FrancophonIA/ELRC3.0 huggingface dataset:
English: When treating actinic keratosis growths, Ameluz can also be activated by exposure to full daylight.
Croatian: Pri liječenju izraslina aktiničke keratoze lijek Ameluz također se može aktivirati izlaganjem punom intenzitetu dnevne svjetlosti.
English: Ameluz was at least as effective as Metvix in this study, with cancerous lesions clearing up in 93% (113 out of 121) of patients treated with Ameluz and 92% (101 out of 110) of those treated with the comparator medicine.
Croatian: U tom ispitivanju Ameluz se pokazao barem jednako učinkovitim kao i Metvix jer su se kancerozne lezije povukle u 93 % (113 od 121) bolesnika liječenih lijekom Ameluz i u 92 % (101 od 110) bolesnika liječenih usporednim lijekom.
English: Ameluz is a medicine used in adults to treat mild to moderate actinic keratoses on the face and scalp as well as the surrounding areas of the skin affected by the condition.
Croatian: Ameluz je lijek koji se primjenjuje u odraslih osoba za liječenje blagog do umjerenog stupnja aktiničke keratoze na licu i vlasištu te na okolnim područjima kože zahvaćenima bolešću.
English: It may also be used to treat an area of sun-induced skin damage with multiple actinic keratosis growths (field cancerisation).
Croatian: Također se može koristiti za liječenje oštećenja kože uzrokovanih izlaganjem suncu s višestrukim izraslinama aktiničke keratoze (početna zloćudna transformacija).
English: What benefits of Ameluz have been shown in studies?
Croatian: Koje su koristi lijeka Ameluz utvrđene u ispitivanjima?
English: A further study in 52 patients with actinic keratosis found that Ameluz was at least as effective as Metvix at clearing actinic keratosis when used in combination with daylight.
Croatian: U dodatnom ispitivanju na 52 bolesnika s aktiničkom keratozom utvrđeno je da je Ameluz pri primjeni u kombinaciji s dnevnom svjetlosti barem jednako učinkovit u uklanjanju aktiničke keratoze kao i lijek Metvix.
English: The condition cleared up in 91% (50 out of 55) of patients given Ameluz, compared with 22% (7 out of 32) given placebo.
Croatian: Stanje se povuklo u 91 % (50 od 55) bolesnika koji su primili Ameluz, u usporedbi s 22 % (7 od 32) bolesnika koji su primili placebo.
English: Actinic keratosis cleared up in 78% (194 out of 248) of patients treated with Ameluz, compared with 64% (158 out of 246) of patients treated with Metvix and 17% (13 out of 76) of patients treated with placebo.
Croatian: Aktinička keratoza povukla se u 78 % (194 od 248) bolesnika liječenih lijekom Ameluz, u usporedbi sa 64 % (158 od 246) bolesnika liječenih lijekom Metvix i 17 % (13 od 76) bolesnika koji su primali placebo.
English: How is Ameluz used?
Croatian: Kako se Ameluz koristi?
English: In the third study involving 87 patients with field cancerisation (an area of sun damage with several actinic keratosis growths), Ameluz was compared with placebo used for one together with a red light or two treatment sessions.
Croatian: U trećem ispitivanju koje je uključivalo 87 bolesnika s početnom zloćudnom transformacijom (područje oštećenja zbog sunca s nekoliko izraslina aktiničke keratoze) Ameluz je uspoređen s placebom primijenjenim jedanput ili dvaput u kombinaciji s liječenjem crvenom svjetlosti.
English: Actinic keratosis cleared up in 66% (53 out of 80) of patients treated with Ameluz, compared with 13% (5 out of 40) of patients treated with placebo.
Croatian: Aktinička keratoza povukla se u 66 % (53 od 80) bolesnika liječenih lijekom Ameluz, u usporedbi s 13 % (5 od 40) bolesnika liječenih placebom.
English: How does Ameluz work?
Croatian: Kako djeluje Ameluz?
