natgillin/translations-raw huggingface dataset:
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.
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.
• other medicines used to treat COPD (theophylline, aminophylline or corticosteroids) and diuretics may also cause a fall in your potassium level.
• drugim lijekovima koji se primjenjuju za liječenje KOPB-a (teofilin, aminofilin ili kortikosteroidi) i diureticima koji također mogu prouzročiti sniženje razine kalija u krvi.
Caution is also recommended when a number of reliever bronchodilators are used.
Također se savjetuje oprez kad se primjenjuje veći broj bronhodilatatora za brzo ublažavanje simptoma.
Faecal excretion is the major route of beclometasone dipropionate elimination mainly as polar metabolites.
Izlučivanje stolicom glavni je put eliminacije beklometazondipropionata uglavnom u obliku polarnih metabolita.
• decrease in bone mineral density (thinning of the bones)
• smanjenje mineralne gustoće kostiju (lomljive kosti) • zamućenje očne leće (katarakta).
If you forget to use Riarify
Ako ste zaboravili primijeniti Riarify
120 and 180 actuation pressurised container:
Spremnik pod tlakom sa 120 i 180 potisaka:
How to use Riarify
Kako primjenjivati Riarify
The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for unchanged beclometasone dipropionate and beclometasone 17-monopropionate respectively.
nominalne doze nepromijenjenog beklometazondipropionata i 62 % nominalne doze beklometazon 17-monopropionata.
Adrenal suppression1
Endokrini poremećaji adrenalna supresija1
Pressurised inhalation, solution (pressurised inhalation).
Stlačeni inhalat, otopina (stlačeni inhalat).
Riarify is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left.
Na stražnjoj strani inhalatora Riarify nalazi se brojač doza ili pokazivač doza koji pokazuje koliko je potisaka preostalo.
If you stop using Riarify
Ako prestanete primjenjivati Riarify
• fever or chills
• vrućicu ili zimicu
Multipack: 240 actuations (2 pressurised containers of 120 actuations each).
Višestruko pakiranje: 240 potisaka (2 spremnika pod tlakom, svaki sa 120 potisaka).
• burning sensation of the lips
• osjećaj žarenja usana
Riarify 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Riarify 87 mikrograma/5 mikrograma/9 mikrograma stlačeni inhalat, otopina
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).
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).
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.
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.
Colourless to yellowish liquid solution.
Bezbojna do žućkasta otopina.
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).
Riarify nije indiciran za liječenje akutnih epizoda bronhospazma ili za liječenje akutne egzacerbacije
(<1/10,000) and not known (cannot be estimated from available data).
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):
After priming, the counter/indicator should read 60, 120 or 180.
Nakon pripreme, brojač/pokazivač doza treba pokazivati 60, 120 odnosno 180.
Their lips should then be placed around the mouthpiece, with the tongue flat under it.
Zatim usnama obuhvatite nastavak za usta, a jezik postavite ravno ispod njega.
Therefore, blood glucose should be monitored during treatment following established guidelines in patients with diabetes.
Stoga je, tijekom liječenja, potrebno pratiti glukozu u krvi u bolesnika sa šećernom bolešću prema utvrđenim smjernicama.
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.
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.
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).
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).
In patients with severe hepatic impairment, Riarify should be used only if the expected benefit outweighs the potential risk (see section 5.2).
U bolesnika s teškim oštećenjem funkcije jetre, Riarify se smije primjenjivati samo ako je očekivana korist veća od mogućeg rizika (vidjeti dio 5.2).
Patients should be advised not to drop the inhaler as this may cause the counter to count down.
Bolesnike je potrebno upozoriti da im inhalator ne smije ispasti jer to može uzrokovati odbrojavanje na brojaču.
Glycopyrronium is a high-affinity, long-acting muscarinic receptor antagonist (anticholinergic) used for inhalation as bronchodilator treatment of COPD.
Glikopironij je dugodjelujući antagonist muskarinskih receptora (antikolinergik) za koje pokazuje visok afinitet i primjenjuje se inhalacijom kao bronhodilatacijsko liječenje KOPB-a.
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).
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).
• leakage of blood from a vessel into the tissues surrounding it
• propuštanje krvi iz krvne žile u okolno tkivo
Keep this medicine out of the sight and reach of children.
Kako čuvati Riarify Lijek čuvajte izvan pogleda i dohvata djece.
• 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).
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).
Multipack: 360 actuations (3 pressurised containers of 120 actuations each).
Višestruko pakiranje: 360 potisaka (3 spremnika pod tlakom, svaki sa 120 potisaka).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (MULTIPACK ONLY: no Blue Box is included)
MEĐUPAKIRANJE (SAMO VIŠESTRUKA PAKIRANJA: bez uključenog plavog okvira)
Wipe inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
Obrišite nastavak za usta iznutra i izvana te inhalator čistom, suhom krpicom ili maramicom.
