FrancophonIA/ELRC3.0 huggingface dataset:
English: Riarify significantly improved dyspnoea (measured as the Transition Dyspnoea Index - TDI - focal score) after 26 weeks of treatment compared with baseline (by 1.71 units; p < 0.001), but the adjusted mean difference versus a fixed combination of beclometasone dipropionate and formoterol was not statistically significant (0.21 units; p = 0.160).
Croatian: Transition Dyspnoea Index, TDI]) nakon 26 tjedana liječenja u usporedbi s početnim vrijednostima (za 1,71 jedinica; p < 0,001), ali prilagođena srednja vrijednost razlike naspram fiksne kombinacije beklometazondipropionata i formoterola nije bila statistički značajna (0,21 jedinica; p = 0,160).
English: Glucocorticoids are excreted in human milk.
Croatian: Glukokortikoidi se izlučuju u majčino mlijeko.
English: No specific studies have been performed with Riarify with regard to the safety in human fertility.
Croatian: Nisu provedena posebna ispitivanja lijeka Riarify s obzirom na njegovu sigurnost za plodnost u ljudi.
English: • flu
Croatian: • gripa
English: Inhaled beclometasone dipropionate is rapidly absorbed through the lungs; prior to absorption there is extensive conversion to beclometasone 17-monopropionate via esterase enzymes that are found in most tissues.
Croatian: Udahnuti beklometazondipropionat brzo se apsorbira u plućima; prije apsorpcije dolazi do opsežne konverzije u beklometazon 17-monopropionat putem enzima esteraza koje se nalaze u većini tkiva.
English: A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (focal score greater than or equal to 1) after 26 weeks with Riarify than with a fixed combination of beclometasone dipropionate and formoterol (57.4% versus 51.8%; p = 0.027).
Croatian: Analiza bolesnika s terapijskim odgovorom pokazala je da je postotak bolesnika s klinički značajnim poboljšanjem (fokalni rezultat veći ili jednak 1) bio značajno veći nakon 26 tjedana liječenja lijekom Riarify nego fiksnom kombinacijom beklometazondipropionata i formoterola (57,4 % naspram 51,8 %; p = 0,027).
English: Frequency not known
Croatian: nepoznato nesanica rijetko
English: Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or urinary retention.
Croatian: Glikopironij je potrebno primjenjivati uz oprez u bolesnika s glaukomom uskog kuta, hiperplazijom prostate ili urinarnom retencijom.
English: Riarify should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Croatian: Riarify je potrebno primjenjivati uz oprez u bolesnika s aktivnom ili latentnom plućnom tuberkulozom te gljivičnim i virusnim infekcijama dišnih puteva.
English: High doses of formoterol may increase your blood glucose and therefore you may need to have extra blood tests to check your blood sugar when you start using this medicine, and from time to time during treatment.
Croatian: Vam se stoga provesti neke dodatne krvne pretrage na početku upotrebe ovog lijeka te s vremena na vrijeme tijekom liječenja, kako bi se provjerio šećer u krvi.
English: • inflammation of the mucous membrane of the mouth with or without ulcers
Croatian: • upala sluznice usta s vrijedovima ili bez njih
English: The pharmacokinetics of beclometasone dipropionate in patients with hepatic impairment has not been studied, however, as beclometasone dipropionate undergoes a very rapid metabolism via esterase enzymes present in intestinal fluid, serum, lungs and liver to form the more polar products beclometasone 21-monopropionate, beclometasone 17-monopropionate and beclometasone, hepatic impairment is not expected to modify the pharmacokinetics and safety profile of beclometasone dipropionate.
Croatian: Farmakokinetika beklometazondipropionata u bolesnika s oštećenjem funkcije jetre nije ispitana; međutim, budući da esteraze prisutne u crijevnom soku, serumu, plućima i jetri vrlo brzo metaboliziraju beklometazondipropionat u polarnije produkte beklometazon 21-monopropionat, beklometazon 17-monopropionat i beklometazon, ne očekuje se da će oštećenje funkcije jetre promijeniti farmakokinetiku i sigurnosni profil beklometazondipropionata.
English: What you need to know before you use Riarify Do not use Riarify:
Croatian: Što morate znati prije nego počnete primjenjivati Riarify Nemojte primjenjivati Riarify:
English: This endpoint was only measured in study TRILOGY.
Croatian: Ovaj je ishod bio mjeren samo u ispitivanju TRILOGY.
