FrancophonIA/ELRC3.0 huggingface dataset:
English: In an inhalation study in telemetered dogs, the cardiovascular system was a major target system for acute effects of Riarify (increase in heart rate, decrease in blood pressure, ECG changes at higher doses), effects probably mainly related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium.
Danish: I et inhalationsstudie af hunde i telemetri var det kardiovaskulære system et større målsystem for Riarifys akutte virkninger (øget hjertefrekvens, nedsat blodtryk, EKG-ændringer ved større doser), virkninger, der sandsynligvis er relateret til den beta2-adrenerge aktivitet af formoterol, og den antimuskarine aktivitet af glycopyrronium.
English: In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Riarify significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Riarify and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06).
Danish: Desuden forlængede Riarify signifikant tiden til den første eksacerbationer, sammenlignet med både en fast kombination af beclometasondipropionat og formoterol og med tiotropium (hazard ratio hhv. 0,80 og 0,84, p = hhv. 0,020 og 0,015), uden nogen forskelle mellem Riarify og den ekstemporære trippelkombination bestående af beclometasondipropionat og formoterol fastdosiskombination plus tiotropium (hazard ratio 1,06).
English: Riarify 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Danish: Riarify 87 mikrogram/5 mikrogram/9 mikrogram inhalationsspray, opløsning
English: • leakage of blood from a vessel into the tissues surrounding it
Danish: • udsivning af blod fra et kar til det omgivende væv
English: • if you have an eye problem called narrow-angle glaucoma.
Danish: • hvis du har et øjenproblem, der kaldes snævervinklet grøn stær.
English: A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (focal score greater than or equal to 1) after 26 weeks with Riarify than with a fixed combination of beclometasone dipropionate and formoterol (57.4% versus 51.8%; p = 0.027).
Danish: En analyse af patienter, der responderede, viste, at en signifikant større procentdel af patienterne havde en klinisk signifikant forbedring (fokal score større end eller lig med 1) efter 26 uger med Riarify end med en fast kombination af beclometasondipropionat og formoterol (57,4 % versus 51,8 %; p = 0,027).
English: Following inhalation, formoterol is absorbed from both the lung and the gastrointestinal tract.
Danish: Efter inhalation absorberes formoterol fra både lungerne og mave-tarm-kanalen.
English: Patients should be advised not to drop the inhaler as this may cause the counter to count down.
Danish: Patienterne skal rådes til ikke at tabe inhalatoren, da det kan få dosistælleren til at tælle ned.
English: • a container providing 180 puffs.
Danish: • en beholder, der leverer 180 pust.
English: You should get a replacement when the counter or indicator shows the number 20.
Danish: Du bør få en ny inhalator, når dosistælleren eller indikatoren viser tallet 20.
English: 2-hour post-dose FEV1
Danish: FEV1 2 timer efter dosering
English: Similar effects were seen when comparing Riarify with the extemporary triple combination.
Danish: Der blev observeret tilsvarende virkninger, når Riarify blev sammenlignet med den ekstemporære trippelkombination.
English: Each time you press the pressurised container, a puff of medicine is released and the dose indicator rotates by a small amount.
Danish: Hver gang du trykker på trykbeholderen, leveres et pust af medicin, og dosisindikatoren roterer lidt.
English: In repeat dose inhalation studies with Riarify in rats and dogs of up to 13 weeks duration, the main observed alterations were related to effects on the immune system (probably due to systemic corticosteroid effects of beclometasone dipropionate and its active metabolite beclometasone17-monopropionate) and on the cardiovascular system (probably related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium).
Danish: I inhalationsstudier af op til 13 ugers varighed med gentagne doser Riarify af rotter og hunde, var de vigtigste observerede ændringer relateret til virkningen på immunsystemet (sandsynligvis fra de systemiske kortikosteroidvirkninger af beclometasondipropionat, og dens aktive metabolit beclometason-17-monopropionat), og på det kardiovaskulære system (sandsynligvis relateret til den beta2-adrenerge aktivitet af formoterol, og den antimuskarine aktivitet af glycopyrronium).
English: Compared with tiotropium, Riarify significantly improved IC by 39 mL (p = 0.025) and 60 mL (p = 0.001) after 26 and 52 weeks of treatment respectively.
Danish: Sammenlignet med tiotropium forbedrede Riarify signifikant IC med 39 ml (p = 0,025) og 60 ml (p = 0,001) efter hhv. 26 og 52 ugers behandling.
