FrancophonIA/ELRC3.0 huggingface dataset:
English: You should only use Riarify during pregnancy if you are advised to do so by your doctor.
Danish: Du må kun anvende Riarify under graviditet, hvis lægen har rådet dig til det.
English: • if you have difficulty passing urine.
Danish: • hvis du har svært ved at lade vandet.
English: Prior to dispensing: Store in a refrigerator (2°C-8°C).
Danish: Før udlevering: Opbevares i køleskab (2 °C - 8 °C).
English: • if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes.
Danish: • hvis du oplever øjensmerter eller -besvær, forbigående sløret syn, visuelle haloer eller farvet syn i forbindelse med røde øjne.
English: Non-cardioselective beta-blockers (including eye drops) should be avoided in patients taking inhaled formoterol.
Danish: Ikke-kardioselektive betablokkere (herunder øjendråber) bør undgås hos patienter, der tager inhaleret formoterol.
English: 1 Adverse reactions reported in the SmPC of at least one of the individual components, but not observed as adverse reactions in the clinical development of Riarify
Danish: 1 Bivirkninger rapporteret i produktresuméet for mindst én af de individuelle komponenter, men ikke observeret som bivirkninger under den kliniske udvikling af Riarify
English: Carcinogenicity studies have not been performed with Riarify.
Danish: Der er ikke udført karcinogenicitetsstudier med Riarify.
English: Symptomatic outcomes
Danish: Symptomatiske udfald
English: Alternatively, patients may simply breathe in and out (through the mouth) after the actuation, as instructed in the spacer leaflet, to obtain the active substance.
Danish: Ellers kan patienterne blot ind- og udånde (via munden) efter pustet, som anvist i indlægssedlen for spaceren, for at få det aktive stof.
English: • if you have an infection of the mouth or throat.
Danish: • hvis du har en infektion i munden eller halsen.
English: If you feel that the medicine is not very effective, talk to your doctor.
Danish: Hvis du mener, at lægemidlet ikke virker ret godt, skal du kontakte lægen.
English: (<1/10,000) and not known (cannot be estimated from available data).
Danish: <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Repeat dose toxicity
Danish: Toksicitet efter gentagne doser
English: Depending on the type of anaesthetic, it may be necessary to stop using Riarify at least 12 hours before the anaesthesia.
Danish: Afhængigt af typen af bedøvelse kan det være nødvendigt at stoppe med at bruge Riarify i mindst 12 timer før bedøvelsen.
English: Regular treatment with these three active substances helps to relieve and prevent symptoms such as shortness of breath, wheezing and cough in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Regelmæssig behandling med disse tre aktive stoffer hjælper med at lindre og forhindre symptomer såsom stakåndethed, hvæsende vejrtrækning og hoste hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Danish: Hypokaliæmi kan øge disponeringen for arytmier hos patienter, der behandles med digitalis-glykosider.
English: Prevention of oropharyngeal infections
Danish: Forebyggelse af orofaryngeale infektioner
English: Riarify is available in three container sizes:
Danish: Riarify fås i tre beholderstørrelser:
English: There is an approximately linear increase in systemic exposure with increasing inhaled dose.
Danish: Der er en omtrentlig lineær forøgelse af den systemiske eksponering, når den inhalerede dosis øges.
English: TDI was only measured in study TRILOGY.
Danish: TDI blev kun målt i TRILOGY-studiet.
English: There was no evidence for overadditive effects of the triple combination when compared with the single components.
Danish: Der var ikke evidens for en overadditiv virkning af trippelkombinationen, sammenlignet med de enkelte komponenter.
English: Remove the protective cap from the mouthpiece by pulling it away from your inhaler.
Danish: Fjern beskyttelseslåget fra mundstykket ved at trække det væk fra inhalatoren.
English: This endpoint was only measured in study TRILOGY.
Danish: Dette endepunkt blev kun målt i TRILOGY-studiet.
English: Particular caution is advised in severe COPD as this effect may be potentiated by hypoxia.
Danish: Der rådes til at udvise særligt hensyn ved svær KOL, da denne virkning kan potenseres af hypoxi.