English: • muscle cramps and pain in muscles
Croatian: • pojačano znojenje • mišićni grčevi i bol u mišićima
English: They should not remove the pressurised container from the actuator and should not use water or other liquids to clean the mouthpiece.
Croatian: Ne smiju vaditi spremnik pod tlakom iz aktivatora i ne smiju čistiti nastavak za usta vodom ili drugom tekućinom.
English: EXP 60 actuation pressurised container:
Croatian: EXP Spremnik pod tlakom sa 60 potisaka:
English: If you are already using Riarify
Croatian: Ako već primjenjujete Riarify
English: Check that the dose counter (60/120 puffs) has moved down by one or that the dose indicator (180 puffs) has rotated by a small amount.
Croatian: Provjerite pokazuje li brojač doza (60/120 raspršenih doza) jedan broj manje ili da se pokazivač doza (180 raspršenih doza) malo zakrenuo.
English: Riarify can be used at the recommended dose in patients with mild to moderate renal impairment.
Croatian: Riarify se može primjenjivati u preporučenoj dozi u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
English: injection, 40% of the dose was excreted in the urine within 24 hours.
Croatian: Nakon jedne i.v. injekcije glikopironija, 40 % doze izlučilo se u mokraći unutar 24 sata.
English: Influenza1, oral fungal infection, oropharyngeal candidiasis, oesophageal candidiasis1, sinusitis1, rhinitis1, gastroenteritis1, vulvovaginal candidiasis1
Croatian: često influenca1, oralna gljivična infekcija, orofaringealna kandidijaza, ezofagealna kandidijaza1, sinusitis1, rinitis1, gastroenteritis1, vulvovaginalna kandidijaza1
English: Beclometasone dipropionate belongs to a group of medicines called corticosteroids which act to reduce the swelling and irritation in your lungs.
Croatian: Beklometazondipropionat pripada skupini lijekova koji se nazivaju kortikosteroidi i djeluju tako što smanjuju oticanje i nadraženost u plućima.
English: Lower respiratory tract infection (fungal)
Croatian: manje često infekcija donjih dišnih puteva (gljivična)
English: They should be advised by their doctor or pharmacist about the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled active substance to the lungs.
Croatian: Liječnik ili ljekarnik trebaju podučiti bolesnike kako ispravno koristiti i održavati inhalator i komoru za inhaliranje te provjeriti tehniku bolesnika kako bi bili sigurni da u pluća dopire optimalna količina udahnute djelatne tvari.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Croatian: < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Patients should breathe out slowly and as deeply as comfortable, in order to empty their lungs.
Croatian: Bolesnici trebaju polako i što dublje izdahnuti, koliko god mogu, kako bi ispraznili pluća.
English: • medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level.
Croatian: • lijekovima za liječenje srčane bolesti (digoksin) koji mogu prouzročiti sniženje razine kalija u krvi.
English: Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.
Croatian: Glikopironij djeluje tako što blokira bronhokonstrikcijsko djelovanje acetilkolina na stanice glatkih mišića u dišnim putovima te na taj način proširuje dišne putove.
English: • medicines for treating Parkinson's disease (levodopa), to treat an underactive thyroid gland (levothyroxine), medicines containing oxytocin (which causes uterine contraction) and alcohol can increase the chances of formoterol side effects on the heart.
Croatian: • lijekovima za liječenje Parkinsonove bolesti (levodopa), lijekovima za liječenje premalo aktivne štitne žlijezde (levotiroksin), lijekovima koji sadrže oksitocin (koji uzrokuje kontrakcije maternice) i alkoholom koji može povećati vjerojatnost srčanih nuspojava formoterola.
English: It is recommended that treatment with Riarify should not be stopped abruptly.
Croatian: Ne preporučuje se naglo prekinuti liječenje lijekom Riarify.
English: Prevention of oropharyngeal infections
Croatian: Sprječavanje orofaringealnih infekcija
English: • if you have an overactive thyroid gland.
Croatian: • ako imate prekomjerno aktivnu štitnu žlijezdu.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: The study compared data obtained after treatment with a single dose of Riarify (4 inhalations of 100/6/25 micrograms, a non-marketed formulation containing twice the approved strength of glycopyrronium) or a single dose of the extemporary combination of beclometasone dipropionate/formoterol (4 inhalations of 100/6 micrograms) plus glycopyrronium (4 inhalations of 25 micrograms).
