FrancophonIA/ELRC3.0 huggingface dataset:
English: Glycopyrronium bromide and its metabolites did not significantly cross the placental barrier of pregnant mice, rabbits and dogs.
Danish: Glycopyrroniumbromid og dets metabolitter krydsede ikke i signifikant grad placentabarrieren hos drægtige mus, kaniner og hunde.
English: Indacaterol, one of the active substances in Ultibro Breezhaler, may prevent labour due to its effect on the uterus.
Danish: Indacaterol, et af de aktive stoffer i Ultibro Breezhaler, kan muligvis forhindre veer på grund af effekten på livmoderen.
English: During treatment with Ultibro Breezhaler - Stop using this medicine and seek medical help immediately if you experience any of the following: eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes - these may be signs of an acute attack of narrow-angle glaucoma.
Danish: Under behandling med Ultibro Breezhaler - Stop med at tage medicinen og søg lægehjælp øjeblikkeligt, hvis du oplever en af følgende tilstande: øjensmerter eller -ubehag, midlertidig sløring af synet, visuelle ringe eller farvet syn i forbindelse med røde øjne.
English: - When you start a new pack, use the new Ultibro Breezhaler inhaler that is supplied in the pack.
Danish: - Når du starter på en ny pakning, skal du bruge den nye Ultibro Breezhaler-inhalator, som er vedlagt pakningen.
English: When indacaterol and glycopyrronium are administered together in Ultibro Breezhaler, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve smooth muscle relaxation.
Danish: Når indacaterol og glycopyrronium gives samtidig i Ultibro Breezhaler, udøver de en additiv virkning grundet deres forskellige virkningsmekanisme, der er målrettet forskellige receptorer og signalveje til at opnå afslappelse af den glatte muskulatur.
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.
Danish: Virkninger, som kan tilskrives glycopyrroniumbromids egenskaber som muskarinreceptorantagonist, omfattede mildt til moderat forøgelse i hjertefrekvensen hos hunde, uklarhed i linse hos rotter og reversible ændringer forbundet med reduceret glandulær sekretion hos rotter og hunde.
English: However, the occurrence of dizziness may influence the ability to drive and use machines (see section 4.8).
Danish: Forekomst af svimmelhed kan dog påvirke evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: Excipient(s) with known effect Each capsule contains 23.5 mg lactose (as monohydrate).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver kapsel indeholder 23,5 mg lactose (som monohydrat).
English: Following inhalation of Ultibro Breezhaler, the median time to reach peak plasma concentrations of indacaterol and glycopyrronium was approximately 15 minutes and 5 minutes, respectively.
Danish: Efter inhalation af Ultibro Breezhaler var mediantiden for opnåelse af maksimal plasmakoncentration af glycopyrronium og indacaterol henholdsvis ca. 15 minutter og 5 minutter.
English: Active tubular secretion contributes to the renal elimination of glycopyrronium.
Danish: Aktiv tubular sekretion bidrager til renal udskillelse af glycopyrronium.
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.
Danish: Hos KOL-patienter med mildt og moderat nedsat nyrefunktion (estimeret glomerulær filtrationshastighed, eGFR ≥30 ml/min/1,73 m2) kan glycopyrroniumbromid anvendes ved den anbefalede dosis.
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.
Danish: Patienter skal informeres om tegn og symptomer på akut snævervinklet glaukom og skal informeres om øjeblikkelig seponering af Ultibro Breezhaler, hvis patienten udvikler nogle af disse tegn eller symptomer.
English: There were no relevant effects of Ultibro Breezhaler on mean heart rate over 24 h and heart rate assessed after 30 minutes, 4 h and 24 h.
Danish: Der var ingen relevante virkninger af Ultibro Breezhaler på den gennemsnitlige hjertefrekvens i løbet af 24 timer og på hjertefrekvensen målt efter 30 minutter, 4 timer og 24 timer.
English: A population pharmacokinetic analysis showed that there is no clinically relevant effect of age (adults up to 88 years), sex, weight (32-168 kg) or race on the pharmacokinetics of indacaterol.