English: • pain in the back of the mouth and throat
Danish: • smerter bagest i munden og halsen
English: They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias).
Danish: Det kan også øge risikoen for forstyrrelser af hjerterytmen (ventrikulære arytmier).
English: Not for acute use
Danish: Ikke til akutbehandling
English: Riarify is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Danish: Riarify er ikke indiceret til behandling af akutte episoder med bronkospasme eller til behandling af en akut forværring af KOL (det vil sige som akutbehandling).
English: If you find it difficult to use the inhaler while starting to breathe in, you may use the AeroChamber Plus spacer device.
Danish: Hvis du finder det svært at bruge inhalatoren, når du begynder at trække vejret ind, kan du bruge AeroChamber Plus spacer-anordningen.
English: If anaesthesia with halogenated anaesthetics is planned, it should be ensured that Riarify is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias.
Danish: Hvis der planlægges anæstesi med halogenerede anæstetika, skal det sikres, at Riarify ikke administreres i mindst 12 timer før start af anæstesi, da der er en risiko for hjertearytmier.
English: Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Danish: Du må ikke bruge dette lægemiddel til at behandle pludselige anfald af åndenød eller en hvæsende vejrtrækning.
English: At the same time, patients should breathe in slowly and deeply through the mouth until the lungs are full of air (this should take approximately 4 - 5 seconds).
Danish: Samtidigt skal patienterne trække vejret langsomt og dybt ind gennem munden, indtil lungerne er fulde af luft (det bør tage ca. 4-5 sekunder).
English: Before using the inhaler for the first time, you should test your inhaler to make sure that it is working properly, as follows.
Danish: Før du bruger inhalatoren første gang, skal du teste din inhalator for at sikre, at den virker korrekt, på følgende måde.
English: Patients who find it difficult to synchronise aerosol actuation with inspiration of breath may use the AeroChamber Plus spacer device, properly cleaned as described in the relevant leaflet.
Danish: Patienter, som synes at det er besværligt at synkronisere et pust af aerosol med indåndingen, kan bruge AeroChamber Plus spacer-anordningen, rengjort korrekt som beskrevet i den relevante indlægsseddel.
English: Riarify can be used at the recommended dose in patients with mild to moderate renal impairment.
Danish: Riarify kan anvendes ved den anbefalede dosis hos patienter med let til moderat nedsat nyrefunktion.
English: If mist appears after the inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2.
Danish: Hvis der opstår en vandtåge efter inhalationen, enten fra inhalatoren eller fra mundvigene, skal proceduren gentages fra trin 2.
English: • if you have low blood levels of potassium (hypokalaemia).
Danish: • hvis du har lave niveauer af kalium i blodet (hypokaliæmi).
English: • if you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you have an aneurysm (abnormal bulging of the blood vessel wall).
Danish: • hvis du har en forsnævring af arterierne (også kaldet arteriosklerose), hvis du har højt blodtryk eller hvis du ved, at du har et aneurisme (en unormal udposning af væggen på et blodkar).
English: If you use more Riarify than you should, side effects, as described in section 4, may occur.
Danish: Hvis du har brugt for meget Riarify, kan der forekomme bivirkninger, som beskrevet i punkt 4.
English: The patient should be advised to read the Package Leaflet carefully and follow the instructions for use as given in the leaflet.
Danish: Patienten skal rådes til at læse indlægssedlen grundigt og følge de angivne brugsanvisninger i indlægssedlen.
English: Breathe out as slowly and deeply as possible, in order to empty your lungs.
Danish: Pust ud så langsomt og dybt som muligt for at tømme lungerne.
English: Talk to your doctor or pharmacist before using Riarify:
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Riarify:
English: Riarify contains a small amount of ethanol.
Danish: Riarify indeholder en mindre mængde alkohol.
English: Riarify should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus.
Danish: Riarify bør kun anvendes under graviditeten, hvis de forventede fordele for patienten opvejer de mulige risici for fosteret.
English: Depending on the container size prescribed to you, check that the dose counter reads 61 or 121 and that the dose indicator reads 180
Danish: Afhængig af den beholderstørrelse, du har fået ordineret, skal du kontrollere, at dosistælleren står på 61 eller 121, og at dosisindikatoren står på 180
English: Riarify is unlikely to affect your ability to drive and use machines.
