FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza te reproduktivne i razvojne toksičnosti.
English: Riarify is available in three container sizes:
Croatian: Riarify je dostupan u 3 veličine spremnika:
English: • increased cough or increased breathing difficulties.
Croatian: • pojačan kašalj ili pojačane teškoće s disanjem.
English: Formoterol does not inhibit CYP450 enzymes at therapeutically relevant concentrations.
Croatian: Formoterol ne inhibira enzime CYP450 u terapijski važnim koncentracijama.
English: Liver appears to be the primary site of metabolism.
Croatian: Čini se da je jetra glavno mjesto metabolizma.
English: Medicines should not be disposed of via waste water or household waste.
Croatian: Lijekovi se ne smiju bacati u otpadne vode ili kućni otpad.
English: Glucuronide acid conjugate is inactive.
Croatian: Konjugat glukuronske kiseline je neaktivan.
English: There is no experience with or evidence of safety issues on the use of the propellant norflurane (HFA134a) during human pregnancy or lactation.
Croatian: Nema iskustva niti znakova upitne sigurnosti primjene potisnog plina norflurana (HFA134a) tijekom trudnoće ili dojenja u ljudi.
English: What Riarify looks like and contents of the pack
Croatian: Kako Riarify izgleda i sadržaj pakiranja
English: It is important to use Riarify every day.
Croatian: Važno je da se Riarify primjenjuje svaki dan.
English: Your COPD may be getting worse and your doctor may need to prescribe different treatment.
Croatian: Možda Vam se pogoršava KOPB i liječnik će možda trebati propisati drugo liječenje.
English: In addition, two Phase IIIb studies were conducted to support the clinical efficacy and safety of Riarify.
Croatian: Nadalje, provedena su dva klinička ispitivanja faze IIIb da bi se potkrijepila klinička djelotvornost i sigurnost lijeka Riarify.
English: Do not exceed your prescribed dose without talking to your doctor.
Croatian: Nemojte prekoračiti propisanu dozu ako prethodno o tome niste porazgovarali s liječnikom.
English: These patients should be monitored for potential adverse reactions.
Croatian: Ove je bolesnike potrebno pratiti zbog mogućih nuspojava.
English: • pain in the back of the mouth and throat
Croatian: • bol u stražnjem dijelu usta i grla
English: If you see 'mist' coming from the top of the inhaler or the sides of your mouth, this means that Riarify will not be getting into your lungs as it should.
Croatian: Ako vidite „maglicu“ kako izlazi s vrha inhalatora ili sa strane Vaših usta, to znači da Riarify neće dospjeti u Vaša pluća kao što bi trebao.
English: Do not use this medicine with a beta-blocker medicine (used for treating certain heart problems such as angina or for reducing blood pressure) unless your doctor has chosen a beta-blocker that does not affect your breathing.
Croatian: Nemojte primjenjivati ovaj lijek s lijekom koji je beta-blokator (koristi se za liječenje nekih srčanih bolesti kao što je angina ili za snižavanje krvnog tlaka) osim ako Vam liječnik nije propisao beta-blokator koji ne utječe na disanje.
English: You should inhale the medicine through your mouth and this takes the medicine directly into your lungs.
Croatian: Trebate udahnuti lijek kroz usta i tako lijek dopire izravno u Vaša pluća.
English: Riarify 87/5/9 mcg
Croatian: Riarify 87/5/9 μg
English: After use, replace the protective cap.
Croatian: Nakon upotrebe, vratite zaštitni zatvarač.
English: Very rare
Croatian: vrlo rijetko
English: Sudden and progressive deterioration in the symptoms of COPD is potentially life-threatening and the patient should undergo urgent medical assessment.
Croatian: Iznenadno i progresivno pogoršanje simptoma KOPB-a može ugroziti život i bolesniku je potreban hitan liječnički pregled.
English: Both studies were conducted in a similar population of COPD patients as studies TRILOGY and TRINITY.
Croatian: Oba su ispitivanja provedena na sličnoj populaciji bolesnika s KOPB-om kao i ispitivanja TRILOGY i TRINITY.
English: The bronchodilating effect sets in rapidly, within 1-3 minutes after inhalation, and has a duration of 12 hours after a single dose.
Croatian: Bronhodilatacijski učinak nastupa brzo, unutar 1-3 minute nakon inhalacije, a traje 12 sati nakon jedne doze.
English: Your doctor will assess your symptoms and if necessary may start you on a different treatment.
