FrancophonIA/ELRC3.0 huggingface dataset:
English: The elimination pattern suggests sustained lung absorption and/or transfer of glycopyrronium into the systemic circulation at and beyond 24 h after inhalation.
Slovenian: Način izločanja kaže, da potekata absorpcija učinkovine v pljučih in/ali prehod glikopironija v sistemski krvni obtok vseh 24 ur in še dlje po inhalaciji zdravila.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Ultibro Breezhaler should any of these signs or symptoms develop.
Slovenian: Bolnike je treba seznaniti z znaki in simptomi akutnega glavkoma zaprtega zakotja in jim naročiti, naj v primeru pojava teh simptomov ali znakov prenehajo uporabljati zdravilo Ultibro Breezhaler.
English: Limited treatment experience is available for the black population.
Slovenian: O uporabi v populaciji pripadnikov črne rase je na voljo le malo podatkov.
English: • Never wash your inhaler with water.
Slovenian: • Inhalatorja nikoli ne umivajte z vodo.
English: Remove empty capsule Put the empty capsule in your household waste.
Slovenian: Prazno kapsulo odvrzite med gospodinjske odpadke.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: Similarly, for glycopyrronium no QT prolongation was observed in a TQT study after an inhaled dose of 8 times the recommended therapeutic dose.
Slovenian: Podobno tudi pri glikopironiju v študiji TQT niso opažali podaljšanja intervala QT po inhaliranju odmerkov, ki so 8-krat presegali priporočeni terapevtski odmerek.
English: • Never place the capsule into your mouth or the mouthpiece of the inhaler.
Slovenian: • Kapsule nikoli ne dajajte v usta oziroma je ne nameščajte v ustnik inhalatorja.
English: Method of administration For inhalation use only.
Slovenian: Način uporabe Samo za inhaliranje.
English: Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ultibro Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Slovenian: Drugi najbolj pogosti neželeni učinki, ki jih povzroča zdravilo (pri najmanj 3 % bolnikov, ki so prejemali zdravilo Ultibro Breezhaler, in z večjo pogostnostjo kot pri uporabi placeba), so bili kašelj, nazofaringitis in glavobol.
English: Insufficient pharmacokinetic data is available for other ethnicities or races.
Slovenian: O uporabi pri pripadnikih drugih etničnih skupin ali ras ni na voljo dovolj farmakokinetičnih podatkov.
English: The co-administration of Ultibro Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Slovenian: Sočasne uporabe zdravila Ultibro Breezhaler z drugimi zdravili, ki vsebujejo antiholinergične učinkovine, niso proučevali in zato ni priporočena (glejte poglavje 4.4).
English: The presentation of the safety profile is based on the experience with Ultibro Breezhaler and the individual active substances.
Slovenian: Predstavitev varnostnih lastnosti temelji na izkušnjah z uporabo zdravila Ultibro Breezhaler in njegovih posameznih učinkovin.
English: Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged (>450 ms) were excluded from the clinical trials, and therefore there is no experience in these patient groups.
Slovenian: Bolniki z nestabilno ishemično boleznijo srca, s popuščanjem levega prekata, z anamnezo miokardnega infarkta, z aritmijo (z izjemo tistih s kronično stabilno atrijsko fibrilacijo), z anamnezo sindroma dolgega intervala QT ali s podaljšanim intervalom QTc (s trajanjem intervala po metodi s korekcijo Fridericia >450 ms) niso bili vključeni v klinične študije, zato pri teh skupinah bolnikov z uporabo zdravila ni nobenih izkušenj.
English: The safety and efficacy of Ultibro Breezhaler in children have not been established.
Slovenian: Varnost in učinkovitost zdravila Ultibro Breezhaler pri otrocih nista bili dokazani.
English: In vitro inhibition studies demonstrated that glycopyrronium bromide has no relevant capacity to inhibit CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4/5, the efflux transporters MDR1, MRP2 or MXR, and the uptake transporters OCT1 or OCT2.
Slovenian: V in vitro študijah zaviranja so dokazali, da glikopironijev bromid nima ustreznih lastnosti, da bi lahko zaviral encime CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A4/5, izlivne prenašalce MDR1, MRP2 ali MXR in privzemne prenašalce OCT1 ali OCT2.
English: There were no major differences in total systemic exposure (AUC) between Japanese and Caucasian subjects.
Slovenian: Med Japonci in belci ni bilo večjih razlik v celotni sistemski izpostavljenosti (AUC).
English: • difficulty breathing with wheezing or coughing.
