FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic Impairment
Croatian: Krvožilni poremećaji
English: Vascular disorders
Croatian: Nepoznato - trombocitopenija
English: MARKETING AUTHORISATION HOLDER To be completed nationally 8.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Ispunjava država članica
English: Hepatobiliary disorders
Croatian: Inhalacijski anestetici
English: Excretion
Croatian: OBLIK
English: Reduction in blood platelets, which may increase the risk of bleeding or bruising Slow heart rhythm
Croatian: smanjenje broja trombocita u krvi, što može povećati rizik od krvarenja ili nastanka modrica usporeni srčani ritam bol u prsnom košu problemi sa srcem koji uzrokuju nakupljanje tekućine u plućima i nedostatak zraka bol u trbuhu crvenilo kože upala vene na mjestu primjene lijeka promjene u nalazima krvnih pretraga funkcije jetre
English: Patients with Stroke
Croatian: Bolesnici s moždanim udarom
English: Do not take Nicardipine solution for injection
Croatian: Nikardipin otopine za injekciju.
English: Management
Croatian: Učestalost
English: How to take Nicardipine solution for injection
Croatian: Nikardipin otopinu za injekciju Kako uzimati
English: - Dantrolene (used to treat long-term muscle stiffness) - Beta-blockers (used to treat high blood pressure and heart conditions) such as propranolol, atenolol and metoprolol - Medicines used to control seizures, such as carbamazepine , phenobarbitone, primidone and phenytoin - Baclofen (used to treat muscle spasms) - Medicines used to control the body's immune system, such as tacrolimus, sirolimus and ciclosporin - Itraconazole (used to treat certain types of fungal infection) - Rifampicin (used to treat tuberculosis and certain other types of infection) - Alpha-blockers (used to treat high blood pressure, or prostate problems in men) such as doxazosin,
Croatian: - dantrolen (primjenjuje se za liječenje dugotrajne ukočenosti mišića) - beta-blokatori (primjenjuju se za liječenje visokog krvnog tlaka i bolesti srca) poput propranolola,
English: Esbriet pirfenidone
Croatian: Esbriet pirfenidon
English: The CHMP also noted the lack of effective alternative treatments.
Croatian: CHMP je također naglasio nedostatak djelotvornih alternativnih vrsta liječenja.
English: The first study also found Esbriet to be most effective at the higher dose.
Croatian: Prvo ispitivanje također je pokazalo da je lijek Esbriet najučinkovitiji u višoj dozi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Esbriet on 28 February 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Esbriet na snazi u Europskoj uniji od 28. veljače 2011.
English: What measures are being taken to ensure the safe and effective use of Esbriet?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Esbriet?
English: Other information about Esbriet
Croatian: Ostale informacije o lijeku Esbriet
English: Esbriet is available as capsules (267 mg) and tablets (267, 534 and 801 mg) that are taken at mealtimes.
Croatian: Lijek Esbriet dostupan je u obliku kapsula (267 mg) i tableta (267, 534 i 801 mg) koje su uzimaju uz obrok.
English: Patients who have side effects such as stomach problems, skin reactions to light or significant changes in the levels of liver enzymes may need to take a lower dose at least temporarily.
Croatian: U bolesnika kod kojih se razviju nuspojave poput želučanih problema, kožnih reakcija na svjetlost ili znatnih promjena razine jetrenih enzima možda će biti potrebno barem privremeno smanjiti dozu.
English: This is a summary of the European public assessment report (EPAR) for Esbriet.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Esbriet.
English: What is Esbriet and what is it used for?
Croatian: Što je Esbriet i za što se koristi?
English: The dose of Esbriet is increased steadily, starting with 267 mg three times a day in the first week, 534 mg three times a day in the second week and 801 mg three times a day from the third week onwards.
Croatian: Doza lijeka Esbriet kontinuirano se povećava, počevši s 267 mg tri puta dnevno tijekom prvog tjedna, na 534 mg tri puta dnevno tijekom drugog tjedna te na 801 mg tri puta dnevno od trećeg tjedna nadalje.
English: The first study also compared two doses of Esbriet (399 mg and 801 mg three times a day).