Croatian: Liječnik će procijeniti Vaše simptome i, ako bude potrebno, odmah uvesti drugo liječenje.
English: If they are administered for compelling reasons, the effect of formoterol will be reduced or abolished.
Croatian: Ako se oni moraju primjenjivati, učinak formoterola bit će smanjen ili poništen.
English: If overdose occurs, the patient's symptoms should be treated supportively with appropriate monitoring as necessary.
Croatian: Ako nastupi predoziranje, potrebno je potporno liječenje simptoma bolesnika uz odgovarajuće praćenje po potrebi.
English: If patients find the treatment ineffective, they should continue treatment but medical attention must be sought.
Croatian: Ako bolesnici smatraju da liječenje nije učinkovito, trebaju nastaviti s liječenjem, ali moraju potražiti liječnički savjet.
English: The number of puffs remaining is displayed in intervals of 20.
Croatian: Broj preostalih raspršenih doza prikazuje se u razmacima od 20.
English: There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.
Croatian: Postoji teoretska mogućnost interakcije u osobito osjetljivih bolesnika koji uzimaju disulfiram ili metronidazol.
English: In such a situation, your doctor may need to increase your dose of corticosteroids to cope with the stress and may prescribe them as tablets or injections.
Croatian: U takvoj situaciji liječnik će Vam možda trebati povisiti dozu kortikosteroida kako biste se nosili sa stresom, a može ih propisati u obliku tableta ili injekcija.
English: The renal clearance of formoterol is 150 mL/min.
Croatian: Bubrežni klirens formoterola je 150 ml/min.
English: You should only use Riarify during pregnancy if you are advised to do so by your doctor.
Croatian: Riarify smijete primjenjivati tijekom trudnoće samo ako Vam je tako savjetovao liječnik.
English: Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Croatian: Nemojte primjenjivati ovaj lijek za liječenje iznenadnih napada zaduhe ili piskanja.
English: Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects; therefore, caution is required when other beta-adrenergic medicinal products are prescribed concomitantly with formoterol.
Croatian: Istodobna primjena drugih beta-adrenergičkih lijekova može imati aditivne učinke; stoga je potreban oprez kad se drugi beta-adrenergički lijekovi propisuju istodobno s formoterolom.
English: • stomach discomfort after meals
Croatian: • nelagoda u trbuhu nakon obroka
English: Take another puff, following the instructions starting again from step 2.
Croatian: Uzmite drugi udah, slijedeći upute i počevši ponovno od
English: If you are using Riarify or high doses of other inhaled corticosteroids over long periods and you come into a situation of stress (e.g. being taken to hospital after an accident, having a serious injury or before an operation) you may need more of this medicine.
Croatian: Ako primjenjujete Riarify ili visoke doze drugih inhalacijskih kortikosteroida tijekom dugih razdoblja i nađete se u nekoj stresnoj situaciji (npr. ako Vas vode u bolnicu nakon nezgode, ako imate ozbiljnu ozljedu ili prije operacije) možete trebati više tog lijeka.
English: There was no saturation of binding in the concentration range attained with therapeutic doses.
Croatian: Nije bilo zasićenja vezanja u rasponu koncentracija koje se postižu terapijskim dozama.
English: • if you have an infection of the mouth or throat.
Croatian: • ako imate infekciju usta ili grla.
English: Do not expose to temperatures higher than 50°C.
Croatian: Ne izlagati temperaturama višima od 50°C.
English: If you feel that the medicine is not very effective, talk to your doctor.
Croatian: Ako osjećate da lijek nije učinkovit, obavezno se obratite liječniku.
English: Riarify does not contain a high-dose inhaled corticosteroid, but your doctor may wish to measure the cortisol levels in your blood from time to time.
Croatian: Riarify ne sadrži visoku dozu inhalacijskog kortikosteroida, ali liječnik će Vam možda htjeti povremeno izmjeriti razine kortizola u krvi.
English: Riarify contains a small amount of ethanol.
Croatian: Pomoćne tvari Riarify sadrži male količine etanola.
English: Dispensing date dd/mm/yyyy
Croatian: Datum izdavanja dd/mm/gggg
English: If you are testing your inhaler for the first time, the counter should read:
Croatian: Ako prvi put provjeravate svoj inhalator, brojač mora pokazati:
English: If you have a weak grip, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.
Croatian: Ako imate slab stisak ruke, možda će Vam biti lakše držati inhalator objema rukama: držite gornji dio inhalatora pomoću oba kažiprsta, a donji dio pomoću oba palca.
