FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not put the pressurised container back into the actuator if it is still wet.
Danish: Sæt ikke trykbeholderen tilbage i plasthylsteret, hvis det stadigvæk er fugtigt.
English: There were improvements compared to formoterol in PINNACLE 1 and PINNACLE 2.
Danish: Der var forbedringer sammenlignet med formoterol i PINNACLE 1 og PINNACLE 2.
English: Studies evaluating the effect of renal impairment on the pharmacokinetics of glycopyrronium and formoterol have not been conducted.
Danish: Studier, der vurderer effekten af nyreinsufficiens på farmakokinetikken af glycopyrronium og formoterol, er ikke udført.
English: Clinical drug-drug interaction studies have not been conducted with Bevespi Aerosphere, however, the potential for metabolic interactions is considered to be low based on in-vitro studies (see section 5.2).
Danish: Kliniske interaktionsstudier er ikke blevet udført for Bevespi Aerosphere, dog anses den potentielle risiko for metaboliske interaktioner for lav baseret på in vitro-studier (se pkt.
English: Step 2: Shake the inhaler well before each use (See Figure 7).
Danish: Trin 2: Omryst inhalatoren omhyggeligt før hver brug (se figur 7).
English: The effect of renal impairment on the exposure to glycopyrronium and formoterol for up to 12 weeks was evaluated in a population pharmacokinetic analysis.
Danish: Effekten af nyreinsufficiens på eksponeringen af glycopyrronium og formoterol i op til 12 uger, er blevet evalueret i en populationsfarmakokinetisk analyse.
English: • shaking or tremor
Danish: • rysten eller skælven
English: These include medicines for the treatment of: o depression (such as monoamine oxidase inhibitors or tricyclic antidepressants), o bacterial infections (such as erythromycin, clarithromycin, telithromycin), o allergic reactions (anti-histamines).
Danish: Dette omfatter medicin til behandling af: o depression (såsom monoaminoxidasehæmmere eller tricykliske antidepressive lægemidler) o bakterieinfektioner (såsom erythromycin, clarithromycin, telithromycin) o allergiske reaktioner (antihistaminer).
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including glycopyrronium or formoterol.
Danish: Kardiovaskulære virkninger såsom hjertearytmier, f.eks. arterieflimren og takykardi, kan ses efter administration af muskarine receptorantagonister og sympatomimetika, inklusive glycopyrronium eller formoterol.
English: number in Intent to Treat population primary endpoint in all studies PINNACLE 1 and PINNACLE 2 used SAC-TDI.
Danish: Antal i Intent to treat-population primært endemål i alle studier PINNACLE 1 og PINNACLE 2 anvendte SAC-TDI.
English: Improvements compared to formoterol were observed in PINNACLE 2 (see Table 2).
Danish: Der blev observeret forbedringer sammenlignet med formoterol i PINNACLE 2 (se tabel 2).
English: EXP To be used within 3 months of opening the pouch.
Danish: EXP Skal anvendes inden for 3 måneder efter åbning af posen.
English: A population pharmacokinetic analysis of formoterol was performed based on data collected in a total of 437 subjects with COPD.
Danish: En populationsfarmakokinetisk analyse af formoterol blev udført baseret på data indsamlet fra i alt 437 forsøgspersoner med KOL.
English: • medicines called beta-blockers that may be used to treat high blood pressure or other heart problems (such as atenolol or propranolol) or to treat glaucoma (such as timolol)
Danish: • medicin, der kaldes betablokkere, som kan bruges til behandling af forhøjet blodtryk eller andre hjerteproblemer (såsom atenolol eller propranolol) eller til behandling af grøn stær (såsom timolol)
English: Figure 2a 120 puffs
Danish: Figur 2a 120 doser
English: The clinical development program for Bevespi Aerosphere included three 24-week, randomised, double-blind, placebo-controlled, parallel-group pivotal Phase III studies in 5,433 patients with moderate to very severe COPD (PINNACLE 1, PINNACLE 2 and PINNACLE 4).
