FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Brilique.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Brilique.
English: This is a summary of the European public assessment report (EPAR) for Brilique.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Brilique.
English: These are medicines such as ketoconazole (used to treat fungal infections), clarithromycin (an antibiotic), atazanavir and ritonavir (medicines used in HIV-positive patients) and nefazodone (used to treat depression).
Croatian: To su lijekovi kao što su ketokonazol (za liječenje gljivičnih infekcija), klaritromicin (antibiotik), atazanavir i ritonavir (lijekovi koji se primjenjuju za bolesnike koji su pozitivni na virus HIV) i nefazodon (za liječenje depresije).
English: The main measure of effectiveness for both studies was based on the number of patients having another heart attack, a stroke or dying from a cardiovascular disease.
Croatian: Glavna mjera učinkovitosti u oba ispitivanja temeljila se na broju bolesnika koji su imali ponovni srčani udar, moždani udar ili koji su umrli od kardiovaskularne bolesti.
English: Brilique was shown to be beneficial to patients who have had a heart attack or unstable angina.
Croatian: Brilique se pokazao korisnim za bolesnike koji su imali srčani udar ili nestabilnu anginu.
English: Ticagrelor stops the platelets aggregating by blocking the action of a substance called ADP when it attaches to the surface of the platelets.
Croatian: Tikagrelor zaustavlja nakupljanje trombocita sprečavajući djelovanje tvari koja se naziva ADP kada se ona vezuje za površinu trombocita.
English: Brilique is a medicine that contains the active substance ticagrelor.
Croatian: Brilique je lijek koji sadrži djelatnu tvar tikagrelor.
English: Brilique is used together with aspirin (acetylsalicylic acid) to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes.
Croatian: Brilique se koristi zajedno s aspirinom (acetilsalicilna kiselina) radi sprečavanja aterotrombotskih događaja (problema uzrokovanih krvnim ugrušcima i otvrdnućem arterija) kao što su srčani ili moždani udari.
English: The CHMP decided that Brilique's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Brilique nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent a stroke or another heart attack.
Croatian: To sprečava da trombociti postanu „ljepljivi”, čime se smanjuje rizik od stvaranja krvnih ugrušaka i pomaže u sprečavanju moždanog udara ili ponovnog srčanog udara.
English: For longer treatment, the dose of Brilique should be reduced to one 60-mg tablet twice a day.
Croatian: U slučaju dulje terapije, dozu lijeka Brilique treba smanjiti na jednu tabletu od 60 mg dvaput dnevno.
English: Patients took Brilique twice a day in a dose of either 60 mg or 90 mg.
Croatian: Bolesnici su uzimali Brilique dvaput dnevno u dozi od 60 ili 90 mg.
English: It is used in adults with acute coronary syndrome, a group of conditions in which blood flow in the vessels supplying the heart is blocked so heart tissue cannot work properly or dies, and which includes heart attack and unstable angina (a severe type of chest pain).
Croatian: Primjenjuje se u odraslih osoba s akutnim koronarnim sindromom, skupinom stanja pri kojima dolazi do prekida protoka krvi u žilama koje opskrbljuju srce zbog čega srčano tkivo ne može pravilno funkcionirati ili odumire i koje uključuju srčani udar i nestabilnu anginu (teški oblik boli u prsima).
English: Why has Brilique been approved?
Croatian: Zašto je lijek Brilique odobren?
English: For patients who have had a heart attack a year or more ago (but less than 2 years ago) and are at high risk of an atherothrombotic event, the dose of Brilique is one 60-mg tablet twice a day.
Croatian: Za bolesnike koji su imali srčani udar prije godinu ili više dana (ali prije manje od dvije godine) i kod kojih postoji velik rizik od pojave aterotrombotskog događaja, doza lijeka Brilique je jedna tableta od 60 mg dvaput dnevno.
English: The most common side effects with Brilique (seen in more than 1 patient in 10) are dyspnoea (difficulty breathing), bleeding and raised uric acid level in the blood.
Croatian: Najčešće nuspojave lijeka Brilique (mogu se javiti u više od 1 na 10 bolesnika) su dispneja (poteškoće u disanju), krvarenje i povećana razina mokraćne kiseline u krvi.
