FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no differences in safety parameters between the two treatment arms.
Danish: Der var ingen forskelle i sikkerhedsparametrene mellem de to behandlingsgrupper.
English: Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway.
Danish: Paradoks bronkospasme responderer på en hurtigtvirkende bronkodilatator og skal behandles omgående.
English: Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability.
Danish: Børn kan også opleve angst, søvnforstyrrelser og adfærdsændringer, herunder hyperaktivitet og
English: The Spiromax device is a breath actuated, inspiratory flow-driven inhaler, which means that the active substances are delivered into the airways when the patient inhales through the mouthpiece.
Danish: Spiromax-inhalatoren er en åndedrætsaktiveret inspiratorisk flowdrevet inhalator, hvilket betyder, at de aktive stoffer leveres til luftvejene, når patienten inhalerer gennem mundstykket.
English: Breathe: Breathe out gently (as far as is comfortable).
Danish: Indånding: Pust roligt ud (så længe, det er behageligt).
English: • Pneumonia and bronchitis (lung infection).
Danish: • Lungebetændelse og bronkitis (lungeinfektion).
English: If you get any of these effects or if they happen suddenly after using Aerivio Spiromax, stop using Aerivio Spiromax and tell your doctor straight away.
Danish: Hvis du oplever nogen af disse virkninger, eller hvis de opstår straks efter, du har brugt Aerivio Spiromax, skal du holde op med at bruge Aerivio Spiromax og straks fortælle det til lægen.
English: <2D barcode carrying the unique identifier included.>]
Danish: <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: This can increase your risk of side effects with Aerivio Spiromax, including irregular heartbeats, or may make
Danish: Det kan øge risikoen for, at du får bivirkninger ved Aerivio Spiromax, herunder uregelmæssige hjerteslag, eller
English: Appropriate treatment should be promptly
Danish: Passende behandling skal iværksættes omgående, hvis det er indiceret.
English: • Uneven or irregular heart beat or an extra heart beat (arrhythmias).
Danish: • Uensartede eller uregelmæssige hjerteslag eller et ekstra hjerteslag (arytmi).
English: Systemic effects may occur, particularly at high doses prescribed for long periods.
Danish: Der kan opstå systemiske virkninger, især ved høje doser ordineret i længere perioder.
English: • You do not need to shake your inhaler before you use it.
Danish: • Du behøver ikke at ryste inhalatoren, før du bruger den.
English: • Do not stop taking Aerivio Spiromax or reduce the dose of Aerivio Spiromax without talking to your doctor first.
Danish: • Du må ikke stoppe med at bruge Aerivio Spiromax eller reducere dosis uden først at tale med lægen.
English: If necessary you may wipe the mouthpiece of your inhaler after use with a dry cloth or tissue.
Danish: Hvis det er nødvendigt, kan du tørre mundstykket på inhalatoren af efter brug med en tør klud eller en serviet.
English: Open: Hold the Spiromax with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when one click is heard.
Danish: Åbning: Hold Spiromax med mundstykkets låg nedad og åbn låget på mundstykket ved at folde det ned, indtil mundstykket er helt åbnet, og der høres et klik.
English: • Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin).
Danish: • Lægemidler til behandling af infektioner (såsom ritonavir, ketoconazol, itraconazol og erythromycin).
English: In a 12-week trial of children 4 to 11 years of age [n=203] randomized in a parallel-group study with persistent asthma and who were symptomatic on inhaled corticosteroid, safety was the primary objective.
Danish: I et 12-ugers parallelgruppestudie med børn i alderen 4 til 11 år [n=203] med vedvarende astma, som havde symptomer på inhaleret kortikosteroid, var sikkerhed det primære mål.
English: If you forget to use Aerivio Spiromax Do not take a double dose to make up for a forgotten dose.
Danish: Hvis du har glemt at bruge Aerivio Spiromax Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: All patients should be provided with training by the prescribing Health Care Professional on how to use Aerivio Spiromax.
Danish: Alle patienter bør få undervisning af lægen eller sundhedspersonalet i, hvordan de skal anvende Aerivio Spiromax.
English: If you have used too many doses of Aerivio Spiromax for a long time, you should talk to your doctor or pharmacist for advice.
Danish: Hvis du har taget for mange doser Aerivio Spiromax i lang tid, skal du kontakte lægen eller apotekspersonalet for rådgivning.