Danish: Det kliniske udviklingsprogram for Bevespi Aerosphere inkluderede tre 24-ugers, randomiserede, dobbeltblindede, placebo-kontrollerede, pivotale Fase III-studier med parallelgrupper med 5.433 patienter med moderat til meget svær KOL (PINNACLE 1, PINNACLE 2 og PINNACLE 4).
English: The use of Bevespi Aerosphere with the Aerochamber Plus Flow-Vu spacer in COPD patients increased the total systemic exposure to glycopyrronium (as measured by AUC0-12) by 16% while formoterol exposure was unchanged.
Danish: Brugen af Bevespi Aerosphere med Aerochamber Plus Flow-Vu spacerenhed til KOL-patienter øgede den totale systemiske eksponering af glycopyrronium (målt ved AUC0-12) med 16 %, mens eksponeringen for formoterol var uændret.
English: Bevespi Aerosphere is used regularly for long-term treatment of COPD.
Danish: Bevespi Aerosphere bruges regelmæssigt som langtidsbehandling af KOL.
English: The pharmacokinetics of glycopyrronium was best described by a two-compartment disposition model with first-order absorption and linear elimination.
Danish: Farmakokinetikken for glycopyrronium blev bedst beskrevet ved en to-kammerdispositionsmodel med 1. ordens absorption og lineær elimination.
English: Bevespi Aerosphere should only be used during pregnancy if the expected benefits outweigh the potential risks.
Danish: Bevespi Aerosphere bør kun anvendes under graviditet, hvis den forventede virkning opvejer den potentielle risiko.
English: If you have used more Bevespi Aerosphere than you should, talk to a doctor or pharmacist immediately.
Danish: Hvis du har brugt mere Bevespi Aerosphere end du skal, skal du straks tale med lægen eller apotekspersonalet.
English: As glycopyrronium is predominantly renally excreted, patients with severe renal impairment (creatinine clearance of < 30 mL/min), including those with end-stage renal disease requiring dialysis, should only be treated with Bevespi Aerosphere if the expected benefit outweighs the potential risk (see section 5.2).
Danish: Da glycopyrronium overvejende udskilles via nyrerne, bør patienter med alvorlig nyreinsufficiens (kreatininclearance på <30 ml/min), herunder dem med dialysekrævende terminal nyresygdom, kun behandles med Bevespi Aerosphere, hvis den forventede fordel opvejer den potentielle risiko (se pkt.
English: The systemic exposure (AUC0-12) in subjects with COPD with moderate-severe renal impairment (eGFR of 30-45 mL/min) is approximately 30% higher for glycopyrronium compared to subjects with COPD with normal renal function (eGFR of >90 mL/min).
Danish: Den systemiske eksponering (AUC0-12) hos patienter med KOL med moderat til svær nyreinsufficiens (eGFR på 30-45 ml/min) er cirka 30 % højere for glycopyrronium sammenlighed med personer med KOL med normal nyrefunktion (eGFR på >90 ml/min).
English: Linear pharmacokinetics were observed for glycopyrronium (dose range: 14.4 to 115.2 mcg) and formoterol (dose range: 2.4 to 19.2 mcg) after oral inhalation.
Danish: Lineær farmakokinetik blev observeret for glycopyrronium (dosisinterval: 14,4 til 115,2 mikrog) og formoterol (dosisinterval: 2,4 til 19,2 mikrog) efter oral inhalation.
English: • you have prostate problems, or difficulty passing urine
Danish: • du har prostataproblemer eller vandladningsbesvær
English: Elderly No dose adjustments are required in elderly patients (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig til ældre patienter (se pkt.
English: Evidence of transfer of glycopyrronium and formoterol into maternal milk in rats has been reported.
Danish: Der er rapporteret om fund af overført glycopyrronium og formoterol til modermælk hos rotter.
