FrancophonIA/ELRC3.0 huggingface dataset:
English: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
Danish: En øget forekomst af pneumoni, herunder indlæggelseskrævende pneumoni, er blevet observeret hos patienter med KOL, der fik inhalerede kortikosteroider.
English: Therefore these patients should be treated with special care and adrenocortical function regularly monitored.
Danish: Disse patienter bør derfor behandles med særlig forsigtighed, og binyrebarkfunktionen bør monitoreres regelmæssigt.
English: Regular review of patients as treatment is stepped down is important.
Danish: Det er vigtigt at vurdere patienterne regelmæssigt, mens behandlingen trappes ned.
English: Co-treatment with other potent CYP3A inhibitors, such as itraconazole, and moderate CYP3A inhibitors, such as erythromycin, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic undesirable effects.
Danish: Samtidig behandling med andre potente CYP3A-hæmmere, såsom itraconazol, og moderate CYP3A-hæmmere, såsom erythromycin, forventes også at øge den systemiske eksponering for fluticasonpropionat og risikoen for systemiske bivirkninger.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV
English: • Low levels of sugar in your blood
Danish: • lave niveauer af kalium i blodet
English: If Aerivio Spiromax therapy has to be withdrawn due to overdose of the β agonist component of the medicinal product, provision of appropriate replacement steroid therapy should be considered.
Danish: Hvis Aerivio Spiromax skal seponeres som følge af overdosering af β-agonistkomponenten i lægemidlet, bør det overvejes at give passende erstatningsbehandling med steroid.
English: Additional systemic corticosteroid cover should be considered during periods of stress or elective
Danish: Det bør overvejes at tilføje dækning med systemisk kortikosteroid i stressperioder eller i forbindelse med operation.
English: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored.
Danish: Det anbefales at måle højden regelmæssigt på børn i langtidsbehandling med inhalerede kortikosteroider.
English: In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations).
Danish: Reproduktionsstudier hos dyr har vist, at glukokortikoider kan inducere misdannelser (ganespalte, knogledeformiteter).
English: For patients with COPD experiencing exacerbations, treatment with systemic corticosteroids is typically indicated, therefore patients should be instructed to seek medical attention if symptoms deteriorate with
Danish: Behandling med systemisk kortikosteroid er typisk nødvendig til patienter med KOL, der oplever eksacerbationer, og derfor bør patienterne informeres om at søge lægehjælp, hvis symptomerne forværres
English: The data presented below refer to a lower dose of the fixed-dose combination containing these two actives, a dose and strength which is not available for Aerivio Spiromax.
Danish: Dataene nedenfor refererer til en fastdosiskombination med lavere doser af disse to aktive stoffer, en dosis og styrke, som ikke fås for Aerivio Spiromax.
English: The pharmacological effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Danish: De farmakologiske virkninger af behandling med β2-agonister, såsom tremor, palpitationer og hovedpine, er blevet rapporteret med en tendens til at være forbigående og aftagende ved regelmæssig behandling.
English: In cases of both acute and chronic fluticasone propionate overdose Aerivio Spiromax therapy should be continued at a suitable dose for symptom control.
Danish: Både i tilfælde af akut og kronisk overdosering med fluticasonpropionat bør behandlingen med Aerivio Spiromax fortsætte med en passende dosis med henblik på symptomkontrol.
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Aerivio Spiromax.
Danish: Patienterne skal informeres om at fortsætte behandlingen, men at søge læge, hvis astmasymptomerne bliver ved med at være ukontrollerede, eller hvis de forværres, efter behandling med Aerivio Spiromax påbegyndes.
English: Do not breathe out through your inhaler.
Danish: Pust ikke ud gennem inhalatoren.
English: Side panel: For use in adults 18 years of age and older only.
Danish: Sidepanel: Må kun anvendes til voksne i alderen 18 år og ældre.
