FrancophonIA/ELRC3.0 huggingface dataset:
English: This study also investigated the potential pharmacokinetic interaction between the active components of Trimbow by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium.
Croatian: U ovom se ispitivanju također istražila moguća farmakokinetička interakcija između djelatnih komponenti lijeka Trimbow tako što su se usporedili farmakokinetički podaci dobiveni nakon primjene jedne doze ex tempore kombinacije i nakon primjene jedne doze pojedinačnih komponenti beklometazondipropionata/formoterola ili glikopironija.
English: You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Trimbow therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Croatian: Vi i liječnik morate odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Trimbow uzimajući u obzir korist dojenja za Vaše dijete i korist liječenja za Vas.
English: There are no relevant clinical data on the use of Trimbow during breast-feeding in humans.
Croatian: Nema relevantnih kliničkih podataka o primjeni lijeka Trimbow tijekom dojenja u ljudi.
English: Formoterol is a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction.
Croatian: Formoterol je selektivni beta-2 adrenergički agonist koji izaziva relaksaciju glatkog mišićja bronha u bolesnika s reverzibilnom opstrukcijom dišnih puteva.
English: The most frequently reported adverse reactions with Trimbow were oral candidiasis (which occurred in 0.8% of the exposed subjects), which is normally associated with inhaled corticosteroids; muscle spasms (0.4%), which can be attributed to the long-acting beta2-agonist component; dry mouth (0.4%), which is a typical anticholinergic effect.
Croatian: Najčešće zabilježene nuspojave lijeka Trimbow bile su oralna kandidijaza (koja je nastala u 0,8 % izloženih ispitanika), koja je uobičajeno povezana s inhalacijskim kortikosteroidima; mišićni grčevi (0,4 %), koji se mogu pripisati komponenti dugodjelujućih beta-2 agonista; suha usta (0,4 %), što je uobičajeni antikolinergički učinak.
English: Additionally, due to the anticholinergic effect of glycopyrronium, the long-term co-administration of Trimbow with other anticholinergic-containing medicinal products is not recommended (see section 4.5).
Croatian: Nadalje, zbog antikolinergičkog učinka glikopironija, ne preporučuje se dugotrajna istodobna primjena lijeka Trimbow s drugim antikolinergičkim lijekovima (vidjeti dio 4.5).
English: The combination of Trimbow with some other COPD medicines or medicines such as diuretics (medicines that make the body lose water, to treat heart disease or high blood pressure), can cause a sharp fall in your blood level of potassium.
Croatian: Kombinacija lijeka Trimbow s nekim drugim lijekovima za KOPB ili lijekovima kao što su diuretici (lijekovi koji uzrokuju izlučivanje vode iz tijela, za liječenje srčane bolesti ili visokog krvnog tlaka), može uzrokovati naglo sniženje razine kalija u krvi.
English: Some medicines may increase the effects of Trimbow and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Croatian: Neki lijekovi mogu povećati učinke lijeka Trimbow i ako uzimate takve lijekove (uključujući neke lijekove za HIV: ritonavir, kobicistat), Vaš liječnik će Vas možda htjeti pažljivo pratiti.
English: The use of Trimbow with the AeroChamber Plus spacer in COPD patients increased the lung delivery of beclometasone 17-monopropionate, formoterol and glycopyrronium (maximum plasma concentration increased by 15%, 58% and 60% respectively).
Croatian: Primjena lijeka Trimbow s komorom za inhaliranje AeroChamber Plus u bolesnika s KOPB-om povećala je dopiranje beklometazon 17-monopropionata, formoterola i glikopironija do pluća (maksimalne koncentracije u plazmi bile su povećane za 15 %, 58 % odnosno 60 %).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trimbow therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mothers.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Trimbow uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Simulations performed with a pharmacokinetic model showed that even when covariates had extreme values (body weight less than 40 kg and concomitant glomerular filtration rate below 27 mL/min/1.73 m²), exposure to Trimbow active substances remains in approximately a 2.5-fold range compared to the exposure in a typical patient with median covariate values.
Croatian: Simulacije provedene na farmakokinetičkom modelu pokazale su da, čak i kad kovarijate imaju ekstremne vrijednosti (tjelesna težina manja od 40 kg i istodobna brzina glomerularne filtracije manja od 27 ml/min/1,73 m²), izloženost djelatnim tvarima lijeka Trimbow ostaje veća za približno 2,5 puta u usporedbi s izloženošu u uobičajenog bolesnika s medijanom vrijednosti kovarijata.
