelaka.
Each hard capsule contains panobinostat lactate anhydrous equivalent to 15 mg panobinostat. 
Svaka tvrda kapsula sadrži bezvodni panobinostatlaktat što odgovara 15 mg panobinostata.
Farydak 15 mg capsules panobinostat 
NAZIV LIJEKA Farydak 15 mg kapsule panobinostat
Farydak bortezomib and dexamethasone N=73 
Farydak bortezomib i deksametazon
Each hard capsule contains panobinostat lactate anhydrous equivalent to 20 mg panobinostat. 
Svaka tvrda kapsula sadrži bezvodni panobinostatlaktat što odgovara 20 mg panobinostata.
Titanium dioxide (E171) Brilliant blue FCF (E133) Iron oxide, yellow (E172) 
briljantno plava FCF (E133)
Table 2 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 9-16). 
Tablica 2 Preporučeni raspored uzimanja Farydaka u kombinaciji s bortezomibom i deksametazonom (9.-16. ciklus)
95% CI [0.31; 0.72] Logrank p-value=0.0003 
+ deksametazon [HR: 0,47 (0,31, 0,72)].
Farydak 20 mg hard capsules are red opaque capsules (19.1-19.7 mm) containing white to almost white powder, with radial marking “LBH 20 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters. 
Farydak 20 mg tvrde kapsule su crvene neprozirne kapsule (19,1-19,7 mm) koje sadrže bijeli do gotovo bijeli prašak, s radijalnom oznakom „LBH 20 mg“ otisnutom crnom tintom na kapici i dvije radijalne pruge otisnute crnom tintom na tijelu, koje se isporučuju u blisterima.
Farydak 20 mg capsules panobinostat 
NAZIV LIJEKA Farydak 20 mg kapsule panobinostat
- if you are allergic to panobinostat or any of the other ingredients of this medicine (listed in section 6). 
Što morate znati prije nego počnete uzimati Farydak Nemojte uzimati Farydak: - ako ste alergični na panobinostat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako dojite.
Grade 4 neutropenia (<0.5 x 109/l) or febrile neutropenia (<1.0 x 109/l and fever ≥38.5°C) 
(<0,5 x 109/l) ili febrilna neutropenija
Farydak 10 mg hard capsules are light green opaque capsules (15.6-16.2 mm) containing white to almost white powder, with radial marking “LBH 10 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters. 
Farydak 10 mg tvrde kapsule su svijetlo zelene neprozirne kapsule (15,6-16,2 mm) koje sadrže bijeli do gotovo bijeli prašak, s radijalnom oznakom „LBH 10 mg“ otisnutom crnom tintom na kapici i dvije radijalne pruge otisnute crnom tintom na tijelu, koje se isporučuju u blisterima.
The median OS was 40.3 months in the panobinostat + bortezomib + dexamethasone arm and 35.8 months in the placebo + bortezomib + dexamethasone arm (Hazard ratio: 0.94 (95% CI: 0.78, 1.14)). 
+ deksametazon (omjer hazarda: 0,94 (95% CI: 0,78, 1,14)).
Each hard capsule contains panobinostat lactate anhydrous equivalent to 10 mg panobinostat. 
Svaka tvrda kapsula sadrži bezvodni panobinostatlaktat što odgovara 10 mg panobinostata.