Croatian: U prvom ispitivanju uspoređene su i dvije doze lijeka Esbriet (399 mg i 801 mg tri puta dnevno).
English: FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath, which decreases as the condition gets worse.
Croatian: FVC predstavlja maksimalnu količinu zraka koju bolesnik može forsirano izdahnuti nakon što duboko udahne, a smanjuje se kako se stanje pogoršava.
English: In both studies, the main measure of effectiveness was the change in the functioning of the patients' lungs after 72 weeks of treatment, measured by their ‘forced vital capacity' (FVC).
Croatian: U oba ispitivanja glavna mjera djelotvornosti bila je promjena u plućnoj funkciji bolesnika nakon 72 tjedna liječenja, mjereno „forsiranim vitalnim kapacitetom” (FVC).
English: The full EPAR for Esbriet can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Esbriet nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For more information about treatment with Esbriet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Esbriet pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Because the number of patients with IPF is low, the disease is considered ‘rare', and Esbriet was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 November 2004.
Croatian: Budući da je broj bolesnika s IPF-om nizak, ta se bolest smatra „rijetkom” te je lijek Esbriet uvršten u skupinu lijekova za rijetke bolesti od 16. studenoga 2004.
English: The company must also ensure that all doctors who are expected to prescribe Esbriet are provided with information material containing safety information on liver function and light-sensitive reactions.
Croatian: Proizvođač također mora osigurati da se svim liječnicima za koje se očekuje da će propisivati lijek Esbriet dostave informativni materijali koji sadržavaju sigurnosne informacije o jetrenoj funkciji i reakcijama fotoosjetljivosti.
English: What are the risks associated with Esbriet?
Croatian: Koji su rizici povezani s lijekom Esbriet?
English: The most common side effects with Esbriet during clinical studies were nausea (feeling sick), rash, tiredness, diarrhoea, dyspepsia (heartburn), loss of appetite, headache and photosensitivity reactions (sunburn-like reactions following exposure to light).
Croatian: Najčešće nuspojave lijeka Esbriet tijekom kliničkih ispitivanja bile su mučnina, osip, umor, proljev, dispepsija (žgaravica), gubitak apetita, glavobolja i fotoosjetljivost (reakcije nalik opekotinama od sunca nakon izlaganja svjetlosti).
English: The higher dose results from the first study, combined with the results of the second study (which involved the same higher dose), showed that the average reduction in FVC was 8.5% for patients taking Esbriet compared with 11% for patients taking placebo.
Croatian: Rezultati prvog ispitivanja u višoj dozi, promatrani zajedno s rezultatima drugog ispitivanja (u jednakoj višoj dozi), pokazali su da je prosječno smanjenje FVC-a bilo 8,5 % u bolesnika koji su uzimali lijek Esbriet, u usporedbi s 11 % u bolesnika koji su uzimali placebo.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Esbriet can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Esbriet dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: Esbriet can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of IPF.
Croatian: Lijek Esbriet izdaje se samo na recept, a liječenje treba započeti i nadzirati liječnik iskusan u dijagnosticiranju i liječenju IPF-a.
English: Esbriet must not be used by patients already taking fluvoxamine (a medicine used to treat depression and obsessive compulsive disorder) or patients with severe liver or kidney problems.
Croatian: Lijek Esbriet ne smiju uzimati bolesnici koji već uzimaju fluvoksamin (lijek koji se primjenjuje u liječenju depresije i opsesivno-kompulzivnog poremećaja) niti bolesnici s ozbiljnim jetrenim ili bubrežnim problemima.
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 Esbriet.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke za primjenu lijeka Esbriet.
English: Why is Esbriet approved?
Croatian: Zašto je lijek Esbriet odobren?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that Esbriet has been shown to slow down the progression of IPF, as measured by FVC, without serious risks for patients.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da je dokazano kako lijek Esbriet usporava napredovanje IPF-a, izmjereno FVC-om, bez ozbiljnih rizika za bolesnike.
English: The mechanism of action of pirfenidone, the active substance in Esbriet, is not fully understood but it has been shown to reduce the production of fibroblasts and other substances involved in the formation of fibrous tissue during the body's tissue repair process, thereby slowing down the progression of the disease in IPF patients.
