FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated in 09-2017.
Croatian: Sažetak je posljednji put ažuriran: 09. 2017.
English: The recommended dose is one 150 microgram capsule, once a day at the same time each day.
Croatian: Preporučena doza je jedna kapsula od 150 mikrograma, jednom dnevno u isto vrijeme svakog dana.
English: The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.
Croatian: Glavna mjera djelotvornosti temeljila se na promjenama forsiranog izdisajnog volumena u bolesnika (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u jednoj sekundi) nakon 12 tjedana.
English: The full EPAR for Onbrez Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Onbrez Breezhaler nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Croatian: Djeluje tako što se veže na beta-2 receptore koji se nalaze u mišićnim stanicama mnogih organa, a to dovodi do opuštanja mišića.
English: This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Croatian: To dovodi do opuštanja mišića dišnih putova, što pomaže održati dišne putove otvorenima i omogućava bolesniku lakše disanje.
English: The increase in FEV1 was 130 ml with tiotropium, and 80 ml with formoterol.
Croatian: Povećanje vrijednosti FEV1 iznosilo je 130 ml uz primjenu tiotropija i 80 ml uz formoterol.
English: Overall, the effects of the 150 and 300 microgram doses of Onbrez Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Croatian: Sveukupno, učinci doza lijeka Onbrez Breezhaler od 150 i 300 mikrograma bili su slični, ali rezultati su pokazali da bolesnicima s težom bolesti veće olakšanje može pružiti doza od 300 mikrograma.
English: The medicine contains the active substance indacaterol.
Croatian: Lijek sadržava djelatnu tvar indakaterol.
English: To receive a dose, the patient places a capsule into the inhaler and breathes the powder in through the mouth.
Croatian: Kako bi uzeli potrebnu dozu, bolesnici trebaju staviti kapsulu u inhalator i kroz usta udahnuti prašak iz kapsule.
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 su dišni putovi i plućni mjehurići oštećeni ili začepljeni, što dovodi do otežanog disanja.
English: In three main studies involving over 4,000 patients with COPD, Onbrez Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Croatian: U tri glavna ispitivanja koja su obuhvatila više od 4000 bolesnika s KOPB-om, Onbrez Breezhaler uspoređen je s placebom (prividno liječenje), tiotropijem ili formoterolom (drugi lijekovi za inhalaciju kojima se liječi KOPB).
English: Other common side effects include chest pain, cough and muscle cramps.
Croatian: Druge česte nuspojave uključuju bol u prsnom košu, kašalj i grčeve mišića.
English: On average, the increase in FEV1 in patients who received Onbrez Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Croatian: Povećanje vrijednosti FEV1 u bolesnika koji su primili Onbrez Breezhaler iznosilo je u prosjeku između 150 i 190 ml, dok se u bolesnika koji su primali placebo promjena FEV1 kretala u rasponu od smanjenja od 10 ml do povećanja od 20 ml.
English: The most common side effects with Onbrez Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Croatian: Najčešće nuspojave lijeka Onbrez Breezhaler (koje se mogu javiti u više od 1 na 10 osoba) jesu nazofaringitis (upala nosa i grla) i infekcija gornjeg dišnog sustava (infekcija nosa i grla).
English: This is a summary of the European public assessment report (EPAR) for Onbrez Breezhaler.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Onbrez Breezhaler.
English: Onbrez Breezhaler is used for maintenance (regular) treatment.
Croatian: Onbrez Breezhaler primjenjuje se za (redovitu) terapiju održavanja.
English: European Commission granted a marketing authorisation valid throughout the European Union for Onbrez Breezhaler on 30 November 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Onbrez Breezhaler u promet koje vrijedi na prostoru Europske unije od 30. studenoga 2009.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onbrez Breezhaler 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 Onbrez Breezhaler nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Onbrez Breezhaler capsules, which contain a power for inhalation, are only used with a Onbrez Breezhaler inhaler and must not be swallowed.
Croatian: Kapsule lijeka Onbrez Breezhaler, koje sadržavaju prašak inhalata, primjenjuju se samo s inhalatorom za Onbrez Breezhaler i ne smiju se progutati.
English: Therefore, the Agency decided that Onbrez Breezhaler's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Agencija je stoga odlučila da koristi lijeka Onbrez Breezhaler nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: Onbrez Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Croatian: Onbrez Breezhaler je lijek koji se primjenjuje kako bi se dišne putove u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (KOPB) držalo otvorenima.
English: The European Medicines Agency concluded that Onbrez Breezhaler was shown to be effective at improving the lung function in COPD.
