FrancophonIA/ELRC3.0 huggingface dataset:
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Croatian: Sistemski učinci kortikosteroida Sistemski učinci mogu nastati uz bilo koji inhalacijski kortikosteroid, osobito kad su propisane visoke doze tijekom dugog razdoblja.
English: • changes in the electrocardiogram (heart trace)
Croatian: • promjene u elektrokardiogramu (EKGu)
English: Regular treatment with these three active substances helps to relieve and prevent symptoms such as shortness of breath, wheezing and cough in adult patients with chronic obstructive pulmonary disease (COPD).
Croatian: Redovito liječenje pomoću ove tri djelatne tvari pomaže olakšati i spriječiti simptome poput nedostatka zraka, piskanja pri disanju i kašlja u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB-om).
English: Riarify should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus.
Croatian: Riarify se smije primjenjivati tijekom trudnoće samo ako je očekivana korist za bolesnicu veća od mogućeg rizika za fetus.
English: Non-cardioselective beta-blockers (including eye drops) should be avoided in patients taking inhaled formoterol.
Croatian: Potrebno je izbjegavati beta-blokatore koji nisu kardioselektivni (uključujući kapi za oko) u bolesnika koji uzimaju inhalacijski formoterol.
English: Breathe out as slowly and deeply as possible, in order to empty your lungs.
Croatian: Izdahnite što sporije i dublje možete, kako biste ispraznili pluća.
English: Mean renal clearance was similar across the range of doses tested and after single and repeated inhalation (range 281-396 mL/min).
Croatian: Srednja vrijednost bubrežnog klirensa bila je slična u rasponu ispitanih doza i nakon jednokratne i ponovljene inhalacije (raspon: 281-396 ml/min).
English: • increase of blood pressure
Croatian: • povišenje krvnog tlaka
English: The terminal elimination half-lives are 0.5 hours and 2.7 hours for beclometasone dipropionate and beclometasone 17-monopropionate respectively.
Croatian: Terminalni poluvijek eliminacije iznosi 0,5 sati za beklometazondipropionat i 2,7 sati za beklometazon 17-monopropionat.
English: They act in different ways to relax the muscles in your airways, helping to open the airways wider and allowing you to breathe more easily.
Croatian: Oni na različite načine opuštaju mišiće dišnih puteva, tako ih proširuju te Vam omogućuju da lakše dišete.
English: For the second puff, keep the inhaler in the upright position for about half a minute, then repeat steps 2 to 5.
Croatian: Za drugu raspršenu dozu držite inhalator u uspravnom položaju oko pola minute, a zatim ponovite postupak od 2. do 5. koraka.
English: Riarify is unlikely to affect your ability to drive and use machines.
Croatian: Riarify najvjerojatnije neće utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: • if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes.
Croatian: • ako osjetite bol ili nelagodu u očima, privremeno zamagljenje vida, vidite svjetlosne krugove oko predmeta ili obojene slike udružene s crvenilom očiju.
English: Do not remove the pressurised container from the inhaler and do not use water or other liquids to clean your inhaler.
Croatian: Nemojte vaditi spremnik pod tlakom iz inhalatora i nemojte koristiti vodu ili druge tekućine za čišćenje inhalatora.
English: At the same time, patients should breathe in slowly and deeply through the mouth until the lungs are full of air (this should take approximately 4 - 5 seconds).
Croatian: Istovremeno, bolesnici trebaju polako i duboko udahnuti na usta sve dok im se pluća ne ispune zrakom (za to je potrebno približno 4-5 sekundi).
English: There was no evidence for overadditive effects of the triple combination when compared with the single components.
Croatian: Nije bilo dokaza više nego aditivnih učinaka trojne kombinacije u usporedbi s pojedinačnim komponentama.
English: 1 Adverse reactions reported in the SmPC of at least one of the individual components, but not observed as adverse reactions in the clinical development of Riarify
Croatian: 1Nuspojave prijavljene u sažetku opisa svojstava lijeka najmanje jedne od pojedinačnih komponenti, ali nisu uočene kao nuspojave u kliničkom razvoju lijeka Riarify.
English: 67% of an oral dose of formoterol is excreted in urine (mainly as metabolites) and the remainder in the faeces.
Croatian: Ukupno se 67 % peroralne doze formoterola izluči mokraćom (uglavnom kao metaboliti), a ostatak stolicom.