English: The patients also took aspirin and were treated for up to 3 years.
Croatian: Također su uzimali aspirin te su primali terapiju u vremenskom razdoblju do tri godine.
English: Brilique must not be used in patients who have severe liver disease or are currently bleeding, or in patients who have had bleeding within the brain.
Croatian: Brilique se ne smije primjenjivati u bolesnika s teškom bolesti jetre ili u bolesnika koji imaju krvarenje ili u bolesnika koji su imali krvarenje u mozgu.
English: The active substance in Brilique, ticagrelor, is an inhibitor of platelet aggregation.
Croatian: Djelatna tvar u lijeku Brilique, tikagrelor, jest inhibitor nakupljanja trombocita.
English: Brilique is also used in adults who had a heart attack a year or more ago and are at a high risk of an atherothrombotic event.
Croatian: Brilique se također primjenjuje u odraslih osoba koje su imale srčani udar prije godinu ili više dana i kod kojih postoji velik rizik od pojave aterotrombotskog događaja.
English: For patients with acute coronary syndrome, the starting dose of Brilique is two 90-mg tablets taken at once, followed by a regular dose of one 90-mg tablet twice a day.
Croatian: Za bolesnike s akutnim koronarnim sindromom, početna doza lijeka Brilique jest dvije tablete od 90 mg koje se uzimaju odjednom, nakon čega slijedi uzimanje redovite doze, odnosno jedne tablete od 90 mg dvaput dnevno.
English: The full EPAR for Brilique can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Brilique nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom Brilique pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In the first main study (in patients with acute coronary syndrome), 9.3% of the patients taking Brilique had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.
Croatian: U prvom glavnom ispitivanju (u bolesnika s akutnim koronarnim sindromom), 9,3 % bolesnika koji su uzimali lijek Brilique imalo je ponovni srčani udar, moždani udar ili je umrlo od kardiovaskularne bolesti u usporedbi s 10,9 % bolesnika koji su uzimali klopidogrel.
English: Brilique was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina.
Croatian: Lijek Brilique uspoređivan je s klopidogrelom (drugim inhibitorom nakupljanja trombocita) u glavnom ispitivanju koje je uključivalo više od 18 000 odraslih osoba koje su imale srčani udar ili nestabilnu anginu.
English: The CHMP considered that in patients with acute coronary artery syndrome, Brilique at a dose of 90 mg twice daily and given with aspirin, reduces the risk of atherothrombotic events such as heart attack, stroke and death from a cardiovascular event.
Croatian: CHMP je smatrao da primjena lijeka Brilique u dozi od 90 mg dvaput dnevno uz aspirin u bolesnika s akutnim koronarnim arterijskim sindromom smanjuje rizik od aterotrombotskih događaja kao što su srčani ili moždani udari ili smrt zbog kardiovaskularnih problema.
English: The patients also took aspirin and were treated for up to a year.
Croatian: Bolesnici su uzimali i aspirin te su primali terapiju u vremenskom razdoblju do godine dana.
English: Benefit regarding heart attack, stroke and death from a cardiovascular event has also been shown in patients who had a heart attack at least one year ago and have a high risk of an atherothrombotic event and a lower 60 mg dose twice daily dose is recommended for these patients.
Croatian: Koristi u pogledu sprečavanja srčanog ili moždanog udara ili smrti zbog kardiovaskularnih problema utvrđene su također u bolesnika koji su imali srčani udar prije barem godinu dana i kod kojih postoji velik rizik od pojave aterotrombotskog događaja i za te se bolesnike preporučuje manja doza od 60 mg dvaput dnevno.
English: In another main study, Brilique was compared with placebo (a dummy treatment) in over 21,000 adults who had a heart attack one to three years previously and were at high risk of an atherothrombotic event.
Croatian: U drugom glavnom ispitivanju, lijek Brilique uspoređivan je s placebom (prividnim lijekom) na više od 21 000 odraslih osoba koje su imale srčani udar jednu do tri godine ranije i kod kojih je postojao velik rizik od pojave aterotrombotskog događaja.