English: • Depression or aggression (although these effects are more likely to occur in children when prescribed this combination of drugs but in a lower strength).
Danish: • Depression eller aggression (selvom disse bivirkninger er mere sandsynlige hos børn, der får denne lægemiddelkombination i en lavere styrke).
English: Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection or any rapid reduction in dosage.
Danish: Situationer med potentiale for at udløse en akut adrenal krise omfatter traume, operation, infektion eller hurtig dosisnedsættelse.
English: • Very fast heart beat (tachycardia).
Danish: • Meget hurtige hjerteslag (takykardi).
English: When the numbers become red in the window, you should see your doctor and get a
Danish: Når tallene i vinduet bliver røde, skal du kontakte lægen og få en ny inhalator.
English: Use your fast acting ‘reliever' inhaler to help your breathing and tell your doctor straight away.
Danish: Brug din hurtigtvirkende 'anfalds'-inhalator som hjælp til din vejrtrækning og fortæl det
English: COPD patients with a baseline (pre-bronchodilator) FEV1 <60% of predicted normal were randomised to double-blind medication.
Danish: KOL-patienter med en baseline (før bronkodilatator) FEV1 <60 % af forventet normal blev randomiseret til dobbeltblind medicinering.
English: Do not try to take your inhaler apart, remove or twist the mouthpiece cover.
Danish: Forsøg ikke at skille inhalatoren ad eller at fjerne eller dreje låget på mundstykket.
English: Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.
Danish: Der rådes til særlig forsigtighed ved akut svær astma, da hypokaliæmi kan forstærkes ved samtidig behandling med xanthinderivater, steroider og diuretika.
English: Salmeterol/fluticasone propionate 50/500 N = 1533
Danish: Salmeterol/ fluticasonpropionat 50/500 N = 1.533
English: Each Aerivio Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent yellow
Danish: Hver Aerivio Spiromax inhalator indeholder 60 inhalationer og har en hvid underdel med et halvgennemsigtigt gult låg på mundstykket.
English: Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of asthma control and patients should be reviewed by a
Danish: Et øget behov for anvendelse af anfaldsmedicin (kortvirkende bronkodilatatorer) eller nedsat respons på anfaldsmedicin indikerer en dårligere astmakontrol, og patienten skal evalueres af en læge.
English: Method of administration/Instructions for use
Danish: Administration/brugervejledning
English: Tell your doctor, but do not stop taking Aerivio Spiromax unless the doctor tells you to stop.
Danish: Fortæl det straks til lægen, men hold ikke op med at bruge Aerivio Spiromax, medmindre lægen fortæller dig, at du skal stoppe.
English: • Feeling worried (although this effect occurs mainly in children when prescribed this combination of
Danish: • Bekymring (selvom denne bivirkning primært opstår hos børn, når de får denne lægemiddelkombination
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index
Danish: Risikofaktorer for pneumoni hos patienter med KOL omfatter aktuel rygning, højere alder, lavt BMI og svær
English: There was a trend towards improved survival in subjects treated with salmeterol/fluticasone propionate compared with placebo over 3 years however this did not achieve the statistical significance level p≤0.05.
Danish: Over 3 år var der en tendens mod forbedret overlevelse hos personer i behandling med salmeterol/fluticasonpropionat sammenlignet med placebo, men det statistiske signifikansniveau på p≤0,05
English: The extent of the adrenal impairment may require specialist advice before elective procedures.
Danish: Afhængigt af graden af binyrebarksuppression kan specialistrådgivning være nødvendig før planlagte
English: In a study in 158 children aged 6 to 16 years with symptomatic asthma, the combination of salmeterol/ fluticasone propionate is as efficacious as doubling the dose of fluticasone propionate in respect of symptom control and lung function.
Danish: I et studie med 158 børn i alderen 6 til 16 år med symptomatisk astma er kombinationen med salmeterol/fluticasonpropionat ligeså virkningsfuld som en fordobling af dosen af fluticasonpropionat med hensyn til symptomkontrol og lungefunktion.
English: The main part of the dose is excreted in faeces as metabolites and unchanged drug.
Danish: Hovedparten af dosis udskilles i fæces som metabolitter eller uomdannet lægemiddel.
English: The results of this study suggest that salmeterol/fluticasone propionate 50/100 micrograms twice daily may be considered as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is deemed essential (see section 4.2).
