FrancophonIA/ELRC3.0 huggingface dataset:
English: Light green, oval (approximately 12.2 mm long and 7.6 mm wide), film-coated tablet marked “AMG” on one side and “60” on the other.
Croatian: Svijetlozelene, ovalne (otprilike 12,2 mm duge i 7,6 mm široke), filmom obložene tablete s oznakom „AMG“ na jednoj i „60“ na drugoj strani.
English: Capsule consists of a blue colour cap, marked “AMG” and white opaque body, marked “5 mg”.
Croatian: Kapsula se sastoji od plave kapice s oznakom „AMG“ i bijelog neprozirnog tijela s oznakom „5 mg“.
English: Anorexia Decreased appetite
Croatian: Poremećaji metabolizma i prehrane često anoreksija smanjeni apetit
English: How to take Mimpara
Croatian: Kako uzimati lijek Mimpara
English: After titration to the maximum dose of Mimpara, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Mimpara therapy should be considered (see section 5.1).
Croatian: Ako se ne postigne klinički značajno smanjenje serumskog kalcija, treba razmotriti prekid terapije lijekom Mimpara (vidjeti dio 5.1).
English: Capsule consists of a rich yellow colour cap, marked “AMG” and white opaque body, marked “2.5 mg”.
Croatian: Kapsula se sastoji od intenzivno žute kapice s oznakom „AMG“ i bijelog neprozirnog tijela s oznakom „2,5 mg“.
English: The majority of patients (91%) were using vitamin D sterols at baseline.
Croatian: Većina bolesnika (91%) je koristila sterole vitamina
English: Light green, oval (approximately 9.7 mm long and 6.0 mm wide), film-coated tablet marked “AMG” on one side and “30” on the other.
Croatian: Svijetlozelene, ovalne (otprilike 9,7 mm duge i 6,0 mm široke), filmom obložene tablete s oznakom „AMG“ na jednoj i „30“ na drugoj strani.
English: INFORMATION IN BRAILLE mimpara 5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mimpara 5 mg
English: Mimpara 1 mg granules in capsules for opening Mimpara 2.5 mg granules in capsules for opening Mimpara 5 mg granules in capsules for opening Cinacalcet
Croatian: Mimpara 1 mg granule u kapsulama za otvaranje Mimpara 2,5 mg granule u kapsulama za otvaranje Mimpara 5 mg granule u kapsulama za otvaranje
English: Children who require doses of 30 mg or more and who are able to swallow tablets may receive Mimpara tablets.
Croatian: Kod djece koja trebaju primijeniti doze od 30 mg ili više i koja mogu progutati tablete, mogu se primijeniti Mimpara tablete.
English: Dose adjustment based on serum calcium levels Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara.
Croatian: Prilagodba doze na temelju vrijednosti serumskog kalcija Vrijednost serumskog kalcija treba se mjeriti unutar tjedan dana od započete terapije ili prilagodbe doze lijeka Mimpara.
English: Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara.
Croatian: Serumski kalcij treba kontrolirati unutar 1 tjedna nakon početka primjene ili prilagodbe doze lijeka Mimpara.
English: INFORMATION IN BRAILLE mimpara 90
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mimpara 90
English: Each capsule contains 1 mg, 2.5 mg or 5 mg of cinacalcet (as hydrochloride) granules.
Croatian: Jedna kapsula sadrži granule s 1 mg, 2,5 mg ili 5 mg cinakalceta (u obliku cinakalcetklorida).
English: The majority of patients (89%) were using vitamin D sterols at baseline.
Croatian: Većina bolesnika (89 %) koristila je sterole vitamina
English: How to store Mimpara
Croatian: Kako čuvati lijek Mimpara
English: • a medicine used to relieve cough (dextromethorphan);
Croatian: • lijeka za ublažavanje kašlja (dekstrometorfan);
English: Children who require doses lower than 30 mg, or who are unable to swallow tablets should receive Mimpara granules.
Croatian: Kod djece koja trebaju primiti doze manje od 30 mg ili ne mogu progutati tablete, potrebno je primijeniti Mimpara granule.