Danish: En farmakokinetisk populationsanalyse viste, at alder (voksne op til 88 år), køn, vægt (32-168 kg) eller race ikke har klinisk relevant indflydelse på farmakokinetikken af indacaterol.
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.
Danish: Steady state-eksponering for glycopyrronium (AUC i løbet af dosisregimet på 24 timer) var ca. 1,4 til 1,7 gange større end efter første dosis.
English: There is no information on clinically relevant overdosing with Ultibro Breezhaler.
Danish: Der er ingen information vedrørende klinisk relevant overdosering med Ultibro Breezhaler.
English: Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.
Danish: Glycopyrronium virker ved at blokere den bronkokonstriktive virkning af acetylkolin på luftvejenes glatte muskelceller, hvilket udvider luftvejene.
English: Ultibro Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Danish: Indgift af Ultibro Breezhaler om morgenen reducerede dynamisk hyperinflation og forøgede tiden hvor fysisk aktivitet kunne opretholdes fra første dosis.
English: Ultibro Breezhaler showed clinically meaningful improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) in a number of clinical studies.
Danish: Ultibro Breezhaler viste klinisk relevant forbedring af lungefunktionen (målt ved forceret ekspiration i et sekund, FEV1) i en række kliniske studier.
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.
Danish: Karcinogenicitetsforsøg hos transgene mus ved oral administration og hos rotter ved inhalationsadministration viste ikke tegn på karcinogenicitet ved systemisk eksponering (AUC) på ca. 53 gange større hos mus og 75 gange større hos rotter end den anbefalede maksimale én gang daglig dosis for mennesker
English: The use of Ultibro Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Danish: Anvendelsen af Ultibro Breezehaler hos ammende kvinder bør kun overvejes, hvis den forventede fordel for kvinden er større end den potentielle risiko for spædbarnet (se pkt.
English: Genotoxicity studies did not reveal any mutagenic or clastogenic potential.
Danish: Genotoksicitetsforsøg viste ikke mutagent eller klastogent potentiale.
English: Close the inhaler and repeat steps 3a to 3c.
Danish: Luk inhalatoren og gentag trin 3a til 3c.
English: Close the inhaler.
Danish: Luk inhalatoren.
English: Effects on the cardiovascular system attributable to the beta2-agonistic properties of indacaterol included tachycardia, arrhythmias and myocardial lesions in dogs.
Danish: Virkninger på det kardiovaskulære system, som skyldes indacaterols beta2-agonistiske egenskaber, omfattede takykardi, arytmier og myokardielæsioner hos hunde.
English: Capsules with transparent yellow cap and natural transparent body containing a white to almost white powder, with the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap.
Danish: Kapsler med gennemsigtig gul hætte og naturfarvet gennemsigtig underdel indeholdende et hvidt til næsten hvidt pulver og påtrykt produktkoden ”IGP110.50” i blåt under to blå bjælker på underdelen og firmalogoet ( ) i sort på hætten.
English: Inhale the medicine again by repeating steps 3a to 3c.
Danish: Inhaler medicinen igen ved at gentage trin 3a til 3c.
English: Ultibro Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Danish: Ultibro Breezhaler skal anvendes med forsigtighed hos patienter med kardiovaskulære sygdomme (koronar hjertesygdom, akut myokardieinfarkt, hjertearytmier, hypertension)
English: Concomitant administration of other sympathomimetics (alone or as part of combination therapy) may potentiate the adverse events of indacaterol (see section 4.4).
Danish: Samtidig anvendelse af andre sympatomimetika stoffer (alene eller som del af kombinationsbehandling) kan potensere bivirkninger ved indacaterol (se pkt.
English: Beta2-adrenergic agonists may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms.
Danish: Beta2-adrenerge agonister kan medføre klinisk signifikante kardiovaskulære virkninger hos nogle patienter, hvilket ses som øget pulsfrekvens, blodtryk og/eller andre symptomer.
English: There was no evidence for tachyphylaxis to the effect of Ultibro Breezhaler over time when compared to placebo or its monotherapy components.