Slovenian: • oteženo dihanje s piskanjem v pljučih ali s kašljem;
English: Step 1a: Pull off cap
Slovenian: Korak 1a: Snemite pokrovček.
English: Following inhalation of Ultibro Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.
Slovenian: Ocenjujejo, da je po inhaliranju zdravila Ultibro Breezhaler absolutna biološka uporabnost indakaterola v razponu od 61 % do 85 % prejetega odmerka, za glikopironij pa znaša približno 47 % prejetega odmerka.
English: • feeling of pressure or pain in the cheeks and forehead - these may be signs of inflammation of the sinuses called sinusitis.
Slovenian: • občutek pritiska ali bolečine pod očmi ali v čelu - to je lahko znak vnetja sinusov, ki se imenuje sinusitis
English: In vitro studies have shown that indacaterol has multi-fold greater agonist activity at beta2-receptors compared to beta1 and beta3-receptors.
Slovenian: Rezultati raziskav in vitro so pokazali, da ima indakaterol mnogokrat večjo agonistično aktivnost na receptorje beta-2 kot na receptorje beta-1 in beta-3.
English: You should not use Ultibro Breezhaler unless your doctor tells you to do so.
Slovenian: Zdravila Ultibro Breezhaler ne smete uporabljati, razen če vam tako naroči zdravnik.
English: • pain that affects the muscles, ligaments, tendons, joints and bones.
Slovenian: • bolečine v mišicah, sklepnih vezeh, kitah, sklepih in kosteh
English: Inhale the medicine again by repeating steps 3a to 3c.
Slovenian: Ponovno inhalirajte zdravilo, tako da ponovite korake 3a do 3c.
English: Effects attributable to the muscarinic receptor antagonist properties of glycopyrronium bromide included mild to moderate increases in heart rate in dogs, lens opacities in rats and, reversible changes associated with reduced glandular secretions in rats and dogs.
Slovenian: Učinki, ki jih je pri glikopironijevemu bromidu mogoče pripisati lastnostim antagonista muskarinskih receptorjev, vključujejo blago do zmerno zvišanje srčne frekvence pri psih, motnjavo leče pri podganah in reverzibilne spremembe povezane z zmanjšanim izločanjem žlez pri podganah in psih.
English: A population pharmacokinetic analysis of data in COPD patients identified body weight and age as factors contributing to inter-patient variability in systemic exposure.
Slovenian: Populacijska farmakokinetična analiza podatkov pri bolnikih s KOPB je pokazala, da sta dejavnika, ki prispevata k interindividualni variabilnosti sistemske izpostavljenosti, telesna masa in starost.
English: Although beta2-adrenergic receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-adrenergic receptors are the predominant receptors in the human heart, there are also beta2-adrenergic receptors in the human heart comprising 10% to 50% of the total adrenergic receptors.
Slovenian: Kljub temu, da so v gladkem mišičju bronhusov od adrenergičnih receptorjev prisotni predvsem beta-2 adrenergični receptorji, v človeškem srcu pa predvsem beta-1 adrenergični receptorji, so tudi v človeškem srcu prisotni beta-2 adrenergični receptorji, ki lahko predstavljajo 10-50 % vseh adrenergičnih receptorjev.
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) glycopyrronium bromide can be used at the recommended dose.
Slovenian: Pri bolnikih s KOPB in blago oziroma zmerno okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije, eGFR ≥30 ml/min/1,73 m je glikopironijev bromid mogoče uporabljati v priporočenem odmerku.
English: Check
Slovenian: preveri te
English: Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.
Slovenian: Posamično pakiranje vsebuje 6x1, 10x1, 12x1, 30x1 ali 90x1 trdo kapsulo in 1 inhalator.
English: Do not push the capsule through the foil.
Slovenian: Kapsule ne potiskajte skozi folijo.
English: Due to the very low contribution of the urinary pathway to total body elimination of indacaterol maleate, a study in renal impaired subjects was not performed.
Slovenian: Ker ima izločanje z urinom tako majhen pomen pri celotnem izločanju indakaterolijevega maleata iz organizma, niso izvedli nobene študije pri bolnikih z okvaro ledvic.
English: INNER LID OF OUTER CARTON OF UNIT PACK AND OF INTERMEDIATE CARTON OF MULTIPACK
Slovenian: NOTRANJA STRAN ZAVIHKA ZUNANJE ŠKATLE POSAMIČNEGA PAKIRANJA IN VMESNE ŠKATLE SKUPNEGA PAKIRANJA
English: In COPD patients both systemic exposure and total urinary excretion of glycopyrronium at pharmacokinetic steady state increased about dose-proportionally over the (delivered) dose range of 44 to 176 micrograms.
