FrancophonIA/ELRC3.0 huggingface dataset:
English: During transfer from oral therapy to a budesonide/formoterol fumarate fixed-dose combination therapy, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain.
Croatian: Za vrijeme prijelaza s oralne terapije na kombiniranu terapiju fiksnom dozom budezonid/ formoterolfumarata, doći će do općenito sniženog sistemskog djelovanja steroida, što može rezultirati pojavom simptoma alergije ili artritisa, poput rinitisa, ekcema i bolova u mišićima i zglobovima.
English: You should speak to your doctor if you are concerned as to whether you should continue to use Budesonide/Formoterol Teva Pharma B.V.
Croatian: Trebate razgovarati sa svojim liječnikom ako Vas brine trebate li nastaviti s uzimanjem inhalatora Budezonid/Formoterol Teva Pharma B.V.
English: Palpitations
Croatian: Palpitacije
English: A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years), and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Croatian: Randomizirano, otvoreno ispitivanje s placebom provedeno je na djeci i adolescentima s astmom (u dobi od 6-17 godina), odraslima s astmom (u dobi od 18- 45 godina) i zdravim dobrovoljcima (u dobi od 18-45 godina) za procjenu brzine vršnog inspiratornog protoka (eng. peak inspiratory flow rate, PIFR) i drugih povezanih inhalacijskih parametara nakon inhalacije iz inhalatora Spiromax (koji sadrži placebo), u usporedbi s inhalacijom iz već na tržištu dostupnog inhalatora s više doza suhog praška
English: • Use within 6 months of removing from the foil wrapping.
Croatian: • Upotrijebite unutar 6 mjeseci nakon vađenja iz folije.
English: Patients should be advised to have their rescue inhaler available at all times.
Croatian: Bolesnicima se mora savjetovati da uvijek imaju kod sebe inhalator za hitno simptomatsko liječenje dostupan u svako doba.
English: Budesonide
Croatian: Budezonid
English: Inhalation powder.
Croatian: Prašak inhalata.
English: Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Croatian: Svaki inhalator Budezonid/Formoterol Teva Pharma B.V. sadrži 60 inhalacija i ima bijelo tijelo s poluprozirnim poklopcem nastavka za usta boje crvenog vina.
English: It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.
Croatian: Preporučuje se postupno smanjivanje doze pri prekidu liječenja.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog i vezivnog tkiva
English: These effects are much less likely to occur than with oral corticosteroids.
Croatian: Mnogo je manja vjerojatnost pojave tih učinaka nego uz oralne kortikosteroide.
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: 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).
English: The pharmacokinetics of budesonide or formoterol in children and patients with renal failure are unknown.
Croatian: Farmakokinetika budezonida ili formoterola u djece i bolesnika sa zatajenjem bubrega nije poznata.
English: • you have a lung infection.
Croatian: • imate infekciju pluća.
English: Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Croatian: Svaki inhalator Budezonid/Formoterol Teva Pharma B.V. sadrži 120 inhalacija i ima bijelo tijelo s poluprozirnim poklopcem nastavka za usta boje crvenog vina.
English: Talk to your doctor,pharmacist or nurse before taking Budesonide/Formoterol Teva Pharma B.V. if
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Budezonid/Formoterol Teva Pharma B.V. ako:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/950/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/950/001
English: • Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide and procainamide).
Croatian: • lijekove za liječenje ubrzanih ili neravnomjernih otkucaja srca (poput kinidina, dizopiramida i prokainamida).
English: Always keep your ‘reliever inhaler' with you and use it to relieve sudden attacks of breathlessness and wheezing.
Croatian: Uvijek imajte pri ruci „inhalator za brzo ublažavanje simptoma” i primjenjujte ga za ublažavanje iznenadnih napadaja nedostatka zraka i zviždanja u plućima.
English: Budesonide/Formoterol Teva Pharma B.V. has no or negligible influence on the ability to drive and use machines.
Croatian: Budezonid/Formoterol Teva Pharma B.V. ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Before using your Budesonide/Formoterol Teva Pharma B.V. for the first time, you need to prepare it for use as follows:
Croatian: Prije prve primjene inhalatora Budezonid/Formoterol Teva Pharma B.V., trebate ga pripremiti za primjenu na sljedeći način:
English: What Budesonide/Formoterol Teva Pharma B.V. looks like and contents of the pack Budesonide/Formoterol Teva Pharma B.V. is an inhalation powder.
Croatian: Kako Budezonid/Formoterol Teva Pharma B.V. izgleda i sadržaj pakiranja Budezonid/Formoterol Teva Pharma B.V. je prašak inhalata.
English: Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms should be used as maintenance therapy only.