Danish: Der var ikke tegn på takyfylaksi over for virkningen af Ultibro Breezhaler over tid ved sammenligning med placebo eller dets monoterapikomponenter.
English: Please read the full Instructions for Use before using the Ultibro Breezhaler.
Danish: Læs venligst den fulde anvisning for brug inden du bruger Ultibro Breezhaler.
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.
Danish: In vitro-hæmningsforsøg påviste, at glycopyrroniumbromid ikke har relevant kapacitet til at hæmme CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A4/5, effluxtransportørerne MDR1, MRP2 eller MXR og optagelsestransportørerne OCT1 eller OCT2.
English: Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ultibro Breezhaler.
Danish: Der er rapporteret øjeblikkelige overfølsomhedsreaktioner efter administration af indacaterol eller glycopyrronium, som er de aktive stoffer i Ultibro Breezhaler.
English: Available pharmacokinetic/toxicological data have shown excretion of indacaterol, glycopyrronium and their metabolites in the milk of lactating rats.
Danish: De tilgængelige farmakokinetiske/toksikologiske data har vist udskillelse af indacaterol, glycopyrronium og deres metabolitter i mælk fra diende rotter.
English: This medicinal product has no or negligible influence on influence on the ability to drive and use machines.
Danish: Dette lægemiddel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: • blocked nose, sneezing, cough, headache with or without fever - these may be signs of an upper respiratory tract infection.
Danish: • tilstoppet næse, nysen, hoste, hovedpine med eller uden feber - disse kan være tegn på øvre luftvejsinfektion.
English: The combination of indacaterol and glycopyrronium in Ultibro Breezhaler showed a rapid onset of action within 5 minutes after dosing.
Danish: Kombinationen af indacaterol og glycopyrronium i Ultibro Breezhaler viste en hurtigt indsættende virkning inden for 5 minutter efter dosering.
English: Inhalation powder, hard capsule (inhalation powder).
Danish: Inhalationspulver, hård kapsel (inhalationspulver).
English: Clinical studies have not been conducted in patients with hepatic impairment.
Danish: Der er ikke udført kliniske studier hos patienter med nedsat leverfunktion.
English: Parasympathetic nerves are the major bronchoconstrictive neural pathway in airways, and cholinergic tone is the key reversible component of airflow obstruction in COPD.
Danish: Parasympatiske nerver er de primære bronkokonstriktive neurale signalveje i luftvejene, og kolinerg tonus er den vigtigste reversible komponent for luftvejsobstruktion ved KOL.
English: • feeling of pressure or pain in the cheeks and forehead - these may be signs of inflammation of the sinuses called sinusitis.
Danish: • følelsen af trykken eller smerte i kinder og pande - dette kan være tegn på bihulebetændelse kaldet sinusitis.
English: • Do not press the side buttons while inhaling through the mouthpiece.
Danish: • Tryk ikke på sideknapperne mens du inhalerer gennem mundstykket.
English: If you use more Ultibro Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Danish: Hvis du har inhaleret for meget af dette lægemiddel, eller hvis andre personer ved et uheld bruger dine kapsler, skal du øjeblikkeligt fortælle det til din læge eller henvende dig til den nærmeste skadestue.
English: Method of administration For inhalation use only.
Danish: Administration Kun til inhalation.
English: In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility to cardiac arrhythmias (see section 4.5).
Danish: Hos patienter med svær KOL kan hypokaliæmi potenseres af hypoksi og samtidig behandling, hvilket kan øge tilbøjeligheden til hjertearytmier (se pkt.
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.
Danish: Ultibro Breezhaler skal anvendes med forsigtighed hos patienter med konvulsive sygdomme eller tyrotoksikose og hos patienter, som er usædvanlig responsive over for beta2-adrenerge agonister.
English: This will also help you to remember to use it. You can inhale Ultibro Breezhaler any time before or after food or drink.
Danish: Du kan inhalere Ultibro Breezhaler på hvilket som helst tidspunkt før og efter indtagelse af mad og drikke.