English: Genotoxicity of Riarify has not been evaluated, however, the single active components were devoid of genotoxic activity in the conventional test systems.
Croatian: Genotoksičnost lijeka Riarify nije procjenjivana, međutim, pojedinačne djelatne tvari bile su bez genotoksičnog djelovanja u konvencionalnim sustavima ispitivanja.
English: At least 65% of the fraction that is swallowed is absorbed from the gastrointestinal tract.
Croatian: Najmanje se 65 % dijela koji se proguta apsorbira u gastrointestinalnom traktu.
English: Check the dose counter or dose indicator.
Croatian: Provjerite brojač doza ili pokazivač doza.
English: However, available safety data from long-term clinical studies have not raised any significant safety concerns (see section 5.1).
Croatian: dostupni podaci o sigurnosti primjene iz dugotrajnih kliničkih ispitivanja nisu dali nikakav značajan razlog za zabrinutost zbog sigurnosti primjene (vidjeti dio 5.1).
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Riarify and to contact their doctor immediately should any of these signs or symptoms develop.
Croatian: Bolesnike je potrebno obavijestiti o znakovima i simptomima akutnog glaukoma uskog kuta te im savjetovati da prestanu primjenjivati Riarify i da se odmah obrate svom liječniku ako se razviju bilo koji od tih znakova i simptoma.
English: If you are allergic to beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na beklometazondipropionat, formoterolfumarat dihidrat i glikopironij ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Riarify is a medicine to help breathing that contains the three active substances:
Croatian: Riarify je lijek za olakšavanje disanja koji sadrži tri djelatne tvari:
English: • formoterol fumarate dihydrate and
Croatian: • formoterolfumarat dihidrat i
English: Therefore, as a precautionary measure, it is preferable to avoid the use of Riarify during pregnancy and during labour.
Croatian: Stoga, kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Riarify tijekom trudnoće i tijekom porođaja.
English: Beta-blockers (including beta-blocker eye-drops) may reduce the effects of formoterol or make it not work at all.
Croatian: Beta-blokatori (uključujući kapi za oči s beta-blokatorom) mogu smanjiti učinke formoterola ili on možda uopće neće djelovati.
English: • if you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you have an aneurysm (abnormal bulging of the blood vessel wall).
Croatian: • ako imate suženje arterija (također poznato kao arterioskleroza), ako imate visok krvni tlak ili ako znate da imate aneurizmu (abnormalno izbočenje stijenke krvne žile).
English: Breathe in slowly and deeply through your mouth to fill your lungs with air (this should take about 4-5 seconds).
Croatian: Polako i duboko udahnite na usta kako bi Vam se pluća napunila zrakom (za to je potrebno oko 4-5 sekundi).
English: There is a risk of worsening shortness of breath and wheezing immediately after using Riarify and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people).
Croatian: Postoji rizik od pogoršanja nedostatka zraka i piskanja neposredno nakon primjene lijeka Riarify, što je pojava poznata pod nazivom paradoksalni bronhospazam (može se javiti u do 1 na 1000 osoba).
English: Related to formoterol
Croatian: Povezano s formoterolom
English: These may be signs of an acute attack of narrow-angle glaucoma (may affect up to 1 in 10,000 people).
Croatian: To mogu biti znakovi akutnog napadaja glaukoma uskog kuta (mogu se javiti u do 1 na 10 000 osoba).
English: When to get a new inhaler
Croatian: Kada nabaviti novi inhalator
English: The toxicological profile of the triple combination reflected that of the single active components without a relevant increase in toxicity and without unexpected findings.
Croatian: Toksikološki profil trojne kombinacije odražavao je onaj pojedinačnih komponenti bez značajnog porasta toksičnosti i bez neočekivanih promjena.
English: CYP2D6 was found to be the only enzyme responsible for glycopyrronium metabolism.
Croatian: Pronašlo se da je CYP2D6 jedini enzim zaslužan za metabolizam glikopironija.
English: The patient should be advised to read the Package Leaflet carefully and follow the instructions for use as given in the leaflet.
Croatian: Bolesniku treba savjetovati da pažljivo pročita uputu o lijeku i slijedi upute za uporabu navedene u uputi o lijeku.
English: Talk to your doctor or pharmacist before using Riarify:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Riarify:
English: There is an approximately linear increase in systemic exposure with increasing inhaled dose.
