FrancophonIA/ELRC3.0 huggingface dataset:
English: Some cases of hospitalisation to further investigate the event of diarrhoea were also reported.
Croatian: Također su poduzeti neki slučajevi hospitalizacija kako bi se daljnje istražio događaj proljeva.
English: Furthermore, evidence of hepatic reactions was reported, including symptomatic acute liver injury.
Croatian: Nadalje, zabilježen je dokaz jetrenih reakcija uključujući simptomatsku akutnu ozljedu jetre.
English: Overall summary of the scientific evaluation of diacerein containing medicinal products (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene lijekova koji sadrže diacerein (vidjeti Dodatak I.)
English: The MAHs considered that there is adequate data supporting the efficacy of diacerein in the symptomatic treatment of osteoarthritis of the hip and the knee and proposed further risk minimisation measures to reduce the risk of diarrhoea and potential risk of hepatic reactions associated with diacerein.
Croatian: Nositelji odobrenja smatrali su da nema dovoljno podataka koji podupiru djelotvornost diacereina u simptomatskom liječenju osteoartritisa kuka i koljena i predložene su daljnje mjere minimizacije rizika kako bi se smanjio daljnji rizik od proljeva i potencijalni rizik od jetrenih reakcija povezanih s diacereinom.
English: • The PRAC considered that available data from pre-clinical studies, clinical trials, post-marketing spontaneous case reports, and published literature have shown that the use of diacereincontaining products is associated with safety concerns such as frequent cases of severe diarrhoea and cases of potentially serious hepatotoxicity; a risk of cutaneous reactions could not be excluded.
Croatian: • PRAC je smatrao da su podaci dostupni iz nekliničkih ispitivanja, kliničkih ispitivanja, spontanih slučajeva nakon stavljanja lijeka u promet i objavljene literature pokazali da je uporaba lijekova koji sadrže diacerein povezana sa sigurnosnim bojaznima poput učestalih slučajeva teškog proljeva i slučajeva potencijalne ozbiljne hepatotoksičnosti; rizik od kutanih reakcija ne može se isključiti.
English: Hepatic reactions were reported, including symptomatic acute liver injury and one fatal case of fulminant hepatitis.
Croatian: Prijavljene su jetrene reakcije uključujući simptomatsko, akutno zatajenje jetre i jedan smrtonosni slučaj fulminantnog hepatitisa.
English: The PRAC was of the view that diacerein should be contraindicated in patients with current and/or history of liver disease and that patient should be screened for major causes of active hepatic disease before start of treatment.
Croatian: PRAC je smatrao da diacerein treba biti kontraindiciran u bolesnika s aktualnom bolesti jetre i/ili s anamnezom bolesti jetre i da je potrebno provesti probir bolesnika na glavne uzroke aktivne bolesti jetre prije početka liječenja.
English: However, treatment with diacerein is not recommended in patients with rapidly progressive hip osteoarthritis, as they may have a weaker response to diacerein.
Croatian: Međutim, liječenje diacereinom ne preporučuje se kod bolesnika s rapidnim, uznapredovalim osteoartritisom kuka jer mogu slabije reagirati na diacerein.
English: • The PRAC concluded that the risk of severe diarrhoea associated with the use of diacerein containing medicinal products and the occurrence of potentially severe hepatic reactions could be mitigated by the above mentioned risk minimisation measures to be reflected in the SmPC and adequately monitored with yearly PSUR submissions.
Croatian: • PRAC je zaključio da bi se rizik od teškog proljeva povezan s uporabom lijekova koji sadrže diacerein i pojava potencijalno teških jetrenih reakcija mogao umanjiti prethodno navedenim mjerama minimizacije rizika koje treba uključiti u Sažetak opisa svojstava lijeka te motriti na odgovarajući način uz godišnje dostave PSUR-eva.
English: Furthermore, cases of hepatic enzymes elevations have been reported and as well as serious cases, including a fatal hepatic reaction in a patient treated with diacerein.
Croatian: Nadalje, slučajevi povišenja jetrenih enzima također su prijavljeni kao i ozbiljni slučajevi uključujući smrtonosne jetrene reakcije kod bolesnika liječenih diacereinom.