Danish: Resultaterne fra dette studie tyder på, at salmeterol/fluticasonpropionat 50/100 mikrogram to gange dagligt kan overvejes som initial vedligeholdelsesbehandling hos patienter med vedvarende moderat astma, hvor hurtig astmakontrol anses for at være afgørende (se pkt.
English: Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler.
Danish: Placer mundstykket mellem tænderne med læberne lukket rundt om mundstykket, men bid ikke i inhalatorens mundstykke.
English: Hold your breath for 10 seconds or as long as you comfortably can.
Danish: Hold vejret i 10 sekunder eller i så lang tid, det føles behageligt.
English: Patients are not required to shake the inhaler prior to use.
Danish: Patienterne behøver ikke at ryste inhalatoren før brug.
English: In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%.
Danish: I et lille studie med raske frivillige personer øgede den mindre potente CYP3A-hæmmer ketoconazol eksponeringen for fluticasonpropionat med 150 % efter en enkelt inhalation.
English: • Breathing difficulties or wheezing that gets worse straight after taking Aerivio Spiromax.
Danish: • Vejrtrækningsbesvær eller hvæsende vejrtrækning, der bliver værre straks efter, du har taget Aerivio Spiromax.
English: The trials had a 4 week run-in period during which all subjects received open-label salmeterol/FP 50/250 to standardize COPD pharmacotherapy and stabilise disease prior to randomisation to blinded study medication for 52 weeks.
Danish: Studierne havde en 4-ugers indkøringsperiode, hvor alle personer fik åben salmeterol/FP 50/250 for at standardisere KOL-behandlingen og stabilisere sygdommen før randomisering til blindet studiemedicin i 52 uger.
English: The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time.
Danish: Hensigten med behandling med inhaleret fluticasonpropionat er at minimere behovet for orale steroider, men patienter, der skifter fra oralt steroid, kan have risiko for en nedsat adrenal reserve i en betragtelig periode.
English: Front panel: Not for use in children and adolescents.
Danish: Forpanel: Må ikke anvendes til børn og unge.
English: Patients should be regularly reassessed by a doctor, so that the strength of the salmeterol/fluticasone propionate inhaler they are receiving remains optimal and is only changed on medical advice.
Danish: Patienterne skal kontrolleres jævnligt af en læge, så den styrke af salmeterol/fluticasonpropionat-inhalatoren, som de får, forbliver optimal, og denne må kun ændres af lægen.
English: Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma.
Danish: Lægen vil hjælpe dig med at behandle din astma og vil justere dosen af dette lægemiddel til den laveste dosis, der kontrollerer din astma.
English: • Feeling shaky (tremor) and fast or uneven heart beat (palpitations) - these are usually harmless and get
Danish: • Følelse af at ryste (tremor) og af hurtige eller uregelmæssige hjerteslag (palpitationer) - dette er normalt harmløst og reduceres med fortsat behandling.
English: In order to ensure that patients achieve the PIFR needed to deliver the required dose, the patient is required to be trained on the use of the Spiromax device including instruction on the need to inhale forcefully (see Section 4.2).
Danish: For at sikre at patienterne opnår den nødvendige PIFR til at levere den påkrævede dosis, skal de trænes i at bruge Spiromax-inhalationsdevicet, herunder instrueres i, at det er nødvendigt at inhalere kraftigt (se
English: However, Aerivio Spiromax should not be used to relieve an attack of breathlessness or wheezing.
Danish: Aerivio Spiromax må imidlertid ikke bruges til at lindre et anfald af åndenød eller hvæsende vejrtrækning.
English: • Behavioural changes, such as being unusually active and irritable (although these effects occur mainly in children when prescribed this combination of drugs but in a lower strength).
Danish: • Adfærdsændringer, såsom usædvanligt højt aktivitetsniveau og irritabilitet (selvom disse bivirkninger primært opstår hos børn, når de får denne lægemiddelkombination i en lavere styrke).
English: Your doctor, nurse or pharmacist should also check how you use your Spiromax device from time to time to ensure that you are using the device properly and as prescribed.
Danish: Lægen, sundhedspersonalet eller apotekspersonalet skal også indimellem kontrollere, hvordan du anvender Spiromax-inhalatoren, for at sikre, at du anvender den korrekt og som ordineret.