English: • unusually fast heart beat and disorders of the heart rhythm
Croatian: • neobično brz rad srca i poremećaji srčanog ritma
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Croatian: Ako bolesnik ima simptome kao što su zamućen vid ili neke druge poremećaje vida, treba razmotriti potrebu da ga se uputi oftalmologu radi procjene mogućih uzroka, koji mogu uključivati kataraktu, glaukom ili rijetke bolesti kao što je centralna serozna korioretinopatija (CSCR) koja je zabilježena nakon sistemske i topikalne uporabe kortikosteroida.
English: Riarify was also statistically significantly superior to a fixed combination of beclometasone dipropionate and formoterol, to tiotropium and to a fixed combination of indacaterol and glycopyrronium in terms of improvement in quality of life (measured by the Saint George Respiratory Questionnaire - SGRQ - total score).
Croatian: Riarify je također bio statistički značajno superiorniji fiksnoj kombinaciji beklometazondipropionata i formoterola, tiotropiju te fiksnoj kombinaciji indakaterola i glikopironija u pogledu poboljšanja kvalitete života (mjerene ukupnim rezultatom na Saint George respiratornom upitniku, SGRQ).
English: Multipack outer carton Also enter the date of dispensing on each individual pack.
Croatian: Vanjsko pakiranje višestrukog pakiranja Zapišite datum izdavanja lijeka i na svako pojedinačno pakiranje.
English: This medicine is contained in a pressurised container in a plastic inhaler with a mouthpiece.
Croatian: Ovaj lijek se nalazi u spremniku pod tlakom u plastičnom inhalatoru s nastavkom za usta.
English: Riarify can reduce exacerbations (flare-ups) of COPD symptoms.
Croatian: Riarify može smanjiti egzacerbacije (razbuktavanje) simptoma KOPB
English: Riarify has no or negligible influence on the ability to drive and use machines.
Croatian: Riarify ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • some anaesthetics can increase the risk of abnormal heart rhythms.
Croatian: • nekim anesteticima koji mogu povećati rizik od abnormalnog srčanog ritma.
English: If your COPD gets worse:
Croatian: Ako Vam se KOPB pogoršava:
English: Patients should be advised to get a new inhaler when the dose counter or indicator shows the number 20.
Croatian: Bolesnicima treba savjetovati da nabave novi inhalator kad brojač ili pokazivač doza pokaže broj 20.
English: Patients who find it difficult to synchronise aerosol actuation with inspiration of breath may use the AeroChamber Plus spacer device, properly cleaned as described in the relevant leaflet.
Croatian: Bolesnici kojima je teško uskladiti potisak i oslobađanje aerosola s udisanjem mogu koristiti komoru za inhaliranje AeroChamber Plus, temeljito očišćenu kako je opisano u odgovarajućoj uputi.
English: COPD is a serious longterm disease in which the airways become blocked and air sacs inside the lungs become damaged, leading to difficulty breathing.
Croatian: KOPB je ozbiljna dugotrajna bolest u kojoj dolazi do začepljenja dišnih puteva i oštećenja zračnih vrećica u plućima, a to dovodi do otežanog disanja.
English: There are no relevant data on the use of Riarify in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see section 4.4 and section 5.2).
Croatian: Nema relevantnih podataka o primjeni lijeka Riarify u bolesnika s teškim oštećenjem funkcije jetre pa je u tih bolesnika lijek potrebno primjenjivati s oprezom (vidjeti dio 4.4 i dio 5.2).
English: Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Croatian: Hipokalijemija može povećati sklonost aritmijama u bolesnika koji se liječe glikozidima digitalisa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS AND MULTIPACK ONLY: contains Blue Box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE (SAMO JEDNOSTRUKA PAKIRANJA I VIŠESTRUKO PAKIRANJE: sadrži plavi okvir)
English: The metabolic pattern of glycopyrronium in vitro (humans, dogs, rats, mice and rabbits liver microsomes and hepatocytes) was similar among species and the main metabolic reaction was the hydroxylation on the phenyl or ciclopentyl rings.
Croatian: Metabolički obrazac glikopironija in vitro (mikrosomi i hepatociti ljudske, pseće, štakorske, mišje i kunićje jetre) bio je sličan među vrstama i glavna metabolička reakcija bila je hidroksilacija na fenilnom ili ciklopentilnom prstenu.
