natgillin/translations-raw huggingface dataset:
This should be treated immediately with a fast-acting inhaled bronchodilator (reliever).
To je potrebno odmah liječiti brzodjelujućim inhalacijskim bronhodilatatorom (lijekom koji brzo ublažava simptome).
Riarify is used as a maintenance treatment for your COPD.
Riarify se primjenjuje kao terapija održavanja kod KOPB-a.
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).
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 %).
Inspiratory Capacity (IC)
Inspiracijski kapacitet
The recommended dose is two inhalations of Riarify twice daily.
Odrasli Preporučena doza je dva udaha lijeka Riarify dvaput na dan.
Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.
Nakon doziranja može doći do paradoksalnog bronhospazma uz trenutno pojačanje piskanja pri disanju i nedostatka zraka.
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.
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.
• sensation of a missed heart beat, unusually slow heart beat
• osjećaj preskakanja srca, neobično spori otkucaji srca
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.
Istodobno liječenje kinidinom, dizopiramidom, prokainamidom, antihistaminicima, inhibitorima monoaminooksidaze, tricikličkim antidepresivima i fenotiazinima može produljiti QT interval i povećati rizik od ventrikularnih aritmija.
• problems with how your adrenal glands work (adrenal suppression)
• probleme u radu nadbubrežnih žlijezdi (adrenalna supresija)
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.
Potrebno je napomenti da glikopironij kao zasebna komponenta u obliku stlačenog inhalata, koji se koristio u farmakokinetičkim ispitivanjima, nije dostupan na tržištu.
2-hour post-dose FEV1
FEV1 dva sata poslije doziranja
Caution is also required when Riarify is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia.
Oprez je potreban i kad Riarify primjenjuju bolesnici s tireotoksikozom, šećernom bolešću, feokromocitomom i neliječenom hipokalijemijom.
Psychomotor hyperactivity1, sleep disorders1, anxiety, depression1, aggression1, behavioural changes (predominantly in children) 1
anksioznost, depresija1, agresija1, promjene ponašanja (pretežno u djece) 1
Formoterol is widely metabolised and the prominent pathway involves direct conjugation at the phenolic hydroxyl group.
Formoterol se opsežno metabolizira, a glavni put uključuje izravnu konjugaciju na mjestu fenolne hidroksilne skupine.
Ear and labyrinth disorders Otosalpingitis1
Poremećaji uha i labirinta otosalpingitis1
Animal studies have shown impairment of fertility (see section 5.3).
Ispitivanja na životinjama pokazala su smanjenu plodnost (vidjeti dio 5.3).
• if you have an eye problem called narrow-angle glaucoma.
• ako imate problem s okom koji se naziva glaukom uskog kuta.
The systemic exposure to beclometasone dipropionate, formoterol and glycopyrronium has been investigated in a pharmacokinetic study conducted in healthy subjects.
Povezano s lijekom Riarify Sistemska izloženost beklometazondipropionatu, formoterolu i glikopironiju ispitana je u farmakokinetičkom ispitivanju provedenom u zdravih ispitanika.
Dermatitis allergic1
Poremećaji imunološkog sustava alergijski dermatitis1
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.
Nije poznato prelaze li formoterol ili glikopironij (uključujući njihove metabolite) u majčino mlijeko,
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.
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.
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.
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.
You should get a replacement when the counter or indicator shows the number 20.
Trebali biste nabaviti novi inhalator kad brojač ili pokazivač doza pokaže broj 20.
Peak plasma concentrations of the unchanged active substance occur within 0.5 to 1 hours after oral administration.
Nepromijenjena djelatna tvar postiže vršne koncentracije u plazmi unutar 0,5 do 1 sata nakon peroralne primjene.
• fungal infections of the throat or of the food pipe (oesophagus)
• gljivične infekcije grla ili jednjaka (ezofagusa)
Patients should then hold their breath for as long as comfortably possible, then remove the inhaler from the mouth and breathe out slowly.
Bolesnici potom trebaju zadržati dah koliko god mogu dok im nije neugodno, a zatim izvaditi inhalator iz usta i polako izdahnuti.
The cumulative urinary excretion of formoterol after single inhalation from a dry powder inhaler increased linearly in the 12-96 micrograms dose range.
Eliminacija Kumulativno izlučivanje formoterola mokraćom nakon jednog udaha praška inhalata povećavalo se linearno u rasponu doza od 12 do 96 mikrograma.
• increased mucus production, change in mucus colour
• pojačano stvaranje sluzi, promjena boje sluzi
Riarify comes in a pressurised container (coated aluminium), with a metering valve.
Riarify se isporučuje u spremniku pod tlakom (obloženom aluminijem) s odmjernim ventilom.
If this occurs you should stop using Riarify and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing.
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.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 actuations
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 potisaka
If any of the above applies to you, tell your doctor before you use Riarify.
Ako se nešto od navedenog odnosi na Vas, obavijestite svog liječnika prije nego što primijenite
• 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).
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).
Glycopyrronium has a quaternary ammonium structure which limits its passage across biological membranes and produces slow, variable and incomplete gastrointestinal absorption.
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.
There are no or limited amount of data from the use of Riarify in pregnant women.
Nema podataka ili su podaci o primjeni lijeka Riarify u trudnica ograničeni.