Croatian: Mehanizam djelovanja pirfenidona, djelatne tvari u lijeku Esbriet, nije potpuno jasan, no dokazano je da smanjuje stvaranje fibroblasta i ostalih tvari koje sudjeluju u stvaranju fibroznog tkiva tijekom procesa zacjeljivanja tkiva, čime usporava napredovanje bolesti u bolesnika s IPF-om.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Esbriet 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 Esbriet također se nalaze u sažetku opisa svojstava i uputi o lijeku.
English: It therefore decided that Esbriet's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Stoga je odlučio da koristi od lijeka Esbriet nadmašuju s njim povezane rizike te je preporučio davanje odobrenja za stavljanje lijeka u promet.
English: Esbriet is a medicine used to treat adults with mild to moderate idiopathic pulmonary fibrosis (IPF).
Croatian: Esbriet je lijek za liječenje odraslih osoba s blagim do umjereno teškim oblikom idiopatske plućne fibroze (IPF).
English: What benefits of Esbriet have been shown in studies?
Croatian: Koje su koristi lijeka Esbriet dokazane u ispitivanjima?
English: How does Esbriet work?
Croatian: Kako djeluje Esbriet?
English: In the first study, the patients taking Esbriet had a smaller reduction in FVC after 72 weeks than the patients taking placebo.
Croatian: Tijekom prvog ispitivanja u bolesnika koju su primali lijek Esbriet smanjenje FVC-a nakon 72 tjedna bilo je manje negoli u bolesnika koji su primali placebo.
English: How is Esbriet used?
Croatian: Kako se Esbriet koristi?
English: Esbriet contains the active substance pirfenidone.
Croatian: Esbriet sadrži djelatnu tvar pirfenidon.
English: The company that makes Esbriet has set up a post-authorisation safety study in order to collect additional information on patients prescribed Esbriet and suspected side effects.
Croatian: Proizvođač lijeka Esbriet proveo je ispitivanje o sigurnoj primjeni lijeka nakon davanja odobrenja kako bi se prikupile dodatne informacije o bolesnicima kojima se propisuje lijek Esbriet i nuspojavama na koje se sumnja.
English: IPF is a long-term disease in which fibrous scar tissue continuously forms in the lungs, causing persistent cough, frequent lung infections and severe shortness of breath.
Croatian: Idiopatska plućna fibroza kronična je bolest kod koje se u plućima neprestano stvara tvrdo fibrozno tkivo, što uzrokuje tvrdokoran kašalj, učestale infekcije pluća i tešku zadihanost. „Idiopatska” znači da uzrok bolesti nije poznat.
English: For the full list of all side effects reported with Esbriet, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Esbriet potražite u uputi o lijeku.
English: Esbriet was more effective than placebo (a dummy treatment) at slowing down the worsening of lung function in two main studies involving a total of 779 IPF patients.
Croatian: U dvama glavnim ispitivanjima koja su obuhvatila 779 bolesnika s IPF-om lijek Esbriet bio je djelotvorniji od placeba (prividnog liječenja) u usporavanju slabljenja funkcije pluća.
English: Further information on Trelegy Ellipta can be found on the Agency's website: ema.europa.eu/ medicines/Human/EPAR/Trelegy-Ellipta.
Croatian: Više informacija o lijeku Trelegy Ellipta možete naći na internetskim stranicama Agencije: ema.europa.eu/ medicines/Human/EPAR/Trelegy-Ellipta.
English: It is available as an inhalation powder, which the patient inhales through the mouth using a portable inhaler device; the patient should inhale the medicine once a day at around the same time each day.
Croatian: Dostupan je kao prašak inhalata, koji bolesnik inhalira na usta s pomoću prijenosnog inhalatora; bolesnik treba inhalirati lijek jednom dnevno u isto vrijeme.
English: Fluticasone furoate is a corticosteroid.
Croatian: Flutikazonfuroat je kortikosteroid.
English: More serious side effects include pneumonia (which may affect up to 1 in 10 people).
