FrancophonIA/ELRC3.0 huggingface dataset:
English: Study TRILOGY compared Trydonis with a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily (1,368 randomised patients).
Croatian: U ispitivanju TRILOGY, Trydonis se uspoređivao s fiksnom kombinacijom beklometazondipropionata i formoterola 100/6 mikrograma primijenjenom u dva udaha dvaput na dan (1368 randomiziranih bolesnika).
English: In repeat dose inhalation studies with Trydonis in rats and dogs of up to 13 weeks duration, the main observed alterations were related to effects on the immune system (probably due to systemic corticosteroid effects of beclometasone dipropionate and its active metabolite beclometasone17-monopropionate) and on the cardiovascular system (probably related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium).
Croatian: 13 tjedana glavne uočene promjene bile su povezane s učincima na imunosni sustav (vjerojatno zbog sistemskih kortikosteroidnih učinaka beklometazondipropionata i njegovog aktivnog metabolita beklometazon 17-monopropionata) i kardiovaskularni sustav (vjerojatno povezanima s beta-2
English: No differences were observed when comparing Trydonis with the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (moderate/severe exacerbation rate: 0.46 versus 0.45 events per patient/year).
Croatian: Trydonis uspoređivao s ex tempore trostrukom fiksnom kombinacijom beklometazondipropionata i formoterola uz tiotropij (stopa umjerenih/teških egzacerbacija: 0,46 naspram 0,45 događaja po bolesniku godišnje).
English: Package leaflet: Information for the user Trydonis 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Croatian: Uputa o lijeku: Informacije za korisnika Trydonis 87 mikrograma/5 mikrograma/9 mikrograma stlačeni inhalat, otopina beklometazondipropionat/formoterolfumarat dihidrat/glikopironij
English: TRISTAR was a 26-week active-controlled open label study comparing Trydonis with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Croatian: TRISTAR je bilo aktivno kontrolirano otvoreno ispitivanje u trajanju od 26 tjedana u kojem se Trydonis uspoređivao s ex tempore fiksnom kombinacijom flutikazona/vilanterola od 92/22 mikrograma u obliku praška inhalata, primijenjenom kao jedan udah jedanput na dan, u kombinaciji s tiotropijem od 18 mikrograma u obliku praška inhalata, u tvrdim kapsulama, primijenjenim kao jedan udah jedanput na dan (u 1157 randomiziranih bolesnika).
English: TRIBUTE was a 52-week activecontrolled study comparing Trydonis with a fixed combination of indacaterol/glycopyrronium 85/43 micrograms inhalation powder, hard capsule, one inhalation once daily (1,532 randomised patients).
Croatian: TRIBUTE je bilo aktivno kontrolirano ispitivanje u trajanju od 52 tjedna u kojem se Trydonis uspoređivao s fiksnom kombinacijom indakaterola/glikopironija od 85/43 mikrograma u obliku praška inhalata, u tvrdim kapsulama, primijenjenom kao jedan udah jedanput na dan (u 1532 randomizirana bolesnika).
English: The study compared data obtained after treatment with a single dose of Trydonis (4 inhalations of 100/6/25 micrograms, a non-marketed formulation containing twice the approved strength of glycopyrronium) or a single dose of the extemporary combination of beclometasone dipropionate/formoterol (4 inhalations of 100/6 micrograms) plus glycopyrronium (4 inhalations of 25 micrograms).
Croatian: formulacija koja sadrži dvostruko veću jačinu glikopironija od odobrene i koja nije na tržištu) ili jednom dozom ex tempore kombinacije beklometazondipropionat/formoterol (4 udaha od 100/6 mikrograma) plus glikopironij (4 udaha od 25 mikrograma).
English: Immediate hypersensitivity reactions have been reported after administration of Trydonis.
Croatian: Nakon primjene lijeka Trydonis zabilježene su rane reakcije preosjetljivosti.
