FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs include stomach (abdominal) area pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other symptoms listed above), itching.
Croatian: Znakovi uključuju bol ili nelagodu u području trbuha (abdomena), gubitak apetita, mučninu, povraćanje, žutu boju kože ili bjeloočnica
English: Tablet coat
Croatian: Ovojnica tablete:
English: sinus node dysfunction, atrial conduction defects, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
Croatian: • Atrioventrikularni blok drugog ili trećeg stupnja, potpuni blok grane Hisova snopa, distalni blok, disfunkcija sinusnog čvora, poremećaj atrijskog provođenja ili sindrom bolesnog sinusnog čvora (osim u bolesnika s ugrađenim elektrostimulatorom)
English: What is in this leaflet
Croatian: (vidjeti ispod)
English: You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when moving around, - if the percentage of blood leaving your heart each time it contracts is too low (condition called left ventricular dysfunction), - if you took amiodarone (another antiarrhythmic medicine) previously and experienced lung or liver problems, - if you take medicines for infection (including fungal infection or AIDS), allergies, heart beat problems, depression, after a transplant (see section below on “Other medicines and MULTAQ”.
Croatian: - ako uzimate lijekove za liječenje infekcije (uključujući gljivičnu infekciju ili AIDS), alergije, problema s otkucajima srca, depresije ili lijekove koji se propisuju nakon presađivanja organa (pogledajte dio "Drugi lijekovi i MULTAQ" u nastavku.
English: itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir (see section 4.5)
Croatian: • Istodobna primjena s potentnim inhibitorima CYP3A4 citokroma P450, poput ketokonazola, itrakonazola, vorikonazola, posakonazola, telitromicina, klaritromicina, nefazodona i ritonavira (vidjeti dio 4.5)
English: Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi intersticijske bolesti pluća, uključujući pneumonitis i plućnu fibrozu.
English: What MULTAQ is and what it is used for What you need to know before you take MULTAQ How to take MULTAQ
Croatian: Što se nalazi u ovoj uputi Što je MULTAQ i za što se koristi
English: Ageusia
Croatian: ATHENA.
English: • Problem where your heart does not adequately pump the blood round your body as well as it should (congestive heart failure) In clinical studies, this side effect was observed at a similar rate in patients receiving MULTAQ and in patients receiving placebo.
Croatian: U kliničkim je ispitivanjima ta nuspojava primijećena jednako često u bolesnika koji su primali MULTAQ i u bolesnika koji su primali placebo.
English: machine.
Croatian: OBLIK
English: In patients already on calcium antagonists or beta blockers at time of dronedarone initiation, an ECG should be performed and the dose should be adjusted if needed.
Croatian: U bolesnika koji u vrijeme započinjanja liječenja dronedaronom već uzimaju antagoniste kalcija ili beta-blokatore treba snimiti EKG
English: NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg film-coated tablets dronedarone
Croatian: Uputa o lijeku: Informacije za bolesnika MULTAQ 400 mg filmom obložene tablete dronedaron
English: • History of, or current heart failure or left ventricular systolic dysfunction
Croatian: • Bolesnici sa trenutnim ili u anamnezi zabilježenim zatajenjem srca ili sistoličkom disfunkcijom lijeve klijetke
English: How to store MULTAQ
Croatian: Moguće nuspojave Kako čuvati MULTAQ
English: quinidine, disopyramide, dofetilide, sotalol, amiodarone,
Croatian: propafenona, kinidina, dizopiramida, dofetilida, sotalola, amiodarona).
English: Lactose monohydrate Colloidal anhydrous silica Magnesium stearate (E572)
Croatian: hipromeloza (E464), kukuruzni škrob, krospovidon (E1202), poloksamer 407, laktoza hidrat, silicijev dioksid, koloidni, bezvodni, magnezijev stearat (E572).
English: and III antiarrhythmics (see section 4.5)
Croatian: (poput eritromicina), terfenadina te antiaritmika skupine I i III (vidjeti dio 4.3).
English: • your atrial fibrillation becomes permanent while you are taking MULTAQ.
Croatian: Dok uzimate MULTAQ, obavijestite svog liječnika: • ako fibrilacija atrija postane permanentna tijekom liječenja lijekom MULTAQ.
English: Dronedarone 800 mg daily increased metoprolol exposure by 1.6-fold and propranolol exposure by 1.3-fold (i.e. much below the 6-fold differences observed between poor and extensive CYP 2D6 metabolisers).
Croatian: Primjena dronedarona u dozi od 800 mg na dan povećala je izloženost metoprololu 1,6 puta, a propranololu 1,3 puta
English: MULTAQ.
Croatian: Ne
English: Sanofi S.p.A. Tel: 800.536389
Croatian: Tel: 800.536 389
English: Consequently, INR should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per their label.
