FrancophonIA/ELRC3.0 huggingface dataset:
English: Systemic absorption occurs mainly through the lungs and is initially rapid then prolonged.
Danish: Systemisk absorption sker hovedsageligt via lungerne og er hurtig i starten og derefter langsommere.
English: Animal studies with salmeterol have shown embryofetal toxicity only at high exposure levels.
Danish: Dyrestudier med salmeterol har kun vist embryoføtal toksicitet ved høje eksponeringsniveauer.
English: Number of primary endpoint events /number of patients
Danish: Antal hændelser (sekundære endepunkter)/antal patienter
English: • Tiredness and loss of appetite, feeling sick
Danish: • træthed og appetitløshed, kvalme
English: The absolute bioavailability of a single dose of inhaled fluticasone propionate in healthy subjects varies between approximately 5 to 11% of the nominal dose depending on the inhalation device used.
Danish: Den absolutte biotilgængelighed af en enkelt dosis inhaleret fluticasonpropionat hos raske personer varierer fra ca. 5 til 11 % af den nominelle dosis afhængigt af det anvendte inhalationsdevice.
English: Additionally, hypokalaemia can occur and therefore serum potassium levels should be monitored.
Danish: Desuden kan der opstå hypokaliæmi, hvorfor serumkalium skal monitoreres.
English: Some medicines may increase the effects of Aerivio Spiromax 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 Aerivio Spiromax, og din læge vil overvåge dig omhyggeligt, hvis du tager sådanne lægemidler (inklusive visse former for hiv-medicin, herunder ritonavir og cobicistat).
English: • The dose indicator on the rear of the device tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full.
Danish: • Dosisindikatoren bag på inhalatoren fortæller dig, hvor mange doser (inhalationer) der er tilbage i din inhalator, startende med 60 inhalationer, når den er fuld.
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside
English: • Increases in the amount of sugar (glucose) in your blood (hyperglycaemia).
Danish: • Forhøjet indhold af sukker (glucose) i blodet (hyperglykæmi).
English: The primary endpoint in SMART was the combined number of respiratory-related deaths and respiratory-related life-threatening experiences.
Danish: Det primære endepunkt i SMART var det kombinerede antal luftvejsrelaterede dødsfald og luftvejsrelaterede livstruende
English: If your asthma or breathing gets worse tell your doctor straight away.
Danish: Hvis din astma bliver værre eller din vejrtrækning dårligere, skal du straks fortælle det til lægen.
English: Combined asthma-related death or life-threatening experience
Danish: Kombinerede astmarelaterede dødsfald eller livstruende hændelse
English: Open the mouthpiece cover by folding it down until you hear one loud click.
Danish: Åbn låget på mundstykket ved at folde det nedad, indtil du hører et højt klik.
English: Teva Eesti esindus UAB Sicor Biotech Eesti
Danish: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
English: *Well controlled asthma was achieved more rapidly with salmeterol/fluticasone propionate than with ICS alone.
Danish: *Velkontrolleret astma blev opnået hurtigere med salmeterol/fluticasonpropionat end med ICS alene.
English: Bronchodilators help the airways in the lungs to stay open.
Danish: Bronkodilatatorer hjælper med at holde luftvejene i lungerne åbne.
English: Moderate/ severe exacerbations were defined as worsening symptoms that required treatment with oral corticosteroids and/or antibiotics or in-patient hospitalisation.
Danish: Moderate/svære eksacerbationer blev defineret som forværrede symptomer, der krævede behandling med orale kortikosteroider og/eller antibiotika eller medførte hospitalsindlæggelse.
English: Administration of Aerivio Spiromax to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Danish: Administration af Aerivio Spiromax til gravide kvinder bør kun overvejes, hvis den forventede fordel for moderen opvejer alle mulige risici for fosteret.
English: Chronic overdose: Adrenal reserve should be monitored and treatment with a systemic corticosteroid may be necessary.
Danish: Kronisk overdosering: Den adrenale reserve bør monitoreres, og systemisk kortikosteroidbehandling kan være nødvendig.
English: All subjects with asthma or COPD achieved PIFR values greater than 60L/min after optimal training.
Danish: Alle personer med astma eller KOL opnåede PIFR-værdier over 60 l/min efter optimal træning.
