FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have to vomit after you swallow the Farydak capsules, do not take any more capsules until your next scheduled dose.
Croatian: Ako morate povraćati nakon što progutate Farydak kapsule, ne uzimajte više kapsula do sljedeće doze po rasporedu.
English: • being unable to control the flow of urine because of loss of or weak bladder control
Croatian: • nesposobnost kontroliranja toka mokraće zbog gubitka ili slabe kontrole mjehura
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX42
Croatian: Farmakoterapijska skupina: Ostali antineoplastici, ATK oznaka: L01XX42
English: Cycle:Day
Croatian: Ciklus:Dan
English: Farydak blocks the growth of cancerous plasma cells and reduces the number of cancer cells.
Croatian: Farydak blokira rast kanceroznih plazma stanica i smanjuje broj stanica raka.
English: Progression-free survival Probability
Croatian: Vjerojatnost preživljenja bez progresije
English: - if you have blood clotting problems (coagulation disorder).
Croatian: - ako imate problema sa zgrušavanjem krvi (poremećaj koagulacije).
English: What Farydak looks like and contents of the pack
Croatian: Kako Farydak izgleda i sadržaj pakiranja
English: Farydak may have a minor influence on the ability to drive and use machines.
Croatian: Farydak može malo utjecati na sposobnost upravljanja vozilima i strojevima.
English: Your doctor will discuss with you the possible risks of taking Farydak during pregnancy.
Croatian: Liječnik će razgovarati s Vama o mogućim rizicima uzimanja Farydaka tijekom trudnoće.
English: Metabolism via CYP2D6 and 2C19 was minor.
Croatian: Metabolizam putem CYP2D6 i 2C19 bio je malog razmjera.
English: Treatment was administered for a maximum of 16 cycles (see Tables 1 and 2).
Croatian: Terapija se primjenjivala u najviše 16 ciklusa (vidjeti Tablice 1 i 2).
English: o A table describing the treatment regimen for each day of the cycle with space for the patient to note what medication they took.
Croatian: o Tablica koja opisuje režim liječenja za svaki dan ciklusa s praznim prostorom u koji bolesnik može upisati lijek koji je uzeo.
English: The median time to response was 1.4 months and the median duration of response was 6.0 months.
Croatian: Medijan vremena do odgovora bio je 1,4 mjeseci, a medijan trajanja odgovora bio je 6,0 mjeseci.
English: • decreased appetite or weight loss
Croatian: • smanjeni apetit ili gubitak tjelesne težine
English: In the phase III clinical study 162 out of 387 patients were aged 65 years or over.
Croatian: U kliničkom ispitivanju faze III, 162 od 387 bolesnika bilo je u dobi od 65 ili više godina.
English: The median age was 63 years, range 28-84; 42.1% of patients were older than 65 years.
Croatian: Medijan dobi bio je 63 godine, raspon 28-84; 42,1% bolesnika bilo je starije od 65 godina.
English: More than 1 dose omitted
Croatian: Više od 1 doze propušteno
English: Take Farydak once a day at the same time each day only on the scheduled days.
Croatian: Uzimajte Farydak jedanput na dan u isto vrijeme svakoga dana, samo u dane određene rasporedom.
English: • with long QT syndrome.
Croatian: • sa sindromom dugog QT-a.
English: • difficulty falling or staying asleep (insomnia)
Croatian: • poteškoće prilikom usnivanja ili spavanja (nesanica)
English: Other medicines and Farydak
Croatian: Drugi lijekovi i Farydak
English: Farydak should not be taken during pregnancy, unless the potential benefit to the mother is greater than the potential risk to the baby.
Croatian: Farydak se ne smije uzimati tijekom trudnoće, osim ako je potencijalna korist za majku veća od potencijalnog rizika za dijete.
English: Your doctor will monitor your condition to see if the treatment is working.
Croatian: Vaše stanje kako bi vidio funkcionira li liječenje.