English: • upset stomach
Croatian: • nadražaj želuca
English: Carcinogenicity studies have not been performed with Riarify.
Croatian: Ispitivanja kancerogenosti lijeka Riarify nisu provedena.
English: If mist appears after the inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2.
Croatian: Ako se nakon udisanja pojavi maglica, bilo iz inhalatora bilo sa strane usta, potrebno je ponoviti postupak od 2. koraka.
English: The long-term co-administration of Riarify with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Croatian: Dugotrajna istodobna primjena lijeka Riarify s drugim antikolinergičkim lijekovima nije ispitana pa se stoga ne preporučuje (vidjeti dio 4.4).
English: Their action is mediated by the binding to glucocorticoid receptors in the cytoplasm resulting in the increased transcription of genes coding for antiinflammatory proteins.
Croatian: Njihovo djelovanje posredovano je vezanjem na glukokortikoidne receptore u citoplazmi, što dovodi do povećane transkripcije gena koji kodiraju protuupalne proteine.
English: The maximum dose is two inhalations of Riarify twice daily.
Croatian: Maksimalna doza je dva udaha lijeka Riarify dvaput na dan.
English: Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics (see section 4.5).
Croatian: Hipokalijemija može biti pojačana i istodobnim liječenjem drugim lijekovima koji mogu izazvati hipokalijemiju, kao što su derivati ksantina, steroidi i diuretici (vidjeti dio 4.5).
English: Patients should then check the dose counter or dose indicator to ensure it has moved accordingly.
Croatian: Bolesnici zatim trebaju provjeriti brojač doza ili pokazivač doza kako bi provjerili da se odgovarajuće pomaknuo.
English: To prevent a fungal infection in the mouth and throat, rinse your mouth or gargle with water without swallowing it or brush your teeth after each use of your inhaler.
Croatian: Da biste spriječili gljivičnu infekciju u ustima i grlu, isperite usta ili progrgljajte vodu bez gutanja ili operite zube nakon svake upotrebe inhalatora.
English: To inhale the second puff, patients should keep the inhaler in a vertical position for approximately 30 seconds and repeat steps 2 to 6.
Croatian: Da bi udahnuli drugu raspršenu dozu, bolesnici trebaju držati inhalator u uspravnom položaju približno 30 sekundi i ponoviti postupak od 2. do 6. koraka.
English: Before using the inhaler for the first time, the patient should release one actuation into the air in order to ensure that the inhaler is working properly (priming).
Croatian: Prije nego što inhalator upotrijebi prvi put, bolesnik treba jedanput pritisnuti spremnik i raspršiti jedan potisak u zrak kako bi bio siguran da inhalator pravilno radi (priprema).
English: The relative proportion of the two enantiomers remained constant over the dose range studied and there was no evidence of relative accumulation of one enantiomer over the other after repeated dosing.
Croatian: Relativni udio ta dva enantiomera u ispitivanom rasponu doza ostao je nepromijenjen i nije bilo dokaza relativnog nakupljanja jednog enantiomera u odnosu na drugi nakon ponovljenog doziranja.
English: It is reasonable to assume that beclometasone dipropionate and its metabolites are also excreted into breast-milk.
Croatian: Razumno je pretpostaviti da se i beklometazondipropionat i njegovi metaboliti izlučuju u majčino mlijeko.
English: • growth retardation in children and adolescents.
Croatian: • oticanje šaka i stopala • zaostajanje u rastu djece i adolescenata.
English: Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists (see section 4.4).
Croatian: Istodobno liječenje derivatima ksantina, steroidima ili diureticima može pojačati mogući hipokalijemijski učinak beta-2 agonista (vidjeti dio 4.4).
English: Vision, blurred1 (see also section 4.4)
Croatian: Poremećaji oka zamućen vid1 (vidjeti također dio 4.4)
English: The pressurised container is inserted in a plastic inhaler.
Croatian: Spremnik pod tlakom umetnut je u plastični inhalator.
English: However, in a 104-week rat inhalation carcinogenicity study and an oral 26-week carcinogenicity study in transgenic Tg.rasH2 mice, glycopyrronium bromide showed no carcinogenic potential and published data concerning long-term studies conducted with beclometasone dipropionate and formoterol fumarate in rats do not indicate a clinically relevant carcinogenic potential.
