FrancophonIA/ELRC3.0 huggingface dataset:
English: After use, patients should close the inhaler with the protective mouthpiece cover and check the dose counter or dose indicator.
Danish: Efter brug skal patienterne lukke inhalatoren med beskyttelseslåget til mundstykket, og kontrollere dosistælleren eller dosisindikatoren.
English: Formoterol is a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction.
Danish: Formoterol er en selektiv beta2-adrenerg agonist, som medfører afslapning af den glatte muskulatur i bronkierne hos patienter med reversibel luftvejsobstruktion.
English: • if you experience any allergic reactions like skin allergies, hives, skin itching, skin rash (may affect up to 1 in 100 people), reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat (may affect up to 1 in 1,000 people).
Danish: • hvis du oplever allergiske reaktioner, såsom hudallergier, nældefeber, hudkløe, hududslæt (kan forekomme hos op til 1 ud af 100 personer), hudrødmen, hævelse af hud eller slimhinder, især i øjnene, ansigtet, læber og hals (kan forekomme hos op til 1 ud af 1.000 personer).
English: The total systemic exposure (as measured by AUC0-t) was slightly reduced for beclometasone 17-monopropionate (by 37%) and formoterol (by 24%), while it was increased for glycopyrronium (by 45%).
Danish: Den totale systemiske eksponering (målt ved AUC0-t) var let reduceret for beclometason-17-monopropionat (med 37 %) og formoterol (med 24 %), mens den var øget for glycopyrronium (med 45 %).
English: The recommended dose is two inhalations of Riarify twice daily.
Danish: Den anbefalede dosis er to inhalationer af Riarify to gange dagligt.
English: The terminal elimination half-lives are 0.5 hours and 2.7 hours for beclometasone dipropionate and beclometasone 17-monopropionate respectively.
Danish: De terminale halveringstider for elimination er hhv. 0,5 timer og 2,7 timer for beclometasondipropionat og beclometason-17-monopropionat.
English: The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for unchanged beclometasone dipropionate and beclometasone 17-monopropionate respectively.
Danish: Den absolutte biotilgængelighed efter inhalationen er hhv. ca. 2 % og 62 % af den nominelle dosis af uændret beclometasondipropionat og beclometason-17-monopropionat.
English: Riarify contains beclometasone dipropionate, formoterol and glycopyrronium in a solution formulation resulting in an aerosol with extrafine particles with an average mass median aerodynamic diameter (MMAD) of around 1.1 micrometres and co-deposition of the three components.
Danish: Riarify indeholder beclometasondipropionat, formoterol og glycopyrronium i en opløsning, der er formuleret således, at der dannes en aerosol med ekstrafine partikler med en gennemsnitlig massemedian aerodynamisk diameter (MMAD) på ca. 1,1 mikrometer, og en ko-deponering af alle tre komponenter.
English: • muscle cramps and pain in muscles
Danish: • muskelkramper og smerter i musklerne
English: Riarify was also statistically significantly superior to a fixed combination of beclometasone dipropionate and formoterol, to tiotropium and to a fixed combination of indacaterol and glycopyrronium in terms of improvement in quality of life (measured by the Saint George Respiratory Questionnaire - SGRQ - total score).
Danish: Riarify var også statistisk signifikant bedre end en fast kombination af beclometasondipropionat og formoterol, end tiotropium og en fast kombination af indacaterol og glycopyrronium hvad angår en forbedring af livskvaliteten (målt ved Saint George Respiratory Questionnaire - SGRQ - total score).
English: Glucocorticoids are widely used for the suppression of inflammation in chronic inflammatory diseases of the airways such as COPD.
Danish: Glukokortikoider bruges udbredt til at undertrykke inflammation ved kronisk inflammatorisk sygdom i luftvejene, såsom KOL.
English: Patients should be advised to get a new inhaler when the dose counter or indicator shows the number 20.
Danish: Patienterne bør rådes til at få en ny inhalator, når dosistælleren eller dosisindikatoren viser tallet 20.
English: However, in a 104-week rat inhalation carcinogenicity study and an oral 26-week carcinogenicity study in transgenic Tg.rasH2 mice, glycopyrronium bromide showed no carcinogenic potential and published data concerning long-term studies conducted with beclometasone dipropionate and formoterol fumarate in rats do not indicate a clinically relevant carcinogenic potential.