Croatian: Budezonid/Formoterol Teva Pharma B.V. od 320 mikrograma/9 mikrograma treba koristiti samo kao terapiju održavanja.
English: If you have been taking steroid tablets for your asthma, your doctor may reduce the number of tablets that you take, once you start to use Budesonide/Formoterol Teva Pharma B.V.
Croatian: Ako ste uzimali tablete steroida za astmu, Vaš liječnik može smanjiti broj tableta koje uzimate nakon što počnete koristiti Budezonid/Formoterol Teva Pharma B.V.
English: If the patient experiences paradoxical bronchopasm Budesonide/Formoterol Teva Pharma B.V. 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 Pharma B.V. se mora trenutno prekinuti, bolesnika se mora pregledati, te po potrebi, treba uvesti zamjensku terapiju.
English: Patients with renal or hepatic impairment
Croatian: Bolesnici s oštećenjem bubrega ili jetre
English: To treat your asthma your doctor will prescribe two asthma inhalers: Budesonide/Formoterol Teva Pharma B.V. together with a separate ‘reliever inhaler' such as salbutamol.
Croatian: Za liječenje astme liječnik će Vam propisati dva inhalatora za astmu: Budezonid/Formoterol Teva Pharma B.V. i zasebni „inhalator za brzo ublažavanje simptoma” poput salbutamola.
English: Some patients may require up to a maximum of 2 inhalations twice daily.
Croatian: Nekim bolesnicima može biti potrebno do najviše 2 inhalacije dvaput dnevno.
English: In two 12-week studies the effect on lung function of budesonide/formoterol was equal to that of the free combination of budesonide and formoterol, and exceeded that of budesonide alone.
Croatian: U dva ispitivanja u trajanju od 12 tjedana učinak kombinacije budezonida/formoterola na funkciju pluća bio je istovjetan onom slobodne kombinacije budezonida i formoterola, te se pokazao većim od učinka samog budezonida.
English: Patients should be advised to have their separate rapid-acting bronchodilator reliever inhaler available for rescue use at all times.
Croatian: Bolesnike se mora savjetovati da uvijek imaju kod sebe zasebni brzodjelujući bronhodilatator za hitno simptomatsko liječenje u svakom trenutku.
English: Use the product within 6 months of removing from foil wrapping.
Croatian: Lijek upotrijebite u roku od 6 mjeseci nakon vađenja iz folije.
English: Your doctor may increase this to 4 inhalations, twice a day.
Croatian: Vaš liječnik može povećati dozu na 4 inhalacije, dvaput dnevno.
English: Some patients may require up to a maximum of 4 inhalations twice daily.
Croatian: Nekim bolesnicima može biti potrebno do najviše 4 inhalacije dvaput dnevno.
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: Rijetke nuspojave: mogu se javiti kod do 1 na 1 000 osoba • 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: Patients should not be initiated on Budesonide/Formoterol Teva Pharma B.V. during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Croatian: Bolesnici ne smiju započinjati liječenje lijekom Budezonid/Formoterol Teva Pharma B.V. tijekom egzacerbacije, niti tijekom značajnog ili akutnog pogoršanja astme.
English: Since Budesonide/Formoterol Teva Pharma B.V. contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Croatian: Budući da Budezonid/Formoterol Teva Pharma B.V. sadrži i budezonid i formoterol, može se pojaviti isti obrazac nuspojava koji je primijećen za te dvije tvari.
English: Each inhaler contains 120 doses and is foil-wrapped.
Croatian: Jedan inhalator sadrži 120 doza i omotan je folijom.
English: The most common adverse reactions are pharmacologically predictable adverse reactions of β2 adrenoceptor agonist therapy, such as tremor and palpitations.
Croatian: Najčešće nuspojave su farmakološki predvidive nuspojave terapije ß2-adrenoreceptorskim agonistima, kao što su tremor i palpitacije.
English: Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Croatian: Agresivnost, psihomotorna hiperaktivnost,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/950/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/950/002
English: or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.
Croatian: ili -u bolesnika u kojih astma već zadovoljavajuće kontrolirana primjenom i inhalacijskih kortikosteroida i dugodjelujućim agonistima ß2-adrenergičkih receptora.
English: To treat your asthma your doctor will prescribe Budesonide/Formoterol Teva Pharma B.V. together with a separate ‘reliever inhaler' such as salbutamol.
Croatian: Za liječenje astme, liječnik će Vam propisati Budezonid/Formoterol Teva Pharma B.V. zajedno sa zasebnim „inhalatorom za brzo ublažavanje simptoma“ poput salbutamola.
English: Your doctor may increase this to 2 inhalations, twice a day.
