FrancophonIA/ELRC3.0 huggingface dataset:
English: For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet or contact your doctor or pharmacist.
Croatian: Detaljne informacije o pravilnoj upotrebi inhalatora pogledajte u uputi o lijeku ili se obratite liječniku ili ljekarniku.
English: (umeclidinium bromide / vilanterol)
Croatian: (umeklidinijev bromid / vilanterol)
English: Vilanterol is a long-acting beta-2 adrenergic agonist.
Croatian: Vilanterol je dugodjelujući beta-2 adrenergički agonist.
English: It works by blocking other receptors called muscarinic receptors, which control the contraction of muscles.
Croatian: Djeluje blokiranjem drugih receptora zvanih muskarinski receptori koji kontroliraju stezanje mišića.
English: As medicines of the same class as Anoro Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets the medicine will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.
Croatian: Budući da lijekovi iste klase kao i Anoro Ellipta mogu imati učinak na srce i krvne žile u mozgu, tvrtka koja ovaj lijek stavlja u promet provest će dugoročno ispitivanje u bolesnika kako bi se prikupile daljnje informacije u usporedbi s tiotropijem.
English: The most common side effects with Anoro Ellipta (which may affect up to 1 in 10 people) are upper respiratory tract infections (nose and throat infection), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth.
Croatian: Najčešće nuspojave lijeka Anoro Ellipta (koje se mogu pojaviti u do 1 na 10 osoba) bile su infekcije gornjeg dišnog sustava (infekcije nosa i grla), infekcije mokraćnog sustava (infekcije struktura koje odvode mokraću), faringitis (upala grla), sinusitis (upala sinusa), nazofaringitis (upala nosa i grla), glavobolja, kašalj, orofaringealna bol (bol u ustima i grlu), zatvor i suha usta.
English: Umeclidinium is a muscarinic receptor antagonist.
Croatian: Umeklidinij je antagonist muskarinskih receptora.
English: It works by attaching to beta-2 adrenergic receptors found in the muscle cells of many organs including the airways in the lungs.
Croatian: Djeluje vezivanjem na beta-2 adrenergičke receptore koji se nalaze u stanicama mišića mnogih organa, uključujući dišne putove u plućima.
English: The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily.
Croatian: Kombinirano djelovanje dviju djelatnih tvari pomaže držati dišne putove otvorenima i bolesniku olakšava disanje.
English: Anoro Ellipta received a marketing authorisation valid throughout the EU on 8 May 2014.
Croatian: Lijek Anoro Ellipta dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 8. svibnja 2014.
English: Side effects reported with Anoro Ellipta are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Anoro Ellipta pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: When inhaled, vilanterol reaches the receptors in the airways and activates them.
Croatian: Udisanjem lijeka vilanterol dospijeva do receptora u dišnim putovima i aktivira ih.
English: What measures are being taken to ensure the safe and effective use of Anoro Ellipta?
Croatian: Koje se mjere poduzimaju da bi se osigurala sigurna i učinkovita primjena lijeka Anoro Ellipta?
English: Anoro Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Anoro Ellipta je lijek za ublažavanje simptoma kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: The Agency also noted that there were no major safety concerns with Anoro Ellipta, with side effects being manageable, although the long-term safety data so far are limited.
Croatian: Agencija je također zaključila da za lijek Anoro Ellipta nisu ustanovljeni ozbiljni razlozi u pogledu sigurnosti primjene te da se nuspojave mogu liječiti, iako su zasad podatci o dugoročnoj sigurnosti primjene ograničeni.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Anoro Ellipta 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 Anoro Ellipta nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: As for all medicines, data on the use of Anoro Ellipta are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Anoro Ellipta kontinuirano se prate.
English: Anoro Ellipta contains the active substances umeclidinium bromide and vilanterol.
Croatian: Anoro Ellipta sadrži djelatne tvari umeklidinijev bromid i vilanterol.
English: The Agency concluded that Anoro Ellipta was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium.
