FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly No dosage adjustment is required in elderly patients (65 years of age and older).
Danish: Ældre Det er ikke nødvendigt at justere dosis hos ældre patienter (65 år og ældre).
English: infusion (6420 L versus 323 L), reflecting the slower elimination after inhalation.
Danish: infusion (6.420 l versus 323 l), hvilket afspejler den langsommere elimination efter inhalation.
English: Warnings and precautions:
Danish: Advarsler og forsigtighedsregler:
English: Among the observed adverse reactions the following are typically associated with:
Danish: Blandt de observerede bivirkninger er følgende typisk forbundet med:
English: Inspiratory Capacity (IC)
Danish: Inspirationskapacitet (IC)
English: Possible side effects are listed below according to their frequency.
Danish: Mulige bivirkninger er opstillet nedenfor efter hyppighed.
English: The elimination half-life determined after oral administration is 2-3 hours.
Danish: Halveringstiden for elimination bestemt efter oral administration er 2-3 timer.
English: ZA des Gailletrous 41260 La Chaussée Saint Victor France
Danish: ZA des Gailletrous 41260 La Chaussée Saint Victor Frankrig
English: See also section 4, “Possible side effects”.
Danish: Se også punkt 4, ”Bivirkninger”.
English: The Phase III clinical development programme in COPD included two 52-week active-controlled studies.
Danish: Det kliniske fase III-udviklingsprogram for KOL omfattede to 52-ugers aktivt kontrollerede studier.
English: Your doctor may wish to carry out some blood tests.
Danish: Det kan være, at lægen gerne vil tage nogle blodprøver.
English: Plasma protein binding is moderately high.
Danish: Graden af plasmaproteinbinding er moderat høj.
English: Additional instructions for specific groups of patients For patients with weak hands it may be easier to hold the inhaler with both hands.
Danish: Yderligere anvisninger for specifikke patientgrupper For patienter med svage hænder kan det være nemmere at holde inhalatoren med begge hænder.
English: Do not exceed your prescribed dose without talking to your doctor.
Danish: Du må ikke overskride din ordinerede dosis uden at kontakte lægen.
English: • if you are being, or have ever been, treated for tuberculosis (TB) or if you have a chest infection.
Danish: • hvis du bliver, eller nogensinde er blevet, behandlet for tuberkulose (TB), eller hvis du har en infektion i brystet.
English: {DD month YYYY}
Danish: {DD måned ÅÅÅÅ}
English: Tell your doctor if you have any of these symptoms.
Danish: Fortæl det til lægen, hvis du har nogle af disse symptomer.
English: Effect of a spacer
Danish: Virkning af en spacer
English: SPECIAL STORAGE CONDITIONS Prior to dispensing:
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Før udlevering:
English: Immediate hypersensitivity reactions have been reported after administration of Riarify.
Danish: Der er rapporteret om øjeblikkelige overfølsomhedsreaktioner efter administration af Riarify.
English: • problems with how your adrenal glands work (adrenal suppression)
Danish: • problemer med, hvordan dine binyrer virker (adrenal suppression)
English: Liver appears to be the primary site of metabolism.
Danish: Leveren forekommer at være det primære sted for metabolismen.
English: If they are administered for compelling reasons, the effect of formoterol will be reduced or abolished.
Danish: Hvis de administreres af tvingende årsager, vil formoterols virkning være reduceret eller helt fjernet.
English: If overdose occurs, the patient's symptoms should be treated supportively with appropriate monitoring as necessary.
Danish: Hvis der opstår en overdosering, skal patientens symptomer behandles støttende med passende overvågning, efter behov.
English: Plasma protein binding of formoterol is 61-64% with 34% bound to albumin.
Danish: Graden af plasmaproteinbinding for formoterol er 61-64 %, hvoraf 34 % er bundet til albumin.
English: Do not stop using Riarify or lower the dose, even if you are feeling better or you have no symptoms.
Danish: Du må ikke holde op med at bruge Riarify eller bruge en lavere dosis, selvom du har det bedre, eller du ikke har nogen symptomer.
English: These patients should be monitored for potential adverse reactions.
Danish: Disse patienter skal overvåges for mulige bivirkninger.
English: If patients find the treatment ineffective, they should continue treatment but medical attention must be sought.
Danish: Hvis patienterne mener, at behandlingen ikke virker, skal de fortsætte med behandlingen, men der skal søges lægehjælp.