Croatian: Prisutno je približno linearno povećanje sistemske izloženosti s povećanjem udahnute doze.
English: In addition, L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.
Croatian: Osim toga, L-dopa, L-tiroksin, oksitocin i alkohol mogu smanjiti srčanu podnošljivost beta-2-simpatomimetika.
English: • if you are being, or have ever been, treated for tuberculosis (TB) or if you have a chest infection.
Croatian: • ako se liječite ili ste se ikad liječili od tuberkuloze ili ako imate infekciju u prsnom košu.
English: Infants and neonates born to mothers receiving substantial doses of Riarify should be observed for adrenal suppression.
Croatian: Dojenčad i novorođenčad majki koje primaju znatne doze lijeka Riarify potrebno je promatrati zbog moguće adrenalne supresije.
English: They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias).
Croatian: Oni također mogu povećati rizik od poremećaja srčanog ritma (ventrikularne aritmije).
English: The elimination half-life determined after oral administration is 2-3 hours.
Croatian: Poluvijek eliminacije određen nakon peroralne primjene je 2-3 sata.
English: If you use more Riarify than you should
Croatian: Ako primijenite više lijeka Riarify nego što ste trebali
English: Using Riarify together with:
Croatian: Primjena lijeka Riarify zajedno s:
English: If anaesthesia with halogenated anaesthetics is planned, it should be ensured that Riarify is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias.
Croatian: Ako je planirana anestezija halogeniranim anesteticima, potrebno je osigurati da se lijek Riarify ne primjenjuje najmanje 12 sati prije početka anestezije jer postoji rizik od srčanih aritmija.
English: Tell your doctor if you have any of the following while using Riarify as they could be symptoms of a lung infection (may affect up to 1 in 10 people):
Croatian: Obratite se svom liječniku ako za vrijeme primjene lijeka Riarify imate nešto od sljedećeg jer to mogu biti simptomi infekcije pluća (mogu se javiti u do 1 na 10 osoba):
English: Particular caution is advised in severe COPD as this effect may be potentiated by hypoxia.
Croatian: Osobit se oprez savjetuje kod teškog KOPB-a jer taj učinak može biti pojačan hipoksijom.
English: Repeat dose toxicity
Croatian: Toksičnost ponovljenih doza
English: On the other hand, using other beta2-agonist medicines (which work in the same way as formoterol) may increase the effects of formoterol.
Croatian: S druge strane, primjena drugih beta-2 agonista (koji djeluju na isti način kao formoterol) može pojačati učinke formoterola.
English: • if you have low blood levels of potassium (hypokalaemia).
Croatian: • ako imate niske razine kalija u krvi (hipokalijemija).
English: • if you are due to have an anaesthetic.
Croatian: • ako je planirano da primite anestetik.
English: The clinical development programme of Riarify was conducted in patients with moderate, severe or very severe COPD.
Croatian: Klinički program razvoja lijeka Riarify proveden je u bolesnika s umjerenim, teškim ili vrlo teškim KOPB-om.
English: For instructions for use, see section 6.6.
Croatian: Za upute za uporabu vidjeti dio 6.6.
English: This has the potential to produce adverse cardiovascular effects.
Croatian: To može izazvati štetne kardiovaskularne učinke.
English: The Phase III clinical development programme in COPD included two 52-week active-controlled studies.
Croatian: Klinička djelotvornost i sigurnost Program faze III kliničkog razvoja u KOPB-u uključio je dva ispitivanja s aktivnom kontrolom u trajanju od 52 tjedna.
English: Other in-use storage times and conditions are under the responsibility of the user.
Croatian: Drugačije trajanje i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika.
English: Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation may help to prevent these side effects
Croatian: Ispiranje usta ili grgljanje vode te pranje zubi neposredno nakon udisanja mogu pomoći u sprječavanju ovih nuspojava.
English: Do not pierce the pressurised container.
Croatian: Ne bušiti spremnik pod tlakom.
English: This includes medicines similar to Riarify used for your lung disease.
Croatian: To uključuje lijekove slične lijeku Riarify koje primjenjujete zbog svoje plućne bolesti.
English: If you have been using a different inhaler containing beclometasone dipropionate previously, ask your doctor for advice, as the effective dose of beclometasone dipropionate in Riarify for the treatment of COPD may be lower than that of some other inhalers.
Croatian: Ako ste prethodno koristili drugačiji inhalator koji je sadržavao beklometazondipropionat, potražite savjet liječnika, jer učinkovita doza beklometazondipropionata u lijeku Riarify za liječenje KOPB-a može biti niža od one u nekim drugim inhalatorima.
