FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Dukoral, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Dukoral pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku
English: A further study was carried out to show that Dukoral could produce antibodies in people who do not come from areas where cholera is found.
Croatian: Provedeno je još jedno ispitivanje kako bi se dokazalo da lijek Dukoral može proizvesti protutijela u osoba koje ne potječu iz područja gdje je prisutna kolera.
English: The vaccine contains four different inactivated strains (types) of the bacterium Vibrio cholerae (V. cholerae) serotype O1, and part of a toxin from one of these strains as active substances.
Croatian: Cjepivo sadrži četiri različita inaktivna soja (tipa) bakterije Vibrio cholerae (V. cholerae) serotipa O1, i dio toksina iz jednog od ovih sojeva kao djelatne tvari.
English: The other two studies compared Dukoral (containing recombinant cholera toxin) with placebo in over 22,000 people in Peru.
Croatian: Druga dva ispitivanja usporedila su Dukoral (sadržavao je rekombinantni toksin kolere) s placebom u više od 22.000 osoba u Peruu.
English: Dukoral is a vaccine.
Croatian: Dukoral je cjepivo.
English: When a person is given the vaccine, the immune system recognises the bacteria and the toxin, and makes antibodies against them.
Croatian: Nakon što osoba primi cjepivo, imunosni sustav prepoznaje bakteriju i toksin, i proizvodi protutijela protiv njih.
English: Why has Dukoral been approved?
Croatian: Zašto je Dukoral odobren?
English: This document is a summary of the European public assessment report (EPAR) for Dukoral.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Dukoral.
English: The granules are dissolved in water and mixed with the vaccine before intake.
Croatian: Granule su topive u vodi i miješaju se s cjepivom prije primjene.
English: What is the risk associated with Dukoral?
Croatian: Koji su rizici povezani s lijekom Dukoral?
English: Dukoral must not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to formaldehyde.
Croatian: Dukoral se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na bilo koju djelatnu tvar ili na neku pomoćnu tvar ili na formaldehid.
English: The information presented was not sufficient to support the use of Dukoral in traveller's diarrhoea.
Croatian: Dostavljene informacije nisu bile dovoljne da potvrde uporabu lijeka Dukoral u slučaju putničkog proljeva.
English: The vaccine is made up by dissolving the granules in a glass of water to prepare an effervescent (sparkling) solution, and adding the contents of the bottle.
Croatian: Cjepivo se priprema otapanjem granula u čaši vode kako bi se pripremila šumeća otopina, i dodavanjem sadržaja boce.
English: For continuous protection against cholera, a single booster dose is recommended within two years for people from six years of age, and within six months for children aged between two and six years.
Croatian: Za potrebu kontinuirane zaštite od kolere, preporučuje se jedna booster doza unutar roka od dvije godine za osobe starije od šest godina, te unutar roka od šest mjeseci za djecu u dobi između dvije i šest godina.
English: Dukoral contains small amounts of inactivated (killed) cholera bacteria and a part of the cholera toxin called the ‘B subunit'.
Croatian: Dukoral sadrži male količine inaktivne (ubijene) bakterije kolere i dio toksina kolere naziva „podjedinica B“.
English: In all three studies, Dukoral, given as either two or three doses, was compared with placebo (a dummy vaccine).
Croatian: U sva tri ispitivanja, Dukoral, je primjenjivan u dvije ili tri doze, uspoređen je s placebom (lažnim liječenjem).
English: What is Dukoral?
Croatian: Što je Dukoral?
English: In this study, Dukoral was made using cholera toxin extracted from cholera bacteria in place of the newer recombinant toxin.
Croatian: U ovom ispitivanju, Dukoral je pripremljen pomoću toksina kolere ektrahiranog iz bakterije kolere umjesto novijeg rekombinantnog toksina.
English: Children aged between two and six years should receive three doses, with an interval of one to six weeks between each dose.
Croatian: Djeca u dobi između dvije i šest godina starosti trebaju primiti tri doze, u razmaku od šest tjedna između svake doze.
English: The length of protection was different for adults and children, lasting for six months in children and for two years in adults.
Croatian: Trajanje imunizacije razlikovalo se između odraslih osoba i djece, pri čemu je trajalo šest mjeseci u djece i dvije godine u odraslih osoba.