English: Absorption, distribution and biotransformation
Danish: Absorption, fordeling og biotransformation
English: However, studies on the effect of HFA134a on the reproductive function and embryofoetal development in animals revealed no clinically relevant adverse effects.
Danish: Studier af virkningen af HFA134a på reproduktionsfunktionen og embryoføtal udvikling hos dyr afdækkede imidlertid ingen klinisk relevante bivirkninger.
English: Use with a spacer
Danish: Anvendelse med en spacer
English: Therefore, blood glucose should be monitored during treatment following established guidelines in patients with diabetes.
Danish: Derfor skal glukose i blodet overvåges under behandlingen i henhold til fastlagte retningslinjer hos patienter med diabetes.
English: However, available safety data from long-term clinical studies have not raised any significant safety concerns (see section 5.1).
Danish: Tilgængelige sikkerhedsdata fra langvarige kliniske studier har imidlertid ikke vist nogen signifikant sikkerhedsproblematik (se pkt.
English: Do not double the dose.
Danish: Du må ikke tage en dobbeltdosis.
English: Riarify is a medicine to help breathing that contains the three active substances:
Danish: Riarify er et lægemiddel, der hjælper dig med at trække vejret, og indeholder de tre aktive stoffer:
English: If your COPD gets worse:
Danish: Hvis din KOL bliver værre:
English: In addition, two Phase IIIb studies were conducted to support the clinical efficacy and safety of Riarify.
Danish: Desuden blev der udført to fase IIIb-studier for at støtte Riarifys kliniske virkning og sikkerhed.
English: Peak plasma concentrations of the unchanged active substance occur within 0.5 to 1 hours after oral administration.
Danish: Maksimale plasmakoncentrationer af det uændrede aktive stof opstår i løbet af 0,5 til 1 time efter oral administration.
English: Not known (frequency cannot be estimated from the available data): • blurred vision.
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data): • sløret syn
English: The renal clearance of formoterol is 150 mL/min.
Danish: Nyreclearance af formoterol er 150 ml/min.
English: The aerosol particles of Riarify are on average much smaller than the particles delivered in non-extrafine formulations.
Danish: Riarifys aerosolpartikler er gennemsnitligt meget mindre end de partikler, der leveres i formuleringer, som ikke er ekstrafine.
English: • painful and frequent urination
Danish: • smertefuld og hyppig vandladning
English: There is no experience with or evidence of safety issues on the use of the propellant norflurane (HFA134a) during human pregnancy or lactation.
Danish: Der er ingen erfaring med, eller evidens for sikkerhedsproblematik ved anvendelsen af drivmidlet norfluran (HFA134a) under graviditet eller amning hos mennesker.
English: • increased cough or increased breathing difficulties.
Danish: • tiltagende hoste eller tiltagende vejrtrækningsbesvær.
English: On average, 8% and 25% of the dose was excreted as unchanged and total formoterol, respectively.
Danish: I gennemsnit blev hhv. 8 % og 25 % af dosis udskilt som uændret og totalt formoterol.
English: • burning sensation of the lips
Danish: • brændende fornemmelse på læberne
English: The following side effects can also occur with high-dose inhaled corticosteroids used over a long time, but the frequency is not known (frequency cannot be estimated from the available data) at present:
Danish: De følgende bivirkninger kan også forekomme med højdosis, inhalerede kortikosteroider, der bruges i en lang periode, men hyppigheden er ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data) på nuværende tidspunkt:
English: Using Riarify together with:
Danish: Brug af Riarify sammen med:
English: They act in different ways to relax the muscles in your airways, helping to open the airways wider and allowing you to breathe more easily.
Danish: De virker på forskellige måder for at afslappe musklerne i luftvejene, hvorved luftvejene får hjælp til at åbne mere, og gøre det muligt for dig nemmere at trække vejret.
English: Ask your doctor or pharmacist about this device.
Danish: Spørg lægen eller apotekspersonalet om denne anordning.
English: High doses of formoterol may increase your blood glucose and therefore you may need to have extra blood tests to check your blood sugar when you start using this medicine, and from time to time during treatment.
Danish: Store doser formoterol kan øge dit sukkerindhold i blodet, og derfor kan det være nødvendigt at tage nogle ekstra blodprøver for at kontrollere dit blodsukker, når du begynder at bruge dette lægemiddel, og fra tid til anden i løbet af behandlingen.
