FrancophonIA/ELRC3.0 huggingface dataset:
English: Most of the side effects are as expected with antipsychotic medicines and many can be treated.
Croatian: Većina je nuspojava očekivana jer se javljaju i kod ostalih antipsihotičkih lijekova i većina ih se može liječiti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Reagila have 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 Reagila nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: In three main studies in a total of 1,795 adults, Reagila was more effective than placebo (a dummy treatment) at reducing symptoms on a standard rating scale called PANSS (positive and negative syndrome scale).
Croatian: U trima glavnim ispitivanjima koja su obuhvatila ukupno 1 795 odraslih osoba Reagila je bila djelotvornija od placeba (prividno liječenje) u smanjenju simptoma na standardnoj ljestvici ocjenjivanja pod nazivom PANSS (ljestvica pozitivnih i negativnih sindroma).
English: The most common side effects with Reagila are akathisia (a constant urge to move) and parkinsonism (effects similar to Parkinson's disease such as shaking, muscle stiffness and slow movement).
Croatian: Najčešće nuspojave lijeka Reagila jesu akatizija (neprestani poriv za kretanje) i parkinsonizam (učinci slični Parkinsonovoj bolesti, kao što su drhtanje, ukočenost mišića i sporo kretanje).
English: What are the risks associated with Reagila?
Croatian: Koji su rizici povezani s lijekom Reagila?
English: Why is Reagila approved?
Croatian: Zašto je lijek Reagila odobren?
English: Reagila can only be obtained with a prescription.
Croatian: Reagila se izdaje samo na liječnički recept.
English: Finally, a fifth main study in 200 patients showed that Reagila was more effective than placebo at preventing symptoms from coming back after initial treatment.
Croatian: U konačnom, petom glavnom ispitivanju provedenom na 200 bolesnika pokazalo se da je lijek Reagila djelotvorniji od placeba kod sprečavanja povratka simptoma nakon početnog liječenja.
English: For more information about treatment with Reagila, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Reagila pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Reagila contains the active substance cariprazine.
Croatian: Reagila sadržava djelatnu tvar kariprazin.
English: For practical information about using Reagila, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Reagila bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Studies showed that Reagila improves symptoms of schizophrenia and prevents symptoms from returning.
Croatian: Ispitivanja su pokazala da lijek Reagila poboljšava simptome shizofrenije i sprečava njihov povratak.
English: What benefits of Reagila have been shown in studies?
Croatian: Koje su koristi lijeka Reagila dokazane u ispitivanjima?
English: For the full list of all side effects and restrictions with Reagila, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Reagila potražite u uputi o lijeku.
English: How does Reagila work?
Croatian: Kako djeluje Reagila?
English: How is Reagila used?
Croatian: Kako se lijek Reagila koristi?
English: The PANSS score, which ranges from a minimum of 30 (no symptoms) to a maximum of 210 (severest symptoms), was around 96 at the start of treatment.
Croatian: Rezultat na PANSS ljestvici, koji može biti između 30 (bez simptoma) i 210 (najteži simptomi), na početku liječenja bio je oko 96. Nakon 6 tjedana, ovisno o ispitivanju, rezultat na PANSS ljestvici smanjio se za između 17 i 23 boda za lijek Reagila, dok se za placebo smanjio za između 9 i 14 bodova.
English: • Stir and drink immediately.
Croatian: • Promućkajte i odmah popijte
English: • a heart attack, over a year ago.
Croatian: • srčani udar, prije više od godinu dana.
English: This will tell you whether you have taken the dose.
Croatian: To će Vam pokazati jeste li uzeli dozu.
English: How much to take
Croatian: Koliko treba uzeti
English: You have been given this medicine because you have had:
Croatian: Dobili ste ovaj lijek zato što ste imali:
English: About 30% of episodes resolved within 7 days.
Croatian: Oko 30% epizoda je razriješeno unutar 7 dana.
English: KM percentage calculated at 36 months.
Croatian: KM postotak izračunat nakon 36 mjeseci.
English: This can be very dangerous because:
Croatian: To može biti vrlo opasno iz sljedećih razloga:
English: This dose will usually be given to you in the hospital.
Croatian: Ovu ćete dozu obično primiti u bolnici.
English: • Take this medicine around the same time every day (for example, one tablet in the morning and one in the evening).
Croatian: • Uzimajte ovaj lijek otprilike u isto vrijeme svakog dana (primjerice, jednu tabletu ujutro i jednu navečer).
English: Fatal: A bleeding event that directly led to death within 7 days.
Croatian: Fatalna: Događaj krvarenja koji je izravno doveo do smrti unutar 7 dana.
