natgillin/translations-raw huggingface dataset:
Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides. 
Hipokalemija može povećati sklonost aritmijama u bolesnika koji se liječe glikozidima digitalisa
You may notice a taste when you take your inhalation. 
Kod uzimanja inhalacije možda ćete osjetiti okus.
Clinical studies in adults have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbations. 
Klinička ispitivanja na odraslima pokazala su da su se dodavanjem formoterola budezonidu simptomi astme poboljšali, a egzacerbacije smanjile.
This helps to prevent asthma symptoms from occurring. 
To pomaže u sprječavanju pojavljivanja simptoma astme.
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. 
Terapija kombinacijom fiksne doze budezonida i formoterolfumarat dihidrata se stoga ne smije davati zajedno s beta adrenergičkim blokatorima (uključujući kapi za oči) osim ako za to ne postoje jako uvjerljivi razlozi.
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. 
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.
Concomitant use of other β adrenergic medicinal products and anticholinergic medicinal products can have a potentially additive bronchodilating effect. 
Istodobna primjena drugih β -adrenergičkih lijekova i antikolinergičkih lijekova potencijalno može imati i aditivni bronhodilatatorni učinak.
• β blockers (such as atenolol or propranolol for high blood pressure or a heart condition), including eyedrops (such as timolol for glaucoma). 
• beta-blokatore (poput atenolola ili propranolola za visok krvni tlak ili srčanu bolest), uključujući kapi za oči (poput timolola za glaukom).
In studies the mean lung deposition of formoterol after inhalation via the powder inhaler ranged from 28% to 49% of the delivered dose. 
U ispitivanjima je srednja vrijednost odlaganja formoterola u plućima nakon inhalacije pomoću inhalatora praška inhalata, bila u rasponu od 28% do 49% isporučene doze.
In patients using potent CYP3A4 inhibitors, a budesonide/formoterol fumarate fixed-dose combination is not recommended. 
U bolesnika koji uzimaju potentne inhibitore CYP3A4, ne preporučuje se kombinirana terapija fiksnom dozom budezonida/formoterolfumarata.
Each dose contains approximately 5 milligrams of lactose (as monohydrate). 
Jedna doza sadrži oko 5 miligrama laktoze (u obliku hidrata).
In studies, mean lung deposition of budesonide after inhalation via the powder inhaler ranged from 32% to 44% of the delivered dose. 
U ispitivanjima je srednja vrijednost odlaganja budezonida u plućima nakon inhalacije praška pomoću inhalatora bila u rasponu od 32% do 44% isporučene doze.
Concomitant treatment with monoamine oxidase inhibitors including medicinal products with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions. 
Istodobno liječenje s inhibitorima monoaminooksidaze, uključujući lijekove sličnih osobina poput furazolidona i prokarbazina mogu potaknuti hipertenzivne reakcije.
As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis. 
Budući da se budezonid i formoterol primarno eliminiraju metabolizmom u jetri, može se očekivati povećana izloženost u bolesnika s teškom cirozom jetre.
Recovery may take a considerable amount of time after cessation of oral steroid therapy and hence oral steroid-dependent patients transferred to inhaled budesonide may remain at risk from impaired adrenal function for some considerable time. 
Oporavak može trajati još neko značajnije vrijeme nakon prekida terapije oralnim steroidima, stoga bolesnici ovisni o oralnim steroidima, a koji su prebačeni na inhalacijski budezonid mogu još neko značajnije vrijeme biti izloženi riziku narušavanja adrenalne funkcije.
Two 12-week paediatric studies have been performed in which 265 children aged 6-11 years were treated with a maintenance dose of budesonide/formoterol (2 inhalations of 80 micrograms/4.5 micrograms /inhalation twice daily), and a short acting β2 adrenoceptor agonist as needed. 
Provedena su dva pedijatrijska ispitivanja u trajanju od 12 tjedana u kojima je 265 djece u dobi od 6 do 11 godina bilo liječeno dozom održavanja budezonida/formoterola (2 inhalacije od 80 mikrograma/4,5 mikrograma po inhalaciji dva puta dnevno) i kratkodjelujućim ß2 adrenoreceptorskim agonistom po potrebi.