English: If you are already using Riarify
Danish: Hvis du allerede bruger Riarify
English: Other medicines and Riarify
Danish: Brug af anden medicin sammen med Riarify
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics incl.
Danish: Farmakoterapeutisk klassifikation: Midler mod obstruktiv lungesygdom, adrenergika kombineret med anticholinergika, inkl.
English: • upset stomach
Danish: • dårlig mave
English: • flu
Danish: • influenza
English: EXP 60 actuation pressurised container:
Danish: EXP Trykbeholder med 60 pust:
English: Formoterol: hypokalaemia, hyperglycaemia, tremor, palpitations, muscle spasms, electrocardiogram QT prolonged, blood pressure increased, blood pressure decreased, atrial fibrillation, tachycardia, tachyarrhythmia, angina pectoris (stable and unstable), ventricular extrasystoles, nodal rhythm.
Danish: Formoterol: hypokaliæmi, hyperglykæmi, tremor, palpitationer, muskelspasmer, QT-forlængelse på elektrokardiogram, forhøjet blodtryk, nedsat blodtryk, atrieflimmer, takykardi, takyarytmi, angina pectoris (stabil og ustabil), ventrikulære ekstrasystoler, nodal rytme.
English: For the regular cleaning of the inhaler, patients should remove weekly the cap from the mouthpiece and wipe the outside and inside of the mouthpiece with a dry cloth.
Danish: Patienterne skal fjerne låget fra mundstykket ugentligt for regelmæssig rengøring af inhalatoren, og tørre ydersiden og indersiden af mundstykket af med en tør klud.
English: Beclometasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity that is hydrolysed via esterase enzymes to an active metabolite beclometasone 17-monopropionate which has a more potent topical anti-inflammatory activity compared with the pro-drug beclometasone dipropionate.
Danish: Beclometasondipropionat er et prodrug med en svag bindingsaffinitet til glukokortikoidreceptoren, som hydrolyseres af esteraseenzymer til en aktiv metabolit, beclometason-17-monopropionat, der har en mere potent topikal antiinflammatorisk aktivitet, sammenlignet med beclometasondipropionatprodrug.
English: This incorporates a mouthpiece provided with a plastic protective cap, and either a dose counter (containers with 60 and 120 puffs) or a dose indicator (containers with 180 puffs).
Danish: Denne består af et mundstykke, der leveres med et beskyttelseslåg af plastic, og enten en dosistæller (beholdere med 60 og 120 pust) eller en dosisindikator (beholdere med 180 pust).
English: No differences were observed when comparing Riarify and the extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol plus tiotropium (difference of 3 mL in pre-dose FEV1 after 52 weeks of treatment).
Danish: Der blev ikke observeret nogen forskelle ved sammenligning af Riarify og den ekstemporære trippelkombination bestående af en fastdosiskombination af beclometasondipropionat og formoterol plus tiotropium (forskel på 3 ml i FEV1 før dosering efter 52 ugers behandling).
English: You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Riarify therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Danish: Du skal sammen med lægen beslutte, om amning skal ophøre eller behandling med Riarify stoppes, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for dig.
English: Glycopyrronium is a high-affinity, long-acting muscarinic receptor antagonist (anticholinergic) used for inhalation as bronchodilator treatment of COPD.
Danish: Glycopyrronium er en langtidsvirkende muskarin receptorantagonist (antikolinerg) med høj affinitet, der anvendes til inhalation som en bronkodilaterende behandling af KOL.
English: Beclometasone dipropionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs.
Danish: Beclometasonpropionat administreret som inhalation ved de anbefalede doser giver en antiinflammatorisk glukokortikoidvirkning i lungerne.
English: Anticholinergic effect
Danish: Antikolinerg virkning
English: What you need to know before you use Riarify Do not use Riarify:
Danish: Det skal du vide, før du begynder at bruge Riarify Brug ikke Riarify:
English: Each pack contains one pressurised container either providing 60 puffs, 120 puffs or 180 puffs.
Danish: Hver pakning indeholder en trykbeholder, der lever 60 pust, 120 pust eller 180 pust.
English: Systemic exposure (AUC0-t) to beclometasone dipropionate, to its metabolite beclometasone 17-monopropionate and to formoterol was not affected by mild to severe renal impairment.
Danish: Den systemiske eksponering (AUC0-t) for beclometasondipropionat, for metabolitten beclometason-17-monopropionat og for formoterol var ikke påvirket ved en let til svært nedsat nyrefunktion.
