FrancophonIA/ELRC3.0 huggingface dataset:
English: Warning: Do not break, puncture or burn the pressurised container, even when apparently empty.
Danish: Advarsel: Undgå at bryde, punktere eller brænde trykbeholderen, selv når den tilsyneladende er tom.
English: Press here
Danish: Tryk her
English: It is not known whether glycopyrronium or formoterol are excreted in human milk.
Danish: Det vides ikke, om glycopyrronium eller formoterol udskilles i human mælk.
English: There are no data on the use of Bevespi Aerosphere in pregnant women.
Danish: Der er ingen data fra brugen af Bevespi Aerosphere hos gravide kvinder.
English: Repeat steps 2 to 7 to take your second puff of Bevespi Aerosphere.
Danish: Gentag trin 2 til 7 for at tage dit andet Bevespi Aerosphere pust.
English: • Use Bevespi Aerosphere exactly as your doctor tells you to.
Danish: • Brug Bevespi Aerosphere nøjagtigt som lægen har fortalt dig.
English: Please read the instructions for use at the end of this leaflet.
Danish: Læs brugsanvisningen i slutningen af denne indlægsseddel.
English: Do not clean the pressurised container or let it get wet.
Danish: Rengør ikke trykbeholderen, og lad den ikke blive våd.
English: A double dose should not be taken to make up for a forgotten dose.
Danish: Der må ikke tages en dobbeltdosis som erstatning for den glemte dosis.
English: If β-adrenergic blockers are required (including eye drops), cardioselective β-adrenergic blockers are preferred, although they should also be administered with caution.
Danish: Hvis β-adrenerge blokkere er nødvendige (inklusive øjendråber), er kardioselektive β-adrenerge blokkere at foretrække, selvom de også bør administreres med forsigtighed.
English: The number in the dose indicator display window will change after every 20 puffs.
Danish: Tallet i dosisindikatorvinduet vil ændre sig efter hver 20. dosis.
English: Bevespi Aerosphere has no or negligible influence on the ability to drive and use machines.
Danish: Bevespi Aerosphere påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The most common adverse reactions reported in the clinical development program (comprised of 1,588 patients receiving Bevespi Aerosphere) were headache (1.9%), nausea (1.4%), muscle spasms (1.4%), and dizziness (1.3%).
Danish: De mest almindelige bivirkninger, som blev rapporteret i det kliniske udviklingsprogram (omfatter 1.588 patienter, der fik Bevespi Aerosphere) var hovedpine (1,9 %), kvalme (1,4 %), muskelspasmer (1,4 %) og svimmelhed (1,3 %).
English: Step 5: Look into the actuator and the mouthpiece to make sure any medicine build-up has been completely washed away.
Danish: Trin 5: Se ind i plasthylsteret og mundstykket for at sikre, at eventuelle medicinrester er blevet vasket helt væk.
English: To get adequate lung deposition of the active substances actuation must be co-ordinated with inhalation.
Danish: For at få tilstrækkelig lungedeponering af det aktive stof skal tryk og inhalering koordineres.
English: In-vitro studies indicate that formoterol does not inhibit the CYP450 enzymes at therapeutically relevant concentrations.
Danish: In vitro-studier viser, at formoterol ikke hæmmer CYP450-enzymerne ved terapeutisk relevante koncentrationer.
English: Read this instructions for use and the package leaflet before you start using Bevespi Aerosphere and each time you get a new inhaler.
Danish: Læs denne brugsvejledning og indlægssedlen, inden du begynder at bruge Bevespi Aerosphere, og hver gang du får en ny inhalator.
English: The medicine prevents the tightening of the muscles around the airways, making it easier for air to get in and out of the lungs.
Danish: Denne medicin forhindrer, at musklerne omkring luftvejene spændes, hvilket gør det nemmere for luften at komme ind og ud af lungerne.
English: Glycopyrronium did not cause any adverse effects on fertility in rats.