English: Brilique is available in:
Croatian: Brilique je dostupan u:
English: There was no difference in overall fatal bleeds.
Croatian: Nije bilo razlike u ukupnim fatalnim krvarenjima.
English: Your doctor will decide if it needs treatment or further investigations.
Croatian: Vaš će liječnik odlučiti trebate li liječenje ili daljnje pretrage.
English: If bleeding occurs other appropriate supportive measures should be taken.
Croatian: Ako dođe do krvarenja treba poduzeti druge odgovarajuće potporne mjere.
English: If you are taking both Brilique and heparin:
Croatian: Ako uzimate i Brilique i heparin:
English: Other medicines and Brilique
Croatian: Drugi lijekovi i Brilique
English: Your doctor may want you to stop taking this medicine 5 days prior to surgery.
Croatian: Vaš će liječnik možda htjeti da prestanete uzimati ovaj lijek 5 dana prije operacije.
English: Do not take Brilique if:
Croatian: Nemojte uzimati Brilique:
English: Children and adolescents Brilique is not recommended for children and adolescents under 18 years.
Croatian: Djeca i adolescenti Brilique se ne preporučuje za djecu i adolescente u dobi ispod 18 godina.
English: These small changes are considered of minimal clinical significance; therefore, ticagrelor can be given with or without food.
Croatian: Za ove male promjene smatra se da imaju minimalni klinički značaj; stoga se tikagrelor može davati sa ili bez hrane.
English: • You are bleeding now.
Croatian: • ako trenutno krvarite.
English: It can then be swallowed with or without water (see section 5.2).
Croatian: Tada se može progutati sa ili bez vode (vidjeti dio 5.2).
English: • Do not take a double dose (two doses at the same time) to make up for the forgotten dose.
Croatian: • Nemojte uzimati dvostruku dozu (dvije doze u isto vrijeme) kako biste nadomjestili zaboravljenu dozu.
English: Bleeding may occur in any part of the body.
Croatian: Do krvarenja može doći u bilo kojem dijelu tijela.
English: • a heart attack, or
Croatian: • srčani udar, ili
English: In absolute terms, this risk was higher than in the overall PLATO population.
Croatian: Sveukupno, ovaj je rizik bio veći nego kod ukupne populacije u studiji PLATO.
English: • Pour the powder into half a glass of water.
Croatian: • Naspite prašak u pola čaše vode
English: Therefore, in the absence of data, treatment beyond one year is not recommended in these patients.
Croatian: Stoga se u ovih bolesnika, zbog nedostatka podataka, ne preporučuje liječenje u trajanju duljem od godinu dana.
English: The tablet should be placed on the tongue, where it will rapidly disperse in saliva.
Croatian: Tabletu treba staviti na jezik, na kojem će se brzo rastopiti u slini.
English: Ticagrelor may have similar effect on lovastatin.
Croatian: Tikagrelor bi mogao imati sličan učinak na lovastatin.
English: • rifampicin (an antibiotic)
Croatian: • rifampicin (antibiotik),
English: For further details see section 4.8.
Croatian: Za dodatne informacije, vidjeti dio 4.8.
English: • Put the tablet on your tongue and let it disintegrate.
Croatian: • Stavite tabletu na jezik i pustite je da se rastopi.
English: • High level of uric acid in your blood (as seen in tests)
Croatian: • Visoka razina mokraćne kiseline u Vašoj krvi (kako se vidi na pretragama)
English: Date of first authorisation: 03 December 2010 Date of latest renewal: 17 July 2015
Croatian: Datum posljednje obnove odobrenja: 17. srpnja 2015.
English: • You can then swallow it with or without water.
Croatian: • Tada ju možete progutati sa ili bez vode.
English: Patients with events
Croatian: Bolesnici s događajem
English: • You can check when you last took a tablet of Brilique by looking on the blister.
Croatian: • Možete provjeriti kada ste zadnji put uzeli tabletu lijeka Brilique tako da pogledate na blister.
English: Hypersensitivity including angioedema
Croatian: Preosjetljivost, uključujući angioedem
English: Sun/Moon symbol
Croatian: simbol sunca i mjeseca
English: It is not recommended to use Brilique if you are pregnant or may become pregnant.
Croatian: Ne preporučuje se uzimanje lijeka Brilique ako ste trudni ili biste mogli zatrudnjeti.
English: • If you forget to take a dose, just take your next dose as normal.
Croatian: • Ako ste zaboravili uzeti dozu, samo uzmite sljedeću dozu u uobičajeno vrijeme.
