natgillin/translations-raw huggingface dataset:
The maximum dose is two inhalations of Riarify twice daily.
Maksimalna doza je dva udaha lijeka Riarify dvaput na dan.
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).
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).
Patients should then check the dose counter or dose indicator to ensure it has moved accordingly.
Bolesnici zatim trebaju provjeriti brojač doza ili pokazivač doza kako bi provjerili da se odgovarajuće pomaknuo.
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.
Da biste spriječili gljivičnu infekciju u ustima i grlu, isperite usta ili progrgljajte vodu bez gutanja ili operite zube nakon svake upotrebe inhalatora.
To inhale the second puff, patients should keep the inhaler in a vertical position for approximately 30 seconds and repeat steps 2 to 6.
Da bi udahnuli drugu raspršenu dozu, bolesnici trebaju držati inhalator u uspravnom položaju približno 30 sekundi i ponoviti postupak od 2. do 6. koraka.
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).
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).
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.
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.
It is reasonable to assume that beclometasone dipropionate and its metabolites are also excreted into breast-milk.
Razumno je pretpostaviti da se i beklometazondipropionat i njegovi metaboliti izlučuju u majčino mlijeko.
• growth retardation in children and adolescents.
• oticanje šaka i stopala • zaostajanje u rastu djece i adolescenata.
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists (see section 4.4).
Istodobno liječenje derivatima ksantina, steroidima ili diureticima može pojačati mogući hipokalijemijski učinak beta-2 agonista (vidjeti dio 4.4).
Vision, blurred1 (see also section 4.4)
Poremećaji oka zamućen vid1 (vidjeti također dio 4.4)
The pressurised container is inserted in a plastic inhaler.
Spremnik pod tlakom umetnut je u plastični inhalator.
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.
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.
• sleep disorders (sleeping too little or too long)
• poremećaji spavanja (premalo ili previše spavanja) • bol poput gnječenja u prsnom košu
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.
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.
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.
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.
Pack sizes of 1 container of 60, 120 or 180 actuations and multipacks of 2 or 3 containers of 120 actuations each.
Veličine pakiranja s jednim spremnikom od 60, 120 ili 180 potisaka ili višestruka pakiranja s 2 ili 3 spremnika od 120 potisaka svaki.
• pain in muscles, bones or joints of the chest
• bol u mišićima, kostima ili zglobovima prsnog koša
Glucocorticoid agents are known to cause effects in the early gestation phase, while beta2-sympathomimetic agents like formoterol have tocolytic effects.
Poznato je da glukokortikoidni lijekovi uzrokuju učinke u ranoj fazi gestacije, dok beta-2 simpatomimetički lijekovi poput formoterola imaju tokolitičke učinke.
There is no relevant use of Riarify in the paediatric population (under 18 years of age) for the indication of COPD.
Nema relevantne primjene lijeka Riarify u pedijatrijskoj populaciji (mlađoj od 18 godina) za indikaciju kronične opstruktivne plućne bolesti (KOPB).
Plasma protein binding is moderately high.
Vezanje za proteine plazme je umjereno.
Anticholinergic effect
Antikolinergički učinak
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.
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.
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.
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.
• difficulty and pain when passing urine
• poteškoće i bol pri mokrenju
Cleaning of the Riarify inhaler
Čišćenje Riarify inhalatora
The apparent volume of distribution (Vz) of inhaled glycopyrronium was increased compared to intravenous (i.v.)
Prividni volumen distribucije (Vz) udahnutog glikopironija bio je povećan u usporedbi s intravenskom
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.
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.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM CONTAINER
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKI SPREMNIK
Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy.
Povećana uporaba bronhodilatatora koji brzo ublažavaju simptome ukazuje na pogoršanje osnovne bolesti i zahtijeva ponovnu procjenu terapije.
Symptomatic outcomes
Simptomatski ishodi
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)}.
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
Formoterol and glycopyrronium are medicines called long-acting bronchodilators.
Formoterol i glikopironij su lijekovi koji se nazivaju dugodjelujući bronhodilatatori.
It is preferable to avoid the use of Riarify during labour due to the inhibitory effects of formoterol on uterine contractions.
Poželjno je izbjegavati primjenu lijeka Riarify tijekom porođaja zbog inhibicijskih učinaka formoterola na kontrakcije maternice.
Following inhalation, formoterol is absorbed from both the lung and the gastrointestinal tract.
Nakon inhalacije, formoterol se apsorbira i iz pluća i iz gastrointestinalnog trakta.
If you find it difficult to use the inhaler while starting to breathe in, you may use the AeroChamber Plus spacer device.
Ako Vam je teško rukovati inhalatorom kad počinjete udisati, možete se koristiti komorom za inhaliranje AeroChamber Plus.
There are no relevant clinical data on the use of Riarify during breast-feeding in humans.
Nema relevantnih kliničkih podataka o primjeni lijeka Riarify tijekom dojenja u ljudi.
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).
Nadalje, zbog antikolinergičkog učinka glikopironija, ne preporučuje se dugotrajna istodobna primjena lijeka Riarify s drugim antikolinergičkim lijekovima (vidjeti dio 4.5).
This endpoint was only measured in study TRINITY.
Ovaj je ishod bio mjeren samo u ispitivanju TRINITY.
Therefore, your doctor may wish to measure the potassium levels in your blood from time to time.