Danish: Glycopyrronium medførte ikke nogen uønskede indvirkninger på fertiliteten hos rotter.
English: The primary metabolism of formoterol is by direct glucuronidation and by O-demethylation followed by conjugation to inactive metabolites.
Danish: Den primære metabolisme af formoterol er ved direkte glukuronidering og ved O-demethylering efterfulgt af konjugering til inaktive metabolitter.
English: To re-prime the inhaler, shake the inhaler well and press down on the centre of the dose indicator twice to release a total of 2 puffs into the air away from your face.
Danish: For at klargøre inhalatoren igen skal du omryste inhalatoren grundigt og trykke ned på midten af dosisindikatoren to gange for at frigive i alt 2 pust ud i luften væk fra dit ansigt.
English: You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache or feel nauseous (sick).
Danish: Du kan mærke, at dit hjerte slår hurtigere end normalt, du kan føle dig usikker, have synsforstyrrelser, tør mund eller hovedpine og kvalme.
English: Daily rescue Ventolin (inhalations/day)
Danish: Daglig Ventoline anfaldsmedicin (inhalationer/ dag)
English: In PINNACLE 2, the results were similar to those observed in PINNACLE 1.
Danish: I PINNACLE 2 var resultaterne sammenlignelige med dem, der blev observeret i PINNACLE 1.
English: A placebo- and active-controlled (moxifloxacin) thorough QT study in 69 healthy subjects did not demonstrate a clinically relevant effect on the QT interval, using a threshold of 10 ms.
Danish: Et placebo- og aktivt kontrolleret (moxifloxacin) grundigt QT-studie hos 69 raske forsøgspersoner viste ikke nogen klinisk relevant effekt på QT-intervallet ved anvendelse af en grænse på 10 ms.
English: The typical clearance (CL/F) of glycopyrronium was 124 L/h.
Danish: Den typiske clearance (CL/F) for glycopyrronium var 124 l/time.
English: Formoterol causes direct relaxation of airway smooth muscle as a consequence of the increase in cyclic AMP through activation of adenylate cyclase.
Danish: Formoterol forårsager direkte afslapning af luftvejenes glatte muskulatur som en konsekvens af forøget cyklisk AMP gennem aktivering af adenylatcyklase.
English: • you have low levels of potassium in the blood
Danish: • du har lav koncentration af kalium i blodet
English: If you do not use your Bevespi Aerosphere for more than 7 days or if exposed to low temperatures or is dropped:
Danish: Hvis du ikke bruger din Bevespi Aerosphere i mere end 7 dage, eller hvis den udsættes for lave temperaturer eller tabes:
English: The mean bronchodilator effect derived from serial FEV1 measurements at Day 1 and Week 12 from PINNACLE 1 are shown in Figure 1.
Danish: Den gennemsnitlige bronkodilaterende virkning afledt ud fra serielle FEV1-målinger på dag 1 og uge 12 fra PINNACLE 1 er vist i figur 1.
English: DAY 1
Danish: Dag 1
English: A lung deposition study with Bevespi Aerosphere conducted in healthy volunteers demonstrated that on average 38% of the nominal dose is deposited into the lung.
Danish: Et lungedeponeringsstudie af Bevespi Aerosphere udført i raske frivillige viste, at 38 % af den nominelle dosis i gennemsnit deponeres i lungen.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelig: kan påvirke op til 1 ud af 100 personer
English: Steady state is achieved within 2-3 days of repeated dosing of Bevespi Aerosphere, and the extent of exposure is approximately 2.3 times and 1.5 times higher than after the first dose, for glycopyrronium and formoterol, respectively.
Danish: Steady state blev opnået indenfor 2-3 dage med gentagen dosering af Bevespi Aerosphere, og eksponeringsgraden er ca. 2,3 gange og 1,5 gange højere end efter første dosis for henholdsvis glycopyrronium og formoterol.
English: • The pointer points to 120 after 10 puffs are delivered from Bevespi Aerosphere.
