FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you notice any of the following symptoms while taking Aerivio Spiromax as they could be symptoms of a lung infection: fever or chills; increased mucus production, changes in mucus colour; increased cough or increased breathing difficulties.
Croatian: Obavijestite liječnika ako primijetite neki od sljedećih simptoma dok uzimate Aerivio Spiromax jer to mogu biti simptomi plućne infekcije: vrućica ili zimice; pojačano stvaranje sluzi, promjena boje sluzi; pojačan kašalj ili pojačane tegobe s disanjem.
English: • Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.
Croatian: • Flutikazonpropionat je kortikosteroid koji smanjuje otečenost i nadraženost u plućima.
English: • Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin).
Croatian: • lijekove za liječenje infekcija (kao što su ritonavir, ketokonazol, itraconazol i eritromicin).
English: The main part of the dose is excreted in faeces as metabolites and unchanged drug.
Croatian: Glavni dio doze izluči se stolicom u obliku metabolita i nepromijenjenog lijeka.
English: • Low levels of sugar in your blood
Croatian: • niske razine šećera u krvi
English: • Aerivio Spiromax should be inhaled through the mouth into the lungs.
Croatian: • Aerivio Spiromax treba udahnuti u pluća kroz usta.
English: • Inflammation of sinuses (sinusitis, a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache).
Croatian: • upala sinusa (sinusitis, osjećaj pritiska i punoće u nosu, obrazima i iza očiju, ponekad s pulsirajućim
English: Each Aerivio Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent yellow
Croatian: Jedan Aerivio Spiromax inhalator sadrži 60 udaha i ima bijelo tijelo s poluprozirnim žutim poklopcem
English: If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed
Croatian: Ako pojednom bolesniku bude potrebna doza izvan preporučenog režima doziranja, treba propisati odgovarajuće doze β2 agonista i/ili kortikosteroida.
English: Concomitant use of systemic ketoconazole significantly increases systemic exposure to salmeterol.
Croatian: Istodobna primjena sistemskog ketokonazola značajno povećava sistemsku izloženost salmeterolu.
English: There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all
Croatian: Ima dokaza koji ukazuju na povećanje rizika od pneumonije s povećanjem doze steroida, ali na temelju dokaza o tome se ne može donijeti konačan zaključak
English: When stabilised, treatment should be continued with an inhaled corticosteroid at the recommended dose.
Croatian: Nakon stabilizacije, liječenje treba nastaviti inhalacijskim kortikosteroidom u preporučenoj dozi.
English: Percentage of Patients Attaining *Well Controlled (WC) and **Totally Controlled (TC) Asthma over
Croatian: Postotak bolesnika koji su postigli *dobru kontrolu (DK) i **potpunu kontrolu (PK) astme tijekom
English: This is because using too much Aerivio Spiromax may reduce the amount of steroid hormones produced by your adrenal glands.
Croatian: To je zato što uzimanje previše Aerivio Spiromaxa može smanjiti količinu steroidnih hormona koje stvaraju
English: There were no other differences in safety profile between the treatment arms.
Croatian: Nije bilo drugih razlika u sigurnosnom profilu između terapijskih skupina.
English: See leaflet for further information
Croatian: Pogledajte uputu za dodatne informacije.
English: Open the mouthpiece cover by folding it down until you hear one loud click.
Croatian: Odmaknite poklopac nastavka za usta tako što ćete ga zakretati prema dolje sve dok ne začujete glasni škljocaj.
English: • Do not stop taking Aerivio Spiromax or reduce the dose of Aerivio Spiromax without talking to your doctor first.
Croatian: • Nemojte prestati uzimati Aerivio Spiromax ili smanjiti dozu Aerivio Spiromaxa a da o tome prvo niste razgovarali sa svojim liječnikom.
English: Remove the Spiromax device from the mouth and hold the breath for 10 seconds or as long as comfortable for the patients.
Croatian: Izvadite Spiromax iz usta i zadržite dah na 10 sekundi ili onoliko
English: The disposition of fluticasone propionate is characterised by high plasma clearance (1150 mL/min), a large volume of distribution at steady-state (approximately 300 L) and a terminal half-life of approximately 8 hours.
Croatian: Raspoloživost flutikazonpropionata obilježena je visokim klirensom plazme (1150 ml/min), velikim volumenom distribucije u stanju dinamičke ravnoteže (približno 300 l) i terminalnim poluvijekom od približno 8 sati.