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.
Danish: For at opnå bronkodilatation i både de perifære og centrale luftveje hos mennesker, kan det derfor være en fordel at kombinere en beta2-adrenerg agonist og en muskarinantagonist.
English: Heart rate in COPD patients at supratherapeutic dose levels was investigated.
Danish: Der blev udført undersøgelse af hjertefrekvensen hos KOL-patienter ved supraterapeutiske dosisniveauer.
English: If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.
Danish: Hvis noget af ovenstående passer på dig (eller du er usikker) så tal med din læge, apotekspersonalet eller sygeplejerske, før du tager denne medicin.
English: Inhibition or induction of the metabolism of glycopyrronium is unlikely to result in a relevant change of systemic exposure to the active substance.
Danish: Det er usandsynligt, at en hæmning eller induktion af glycopyrroniums metabolisme resulterer i en relevant ændring i systemisk eksponering for det aktive stof.
English: Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Ultibro Breezhaler er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: A diastereomer of the hydroxylated derivative, a N-glucuronide of indacaterol, and C- and N-dealkylated products were further metabolites identified.
Danish: En diastereomer af det hydroxylerede derivat, en N-glucuronid af indacaterol og C- og N-dealkylerede stoffer var andre identificerede metabolitter.
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).
Danish: Brug af Ultibro Breezhaler sammen med andre lægemidler indeholdende antikolinergika er ikke undersøgt og kan derfor ikke anbefales (se pkt.
English: Remove empty capsule Put the empty capsule in your household waste.
Danish: Fjern den tomme kapsel Smid kapslen ud med almindeligt husholdningsaffald.
English: Increased heart rates were apparent in dogs at all doses of Ultibro Breezhaler and each monotherapy component.
Danish: Der var tydeligt øget hjertefrekvens hos hunde ved alle doser Ultibro Breezhaler og hver monoterapikomponent.
English: Ultibro Breezhaler is used as an ongoing treatment for your COPD.
Danish: Ultibro Breezhaler anvendes som en vedvarende behandling af din KOL.
English: Therefore, Ultibro Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Danish: Derfor må Ultibro Breezhaler kun anvendes under graviditet, hvis den forventede fordel opvejer den potentielle risiko for fosteret.
English: - Peel the backing away from the blister to open it - do not push the capsule through the foil.
Danish: - Træk bagbeklædningen af blisteren for at åbne den - tryk ikke kapslen gennem folien.
English: • Do not use the Ultibro Breezhaler capsules with any other inhaler.
Danish: • Brug ikke Ultibro Breezhaler kapsler med nogen anden inhalator.
English: The steady-state mean peak and trough plasma concentrations of glycopyrronium at the recommended once-daily dosing regimen were 166 picograms/ml and 8 picograms/ml, respectively.
Danish: Gennemsnitlige maksimal og minimum plasmakoncentrationer af glycopyrronium for det anbefalede dosisregime én gang dagligt var henholdsvis 166 picogram/ml og 8 picogram/ml.
English: Your Ultibro Breezhaler Inhaler pack contains:
Danish: Din Ultibro Breezhaler inhalatorpakning indeholder:
English: Step 1d:
Danish: Trin 1d:
English: Phenolic O-glucuronides of indacaterol and hydroxylated indacaterol were further prominent metabolites.
Danish: Phenol-O-glucuronid af indacaterol og hydroxyleret indacaterol var ligeledes fremtrædende metabolitter.
English: Mean renal clearance of glycopyrronium following inhalation was in the range of 17.4 and 24.4 litres/h.
Danish: Middeltallet for renal clearance af glycopyrronium efter inhalation lå i intervallet fra 17,4 til 24,4 liter/time.
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.