English: Oxidative metabolism of panobinostat played a less prominent role, with approximately 40% of the dose eliminated by this pathway.
Croatian: Oksidativni metabolizam panobinostata igrao je manje istaknutu ulogu, s otprilike 40% doze eliminirane ovim putem.
English: If a dose reduction is required, the dose of panobinostat should be reduced by decrements of 5 mg (i.e. from 20 mg to 15 mg or from 15 mg to 10 mg).
Croatian: Ako je potrebno smanjenje doze, dozu panobinostata treba smanjivati za po 5 mg (tj. s 20 mg na 15 mg ili s 15 mg na 10 mg).
English: QTcF >500 msec was not reported in any patient.
Croatian: QTcF >500 msec nije bio prijavljen ni u jednog bolesnika.
English: Patients achieved an ORR (≥PR (partial response)) of 34.5% and 52.7% (≥MR (minimal response)).
Croatian: Bolesnici su postigli ORR (≥PR (eng. partial response, djelomični odgovor)) od 34,5% i 52,7% (≥MR (eng. minimal response, minimalni odgovor)).
English: 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.
Croatian: Prije stavljanja lijeka Farydak u promet u svakoj državi članici nositelj odobrenja mora s nacionalnim nadležnim tijelom dogovoriti sadržaj i oblik edukativnog programa, uključujući komunikaciju s medijima, načine distribucije i bilo koji drugi aspekt programa.
English: The median duration of exposure to study treatment was 4.6 months (range: 0.1-24.1 months).
Croatian: Medijan trajanja izloženosti ispitivanoj terapiji bio je 4,6 mjeseci (raspon: 0,1-24,1 mjesec).
English: congestive heart failure, unstable angina or clinically significant bradycardia.
Croatian: kongestivno zatajenje srca, nestabilnu anginu ili klinički značajnu bradikardiju.
English: Refractoriness to bortezomib was defined as disease progression on or within 60 days of the last bortezomib-containing line of therapy.
Croatian: Refraktornost na bortezomib bila je definirana kao progresija bolesti tijekom ili u roku od 60 dana od posljednje linije terapije koja je sadržavala bortezomib.
English: The absolute oral bioavailability of panobinostat was approximately 21%.
Croatian: Apsolutna oralna bioraspoloživost panobinostata bila je otprilike 21%.
English: Pre-existing infections should be treated prior to initiation of the therapy.
Croatian: Već postojeće infekcije moraju se liječiti prije početka terapije.
English: Contents of the pack and other information What Farydak contains
Croatian: Sadržaj pakiranja i druge informacije Što Farydak sadrži
English: Additional analysis suggests that the risk of QTc prolongation does not increase over time (see section 4.2).
Croatian: Dodatna analiza upućuje na to da se rizik od produljenja QTc-a ne povećava tijekom vremena (vidjeti dio 4.2).
English: Anticipated pharmacodynamic interactions
Croatian: Očekivane farmakodinamičke interakcije
English: Strong CYP3A4 inhibitors
Croatian: Snažni CYP3A4 inhibitori
English: 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.
Croatian: Ne smijete jesti karambolu (zvjezdano voće), šipak ili grejp ili piti sok od šipka ili grejpa tijekom liječenja Farydakom, budući da oni mogu povećati količinu lijeka koja prelazi u Vašu krv.
English: Farydak is used to treat adult patients with a rare type of blood cancer called multiple myeloma.
Croatian: Farydak se koristi za liječenje odraslih bolesnika s rijetkom vrstom raka krvi koji se naziva multipli mijelom.
English: The primary endpoint was progression free survival (PFS) as per modified European Bone Marrow Transplant Group (mEBMT) criteria and as assessed by the investigator.
Croatian: Primarni ishod bio je preživljenje bez progresije (eng. progression free survival, PFS) prema modificiranim kriterijima Europske skupine za transplantaciju koštane srži (mEBMT) i procjeni ispitivača.