English: These antibodies will help to protect against cholera by preventing the bacteria and the toxins from attaching to the walls of the gut and entering the body's cells.
Croatian: Ova protutijela pomažu u zaštiti protiv kolere sprječavajući vezivanje bakterija i toksina za stjenke crijeva i ulaženje u tjelesne stanice.
English: The Committee decided that Dukoral's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je da koristi od lijeka Dukoral nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The company also presented information on the use of Dukoral for the prevention of a severe type of traveller's diarrhoea caused by a bacterium called ‘enterotoxigenic Escherichia coli'.
Croatian: Tvrtka je dostavila informacije o prevenciji ozbiljnog tipa proljeva u putnika uzrokovanog bakterijom naziva „enterotoksigena Escherichia coli'.
English: The course should be repeated in adults who have not been given a booster within two years and in children not given a booster within six months.
Croatian: Ciklus cjepiva treba ponoviti u odraslih osoba koje nisu primile booster dozu unutar roka od dvije godine, te u djece koja nisu primila booster dozu unutar roka od šest mjeseci.
English: In the study in Bangladesh, the protective effectiveness of Dukoral was 85% over the first six months of follow-up.
Croatian: U ispitivanju provedenom u Bangladešu, zaštitna djelotvornost lijeka Dukoral bila je 85% tijekom prvih šest mjeseci kontrole.
English: In adults and children from six years of age, Dukoral is given as two doses, one to six weeks apart.
Croatian: U odraslih osoba i djece u dobi od šest godina i stariji, Dukoral se primjenjuje u dvije doze, jedna svakih šest tjedana.
English: In the first of the two studies in Peru, the protective effectiveness of Dukoral was 85% for the first five months of follow-up.
Croatian: U prvom od dva ispitivanja provedena u Peruu, zaštitna djelotvornost lijeka Dukoral iznosila je 85% tijekom prvih pet mjeseci kontrole.
English: Side effects with Dukoral are not common.
Croatian: Nuspojave lijeka Dukoral nisu česte.
English: The other study in Peru showed that after a booster dose, the protective effectiveness of Dukoral during the second year of follow-up was 61%.
Croatian: Drugim ispitivanjem provedenim u Peruu utvrđeno je da je zaštitna djelotvornost lijeka Dukoral nakon booster doze tijekom druge godine kontrole iznosila 61%.
English: What benefit has Dukoral shown during the studies?
Croatian: Koje su koristi lijeka Dukoral utvrđene u ispitivanjima?
English: What is Dukoral used for?
Croatian: Za što se Dukoral koristi?
English: Dukoral is a vaccine that is given by mouth.
Croatian: Dukoral je cjepivo koje se daje peroralno.
English: How is Dukoral used?
Croatian: Kako se Dukoral koristi?
English: For the full list of side effects reported with Dukoral, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Dukoral, potražite u uputi o lijeku.
English: How has Dukoral been studied?
Croatian: Kako je Dukoral ispitivan?
English: How does Dukoral work?
Croatian: Kako djeluje Dukoral?
English: Further information on Brinavess can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/brinavess.
Croatian: Više informacija o lijeku Brinavess dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/brinavess.
English: If the blood pressure or heart rate suddenly decreases the infusion should be stopped immediately.
Croatian: Ako se krvni tlak ili otkucaji srca odjednom smanje, odmah je potrebno prekinuti infuziju.
English: If the heart rhythm has not returned to normal 15 minutes after the end of the first infusion, a second, smaller dose may be given.
Croatian: Ako se srčani ritam nije vratio u normalu nakon 15 minuta od prve infuzije, može se dati druga, manja doza.
English: Patients should not be given more than 5 mg of Brinavess per kg body weight within any 24-hour period, or a maximum of 565 mg in patients weighing more than 113 kg.
Croatian: Bolesnicima se ne smije davati više od 5 mg lijeka Brinavess po kili tjelesne težine tijekom razdoblja od 24 sata, ili najviše 565 mg u bolesnika težih od 113 kg.
English: What is Brinavess and what is it used for?
Croatian: Što je Brinavess i za što se koristi?
English: By blocking these channels, vernakalant can prevent abnormal electrical activity that can lead to atrial fibrillation.
Croatian: Blokiranjem tih kanala vernakalant može spriječiti abnormalnu električnu aktivnost koja dovodi do fibrilacije atrija.