Danish: Det er ikke sandsynligt, at Riarify vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Riarify is used as a maintenance treatment for your COPD.
Danish: Riarify anvendes som vedligeholdelsesbehandling af din KOL.
English: No specific studies have been performed with Riarify with regard to the safety in human fertility.
Danish: Der er ikke udført specifikke studier med Riarify hvad angår sikkerheden på fertiliteten hos mennesker.
English: At least 65% of the fraction that is swallowed is absorbed from the gastrointestinal tract.
Danish: Mindst 65 % af den fraktion, der synkes, absorberes fra mave-tarm-kanalen.
English: Psychomotor hyperactivity1, sleep disorders1, anxiety, depression1, aggression1, behavioural changes (predominantly in children) 1
Danish: Psykomotorisk hyperaktivitet1, søvnforstyrrelser1, angst, depression1, aggression1, adfærdsændringer (hovedsageligt hos børn) 1
English: • cough and productive cough
Danish: • hoste og produktiv hoste
English: If your symptoms get worse or are difficult to control (e.g. if you are using a separate “reliever” inhaler more frequently) or if your “reliever” inhaler does not improve your symptoms, see your doctor immediately.
Danish: Hvis dine symptomer bliver værre, eller de er svære at kontrollere (f.eks. hvis du hyppigere bruger en separat ”lindrende” inhalator), eller hvis din ”lindrende” inhalator ikke forbedrer dine symptomer, skal du straks gå til lægen.
English: If you are testing your inhaler for the first time, the counter should read:
Danish: Hvis du tester din inhalator for første gang, skal tælleren stå på:
English: Dermatitis allergic1
Danish: Allergisk dermatitis1
English: The fraction of an inhaled dose that is swallowed after administration with a metered dose inhaler may range between 60% and 90%.
Danish: Fraktionen af en inhaleret dosis, der synkes efter administration med en inhalator med afmålte doser, kan variere fra 60 % til 90 %.
English: Their action is mediated by the binding to glucocorticoid receptors in the cytoplasm resulting in the increased transcription of genes coding for antiinflammatory proteins.
Danish: Deres virkning er medieret ved at binde til glukokortikoidreceptorer i cytoplasmaet, hvilket fører til en øget transkription af gener, der koder for antiinflammatoriske proteiner.
English: COPD is a serious longterm disease in which the airways become blocked and air sacs inside the lungs become damaged, leading to difficulty breathing.
Danish: KOL er en alvorlig langvarig sygdom, hvor luftvejene blokeres, og luftsækkene i lungerne beskadiges, hvilket fører til vejrtrækningsbesvær.
English: There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.
Danish: Der er en teoretisk risiko for interaktion, især hos følsomme patienter, der tager disulfiram eller metronidazol.
English: Related to Riarify
Danish: Med relation til Riarify
English: Therefore, your doctor may wish to measure the potassium levels in your blood from time to time.
Danish: Derfor kan det være, at lægen gerne vil måle kaliumniveauet i blodet fra tid til anden.
English: Absorption of formoterol is linear following inhalation of 12 to 96 micrograms of formoterol.
Danish: Absorptionen af formoterol er lineær efter inhalation af 12 til 96 mikrogram formoterol.
English: Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation may help to prevent these side effects
Danish: Hvis du skyller mund eller gurgler med vand og børster tænder umiddelbart efter inhalationen, kan det hjælpe med at undgå disse bivirkninger
English: Glycopyrronium has a quaternary ammonium structure which limits its passage across biological membranes and produces slow, variable and incomplete gastrointestinal absorption.
Danish: Glycopyrronium har en kvarternær ammoniumstruktur, der begrænser passagen over biologiske membraner, og giver en langsom, variabel og ufuldstændig mave-tarm-absorption.
English: If you see 'mist' coming from the top of the inhaler or the sides of your mouth, this means that Riarify will not be getting into your lungs as it should.
Danish: Hvis du ser en 'vandtåge' fra toppen af inhalatoren, eller fra mundvigene, betyder det, at Riarify ikke kommer ned i lungerne, som det skal.