Croatian: Vaš liječnik može povećati dozu na 2 inhalacije, dvaput dnevno.
English: • If you get pregnant while using Budesonide/Formoterol Teva Pharma B.V., do NOT stop using Budesonide/Formoterol Teva Pharma B.V. but talk to your doctor immediately.
Croatian: • Ako zatrudnite tijekom uzimanja lijeka Budezonid/Formoterol Teva Pharma B.V., NEMOJTE prestati s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V., ali se odmah javite svojem liječniku.
English: INFORMATION IN BRAILLE Budesonide/Formoterol Teva Pharma B.V.320 mcg/9 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Budezonid/Formoterol Teva Pharma B.V. 320 mcg/9 mcg
English: The effects include: - changes in bone mineral density (thinning of the bones) - cataract (clouding of the lens in the eye) - glaucoma (increased pressure in the eye) - a slowing of the rate of growth of children and adolescents - an effect on the adrenal gland (a small gland next to the kidney)
Croatian: Ti učinci uključuju: - promjene mineralne gustoće kostiju (stanjivanje kostiju) - očnu mrenu (zamućenje očne leće) - glaukom (povišen očni tlak)
English: 2 years.
Croatian: 6.3 Rok valjanosti 2 godine
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Croatian: Sistemski učinci mogu se pojaviti kod primjene svakog inhalacijskog kortikosteroida, posebice kad su propisane visoke doze kroz dulja razdoblja.
English: What Budesonide/Formoterol Teva Pharma B.V. contains - The active substances are budesonide and formoterol fumarate dihydrate.
Croatian: Što Budezonid/Formoterol Teva Pharma B.V. sadrži - Djelatne tvari su budezonid i formoterolfumarat dihidrat.
English: • Thrush (a fungal infection) in the mouth.
Croatian: • Kandidijaza (gljivična infekcija) usne šupljine.
English: Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom.
Croatian: Držite svoj inhalator s poluprozirnim poklopcem nastavka za usta u boji crvenog vina prema dolje.
English: When it is appropriate to titrate down to a lower strength than is available for Budesonide/Formoterol Teva Pharma B.V., a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Croatian: Kad je primjereno titriranje doze na nižu jačinu od one koja je dostupna u inhalatoru Budezonid/Formoterol Teva Pharma B.V., potrebna je promjena na drugi kombinirani lijek s fiksnom dozom budezonida i formoterol fumarata, koji sadrži nižu dozu inhalacijskog kortikosteroida.
English: If you are doing exercise and you get asthma symptoms, use your separate ‘reliever inhaler' to relieve these symptoms.
Croatian: Ako tijekom tjelovježbe dobijete simptome astme, primijenite zasebni „inhalator za brzo ublažavanje simptoma” kako biste ublažili simptome.
English: There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment.
Croatian: Nema dostupnih podataka o primjeni kombiniranog lijeka s fiksnom dozom budezonida i formoterol fumarat dihidrata u bolesnika s oštećenom jetrom ili bubrezima.
English: INFORMATION IN BRAILLE Budesonide/Formoterol Teva Pharma B.V. 160 mcg/4.5 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Budezonid/Formoterol Teva Pharma B.V. 160 mcg/4,5 mcg
English: • Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
Croatian: • fenotiazinske lijekove (poput klorpromazina i proklorperazina).
English: • Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole,
Croatian: • lijekove za liječenje infekcija (poput ketokonazola, itrakonazola, vorikonazola, pozakonazola,
English: Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Budesonide/Formoterol Teva Pharma B.V.
Croatian: Kad su simptomi astme dobro kontrolirani, Vaš liječnik će možda smatrati da je prikladno postupno smanjivati dozu lijeka Budezonid/Formoterol Teva Pharma B.V.
English: If any of the following happen to you, stop using Budesonide/Formoterol Teva Pharma B.V. and talk to your doctor immediately:
Croatian: Ako vam se dogodi išta od navedenog, prekinite s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V. i odmah se javite liječniku:
English: Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath, after dosing.
Croatian: Nakon doziranja može doći do paradoksalnog bronhospazma s trenutnim pojačanjem zviždanja u plućima i nedostatkom zraka.
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)
English: These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.
Croatian: Mnogo je manja vjerojatnost pojave tih učinaka uz inhalacijsko liječenje nego pri peroralnom uzimanju kortikosteroida.
English: The safety and efficacy of Budesonide/Formoterol Teva Pharma B.V. in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Budezonid/Formoterol Teva Pharma B.V. u djece stare 12 godina i mlađe, te u adolescenata od 13 do 17 godina, nisu još ustanovljene.
English: In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva Pharma B.V. 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: Pharma B.V. 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: Budesonide/Formoterol Teva Pharma B.V. is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled shortacting β2 adrenoreceptor agonists.
