FrancophonIA/ELRC3.0 huggingface dataset:
English: Beta blockers are mostly used for high blood pressure or heart conditions such as angina.
Croatian: Beta-blokatori se većinom primjenjuju zbog visokog krvnog tlaka ili srčanih bolesti poput angine.
English: Some of these medicines may increase the amount of salmeterol or fluticasone propionate in your body.
Croatian: Neki od tih lijekova mogu povećati količinu salmeterola ili flutikazonpropionata u Vašem tijelu.
English: βeta 2 adrenoreceptor agonists
Croatian: Agonisti beta 2 adrenoreceptora
English: Ritonavir can greatly increase the concentration of fluticasone propionate in plasma.
Croatian: Ritonavir može jako povećati koncentraciju flutikazonpropionata u plazmi.
English: This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.
Croatian: To ne zahtijeva hitno djelovanje jer se funkcija nadbubrežnih žlijezda oporavi za nekoliko dana, kako je potvrđeno mjerenjima kortizola u plazmi.
English: • Other bronchodilators (such as salbutamol).
Croatian: • druge bronhodilatatore (kao što je salbutamol).
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove:
English: Lactose contains small amounts of milk protein which may cause allergic reactions.
Croatian: Laktoza sadrži male količine proteina mlijeka, koji mogu uzrokovati alergijske reakcije.
English: To prevent these symptoms, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).
Croatian: Da bi se spriječili ti simptomi, liječnik Vam može propisati dodatne kortikosteroide u obliku tablete (kao što je prednizon).
English: Treatment was stepped up every 12 weeks until **total control was achieved or the highest dose of study drug was reached.
Croatian: Svakih 12 tjedana primjenjivalo se sve veće doze u liječenju dok se nije uspostavila **potpuna kontrola ili postigla najviša doza ispitivanog lijeka.
English: Administration of Aerivio Spiromax to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Croatian: Primjenu Aerivio Spiromaxa u trudnica treba razmotriti samo ako je očekivana korist za majku veća od svakog mogućeg rizika za fetus.
English: Consideration should be given to referring the child or adolescent to a paediatric respiratory specialist.
Croatian: Potrebno je razmotriti upućivanje djeteta ili adolescenta pedijatru specialistu za respiratorne bolesti.
English: (*=could not be calculated because of no events in placebo group.
Croatian: (*=nije se moglo izračunati jer u skupini koja je primala placebo nije bilo događaja.
English: Risk in bold figures is statistically significant at the 95% level.
Croatian: Rizik koji je podebljano otisnut statistički je značajan na razini od 95%.
English: Frequencies were derived from clinical trial data.
Croatian: Učestalosti su izvedene iz podataka iz kliničkih ispitivanja.
English: When the numbers become red in the window, you should see your doctor and get a
Croatian: Kad u prozorčiću brojevi postanu crveni, trebate posjetiti liječnika i dobiti novi inhalator.
English: • Aerivio Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time.
Croatian: • Aerivio Spiromax može utjecati na normalno stvaranje steroidnih hormona u tijelu, osobito ako ste uzimali visoke doze tijekom duljih razdoblja.
English: It is impossible to accidentally take extra medicine or a double dose in
Croatian: Nije moguće slučajno uzeti previše lijeka ili dvostruku dozu u jednom udahu.
English: See your doctor at once as you may need
Croatian: Odmah posjetite liječnika jer Vam možda
English: Method of administration/Instructions for use
Croatian: Način primjene/Upute za uporabu
English: Less than 5% of the dose is excreted in urine, mainly as metabolites.
Croatian: Manje od 5% doze izluči se mokraćom, uglavnom u obliku metabolita.
English: Front panel: Not for use in children and adolescents.
Croatian: Prednja strana: Nije za primjenu u djece i adolescenata.
English: Before using your Aerivio Spiromax for the first time, you need to prepare it for use as follows:
Croatian: Prije nego što ćete prvi put uporabiti Aerivio Spiromax, trebate ga pripremiti za uporabu na sljedeći način:
English: Therefore these patients should be treated with special care and adrenocortical function regularly monitored.
Croatian: Stoga te bolesnike treba liječiti s posebnom pažnjom i redovito im pratiti adrenokortikalnu funkciju.