English: Physicians should remain vigilant for the possible development of pneumonia and other lower respiratory tract infections in patients with COPD as the clinical features of such infections and exacerbation frequently overlap.
Danish: Læger skal være opmærksomme på eventuel udvikling af pneumoni og andre nedre luftvejsinfektioner hos patienter med KOL, da de kliniske tegn på sådanne infektioner og på eksacerbationer ofte overlapper.
English: It is unknown whether salmeterol and fluticasone propionate /metabolites are excreted in human milk.
Danish: Amning Det er ukendt, om salmeterol og fluticasonpropionat /metabolitter udskilles i human mælk.
English: Severe asthma in adults 18 years of age and older
Danish: Svær astma hos voksne i alderen 18 år og derover
English: • Xanthine medicines such as aminophylline and theophylline.
Danish: • Xanthin-lægemidler, såsom theophyllin-ethylendiamin (aminophyllin) og theophyllin.
English: Hold your inhaler with the semi-transparent yellow mouthpiece cover at the bottom.
Danish: Hold din inhalator med det halvgennemsigtige gule låg på mundstykket nedad.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6
English: This may help to stop you getting thrush in your mouth and/or becoming hoarse.
Danish: Det kan hjælpe dig med at undgå svampeinfektion i munden og/eller hæshed.
English: Patients of black African or Afro-Caribbean ancestry should therefore be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen whilst using
Danish: Patienter af sort afrikansk eller afrocaribisk oprindelse bør derfor informeres om, at de skal fortsætte behandlingen, men søge lægehjælp, hvis astmasymptomerne fortsat er ukontrollerede under behandling med Aerivio Spiromax, eller hvis de forværres.
English: • Write the date you opened the foil pouch on the label on the inhaler.
Danish: • Skriv den dato, du åbnede folien, ned på etiketten på inhalatoren.
English: There is no need to adjust the dose in elderly patients or in those with renal impairment.
Danish: Særlige patientgrupper Dosisjustering er ikke nødvendig hos ældre patienter eller hos patienter med nedsat nyrefunktion.
English: A double blind, randomised, parallel group study in 318 patients with persistent asthma aged ≥18 years evaluated the safety and tolerability of administering two inhalations twice daily (double dose) of salmeterol/fluticasone propionate for two weeks.
Danish: I et dobbeltblindt, randomiseret studie med parallelle grupper blev 318 patienter ≥ 18 år med vedvarende astma evalueret med henblik på sikkerheden og tolerabiliteten ved administration af 2 inhalationer 2 gange dagligt (dobbelt dosis) af salmeterol/fluticasonpropionat i to uger.
English: • Salmeterol is a long-acting bronchodilator.
Danish: • Salmeterol tilhører en gruppe lægemidler, der kaldes langtidsvirkende bronkodilatatorer.
English: Potassium replacement should be considered.
Danish: Der bør overvejes at give kaliumtilskud.
English: Patients should be given a strength of salmeterol/fluticasone propionate inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease.
Danish: Patienterne skal have en salmeterol/fluticasonpropionat-inhalator, der indeholder fluticasonpropionat i en styrke, der passer til sværhedsgraden af deres sygdom.
English: Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Danish: Aerivio Spiromax er indiceret til symptomatisk behandling af KOL-patienter med FEV1 <60 % af forventet normal (før bronkodilatator) og en anamnese med gentagne eksacerbationer, og hvor patienterne har signifikante symptomer trods regelmæssig behandling med bronkodilatator.
English: There are no data available on the use of Aerivio Spiromax in patients with hepatic impairment.
Danish: Der foreligger ingen data om anvendelse af Aerivio Spiromax hos patienter med nedsat leverfunktion.
English: Therapy should be down-titrated under physician supervision.
Danish: Behandlingen bør nedtrappes under lægens opsyn.
English: In addition, if you suddenly stop taking Aerivio Spiromax or reduce your dose of Aerivio Spiromax this may (very rarely) cause you to have problems with your adrenal glands (adrenal insufficiency) which sometimes causes side effects.