English: The main measure of effectiveness was the proportion of patients whose heart rhythm returned to normal.
Croatian: Glavno mjerilo djelotvornosti bio je udio bolesnika čiji se srčani ritam vratio u normalu.
English: The healthcare professional should monitor the patient's blood pressure and heart rate while the medicine is being given and for at least 15 minutes afterwards.
Croatian: Zdravstveni radnik treba nadzirati krvni tlak i otkucaje srca bolesnika tijekom davanja lijeka te barem 15 minuta nakon toga.
English: What measures are being taken to ensure the safe and effective use of Brinavess?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Brinavess?
English: As for all medicines, data on the use of Brinavess are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Brinavess kontinuirano se prate.
English: Brinavess must not be used in patients with severe aortic stenosis (narrowing of the aorta), low systolic blood pressure (blood pressure when the heart is contracting), advanced heart failure (when the heart does not pump enough blood around the body), some types of altered electrical activity in the heart or a very slow heart rate.
Croatian: Brinavess se ne smije koristiti u bolesnika s teškom aortnom stenozom (sužavanjem aorte), niskim sistoličkim krvnim tlakom (krvnim tlakom pri stezanju srca), uznapredovalim zatajenjem srca (kad krv ne pumpa dovoljno krvi u tijelu), nekih oblika promijenjene električne aktivnosti u srcu ili vrlo sporog srčanog ritma.
English: The European Medicines Agency decided that Brinavess'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 Brinavess nadmašuju s njim povezane rizike te da može biti odobren za primjenu u EU-u.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Brinavess 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 Brinavess također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: The most common side effects with Brinavess (which may affect more than 1 person in 10) are dysgeusia (taste disturbances) and sneezing.
Croatian: Najčešće nuspojave lijeka Brinavess (koje se mogu javiti u više od 1 na 10 osoba) su disgeuzija (poremećaji okusa) i kihanje.
English: The dose of Brinavess depends on the patient's body weight.
Croatian: Doza lijeka Brinavess ovisi o tjelesnoj težini bolesnika.
English: Side effects reported with Brinavess are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Brinavess pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Brinavess must not be given within 30 days of having acute coronary syndrome (a group of heart problems that include unstable angina and heart attacks).
Croatian: Brinavess se ne smije davati unutar 30 dana od akutnog koronarnog sindroma (skupine srčanih problema koji uključuju nestabilnu anginu i srčane udare).
English: Brinavess is a solution that is given by infusion (drip) into a vein over a period of 10 minutes.
Croatian: Brinavess je otopina koja se daje infuzijom (ukapavanjem) u venu tijekom 10 minuta.
English: It restores normal heart rhythm by blocking channels through which charged particles of potassium and sodium move in and out of the muscle cells in the atria.
Croatian: Vraća srčani ritam u normalu blokiranjem kanala kroz koje nabijene čestice kalija i natrija u atrijima putuju u stanice mišića i iz njih.
English: In the first two studies, among patients who had recently started having atrial fibrillation, heart rhythm returned to normal in 51% of those receiving Brinavess (118 out of 231) compared with 4% (6 out of 159) of those taking placebo.
Croatian: U prva dva ispitivanja, među bolesnicima koji su tek nedavno iskusili fibrilaciju atrija, srčani se ritam vratio u normalu kod 51 % bolesnika koji su primali Brinavess (118 od 231) u usporedbi s 4 % (6 od159) bolesnika koji su dobivali placebo.
English: In two main studies involving 596 adults with atrial fibrillation, Brinavess was compared with placebo (a dummy treatment).
Croatian: U dva glavna ispitivanja koja su uključivala 596 odraslih osoba s fibrilacijom atrija, Brinavess je bio uspoređen s placebom (prividnim liječenjem).
English: Brinavess can only be obtained with a prescription and should be given by a qualified healthcare professional in a setting where the patient's heart can be properly monitored.
Croatian: Brinavess se izdaje samo na recept i treba ga davati samo kvalificirani zdravstveni radnik u okružju gdje se rad bolesnikova srca može nadzirati na odgovarajući način.
English: Why has Brinavess been authorised in the EU?
Croatian: Zašto je lijek Brinavess odobren u EU-u?