English: TIMI Major or Minor or Requiring medical attention
Croatian: TIMI velika ili manja ili koja zahtijevaju medicinsku pozornost
English: TIMI Requiring medical attention: Requiring intervention, OR leading to hospitalisation, OR prompting evaluation.
Croatian: TIMI koja zahtijevaju medicinsku pozornost: Koja zahtijevaju intervenciju, ILI koja su dovela do hospitalizacije, ILI koja zahtijevaju hitnu medicinsku procjenu.
English: What Brilique is and what it is used for What you need to know before you take Brilique How to take Brilique
Croatian: Što je Brilique i za što se koristi Što morate znati prije nego počnete uzimati Brilique Kako uzimati Brilique
English: The glass should be rinsed with a further half glass of water and the contents drunk.
Croatian: Čaša se treba isprati sa dodatnih pola čaše vode te sadržaj popiti.
English: • You have had any problems with your liver or have previously had any disease which may have affected your liver.
Croatian: • Ako ste ikada imali problema s jetrom ili ste prethodno patili od bolesti koja je mogla utjecati na Vašu jetru.
English: • unstable angina (angina or chest pain that is not well controlled).
Croatian: • nestabilnu anginu (anginu ili bol u prsnom košu koja nije dobro kontrolirana).
English: The systemic exposure to the active metabolite is approximately 30-40% of that obtained for ticagrelor.
Croatian: Sistemska izloženost aktivnom metabolitu iznosi približno 30-40% od one dobivene za tikagrelor.
English: If a switch is needed, the first dose of Brilique should be administered 24 hours following the last dose of the other antiplatelet medication.
Croatian: Ako je potrebno prebacivanje, prva doza lijeka Brilique mora se primijeniti 24 sata nakon posljednje doze drugog antitrombocitnog lijeka.
English: Thus, no particular group was identified at risk for any subset of bleeding.
Croatian: Stoga nije izdvojena niti jedna skupina kao rizična za neku od podskupina krvarenja.
English: Therefore, patients who experience these symptoms should be cautious while driving or using machines.
Croatian: Stoga, bolesnici koji osjete ove simptome trebaju biti oprezni tijekom vožnje ili korištenja strojeva.
English: • You are due to have surgery (including dental work) at any time while taking Brilique.
Croatian: • Ako trebate imati operaciju (uključujući i zahvate kod zubara) u bilo koje vrijeme dok uzimate Brilique.
English: Frequency categories are defined according to the following conventions: Very common (≥1/10), common (≥1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
English: This interaction may be related to reduced gastrointestinal motility and apply to other opioids.
Croatian: Ova interakcija može biti povezana sa smanjenim gastrointestinalnim motilitetom i vrijedi i za druge opioide.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Brilique if:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Brilique ako:
English: If your feeling of shortness of breath gets worse or lasts a long time, tell your doctor.
Croatian: Ako se osjećaj nedostatka zraka pogorša ili ako traje dulje vrijeme, recite to liječniku.
English: Treatment of overdose should follow local standard medical practice.
Croatian: Terapija u slučaju predoziranja treba slijediti standardnu lokalnu medicinsku praksu.
English: ARR = absolute risk reduction; RRR = relative risk reduction = (1-Hazard ratio) x 100%.
Croatian: ARR = smanjenje apsolutnog rizika; RRR = smanjenje relativnog rizika = (1-omjer hazarda) x 100%.
English: Your doctor will tell you how much to take (usually between 75-150 mg daily).
Croatian: Liječnik će Vam reći koju dozu trebate uzimati (obično između 75-150 mg dnevno).
English: • Bleeding after surgery or from cuts (for example while shaving) and wounds more than is normal
Croatian: • Krvarenje nakon operacije ili iz posjekotina (na primjer tijekom brijanja) i rana više od normalnog
English: This is because Brilique can affect the way some medicines work and some medicines can have an effect on Brilique.
Croatian: Razlog tomu je što Brilique može utjecati na način djelovanja drugih lijekova, a i neki drugi lijekovi mogu utjecati na Brilique.
English: See a doctor straight away if you notice any of the following - you may need urgent medical treatment:
Croatian: Odmah se javite liječniku ako primijetite bilo što od dolje navedenog - možda Vam je potrebno hitno medicinsko liječenje:
English: • cyclosporine (used to lessen your body's defenses)
Croatian: • ciklosporin (za smanjenje obrane Vašeg organizma),
English: • Your heart rate is abnormally low (usually lower than 60 beats per minute) and you do not already have in place a device that paces your heart (pacemaker).
Croatian: • Ako je Vaš puls neuobičajeno nizak (obično niži od 60 otkucaja u minuti) a nemate već ugrađen uređaj koji stimulira rad srca (elektrostimulator).