Danish: I et inhalations-karcinogenicitetsstudie på 104 uger af rotter og i et oralt 26 ugers karcinogenicitetsstudie af transgene Tg.rasH2-mus viste glycopyrroniumbromid imidlertid ikke karcinogenicitet, og offentliggjorte data fra langvarige studier udført med beclometasondipropionat og formoterolfumarate af rotter indikerer ikke klinisk relevant karcinogenicitet.
English: These may be signs of an acute attack of narrow-angle glaucoma (may affect up to 1 in 10,000 people).
Danish: Det kan være tegn på et akut anfald af snævervinklet grøn stær (kan forekomme hos op til 1 ud af 10.000 personer).
English: The systemic exposure to beclometasone dipropionate, formoterol and glycopyrronium has been investigated in a pharmacokinetic study conducted in healthy subjects.
Danish: Den systemiske eksponering over for beclometasondipropionat, formoterol og glycopyrronium er blevet undersøgt i et farmakokinetisk studie udført hos raske personer.
English: The metabolic pattern of glycopyrronium in vitro (humans, dogs, rats, mice and rabbits liver microsomes and hepatocytes) was similar among species and the main metabolic reaction was the hydroxylation on the phenyl or ciclopentyl rings.
Danish: Det metaboliske mønster for glycopyrronium in vitro (levermikrosomer og hepatocytter hos mennesker, hunde, rotter, mus og kaniner) var sammenlignelig blandt arterne, og den største metaboliske reaktion fra hydroxyleringen til fenyl- eller ciclopentylringene.
English: Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists (see section 4.4).
Danish: Samtidig behandling med xanthinderivater, steroider eller diuretika kan potensere en mulig hypokaliæmisk virkning af beta2-agonister (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS AND MULTIPACK ONLY: contains Blue Box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (KUN FOR ENKELTPAKNINGER OG MULTIPAKNINGER: indeholder Blå Boks)
English: Patients should not breathe out into the inhaler.
Danish: Patienterne må ikke puste ud i inhalatoren.
English: Tell your doctor if you have used more Riarify than you should and if you experience any of these symptoms.
Danish: Fortæl lægen, hvis du har brugt for meget Riarify, og hvis du oplever nogle af disse symptomer.
English: Angina pectoris (stable1 and unstable), ventricular extrasystoles1, nodal rhythm, sinus bradycardia
Danish: Angina pectoris (stabil1 og ustabil), ventrikulære ekstrasystoler1, nodal rytme, sinus bradykardi
English: There are no relevant clinical data on the use of Riarify during breast-feeding in humans.
Danish: Der er ingen relevante kliniske data for anvendelsen af Riarify under amning hos mennesker.
English: Glucocorticoid agents are known to cause effects in the early gestation phase, while beta2-sympathomimetic agents like formoterol have tocolytic effects.
Danish: Det er kendt, at glukokortikoider forårsager virkninger i den tidlige gestationsfase, hvor beta2-sympatomimetika som formoterol har tokolytiske virkninger.
English: After oral administration (40 to 80 micrograms), 6% to 10% of the dose was recovered in urine as unchanged active substance in healthy subjects; up to 8% of the dose was recovered as the glucuronide.
Danish: Efter oral administration (40 til 80 mikrogram) blev 6 % til 10 % af dosis genfundet i urinen som uændret aktivt stof hos de raske personer.
English: Additional there are multipacks containing either 2 or 3 pressurised containers with 120 puffs, each.
Danish: Desuden er der multipakninger, der indeholder enten 2 eller 3 trykbeholdere, hver med 120 pust.
English: Chemical and physical in-use stability has been demonstrated for 4 months at 25°C.
Danish: Der er blevet påvist en kemisk og fysisk stabilitet ved brug i 4 måneder ved 25 ºC.
English: Chemical and physical in-use stability has been demonstrated for 2 months at 25°C.
Danish: Der er blevet påvist en kemisk og fysisk stabilitet ved brug i 2 måneder ved 25 ºC.
English: Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics (see section 4.5).
Danish: Hypokaliæmi kan også potenseres af samtidig behandling med andre lægemidler, der kan inducere hypokaliæmi, såsom xanthinderivater, steroider og diuretika (se pkt.
English: • some anaesthetics can increase the risk of abnormal heart rhythms.
Danish: • nogle bedøvelser kan øge risikoen for unormale hjerterytmer.
