natgillin/translations-raw huggingface dataset:
Moderate and severe asthmatic patients were shown to be able to generate sufficient inspiratory flow rate for Spiromax to deliver the therapeutic dose (see section 5.1).
Pokazalo se da bolesnici s umjerenom i teškom astmom mogu proizvesti dostatnu brzinu protoka zraka udahom kako bi Spiromax dostavio terapijsku dozu lijeka (vidjeti dio 5.1).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
• It is important to use Budesonide/Formoterol Teva Pharma B.V. every day, even if you have no asthma symptoms at the time.
• Bitno je primjenjivati Budezonid/Formoterol Teva Pharma B.V. svakodnevno, čak i ako trenutno nemate simptome astme.
• At the request of the European Medicines Agency;
Nadalje, nadopunjeni RMP treba dostaviti: • Na zahtjev Europske agencije za lijekove;
Also tell your doctor, pharmacist or nurse if you are going to have a general anaesthetic for an operation or for dental work.
Također obavijestite svojeg liječnika, ljekarnika ili medicinsku sestru ako ćete primiti opću anesteziju zbog kirurškog ili stomatološkog zahvata.
• Medicines for Parkinson's disease (such as levodopa).
• lijekove za liječenje Parkinsonove bolesti (poput levodope).
The glucocorticosteroid activity of the major metabolites, 6-beta-hydroxy-budesonide and 16-alfa-hydroxyprednisolone, is less than 1% of that of budesonide.
Glukokortikosteroidna aktivnost glavnih metabolita, 6-beta-hidroksibudezonida i 16-alfahidroksiprednizolona manja je od 1% aktivnosti budezonida.
When to start using a new Spiromax
Kada početi s primjenom novog inhalatora Spiromax
Possible side effects (page 16)
Moguće nuspojave (stranica 16)
Place the mouthpiece between your teeth.
Stavite nastavak za usta između zuba.
There are no adequate data from use of formoterol in pregnant women.
Nema odgovarajućih podataka o primjeni formoterola u trudnica.
• Do not store above 25oC.
• Ne čuvati na temperaturi iznad 25°C.
Cushing´s syndrome, adrenal suppression, growth retardation, decrease in bone mineral density
Cushingov sindrom, adrenalna supresija, zastoj u rastu, smanjenje mineralne gustoće kostiju
In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards β2 sympathomimetics.
Osim toga, L-Dopa, L-tiroksin, oksitocin i alkohol mogu narušiti srčanu toleranciju β 2simpatomimetika.
The benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed.
Prednosti kortikosteroidne terapije i moguće rizike supresije rasta mora se pomno odvagnuti.
Side panel: For use in adults 18 years of age and older only.
Bočna strana: Samo za primjenu kod odraslih u dobi od 18 godina i starijih.
The mean PIFR achieved by patients with asthma was over 60L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Srednja vrijednost PIFR postignuta u bolesnika s astmom 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.
When reducing steroid tablets, you may feel generally unwell even though your chest symptoms may be improving.
Kod smanjenja uzimanja tableta steroida, možda ćete se općenito loše osjećati iako će se simptomi u vašem prsištu ublažiti.
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• triciklične antidepresive (poput amitriptilina) i antidepresiv nefazodon.
• Steroid medicines that you take by mouth (such as prednisolone).
• steroidne lijekove koje uzimate na usta (poput prednizolona).
In rats, small amounts of formoterol have been detected in maternal milk.
U mlijeku štakora otkrivene su male količine formoterola.
The systemic bioavailability is approximately 49% of the delivered dose.
Sistemska bioraspoloživost iznosila je oko 49% isporučene doze.
There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Povećan je rizik aritmija u bolesnika koji istodobno primaju anesteziju halogeniranim ugljikovodicima.
The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.
Nužno je koristiti najnižu učinkovitu dozu budezonida potrebnu za održavanje adekvatne kontrole astme.
• Write the date you opened the foil pouch on the label of the inhaler.
• zapišite datum otvaranja vrećice od folije na naljepnicu inhalatora
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 1 inhaler.
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Sadrži 1 inhalator.
A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur.
