FrancophonIA/ELRC3.0 huggingface dataset:
English: Genotoxicity studies did not reveal any mutagenic or clastogenic potential for glycopyrronium bromide.
Danish: Genotoksicitetsstudier viste ikke mutagent eller klastogent potentiale for glycopyrroniumbromid.
English: • Feeling of pressure or pain in the cheeks and forehead
Danish: • En fornemmelse af trykken eller smerter i kinder og pande
English: Adverse reactions reported during the first six months of two pooled pivotal Phase III trials of 6 and 12 months duration are listed by MedDRA system organ class (Table 1).
Danish: Bivirkninger rapporteret i løbet af de første seks måneder i to pivotale fase III-studier med en varighed på 6 og 12 måneder er angivet i henhold til MedDRA-systemorganklasserne (tabel 1).
English: Pierce capsule by firmly pressing both side buttons at the same time.
Danish: Perforer kapslen ved samtidigt at trykke begge sideknapper helt ind.
English: Tovanor Breezhaler 44 micrograms once daily provided consistently statistically significant improvement in lung function (forced expiratory volume in one second, FEV1, forced vital capacity, FVC, and inspiratory capacity, IC) in a number of clinical studies.
Danish: Tovanor Breezhaler 44 mikrogram én gang dagligt medførte konsekvent, statistisk signifikant forbedring af lungefunktionen (forceret udåndingsvolumen i et sekund, FEV1, forceret vitalkapacitet, FVC, og inspiratorisk kapacitet, IC) i en række kliniske studier.
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-hæmningsstudier 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: Tovanor Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).
Danish: Tovanor Breezhaler kan bruges ved den anbefalede dosis til ældre patienter (75 år eller ældre) (se pkt.
English: 3H]-labelled glycopyrronium bromide to humans, the mean urinary excretion of radioactivity in 48 hours amounted to 85% of the dose.
Danish: 3H]-mærket glycopyrroniumbromid hos mennesker udgjorde middelværdien for urinudskillelse af radioaktivitet over 48 timer 85 % af dosis.
English: COPD exacerbation data was collected in the 6- and 12-month pivotal studies.
Danish: Data vedrørende KOL-eksacerbationer blev indsamlet i de 6-måneders og 12-måneders pivotale studier.
English: The clinical Phase III development programme included two phase III studies: a 6-month placebo-controlled study and a 12-month placebo and active-controlled (open label tiotropium 18 micrograms once daily) study, both in patients with clinical diagnosis of moderate to severe COPD.
Danish: Udviklingsprogrammet for den kliniske fase III omfattede to fase III-studier: et placebokontrolleret studie på 6 måneder og et placebo- og aktivkontrolleret studie (open-label tiotropium på 18 mikrogram én gang dagligt) på 12 måneder, hvor begge studier var med patienter med klinisk diagnosticeret moderat til svær KOL.
English: - When you start a new pack, use the new Tovanor Breezhaler inhaler that is supplied in the pack.
Danish: - Når du starter på en ny pakning, skal du bruge den nye Tovanor Breezhaler-inhalator, som er vedlagt pakningen.
English: The values for FEV1 at the end of the dosing interval (24 h post dose) were similar between the first dose and those seen after 1 year of dosing.
Danish: Værdierne for FEV1 i slutningen af doseringsintervallet (24 timer efter dosis) var tilsvarende mellem første dosis og dem, der sås efter 1 års dosering.
English: The absolute bioavailability of glycopyrromium inhaled via Tovanor Breezhaler was estimated to be about 45% of the delivered dose.
Danish: Den absolutte biotilgængelighed for glycopyrronium, inhaleret med Tovanor Breezhaler, blev estimeret til ca. 45 % af leveret dosis.
English: There was no attenuation of the bronchodilator effect over time in the 6and 12-month studies.
Danish: Den bronkodilaterende virkning aftog ikke over tid i studierne på 6 og 12 måneder.
English: In vitro metabolism studies showed consistent metabolic pathways for glycopyrronium bromide between animals and humans.
Danish: In vitro-metabolismestudier har vist overensstemmende metaboliske signalveje for glycopyrroniumbromid mellem dyr og mennesker.