Before priming the 60, 120 or 180 actuation pressurised containers, the counter/indicator should read 61, 121 or 180, respectively.
Prije pripreme spremnika pod tlakom sa 60, 120 ili 180 potisaka, brojač/pokazivač doza treba pokazivati 61, 121 odnosno 180.
Glaucoma1, cataract1
učestalost nepoznata glaukom1, katarakta1
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.
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.
• 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.
• 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.
• runny or stuffy nose and sneezing
• curenje ili začepljenost nosa i kihanje
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).
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).
Glucocorticoids are excreted in human milk.
Glukokortikoidi se izlučuju u majčino mlijeko.
No specific studies have been performed with Riarify with regard to the safety in human fertility.
Nisu provedena posebna ispitivanja lijeka Riarify s obzirom na njegovu sigurnost za plodnost u ljudi.
• flu
• gripa
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.
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.
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).
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).
Frequency not known
nepoznato nesanica rijetko
Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or urinary retention.
Glikopironij je potrebno primjenjivati uz oprez u bolesnika s glaukomom uskog kuta, hiperplazijom prostate ili urinarnom retencijom.
Riarify should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Riarify je potrebno primjenjivati uz oprez u bolesnika s aktivnom ili latentnom plućnom tuberkulozom te gljivičnim i virusnim infekcijama dišnih puteva.
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.
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.
• inflammation of the mucous membrane of the mouth with or without ulcers
• upala sluznice usta s vrijedovima ili bez njih
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.
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.
What you need to know before you use Riarify Do not use Riarify:
Što morate znati prije nego počnete primjenjivati Riarify Nemojte primjenjivati Riarify:
This endpoint was only measured in study TRILOGY.
Ovaj je ishod bio mjeren samo u ispitivanju TRILOGY.
• muscle cramps and pain in muscles
• pojačano znojenje • mišićni grčevi i bol u mišićima
They should not remove the pressurised container from the actuator and should not use water or other liquids to clean the mouthpiece.
Ne smiju vaditi spremnik pod tlakom iz aktivatora i ne smiju čistiti nastavak za usta vodom ili drugom tekućinom.
EXP 60 actuation pressurised container:
EXP Spremnik pod tlakom sa 60 potisaka:
If you are already using Riarify
Ako već primjenjujete Riarify
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.
Provjerite pokazuje li brojač doza (60/120 raspršenih doza) jedan broj manje ili da se pokazivač doza (180 raspršenih doza) malo zakrenuo.
Riarify can be used at the recommended dose in patients with mild to moderate renal impairment.
Riarify se može primjenjivati u preporučenoj dozi u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
injection, 40% of the dose was excreted in the urine within 24 hours.
Nakon jedne i.v. injekcije glikopironija, 40 % doze izlučilo se u mokraći unutar 24 sata.
Influenza1, oral fungal infection, oropharyngeal candidiasis, oesophageal candidiasis1, sinusitis1, rhinitis1, gastroenteritis1, vulvovaginal candidiasis1
često influenca1, oralna gljivična infekcija, orofaringealna kandidijaza, ezofagealna kandidijaza1, sinusitis1, rinitis1, gastroenteritis1, vulvovaginalna kandidijaza1
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which act to reduce the swelling and irritation in your lungs.
Beklometazondipropionat pripada skupini lijekova koji se nazivaju kortikosteroidi i djeluju tako što smanjuju oticanje i nadraženost u plućima.
Lower respiratory tract infection (fungal)
manje često infekcija donjih dišnih puteva (gljivična)
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.
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.
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
< 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).
Patients should breathe out slowly and as deeply as comfortable, in order to empty their lungs.
Bolesnici trebaju polako i što dublje izdahnuti, koliko god mogu, kako bi ispraznili pluća.
• medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level.
• lijekovima za liječenje srčane bolesti (digoksin) koji mogu prouzročiti sniženje razine kalija u krvi.
Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.
Glikopironij djeluje tako što blokira bronhokonstrikcijsko djelovanje acetilkolina na stanice glatkih mišića u dišnim putovima te na taj način proširuje dišne putove.
• 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.
• 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.
It is recommended that treatment with Riarify should not be stopped abruptly.
Ne preporučuje se naglo prekinuti liječenje lijekom Riarify.
Prevention of oropharyngeal infections
Sprječavanje orofaringealnih infekcija
• if you have an overactive thyroid gland.
• ako imate prekomjerno aktivnu štitnu žlijezdu.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
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).
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).
Glucocorticoids are widely used for the suppression of inflammation in chronic inflammatory diseases of the airways such as COPD.
Glukokortikoidi se široko primjenjuju za supresiju upale u kroničnim upalnim bolestima dišnih putova kao što je KOPB.
Additional there are multipacks containing either 2 or 3 pressurised containers with 120 puffs, each.
Nadalje, postoje višestruka pakiranja koja sadrže 2 ili 3 spremnika pod tlakom sa 120 raspršenih doza u svakom spremniku.
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).
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,
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.
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.
No differences were observed when comparing Riarify and the extemporary triple combination made of fluticasone and vilanterol fixed combination plus tiotropium.
Nisu opažene razlike kad se Riarify uspoređivao s ex tempore trostrukom fiksnom kombinacijom flutikazona i vilanterola uz tiotropij.
• 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.
• 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.
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.
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.
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.
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.
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.
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.