English: There have been very rare reports of increases in blood glucose levels (see section 4.8) and this should be considered when prescribing to patients with a history of diabetes mellitus.
Croatian: Vrlo je rijetko zabilježeno povišenje razine glukoze u krvi (vidjeti dio 4.8) pa to treba uzeti u obzir kad se propisuje bolesnicima sa šećernom bolešću u anamnezi.
English: • Salmeterol is a long-acting bronchodilator.
Croatian: • Salmeterol je dugodjelujući bronhodilatator.
English: Systemic absorption occurs mainly through the lungs and is initially rapid then prolonged.
Croatian: Sistemska apsorpcija odvija se uglavnom kroz pluća i isprva je brza, a zatim produljena.
English: Non-significant p value after adjustment for 2 interim analyses on the primary efficacy comparison from a log-rank analysis stratified by smoking status
Croatian: P-vrijednost nije bila značajna nakon prilagodbe zbog 2 interim analize usporedbe primarne djelotvornosti iz log-rang analize stratificirane prema pušačkom statusu
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije
English: • Heart disease, including an irregular or fast heart beat
Croatian: • srčanu bolest, uključujući nepravilan ili ubrzan rad srca
English: Allergic reactions to Aerivio Spiromax are uncommon (they may affect up to 1 in 100 people).
Croatian: Alergijske reakcije na Aerivio Spiromax su manje česte (mogu se javiti u do 1 na 100 osoba).
English: • Check the dose indicator to see that there are 60 inhalations in the inhaler.
Croatian: • Provjerite pokazatelj doza da vidite ima li u inhalatoru 60 udaha.
English: Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability.
Croatian: Djeca također mogu imati anksioznost, poremećaje spavanja i promjene u ponašanju, uključujući hiperaktivnost i razdražljivost.
English: • Tiredness and loss of appetite, feeling sick
Croatian: • umor i gubitak apetita, mučninu
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Aerivio Spiromax contains lactose').
Croatian: - Drugi sastojci su laktoza hidrat (vidjeti dio 2 pod „Aerivio Spiromax sadrži laktozu”).
English: Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk.
Croatian: Bolesnici kojima je u prošlosti bilo potrebno hitno liječenje visokim dozama kortikosteroida također mogu biti pod rizikom.
English: Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment.
Croatian: Iznenadno i progresivno slabljenje kontrole astme može ugroziti život i bolesnik treba biti podvrgnut hitnoj liječničkoj procjeni.
English: • Increases in the amount of sugar (glucose) in your blood (hyperglycaemia).
Croatian: • povećanje količine šećera (glukoze) u krvi (hiperglikemija).
English: Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection or any rapid reduction in dosage.
Croatian: Situacije koje potencijalno mogu dovesti do akutne adrenalne krize uključuju traumu, kirurški zahvat, infekciju ili svako brzo sniženje doze.
English: A clear benefit has not been shown as compared with inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing.
Croatian: Nije pokazana jasna korist u usporedbi s primjenom samo inhalacijskog flutikazonpropionata kao početne terapije održavanja kad nisu prisutni jedan ili dva kriterija težine bolesti.
English: Animal studies with salmeterol have shown embryofetal toxicity only at high exposure levels.
Croatian: Ispitivanja salmeterola na životinjama pokazala su embriofetalnu toksičnost samo pri visokim razinama izloženosti.
English: After 12 weeks no children in either treatment arm had abnormally low 24-hour urinary cortisol excretion.
Croatian: Nakon 12 tjedana, nijedno dijete ni u jednoj skupini nije imalo abnormalno nisko izlučivanje kortizola u 24-satnoj mokraći.
English: There was a trend towards improved survival in subjects treated with salmeterol/fluticasone propionate compared with placebo over 3 years however this did not achieve the statistical significance level p≤0.05.
Croatian: Postojao je trend prema poboljšanom preživljenju ispitanika liječenih salmeterolom/flutikazonpropionatom u usporedbi s placebom tijekom 3 godine, međutim, to nije postiglo razinu statističke značajnosti od p≤0,05.
English: Just take your next dose at the usual time.
Croatian: Samo uzmite sljedeću dozu u
English: Then breathe out gently (do not breathe out through the inhaler).