English: This includes medicines similar to Riarify used for your lung disease.
Danish: Dette gælder også for lægemidler, der ligner Riarify og bruges til din lungesygdom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (MULTIPACK ONLY: no Blue Box is included)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MELLEMSTE YDERKARTON (KUN MULTIPAKNING: Blå Boks er ikke inkluderet)
English: Before using the inhaler for the first time, the patient should release one actuation into the air in order to ensure that the inhaler is working properly (priming).
Danish: Før inhalatoren bruges første gang, skal patienten sprøjte et pust ud i luften for at sikre, at inhalatoren virker korrekt (priming).
English: Mean renal clearance was similar across the range of doses tested and after single and repeated inhalation (range 281-396 mL/min).
Danish: Den gennemsnitlige nyreclearance var sammenlignelig for alle de testede doser, og efter en enkelt og gentagne inhalationer (interval 281-396 ml/min).
English: Riarify should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Danish: Riarify skal straks seponeres og patienten vurderes med iværksættelse af alternativ behandling, hvis det er nødvendigt.
English: The systemic availability of the active metabolite arises from lung (36%) and from gastrointestinal absorption of the swallowed dose.
Danish: Den systemiske tilgængelighed af den aktive metabolit stammer fra lungerne (36 %) og fra mave-tarmabsorptionen af den indtagede dosis.
English: If you have been using a different inhaler containing beclometasone dipropionate previously, ask your doctor for advice, as the effective dose of beclometasone dipropionate in Riarify for the treatment of COPD may be lower than that of some other inhalers.
Danish: Hvis du tidligere har brugt en anden inhalator, der indeholdt beclometasondipropionat, skal du spørge lægen til råds, da den effektive dosis af beclometasondipropionat i Riarify til behandling af KOL kan være lavere end dosis for andre inhalatorer.
English: • formoterol fumarate dihydrate and
Danish: • formoterolfumaratdihydrat og
English: Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly.
Danish: Hold vejret så længe som muligt, og fjern til sidst inhalatoren fra munden, og pust langsomt ud.
English: There are no relevant data on the use of Riarify in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see section 4.4 and section 5.2).
Danish: Der er ingen relevante data for anvendelsen af Riarify hos patienter med svært nedsat leverfunktion, og lægemidlet bør anvendes med forsigtighed hos disse patienter (se pkt.
English: • medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level.
Danish: • lægemidler til at behandle hjertesygdomme (digoxin) kan forårsage en reduktion af dit kaliumniveau i blodet.
English: Check the dose counter or dose indicator.
Danish: Kontroller dosistælleren eller dosisindikatoren.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Danish: (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til
English: For pharmacists: Enter the date of dispensing to the patient on the pack.
Danish: Skriv datoen for udlevering til patienten på pakningen.
English: For glycopyrronium, the maximum plasma concentration was similar after administration of the fixed or extemporary combination, while the systemic exposure was slightly higher after administration of Riarify than with the extemporary combination.
Danish: For glycopyrronium var den maksimale plasmakoncentration tilsvarende efter administration af den faste eller ekstemporære kombination, hvorimod den systemiske eksponering var lidt højere efter administration af Riarify end med den ekstemporære kombination.
English: The second major pathway involves O-demethylation followed by conjugation at the phenolic 2'-hydroxyl group.
Danish: Den andenstørste rute involverer O-demethylering, efterfulgt af konjugation ved den fenoliske 2'-hydroxylgruppe.
English: • pain in arms or legs
Danish: • smerter i arme og ben
English: Both studies were conducted in patients with a clinical diagnosis of COPD with severe to very severe airflow limitation (FEV1 less than 50% predicted), with symptoms assessed as a COPD Assessment Test (CAT) score of 10 or above, and with at least one COPD exacerbation in the previous year.
Danish: Begge studier blev udført hos patienter med en klinisk diagnose på KOL med en svær til meget svær begrænsning af luftgennemstrømningen (FEV1 mindre end 50 % af den forventede normal), med symptomer, der blev vurderet som en score på 10 eller derover i en vurderingstest for KOL (COPD Assessment Test, CAT), og med mindst en forværring af KOL i løbet af det foregående år.