Croatian: Međutim, u inhalacijskom ispitivanju kancerogenosti na štakorima u trajanju od 104 tjedna, te u ispitivanju kancerogenosti pri peroralnoj primjeni na transgeničnim miševima Tg.rasH2 u trajanju od 26 tjedana, glikopironijev bromid nije pokazao kancerogeni potencijal, a objavljeni podaci iz dugoročnih ispitivanja provedenih s beklometazondipropionatom i formoterolfumaratom u štakora ne upućuju na klinički značajan kancerogeni potencijal.
English: • sleep disorders (sleeping too little or too long)
Croatian: • poremećaji spavanja (premalo ili previše spavanja) • bol poput gnječenja u prsnom košu
English: To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient's inhalation technique.
Croatian: Da bi se osigurala pravilna primjena ovog lijeka, liječnik ili drugi zdravstveni radnik treba pokazati bolesniku kako da ispravno koristi inhalator te također treba redovito provjeravati ispravnost bolesnikove tehnike inhaliranja.
English: This study also investigated the potential pharmacokinetic interaction between the active components of Riarify by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium.
Croatian: U ovom se ispitivanju također istražila moguća farmakokinetička interakcija između djelatnih komponenti lijeka Riarify tako što su se usporedili farmakokinetički podaci dobiveni nakon primjene jedne doze ex tempore kombinacije i nakon primjene jedne doze pojedinačnih komponenti beklometazondipropionata/formoterola ili glikopironija.
English: Pack sizes of 1 container of 60, 120 or 180 actuations and multipacks of 2 or 3 containers of 120 actuations each.
Croatian: Veličine pakiranja s jednim spremnikom od 60, 120 ili 180 potisaka ili višestruka pakiranja s 2 ili 3 spremnika od 120 potisaka svaki.
English: • pain in muscles, bones or joints of the chest
Croatian: • bol u mišićima, kostima ili zglobovima prsnog koša
English: Glucocorticoid agents are known to cause effects in the early gestation phase, while beta2-sympathomimetic agents like formoterol have tocolytic effects.
Croatian: Poznato je da glukokortikoidni lijekovi uzrokuju učinke u ranoj fazi gestacije, dok beta-2 simpatomimetički lijekovi poput formoterola imaju tokolitičke učinke.
English: There is no relevant use of Riarify in the paediatric population (under 18 years of age) for the indication of COPD.
Croatian: Nema relevantne primjene lijeka Riarify u pedijatrijskoj populaciji (mlađoj od 18 godina) za indikaciju kronične opstruktivne plućne bolesti (KOPB).
English: Plasma protein binding is moderately high.
Croatian: Vezanje za proteine plazme je umjereno.
English: Anticholinergic effect
Croatian: Antikolinergički učinak
English: You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Riarify therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Croatian: Vi i liječnik morate odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Riarify uzimajući u obzir korist dojenja za Vaše dijete i korist liječenja za Vas.
English: The pharmacokinetics of formoterol has not been studied in patients with hepatic impairment; however, as formoterol is primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe hepatic impairment.
Croatian: Farmakokinetika formoterola nije ispitana u bolesnika s oštećenjem funkcije jetre; međutim, budući da se formoterol prvenstveno eliminira putem metabolizma u jetri, u bolesnika s teškim oštećenjem funkcije jetre može se očekivati povećana izloženost.
English: • difficulty and pain when passing urine
Croatian: • poteškoće i bol pri mokrenju
English: Cleaning of the Riarify inhaler
Croatian: Čišćenje Riarify inhalatora
English: The apparent volume of distribution (Vz) of inhaled glycopyrronium was increased compared to intravenous (i.v.)
Croatian: Prividni volumen distribucije (Vz) udahnutog glikopironija bio je povećan u usporedbi s intravenskom
English: If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, Riarify should be discontinued immediately and alternative therapy instituted.
Croatian: Ako se pojave znakovi koji ukazuju na alergijske reakcije, osobito angioedem (uključujući otežano disanje ili gutanje, oticanje jezika, usana i lica), urtikariju ili kožni osip, potrebno je odmah prekinuti primjenu lijeka Riarify i uvesti drugu terapiju.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM CONTAINER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKI SPREMNIK
English: Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy.
