FrancophonIA/ELRC3.0 huggingface dataset:
English: Following oral administration of gilteritinib, peak plasma concentrations are observed at a median tmax approximately between 4 and 6 hours in healthy volunteers and patients with relapsed or refractory AML.
Croatian: Nakon peroralne primjene gilteritiniba u zdravih dobrovoljaca i bolesnika s relapsirajućim ili refraktornim AML-om vršne plazmatske koncentracije opažene su uz medijan tmax od približno 4 - 6 sati.
English: There have been reports of posterior reversible encephalopathy syndrome (PRES) in patients receiving Xospata (see section 4.8).
Croatian: U bolesnika liječenih lijekom Xospata prijavljeni su slučajevi sindroma posteriorne reverzibilne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES) (vidjeti dio 4.8).
English: How to take Xospata
Croatian: Kako uzimati lijek Xospata
English: • If differentiation syndrome is suspected, corticosteroid therapy should be initiated along with hemodynamic monitoring until symptom resolution.
Croatian: • Ako se sumnja na sindrom diferencijacije, potrebno je uvesti liječenje kortikosteroidima i praćenje hemodinamičkih parametara dok se simptomi ne povuku.
English: b. The daily dose can be reduced from 120 mg to 80 mg or from 200 mg to 120 mg. c. Composite complete remission (CRc) is defined as the remission rate of all CR (see section 5.1 for definition of CR), CRp [achieved CR except for incomplete platelet recovery (<100 x 109/L)] and CRi (achieved all criteria for CR except for incomplete haematological recovery with residual neutropenia <1 x 109/L with or without complete platelet recovery).
Croatian: Objedinjena potpuna remisija (CRc) definira se kao stopa remisije svih slučajeva potpune remisije (vidjeti dio 5.1 za definiciju potpune remisije), potpune remisije s nepotpunim oporavkom trombocita (postignuta je potpuna remisija, ali se broj trombocita nije potpuno oporavio [< 100 x 109/l]) i potpune remisije s nepotpunim hematološkim oporavkom (ispunjeni su svi kriteriji za potpunu remisiju osim hematološkog oporavka, koji je nepotpun i praćen rezidualnom neutropenijom [< 1 x 10
English: Complete remission
Croatian: Potpuna remisija CR
English: Blood creatine phosphokinase increased*
Croatian: vrlo često povišene vrijednosti alkalne fosfataze u krvi*
English: Symptoms and clinical findings of differentiation syndrome in patients treated with Xospata included fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Croatian: Simptomi i klinički nalazi sindroma diferencijacije u bolesnika liječenih lijekom Xospata uključivali su vrućicu, dispneju, pleuralni izljev, perikardijalni izljev, plućni edem, hipotenziju, brzo povećanje tjelesne težine, periferni edem, osip i poremećaj bubrežne funkcije.
English: CRa (95% CIb) CRhc (95% CIb) CR/CRh (95% CIb) CI: confidence interval a. CR was defined as an absolute neutrophil count ≥1.0 x 109/L, platelets ≥100 x 109/L, normal marrow differential with <5% blasts, must have been red blood cells, platelet transfusion independent and no evidence of extramedullary leukemia.
Croatian: CR se definirao kao apsolutni broj neutrofila ≥ 1,0 x 109/l, broj trombocita ≥ 100 x 109/l, uredna diferencijalna slika koštane srži uz < 5% blasta, neovisnost o transfuzijama eritrocita i trombocita te nepostojanje dokaza ekstramedularne leukemije.
English: Symptoms and clinical findings of differentiation syndrome include fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Croatian: Simptomi i klinički nalazi sindroma diferencijacije uključuju vrućicu, dispneju, pleuralni izljev, perikardijalni izljev, plućni edem, hipotenziju, naglo povećanje tjelesne težine, periferni edem, osip i poremećaj bubrežne funkcije.
English: Contact your doctor straight away if you have a seizure, quickly worsening headache, confusion, or other vision problems.There have been uncommon reports of a condition involving the brain, in patients treated with Xospata, called PRES (may affect up to 1 in 100 people).
Croatian: U bolesnika liječenih lijekom Xospata manje je često prijavljeno stanje koje zahvaća mozak, a zove se PRES (može se javiti u do 1 na 100 osoba).
English: • Interrupt gilteritinib.
Croatian: • Privremeno prekinuti primjenu gilteritiniba.
English: Before taking gilteritinib, relapsed or refractory AML patients must have confirmation of FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test.