English: In the first main study involving 571 patients, Ameluz was compared with placebo and Metvix, a product containing methylaminolaevulinate, used together with a red light for one or two treatment sessions.
Croatian: U prvom glavnom ispitivanju koje je uključivalo 571 bolesnika Ameluz je uspoređen s placebom i lijekom Metvix, proizvodom koji sadrži metilaminolevulinat, primijenjenim jedanput ili dvaput u kombinaciji s liječenjem crvenom svjetlosti.
English: In the second main study involving 122 patients, Ameluz was compared with placebo used together with a red light for one or two treatment sessions.
Croatian: U drugom glavnom ispitivanju koje je uključivalo 122 bolesnika lijek Ameluz uspoređen je s placebom primijenjenim jedanput ili dvaput u kombinaciji s liječenjem crvenom svjetlosti.
English: When the affected skin is exposed to light,
Croatian: Nakon izlaganja zahvaćene kože
English: This overview was last updated in 03-2018.
Croatian: Više informacija o lijeku Ameluz možete naći na internetskim stranicama Agencije: Sažetak je posljednji put ažuriran u 03. 2018.
English: For the full list of side effects reported with Ameluz, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih prilikom primjene lijeka Ameluz potražite u uputi o lijeku.
English: Further information on Elebrato Ellipta can be found on the Agency's website: ema.europa.eu/ medicines/human/EPAR/elebrato-ellipta.
Croatian: Više informacija o lijeku Elebrato Ellipta nalazi se na internetskim stranicama Agencije: ema.europa.eu/ medicines/human/EPAR/elebrato-ellipta.
English: Elebrato Ellipta receiveda marketing authorisation valid throughout the EU on 15 November 2017.
Croatian: Lijek Elebrato Ellipta dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 15. studenoga 2017.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors (targets) in various types of immune cells.
Croatian: Djeluje na sličan način kao prirodni kortikosteroidni hormoni, tj. smanjuje aktivnost imunosnog sustava spajanjem na receptore (ciljeve) u raznim vrstama imunosnih stanica.
English: Elebrato Ellipta is used for maintenance (regular) treatment on a daily basis.
Croatian: Lijek Elebrato Ellipta primjenjuje se u svakodnevnoj (redovnoj) terapiji održavanja.
English: After 24 weeks, patients taking Elebrato Ellipta had their FEV1 (the maximum volume of air they could breathe out in one second) improve by 142 ml.
Croatian: Nakon 24 tjedna kod bolesnika koji su uzimali lijek Elebrato Ellipta došlo je do poboljšanja vrijednosti FEV1 (najveće količine zraka koju osoba može izdahnuti u jednoj sekundi) za 142 ml.
English: Elebrato Ellipta (fluticasone furoate / umeclidinium bromide / vilanterol)
Croatian: Elebrato Ellipta (flutikazonfuroat / umeklidinijev bromid / vilanterol)
English: This compares with an average reduction of 29 ml seen in patients taking the combination of budesonide and formoterol over the same period.
Croatian: To se može usporediti s prosječnim smanjenjem od 29 ml zabilježenim kod bolesnika koji su tijekom istog razdoblja uzimali kombinaciju budezonida i formoterola.
English: The most common side effects with Elebrato Ellipta (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache and upper respiratory tract infection (nose and throat infection).
Croatian: Najčešće nuspojave lijeka Elebrato Ellipta (koje se mogu javiti u najviše 1 na 10 osoba) jesu nazofaringitis (upala nosa i grla), glavobolja i infekcija gornjeg dišnog sustava (infekcija nosa i grla).
English: It works by blocking muscarinic receptors, which are involved in the contraction of muscles.
Croatian: Djeluje blokirajući muskarinske receptore koji sudjeluju u kontrakciji mišića.
English: What measures are being taken to ensure the safe and effective use of Elebrato Ellipta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Elebrato Ellipta?
English: What is Elebrato Ellipta and what is it used for?
Croatian: Što je Elebrato Ellipta i za što se primjenjuje?