English: Compared with a fixed combination of indacaterol and glycopyrronium, Trydonis reduced the rate of moderate/severe exacerbations over 52 weeks by 15% (rate: 0.50 versus 0.59 events per patient/year; p = 0.043).
Croatian: U usporedbi s fiksnom kombinacijom indakaterola i glikopironija, Trydonis je smanjio stopu umjerenih/teških egzacerbacija tijekom 52 tjedna za 15 % (stopa: 0,50 naspram 0,59 događaja po bolesniku godišnje; p = 0,043).
English: Trydonis 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Croatian: Trydonis 87/5/9 mikrograma stlačeni inhalat, otopina beklometazondipropionat/formoterolfumarat dihidrat/glikopironij
English: Caution is also required when Trydonis is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia.
Croatian: Oprez je potreban i kad Trydonis primjenjuju bolesnici s tireotoksikozom, šećernom bolešću,
English: If you have or have had any medical problems or any allergies or if you are not sure if you can use Trydonis, talk to your doctor or pharmacist before using the inhaler.
Croatian: Ako imate ili ste imali neke zdravstvene tegobe ili alergije ili niste sigurni smijete li primjenjivati
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trydonis reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005).
Croatian: U usporedbi s fiksnom kombinacijom beklometazondipropionata i formoterola, Trydonis je smanjio stopu umjerenih/teških egzacerbacija tijekom 52 tjedna za 23 % (stopa: 0,41 naspram 0,53 događaja po bolesniku godišnje; p = 0,005).
English: Compared with tiotropium, Trydonis reduced the rate of moderate/severe exacerbations over 52 weeks by 20% (rate: 0.46 versus 0.57 events per patient/year; p = 0.003).
Croatian: U usporedbi s tiotropijem, Trydonis je smanjio stopu umjerenih/teških egzacerbacija tijekom 52 tjedna za 20 % (stopa: 0,46 naspram 0,57 događaja po bolesniku godišnje; p = 0,003).
English: In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Trydonis significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Trydonis and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06).
Croatian: odnosno 0,84; p = 0,020 odnosno p = 0,015), s time da nije bilo razlika između lijeka Trydonis i ex tempore trostruke fiksne kombinacije beklometazondipropionata i formoterola uz tiotropij (omjer hazarda 1,06).
English: If you use more Trydonis than you should, side effects, as described in section 4, may occur.
Croatian: Ako primijenite više lijeka Trydonis nego što ste trebali, može doći do nuspojava koje su opisane u dijelu 4. Ako ste primijenili više lijeka Trydonis nego što ste trebali i ako Vam se javi bilo koji od tih simptoma, obratite se svome liječniku.
English: Trydonis contains beclometasone dipropionate, formoterol and glycopyrronium in a solution formulation resulting in an aerosol with extrafine particles with an average mass median aerodynamic diameter (MMAD) of around 1.1 micrometres and co-deposition of the three components.
Croatian: Trydonis sadrži beklometazondipropionat, formoterol i glikopironij u obliku otopine koja se može raspršiti u aerosol s vrlo sitnim česticama prosječnog medijana masenog aerodinamičkog promjera
English: If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, Trydonis should be discontinued immediately and alternative therapy instituted.
Croatian: oticanje jezika, usana i lica), urtikariju ili kožni osip, potrebno je odmah prekinuti primjenu lijeka Trydonis i uvesti drugu terapiju.
English: Study TRINITY compared Trydonis with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients).
Croatian: osim toga, učinci su bili uspoređeni s učincima ex tempore trostruke kombinacije napravljene od fiksne kombinacije beklometazondipropionata i formoterola 100/6 mikrograma za dva udaha dvaput na dan i tiotropija 18 mikrograma praška inhalata, tvrde kapsule, primijenjenog kao jedan udah jedanput na dan (2691 randomiziran bolesnik).
English: What Trydonis is and what it is used for What you need to know before you use Trydonis How to use Trydonis
Croatian: Što morate znati prije nego počnete primjenjivati Trydonis
English: How to store Trydonis
Croatian: Moguće nuspojave Kako čuvati Trydonis
English: Trydonis is for inhalation use.
