FrancophonIA/ELRC3.0 huggingface dataset:
English: Median FEV1 at inclusion in the trials was 36% of predicted normal.
Croatian: Pri uključivanju u ispitivanja, medijan FEV1 bio je 36% od predviđene normale.
English: These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.
Croatian: Ti znakovi mogu značiti da astma ili KOPB kod Vas nisu adekvatno kontrolirani i da Vam je možda odmah potrebno drukčije ili dodatno liječenje.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti u svakoga.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updatespublished on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljisvosti za ovaj lijek usklađeni su s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim naknadnim izmjenama objavljenim na europskom internetskom portalu za lijekove.
English: There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Croatian: Postoje neki pokazatelji povećanog rizika od pneumonije s povećanjem doze steroida, ali to se nije uvjerljivo dokazalo u svim ispitivanjima.
English: Adults (18 years and older)
Croatian: Odrasli (s 18 godina i više)
English: • An increase in the amount of sugar (glucose) in your blood.
Croatian: • Povišena razina šećera (glukoze) u krvi.
English: Contact your doctor immediately as you may need to have your treatment changed.
Croatian: Odmah se javite svojem liječniku jer Vam može biti potrebna promjena liječenja.
English: • Disturbance of the heart's electrical system (prolongation of the QTc-interval).
Croatian: • Poremećaj električnog sustava srca (produljenje QTc-intervala)
English: Frequencies are defined as: very common (1/10), common (1/100, <1/10), uncommon (1/1,000, < 1/100), rare (1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The mechanisms of action of the two substances respectively are discussed below.
Croatian: O mehanizmima djelovanja dviju djelatnih tvari je više rečeno u dolje navedenom tekstu.
English: • Increased cough or increased breathing difficulties
Croatian: • pojačan kašalj ili otežano disanje
English: Sudden and progressive deterioration in control of asthma or COPD is potentially life-threatening and the patient should undergo urgent medical assessment.
Croatian: Iznenadno i progresivno pogoršanje kontrole astme ili KOPB-a potencijalno je opasno po život te bolesnik mora pristupiti hitnoj medicinskoj procjeni.
English: Remove your inhaler from your mouth.
Croatian: 6. Izvadite inhalator iz usta.
English: It is important that you take your dose as advised by your doctor.
Croatian: Važno je da svoju dozu uzimate prema naputku Vašeg liječnika.
English: A separate rapid-acting bronchodilator should be considered for such prophylactic use.
Croatian: Mora se razmotriti korištenje zasebnog brzodjelujućeg bronhodilatatora kod takve profilaktičke uporabe.
English: If patients find the treatment ineffective, or exceed the highest recommended dose of Budesonide/Formoterol Teva, medical attention must be sought (see section 4.2).
Croatian: Ako bolesnici smatraju liječenje neučinkovitim ili prekorače najvišu preporučenu dozu lijeka Budezonid/Formoterol Teva, moraju zatražiti liječničku pomoć (vidjeti dio 4.2).
English: Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Croatian: Simptomatsko liječenje bolesnika s teškom KOPB (FEV1 < 50% od predviđene normale) i anamnezom ponavljanih egzacerbacija, koji imaju značajne simptome unatoč redovnoj terapiji bronhodilatatorima dugog djelovanja.
English: Headache, tremor Dizziness Taste disturbances
Croatian: Glavobolja, tremor Omaglica Poremećaji okusa
English: What Budesonide/Formoterol Teva is and what it is used for
Croatian: Što je Budezonid/Formoterol Teva i za što se koristi
English: Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Croatian: Agresivnost, psihomotorna hiperaktivnost, anksioznost, poremećaji spavanja
English: You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Croatian: ste alergični na budezonid, formoterolfumarat dihidrat, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: In spite of this, a small increase in cortisol suppression was seen after administration of fixed-dose combination compared to the monoproducts.
Croatian: Usprkos tome, primijećeno je malo povećanje supresije kortizola nakon primjene kombinacije fiksne doze u usporedbi s monokomponentama.