English: • The PRAC reviewed all the available data on the efficacy and safety of diacerein-containing medicines in particular data in relation to the risk of hepatotoxicity, gastrointestinal disorders and cutaneous reactions provided by the MAHs in writing and in the oral explanations;
Croatian: • PRAC je pregledao sve dostupne podatke o djelotvornosti i sigurnosti lijekova koji sadrže diacerein , a posebice podatke povezane s rizikom od hepatotoksičnosti, probavnih poremećaja i kutanih reakcija koje su osigurali nositelji odobrenja napismeno i usmeno;
English: Having considered the overall submitted data provided by the MAHs in writing and at the oral explanation, the PRAC concluded that the benefit-risk balance of diacerein containing products is not favourable in the currently approved indications.
Croatian: Imajući u vidu ukupne predane podatke koje je nositelj odobrenja osigurao napismeno kao i usmeno objašnjenje, PRAC je zaključio da je omjer koristi i rizika kod lijekova koji sadrže diacerein nepovoljan za trenutno odobrene indikacije.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products containing diacerein identified in Annex I remains favourable, subject to the changes to the product information and conditions as provided for in Annex IV.
Croatian: PRAC je posljedično zaključio da je omjer koristi i rizika lijekova koji sadrže diacerein identificiran u Dodatku I. ostao povoljan te da je podložan promjenama u informacijama o lijekovima i uvjetima iznesenim u Dodatku IV.
English: The PRAC reviewed all available data from clinical studies, published literature, and post-marketing experience on the safety of the diacerein containing products, in particular in relation to the risk of hepatotoxicity, gastro-intestinal disorders and cutaneous disorders.
Croatian: PRAC je pregledao sve podatke dostupne iz kliničkih ispitivanja, objavljene literature i iskustva nakon stavljanja lijeka u promet o sigurnosi lijekova koji sadrže diacerein posebice u vezi s hepatotoksičnošću, probavnim poremećajima i kutanim poremećajima.
English: Package Leaflet (PL) to better reflect the PRAC recommendations and to correct minor discrepancies.
Croatian: Međutim, CMDh je smatrao da su bile potrebne određene promjene u Sažetku opisa svojstava lijeka i Uputi o lijeku kako bi se bolje odrazile preporuke PRAC-a i ispravile minorne nepodudarnosti.
English: The recommended starting dose is three tablets once daily and can be increased to 5 tablets once daily after 4 weeks depending on the patient's response.
Croatian: Preporučena početna doza je tri tablete jedanput dnevno i može se nakon četiri tjedna povećati na pet tableta jedanput dnevno, ovisno o odgovoru bolesnika.
English: What is Xospata and what is it used for?
Croatian: Što je Xospata i za što se koristi?
English: Treatment should continue for as long as the patient benefits from it.
Croatian: Liječenje treba trajati onoliko dugo koliko bolesnik ima koristi od liječenja.
English: The doctor will also carry out regular blood tests and check the patient's heart function before and during treatment.
Croatian: Liječnik će redovito provoditi krvne pretrage i provjeriti bolesnikovu srčanu funkciju prije i tijekom liječenja.
English: If certain side effects develop, the doctor may decide to reduce the dose or stop the treatment intermittently or entirely.
Croatian: Ako dođe do određenih nuspojava, liječnik može odlučiti smanjiti dozu ili liječenje povremeno ili u potpunosti prekinuti.
English: Other information about Xospata
Croatian: Ostale informacije o lijeku Xospata
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3171961.
Croatian: Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/medicines/human/orphan-designations/eu3171961.
English: What measures are being taken to ensure the safe and effective use of Xospata?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xospata?
English: Xospata is available as tablets (40 mg).
Croatian: Lijek Xospata dostupan je u obliku tableta (40 mg).
English: Patients will also receive a patient card with information on when to seek medical advice if differentiation syndrome is suspected.
Croatian: Bolesnici će dobiti i karticu s informacijama o tome kada trebaju potražiti savjet liječnika ako sumnjaju na sindrom diferencijacije.
English: Patients receiving Xospata lived on average 9.3 months compared with 5.6 months for those receiving various types of chemotherapy.
Croatian: Bolesnici koji su primali lijek Xospata živjeli su u prosjeku 9,3 mjeseca u usporedbi s 5,6 mjeseci u bolesnika koji su primali različite vrste kemoterapije.