English: • Tovanor Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
Danish: • Tovanor Breezhaler kapsler skal altid opbevares i den originale blister og må først tages ud umiddelbart inden anvendelse.
English: Each pack contains a device called an inhaler, together with capsules in blisters.
Danish: Hver pakning indeholder en inhalator, samt kapsler i blister.
English: • Difficulty breathing with wheezing or coughing (signs of paradoxical bronchospasm)
Danish: • Vejrtrækningsbesvær med hiven efter vejret eller hoste (tegn på paradoks bronkospasme)
English: In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%.
Danish: I et klinisk studie med raske frivillige forårsagede cimetidin, en hæmmer af organisk kation-transport, som menes at bidrage til renal udskillelse af glycopyrronium, en stigning i den samlede eksponering (AUC) for glycopyrronium på 22 % og en reduktion i renal clearance på 23 %.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tovanor Breezhaler in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Tovanor Breezhaler i alle undergrupper af den pædiatriske population med KOL (se pkt.
English: Concomitant administration of glycopyrronium and orally inhaled indacaterol, a beta2-adrenergic agonist, under steady-state conditions of both active substances did not affect the pharmacokinetics of either medicinal product.
Danish: Samtidig administration af glycopyrronium og oralt inhaleret indacaterol, som er en adrenerg beta2agonist, havde ingen indvirkning på farmakokinetikken for de to lægemidler under steady stateforhold for begge aktive stoffer.
English: This medicine contains an active substance called glycopyrronium bromide.
Danish: Dette lægemiddel indeholder et aktivt stof, der kaldes glycopyrroniumbromid.
English: Tovanor Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Danish: Tovanor Breezhaler er til langtidsvedligeholdelsesbehandling én gang daglig, og er ikke indiceret til initialbehandling af akutte tilfælde af bronkospasmer, dvs som anfaldsbehandling.
English: No change in mean heart rate or QTc interval was observed with Tovanor Breezhaler in doses up to 176 micrograms in COPD patients.
Danish: Der blev ikke observeret ændringer i middelhjertefrekvens eller QTc-interval med Tovanor Breezhaler i doser på op til 176 mikrogram hos KOL-patienter.
English: The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Tovanor Breezhaler inhaler in contrast to the half life after intravenous administration (see section 5.2).
Danish: Den lange virkningsvarighed kan delvist tillægges vedvarende koncentrationer af det aktive stof i lungerne, som afspejles af den forlængede terminale eliminationshalveringstid for glycopyrronium efter inhalation via Tovanor Breezhaler-inhalatoren i modsætning til halveringstiden efter intravenøs administration (se pkt.
English: In the 12-month study, the improvement versus placebo for tiotropium was 83 ml (p<0.001).
Danish: I studiet på 12 måneder var forbedringen i forhold til placebo for tiotropium 83 ml (p<0,001).
English: If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Danish: Hvis der opstår symptomer, som antyder allergiske reaktioner (specielt vejrtræknings- eller synkebesvær, hævet tunge, læber og ansigt, urticaria, hududslæt), skal behandlingen seponeres med det samme og alternativ terapi startes.
English: This includes medicines similar to Tovanor Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
Danish: Det gælder også for medicin tilsvarende Tovanor Breezhaler, som bruges i forbindelse med din lungelidelse, f.eks. ipratropium, oxitropium eller tiotropium (såkaldte antikolinerge lægemidler).
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 for males or >470 ms for females) were excluded from the clinical trials, and therefore the experience in these patient groups is limited.
Danish: Patienter med ustabil iskæmisk hjertelidelse, venstreventrikulær dysfunktion, tidligere myokardie infarkt, arytmi (eksklusive kronisk stabil atriflimren), kendt langt QT-syndrom eller hvis QTc (Fridericia metode) var forlænget (>450 ms for mænd eller >470 ms for kvinder) blev ekskluderet i de kliniske studier, og erfaringen med disse patientgrupper er derfor begrænset.