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, Riarify should be discontinued immediately and alternative therapy instituted.
Danish: Hvis der opstår tegn, der tyder på allergiske reaktioner, især angioødem (herunder vejrtræknings- eller synkebesvær, hævelse af tunge, læber og ansigt), urticaria eller hududslæt, skal Riarify straks seponeres, og der skal iværksættes en alternativ behandling.
English: The use of Riarify with the AeroChamber Plus spacer in COPD patients increased the lung delivery of beclometasone 17-monopropionate, formoterol and glycopyrronium (maximum plasma concentration increased by 15%, 58% and 60% respectively).
Danish: Anvendelsen af Riarify sammen med AeroChamber Plus-spaceren til KOL-patienter øgede leveringen af beclometason-17-monopropionat, formoterol og glycopyrronium i lungerne (maksimal plasmakoncentration var forhøjet med hhv. 15 %, 58 % og 60 %).
English: • increase of blood pressure
Danish: • forhøjet blodtryk
English: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
Danish: Der er set en øget forekomst af pneumoni, herunder pneumoni, der krævede hospitalsindlæggelse, hos KOL-patienter der fik kortikosteroider til inhalation.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Riarify in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur (EMA) har dispenseret fra kravet om at fremlægge resultaterne af studier med Riarify i alle undergrupper af den pædiatriske population ved KOL (se pkt.
English: • abnormal or reduced sense of taste
Danish: • unormal eller nedsat smagssans
English: Beclometasone dipropionate belongs to a group of medicines called corticosteroids which act to reduce the swelling and irritation in your lungs.
Danish: Beclometasondipropionat tilhører en gruppe lægemidler, der kaldes kortikosteroider, som virker ved at reducere hævelse og irritation i lungerne.
English: This may increase the likelihood of abnormal heart rhythms.
Danish: Dette kan øge sandsynligheden for unormale hjerterytmer.
English: Beclometasone dipropionate
Danish: Beclometasondipropionat
English: It is reasonable to assume that beclometasone dipropionate and its metabolites are also excreted into breast-milk.
Danish: Det er rimeligt at antage, at beclometasondipropionat og dets metabolitter også udskilles i brystmælken.
English: Riarify is for inhalation use.
Danish: Riarify er til inhalation.
English: Genotoxicity of Riarify has not been evaluated, however, the single active components were devoid of genotoxic activity in the conventional test systems.
Danish: De enkelte aktive komponenter var imidlertid uden genotoksisk aktivitet i de konventionelle testsystemer.
English: It is noted that single component glycopyrronium, formulated as pressurised metered dose inhaler, which was used in the PK studies, is not available on the market.
Danish: Det er blevet bemærket, at den enkelte komponent glycopyrronium, der var formuleret som en inhalationsspray med afmålte doser, og som blev anvendt i de farmakokinetiske studier, ikke findes på markedet.
English: Do not remove the pressurised container from the inhaler and do not use water or other liquids to clean your inhaler.
Danish: Du må ikke fjerne trykbeholderen fra inhalatoren, og brug ikke vand eller andre væsker til at rengøre inhalatoren.
English: In COPD patients receiving repeated twice daily administration of inhaled glycopyrronium, the fraction of the dose excreted in urine ranged from 13.0% to 14.5% at steady state.
Danish: Hos patienter med KOL, der fik gentagen administration med inhaleret glycopyrronium to gange dagligt, var fraktionen af dosis udskilt i urinen i intervallet fra 13,0 % til 14,5 % ved steady state.
English: A comparison across studies showed that the pharmacokinetics of beclometasone 17-monopropionate, formoterol and glycopyrronium is similar in COPD patients and in healthy subjects.
Danish: En sammenligning af studierne viste, at farmakokinetikken for beclometason-17-monopropionat, formoterol og glycopyrronium er tilsvarende hos patienter med KOL og hos raske personer.
English: The long-term co-administration of Riarify with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Danish: Den langvarige administration af Riarify sammen med andre lægemidler, der indeholder antikolinergika, er ikke blevet undersøgt, og de bør derfor ikke anvendes (se pkt.
English: For glycopyrronium, there was no impact in subjects with mild and moderate renal impairment.
Danish: For glycopyrronium var der ingen påvirkning hos personer med let og moderat nedsat nyrefunktion.
English: Stand or sit up when inhaling.
Danish: Stå eller sid op, mens du bruger din inhalator.