Croatian: Teže nuspojave uključuju upalu pluća (koja se može javiti u najviše 1 na 10 osoba).
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors (targets) in various types of immune cells.
Croatian: Djeluje na sličan način kao prirodni kortikosteroidni hormoni, tj. smanjuje aktivnost imunosnog sustava spajanjem na receptore (ciljna mjesta) u raznim vrstama imunosnih stanica.
English: Trelegy Ellipta is used for maintenance (regular) treatment on a daily basis.
Croatian: Trelegy Ellipta primjenjuje se za (redovnu) terapiju održavanja na svakodnevnoj osnovi.
English: Vilanterol is a long-acting beta-2 agonist.
Croatian: Vilanterol je dugodjelujući beta-2 agonist.
English: After 24 weeks, patients taking Trelegy Ellipta had their FEV1 (the maximum volume of air they could breathe out in one second) improve by 142 ml.
Croatian: Nakon 24 tjedna kod bolesnika koji su uzimali lijek Trelegy Ellipta došlo je do poboljšanja vrijednosti FEV1 (najveće količine zraka koju mogu izdahnuti u jednoj sekundi) za 142 ml.
English: Trelegy Ellipta received a marketing authorisation valid throughout the EU on 15 November 2017.
Croatian: Lijek Trelegy Ellipta dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 15. studenoga 2017.
English: This compares with an average reduction of 29 ml seen in patients taking the combination of budesonide and formoterol over the same period.
Croatian: To je usporedivo s prosječnim smanjenjem od 29 ml uočenim u bolesnika koji su tijekom istog razdoblja uzimali kombinaciju budezonida i formoterola.
English: Trelegy Ellipta (fluticasone furoate / umeclidinium bromide / vilanterol)
Croatian: Trelegy Ellipta (flutikazonfuroat / umeklidinijev bromid / vilanterol)
English: The most common side effects with Trelegy Ellipta (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache and upper respiratory tract infection (nose and throat infection).
Croatian: Najčešće nuspojave lijeka Trelegy Ellipta (koje se mogu javiti u najviše 1 na 10 osoba) jesu nazofaringitis (upala nosa i grla), glavobolja i infekcija gornjeg dišnog sustava (infekcija nosa i grla).
English: It works by blocking muscarinic receptors, which are involved in the contraction of muscles.
Croatian: Djeluje tako da blokira muskarinske receptore, koji sudjeluju u kontrakciji mišića.
English: For more information about using Trelegy Ellipta, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Trelegy Ellipta pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Umeclidinium bromide is a muscarinic receptor antagonist.
Croatian: Umeklidinijev bromid je antagonist muskarinskih receptora.
English: What measures are being taken to ensure the safe and effective use of Trelegy Ellipta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Trelegy Ellipta?
English: Regarding the safety profile of the medicine, the most frequent side effects reported with Trelegy Ellipta were similar to those with the individual active substances of the medicine and are well known.
Croatian: Što se tiče sigurnosnog profila lijeka, najčešće nuspojave prijavljene prilikom primjene lijeka Trelegy Ellipta bile su slične nuspojavama koje se javljaju prilikom primjene pojedinačnih djelatnih tvari lijeka i dobro su poznate.
English: It contains the active substances fluticasone furoate, umeclidinium bromide and vilanterol.
Croatian: Sadržava djelatne tvari flutikazonfuroat, umeklidinijev bromid i vilanterol.
English: This overview was last updated in 10-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 10.
English: It works by attaching to beta-2 receptors in some types of muscle cells.
Croatian: Djeluje na način da se spaja na beta-2 receptore u određenim vrstama mišićnih stanica.
English: Side effects reported with Trelegy Ellipta are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Trelegy Ellipta pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What is Trelegy Ellipta and what is it used for?
Croatian: Što je Trelegy Ellipta i za što se koristi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trelegy Ellipta 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 Trelegy Ellipta nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: In this study, Trelegy Ellipta reduced the rate of moderate and severe exacerbations over one year by 15% compared with treatment with vilanterol and fluticasone furoate, and by 25% compared with treatment with vilanterol and umeclidinium bromide.