Danish: • Pilen peger på 120 efter 10 doser er frigivet fra Bevespi Aerosphere.
English: Write the date the pouch is opened on the inhaler label in the space provided.
Danish: Skriv den dato, hvor posen åbnes på inhalatorens etiket, hvor der er gjort plads.
English: The excretion of formoterol was studied in six healthy subjects following simultaneous administration of radiolabelled formoterol via the oral and IV routes.
Danish: Udskillelsen af formoterol blev undersøgt hos seks raske forsøgspersoner efter samtidig administration af radioaktivt mærket formoterol via oral og IV-vej.
English: The pressurised container should not be broken, punctured or burnt, even when apparently empty.
Danish: Trykbeholderen må ikke brydes, perforeres eller brændes, selv om den tilsyneladende er tom.
English: There is no relevant use of Bevespi Aerosphere in children and adolescents (under 18 years of age) for the indication of COPD.
Danish: Der er ingen relevant anvendelse af Bevespi Aerosphere til børn og unge (under 18 år) for indikationen KOL.
English: Do not take more than two puffs twice a day.
Danish: Tag ikke mere end to pust to gange dagligt.
English: Estimated glomerular filtration rate (eGFR) varied from 30-196 mL/min, representing a range of moderate to no renal impairment.
Danish: Den estimerede glomerulære filtreringshastighed (eGFR) varierede fra 30-196 ml/min, hvilket repræsenterer et interval fra moderat til ingen nyreinsufficiens.
English: Bevespi Aerosphere is not for use in children or adolescents below 18 years of age.
Danish: Bevespi Aerosphere må ikke anvendes til børn og unge under 18 år.
English: It is unlikely that Bevespi Aerosphere administered at the recommended dose will affect fertility in humans.
Danish: Det er usandsynligt, at Bevespi Aerosphere administreret i den anbefalede dosis vil påvirke fertiliteten hos mennesker.
English: Step 4: Close your lips around the mouthpiece and tilt your head back, keeping your tongue below the mouthpiece (See Figure 9).
Danish: Trin 4: Luk dine læber rundt om mundstykket og vip hovedet tilbage og hold tungen under mundstykket (se figur 9).
English: In-vitro studies indicate the glycopyrronium does not inhibit any subtype of cytochrome P450 and that there is no induction of CYP1A2, 2B6, or 3A4.
Danish: In vitro-studier viser, at glycopyrronium ikke hæmmer nogen undergrupper af cytokrom P450, og at der ikke er induktion af CYP1A2, 2B6 eller 3A4.
English: • difficulty passing urine (urinary retention)
Danish: • vandladningsbesvær (urinretention)
English: Non-clinical data reveal no specific hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: Step 8: Re-prime your Bevespi Aerosphere inhaler after each cleaning.
Danish: Trin 8: Klargør din Bevespi Aerosphere-inhalator igen efter hver rengøring.
English: Patients who find it difficult to co-ordinate actuation with inspiration of breath may use Bevespi Aerosphere with a spacer to ensure proper administration of the product.
Danish: Patienter, der finder det svært at koordinere tryk med inhalering, kan anvende Bevespi Aerosphere med en spacerenhed, for at sikre korrekt administration af lægemidlet.
English: Before you use Bevespi Aerosphere for the first time Before you use Bevespi Aerosphere for the first time, make sure that the pointer on the dose indicator is pointing to the right of the “120” inhalation mark in the dose indicator display window (See Figure
Danish: Før du bruger Bevespi Aerosphere for første gang Før du bruger Bevespi Aerosphere for første gang, skal du sørge for, at pilen på dosisindikatoren peger til højre for ”120” indåndingsmærket i dosisindikatorvinduet (se figur 1).
English: B.
Danish: D.
English: An overdose of Bevespi Aerosphere may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms, the most frequent of which include blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and systolic hypertension.