English: Before you use Bevespi Aerosphere for the first time, you must prime the inhaler.
Danish: Inden du bruger Bevespi Aerosphere for første gang skal du klargøre inhalatoren.
English: Bevespi Aerosphere is not indicated for the treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Danish: Bevespi Aerosphere er ikke indiceret til behandling af akutte anfald af bronkospasme, dvs. som anfaldsbehandling.
English: dizziness and nausea are common side effects which may occur.
Danish: Men der kan opstå svimmelhed og kvalme, som er almindelige bivirkninger.
English: Animal reproduction studies with formoterol have shown a slightly reduced fertility in male rats at high systemic exposure and implantation losses, as well as decreased early postnatal survival and birth weight at considerably higher systemic exposures than those reached during clinical use.
Danish: Dyrereproduktionsstudier af formoterol har vist en lidt reduceret frugtbarhed hos hanrotter ved høj systemisk eksponering og implantationstab, samt nedsat tidlig postnatal overlevelse og fødselsvægt ved væsentligt højere systemiske eksponeringer end dem, der blev opnået under klinisk brug.
English: In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see section 4.5).
Danish: Hos patienter med svær KOL kan hypokaliæmi potenseres af hypoksi og samtidig behandling (se pkt.
English: Inhalation of high doses of β2-adrenergic agonists may produce increases in plasma glucose.
Danish: Inhalation af høje doser β2-adrenerge agonister kan medføre forhøjet plasmaglukose.
English: Shake the inhaler well before each priming puff.
Danish: Omryst inhalatoren omhyggeligt før hvert klargøringspust.
English: • The pointer points to 100 after you take 10 more puffs.
Danish: • Pilen peger på 100, når du har taget yderligere 10 doser.
English: There are no relevant data on the use of Bevespi Aerosphere in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see sections 4.4 and 5.2).
Danish: Der er ingen relevant data om brugen af Bevespi Aerosphere til patienter med svær leverinsufficiens, og lægemidlet bør anvendes med forsigtighed til disse patienter (se pkt.
English: A population pharmacokinetic analysis of glycopyrronium was performed based on data collected in a total of 311 subjects with COPD.
Danish: En populationsfarmakokinetisk analyse af glycopyrronium blev udført baseret på data indsamlet fra i alt 311 forsøgspersoner med KOL.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Bevespi Aerosphere.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger Bevespi Aerosphere.
English: As a consequence of the differential density of muscarinic receptors and β2-adrenoceptors in the central and peripheral airways of the lung, muscarinic antagonists are more effective in relaxing central airways, and β2-adrenergic agonists are more effective in relaxing peripheral airways; relaxation of both central and peripheral airways with combination treatment may contribute to its beneficial effects on lung function.
Danish: Som en konsekvens af differencetætheden af muskarinreceptorer og β2-adrenoceptorer i de centrale og perifere luftveje i lungen, er muskarine antagonister mere effektive til afslapning af de centrale luftveje, og β2-adrenerge agonister er mere effektive til afslapning af de perifere luftveje.
English: Step 2: Take the cap off the mouthpiece.
Danish: Trin 2: Tag hætten af mundstykket
English: Step 3: Hold the inhaler with the mouthpiece pointing towards you and breathe out as fully as you comfortably can through your mouth (See Figure 8).
Danish: Trin 3: Hold inhalatoren med mundstykket pegende mod dig og ånd ud gennem munden, så meget som du kan (se figur 8).
English: In animal studies formoterol and glycopyrronium, individually, have caused adverse effects in reproduction studies at very high doses/systemic exposure levels (see section 5.3).
Danish: I reproduktionsstudier hos dyr har henholdsvis formoterol og glycopyrronium forårsaget uønskede virkninger ved meget høje doser/systemiske eksponeringsniveauer (se pkt.
English: Following inhaled administration of Bevespi Aerosphere in subjects with COPD, glycopyrronium Cmax occurred at approximately 5 minutes, and formoterol Cmax occurred within 20 to 60 minutes.
