FrancophonIA/ELRC3.0 huggingface dataset:
English: • chest pain or discomfort, changes in heartbeat (faster or slower), palpitations, light-headedness, fainting, dizziness, blue discolouration of your lips, shortness of breath, swelling of lower limbs or skin (signs of heart problems)
Croatian: • bol ili nelagoda u grudima, promjene u otkucajima srca (ubrzani ili usporeni), palpitacije, ošamućenost, nesvjestica, omaglica, plava boja usnica, nedostatak zraka, oticanje donjih udova ili kože (znakovi srčanih problema)
English: Women of child-bearing potential should have a pregnancy test prior to the initiation of treatment with Farydak and must use a highly effective method of contraception during treatment and for three months after the last dose of Farydak.
Croatian: Žene reproduktivne dobi moraju napraviti test na trudnoću prije početka liječenja Farydakom i moraju koristiti vrlo učinkovitu metodu kontracepcije tijekom liječenja te tri mjeseca nakon zadnje doze Farydaka.
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.
Croatian: U podskupini bolesnika koji su primili najmanje dva prethodna režima uključujući bortezomib i imunomodulator (n=147), stopa ukupnog odgovora prema modificiranim EBMT kriterijima bila je 59% u skupini koja je primala panobinostat + bortezomib
English: PAN=panobinostat BTZ= bortezomib Dex = dexamethasone
Croatian: PAN=panobinostat BTZ= bortezomib Dex = deksametazon
English: The frequency category reflects the combination of all the medicinal products i.e. panobinostat + bortezomib + dexamethasone.
Croatian: Kategorija učestalosti prikazuje kombinaciju svih lijekova, odnosno panobinostat + bortezomib
English: - check the amount of electrolytes (such as potassium, magnesium, phosphate) in your body.
Croatian: - provjeri količina elektrolita (kao što su kalij, magnezij, fosfat) u Vašem tijelu. - provjeri koliko dobro funkcioniraju Vaša štitnjača i hipofiza (mjerenjem hormona štitnjače u
English: Most patients with thrombocytopenia did not experience haemorrhage.
Croatian: Većina bolesnika s trombocitopenijom nije imala krvarenje.
English: Platelets 10 x 109/l
Croatian: Trombociti 10 x 109/l
English: • sudden and crushing chest pain, feeling tired, irregular heartbeat (potential signs of a heart attack)
Croatian: • iznenadna i pritiskajuća bol u grudima, osjećaj umora, neredoviti otkucaji srca (potencijalni znakovi srčanog udara)
English: - Pregnancy
Croatian: • Trudnoće
English: Haemorrhage has been reported in patients during treatment with panobinostat.
Croatian: Krvarenje je bilo prijavljeno u bolesnika tijekom liječenja panobinostatom.
English: Table 6 Recommended starting dose modification for patients with hepatic impairment Grade of hepatic impairment*
Croatian: Tablica 6 Preporučena modifikacija početne doze za bolesnike s oštećenjem jetre
English: Thyroid and pituitary function should be monitored by measuring hormone levels (e.g. free T4 and TSH) as clinically indicated (see section 4.2).
Croatian: Funkciju štitnjače i hipofize treba pratiti mjerenjem razina hormona (npr. slobodnog T4 i TSH-a) prema kliničkim indikacijama (vidjeti dio 4.2).
English: The most frequently reported infections include upper respiratory tract infection, pneumonia and nasopharyngitis.
Croatian: Najučestalije prijavljene infekcije uključuju infekciju gornjeg dijela dišnog sustava, pneumoniju i nazofaringitis.
English: Bilirubin level
Croatian: Razina bilirubina
English: Skin lesions, rash, erythema
Croatian: Kožne lezije, osip, eritem
English: • reduced blood level of phosphate or sodium
Croatian: • smanjena razina fosfata ili natrija u krvi
English: • vomiting, nausea, upset stomach, indigestion
Croatian: • povraćanje, mučnina, uznemireni želudac, loša probava
English: Abnormal values should be corrected as clinically indicated (see section 4.4).
Croatian: Poremećene vrijednosti moraju se ispraviti prema kliničkim indikacijama (vidjeti dio 4.4).
English: Blood electrolytes, especially potassium, magnesium and phosphorus, should be measured at baseline and monitored periodically as clinically indicated, especially in patients with diarrhoea.
Croatian: Elektrolite u krvi, osobito kalij, magnezij i fosfor, potrebno je izmjeriti na početku te periodički pratiti prema kliničkim indikacijama, osobito u bolesnika s proljevom.
English: Bradycardia, atrial fibrillation, sinus tachycardia, tachycardia, palpitation
Croatian: Bradikardija, fibrilacija atrija, sinusna tahikardija,
English: Agents that may increase panobinostat plasma concentrations
Croatian: Tvari koje mogu povećati koncentracije panobinostata u 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).