Slovenian: Pri bolnikih s KOPB sta se tako sistemska izpostavljenost glikopironiju kot njegovo celotno izločanje z urinom v farmakokinetičnem stanju dinamičnega ravnovesja povečevala sorazmerno s prejetim odmerkom v okviru odmerjanja od 44 mikrogramov do 176 mikrogramov.
English: Glycopyrronium bromide and its metabolites did not significantly cross the placental barrier of pregnant mice, rabbits and dogs.
Slovenian: Glikopironijev bromid in njegovi presnovki niso v pomembni meri prehajali skozi posteljico pri nosečih samicah miši, kuncev in psov.
English: There is no relevant use of Ultibro Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Slovenian: Zdravilo Ultibro Breezhaler ni primerno za uporabo pri pediatrični populaciji (v starosti pod 18 let) za indikacijo KOPB.
English: Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-glycoprotein (P-gp), raises the systemic exposure of indacaterol up to two-fold.
Slovenian: Zaviranje delovanja dveh dejavnikov, ki sta bistveno vpletena v izločanje indakaterola - CYP3A4 in P-glikoproteina (P-gp), do dvakrat poveča sistemsko izpostavljenost indakaterolu.
English: • pain in arms or legs.
Slovenian: • bolečine v rokah ali nogah
English: Only pierce the capsule once.
Slovenian: Kapsulo predrite samo enkrat.
English: A thorough QT (TQT) study in healthy volunteers with high doses of inhaled indacaterol (up to twice the maximum recommended therapeutic dose) did not demonstrate a clinically relevant effect on the QT interval.
Slovenian: V študiji TQT, v kateri so temeljito raziskali vpliv na interval QT pri zdravih prostovoljcih, ki so prejemali visoke odmerke inhalacijskega indakaterola (do odmerka, ki je dvakrat presegal najvišji priporočeni terapevtski odmerek), niso dokazali klinično pomembnega učinka na interval QT.
English: Do not press the side buttons.
Slovenian: Pri tem ne pritiskajte stranskih gumbov.
English: Increased cyclic AMP levels cause relaxation of bronchial smooth muscle.
Slovenian: Zvišana koncentracija cikličnega AMP povzroča relaksacijo gladkih mišic v bronhusih.
English: Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose.
Slovenian: Inhaliranje visokih odmerkov agonistov beta-2 adrenergičnih receptorjev lahko povzroči zvišanje koncentracije glukoze v plazmi.
English: Concomitant administration of other sympathomimetics (alone or as part of combination therapy) may potentiate the adverse events of indacaterol (see section 4.4).
Slovenian: Sočasna uporaba drugih simpatikomimetikov (samih ali v sklopu kombinacije zdravil) lahko okrepi neželene učinke indakaterola (glejte poglavje 4.4).
English: Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo Ultibro Breezhaler je indicirano kot vzdrževalno bronhodilatatorno zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
English: However, as shown in a clinical study in populations with different UGT1A1 genotypes, systemic exposure to indacaterol is not significantly affected by the UGT1A1-genotype.
Slovenian: Po podatkih kliničnih študij v populacijah z drugačnimi genotipi za encim UGT1A1 pa vrsta genotipa UGT1A1 ne vpliva bistveno na izpostavljenost indakaterolu.
English: Available pharmacokinetic/toxicological data have shown excretion of indacaterol, glycopyrronium and their metabolites in the milk of lactating rats.
Slovenian: Razpoložljivi farmakokinetični/toksikološki podatki kažejo, da se indakaterol, glikopironij in njuni presnovki izločajo v mleko doječih podgan.
English: Thus for bronchodilation in both peripheral and central airways of the human lung a combination of a beta2-adrenergic agonist and a muscarinic antagonist may be beneficial.
Slovenian: Za bronhodilatacijo tako v perifernih kot v centralnih dihalnih poteh človeških pljuč je lahko koristna kombinacija agonista beta-2 adrenergičnih receptorjev in antagonista muskarinskih receptorjev.
English: Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene.
Slovenian: Telo in pokrovček inhalatorja sta iz akrilonitril-butadien-stirena, potisni gumbi so narejeni iz metilmetakrilat-akrilonitril-butadien-stirena.
English: The magnitude of the effect was dependent on the degree of reversibility of airflow limitation at baseline (tested by administration of a short-acting muscarinic antagonist bronchodilator and a short-acting beta2-agonist bronchodilator): Patients with the lowest degree of reversibility at baseline (<5%) generally exhibited a lower bronchodilator response than patients with a higher degree of reversibility at baseline (≥5%).