English: Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females), either congenital or induced by medicinal products as these patients were excluded from clinical trials with Riarify.
Croatian: Također je potreban oprez kod liječenja bolesnika za koje se zna ili sumnja da imaju produljenje QTc intervala (QTc > 450 milisekundi za muškarce ili > 470 milisekundi za žene), bilo kongenitalno bilo inducirano lijekovima, jer su ti bolesnici bili isključeni iz kliničkih ispitivanja lijeka Riarify.
English: Contact your doctor if you experience blurred vision or other visual disturbances.
Croatian: Obratite se liječniku u slučaju zamućenog vida ili drugih poremećaja vida.
English: Ask your doctor or pharmacist about this device.
Croatian: Upitajte svog liječnika ili ljekarnika za tu komoru.
English: It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you carefully follow the instructions on how to use the AeroChamber Plus spacer device and how to clean it.
Croatian: Važno je da pročitate uputu priloženu uz komoru za inhaliranje AeroChamber Plus i da pažljivo slijedite upute o tome kako koristiti komoru za inhaliranje AeroChamber Plus i kako je čistiti.
English: Using high-dose inhaled corticosteroids over a long time can cause in very rare cases effects on the body:
Croatian: Primjena visokih doza inhalacijskih kortikosteroida tijekom dugog razdoblja može, u vrlo rijetkim slučajevima, utjecati na tijelo i uzrokovati:
English: This may increase the likelihood of abnormal heart rhythms.
Croatian: To može povećati vjerojatnost abnormalnog srčanog ritma.
English: Depending on the type of anaesthetic, it may be necessary to stop using Riarify at least 12 hours before the anaesthesia.
Croatian: Ovisno o vrsti anestetika, možda ćete morati prestati primjenjivati Riarify najmanje 12 sati prije anestezije.
English: The daily dose of Riarify corresponds to a medium dose of inhaled corticosteroid; furthermore, these effects are much less likely to occur than with oral corticosteroids.
Croatian: Dnevna doza lijeka Riarify odgovara srednjoj dozi inhalacijskog kortikosteroida; nadalje, nastanak tih učinaka manje je vjerojatan nego uz peroralne kortikosteroide.
English: Remove the protective cap from the mouthpiece by pulling it away from your inhaler.
Croatian: Uklonite zaštitni zatvarač s nastavka za usta tako što ćete ga povući s inhalatora.
English: Therefore, the index fingers should be placed on the top of the pressurised container and both thumbs on the base of the inhaler.
Croatian: Tada je potrebno kažiprste postaviti na vrh spremnika pod tlakom, a oba palca na bazu inhalatora.
English: The two studies included approximately 20% of patients who used the AeroChamber Plus spacer.
Croatian: U ta je dva ispitivanja bilo uključeno 20% bolesnika koji su se koristili komorom za inhaliranje AeroChamber Plus.
English: TDI was only measured in study TRILOGY.
Croatian: TDI je bio mjeren samo u ispitivanju TRILOGY.
English: Possible side effects are listed below according to their frequency.
Croatian: Moguće nuspojave navedene su niže prema njihovoj učestalosti.
English: The inhalation of formoterol may cause a rise in blood glucose levels.
Croatian: Inhalacija formoterola može prouzročiti povišenje razine glukoze u krvi.
English: Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly.
Croatian: Zadržite dah koliko god dugo možete i, na kraju, izvadite inhalator iz usta i polako izdahnite.
English: After use, patients should close the inhaler with the protective mouthpiece cover and check the dose counter or dose indicator.
Croatian: Nakon upotrebe, bolesnici trebaju zatvoriti inhalator zaštitnim zatvaračem nastavka za usta i provjeriti brojač doza ili pokazivač doza.
English: Depending on the container size prescribed to you, check that the dose counter reads 61 or 121 and that the dose indicator reads 180
Croatian: Ovisno o veličini spremnika koji Vam je propisan provjerite da brojač doza pokazuje 61 ili 121, a pokazivač doza 180
English: The aerosol particles of Riarify are on average much smaller than the particles delivered in non-extrafine formulations.
Croatian: Čestice aerosola Riarify u prosjeku su puno manje od čestica formulacija koje se ne raspršuju u vrlo sitne čestice.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Riarify in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Riarify u svim podskupinama pedijatrijske populacije za KOPB (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).