English: Chronic overdose: Adrenal reserve should be monitored and treatment with a systemic corticosteroid may be necessary.
Croatian: Kronično predoziranje: Potrebno je pratiti adrenalnu rezervu i može biti nužno liječenje sistemskim kortikosteroidima.
English: What Aerivio Spiromax is and what it is used for
Croatian: Što je Aerivio Spiromax i za što se koristi
English: • Do not use this medicine after the expiry date which is stated on the carton and the label of your inhaler after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici inhalatora iza oznake „Rok valjanosti” i „EXP”.
English: Two children on salmeterol/fluticasone propionate and 5 children on fluticasone propionate withdrew because of worsening asthma.
Croatian: Dvoje djece koje je primalo salmeterol/ flutikazonpropionat i 5 djece koja su primala flutikazonpropionat povuklo se iz ispitivanja zbog pogoršanja astme.
English: Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Aerivio Spiromax.
Croatian: Alergijske reakcije: možete opaziti naglo pogoršanje disanja neposredno nakon uzimanja Aerivio Spiromaxa.
English: Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma.
Croatian: Liječnik će Vam pomoći u liječnju astme i prilagodit će dozu ovog lijeka na najnižu dozu kojom se kontrolira Vaša astma.
English: Patients were enrolled if ≥12 years of age, with asthma and if currently using asthma medication (but not a LABA).
Croatian: ≥12 godina, s astmom i ako su trenutno uzimali lijek protiv astme (ali ne LABA - engl.
English: If you get any of these effects or if they happen suddenly after using Aerivio Spiromax, stop using Aerivio Spiromax and tell your doctor straight away.
Croatian: Ako primijetite neki od ovih učinaka ili ako se iznenada pojave nakon primjene Aerivio Spiromaxa, prestanite primjenjivati Aerivio Spiromax i odmah obavijestite liječnika.
English: If Aerivio Spiromax therapy has to be withdrawn due to overdose of the β agonist component of the medicinal product, provision of appropriate replacement steroid therapy should be considered.
Croatian: Ako se terapija Aerivio Spiromaxom mora obustaviti zbog predoziranja komponentom β agonista u ovom lijeku, potrebno je razmotriti davanje odgovarajuće zamjenske steroidne terapije.
English: In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%.
Croatian: U malom ispitivanju u zdravih dobrovoljaca, malo manje jak inhibitor CYP3A, ketokonazol, povećao je izloženost flutikazonpropionatu nakon jedne inhalacije za 150%.
English: This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see section 4.4).
Croatian: To može dovesti do značajnog povećanja incidencije drugih sistemskih učinaka liječenja salmeterolom (npr. produljenja QTc intervala i palpitacije) u usporedbi s liječenjem samo salmeterolom ili samo ketokonazolom (vidjeti dio 4.4).
English: Also sore tongue and hoarse voice and throat irritation.
Croatian: Također bolan jezik, promukao glas i nadraženost grla.
English: If you have used too many doses of Aerivio Spiromax for a long time, you should talk to your doctor or pharmacist for advice.
Croatian: Ako ste uzimali previše doza Aerivio Spiromaxa tijekom duljeg razdoblja, obratite se liječniku ili ljekarniku za savjet.
English: A decision must be made whether to discontinue breastfeeding or to discontinue Aerivio Spiromax therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Aerivio Spiromax uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: This medicine should not be used in children or adolescents under the age of 18 years.
Croatian: Ovaj se lijek ne smije primjenjivati u djece ili adolescenata mlađih od 18 godina.
English: Severe asthma in adults 18 years of age and older
Croatian: Teška astma u odraslih u dobi od 18 godina i starijih
English: If you open and close the mouthpiece without taking an inhalation the dose will be securely held inside the inhaler ready for the next inhalation.
Croatian: Ako otvorite i zatvorite poklopac nastavka za usta bez udisanja, doza će sigurno ostati unutar inhalatora spremna za sljedeći udah.
English: You must use Aerivio Spiromax every day as directed by your doctor.
Croatian: Aerivio Spiromax morate koristiti svaki dan prema uputama Vašeg liječnika.
English: Patients are not required to shake the inhaler prior to use.
Croatian: Nije potrebno da bolesnici protresaju inhalator prije uporabe.
English: If you have not received this training please ask your doctor, nurse or pharmacist to show you how to use your inhaler properly before you use it for the first time.