Croatian: Europska agencija za lijekove zaključila je da se Onbrez Breezhaler pokazao učinkovitim u poboljšanju funkcije pluća kod KOPB-a.
English: The Agency also noted that there were no major safety concerns with Onbrez Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Croatian: Agencija je također zaključila da nisu ustanovljeni razlozi za ozbiljnu zabrinutost u pogledu sigurnosti lijeka Onbrez Breezhaler te da se nuspojave mogu liječiti i slične su onima drugih agonista beta-2 adrenergičkih receptora.
English: What measures are being taken to ensure the safe and effective use of Onbrez Breezhaler?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Onbrez Breezhaler?
English: The active substance in Onbrez Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Croatian: Djelatna tvar lijeka Onbrez Breezhaler je indakaterol, agonist beta-2 adrenergičkih receptora.
English: For more information about treatment with Onbrez Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Onbrez Breezhaler pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Onbrez Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Croatian: Onbrez Breezhaler pokazao se učinkovitijim od placeba u poboljšanju rada pluća u bolesnika s KOPB-om.
English: When Onbrez Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them.
Croatian: Udisanjem lijeka Onbrez Breezhaler, indakaterol dospijeva do receptora u dišnim putovima i aktivira ih.
English: Onbrez Breezhaler indacaterol
Croatian: Onbrez Breezhaler indakaterol
English: What is Onbrez Breezhaler and what is it used for?
Croatian: Što je Onbrez Breezhaler i za što se koristi?
English: The doctor may increase the dose to one 300 microgram capsule once a day in cases of severe COPD.
Croatian: U slučaju teškog KOPB-a, liječnik može povećati dozu na jednu kapsulu od 300 mikrograma jednom dnevno.
English: For practical information about using Onbrez Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Onbrez Breezhaler bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svom liječniku ili ljekarniku.
English: It is not intended to provide practical advice on how to use Onbrez Breezhaler.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Onbrez Breezhaler.
English: Other information about Onbrez Breezhaler
Croatian: Ostale informacije o lijeku Onbrez Breezhaler
English: What are the risks associated with Onbrez Breezhaler?
Croatian: Koji su rizici povezani s lijekom Onbrez Breezhaler?
English: For the full list of all side effects and restrictions with Onbrez Breezhaler, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Onbrez Breezhaler potražite u uputi o lijeku.
English: Why is Onbrez Breezhaler approved?
Croatian: Zašto je lijek Onbrez Breezhaler odobren?
English: How is Onbrez Breezhaler used?
Croatian: Kako se Onbrez Breezhaler koristi?
English: How does Onbrez Breezhaler work?
Croatian: Kako djeluje Onbrez Breezhaler?
English: What benefits of Onbrez Breezhaler have been shown in studies?
Croatian: Koje su koristi lijeka Onbrez Breezhaler utvrđene u ispitivanjima?
English: Their frequency is unknown.
Croatian: Njihova učestalost nije poznata.
English: The expressed juice may then be dried.
Croatian: Istisnuti sok se zatim može osušiti.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Croatian: To znači da postoje bibliografski podaci koji pružaju znanstvene dokaze o njihovoj učinkovitoj i sigurnoj primjeni kada se koriste na opisani način, a pokrivaju razdoblje od najmanje 10 godina u EU.
English: The flowering aerial parts for medicinal uses are obtained from plants that have been cultivated or found in the wild.
Croatian: Cvjetajući nadzemni dijelovi za medicinsku uporabu dobivaju se iz biljaka koje su kultivirane ili pronađene u divljini.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da, iako postoji nedovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna i postoje dokazi o njihovoj sigurnoj primjeni na opisani način najmanje 30 godina (uključujući najmanje 15 godina u EU).
English: When used for prevention and treatment of common cold, cases of serious allergic reactions (such as Stevens-Johnson syndrome, asthma and anaphylactic shock) have been reported, especially in patients who are atopic (have a predisposition to allergic reactions).
Croatian: Prilikom primjene za sprječavanje i liječenje prehlade, zabilježeni su slučajevi ozbiljnih alergijskih reakcija (poput Stevens-Johnsonovog sindroma, astme i anafilaktičkog šoka), posebice u bolesnika koji su atopičari (imaju predispoziciju na alergijske reakcije).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom persist for more than one week.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20. listopada 2015. EMA/481797/2015
English: However, these data were insufficient to be used as evidence of effectiveness and the HMPC conclusions for this indication are based on the medicines' long-standing use.