English: In the second main study (in patients with a history of the heart attack), 7.8% of patients taking Brilique 60 mg twice a day had another heart attack, stroke or died from cardiovascular disease compared with 9.0% of patients taking placebo.
Croatian: U drugom glavnom ispitivanju (u bolesnika koji su u prošlosti imali srčani udar), 7,8 % bolesnika koji su uzimali lijek Brilique u dozi od 60 mg dvaput dnevno imalo je ponovni srčani udar, moždani udar ili je umrlo od kardiovaskularne bolesti u usporedbi s 9,0 % bolesnika koji su uzimali placebo.
English: When the blood clots, this is due to cell fragments in the blood called platelets aggregating (sticking together).
Croatian: Krvni se ugrušci stvaraju zbog nakupljanja (povezivanja) dijelova stanica u krvi koji se nazivaju trombociti.
English: What benefit has Brilique shown during the studies?
Croatian: Koje su koristi lijeka Brilique dokazane u ispitivanjima?
English: What is Brilique used for?
Croatian: Za što se Brilique koristi?
English: How does Brilique work?
Croatian: Kako djeluje Brilique?
English: How is Brilique used?
Croatian: Kako se Brilique koristi?
English: For the full list of restrictions with Brilique, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Brilique potražite u uputi o lijeku.
English: For the full list of all side effects reported with Brilique, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Brilique potražite u uputi o lijeku.
English: How has Brilique been studied?
Croatian: Kako je lijek Brilique ispitivan?
English: It is available as tablets (75 mg).
Croatian: Dostupan je u obliku tableta (75 mg).
English: Previously known as Zylagren
Croatian: Prethodno poznat kao Zylargen
English: This summary was last updated in 10-2014.
Croatian: Sažetak je posljednji put ažuriran u 10.2014.
English: • patients who have recently had a myocardial infarction (heart attack).
Croatian: • bolesnicima koji su nedavno doživjeli infarkt miokarda (srčani udar).
English: The full EPAR for Clopidogrel BGR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o ocjeni dokumentacije za lijek Clopidogrel BGR (EPAR) nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Croatian: To sprječava da trombociti postanu „ljepljivi”, smanjujući rizik od nastanka ugruška i pomažući u sprječavanju drugog srčanog ili moždanog udara.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zylagren on 21 September 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Zylargen vrijedi na prostoru Europske unije od 21. rujna 2009.
English: The standard dose of Clopidogrel BGR is one 75 mg tablet once a day.
Croatian: Uobičajena doza lijeka Clopidogrel BGR je jedna tableta od 75 mg jednom na dan.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Croatian: • bolesnicima s perifernom bolešću arterija (problemima s protokom krvi u arterijama);
English: This means that Clopidogrel BGR is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Croatian: To znači da je Clopidogrel BGR sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Plavix.
English: Clopidogrel BGR is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Croatian: Clopidogrel BGR koristi se u odraslih za sprječavanje aterotrombotičkih događaja (problema uzrokovanih krvnim ugrušcima i otvrdnućem arterija).
English: For more information about treatment with Clopidogrel BGR, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Clopidogrel BGR pročitajte u uputama o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Clopidogrel BGR can be given to the following groups of patients:
Croatian: Clopidogrel BGR može se davati sljedećim skupinama bolesnika:
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel BGR.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Clopidogrel BGR.
English: • patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Croatian: • bolesnicima koji su nedavno doživjeli ishemijski udar (moždani udar uzrokovan zatajenjem dotoka krvi u dio mozga).
English: Clopidogrel BGR can be started between a few days and 35 days after the attack;
Croatian: Terapija lijekom Clopidogrel BGR može započeti između nekoliko dana i 35 dana nakon srčanog udara;
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Croatian: Klopidogrel zaustavlja agregaciju trombocita sprječavajući da se tvar ADP pričvrsti na poseban receptor na njihovoj površini.