Croatian: Ispitivanje je usporedilo podatke dobivene nakon liječenja jednom dozom lijeka Riarify (4 udaha od 100/6/25 mikrograma, formulacija koja sadrži dvostruko veću jačinu glikopironija od odobrene i koja nije na tržištu) ili jednom dozom ex tempore kombinacije beklometazondipropionat/formoterol (4 udaha od 100/6 mikrograma) plus glikopironij (4 udaha od 25 mikrograma).
English: Glucocorticoids are widely used for the suppression of inflammation in chronic inflammatory diseases of the airways such as COPD.
Croatian: Glukokortikoidi se široko primjenjuju za supresiju upale u kroničnim upalnim bolestima dišnih putova kao što je KOPB.
English: Additional there are multipacks containing either 2 or 3 pressurised containers with 120 puffs, each.
Croatian: Nadalje, postoje višestruka pakiranja koja sadrže 2 ili 3 spremnika pod tlakom sa 120 raspršenih doza u svakom spremniku.
English: Possible systemic effects include: Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation, decrease in bone mineral density, cataract, glaucoma and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Croatian: Mogući sistemski učinci uključuju: Cushingov sindrom, kušingoidne značajke, adrenalnu supresiju, zastoj u rastu, smanjenje mineralne gustoće kostiju, kataraktu, glaukom i, rjeđe, niz psiholoških učinaka ili učinaka na ponašanje uključujući psihomotornu hiperaktivnost, poremećaje spavanja,
English: For the 60 and 120 actuation pressurised containers each time the patient presses the container a puff of the solution is released and the counter counts down by one.
Croatian: Za spremnike pod tlakom sa 60 i 120 potisaka, svaki put kad bolesnik pritisne spremnik, oslobodi se odmjerena doza raspršene otopine i brojač pokaže jedan broj manje.
English: No differences were observed when comparing Riarify and the extemporary triple combination made of fluticasone and vilanterol fixed combination plus tiotropium.
Croatian: Nisu opažene razlike kad se Riarify uspoređivao s ex tempore trostrukom fiksnom kombinacijom flutikazona i vilanterola uz tiotropij.
English: • monoamine oxidase inhibitors (MAOIs), including medicines with similar properties like furazolidone and procarbazine, used to treat mental disorders, can cause a rise in blood pressure.
Croatian: • inhibitorima monoaminooksidaze (MAOI), uključujući lijekove sa sličnim svojstvima poput furazolidona i prokarbazina koji se primjenjuju za liječenje duševnih poremećaja, koji mogu prouzročiti povišenje krvnog tlaka.
English: In COPD patients receiving repeated twice daily administration of inhaled glycopyrronium, the fraction of the dose excreted in urine ranged from 13.0% to 14.5% at steady state.
Croatian: U bolesnika s KOPB-om u kojih se udahnuti glikopironij ponovljeno primjenjivao dvaput dnevno, udio doze izlučene mokraćom kretao se u rasponu od 13,0 % do 14,5 % u stanju dinamičke ravnoteže.
English: In order to reduce the risk of oropharyngeal candida infection, patients should be advised to rinse their mouth or gargle with water without swallowing it or brush their teeth after inhaling the prescribed dose.
Croatian: Da bi se smanjio rizik od orofaringealnih infekcija kandidom, bolesnicima treba savjetovati da nakon udisanja propisane doze isperu usta ili progrgljaju vodu bez gutanja ili da operu zube.
English: Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however, the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such medicinal products.
Croatian: općenito, interakcije nisu vjerojatne; međutim, ne može se isključiti mogućnost sistemskih učinaka prilikom istodobne primjene jakih inhibitora CYP3A (npr. ritonavir, kobicistat) te se stoga prilikom upotrebe takvih lijekova preporučuje oprez i odgovarajući nadzor.
English: The most frequently reported adverse reactions with Riarify were oral candidiasis (which occurred in 0.8% of the exposed subjects), which is normally associated with inhaled corticosteroids; muscle spasms (0.4%), which can be attributed to the long-acting beta2-agonist component; dry mouth (0.4%), which is a typical anticholinergic effect.
Croatian: izloženih ispitanika), koja je uobičajeno povezana s inhalacijskim kortikosteroidima; mišićni grčevi (0,4 %), koji se mogu pripisati komponenti dugodjelujućih beta-2 agonista; suha usta (0,4 %), što je uobičajeni antikolinergički učinak.