English: Trimbow should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Croatian: Potrebno je odmah prekinuti primjenu lijeka Trimbow, procijeniti bolesnika i, ako je potrebno, uvesti drugu terapiju.
English: You should not use Trimbow during breast-feeding.
Croatian: Ne smijete primjenjivati Trimbow tijekom dojenja.
English: The bronchodilating effect sets in rapidly, within 1-3 minutes after inhalation, and has a duration of 12 hours after a single dose.
Croatian: 1-3 minute nakon inhalacije, a traje 12 sati nakon jedne doze.
English: An overdose of Trimbow may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists or anticholinergics and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Croatian: Predoziranje lijekom Trimbow može izazvati znakove i simptome zbog djelovanja pojedinačnih komponenti, uključujući one opažene kod predoziranja drugim beta-2 agonistima i antikolinergicima i sukladne poznatim učincima skupine inhalacijskih kortikosteroida (vidjeti dio 4.4).
English: Trimbow can reduce exacerbations (flare-ups) of COPD symptoms.
Croatian: Trimbow može smanjiti egzacerbacije (razbuktavanje) simptoma
English: Caution is also required when Trimbow is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia.
Croatian: Oprez je potreban i kad Trimbow primjenjuju bolesnici s tireotoksikozom, šećernom bolešću, feokromocitomom i neliječenom hipokalijemijom.
English: The recommended dose is two inhalations of Trimbow twice daily.
Croatian: Odrasli Preporučena doza je dva udaha lijeka Trimbow dvaput na dan.
English: Trimbow should be used with caution in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure), occlusive vascular diseases (particularly arteriosclerosis), arterial hypertension and aneurysm.
Croatian: Trimbow je potrebno primjenjivati uz oprez u bolesnika sa srčanim aritmijama, osobito atrioventrikularnim blokom trećeg stupnja i tahiaritmijama (ubrzanim i/ili nepravilnim otkucajima srca), idiopatskom subvalvularnom aortalnom stenozom, hipertrofičnom opstruktivnom kardiomiopatijom, teškom bolešću srca (osobito akutnim infarktom miokarda, ishemijskom bolešću srca, kongestivnim zatajenjem srca), okluzivnim krvožilnim bolestima (osobito arteriosklerozom), arterijskom hipertenzijom i aneurizmom.
English: In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Trimbow significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Trimbow and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06).
Croatian: Osim toga, u usporedbi i s fiksnom kombinacijom beklometazondipropionata i formoterola, i s tiotropijem, Trimbow je značajno produljio vrijeme do prve egzacerbacije (omjer hazarda 0,80 odnosno 0,84; p = 0,020 odnosno p = 0,015), s time da nije bilo razlika između lijeka Trimbow i ex tempore trostruke fiksne kombinacije beklometazondipropionata i formoterola uz tiotropij (omjer hazarda 1,06).
English: Trimbow is used as a maintenance treatment for your COPD.
Croatian: Trimbow se primjenjuje kao terapija održavanja kod KOPB-a.
English: No specific studies have been performed with Trimbow with regard to the safety in human fertility.
Croatian: Nisu provedena posebna ispitivanja lijeka Trimbow s obzirom na njegovu sigurnost za plodnost u ljudi.
English: The systemic exposure to beclometasone dipropionate, formoterol and glycopyrronium has been investigated in a pharmacokinetic study conducted in healthy subjects.
Croatian: Povezano s lijekom Trimbow Sistemska izloženost beklometazondipropionatu, formoterolu i glikopironiju ispitana je u farmakokinetičkom ispitivanju provedenom u zdravih ispitanika.
English: Beclometasone dipropionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs.
Croatian: Beklometazondipropionat Beklometazondipropionat koji se daje inhalacijom u preporučenim dozama ima glukokortikoidno protuupalno djelovanje unutar pluća.
English: It is recommended that treatment with Trimbow should not be stopped abruptly.
Croatian: Ne preporučuje se naglo prekinuti liječenje lijekom Trimbow.
English: There are no or limited amount of data from the use of Trimbow in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lijeka Trimbow u trudnica ograničeni.