English: The following pack sizes are available: blister packs containing 6, 12 or 24 capsules.
Croatian: Dostupne su sljedeće veličine pakiranja: blister pakiranja koja sadrže 6, 12 ili 24 kapsule.
English: • reduced level of calcium in the blood, sometimes leading to cramps
Croatian: • smanjena razina kalcija u krvi koja ponekad dovodi do grčeva
English: This is a long-term treatment with 16 cycles (48 weeks).
Croatian: Ovo je dugoročno liječenje sa 16 ciklusa (48 tjedana).
English: Patients were heavily pre-treated and had received multiple prior regimens (median: 4; range: 2-11).
Croatian: Bolesnici su ranije primali puno terapija i višestruke prethodne režime (medijan: 4; raspon: 2-11).
English: Cytochrome P450 3A4 (CYP3A4) is the main oxidation enzyme, with potential minor involvement of CYP2D6 and 2C19.
Croatian: Citokrom P450 3A4 (CYP3A4) glavni je oksidacijski enzim, s potencijalnom manjom uključenošću CYP2D6 i 2C19.
English: Therefore, physicians and patients should be aware of the increased risk of thrombocytopenia and the potential for haemorrhage, especially in patients with coagulation disorders or in those who are receiving chronic anti-coagulation therapy.
Croatian: Stoga liječnici i bolesnici moraju biti svjesni povećanog rizika od trombocitopenije i mogućnosti krvarenja, osobito u bolesnika s poremećajima koagulacije ili u onih koji primaju kroničnu antikoagulacijsku terapiju.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, such as vitamins or herbal supplements, because they might interact with Farydak.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koji se dobivaju bez recepta, kao što su vitamini ili biljni dodaci, zato što bi oni mogli imati međudjelovanje s Farydakom.
English: No pharmacokinetic data are available for patients with severe hepatic impairment.
Croatian: Nema dostupnih farmakokinetičkih podataka za bolesnike s teškim oštećenjem jetre.
English: None
Croatian: Nikakva
English: What Farydak is and what it is used for What you need to know before you take Farydak How to take Farydak
Croatian: Što je Farydak i za što se koristi Što morate znati prije nego počnete uzimati Farydak Kako uzimati Farydak
English: On days when you do not have to take Farydak, including the rest period in week 3, scratch the relevant empty cavities with your finger nail to help you keep track of your medication schedule.
Croatian: Za dane kada ne morate uzeti Farydak, uključujući stanku u 3. tjednu, noktom postružite odgovarajuće prazne šupljine kako biste lakše pratili raspored svog liječenja.
English: Pneumonia fungal, hepatitis B, aspergillosis
Croatian: Gljivična pneumonija, hepatitis B, aspergiloza
English: The MAH shall ensure that in each Member State where Farydak is marketed, all patients/carers who are expected to use Farydak have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja mora osigurati da u svakoj državi članici u kojoj se Farydak nalazi u prometu, svi bolesnici/skrbnici za koje se očekuje da primjenjuju Farydak imaju pristup, odnosno da im je dan sljedeći edukativni paket:
English: • If QT prolongation is unresolved within 7 days, treatment should be discontinued.
Croatian: • Ako se produljenje QT-a ne riješi unutar 7 dana, liječenje treba prekinuti.
English: Adverse drug reactions from the phase III study (Panorama 1) are shown in Table 7.
Croatian: Nuspojave na lijek iz ispitivanja faze III (Panorama 1) prikazane su u Tablici 7.
English: Only 0.3% of the patients were discontinued from the treatment due to neutropenia.
Croatian: Samo 0,3% bolesnika prekinulo je liječenje zbog neutropenije.
English: • If any QTcF value is above 500 msec, Farydak therapy should be permanently discontinued.
Croatian: • Ako je bilo koja vrijednost QTcF-a iznad 500 msec, terapiju Farydakom treba trajno prekinuti.