Stoga će Vam liječnik s vremena na vrijeme možda htjeti izmjeriti razine kalija u krvi.
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).
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.
Before using the inhaler for the first time, you should test your inhaler to make sure that it is working properly, as follows.
Prije nego što prvi put upotrijebite inhalator, morate ga isprobati da provjerite radi li ispravno i to na sljedeći način:
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:
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
Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt.
Uklonite zaštitni poklopac s nastavka za usta i provjerite da je nastavak za usta čist i da nije prašnjav i prljav.
• decrease of blood pressure
• sniženje krvnog tlaka
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.
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.
There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Postoji povećan rizik od aritmija u bolesnika koji istodobno prime anesteziju halogeniranim ugljikovodicima.
• 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.
• ako imate poremećaje srčanog ritma poput nepravilnih otkucaja srca, ubrzan rad srca ili palpitacije ili ako su Vam rekli da imate abnormalan EKG nalaz.
The systemic availability of the active metabolite arises from lung (36%) and from gastrointestinal absorption of the swallowed dose.
Sistemska raspoloživost djelatnog metabolita posljedica je apsorpcije u plućima (36 %) i apsorpcije progutane doze u gastrointestinalnom traktu.
Additional instructions for specific groups of patients For patients with weak hands it may be easier to hold the inhaler with both hands.
Bolesnicima sa slabim rukama možda će biti lakše držati inhalator objema rukama.
60 actuation pressurised container: 21 months.
Spremnik pod tlakom sa 60 potisaka: 21 mjesec.
Pressurised container (coated aluminium), with a metering valve.
Spremnik pod tlakom (obložen aluminijem), s odmjernim ventilom.
Formoterol is a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction.
Formoterol Formoterol je selektivni beta-2 adrenergički agonist koji izaziva relaksaciju glatkog mišićja bronha u bolesnika s reverzibilnom opstrukcijom dišnih puteva.
For pharmacists: Enter the date of dispensing to the patient on the pack.
Zapišite na pakiranje datum izdavanja lijeka bolesniku.
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.
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.
On average, 8% and 25% of the dose was excreted as unchanged and total formoterol, respectively.
U prosjeku se 8 % doze izlučilo u obliku nepromijenjenog formoterola, a 25 % u obliku ukupnog formoterola.
• if you have any disease of your liver or kidneys.
• ako imate ikakvu bolest jetre ili bubrega.
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.
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.
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).
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).
120 and 180 actuation pressurised container: 22 months.
Spremnik pod tlakom sa 120 i 180 potisaka: 22 mjeseca.
Riarify should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Potrebno je odmah prekinuti primjenu lijeka Riarify, procijeniti bolesnika i, ako je potrebno, uvesti drugu terapiju.
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).
Nakon udisanja, bolesnici trebaju isprati usta ili progrgljati vodu bez gutanja ili oprati zube (vidjeti dio 4.4 i 6.6).
Cytochrome P450 isoenzymes CYP2D6, CYP2C19 and CYP2C9 are involved in the O-demethylation of formoterol.
U O-demetilaciji formoterola sudjeluju izoenzimi citokroma P450 - CYP2D6, CYP2C19 i CYP2C9.
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.
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.
Rare
rijetko
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.
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.
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).
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).
You should not use Riarify during breast-feeding.
Ne smijete primjenjivati Riarify tijekom dojenja.
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).
Nakon udisanja, bolesnici trebaju isprati usta ili progrgljati vodu bez gutanja ili oprati zube (vidjeti dijelove 4.2 i 4.4).
• fungal infections of the mouth.
• gljivične infekcije usta.
• if you have a tumour of the adrenal gland (known as a phaeochromocytoma).
• ako imate tumor nadbubrežne žlijezde (poznat kao feokromocitom).
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.
Bioraspoloživost progutanog beklometazondipropionata je zanemariva; međutim, zbog predsistemske konverzije u beklometazon 17-monopropionat, 41 % doze apsorbira se kao djelatni metabolit.
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.
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.
• fall in the level of some constituents of your blood: of certain white blood cells called granulocytes, of potassium or of cortisol
• sniženje razine nekih sastojaka krvi: određenih bijelih krvnih stanica koje se nazivaju granulociti, kalija ili kortizola
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).
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 %).
Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions.
Istodobno liječenje inhibitorima monoaminooksidaze, uključujući lijekove koji imaju svojstva slična furazolidonu i prokarbazinu, može izazvati hipertenzivne reakcije.
Stand or sit up when inhaling.
Za vrijeme udisanja stojte ili uspravno sjedite.
Patients should not breathe out into the inhaler.
Bolesnici ne smiju izdisati zrak kroz inhalator.
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.
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.
Beclometasone dipropionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs.
Beklometazondipropionat koji se daje inhalacijom u preporučenim dozama ima glukokortikoidno protuupalno djelovanje unutar pluća.
The fraction of an inhaled dose that is swallowed after administration with a metered dose inhaler may range between 60% and 90%.
Dio udahnute doze koji se proguta nakon primjene stlačenog inhalata može se kretati u rasponu od 60 % do 90 %.
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.
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.
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).
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).
It is recommended that serum potassium levels are monitored in such situations.
U takvim se situacijama preporučuje pratiti razine kalija u serumu.
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.
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.
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.
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.
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).
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).