English: • other medicines used to treat COPD (theophylline, aminophylline or corticosteroids) and diuretics may also cause a fall in your potassium level.
Croatian: • drugim lijekovima koji se primjenjuju za liječenje KOPB-a (teofilin, aminofilin ili kortikosteroidi) i diureticima koji također mogu prouzročiti sniženje razine kalija u krvi.
English: Caution is also recommended when a number of reliever bronchodilators are used.
Croatian: Također se savjetuje oprez kad se primjenjuje veći broj bronhodilatatora za brzo ublažavanje simptoma.
English: Faecal excretion is the major route of beclometasone dipropionate elimination mainly as polar metabolites.
Croatian: Izlučivanje stolicom glavni je put eliminacije beklometazondipropionata uglavnom u obliku polarnih metabolita.
English: • decrease in bone mineral density (thinning of the bones)
Croatian: • smanjenje mineralne gustoće kostiju (lomljive kosti) • zamućenje očne leće (katarakta).
English: If you forget to use Riarify
Croatian: Ako ste zaboravili primijeniti Riarify
English: 120 and 180 actuation pressurised container:
Croatian: Spremnik pod tlakom sa 120 i 180 potisaka:
English: How to use Riarify
Croatian: Kako primjenjivati Riarify
English: The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for unchanged beclometasone dipropionate and beclometasone 17-monopropionate respectively.
Croatian: nominalne doze nepromijenjenog beklometazondipropionata i 62 % nominalne doze beklometazon 17-monopropionata.
English: Adrenal suppression1
Croatian: Endokrini poremećaji adrenalna supresija1
English: Pressurised inhalation, solution (pressurised inhalation).
Croatian: Stlačeni inhalat, otopina (stlačeni inhalat).
English: Riarify is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left.
Croatian: Na stražnjoj strani inhalatora Riarify nalazi se brojač doza ili pokazivač doza koji pokazuje koliko je potisaka preostalo.
English: If you stop using Riarify
Croatian: Ako prestanete primjenjivati Riarify
English: • fever or chills
Croatian: • vrućicu ili zimicu
English: Multipack: 240 actuations (2 pressurised containers of 120 actuations each).
Croatian: Višestruko pakiranje: 240 potisaka (2 spremnika pod tlakom, svaki sa 120 potisaka).
English: • burning sensation of the lips
Croatian: • osjećaj žarenja usana
English: Riarify 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Croatian: Riarify 87 mikrograma/5 mikrograma/9 mikrograma stlačeni inhalat, otopina
English: Use of Riarify in patients with severe renal impairment or end-stage renal disease requiring dialysis, especially if associated with significant body weight reduction, should be considered only if the expected benefit outweighs the potential risk (see section 4.4 and section 5.2).
Croatian: Primjena lijeka Riarify u bolesnika s teškim oštećenjem funkcije bubrega kojima je potrebna dijaliza, osobito ako je povezana sa značajnim smanjenjem tjelesne težine, može se uzeti u obzir samo ako je očekivana korist veća od mogućeg rizika (vidjeti dio 4.4 i dio 5.2).
English: Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Riarify with the AeroChamber Plus spacer device increased the total systemic exposure (AUC0-t) to glycopyrronium.
Croatian: Farmakokinetički podaci o primjeni jedne doze (vidjeti dio 5.2) pokazali su da je primjena lijeka Riarify sa AeroChamber Plus komorom za inhaliranje, u usporedbi s rutinskom primjenom bez komore za inhaliranje, povećala ukupnu sistemsku izloženost (AUC0-t) glikopironiju.
English: Colourless to yellowish liquid solution.
Croatian: Bezbojna do žućkasta otopina.
English: Riarify is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Croatian: Riarify nije indiciran za liječenje akutnih epizoda bronhospazma ili za liječenje akutne egzacerbacije
English: (<1/10,000) and not known (cannot be estimated from available data).
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):
English: After priming, the counter/indicator should read 60, 120 or 180.
Croatian: Nakon pripreme, brojač/pokazivač doza treba pokazivati 60, 120 odnosno 180.
English: Their lips should then be placed around the mouthpiece, with the tongue flat under it.
Croatian: Zatim usnama obuhvatite nastavak za usta, a jezik postavite ravno ispod njega.
English: Therefore, blood glucose should be monitored during treatment following established guidelines in patients with diabetes.
Croatian: Stoga je, tijekom liječenja, potrebno pratiti glukozu u krvi u bolesnika sa šećernom bolešću prema utvrđenim smjernicama.