Croatian: No, ovi podaci su nedostatni da bi se koristili kao dokaz o učinkovitosti, te je HMPC temeljio svoje zaključke za ovu indikaciju na dugotrajnoj uporabi lijekova.
English: The HMPC noted possible beneficial effects on wound healing in animal studies.
Croatian: HMPC je naveo moguće korisno djelovanje na zarastanje rana u ispitivanjima na životinjama.
English: Purple coneflower herb medicines should only be used in adults and adolescents above the age of 12 years.
Croatian: Lijekovi koji sadrže zelen purpurne rudbekije smiju se koristiti samo u odraslih osoba i adolescenata starijih od 12 godina.
English: For further information on the studies assessed by the HMPC, see the HMPC assessment report.
Croatian: Za podrobnije informacije o ispitivanjima koje je HMPC ocijenio pogledajte izvješće HMPC-a o ocjeni lijeka.
English: A doctor or pharmacist should be consulted if symptoms persist for more than 10 days when using purple coneflower herb medicines for the treatment of common colds.
Croatian: Potrebno je potražiti savjet liječnika ili ljekarnika ako se simptomi nastave dulje od 10 dana prilikom primjene lijekova koji sadrže zelen purpurne rudbekije za liječenje prehlade.
English: Purple coneflower herb is the common name for the flowering aerial parts of the plant Echinacea purpurea (L.) Moench.
Croatian: Zelen purpurne rudbekije je uobičajeni naziv za cvjetajuće nadzemne dijelove biljke Echinacea purpurea (L.) Moench.
English: Any applications for the licensing of medicines containing purple coneflower herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže zelen purpurne rudbekije moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Purple coneflower herb medicines must not be used in patients who are hypersensitive (allergic) to purple coneflower or other plants of the Asteraceae (Compositae) family.
Croatian: Lijekovi koji sadrže zelen purpurne rudbekije ne smiju se koristiti u bolesnika koji su preosjetljivi (alergični) na purpurnu rudbekiju ili na druge biljke iz porodice Asteraceae (Compositae).
English: Further information on the HMPC assessment of purple coneflower herb medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže zelen purpurne rudbekije, uključujući pojedinosti zaključaka Povjerenstva, nalaze se u dokumentu u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: For the treatment of superficial wounds, a doctor or a qualified healthcare practitioner should be consulted if symptoms
Croatian: Za potrebe liječenja površinskih rana potrebno je savjetovati se s liječnikom ili kvalificiranim zdravstvenim djelatnikom u slučaju da se simptomi nastave dulje od tjedan dana.
English: Herbal medicines containing purple coneflower herb preparations are usually available in liquid or solid forms to be taken by mouth and in semi-solid (such as ointments) or liquid forms to be applied to the skin.
Croatian: Biljni lijekovi koji sadrže zelen purpurne rudbekije najčešće su dostupni u tekućim ili krutim oblicima koji se uzimaju kroz usta te u polukrutim (poput primjerice masti) ili tekućim oblicima koji se primjenjuju na kožu.
English: Further information on the risks associated with purple coneflower herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže zelen purpurne rudbekije, uključujući odgovarajuće mjere opreza za njihovu sigurnu uporabu, nalazi se u monografiji u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The most relevant clinical trials performed in adults indicated that purple coneflower herb medicines containing the expressed juice to be taken by mouth can prevent and improve the symptoms of cold more rapidly than placebo when taken early.
Croatian: Najznačajnija klinička ispitivanja provedena u odraslih osoba ukazuju da lijekovi predviđeni za primjenu kroz usta koji sadrže istisnuti sok zeleni purpurne rudbekije mogu spriječiti i poboljšati simptome prehlade brže od placeba kada se uzmu u ranoj fazi bolesti.
English: Information on the use and licensing of purple coneflower leaf medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže zelen purpurne rudbekije u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: In its assessment, the HMPC considered a number of clinical studies comparing purple coneflower herb medicines with placebo for short-term prevention and treatment of upper airways infections.
Croatian: U svojoj ocjeni, HMPC je razmotrio niz kliničkih ispitivanja uspoređujući lijekove koji sadrže zelen purpurne rudbekije s placebom za kratkoročnu prevenciju i liječenje infekcija gornjih dišnih putova.
English: This summary is not intended to provide practical advice on how to use medicines containing purple coneflower herb.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže zelen purpurne rudbekije.
English: The HMPC also concluded that, on the basis of their long-standing use, purple coneflower herb medicines to be applied to the skin can be used to treat small superficial wounds.