English: • Disulfiram, a medicine used in the treatment of people with alcoholism (drinking problems) or metronidazole, an antibiotic to treat infection in your body can cause side effects (e.g. feeling sick, being sick, stomach pain) due to the small amount of alcohol in Trimbow.
Croatian: • disulfiramom, lijekom koji se primjenjuje za liječenje osoba s alkoholizmom (problem s prekomjernim pijenjem) ili metronidazolom, antibiotikom koji se primjenjuje za liječenje infekcije u tijelu (metronidazol) može uzrokovati nuspojave (npr. mučninu, povraćanje, bol u trbuhu) zbog male količine alkohola u lijeku Trimbow.
English: If you develop worsening shortness of breath or wheezing (breathing with a whistling sound), straight after inhaling your medicine, stop using Trimbow inhaler and use your quick-acting “reliever” inhaler straightaway.
Croatian: Ako Vam se pogorša nedostatak zraka ili piskanje (zviždanje pri disanju) neposredno nakon udisanja lijeka, prestanite koristiti inhalator Trimbow i smjesta upotrijebite inhalator s brzodjelujućim lijekom za brzo ublažavanje simptoma.
English: Trimbow comes in a pressurised container (coated aluminium), with a metering valve.
Croatian: Trimbow se isporučuje u spremniku pod tlakom (obloženom aluminijem) s odmjernim ventilom.
English: If this occurs you should stop using Trimbow and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing.
Croatian: Ako se to dogodi, morate prestati primjenjivati Trimbow i uzeti svoj inhalator s brzodjelujućim lijekom za brzo ublažavanje simptoma radi liječenja nedostatka zraka i piskanja.
English: If any of the above applies to you, tell your doctor before you use Trimbow.
Croatian: Ako se nešto od navedenog odnosi na Vas, obavijestite svog liječnika prije nego što primijenite
English: Trimbow significantly improved dyspnoea (measured as the Transition Dyspnoea Index - TDI - focal score) after 26 weeks of treatment compared with baseline (by 1.71 units; p < 0.001), but the adjusted mean difference versus a fixed combination of beclometasone dipropionate and formoterol was not statistically significant (0.21 units; p = 0.160).
Croatian: Transition Dyspnoea Index, TDI]) nakon 26 tjedana liječenja u usporedbi s početnim vrijednostima (za 1,71 jedinica; p < 0,001), ali prilagođena srednja vrijednost razlike naspram fiksne kombinacije beklometazondipropionata i formoterola nije bila statistički značajna (0,21 jedinica; p = 0,160).
English: Trimbow should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Croatian: Trimbow je potrebno primjenjivati uz oprez u bolesnika s aktivnom ili latentnom plućnom tuberkulozom te gljivičnim i virusnim infekcijama dišnih puteva.
English: Trimbow is a pressurised inhalation, solution.
Croatian: Trimbow je stlačeni inhalat, otopina.
English: Trimbow can be used at the recommended dose in patients with mild to moderate renal impairment.
Croatian: Trimbow se može primjenjivati u preporučenoj dozi u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
English: No differences were observed when comparing Trimbow and the extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol plus tiotropium (difference of 3 mL in pre-dose FEV1 after 52 weeks of treatment).
Croatian: Nisu bile opažene razlike kad se Trimbow uspoređivao s ex tempore trostrukom fiksnom kombinacijom beklometazondipropionata i formoterola uz tiotropij (razlika od 3 ml u FEV1 prije doziranja nakon 52 tjedna liječenja).
English: For glycopyrronium, the maximum plasma concentration was similar after administration of the fixed or extemporary combination, while the systemic exposure was slightly higher after administration of Trimbow than with the extemporary combination.
Croatian: Maksimalna koncentracija glikopironija u plazmi bila je slična nakon primjene fiksne i ex tempore kombinacije, dok je sistemska izloženost bila nešto veća nakon primjene lijeka Trimbow nego ex tempore kombinacije.
English: If you are already using Trimbow
Croatian: Ako već primjenjujete Trimbow
English: Trimbow is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left.
Croatian: Na stražnjoj strani inhalatora Trimbow nalazi se brojač doza ili pokazivač doza koji pokazuje koliko je potisaka preostalo.