English: INFORMATION IN BRAILLE mimpara 60
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mimpara 60
English: FD&C Blue (E132), iron oxide yellow (E172))
Croatian: (E132), željezov oksid, žuti (E172))
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BOCU
English: PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
Croatian: Vrijednosti PTH-a trebaju se kontrolirati 1 do 4 tjedna nakon započete terapije ili prilagodbe doze lijeka Mimpara.
English: Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism Based on available data from patients receiving cinacalcet in placebo-controlled studies and single-arm studies the most commonly reported adverse reactions were nausea and vomiting.
Croatian: Na temelju dostupnih podataka od bolesnika koji su primali cinakalcet u placebom kontroliranim ispitivanjima i ispitivanjima na jednoj skupini, najčešće zabilježene nuspojave bile su mučnina i povraćanje.
English: INFORMATION IN BRAILLE mimpara 30
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mimpara 30
English: The mean (SD) iPTH concentrations at baseline were 946 (635) pg/mL for the cinacalcet + SOC group and 1228 (732) pg/mL for the SOC group.
Croatian: Srednja vrijednost (SD) koncentracija iPTH-a na početku ispitivanja bila je 946 (635) pg/ml u skupinl koja je primala cinakalcet uz standardno liječenje i 1228 (732) pg/ml u skupini koja je primala samo standardno liječenje.
English: Reduction of ≥ 30% from baseline in mean plasma iPTH during the EAP was achieved by 22% of patients in the cinacalcet + SOC group and 32% of patients in the SOC group.
Croatian: Smanjenje srednje vrijednosti iPTH-a u plazmi od ≥ 30 % u odnosu na početnu tijekom faze ocjene djelotvornosti postignuto je u 22 % bolesnika u skupini koja je primala cinakalcet uz standardno liječenje i u 32 % bolesnika u skupini koja je primala samo standardno liječenje.
English: Mimpara 1 mg granules in capsules for opening
Croatian: Mimpara 1 mg granule u kapsulama za otvaranje
English: If you are being treated for secondary hyperparathyroidism The usual starting dose for Mimpara in adults is 30 mg (one tablet) once per day.
Croatian: Uobičajena početna doza lijeka Mimpara u odraslih je 30 mg (jedna tableta) jednom dnevno.
English: Corrected serum calcium should be measured and monitored and should be at or above the lower limit of the normal range prior to administration of first dose of Mimpara (see section 4.4).
Croatian: Prilagodba doze na temelju vrijednosti serumskog kalcija Korigirana vrijednost serumskog kalcija treba se mjeriti i kontrolirati te treba biti u razini ili iznad donje granice referentnih vrijednosti prije primjene prve doze lijeka Mimpara (vidjeti dio 4.4).
English: Parathyroid carcinoma and Primary Hyperparathyroidism
Croatian: Paratireoidni karcinom i primarni hiperparatireoidizam
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/009 - carton of 14 tablets
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/292/009 - kutija s 14 tableta
English: Mimpara 2.5 mg granules in capsules for opening
Croatian: Mimpara 2,5 mg granule u kapsulama za otvaranje
English: Dispose of the capsule shells.
Croatian: Bacite kapsulu.
English: Life threatening events and fatal outcomes associated with low calcium levels (hypocalcaemia) have been reported in adults and children treated with Mimpara.
Croatian: U odraslih i djece liječenih lijekom Mimpara zabilježeni su događaji opasni po život i smrtni ishodi povezani s niskim razinama kalcija (hipokalcemijom).
English: Mimpara 5 mg granules in capsules for opening
Croatian: Mimpara 5 mg granule u kapsulama za otvaranje
English: Iron oxide yellow (E172) Indigo carmine (E132)
Croatian: Mimpara 1 mg granule u kapsulama za otvaranje želatina željezov oksid, žuti (E172) boja indigo carmine (E132) titanijev dioksid (E171)
English: Iron oxide yellow (E172) Titanium dioxide (E171)
Croatian: Mimpara 2,5 mg granule u kapsulama za otvaranje želatina željezov oksid, žuti (E172) titanijev dioksid (E171)
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 2.5 mg of cinacalcet (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna kapsula sadrži 2,5 mg cinakalceta (u obliku cinakalcetklorida).
English: Mimpara 30 mg film-coated tablets
Croatian: Mimpara 30 mg filmom obložene tablete
English: The mean (SD) corrected total serum calcium concentrations at baseline were 9.8 (0.6) mg/dL for the cinacalcet + SOC group and 9.8 (0.6) mg/dL for the SOC group.