English: For glycopyrronium, the maximum plasma concentration was similar after administration of the fixed or extemporary combination, while the systemic exposure was slightly higher after administration of Riarify than with the extemporary combination.
Croatian: Maksimalna koncentracija glikopironija u plazmi bila je slična nakon primjene fiksne i ex tempore kombinacije, dok je sistemska izloženost bila nešto veća nakon primjene lijeka Riarify nego ex tempore kombinacije.
English: In patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, especially if associated with a significant body weight reduction, Riarify should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega, uključujući one sa završnim stadijem bubrežne bolesti koji zahtijevaju dijalizu, osobito ako je prisutno i značajno smanjenje tjelesne težine, Riarify se smije primjenjivati samo ako je očekivana korist veća od mogućeg rizika (vidjeti dio 5.2).
English: In patients with severe hepatic impairment, Riarify should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Croatian: U bolesnika s teškim oštećenjem funkcije jetre, Riarify se smije primjenjivati samo ako je očekivana korist veća od mogućeg rizika (vidjeti dio 5.2).
English: Patients should be advised not to drop the inhaler as this may cause the counter to count down.
Croatian: Bolesnike je potrebno upozoriti da im inhalator ne smije ispasti jer to može uzrokovati odbrojavanje na brojaču.
English: Glycopyrronium is a high-affinity, long-acting muscarinic receptor antagonist (anticholinergic) used for inhalation as bronchodilator treatment of COPD.
Croatian: Glikopironij je dugodjelujući antagonist muskarinskih receptora (antikolinergik) za koje pokazuje visok afinitet i primjenjuje se inhalacijom kao bronhodilatacijsko liječenje KOPB-a.
English: This incorporates a mouthpiece provided with a plastic protective cap, and either a dose counter (containers with 60 and 120 puffs) or a dose indicator (containers with 180 puffs).
Croatian: To uključuje nastavak za usta opremljen plastičnim zaštitnim zatvaračem te brojač doza (spremnici sa 60 i 120 raspršenih doza) ili pokazivač doza (spremnici sa 180 raspršenih doza).
English: • leakage of blood from a vessel into the tissues surrounding it
Croatian: • propuštanje krvi iz krvne žile u okolno tkivo
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Riarify Lijek čuvajte izvan pogleda i dohvata djece.
English: • if you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary heart disease), disease of your heart valves or any other abnormalities of your heart or if you have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal).
Croatian: nedavni srčani udar (infarkt miokarda), zatajenje srca, suženje arterija srca (koronarna bolest), bolest srčanih zalistaka ili neku drugu abnormalnost srca ili ako imate stanje poznato pod nazivom hipertrofična opstruktivna kardiomiopatija (stanje u kojem je srčani mišić abnormalan).
English: Multipack: 360 actuations (3 pressurised containers of 120 actuations each).
Croatian: Višestruko pakiranje: 360 potisaka (3 spremnika pod tlakom, svaki sa 120 potisaka).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (MULTIPACK ONLY: no Blue Box is included)
Croatian: MEĐUPAKIRANJE (SAMO VIŠESTRUKA PAKIRANJA: bez uključenog plavog okvira)
English: Wipe inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
Croatian: Obrišite nastavak za usta iznutra i izvana te inhalator čistom, suhom krpicom ili maramicom.
English: Patients should hold the inhaler vertically with its body upwards and place the mouthpiece between their teeth without biting.
Croatian: Bolesnici trebaju držati inhalator okomito, tako da mu je tijelo okrenuto prema gore, i postaviti nastavak za usta između zuba, ali ga ne smiju zagristi.
English: Stop using the inhaler when the counter or indicator shows 0, as any medicine left in the inhaler may not be enough to give you a full puff.
Croatian: Kada brojač ili pokazivač doza pokaže 0, prestanite upotrebljavati taj inhalator jer preostala količina lijeka u inhalatoru možda neće biti dovoljna da se rasprši puna doza.
English: Absorption of formoterol is linear following inhalation of 12 to 96 micrograms of formoterol.
Croatian: Apsorpcija formoterola nakon inhalacije 12 do 96 mikrograma formoterola je linearna.
English: Chemical and physical in-use stability has been demonstrated for 2 months at 25°C.
Croatian: Dokazano je da je lijek u primjeni kemijski i fizikalno stabilan 2 mjeseca na temperaturi od 25°C.