English: How to inhale Tovanor Breezhaler - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Danish: Sådan skal du inhalere Tovanor Breezhaler - Denne pakning indeholder en inhalator og kapsler (i blister), som indeholder medicinen i form af et inhalationspulver.
English: Please read the full Instructions for Use before using the Tovanor Breezhaler.
Danish: Læs venligst den fulde anvisning for brug inden du bruger Tovanor Breezhaler.
English: Remove empty capsule Put the empty capsule in your household waste.
Danish: Fjern den tomme kapsel Smid kapslen ud sammen med almindeligt husholdningsaffald.
English: The co-administration of Tovanor Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.
Danish: Samtidig behandling med Tovanor Breezhaler og andre antikolinerge lægemidler er ikke undersøgt og anbefales derfor ikke.
English: They have the product code “GPL50” printed in black above and a company logo ( ) printed in black below a black bar.
Danish: De har påtrykt en sort produktkode ”GPL50” over og virksomhedens logo ( ) er påtrykt i sort under en sort bjælke.
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 of 44 micrograms once daily for humans.
Danish: Karcinogenicitetsstudier 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 dosis på 44 mikrogram én gang dagligt for mennesker.
English: Patients with a history of cardiovascular disease
Danish: Patienter med kendt kardiovaskulær sygdom
English: A slight reduction in heart rate (mean difference over 24 h -2 bpm when compared to placebo), which is a known effect of low exposures to anticholinergic compounds in young healthy subjects, was observed.
Danish: Der blev observeret en mindre reduktion i hjertefrekvens (middel forskel over 24 timer var -2 slag pr. minut ved sammenligning med placebo), hvilket er en kendt virkning af lave eksponeringer for antikolinerge stoffer hos unge raske forsøgspersoner.
English: • Pain in muscles, bones or joints of the chest
Danish: • Smerter i muskler, knogler eller led i brystet
English: • Diarrhoea or stomach ache
Danish: • Diare eller mavesmerter
English: Glycopyrronium is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment.
Danish: Glycopyrronium udskilles hovedsageligt via nyren, og der forventes derfor ikke en større stigning i eksponeringen hos patienter med nedsat leverfunktion.
English: • Rash, itching, hives, difficulty breathing or swallowing, dizziness (possible signs of allergic reaction)
Danish: • Udslæt, kløe, nældefeber, problemer med at trække vejret eller synke, svimmelhed (mulige tegn på allergisk reaktion)
English: Glycopyrronium should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Danish: Glycopyrronium må kun anvendes under graviditet, hvis den forventede fordel opvejer den potentielle risiko for fosteret.
English: Peak exposures (Cmax) about 50-fold higher than after inhalation of glycopyrronium 44 micrograms at steady state were achieved and did not result in tachycardia or QTc prolongation.
Danish: Maksimal eksponering (Cmax) på omkring 50 gange større end efter inhalation af glycopyrronum 44 mikrogram ved steady state blev opnået og medførte ikke takykardi eller QTcforlængelse.
English: Transparent orange capsules containing a white powder, with the product code “GPL50” printed in black above and the company logo ( ) printed in black below a black bar.
Danish: Gennemsigtige, orange kapsler med et hvidt pulver med ”GPL50” påtrykt i sort over og virksomhedens logo ( ) påtrykt i sort under en sort bjælke.
English: • Do not use the Tovanor Breezhaler capsules with any other inhaler.
Danish: • Brug ikke Tovanor Breezhaler kapsler med nogen anden inhalator.
English: Talk to your doctor before using Tovanor Breezhaler, if any of the following applies to you: - you have kidney problems.
Danish: Kontakt lægen, før du bruger Tovanor Breezhaler, hvis nogen af nedenstående forhold gælder for dig: - hvis du har nyreproblemer.
English: In the 12-month study, the improvements were 87 ml at 5 minutes and 143 ml at 15 minutes (both p<0.001).
Danish: I studiet på 12 måneder var forbedringerne på 87 ml ved 5 minutter og 143 ml ved 15 minutter (begge med p<0,001).
English: On the first day of treatment inspiratory capacity under exercise was improved by 230 ml and exercise endurance time was improved by 43 seconds (an increase of 10%) compared to placebo.