Croatian: Srednja vrijednost (SD) korigiranih koncentracija ukupnog serumskog kalcija na početku ispitivanja bila je 9,8 (0,6) mg/dl u skupinu koja je primala cinakalcet uz standardno liječenje i 9,8 (0,6) mg/dl u skupini koja je primala samo standardno liječenje.
English: Mimpara 90 mg film-coated tablets
Croatian: Mimpara 90 mg filmom obložene tablete
English: Mimpara 60 mg film-coated tablets
Croatian: Mimpara 60 mg filmom obložene tablete
English: EU/1/04/292/011 - carton of 84 tablets
Croatian: EU/1/04/292/011 - kutija s 84 tablete
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 1 mg of cinacalcet (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna kapsula sadrži 1 mg cinakalceta (u obliku cinakalcetklorida).
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 90 mg of cinacalcet (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 90 mg cinakalceta (u obliku cinakalcetklorida).
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 30 mg of cinacalcet (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 30 mg cinakalceta (u obliku cinakalcetklorida).
English: EU/1/04/292/010 - carton of 28 tablets
Croatian: EU/1/04/292/010 - kutija s 28 tableta
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 60 mg of cinacalcet (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 60 mg cinakalceta (u obliku cinakalcetklorida).
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 5 mg of cinacalcet (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna kapsula sadrži 5 mg cinakalceta (u obliku cinakalcetklorida).
English: NAME OF THE MEDICINAL PRODUCT Mimpara 90 mg film-coated tablets Cinacalcet
Croatian: NAZIV LIJEKA Mimpara 90 mg tableta cinakalcet
English: METHOD AND ROUTE OF ADMINISTRATION For oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: NAME OF THE MEDICINAL PRODUCT Mimpara 30 mg film-coated tablets Cinacalcet
Croatian: NAZIV LIJEKA Mimpara 30 mg tableta cinakalcet
English: Mimpara 2.5 mg granules in capsules for opening Gelatin
Croatian: Mimpara 2,5 mg granule u kapsulama za otvaranje cinakalcet
English: Hepatic impairment
Croatian: Srčani poremećaji nepoznato*
English: The capsule shell is not for ingestion.
Croatian: Kapsula nije namijenjena za gutanje.
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/001 - carton of 14 tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/292/001 - kutija s 14 tableta
English: NAME OF THE MEDICINAL PRODUCT Mimpara 60 mg film-coated tablets Cinacalcet
Croatian: NAZIV LIJEKA Mimpara 60 mg tableta cinakalcet
English: EU/1/04/292/007 - carton of 84 tablets
Croatian: EU/1/04/292/007 - kutija s 84 tablete
English: EU/1/04/292/006 - carton of 28 tablets
Croatian: EU/1/04/292/006 - kutija s 28 tableta
English: Mimpara 5 mg granules in capsules for opening Gelatin
Croatian: Mimpara 5 mg granule u kapsulama za otvaranje cinakalcet
English: EU/1/04/292/003 - carton of 84 tablets
Croatian: EU/1/04/292/003 - kutija s 84 tablete
English: Following careful benefit/risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Mimpara.
Croatian: Odluku o prekidu dojenja ili liječenja lijekom Mimpara treba donijeti na osnovi pomne procjene koristi i rizika.
English: Seizures† Dizziness Paraesthesia Headache
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
English: What Mimpara looks like and contents of the pack Mimpara is a light green film-coated tablet.
Croatian: Kako Mimpara izgleda i sadržaj pakiranja
English: Mimpara 1 mg granules in capsules for opening Gelatin
Croatian: Mimpara 1 mg granule u kapsulama za otvaranje cinakalcet
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/005 - carton of 14 tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/292/005 - kutija s 14 tableta
English: Nervous system disorders
Croatian: MedDRA klasifikacija organskih sustava
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/008
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/292/008
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/012
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/292/012
English: Granules
Croatian: Nuspojava
English: EU/1/04/292/002 - carton of 28 tablets
Croatian: EU/1/04/292/002 - kutija s 28 tableta
English: Cinacalcet is not indicated for CKD patients not on dialysis.