Croatian: Zatim polako izdahnite (nemojte izdisati kroz inhalator).
English: This will make sure that it works properly in controlling your asthma or COPD.
Croatian: Tako ćete osigurati njegovo ispravno djelovanje u kontroli astme ili KOPB-a.
English: Salmeterol acts locally in the lung therefore plasma levels are not an indication of therapeutic effects.
Croatian: Salmeterol djeluje lokalno u plućima pa stoga razine u plazmi nisu pokazatelj terapijskih učinaka.
English: This makes it easier for air to get in and out.
Croatian: Tako zrak lakše ulazi i izlazi iz pluća.
English: Salmeterol produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting β2 agonists.
Croatian: Salmeterol izaziva dugotrajniju bronhodilataciju, koja traje najmanje 12 sati, nego preporučene doze uobičajenih kratkodjelujućih β2 agonista.
English: Bronchodilators help the airways in the lungs to stay open.
Croatian: Bronhodilatatori pomažu da dišni putovi u plućima ostanu otvoreni.
English: As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.
Croatian: Tako bolesnicima treba savjetovati da pažljivo pročitaju uputu o lijeku i slijede upute za primjenu koje su tamo detaljno opisane.
English: • Diabetes mellitus (Aerivio Spiromax may increase your blood sugar)
Croatian: • šećernu bolest (Aerivio Spiromax može povisiti šećer u krvi)
English: The extent of the adrenal impairment may require specialist advice before elective procedures.
Croatian: Opseg oštećenja nadbubrežne žlijezde može iziskivati specijalistički savjet prije elektivnih zahvata.
English: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG
Croatian: Teva Pharma Belgium N.V./S.A./AG
English: Salmeterol/fluticasone propionate 50/500 N = 1533
Croatian: Salmeterol/ flutikazonpropionat 50/500 N = 1533
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland
Croatian: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irska
English: If you forget to use Aerivio Spiromax Do not take a double dose to make up for a forgotten dose.
Croatian: Ako ste zaboravili primijeniti Aerivio Spiromax Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: If you are using Aerivio Spiromax for asthma, your doctor will want to check your symptoms regularly.
Croatian: Ako primjenjujete Aerivio Spiromax zbog astme, liječnik će htjeti redovito provjeravati Vaše simptome.
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35 IDA Industrial Park
Croatian: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35 IDA Industrial Park Cork Road
English: Your doctor, nurse or pharmacist should also check how you use your Spiromax device from time to time to ensure that you are using the device properly and as prescribed.
Croatian: Liječnik, medicinska sestra ili ljekarnik također trebaju povremeno provjeriti kako koristite inhalator Spiromax kako bi bili sigurni da ga koristite na ispravan način i kako je propisano.
English: This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone.
Croatian: Rezultat toga bilo je veće smanjenje kortizola u plazmi u usporedbi sa samo flutikazonpropionatom.
English: Teva Eesti esindus UAB Sicor Biotech Eesti
Croatian: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u
English: Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.
Croatian: Savjetuje se poseban oprez kod akutne teške astme jer taj učinak može biti pojačan istodobnim liječenjem derivatima ksantina, steroidima i
English: In addition there are only limited data available on the pharmacokinetics of salmeterol because of the technical difficulty of assaying the drug in plasma due to the low plasma concentrations at therapeutic doses (approximately 200 picogram/mL or less) achieved after inhaled dosing.
Croatian: Osim toga, dostupni su samo ograničeni podaci o farmakokinetici salmeterola zato što je tehnički teško procijenjivati lijek u plazmi zbog niskih koncentracija u plazmi pri terapijskim dozama (približno 200 pikograma/ml ili manje) koje se postižu nakon doziranja udisanjem.
English: • Beta blockers (such as atenolol, propranolol and sotalol).
Croatian: • beta-blokatore (kao što su atenolol, propranolol i sotalol).
English: There is no need to adjust the dose in elderly patients or in those with renal impairment.
Croatian: Nije potrebna prilagodba doze u starijih bolesnika ili onih s oštećenjem funkcije bubrega.
English: Do not try to take your inhaler apart, remove or twist the mouthpiece cover.