English: How to take an inhalation
Croatian: Kako inhalirati
English: • Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
Croatian: • se pogorša Vaše disanje ili se noću često budite zbog nedostatka ili zviždanja u plućima.
English: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Croatian: Liječnici moraju pozorno pratiti mogući razvoj pneumonije u bolesnika s KOPB-om s obzirom da se kliničke manifestacije tih infekcija podudaraju sa simptomima egzacerbacije KOPB-a.
English: A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur.
Croatian: Na općenito insuficijentan glukokortikosteroidni učinak mora se posumnjati ako se, u rijetkim slučajevima, pojave simptomi poput umora, glavobolje, mučnine i povraćanja.
English: COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking.
Croatian: KOPB je dugotrajna bolest dišnih puteva u plućima, koja je često uzrokovana pušenjem cigareta.
English: If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use Budesonide/Formoterol Teva.
Croatian: Ako ste uzimali tablete steroida za astmu ili KOPB, Vaš liječnik može smanjiti broj tableta koje uzimate nakon što počnete koristiti Budezonid/Formoterol Teva.
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Croatian: Čimbenici rizika za pneumoniju u bolesnika s KOPB-om uključuju aktivne pušače, stariju dob, niski indeks tjelesne mase (BMI) i teški oblik KOPB-a.
English: • Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time.
Croatian: • Inhalirani kortikosteroidi mogu utjecati na normalno stvaranje steroidnih hormona u Vašem tijelu, posebice ako dulje vrijeme primjenjujete visoke doze.
English: • Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness.
Croatian: • Oticanje lica, posebice oko usta (jezik i/ili grlo i/ili otežano gutanje) ili koprivnjača u kombinaciji s otežanim disanjem (angioedem) i/ili iznenadni osjećaj nesvjestice.
English: Important information about your asthma or COPD symptoms
Croatian: Važne informacije o simptomima astme ili KOPB-a
English: Place the mouthpiece between your teeth.
Croatian: 4. Stavite nastavak za usta između zuba.
English: (budesonide/formoterol fumarate dihydrate)
Croatian: (budezonid/ formoterolfumarat dihidrat)
English: • Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm').
Croatian: • Iznenadno akutno zviždanje u plućima i/ili nedostatak zraka neposredno nakon primjene inhalatora (također se naziva 'paradoksalni bronhospazam').
English: Contains 1 inhaler.
Croatian: Sadrži 1 inhalator.
English: Use of your ‘reliever inhaler' should not exceed 8 inhalations (puffs) in any 24 hours and you should not use your ‘reliever inhaler' more often than every 4 hours.
Croatian: “Inhalator za brzo ublažavanje simptoma” ne smije se koristiti za više od 8 inhalacija (potisaka) u 24 sata i češće od svaka 4 sata.
English: For changes in lung-function parameters, such as FEV1, budesonide/formoterol was not superior to treatment with formoterol alone.
Croatian: Za promjene parametara plućne funkcije poput FEV1, liječenje kombinacijom budezonida/formoterola nije bilo superiornije od liječenja samo formoterolom.
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Croatian: Ne postoje uvjerljivi klinički dokazi o razlikama u veličini rizika za pneumoniju između pojedinih inhalacijskih kortikosteroida unutar te skupine.
English: Hold your breath for 10 seconds or as long as you comfortably can. 6.
Croatian: Zadržite dah 10 sekundi ili koliko god možete izdržati.
English: Recommended doses:
Croatian: Preporučene doze:
English: Before using your Budesonide/Formoterol Teva for the first time, you need to prepare it for use as follows:
Croatian: Prije prve primjene inhalatora Budezonid/Formoterol Teva, trebate ga pripremiti za primjenu na sljedeći način:
English: Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).
Croatian: Liječnik Vam je propisao ovaj lijek za liječenje astme ili kronične opstruktivne plućne bolesti (KOPB).