Croatian: Ako Vas nisu podučili, molimo Vas da se obratite liječniku, medicinskoj sestri ili ljekarniku prije nego što prvi put primjenite svoj inhalator tako da Vam mogu pokazati kako ga
English: • Breathing difficulties or wheezing that gets worse straight after taking Aerivio Spiromax.
Croatian: • tegobe s disanjem ili piskanje pri disanju koje se pogorša neposredno nakon uzimanja Aerivio Spiromaxa.
English: • Pneumonia and bronchitis (lung infection).
Croatian: • upala pluća i bronhitis (plućna infekcija).
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Croatian: Dozu treba titrirati na najnižu dozu kojom se održava učinkovita kontrola simptoma.
English: It should not be used to treat acute asthma symptoms for which a fast- and short-acting bronchodilator is required.
Croatian: Ne smije se primjenjivati za liječenje akutnih simptoma astme za koje je potreban brzo- i kratkodjelujući brohnodilatator.
English: The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4.
Croatian: Glavni put je metabolizam do nedjelatnog metabolita karboksilne kiseline, putem enzima CYP3A4 citokroma P450.
English: This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered.
Croatian: Mogućnost rezidualnog smanjenja adrenalne rezerve uvijek treba imati na umu u hitnim i elektivnim situacijama koje će vjerojatno izazvati stres pa se mora razmotriti odgovarajuće kortikosteroidno liječenje.
English: The use of concurrent inhaled long-acting β2 agonists and anticholinergic drugs, salbutamol/ipratropium bromide combination products, oral β2 agonists and theophylline preparations were not allowed during the treatment period.
Croatian: Istodobna primjena inhalacijskih dugodjelujućih β2 agonista i antikolinergičkih lijekova, kombiniranih lijekova salbutamol/ipratropij bromid, peroralnih β2 agonista i preparata teofilina nije bila dopuštena tijekom razdoblja liječenja.
English: • Feeling shaky (tremor) and fast or uneven heart beat (palpitations) - these are usually harmless and get
Croatian: • osjećaj drhtanja (tremor) i ubrzan ili neujednačeni otkucaji srca (palpitacije) - to je obično bezopasno i smanjuje se s nastavkom liječenja.
English: The only safety concerns for human use derived from animal studies of salmeterol and fluticasone propionate given separately were effects associated with exaggerated pharmacological actions.
Croatian: Jedini razlog za zabrinutost oko sigurnosti primjene u ljudi proizašao iz ispitivanja zasebno primjenjivanih salmeterola i flutikazonpropionata na životinjama bili su učinci povezani s pretjeranim farmakološkim
English: • Chronic obstructive pulmonary disease (COPD), to reduce the number of flare ups of symptoms.
Croatian: • kronične opstruktivne plućne bolesti (KOPB), da se smanji broj razbuktavanja simptoma.
English: • Use your Aerivio Spiromax every day until your doctor advises you to stop.
Croatian: • Primjenjujte svoj Aerivio Spiromax svaki dan dok Vam liječnik ne kaže da prestanete.
English: The studies described below (GOAL, TORCH and SMART) were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product; the studies described were not carried out with Aerivio Spiromax.
Croatian: Niže opisana ispitivanja (GOAL, TORCH i SMART) provedena su s ovom istom fiksnom kombinacijom salmeterolksinafoata i flutikazonpropionata, ali su ispitivala prethodno odobren lijek; opisana ispitivanja nisu bila provedena s Aerivio Spiromaxom.
English: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored.
Croatian: Preporučuje se redovito pratiti visinu djece koja primaju produljeno liječenje inhalacijskim kortikosteroidima.
English: There is likely to be a similar risk of interaction with other potent CYP3A4 inhibitors (e.g. itraconazole, telithromycin, ritonavir).
Croatian: Vjerojatno postoji sličan rizik od interakcija s drugim jakim inhibitorima CYP3A4 (npr. itrakonazolom, telitromicinom, ritonavirom).
English: Each dose contains approximately 10 milligrams of lactose (as monohydrate).
Croatian: Jedna doza sadrži približno 10 miligrama laktoze (u obliku hidrata).
English: There are no data available from clinical trials on overdose with Aerivio Spiromax, however data on overdose with both active substances are given below:
Croatian: Nema dostupnih podataka iz kliničkih ispitivanja o predoziranju Aerivio Spiromaxom; međutim, podaci o predoziranju objema djelatnim tvarima navedeni su niže:
English: 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to <1/1000) and not known (frequency cannot be estimated from the available data).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥1/10), često (1/100 i 1/10), manje često (1/1000 i 1/100), rijetko (1/10 000 i <1/1000) i nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
English: • Depression or aggression (although these effects are more likely to occur in children when prescribed this combination of drugs but in a lower strength).
