FrancophonIA/ELRC3.0 huggingface dataset:
English: The systemic availability of the active metabolite arises from lung (36%) and from gastrointestinal absorption of the swallowed dose.
Croatian: Sistemska raspoloživost djelatnog metabolita posljedica je apsorpcije u plućima (36 %) i apsorpcije progutane doze u gastrointestinalnom traktu.
English: Additional instructions for specific groups of patients For patients with weak hands it may be easier to hold the inhaler with both hands.
Croatian: Bolesnicima sa slabim rukama možda će biti lakše držati inhalator objema rukama.
English: 60 actuation pressurised container: 21 months.
Croatian: Spremnik pod tlakom sa 60 potisaka: 21 mjesec.
English: Pressurised container (coated aluminium), with a metering valve.
Croatian: Spremnik pod tlakom (obložen aluminijem), s odmjernim ventilom.
English: Formoterol is a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction.
Croatian: Formoterol Formoterol je selektivni beta-2 adrenergički agonist koji izaziva relaksaciju glatkog mišićja bronha u bolesnika s reverzibilnom opstrukcijom dišnih puteva.
English: For pharmacists: Enter the date of dispensing to the patient on the pack.
Croatian: Zapišite na pakiranje datum izdavanja lijeka bolesniku.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Riarify therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mothers.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Riarify uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: On average, 8% and 25% of the dose was excreted as unchanged and total formoterol, respectively.
Croatian: U prosjeku se 8 % doze izlučilo u obliku nepromijenjenog formoterola, a 25 % u obliku ukupnog formoterola.
English: • if you have any disease of your liver or kidneys.
Croatian: • ako imate ikakvu bolest jetre ili bubrega.
English: The combination of Riarify with some other COPD medicines or medicines such as diuretics (medicines that make the body lose water, to treat heart disease or high blood pressure), can cause a sharp fall in your blood level of potassium.
Croatian: Kombinacija lijeka Riarify s nekim drugim lijekovima za KOPB ili lijekovima kao što su diuretici (lijekovi koji uzrokuju izlučivanje vode iz tijela, za liječenje srčane bolesti ili visokog krvnog tlaka), može uzrokovati naglo sniženje razine kalija u krvi.
English: Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms (see section 5.2).
Croatian: Budući da se glikopironij eliminira uglavnom putem bubrega, mogle bi nastati interakcije s lijekovima koji utječu na mehanizme izlučivanja u bubregu (vidjeti dio 5.2).
English: 120 and 180 actuation pressurised container: 22 months.
Croatian: Spremnik pod tlakom sa 120 i 180 potisaka: 22 mjeseca.
English: Riarify should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Croatian: Potrebno je odmah prekinuti primjenu lijeka Riarify, procijeniti bolesnika i, ako je potrebno, uvesti drugu terapiju.
English: After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see section 4.4 and 6.6).
Croatian: Nakon udisanja, bolesnici trebaju isprati usta ili progrgljati vodu bez gutanja ili oprati zube (vidjeti dio 4.4 i 6.6).
English: Cytochrome P450 isoenzymes CYP2D6, CYP2C19 and CYP2C9 are involved in the O-demethylation of formoterol.
Croatian: U O-demetilaciji formoterola sudjeluju izoenzimi citokroma P450 - CYP2D6, CYP2C19 i CYP2C9.
English: There was no clear evidence of pharmacokinetic interaction, however the extemporary combination showed formoterol and glycopyrronium levels transiently slightly higher immediately after dosing compared with the single components.
Croatian: Nije bilo jasnog dokaza farmakokinetičke interakcije, međutim, pokazalo se da su kod ex tempore kombinacije razine formoterola i glikopironija privremeno bile nešto više neposredno nakon doziranja u usporedbi s pojedinačnim komponentama.
English: Rare
Croatian: rijetko
English: After oral administration (40 to 80 micrograms), 6% to 10% of the dose was recovered in urine as unchanged active substance in healthy subjects; up to 8% of the dose was recovered as the glucuronide.
Croatian: Nakon peroralne primjene (40 do 80 mikrograma), 6 % do 10 % doze pronađeno je u mokraći zdravih ispitanika u obliku nepromijenjene djelatne tvari; do 8 % doze pronađeno je u obliku glukuronida.
English: An overdose of Riarify may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists or anticholinergics and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Croatian: Predoziranje lijekom Riarify može izazvati znakove i simptome zbog djelovanja pojedinačnih komponenti, uključujući one opažene kod predoziranja drugim beta-2 agonistima i antikolinergicima i sukladne poznatim učincima skupine inhalacijskih kortikosteroida (vidjeti dio 4.4).