Croatian: Povećana uporaba bronhodilatatora koji brzo ublažavaju simptome ukazuje na pogoršanje osnovne bolesti i zahtijeva ponovnu procjenu terapije.
English: Symptomatic outcomes
Croatian: Simptomatski ishodi
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu, and on the website of {name of MS Agency (link)}.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu, kao i na internetskoj stranici {naziv nadležnog tijela države članice
English: Formoterol and glycopyrronium are medicines called long-acting bronchodilators.
Croatian: Formoterol i glikopironij su lijekovi koji se nazivaju dugodjelujući bronhodilatatori.
English: It is preferable to avoid the use of Riarify during labour due to the inhibitory effects of formoterol on uterine contractions.
Croatian: Poželjno je izbjegavati primjenu lijeka Riarify tijekom porođaja zbog inhibicijskih učinaka formoterola na kontrakcije maternice.
English: Following inhalation, formoterol is absorbed from both the lung and the gastrointestinal tract.
Croatian: Nakon inhalacije, formoterol se apsorbira i iz pluća i iz gastrointestinalnog trakta.
English: If you find it difficult to use the inhaler while starting to breathe in, you may use the AeroChamber Plus spacer device.
Croatian: Ako Vam je teško rukovati inhalatorom kad počinjete udisati, možete se koristiti komorom za inhaliranje AeroChamber Plus.
English: There are no relevant clinical data on the use of Riarify during breast-feeding in humans.
Croatian: Nema relevantnih kliničkih podataka o primjeni lijeka Riarify tijekom dojenja u ljudi.
English: Additionally, due to the anticholinergic effect of glycopyrronium, the long-term co-administration of Riarify with other anticholinergic-containing medicinal products is not recommended (see section 4.5).
Croatian: Nadalje, zbog antikolinergičkog učinka glikopironija, ne preporučuje se dugotrajna istodobna primjena lijeka Riarify s drugim antikolinergičkim lijekovima (vidjeti dio 4.5).
English: This endpoint was only measured in study TRINITY.
Croatian: Ovaj je ishod bio mjeren samo u ispitivanju TRINITY.
English: Therefore, your doctor may wish to measure the potassium levels in your blood from time to time.
Croatian: Stoga će Vam liječnik s vremena na vrijeme možda htjeti izmjeriti razine kalija u krvi.
English: Some medicines may increase the effects of Riarify and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Croatian: Neki lijekovi mogu povećati učinke lijeka Riarify i ako uzimate takve lijekove (uključujući neke lijekove za HIV: ritonavir, kobicistat), Vaš liječnik će Vas možda htjeti pažljivo pratiti.
English: Before using the inhaler for the first time, you should test your inhaler to make sure that it is working properly, as follows.
Croatian: Prije nego što prvi put upotrijebite inhalator, morate ga isprobati da provjerite radi li ispravno i to na sljedeći način:
English: The following side effects can also occur with high-dose inhaled corticosteroids used over a long time, but the frequency is not known (frequency cannot be estimated from the available data) at present:
Croatian: Uz visoke doze inhalacijskih kortikosteroida koji se primjenjuju tijekom dugog razdoblja mogu nastati i sljedeće nuspojave, ali njihova učestalost za sada nije poznata (učestalost se ne može procijeniti iz dostupnih podataka): • depresija
English: Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt.
Croatian: Uklonite zaštitni poklopac s nastavka za usta i provjerite da je nastavak za usta čist i da nije prašnjav i prljav.
English: • decrease of blood pressure
Croatian: • sniženje krvnog tlaka
English: Glycopyrronium bromide is a high affinity muscarinic receptor antagonist with a greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor as it has been demonstrated.
Croatian: Glikopironijev bromid je antagonist visokog afiniteta za muskarinske receptore te je dokazano da ima više od četiri puta veću selektivnost za ljudske M3 receptore nego za ljudske M2 receptore.
English: There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Croatian: Postoji povećan rizik od aritmija u bolesnika koji istodobno prime anesteziju halogeniranim ugljikovodicima.
English: • if you have disorders of your heart rhythm such as irregular heart rate, a fast pulse rate or palpitations or if you have been told that your heart trace (ECG) is abnormal.
Croatian: • ako imate poremećaje srčanog ritma poput nepravilnih otkucaja srca, ubrzan rad srca ili palpitacije ili ako su Vam rekli da imate abnormalan EKG nalaz.