Inhaled budesonide is rapidly absorbed and the maximum plasma concentration is reached within 30 minutes after inhalation. 
Inhalirani budezonid brzo se apsorbira, a maksimalna koncentracija u plazmi postiže se unutar 30 minuta nakon inhalacije.
The dosage of Budesonide/Formoterol Teva Pharma B.V. is individual and should be adjusted to the severity of the disease. 
Doziranje lijeka Budezonid/Formoterol Teva Pharma B.V. je individualno i mora se prilagoditi težini bolesti.
Spiromax is a breath actuated, inspiratory flow-driven inhaler, which means that the active substances are delivered into the airways when the patient inhales through the mouthpiece. 
Spiromax je inhalator koji se aktivira udisajnim protokom zraka, što znači da se djelatne tvari dostavljaju u dišne puteve kada bolesnik udahne kroz nastavak za usta.
Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics and other drugs for obstructive airway diseases. 
Farmakoterapijska skupina: Lijekovi za opstruktivne bolesti dišnih puteva, adrenergici i ostali lijekovi za opstruktivne bolesti dišnih puteva.
1 inhaler containing 120 doses. 
1 inhalator sa 120 doza.
Do not open and close the mouthpiece cover unless you are about to use your inhaler. 
Nemojte otvarati i zatvarati poklopac nastavka za usta, osim ako se ne spremate uzeti inhalaciju.
Mild irritation in the throat, coughing, hoarseness 
Blaga iritacija grla, kašalj, promuklost
Close: Breathe out gently and close the mouthpiece cover. 
Zatvorite: Lagano izdahnite i zatvorite poklopac nastavka za usta
• Use the ‘reliever inhaler' when you get asthma symptoms, to make it easier to breathe again. 
• Koristite „inhalator za brzo ublažavanje simptoma” kad dobijete simptome astme, kako bi Vam se olakšalo ponovno disanje.
Pharmacokinetic parameters for the respective substances were comparable after the administration of budesonide and formoterol as monoproducts or as the fixed-dose combination. 
Farmakokinetički parametri odgovarajućih tvari bili su usporedivi nakon primjene budezonida i formoterola kao monokomponenti ili u kombinaciji fiksne doze.
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 Pharma B.V. 
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 Pharma B.V.
Not for use in children or adolescents under 18 years of age. 
Nije za primjenu u djece ili adolescenata mlađih od 18 godina.
This medicinal product is not recommended for use in children and adolescents under the age of 18 years. 
Ovaj lijek ne preporučuje se za primjenu u djece i adolescenata mlađih od 18 godina.
For budesonide, AUC was slightly higher, rate of absorption more rapid and maximal plasma concentration higher after administration of the fixed combination. 
Budezonid je imao neznatno viši AUC, veću brzinu apsorpcije i višu maksimalnu plazmatsku koncentraciju nakon primjene fiksne kombinacije.
Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias. 
Istodobno liječenje s kinidinom, dizopiramidom, prokainamidom, fenotiazinima, antihistaminicima (terfenadin), inhibitorima monoaminooksidaze i tricikličkim antidepresivima mogu produljiti QTcinterval i povećati rizik od ventrikularnih aritmija.
In both studies, lung function was improved and the treatment was well tolerated compared to the corresponding dose of budesonide alone. 
Plućna funkcija poboljšala se u oba ispitivanja, a liječenje je dobro podnešeno u usporedbi s odgovarajućom dozom budezonida primijenjenog samostalno.
If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations. 
Ako se razvije orofaringealna kandidijaza, bolesnici također moraju ispirati usta vodom nakon inhaliranja po potrebi.
• Medicines called ‘HIV protease inhibitors' (such as ritonavir) to treat HIV infection. 
• lijekove nazvane „inhibitori HIV-proteaze” (poput ritonavira) za liječenje infekcije virusom koji izaziva imunodeficijenciju u ljudi (HIV; eng.
Effects on bone density 
Učinak na gustoću kostiju
• Disturbance of the heart's electrical system (prolongation of the QTc-interval). 
• Poremećaj električnog sustava srca (produljenje QTc-intervala) • Povišena razina šećera (glukoze) u krvi.
Budesonide/Formoterol Teva Pharma B.V. contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations. 
Budezonid/Formoterol Teva Pharma B.V. sadrži formoterol i budezonid koji imaju različite mehanizme djelovanja i pokazuju aditivne učinke u smislu smanjenja egzacerbacija astme.
Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range. 
Ispitivanjima na životinjama također je utvrđen utjecaj prekomjerne prenatalne razine glukokortikosteroida na povećane rizike intrauterinog zastoja u rastu, kardiovaskularne bolesti u odrasloj dobi i trajnih promjena gustoće glukokortikoidnih receptora, pretvorbe neurotransmitera i ponašanje pri izloženosti dozama ispod teratogenog raspona doza.
• Medicines called monoamine oxidase inhibitors (such as phenelzine, furazolidone and procardazine). 
• lijekove pod nazivom inhibitori monoaminooksidaze (poput fenelzina, furazolidona i prokardazina).
In animal studies glucocorticosteroids have been shown to induce malformations (see section 5.3). 
U ispitivanjima na životinjama, pokazalo se da glukokortikosteroidi izazivaju malformacije (vidjeti dio 5.3).
Hypokalaemia 
Hipokalemija
During pregnancy, a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate should only be used when the benefits outweigh the potential risks. 
Za vrijeme trudnoće, terapiju kombinacijom budezonida i formoterolfumarat dihidrata u fiksnoj dozi smije se samo koristiti ako koristi premašuju potencijalne rizike.
Budesonide/Formoterol Teva Pharma B.V. is not indicated in children and adolescents under the age of 18 years (see section 4.2). 
Budezonid/Formoterol Teva Pharma B.V. nije indiciran u djece i adolescenata u dobi manjoj od 18 godina starosti (vidjeti dio 4.2).
• Xanthine medicines (such as theophylline or aminophylline). 
• ksantinske lijekove (poput teofilina ili aminofilina).
In animal reproduction studies, corticosteroids such as budesonide have been shown to induce malformations (cleft palate, skeletal malformations). 
U životinjskim reprodukcijskim ispitivanjima pokazalo se da kortikosteroidi poput budezonida izazivaju malformacije (rascjep nepca, malformacije kostura).
Particular caution is recommended in unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalaemia is increased. 
Poseban se oprez preporučuje u nestabilnoj astmi gdje varira uporaba bronhodilatatora za hitno simptomatsko liječenje, u akutnoj teškoj astmi jer postojeći rizik može povećati hipoksija, i u drugim stanjima kad je veća vjerojatnost nastanka hipokalemije.
The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased plasma levels of concomitantly orally administered budesonide (single dose 3 mg) on average six-fold. 
Potentan inhibitor CYP3A4, ketokonazol, 200 mg jednom dnevno, je povisio plazmatske razine istodobno oralno primijenjenog budezonida (jednokratna doza od 3 mg) za prosječno šest puta.
In animal studies formoterol has caused adverse reactions in reproduction studies at very high systemic exposure levels (see section 5.3). 
U reproduktivnim ispitivanjima na životinjama, formoterol je pri vrlo visokim razinama sistemske izloženosti uzrokovao nuspojave (vidjeti dio 5.3).
Formoterol has a high systemic clearance (approximately 1.4 L/min) and the terminal elimination half-life averages 17 hours. 
Formoterol ima visok sistemski klirens (oko 1,4 l/min) a poluvrijeme eliminacije prosječno iznosi 17 sati.
If these effects occur, they are usually mild and usually disappear as you continue to use Budesonide/Formoterol Teva Pharma B.V. 
Ako se ti učinci pojave, obično su blagi i nestanu kad nastavite s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V.
The benefits of inhaled budesonide therapy would normally minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. 
Koristi terapije inhalacijskim budezonidom obično bi trebale svesti na najmanju moguću mjeru potrebu za uzimanjem oralnih steroida, ali bolesnici koji prelaze s terapije oralnim steroidima mogu značajnije vrijeme biti izloženi riziku narušene adrenalne rezerve.
Uncommon: may affect up to 1 in 100 people 
Manje često: mogu se javiti kod do 1 na 100 osoba
Caution should be observed when treating patients with prolongation of the QTc-interval. 
Nužan je oprez u liječenju bolesnika s produljenim QTc-intervalom.
• Fast heartbeat. 
• Brzi otkucaji srca.
Budesonide/Formoterol Teva Pharma B.V. is not intended for the initial management of asthma. 
Budezonid/Formoterol Teva Pharma B.V. nije namijenjen za početno zbrinjavanje astme.
Open the mouthpiece cover by folding it down until one loud click is heard. 
Otvorite poklopac nastavka za usta zakretanjem prema dolje dok se ne začuje glasan škljocaj.
• Your breathing is getting worse or you often wake up at night with breathlessness and wheezing. 
Vaše disanje ili se noću često budite zbog nedostatka zraka ili zviždanja u plućima.
• Low levels of potassium in your blood. 
• Snižene razine kalija u krvi.
Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using Budesonide/Formoterol Teva Pharma B.V. due to the lactose excipient. 
Bolesnicima se također mora savjetovati da nakon inhalacije isperu usta vodom (vidjeti dio 4.4) Bolesnik kod primjene lijeka Budezonid/Formoterol Teva Pharma B.V. može osjetiti okus zbog pomoćne tvari , laktoze.
Inhalation use. 
Za primjenu inhalacijom.
Budesonide/formoterol maintenance therapy 
Terapija održavanja budezonidom/formoterolom
A fixed-dose combination of budesonide and formoterol fumarate dihydrate should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure. 
Kombinaciju fiksne doze budezonida i formoterolfumarat dihidrata mora se primjenjivati s oprezom bolesnicima s tirotoksikozom, feokromocitomom, šećernom bolešću, neliječenom hipokalemijom, hipertrofičnom opstruktivnom kardiomiopatijom, idiopatskom subvalvularnom stenozom aortne, teškom hipertenzijom, aneurizmom ili drugim teškim kardiovaskularnim poremećajima, kao što su ishemijska srčana bolest, tahiaritmije ili teško srčano zatajenje.
Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax. 
Ne pokušavajte rastavljati inhalator, ukloniti ili zakretati poklopac nastavka za usta, on je pričvršćen za inhalator i ne smije se skidati.
Teva Operations Poland Sp. z o.o. 
Teva Operations Sp. z o.o., Ul.
Formoterol is a selective β2 adrenoceptor agonist that when inhaled results in rapid and long-acting relaxation of bronchial smooth muscle in patients with reversible airways obstruction. 
Formoterol je selektivni β2-adrenoreceptorski agonist koji kad se inhalira uzrokuje brzu i dugotrajnu relaksaciju glatkih mišića bronha u bolesnika s reverzibilnom opstrukcijom dišnih puteva.
It is recommended that serum potassium levels are monitored during these circumstances. 
U tim stanjima preporučuje se pratiti razine kalija u serumu.
This helps to prevent asthma symptoms such as breathlessness and wheezing from occurring. 
To pomaže u sprječavanju pojavljivanja simptoma astme poput nedostatka zraka i zviždanja u plućima.
Potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided. 
Potentni inhibitori CYP3A4 (npr. ketokonazol, itrakonazol, vorikonazol, pozakonazol, klaritromicin, telitromicin, nefazodon i inhibitori HIV proteaze) vjerojatno će značajno povisiti razine budezonida u
An overdose of formoterol would likely lead to effects that are typical for β2 adrenoceptor agonists: tremor, headache, palpitations. 
Predoziranje formoterolom vjerojatno bi uzrokovalo učinke tipične za agoniste β2-adrenoreceptora: tremor, glavobolju, palpitacije.
Budesonide/Formoterol Teva Pharma B.V. is not likely to affect your ability to drive or to use tools or machines. 
Budezonid/Formoterol Teva Pharma B.V. vjerojatno neće utjecati na Vašu sposobnost upravljanja vozilima, alatima ili strojevima.
If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to a budesonide/formoterol fumarate fixed-dose combination therapy. 
Ukoliko postoji ikakav razlog za pretpostavku da je funkcija nadbubrežne žlijezde narušena prethodnom terapijom sistemskim steroidima, mora se obratiti pozornost kod prebacivanja bolesnika na kombiniranu terapiju fiksnom dozom budezonida/formoterolfumarata.
The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma 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. 
Podaci iz ispitivanja upućuju da neovisno o dobi i težini postojeće bolesti, djeca, adolescenti i odrasli s astmom su mogli postići brzine inspiratornog protoka kroz inhalator Spiromax slične onima postignutim kroz na tržištu dostupan inhalator koji sadrži više doza suhog praška.
Nervous system disorders Common 
Poremećaji živčanog sustava
These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets. 
Ti učinci pojavljuju se vrlo rijetko i mnogo je manja vjerojatnost njihove pojave kod uzimanja udahnutih kortikosteroida nego kod uzimanja tableta kortikosteroida.
The exposure of budesonide and formoterol may be increased in patients with liver disease. 
Izloženost budezonida i formoterola može se povećati u bolesnika s bolešću jetre.
Treatment with β2 adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies. 
Liječenje agonistima ß2 adrenoreceptora može rezultirati povećanjem razina inzulina, slobodnih masnih kiselina, glicerola i ketonskih tijela u krvi.
• Check the dose indicator to see that there are 60 inhalations in the inhaler. 
• provjerite indikator doze kako biste se uvjerili da inhalator sadrži 60 inhalacija.
Taste disturbances 
Poremećaji okusa
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INHALER 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE INHALATOR
Budesonide is a glucocorticosteroid which when inhaled has a dose-dependent anti-inflammatory action in the airways, resulting in reduced symptoms and fewer asthma exacerbations. 
Budezonid je glukokortikosteroid koji inhaliran ima protuupalno djelovanje u dišnim putevima ovisno o dozi, što rezultira ublažavanjem simptoma i smanjenjem egzacerbacija astme.
Only negligible amounts of unchanged budesonide have been detected in the urine. 
U mokraći su otkrivene samo zanemarive količine neizmijenjenog budezonida.
• you have problems with your thyroid or adrenal glands. 
• imate tegobe sa štitnjačom ili nadbubrežnom žlijezdom.
Breathe: Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler. 
Udahnite: Stavite nastavak za usta između zubi tako da usnama obuhvatite nastavak za usta, nemojte zubima gristi nastavak za usta inhalatora.
To minimise the risk of oropharyngeal candida infection, the patient should be instructed to rinse their mouth out with water after inhaling the dose. 
Za smanjenje rizika od orofaringealne kandidijaze, bolesnika se mora uputiti da ispere usta vodom nakon inhaliranja doze.
• The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60 
• Indikator doze upućuje Vas koliko doza (inhalacija) je još preostalo u Vašem inhalatoru, počevši od 60 inhalacija kad je pun.
Adults (18 years and older): 1-2 inhalations twice daily. 
Odrasli (s 18 godina i više): 1-2 inhalacije dvaput dnevno.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 doses 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. 
Nije primijećeno povećanje incidencije nuspojava nakon istodobne primjene ta dva sastojka.
Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland. 
Mogilska 80, 31-546 Krakow, Poljska
You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). 
Možda ćete imati simptome poput začepljenog nosa ili curenja iz nosa, slabosti ili bolova u zglobovima ili mišićima i osip (ekcem).
Each inhaler contains 60 doses and is foil-wrapped. 
Jedan inhalator sadrži 60 doza i omotan je folijom.
If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler', then seek medical advice. 
Ako se javi zviždanje u plućima ili Vam nedostaje zraka ili se pojave drugi simptomi napadaja astme, primijenite 'inhalator za brzo ublažavanje simptoma', a zatim zatražite liječnički savjet.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for long periods. 
Sistemski učinci inhalacijskih kortikosteroida mogu se pojaviti, posebice pri visokim dozama propisanim za duga razdoblja.
• Do not shake your inhaler before use. 
• nemojte tresti inhalator prije primjene.