Patients should hold the inhaler vertically with its body upwards and place the mouthpiece between their teeth without biting.
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.
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.
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.
Absorption of formoterol is linear following inhalation of 12 to 96 micrograms of formoterol.
Apsorpcija formoterola nakon inhalacije 12 do 96 mikrograma formoterola je linearna.
Chemical and physical in-use stability has been demonstrated for 2 months at 25°C.
Dokazano je da je lijek u primjeni kemijski i fizikalno stabilan 2 mjeseca na temperaturi od 25°C.
The pressurised container is inserted in a polypropylene inhaler which incorporates a mouthpiece and a dose counter (60 actuations or 120 actuations per pressurised container) or dose indicator (180 actuations per pressurised container) and is provided with a polypropylene mouthpiece cap.
Spremnik pod tlakom umetnut je u polipropilenski inhalator, koji ima nastavak za usta i brojač doza (60 potisaka ili 120 potisaka po spremniku pod tlakom) ili pokazivač doza (180 potisaka po spremniku pod tlakom) i opremljen je polipropilenskim zatvaračem nastavka za usta.
For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Riarify are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation).
Posljedica toga je jači učinak beklometazondipropionata nego u formulacijama s distribucijom čestica čija veličina nije vrlo sitna (100 mikrograma beklometazondipropionata u vrlo sitnim česticama u lijeku Riarify odgovara 250 mikrograma beklometazondipropionata u formulaciji koja se ne raspršuje u vrlo sitne čestice).
The second major pathway involves O-demethylation followed by conjugation at the phenolic 2'-hydroxyl group.
demetilaciju, nakon koje slijedi konjugacija na mjestu fenolne 2'-hidroksilne skupine.
• dry throat
• suhoća grla
Riarify is a pressurised inhalation, solution.
Riarify je stlačeni inhalat, otopina.
Fatigue1
nazofaringitis1
Chemical and physical in-use stability has been demonstrated for 4 months at 25°C.
Dokazano je da je lijek u primjeni kemijski i fizikalno stabilan 4 mjeseca na temperaturi od 25°C.
Anticholinergic agents like glycopyrronium could suppress lactation.
Antikolinergici poput glikopironija mogu potisnuti stvaranje mlijeka.
Compared with tiotropium, Riarify also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017).
U usporedbi s tiotropijem, Riarify je također smanjio stopu teških egzacerbacija (tj. isključujući umjerene egzacerbacije) za 32 % (stopa: 0,067 naspram 0,098 događaja po bolesniku godišnje; p = 0,017).
180 actuations
180 potisaka
Compared with tiotropium, Riarify significantly improved IC by 39 mL (p = 0.025) and 60 mL (p = 0.001) after 26 and 52 weeks of treatment respectively.
U usporedbi s tiotropijem,Riarify je značajno poboljšao inspiracijski kapacitet za 39 ml (p = 0,025) odnosno 60 ml (p = 0,001) nakon 26 odnosno 52 tjedna liječenja.
• fungal infections of the vagina
• vaginalne gljivične infekcije
No differences were observed when comparing Riarify and the extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol plus tiotropium (difference of 3 mL in pre-dose FEV1 after 52 weeks of treatment).
Nisu bile opažene razlike kad se Riarify uspoređivao s ex tempore trostrukom fiksnom kombinacijom beklometazondipropionata i formoterola uz tiotropij (razlika od 3 ml u FEV1 prije doziranja nakon
In repeat dose inhalation studies with Riarify in rats and dogs of up to 13 weeks duration, the main observed alterations were related to effects on the immune system (probably due to systemic corticosteroid effects of beclometasone dipropionate and its active metabolite beclometasone17-monopropionate) and on the cardiovascular system (probably related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium).
13 tjedana glavne uočene promjene bile su povezane s učincima na imunosni sustav (vjerojatno zbog sistemskih kortikosteroidnih učinaka beklometazondipropionata i njegovog aktivnog metabolita beklometazon 17-monopropionata) i kardiovaskularni sustav (vjerojatno povezanima s beta-2
They should stop using the inhaler when the counter or indicator shows 0 as any puffs left in the device may not be enough to release a full actuation.
Kada brojač ili pokazivač pokaže 0, trebaju prestati koristiti inhalator jer preostala količina u inhalatoru ne mora biti dovoljna za oslobađanje pune doze u potisku.
Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics incl.
Farmakoterapijska skupina: lijekovi za opstruktivne bolesti dišnih putova, adrenergici u kombinaciji s antikolinergicima, uključujući trostruke kombinacije s kortikosteroidima.
Potentially serious hypokalaemia may result from beta2-agonist therapy.
Terapija beta-2 agonistima može rezultirati potencijalno ozbiljnom hipokalijemijom.