English: Trimbow is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Croatian: Trimbow nije indiciran za liječenje akutnih epizoda bronhospazma ili za liječenje akutne egzacerbacije
English: No differences were observed when comparing Trimbow and the extemporary triple combination made of fluticasone and vilanterol fixed combination plus tiotropium.
Croatian: Nisu opažene razlike kad se Trimbow uspoređivao s ex tempore trostrukom fiksnom kombinacijom flutikazona i vilanterola uz tiotropij.
English: If you forget to use Trimbow
Croatian: Ako ste zaboravili primijeniti Trimbow
English: Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Trimbow with the AeroChamber Plus spacer device increased the total systemic exposure (AUC0-t) to glycopyrronium.
Croatian: Farmakokinetički podaci o primjeni jedne doze (vidjeti dio 5.2) pokazali su da je primjena lijeka Trimbow sa AeroChamber Plus komorom za inhaliranje, u usporedbi s rutinskom primjenom bez komore za inhaliranje, povećala ukupnu sistemsku izloženost (AUC0-t) glikopironiju.
English: In patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, especially if associated with a significant body weight reduction, Trimbow should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega, uključujući one sa završnim stadijem bubrežne bolesti koji zahtijevaju dijalizu, osobito ako je prisutno i značajno smanjenje tjelesne težine, Trimbow se smije primjenjivati samo ako je očekivana korist veća od mogućeg rizika (vidjeti dio 5.2).
English: How to use Trimbow
Croatian: Kako primjenjivati Trimbow
English: Use of Trimbow in patients with severe renal impairment or end-stage renal disease requiring dialysis, especially if associated with significant body weight reduction, should be considered only if the expected benefit outweighs the potential risk (see section 4.4 and section 5.2).
Croatian: Primjena lijeka Trimbow u bolesnika s teškim oštećenjem funkcije bubrega kojima je potrebna dijaliza, osobito ako je povezana sa značajnim smanjenjem tjelesne težine, može se uzeti u obzir samo ako je očekivana korist veća od mogućeg rizika (vidjeti dio 4.4 i dio 5.2).
English: If you stop using Trimbow
Croatian: Ako prestanete primjenjivati Trimbow
English: In patients with severe hepatic impairment, Trimbow should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Croatian: U bolesnika s teškim oštećenjem funkcije jetre, Trimbow se smije primjenjivati samo ako je očekivana korist veća od mogućeg rizika (vidjeti dio 5.2).
English: For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Trimbow are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation).
Croatian: Posljedica toga je jači učinak beklometazondipropionata nego u formulacijama s distribucijom čestica čija veličina nije vrlo sitna (100 mikrograma beklometazondipropionata u vrlo sitnim česticama u lijeku Trimbow odgovara 250 mikrograma beklometazondipropionata u formulaciji koja se ne raspršuje u vrlo sitne čestice).
English: Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Croatian: Trimbow 87 mikrograma/5 mikrograma/9 mikrograma stlačeni inhalat, otopina
English: Compared with tiotropium, Trimbow significantly improved IC by 39 mL (p = 0.025) and 60 mL (p = 0.001) after 26 and 52 weeks of treatment respectively.
Croatian: U usporedbi s tiotropijem,Trimbow je značajno poboljšao inspiracijski kapacitet za 39 ml (p = 0,025) odnosno 60 ml (p = 0,001) nakon 26 odnosno 52 tjedna liječenja.
English: Compared with a fixed combination of indacaterol and glycopyrronium, Trimbow improved average pre-dose FEV1 over the 52-week treatment period by 22 mL (p=0.018).
Croatian: U usporedbi s fiksnom kombinacijom indakaterola i glikopironija, Trimbow je poboljšao prosječni FEV1 prije doziranja tijekom razdoblja liječenja u trajanju od 52 tjedna za 22 ml (p = 0,018).
English: Compared with tiotropium, Trimbow improved pre-dose FEV1 by 51 mL after 26 weeks of treatment and by 61 mL after 52 weeks of treatment.
Croatian: usporedbi s tiotropijem, Trimbow je poboljšao FEV1 prije doziranja za 51 ml nakon 26 tjedana liječenja i za 61 ml nakon 52 tjedna liječenja.
English: Compared with tiotropium, Trimbow also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017).
Croatian: U usporedbi s tiotropijem, Trimbow je također smanjio stopu teških egzacerbacija (tj. isključujući umjerene egzacerbacije) za 32 % (stopa: 0,067 naspram 0,098 događaja po bolesniku godišnje; p = 0,017).