Danish: På behandlingens første dag blev den inspiratoriske kapacitet under motion forbedret med 230 ml, og den fysiske udholdenhed blev forbedret med 43 sekunder (en forøgelse på 10 %) sammenlignet med placebo.
English: In vitro enzyme induction studies did not indicate a clinically relevant induction by glycopyrronium bromide for cytochrome P450 isoenzymes, or for UGT1A1 and the transporters MDR1 and MRP2.
Danish: In vitro-studier med enzyminduktion har ikke indikeret, at glycopyrroniumbromid medfører en klinisk relevant induktion af cytochrom P450-isoenzymer eller af UGT1A1 og transportørerne MDR1 og MRP2.
English: The use of glycopyrronium 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 glycopyrronium hos ammende kvinder bør kun overvejes, hvis den forventede fordel for kvinden er større end den potentielle risiko for spædbarnet (se pkt.
English: In phase III studies, bronchodilator effects were seen within 5 minutes after the first dose and were maintained over the 24-hour dosing interval from the first dose.
Danish: I kliniske fase III-studier sås bronkodilaterende virkninger inden for 5 minutter efter første dosis, og disse blev opretholdt i løbet af doseringsintervallet på 24 timer fra første dosis.
English: These were reported voluntarily from a population of uncertain size, and it is therefore not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Danish: Det er derfor ikke altid muligt på pålidelig vis at estimere frekvensen eller fastslå en årsagssammenhæng til eksponering for lægemidlet.
English: In a 3-week study where exercise tolerance was tested via cycle ergometer at submaximal (80%) workload (submaximal exercise tolerance test), Tovanor Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Danish: I et studie på 3 uger, hvor fysisk udholdenhed blev undersøgt ved cykelergometri ved submaksimal (80 %) arbejdsbelastning (submaksimal fysisk udholdenhedstest), reducerede Tovanor Breezhaler givet om morgenen dynamisk hyperinflation og forbedrede varigheden af den tid patienten kunne motionere fra første dosis og frem.
English: Tovanor Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Danish: Tovanor Breezhaler skal bruges med forsigtighed til patienter med snævervinklet glaukom eller urinretention.
English: The effect on heart rate and QTc interval of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) administered intravenously was investigated in young healthy subjects.
Danish: Virkningen på hjertefrekvens og QTc-interval for 150 mikrogram glycopyrroniumbromid (svarende til 120 mikrogram glycopyrronium), administreret intravenøst, blev undersøgt hos unge raske forsøgspersoner.
English: Step 1b: Open inhaler
Danish: Trin 1b: Åben inhalatoren
English: Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Tovanor Breezhaler er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: Tovanor Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI).
Danish: Tovanor Breezhaler administreret som 44 mikrogram én gang dagligt reducerer åndenød statistisk signifikant evalueret ved TDI (Transitional Dyspnoea Index).
English: In the pooled 6-month database the frequency of dry mouth was 2.2% versus 1.1%, of insomnia 1.0% versus 0.8%, and of gastroenteritis 1.4% versus 0.9%, for Tovanor Breezhaler and placebo respectively.
Danish: I den samlede database for 6 måneder var hyppigheden for mundtørhed 2,2 % vs. 1,1 %, for søvnløshed 1,0 % vs. 0,8 % og for gastroenteritis 1,4 % vs. 0,9 %, for henholdsvis Tovanor Breezhaler og placebo.
English: In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Tovanor Breezhaler 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 Tovanor Breezhaler anvendes ved den anbefalede dosis.
English: Secondary pharmacodynamic effects
Danish: Sekundære farmakodynamiske virkninger
English: Store the capsules in the original blister in order to protect from moisture.
Danish: Opbevar kapslerne i den originale blister for at beskytte mod fugt.
English: Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Tovanor Breezhaler and were well tolerated.
Danish: Maksimale plasmaniveauer og samlet systemisk eksponering efter intravenøs administration af 150 mikrogram glycopyrroniumbromid (svarende til 120 mikrogram glycopyrronium) hos raske frivillige var henholdsvis omkring 50 og 6 gange højere end det maksimale plasmaniveau og den samlede eksponering ved steady state, som blev opnået med den anbefalede dosis (44 mikrogram én gang dagligt) af Tovanor Breezhaler, og var veltolereret.