English: The European Medicines Agency therefore decided that Xospata's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Xospata nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The company that markets Xospata will provide educational materials to healthcare professionals and patients about the signs and symptoms of differentiation syndrome.
Croatian: Tvrtka koja stavlja lijek Xospata u promet osigurat će za zdravstvene radnike i bolesnike edukativne materijale o znakovima i simptomima sindroma diferencijacije.
English: What are the risks associated with Xospata?
Croatian: Koji su rizici povezani s lijekom Xospata?
English: Side effects reported with Xospata are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Xospata pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other serious side effects include a disorder related to white blood cells known as differentiation syndrome, a brain condition known as posterior reversible encephalopathy syndrome (PRES) and heart rhythm problems.
Croatian: Ostale ozbiljne nuspojave uključuju poremećaj povezan s bijelim krvnim stanicama poznat pod nazivom sindrom diferencijacije, oštećenje mozga poznato kao sindrom posteriorne reverzibilne encefalopatije (PRES) i problemi sa srčanim ritmom.
English: An overview of Xospata and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Xospata i zašto je odobren u EU-u
English: AML is rare, and Xospata was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 January 2018.
Croatian: AML je rijetka bolest, a lijek Xospata dobio je status „lijeka za rijetku bolest” 17. siječnja 2018.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xospata have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Xospata također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: The most common side effects with Xospata (which may affect more than 1 in 10 people) are increased levels of some enzymes in the blood (creatine phosphokinase, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase), diarrhoea, tiredness, nausea (feeling sick), constipation, cough, peripheral oedema (swelling, especially of the ankles and feet), dyspnoea (shortness of breath), dizziness, hypotension (low blood pressure), pain in the extremities, weakness, joint pain and muscle pain.
Croatian: Najčešće nuspojave povezane s lijekom Xospata (koje se mogu javiti u više od 1 na 10 osoba) jesu povišene vrijednosti određenih enzima u krvi (kreatin fosfokinaze, alanin aminotransferaze, aspartat aminotransferaze, alkalne fosfataze), proljev, umor, mučnina, konstipacija, kašalj, periferni edem (oticanje, posebno gležnjeva i stopala), dispneja (otežano disanje), omaglica, hipotenzija (nizak krvni tlak), bol u ektremitetima, iscrpljenost, bol u zglobovima i mišićima.
English: The active substance in Xospata is gilteritinib.
Croatian: Djelatna tvar lijeka Xospata je gilteritinib.
English: As for all medicines, data on the use of Xospata are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Xospata kontinuirano se prate.
English: Before starting treatment, doctors will use a genetic test to confirm that the patient has an FLT3 mutation.
Croatian: Prije početka liječenja liječnici će provesti genetsko testiranje kako bi potvrdili mutaciju gena FLT3 u bolesnika.
English: Xospata can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in using cancer medicines.
Croatian: Xospata se izdaje samo na recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: The most common serious side effects (which may affect up to 1 in 10 people) are diarrhoea, increased levels of liver enzymes in the blood, dyspnoea and hypotension.
Croatian: Najčešće ozbiljne nuspojave (koje se mogu javiti u najviše 1 na 10 osoba) jesu proljev, povišene vrijednosti jetrenih enzima u krvi, dispneja i hipotenzija.
English: Why is Xospata authorised in the EU?
Croatian: Zašto je lijek Xospata odobren u EU-u?
English: For more information about using Xospata, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Xospata pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The active substance in Xospata, gilteritinib, blocks the action of enzymes known as tyrosine kinases, in particular a tyrosine kinase called FLT3 which normally controls growth and division of white blood cells.
Croatian: Djelatna tvar u lijeku Xospata, gilteritinib, blokira djelovanje enzima poznatih pod nazivom tirozin kinaze, osobito tirozin kinazu FLT3 koja uglavnom kontrolira rast i diobu bijelih krvnih stanica.
English: Xospata was shown to prolong patients' lives in comparison to other cancer therapies.
Croatian: Pokazalo se da lijek Xospata produljuje život bolesnika u usporedbi s drugim lijekovima protiv raka.
English: Xospata is a cancer medicine used to treat adults with acute myeloid leukaemia (AML), a cancer of white blood cells.
Croatian: Xospata je lijek protiv raka koji koristi za liječenje odraslih osoba s akutnom mijeloičnom leukemijom (ALM), vrstom raka bijelih krvnih stanica.