English: In repeat dose inhalation studies with Trimbow in rats and dogs of up to 13 weeks duration, the main observed alterations were related to effects on the immune system (probably due to systemic corticosteroid effects of beclometasone dipropionate and its active metabolite beclometasone17-monopropionate) and on the cardiovascular system (probably related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium).
Croatian: 13 tjedana glavne uočene promjene bile su povezane s učincima na imunosni sustav (vjerojatno zbog sistemskih kortikosteroidnih učinaka beklometazondipropionata i njegovog aktivnog metabolita beklometazon 17-monopropionata) i kardiovaskularni sustav (vjerojatno povezanima s beta-2
English: A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (reduction versus baseline of greater than or equal to 4) after 26 and 52 weeks with Trimbow than with a fixed combination of beclometasone dipropionate and formoterol and with tiotropium.
Croatian: Analiza bolesnika s terapijskim odgovorom pokazala je da je postotak bolesnika s klinički značajnim poboljšanjem (fokalni rezultat veći ili jednak 1) bio značajno veći nakon 26 tjedana liječenja lijekom Trimbow nego fiksnom kombinacijom beklometazondipropionata i formoterola
English: Similar effects were seen when comparing Trimbow with the extemporary triple combination.
Croatian: Trimbow uspoređivao s ex tempore trostrukom kombinacijom.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Trimbow Lijek čuvajte izvan pogleda i dohvata djece.
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trimbow significantly improved 2-hour post dose FEV1 by 117 mL after 26 weeks of treatment and by 103 mL after 52 weeks of treatment (p < 0.001).
Croatian: U usporedbi s fiksnom kombinacijom beklometazondipropionata i formoterola, Trimbow je značajno poboljšao FEV1 dva sata poslije doziranja za 117 ml nakon 26 tjedana liječenja te za 103 ml nakon 52 tjedna liječenja (p < 0,001).
English: No differences were observed when comparing Trimbow with the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (moderate/severe exacerbation rate: 0.46 versus 0.45 events per patient/year).
Croatian: Trimbow uspoređivao s ex tempore trostrukom fiksnom kombinacijom beklometazondipropionata i formoterola uz tiotropij (stopa umjerenih/teških egzacerbacija: 0,46 naspram 0,45 događaja po bolesniku godišnje).
English: TRISTAR was a 26-week active-controlled open label study comparing Trimbow with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Croatian: TRISTAR je bilo aktivno kontrolirano otvoreno ispitivanje u trajanju od 26 tjedana u kojem se Trimbow uspoređivao s ex tempore fiksnom kombinacijom flutikazona/vilanterola od 92/22 mikrograma u obliku praška inhalata, primijenjenom kao jedan udah jedanput na dan, u kombinaciji s tiotropijem od 18 mikrograma u obliku praška inhalata, u tvrdim kapsulama, primijenjenim kao jedan udah jedanput na dan (u 1157 randomiziranih bolesnika).
English: TRIBUTE was a 52-week activecontrolled study comparing Trimbow with a fixed combination of indacaterol/glycopyrronium 85/43 micrograms inhalation powder, hard capsule, one inhalation once daily (1,532 randomised patients).
Croatian: TRIBUTE je bilo aktivno kontrolirano ispitivanje u trajanju od 52 tjedna u kojem se Trimbow uspoređivao s fiksnom kombinacijom indakaterola/glikopironija od 85/43 mikrograma u obliku praška inhalata, u tvrdim kapsulama, primijenjenom kao jedan udah jedanput na dan (u 1532 randomizirana bolesnika).
English: The study compared data obtained after treatment with a single dose of Trimbow (4 inhalations of 100/6/25 micrograms, a non-marketed formulation containing twice the approved strength of glycopyrronium) or a single dose of the extemporary combination of beclometasone dipropionate/formoterol (4 inhalations of 100/6 micrograms) plus glycopyrronium (4 inhalations of 25 micrograms).
Croatian: formulacija koja sadrži dvostruko veću jačinu glikopironija od odobrene i koja nije na tržištu) ili jednom dozom ex tempore kombinacije beklometazondipropionat/formoterol (4 udaha od 100/6 mikrograma) plus glikopironij (4 udaha od 25 mikrograma).