Croatian: Agencija je zaključila da se lijek Anoro Ellipta pokazao učinkovitim u poboljšanju funkcije pluća i simptoma KOPB-a u usporedbi s placebom ili pojedinačnim komponentama kao i tiotropijem.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Croatian: KOPB je dugotrajna bolest kod koje dolazi do postupnog oštećenja ili začepljenja dišnih putova i zračnih mjehurića u plućima, što dovodi do poteškoća pri disanju.
English: The European Medicines Agency decided that Anoro 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 Anoro Ellipta nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Each inhalation provides 55 micrograms of umeclidinium (as umeclidinium bromide) and 22 micrograms of vilanterol.
Croatian: Jednom inhalacijom oslobađa se 55 mikrograma umeklidinija (kao umeklidinijev bromid) i 22 mikrograma vilanterola.
English: What is Anoro Ellipta and what is it used for?
Croatian: Što je Anoro Ellipta i za što se primjenjuje?
English: Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Croatian: Antagonisti muskarinskih receptora i dugodjelujući beta-2 agonisti obično se kombiniraju pri liječenju KOPB-a.
English: Anoro Ellipta is used for maintenance (regular) treatment.
Croatian: Anoro Ellipta primjenjuje se kao (redovita) terapija održavanja.
English: An overview of Anoro Ellipta and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Anoro Ellipta i zašto je odobren u EU-u
English: When umeclidinium is inhaled, it also relaxes the muscles of the airways.
Croatian: Udisanjem umeklidinija također dolazi do opuštanja mišića dišnih puteva.
English: The higher dose combination of umeclidinium and vilanterol did not consistently lead to better improvements in lung function than Anoro Ellipta to justify its use.
Croatian: Kombinacija veće doze umeklidinija i vilanterola nije dosljedno dovodila do poboljšanja većih od lijeka Anoro Ellipta, što bi opravdalo njezinu primjenu.
English: What are the risks associated with Anoro Ellipta?
Croatian: Koji su rizici povezani s lijekom Anoro Ellipta?
English: Anoro Ellipta can only be obtained with a prescription.
Croatian: Anoro Ellipta izdaje se samo na liječnički recept.
English: Other information about Anoro Ellipta
Croatian: Ostale informacije o lijeku Anoro Ellipta
English: Why is Anoro Ellipta authorised in the EU?
Croatian: Zašto je lijek Anoro Ellipta odobren u EU-u?
English: Anoro Ellipta also increased FEV1 by an average of up to 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone.
Croatian: Osim toga, uz lijek Anoro Ellipta povećanje FEV1 bilo je u prosjeku do 95 ml veće nego uz primjenu samo vilanterola, a za 52 ml veće nego uz primjenu samo umeklidinijevog bromida.
English: The active substances in Anoro Ellipta, umeclidinium and vilanterol, work in different ways to widen the airways and improve breathing in COPD.
Croatian: Djelatne tvari koje sadrži Anoro Ellipta, umeklidinij i vilanterol, svojim različitim djelovanjem proširuju dišne putove i olakšavaju disanje u bolesnika s KOPB-om.
English: This causes the muscles of the airways to relax.
Croatian: Time dolazi do opuštanja mišića dišnih putova.
English: Results showed that Anoro Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment.
Croatian: Rezultati su pokazali da je nakon 24 tjedna liječenja Anoro Ellipta poboljšao funkciju pluća i to povećanjem FEV1 u prosjeku za 167 ml više nego placebo.
English: Anoro Ellipta and a higher-dose combination of umeclidinium and vilanterol (113 micrograms/22 micrograms) were compared with placebo (a dummy treatment), vilanterol alone, umeclidinium alone or another COPD medicine called tiotropium in 5 main studies.
Croatian: U pet glavnih ispitivanja uspoređena je primjena lijeka Anoro Ellipta i kombinacije veće doze umeklidinija i vilanterola (113 mikrograma/22 mikrograma) s primjenom placeba (prividno liječenje), samo vilanterola, samo umeklidinija ili lijeka za liječenje KOPB-a pod nazivom tiotropij.
English: Anoro Ellipta was also shown to improve breathlessness when compared with placebo.