Croatian: Trydonis je za primjenu u dišne putove.
English: The maximum plasma concentration and systemic exposure of beclometasone dipropionate main active metabolite (beclometasone 17-monopropionate) and formoterol were similar after administration of the fixed or extemporary combination.
Croatian: Maksimalna koncentracija u plazmi i sistemska izloženost glavnom djelatnom metabolitu beklometazondipropionata (beklometazon
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trydonis improved pre-dose FEV1 by 81 mL after 26 weeks of treatment and by 63 mL after 52 weeks of treatment.
Croatian: FEV1 prije doziranja za 81 ml nakon 26 tjedana liječenja te za 63 ml nakon 52 tjedna liječenja.
English: A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (reduction versus baseline of greater than or equal to 4) after 26 and 52 weeks with Trydonis than with a fixed combination of beclometasone dipropionate and formoterol and with tiotropium.
Croatian: Analiza bolesnika s terapijskim odgovorom pokazala je da je postotak bolesnika s klinički značajnim poboljšanjem (smanjenje veće ili jednako 4 u odnosu na početne vrijednosti) bio značajno veći nakon
English: Safety pharmacology
Croatian: FARMAKOLOŠKA SVOJSTVA
English: The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day.
Croatian: Doza iznosi 120 mg dva puta na dan tijekom prvih sedam dana, nakon čega slijedi povećanje na 240 mg dva puta na dan.
English: Tecfidera dimethyl fumarate
Croatian: Tecfidera dimetilfumarat
English: Tecfidera is available as oral capsules (120 and 240 mg) to be taken with food.
Croatian: Lijek Tecfidera dostupan je u obliku kapsula (120 i 240 mg) koje se uzimaju s hranom.
English: The full EPAR for Tecfidera 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 o lijeku (EPAR) za lijek Tecfidera nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The number of relapses per patient per year for glatiramer acetate was 0.3.
Croatian: Broj relapsa po bolesniku po godini za glatiramer acetat iznosio je 0,3.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tecfidera on 30 January 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Tecfidera vrijedi na prostoru Europske unije od 30. siječnja 2014.
English: Other information about Tecfidera
Croatian: Ostale informacije o lijeku Tecfidera
English: This is a summary of the European public assessment report (EPAR) for Tecfidera.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Tecfidera.
English: In MS, the body's immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths.
Croatian: U slučaju MS-a, imunosni sustav tijela ne funkcionira ispravo i napada dijelove središnjeg živčanog sustava (mozak i kralježničnu moždinu), što uzrokuje upalu koja oštećuje ovojnice živca.
English: What is Tecfidera and what is it used for?
Croatian: Što je Tecfidera i za što se koristi?
English: It is not intended to provide practical advice on how to use Tecfidera.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Tecfidera.
English: It is used to treat multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Croatian: Koristi se za liječenje multiple skleroze (MS), bolesti pri kojoj upala uništava zaštitnu ovojnicu oko živaca.
English: In a second main study involving 1,417 patients, patients were given Tecfidera, placebo or another medicine, glatiramer acetate.
Croatian: U drugom glavnom ispitivanju koje je obuhvatilo 1 417 bolesnika, bolesnici su primili lijek Tecfidera, placebo ili drugi lijek, glatiramer acetat.
English: What measures are being taken to ensure the safe and effective use of Tecfidera?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tecfidera?
English: These side effects tend to start early during treatment, usually in the first month, and may continue intermittently throughout treatment.
Croatian: Ove su nuspojave najčešće vidljive u ranoj fazi liječenja, najčešće tijekom prvog mjeseca, te se mogu nastaviti periodički tijekom cijelog liječenja.
English: It is used specifically in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Croatian: Koristi se isključivo u odraslih osoba s tipom MS-a poznatim kao s relapsno-remitirajući MS, gdje bolesnik ima razdoblja pogoršanja simptoma (relapse) nakon kojih slijede razdoblja oporavka (remisija).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Tecfidera's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo da koristi lijeka Tecfidera nadmašuju s njim povezane rizike i preporučilo je njegovo odobrenje za primjenu u EU-u.