English: Their lips should then be placed around the mouthpiece, with the tongue flat under it.
Danish: Luk læberne rundt om mundstykket med en flad tunge nedenunder.
English: In patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, especially if associated with a significant body weight reduction, Riarify should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Danish: Hos patienter med svært nedsat nyrefunktion, herunder med nyresygdom i slutstadiet, der kræver dialyse, især hvis det er forbundet med en signifikant reduktion af legemsvægten, bør Riarify kun anvendes, hvis den forventede fordel opvejer den mulige risiko (se pkt.
English: Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Riarify with the AeroChamber Plus spacer device increased the total systemic exposure (AUC0-t) to glycopyrronium.
Danish: 5.2) har påvist, at ved sammenligning med rutinemæssig anvendelse uden en spacer-anordning, forlængede anvendelsen af Riarify med AeroChamber Plus spacer-anordningen den totale systemiske eksponering (AUC0-t) over for glycopyrronium.
English: The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium.
Danish: Aktive stoffer: beclometasondipropionat, formoterolfumaratdihydrat og glycopyrronium.
English: Dyspnoea1
Danish: Dyspnø1
English: Atrial fibrillation, electrocardiogram QT prolonged, tachycardia, tachyarrhythmia1, palpitations
Danish: Atrieflimmer, QT-forlængelse på elektrokardiogram, takykardi, takyarytmi1, palpitationer
English: They should stop using the inhaler when the counter or indicator shows 0 as any puffs left in the device may not be enough to release a full actuation.
Danish: De skal holde op med at bruge inhalatoren, når tælleren eller indikatoren viser 0, da den resterende opløsning i inhalatoren måske ikke er nok til at give et helt pust.
English: • decrease in bone mineral density (thinning of the bones)
Danish: • nedsat knoglemineralsk densitet (knoglerne bliver mere skøre)
English: • urinary tract infection.
Danish: • urinvejsinfektion.
English: Cleaning
Danish: Rengøring
English: If you stop using Riarify
Danish: Hvis du holder op med at bruge Riarify
English: If you have been prescribed a container providing 60 puffs or 120 puffs There is a counter on the back of the inhaler, which tells you how many doses are left.
Danish: Hvis du har fået ordineret en beholder, der leverer 60 pust eller 120 pust Der er en dosistæller bag på inhalatoren, som viser dig hvor mange doser, der er tilbage.
English: Take care not to drop the inhaler as this may cause the dose indicator to count down.
Danish: Sørg for ikke at tabe inhalatoren, da det kan få dosisindikatoren til at tælle ned.
English: Granulocytopenia1
Danish: Granulocytopeni1
English: Pressurised inhalation, solution (pressurised inhalation).
Danish: Inhalationsspray, opløsning (inhalationsspray).
English: Bronchospasm paradoxical1, oropharyngeal pain, pharyngeal erythema, pharyngeal inflammation, dry throat
Danish: Paradoks bronkospasme1, orofaryngeale smerter, faryngealt erytem, faryngeal inflammation, tør i halsen
English: For the 60 and 120 actuation pressurised containers each time the patient presses the container a puff of the solution is released and the counter counts down by one.
Danish: For trykbeholdere med 60 og 120 pust vil tælleren tælle ned med en, hver gang patienten trykker på beholderen, og et pust af opløsningen frigives.
English: Multipack: 360 actuations (3 pressurised containers of 120 actuations each).
Danish: Multipakning: 360 pust (3 trykbeholdere med 120 pust hver).
English: A total of 3,346 patients were treated with beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium 87 micrograms/5 micrograms/9 micrograms at the target dose regimen (two inhalations twice daily) in multiple dose studies.
Danish: I alt 3.346 patienter blev behandlet med beclometasondipropionat/formoterolfumaratdihydrat/glycopyrronium 87 mikrogram/5 mikrogram/9 mikrogram i behandlingsprogrammer, hvor der blev givet måldosen (to inhalationer to gange dagligt) i flerdosisstudier.
English: Pressurised container (coated aluminium), with a metering valve.
Danish: Trykbeholder (belagt aluminium) med en doseringsventil.
English: • a container providing 60 puffs
Danish: • en beholder, der leverer 60 pust
English: Multipack: 240 actuations (2 pressurised containers of 120 actuations each).
Danish: Multipakning: 240 pust (2 trykbeholdere med 120 pust hver).