Croatian: Pokazalo se također da Anoro Ellipta u usporedbi s placebom olakšava nedostatak zraka.
English: What benefits of Anoro Ellipta have been shown in studies?
Croatian: Koje su koristi od lijeka Anoro Ellipta utvrđene u ispitivanjima?
English: The average increase in FEV1 with Anoro Ellipta was 60, 90 and 112 ml more than with tiotropium after 24 weeks of treatment in the three studies where Anoro Ellipta was compared with tiotropium.
Croatian: U tri ispitivanja u kojima se lijek Anoro Ellipta uspoređivao s tiotropijem, nakon 24 tjedna liječenja prosječno povećanje FEV1 uz primjenu lijeka Anoro Ellipta iznosilo je 60, 90 i 112 ml više nego uz tiotropij.
English: How is Anoro Ellipta used?
Croatian: Kako se Anoro Ellipta primjenjuje?
English: How does Anoro Ellipta work?
Croatian: Kako djeluje Anoro Ellipta?
English: Pack size bottle (HDPE)
Croatian: Veličina pakovanja boca (HDPE) 100 tableta
English: (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging
Croatian: Farmaceutski oblik
English: In Italy: Nubriveo
Croatian: U Italiji: Nubriveo
English: Further information on Briviact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Briviact nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This was shown in three main studies involving a total of 1,558 patients aged 16 years and above.
Croatian: To su pokazala tri glavna ispitivanja u kojima je sudjelovalo ukupno 1 558 bolesnika u dobi od 16 godina i više.
English: Therefore Briviact is expected to work in children in the same way.
Croatian: Stoga se očekuje da Briviact djeluje u djece na jednak način.
English: What measures are being taken to ensure the safe and effective use of Briviact?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Briviact?
English: Epilepsy is caused by excessive electrical activity in certain areas of the brain.
Croatian: Epilepsiju uzrokuje pretjerana električna aktivnost u određenim dijelovima mozga.
English: It can be used in patients from the age of 4 years with partial-onset seizures with or without secondary generalisation (where the abnormal electrical activity spreads through the brain).
Croatian: Može se upotrebljavati u bolesnika u dobi od četiri godine naviše s parcijalnim napadajima koji se sekundarno generaliziraju ili ne (gdje je abnormalna električna aktivnost širi kroz mozak).
English: Other information about Briviact
Croatian: Ostale informacije o lijeku Briviact
English: Supportive studies showed that the doses recommended for children produced similar amounts of the medicine in the body to those seen with recommended doses in adults.
Croatian: Potporna ispitivanja pokazala su da su preporučene doze za djecu proizvele slične količine lijeka u organizmu kao što su količine koje su proizvele preporučene u odraslih.
English: This helps Briviact to stabilise electrical activity in the brain and prevent seizures.
Croatian: To pomaže lijeku Briviact da stabilizira električnu aktivnost u mozgu i spriječi napadaje.
English: Briviact received a marketing authorisation valid throughout the EU on 14 January 2016.
Croatian: Lijek Briviact dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 14. siječnja 2016.
English: The exact way in which brivaracetam, the active substance in Briviact, works is not clear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Croatian: Točan način na koji djeluje brivaracetam, djelatna tvar u lijeku Briviact, nije jasan, no on se veže uz protein koji se naziva protein sinaptičkih vezikula 2A, koji je uključen u otpuštanje kemijskih poruka iz živčanih stanica.
English: What is Briviact and what is it used for?
Croatian: Što je Briviact i za što se primjenjuje?
English: Briviact is available as tablets (10, 25, 50, 75 and 100 mg), an oral solution (10 mg/ml) and a solution for injection or infusion (drip) into a vein (10 mg/ml), which is used when the medicine cannot be given by mouth.
Croatian: Briviact je dostupan u obliku tableta (10, 25, 50, 75 i 100 mg), u obliku otopine za peroralnu upotrebu (10 mg/ml) te u obliku otopine za injekciju ili infuziju (drip) u venu (10 mg/ml), koja se može upotrebljavati ako se lijek ne može primijeniti peroralno.