Croatian: Nemojte pokušavati rastaviti inhalator, ukloniti ili uvrtati poklopac nastavka za usta.
English: If you are not using Aerivio Spiromax properly and/or you are not breathing in forcefully enough, this may mean that you are not getting enough of the medicine into your lungs.
Croatian: Ako ne koristite Aerivio Spiromax na ispravan način i/ili ne udišete dovoljno snažno, to može značiti da ne dobivate dovoljno lijeka u pluća.
English: Systemic effects may occur, particularly at high doses prescribed for long periods.
Croatian: Mogu nastati sistemski učinci, osobito pri visokim dozama propisanima tijekom dugih razdoblja.
English: The absolute bioavailability of a single dose of inhaled fluticasone propionate in healthy subjects varies between approximately 5 to 11% of the nominal dose depending on the inhalation device used.
Croatian: Apsolutna bioraspoloživost jedne doze udahnutog flutikazonpropionata u zdravih ispitanika varira između približno 5% i 11% nominalne doze ovisno o tome kakav se inhalator uporabio.
English: Aerivio Spiromax may not be suitable to be taken with some other medicines.
Croatian: Aerivio Spiromax možda neće biti pogodno uzimati s nekim drugim lijekovima.
English: The safety and efficacy of Aerivio Spiromax in this young population have not been established.
Croatian: Sigurnost i djelotvornost Aerivio Spiromaxa u ove mlade populacije nisu ustanovljene.
English: This is to ensure that they understand how to use the inhaler correctly, and so that they understand the need to breathe in forcefully when inhaling to obtain the required dose.
Croatian: Na taj način će se osigurati da razumiju kako ispravno koristiti inhalator i shvate zašto je potrebno snažno udahnuti tijekom inhalacije kako bi uzeli potrebnu dozu.
English: When your body is under stress such as from fever, trauma (such as an accident or injury), infection, or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above.
Croatian: Kad Vam je tijelo pod stresom, kao kod vrućice, traume (kao što je nezgoda ili ozljeda), infekcije ili kirurškog zahvata, insuficijencija nadbubrežnih žlijezda može se pogoršati i možete razviti bilo koju od gore navedenih nuspojava.
English: Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected.
Croatian: Informacija o toj interakciji za inhalacijski flutikazonpropionat nema, ali očekuje se izrazito povišenje razina flutikazonpropionata u plazmi.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics, ATC code: R03AK06
Croatian: Farmakoterapijska skupina: lijekovi za opstruktivne bolesti dišnih putova, adrenergici u kombinaciji s kortikosteroidima ili drugim lijekovima, osim antikolinergicima, ATK oznaka: R03AK06
English: Moderate/ severe exacerbations were defined as worsening symptoms that required treatment with oral corticosteroids and/or antibiotics or in-patient hospitalisation.
Croatian: Umjerene/teške egzacerbacije bile su definirane kao pogoršanje simptoma koje iziskuje liječenje peroralnim kortikosteroidima i/ili antibiotcima ili hospitalizaciju.
English: In order to ensure that patients achieve the PIFR needed to deliver the required dose, the patient is required to be trained on the use of the Spiromax device including instruction on the need to inhale forcefully (see Section 4.2).
Croatian: Kako bi se osiguralo da bolesnici postignu PIFR potreban da se dostavi potrebna doza, bolesnike treba podučiti uporabi inhalatora Spiromax uključujući uputu o potrebi snažnog udaha (vidjeti dio 4.2).
English: Suomi/Finland Teva FinlandPuh/Tel: +358 20 180 5900
Croatian: Suomi/Finland Teva Finland Puh/Tel: +358 20 180 5900
English: All subjects with asthma or COPD achieved PIFR values greater than 60L/min after optimal training.
Croatian: Svi su ispitanici s astmom ili KOPB-om postigli vrijednosti PIFR-a iznad 60 L/min nakon optimalne poduke.
English: This may lead to an increase in the incidence of systemic effects (e.g. prolongation in the QTc interval and palpitations).
Croatian: To može dovesti do povećane incidencije sistemskih učinaka (npr. produljenja QTc intervala i palpitacija).
English: Talk to your doctor, pharmacist or nurse before using Aerivio Spiromax if you have:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Aerivio Spiromax ako imate:
English: The use of Aerivio Spiromax follows three simple steps: open, breathe and close which are outlined below.