English: You should not use Riarify during breast-feeding.
Croatian: Ne smijete primjenjivati Riarify tijekom dojenja.
English: After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see sections 4.2 and 4.4).
Croatian: Nakon udisanja, bolesnici trebaju isprati usta ili progrgljati vodu bez gutanja ili oprati zube (vidjeti dijelove 4.2 i 4.4).
English: • fungal infections of the mouth.
Croatian: • gljivične infekcije usta.
English: • if you have a tumour of the adrenal gland (known as a phaeochromocytoma).
Croatian: • ako imate tumor nadbubrežne žlijezde (poznat kao feokromocitom).
English: The bioavailability of swallowed beclometasone dipropionate is negligible; however, pre-systemic conversion to beclometasone 17-monopropionate results in 41% of the dose being absorbed as the active metabolite.
Croatian: Bioraspoloživost progutanog beklometazondipropionata je zanemariva; međutim, zbog predsistemske konverzije u beklometazon 17-monopropionat, 41 % doze apsorbira se kao djelatni metabolit.
English: If your symptoms get worse or are difficult to control (e.g. if you are using a separate “reliever” inhaler more frequently) or if your “reliever” inhaler does not improve your symptoms, see your doctor immediately.
Croatian: Ako Vam se simptomi pogoršavaju ili ih je teško kontrolirati (npr. ako češće koristite posebni inhalator s lijekom za brzo ublažavanje simptoma) ili ako Vam inhalator s lijekom za brzo ublažavanje simptoma ne olakšava simptome, odmah se obratite liječniku.
English: • fall in the level of some constituents of your blood: of certain white blood cells called granulocytes, of potassium or of cortisol
Croatian: • sniženje razine nekih sastojaka krvi: određenih bijelih krvnih stanica koje se nazivaju granulociti, kalija ili kortizola
English: The use of Riarify with the AeroChamber Plus spacer in COPD patients increased the lung delivery of beclometasone 17-monopropionate, formoterol and glycopyrronium (maximum plasma concentration increased by 15%, 58% and 60% respectively).
Croatian: Primjena lijeka Riarify s komorom za inhaliranje AeroChamber Plus u bolesnika s KOPB-om povećala je dopiranje beklometazon 17-monopropionata, formoterola i glikopironija do pluća (maksimalne koncentracije u plazmi bile su povećane za 15 %, 58 % odnosno 60 %).
English: Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions.
Croatian: Istodobno liječenje inhibitorima monoaminooksidaze, uključujući lijekove koji imaju svojstva slična furazolidonu i prokarbazinu, može izazvati hipertenzivne reakcije.
English: Stand or sit up when inhaling.
Croatian: Za vrijeme udisanja stojte ili uspravno sjedite.
English: Patients should not breathe out into the inhaler.
Croatian: Bolesnici ne smiju izdisati zrak kroz inhalator.
English: Alternatively, patients may simply breathe in and out (through the mouth) after the actuation, as instructed in the spacer leaflet, to obtain the active substance.
Croatian: Drugi je način da bolesnici jednostavno udahnu i izdahnu (na usta) nakon potiska, kako je opisano u uputama za komoru za inhaliranje, kako bi primili djelatnu tvar.
English: Beclometasone dipropionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs.
Croatian: Beklometazondipropionat koji se daje inhalacijom u preporučenim dozama ima glukokortikoidno protuupalno djelovanje unutar pluća.
English: The fraction of an inhaled dose that is swallowed after administration with a metered dose inhaler may range between 60% and 90%.
Croatian: Dio udahnute doze koji se proguta nakon primjene stlačenog inhalata može se kretati u rasponu od 60 % do 90 %.
English: The maximum plasma concentration and systemic exposure of beclometasone dipropionate main active metabolite (beclometasone 17-monopropionate) and formoterol were similar after administration of the fixed or extemporary combination.
Croatian: Maksimalna koncentracija u plazmi i sistemska izloženost glavnom djelatnom metabolitu beklometazondipropionata (beklometazon 17-monopropionatu) i formoterolu bile su slične nakon primjene fiksne odnosno ex tempore kombinacije.
English: Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).