Croatian: K mora pažljivo pratiti INR nakon početka liječenja dronedaronom.
English: The tablets should be taken at the same time each day.
Croatian: Tablete treba uzimati svakog dana u isto vrijeme.
English: The company is also carrying out an observational study on the long-term safety of the medicine.
Croatian: Tvrtka također provodi opservacijsko ispitivanje o dugoročnoj sigurnosti lijeka.
English: This overview was last updated in 03-2018.
Croatian: Pregled informacija posljednji je put ažuriran u 03-2018.
English: FEV1 is the most air a person can breathe out in one second.
Croatian: FEV1 je najveća količina zraka koju osoba može izdahnuti u jednoj sekundi.
English: Further information on Daxas can be found on the Agency's website: ema.europa/Find medicine/Human medicine/European public assessment reports.
Croatian: Više informacija o lijeku Daxas nalazi se na internetskim stranicama Agencije: ema.europa/Find medicine/Human medicine/European public assessment reports.
English: This benefit was seen on top of the effects of the treatments that the patients were already receiving.
Croatian: Ta se korist smatrala dodatkom drugim terapijama koje su već primali bolesnici.
English: Daxas received a marketing authorisation valid throughout the EU on 5 July 2010.
Croatian: Lijek Daxas dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u EU-u od 5. srpnja 2010.
English: What measures are being taken to ensure the safe and effective use of Daxas?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Daxas?
English: At the beginning of the studies, both groups of patients had an FEV1 of around 1 litre (1,000 ml).
Croatian: Na početku ispitivanja obje su skupine bolesnika imale FEV1 od otprilike 1 litre (1000 ml).
English: The doctor may stop treatment with Daxas if the patient loses too much weight.
Croatian: Liječnik može zaustaviti liječenje lijekom Daxas ako bolesnik izgubi previše tjelesne težine.
English: By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient's symptoms or to prevent them from getting worse.
Croatian: Blokiranjem djelovanja PDE4 roflumilast smanjuje upalu u plućima i time pomaže pri ublažavanju simptoma bolesnika ili sprečava njihovo pogoršavanje.
English: What is Daxas and what is it used for?
Croatian: Što je Daxas i za što se koristi?
English: The company will also provide cards for patients, telling them what information about their symptoms and past illnesses they need to give their doctor to help the doctor determine whether Daxas is appropriate for them.
Croatian: Tvrtka će također osigurati kartice za bolesnike na kojima je navedeno što moraju reći liječniku o svojim simptomima i povijesti bolesti kako bi liječnik mogao utvrditi je li Daxas odgovarajući lijek za njih.
English: The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment.
Croatian: Glavno mjerilo djelotvornosti bio je napredak u odnosu na forsirani ekspiratorni volumen (FEV1) i smanjenje broja umjerenih ili teških izbijanja KOPB-a tijekom jedne godine liječenja.
English: The most common side effects with Daxas (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Croatian: Najčešće nuspojave lijeka Daxas (uočene u između 1 i 10 na 100 bolesnika) jesu smanjenje težine, smanjenje teka, nesanica (poteškoće sa spavanjem), glavobolja, proljev, mučnina (slabost) i abdominalna bol (bol u trbuhu).
English: The active substance in Daxas, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Croatian: Djelatna tvar u lijeku Daxas, roflumilast, pripada skupini lijekova zvanih inhibitori fosfodiesteraze tipa 4 (PDE4).
English: The company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Croatian: Tvrtka koja stavlja lijek Daxas u promet osigurat će da zdravstveni radnici koji će propisivati lijek u svim državama članicama Europske unije (EU) prime edukacijski paket koji sadrži informacije o nuspojavama lijeka i kako ga treba koristiti.
English: After considering all of the available data on the effects of the medicine, the Agency decided that Daxas's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Nakon razmatranja svih dostupnih podataka o učincima lijeka, Agencija je zaključila da koristi od lijeka Daxas nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Why is Daxas authorised in the EU?
Croatian: Zašto je lijek Daxas odobren u EU-u?
English: Daxas contains the active substance roflumilast.
Croatian: Daxas sadrži djelatnu tvar roflumilast.
English: Side effects reported with Daxas are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Daxas pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daxas 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 Daxas također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
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 air in and out of the lungs.
Croatian: KOBP je dugotrajna bolest kod koje su dišni putevi i zračne vrećice u plućima oštećeni ili blokirani, što uzrokuje otežano udisanje i izdisanje zraka iz pluća.
English: These involved over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Croatian: Ispitivanja su obuhvatila više od 3000 odraslih osoba s teškim KOPB-om kojima se bolest pogoršala barem jedanput tijekom prethodne godine.
English: The benefits in improving FEV1 were similar in both groups at the end of the study; however, patients who could not take 500 micrograms daily and were then just given 250 micrograms daily did not show an improvement in lung function.