English: Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected.
Danish: Der mangler oplysninger om denne interaktion for inhaleret fluticasonpropionat, men en markant forhøjelse af plasma-fluticasonpropionat forventes.
English: If you are not using Aerivio Spiromax properly and/or you are not breathing in forcefully enough, this may mean that you are not getting enough of the medicine into your lungs.
Danish: Hvis du ikke anvender Aerivio Spiromax korrekt, og/eller du ikke trækker vejret kraftigt nok, kan det betyde, at du ikke får en tilstrækkelig mængde medicin ned i lungerne.
English: This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered.
Danish: Denne risiko for binyrebarksuppression skal altid tages i betragtning i akutte og elektive situationer, som kan være stressfremkaldende, og passende kortikosteroidbehandling skal overvejes.
English: • High blood pressure
Danish: • forhøjet blodtryk
English: Remove the Spiromax device from the mouth and hold the breath for 10 seconds or as long as comfortable for the patients.
Danish: Fjern Spiromax-inhalatoren fra munden og hold vejret i 10 sekunder eller så længe, det føles behageligt.
English: Non-significant p value after adjustment for 2 interim analyses on the primary efficacy comparison from a log-rank analysis stratified by smoking status
Danish: Ikke-signifikant p-værdi efter justering for 2 interimanalyser af den primære virkningssammenligning fra en log-rank-analyse, stratificeret efter rygestatus.
English: Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000 micrograms.
Danish: Der er også beskrevet meget sjældne tilfælde af adrenal suppression og akut adrenal krise med fluticasonpropionatdoser fra 500 til under 1.000 mikrogram.
English: This is to ensure that they understand how to use the inhaler correctly, and so that they understand the need to breathe in forcefully when inhaling to obtain the required dose.
Danish: Dette er for at sikre, at patienterne forstår, hvordan de skal anvende inhalatoren korrekt, og så de forstår nødvendigheden af at trække vejret kraftigt ind, når de inhalerer, for at få den nødvendige dosis.
English: The safety and efficacy of Aerivio Spiromax in this young population have not been established.
Danish: Virkningen og sikkerheden af Aerivio Spiromax hos denne unge population er ikke klarlagt.
English: Some of these medicines may increase the amount of salmeterol or fluticasone propionate in your body.
Danish: Nogle af disse lægemidler kan øge mængden af salmeterol eller fluticasonpropionat i kroppen.
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Aerivio Spiromax contains lactose').
Danish: - Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 "Aerivio Spiromax indeholder lactose").
English: • Diabetes mellitus (Aerivio Spiromax may increase your blood sugar)
Danish: • diabetes mellitus (sukkersyge, Aerivio Spiromax kan forhøje blodsukkeret)
English: This may lead to an increase in the incidence of systemic effects (e.g. prolongation in the QTc interval and palpitations).
Danish: Det kan medføre en øget forekomst af systemiske virkninger (f.eks. forlænget QTc-interval og palpitationer).
English: This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone.
Danish: Dette medførte en større reduktion af plasma-cortisol sammenlignet med fluticasonpropionat alene.
English: Fluticasone propionate is cleared very rapidly from the systemic circulation.
Danish: Fluticasonpropionat fjernes meget hurtigt fra det systemiske kredsløb.
English: There is a linear increase in systemic exposure with increasing inhaled dose.
Danish: Der er lineær stigning i den systemiske eksponering med stigende inhaleret
English: Read the package leaflet carefully before use.
Danish: Læs indlægssedlen grundigt inden brug.
English: Close your lips around the mouthpiece.
Danish: Luk læberne rundt om mundstykket.
English: The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.
Danish: Den laveste effektive dosis af fluticasonpropionat, der er nødvendig for at opretholde en tilstrækkelig astmakontrol, skal anvendes ved behandling af gravide kvinder.
English: Breathe in forcefully and deeply through the mouthpiece.
Danish: Træk vejret kraftigt og dybt ind gennem mundstykket.
English: The remainder of the inhaled dose of fluticasone propionate may be swallowed but contributes minimally to systemic exposure due to the low aqueous solubility and presystemic metabolism, resulting in oral availability of less than 1%.