Croatian: Prije primjene gilteritiniba u bolesnika s relapsirajućim ili refraktornim AML-om mora se validiranim testom potvrditi mutacija gena za FMS-u sličnu tirozinsku kinazu 3 (engl.
English: 84 film-coated tablets
Croatian: OBLIK I SADRŽAJ 84 filmom obložene tablete
English: Of the 317 patients treated with gilteritinib at 120 mg with a post-baseline QTC value in clinical studies, 4 patients (1%) experienced a QTcF >500 msec. Additionally, across all doses, 12 patients (2.3%) with relapsed/refractory AML had a maximum post-baseline QTcF interval >500 msec (see sections 4.2, 4.4 and 5.1).
Croatian: Od 317 bolesnika liječenih gilteritinibom u dozi od 120 mg kojima je određena vrijednost QTc intervala nakon početka kliničkih ispitivanja, 4 bolesnika (1%) imala su QTcF interval > 500 ms.
English: Transporter drug-drug interactions
Croatian: Interakcije između prijenosnika i lijeka
English: - collection of fluid around the heart, which, if severe, can decrease the heart's ability to pump blood (pericardial effusion) - a vague feeling of discomfort, feeling unwell (malaise) - a severe life-threatening allergic reaction, e.g., swelling in the mouth, tongue, face and throat, itching, hives (anaphylactic reaction) - muscle stiffness - passing less urine, swelling in the legs (signs of sudden kidney injury)
Croatian: - neodređen osjećaj nelagode, opće loše osjećanje (malaksalost) - teška i po život opasna alergijska reakcija, npr. oticanje usta, jezika, lica i grla, svrbež,
English: A concentration-related increase in change from baseline of QTcF was observed across gilteritinib doses ranging from 20 to 450 mg.
Croatian: Kod primjene doza gilteritiniba od 20 do 450 mg opaženo je koncentracijom uvjetovano povećanje promjene QTcF intervala od početne vrijednosti.
English: - if you have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, blurred vision or other problems with seeing.
Croatian: smanjena budnost, smetenost, zamagljen vid ili druge tegobe s vidom.
English: In healthy adults, gilteritinib Cmax and AUC decreased by approximately 26% and less than 10%, respectively, when a single 40 mg dose of gilteritinib was co-administered with a high fat meal compared to gilteritinib exposure in fasted state.
Croatian: Kod primjene jedne doze gilteritiniba od 40 mg uz obrok s visokim udjelom masnoća u zdravih odraslih osoba, Cmax gilteritiniba smanjio se za približno 26%, a AUC za manje od 10% u odnosu na primjenu gilteritiniba natašte.
English: All Grades
Croatian: Svi stupnjevi stupanj
English: Astellas Pharma s.r.o.
Croatian: Slovenská republika Astellas Pharma s.r.o.
English: How to store Xospata
Croatian: Kako čuvati lijek Xospata
English: • granulocyte colony-stimulating factor 300 mcg/m2 once daily by SC for 5 days (days 1 to 5), fludarabine 30 mg/m2 once daily by IV for 5 days (days 2 through 6), cytarabine 2000 mg/m2 once daily by IV for 5 days (days 2 through 6), idarubicin 10 mg/m2 once daily by IV for 3 days (days 2 through 4) (FLAG-Ida).
Croatian: 1000 mg/m jedanput na dan i.v. tijekom 5 dana (od 1. do 5. dana) (MEC) • faktor stimulacije kolonije granulocita u dozi od 300 μg/m jedanput na dan s.c. tijekom 5 dana
English: Hydroxypropylcellulose Hydroxypropylcellulose, low-substituted
Croatian: Jezgra tablete manitol (E421) hidroksipropilceluloza hidroksipropilceluloza, nisko supstituirana magnezijev stearat
English: Taking Xospata
Croatian: Uzimanje lijeka Xospata
English: In clinical studies, 12 patients had QTcF >500 msec. Three patients interrupted and reinitiated treatment without recurrence of QT prolongation.
Croatian: U kliničkim je ispitivanjima 12 bolesnika imalo QTcF interval > 500 ms.
English: Astellas Pharma S.p.A. Tel: +39 (0)2 921381
Croatian: Tel: +39 (0)2 921381
English: Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment.
Croatian: U slučaju prijevremenog prekida liječenja kortikosteroidima simptomi sindroma diferencijacije mogu se ponovno pojaviti.