English: It is currently unknown whether panobinostat may reduce the effectiveness of hormonal contraceptives.
Croatian: Trenutačno nije poznato može li panobinostat smanjiti djelotvornost hormonskih kontraceptiva.
English: Therefore an ECG should be recorded prior to the start of therapy and repeated periodically before each treatment cycle.
Croatian: Stoga treba napraviti EKG prije početka terapije te ponoviti periodički prije svakog ciklusa terapije.
English: More than one third (35.8%) of the patients were relapsed and refractory to prior treatment.
Croatian: Više od jedne trećine (35,8%) bolesnika imalo je relaps i bilo refraktorno na prethodnu terapiju.
English: Packs containing 6, 12 or 24 capsules.
Croatian: Pakiranja koja sadrže 6, 12 ili 24 kapsule.
English: 1 Hazard ratio obtained from stratified Cox model
Croatian: 1 Omjer hazarda dobiven iz stratificiranog Coxovog modela
English: Response rates are summarised in Table 9.
Croatian: Stope odgovora sažete su u Tablici 9.
English: 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.
Croatian: Prekid liječenja može se razmotriti ako se neutropenija ne popravi usprkos modifikacijama doze i/ili usprkos dodavanju terapije čimbenikom stimulacije kolonije granulocita u skladu s lokalnom medicinskom praksom i smjernicama za liječenje, i/ili u slučaju teških sekundarnih infekcija.
English: Panobinostat is a P-gp substrate.
Croatian: Panobinostat je supstrat P-gp-a.
English: Panobinostat is moderately (approximately 90%) bound to human plasma proteins.
Croatian: Panobinostat se umjereno (otprilike 90%) veže za proteine u ljudskoj plazmi.
English: The median duration of exposure in the study was 5.0 months.
Croatian: Medijan trajanja izloženosti u ispitivanju bio je 5,0 mjeseci.
English: If your partner is able to become pregnant she should also use a highly effective method of contraception during your treatment and for six months after.
Croatian: Ako Vaša partnerica može zatrudnjeti, također mora koristiti vrlo učinkovitu metodu kontracepcije tijekom Vašeg liječenja te šest mjeseci nakon njega.
English: The total duration of treatment is up to 16 cycles (48 weeks).
Croatian: Ukupno trajanje liječenja je do 16 ciklusa (48 tjedana).
English: Therefore, medicinal products that can influence CYP3A4 enzyme activity may alter the pharmacokinetics of panobinostat.
Croatian: Stoga lijekovi koji mogu utjecati na aktivnosti enzima CYP3A4 mogu promijeniti farmakokinetiku panobinostata.
English: Farydak should be administered orally once daily on scheduled days only, at the same time each day.
Croatian: Farydak treba primjenjivati peroralno jedanput na dan samo u dane određene rasporedom, svaki put u isto vrijeme.
English: Panobinostat has a terminal elimination half-life of approximately 37 hours based on final parameters estimate in the population PK analysis.
Croatian: Panobinostat je imao terminalni poluživot eliminacije od otprilike 37 sati na temelju konačne procjene parametara u populaciji PK
English: Thrombocytopenia rarely leads to treatment discontinuation (1.6% of patients).
Croatian: Trombocitopenija rijetko dovodi do trajnog prekida liječenja (1,6% bolesnika).
English: If you have questions about how long to take Farydak, talk to your doctor or pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo uzimati Farydak, obratite se svom liječniku ili ljekarniku.
English: After oral administration, panobinostat pharmacokinetics appear to be linear in the dose range 10-30 mg, but AUC increases less than proportionally with dose at higher doses.
Croatian: Nakon peroralne primjene, čini se da je farmakokinetika panobinostata linearna u rasponu doza od 10-30 mg, ali AUC se povećava manje nego proporcionalno s dozom pri višim dozama.
English: The incidence of deaths not related to study indication was 8.8% in patients ≥65 years of age compared to 5.4% in patients <65 years of age.