Croatian: U tom se ispitivanju lijekom Trelegy Ellipta za 15 % smanjila stopa umjerenih i teških pogoršanja tijekom godine dana u usporedbi s vilanterolom i flutikazonfuroatom te za 25 % u usporedbi s liječenjem vilanterolom i umeklidinijevim bromidom.
English: Trelegy Ellipta is used in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a longacting muscarinic antagonist.
Croatian: Trelegy Ellipta se primjenjuje u odraslih osoba čija bolest nije dovoljno kontrolirana kombinacijom inhaliranih lijekova koji se sastoje od dugodjelujućeg beta-2 agonista uz primjenu kortikosteroida ili dugodjelujućeg muskarinskog antagonista.
English: Long-acting beta-2 agonists widen the airways; corticosteroids reduce inflammation in the airways and lungs; and muscarinic receptor antagonists cause the muscles of the airways to relax.
Croatian: Dugodjelujući beta-2 agonisti proširuju dišne putove, a kortikosteroidi smanjuju upalu u dišnim putovima i plućima, dok antagonisti muskarinskih receptora uzrokuju opuštanje mišića dišnih putova.
English: The European Medicines Agency therefore decided that Trelegy Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Trelegy Ellipta nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Other information about Trelegy Ellipta
Croatian: Ostale informacije o lijeku Trelegy Ellipta
English: As for all medicines, data on the use of Trelegy Ellipta are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Trelegy Ellipta kontinuirano se prate.
English: Trelegy Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Croatian: Trelegy Ellipta je lijek kojim se ublažavaju simptomi umjerene do teške kronične opstruktivne plućne bolesti (KOPB).
English: When inhaled, vilanterol activates the beta-2 receptors in the airways.
Croatian: Prilikom inhalacije vilanterol aktivira beta-2 receptore u dišnim putevima.
English: An overview of Trelegy Ellipta and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Trelegy Ellipta i zašto je odobren u EU-u
English: Patients treated with Trelegy Ellipta also reported improved health compared with those treated with the comparator treatment.
Croatian: Kod bolesnika liječenih lijekom Trelegy Ellipta također je zabilježeno poboljšanje zdravstvenog stanja u usporedbi s bolesnicima liječenima usporednim lijekom.
English: Why is Trelegy Ellipta authorised in the EU?
Croatian: Zašto je lijek Trelegy Ellipta odobren u EU-u?
English: What are the risks associated with Trelegy Ellipta?
Croatian: Koji su rizici povezani s lijekom Trelegy Ellipta?
English: Trelegy Ellipta contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.
Croatian: Trelegy Ellipta sadržava tri djelatne tvari, koje različito djeluju kako bi proširile dišne puteve i poboljšale disanje u bolesnika s KOPB-om.
English: Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Trelegy Ellipta more effective at improving patients' breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.
Croatian: Glavnim ispitivanjem, koje je obuhvatilo 1 810 bolesnika kod kojih KOPB nije zadovoljavajuće kontroliran dnevnom terapijom održavanja za KOPB, utvrđeno je da je lijek Trelegy Ellipta učinkovitiji u poboljšanju disanja bolesnika od inhalirane kombinacije kortikosteroida budezonida i dugodjelujućeg beta-2 agonista formoterola.
English: When umeclidinium bromide is inhaled, it causes the muscles of the airways to relax.
Croatian: Prilikom inhalacije umeklidinijeva bromida dolazi do opuštanja mišića dišnih puteva.
English: This reduces the release of substances involved in the inflammation process, such as histamine, thereby reducing inflammation and helping to keep the airways clear and allowing the patient to breathe more easily.
Croatian: Time se smanjuje otpuštanje tvari koje sudjeluju u procesu upale, kao što je histamin, čime se smanjuje upala, dišni putovi drže se prohodnima i bolesnik lakše diše.
English: Trelegy Ellipta can only be obtained with a prescription.
Croatian: Lijek Trelegy Ellipta izdaje se samo na liječnički recept.
English: For the full list of side effects and restrictions with Trelegy Ellipta, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Trelegy Ellipta potražite u uputi o lijeku.
English: How is Trelegy Ellipta used?
Croatian: Kako se Trelegy Ellipta koristi?