English: • sensation of a missed heart beat, unusually slow heart beat
Danish: • en fornemmelse af, at hjertet springer et slag over, usædvanligt langsomt hjerteslag
English: Hypokalaemia, hyperglycaemia
Danish: Hypokaliæmi, hyperglykæmi
English: They should not remove the pressurised container from the actuator and should not use water or other liquids to clean the mouthpiece.
Danish: De må ikke fjerne trykbeholderen fra aktuatoren, og de må ikke bruge vand eller andre væsker til at rengøre mundstykket.
English: • unusually fast heart beat and disorders of the heart rhythm
Danish: • usædvanligt hurtigt hjerteslag og hjerterytmeforstyrrelser
English: • fungal infections of the mouth.
Danish: • svampeinfektioner i munden.
English: The pressurised container is inserted in a plastic inhaler.
Danish: Trykbeholderen er indsat i en plasticinhalator.
English: The most frequently reported adverse reactions with Riarify were oral candidiasis (which occurred in 0.8% of the exposed subjects), which is normally associated with inhaled corticosteroids; muscle spasms (0.4%), which can be attributed to the long-acting beta2-agonist component; dry mouth (0.4%), which is a typical anticholinergic effect.
Danish: De hyppigst rapporterede bivirkninger med Riarify var oral candidiasis (som opstod hos 0,8 % af de eksponerede personer), hvilket normalt er forbundet med inhalerede kortikosteroider, muskelspasmer (0,4 %), som kan tilskrives den langtidsvirkende beta2-agonist-komponent, mundtørhed (0,4 %), som er en typisk antikolinerg virkning.
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Danish: Der er ikke fundet endegyldig klinisk evidens på forskelle i risikoen for pneumoni mellem de enkelte klasser af kortikosteroid til inhalation.
English: • if you have disorders of your heart rhythm such as irregular heart rate, a fast pulse rate or palpitations or if you have been told that your heart trace (ECG) is abnormal.
Danish: • hvis du har hjerterytmeforstyrrelser, såsom en øget eller uregelmæssig hjertefrekvens, en hurtig puls eller hjertebanken, eller hvis du har fået at vide, at dit hjertediagram (EKG) er unormalt.
English: For the second puff, keep the inhaler in the upright position for about half a minute, then repeat steps 2 to 5.
Danish: For det andet pust skal du holde inhalatoren opret i ca. et halvt minut, og så gentage trin 2 til 5.
English: The combination of Riarify with some other COPD medicines or medicines such as diuretics (medicines that make the body lose water, to treat heart disease or high blood pressure), can cause a sharp fall in your blood level of potassium.
Danish: Kombinationen af Riarify med nogle andre lægemidler mod KOL, eller lægemidler som f.eks. diuretika (lægemidler, der får kroppen til at udskille vand, til at behandle hjertesygdom eller højt blodtryk), kan forårsage et brat fald i niveauet i kalium i blodet.
English: The effect of organic cation transport inhibition (using cimetidine as a probe inhibitor of OCT2 and MATE1 transporters) in the kidneys on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 16% and a slight decrease in renal clearance by 20% due to co administration of cimetidine.
Danish: Virkningen i nyrerne af en hæmning af den organiske kationtransporter (der bruger cimetidin som en probe-hæmmer for OCT2- og MATE1-transportere) på disponeringen af inhaleret glycopyrronium, viste en begrænset stigning i den totale systemiske eksponering (AUC0-t) med 16 %, og en let reduktion i nyreclearance med 20 % på grund af den samtidige administration af cimetidin.
English: • pain in muscles, bones or joints of the chest
Danish: • smerter i muskler, knogler eller led i brystet
English: 60 actuation pressurised container: 21 months.
Danish: Trykbeholder med 60 pust: 21 måneder.
English: Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms (see section 5.2).
Danish: Da glycopyrronium primært elimineres via nyrerne, er det muligt, at der kan opstå lægemiddelinteraktioner med lægemidler, der påvirker mekanismen for udskillelse via nyrerne (se pkt.
English: Riarify significantly improved dyspnoea (measured as the Transition Dyspnoea Index - TDI - focal score) after 26 weeks of treatment compared with baseline (by 1.71 units; p < 0.001), but the adjusted mean difference versus a fixed combination of beclometasone dipropionate and formoterol was not statistically significant (0.21 units; p = 0.160).