Na općenito insuficijentan glukokortikosteroidni učinak mora se posumnjati ako se, u rijetkim slučajevima, pojave simptomi poput umora, glavobolje,
Budesonide is excreted in breast milk.
Budezonid se izlučuje u majčino mlijeko.
• you have low levels of potassium in your blood.
• imate snižene razine kalija u krvi.
Regular review of patients as treatment is stepped down is important.
Važno je redovno pregledavati bolesnike pri postupnom smanjivanju doze liječenja.
The toxicity observed in animal studies with budesonide and formoterol, given in combination or separately, were effects associated with exaggerated pharmacological activity.
Toksičnost zabilježena u ispitivanjima na životinjama s budezonidom i formoterolom, davanima kombinirano ili zasebno, bili su učinci povezani s prekomjernom farmakološkom aktivnošću.
There was no evidence of pharmacokinetic interactions between budesonide and formoterol.
Nema dokaza o farmakokinetičkim interakcijama između budezonida i formoterola.
In spite of this, a small increase in cortisol suppression was seen after administration of fixed-dose combination compared to the monoproducts.
primijećeno je malo povećanje supresije kortizola nakon primjene kombinacije fiksne doze u usporedbi s monokomponentama.
1 or 2 inhalations (actuations), twice a day.
1 ili 2 inhalacije (potisaka), dvaput dnevno.
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Povećana uporaba zasebnog brzodjelujućeg bronhodilatatora ukazuje na pogoršanje postojećeg stanja i zahtijeva ponovnu procjenu terapije astme.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Dozu se mora titrirati na najnižu dozu pri kojoj se održava učinkovita kontrola simptoma.
Symptoms and signs which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and hypoglycaemia.
Simptomi i znakovi koji mogu biti viđeni u akutnoj adrenalnoj krizi mogu biti ponešto nejasni ali mogu uključivati anoreksiju, bol u abdomenu, gubitak težine, umor, glavobolju, mučninu, povraćanje, smanjenu razinu svijesti, napadaje, hipotenziju i hipoglikemiju.
• If you are using Budesonide/Formoterol Teva Pharma B.V. for asthma, your doctor will want to regularly check your symptoms.
• Ako primjenjujete Budezonid/Formoterol Teva Pharma B.V. za astmu, Vaš liječnik će tražiti redovitu kontrolu vaših simptoma.
Volume of distribution is about 4 L/kg for formoterol and 3 L/kg for budesonide.
Volumen distribucije formoterola iznosi oko 4 l/kg, a budezonida 3 l/kg.
For formoterol, maximal plasma concentration was similar after administration of the fixed combination.
Maksimalna plazmatska koncentracija formoterola bila je slična nakon primjene fiksne kombinacije.
When used chronically in excessive doses, systemic glucocorticosteroid effects, such as hypercorticism and adrenal suppression, may appear.
Kad se kronično koristi u prekomjernim dozama, mogu se pojaviti sistemski učinci glukokortikosteroida poput hiperkorticizma i adrenalne supresije.
It is not known whether formoterol passes into human breast milk.
Nije poznato izlučuje li se formoterol u majčino mlijeko u ljudi.
Limited data about this interaction for high-dose inhaled budesonide indicates that marked increases in plasma levels (on average four fold) may occur if itraconazole, 200 mg once daily, is administered concomitantly with inhaled budesonide (single dose of 1000 micrograms).
Ograničeni podaci o ovoj interakciji visokih doza inhalacijskog budezonida upućuju da može doći do značajnog povećanja razina u plazmi (prosječno za četiri puta) ako se itrakonazol u dozi od 200 mg jednom dnevno, istodobno primjenjuje s inhalacijskim budezonidom (jednokratna doza od 1000 mikrograma).
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
Paradoxical bronchopasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway (see section 4.8).
Paradoksalni bronhospazam reagira na brzodjelujući inhalacijski bronhodilatator te ga se mora odmah liječiti (vidjeti dio 4.8).
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β2 adrenoceptor agonists' or ‘bronchodilators'.
• Formoterolfumarat dihidrat pripada skupini lijekova pod nazivom „dugodjelujući agonisti ß2adrenoceptora” ili „bronhodilatator i”.
Budesonide/Formoterol Teva Pharma B.V. should be used correctly in order to achieve effective treatment.