Croatian: Tijekom terapije potrebno je periodički pratiti razine tekućine i elektrolita u krvi, osobito kalija, magnezija i fosfata, te korigirati prema kliničkim indikacijama da bi se spriječila potencijalna dehidracija i poremećaji elektrolita (vidjeti dio 4.2).
English: • blood in urine (a sign of a kidney problem)
Croatian: • krv u mokraći (znak problema s bubrezima)
English: QTc prolongation
Croatian: Produljenje QTc-a
English: Based on animal data, the likelihood of panobinostat increasing the risk of foetal death and developmental skeletal abnormalities is predicted to be high.
Croatian: Na temelju podataka dobivenih od životinja, predviđa se da je velika vjerojatnost da će panobinostat povećati rizik od smrti fetusa i od razvojnih skeletnih poremećaja.
English: Gastrointestinal haemorrhage, haematochezia, gastritis, cheilitis, abdominal distension, dry mouth, flatulence
Croatian: Gastrointestinalno krvarenje, hematokezija, gastritis, heilitis, abdominalna distenzija, suha usta, flatulencija
English: The baseline platelet count should be ≥100 x 109/l and the baseline absolute neutrophil count (ANC) ≥1.0 x 109/l.
Croatian: Početna razina trombocita treba biti ≥100 x 109/l, a početni apsolutni broj neutrofila (ANC) ≥1,0 x 109/l.
English: • feeling tired, itching, yellowing of the skin and whites of the eyes, nausea or vomiting, loss of appetite, pain on the right side of your stomach, dark or brown urine, bleeding or bruising more easily than normal (signs of a liver problem)
Croatian: • osjećaj umora, svrbež, žutilo kože i bjeloočnica, mučnina ili povraćanje, gubitak apetita, bol na desnoj strani želuca, tamna ili smeđa mokraća, krvarenje ili stvaranje modrica lakše nego inače (znakovi problema s jetrom)
English: Hypothyroidism events were reported in 8 of 381 patients treated with panobinostat + bortezomib + dexamethasone in Study D2308, of whom 2 required treatment.
Croatian: U ispitivanju D2308 prijavljeni su događaji hipotireoidizma u 8 od 381 bolesnika liječenih panobinostatom + bortezomibom + deksametazonom, od kojih su dvoje trebali liječenje.
English: A dose escalation from 10 mg to 15 mg may be considered based on patient tolerability.
Croatian: Eskalacija doze s 10 mg na 15 mg može se razmotriti na temelju bolesnikove podnošljivosti.
English: Respiratory failure, rales, wheezing, epistaxis
Croatian: Respiratorno zatajenje, šumovi, piskanje, epistaksa
English: Table 7 includes adverse drug reactions that occur due to the addition of panobinostat to the bortezomib and dexamethasone combination.
Croatian: Tablica 7 uključuje nuspojave koje su se javile zbog uvođenja panobinostata kombinaciji bortezomiba i deksametazona.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svake klasifikacije organskog sustava nuspojave su poredane po učestalosti, počevši od najučestalijih.
English: Farydak metabolism is through both non-CYP and CYP mediated routes.
Croatian: Farydaka odvija se putevima kojima posreduje CYP i onima kojima CYP ne posreduje.
English: • weight gain, feeling tired, hair loss, muscle weakness, feeling cold (signs of an underactive thyroid gland, which is known as hypothyroidism)
Croatian: • porast tjelesne težine, osjećaj umora, gubitak kose, slabost mišića, osjećaj hladnoće (znakovi smanjene aktivnosti štitnjače, što se naziva hipotireoidizam)
English: CTC grade 3 or 4 haemorrhage was reported in 4.2% of patients, mostly commonly involving gastrointestinal haemorrhage.
Croatian: Krvarenje 3. ili 4. stupnja prema CTC-u bilo je prijavljeno u 4,2% bolesnika, a najčešće je uključivalo gastrointestinalno krvarenje.
English: It is not known whether panobinostat is dialysable.
Croatian: Nije poznato može li se panobinostat izlučiti dijalizom.
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)).
Croatian: U ukupnoj populaciji bolesnika PFS temeljen na potpunom setu za analizu (eng. full analysis set, FAS) bio je statistički značajno različit između terapijskih skupina (stratificirani Log-rank test p<0,0001, uz procijenjeno smanjenje rizika od 37% u skupini panobinostat + bortezomib
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).
Croatian: Kod prvog znaka grčeva u abdomenu, meke stolice ili nastupa proljeva, preporučuje se liječiti bolesnika antidijaroikom (npr. loperamidom).
English: 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).
Croatian: Antiemetici s poznatim rizikom od produljenja QT-a kao što su dolasetron, granisetron, ondansetron i tropisetron moraju se koristiti oprezno (vidjeti dio 4.4).
