natgillin/translations-raw huggingface dataset:
If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse you should contact your doctor for advice as soon as possible.
Ako se simptomi KOPB-a (nedostatak zraka, piskanje, kašalj) ne poboljšaju ili se pogoršaju, trebate se što prije obratiti svom liječniku za savjet.
If you are affected by any of these side effects do not drive or use machinery until the headache has cleared, the feeling of dizziness has passed and your vision has returned to normal.
Ako imate bilo koju od ovih nuspojava nemojte voziti niti upravljati strojevima dok glavobolja ili osjećaj omaglice ne prestane, a Vaš vid se vrati u normalu.
Children and adolescents Bretaris Genuair is not for use in children or adolescents below 18 years of age.
Djeca i adolescenti Bretaris Genuair nije namijenjen djeci i adolescentima mlađim od 18 godina.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ako ste trudni ili dojite, mislite da ste trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
• The dose indicator shows the total number of doses left in the inhaler (Figure N).
• Pokazivač doze pokazuje ukupan broj doza koje su preostale u inhalatoru (Slika N).
Push the protective cap back onto the mouthpiece after each use (Figure M), to prevent contamination of the inhaler with dust or other materials.
Vratite zaštitnu kapicu na nastavak za usta nakon svake primjene (Slika M) kako biste spriječili ulazak prašine ili drugih materijala u inhalator.
You should get a new inhaler:
Novi inhalator trebate nabaviti:
Up to 65% of the dose was eliminated as metabolites in the urine and up to 33% as metabolites in the faeces.
Do 65% doze bilo je uklonjeno u obliku metabolita u urinu i do 33% u obliku metabolita u stolici.
What Bretaris Genuair looks like and contents of the pack Bretaris Genuair is a white or almost white powder.
Kako Bretaris Genuair izgleda i sadržaj pakiranja Bretaris Genuair je bijel ili gotovo bijeli prašak.
Green button
Zeleni gumb
Your medicine is ready to be inhaled.
Vaš je lijek spreman za inhalaciju.
Then take a strong, deep breath through the mouthpiece.
Zatim udahnite snažno i duboko kroz nastavak za usta.
It is important to instruct the patients to carefully read the Instructions for Use in the Package Leaflet, which is packed together with each inhaler.
Važno je bolesnicima napomenuti da pažljivo pročitaju upute za uporabu navedene u uputi o lijeku, koja se nalazi u pakiranju svakog inhalatora..
Anaphylactic reaction Not known
Nepoznato Anafilaktička reakcija Nepoznato
If you wish to clean your inhaler, just wipe the outside of the mouthpiece with a dry tissue or paper towel.
Ako želite očistiti inhalator, jednostavno obrišite vanjski dio nastavka za usta suhom krpom ili papirnatim ručnikom.
1.1 Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).
1.1 Pogledajte kroz otvor nastavka za usta i uvjerite se da ga ništa ne blokira (Slika C).
- Getting started - Step 1: Prepare your dose - Step 2: Inhale your medicine - Additional information
- Početak - 1. korak: Pripremite dozu - 2. korak: Inhalirajte lijek - Dodatne informacije
Also contains: Lactose
Također sadrži: laktozu
Inform your doctor if you have been or are using similar medicines for breathing problems, such as medicines containing tiotropium, ipratropium.
Obavijestite svog liječnika ako ste uzimali ili uzimate slične lijekove za probleme s disanjem, kao što su lijekovi koji sadrže tiotropij, ipratropij.
This medicine may cause headache, dizziness or blurred vision.
Ovaj lijek može uzrokovati glavobolju, omaglicu ili zamagljen vid.
Read these Instructions for Use before you start using the medicine.
Pročitajte ove upute za uporabu prije nego što počnete primjenjivati lijek.
Cardiovascular effects:
Kardiovaskularni učinci:
The occurrence of headache, dizziness or blurred vision following administration of aclidinium bromide (see section 4.8) may influence the ability to drive or to use machinery.
Pojava glavobolje, omaglice ili zamagljenog vida nakon primjene aklidinijevog bromida (vidjeti dio 4.8) može utjecati na sposobnost upravljanja vozilom ili rada sa strojevima.
Maximal bronchodilatory effects were evident from day one and were maintained over the 6-month treatment period.
Maksimalni bronhodilatorni učinci bili su vidljivi od prvog dana i održali su se tijekom 6-mjesečnog razdoblja.
2.4 Take the inhaler out of your mouth.
2.4 Izvadite inhalator iz usta.
• If your inhaler is empty (Figure O).