Slovenian: Velikost učinka je bila odvisna od stopnje reverzibilnosti zmanjšanja pretoka zraka ob izhodišču (kar so testirali z odmerjanjem bronhodilatatorjev, in sicer kratkodelujočega antagonista muskarinskih receptorjev in kratkodelujočega agonista beta-2 adrenergičnih receptorjev): pri bolnikih z najnižjo stopnjo reverzibilnosti ob izhodišču (<5 %) je večinoma prišlo do manjšega bronhodilatatornega odziva kot pri bolnikih z višjo stopnjo reverzibilnosti ob izhodišču (≥5 %).
English: - When you start a new pack, use the new Ultibro Breezhaler inhaler that is supplied in the pack.
Slovenian: - Ko odprete novo škatlo z zdravilom, začnite uporabljati tudi nov inhalator Ultibro Breezhaler, ki je priložen pakiranju.
English: Keep the inhaler dry.
Slovenian: Inhalator naj bo vedno suh.
English: Breathe out fully Do not blow into the inhaler.
Slovenian: Izdihnite kolikor morete Ne pihajte v inhalator.
English: Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at an exposure 14-fold higher than in humans treated with indacaterol.
Slovenian: Čeprav indakaterol ni vplival na splošno sposobnost za razmnoževanje v študiji plodnosti na podganah, so v študiji obdobja razvoja in po zaključenem razvoju pri podganah opažali zmanjšano število nosečnosti v generaciji F1 pri izpostavljenosti zdravilu, ki je bila 14-krat večja kot pri ljudeh, ki prejemajo indakaterol.
English: Ultibro Breezhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Slovenian: Pri uporabi zdravila Ultibro Breezhaler je potrebna previdnost pri bolnikih s konvulzivnimi motnjami ali s hipertiroidizmom in pri bolnikih, ki so neobičajno odzivni na agoniste beta-2 adrenergičnih receptorjev.
English: Renal impairment has an impact on the systemic exposure to glycopyrronium bromide.
Slovenian: Okvara ledvic vpliva na sistemsko izpostavljenost glikopironijevemu bromidu.
English: Capsule content Lactose monohydrate Magnesium stearate
Slovenian: 6.1 Seznam pomožnih snovi Vsebina kapsule laktoza monohidrat magnezijev stearat
English: • Ultibro Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
Slovenian: • Ultibro Breezhaler kapsule vedno shranjujte v pretisnem omotu in jih vzemite iz njega šele tik pred uporabo.
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis, Ultibro Breezhaler should be used only if the expected benefit outweighs the potential risk.
Slovenian: Pri bolnikih s hudo okvaro ledvic ali s končno ledvično odpovedjo, ki potrebujejo dializo, se sme zdravilo Ultibro Breezhaler uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje.
English: Description of selected adverse reactions Cough was common, but usually of mild intensity.
Slovenian: Opis izbranih neželenih učinkov Kašelj se je pojavljal pogosto, vendar je bil običajno le blago izražen.
English: Symptomatic outcomes
Slovenian: Rezultati glede simptomov
English: Empty remaining
Slovenian: ostanki prazno praška
English: No specific interaction studies were conducted with Ultibro Breezhaler.
Slovenian: Specifičnih študij medsebojnega delovanja z zdravilom Ultibro Breezhaler niso izvedli.
English: Therefore, long-acting beta2-adrenergic agonists should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
Slovenian: Iz navedenih razlogov je pri uporabi dolgodelujočih agonistov beta-2 adrenergičnih receptorjev pri bolnikih z ugotovljenim ali domnevnim podaljšanjem intervala QT in pri tistih, ki prejemajo zdravila z vplivom na interval QT, potrebna previdnost.
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassiumsparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution (see section 4.4).
Slovenian: Sočasno zdravljenje z derivati metilksantina, s steroidi ali z diuretiki, ki ne varčujejo s kalijem, lahko okrepi možne hipokaliemične učinke agonistov beta-2 adrenergičnih receptorjev, zato je pri sočasni uporabi potrebna previdnost (glejte poglavje 4.4).
English: There are no data from the use of Ultibro Breezhaler in pregnant women available.
Slovenian: Ni podatkov o uporabi zdravila Ultibro Breezhaler pri nosečnicah.
English: Carcinogenicity studies in transgenic mice using oral administration and in rats using inhalation administration revealed no evidence of carcinogenicity at systemic exposures (AUC) of approximately 53-fold higher in mice and 75-fold higher in rats than the maximum recommended dose once daily for humans.