Croatian: Terapija održavanja u odraslih bolesnika s umjerenom do teškom kroničnom opstruktivnom plućnom bolešću (KOPB) koji nisu odgovarajuće liječeni kombinacijom inhalacijskog kortikosteroida i dugodjelujućeg beta-2 agonista ili kombinacijom dugodjelujućeg beta-2 agonista i dugodjelujućeg muskarinskog antagonista (za učinke na kontrolu simptoma i sprječavanje egzacerbacija vidjeti dio 5.1).
English: It is recommended that serum potassium levels are monitored in such situations.
Croatian: U takvim se situacijama preporučuje pratiti razine kalija u serumu.
English: Simulations performed with a pharmacokinetic model showed that even when covariates had extreme values (body weight less than 40 kg and concomitant glomerular filtration rate below 27 mL/min/1.73 m²), exposure to Riarify active substances remains in approximately a 2.5-fold range compared to the exposure in a typical patient with median covariate values.
Croatian: Simulacije provedene na farmakokinetičkom modelu pokazale su da, čak i kad kovarijate imaju ekstremne vrijednosti (tjelesna težina manja od 40 kg i istodobna brzina glomerularne filtracije manja od 27 ml/min/1,73 m²), izloženost djelatnim tvarima lijeka Riarify ostaje veća za približno 2,5 puta u usporedbi s izloženošu u uobičajenog bolesnika s medijanom vrijednosti kovarijata.
English: For the regular cleaning of the inhaler, patients should remove weekly the cap from the mouthpiece and wipe the outside and inside of the mouthpiece with a dry cloth.
Croatian: Čišćenje Za redovito čišćenje inhalatora, bolesnici trebaju svaki tjedan ukloniti zatvarač s nastavka za usta i obrisati nastavak za usta izvana i iznuta suhom krpicom.
English: Following intravenous dosing, the disposition of beclometasone dipropionate and its active metabolite is characterised by high plasma clearance (150 and 120 L/h respectively), with a small volume of distribution at steady state for beclometasone dipropionate (20 L) and larger tissue distribution for its active metabolite (424 L).
Croatian: Nakon intravenske primjene, dispoziciju beklometazondipropionata i njegovog djelatnog metabolita karakterizira visoki klirens iz plazme (150 odnosno 120 l/sat), uz mali volumen distribucije beklometazondipropionata u stanju dinamičke ravnoteže (20 l) i veću distribuciju njegovog djelatnog metabolita u tkiva (424 l).
English: This should be treated immediately with a fast-acting inhaled bronchodilator (reliever).
Croatian: To je potrebno odmah liječiti brzodjelujućim inhalacijskim bronhodilatatorom (lijekom koji brzo ublažava simptome).
English: Riarify is used as a maintenance treatment for your COPD.
Croatian: Riarify se primjenjuje kao terapija održavanja kod KOPB-a.
English: However, an increase in total systemic exposure of up to 2.5-fold was observed in subjects with severe renal impairment (glomerular filtration rate below 30 mL/min/1.73 m2), as a consequence of a significant reduction of the amount excreted in urine (approximately 90% reduction of glycopyrronium renal clearance).
Croatian: Međutim, bilo je opaženo povećanje ukupne sistemske izloženosti do 2,5 puta u ispitanika s teškim oštećenjem bubrega (brzina glomerularne filtracije manja od 30 ml/min/1,73 m2), kao posljedica značajnog smanjenja količine izlučene u mokraći (smanjenje bubrežnog klirensa glikopironija za približno 90 %).
English: Inspiratory Capacity (IC)
Croatian: Inspiracijski kapacitet
English: The recommended dose is two inhalations of Riarify twice daily.
Croatian: Odrasli Preporučena doza je dva udaha lijeka Riarify dvaput na dan.
English: Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.
Croatian: Nakon doziranja može doći do paradoksalnog bronhospazma uz trenutno pojačanje piskanja pri disanju i nedostatka zraka.
English: Riarify should be used with caution in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure), occlusive vascular diseases (particularly arteriosclerosis), arterial hypertension and aneurysm.
Croatian: Riarify je potrebno primjenjivati uz oprez u bolesnika sa srčanim aritmijama, osobito atrioventrikularnim blokom trećeg stupnja i tahiaritmijama (ubrzanim i/ili nepravilnim otkucajima srca), idiopatskom subvalvularnom aortalnom stenozom, hipertrofičnom opstruktivnom kardiomiopatijom, teškom bolešću srca (osobito akutnim infarktom miokarda, ishemijskom bolešću srca, kongestivnim zatajenjem srca), okluzivnim krvožilnim bolestima (osobito arteriosklerozom), arterijskom hipertenzijom i aneurizmom.
English: • sensation of a missed heart beat, unusually slow heart beat
Croatian: • osjećaj preskakanja srca, neobično spori otkucaji srca
English: Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.
Croatian: Istodobno liječenje kinidinom, dizopiramidom, prokainamidom, antihistaminicima, inhibitorima monoaminooksidaze, tricikličkim antidepresivima i fenotiazinima može produljiti QT interval i povećati rizik od ventrikularnih aritmija.
English: • problems with how your adrenal glands work (adrenal suppression)
Croatian: • probleme u radu nadbubrežnih žlijezdi (adrenalna supresija)
English: It is noted that single component glycopyrronium, formulated as pressurised metered dose inhaler, which was used in the PK studies, is not available on the market.
Croatian: Potrebno je napomenti da glikopironij kao zasebna komponenta u obliku stlačenog inhalata, koji se koristio u farmakokinetičkim ispitivanjima, nije dostupan na tržištu.
English: 2-hour post-dose FEV1
Croatian: FEV1 dva sata poslije doziranja
English: Caution is also required when Riarify is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia.
Croatian: Oprez je potreban i kad Riarify primjenjuju bolesnici s tireotoksikozom, šećernom bolešću, feokromocitomom i neliječenom hipokalijemijom.
English: Psychomotor hyperactivity1, sleep disorders1, anxiety, depression1, aggression1, behavioural changes (predominantly in children) 1
Croatian: anksioznost, depresija1, agresija1, promjene ponašanja (pretežno u djece) 1
English: Formoterol is widely metabolised and the prominent pathway involves direct conjugation at the phenolic hydroxyl group.
Croatian: Formoterol se opsežno metabolizira, a glavni put uključuje izravnu konjugaciju na mjestu fenolne hidroksilne skupine.
English: Ear and labyrinth disorders Otosalpingitis1
Croatian: Poremećaji uha i labirinta otosalpingitis1
English: Animal studies have shown impairment of fertility (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su smanjenu plodnost (vidjeti dio 5.3).
English: • if you have an eye problem called narrow-angle glaucoma.
Croatian: • ako imate problem s okom koji se naziva glaukom uskog kuta.
English: The systemic exposure to beclometasone dipropionate, formoterol and glycopyrronium has been investigated in a pharmacokinetic study conducted in healthy subjects.
Croatian: Povezano s lijekom Riarify Sistemska izloženost beklometazondipropionatu, formoterolu i glikopironiju ispitana je u farmakokinetičkom ispitivanju provedenom u zdravih ispitanika.
English: Dermatitis allergic1
Croatian: Poremećaji imunološkog sustava alergijski dermatitis1
English: It is unknown whether formoterol or glycopyrronium (including their metabolites) pass into human breast-milk but they have been detected in the milk of lactating animals.
Croatian: Nije poznato prelaze li formoterol ili glikopironij (uključujući njihove metabolite) u majčino mlijeko,
English: Following glycopyrronium inhalation, the lung bioavailability was 10.5% (with activated charcoal ingestion) while the absolute bioavailability was 12.8% (without activated charcoal ingestion) confirming the limited gastrointestinal absorption and indicating that more than 80% of glycopyrronium systemic exposure was from lung absorption.
Croatian: Nakon inhalacije glikopironija, njegova bioraspoloživost iz pluća bila je 10,5 % (uz uzimanje aktivnog ugljena), dok je apsolutna bioraspoloživost bila 12,8 % (bez uzimanja aktivnog ugljena), što potvrđuje njegovu ograničenu apsorpciju u gastrointestinalnom traktu i pokazuje da više od 80 % sistemske izloženosti glikopironiju proizlazi iz njegove apsorpcije u plućima.
English: The effect of organic cation transport inhibition (using cimetidine as a probe inhibitor of OCT2 and MATE1 transporters) in the kidneys on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 16% and a slight decrease in renal clearance by 20% due to co administration of cimetidine.
Croatian: Učinak inhibicije prijenosa organskih kationa (pomoću cimetidina kao probnog inhibitora prijenosnika OCT2 i MATE1) u bubrezima na dispoziciju inhaliranog glikopironija pokazuje se kao ograničeno povećanje ukupne sistemske izloženosti (AUC0-t) za 16 % i blago smanjenje bubrežnog klirensa za 20 % zbog istodobne primjene cimetidina.
English: You should get a replacement when the counter or indicator shows the number 20.
Croatian: Trebali biste nabaviti novi inhalator kad brojač ili pokazivač doza pokaže broj 20.