Danish: En overdosis af Bevespi Aerosphere kan føre til overdrevne antikolinerge og/eller β2-adrenerge tegn og symptomer, hvoraf de hyppigste er sløret syn, mundtørhed, kvalme, muskelspasmer, tremor, hovedpine, palpitationer og systolisk hypertension.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases: adrenergics in combination with anticholinergics, ATC code: R03AL07.
Danish: Farmakoterapeutisk klassifikation: Midler mod obstruktiv lungesygdom; adrenergika i kombination med antikolinergika, ATC-kode: R03AL07.
English: Following inhalation of the glycopyrronium and formoterol combination, the pharmacokinetics of each component was similar to those observed when each active substance was administered separately.
Danish: Efter inhalation af glycopyrronium og formoterol-kombinationen svarede farmakokinetikken for hver komponent til det observerede, når hvert aktivt indholdsstof blev administreret separat.
English: There were improvements in trough FEV1 irrespective of age, sex, degree of airflow limitation, baseline symptoms, smoking status, or inhaled corticosteroid use.
Danish: Der var forbedringer i trough-FEV1 uanset alder, køn, grad af luftvejsbegrænsning, baseline-symptomer, rygestatus eller brug af inhalationskortikosteroid.
English: CYP2D6 was found to be the predominant enzyme involved in the metabolism of glycopyrronium.
Danish: CYP2D6 viste sig at være det overvejende enzym, der er involveret i metabolismen af glycopyrronium.
English: Do not use Bevespi Aerosphere if:
Danish: Brug ikke Bevespi Aerosphere hvis:
English: Cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, and extrasystoles)
Danish: Hjertearytmier (atrieflimren, supraventrikulær takykardi og ekstrasystoler)
English: Dose adjustments are not necessary based on the effect of age, sex and weight on the pharmacokinetic parameters of glycopyrronium and formoterol.
Danish: Dosisjusteringer er ikke nødvendige baseret på indvirkningen af alder, køn og vægt ud fra de farmakokinetiske parametre for glycopyrronium og formoterol.
English: Step 5: While breathing in deeply and slowly, press down on the centre of the dose indicator until the pressurised container stops moving in the actuator and a puff of medicine has been released (See Figure 10).
Danish: Trin 5: Mens du trækker vejret dybt og langsomt ind, skal du trykke ned på midten af dosisindikatoren, indtil trykbeholderen holder op med at bevæge sig i plasthylsteret, og der er frigivet et pust medicin (se figur 10).
English: Glycopyrronium has similar affinity to the subtypes of muscarinic receptors M1 to M5.
Danish: Glycopyrronium har en lignende virkning på muskarinreceptorerne subtype M1 til M5.
English: Check inside the mouthpiece before you use the inhaler to make sure it is clear.
Danish: Kontroller indersiden af mundstykket, før du bruger inhalatoren for at sikre, at der er fri passage.
English: • any medicines that work in the same way as Bevespi Aerosphere, such as medicines containing active substances such as tiotropium, ipratropium, aclidinium, umeclidinium, salmeterol, vilanterol, olodaterol, or indacaterol.
Danish: • medicin, der virker på samme måde som Bevespi Aerosphere, såsom medicin indeholdende lignende virksomme stoffer, såsom tiotropium, ipratropium, aclidinium, umeclidinium, salmeterol, vilanterol, olodaterol eller indacaterol.
English: After IV administration of a 0.2 mg dose of radiolabelled glycopyrronium, 85% of the dose was recovered in urine 48 hours post dose and some of radioactivity was also recovered in bile.
Danish: Efter IV-administration med en dosis 0,2 mg radioaktivt mærket glycopyrronium blev 85 % af dosis påvist i urinen 48 timer efter dosis, og noget af radioaktiviteten blev også påvist i galden.
English: In-vitro glycopyrronium is a substrate for the renal transporters OCT2 and MATE1/2K.
Danish: In vitro glycopyrronium er et substrat for nyretransporterne OCT2 og MATE1/2K.
English: When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways.