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva contains lactose')
Croatian: - Drugi sastojak je laktoza hidrat (pogledajte dio 2 pod „Budezonid/Formoterol Teva sadrži laktozu”)
English: When ketoconazole was administered 12 hours after budesonide the concentration was on average increased only three-fold showing that separation of the administration times can reduce the increase in plasma levels.
Croatian: Kad je ketokonazol bio primjenjen 12 sati nakon budezonida, koncentracija se povećala u prosjeku za samo tri puta, pokazujući da odvajanje vremena primjene može smanjiti povećanje razina u plazmi.
English: Do not use Budesonide/Formoterol Teva to treat these asthma symptoms.
Croatian: Nemojte koristiti Budezonid/Formoterol Teva za liječenje tih simptoma astme.
English: Pharmacodynamic interactions β adrenergic blockers can weaken or inhibit the effect of formoterol.
Croatian: Beta-adrenergički blokatori mogu oslabiti ili inhibirati učinak formoterola.
English: Budesonide/Formoterol Teva 320 mcg/9 mcg
Croatian: Budezonid/Formoterol Teva 320 mcg/9 mcg
English: The mean number of exacerbations per year (as defined above) was significantly reduced with budesonide/formoterol as compared with treatment with formoterol alone or placebo (mean rate 1.4 compared with 1.8-1.9 in the placebo/formoterol group).
Croatian: Srednja vrijednost broja egzacerbacija godišnje (prema gornjoj definiciji) bila je značajno smanjena pri liječenju kombinacijom budezonida/formoterola u usporedbi s liječenjem samo formoterolom ili placebom (srednja vrijednost stope 1,4 u usporedbi s 1,8-1,9 u skupini placebo/formoterol).
English: The mean PIFR achieved by patients with asthma or COPD was over 60L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Croatian: Srednja vrijednost PIFR postignuta u bolesnika s astmom ili KOPB-om bila je viša od 60 l/min, a to je brzina protoka pri kojoj je za oba ispitivana inhalatora poznato da su dostavljene usporedive količne lijeka u pluća.
English: Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles Angina pectoris.
Croatian: Srčane aritmije, npr. fibrilacija atrija, supraventrikularna tahikardija, ekstrasistole Angina pektoris.
English: If these effects occur, they are usually mild and usually disappear as you continue to use Budesonide/Formoterol Teva.
Croatian: Ako se ti učinci pojave, obično su blagi i nestanu kad nastavite s primjenom lijeka Budezonid/Formoterol Teva.
English: • Medicines for allergies or antihistamines (such as terfenadine).
Croatian: • lijekove za alergije ili antihistaminike poput terfenadina.
English: • Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β2 adrenoceptor agonists' or ‘bronchodilators'.
Croatian: • Formoterolfumarat dihidrat pripada skupini lijekova pod nazivom „dugodjelujući agonisti beta2adrenoceptora” ili „bronhodilatatori”.
English: Hypokalaemia Hyperglycaemia
Croatian: Hipokalemija Hiperglikemija
English: Recommended dose:
Croatian: Preporučena doza:
English: You should speak to your doctor if you are concerned as to whether you should continue to use Budesonide/Formoterol Teva.
Croatian: Trebate razgovarati sa svojim liječnikom ako Vas brine trebate li nastaviti s uzimanjem inhalatora Budezonid/Formoterol Teva.
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 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 ispitivanja upućuju da neovisno o dobi i težini postojeće bolesti, djeca, adolescenti i odrasli s astmom kao i bolesnici s KOPB-om su mogli postići brzine inspiratornog protoka kroz inhalator Spiromax slične onima postignutim kroz na tržištu dostupan inhalator koji sadrži više doza suhog praška.
English: Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction
Croatian: Neposredne i odgođene reakcije preosjetljivosti, npr. egzantem, urtikarija, svrbež, dermatitis, angioedem i anafilaktička reakcija
English: The prophylactic use of Budesonide/Formoterol Teva , e.g. before exercise, has not been studied.