English: Because Clopidogrel BGR is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Croatian: Budući da je Clopidogrel BGR generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Clopidogrel BGR can be started between seven days and six months after the stroke;
Croatian: Terapija lijekom Clopidogrel BGR može započeti između sedam dana i šest mjeseci nakon moždanog udara;
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Croatian: Do zgrušavanja krvi dolazi zato jer se posebne stanice u krvi zvane trombociti agregiraju (sljepljuju u nakupine).
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel BGR has been shown to have comparable quality and to be bioequivalent to Plavix.
Croatian: CHMP je zaključio kako, u skladu sa zahtjevima EU-a, lijek Clopidogrel BGR posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Plavix.
English: Clopidogrel BGR is a ‘generic medicine'.
Croatian: Clopidogrel BGR je „generički lijek”.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel BGR.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek Clopidogrel BGR da bi preporučio njegovo odobrenje za stavljanje u promet te uvjete za njegovu primjenu.
English: Because Clopidogrel BGR is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Croatian: Budući da je Clopidogrel BGR generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje je li lijek bioekvivalentan referentnom lijeku Plavix.
English: Other information about Clopidogrel BGR
Croatian: Ostale informacije o lijeku Clopidogrel BGR
English: The Committee recommended that Clopidogrel BGR be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Clopidogrel BGR.
English: What are the benefits and risks of Clopidogrel BGR?
Croatian: Koje su koristi i rizici lijeka Clopidogrel BGR?
English: The active substance in Clopidogrel BGR, clopidogrel, is an inhibitor of platelet aggregation.
Croatian: Djelatna tvar u lijeku Clopidogrel BGR, klopidogrel, inhibitor je agregacije trombocita.
English: Clopidogrel BGR is a medicine that contains the active substance clopidogrel.
Croatian: Clopidogrel BGR je lijek koji sadrži djelatnu tvar klopidogrel.
English: What is Clopidogrel BGR?
Croatian: Što je Clopidogrel BGR?
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Plavix.
English: The name of the medicine was changed to Clopidogrel BGR on 14 July 2014.
Croatian: Ime lijeka promijenjeno je u Clopidogrel
English: What is Clopidogrel BGR used for?
Croatian: Za što se Clopidogrel BGR koristi?
English: How is Clopidogrel BGR used?
Croatian: Kako se Clopidogrel BGR koristi?
English: Why has Clopidogrel BGR been approved?
Croatian: Za što je lijek Clopidogrel BGR odobren?
English: How has Clopidogrel BGR been studied?
Croatian: Kako je Clopidogrel BGR ispitivan?
English: How does Clopidogrel BGR work?
Croatian: Kako djeluje Clopidogrel BGR?
English: The available medical guidelines should also be taken into account.
Croatian: U obzir se također moraju uzeti dostupne medicinske smjernice.
English: What Kineret is and what it is used for
Croatian: Što je Kineret i za što se koristi
English: Equipment:
Croatian: Oprema:
English: RA: Adults
Croatian: RA: Odrasli
English: Elderly population (≥ 65 years)
Croatian: Starija populacija (≥ 65 godina)
English: (Your doctor will have told you what dose you need to use.)
Croatian: (Vaš liječnik Vam je rekao koju dozu morate primjenjivati.)
English: Do not use Kineret if you think it has been frozen.
Croatian: Ne upotrebljavajte Kineret ako mislite da je bio zamrznut.
English: Do not warm Kineret in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Kineret na bilo koji drugi način (npr. nemojte ga zagrijavati u mikrovalnoj pećnici ili u vrućoj vodi).
English: A risk to the newborns/ infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče.
English: Paediatric population (< 18 years)
Croatian: Pedijatrijska populacija (<18 godina)
English: Contact your doctor immediately
Croatian: Odmah se obratite svom liječniku
English: No data are available in children under the age of 8 months.
Croatian: Nema dostupnih podataka za djecu mlađu od 8 mjeseci.
English: Check the appearance of Kineret.
Croatian: Provjerite izgled Kinereta.
English: Pfizer Health AB Mariefredsvägen 37 SE-645 41 Strängnäs Sweden
Croatian: Pfizer Health AB Mariefredsvägen 37 SE-645 41 Strängnäs Švedska
English: You should have no serious problems if you accidentally take more Kineret than you need.