Danish: Resten af den inhalerede dosis fluticasonpropionat kan evt. blive slugt, men bidrager minimalt til den systemiske eksponering på grund af lav vandopløselighed og præsystemisk metabolisme, hvilket resulterer i en oral tilgængelighed på under 1 %.
English: However, animal studies showed no effects of salmeterol or fluticasone
Danish: Dyrestudier viste imidlertid ingen indvirkning af salmeterol eller
English: 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to <1/1000) and not known (frequency cannot be estimated from the available data).
Danish: Hyppighederne defineres som: meget almindelig (≥1/10), almindelig (1/100 til 1/10), ikke almindelig (1/1.000 til 1/100), sjælden (1/10.000 til <1/1.000) og ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment.
Danish: Pludselig og tiltagende forværring af astmakontrollen er potentielt livstruende, og patienten skal evalueres under et akut lægebesøg.
English: • Heart disease, including an irregular or fast heart beat
Danish: • hjertesygdom, herunder uregelmæssige eller hurtige hjerteslag
English: Subjects were randomised 1:1 to salmeterol/FP 50/250 (total ITT n=776) or salmeterol (total ITT n=778).
Danish: Personerne blev randomiseret 1:1 til salmeterol/FP 50/250 (total ITT n=776) eller salmeterol (total ITT n=778).
English: Oral corticosteroids and antibiotics were allowed for the acute treatment of COPD exacerbations with specific guidelines for use.
Danish: Orale kortikosteroider og antibiotika var tilladt til akut behandling af KOL-eksacerbationer med specifikke retningslinjer for brug.
English: The use of Aerivio Spiromax follows three simple steps: open, breathe and close which are outlined below.
Danish: Anvendelsen af Aerivio Spiromax følger tre simple trin: åbning, indånding og lukning som beskrevet
English: It should not be used to treat acute asthma symptoms for which a fast- and short-acting bronchodilator is required.
Danish: Det bør ikke anvendes til behandling af akutte astmasymptomer, hvor der er behov for en hurtigt- og kortvirkende bronkodilatator.
English: There is no incidence of additional adverse events following concurrent administration of the two active substances.
Danish: Der er ikke forekommet yderligere bivirkninger efter samtidig administration af de to aktive stoffer.
English: If you are using Aerivio Spiromax for asthma, your doctor will want to check your symptoms regularly.
Danish: Hvis du bruger Aerivio Spiromax mod astma, vil lægen kontrollere dine symptomer regelmæssigt.
English: • Tuberculosis (TB) now or have had in the past, or have other lung infections
Danish: • tuberkulose (TB), har haft tuberkulose, eller hvis du har en anden lungeinfektion.
English: If you have not received this training please ask your doctor, nurse or pharmacist to show you how to use your inhaler properly before you use it for the first time.
Danish: Hvis du ikke har fået denne træning, skal du bede lægen, sundhedspersonalet eller apotekspersonalet om at vise dig, hvordan du skal bruge din inhalator korrekt, før du bruger den første gang.
English: Anaphylactic reactions including anaphylactic shock
Danish: Anafylaktiske reaktioner, herunder anafylaktisk shock
English: If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed
Danish: Hvis en patient har brug for doser, der ligger uden for det anbefalede regime, skal der ordineres passende doser β2-agonist og/eller kortikosteroid.
English: It is very important that you take your Aerivio Spiromax every day as directed.
Danish: Det er meget vigtigt, at du hver dag bruger din Aerivio Spiromax efter anvisningerne.
English: If you open and close the mouthpiece without taking an inhalation the dose indicator will still register it as a count.
Danish: Hvis du åbner og lukker mundstykket uden at tage en inhalation, vil dosisindikatoren stadig tælle det som en dosis.
English: Aerivio Spiromax is not available on the market at strengths lower than 50/500 microgram.
Danish: Aerivio Spiromax er ikke tilgængelig på markedet i styrker under 50/500 mikrogram.
English: In addition there are only limited data available on the pharmacokinetics of salmeterol because of the technical difficulty of assaying the drug in plasma due to the low plasma concentrations at therapeutic doses (approximately 200 picogram/mL or less) achieved after inhaled dosing.