English: Compared with a fixed combination of indacaterol and glycopyrronium, Riarify improved average pre-dose FEV1 over the 52-week treatment period by 22 mL (p=0.018).
Danish: Sammenlignet med en fastdosiskombination af indacaterol og glycopyrronium forbedrede Riarify den gennemsnitlige FEV1 inden dosering i løbet af den 52-ugers behandlingsperiode med 22 ml (p = 0,018).
English: Diarrhoea1, dry mouth, dysphagia1, nausea, dyspepsia1, burning sensation of the lips1, dental caries1, (aphthous) stomatitis
Danish: Diarré1, mundtørhed, dysfagi1, kvalme, dyspepsi1, brændende fornemmelse af læberne1, tandkaries1, (aftøs) stomatitis
English: If you forget to use Riarify
Danish: Hvis du har glemt at bruge Riarify
English: 180 actuations
Danish: 180 pust
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Danish: Ved brug af systemisk og topikalt kortikosteroid kan der blive indberettet synsforstyrrelser.
English: No differences were observed when comparing Riarify with the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (moderate/severe exacerbation rate: 0.46 versus 0.45 events per patient/year).
Danish: Der blev ikke observeret nogen forskelle, når Riarify blev sammenlignet med den ekstemporære trippelkombination bestående af beclometasondipropionat og formoterol fastdosiskombination plus tiopropium (hyppigheden af moderate/svære eksacerbationer: 0,46 versus 0,45 hændelser pr. patient/år).
English: Each time you press the pressurised container, a puff of medicine is released and the counter will count down by one.
Danish: Hver gang du trykker på trykbeholderen, leveres et pust af medicin, og dosistælleren vil tælle ned med en.
English: Hold your inhaler upright with the mouthpiece at the bottom Direct the mouthpiece away from yourself and firmly press the pressurised container to release one puff
Danish: Hold din inhalator lodret med mundstykket forneden Sørg for, at mundstykket vender væk fra dig, og tryk med en fast hånd ned på trykbeholderen, for at levere et pust
English: The pharmacokinetics of formoterol has not been studied in patients with hepatic impairment; however, as formoterol is primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe hepatic impairment.
Danish: Da formoterol primært elimineres via levermetabolismen, kan der imidlertid forventes en øget eksponering hos patienter med svært nedsat leverfunktion.
English: • clouding of the lens of your eyes (cataract).
Danish: • uklar linse i øjnene (grå stær).
English: The pressurised container is inserted in a polypropylene inhaler which incorporates a mouthpiece and a dose counter (60 actuations or 120 actuations per pressurised container) or dose indicator (180 actuations per pressurised container) and is provided with a polypropylene mouthpiece cap.
Danish: Trykbeholder er indsat i en polypropylen inhalator med et indbygget mundstykke og en dosistæller (60 pust eller 120 pust pr. trykbeholder) eller en dosisindikator (180 pust pr. trykbeholder), og den leveres med et polypropylenlåg til mundstykket.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 actuations
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 60 pust
English: Do not pierce the pressurised container.
Danish: Trykbeholderen må ikke perforeres.
English: Therefore, as a precautionary measure, it is preferable to avoid the use of Riarify during pregnancy and during labour.
Danish: For en sikkerheds skyld bør Riarify derfor undgås under graviditeten og fødsel.
English: The pharmacokinetics of beclometasone dipropionate in patients with hepatic impairment has not been studied, however, as beclometasone dipropionate undergoes a very rapid metabolism via esterase enzymes present in intestinal fluid, serum, lungs and liver to form the more polar products beclometasone 21-monopropionate, beclometasone 17-monopropionate and beclometasone, hepatic impairment is not expected to modify the pharmacokinetics and safety profile of beclometasone dipropionate.
Danish: Farmakokinetikken af beclometasondipropionat hos patienter med nedsat leverfunktion er imidlertid ikke undersøgt, da beclometasondipropionat gennemgår en meget hurtig metabolisme via esteraseenzymer i intestinalvæsken, serum, lunger og lever, så der dannes de mere polære produkter beclometason-21-monopropionat, beclometason-17-monopropionat og beclometason.
English: Vision, blurred1 (see also section 4.4)
Danish: Sløret syn1 (se også pkt.
English: Immediately after starting to breathe in, patients should firmly press down on the top of the pressurised container to release one puff.
Danish: Lige efter de begynder at trække vejret ind, skal patienterne med en fast hånd trykke ned foroven på trykbeholderen for at levere et pust.