Croatian: Koristi u pogledu poboljšanja FEV1 bile su slične u obje skupine na kraju ispitivanja; međutim, u bolesnika koji nisu mogli uzimati dnevnu dozu od 500 mikrograma te su potom prebačeni na dnevnu dozu od 250 mikrograma nije zabilježeno poboljšanje funkcije pluća.
English: Because patients taking Daxas may lose weight, they are advised to weigh themselves on a regular basis.
Croatian: S obzirom na to da je u bolesnika koji uzimaju Daxas moguć gubitak tjelesne težine, savjetuje im se da se redovito važu.
English: Around 18% (81 of 441 patients) of those started at 250 micrograms daily dropped out of the study, compared with 25% (109 of 443) of those starting with 500 micrograms daily.
Croatian: Otprilike 18 % (81 od 441) bolesnika koji su započeli liječenje dnevnom dozom od 250 mikrograma prekinulo je sudjelovanje u ispitivanju, u usporedbi s 25 % (109 od 443) bolesnika koji su započeli liječenje dnevnom dozom od 500 mikrograma.
English: Daxas is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Croatian: Daxas se ne primjenjuje kao samostalni lijek, nego kao dodatak liječenju bronhodilatatorima (lijekovi koji šire dišne puteve u plućima).
English: For more information about using Daxas, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Daxas pogledajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The European Medicines Agency noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas 500 micrograms in patients with severe COPD.
Croatian: Europska agencija za lijekove istaknula je potrebu za novim načinima liječenja KOPB-a te da su glavna ispitivanja pokazala umjerenu korist od liječenja lijekom Daxas od 500 mikrograma u bolesnika s teškim KOPB-om.
English: As for all medicines, data on the use of Daxas are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Daxas kontinuirano se prate.
English: Daxas is a medicine used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Croatian: Daxas je lijek koji se primjenjuje za liječenje teške kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba koje imaju kronični bronhitis (dugotrajnu upalu dišnih puteva) i u kojih se KOPB često pogoršava.
English: Although a dose of 250 micrograms daily does not improve lung function it was useful in preventing patients from dropping out because of side effects when starting treatment.
Croatian: Iako dnevna doza od 250 mikrograma ne utječe na poboljšanje funkcije pluća, bila je korisna u sprječavanju prekida liječenja bolesnika zbog nuspojava na počeku liječenja.
English: Patients started on the lower dose had fewer side effects.
Croatian: U bolesnika koji su započeli liječenje nižom dozom zabilježeno je manje nuspojava.
English: In addition, the patients who took Daxas had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Croatian: Osim toga, u bolesnika koji su uzimali lijek Daxas u prosjeku je zabilježeno 1,1 umjereno ili teško izbijanje bolesti, u usporedbi s prosjekom izbijanja od 1,4 u bolesnika koji su uzimali placebo.
English: Daxas is available as tablets (250 and 500 micrograms) and can only be obtained with a prescription.
Croatian: Lijek Daxas dostupan je u obliku tableta (od 250 i 500 mikrograma) te se izdaje samo na liječnički recept.
English: What are the risks associated with Daxas?
Croatian: Koji su rizici povezani s lijekom Daxas?
English: After a year, the patients who took Daxas had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Croatian: Nakon godine dana u bolesnika koji su uzimali lijek Daxas zabilježeno je prosječno povećanje od 40 ml, dok je u bolesnika koji su primali placebo prosječno smanjenje iznosilo 9 ml.
English: Other information about Daxas:
Croatian: Ostale informacije o lijeku Daxas
English: The recommended dose of Daxas for treatment is one 500-microgram tablet once a day, but treatment is started with one 250-microgram tablet daily to reduce side effects that might make patients stop taking the medicine.
Croatian: Preporučena doza lijeka Daxas jest jedna tableta od 500 mikrograma jedanput na dan, ali liječenje se započinje s jednom tabletom od 250 mikrograma dnevno kako bi se smanjile nuspojave koje bi mogle prisiliti bolesnike na prekid liječenja.
English: Patients may need to take Daxas 500 micrograms for several weeks before it starts to have an effect.
Croatian: Bolesnici će ponekad morati uzimati dozu lijeka Daxas od 500 mikrograma nekoliko tjedana prije nego što on počne djelovati.
English: After taking 250 micrograms daily for 4 weeks, the dose is increased to 500 micrograms daily.
Croatian: Nakon četiri tjedna uzimanja jedne tablete od 250 mikrograma na dan doza se povećava na 500 mikrograma dnevno.
English: Another 12-week study involving 1,323 patients examined the effect of starting treatment with Daxas 250 micrograms daily for 4 weeks before increasing the dose to 500 micrograms daily, compared with starting at the higher dose.