Croatian: Bolesnici s kroničnom bolesti bubrega koji nisu na dijalizi Cinakalcet nije indiciran u bolesnika s kroničnom bolesti bubrega koji nisu na dijalizi.
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/015
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/292/015
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/013
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/292/013
English: If you are being treated for parathyroid cancer or primary hyperparathyroidism The usual starting dose for Mimpara in adults is 30 mg (one tablet) twice per day.
Croatian: Uobičajena početna doza lijeka Mimpara u odraslih je 30 mg (jedna tableta) dva puta dnevno.
English: Mimpara is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Croatian: Mimpara 30 mg, 60 mg ili 90 mg filmom obložene tablete dostupne su u blister pakiranjima.
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/014
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/292/014
English: METHOD AND ROUTE OF ADMINISTRATION For oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Kroz usta.
English: The granules should be taken with or shortly after food Mimpara is also available as tablets.
Croatian: Granule je potrebno uzeti za vrijeme ili netom nakon jela.
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend use in reducing exacerbations.
Croatian: Međutim, CHMP je smatrao da su njegovi učinci na smanjivanje stope pogoršavanja bili premaleni kako bi se preporučila njegova upotreba za smanjivanje pogoršavanja.
English: A risk management plan has been developed to ensure that Ulunar Breezhaler is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Ulunar Breezhaler koristi što je sigurnije moguće.
English: It is taken at the same time each day using the Ulunar Breezhaler device.
Croatian: Uzima se svaki dan u isto vrijeme upotrebom uređaja Ulunar Breezhaler.
English: The full EPAR and risk management plan summary for Ulunar Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) kao i plan upravljanja rizikom nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used as maintenance (regular) treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Koristi se za održavanje liječenja (redovito liječenje) i za olakšavanje simptoma kronične opstruktivne plućne bolesti (KOBP) u odraslih.
English: This medicine is the same as Ultibro Breezhaler, which is already authorised in the European Union (EU).
Croatian: Ovaj lijek je isti kao i Ultibro Breezhaler, koji je već odobren u Europskoj uniji.
English: Ulunar Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Croatian: Ulunar Breezhaler ispitan je u dva glavna ispitivanja koja uključuju 2 667 bolesnika s KOBP.
English: Ulunar Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Croatian: Ulunar Breezhaler je lijek koji sadrži dvije djelatne tvari, indakaterol (85 mikrograma) i glikopironij (43 mikrograma).
English: In both studies, the main measure of effectiveness was how Ulunar Breezhaler improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 26 weeks of treatment.
Croatian: U oba ispitivanja, glavna mjera djelotvornosti bila je način na koji je Ulunar Breezhaler poboljšao bolesnikove forsirane izdisajne volumene (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u jednoj sekundi) nakon 26 tjedana liječenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ulunar Breezhaler on 23 April 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Ulunar Breezhaler vrijedi na prostoru Europske unije od 23/04/2014.
English: It is not intended to provide practical advice on how to use Ulunar Breezhaler.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja Ulunar Breezhaler.
English: Ulunar Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml more than glycopyrronium alone.
Croatian: Ulunar Breezhaler također je povećao FEV1 za 70 ml više od samo indakaterola i za 90 ml više od samog glikopirija.
English: This is a summary of the European public assessment report (EPAR) for Ulunar Breezhaler.
Croatian: Ovo je sažetak Europskog javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Ulunar Breezhaler.
English: The most common side effects with Ulunar Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Croatian: Najčešće su nuspojave lijeka Ulunar Breezhaler (koje se mogu javiti u više od 1 na 10 osoba) infekcije gornjeg respiratornog trakta (prehlade).
English: The effects of Ulunar Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Croatian: Učinci lijeka Ulunar Breezhaler, kad se koristi za olakšavanje simptoma KOBP, bili su klinički značajni.
English: The company that makes Ultibro Breezhaler has agreed that its scientific data can be used for Ulunar Breezhaler (‘informed consent').
Croatian: Proizvođač lijeka Ultibro Breezhaler pristao je da se njegovi znanstveni podaci koriste za lijek Ulunar Breezhaler (tzv. „informirani pristanak”).
English: The reduction in the rate of exacerbations was 10 to 12% higher with Ulunar Breezhaler than with tiotropium and glycopyrronium.