• ako je inhalator koji imate prazan (Slika O).
Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics; ATC Code: R03BB05.
Farmakoterapijska skupina: Lijekovi za opstruktivne bolesti dišnih putova, antikolinergici; ATK oznaka: R03BB05.
When the green button will not return to its full upper position and is locked in a middle position, you have reached the last dose (Figure O).
Kada se zeleni gumb ne želi vratiti u početni položaj, već se zaključa u srednjem položaju, došli ste do zadnje doze (Slika O).
Never breathe out into the inhaler (Figure I).
Nikada nemojte izdisati u inhalator (Slika I).
STEP 1: Prepare your dose
1. KORAK: Pripremite dozu
Protective Cap
Zaštitna kapica
- 4.6 units a Minimum clinically important difference (MCID) of at least 1 unit change in TDI.
- 4,6 jedinica a Minimalna klinički značajna razlika (MCID, engl. minimum clinically important difference) promjena od najmanje 1 jedinice u TDI.
59.8% of patients had at least one COPD exacerbation within the past 12 months from the screening visit.
Nadalje, 59,8% bolesnika imalo je najmanje jednu egzacerbaciju KOPB-a unutar posljednjih 12 mjeseci nakon probirnog posjeta.
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 (<1/10,000) and not known (cannot be estimated from the available data).
Učestalost nuspojava definira je prema kategorijama učestalosti: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1 000 i <1/100), rijetko (≥1/10 000 i <1/1 000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
A ‘click' will let you know that you are inhaling correctly.
‘Klik' će Vam dati do znanja da pravilno inhalirate lijek.
After that, the inhaler cannot be used again and you should start using a new inhaler.
Nakon toga više ne možete koristiti taj inhalator, već trebate početi koristiti novi.
COPD is a long-term disease; therefore, it is recommended that Bretaris Genuair is used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
KOPB je dugotrajna bolest; stoga se preporučuje koristiti lijek Bretaris Genuair svakodnevno, dvaput na dan, a ne samo kada se pojave problemi s disanjem ili drugi simptomi KOPB-a.
The recommended dose can be used for elderly patients and for patients with kidney or liver problems.
Preporučenu dozu mogu koristiti stariji bolesnici i bolesnici s oštećenjem bubrega ili jetre.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bretaris Genuair therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Potrebno je odlučiti da li prekinuti dojenje ili prekinuti/suzdržati se od liječenja lijekom Bretaris Genuair uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
Do not use Bretaris Genuair - if you are allergic to aclidinium bromide or any of the other ingredients of this medicine (listed in section 6).
Nemojte primjenjivati Bretaris Genuair - ako ste alergični na aklidinijev bromid ili na neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
However, if it is nearly time for the next dose, the missed dose should be skipped.
Međutim, ako je gotovo došlo vrijeme za sljedeću dozu, propuštenu dozu treba preskočiti.
1.5 Release the green button (Figure F).
1.5 Otpustite zeleni gumb (Slika F).
The effects of Bretaris Genuair last for 12 hours; therefore, you should try to use your Bretaris Genuair inhaler at the same time every morning and evening.
Učinci Bretaris Genuair traju 12 sati; stoga nastojte koristiti Bretaris Genuair uvijek u isto vrijeme ujutro odnosno navečer.
Go back to ‘STEP 1 Prepare your dose' and repeat steps 1.1 to 1.6.
KORAK: Pripremite dozu' i ponovite korake od 1.1 do 1.6.
Approximately 48% of enrolled patients had a prior history of at least 1 documented previous cardiovascular event; cerebrovascular disease (13.1%), coronary artery disease (35.4%), peripheral vascular disease or history of claudication (13.6%).
Približno 48% uključenih bolesnika u anamnezi je imalo najmanje 1 dokumentiran kardiovaskularni događaj: cerebrovaskularnu bolest (13,1%), bolest koronarnih arterija (35,4%), perifernu vaskularnu bolest ili klaudikaciju (13,6%).
Some patients may experience a grainy sensation in their mouth, or a slightly sweet or bitter taste.
Neki će bolesnici možda osjetiti zrnatost ili slatkast ili gorkast okus u ustima.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala te reproduktivne i razvojne toksičnosti.
Excipients with known effect Each delivered dose contains approximately 12 mg lactose (as monohydrate).
Pomoćne tvari s poznatim učinkom Svaka isporučena doza sadrži približno 12 mg laktoze (u obliku hidrata).
c Odds ratio, increase in the likelihood of achieving the MCID compared to placebo.
c Omjer izgleda, povećanje vjerojatnosti postizanja MCID u usporedbi s placebom.