English: Side effects with Xospata are those expected of this class of medicines and considered manageable.
Croatian: Nuspojave lijeka Xospata očekivane su za ovaj razred lijekova i mogu se kontrolirati.
English: Patients with AML who have an FLT3 mutation, and whose disease has come back or has not improved following previous treatment, have a poor prognosis and treatment options are limited.
Croatian: Bolesnici s AML-om koji imaju mutaciju gena FLT3 i čija se bolest vratila ili se njihovo stanje nije poboljšalo nakon prethodne terapije, imaju lošu prognozu i ograničene mogućnosti liječenja.
English: In patients who have an FLT3 mutation, FLT3 is overactive and stimulates the growth of too many white blood cells.
Croatian: U bolesnika koji imaju mutaciju gena FLT3, gen FLT3 pretjerano je aktivan i potiče rast prevelikog broja bijelih krvnih stanica.
English: Further information on Xospata can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xospata This overview was last updated in 10-2019.
Croatian: Više informacija o lijeku Xospata dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/xospata
English: By blocking FLT3, gilteritinib is expected to stop white blood cell growth and thus slow down the development of the cancer.
Croatian: Blokiranjem gena FLT3 očekuje se da će gilteritinib zaustaviti rast bijelih krvnih stanica i usporiti razvoj raka.
English: Xospata is used when AML has either come back or has not improved following previous treatment and is only given to patients whose cancer cells have a particular change (mutation) in the gene for a protein called FLT3.
Croatian: Lijek Xospata koristi se kada se AML vratio ili se stanje bolesnika nije poboljšalo nakon prethodne terapije i daje se samo bolesnicima u čijim stanicama raka dolazi do promjene (mutacije) gena u pogledu proteina FLT3.
English: How does Xospata work?
Croatian: Kako djeluje Xospata?
English: In a main study with 371 patients with AML who have an FLT3 mutation, and whose disease had come back or had not improved following previous treatment, Xospata prolonged patients' lives compared with patients receiving chemotherapy.
Croatian: U glavnom ispitivanju na 371 bolesniku s AML-om koji imaju mutaciju gena FLT3 i čija se bolest vratila ili se njihovo stanje nije poboljšalo nakon prethodne terapije, Xospata je produljio život bolesnika u usporedbi s bolesnicima koji su primali kemoterapiju.
English: What benefits of Xospata have been shown in studies?
Croatian: Koje su koristi od lijeka Xospata utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions of Xospata, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Xospata potražite u uputi o lijeku.
English: How is Xospata used?
Croatian: Kako se Xospata primjenjuje?
English: Xospata received a marketing authorisation valid throughout the EU on 24 October 2019.
Croatian: Pregled informacija posljednji je put ažuriran u 10. 2019.
English: Date of opening:__________
Croatian: Datum otvaranja:___________
English: Do not give this medicine to children less than 12 years of age.
Croatian: Ovaj lijek se ne smije davati djeci mlađoj od 12 godina.
English: The tablet can be taken with or without food.
Croatian: Tableta se može uzeti s hranom ili bez nje.
English: If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Croatian: Ako ste zaboravili uzeti svoju dozu lijeka na vrijeme, uzmite ju što je prije moguće, a zatim nastavite lijek uzimati prema uobičajenom rasporedu.
English: Other medicines and Dasselta
Croatian: Drugi lijekovi i Dasselta
English: 7 film-coated tablets: EU/1/11/739/001 10 film-coated tablets: EU/1/11/739/002 20 film-coated tablets: EU/1/11/739/003 30 film-coated tablets: EU/1/11/739/004 50 film-coated tablets: EU/1/11/739/005 90 film-coated tablets: EU/1/11/739/006 100 film-coated tablets: EU/1/11/739/007 250 film-coated tablets: EU/1/11/739/008
Croatian: 7 filmom obloženih tableta: EU/1/11/739/001 10 filmom obloženih tableta: EU/1/11/739/002 20 filmom obloženih tableta: EU/1/11/739/003 30 filmom obloženih tableta: EU/1/11/739/004 50 filmom obloženih tableta: EU/1/11/739/005 90 filmom obloženih tableta: EU/1/11/739/006 100 filmom obloženih tableta: EU/1/11/739/007 250 filmom obloženih tableta: EU/1/11/739/008
English: Date of first authorisation: 28 November 2011 Date of latest renewal: 16 August 2016
Croatian: Datum posljednje obnove odobrenja: 16. kolovoza 2016.