Croatian: Uporaba Aerivio Spiromaxa odvija se u tri jednostavna koraka: otvaranje, udisanje i zatvaranje, koja su
English: Do not bite the mouthpiece.
Croatian: Nemojte zagristi u nastavak za usta.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP.
English: • The dose indicator on the rear of the device tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full.
Croatian: • Pokazatelj doza na stražnjoj strani inhalatora pokazuje Vam koliko je doza (udaha) preostalo u inhalatoru, počevši od 60 udaha kad je pun.
English: Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000 micrograms.
Croatian: Opisani su i vrlo rijetki slučajevi supresije nadbubrežnih žlijezda i akutne adrenalne krize uz doze flutikazonpropionata između 500 i manje od 1000 mikrograma.
English: In TORCH, older patients, patients with a lower body mass index (<25 kg/m2) and patients with very severe disease (FEV1<30% predicted) were at greatest risk of developing pneumonia regardless of treatment.
Croatian: U ispitivanju TORCH, stariji bolesnici, bolesnici s nižim indeksom tjelesne mase (<25 kg/m2) i bolesnici s jako teškom bolešću (FEV1<30% predviđenog) imali su najveći rizik od razvoja pneumonije bez obzira na liječenje.
English: Breathe: Breathe out gently (as far as is comfortable).
Croatian: Udisanje: Polako izdahnite (onoliko koliko Vam je ugodno).
English: Breathe out gently (as far as is comfortable).
Croatian: Polako izdahnite (onoliko koliko Vam je ugodno).
English: The lowest dose of inhaled corticosteroid should be used.
Croatian: Treba primijeniti najnižu dozu inhalacijskog kortikosteroida.
English: You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness).
Croatian: Također možete opaziti svrbež, osip (koprivnjaču) i oticanje (obično lica, usana, jezika ili grla) ili možete iznenada osjetiti jako ubrzan rad srca ili nesvjesticu ili ošamućenost (što može dovesti do kolapsa i gubitka svijesti).
English: Tell your doctor, but do not stop taking Aerivio Spiromax unless the doctor tells you to stop.
Croatian: Obavijestite liječnika, ali nemojte prestati uzimati Aerivio Spiromax osim ako Vam liječnik ne kaže da prestanete.
English: Your inhaler is now ready
Croatian: Sada je inhalator spreman za uporabu.
English: Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing.
Croatian: Istodobna primjena s ketokonazolom nije produljila poluvijek eliminacije salmeterola ili povećala nakupljanje salmeterola s ponavljanjem doziranja.
English: If you accidentally take more doses than is recommended, talk to your doctor or pharmacist.
Croatian: Ako slučajno uzmete više doza nego što je preporučeno, obratite se liječniku ili ljekarniku.
English: Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway.
Croatian: Paradoksalni bronhospazam odgovara na brzodjelujući bronhodilatator i mora se odmah liječiti.
English: Co-administration with erythromycin was not associated with any serious adverse effects.
Croatian: Istodobna primjena s eritromicinom nije bila povezana ni s kakvim ozbiljnim nuspojavama.
English: These effects are much less likely to occur than with oral corticosteroids.
Croatian: Vjerojatnost nastanka tih učinaka puno je manja nego kod peroralnih kortikosteroida.
English: Do not stop or suddenly reduce your dose of Aerivio Spiromax.
Croatian: Nemojte prestati ili naglo smanjiti dozu Aerivio Spiromaxa.
English: If this happens stop using your Aerivio Spiromax inhaler.
Croatian: Ako se to dogodi, prestanite koristiti svoj Aerivio Spiromax inhalator.
English: The primary endpoint in SMART was the combined number of respiratory-related deaths and respiratory-related life-threatening experiences.
Croatian: Primarni ishod u ispitivanju SMART bio je kombinirani broj smrti povezanih s dišnim sustavom i životno ugrožavajući događaji povezani s dišnim sustavom.
English: It is important to inhale forcefully to ensure optimal dosing.
Croatian: Važno je snažno udahnuti kako bi se osiguralo optimalno doziranje.
English: <2D barcode carrying the unique identifier included.>]
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom.