FrancophonIA/ELRC3.0 huggingface dataset:
English: Remove the Spiromax from mouth and hold the breath for 10 seconds or as long as comfortable for the patients.
Croatian: Izvadite Spiromax iz usta i zadržite dah 10 sekundi ili sve dok je to bolesnicima ugodno.
English: • Medicines like digoxin, often used to treat heart failure.
Croatian: • lijekove poput digoksina koji se često koriste za liječenje zatajenja srca.
English: These signs could mean that your asthma is not being properly controlled and you may need different or additional treatment immediately.
Croatian: Ti znakovi mogu značiti da astma kod Vas nije adekvatno kontrolirana i da Vam je možda odmah potrebno drukčije ili dodatno liječenje.
English: Paradoxical bronchospasm
Croatian: Paradoksalni bronhospazam
English: • Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.
Croatian: • ujutro osjetite stezanje u prsnom košu ili stezanje u prsnom košu traje dulje nego obično.
English: • you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a very fast pulse, narrowing of the arteries or heart failure).
Croatian: • imate visok krvni tlak ili ste ikad imali probleme sa srcem (uključujući neravnomjerne otkucaje srca, vrlo brz puls, suženje arterija ili zatajenje srca).
English: • Feeling restless, nervous, agitated, anxious or angry.
Croatian: • Osjećaj nemira, nervoze, uznemirenosti, tjeskobe ili ljutnje.
English: This may mean that you are having an allergic reaction, which may also include rash and itching.
Croatian: To može značiti da imate alergijsku reakciju koja može uključivati osip i svrbež.
English: However, these animal experimental results do not seem to be relevant in humans at the recommended doses.
Croatian: Međutim, ti eksperimentalni rezultati na životinjama ne čine se relevantnima za ljude pri preporučenim dozama.
English: A dose of 90 micrograms administered during three hours in patients with acute bronchial obstruction raised no safety concerns.
Croatian: Doza od 90 mikrograma primijenjena tijekom 3 sata bolesnicima s akutnom bronhijalnom opstrukcijom nije dovela do sigurnosnih pitanja.
English: Plasma protein binding is approximately 50% for formoterol and 90% for budesonide.
Croatian: Vezivanje za proteine plazme iznosi oko 50% za formoterol i 90% za budezonid.
English: • you are diabetic.
Croatian: • ste dijabetičar.
English: • The mouthpiece will still ‘click' even when your Spiromax is empty.
Croatian: • Nastavak za usta i dalje će se oglašavati „klikom” iako je Spiromax prazan.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcija s drugim lijekovima i drugi oblici interakcije
English: Budesonide undergoes an extensive degree (approximately 90%) of biotransformation on first passage through the liver to metabolites of low glucocorticosteroid activity.
Croatian: Budezonid prolazi značajan stupanj (približno 90%) biotransformacije tijekom prvog prolaza kroz jetru do metabolita niske glukokortikosteroidne aktivnosti.
English: No data on fertility are available.
Croatian: Nisu dostupni podaci o plodnosti.
English: Recommended doses:
Croatian: Preporučena doza:
English: Formoterol itself may induce prolongation of the QTc-interval.
Croatian: Sam formoterol može izazvati produljenje QTc-intervala.
English: It is impossible to accidentally take extra medicine or a double dose in one inhalation.
Croatian: Nije moguće slučajno uzimanje dodatne količine lijeka ili dvostruke doze u istoj inhalaciji.
English: This will help to open the airways and help you to breathe more easily.
Croatian: To će pomoći da se otvore dišni putevi i olakšati Vam disanje.
English: Hold your breath for 10 seconds or as long as you comfortably can.
Croatian: Zadržite dah 10 sekundi ili koliko god možete izdržati.
English: It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily.
Croatian: Djeluje smanjenjem i sprječavanjem oticanja i upale u vašim plućima i pomaže Vam da lakše dišete.
English: • Budesonide belongs to a group of medicines called ‘corticosteroids' also known as ‘steroids'.
Croatian: • Budezonid pripada skupini lijekova pod nazivom „kortikosteroidi” poznati i kao 'steroidi'.
English: In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.
Croatian: U tim je slučajevima ponekad nužno privremeno povećanje doze oralnih glukokortikosteroida.
English: The mechanisms of action of the two substances respectively are discussed below.
Croatian: mehanizmima djelovanja dviju djelatnih tvari je više rečeno u dolje navedenom tekstu.
English: • you have severe liver problems.
Croatian: • imate teške jetrene tegobe.
English: Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide will ultimately achieve their adult target height.
Croatian: Ograničeni podaci iz dugoročnih ispitivanja ukazuju da će većina djece i adolescenata liječenih inhalacijskim budezonidom u konačnici dostići ciljnu visinu u odrasloj dobi.
English: Budesonide is eliminated via metabolism mainly catalysed by the enzyme CYP3A4.
Croatian: Budezonid se eliminira metaboliziranjem uglavnom kataliziranim enzimom CYP3A4.
English: Data from an embryo-fetal development study in the rat, showed no evidence of any additional effect from the combination.
Croatian: Podaci o embrio-fetalnom razvojnom ispitivanju na štakorima nisu pokazali dokaze nikakvih dodatnih učinaka te kombinacije.
English: Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity.
Croatian: Učinci vjerojatno ovise o dozi, vremenu izloženosti, istodobnoj i prethodnoj izloženosti steroidima i individualnoj osjetljivosti.
English: In addition consideration should be given to referring the patient to a paediatric respiratory specialist.
Croatian: Osim toga, nužno je razmotriti upućivanje bolesnika pedijatru specijalistu za respiratorne bolesti.
English: Important information about your asthma symptoms
Croatian: Važne informacije o simptomima astme
English: Additional blood glucose controls should be considered in diabetic patients.
Croatian: Dodatne kontrole glukoze u krvi mora se razmotriti u bolesnika s dijabetesom.
English: This leaflet was last revised in month YYYY.
Croatian: Ova uputa je zadnji puta revidirana u mjesecu GGGG.
English: Acute overdose with budesonide, even in excessive doses, is not expected to be a clinical problem.
Croatian: Ne očekuje se da akutno predoziranje budezonidom, čak i u prekomjernim dozama, predstavlja klinički problem.
English: If this is not possible the time interval between administration of the inhibitor and budesonide should be as long as possible (see section 4.4).
Croatian: Ukoliko to nije moguće, vremenski interval između primjene inhibitora i budezonida mora biti što je moguće duži (vidjeti dio 4.4).
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 nastavak za usta bez uzimanja inhalacije, indikator doze će to ipak registrirati kao odbrojavanje.
English: Mechanism of action and pharmacodynamic effects
Croatian: Mehanizam djelovanja i farmakodinamički učinci
English: The excipient lactose contains small amounts of milk proteins which may cause allergic reactions.
Croatian: Laktoza sadrži male količine mliječnog proteina koji može uzrokovati alergijske reakcije.
English: Rapid reduction in the dose of steroids can induce acute adrenal crisis.
Croatian: Brzo smanjenje doze steroida može uzrokovati akutnu adrenalnu krizu.
English: Formoterol is inactivated via conjugation reactions (active O-demethylated and deformylated metabolites are formed, but they are seen mainly as inactivated conjugates).
Croatian: Formoterol se inaktivira reakcijama konjugacije (stvaraju se aktivni O-demetilirani i deformilirani metaboliti, no oni se uglavnom smatraju inaktiviranim konjugatima).
English: Check with your doctor, pharmacist or nurse if you are not sure.
Croatian: Provjerite sa svojim liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni.
English: Data on approximately 2000 exposed pregnancies indicate no increased teratogenic risk associated with the use of inhaled budesonide.
Croatian: Podaci dobiveni iz približno 2000 izloženih trudnoća ne ukazuju na povećani teratogeni rizik povezan s primjenom inhalacijskog budezonida.
English: If you are regularly using up to 8 inhalations a day or you need to increase the amount of ‘reliever inhaler' you require, you should see your doctor as soon as possible.
Croatian: Ako redovno koristite do 8 inhalacija na dan ili ako trebate povećati potrebnu količinu lijeka koju primate putem “inhalatora za brzo ublažavanje simptoma”, potrebno je javiti se liječniku čim je prije moguće.
English: • Chest pain or tightness in the chest (angina pectoris).
Croatian: • Bol ili stezanje u prsima (angina pectoris).
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 trenutku uzimanja sljedeće inhalacije.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti u svakoga.
English: 6.4 Special precautions for storage Do not store above 25°C.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Ne čuvati na temperaturi iznad 25°C.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku, obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
English: It works by relaxing the muscles in your airways.
Croatian: Djeluje opuštanjem mišića Vaših dišnih puteva.
English: As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.
Croatian: Bolesnike se stoga mora upozoriti da pozorno pročitaju uputu o lijeku i slijede upute za uporabu navedene u njoj.
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: The exact mechanism responsible for the antiinflammatory effect of glucocorticosteroids is unknown.
Croatian: Nije poznat točan mehanizam odgovoran za protuupalni učinak glukokortikosteroida.
English: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Croatian: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
English: • Headache.
Croatian: • Glavobolja.
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: Vaš liječnik pomoći će Vam u zbrinjavanju astme i prilagodit će dozu ovog lijeka na najnižu dozu kojom se postiže kontrola astme.
English: If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately.
Croatian: Ako Vam smeta bilo koji od tih simptoma ili se pojave simptomi poput glavobolje, umora, mučnine ili povraćanja, molimo odmah se obratite svojem liječniku.
English: Your doctor has prescribed this medicine to treat asthma.
Croatian: Liječnik Vam je propisao ovaj lijek za liječenje astme.
English: Infections and infestations Common
Croatian: Infekcije i infestacije
English: • Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath).
Croatian: • Bronhospazam (stezanje mišića u dišnim putevima koje uzrokuje zviždanje u plućima i nedostatak zraka).
English: Use the label on the inhaler to write down the opening date of the foil pouch.
Croatian: Koristite naljepnicu na inhalatoru za zapisivanje datuma otvaranja vrećice od folije.
English: Your doctor may need to change your treatment in order to reduce your symptoms of asthma (breathlessness, wheezing and cough) and improve your asthma control and make your breathing easier.
Croatian: Liječnik će možda trebati promijeniti Vašu terapiju kako bi se ublažili simptomi astme (nedostatak zraka, zviždanje u plućima i kašalj), poboljšala njena kontrola i olakšalo disanje.
English: Treatment with supplementary systematic steroids or inhaled budesonide should not be stopped abruptly.
Croatian: Liječenje dodatnim sistemskim steroidima ili inhalacijskim budezonidom ne smije se naglo prekidati.
English: Possible side effects (page 18)
Croatian: Moguće nuspojave (stranica 18)
English: You should not exceed your prescribed dose without seeking medical advice.
Croatian: Ne smijete prekoračiti propisanu dozu bez savjetovanja s liječnikom.
English: How to take an inhalation Every time you need to take an inhalation, follow the instructions below.
Croatian: Svaki puta kada trebate inhalirati, postupite u skladu s dolje navedenim uputama.
English: You may need to take other medicines if you develop allergic or arthritic symptoms.
Croatian: Možda ćete trebati uzimati druge lijekove ako se kod Vas pojave simptomi alergije ili artritisa.
English: The prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression.
Croatian: Produljeno liječenje visokim dozama inhalacijskih kortikosteroida, posebice dozama višim od preporučenih, također može rezultirati klinički značajnom adrenalnom supresijom.
English: If this is not possible the time interval between administrations of the interacting medicinal products should be as long as possible.
Croatian: Ako to nije moguće, vremenski razmak između primjene lijekova koji stupaju u interakciju mora biti što je moguće duži.
English: The inhaler is made of acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT) , and polypropylene (PP).
Croatian: Inhalator je napravljen od akrilonitril butadien stirena (ABS), polietilen tereftalata (PT) i polipropilena (PP).
English: Then breathe out gently (do not breathe out through the inhaler).
Croatian: 7.Zatim lagano izdahnite (nemojte izdisati u inhalator).
English: Prolongation of QTc-interval
Croatian: Produljenje QTc-intervala
English: The metabolites of budesonide are eliminated in urine as such or in conjugated form.
Croatian: Metaboliti budezonida eliminiraju se mokraćom kao takvi ili u konjugiranom obliku.
English: Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment.
Croatian: Iznenadno i progresivno pogoršanje kontrole astme potencijalno je opasno po život te bolesnik mora pristupiti hitnoj medicinskoj procjeni.
English: Concomitant treatment with itraconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided (see section 4.5).
Croatian: Mora se izbjegavati istodobno liječenje itrakonazolom, ritonavirom ili drugim potentnim inhibitorima CYP3A4 (vidjeti dio 4.5).
English: Pharmacodynamic interactions β adrenergic blockers can weaken or inhibit the effect of formoterol.
Croatian: Farmakodinamičke interakcije Beta-adrenergički blokatori mogu oslabiti ili inhibirati učinak formoterola.
English: The resulting plasma concentrations were not determined.
Croatian: Odgovarajuće koncentracije lijeka u plazmi nisu određivane.
English: Breathe in forcefully and deeply through the mouthpiece.
Croatian: Snažno i duboko udahnite kroz nastavak za usta.
English: If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.
Croatian: Ako su vaši simptomi dobro kontrolirani, liječnik od Vas može zatražiti da lijek primjenjujete jednom dnevno.
English: • Other bronchodilators (such as salbutamol).
Croatian: • ostale bronhodilatatore (poput salbutamola).
English: Variations in blood pressure
Croatian: Promjenjivi krvni tlak
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.com
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu
English: Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur.
Croatian: Može doći i do povećane osjetljivosti na infekcije i smanjene sposobnosti prilagodbe stresu.
English: Adults (18 years and older )
Croatian: Odrasli (s 18 godina i više)
English: • For inhalations remaining from 20 downwards to ‘8', 6','4','2' the numbers are displayed in red on a white background.
Croatian: • Za preostale inhalacije od 20 naniže do ‘8','6','4','2', brojevi se prikazuju crvenom bojom na bijeloj pozadini.
English: • Bruising of the skin.
Croatian: • Modrice na koži.
English: • Medicines for allergies or antihistamines (such as terfenadine).
Croatian: • lijekove za alergije ili antihistaminike (poput terfenadina).
English: The marketing authorisation holder shall submit PSURs for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
English: After inhalation, 8% to 13% of the delivered dose of formoterol is excreted unmetabolised in the urine.
Croatian: Nakon inhalacije, 8% do 13% isporučene doze formoterola izlučuje se nemetabolizirano mokraćom.
English: If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately.
Croatian: Ako zviždanje u plućima nastupi iznenada nakon primjene ovog lijeka prekinite s njegovom primjenom i odmah se javite liječniku.
English: • Changes in your blood pressure.
Croatian: • Promjene krvnog tlaka.
English: Very rare:
Croatian: Vrlo rijetke:
English: When long-term control of symptoms is maintained with the lowest recommended dose, then the next step could include a test of inhaled corticosteroid alone.
Croatian: Kada se kontrola simptoma dugoročno održava najnižom preporučenom dozom, tada se u sljedećem koraku može pokušati sa samim inhalacijskim kortikosteroidom.
English: Cleaning your Spiromax
Croatian: Čišćenje Vašeg inhalatora Spiromax
English: The specific properties of budesonide and formoterol allow the combination to be used as maintenance treatment of asthma.
Croatian: Specifična svojstva budezonida i formoterola omogućuju korištenje kombinacije kao terapiju održavanja astme.
English: However, do not adjust the number of inhalations your doctor has prescribed without talking to your doctor first.
Croatian: Međutim, nemojte prilagođavati broj inhalacija koje je propisao Vaš liječnik bez prethodnog savjetovanja sa svojim liječnikom.
English: This is less likely to occur if you rinse your mouth out with water after using your medicine.
Croatian: Manje je vjerojatna ako nakon primjene lijeka isperete usta vodom.
English: • Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler after EXP.
Croatian: • Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili na naljepnici Vašeg inahlatora iza Rok valjanosti ili EXP.
English: The systemic bioavailability is about 61% of the delivered dose.
Croatian: Sistemska bioraspoloživost iznosila je oko 61% isporučene doze.
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland
Croatian: Norton (Waterford) Limited T/A Teva Pharmaceuticals Irska Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Irska
English: Transfer from oral therapy
Croatian: Prijelaz s oralne terapije
English: Advising the patient to rinse the mouth out with water after each dose will minimise the risk.
Croatian: Savjetovanjem bolesniku da ispere usta vodom nakon svake doze svest će rizik na najmanju moguću mjeru.
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 primijenjen 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: If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid to the lowest dose at which effective control of asthma is maintained, if possible.
Croatian: Ako se rast uspori, terapiju se mora ponovno procijeniti s ciljem smanjivanja doze inhalacijskog kortikosteroida na najnižu dozu kojom se održava učinkovita kontrola astme, ukoliko je moguće.
English: Asthma symptoms
Croatian: Simptomi astme
English: Do not bite the mouthpiece.
Croatian: Nemojte gristi nastavak za usta.
English: The impact of enhanced training in dry powder inhaler inhalation technique on inhalation speed and volume was also assessed in these subject groups.
Croatian: Učinak intenzivnije edukacije u tehnici inhalacije na brzinu i volumen inhalacije iz inhalatora sa suhim praškom također je procijenjen u ovim skupinama ispitanika.
English: In such circumstances hypothalamic pituitary adrenocortical (HPA) axis function should be monitored regularly.
Croatian: U tim okolnostima, mora se redovito pratiti funkciju hipotalamo-hipofizno-adrenalne osi.
English: β2 adrenoreceptor agonists
Croatian: Agonisti ß2-adrenoreceptora
English: Hypersensitivity to the active substances or the excipient listed in section 6.1.
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Long-term studies with inhaled budesonide in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density.
Croatian: Dugoročna ispitivanja s inhalacijskim budezonidom u djece sa srednjim vrijednostima dnevnih doza od 400 mikrograma (odmjerena doza) ili u odraslih kod dnevnih doza od 800 mikrograma (odmjerena doza) nisu pokazala značajne učinke na mineralnu gustoću kostiju.
English: Contact your doctor immediately if:
Croatian: Odmah se javite svojem liječniku jer
English: Close the mouthpiece cover.
Croatian: Zatvorite poklopac nastavka za usta.
English: If you have been taking steroid tablets for a long time, your doctor may want you to have regular blood tests.
Croatian: Ako ste dulje vrijeme uzimali tablete steroida, Vaš liječnik će možda zatražiti da redovito obavljate krvne pretrage.
English: Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure and implantation losses as well as decreased early postnatal survival and birth weight at considerably higher systemic exposures than those reached during clinical use.
Croatian: Reproduktivna ispitivanja na životinjama s formoterolom pokazala su donekle smanjenu plodnost mužjaka štakora pri velikoj sistemskoj izloženosti i gubitak zametaka pri implantaciji, kao i smanjeno rano postnatalno preživljavanje i porođajnu težinu pri značajno većim sistemskim izloženostima od onih postignutih tijekom kliničke primjene.
English: If necessary you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue.
Croatian: Po potrebi možete obrisati nastavak za usta inhalatora Spiromax nakon primjene suhom krpom ili rupčićem.
English: • Palpitations (awareness of your heart beating), trembling or shaking.
Croatian: • Palpitacije (osjećaj lupanja srca), drhtanje ili tresavica.