English: 6 x 1 capsules + 1 inhaler 10 x 1 capsules + 1 inhaler 12 x 1 capsules + 1 inhaler 30 x 1 capsules + 1 inhaler
Danish: 6 x 1 kapsler + 1 inhalator 10 x 1 kapsler + 1 inhalator 12 x 1 kapsler + 1 inhalator 30 x 1 kapsler + 1 inhalator
English: Driving and using machines It is unlikely that this medicine will affect your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Dette lægemiddel menes ikke at påvirke evnen til at køre bil eller betjene maskiner.
English: However, glycopyrronium bromide (including its metabolites) was excreted in the milk of lactating rats (see section 5.3).
Danish: Glycopyrroniumbromid (herunder metabolitter) udskilles imidlertid i mælk fra diende rotter (se pkt.
English: - if you experience difficulties in breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of allergic reaction).
Danish: - hvis du oplever problemer med at trække vejret eller synke, hævelse af tunge, læber eller ansigt, hududslæt, kløe og nældefeber (tegn på allergisk reaktion).
English: The capsules must only be removed immediately before use.
Danish: Kapslerne må først tages ud umiddelbart inden anvendelse.
English: These findings were similar to those seen in patients receiving tiotropium, 53.4% of whom responded with 1 point or greater improvement (p=0.009 compared to placebo).
Danish: Disse resultater var svarende til dem, der sås hos patienter på tiotropium, hvor 53,4 % reagerede med en forbedring på 1 point eller mere (p=0,009 sammenlignet med placebo).
English: Tovanor Breezhaler is used as a maintenance treatment for your COPD.
Danish: Tovanor Breezhaler anvendes som vedligeholdelsesbehandling af din KOL.
English: Blister Card
Danish: Blisterkort
English: In a thorough QT study in 73 healthy volunteers, a single inhaled dose of glycopyrronium 352 micrograms (8 times the therapeutic dose) did not prolong the QTc interval and slightly reduced heart rate (maximal effect -5.9 bpm; average effect over 24 hours -2.8 bpm) when compared to placebo.
Danish: I et thorough QT-studie med 73 raske frivillige forlængede en enkelt inhaleret dosis på 352 mikrogram af glycopyrronium (8 gange den terapeutisk dosis) ikke QTc-intervallet og reducerede hjertefrekvensen lidt (maksimal virkning -5,9 slag pr. minut; gennemsnitlig virkning over 24 timer -2,8 slag pr. minut) sammenlignet med placebo.
English: Tovanor Breezhaler once daily statistically significantly reduced the use of rescue medication (salbutamol) by 0.46 puffs per day (p=0.005) over 26 weeks and by 0.37 puffs per day (p=0.039) over 52 weeks, compared to placebo for the 6- and 12-month studies, respectively.
Danish: Tovanor Breezhaler én gang dagligt reducerede brugen af anfaldsmedicin (salbutamol) statistisk signifikant med 0,46 sug pr. dag (p=0,005) i løbet af 26 uger og med 0,37 sug pr. dag (p=0,039) i løbet af 52 uger sammenlignet med placebo i henholdsvis studierne på 6 og 12 måneder.
English: Tovanor Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Danish: Tovanor Breezhaler kan bruges ved den anbefalede dosis hos patienter med let til moderat nedsat nyrefunktion.
English: • Do not use the Tovanor Breezhaler inhaler to take any other capsule medicine.
Danish: • Brug ikke Tovanor Breezhaler inhalatoren til at tage anden kapselmedicin.
English: The capsules must always be stored in the original blister in order to protect from moisture.
Danish: Kapslerne skal altid opbevares i den originale blisterpakning for at beskytte mod fugt.
English: When to inhale Tovanor Breezhaler Use this medicine at the same time each day.
Danish: Tidspunkt for inhalering af Tovanor Breezhaler Brug dette lægemiddel på samme tidspunkt hver dag.