Croatian: Profilaktična uporaba lijeka Budezonid/Formoterol Teva, npr. prije vježbanja, nije ispitana.
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full.
Croatian: • Indikator doze upućuje Vas koliko doza (inhalacija) je još preostalo u Vašem inhalatoru, počevši od 60 inhalacija kad je pun.
English: Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Croatian: Hipokalemija može povećati sklonost aritmijama u bolesnika koji se liječe glikozidima digitalisa.
English: Chronic obstructive pulmonary disease (COPD)
Croatian: Kronična opstruktivna plućna bolest (KOPB)
English: In usual practice when control of symptoms is achieved with the twice daily dose regimen with a lower strength product, titration to a lower effective dose could include once daily dosing when, in the opinion of the prescriber, a long-acting bronchodilator is required to maintain control rather than treatment with an inhaled corticosteroid alone.
Croatian: U uobičajenoj praksi kad se kontrola simptoma postiže doziranjem dvaput dnevno s nižom jačinom lijeka, titracija na nižu učinkovitu dozu može uključiti doziranje jedanput dnevno, radije nego liječenje samim inhalacijskim kortikosteroidom , kada je po mišljenju liječnika koji propisuje lijek, za održavanje kontrole bolesti potreban bronhodilatator dugog djelovanja.
English: A fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate should therefore not be given together with β adrenergic blockers (including eye drops) unless there are compelling reasons.
Croatian: Terapija kombinacijom fiksne doze budezonida i formoterolfumarat dihidrata se stoga ne smije davati zajedno s betaadrenergičkim blokatorima (uključujući kapi za oči) osim ako za to ne postoje jako uvjerljivi razlozi.
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full.
Croatian: • Indikator doze upućuje Vas koliko doza (inhalacija) je još preostalo u Vašem inhalatoru, počevši od 120 inhalacija kad je pun.
English: This dose will be securely held inside the inhaler for when the next inhalation is due.
Croatian: Ta će se doza zadržati na sigurnom unutar inhalatora za primjenu u
English: To treat your asthma your doctor will prescribe two asthma inhalers: Budesonide/Formoterol Teva together with a separate ‘reliever inhaler' such as salbutamol.
Croatian: Za liječenje astme liječnik će Vam propisati dva inhalatora za astmu: Budezonid/Formoterol Teva i zasebni „inhalator za brzo ublažavanje simptoma” poput salbutamola.
English: In a 3-year clinical trial with budesonide in COPD, skin bruises and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p<0.001 and p<0.01, respectively).
Croatian: U trogodišnjem kliničkom ispitivanju budezonida u liječenju KOPB-a, stvaranje modrica na koži i pneumonija pojavljivali su se s učestalošću od 10%, odnosno 6% u usporedbi s placebo skupinom gdje su se javljale s učestalošću od 4%, odnosno 3% u (p<0,001 odnosno p<0,01).
English: Pneumonia in patients with COPD
Croatian: Pneumonija u bolesnika s KOPB-om
English: This medicine should not be used in children or adolescents under the age of 18 years.
Croatian: Ovaj lijek ne smiju koristiti djeca ili adolescenti mlađi od 18 godina.
English: Budesonide/Formoterol Teva can also be used to treat the symptoms of severe COPD in adults.
Croatian: Teva također se može koristiti za liječenje simptoma teškog KOPB-a u odraslih.
English: In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
Croatian: U farmakokinetičkim ispitivanjima sa i bez blokade aktivnim ugljenom, Budezonid/Formoterol Teva procijenjen je usporedbom sa drugim odobrenim inhalacijskim lijekom koji sadrži kombinaciju fiksne doze istih djelatnih tvari, budezonida i formoterola, te se pokazalo kako je jednak i u smislu sistemske izloženosti (sigurnost) i odlaganja u plućima (učinkovitost).
English: • Fever or chills
Croatian: • vrućica ili zimica
English: Budesonide/Formoterol Teva is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Croatian: Teva nije indiciran u djece i adolescenata u dobi manjoj od 18 godina starosti (vidjeti dio 4.2).