Store your inhaler with the protective cap in place until it is time to inhale your medicine, then remove the cap and start at Step 1.6.
Držite zaštitnu kapicu na inhalatoru dok ne dođe vrijeme za inhaliranje lijeka, a zatim je skinite i počnite od koraka 1.6.
High doses of aclidinium bromide may lead to anticholinergic signs and symptoms.
Visoke doze aklidinijeva bromida mogu dovesti do antikolinergičkih znakova i simptoma.
How should you clean the inhaler?
Kako čistiti inhalator?
1.2 Look at the control window (should be red, Figure C).
1.2 Pogledajte kontrolni prozorčić (mora biti crven, Slika C).
Dose indicator moves slowly from 60 to 0: 60, 50, 40, 30, 20, 10, 0.
Pokazivač doze polako se pomiče od 60 do 0: 60, 50, 40, 30, 20, 10, 0.
Aclidinium bromide is a competitive, selective muscarinic receptor antagonist (also known as an anticholinergic), with a longer residence time at the M3 receptors than the M2 receptors.
Aklidinijev bromid je kompetitivni, selektivni antagonist muskarinskih receptora (poznat i pod nazivom antikolinergik), s duljim vremenom vezanja na M3 nego na M2 receptorima.
Squeeze here and pull
Ovdje pritisnite i povucite
• Obligation to conduct post-authorisation measures
• Obveze za ispunjavanje mjera nakon davanja odobrenja
The inhaler device is a multicomponent device made of polycarbonate, acrylonitrile-butadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene and stainless steel.
Inhalator je naprava koja se sastoji od više dijelova, izrađena od polikarbonata, akrilonitril-butadienstirena, polioksimetilena, poliester-butilen-tereftalata, polipropilena, polistirena i nehrđajućeg čelika.
After you have taken the last dose, the inhaler has to be disposed of.
Nakon uzimanja zadnje doze, inhalator treba zbrinuti.
Patients should be instructed on how to administer the product correctly as the Genuair inhaler may work differently from inhalers the patients may have used previously.
Bolesnike treba podučiti kako ispravno primijeniti lijek jer inhalator Genuair možda radi drugačije od inhalatora koje su bolesnici prije koristili.
Make sure you release the button so the inhaler can work correctly.
Obavezno otpustite zeleni gumb da bi inhalator mogao pravilno raditi.
It is considered unlikely that aclidinium bromide administered at the recommended dose will affect fertility in humans.
Smatra se malo vjerojatnim da će aklidnijev bromid davan u preporučenoj dozi utjecati na plodnost ljudi.
This leaflet was last revised in <{month YYYY}>.
Ova je uputa zadnji puta revidirana u{mjesec GGGG}.
08740 Sant Andreu de la Barca, Barcelona Spain
08740 Sant Andreu de la Barca, Barcelona Španjolska
Red band
Crvena traka
What to do if the control window is still red after pressing the button (Figure H).
Što učiniti ako je kontrolni prozorčić crven i nakon što ste pritisnuli gumb (Slika H).
You should not use Bretaris Genuair if you are pregnant or are breast-feeding unless your doctor tells you so.
Ne smijete uzimati Bretaris Genuair ako ste trudni ili dojite, osim ako to ne odredi Vaš liječnik.
Even though the green button is locked, your last dose may still be inhaled.
Iako je zeleni gumb zaključan u srednjem položaju, ipak možete inhalirati zadnju dozu.
Bretaris Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into your lungs.
Bretaris Genuair je inhalator suhog praška koji koristi Vaše disanje za dostavu lijeka izravno u Vaša pluća.
The rate of moderate or severe COPD exacerbations per patient per year during the first year of treatment was evaluated as the primary efficacy endpoint in the study.
Godišnja stopa umjerenih ili teških egzacerbacija KOPB-a po bolesniku tijekom prvih godinu dana liječenja ocjenjivala se kao primarna mjera ishoda za djelotvornost u ispitivanju.
Anticholinergic activity:
Antikolinergičko djelovanje:
• On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size.
• Svaki inhalator pri prvoj uporabi sadrži 60 doza ili 30 doza, ovisno o veličini pakiranja.
The inhaler is supplied in a plastic laminate pouch, placed in a cardboard carton.
Inhalator se isporučuje u plastičnoj laminarnoj vrećici, u kartonskoj kutiji.
Please contact your doctor if the control window is still green after repeated attempts.
Obratite se svom liječniku ako je nakon nekoliko pokušaja kontrolni prozorčić i dalje zelene boje.