English: Side effects reported with Elebrato Ellipta are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Elebrato Ellipta pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Regarding the safety profile of the medicine, the most frequent side effects reported with Elebrato Ellipta were similar to those with the individual active substances of the medicine and are well known.
Croatian: Što se tiče sigurnosnog profila lijeka, najčešće nuspojave zabilježene prilikom primjene lijeka Elebrato Ellipta bile su slične nuspojavama koje se javljaju prilikom primjene pojedinačnih djelatnih tvari lijeka i dobro su poznate.
English: It contains the active substances fluticasone furoate, umeclidinium bromide and vilanterol.
Croatian: Sadrži djelatne tvari flutikazonfuroat, umeklidinijev bromid i vilanterol.
English: The European Medicines Agency therefore decided that Elebrato Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Elebrato Ellipta nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elebrato Ellipta have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Elebrato Ellipta nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: As for all medicines, data on the use of Elebrato Ellipta are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Elebrato Ellipta kontinuirano se prate.
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 oštećenja ili začepljenja dišnih putova i zračnih vrećica u plućima, što dovodi do poteškoća pri disanju.
English: Elebrato Ellipta is used in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a longacting muscarinic antagonist.
Croatian: Lijek Elebrato Ellipta primjenjuje se u odraslih osoba čija bolest nije dovoljno kontrolirana kombinacijom inhaliranih lijekova koji se sastoje od dugodjelujućeg beta-2 agonista uz primjenu kortikosteroida ili dugodjelujućeg muskarinskog antagonista.
English: An overview of Elebrato Ellipta and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Elebrato Ellipta i zašto je odobren u EU-u
English: In this study, Elebrato Ellipta reduced the rate of moderate and severe exacerbations over one year by 15% compared with treatment with vilanterol and fluticasone furoate, and by 25% compared with treatment with vilanterol and umeclidinium bromide.
Croatian: U tom je ispitivanju lijek Elebrato Ellipta za 15 % smanjio stopu umjerenih i teških pogoršanja tijekom godine dana u usporedbi s vilanterolom i flutikazonfuroatom te za 25 % u usporedbi s liječenjem vilanterolom i umeklidinijevim bromidom.
English: For more information about using Elebrato Ellipta, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Elebrato Ellipta pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Other information about Elebrato Ellipta
Croatian: Ostale informacije o lijeku Elebrato Ellipta
English: When inhaled, vilanterol activates the beta-2 receptors in the airways.
Croatian: Prilikom inhalacije vilanterol aktivira beta-2 receptore u dišnim putovima.
English: Patients treated with Elebrato Ellipta also reported improved health compared with those treated with the comparator treatment.
Croatian: Kod bolesnika liječenih lijekom Elebrato Ellipta također je zabilježeno poboljšanje zdravstvenog stanja u usporedbi s bolesnicima koji su liječeni usporednim lijekom.
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 zbog čega bolesnik lakše diše.
English: What are the risks associated with Elebrato Ellipta?
Croatian: Koji su rizici povezani s lijekom Elebrato Ellipta?
English: Elebrato Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Croatian: Elebrato Ellipta lijek je kojim se ublažavaju simptomi umjerene do teške kronične opstruktivne plućne bolesti (KOPB).
English: Elebrato Ellipta contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.
Croatian: Elebrato Ellipta sadrži tri djelatne tvari koje različito djeluju s ciljem proširenja dišnih putova i poboljšanja disanja u bolesnika s KOPB-om.
English: Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Elebrato Ellipta more effective at improving patients' breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.
Croatian: U drugom ispitivanju koje je obuhvatilo 1 810 bolesnika kod kojih KOPB nije bio u zadovoljavajućoj mjeri kontroliran dnevnom terapijom održavanja, utvrđeno je da je lijek Elebrato Ellipta učinkovitiji u poboljšanju disanja bolesnika od inhalirane kombinacije kortikosteroida budezonida i dugodjelujućeg beta-2 agonista formoterola.
English: When umeclidinium bromide is inhaled, it causes the muscles of the airways to relax.