English: • mitoxantrone 8 mg/m2, etoposide 100 mg/m2 and cytarabine 1000 mg/m2 once daily by IV for 5 days (days 1 through 5) (MEC)
Croatian: • mitoksantron u dozi od 8 mg/m 2, etopozid u dozi od 100 mg/m i citarabin u dozi od
English: • Symptoms include fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Croatian: • Simptomi uključuju vrućicu, dispneju, pleuralni izljev, perikardijalni izljev, plućni edem,
English: x 109/L and platelets ≥50 x 109/L, no evidence of extramedullary leukemia and could not have been classified as CR.
Croatian: c. CRh se definirao kao < 5% blasta u koštanoj srži, djelomičan hematološki oporavak, apsolutan broj neutrofila ≥ 0,5 x 109/l i broj trombocita ≥ 50 x 109/l, nepostojanje dokaza ekstramedularne leukemije i nije se mogao klasificirati kao CR.
English: In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: - medicines used to treat tuberculosis, such as rifampicin; - medicines used to treat epilepsy, such as phenytoin; - medicines used to treat fungal infections such as voriconazole, posaconazole or itraconazole; - medicines used to treat bacterial infections such as erythromycin, clarithromycin or azithromycin; - medicines used to treat high blood pressure (hypertension) such as captopril or carvedilol; - medicines used to treat infections with the human immunodeficiency virus (HIV) such as ritonavir; - medicines used to treat depression such as escitalopram, fluoxetine or sertraline; - St. John's wort (also known as Hypericum perforatum), a herbal medicine used to treat depression.
Croatian: - lijekove koji se koriste za liječenje tuberkuloze, kao što je rifampicin - lijekove koji se koriste za liječenje epilepsije, kao što je fenitoin - lijekove koji se koriste za liječenje gljivičnih infekcija, kao što su vorikonazol, posakonazol ili itrakonazol
English: Deaths, n (%)
Croatian: (95% CI b)
English: Anaphylactic reaction
Croatian: koprivnjača (anafilaktička reakcija)
English: • Patient information leaflet
Croatian: Uputa o lijeku: Informacije za bolesnika
English: Xospata dosing
Croatian: Doziranje lijeka Xospata
English: In general, gilteritinib exhibited linear, dose-proportional pharmacokinetics after single and multiple dose administration at doses ranging from 20 to 450 mg in patients with relapsed or refractory AML.
Croatian: Nakon primjene pojedinačnih i ponovljenih doza u rasponu od 20 do 450 mg u bolesnika s relapsirajućim ili refraktornim AML-om gilteritinib je općenito pokazivao linearnu farmakokinetiku proporcionalnu dozi.
English: Table 2: Adverse reactions Adverse drug reaction
Croatian: Tablica 2: Nuspojave
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: • Discontinue gilteritinib.
Croatian: XOSPATA (gilteritinib)
English: Pericardial effusion
Croatian: Prijavljivanje nuspojava
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava anafilaktička reakcija često
English: Peripheral oedema
Croatian: Sylviusweg 62
English: Date of first authorisation: 26 April 2018
Croatian: Datum prvog odobrenja: 26 travnja 2018
English: What Trydonis is and what it is used for
Croatian: Što je Trydonis i za što se koristi
English: Trydonis contains a small amount of ethanol.
Croatian: Trydonis sadrži male količine etanola.
English: Do not stop using Trydonis or lower the dose, even if you are feeling better or you have no symptoms.
Croatian: Nemojte prestati primjenjivati Trydonis ili sniziti dozu čak i ako se osjećate bolje ili nemate nikakve simptome.
English: What Trydonis looks like and contents of the pack
Croatian: Kako Trydonis izgleda i sadržaj pakiranja
English: If you see 'mist' coming from the top of the inhaler or the sides of your mouth, this means that Trydonis will not be getting into your lungs as it should.
Croatian: Ako vidite „maglicu“ kako izlazi s vrha inhalatora ili sa strane Vaših usta, to znači da Trydonis neće dospjeti u Vaša pluća kao što bi trebao.
English: Trydonis is available in three container sizes:
Croatian: Trydonis je dostupan u 3 veličine spremnika:
English: Talk to your doctor or pharmacist before using Trydonis:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Trydonis:
English: Content of the pack and other information What Trydonis contains
Croatian: Sadržaj pakiranja i druge informacije Što Trydonis sadrži
English: In addition, two Phase IIIb studies were conducted to support the clinical efficacy and safety of Trydonis.
Croatian: Nadalje, provedena su dva klinička ispitivanja faze IIIb da bi se potkrijepila klinička djelotvornost i sigurnost lijeka Trydonis.
English: Other medicines and Trydonis
Croatian: Drugi lijekovi i Trydonis
English: It is important to use Trydonis every day.