English: These very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged.
Croatian: Ove vrlo male krvne stanice pomažu u zaustavljanju krvarenja tako što se nakupljaju kako bi začepile sitne rupe na krvnim žilama koje su oštećene ili porezane.
English: Renal function should be checked according to routine medical practice.
Croatian: Bubrežnu funkciju treba provjeriti u skladu s rutinskom medicinskom praksom.
English: • You are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na tikagrelor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • You have asthma or other lung problems or breathing difficulties.
Croatian: • Ako imate astmu ili druge probleme s plućima ili teškoće pri disanju.
English: 90% of patients had final extent IPA>70% by 2 hours post dose.
Croatian: 90% bolesnika imalo je konačnu razinu IPA >70% do 2 sata nakon uzimanja doze.
English: All-cause mortality
Croatian: Mortalitet svih uzroka
English: • Active pathological bleeding.
Croatian: • Aktivno patološko krvarenje.
English: What you need to know before you take Brilique
Croatian: Što morate znati prije nego počnete uzimati Brilique
English: No evidence of clinically significant adverse interactions with these medicinal products was observed.
Croatian: Nisu uočeni znakovi klinički značajnih štetnih interakcija s ovim lijekovima.
English: It is important that you inform your doctor that you are taking both Brilique and heparin, as Brilique may affect the diagnostic test.
Croatian: Važno je da kažete svom liječniku da uzimate i Brilique i heparin, jer Brilique može utjecati na nalaze dijagnostičkog testa.
English: Do not stop taking Brilique without talking to your doctor.
Croatian: Nemojte prestati uzimati Brilique bez prethodnog savjetovanja s liječnikom.
English: Patients should be advised to inform physicians and dentists that they are taking ticagrelor before any surgery is scheduled and before any new medicinal product is taken.
Croatian: Bolesnike treba savjetovati da obavijeste liječnike i stomatologe da uzimaju tikagrelor prije bilo kakve operacije i prije uzimanja bilo kojeg novog lijeka.
English: • The usual dose is one tablet of 60 mg twice a day.
Croatian: • Uobičajena doza je jedna tableta od 60 mg dvaput na dan.
English: • The starting dose is two tablets at the same time (loading dose of 180 mg).
Croatian: • Početna doza je dvije tablete u isto vrijeme (udarna doza od 180 mg).
English: The safety and efficacy of ticagrelor in children below the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost tikagrelora kod djece mlađe od 18 godina nisu ustanovljene.
English: Note: the number of first events for the components CV death, MI and stroke are the actual number of first events for each component and do not add up to the number of events in the composite endpoint (s) Indicates statistical significance.
Croatian: Napomena: broj prvih događaja za komponente KV smrt, IM i moždani udar su stvarni broj prvih događaja za svaku komponentu i ne zbrajaju se u broj događaja u kompozitnom ishodu. (s) označava statističku značajnost
English: A patient who misses a dose of Brilique should take only one tablet (their next dose) at its scheduled time.
Croatian: Bolesnik koji propusti uzeti dozu lijeka Brilique treba uzeti samo jednu tabletu (svoju sljedeću dozu) u predviđeno vrijeme.
English: Effects of medicinal and other products on ticagrelor
Croatian: Učinci lijekova i drugih proizvoda na tikagrelor
English: Exposure of the active metabolite increased to a lesser extent (AUC 13-14% and Cmax 17-36%).
Croatian: Izloženost aktivnom metabolitu povećana je u manjoj mjeri (AUC 13-14% i Cmax 17-36%).
English: This belongs to a group of medicines called antiplatelet medicines.
Croatian: Pripada skupini lijekova koji se zovu antitromboticima.
English: Severe bleeding is uncommon but can be life threatening.
Croatian: Teško krvarenje je manje često, ali može biti opasno po život.
English: Ticagrelor produced irregular cycles (mostly extended cycles) in female rats, but did not affect overall fertility in male and female rats.
Croatian: Tikagrelor je uzrokovao nepravilne cikluse (uglavnom produljene) kod ženki štakora, ali nije utjecao na sveukupnu plodnost muških i ženskih štakora.
English: If you feel dizzy or confused while taking this medicine, be careful while driving or using machines.
Croatian: Ukoliko osjetite omaglicu ili smetenost tijekom uzimanja ovog lijeka, budite oprezni tijekom vožnje ili korištenja strojeva.
English: • more than 40 mg daily of either simvastatin or lovastatin (medicines used to treat high cholesterol)
Croatian: • više od 40 mg dnevno simvastatina ili lovastatina (lijekovi za liječenje visokog kolesterola)
English: These differences are not considered clinically significant (see section 4.2).