English: Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.
Danish: Der kan opstå paradoks bronkospasme med en øjeblikkeligt forværret hvæsende vejrtrækning og åndenød efter dosering.
English: • reddening of the face
Danish: • rødme i ansigtet
English: Extravasation blood
Danish: Ekstravasation af blodet
English: To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient's inhalation technique.
Danish: For at sikre en korrekt administration af lægemidlet skal en læge eller andet sundhedspersonale instruere patienten i at anvende inhalatoren korrekt, og de skal også regelmæssigt kontrollere, at patientens inhalationsteknik er tilstrækkelig.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Contact your doctor if you experience blurred vision or other visual disturbances.
Danish: Sig det til lægen, hvis du oplever sløret syn eller andre synsforstyrrelser.
English: Anticholinergic agents like glycopyrronium could suppress lactation.
Danish: Antikolinerge stoffer som glycopyrronium kunne undertrykke laktationen.
English: Do not breathe out into the inhaler.
Danish: Du må ikke puste ud i inhalatoren.
English: Formoterol and glycopyrronium are medicines called long-acting bronchodilators.
Danish: Formoterol og glycopyrronium er lægemidler, der kaldes langtidsvirkende bronkodilatatorer.
English: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Danish: Lægerne skal være opmærksomme på mulig udvikling af pneumoni hos KOL-patienter, da de kliniske tegn på sådanne infektioner ligner symptomerne på KOL-eksacerbationer.
English: This study also investigated the potential pharmacokinetic interaction between the active components of Riarify by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium.
Danish: Dette studie undersøgte også den mulige farmakokinetiske interaktion mellem de aktive komponenter af Riarify ved at sammenligne de farmakokinetiske data, der blev opnået efter en enkeltdosis af den ekstemporære kombination, eller efter en enkeltdosis af de enkelte komponenter beclometasondipropionat/formoterol eller glycopyrronium.
English: Systemic corticosteroid effects
Danish: Systemiske kortikosteroide virkninger
English: Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt.
Danish: Fjern beskyttelseslåget fra mundstykket, og kontroller, at mundstykket er rent og uden støv og snavs.
English: If this occurs you should stop using Riarify and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing.
Danish: Hvis dette opstår, skal du straks holde op med at bruge Riarify, og bruge din hurtigtvirkende ”lindrende” inhalator for at behandle stakåndethed og en hvæsende vejrtrækning.
English: Riarify has no or negligible influence on the ability to drive and use machines.
Danish: Riarify påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If you have or have had any medical problems or any allergies or if you are not sure if you can use Riarify, talk to your doctor or pharmacist before using the inhaler.
Danish: Hvis du har eller har haft nogle medicinske problemer eller allergier, eller hvis du er i tvivl om du kan bruge Riarify, skal du kontakte lægen eller apotekspersonalet, før du bruger inhalatoren.
English: Therefore, the index fingers should be placed on the top of the pressurised container and both thumbs on the base of the inhaler.
Danish: Derfor skal pegefingrene placeres øverst på trykbeholderen, og begge tommelfingre forneden på inhalatoren.
English: The maximum dose is two inhalations of Riarify twice daily.
Danish: Den maksimale dosis er to inhalationer af Riarify to gange dagligt.
English: This medicine is contained in a pressurised container in a plastic inhaler with a mouthpiece.
Danish: Dette lægemiddel er indkapslet i en trykbeholder i en plasticinhalator med et mundstykke.
English: • fungal infections of the throat or of the food pipe (oesophagus)
Danish: • svampeinfektioner i halsen eller i spiserøret (øsofagus)
English: Cleaning of the Riarify inhaler
Danish: Rengøring af Riarify-inhalatoren
English: • stomach discomfort after meals
Danish: • mavebesvær efter måltider
English: • fall in the level of some constituents of your blood: of certain white blood cells called granulocytes, of potassium or of cortisol
Danish: • en reduktion af nogle af bestanddelene i blodet: af visse hvide blodlegemer, der kaldes granulocytter, af kalium eller af kortisol