Croatian: • depresija ili agresivnost (iako će ovi učinci vjerojatnije nastati u djece kad im se propisuje ova kombinacija lijekova premda u nižoj dozi)
English: • A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle
Croatian: • sniženje količine kalija u krvi (možete imati neujednačene otkucaje srca , mišićnu slabost, grčeve).
English: Health Related Quality of Life, as measured by the St George's Respiratory Questionnaire (SGRQ) was improved by all active treatments in comparison with placebo.
Croatian: St. George's Respiratory Questionnaire - SGRQ), poboljšala su sva aktivna liječenja u usporedbi s placebom.
English: The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma as well as patients with COPD were able to achieve inspiratory flow rates through the Spiromax device that were similar to those generated through the marketed multi-dose dry powder inhaler device.
Croatian: Podaci iz tog ispitivanja pokazali su da su, bez obzira na dob i težinu osnovne bolesti, djeca, adolescenti i odrasli s astmom, kao i bolesnici s KOPB-om, bili u stanju postići brzine inspiratornog protoka kroz inhalator Spiromax koje su bile slične onima postignutima kroz tržišno dostupan multidozni inhalator sa suhim praškom.
English: For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by
Croatian: I u bolesnika s KOPB-om prestanak terapije može biti povezan sa simptomatskom dekompenzacijom i treba se provesti pod
English: Česká republika Teva Pharmaceuticals CR, s.r.o.
Croatian: Teva Pharmaceuticals CR, s.r.o.
English: There was no increase in pneumonia related deaths; deaths while on treatment that were adjudicated as primarily due to pneumonia were 7 for placebo, 9 for salmeterol, 13 for FP and 8 for salmeterol/fluticasone propionate.
Croatian: Broj smrti povezanih s pneumonijom nije bio povećan; broj smrti za vrijeme liječenja koje su bile pripisane prvenstveno pneumoniji iznosio je 7 za placebo, 9 za salmeterol, 13 za FP i 8 za salmeterol/flutikazonpropionat.
English: If necessary you may wipe the mouthpiece of your inhaler after use with a dry cloth or tissue.
Croatian: Po potrebi, možete obrisati nastavak za usta inhalatora nakon uporabe suhom krpicom ili ubrusom.
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Aerivio Spiromax.
Croatian: Bolesnicima treba savjetovati da nastave s liječenjem, ali da potraže liječnički savjet ako simptomi astme i dalje budu nekontrolirani ili se pogoršaju nakon uvođenja liječenja Aerivio Spiromaxom.
English: In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations).
Croatian: Reproduktivna ispitivanja na životinjama pokazala su da glukokortikosteroidi izazivaju malformacije (rascjep nepca, malformacije kostura).
English: The signs and symptoms of salmeterol overdose are dizziness, increases in systolic blood pressure, tremor, headache and tachycardia.
Croatian: Znakovi i simptomi predoziranja salmeterolom su omaglica, povećanje sistoličkog krvnog tlaka, tremor, glavobolja i tahikardija.
English: Acute: Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function.
Croatian: Akutno: Akutna inhalacija doza flutikazonpropionata koje su veće od preporučenih može dovesti do privremene supresije funkcije nadbubrežnih žlijezdea
English: The results of this study suggest that salmeterol/fluticasone propionate 50/100 micrograms twice daily may be considered as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is deemed essential (see section 4.2).
Croatian: Rezultati ovog ispitivanja pokazuju da se salmeterol/flutikazonpropionat u dozi od 50/100 mikrograma dvaput dnevno može razmatrati kao početna terapija održavanja u bolesnika s umjerenom perzistentnom astmom u kojih se brza kontrola astme smatra neophodnom (vidjeti dio 4.2).
English: • Very fast heart beat (tachycardia).
Croatian: • jako ubrzani otkucaji srca (tahikardija)
English: In a 12-week trial of children 4 to 11 years of age [n=203] randomized in a parallel-group study with persistent asthma and who were symptomatic on inhaled corticosteroid, safety was the primary objective.