Budezonid/Formoterol Teva Pharma B.V. se mora koristiti pravilno kako bi se postiglo učinkovito liječenje.
Budesonide and formoterol have not been observed to interact with any other medicinal products used in the treatment of asthma.
Nije zabilježena interakcija budezonida i formoterola s drugim lijekovima koji se koriste u liječenju astme.
The major part of a dose of formoterol is transformed by liver metabolism followed by renal elimination.
Veći dio doze formoterola metabolizira se u jetri, nakon čega slijedi eliminacija bubrežnim putem.
Administration of a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Primjenu kombinirane terapije budezonida i formoterolfumarat dihidrata u fiksnoj dozi dojiljama se smije razmotriti samo ako je očekivana korist za majku veća od bilo kakvog mogućeg rizika za dijete.
• Diuretics, also known as ‘water tablets' (such as furosemide).
• diuretike poznate i pod nazivom „tablete za izmokravanje” (poput furosemida).
clarithromycin and telithromycin).
klaritromicina i telitromicina).
Peak Inspiratory Flow Rate through the Spiromax Device
Brzina vršnog inspiratornog protoka kroz inhalator Spiromax
All treatment arms used a short-acting β2 adrenoceptor agonist as needed.
U svim liječenim skupinama korišteni su kratkodjelujući β2-adrenoreceptorski agonisti po potrebi.
Paradoxical bronchospasm may occur very rarely, affecting less than 1 in 10,000 people, with an immediate increase in wheezing and shortness of breath after dosing.
Paradoksalni bronhospazam može se pojaviti vrlo rijetko, u manje od 1 na 10 000 ljudi s trenutnim pojačanjem zviždanja u plućima i nedostatkom zraka nakon doziranja.
The prophylactic use of Budesonide/Formoterol Teva Pharma B.V., e.g. before exercise, has not been studied.
Profilaktična uporaba lijeka Budezonid/Formoterol Teva Pharma B.V., npr. prije vježbanja, nije ispitana.
Inhaled budesonide has less severe adverse reactions than systemic corticosteroids.
Budezonid primijenjen inhalacijom ima manje teških nuspojava od sistemskih kortikosteroida.
• Keep the mouthpiece closed all the time unless you are about to use your inhaler.
• Nastavak za usta stalno držite zatvorenim osim ako se ne spremate uzeti inhalaciju.
Oropharyngeal Candida infection usually responds to topical anti-fungal treatment without the need to discontinue the inhaled corticosteroid.
Kandidijaza orofarinksa obično reagira na topikalno antifungalno liječenje bez potrebe za prekidom uzimanja inhalacijskog kortikosteroida.
• Uneven heartbeat.
• Neravnomjerni otkucaji srca.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Lijek koji više nije odobren prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
Do not breathe out through your inhaler.
Nemojte izdisati u inhalator.
It is also important to advise patients not to shake the inhaler before use and not to breathe out through the Spiromax and not to block the air vents when they are preparing the “Breathe” step.
Također je važno uputiti bolesnike da ne protresaju inhalator prije uporabe i da ne izdišu kroz Spiromax te da ne blokiraju ispuste za zrak kod pripreme koraka „Udahnite“.
• The dose indicator, on the rear of the device, shows the number of inhalations remaining in even numbers only.
• Indikator doze na stražnjoj strani uređaja pokazuje broj preostalih inhalacijama samo u parnim brojevima.
There are no indications of any metabolic interactions or any displacement reactions between formoterol and budesonide.
Ne postoje indikacije za bilo kakve metaboličke interakcije ni reakcije istiskivanja između formoterola i budezonida.
Rare:
Rijetke:
Cataract and glaucoma
Katarakta i glaukom
Open: Hold the Spiromax with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when one click is heard.
Otvorite: Držite Spiromax s poklopcem nastavka za usta na dnu i otvorite poklopac nastavka za usta savijanjem prema dolje dok se do kraja ne otvori kad se začuje jedan klik.
Inhaled formoterol is rapidly absorbed and the maximum plasma concentration is reached within 10 minutes after inhalation.
Inhalirani formoterol brzo se apsorbira, a maksimalna koncentracija u plazmi postiže se unutar 10 minuta nakon inhalacije.
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.