English: The most common side effects with Briviact (which may affect more than 1 in 10 people) are somnolence (sleepiness) and dizziness.
Croatian: Najčešće nuspojave lijeka Briviact (mogu se javiti u više od 1 na 10 osoba) jesu somnolencija (pospanost) i omaglica.
English: For more information about using Briviact, see the package leaflet or contact a doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Briviact pročitajte u uputi o lijeku ili se obratite liječniku ili ljekarniku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Briviact 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 Briviact nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Briviact are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Briviact kontinuirano se prate.
English: Side effects reported with Briviact are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Briviact pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Briviact is an epilepsy medicine used as an add-on to other epilepsy medicines to treat partial-onset seizures (epileptic fits starting in one specific part of the brain).
Croatian: Briviact je lijek za epilepsiju koji se upotrebljava kao dodatak drugim lijekovima za epilepsiju za liječenje parcijalnih epileptičkih napadaja (epileptičkih napadaja koji počinju u jednom određenom dijelu mozga).
English: Either Briviact or placebo was added to patients' usual epilepsy treatment.
Croatian: Ili Briviact ili placebo dodani su bolesnikovom uobičajenom liječenju za epilepsiju.
English: Clinical studies have shown add-on treatment with Briviact to be more effective than placebo for controlling partial-onset seizures in adults and children from 4 years of age.
Croatian: Klinička ispitivanja pokazala su da je dodatno liječenje lijekom Briviact učinkovitije od placeba u kontroli parcijalnih napadaja u odraslih i djece starije od četiri godine.
English: Briviact must not be used in patients who are hypersensitive (allergic) to brivaracetam, to other pyrrolidone derivatives (substances that are chemically similar to brivaracetam), or to any of the other ingredients.
Croatian: Briviact se ne smije upotrebljavati u bolesnika koji su preosjetljivi (alergični) na brivaracetam, na druge derivate pirolidona (tvari koje su kemijski slične brivaracetamu) ili na bilo koje druge sastojke.
English: An overview of Briviact and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Briviact i zašto je odobren u EU-u
English: Taking the studies together, the frequency of seizures was at least halved in 34 to 38% of those adding Briviact at doses from 25 to 100 mg twice a day.
Croatian: U ispitivanjima je učestalost napadaja bila barem prepolovljena u 34 do 38 % onih bolesnika u kojih je dodan lijek Briviact u dozama od 25 do 100 mg dva puta dnevno.
English: What are the risks associated with Briviact?
Croatian: Koji su rizici povezani s lijekom Briviact?
English: Briviact is more effective than placebo (a dummy treatment) at reducing seizures.
Croatian: Briviact je učinkovitiji od placeba (prividno liječenje) u smanjenju napadaja.
English: The European Medicines Agency decided that Briviact'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 Briviact nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Why is Briviact authorised in the EU?
Croatian: Zašto je lijek Briviact odobren u EU-u?
English: Most side effects of Briviact were of mild or moderate severity and were considered manageable.
Croatian: Većina nuspojava lijeka Briviact bila je blaga ili umjerena te su se smatrale rješivima.
English: How does Briviact work?
Croatian: Kako djeluje Briviact?
English: (brivaracetam)
Croatian: Briviact1 (brivaracetam)
English: The recommended starting dose in adults and younger patients weighing more than 50 kg is either 25 mg twice a day or 50 mg twice a day, depending on the patient's condition.
Croatian: Preporučena početna doza u odraslih i mlađih bolesnika tjelesne težine veće od 50 kg je ili 25 mg dva puta dnevno ili 50 mg dva puta dnevno, ovisno o stanju bolesnika.
English: In those weighing less than 50 kg the dose is based on body weight and the usual starting dose is 0.5 mg per kg body weight twice a day.
Croatian: U bolesnika tjelesne težine manje od 50 kg, doza se temelji na tjelesnoj težini te je uobičajena početna doza 0,5 mg po kilogramu tjelesne težine dva puta dnevno.
English: What benefits of Briviact have been shown in studies?
Croatian: Koje su koristi od lijeka Briviact utvrđene u ispitivanjima?