Croatian: Važno je da se Trydonis primjenjuje svaki dan.
English: If you use more Trydonis than you should
Croatian: Ako primijenite više lijeka Trydonis nego što ste trebali
English: If you are using Trydonis or high doses of other inhaled corticosteroids over long periods and you come into a situation of stress (e.g. being taken to hospital after an accident, having a serious injury or before an operation) you may need more of this medicine.
Croatian: Ako primjenjujete Trydonis ili visoke doze drugih inhalacijskih kortikosteroida tijekom dugih razdoblja i nađete se u nekoj stresnoj situaciji (npr. ako Vas vode u bolnicu nakon nezgode, ako imate ozbiljnu ozljedu ili prije operacije) možete trebati više tog lijeka.
English: Therefore, as a precautionary measure, it is preferable to avoid the use of Trydonis during pregnancy and during labour.
Croatian: Stoga, kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Trydonis tijekom trudnoće i tijekom porođaja.
English: You should only use Trydonis during pregnancy if you are advised to do so by your doctor.
Croatian: Trydonis smijete primjenjivati tijekom trudnoće samo ako Vam je tako savjetovao liječnik.
English: Trydonis does not contain a high-dose inhaled corticosteroid, but your doctor may wish to measure the cortisol levels in your blood from time to time.
Croatian: Trydonis ne sadrži visoku dozu inhalacijskog kortikosteroida, ali liječnik će Vam možda htjeti povremeno izmjeriti razine kortizola u krvi.
English: However, available safety data from longterm clinical studies have not raised any significant safety concerns (see section 5.1).
Croatian: dostupni podaci o sigurnosti primjene iz dugotrajnih kliničkih ispitivanja nisu dali nikakav značajan razlog za zabrinutost zbog sigurnosti primjene (vidjeti dio 5.1).
English: There is a risk of worsening shortness of breath and wheezing immediately after using Trydonis and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people).
Croatian: Postoji rizik od pogoršanja nedostatka zraka i piskanja neposredno nakon primjene lijeka Trydonis, što je pojava poznata pod nazivom paradoksalni bronhospazam (može se javiti u do 1 na 1000 osoba).
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Trydonis and to contact their doctor immediately should any of these signs or symptoms develop.
Croatian: Bolesnike je potrebno obavijestiti o znakovima i simptomima akutnog glaukoma uskog kuta te im savjetovati da prestanu primjenjivati Trydonis i da se odmah obrate svom liječniku ako se razviju bilo koji od tih znakova i simptoma.
English: Trydonis is a medicine to help breathing that contains the three active substances:
Croatian: Trydonis je lijek za olakšavanje disanja koji sadrži tri djelatne tvari:
English: Using Trydonis together with:
Croatian: Primjena lijeka Trydonis zajedno s:
English: Genotoxicity of Trydonis has not been evaluated, however, the single active components were devoid of genotoxic activity in the conventional test systems.
Croatian: Genotoksičnost lijeka Trydonis nije procjenjivana, međutim, pojedinačne djelatne tvari bile su bez genotoksičnog djelovanja u konvencionalnim sustavima ispitivanja.
English: If anaesthesia with halogenated anaesthetics is planned, it should be ensured that Trydonis is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias.
Croatian: Ako je planirana anestezija halogeniranim anesteticima, potrebno je osigurati da se lijek Trydonis ne primjenjuje najmanje 12 sati prije početka anestezije jer postoji rizik od srčanih aritmija.
English: Tell your doctor if you have any of the following while using Trydonis as they could be symptoms of a lung infection (may affect up to 1 in 10 people):
Croatian: Obratite se svom liječniku ako za vrijeme primjene lijeka Trydonis imate nešto od sljedećeg jer to mogu biti simptomi infekcije pluća (mogu se javiti u do 1 na 10 osoba):
English: The clinical development programme of Trydonis was conducted in patients with moderate, severe or very severe COPD.
Croatian: Klinički program razvoja lijeka Trydonis proveden je u bolesnika s umjerenim, teškim ili vrlo teškim KOPB-om.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trydonis in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Trydonis u svim podskupinama pedijatrijske populacije za KOPB (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you have been using a different inhaler containing beclometasone dipropionate previously, ask your doctor for advice, as the effective dose of beclometasone dipropionate in Trydonis for the treatment of COPD may be lower than that of some other inhalers.