Croatian: Incidencija smrti koje nisu bile povezane s ispitivanom indikacijom bila je 8,8% u bolesnika u dobi ≥65 godina, u usporedbi s 5,4% u bolesnika u dobi <65 godina.
English: The parent substance is deemed to be responsible for the overall pharmacological activity of panobinostat.
Croatian: Smatra se da je matična tvar odgovorna za cjelokupnu farmakološku aktivnost panobinostata.
English: Panobinostat should not be administered in patients with severe hepatic impairment due to lack of experience and safety data in this population.
Croatian: Panobinostat se ne smije primjenjivati u bolesnika s teškim oštećenjem jetre zbog nedostatka iskustva i sigurnosnih podataka u ovoj populaciji.
English: Patients had to be exposed to an IMiD (lenalidomide or thalidomide).
Croatian: Bolesnici su morali biti izloženi imunomodulacijskom lijeku (lenalidomidu ili talidomidu).
English: Efficacy results are summarised in Table 8 and the Kaplan-Meier curves for PFS are provided in Figure 2.
Croatian: Rezultati za djelotvornost sažeti su u Tablici 8, a Kaplan-Meierove krivulje za PFS prikazane su na Slici 2.
English: Platelet counts should be monitored at least twice a week until ≥50 x 109/l.
Croatian: Broj trombocita treba pratiti najmanje dvaput tjedno dok ne dođe do ≥50 x 109/l.
English: No data is available that can be used to exclude the risk that panobinostat could be a weak inducer of the enzyme CYP3A4 in the gastrointestinal tract.
Croatian: Nema dostupnih podataka koji se mogu upotrijebiti za isključivanje rizika da bi panobinostat mogao biti slab induktor enzima CYP3A4 u gastrointestinalnom sustavu.
English: Strong CYP3A4 inducers
Croatian: Snažni CYP3A4 induktori
English: If you use a hormonal contraceptive you must also use a barrier method of contraception (such as condom or diaphragm) in addition.
Croatian: Ako koristite hormonski kontraceptiv, morate uz to koristiti i kontracepcijsku metodu barijere (kao što je kondom ili dijafragma).
English: The European Medicines Agency has waived the obligation to submit the results of studies within all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka u svim podskupinama pedijatrijske populacije u multiplom mijelomu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Panobinostat is extensively metabolised, and a large fraction of the dose is metabolised before reaching the systemic circulation.
Croatian: Panobinostat se opsežno metabolizira, a velika frakcija doze metabolizira se prije nego što dospije u sistemsku cirkulaciju.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA 28. kolovoza 2015.
English: If results of liver function tests show abnormalities according to the NCI-CTEP classification, dose adjustments for patients with mild and moderate hepatic impairment are recommended and the patient should be followed until values return to normal or pre-treatment levels.
Croatian: Ako rezultati testova jetrene funkcije pokazuju abnormalnosti prema NCI-CTEP klasifikaciji, preporučuje se prilagođavanje doze za bolesnike s blagim i umjerenim oštećenjem jetre i bolesnike treba pratiti dok se vrijednosti ne vrate u normalu ili na razine od prije liječenja.
English: PVC/PCTFE/Alu blister containing 6 capsules.
Croatian: 6.5 Vrsta i sadržaj spremnika PVC/PCTFE/Al blister koji sadrži 6 kapsula.
English: Farydak treatment should not be initiated in patients with active infections.
Croatian: Liječenje Farydakom ne smije se započinjati u bolesnika s aktivnim infekcijama.
English: Omit dose Resume at reduced dose or change to once weekly
Croatian: Nastaviti u smanjenoj dozi ili promijeniti na jedanput tjedno
English: Instructions for dose interruptions and reductions for panobinostat are outlined in Table 5.
Croatian: Upute za prekide u doziranju i smanjenja doze za panobinostat navedene su u Tablici 5.