English: It is important that you take your dose as advised by your doctor.
Danish: Det er vigtigt, at du tager din dosis efter lægens anvisninger.
English: Riarify does not contain a high-dose inhaled corticosteroid, but your doctor may wish to measure the cortisol levels in your blood from time to time.
Danish: Riarify indeholder ikke et højdosis, inhaleret kortikosteroid, men lægen kan ønske at måle kortisolniveauet i dit blod fra tid til anden.
English: The (R,R)- and (S,S)-enantiomers represented about 40% and 60% of unchanged active substance excreted in the urine, respectively.
Danish: (R,R)- og (S,S)-enantiomerer udgjorde ca. hhv. 40 % og 60 % af det uændrede aktive stof, der blev udskilt i urinen.
English: After dispensing:
Danish: Efter udlevering:
English: You should inhale the medicine through your mouth and this takes the medicine directly into your lungs.
Danish: Du skal inhalere lægemidlet gennem munden, og dette bringer lægemidlet direkte ned i lungerne.
English: Dispensing date dd/mm/yyyy
Danish: Udleveringsdato dd/mm/åååå
English: Glucuronide acid conjugate is inactive.
Danish: Glucuronidsyre-konjugatet er inaktivt.
English: Some medicines may increase the effects of Riarify and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Danish: Nogle lægemidler kan øge virkningen af Riarify, og din læge vil overvåge dig omhyggeligt, hvis du tager sådanne lægemidler (inklusive visse former for hiv-medicin, herunder ritonavir og cobicistat).
English: Your doctor will assess your symptoms and if necessary may start you on a different treatment.
Danish: Lægen vil vurdere dine symptomer, og kan starte dig på en anden behandling, hvis det er nødvendigt.
English: Do not expose to temperatures higher than 50°C.
Danish: Må ikke udsættes for temperaturer over 50 °C.
English: Formoterol does not inhibit CYP450 enzymes at therapeutically relevant concentrations.
Danish: Formoterol hæmmer ikke CYP450-enzymerne ved de terapeutisk relevante koncentrationer.
English: Multipack outer carton Also enter the date of dispensing on each individual pack.
Danish: Yderkarton på multipakning Skriv også datoen for udlevering på den enkelte pakning.
English: Infants and neonates born to mothers receiving substantial doses of Riarify should be observed for adrenal suppression.
Danish: Spædbørn og neonatale født af mødre, der fik betragtelige doser af Riarify, bør observeres for adrenal suppression.
English: If you want to do this, talk to your doctor.
Danish: Hvis du gerne vil gøre dette, skal du kontakte lægen.
English: If any of the above applies to you, tell your doctor before you use Riarify.
Danish: Hvis noget af det ovenstående gælder for dig, skal du fortælle det til lægen, før du bruger Riarify.
English: In addition, L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.
Danish: Desuden kan L-dopa, L-thyroxin, oxytocin og alkohol hæmme hjertets tolerance mod beta2-sympatomimetika.
English: The number of puffs remaining is displayed in intervals of 20.
Danish: Antallet af resterende doser vises med intervaller på 20.
English: Your COPD may be getting worse and your doctor may need to prescribe different treatment.
Danish: Din KOL kan være blevet værre, og det kan være nødvendigt, at lægen ordinerer en anden behandling.
English: Cytochrome P450 isoenzymes CYP2D6, CYP2C19 and CYP2C9 are involved in the O-demethylation of formoterol.
Danish: CYP450--isoenzymerne CYP2D6, CYP2C19 og CYP2C9 er involveret i O-demethyleringen af formoterol.
English: Glucocorticoids are excreted in human milk.
Danish: Glukokortikoider udskilles i human mælk.
English: It is unknown whether formoterol or glycopyrronium (including their metabolites) pass into human breast-milk but they have been detected in the milk of lactating animals.
Danish: Det er ukendt, om formoterol eller glycopyrronium (herunder deres metabolitter) overføres til human brystmælk, men de er blevet detekteret i mælken hos lakterende dyr.
English: triple combinations with corticosteroids.
Danish: 3-stofkombination med kortikosteroider.
English: CYP2D6 was found to be the only enzyme responsible for glycopyrronium metabolism.
Danish: Det blev fundet, at CYP2D6 var det eneste enzym, der var ansvarligt for metabolismen af glycopyrronium.