Rash1, urticaria1, pruritus, hyperhidrosis1
Poremećaji kože i potkožnog tkiva osip1, urtikarija1, pruritus, hiperhidroza1
Beclometasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity that is hydrolysed via esterase enzymes to an active metabolite beclometasone 17-monopropionate which has a more potent topical anti-inflammatory activity compared with the pro-drug beclometasone dipropionate.
Beklometazondipropionat je prolijek s niskim afinitetom vezanja za glukokortikoidne receptore, koji se hidrolizira putem enzima esteraza do djelatnog metabolita beklometazon 17-monopropionata, koji ima jače topikalno protuupalno djelovanje od prolijeka beklometazondipropionata.
Formoterol: hypokalaemia, hyperglycaemia, tremor, palpitations, muscle spasms, electrocardiogram QT prolonged, blood pressure increased, blood pressure decreased, atrial fibrillation, tachycardia, tachyarrhythmia, angina pectoris (stable and unstable), ventricular extrasystoles, nodal rhythm.
elektrokardiografsko produljenje QT intervala, povišen krvni tlak, snižen krvni tlak, atrijska fibrilacija, tahikardija, tahiaritmija, angina pektoris (stabilna i nestabilna), ventrikularne ekstrasistole, nodalni ritam.
C-reactive protein increased1, platelet count increased1, free fatty acids increased1, blood insulin increased1, blood ketone body increased1, cortisol decreased1
Pretrage povišen C-reaktivni protein1, povećan broj trombocita1, povišene slobodne masne kiseline1, povišena razina inzulina u krvi1, povišena razina ketonskih tijela u krvi1, snižen kortizol1
Compared with a fixed combination of indacaterol and glycopyrronium, Riarify improved average pre-dose FEV1 over the 52-week treatment period by 22 mL (p=0.018).
usporedbi s fiksnom kombinacijom indakaterola i glikopironija, Riarify je poboljšao prosječni FEV1 prije doziranja tijekom razdoblja liječenja u trajanju od 52 tjedna za 22 ml (p = 0,018).
Beclometasone dipropionate/beclometasone-17-monopropionate was considered responsible for reproductive toxicity effects in rats such as reduction of the conception rate, fertility index, early embryonic development parameters (implantation loss), delay in ossification and increased incidence of visceral variations; while tocolytic and anti-muscarinic effects, attributed to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium, affected pregnant rats in the late phase of gestation and/or early phase of lactation, leading to loss of pups.
Smatra se da je beklometazondipropionat / beklometazon 17-monopropionat odgovoran za učinke reproduktivne toksičnosti poput smanjenja stope začeća, indeksa plodnosti, parametara ranog embrionalnog razvoja (implantacijski gubitak), kasne osifikacije i povećane incidencije varijacija unutarnjih organa u štakora; dok su se tokolitički i antimuskarinski učinci pripisani beta-2
• increased blood flow to some tissues in the body
• pojačan protok krvi kroz neka tkiva u tijelu • kašalj i produktivni kašalj
• swallowing difficulties
• otežano gutanje
• medicines for treating - abnormal heart rhythms (quinidine, disopyramide, procainamide), - allergic reactions (antihistamines), - symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines can cause some changes in the electrocardiogram (ECG, heart trace).
- simptoma depresije ili duševnih poremećaja kao što su inhibitori monoaminooksidaze (na primjer, fenelzin i izokarboksazid), triciklički antidepresivi (na primjer, amitriptilin i imipramin) i fenotiazini, koji mogu prouzročiti neke promjene u elektrokardiogramu (EKG-u).
Store at 25°C for a maximum of 4 months.
Čuvati na temperaturi do 25°C najdulje 4 mjeseca.
Patients with severe hepatic impairment
Bolesnici s teškim oštećenjem fukcije jetre
Compared with a fixed combination of beclometasone dipropionate and formoterol, Riarify significantly improved 2-hour post dose FEV1 by 117 mL after 26 weeks of treatment and by 103 mL after 52 weeks of treatment (p < 0.001).
U usporedbi s fiksnom kombinacijom beklometazondipropionata i formoterola, Riarify je značajno poboljšao FEV1 dva sata poslije doziranja za 117 ml nakon 26 tjedana liječenja te za 103 ml nakon 52 tjedna liječenja (p < 0,001).
Store at 25°C for a maximum of 2 months.
Čuvati na temperaturi do 25°C najdulje 2 mjeseca.
Study TRILOGY compared Riarify with a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily (1,368 randomised patients).
U ispitivanju TRILOGY, Riarify se uspoređivao s fiksnom kombinacijom beklometazondipropionata i formoterola 100/6 mikrograma primijenjenom u dva udaha dvaput na dan (1368 randomiziranih bolesnika).
Immediately after starting to breathe in, patients should firmly press down on the top of the pressurised container to release one puff.