English: A risk management plan has been developed to ensure that Tecfidera is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Tecfidera.
English: Tecfidera can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.
Croatian: Tecfidera se izdaje samo na liječnički recept, a liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju MS-a.
English: The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal problems.
Croatian: Doza se može privremeno smanjiti u bolesnika kod kojih se manifestiraju nuspojave crvenila i gastrointestinalnih problema.
English: What are the risks associated with Tecfidera?
Croatian: Koji su rizici povezani s lijekom Tecfidera?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tecfidera, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Tecfidera uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The most common side effects with Tecfidera (which may affect more than 1 in 10 people) are flushing (reddening of skin) and gastrointestinal problems (such as diarrhoea, nausea, and pain in the abdominal area).
Croatian: Najčešće nuspojave lijeka Tecfidera (kod više od 1 na 10 osoba) su crvenilo (rumenilo kože) i gastrointestinalni problemi (poput proljeva, mučnine i boli u abdominalnom području).
English: The main risks identified with Tecfidera are considered to be manageable and include flushing and gastrointestinal problems (the most common side effects), as well as reduced levels of white blood cells and protein in the urine.
Croatian: Smatra se da se osnovne rizike identificirane kod lijeka Tecfidera može kontrolirati, koji uključuju crvenilo i gastrointestinalne probleme (najčešće nuspojave), kao i koncentracije bijelih krvnih stanica i proteina u urinu.
English: Why is Tecfidera approved?
Croatian: Zašto je lijek Tecfidera odobren?
English: This study showed Tecfidera to be more effective than placebo in reducing the number of relapses over the course of two years: the number of relapses per patient per year was around 0.2 with Tecfidera compared with 0.4 with placebo.
Croatian: Ovim je ispitivanjem dokazano da je lijek Tecfidera bio djelotvorniji od placeba u smanjivanju broja relapsa tijekom razdoblja od dvije godine: broj relapsa po bolesniku po godini iznosio je otprilike 0,2 s lijekom Tecfidera u usporedbi s 0,4 s placebom.
English: In a main study involving 1,234 patients, the proportion of patients who experienced a relapse over the course of two years was significantly lower with Tecfidera treatment than with placebo (a dummy treatment): 27% versus 46%.
Croatian: U glavnom ispitivanju koje je obuhvatilo 1 234 bolesnika, udio bolesnika koji su imali relaps tijekom razdoblja od dvije godine bio je značajno niži u slučaju liječenja lijekom Tecfidera nego placebom (prividnim liječenjem): 27% u odnosu na 46%.
English: Dimethyl fumarate, has been shown in studies to reduce the inflammation and modulate the activity of the immune system.
Croatian: U ispitivanjima je dokazano da dimethilfumarat smanjuje upalu i prilagođava aktivnost imunosnog sustava.
English: The active substance, dimethyl fumarate, is thought to work by activating a protein called ‘Nrf2' that regulates certain ‘antioxidant' genes involved in protecting cells from damage.
Croatian: Smatra se da djelatna tvar, dimetilfumarat, djeluje tako što aktivira protein naziva „Nrf2” koji regulira određene
English: For more information about treatment with Tecfidera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Tecfidera pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Tecfidera have been shown in studies?
Croatian: Koje su koristi lijeka Tecfidera dokazane u ispitivanjima?
English: How is Tecfidera used?
Croatian: Kako se Tecfidera koristi?
English: How does Tecfidera work?
Croatian: Kako djeluje Tecfidera ?
English: For practical information about using Tecfidera, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Tecfidera pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku
English: Tecfidera has been shown to be effective in reducing the number of relapses in patients with relapsingremitting MS and in reducing the number of patients who have relapses during treatment.