English: Shelf life after first opening of the tablet container: 3 months.
Croatian: Rok valjanosti nakon prvog otvaranja spremnika za tablete: 3 mjeseca.
English: Talk to your doctor or pharmacist before taking Dasselta: - if you have poor kidney function.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Dasseltu: - ako imate oslabljenu funkciju bubrega.
English: As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu desloratadina tijekom trudnoće.
English: The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products can not be fully excluded.
Croatian: Enzim odgovoran za metabolizam desloratadina još nije utvrđen stoga se neke interakcije s drugim lijekovima ne mogu potpuno isključiti.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from desloratadine therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja desloratadinom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Pharmacotherapeutic group: Other antihistamines for systemic use, ATC code: R06AX27
Croatian: Farmakoterapijska skupina: Ostali antihistaminici za sustavnu primjenu, ATK oznaka: R06AX27
English: What Dasselta is and what it is used for
Croatian: Što je Dasselta i za što se koristi
English: - abnormal behaviour, - aggression, - weight increased, - increased appetite.
Croatian: - agresija - povećana tjelesna težina - povećan apetit.
English: Blister (OPA/Alu/PVC//Alu): 7, 10, 20, 30, 50, 90 and 100 film-coated tablets, in a box.
Croatian: Blister (OPA/Al/PVC//Al): 7, 10, 20, 30, 50, 90 i 100 filmom obloženih tableta, u kutiji.
English: If you take more Dasselta than you should
Croatian: Ako uzmete više Dasselte nego što ste trebali
English: Do not take Dasselta - if you are allergic to desloratadine, to any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Croatian: Nemojte uzimati Dasseltu - ako ste alergični na desloratadin, neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ili na loratadin.
English: Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Dasselta.
Croatian: Vezano za trajanje liječenja, Vaš će liječnik odrediti od kojeg tipa alergijskog rinitisa bolujete te koliko dugo trebate uzimati Dasseltu.
English: Very rare (the following may affect up to 1 in 10,000 people): - severe allergic reactions, - rash, - pounding or irregular heartbeat, - fast heartbeat, - stomach ache, - feeling sick (nausea), - vomiting, - upset stomach, - diarrhoea, - dizziness, - drowsiness, - inability to sleep, - muscle pain, - hallucinations, - seizures, - restlessness with increased body movement, - liver inflammation, - abnormal liver function tests.
Croatian: Vrlo rijetke (sljedeće nuspojave mogu se javiti u do 1 na 10 000 osoba) - teške alergijske reakcije - osip - lupanje ili nepravilni otkucaji srca - ubrzani otkucaji srca - bol u želucu - mučnina - povraćanje - želučane tegobe - proljev - omaglica - omamljenost - nesanica - bol u mišićima - halucinacije - napadaji - nemir s pojačanim kretnjama tijela - upala jetre - odstupanja od normalnih rezultata testova funkcije jetre.
English: What you need to know before you take Dasselta
Croatian: Što morate znati prije nego počnete uzimati Dasseltu
English: for tablet container:
Croatian: za spremnik za tablete:
English: The safety and efficacy of Dasselta 5 mg film-coated tablets in children below the age of 12 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Dasselta 5 mg filmom obložene tablete u djece mlađe od 12 godina nisu ustanovljene.
English: If you forget to take Dasselta
Croatian: Ako ste zaboravili uzeti Dasseltu
English: Dasselta with food, drink and alcohol Dasselta may be taken with or without a meal.
Croatian: Dasselta s hranom, pićem i alkoholom Dasselta se može uzeti uz ili bez obroka.
English: There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Croatian: Postoji ograničeno iskustvo iz kliničkih ispitivanja djelotvornosti primjenom desloratadina u adolescenata u dobi od 12 do 17 godina (vidjeti dijelove 4.8 i 5.1).
English: Adults and adolescents 12 years of age and over The recommended dose is one tablet once a day with water, with or without food.
Croatian: Odrasli i adolescenti u dobi od 12 godina i stariji Preporučena doza je jedna tableta jedanput na dan, a uzima se s vodom, uz obrok ili natašte.