Danish: Desuden er der kun begrænsede data tilgængelige om salmeterols farmakokinetik, da det er teknisk vanskeligt at måle stoffet i plasma på grund af de lave plasmakoncentrationer (ca. 200 pikogram/ml eller mindre), der opnås efter inhalation af terapeutiske doser.
English: This includes other medicines for asthma or any medicines obtained without a prescription.
Danish: Dette gælder også anden medicin mod astma eller medicin, som ikke er købt på recept.
English: Relative Risk (95% confidence intervals)
Danish: Relativ risiko konfidensinterval)
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35 IDA Industrial Park
Danish: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35 IDA Industrial Park Cork Road
English: Salmeterol acts locally in the lung therefore plasma levels are not an indication of therapeutic effects.
Danish: Salmeterol virker lokalt i lungerne, og derfor er plasmaniveauet ikke indikativt for terapeutisk virkning.
English: Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis.
Danish: Langvarig behandling af patienter med høje doser inhalerede kortikosteroider kan føre til adrenal suppression og akut adrenal krise.
English: Behavioural changes, including psychomotor hyperactivity and irritability (predominantly in
Danish: Adfærdsmæssige ændringer, herunder psykomotorisk hyperaktivitet og irritabilitet (især hos børn)
English: Concomitant use of other β adrenergic-containing medicinal products can have a potentially additive effect.
Danish: Samtidig anvendelse af andre β-adrenerge lægemidler kan have en potentielt additiv virkning.
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Danish: Dosis skal titreres til den laveste dosis, hvor der opretholdes en effektiv kontrol af symptomerne.
English: This leaflet was last revised in month YYYY.
Danish: Denne indlægsseddel blev senest ændret måned ÅÅÅÅ.
English: The renal clearance of fluticasone propionate is negligible.
Danish: Den renale clearance af fluticasonpropionat er ubetydelig.
English: It is not known whether this medicine can pass into breast milk.
Danish: Det er ukendt, om dette lægemiddel udskilles i mælken hos mennesker.
English: In TORCH, older patients, patients with a lower body mass index (<25 kg/m2) and patients with very severe disease (FEV1<30% predicted) were at greatest risk of developing pneumonia regardless of treatment.
Danish: I TORCH-studiet havde ældre patienter, patienter med et lavere BMI (body mass index) (<25 kg/m2) og patienter med meget svær sygdom (FEV1<30 % forventet) den største risiko for at udvikle pneumoni, uanset behandling.
English: Each inhaler contains 60 doses and is foil-wrapped.
Danish: Hver inhalator indeholder 60 doser og er pakket i folie.
English: Breathe out gently (as far as is comfortable).
Danish: Pust roligt ud (så længe, det er behageligt).
English: • Other bronchodilators (such as salbutamol).
Danish: • Andre bronkodilatatorer (såsom salbutamol).
English: You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness).
Danish: Du kan også få kløe, udslæt (nældefeber), hævelse (normalt i ansigt, på læber, tunge eller i svælg), eller du kan pludseligt føle, at dit hjerte banker meget hurtigt, eller du føler dig svimmel og omtåget (hvilket kan føre til, at du kollapser eller mister bevidstheden).
English: The secondary endpoints of combined all cause death or life-threatening experience, all cause death, or all cause hospitalisation did not reach statistical significance in the whole population.
Danish: De sekundære endepunkter: kombineret død uanset årsag og livstruende hændelse; død uanset årsag; indlæggelse uanset årsag, opnåede ikke statistisk signifikans i hele populationen.
English: Two children on salmeterol/fluticasone propionate and 5 children on fluticasone propionate withdrew because of worsening asthma.
Danish: To børn på salmeterol/fluticasonpropionat og 5 børn på fluticasonpropionat udgik pga. forværring af astmaen.
English: Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Aerivio Spiromax.
Danish: Allergiske reaktioner: du kan bemærke, at din vejrtrækning pludseligt bliver dårligere lige efter, du har brugt Aerivio Spiromax.
English: If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be
Danish: Hvis du har sukkersyge, kan det være nødvendigt med hyppigere blodsukkerkontroller og eventuel justering af din sædvanlige sukkersygebehandling.
English: Adverse reactions which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency.
Danish: Bivirkninger, som er blevet forbundet med salmeterol/fluticasonpropionat, er opstillet nedenfor, anført efter systemorganklasse og hyppighed.