English: • increased blood flow to some tissues in the body
Danish: • øget blodtilførsel til noget væv i kroppen
English: Related to formoterol
Danish: Med relation til formoterol
English: Caution is also recommended when a number of reliever bronchodilators are used.
Danish: Det anbefales også at udvise forsigtighed, når der anvendes flere forskellige lindrende bronkodilatatorer.
English: It is important to use Riarify every day.
Danish: Det er vigtigt, at du bruger Riarify hver dag.
English: 67% of an oral dose of formoterol is excreted in urine (mainly as metabolites) and the remainder in the faeces.
Danish: I alt 67 % af en oral dosis af formoterol udskilles i urinen (primært som metabolitter) og resten via fæces.
English: Beta-blockers (including beta-blocker eye-drops) may reduce the effects of formoterol or make it not work at all.
Danish: Beta-blokkere (herunder øjendråber med betablokkere) kan reducere virkningen af formoterol, eller få det til slet ikke at virke.
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Danish: Der kan opstå systemiske virkninger med alle inhalerede kortikosteroider, især ved høje doser, der ordineres i længere perioder.
English: • changes in the electrocardiogram (heart trace)
Danish: • ændringer i elektrokardiogrammet (hjertediagrammet)
English: Do not use this medicine with a beta-blocker medicine (used for treating certain heart problems such as angina or for reducing blood pressure) unless your doctor has chosen a beta-blocker that does not affect your breathing.
Danish: Du må ikke bruge dette lægemidldel sammen med beta-blokkere (anvendes til at behandle visse hjerteproblemer, såsom angina eller til at sænke blodtrykket), medmindre lægen har valgt en betablokker, der ikke påvirker din vejrtrækning.
English: The inhalation of formoterol may cause a rise in blood glucose levels.
Danish: Inhalationen af formoterol kan forårsage en stigning i glukoseniveauet i blodet.
English: There are no or limited amount of data from the use of Riarify in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af Riarify til gravide kvinder.
English: In such a situation, your doctor may need to increase your dose of corticosteroids to cope with the stress and may prescribe them as tablets or injections.
Danish: I sådanne tilfælde kan lægen øge din dosis kortikosteroider, så du kan klare den stressede situation, og lægen kan ordinere dem som tabletter eller injektioner.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og reproduktions- og udviklingstoksicitet.
English: Riarify 87/5/9 mcg
Danish: Riarify 87/5/9 mikrog
English: This may be obtained by the patients using the AeroChamber Plus by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation.
Danish: Dette kan opnås ved at patienterne bruger AeroChamber Plus med en kontinuerlig langsom og dyb indånding gennem spaceren, uden nogen forsinkelse mellem pustet og inhalationen.
English: The relative proportion of the two enantiomers remained constant over the dose range studied and there was no evidence of relative accumulation of one enantiomer over the other after repeated dosing.
Danish: Den relative andel af de to enantiomerer forblev konstant over det undersøgte dosisinterval, og der var ikke evidens for en relativ akkumulation af en enantiomer over den anden efter gentagen dosering.
English: If you are using Riarify or high doses of other inhaled corticosteroids over long periods and you come into a situation of stress (e.g. being taken to hospital after an accident, having a serious injury or before an operation) you may need more of this medicine.
Danish: Hvis du bruger Riarify eller højere doser af andre inhalerede kortikosteroider i lange perioder, og du kommer i en situation med stress (f.eks. hvis du bringes på hospitalet efter et uheld, hvis du har en alvorlig skade eller før en operation), kan du have behov for mere af dette lægemiddel.
English: This should be treated immediately with a fast-acting inhaled bronchodilator (reliever).
Danish: Dette skal straks behandles med en hurtigtvirkende inhaleret bronkodilatator (lindring).
English: Breathe in slowly and deeply through your mouth to fill your lungs with air (this should take about 4-5 seconds).
Danish: Træk vejret langsomt og dybt ind gennem munden for at fylde lungerne med luft (dette bør tage omtrent 4-5 sekunder).
English: • swelling of the hands and feet
Danish: • hævelse af hænder og fødder
English: They should be advised by their doctor or pharmacist about the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled active substance to the lungs.
Danish: Deres læge eller apotekspersonalet bør rådgive dem om den korrekte brug og pleje af deres inhalator og spacer, og deres teknik skal kontrolleres for at sikre en optimal levering af det inhalerede aktive stof til lungerne.
English: There was no saturation of binding in the concentration range attained with therapeutic doses.