Croatian: Dokazano je da je lijek Tecfidera djelotvoran u smanjivanju broja relapsa u bolesnika oboljelih od relapsno-remitirajući MS-a, te da smanjuje broj bolesnika koji ih imaju tijekom liječenja.
English: Tecfidera has been shown to reduce the number of relapses in patients with relapsing-remitting MS and to reduce the number of patients who have them.
Croatian: Dokazano je da lijek Tecfidera smanjuje broj relapsa u bolesnika oboljelih od relapsno-remitirajućeg MS-a, te da smanjuje broj bolesnika koji imaju relapse.
English: For the full list of all side effects reported with Tecfidera, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Tecfidera, potražite u uputi o lijeku.
English: Version 4, 02/2016
Croatian: Verzija 04, 02/2016
English: Linguistic adjustments may also be necessary depending on the grammatical rules of the languages used.
Croatian: Također mogu biti potrebne jezične prilagodbe ovisno o gramatičkim pravilima jezika koji se koristi.
English: <The recommended dose is...>
Croatian: <Preporučena doza je…>
English: <The following information is intended for healthcare professionals only:>
Croatian: <Sljedeće informacije namijenjene su samo zdravstvenim radnicima:>
English: <...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...>
Croatian: <...> <6 mjeseci> <...> <1 godina> <18 mjeseci> <2 godine> <30 mjeseci> <3 godine> <...>
English: [*For the printed material, and national translations:
Croatian: [*Za tiskani materijal i nacionalne prijevode:
English: These measures will help protect the environment.>
Croatian: Ove će mjere pomoći u očuvanju okoliša.>
English: <Other sources of information>
Croatian: <Ostali izvori informacija>
English: <The tablet can be divided into equal doses.>
Croatian: <Tableta se može razdijeliti na jednake doze.>
English: Pharmacotherapeutic group: {group}, ATC code: {code} <not yet assigned>
Croatian: Farmakoterapijska skupina: {skupina}, ATK oznaka: {oznaka} <nije još dodijeljena>
English: <{(Invented) Name} is a biosimilar medicinal product.
Croatian: <{(Novoizumljeno) ime} je biosličan lijek.
English: <Interaction studies have only been performed in adults.>
Croatian: <Ispitivanja interakcija provedena su samo u odraslih.>
English: <Clinical efficacy and safety>
Croatian: <Klinička djelotvornost i sigurnost>
English: <Do not take a double dose to make up for a forgotten <tablet> <dose> <…>.>
Croatian: <Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu <tabletu> <dozu> <…>.>
English: <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.>
Croatian: <Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.>
English: <Not relevant.>
Croatian: <Nije značajno.>
English: <Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.>
Croatian: <Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.>
English: <Environmental Risk Assessment (ERA)>
Croatian: <Procjena rizika za okoliš (ERA)>
English: See section 4.>
Croatian: Pogledajte dio 4.>
English: <Linearity/non-linearity>
Croatian: <Linearnost/nelinearnost>
English: <- This medicine has been prescribed for you only.
Croatian: Ovaj je lijek propisan samo Vama.
English: <Do not throw away any medicines via wastewater <or household waste>.
Croatian: <Nikada nemojte nikakve lijekove bacati u otpadne vode <ili kućni otpad>.
English: <Read all of this leaflet carefully before you start <taking> <using> this medicine because it contains important information for you.
Croatian: <Pažljivo pročitajte cijelu uputu prije nego počnete <uzimati> <primjenjivati> ovaj lijek jer sadrži Vama važne podatke.
English: <This medicinal product must not be mixed with other medicinal products except those mentioned in section <6.6> <and> <12>.>
Croatian: <Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu <6.6> <i> <12>.>
English: <This medicinal product is for diagnostic use only.>
Croatian: <Ovaj lijek se koristi samo u dijagnostičke svrhe.>
English: <No data are available.> <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Croatian: <Trenutno dostupni podaci opisani su u dijelu(ovima) <4.8> <5.1> <5.2> međutim nije moguće dati preporuku o doziranju.>