English: The mean PIFR achieved by patients with asthma or COPD with optimal training (i.e. forceful inhalation) was over 60 L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Danish: Den gennemsnitlige PIFR, der blev opnået af patienter med astma eller KOL med optimal træning (dvs. kraftig inhalation), var over 60 l/min, en flowhastighed, hvor det er kendt, at begge de undersøgte inhalationsdevices vil levere sammenlignelige mængder lægemiddel til lungerne.
English: • Use your Aerivio Spiromax every day until your doctor advises you to stop.
Danish: • Brug Aerivio Spiromax hver dag, indtil lægen råder dig til at stoppe.
English: It should not be used for the treatment of patients with mild or moderate asthma or for the initiation of treatment for patients with severe asthma unless the requirement for such a high dose of the corticosteroid together with a long-acting β2 agonist has been established previously.
Danish: Det må ikke anvendes til behandling af patienter med let til moderat astma eller til at påbegynde behandlingen hos patienter med svær astma, medmindre behovet for højdosis kortikosteroid sammen med en langtidsvirkende β2-agonist tidligere er
English: See your doctor at once as you may need
Danish: Kontakt straks din læge, da du kan have behov for yderligere behandling.
English: Key findings from SMART by inhaled steroid use at baseline: secondary endpoints Number of secondary endpoint
Danish: Nøglefund fra SMART for patienter, der brugte inhaleret steroid ved baseline: sekundære endepunkter
English: The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE) , and polypropylene (PP).
Danish: De dele af inhalatoren, som har kontakt med lægemidlet/mucosa, er fremstillet af acrylnitrilbutadienstyren (ABS), polyethylen (PE) og polypropylen (PP).
English: The data from the study indicated that regardless of age and underlying disease severity, children, adolescents and adults with asthma as well as patients with COPD were able to achieve inspiratory flow rates through the Spiromax device that were similar to those generated through the marketed multi-dose dry powder inhaler device.
Danish: Data fra studiet indikerede, at uanset alder og sværhedsgrad af den underliggende sygdom var børn, unge og voksne med astma samt patienter med KOL i stand til at opnå inspiratoriske flowhastigheder med Spiromaxinhalationsdevicet, der svarede til hastighederne ved det markedsførte multidosis pulver-inhalationsdevice.
English: Tell your doctor if you notice any of the following symptoms while taking Aerivio Spiromax as they could be symptoms of a lung infection: fever or chills; increased mucus production, changes in mucus colour; increased cough or increased breathing difficulties.
Danish: Fortæl det til lægen, hvis du bemærker nogle af følgende symptomer, mens du tager Aerivio Spiromax, da de kan være symptomer på en lungeinfektion: feber eller kulderystelser, øget slimproduktion, ændret farve på slimen, mere hosten og mere udtalte
English: Data from a large clinical trial (the Salmeterol Multi-Center Asthma Research Trial, SMART) suggested African-American patients were at increased risk of serious respiratory-related events or deaths when using salmeterol compared with placebo (see section 5.1).
Danish: Data fra et større klinisk studie (Salmeterol Multi-Center Asthma Research Trial, SMART) tydede på, at afroamerikanske patienter havde en større risiko for alvorlige luftvejsrelaterede bivirkninger eller død ved anvendelse af salmeterol, sammenlignet med placebo (se pkt.
English: As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.
Danish: Derfor skal patienterne informeres om at læse indlægssedlen grundigt og følge de angivne brugeranvisninger i indlægssedlen.
English: Parodoxical bronchospasm
Danish: Paradoks bronkospasme
English: Beta blockers are mostly used for high blood pressure or heart conditions such as angina.
Danish: Betablokkere bruges primært mod forhøjet blodtryk eller hjertesygdomme, såsom hjertekramper (angina pectoris).
English: The impact of optimal training (i.e. breathing in forcefully upon inhalation) in dry powder inhaler inhalation technique on inhalation speed and volume was assessed in these subject groups, together with assessment of potential differences in inhalation outputs according to the devices used.
Danish: Virkningen på hastighed og volumen (dvs. kraftig indånding ved inhalation) af optimal træning af inhalationsteknikken for en pulver-inhalator blev vurderet i disse persongrupper sammen med en vurdering af mulige forskelle i den inhalerede mængde afhængigt af det anvendte inhalationsdevice.