Croatian: HMPC je također zaključio da se, na temelju njihove dugotrajne primjene, lijekovi koji sadrže zelen purpurne rudbekije za primjenu na koži mogu koristiti za liječenje malih površinskih rana.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing purple coneflower herb.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže zelen purpurne rudbekije.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of purple coneflower herb.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe zeleni purpurne rudbekije.
English: The HMPC conclusions on the use of purple coneflower herb medicines for superficial wounds are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže zelen purpurne rudbekije za površinske rane temelje se na njihovoj "tradicionalnoj primjeni".
English: The HMPC conclusions on the short-term use of purple coneflower herb medicines to prevent and treat common cold are based on their ‘well-established use' in this indication.
Croatian: Zaključci HMPC-a o kratkotrajnoj uporabi zeleni purpurne rudbekije za sprječavanje i liječenje prehlade temelji se na njihovoj "provjerenoj medicinskoj uporabi" u ovoj indikaciji.
English: Detailed instructions on how to take purple coneflower herb medicines and who can use them can be found in the package leaflets that come with the medicines.
Croatian: Detaljne upute o načinu primjene lijekova koji sadrže zelen purpurne rudbekije kao i o tome tko ih može koristiti navedene su u uputi o lijeku priloženoj uz lijek.
English: Purple coneflower herb preparations are made by expressing the juice of the fresh herb.
Croatian: Pripravci zeleni purpurne rudbekije proizvode se istiskivanjem soka iz svježe biljke.
English: For more information about treatment with purple coneflower herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže zelen purpurne rudbekije pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using purple coneflower herb medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže zelen purpurne rudbekije bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svojem liječniku ili ljekarniku.
English: What is purple coneflower herb?
Croatian: Što je zelen purpurne rudbekije?
English: What are the risks associated with purple coneflower herb medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže zelen purpurne rudbekije?
English: Other information about purple coneflower herb medicines
Croatian: Ostale informacije o lijekovima koji sadrže zelen purpurne rudbekije
English: What evidence supports the use of purple coneflower herb medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže zelen purpurne rudbekije?
English: The HMPC concluded that purple coneflower herb medicines to be taken by mouth can be used short term for the prevention and treatment of common colds.
Croatian: HMPC je zaključio da se lijekovi koji sadrže zelen purpurne rudbekije, a uzimaju se kroz usta, mogu koristiti kratko vrijeme za sprječavanje i liječenje prehlade.
English: Purple coneflower herb
Croatian: Zelen purpurne rudbekije
English: How are purple coneflower herb medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže zelen purpurne rudbekije?
English: Allergic reactions such as rash have been reported with the use of purple coneflower herb medicines.
Croatian: Tijekom primjene lijekova koji sadrže zelen purpurne rudbekije prijavljene su alergijske reakcije poput osipa.
English: The tablets contain 100, 200, 400, 600 or 800 micrograms of fentanyl.
Croatian: Tablete sadrže 100, 200, 400, 600 ili 800 mikrograma fentanila.
English: After 30 minutes, any pieces of tablet remaining can be swallowed with a glass of water.
Croatian: Nakon 30 minuta, bilo koji preostali dio tablete može se progutati sa čašom vode.
English: There must be a gap of at least four hours between treating each episode of pain.
Croatian: Mora postojati vremenski odmak od najmanje četiri sata između liječenja svake epizode boli.
English: This medicine can only be obtained by ‘special' prescription.
Croatian: Ovaj se lijek izdaje samo na „poseban” liječnički recept.
English: Alternatively, the tablets can be placed under the tongue.
Croatian: Tablete se alternativno mogu također staviti ispod jezika.
English: Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out.
Croatian: Budući da se fentanil koristi tijekom mnogo godina, tvrtka je dostavila podatke iz znanstvene literature kao i iz ispitivanja koja je provela.
English: It is a well-known substance, which has been used to control pain for many years.
Croatian: On je dobro poznata tvar koja je korištena za kontrolu boli tijekom dugog niza godina.
English: The tablets should not be broken or crushed, and they should not be sucked, chewed or swallowed whole.
Croatian: Tablete se ne smiju lomiti ili drobiti, te ih se ne smije sisati, žvakati ili gutati cijele.
English: The patient should be monitored carefully while the dose is increased.
Croatian: Bolesnika treba pažljivo pratiti tijekom povećavanja doze.
English: Each patient ranked their pain intensity on an 11-point scale.
Croatian: Svaki je bolesnik rangirao svoj intenzitet boli na skali od 11 bodova.