Croatian: Ove razlike se ne smatraju klinički značajnima (vidjeti dio 4.2).
English: The mean t1/2 was approximately 7 hours for ticagrelor and 8.5 hours for the active metabolite.
Croatian: Srednji t1/2 je bio približno 7 sati za tikagrelor i 8,5 sati za aktivni metabolit.
English: Patients at risk for bradycardic events
Croatian: Bolesnici s rizikom od bradikardijskih događaja
English: What Brilique is and what it is used for
Croatian: Što je Brilique i za što se koristi
English: • You have severe liver disease.
Croatian: • ako imate tešku bolest jetre.
English: This magnitude of increased exposure is not expected to be clinically relevant to most patients.
Croatian: Ne očekuje se da je ova razina povećanog izlaganja klinički relevantna za većinu bolesnika.
English: Holter substudy:
Croatian: Podispitivanje Holter:
English: • Fainting (syncope) - a temporary loss of consciousness due to sudden drop in blood flow to the brain (common)
Croatian: • Nesvjestica (sinkopa) - privremeni gubitak svijesti zbog iznenadnog smanjenja dotoka krvi u mozak (često)
English: • Feeling dizzy or light-headed, or having blurred vision - these are signs of low blood pressure
Croatian: • Osjećaj omaglice ili ošamućenosti, ili zamućen vid - ovo su znakovi niskog krvnog tlaka
English: However, a link between the observed increases in adenosine and clinical outcomes (e.g. morbidity-mortality) has not been clearly elucidated.
Croatian: Međutim, veza između primijećenog porasta razine adenozina i kliničkih ishoda (npr. morbiditet-mortalitet) nije potpuno razjašnjena.
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire, SK10 2NA United Kingdom
Croatian: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire, SK10 2NA Ujedinjeno Kraljevstvo
English: The primary variable of interest was the occurrence of ventricular pauses ≥3 seconds.
Croatian: Primarna varijabla od interesa bila je pojava ventrikularnih stanki > 3 sekunde.
English: Dizziness, Syncope, Headache
Croatian: Omaglica, sinkopa, glavobolja
English: Brilique affects blood clotting, so most side effects are related to bleeding.
Croatian: Brilique utječe na zgrušavanje krvi, stoga je većina nuspojava povezana s krvarenjem.
English: Ticagrelor may be resumed after the cause of bleeding has been identified and controlled.
Croatian: S primjenom tikagrelora se može nastaviti nakon što se uzrok krvarenja otkrije i stavi pod kontrolu.
English: Table 4 - Analysis of primary and secondary efficacy endpoints (PLATO)
Croatian: Tablica 4 - Analiza primarnih i sekundarnih ishoda djelotvornosti (PLATO)
English: For patients who are unable to swallow the tablet(s) whole, the tablets can be crushed to a fine powder and mixed in half a glass of water and drunk immediately.
Croatian: Za bolesnike koji ne mogu progutati cijelu tabletu (tablete), tablete se mogu razmrviti u fini prašak i promiješati u pola čaše vode te odmah popiti.
English: PLATO study (Acute Coronary Syndromes)
Croatian: Studija PLATO (akutni koronarni sindromi)
English: • After this starting dose, the usual dose is one tablet of 90 mg twice a day for up to 12 months unless your doctor tells you differently.
Croatian: • Nakon ove početne doze uobičajena je doza jedna tableta od 90 mg dvaput na dan kroz najviše 12 mjeseci, osim ako Vam liječnik ne kaže drugačije.
English: • You have had a stroke caused by bleeding in the brain.
Croatian: • ako ste imali moždani udar izazvan krvarenjem u mozgu.
English: This is a substance present in many medicines used to prevent blood clotting.
Croatian: Ova je tvar prisutna u mnogim lijekovima koji sprječavaju zgrušavanje krvi.
English: The safety profile of ticagrelor has been evaluated in two large phase 3 outcome trials (PLATO and PEGASUS) including more than 39,000 patients (see section 5.1).
Croatian: Sigurnosni profil tikagrelora procijenjen je u dva velika ispitivanja ishoda faze 3 (PLATO i PEGASUS), uključujući više od 39 000 bolesnika (vidjeti dio 5.1).
English: • Bleeding into your joints and muscles causing painful swelling
Croatian: • Krvarenje u Vaše zglobove i mišiće koje uzrokuje bolno oticanje
English: The mechanism for uterine tumours is likely hormonal imbalance which can lead to tumours in rats.
Croatian: Mehanizam za tumore maternice je vjerojatno hormonalna neravnoteža koja može dovesti do tumora u štakora.