English: For more information about using Brinavess, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Brinavess pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: In the third study, heart rhythm returned to normal in 47% of the patients receiving Brinavess compared with 14% of those receiving placebo.
Croatian: U trećem ispitivanju srčani se ritam vratio u normalu u 47 % bolesnika koji su primali Brinavess u usporedbi s 14 % bolesnika koji su primali placebo.
English: An overview of Brinavess and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Brinavess i zašto je odobren u EU-u
English: Patients on Brinavess must not be given medicines called ‘class I and III anti-arrhythmics' intravenously during the four hours before or after their Brinavess infusion.
Croatian: Bolesnici koji uzimaju Brinavess ne smiju intravenski primati lijekove naziva „antiaritmici klase I i III” tijekom četiri sata prije ili nakon infuzije lijeka Brinavess.
English: Atrial fibrillation happens when the atria (the upper chambers of the heart) contract irregularly and rapidly, resulting in abnormal heart rhythm.
Croatian: Do fibrilacije atrija dolazi kad se atriji (gornje komore srca) nepravilno i brzo stežu, što dovodi do abnormalnog srčanog ritma.
English: Brinavess contains the active substance vernakalant hydrochloride.
Croatian: Brinavess sadrži djelatnu tvar vernakalant hidroklorid.
English: Vernakalant acts mainly in the atria rather than in the ventricles (the lower chambers of the heart).
Croatian: Vernakalant uglavnom djeluje u atrijima, a ne u ventrikulima (donjim komorama srca).
English: Brinavess received a marketing authorisation valid throughout the European Union on 01 September
Croatian: Brinavess je dobio odobrenje za stavljanje u promet koje je na snazi u EU-u od 1. rujna 2010.
English: Brinavess is to be used for atrial fibrillation that has started within the last seven days, or within the last three days if the patient had recently had heart surgery.
Croatian: Brinavess treba primjenjivati za fibrilaciju atrija koja je počela u zadnjih tjedan dana ili unutar tri dana ako je bolesnik nedavno bio na operaciji srca.
English: Other information about Brinavess
Croatian: Ostale informacije o lijeku Brinavess
English: What are the risks associated with Brinavess?
Croatian: Koji su rizici povezani s lijekom Brinavess?
English: Brinavess was more effective than placebo at treating patients who had recently started having atrial fibrillation.
Croatian: Brinavess je bio učinkovitiji od placeba u liječenju bolesnika koji su tek nedavno iskusili fibrilaciju atrija.
English: Brinavess is a medicine used to rapidly restore normal heart rhythm in adult patients who have recently started having atrial fibrillation.
Croatian: Brinavess je lijek za brzo vraćanje srčanog ritma u normalu u odraslih bolesnika koji su nedavno prvi puta iskusili fibrilacije atrija.
English: The company that markets Brinavess will ensure that healthcare professionals expected to use the medicine are provided with educational material explaining how the medicine should be used.
Croatian: Tvrtka koja stavlja lijek Brinavess u promet osigurat će materijale u kojima se objašnjava način primjene lijeka za obuku liječnika koji bi trebali primjenjivati lijek.
English: What benefits of Brinavess have been shown in studies?
Croatian: Koje su koristi od lijeka Brinavess utvrđene u ispitivanjima?
English: A third main study compared Brinavess with placebo in 161 adults who had had atrial fibrillation following heart surgery.
Croatian: s placebom kod 161 odrasle osobe koje su imale fibrilaciju atrija nakon operacije srca.
English: How does Brinavess work?
Croatian: Kako djeluje Brinavess?
English: Brinavess contains vernakalant, a type of substance known as an anti-arrhythmic.
Croatian: Brinavess sadrži vernakalant, antiaritmičku tvar.
English: For the full list of side effects of Brinavess, see the package leaflet.
Croatian: Potpuni popis nuspojava povezanih s lijekom Brinavess potražite u uputi o lijeku.
English: How is Brinavess used?
Croatian: Kako se Brinavess primjenjuje?
English: Mysimba naltrexone / bupropion
Croatian: Mysimba naltrekson / bupropion
English: It will also carry out a further study to assess the effect of the medicine on the heart and blood vessels.
Croatian: Provest će također daljnja ispitivanja kako bi se ocijenilo djelovanje lijeka na srce i krvne žile.