Croatian: U drugom ispitivanju koje je trajalo 12 tjedana i obuhvatilo 1323 bolesnika ispitan je učinak početka liječenja dnevnom dozom lijeka Daxas od 250 mikrograma tijekom četiri tjedna prije povećanja dnevne doze na 500 mikrograma, u usporedbi sa započinjanjem liječenja višom dozom.
English: An overview of Daxas and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Daxas i razlozima njegova odobrenja u EU-u
English: How is Daxas used?
Croatian: Kako se Daxas koristi?
English: What benefit of Daxas have been shown in studies?
Croatian: Koje su koristi od lijeka Daxas utvrđene u ispitivanjima?
English: Daxas 500 micrograms was shown to be more effective than placebo (a dummy treatment) at treating COPD in two main studies.
Croatian: U dvama glavnim ispitivanjima, primjena lijeka Daxas od 500 mikrograma pokazala se djelotvornijom od placeba (prividno liječenje) u liječenju KOPB-a.
English: How does Daxas work?
Croatian: Kako djeluje Daxas?
English: Daxas must not be used in patients who have moderate or severe problems with their liver.
Croatian: Bolesnici koji imaju umjerene ili teške tegobe s jetrom ne smiju uzimati Daxas.
English: For the full list of side effects of Daxas, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Daxas potražite u uputi o lijeku.
English: This summary was last updated in 11-2014.
Croatian: Sažetak je posljednji put ažuriran u 11.2014.
English: The full EPAR and risk management plan summary for Vylaer Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i plan upravljanja rizikom za lijek Vylaer Spiromax nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If patients need to take more than 8 reliever inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Croatian: Ako bolesnici moraju uzeti više od 8 inhalacija na dan, preporuča se da se obrate svojem liječniku kako bi se revidirala njihova terapija protiv astme.
English: Vylaer Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Croatian: Vylaer Spiromax također se koristi za ublažavanje simptoma ozbiljne kronične opstruktivne pulmonalne bolesti (KOPB-a) u odraslih osoba koje su imale eksacerbacije (pogoršanja) bolesti u prošlosti usprkos redovitom liječenju.
English: It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
Croatian: Dostupan je kao prašak inhalata u prijenosnom inhalatoru, a svaka inhalacija pruža određenu dozu lijeka.
English: Vylaer Spiromax budesonide / formoterol
Croatian: Vylaer Spiromax budezonid / formoterol
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Vylaer Spiromax is given using a different inhaler.
Croatian: To znači da je sličan „referentom lijeku” koji sadrži iste djelatne tvari, no Vylaer Spiromax se primjenjuje pomoću drugog inhalatora.
English: The two active substances in Vylaer Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Croatian: Dvije djelatne tvari lijeka Vylaer Spiromax dobro su poznate i prisutne u nekoliko lijekova koji se koriste za liječenje astme i KOPB-a, samostalno ili u kombinaciji s drugim lijekovima.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vylaer Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je potvrđeno da Vylaer Spiromax od 160/4.5 mikrograma i 320/9 mikrograma posjeduje usporedivu kvalitetu te je bioekvivalentan lijeku Symbicort Turbohaler odgovarajuće jačine.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Croatian: Djeluje na sličan način kao hormoni kortikosteroida koji se prirodno pojavljuju u tijelu, te smanjuje aktivnost imunosnog sustava tako što se vezuje na receptore u različitim tipovima imunosnih stanica.
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Croatian: Ovo rezultira smanjenim otpuštanjem tvari koje su uključene u upalni proces, poput histamina, te stoga pomaže u očuvanju zračnih putova čistima i omogućuje bolesniku da lakše diše.
English: Vylaer Spiromax 160/4.5 microgram can be used for the regular treatment of asthma.
Croatian: Vylaer Spiromax od 160/4.5 mikrograma može se primjenjivati u redovitom liječenju astme.
English: For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma.
Croatian: Za redovito liječenje astme, preporučena doza iznosi 1 do 4 inhalacija dva puta na dan, ovisno o jačini koja se koristi i težini astme.
English: When inhaled it mainly attaches to the receptors in the airways and causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Croatian: Prilikom inhaliranja, uglavnom se vezuje na receptore u zračnim putovima, što uzrokuje opuštanje mišića i održava zračne putove otvorenima i pomaže pri disanju bolesnika.
English: Studies were carried out to show that Vylaer Spiromax is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Croatian: Provedena su ispitivanja kako bi se dokazalo da je Vylaer Spiromax bioekvivalentan referentnom lijeku (odnosno da stvara iste razine djelatne tvari u organizmu) te da dva lijeka djeluju na isti način.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vylaer Spiromax on 19 November 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vylaer Spiromax na snazi u Europskoj uniji od 19. studenog 2014.
English: This is a summary of the European public assessment report (EPAR) for Vylaer Spiromax.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Vylaer Spiromax.
English: What measures are being taken to ensure the safe and effective use of Vylaer Spiromax?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vylaer Spiromax?