English: Adjustment of bortezomib dose should also be considered (see bortezomib SmPC and Table 6).
Croatian: Prilagođavanje doze bortezomiba također treba razmotriti (vidjeti Sažetak opisa svojstava lijeka za bortezomib i Tablicu 6).
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.
Croatian: 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).
English: How to take Farydak
Croatian: Kako uzimati Farydak
English: Farydak 10 mg hard capsules Farydak 15 mg hard capsules Farydak 20 mg hard capsules
Croatian: Farydak 10 mg tvrde kapsule Farydak 15 mg tvrde kapsule Farydak 20 mg tvrde kapsule
English: 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).
Croatian: 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).
English: • CTC grade 2 toxicity recurrence or CTC grades 3 and 4 - omit the dose until recovery to CTC
Croatian: • Ponovna pojava toksičnosti 2. stupnja prema CTC-u ili pojava toksičnosti 3. ili 4. stupnja prema
English: Additionally, dose adjustment of bortezomib may be considered (see bortezomib SmPC and Table 3).
Croatian: Uz to, može se razmotriti prilagođavanje doze bortezomiba (vidjeti Sažetak opisa svojstava lijeka za bortezomib i Tablicu 3).
English: Table 8 Progression-free survival in patients who received at least two prior regimens including bortezomib and an immunomodulating agent
Croatian: Tablica 8 Preživljenje bez progresije u bolesnika koji su primili najmanje dva prethodna režima uključujući bortezomib i imunomodulator
English: o Patient information leaflet o A patient compliance card
Croatian: Informativni paket za bolesnika treba sadržavati: o uputu o lijeku o karticu za praćenje suradljivosti bolesnika
English: Progression-free survival Median, months [95% CI] Hazard ratio [95% CI]1
Croatian: Omjer hazarda [95% CI]1
English: Patients with moderate hepatic impairment should be started on panobinostat at a reduced dose of 10 mg during the first treatment cycle.
Croatian: U bolesnika s umjerenim oštećenjem jetre treba početi s primjenom panobinostata u smanjenoj dozi od 10 mg tijekom prvog ciklusa liječenja.
English: 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).
Croatian: Antiemetici s poznatim rizikom od produljenja QT-a, kao što su dolasetron, granisetron, ondansetron i tropisetron, moraju se oprezno koristiti (vidjeti dio 4.5).
English: 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,
Croatian: 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).
English: Agents whose plasma exposure can be decreased by panobinostat
Croatian: Tvari čiju izloženost u plazmi panobinostat može smanjiti
English: Adverse reaction
Croatian: Kompletan odgovor
English: 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).
Croatian: 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).
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
Croatian: Preporučuje se motriti bolesnike starije od 65 godina učestalije, osobito radi otkrivanja trombocitopenije i gastrointestinalne toksičnosti (vidjeti dijelove 4.4 i 4.8).
English: - medicines used to treat irregular heartbeat, such as amiodarone, disopyramide, procainamide,
Croatian: - lijekove koji se koriste za liječenje nepravilnih otkucaja srca, kao što su amiodaron,
English: 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).
Croatian: 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).
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.
Croatian: U toj podskupni bolesnika (N=147), medijan trajanja liječenja bio je 4,5 mjeseci u skupini koja je primala panobinostat + bortezomib
English: Patients with mild hepatic impairment should be started on panobinostat at a reduced dose of 15 mg during the first treatment cycle.
Croatian: U bolesnika s blagim oštećenjem jetre treba započeti primjenu panobinostata u smanjenoj dozi od 15 mg tijekom prvog ciklusa liječenja.
English: Renal failure, haematuria, urinary incontinence
Croatian: Zatajenje bubrega, hematurija, urinarna inkontinencija
English: Grade 3 despite anti-diarrhoeal medicinal product
Croatian: 3. stupanj usprkos antidijaroiku
English: • swelling of the legs or arms
Croatian: • oticanje nogu ili ruku
English: Chills, malaise
Croatian: Zimica, malaksalost
English: • 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,
Croatian: • 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)
English: Other possible side effects If any of the side effects below becomes severe, tell your doctor, or your pharmacist.
Croatian: Ako bilo koja od nuspojava navedenih u nastavku postane teška, obratite se svom liječniku ili ljekarniku.
English: Treatment-emergent haematological toxicities included thrombocytopenia, anaemia, neutropenia and lymphopenia.
Croatian: Hematološke toksičnosti koje su se pojavile tijekom liječenja uključivale su trombocitopeniju, anemiju, neutropeniju i limfopeniju.
English: 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
Croatian: Slika 2 Kaplan-Meierov dijagram preživljenja bez progresije u bolesnika s multiplim mijelomom koji su primili najmanje dva prethodna režima uključujući bortezomib i imunomodulator
English: Consider dose escalation up to 20 mg in subsequent cycles based on patient tolerability.