Croatian: Ako ste prethodno koristili drugačiji inhalator koji je sadržavao beklometazondipropionat, potražite savjet liječnika, jer učinkovita doza beklometazondipropionata u lijeku Trydonis za liječenje KOPB-a može biti niža od one u nekim drugim inhalatorima.
English: Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females), either congenital or induced by medicinal products as these patients were excluded from clinical trials with Trydonis.
Croatian: Također je potreban oprez kod liječenja bolesnika za koje se zna ili sumnja da imaju produljenje QTc intervala (QTc > 450 milisekundi za muškarce ili > 470 milisekundi za žene), bilo kongenitalno bilo inducirano lijekovima, jer su ti bolesnici bili isključeni iz kliničkih ispitivanja lijeka Trydonis.
English: What you need to know before you use Trydonis Do not use Trydonis:
Croatian: Što morate znati prije nego počnete primjenjivati Trydonis Nemojte primjenjivati Trydonis:
English: Trydonis 87/5/9 mcg
Croatian: Trydonis 87/5/9 μg
English: Depending on the type of anaesthetic, it may be necessary to stop using Trydonis at least 12 hours before the anaesthesia.
Croatian: Ovisno o vrsti anestetika, možda ćete morati prestati primjenjivati Trydonis najmanje 12 sati prije anestezije.
English: Infants and neonates born to mothers receiving substantial doses of Trydonis should be observed for adrenal suppression.
Croatian: Dojenčad i novorođenčad majki koje primaju znatne doze lijeka Trydonis potrebno je promatrati zbog moguće adrenalne supresije.
English: The daily dose of Trydonis corresponds to a medium dose of inhaled corticosteroid; furthermore, these effects are much less likely to occur than with oral corticosteroids.
Croatian: Dnevna doza lijeka Trydonis odgovara srednjoj dozi inhalacijskog kortikosteroida; nadalje, nastanak tih učinaka manje je vjerojatan nego uz peroralne kortikosteroide.
English: The aerosol particles of Trydonis are on average much smaller than the particles delivered in non-extrafine formulations.
Croatian: Čestice aerosola Trydonis u prosjeku su puno manje od čestica formulacija koje se ne raspršuju u vrlo sitne čestice.
English: Trydonis has no or negligible influence on the ability to drive and use machines.
Croatian: Trydonis ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Trydonis should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus.
Croatian: Trydonis se smije primjenjivati tijekom trudnoće samo ako je očekivana korist za bolesnicu veća od mogućeg rizika za fetus.
English: Trydonis is unlikely to affect your ability to drive and use machines.
Croatian: Trydonis najvjerojatnije neće utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: This includes medicines similar to Trydonis used for your lung disease.
Croatian: To uključuje lijekove slične lijeku Trydonis koje primjenjujete zbog svoje plućne bolesti.
English: The maximum dose is two inhalations of Trydonis twice daily.
Croatian: Maksimalna doza je dva udaha lijeka Trydonis dvaput na dan.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu, and on the website of {name of MS Agency (link)}.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu, kao i na internetskoj stranici {naziv nadležnog tijela države članice (poveznica)}.
English: Trydonis was also statistically significantly superior to a fixed combination of beclometasone dipropionate and formoterol, to tiotropium and to a fixed combination of indacaterol and glycopyrronium in terms of improvement in quality of life (measured by the Saint George Respiratory Questionnaire - SGRQ - total score).
Croatian: Trydonis je također bio statistički značajno superiorniji fiksnoj kombinaciji beklometazondipropionata i formoterola, tiotropiju te fiksnoj kombinaciji indakaterola i glikopironija u pogledu poboljšanja kvalitete života (mjerene ukupnim rezultatom na Saint George respiratornom upitniku, SGRQ).
English: It is preferable to avoid the use of Trydonis during labour due to the inhibitory effects of formoterol on uterine contractions.
Croatian: Poželjno je izbjegavati primjenu lijeka Trydonis tijekom porođaja zbog inhibicijskih učinaka formoterola na kontrakcije maternice.
English: This study also investigated the potential pharmacokinetic interaction between the active components of Trydonis by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium.
Croatian: U ovom se ispitivanju također istražila moguća farmakokinetička interakcija između djelatnih komponenti lijeka Trydonis tako što su se usporedili farmakokinetički podaci dobiveni nakon primjene jedne doze ex tempore kombinacije i nakon primjene jedne doze pojedinačnih komponenti beklometazondipropionata/formoterola ili glikopironija.
English: You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Trydonis therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Croatian: Vi i liječnik morate odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Trydonis uzimajući u obzir korist dojenja za Vaše dijete i korist liječenja za Vas.