Administration of Bretaris Genuair may cause paradoxical bronchospasm.
Primjena lijeka Bretaris Genuair može uzrokovati paradoksalni bronhospazam.
Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.
Suha usta, koja su često zabilježena uz antikolinergičko liječenje, dugoročno mogu biti povezana sa zubnim karijesom.
Use the control window to ensure you have inhaled correctly.
Pogledajte kontrolni prozorčić kako biste bili sigurni da ste pravilno inhalirali lijek.
This means you have not inhaled your medicine correctly.
To znači da niste pravilno inhalirali lijek.
Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of aclidinium bromide.
Biotransformacija preko enzima CYP450 ima manju ulogu u ukupnom metaboličkom klirensu aklidinijeva bromida.
b) Do not press the green button until you are ready to take a dose.
b) Nemojte pritisnuti zeleni gumb dok ne budete spremni primijeniti dozu.
What Bretaris Genuair is and what it is used for What you need to know before you use Bretaris Genuair How to use Bretaris Genuair Possible side effects
Što je Bretaris Genuair i za što se koristi Što morate znati prije nego počnete primjenjivati Bretaris Genuair Kako primjenjivati Bretaris Genuair Moguće nuspojave
It is supplied in a plastic pouch.
Isporučuje se u plastičnoj vrećici.
What to do if the control window is still green after inhalation (Figure L).
Što učiniti ako je kontrolni prozorčić nakon inhalacije i dalje zelen (Slika L).
The fraction of the inhaled dose that reaches the systemic circulation as unchanged aclidinium is very low at less than 5%.
Udio inhalirane doze koja dospije u krvotok kao nepromijenjeni aklidinij je vrlo niska - niža od 5%.
• Each time you load a dose by pressing the green button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
• Svaki put kad pripremite dozu pritiskom na zeleni gumb, pokazivač doze malo se pomakne prema sljedećem broju (50, 40, 30, 20, 10 ili 0).
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation is in place and functioning before and whilst the medicinal product is on the market.
Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav prikazan u Modulu 1.8.1. odobrenja za stavljanje gotovog lijeka u promet, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
Aclidinium bromide is rapidly absorbed from the lung, achieving maximum plasma concentrations within 5 minutes of inhalation in healthy subjects, and normally within the first 15 minutes in COPD patients.
Aklidinijev bromid brzo se apsorbira iz pluća, uz postizanje maksimalne koncentracije u plazmi unutar 5 minuta od inhalacije u zdravih ispitanika, te uobičajeno unutar prvih 15 minuta kod KOPB bolesnika.
If you use more Bretaris Genuair than you should If you think you may have used more Bretaris Genuair than you should, contact your doctor or pharmacist.
Ako primijenite više lijeka Bretaris Genuair nego što ste trebali Ako mislite da ste možda primijenili više lijeka Bretaris Genuair nego što ste trebali, obratite se svom liječniku ili ljekarniku.
The main plasma protein that binds aclidinium bromide is albumin.
Glavni protein plazme koji veže aklidinijev bromid je albumin.
The mouthpiece is covered with a removable green protective cap.
Nastavak za usta pokriven je zelenom zaštitnom kapicom koja se može skidati.
Because aclidinium bromide acts locally in the lungs and is quickly broken down in plasma there is no direct relationship between pharmacokinetics and pharmacodynamics.
Budući da aklidinijev bromid djeluje lokalno u plućima i brzo se razgrađuje u plazmi, nema direktne povezanosti između farmakokinetike i farmakodinamike.
The plasma protein binding of aclidinium bromide determined in vitro most likely corresponded to the protein binding of the metabolites due to the rapid hydrolysis of aclidinium bromide in plasma; plasma protein binding was 87% for the carboxylic acid metabolite and 15% for the alcohol metabolite.
Vezanje aklidinijeva bromida za proteine plazme određeno in vitro najvjerojatnije odgovara vezanju metabolita za proteine plazme zbog brze hidrolize aklidinijeva bromida u plazmi; vezanje na proteine plazme bilo je 87% za metabolit karboksilne kiseline i 15% za alkoholni metabolit.
Plasma levels of the acid metabolite are approximately 100-fold greater than those of the alcohol metabolite and the unchanged active substance following inhalation.
Razine kiselinskog metabolita u plazmi su oko 100 puta više od alkoholnog metabolita i nepromijenjene djelatne tvari nakon inhalacije.
There is no relevant use of Bretaris Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Nema relevantne primjene lijeka Bretaris Genuair u djece i adolescenata (mlađih od 18 godina) u indikaciji KOPB-a.