English: The full EPAR and risk management plan summary for Mysimba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Mysimba nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mysimba on 26 March 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Mysimba na snazi u Europskoj uniji od 26. ožujka 2015.
English: Prolonged-release means that naltrexone and bupropion are released slowly from the tablet over a few hours.
Croatian: Produljeno otpuštanje znači da se naltrekson i bupripion otpuštaju polako iz tablete tijekom nekoliko sati.
English: It is not intended to provide practical advice on how to use Mysimba.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Mysimba.
English: Treatment with Mysimba is started with a single tablet each morning, with the dose gradually increased over 4 weeks to the recommended dose of two tablets twice a day, preferably taken with food.
Croatian: Terapija lijekom Mysimba započinje s jednom tabletom svako jutro, pri čemu se doza postepeno povećava tijekom razdoblja od 4 tjedana do preporučene doze od dvije tablete dva puta na dan.
English: This is a summary of the European public assessment report (EPAR) for Mysimba.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Mysimba.
English: Other information about Mysimba
Croatian: Ostale informacije o lijeku Mysimba
English: Interim data from an ongoing study of cardiovascular outcomes were reviewed during the assessment although the CHMP also recommended ongoing monitoring of the medicine's cardiovascular effects.
Croatian: Pregledani su privremeni podaci aktualnog ispitivanja kardiovaskularnih ishoda tijekom ocjene iako je CHMP preporučio kontinuirano praćenje kardiovaskularnog djelovanja lijeka.
English: Mysimba is available as prolonged-release tablets containing 7.2 mg naltrexone and 78 mg bupropion and can only be obtained with a prescription.
Croatian: Mysimba je dostupan kao tablete s produljenim otpuštanjem koje sadrže 7,2 mg naltreksona i 78 mg bupropiona, te se izdaje samo na liječnički recept.
English: Why is Mysimba approved?
Croatian: Zašto je Mysimba odobren?
English: What measures are being taken to ensure the safe and effective use of Mysimba?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mysimba?
English: What is Mysimba and what is it used for?
Croatian: Što je Mysimba i za što se koristi?
English: The treatment effect was more marked in patients who completed 56 weeks of treatment, or who had lost at least 5% of their original body weight by 4 months.
Croatian: Djelovanje terapije bio je uočljivije u bolesnika koji su završili 56 tjedana terapije ili koji su izgubili najmanje 5% svoje početne tjelesne mase u roku od 4 tjedana.
English: The most common side effects with Mysimba (which may affect more than 1 in 10 people) are nausea and vomiting (feeling and being sick) and constipation; dizziness and dry mouth were also common (seen in up to 1 patient in 10).
Croatian: Najčešće nuspojave lijeka Mysimba (mogu se javiti u više od 1 na 10 osoba) su mučnina i povraćanje (osjećaj slabosti) i zatvor; omaglica i suha usta su bili također česti (uočeni kod 1 na 10 bolesnika).
English: The main measures of effectiveness were the percentage reduction in body weight over 28 or 56 weeks of treatment, and the proportion of patients who achieved at least a 5% weight reduction; the studies also looked at the number of patients who achieved at least a more stringent 10% reduction in weight, and the results were analysed using various methods to take account of the number of patients who did not complete the studies (around 50% over one year).
Croatian: Glavna mjera djelotvornosti bilo je smanjenje postotka u tjelesnoj masi tijekom 28 ili 56 tjedana, te udio bolesnika koji je postigao smanjenje tjelesne težine od najmanje 5%; ispitivanja su također istražila broj bolesnika koji je postigao strože smanjenje u tjelesnoj težini od 10%, te su rezultati analizirani primjenom različitih metoda kao bi se u obzir uzeo broj bolesnika koji nisu završili ispitivanja (otprilike 50% tijekom godine dana).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that although the effectiveness of the medicine in promoting weight loss was limited, it was sufficient to be clinically significant, and mandatory re-assessment of treatment after 4 months should ensure that the medicine only continues to be used in those in whom the medicine provides adequate benefit.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da iako je djelotvornost lijeka u poticanju smanjenja tjelesne težine ograničena, bila je dostatna kako bi se mogla smatrati klinički značajna, te bi obavezna ponovna ocjena terapije nakon 4 mjeseca trebala osigurati da se lijek nastavi koristiti u osoba u kojih je pokazao primjerene koristi.