Danish: Når patienten inhalerer gennem mundstykket samtidig med aktivering af inhalatoren, vil lægemidlet følge inhalationen ned i luftvejene.
English: This will release a puff of medicine from the mouthpiece (See Figure 5).
Danish: Dette vil frigøre en dosis medicin fra mundstykket (se figur 5).
English: • you have diabetes
Danish: • du har sukkersyge
English: • Press down firmly on the centre of the dose indicator until the pressurised container stops moving in the actuator.
Danish: • Tryk hårdt ned på midten af dosisindikatoren, indtil trykbeholderen stopper med at bevæge sig i plasthylsteret.
English: • The pointer points between 100 and 120 after you use 10 more puffs.
Danish: • Pilen peger mellem 100 og 120, når du har brugt 10 doser mere.
English: Bevespi Aerosphere should not be used to treat asthma.
Danish: Bevespi Aerosphere bør ikke anvendes til behandling af astma.
English: Bevespi Aerosphere delivers the active ingredients directly to the airways in your lungs as you breathe in.
Danish: Bevespi Aerosphere bringer de virksomme stoffer direkte til luftvejene i lungerne, mens du trækker vejret ind.
English: These are known pharmacological manifestations seen after administration of high doses of adrenoceptor agonists.
Danish: Disse er kendte farmakologiske manifestationer set efter administration af høje β-adrenoceptoragonister.
English: The toxicity observed in studies with the combination of glycopyrronium and formoterol in dogs were associated with the pharmacological actions of formoterol, including effects mainly on the cardiovascular system, consisting of hyperaemia, tachycardia, arrhythmias and myocardial lesions.
Danish: Den toksicitet, der blev observeret i forsøg med kombination af glycopyrronium og formoterol hos hunde, var forbundet med de farmakologiske virkninger af formoterol, herunder virkninger hovedsageligt på det kardiovaskulære system, bestående af hyperæmi, takykardi, arytmier og myokardielæsioner.
English: No significant effects attributable to glycopyrronium were seen.
Danish: Der sås ingen signifikante virkninger, der skyldtes glycopyrronium.
English: The tabulated list of adverse reactions is based on the experience with Bevespi Aerosphere in clinical trials and experience with the individual components.
Danish: Tabellen over bivirkninger er baseret på erfaringerne med Bevespi Aerosphere i kliniske studier og erfaring med de enkelte komponenter.
English: The recommended dose is two puffs twice a day.
Danish: Den anbefalede dosis er to pust to gange dagligt.
English: In the airways, it exhibits pharmacological effects through inhibition of the M3 receptor at the smooth muscle leading to bronchodilation.
Danish: I luftvejene sker dets farmakologiske virkning gennem hæmning af M3-receptoren på den glatte muskulatur, hvilket fører til bronkodilatation.
English: • Hold the inhaler upright, away from your face and shake it well (See Figure 4).
Danish: • Hold inhalatoren lodret, væk fra ansigtet, og omryst den omhyggeligt (se figur 4).
English: If you are not sure of how to use Bevespi Aerosphere, contact your doctor or pharmacist.
Danish: Hvis du ikke er sikker på, hvordan du bruger Bevespi Aerosphere, skal du kontakte din læge eller apotekspersonalet.
English: Do not press down too hard on the pressurised container.
Danish: Tryk ikke hårdt på trykbeholderen.
English: Do not use Bevespi Aerosphere if you are pregnant unless your doctor tells you that you can.
Danish: Brug ikke Bevespi Aerosphere, hvis du er gravid, medmindre din læge har fortalt dig, at du kan bruge den.
English: France or
Danish: Frankrig eller
English: Turn the actuator upside down and rinse the actuator again through the mouthpiece for about 30 seconds (See Figure 16).
Danish: Vend plasthylsteret på hovedet og skyl det igen igennem mundstykket i cirka 30 sekunder (se figur 16).