Danish: Hvis du pludseligt holder op med at bruge Aerivio Spiromax, eller hvis du nedsætter din dosis, kan dette (meget sjældent) give dig problemer med dine binyrer (binyrebarkinsufficiens), hvilket til tider giver
English: Clinically significant effects were not seen on blood pressure, heart rate, blood glucose and blood potassium levels.
Danish: Der sås ikke klinisk signifikante virkninger på blodtryk, hjertefrekvens, blodglucose og serumkalium.
English: If your doctor feels that you need a lower dose than is available from your Aerivio Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your Aerivio Spiromax but with a lower dose of the corticosteroid.
Danish: Hvis lægen mener, at du har behov for en lavere dosis, end du kan opnå med Aerivio Spiromax, kan lægen ordinere en anden inhalator, der indeholder de samme aktive stoffer som Aerivio Spiromax, men med en lavere dosis binyrebarkhormon.
English: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects.
Danish: Det forventes, at samtidig behandling med CYP3A-hæmmere, herunder cobicistat-holdige lægemidler, øger risikoen for systemiske bivirkninger.
English: Aerivio Spiromax contains two medicines, salmeterol and fluticasone propionate:
Danish: Aerivio Spiromax indeholder to lægemidler, salmeterol og fluticasonpropionat:
English: Studies have shown that salmeterol and fluticasone propionate and their metabolites, are excreted into the
Danish: Studier har vist, at salmeterol og fluticasonpropionat og deres metabolitter udskilles i mælk hos diegivende
English: Acute: Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function.
Danish: Akut: Akut inhalation af fluticasonpropionat i højere dosis end de anbefalede doser kan medføre midlertidig binyrebarksuppression.
English: If you accidentally take more doses than is recommended, talk to your doctor or pharmacist.
Danish: Hvis du ved en fejl tager flere doser end anbefalet, skal du kontakte lægen eller apotekspersonalet.
English: Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing.
Danish: Samtidig administration af ketoconazol forlængede ikke salmeterols eliminationshalveringstid og øgede heller ikke akkumulationen af salmeterol ved gentagne doser.
English: You may also have dizziness, a headache, muscle weakness and aching joints.
Danish: Du kan også blive svimmel, få hovedpine, muskelsvaghed og ømme led.
English: Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures.
Danish: Symptomerne herpå er typisk vage og kan omfatte anoreksi, abdominalsmerter, vægttab, træthed, hovedpine, kvalme, opkastning, hypotension, nedsat bevidsthedsniveau, hypoglykæmi og krampeanfald.
English: Aerivio Spiromax is not intended as the treatment of asthma when a fixed-dose combination of salmeterol and fluticasone propionate is required for the first time.
Danish: Aerivio Spiromax er ikke beregnet til behandling af astma hos patienter, hvor det er første gang, der er behov for en fastdosiskombination af salmeterol og fluticasonpropionat.
English: The signs and symptoms of salmeterol overdose are dizziness, increases in systolic blood pressure, tremor, headache and tachycardia.
Danish: Symptomer på overdosering med salmeterol er svimmelhed, forhøjet systolisk blodtryk, tremor, hovedpine og takykardi.
English: INHALER
Danish: INHALATOR
English: Patients were enrolled if ≥12 years of age, with asthma and if currently using asthma medication (but not a LABA).
Danish: Patienter kunne indgå, hvis de var ≥12 år, havde astma og brugte astmamedicin (dog ikke en langtidsvirkende ß2-agonist, LABA).
English: Salmeterol/Fluticasone propionate - Asthma clinical trials A twelve month study (Gaining Optimal Asthma ControL, GOAL), in 3416 adult and adolescent patients with persistent asthma, compared the safety and efficacy of salmeterol/fluticasone propionate versus inhaled corticosteroid (fluticasone propionate) alone to determine whether the goals of asthma management were achievable.