Danish: Efter en inhalation af Bevespi Aerosphere hos forsøgspersoner med KOL, forekom glycopyrronium Cmax efter cirka 5 minutter og formoterol Cmax forekom inden for 20-60 minutter.
English: • The dose indicator display window will move after every 10 puffs.
Danish: • Dosisindikatoren i dosisindikatorvinduet vil bevæge sig for hver 10. dosis.
English: Do not use the inhaler if the drying agent has leaked out of its packet.
Danish: Brug ikke inhalatoren, hvis tørremidlet er lækket ud af pakken.
English: EU/1/18/1339/002 360 actuations (3 packs of 120 actuations)
Danish: EU/1/18/1339/002 360 pust (3 inhalatorer med 120 pust hver)
English: Do not expose to temperatures higher than 50°C.
Danish: Må ikke udsættes for temperaturer over 50 C.
English: Compatibility with the Aerochamber Plus Flow-Vu spacer device has been demonstrated (see section 5.2).
Danish: Der er påvist kompatibilitet med Aerochamber Plus Flow-Vu spacerenhed (se pkt.
English: • Not use the inhaler if the drying agent, which is inside the foil pouch, has leaked out of its packet.
Danish: • Brug ikke inhalatoren, hvis tørremidlet, som ligger inden i foliet, har lækket.
English: Based on available data, no adjustment of the dosage of Bevespi Aerosphere in geriatric patients is necessary.
Danish: Baseret på tilgængelige data er dosisjustering af Bevespi Aerosphere til ældre patienter ikke nødvendig.
English: It is not recommended to use Bevespi Aerosphere together with these medicines;
Danish: Det frarådes at bruge Bevespi Aerosphere sammen med disse lægemidler:
English: Bevespi Aerosphere contains two bronchodilators: glycopyrronium a long-acting muscarinic antagonist (also referred to as an anticholinergic) and formoterol a long-acting β2-adrenergic agonist with a rapid onset of action.
Danish: Bevespi Aerosphere indeholder to bronkodilatorer: glycopyrronium, en langtidsvirkende muskarinreceptorantagonist (også kaldet et antikolinergikum) og formoterol, en langtidsvirkende β2-adrenerg agonist med hurtig virkning.
English: Glycopyrronium is primarily cleared from the systemic circulation by renal excretion and hepatic impairment would therefore not be expected to lead to unsafe systemic exposure.
Danish: Glycopyrronium udskilles primært fra det systemiske kredsløb ved nyrerne, og leverinsufficiens forventes derfor ikke at føre til skadelig systemisk eksponering.
English: • you have thyroid gland problems (called ‘thyrotoxicosis')
Danish: • du har problemer med skjoldbruskkirtlen (kaldet tyrotoksikose)
English: • Bevespi Aerosphere comes with a dose indicator on the top of the pressurised container (See Figure 1).
Danish: • Bevespi Aerosphere leveres med en dosisindikator øverst på trykbeholderen (se figur 1).
English: Effects on lung function
Danish: Virkning på lungefunktion
English: Agitation Restlessness Insomnia
Danish: Rastløshed Søvnløshed
English: In clinical studies, paradoxical bronchospasm was not observed with Bevespi Aerosphere at its recommended dose.
Danish: Paradoks bronkospasme blev ikke set i kliniske studier af Bevespi Aerosphere i anbefalede doser.
English: Step 6: Let the actuator air-dry overnight (See Figure 17).
Danish: Trin 6: Lad plasthylsteret lufttørre natten over (se figur 17).