Croatian: Prilikom inhalacije umeklidinijeva bromida dolazi do opuštanja mišića dišnih putova.
English: Why is Elebrato Ellipta authorised in the EU?
Croatian: Zašto je lijek Elebrato Ellipta odobren u EU-u?
English: This reduces the release of substances involved in the inflammation process, such as histamine, thereby reducing inflammation and helping to keep the airways clear and allowing the patient to breathe more easily.
Croatian: Time se smanjuje otpuštanje tvari koje sudjeluju u procesu upale, poput histamina, čime se smanjuje upala, a dišni putovi ostaju prohodni, zbog čega bolesnik lakše diše.
English: Elebrato Ellipta can only be obtained with a prescription.
Croatian: Lijek Elebrato Ellipta izdaje se samo na liječnički recept.
English: It is available as an inhalation powder, which the patient inhales through the mouth using a portable inhaler device; the patient should inhale the medicine once a day at around the same time each day.
Croatian: Dostupan je kao prašak inhalata koji bolesnik inhalira kroz usta s pomoću prijenosnog inhalatora.
English: Elebrato Ellipta improves lung function as well as the quality of life of patients with moderate to severe COPD.
Croatian: Lijek Elebrato Ellipta poboljšava funkciju pluća i kvalitetu života u bolesnika s umjerenim do teškim KOPB-om.
English: What benefits of Elebrato Ellipta have been shown in studies?
Croatian: Koje su koristi od lijeka Elebrato Ellipta utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions with Elebrato Ellipta, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Elebrato Ellipta potražite u uputi o lijeku.
English: A study compared Elebrato Ellipta with either vilanterol given with fluticasone furoate or vilanterol with umeclidinium bromide, in 10,355 patients with advanced COPD who were at risk of exacerbations and whose disease was not satisfactorily controlled with a daily maintenance treatment.
Croatian: Ispitivanje je provedeno na 10 355 bolesnika s uznapredovalim stadijem KOPB-a koji su bili u opasnosti od pogoršanja bolesti i čija bolest nije bila dovoljno dobro kontrolirana dnevnom terapijom održavanja.
English: How does Elebrato Ellipta work?
Croatian: Kako djeluje Elebrato Ellipta?
English: How is Elebrato Ellipta used?
Croatian: Kako se primjenjuje Elebrato Ellipta?
English: Elebrato Ellipta was shown to improve patients' breathing and reduce exacerbations (flare-ups) of the disease in 2 main studies.
Croatian: U dvama glavnim ispitivanjima dokazano je da lijek Elebrato Ellipta pomaže bolesnicima u disanju i smanjuje pogoršanja (razbuktavanja) bolesti.
English: What is Senstend and what is it used for?
Croatian: Što je Senstend i za što se koristi?
English: Further information on Senstend can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/senstend.
Croatian: Više informacija o lijeku Senstend nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/senstend.
English: Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours.
Croatian: Doze se ne smiju ponavljati češće od svakih četiri sata, a unutar 24 sata ne smije se primijeniti više od tri doze.
English: Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.
Croatian: Neki su bolesnici bili pod nadzorom do devet mjeseci u nastavku inicijalnih ispitivanja te su nastavili pokazivati sličan napredak.
English: This medicine is the same as Fortacin, which is already authorised in the EU.
Croatian: Ovaj lijek isti je kao lijek Fortacin, koji je već odobren u EU-u.
English: Senstend (lidocaine / prilocaine)
Croatian: Senstend (lidokain/prilokain)
English: The company that makes Fortacin has agreed that its scientific data can be used for Senstend (‘informed consent').
Croatian: Tvrtka koja proizvodi lijek Fortacin pristala je da se njezini znanstveni podatci upotrijebe za Senstend („informirani pristanak”).
English: Senstend (lidocaine / prilocaine) EMA/519240/2019
Croatian: Senstend (lidokain/prilokain) EMA/519240/2019
English: It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration).