English: Peak plasma concentrations of the unchanged active substance occur within 0.5 to 1 hours after oral administration.
Croatian: Nepromijenjena djelatna tvar postiže vršne koncentracije u plazmi unutar 0,5 do 1 sata nakon peroralne primjene.
English: • fungal infections of the throat or of the food pipe (oesophagus)
Croatian: • gljivične infekcije grla ili jednjaka (ezofagusa)
English: Patients should then hold their breath for as long as comfortably possible, then remove the inhaler from the mouth and breathe out slowly.
Croatian: Bolesnici potom trebaju zadržati dah koliko god mogu dok im nije neugodno, a zatim izvaditi inhalator iz usta i polako izdahnuti.
English: The cumulative urinary excretion of formoterol after single inhalation from a dry powder inhaler increased linearly in the 12-96 micrograms dose range.
Croatian: Eliminacija Kumulativno izlučivanje formoterola mokraćom nakon jednog udaha praška inhalata povećavalo se linearno u rasponu doza od 12 do 96 mikrograma.
English: • increased mucus production, change in mucus colour
Croatian: • pojačano stvaranje sluzi, promjena boje sluzi
English: Riarify comes in a pressurised container (coated aluminium), with a metering valve.
Croatian: Riarify se isporučuje u spremniku pod tlakom (obloženom aluminijem) s odmjernim ventilom.
English: If this occurs you should stop using Riarify and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing.
Croatian: Ako se to dogodi, morate prestati primjenjivati Riarify i uzeti svoj inhalator s brzodjelujućim lijekom za brzo ublažavanje simptoma radi liječenja nedostatka zraka i piskanja.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 actuations
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 potisaka
English: If any of the above applies to you, tell your doctor before you use Riarify.
Croatian: Ako se nešto od navedenog odnosi na Vas, obavijestite svog liječnika prije nego što primijenite
English: • if you experience any allergic reactions like skin allergies, hives, skin itching, skin rash (may affect up to 1 in 100 people), reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat (may affect up to 1 in 1,000 people).
Croatian: osipa na koži (mogu se javiti u do 1 na 100 osoba), crvenila kože, oticanja kože ili sluznica osobito očiju, lica, usana i grla (mogu se javiti u do 1 na 1000 osoba).
English: Glycopyrronium has a quaternary ammonium structure which limits its passage across biological membranes and produces slow, variable and incomplete gastrointestinal absorption.
Croatian: Apsorpcija i distribucija Glikopironij ima strukturu kvarternog amonijevog spoja koja mu ograničava prolaz kroz biološke membrane pa je zato njegova gastrointestinalna apsorpcija spora, promjenjiva i nepotpuna.
English: There are no or limited amount of data from the use of Riarify in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lijeka Riarify u trudnica ograničeni.
English: Before priming the 60, 120 or 180 actuation pressurised containers, the counter/indicator should read 61, 121 or 180, respectively.
Croatian: Prije pripreme spremnika pod tlakom sa 60, 120 ili 180 potisaka, brojač/pokazivač doza treba pokazivati 61, 121 odnosno 180.
English: Glaucoma1, cataract1
Croatian: učestalost nepoznata glaukom1, katarakta1
English: If you develop worsening shortness of breath or wheezing (breathing with a whistling sound), straight after inhaling your medicine, stop using Riarify inhaler and use your quick-acting “reliever” inhaler straightaway.
Croatian: Ako Vam se pogorša nedostatak zraka ili piskanje (zviždanje pri disanju) neposredno nakon udisanja lijeka, prestanite koristiti inhalator Riarify i smjesta upotrijebite inhalator s brzodjelujućim lijekom za brzo ublažavanje simptoma.
English: • Disulfiram, a medicine used in the treatment of people with alcoholism (drinking problems) or metronidazole, an antibiotic to treat infection in your body can cause side effects (e.g. feeling sick, being sick, stomach pain) due to the small amount of alcohol in Riarify.
Croatian: • disulfiramom, lijekom koji se primjenjuje za liječenje osoba s alkoholizmom (problem s prekomjernim pijenjem) ili metronidazolom, antibiotikom koji se primjenjuje za liječenje infekcije u tijelu (metronidazol) može uzrokovati nuspojave (npr. mučninu, povraćanje, bol u trbuhu) zbog male količine alkohola u lijeku Riarify.
English: • runny or stuffy nose and sneezing
Croatian: • curenje ili začepljenost nosa i kihanje