Croatian: Smanjenje stope pogoršanja bila je 10 do 12 % viša s lijekom Ulunar Breezhaler nego s tiotropijem i glikopironijem.
English: Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Croatian: Antagonisti muskarinskih receptora i dugodjelujući beta-2antagonisti često se kombiniraju u liječenju KOBP-a.
English: What is Ulunar Breezhaler and what is it used for?
Croatian: Što je Ulunar Breezhaler i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Ulunar Breezhaler?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ulunar Breezhaler?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ulunar Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Ulunar Breezhaler nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ulunar Breezhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Ulunar Breezhaler uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The first study showed that treatment with Ulunar Breezhaler was more effective than placebo and increased FEV1 by an average of 200 ml more.
Croatian: Prvo je ispitivanje pokazalo da je liječenje lijekom Ulunar Breezhaler bilo djelotvornije od placeba i da je povećalo FEV1 u prosjeku za 200 ml više.
English: The active substances in Ulunar Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
Croatian: Djelatne tvari u lijeku Ulunar Breezhaler, indakaterol i glikopironij, djeluju na različite načine kako bi proširili dišne putove i poboljšali disanje u KOBP.
English: Ulunar Breezhaler is available as capsules containing a powder for inhalation and can only be obtained with a prescription.
Croatian: Ulunar Breezhaler dostupan je u obliku koje sadrže prašak za inhalaciju o može se dobiti samo na recept.
English: In patients with severely reduced kidney function Ulunar Breezhaler should only be used after a careful benefit-risk assessment.
Croatian: U bolesnika s teško oštećenom funkcijom bubrega Ulunar Breezhaler treba koristiti samo nakon pomne procjene omjera koristi i rizika.
English: For more information about treatment with Ulunar Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju s Ulunar Breezhaler pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Regarding its safety, Ulunar Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Croatian: Vezano uz njegovu sigurnosti, Ulunar Breezhaler može se uspoređivati s indakaterolom i glikopironijem koji se koriste kao zasebni lijekovi.
English: While one study compared the effects of Ulunar Breezhaler with those of placebo (a dummy inhalation), or indacaterol or glycopyrronium alone, the other study compared Ulunar Breezhaler with fluticasone plus salmeterol, a standard treatment for COPD.
Croatian: Dok je jedno ispitivanje uspoređivalo učinke lijeka Ulunar Breezhaler s onima od placeba (slijepa inhalacija) ili samog indakaterola ili glikopirija, drugo je ispitivanje uspoređivalo Ulunar Breezhaler s flutikazonom i salmeterolom, standardnim liječenjem za KOBP.
English: In the second study the average increase in FEV1 was 140 ml more with Ulunar Breezhaler treatment than with treatment with fluticasone and salmeterol.
Croatian: U drugom ispitivanju prosječan porast u FEV1 bio je 140 ml viši s Ulunar Breezhaler nego s flutikazonom i salmeterolom.
English: A third study investigated the effects of Ulunar Breezhaler on the rate of exacerbations (flare-ups) patients experienced during 64 weeks of treatment when compared with treatment with glycopyrronium or tiotropium (other treatments for COPD).
Croatian: Treće je ispitivanje proučavalo učinke lijeka Ulunar Breezhaler na stupanj egzarcebacija (pogoršanja) kod bolesnika koji su prošli 64 tjedna liječenja u usporedbi s liječenjem glikopironijem ili tiotropijem (druga liječenja za KOBP).
English: Other information about Ulunar Breezhaler
Croatian: Druge informacije o lijeku Ulunar Breezhaler
English: For practical information about using Ulunar Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju Ulunar Breezhaler bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: What are the risks associated with Ulunar Breezhaler?
Croatian: Koji su rizici povezani s lijekom Ulunar Breezhaler?
English: Why is Ulunar Breezhaler approved?
Croatian: Za što je Ulunar Breezhaler odobren?
English: Ulunar Breezhaler indacaterol / glycopyrronium
Croatian: Indakaterol / glikopironij
English: How is Ulunar Breezhaler used?
Croatian: Kako se Ulunar Breezhaler koristi?
English: What benefits of Ulunar Breezhaler have been shown in studies?
Croatian: Koje su koristi lijeka Ulunar Breezhaler dokazane u ispitivanjima?