English: TRIBUTE was a 52-week activecontrolled study comparing Riarify with a fixed combination of indacaterol/glycopyrronium 85/43 micrograms inhalation powder, hard capsule, one inhalation once daily (1,532 randomised patients).
Danish: TRIBUTE var et 52-ugers aktivt kontrolleret studie, der sammenlignede Riarify med en fastdosiskombination af indacaterol/glycopyrronium 85/43 mikrogram inhalationspulver, hård kapsel, en inhalation én gang dagligt (1.532 randomiserede patienter).
English: In patients with severe hepatic impairment, Riarify should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Danish: Hos patienter med svært nedsat leverfunktion må Riarify kun anvendes, hvis den forventede fordel opvejer den mulige risiko (se pkt.
English: Study TRILOGY compared Riarify with a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily (1,368 randomised patients).
Danish: TRILOGY-studiet sammenlignede Riarify med en fastdosiskombination af beclometasondipropionat og formoterol 100/6 mikrogram givet som to inhalationer to gange dagligt (1.368 randomiserede patienter).
English: • a container providing 120 puffs
Danish: • en beholder, der leverer 120 pust
English: Glycopyrronium: glaucoma, atrial fibrillation, tachycardia, palpitations, dry mouth, dental caries, dysuria, urinary retention, urinary tract infection.
Danish: Glycopyrronium: glaukom, atrieflimmer, takykardi, palpitationer, mundtørhed, tandkaries, dysuri, urinretention, urinvejsinfektion.
English: • if you have any disease of your liver or kidneys.
Danish: • hvis du har lever- eller nyresygdomme.
English: Beclometasone dipropionate: pneumonia, oral fungal infections, lower respiratory tract infection fungal, dysphonia, throat irritation, hyperglycaemia, psychiatric disorders, cortisol decreased, blurred vision.
Danish: Beclometasondipropionat: pneumoni, orale svampeinfektioner, svampeinfektion i de nedre luftveje, dysfoni, halsirritation, hyperglykæmi, psykiske sygdomme, nedsat kortisol, sløret syn.
English: After dispensing, the inhaler may be stored at a temperature up to 25°C for a maximum of 2 months.
Danish: Efter udlevering kan inhalatoren opbevares ved temperaturer op til 25 °C i maksimalt 2 måneder.
English: If you have a weak grip, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.
Danish: Hvis du har et svagt greb, kan det være nemmere at holde inhalatoren med begge hænder.
English: • increase in the level of some constituents of your blood: glucose, C-reactive protein,
Danish: • øget niveau af nogle af bestanddelene i blodet: af glucose, C-reaktivt protein, af antallet af blodplader, af frie fedtsyrer eller af ketoner.
English: • beclometasone dipropionate,
Danish: • beclometasondipropionat
English: How to use your inhaler
Danish: Sådan skal du bruge din inhalator
English: Potentially serious hypokalaemia may result from beta2-agonist therapy.
Danish: Behandling med beta2-agonister kan føre til potentielt alvorlig hypokaliæmi.
English: Store at 25°C for a maximum of 4 months.
Danish: Opbevares ved 25 °C i maksimalt 4 måneder.
English: Related to glycopyrronium
Danish: Med relation til glycopyrronium
English: Riarify is a pressurised inhalation, solution.
Danish: Riarify er en inhalationsspray, opløsning.
English: Effects on lung function
Danish: Virkninger på lungefunktionen
English: C-reactive protein increased1, platelet count increased1, free fatty acids increased1, blood insulin increased1, blood ketone body increased1, cortisol decreased1
Danish: Forhøjet C-reaktivt protein1, forhøjet antal trombocytter1, forhøjet niveau af frie fedtsyrer1, forhøjet insulinindhold i blodet1, forhøjet ketonindhold i blodet1, nedsat kortisol1
English: Just after starting to breathe in, press down firmly on the top of the pressurised container to release one puff.
Danish: Lige efter du begynder at trække vejret ind, skal du med en fast hånd trykke ned foroven på trykbeholderen for at levere et pust.
English: Hold the inhaler upright with the mouthpiece at the bottom and place the mouthpiece between your teeth without biting it. Then place your lips around the mouthpiece, with the tongue flat under it.
Danish: Patienterne skal holde inhalatoren lodret med beholderen øverst, og placere mundstykket mellem tænderne uden at bide i det. Læberne skal lukkes rundt om mundstykket med en flad tunge nedenunder.