English: Patients should be made aware that Aerivio Spiromax must be used daily for optimum benefit, even when asymptomatic.
Danish: Patienterne skal informeres om, at Aerivio Spiromax skal bruges dagligt for at få optimal fordel af præparatet, også i perioder uden symptomer.
English: Keep the mouthpiece closed all the time unless you are about to use your inhaler.
Danish: Hold altid mundstykket lukket, medmindre du skal til at bruge din inhalator.
English: Animal studies have shown reproductive toxicity after administration of β2 adrenoreceptor agonists and glucocorticosteroids (see section
Danish: Dyrestudier har påvist reproduktionstoksicitet efter administration af β2-agonister og glukokortikoider (se pkt.
English: GOAL showed more patients treated with salmeterol/fluticasone propionate achieved asthma control than patients treated with inhaled corticosteroid (ICS) alone and this control was attained at a lower corticosteroid dose.
Danish: GOAL viste, at der var flere patienter i salmeterol/fluticasonpropionat-gruppen, der opnåede astmakontrol, end patienter i gruppen med inhaleret kortikosteroid (ICS) alene, og denne kontrol blev opnået med en lavere kortikosteroiddosis.
English: Talk to your doctor, pharmacist or nurse before using Aerivio Spiromax if you have:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Aerivio Spiromax, hvis du har:
English: Close: Breathe out gently and close the mouthpiece cover.
Danish: Lukning: Pust roligt ud og luk låget på mundstykket.
English: A moderate amount of data on pregnant women (between 300 to 1000 pregnancy outcomes) indicates no malformative or feto/neonatal toxicity of salmeterol and fluticasone propionate.
Danish: Data fra anvendelse af salmeterol og fluticasonpropionat hos et begrænset antal gravide kvinder (mellem 300 og 1.000) indikerer ingen misdannelser eller føtal/neonatal toksicitet af salmeterol og fluticasonpropionat.
English: This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see section 4.4).
Danish: Dette kan medføre en øget forekomst af andre systemiske bivirkninger ved salmeterol (f.eks. forlænget QTc-interval og palpitationer) sammenlignet med behandling med salmeterol eller ketoconazol alene (se pkt.
English: Route of administration: Inhalation use
Danish: Administration: Til inhalation.
English: • Do not use this medicine after the expiry date which is stated on the carton and the label of your inhaler after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og inhalatorens etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Danish: Teva B.V., Swensweg 5, 2031 GA Haarlem, Holland
English: Fluticasone propionate:
Danish: Fluticasonpropionat
English: A similar incidence of pneumonia in the salmeterol/fluticasone propionate group was seen across all studies.
Danish: Forekomsten af pneumoni i gruppen med salmeterol/fluticasonpropionat var sammenlignelig på tværs af alle studierne.
English: Your doctor, nurse or pharmacist should provide you with training on how to use your inhaler, including how to take a dose effectively.
Danish: Lægen, sundhedspersonalet eller apotekspersonalet skal sørge for, at du får vist, hvordan du bruger inhalatoren, herunder hvordan du tager en dosis effektivt.
English: During the study, patients were permitted usual COPD therapy with the exception of other inhaled corticosteroids, long-acting bronchodilators and long-term systemic corticosteroids.
Danish: Patientens sædvanlige KOL-behandling var tilladt i studiet med undtagelse af andre inhalerede kortikosteroider, langtidsvirkende bronkodilatatorer og systemiske kortikosteroider med lang virkningsvarighed.
English: • Beta blockers (such as atenolol, propranolol and sotalol).
Danish: • Betablokkere (såsom atenolol, propranolol og sotalol).
English: This medicine should not be used in children or adolescents under the age of 18 years.
Danish: Dette lægemiddel må ikke bruges til børn og unge under 18 år.
English: The percentage of patients who died within 3 years due to COPD-related causes was 6.0% for placebo, 6.1% for salmeterol, 6.9% for FP and 4.7% for salmeterol/fluticasone propionate.
Danish: Procentdelen af patienter, der døde inden for 3 år af KOL-relaterede årsager, var 6,0 % for placebo, 6,1 % for salmeterol, 6,9 % for FP og 4,7 % for salmeterol/fluticasonpropionat.
English: • The dose indicator shows the number of inhalations remaining in even numbers only.
Danish: • Dosisindikatoren viser i lige tal, hvor mange inhalationer der er tilbage.