English: Talk to your doctor or pharmacist before using Bevespi Aerosphere if:
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Bevespi Aerosphere, hvis:
English: These include: o corticosteroids that you take by mouth (such as prednisolone), o diuretics (such as furosemide or hydrochlorothiazide) used for high blood pressure, o some medicines used to treat breathing conditions called methylxanthines (such as theophylline);
Danish: Dette omfatter: o kortikosteroider, som du tager gennem munden (såsom prednisolon) o vanddrivende medicin (såsom furosemid eller hydrochlorthiazid), der bruges mod forhøjet blodtryk o nogle typer medicin, der bruges til at behandle åndedrætsproblemer, kaldet metylxantiner (såsom teofyllin)
English: • you have an eye problem called narrow-angle glaucoma (also called angle-closure glaucoma)
Danish: • du har en øjenlidelse, som kaldes snævervinklet glaukom (kaldes også lukketvinklet grøn stær)
English: Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible initial hypokalaemic effect of β2-adrenergic agonists, therefore, caution is advised in their concomitant use (see section 4.4).
Danish: Samtidig behandling med methylxanthinderivater, steroider eller ikke-kaliumbesparende diuretika kan forstærke den mulige hypokaliæmiske virkning af β2-adrenerge agonister, hvorfor forsigtighed bør udvises ved samtidig brug (se pkt.
English: Bevespi Aerosphere comes as a pressurised container with a dose indicator, supplied with a white plastic actuator body and mouthpiece (see Figure 1 of the Instructions for Use at the end of this leaflet).
Danish: Bevespi Aerosphere leveres som en trykbeholder med en dosisindikator, forsynet med et hvidt plasthylster og et mundstykke (se figur 1 i brugsvejledningen i slutningen af denne indlægsseddel).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Bevespi Aerosphere 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 Bevespi Aerosphere i alle undergrupper af den pædiatriske population med KOL (se pkt.
English: • For inhalation use only.
Danish: • Kun til inhalation
English: Animal reproduction studies with glycopyrronium have shown reduced rat and rabbit fetal weights, and low body weight gain of rat offspring before weaning was observed at considerably higher systemic exposures than those reached during clinical use.
Danish: Dyrereproduktionsstudier af glycopyrronium har vist reduceret rotte- og kaninfostervægt og lav stigning i kropsvægt hos rotteafkom før afvænning blev observeret ved betydeligt højere systemisk eksponering end det, som blev opnået ved klinisk anvendelse.
English: Bevespi Aerosphere should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval (see section 4.4).
Danish: Bevespi Aerosphere bør administreres med forsigtighed til patienter, der behandles med lægemidler, som er kendt for at forlænge QTc-intervallet (se pkt.
English: • Remove the cap from the mouthpiece (See Figure 3).
Danish: • Fjern hætten fra mundstykket (se figur 3).
English: Figure 17 Step 7: When the actuator is dry, gently press the pressurised container down in the actuator (See Figure 18).
Danish: Trin 7: Når plasthylsteret er tørt, tryk forsigtigt trykbeholderen ned i plasthylsteret (se figur 18).
English: Treatment difference (95% confidence intervals, p-value)
Danish: Behandlingsforskel (95 % konfidensintervaller, p-værdi) Trough-FEV1 (ml)
English: 2 years To be used within 3 months of opening the pouch.
Danish: Anvendes inden for 3 måneder efter åbning af posen.
English: Multipack containing 3 inhalers each with 120 actuations.
Danish: Multipakning indeholdende 3 inhalatorer med 120 pust hver.
English: Bevespi Aerosphere is used to make breathing easier for adults who have a lung disease called chronic obstructive pulmonary disease (COPD).
Danish: Bevespi Aerosphere bruges til at lette vejrtrækningen hos voksne, der har en lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL).
English: In COPD, the muscles around the airways tighten which makes breathing difficult.
Danish: Ved KOL strammes musklerne omkring luftvejene, hvilket gør vejrtrækningen vanskelig.