Croatian: U 12-tjednom ispitivanju u djece u dobi od 4 do 11 godina [n=203] randomizirane u usporedne skupine koja su imala perzistentnu astmu i simptome uz terapiju inhalacijskim kortikosteroidima, primarni je cilj bila sigurost primjene.
English: If you open and close the mouthpiece without taking an inhalation the dose indicator will still register it as a count.
Croatian: Ako otvorite i zatvorite poklopac nastavka za usta bez udisanja, pokazatelj doza će ipak to registrirati kao jedan udah.
English: Open: Hold the Spiromax with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when one click is heard.
Croatian: Otvaranje: Držite Spiromax tako da nastavak za usta s poklopcem bude dolje pa odmaknite poklopac nastavka za usta tako što ćete poklopac zakrenuti prema dolje sve dok ne bude potpuno otvoren, kada će se
English: There is also an increased risk of systemic undesirable effects when combining fluticasone propionate with other potent CYP3A inhibitors (see section 4.5).
Croatian: Povećan rizik od sistemskih nuspojava postoji i kad se flutikazonpropionat kombinira s drugim jakim inhibitorima CYP3A (vidjeti dio 4.5).
English: The remainder of the inhaled dose of fluticasone propionate may be swallowed but contributes minimally to systemic exposure due to the low aqueous solubility and presystemic metabolism, resulting in oral availability of less than 1%.
Croatian: Preostala udahnuta doza flutikazonpropionata može biti progutana, no minimalno pridonosi sistemskoj izloženosti zbog male topljivosti u vodi i presistemskog metabolizma, što rezultira peroralnom raspoloživošću manjom od 1%.
English: Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist with a long side chain which binds to
Croatian: Salmeterol je selektivni dugodjelujući (12 sati) agonist β2 adrenoceptora s dugim postraničnim lancem kojim se veže za egzo-mjesto na receptoru.
English: Cases of Cushing's syndrome and adrenal suppression have been reported.
Croatian: Zabilježeni su slučajevi Cushingovog sindroma i supresije nadbubrežnih žlijezda.
English: The trials had a 4 week run-in period during which all subjects received open-label salmeterol/FP 50/250 to standardize COPD pharmacotherapy and stabilise disease prior to randomisation to blinded study medication for 52 weeks.
Croatian: Ta su ispitivanja imala uvodno razdoblje od 4 tjedna tijekom kojeg su svi ispitanici na otvoreni način primali salmeterol/FP 50/250 radi standardizacije farmakoterapije KOPB-a i stabilizacije bolesti prije randomizacije na maskirani ispitivani lijek tijekom 52 tjedna.
English: Clinically significant effects were not seen on blood pressure, heart rate, blood glucose and blood potassium levels.
Croatian: Nisu bili opaženi klinički značajni učinci na krvni tlak, frekvenciju srca, glukozu u krvi i razine kalija u krvi.
English: Additionally, hypokalaemia can occur and therefore serum potassium levels should be monitored.
Croatian: Uz to, može nastati hipokalijemija pa je stoga potrebno pratiti razine kalija u serumu.
English: Patients should not block the air vents at any time, or breathe out through the Spiromax device when they are preparing the “Breathe” step.
Croatian: Bolesnici ni u kojem trenutku ne smiju zatvoriti otvore za zrak niti izdisati kroz Spiromax kad se pripremaju za korak „Udisanje”.
English: Oral corticosteroids and antibiotics were allowed for the acute treatment of COPD exacerbations with specific guidelines for use.
Croatian: Peroralni kortikosteroidi i antibiotici bili su dopušteni za akutno liječenje egzacerbacija KOPB-a s posebnim smjernicama za primjenu.
English: Aerivio Spiromax is not intended as the treatment of asthma when a fixed-dose combination of salmeterol and fluticasone propionate is required for the first time.
Croatian: Aerivio Spiromax nije namijenjen za liječenje astme kada se prvi put pokaže da je potrebna fiksna kombinacija salmeterola i flutikazon propionata.
English: Patients should be regularly reassessed by a doctor, so that the strength of the salmeterol/fluticasone propionate inhaler they are receiving remains optimal and is only changed on medical advice.
Croatian: Liječnik treba redovito pregledavati bolesnike kako bi doza salmeterola/flutikazonpropionata koju primaju iz inhalatora bila optimalna i mijenjana samo na liječnički savjet.
English: However, animal studies showed no effects of salmeterol or fluticasone
Croatian: Međutim, ispitivanja na životinjama nisu pokazala da salmeterol ili flutikazonpropionat utječu na plodnost.