Danish: Riarify forbedrede dyspnø signifikant (målt som transitionalt dyspnøindeks - TDI - fokal score) efter 26 ugers behandling sammenlignet med baseline (med 1,71 enheder, p < 0,001), men den justerede gennemsnitlige forskel versus en fast kombination af beclometasondipropionat og formoterol var ikke statistisk signifikant (0,21 enheder, p = 0,160).
English: In order to reduce the risk of oropharyngeal candida infection, patients should be advised to rinse their mouth or gargle with water without swallowing it or brush their teeth after inhaling the prescribed dose.
Danish: For at reducere risikoen for orofaryngeale candidainfektioner, skal patienterne rådes til at skylle munden eller gurgle med vand uden at synke det, eller børste tænder efter inhalation af den ordinerede dosis.
English: • if you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary heart disease), disease of your heart valves or any other abnormalities of your heart or if you have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal).
Danish: • hvis du har hjerteproblemer, såsom angina (hjertesmerter, smerter i brystet), har haft et hjerteanfald for nylig (myokardieinfarkt), hjertesvigt, forsnævring af arterierne rundt om hjertet (koronar hjertesygdom), sygdom i hjerteklapperne eller andre anomalier af hjertet, eller hvis du har en sygdom, der kaldes hypertrofisk obstruktiv kardiomyopati (også kaldet HOCM, en sygdom, hvor hjertemuskulaturen er unormal).
English: Simulations performed with a pharmacokinetic model showed that even when covariates had extreme values (body weight less than 40 kg and concomitant glomerular filtration rate below 27 mL/min/1.73 m²), exposure to Riarify active substances remains in approximately a 2.5-fold range compared to the exposure in a typical patient with median covariate values.
Danish: Simuleringer udført med en farmakokinetisk model viste, at selv når kovariaterne havde ekstreme værdier (legemsvægt under 40 kg og samtidig glomerulær filtrationshastighed under 27 ml/min/1,73 m²), forblev eksponeringen over for de aktive stoffer i Riarify ca. 2,5 gange højere, sammenlignet med eksponeringen hos en typisk patient med mediane kovariate værdier.
English: For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Riarify are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation).
Danish: For beclometasondipropionat fører dette til en kraftigere virkning end for formuleringer med en fordeling af partikelstørrelsen, der ikke er ekstrafin (100 mikrogram ekstrafint beclometasondipropionat i Riarify svarer til 250 mikrogram beclometasondipropionat i en formulering, der ikke er ekstrafin).
English: The maximum plasma concentration and systemic exposure of beclometasone dipropionate main active metabolite (beclometasone 17-monopropionate) and formoterol were similar after administration of the fixed or extemporary combination.
Danish: Den maksimale plasmakoncentration og den systemiske eksponering af den primære aktive metabolit af beclometasondipropionat (beclometason-17-monopropionat) og formoterol var tilsvarende efter administration af den faste eller ekstemporære kombination.
English: Influenza1, oral fungal infection, oropharyngeal candidiasis, oesophageal candidiasis1, sinusitis1, rhinitis1, gastroenteritis1, vulvovaginal candidiasis1
Danish: Influenza1, oral svampeinfektion, orofaryngeal candidiasis, øsofageal candidiasis1, sinuitis1, rhinitis1, gastroenteritis1, vulvovaginal candidiasis1
English: Faecal excretion is the major route of beclometasone dipropionate elimination mainly as polar metabolites.
Danish: Udskillelse via fæces er den største eliminationsvej for beclometasondipropionat, primært som polære metabolitter.
English: An overdose of Riarify may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists or anticholinergics and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Danish: En overdosering af Riarify kan give tegn og symptomer, der kan skyldes virkningerne af de enkelte komponenter, herunder tegn og symptomer ved overdosering med andre beta2-agonister eller antikolinergika, og som svarer til de kendte klassevirkninger for kortikosteroider (se pkt.
English: Caution is also required when Riarify is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia.
Danish: Det er også nødvendigt at udvise forsigtighed, når Riarify anvendes af patienter med tyrotoksikose, diabetes mellitus, fæokromocytom og ubehandlet hypokaliæmi.
English: When to get a new inhaler
Danish: Hvornår skal du have en ny inhalator?
English: There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Danish: Der er en øget risiko for arytmier hos patienter, der samtidigt får anæstetika med halogenerede kulbrinter.