Croatian: Koristi se za liječenje muškaraca s primarnom (doživotnom) preuranjenom ejakulacijom (kada do ejakulacije redovito dolazi prije ili puno prerano tijekom penetracije).
English: The most common side effects with Senstend (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men.
Croatian: Najčešće nuspojave lijeka Senstend (koje se mogu javiti u do 1 na 10 osoba) su hipoestezija (smanjeni osjet) i osjećaj peckanja u genitalnom području u muškaraca i njihovih ženskih seksualnih partnera te erektilna disfunkcija (nemogućnost održavanja normalne erekcije) kod muškaraca.
English: What measures are being taken to ensure the safe and effective use of Senstend?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Senstend?
English: Other information about Senstend
Croatian: Ostale informacije o lijeku Senstend
English: Side effects reported with Senstend are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Senstend pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: There were also positive psychological benefits to patients and their partners, and side effects were local and generally manageable.
Croatian: Također su zabilježene i pozitivne psihološke koristi za bolesnike i njihove partnere te su nuspojave bile lokalne i moglo ih se kontrolirati.
English: This reduces sensitivity to stimulation, and when applied onto the head of the penis this will help to increase the time taken to ejaculate.
Croatian: Time se smanjuje osjetljivost na stimulaciju, a primjena na glavić penisa pomaže u produljenju vremena potrebnog za ejakulaciju.
English: Senstend must also not be used in patients whose partners are hypersensitive to these substances.
Croatian: Senstend se ne smije primjenjivati u bolesnika čiji su partneri preosjetljivi na te tvari.
English: As for all medicines, data on the use of Senstend are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Senstend kontinuirano se prate.
English: The main measures of effectiveness were the time taken to ejaculate after penetration and the amount of control over ejaculation, sexual satisfaction and distress reported by the patients.
Croatian: Glavno mjerilo učinkovitosti bilo je vrijeme koje je nakon penetracije proteklo do ejakulacije i količina kontrole nad ejakulacijom, seksualnim zadovoljstvom i tjeskobom koje su prijavili bolesnici.
English: An overview of Senstend and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Senstend i zašto je odobren u EU-u
English: Senstend is a medicine containing the active substances lidocaine and prilocaine.
Croatian: Senstend je lijek koji sadrži djelatne tvari lidokain i prilokain.
English: The Agency therefore decided that Senstend's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Senstend nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves.
Croatian: Djelatne tvari u lijeku, lidokain i prilokain, lokalni su anestetici koji privremeno umrtve kontaktno područje reverzibilnom blokadom prijenosa signala u živcima.
English: The European Medicines Agency considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole.
Croatian: Europska agencija za lijekove smatrala je da su djelatne tvari dobro poznata kombinacija lokalnih anestetika te da se lokalnom primjenom spreja smanjuje količina djelatne tvari koju se apsorbira, a time i opasnost od nuspojava koje utječu na cijelo tijelo.
English: Why is Senstend authorised in the EU?
Croatian: Zašto je lijek Senstend odobren u EU-u?
English: Senstend must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amidetype local anaesthetics).
Croatian: Senstend se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na bilo koji od sastojaka lijeka ili na druge anestetike čija je struktura slična onima djelatnih tvari (lokalnim anesteticima amidnog tipa).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Senstend 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 Senstend nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Senstend can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray.
Croatian: Senstend se izdaje samo na recept i dostupan je u otopini u obliku spreja u kojoj svaki potisak sadrži 7,5 mg lidokaina i 2,5 mg prilokaina.
English: For more information about using Senstend, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Senstend pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: What are the risks associated with Senstend?
Croatian: Koji su rizici povezani s lijekom Senstend?
English: In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo.
Croatian: U oba su ispitivanja bolesnici koji su primili lijek prijavili znatno veći napredak u pogledu kontrole, seksualnog zadovoljstva i tjeskobe u odnosu na skupinu koja je primila placebo.
English: The recommended dose is three sprays onto the head (glans) of the penis before intercourse.
Croatian: Preporučena je doza tri potiska na glavić (vrh) penisa prije seksualnog odnosa.