English: Consideration should be given to increasing corticosteroid
Danish: Det bør overvejes at intensivere kortikosteroidbehandlingen.
English: • Inflammation of sinuses (sinusitis, a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache).
Danish: • Bihulebetændelse (sinuitis, en trykkende fornemmelse i næsen, kinderne og bag ved øjnene, til tider med en dunkende smerte).
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for
English: • Aerivio Spiromax should be inhaled through the mouth into the lungs.
Danish: • Aerivio Spiromax skal inhaleres ned i lungerne gennem munden.
English: When your body is under stress such as from fever, trauma (such as an accident or injury), infection, or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above.
Danish: Hvis din krop bliver stresset af f.eks. feber, et traume (såsom et uheld eller en skade), en infektion eller en operation, kan binyrebarkinsufficiens blive værre, og du kan få de ovenfor angivne bivirkninger.
English: Patients should not block the air vents at any time, or breathe out through the Spiromax device when they are preparing the “Breathe” step.
Danish: Patienterne må ikke blokere luftventilerne på noget tidspunkt eller puste ud gennem Spiromax-inhalatoren, når de forbereder trinet ”Indånding”.
English: Concomitant use of systemic ketoconazole significantly increases systemic exposure to salmeterol.
Danish: Samtidig anvendelse af systemisk ketoconazol øger den systemiske eksponering for salmeterol signifikant.
English: The use of concurrent inhaled long-acting β2 agonists and anticholinergic drugs, salbutamol/ipratropium bromide combination products, oral β2 agonists and theophylline preparations were not allowed during the treatment period.
Danish: Samtidig anvendelse af inhalerede langtidsvirkende β2-agonister og antikolinerge lægemidler, salbutamol/ipratropiumbromid-kombinationspræparater, orale β2-agonister og theophyllinpræparater var ikke tilladt i behandlingsperioden.
English: There is likely to be a similar risk of interaction with other potent CYP3A4 inhibitors (e.g. itraconazole, telithromycin, ritonavir).
Danish: Der er sandsynligvis en lignende risiko for interaktion med andre potente CYP3A4-hæmmere (f.eks. itraconazol, telithromycin, ritonavir).
English: Aerivio Spiromax should be used correctly in order to achieve effective treatment.
Danish: Aerivio Spiromax skal anvendes korrekt for at opnå en effektiv behandling.
English: There were no differences between the two treatment arms.
Danish: Der var ingen forskelle mellem de to behandlingsgrupper.
English: If you open and close the mouthpiece without taking an inhalation the dose will be securely held inside the inhaler ready for the next inhalation.
Danish: Hvis du åbner og lukker mundstykket uden at tage en inhalation, vil dosis opbevares sikkert inden i inhalatoren klar til den næste inhalation.
English: When stabilised, treatment should be continued with an inhaled corticosteroid at the recommended dose.
Danish: Efter stabilisering bør behandlingen fortsætte med inhaleret kortikosteroid i den anbefalede dosering.
English: However, do not change the number of inhalations your doctor has prescribed without talking to your doctor first.
Danish: Du må imidlertid ikke tage flere eller færre inhalationer, end lægen har ordineret, uden først at tale med lægen.
English: The studies described below (GOAL, TORCH and SMART) were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product; the studies described were not carried out with Aerivio Spiromax.
Danish: De nedenfor beskrevne studier (GOAL, TORCH og SMART) blev udført med den samme fastdosiskombination, salmeterolxinafoat og fluticasonpropionat (FP), men undersøgte et tidligere godkendt præparat; de beskrevne studier blev ikke udført med Aerivio Spiromax.
English: Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk.
Danish: Patienter, der tidligere har haft behov for krisebehandling med høje kortikosteroiddoser, kan også være i risikogruppe.
English: The disposition of fluticasone propionate is characterised by high plasma clearance (1150 mL/min), a large volume of distribution at steady-state (approximately 300 L) and a terminal half-life of approximately 8 hours.
Danish: Fluticasonpropionats fordeling er karakteriseret ved en høj plasmaclearance (1.150 ml/min), et stort fordelingsvolumen ved steady state (ca.300 l) og en terminal halveringstid på ca. 8 timer.