Danish: Der var ingen mætning i bindingen i det koncentrationsinterval, der blev opnået med terapeutiske doser.
English: The clinical development programme of Riarify was conducted in patients with moderate, severe or very severe COPD.
Danish: Det kliniske udviklingsprogram for Riarify blev udført hos patienter med moderat, svær eller meget svær KOL.
English: Using high-dose inhaled corticosteroids over a long time can cause in very rare cases effects on the body:
Danish: Hvis højdosis inhalerede kortikosteroider bruges i en lang periode, kan det føre til virkninger på kroppen i meget sjældne tilfælde:
English: Based on plasma concentrations measured following inhalation of a single 120 micrograms dose by 12 healthy subjects, the mean terminal elimination half-life was determined to be 10 hours.
Danish: Baseret på plasmakoncentrationer målt efter inhalation af en enkelt dosis på 120 mikrogram hos 12 raske personer blev den gennemsnitlige terminale halveringstid for elimination bestemt til at være 10 timer.
English: This has the potential to produce adverse cardiovascular effects.
Danish: Dette har potentialet til at give kardiovaskulære bivirkninger.
English: The bronchodilating effect sets in rapidly, within 1-3 minutes after inhalation, and has a duration of 12 hours after a single dose.
Danish: Den bronkodilaterende virkning indsætterhurtigt, inden for 1-3 minutter efter inhalation, med en varighed på 12 timer efter en enkelt dosis.
English: The toxicological profile of the triple combination reflected that of the single active components without a relevant increase in toxicity and without unexpected findings.
Danish: Den toksikologiske profil af trippelkombinationen afspejlede profilerne for de enkelte, aktive komponenter, uden en relevant øget toksicitet, og uden uventede fund.
English: The recommended dose is two puffs in the morning and two puffs in the evening.
Danish: Den anbefalede dosis er to pust om morgenen og to pust om aftenen.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Riarify and to contact their doctor immediately should any of these signs or symptoms develop.
Danish: Patienterne skal informeres om tegn og symptomer på akut snævervinklet glaukom, og de skal informeres om at stoppe Riarify og straks kontakte deres læge, hvis der opstår nogle af disse tegn og symptomer.
English: Both studies were conducted in a similar population of COPD patients as studies TRILOGY and TRINITY.
Danish: Begge studier blev udført hos en population af KOL-patienter, der svarede til populationerne i studierne TRILOGY og TRINITY.
English: Sudden and progressive deterioration in the symptoms of COPD is potentially life-threatening and the patient should undergo urgent medical assessment.
Danish: Pludselig og tiltagende forværring af symptomer på KOL er potentielt livstruende, og patienten skal evalueres under et akut lægebesøg.
English: It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you carefully follow the instructions on how to use the AeroChamber Plus spacer device and how to clean it.
Danish: Det er vigtigt, at du læser indlægssedlen, som leveres sammen med din AeroChamber Plus spaceranordning, og at du nøje følger anvisningerne i, hvordan du skal bruge AeroChamber Plus spaceranordningen, og hvordan du skal rengøre den.
English: There is a risk of worsening shortness of breath and wheezing immediately after using Riarify and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people).
Danish: Der er en risiko for forværret stakåndethed og en hvæsende vejrtrækning umiddelbart efter brug af Riarify, og dette kaldes paradoks bronkospasme (kan forekomme hos op til 1 ud af 1.000 personer).
English: The apparent volume of distribution (Vz) of inhaled glycopyrronium was increased compared to intravenous (i.v.)
Danish: Det tilsyneladende fordelingsvolumen (Vz) af det inhalerede glycopyrronium var øget, sammenlignet med en intravenøs (i.v.)
English: Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy.
Danish: En øget anvendelse af lindrende bronkodilatatorer indikerer en forværring af den underliggende sygdom, og en revurdering af behandlingen er nødvendig.
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Danish: Risikofaktorerne for pneumoni hos patienter med KOL omfatter nuværende rygning, højere alder, lavt BMI (body mass index) og svær KOL.
English: Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females), either congenital or induced by medicinal products as these patients were excluded from clinical trials with Riarify.
Danish: Der bør også udvises forsigtighed ved behandling af patienter med kendt eller formodet forlængelse af QTc-intervallet (QTc > 450 millisekunder for mænd eller > 470 millisekunder for kvinder), enten medfødt eller induceret af lægemidler, da disse patienter blev ekskluderet fra kliniske studier med Riarify.