Croatian: Budezonid/Formoterol Teva Pharma B.V. nije odgovarajuće liječenje za odraslog bolesnika koji ima samo blagi oblik astme i koji nije zadovoljavajuće kontroliran inhalacijskim kortikosteroidom i ″prema potrebi″ inhalacijskim ß2-adrenoreceptorskim agonistima kratkog djelovanja.
English: What you need to know before you use Budesonide/Formoterol Teva Pharma B.V.
Croatian: Što morate znati prije nego počnete primjenjivati Budezonid/Formoterol Teva Pharma B.V.
English: Immune system disorders Rare
Croatian: Poremećaji imunološkog sustava
English: You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Budezonid/Formoterol Teva Pharma B.V. ako: ste alergični na budezonid, formoterolfumarat dihidrat, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Do not use Budesonide/Formoterol Teva Pharma B.V. to treat these asthma symptoms.
Croatian: Teva Pharma B.V. za liječenje tih simptoma astme.
English: Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting.
Croatian: hiperglikemija, hipokalemija, produljeni QTc-interval, aritmija, mučnina i povraćanje.
English: No information regarding the effect of a budesonide/formoterol fumarate dihydrate fixed-dose combination at higher doses is available.
Croatian: Nema dostupnih informacija o učinku viših doza kombinirane terapije fiksnom dozom budezonida/formoterolfumarat dihidrata.
English: • Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm'.
Croatian: Vrlo rijetke nuspojave: mogu se javiti kod do 1 na 10 000 osoba • Iznenadno akutno zviždanje u plućima i/ili nedostatak zraka neposredno nakon primjene inhalatora (također se naziva 'paradoksalni bronhospazam').
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Budesonide/Formoterol Teva Pharma B.V.
Croatian: Nakon što se postigne kontrola simptoma astme, može se razmotriti postupno smanjenje doze lijeka Budezonid/Formoterol Teva Pharma B.V.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE FOLIJA
English: Budesonide/Formoterol Teva Pharma B.V. is taken as regular maintenance treatment with a separate rapidacting bronchodilator reliever inhaler.
Croatian: Budezonid/Formoterol Teva Pharma B.V. uzima se kao redovita terapija održavanja s posebnim inhalatorom koji sadrži brzodjelujući bronhodilatator za hitno simptomatsko liječenje.
English: Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
Croatian: Srčane aritmije, npr. fibrilacija atrija,
English: OTHER
Croatian: O
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
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht,The Netherlands 12.
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska
English: Keep the mouthpiece cover closed after removal of the foil wrap.
Croatian: Poklopac nastavka za usta držite zatvorenim nakon skidanja folije.
English: Do not use Budesonide/Formoterol Teva Pharma B.V. 320/9 micrograms as a ‘reliever inhaler'.
Croatian: Nemojte koristiti Budezonid/Formoterol Teva Pharma B.V. 320/9 mikrograma kao „inhalator za brzo ublažavanje simptoma“.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE
English: Budesonide has a high systemic clearance (approximately 1.2 L/min) and the plasma elimination half-life after i.v.
Croatian: Budezonid ima visok sistemski klirens (oko 1,2 l/min), a poluvrijeme eliminacije iz plazme nakon i.v. doziranja prosječno iznosi 4 sata.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking Budesonide/Formoterol Teva Pharma B.V. - do NOT use this medicine unless your doctor tells you to.
Croatian: • Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego uzmete Budezonid/Formoterol Teva Pharma B.V.
English: Potentially serious hypokalaemia may result from high doses of β2 adrenoceptor agonists.
Croatian: Visoke doze ß2-adrenoreceptorskih agonista mogu izazvati potencijalno ozbiljnu hipokalemiju.
English: Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Croatian: Budezonid/Formoterol Teva Pharma B.V. je indiciran u redovitom liječenju astme kad je primjereno kombinirano liječenje (inhalacijskim kortikosteroidom i dugodjelujućim agonistima ß2-adrenergičkih receptora): -u bolesnika u kojih astma nije zadovoljavajuće kontrolirana inhalacijskim kortikosteroidima i „prema potrebi“ inhalacijskim kratkodjelujućim agonistima ß2-adrenergičkih receptora.
English: What Budesonide/Formoterol Teva Pharma B.V. is and what it is used for (page 3) 2.
Croatian: Što se nalazi u ovoj uputi: Što je Budezonid/Formoterol Teva Pharma B.V. i za što se koristi (stranica 3)
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.
Croatian: adrenalnu supresiju, zastoj u rastu djece i adolescenata, smanjenje mineralne gustoće kosti, kataraktu i glaukom.