English: Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus.
Croatian: Simptomi uključuju nedostatak zraka, kašalj, nelagodu u prsima i iskašljavanje sluzi.
English: • If you get pregnant while using Budesonide/Formoterol Teva, do NOT stop using Budesonide/Formoterol Teva but talk to your doctor immediately.
Croatian: • Ako zatrudnite tijekom uzimanja lijeka Budezonid/Formoterol Teva, NEMOJTE prestati s primjenom lijeka Budezonid/Formoterol Teva, ali se odmah javite svojem liječniku.
English: • It is important to use Budesonide/Formoterol Teva every day, even if you have no asthma or COPD symptoms at the time.
Croatian: Teva svakodnevno, čak i ako trenutno nemate simptome astme ili KOPB-a.
English: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Croatian: Jedna doza sadrži oko 10 miligrama laktoze (u obliku hidrata).
English: 1 inhalation (actuation), twice a day.
Croatian: 1 inhalacija (potisak), dvaput dnevno.
English: Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting.
Croatian: U izoliranim slučajevima prijavljeni simptomi su tahikardija, hiperglikemija, hipokalemija, produljeni QTc-interval, aritmija, mučnina i povraćanje.
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Budesonide/Formoterol Teva .
Croatian: Bolesnike treba savjetovati da nastave liječenje, ali da zatraže savjet liječnika ako simptomi astme ostanu nekontrolirani ili se pogoršaju nakon početka primjene lijeka Budezonid/Formoterol Teva.
English: Inhalation powder 1 inhaler containing 60 doses.
Croatian: Prašak inhalata 1 inhalator sa 60 doza.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićnokoštanog i vezivnog tkiva
English: COPD Recommended doses:
Croatian: KOPB Preporučene doze:
English: If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
Croatian: Ako je nekom bolesniku nužna drukčija kombinacija doza u odnosu na one dostupne u kombiniranom inhalatoru, moraju mu se propisati odgovarajuće doze β2 adrenoceptorskih agonista i/ili kortikosteroida u pojedinačnim inhalatorima.
English: Budesonide/Formoterol Teva contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Croatian: Teva sadrži formoterol i budezonid koji imaju različite mehanizme djelovanja i pokazuju aditivne učinke u smislu smanjenja egzacerbacija astme.
English: Other medicines and Budesonide/Formoterol Teva
Croatian: Drugi lijekovi i Budezonid/Formoterol Teva
English: Inhalation powder 1 inhaler containing 120 doses.
Croatian: Prašak inhalata 1 inhalator sa 120 doza.
English: If the patient experiences paradoxical bronchopasm Budesonide/Formoterol Teva should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Croatian: Ako bolesnik osjeti paradoksalni bronhospazam, Budezonid/Formoterol Teva se mora trenutno prekinuti, bolesnika se mora pregledati,te po potrebi, treba uvesti zamjensku terapiju.
English: The inhaler is made of acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT) , and polypropylene (PP).
Croatian: . Dijelovi inhalera kod kojih dolazi do dodira lijeka sa sluznicom napravljeni su od akrilonitril butadien stirena (ABS), polietilena (PE) i polipropilena (PP).
English: Candida infections in the oropharynx, pneumonia (in COPD patients)
Croatian: Kandidijaza orofarinksa, pneumonija (u bolesnika s KOPB-om)
English: Possible systemic effects include Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see section 4.8).
Croatian: Mogući sistemski učinci uključuju Cushingov sindrom, Cushingoidna obilježja, adrenalnu supresiju, zastoj u rastu djece i adolescenata, smanjenje mineralne gustoće kostiju, kataraktu i glaukom, i rjeđe niz psiholoških učinaka ili učinaka na ponašanje uključujući psihomotornu hiperaktivnost, poremećaje spavanja, anksioznost, depresiju ili agresivnost (pogotovo u djece) (vidjeti dio 4.8).