This section contains information on how to use your Genuair inhaler.
Ovaj dio sadrži upute o tome kako koristiti inhalator Genuair.
The use of Bretaris Genuair with these medicines is not recommended.
Ne preporučuje se uzimanje Bretaris Genuair uz ove lijekove.
Locked
Zaključano
Stop using the medicine and contact your doctor immediately if you develop swelling of your face, throat, lips or tongue (with or without difficulty breathing or swallowing), dizziness or fainting, faster heart rate or if you get raised severely itchy bumps on your skin (hives) as these may be symptoms of an allergic reaction.
Prestanite uzimati lijek i odmah kontaktirajte liječnika ako Vam se pojavi oticanje lica, grla, usana ili jezika (sa ili bez otežanog disanja ili gutanja), omaglica ili nesvjestica, ubrzan puls ili ako Vam se na koži pojave crvene izbočine koje izrazito svrbe (koprivnjača), jer to mogu biti simptomi alergijske reakcije.
To be used within 90 days of opening the pouch.
Upotrijebiti u roku od 90 dana nakon otvaranja vrećice.
2.3 Take a strong, deep breath through your mouth.
2.3 Udahnite snažno i duboko kroz usta.
If you are not sure of how to use Bretaris Genuair, contact your doctor or pharmacist.
Ako niste sigurni kako koristiti lijek Bretaris Genuair, obratite se svom liječniku ili ljekarniku.
2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips tightly around it (Figure J).
2.2 Držeći glavu uspravno, stavite nastavak u usta i čvrsto ga obujmite usnama (Slika J).
The safety margins for human systemic exposure with 400 µg twice daily over the no observed adverse effect levels in these studies ranged from 7- to 73-fold.
Granice sigurnosti za sistemsku izloženost kod ljudi pri dozi od 400 µg dvaput dnevno u odnosu na najviše doze koje ne uzrokuju štetan učinak u tim je ispitivanjima imala raspon od 7 do 73 puta.
If this occurs, treatment with Bretaris Genuair should be stopped and other treatments considered.
Ako dođe do toga, liječenje lijekom Bretaris Genuair treba prekinuti i razmotriti uzimanje drugih lijekova.
Pregnancy There are no data available on the use of aclidinium bromide in pregnant women.
Trudnoća Nema podataka o primjeni aklidinijeva bromida u trudnica.
The primary safety endpoint was the time to first occurrence of MACE, defined as any of the following adjudicated events: cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal ischemic stroke.
Primarna mjera ishoda za sigurnost bilo je vrijeme do prvog nastupa MACE događaja, koji se definirao kao bilo koji od sljedećih potvrđenih događaja: smrt zbog kardiovaskularnih uzroka, infarkt miokarda bez smrtnog ishoda (IM) ili ishemijski moždani udar bez smrtnog ishoda.
Bretaris Genuair should be used with caution in patients who had a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the “New York Heart Association”.
Bretaris Genuair treba koristiti oprezno kod bolesnika koji su imali infarkt miokarda u prethodnih 6 mjeseci, nestabilnom anginom, novo dijagnosticiranom aritmijom u prethodna 3 mjeseca, ili hospitalizacijom u prethodnih 12 mjeseci zbog zatajenja srca klase III i IV, prema „New York Heart Association“ (NYHA) klasifikaciji.
Go back to ‘STEP 2 Inhale your medicine' and repeat steps 2.1 to 2.7.
KORAK: Inhalirajte lijek' i ponovite korake od 2.1 do 2.7.
This means you have inhaled your medicine correctly.
To znači da ste pravilno inhalirali lijek.
- if you have an enlarged prostate, problems passing urine, or a blockage in your bladder.
- ako imate povećanu prostatu, probleme s mokrenjem ili zastoj mokraće u mokraćnom mjehuru.
The European Medicines Agency has waived the obligation to submit the results of studies with Bretaris Genuair in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja s Bretaris Genuairom u svim podskupinama pedijatrijske populacije za KOPB (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
The hydrolysis occurs both chemically (non-enzymatically) and enzymatically by esterases, butyrylcholinesterase being the main human esterase involved in the hydrolysis.
Do hidrolize dolazi i kemijskim (neenzimatskim) putem i enzimatskim putem s esterazama, pri čemu je butirilkolinesteraza glavna humana esteraza uključena u hidrolizu.
Make sure you have released the green button, and you have breathed out completely.
Obavezno otpustite zeleni gumb i potpuno izdahnite.