Odmah nakon početka udisaja, bolesnici trebaju čvrsto pritisnuti vrh spremnika pod tlakom prema dolje kako bi raspršili jednu dozu.
How to use your inhaler
Kako se upotrebljava inhalator
The other ingredients are: ethanol anhydrous, hydrochloric acid, propellant: norflurane.
Drugi sastojci su: etanol bezvodni, kloridna kiselina, potisni plin: norfluran.
Compared with tiotropium, Riarify improved pre-dose FEV1 by 51 mL after 26 weeks of treatment and by 61 mL after 52 weeks of treatment.
usporedbi s tiotropijem, Riarify je poboljšao FEV1 prije doziranja za 51 ml nakon 26 tjedana liječenja i za 61 ml nakon 52 tjedna liječenja.
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium.
Djelatne tvari su: beklometazondipropionat, formoterolfumarat dihidrat i glikopironij.
Each time you press the pressurised container, a puff of medicine is released and the dose indicator rotates by a small amount.
Svaki put kad pritisnete spremnik pod tlakom, oslobodi se jedna raspršena doza lijeka i brojač pokaže jedan broj manje.
Just after starting to breathe in, press down firmly on the top of the pressurised container to release one puff.
Neposredno nakon što počnete udisati, čvrsto pritisnite vrh spremnika pod tlakom prema dolje kako bi se oslobodila jedna raspršena doza.
A total of 3,346 patients were treated with beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium 87 micrograms/5 micrograms/9 micrograms at the target dose regimen (two inhalations twice daily) in multiple dose studies.
U ispitivanjima višestrukih doza, ukupno je 3346 bolesnika bilo liječeno beklometazondipropionatom/formoterolfumarat dihidratom/glikopironijem 87 mikrograma/5 mikrograma/9 mikrograma prema ciljnom režimu doziranja (dva udaha dvaput na dan).
Pressurised inhalation, solution.
Stlačeni inhalat, otopina.
Take care not to drop the inhaler as this may cause the counter to count down.
Pazite da Vam inhalator ne ispadne jer to može prouzročiti odbrojavanje na pokazivaču.
For in-use storage conditions, see section 6.3.
Uvjete čuvanja lijeka u primjeni vidjeti u dijelu 6.3.
1 pressurised container of 120 actuations.
1 spremnik pod tlakom sa 120 potisaka.
Both studies were conducted in patients with a clinical diagnosis of COPD with severe to very severe airflow limitation (FEV1 less than 50% predicted), with symptoms assessed as a COPD Assessment Test (CAT) score of 10 or above, and with at least one COPD exacerbation in the previous year.
Oba su ispitivanja provedena u bolesnika s kliničkom dijagnozom KOPB-a s teškim do vrlo teškim ograničenjem protoka zraka (FEV1 manji od 50 %
Remove the protective cap from the mouthpiece
Uklonite zaštitni zatvarač s nastavka za usta
Testing your inhaler
Isprobavanje inhalatora
• glycopyrronium.
• glikopironij.
The total systemic exposure (as measured by AUC0-t) was slightly reduced for beclometasone 17-monopropionate (by 37%) and formoterol (by 24%), while it was increased for glycopyrronium (by 45%).
(za 37 %) i formoterol (za 24 %), dok je za glikopironij bila povećana (za 45 %).
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava granulocitopenija1
Each pack contains one pressurised container either providing 60 puffs, 120 puffs or 180 puffs.
Jedno pakiranje sadrži jedan spremnik pod tlakom sa 60, 120 ili 180 raspršenih doza.
Glycopyrronium: glaucoma, atrial fibrillation, tachycardia, palpitations, dry mouth, dental caries, dysuria, urinary retention, urinary tract infection.
Glikopironijem: glaukom, atrijska fibrilacija, tahikardija, palpitacije, suha usta, zubni karijes, dizurija,
No differences were observed when comparing Riarify with the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (moderate/severe exacerbation rate: 0.46 versus 0.45 events per patient/year).
Riarify uspoređivao s ex tempore trostrukom fiksnom kombinacijom beklometazondipropionata i formoterola uz tiotropij (stopa umjerenih/teških egzacerbacija: 0,46 naspram 0,45 događaja po bolesniku godišnje).
Excipients: anhydrous ethanol, hydrochloric acid; propellant: norflurane.
Pomoćne tvari: bezvodni etanol, kloridna kiselina; potisni plin: norfluran.
For glycopyrronium, there was no impact in subjects with mild and moderate renal impairment.
Nije bilo učinka na glikopironij u ispitanika s blagim i umjerenim oštećenjem bubrega.
60 actuation pressurised container:
Spremnik pod tlakom sa 60 potisaka:
Visual disturbance may be reported with systemic and topical corticosteroid use.
Pri sistemskoj i topikalnoj uporabi kortikosteroida moguća je pojava poremećaja vida.