English: Immune system disorders Hypersensitivity reactions including rash and pruritus
Danish: Hypersensitivitetsreaktioner, herunder udslæt og kløe
English: Figure 2b 110 puffs
Danish: Figur 2b 110 doser
English: In three Phase III, 24-week studies (PINNACLE 1, PINNACLE 2 and PINNACLE 4) Bevespi Aerosphere provided improvements over placebo in lung function (as measured by morning pre-dose trough forced expiratory volume in 1 second [FEV1]), with a demonstrated onset of action at 5 minutes following administration of the first dose on Day 1 (improvement over placebo by 187 mL, 186 mL and 179 mL in PINNACLE 1, PINNACLE 2 and PINNACLE 4, respectively [p <0.001]).
Danish: I tre Fase-III, 24-ugers studier (PINNACLE 1, PINNACLE 2 og PINNACLE 4) viste Bevespi Aerosphere forbedringer i lungefunktionen over for placebo (målt ved lavest forceret respiratorisk volumen i 1 sekund [FEV1] om morgenen før dosering, med en påvist virkning på 5 minutter efter administration af den første dosis på dag 1 (forbedring over for placebo med 187 ml, 186 ml og 179 ml i henholdsvis PINNACLE 1, PINNACLE 2 og PINNACLE 4 [p<0,001]).
English: Common conditions adverse reaction relates to formoterol adverse reaction relates to glycopyrronium
Danish: Almindelig bivirkning relateret til formoterol bivirkning relateret til glycopyrronium
English: Figure 2c 100 puffs
Danish: Figur 2c 100 doser
English: Table 2 Lung function, symptomatic and health related quality of life outcomes over 24 weeks Treatment comparisons with Bevespi
Danish: Tabel 2 Lungefunktion, symptomatiske og helbredsrelaterede livskvalitets-resultater ved uge 24
English: Do not use Bevespi Aerosphere if you are breast-feeding unless your doctor tells you that you can.
Danish: Brug ikke Bevespi Aerosphere, hvis du ammer, medmindre din læge har fortalt dig, at du kan bruge den.
English: On actuation of Bevespi Aerosphere, a volume of the suspension is expelled from the pressurised container at high velocity.
Danish: Ved tryk på Bevespi Aerosphere udløses en mængde suspension fra trykbeholderen med stor hastighed.
English: If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere.
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, skal du tale med din læge eller apotekspersonalet, før du bruger Bevespi Aerosphere.
English: Due to its anticholinergic activity, Bevespi Aerosphere should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma (see section 4.8).
Danish: På grund af dets antikolinerge aktivitet bør Bevespi Aerosphere anvendes med forsigtighed til patienter med symptomatisk prostatahyperplasi, urinretention eller med snævervinklet glaukom (se pkt
English: Bevespi Aerosphere contains two active substances called glycopyrronium and formoterol fumarate dihydrate.
Danish: Bevespi Aerosphere indeholder to virksomme stoffer kaldet glycopyrronium og formoterolfumaratdihydrat.
English: Step 7: Breathe out gently (See Figure 12).
Danish: Trin 7: Ånd forsigtigt ud (se figur 12).
English: The largest mean (90% upper confidence bound) differences from placebo in baseline- and individually corrected QT was 3.1 (4.7) ms for Bevespi Aerosphere (14.4 /10 micrograms) and 7.6 (9.2) ms for glycopyrronium/formoterol with eight times the recommended dose of glycopyrronium and four times the recommended dose of formoterol.
Danish: Placebo korrigeret QT var 3,1 (4,7) ms for Bevespi Aerosphere (14,4 mikrogram/10 mikrogram) og 7,6 (9,2) ms for glycopyrronium/formoterol med otte gange den anbefalede dosis af glycopyrronium og fire gange den anbefalede dosis af formoterol.
English: • Bevespi Aerosphere comes as a pressurised container with a dose indicator that fits into an actuator.
Danish: • Bevespi Aerosphere leveres som en trykbeholder med en dosisindikator, der passer ind i et plasthylster.
English: Anticholinergic activity
Danish: Antikolinerge aktiviteter
English: Hypersensitivity to the active substances or any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: General disorders and administration site
Danish: Almene symptomer og reaktioner på administrationsstedet