Slovenian: V študijah kancerogenosti na transgenskih miših, ki so jim učinkovino dajali peroralno, in na podganah, ki so učinkovino prejemale z inhalacijami, ni bilo nobenih znakov kancerogenega delovanja pri sistemski izpostavljenosti (AUC), ki je pri miših približno 53-krat, pri podganah pa 75-krat presegala izpostavljenost pri ljudeh pri odmerjanju najvišjega priporočenega odmerka enkrat na dan.
English: Patients with mild and moderate hepatic impairment showed no relevant changes in Cmax or AUC of indacaterol, nor did protein binding differ between mild and moderate hepatic impaired subjects and their healthy controls.
Slovenian: Pri bolnikih z blago in zmerno okvaro jeter ni prišlo do pomembnih sprememb Cmax ali AUC indakaterola, pa tudi vezava na proteine se pri bolnikih z blago in zmerno okvaro jeter ni razlikovala od tiste pri zdravih kontrolah.
English: This will also help you to remember to use it. You can inhale Ultibro Breezhaler any time before or after food or drink.
Slovenian: Zdravilo Ultibro Breezhaler lahko inhalirate kadarkoli, pred ali po uživanju hrane oziroma pijače.
English: Check Check capsule is empty
Slovenian: Preverite, da je kapsula prazna
English: The Ultibro Breezhaler clinical Phase III development programme included six studies in which over 8,000 patients were enrolled: 1) a 26-week placebo- and active-controlled (indacaterol once daily, glycopyrronium once daily, open-label tiotropium once daily) study; 2) a 26-week active-controlled (fluticasone/salmeterol twice daily) study; 3) a 64-week active-controlled (glycopyrronium once daily, open-label tiotropium once daily) study; 4) a 52-week placebo-controlled study; 5) a 3-week placeboand active-controlled (tiotropium once daily) exercise tolerance study; and 6) a 52-week activecontrolled (fluticasone/salmeterol twice daily) study.
Slovenian: Klinični razvojni program študij faze III zdravila Ultibro Breezhaler je vključeval šest študij, v katere je bilo vključenih več kot 8.000 bolnikov: 1) 26-tedensko s placebom in aktivno kontrolirano študijo (indakaterol enkrat na dan, glikopironij enkrat na dan in odprto zdravljenje s tiotropijem enkrat na dan), 2) 26-tedensko aktivno kontrolirano študijo (flutikazon/salmeterol dvakrat na dan), 3) 64-tedensko aktivno kontrolirano študijo (glikopironij enkrat na dan, odprto zdravljenje s tiotropijem enkrat na dan), 4) 52-tedensko s placebom kontrolirano študijo, 5) 3-tedensko s placebom in aktivno (s tiotropijem enkrat na dan) kontrolirano študijo prenašanja napora in 6) 52-tedensko aktivno kontrolirano študijo (flutikazon/salmeterol dvakrat na dan).
English: Glycopyrronium plasma concentrations declined in a multi-phasic manner.
Slovenian: Koncentracija glikopironija v plazmi se znižuje večfazno.
English: Steady-state exposure to glycopyrronium (AUC over the 24-hour dosing interval) was about 1.4- to 1.7-fold higher than after the first dose.
Slovenian: Izpostavljenost glikopironiju v stanju dinamičnega ravnovesja (AUC v 24-urnem odmernem intervalu) je bila približno 1,4-krat do 1,7-krat večja kot po prvem odmerku.
English: Renal elimination of parent drug accounts for about 60 to 70% of total clearance of systemically available glycopyrronium whereas non-renal clearance accounts for about 30 to 40%.
Slovenian: Izločanje nespremenjene učinkovine skozi ledvice znaša približno 60 % do 70 % celotnega očistka sistemsko razpoložljivega glikopironija, medtem ko procesi izločanja učinkovine po drugih poteh (neledvični očistek) prispevajo približno 30 % do 40 %.
English: What Ultibro Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Slovenian: Kaj vsebuje zdravilo Ultibro Breezhaler - Učinkovini sta indakaterol (v obliki maleata) in glikopironijev bromid.
English: Overall the effect on heart rate over time did not show a consistent pharmacodynamic effect of Ultibro Breezhaler.
Slovenian: V celoti rezultati opazovanja delovanja na srčno frekvenco v danem času niso potrdili enotnega farmakodinamičnega učinka zdravila Ultibro Breezhaler.
English: Upon initiation of treatment with Ultibro Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Slovenian: Pri sladkornih bolnikih je treba po začetku zdravljenja z zdravilom Ultibro Breezhaler še bolj natančno spremljati koncentracije glukoze v plazmi.