English: Do not use this medicine after the expiry date which is stated on the carton, pouch and pressurised container after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen, posen og trykbeholderen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Drug-induced hypokalaemia
Danish: Lægemiddelinduceret hypokaliæmi
English: Caution should also be exercised in patients with thyrotoxicosis or known or suspected prolongation of the QTc interval (see section 4.5).
Danish: Forsigtighed bør også udvises hos patienter med tyreotoksikose eller kendt eller formodet forlængelse af QTc-intervallet (se pkt.
English: The effect of cimetidine, a probe inhibitor of OCT2 and MATE1, on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 22% and a slight decrease in renal clearance by 23% due to co-administration of cimetidine.
Danish: Virkningen af cimetidin, en probe-inhibitor af OCT2 og MATE1, på inhaleret glycopyrroniumdisposition viste en begrænset stigning i dets totale systemiske eksponering (AUC0-t) på 22 % og en lille reduktion in renal clearance på 23 % som følge af samtidig administration af cimetidin.
English: Studies in rats have shown adverse effects on fertility only at dose levels higher than the maximum human exposure to formoterol (see section 5.3).
Danish: Studier i rotter har kun vist uønsket indvirkning på fertiliteten ved doser højere end den maksimale humane eksponering for formoterol (se pkt.
English: Bevespi Aerosphere is available in packs containing 1 inhaler with 120 puffs and in multipacks comprising 3 inhalers, each containing 120 puffs.
Danish: Bevespi Aerosphere er tilgængelig i pakninger indeholdende 1 inhalator med 120 pust og i multipakninger bestående af 3 inhalatorer, hver indeholdende 120 pust.
English: β-adrenergic blockers β-adrenergic blockers (including eye drops) can weaken or inhibit the effect of β2-adrenergic agonists, such as formoterol.
Danish: β-adrenerge blokkere β-adrenerge blokkere (inklusive øjendråber) kan svække eller hæmme virkningen af β2-adrenerge agonister, såsom formoterol.
English: Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms.
Danish: Da glycopyrronium hovedsageligt elimineres via nyrerne, kan lægemiddelinteraktion potentielt forekomme med lægemidler, der påvirker nyrernes udskillelsesmekanisme.
English: Hypokalaemia β2-adrenergic agonists may produce significant hypokalaemia, which may increase the susceptibility to cardiac arrhythmias.
Danish: Hypokaliæmi β2-adrenerge agonister kan medføre signifikant hypokaliæmi, hvilket kan øge tilbøjeligheden til hjertearytmier.
English: If you do not use your Bevespi Aerosphere for more than 7 days, or if the inhaler is exposed to low temperatures or has been dropped, you will need to re-prime it before use.
Danish: Hvis du ikke bruger din Bevespi Aerosphere i mere end 7 dage, eller hvis inhalatoren har været udsat for lave temperaturer eller er blevet tabt, skal du atter klargøre den før brug.
English: Subjects with COPD with both low body weight and moderate-severe impaired renal function may have an approximate doubling of systemic exposure to glycopyrronium.
Danish: Personer med KOL med både lav kropsvægt og moderat til svær nyreinsufficiens kan have en omtrentlig fordobling af systemisk eksponering for glycopyrronium.
English: Although no formal in-vivo drug interaction studies have been performed with Bevespi Aerosphere, studies indicate no clinical evidence of interactions when used concomitantly with other COPD medicinal products including short-acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids.
Danish: Selvom der ikke er udført formelle in vivo-interaktionsstudier af Bevespi Aerosphere, indikerer studier ikke klinisk evidens for interaktion, når de anvendes samtidigt med andre lægemidler mod KOL, inklusive kortvirkende β2-adrenerge bronkodilatorer, methylxanthiner samt orale og inhalerede steroider.
English: Bevespi Aerosphere should be used with caution in patients with severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Danish: Bevespi Aerosphere bør anvendes med forsigtighed til patienter med svær kardiovaskulær sygdom, såsom iskæmisk hjertesygdom, takyarytmier eller alvorlig hjerteinsufficiens.