English: - If it is more than 12 hours since you should have taken the medicine, skip the missed dose.
Croatian: - Ako je prošlo više od 12 sati otkad ste trebali uzeti lijek, preskočite propuštenu dozu.
English: Women of child-bearing potential/Contraception in males and females
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena
English: - check the amounts of certain cells of your blood (white blood cells, red blood cells, platelets).
Croatian: tvari koje proizvodi jetra). - provjeri količina određenih stanica u Vašoj krvi (bijelih krvnih stanica, crvenih krvnih stanica,
English: • 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.
Croatian: • Ako se produljenje QT-a riješi unutar 7 dana, nastaviti liječenje u prijašnjoj dozi u slučaju prve pojave ili u smanjenoj dozi ako se produljenje QT-a ponavlja.
English: Strong CYP3A inhibitors should not be started in patients who have already received a reduced dose of panobinostat due to adverse events.
Croatian: Snažni CYP3A inhibitori ne smiju se početi primjenjivati u bolesnika koji već primaju smanjenu dozu panobinostata zbog štetnih događaja.
English: If a dose is missed, it can be taken up to 12 hours after the specified dose time.
Croatian: Ako se propusti doza, može se uzeti unutar 12 sati od vremena određenog za uzimanje doze.
English: The recommended dose of dexamethasone is 20 mg taken orally on a full stomach.
Croatian: Preporučena doza deksametazona je 20 mg uzeta peroralno na pun želudac.
English: You will have regular blood tests during treatment with Farydak.
Croatian: Obavljat ćete redovito krvne pretrage tijekom liječenja Farydakom.
English: These are to: - check how well your liver is working (by measuring your blood levels of bilirubin and transaminase, which are substances made by the liver).
Croatian: Njihova je svrha da se: - provjeri koliko dobro funkcionira Vaša jetra (mjerenjem razina bilirubina i transaminaze u krvi,
English: Farydak should only be used during pregnancy if the expected benefits outweigh the potential risks to the foetus.
Croatian: Farydak se smije koristiti tijekom trudnoće samo ako očekivane koristi premašuju potencijalne rizike za fetus.
English: If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Farydak.
Croatian: Ako uzimate bilo koji od ovih lijekova, liječnik će Vam možda propisati neki drugi lijek tijekom liječenja Farydakom.
English: The volume of distribution of panobinostat at steady state (Vss) is approximately 1,000 litres based on final parameter estimates in the population pharmacokinetic analysis.
Croatian: Volumen distribucije panobinostata u stanju dinamičke ravnoteže (Vss) otprilike je 1000 litara na temelju konačnih procjena parametara u populaciji farmakokinetičke analize.
English: You must also use this for three months after you have stopped taking Farydak.
Croatian: Morate je također koristiti tri mjeseca nakon što prestanete uzimati Farydak.
English: Amongst the patients who died of haemorrhage, one patient had thrombocytopenia grade 4, three patients had thrombocytopenia grade 3 and 1 patient had thrombocytopenia grade 1.
Croatian: Među bolesnicima koji su umrli od krvarenja, jedan je bolesnik imao trombocitopeniju 4. stupnja, tri je bolesnika imalo trombocitopeniju 3. stupnja, a jedan je bolesnik imao trombocitopeniju 1. stupnja.
English: • light-headedness, particularly when standing up (a sign of low blood pressure)
Croatian: • ošamućenost, osobito kod ustajanja (znak niskog krvnog tlaka)
English: Plasma exposure of panobinostat in patients aged 65 years or younger was similar to those older than 65 years in the pooling of single-agent panobinostat studies between the dose range of 10 mg and 80 mg.
Croatian: Izloženost panobinostata u plazmi u bolesnika u dobi od 65 ili manje godina bila je slična onima starijima od 65 godina kada su bila objedinjena ispitivanja panobinostata kao jedinog lijeka u rasponu doza od 10 mg do 80 mg.