Croatian: Ne biste trebali imati ozbiljnih problema ako slučajno primijenite više Kinereta nego što ste trebali.
English: If any of the following happen, tell your doctor immediately:
Croatian: Ako se dogodi bilo što od sljedećeg, odmah obavijestite svog liječnika:
English: Your doctor will discuss with you the potential risks of taking Kineret during pregnancy.
Croatian: Liječnik će razgovarati s Vama o mogućim rizicima uzimanja Kinereta tijekom trudnoće.
English: Distribution into the cerebrospinal fluid has been demonstrated.
Croatian: Dokazana je distribucija u cerebrospinalnu tekućinu.
English: No overall differences in safety or effectiveness were observed between these patients and younger patients.
Croatian: Nije primijećena ukupna razlika u sigurnosti ili djelotvornosti između ovih bolesnika i mlađih bolesnika.
English: No data are available on LDL or HDL cholesterol.
Croatian: Nema podataka o LDL i HDL kolesterolu.
English: Your doctor will tell you the dose that you need or whether you need a dose higher than 100 mg.
Croatian: Vaš će Vam liječnik reći koju dozu trebate i je li Vam potrebna doza veća od 100 mg.
English: If someone else is injecting for you, they can also use the back of your arms.
Croatian: Ako Vam netko drugi daje injekciju, može koristiti i stražnju stranu
English: The instructions for use and handling are given in section 6.6.
Croatian: Upute za uporabu i rukovanje nalaze se u dijelu 6.6.
English: Other anti-rheumatic therapies have been associated with hepatitis B reactivation.
Croatian: Druge antireumatske terapije povezane su reaktivacijom hepatitisa B.
English: It is important to tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby.
Croatian: Važno je da kažete liječniku ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Croatian: Nađite udobnu, dobro osvijetljenu i čistu površinu te stavite svu opremu koju trebate na dohvat ruke.
English: No dose adjustment is required based on age or gender.
Croatian: Nije potrebna prilagodba doze na temelju dobi i spola.
English: • Do not put the cover back on used needles.
Croatian: • Nemojte stavljati pokrov natrag na korištene igle.
English: Date of first authorisation: 8 March 2002 Date of latest renewal: 20 March 2007
Croatian: Datum posljednje obnove odobrenja: 20. ožujka 2007.
English: The most suitable places to inject yourself or your child are (See Figure D):
Croatian: Najprikladnija mjesta na kojima sebi ili svom djetetu možete dati injekciju su (Pogledajte sliku D):
English: • the abdomen (except for the area around the navel)
Croatian: • trbuh (osim područja oko pupka)
English: Decreased acute phase protein levels are noted within the first weeks of treatment.
Croatian: Smanjene razine proteina akutne faze primijećene su u prvim tjednima liječenja.
English: Your doctor or nurse will show you how to inject yourself.
Croatian: Vaš liječnik ili medicinska sestra pokazat će Vam kako da sami sebi injicirate lijek.
English: Anakinra is produced by DNA technology using the micro-organism E. coli.
Croatian: Anakinra se proizvodi DNK tehnologijom pomoću mikroorganizma E. coli.
English: If you use more Kineret than you should
Croatian: Ako primijenite više Kinereta nego što ste trebali
English: Do not reuse a syringe as this can cause infection.
Croatian: Nemojte ponovno upotrebljavati štrcaljku jer to može uzrokovati infekciju.
English: EU/1/02/203/005 - 1-pack EU/1/02/203/006 - 7-pack EU/1/02/203/007 - 28-pack
Croatian: EU/1/02/203/005 - pakiranje od 1 EU/1/02/203/006 - pakiranje od 7 EU/1/02/203/007 - pakiranje od 28
English: However, any of the following symptoms may indicate an allergic reaction to Kineret, so you should seek immediate medical attention.
Croatian: Međutim, bilo koji od sljedećih simptoma mogu ukazivati na alergijsku reakciju na Kineret pa trebate odmah potražiti liječničku pomoć.
English: • A description of the signs of serious infections
Croatian: • Opis znakova ozbiljnih infekcija