English: The dose can then be adjusted according to the patient's needs up to a maximum of 100 mg or 2 mg per kg respectively, twice a day.
Croatian: Dozu je moguće prilagoditi u skladu s bolesnikovim potrebama do najviše 100 mg, odnosno 2 mg po kilogramu, dva puta dnevno.
English: This compares with 20% in those adding placebo.
Croatian: U bolesnika kojima je dodan placebo je, za usporedbu, to bilo 20 %.
English: How is Briviact used?
Croatian: Kako se Briviact koristi?
English: For the full list of side effects of Briviact, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Briviact potražite u uputi o lijeku.
English: In Asian countries: reported as rare d
Croatian: U azijskim državama: prijavljenji kao rijetko d
English: Your doctor will not prescribe PROTELOS for you if you are at particular risk.
Croatian: Vaš liječnik neće Vam propisati PROTELOS ako ste u osobitom riziku.
English: What protelos is and what it is used for
Croatian: Što je PROTELOS i za što se koristi
English: PROTELOS contains aspartame:
Croatian: PROTELOS sadrži aspartam:
English: Like all medicines, this medecine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: What PROTELOS is and what it is used for What you need to know before you take PROTELOS How to take PROTELOS
Croatian: Sto je PROTELOS i za što se koristi Što morate znati prije nego počnete uzimati PROTELOS
English: If you are of Asian origin, talk to your doctor before taking PROTELOS as you may be at higher risk of skin reactions.
Croatian: Ako ste azijskog porijekla, porazgovarajte sa svojim liječnikom prije uzimanja PROTELOS -a budući da možete imati veći rizik nastanka kožnih reakcija.
English: However, it is recommended to drink the suspension immediately after preparation (see section 3) Do not throw away any medicines via wastewater or household waste.
Croatian: Međutim, preporučuje se suspenziju popiti odmah nakon njene pripreme (vidjeti dio 3.) Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Heart attack may occur commonly in patients at high risk for heart disease.
Croatian: Srčani udar može se dogoditi često kod bolesnika s visokim rizikom za nastanak srčanih bolesti.
English: The safety and efficacy of PROTELOS in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka PROTELOS u djece starosti do 18 godina nisu još ustanovljene.
English: It is important that you continue taking PROTELOS for as long as your doctor prescribes the medicine.
Croatian: Važno je da PROTELOS uzimate onoliko dugo koliko Vam je liječnik odredio.
English: Therefore, administration of PROTELOS and such products should be separated by at least two hours (see section 5.2).
Croatian: Stoga razmak između uzimanja PROTELOS-a i tih proizvoda mora iznositi najmanje dva sata (vidjeti dio 5.2)
English: If you have stopped treatment due to hypersensitivity reactions, do not take PROTELOS again
Croatian: Ukoliko ste prestali uzimati lijek zbog reakcija preosjetljivosti, ne smijete ponovo započeti uzimanje PROTELOS-a
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where PROTELOS is marketed, all physicians who are expected to prescribe PROTELOS are provided with the following educational package:
Croatian: Nositelj odobrenja će osigurati da, nakon rasprave i dogovora sa nacionalnim nadležnim tijelom svake države članice gdje je PROTELOS prisutan na tržištu, svi liječnici za koje se očekuje da će propisivati
English: After approval of the protocol, annual reports from this study shall be provided within the PSUR until submission of the final study report, which is due by December 2017.
Croatian: PSURom sve dok se ne preda završno izvješće koje se treba predati do prosinca 2017. godine.
English: EU/1/04/288/001 EU/1/04/288/002 EU/1/04/288/003 EU/1/04/288/004 EU/1/04/288/005
Croatian: EU/1/04/288/001 EU/1/04/288/002 EU/1/04/288/003 EU/1/04/288/004 EU/1/04/288/005 EU/1/04/288/006
English: What you need to know before you take protelos Do not take PROTELOS:
Croatian: Što morate znati prije nego počnete uzimati PROTELOS
English: PROTELOS contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Croatian: Pomoćna tvar PROTELOS sadržava izvor fenilalanina, koji može biti štetan za osobe s fenilketonurijom.