Croatian: Razmotriti povećanje doze do 20 mg u naknadnim ciklusima na temelju bolesnikove podnošljivosti.
English: Week 1 Days
Croatian: 1. tjedan
English: Grade 4 despite anti-diarrhoeal medicinal product
Croatian: 4. stupanj usprkos antidijaroiku
English: 1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate.
Croatian: 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.
English: Patients who experience diarrhoea and nausea or vomiting may require temporary dose discontinuation or dose reduction as outlined in Table 4.
Croatian: 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
English: Table 5 Recommended dose modifications for neutropenia Neutropenia grade on day of treatment
Croatian: Tablica 5 Preporučene modifikacije doze kod neutropenije
English: - Each Farydak 20 mg hard capsule contains 20 mg panobinostat.
Croatian: - Svaka Farydak 20 mg tvrda kapsula sadrži 20 mg panobinostata.
English: 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%).
Croatian: deksametazon 81,1%, talidomid 51,2%, ciklofosfamid 45,3%, bortezomib 43,0%, kombinirani bortezomib i deksametazon 37,8%, lenalidomid 20,4%).
English: Capsule content
Croatian: 6 kapsula
English: • feeling dizzy, tired or weak
Croatian: • osjećaj omaglice, umora ili slabosti
English: Agents whose plasma concentrations may be increased by panobinostat
Croatian: Tvari čije koncentracije u plazmi panobinostat može povećati
English: Bortezomib dose on recovery to grade 2 neutropenia
Croatian: Doza bortezomiba nakon oporavka do neutropenije 2. stupnja
English: Very common Pancytopenia, thrombocytopenia, anaemia, leukopenia, neutropenia, lymphopenia
Croatian: Pancitopenija, trombocitopenija, anemija, leukopenija, neutropenija, limfopenija
English: • severely decreased urine output, swelling of the legs (signs of a kidney problem)
Croatian: • jako smanjena proizvodnja mokraće, oticanje nogu (znakovi problema s bubrezima)
English: - Each Farydak 15 mg hard capsule contains 15 mg panobinostat.
Croatian: - Svaka Farydak 15 mg tvrda kapsula sadrži 15 mg panobinostata.
English: Reduce panobinostat dose to 10 mg in the first treatment cycle.
Croatian: Bilo koja Smanjiti dozu panobinostata na 10 mg u prvom ciklusu liječenja.
English: Table 9 Response rates in patients with multiple myeloma who received at least two prior regimens including bortezomib and an immunomodulatory agent
Croatian: Tablica 9 Stope odgovora u bolesnika s multiplim mijelomom koji su primili najmanje dva prethodna režima uključujući bortezomib i imunomodulator
English: Consider dose escalation up to 15 mg in subsequent cycles based on patient tolerability.
Croatian: Razmotriti povećanje doze do 15 mg u naknadnim ciklusima na temelju bolesnikove podnošljivosti.
English: - Breast-feeding You should not take Farydak if you are breast-feeding.
Croatian: Ne smijete uzimati Farydak ako dojite.
English: Pulmonary haemorrhage, haemoptysis
Croatian: Krvarenje u plućima, hemoptiza
English: Bortezomib dose on recovery to ≤ grade 1
Croatian: Doza bortezomiba nakon oporavka do ≤1. stupnja
English: Week 1 Week 2 Week 3 Day 1
Croatian: 1. tjedan 2. tjedan 3. tjedan 1. dan 2. dan 3. dan 4. dan 5. dan 6. dan 7. dan 8. dan 9. dan
English: - Each Farydak 10 mg hard capsule contains 10 mg panobinostat.
Croatian: - Svaka Farydak 10 mg tvrda kapsula sadrži 10 mg panobinostata.
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.
Croatian: Izgurajte Farydak kapsulu iz džepića 1., 3. i 5. dana 1. tjedna te
English: Diarrhoea Grade 2 despite anti-diarrhoeal medicinal product
Croatian: Proljev 2. stupanj usprkos antidijaroiku
English: 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.
Croatian: 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.
English: Week 2 Days
Croatian: 2. tjedan Dani
English: Cycles 9-16 (3-week cycles)
Croatian: 9.-16. ciklus
English: 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.
Croatian: Kada se Farydak istodobno primjenjuje s osjetljivim supstratima CYP2D6 (npr. atomoksetinom, dekstrometorfanom, metoprololom, nebivololom,
English: Table 4 Recommended dose modifications for gastrointestinal toxicity Adverse drug reaction
Croatian: Tablica 3 Preporučene modifikacije doze kod trombocitopenije
English: • diarrhoea, abdominal pain, fever (signs of an inflamed colon)
Croatian: • proljev, bol u trbuhu, vrućica (znakovi upale debelog crijeva)