Danish: Det kliniske Fase III-udviklingsprogram for Ultibro Breezhaler omfattede seks studier, der inkluderede mere end 8.000 patienter: 1) et 26-ugers placebo- og aktiv-kontrolleret studie (indacaterol én gang dagligt, glycopyrronium én gang dagligt, open-label tiotropium én gang dagligt); 2) et 26-ugers aktivkontrolleret studie (fluticason/salmeterol to gange dagligt); 3) et 64-ugers aktivkontrolleret studie (glycopyrronium én gang dagligt, open-label tiotropium én gang dagligt); 4) et 52-ugers placebokontrolleret studie; 5) et 3-ugers placebo- og aktiv-kontrolleret (tiotropium én gang dagligt) arbejdstolerance-studie og 6) et 52-ugers aktiv-kontrolleret studie (fluticason/salmeterol to gange dagligt).
English: Check Check capsule is empty
Danish: Tjek Tjek at kapslen er tom
English: Symptomatic outcomes
Danish: Symptomatiske fordele
English: In vitro enzyme induction studies did not indicate a clinically relevant induction by glycopyrronium bromide for any of the cytochrome P450 isoenzymes tested or for UGT1A1 and the transporters MDR1 and MRP2.
Danish: In vitro-forsøg med enzyminduktion har ikke indikeret, at glycopyrroniumbromid medfører en klinisk relevant induktion af de testede cytochrom P450-isoenzymer eller af UGT1A1 og transportørerne MDR1 og MRP2.
English: A population pharmacokinetic analysis of data in COPD patients after inhalation of Ultibro Breezhaler indicated no significant effect of age, gender and (lean body) weight on the systemic exposure to indacaterol and glycopyrronium.
Danish: En farmakokinetisk populationsanalyse af data fra KOL-patienter efter inhalation af Ultibro Breezhaler viste ingen signifikant virkning af alder, køn og (fedt-fri) legemsvægt på systemisk eksponering af indacaterol og glycopyrronium.
English: • eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes - these may be signs of glaucoma.
Danish: • øjensmerte eller utilpashed, midlertidig sløring af synet, visuelle ringe i synet eller farvede billeder samtidig med røde øjne - dette kan være tegn på grøn stær.
English: You should not use Ultibro Breezhaler unless your doctor tells you to do so.
Danish: Du må ikke tage Ultibro Breezhaler, medmindre du har aftalt det med din læge.
English: • irregular heartbeat.
Danish: • uregelmæssig hjerterytme.
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.
Danish: Hos KOL-patienter øges både systemisk eksponering for og samlet urinudskillelse af glycopyrronium omtrentligt dosisproportionalt i (leveret) dosisområde 44 til 176 mikrogram ved farmakokinetisk steady state.
English: Glycopyrronium After intravenous administration of [
Danish: Glycopyrronium Efter intravenøs administration af [
English: Capsule content Lactose monohydrate Magnesium stearate
Danish: Kapselindhold Lactosemonohydrat Magnesiumstearat
English: Ultibro Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Ultibro Breezhaler belong (see section 4.5).
Danish: Ultibro Breezhaler bør ikke anvendes sammen med lægemidler indeholdende andre langtidsvirkende beta-adrenerge agonister eller langtidsvirkende muskarine antagonister, der er de farmakoterapeutiske grupper, som komponenterne i Ultibro Breezhaler tilhører (se pkt.
English: There was no attenuation of the bronchodilator effect over time.
Danish: Den bronkodilaterende virkning aftog ikke over tid.
English: The highest dose level of 464 micrograms/86 micrograms Ultibro Breezhaler also showed a higher proportion of absolute QTcF values >450 ms (12.2% vs. 5.7% for placebo).
Danish: Det højeste doseringsniveau på 464 mikrogram/86 mikrogram Ultibro Breezhaler viste også en højere andel af absolutte QTcF-værdier >450 ms (12,2 % versus 5,7 % for placebo).
English: Similarly, for glycopyrronium no QT prolongation was observed in a TQT study after an inhaled dose of 8 times the recommended therapeutic dose.
Danish: Ligeledes blev der ikke set QT-forlængelse i et TQT-studie for glycopyrronium efter inhalation af en dosis, der var 8 gange højere end den anbefalede terapeutiske dosis.
English: Infections and infestations Upper respiratory tract infection
Danish: Infektioner og parasitære sygdomme Infektion i øvre luftveje