Danish: Kliniske studier med salmeterol/fluticasonpropionat astma Et 12-måneders studie (Gaining Optimal Asthma ControL, GOAL) med 3.416 voksne og unge patienter med vedvarende astma sammenlignede sikkerheden og virkningen af salmeterol/fluticasonpropionat versus inhaleret kortikosteroid (fluticasonpropionat) alene for at fastlægge, om målene for astmabehandling kan opnås.
English: Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, with less adverse effects than when corticosteroids are administered systemically.
Danish: Fluticasonpropionat administreret som inhalation ved de anbefalede doser giver en glukokortikoidinduceret antiinflammatorisk virkning i lungerne, som resulterer i reducerede astmasymptomer og færre eksacerbationer og med færre bivirkninger end ved administration af systemiske kortikosteroider.
English: Aerivio Spiromax should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway.
Danish: Der skal udvises forsigtighed ved administration af Aerivio Spiromax hos patienter med aktiv eller latent lungetuberkulose eller med svampeinfektioner, virale infektioner eller andre infektioner i luftvejene.
English: Placebo-controlled clinical trials, over 6 and 12 months, have shown that regular use of salmeterol/fluticasone propionate 50/500 micrograms improves lung function and reduces breathlessness and
Danish: Placebokontrollerede kliniske studier over 6 og 12 måneder har vist, at regelmæssig anvendelse af salmeterol/fluticasonpropionat 50/500 mikrogram forbedrer lungefunktionen og nedsætter graden af åndenød og anvendelsen af anfaldsmedicin.
English: Aerivio Spiromax should be discontinued immediately, the patient assessed and alternative
Danish: Aerivio Spiromax skal omgående seponeres og patienten vurderes med iværksættelse af alternativ
English: This is because using too much Aerivio Spiromax may reduce the amount of steroid hormones produced by your adrenal glands.
Danish: Dette er nødvendigt, da for meget Aerivio Spiromax kan nedsætte mængden af steroidhormoner, der dannes i binyrerne.
English: In a population pharmacokinetic analysis from 9 controlled clinical trials of 350 patients with asthma aged 4 to 77 years (174 patients 4 to 11 years of age) higher fluticasone propionate systemic exposure following treatment with salmeterol/fluticasone propionate inhalation powder 50/100 compared with fluticasone propionate inhalation powder 100 was seen.
Danish: I en populationsfarmakokinetisk analyse af 9 kontrollerede kliniske forsøg med 350 patienter med astma i alderen 4 til 77 år (174 patienter mellem 4 og 11 år) blev der set en højere systemisk eksponering for fluticasonpropionat efter behandling med salmeterol/fluticasonpropionat-inhalationspulver 50/100 mikrogram sammenlignet med fluticasonpropionat-inhalationspulver 100 mikrogram.
English: Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450
Danish: Under normale omstændigheder opnås lave plasmakoncentrationer af fluticasonpropionat efter inhalation på grund af udtalt first pass-metabolisme og høj systemisk clearance medieret af CYP3A4 i tarm og lever.
English: Patients should also be advised to rinse their mouth with water and spit the water out, and/or brush their teeth
Danish: Patienterne skal også informeres om at skylle munden med vand og spytte vandet ud og/eller børste tænder
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk
Danish: Der er ikke endegyldigt klinisk bevis for en forskel i risikoen for pneumoni blandt de forskellige klasser af inhalerede kortikosteroider.
English: If this happens you need to use a fast-acting ‘reliever' (‘rescue') inhaler, such as salbutamol.
Danish: Hvis det sker, skal du bruge en særskilt inhalator med hurtigtvirkende anfaldsmedicin, f.eks. salbutamol, til lindring af disse symptomer.
English: Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.
Danish: Der kan opstå paradoks bronkospasme med akut forværret hvæsende vejrtrækning og åndenød efter dosering.
English: Endocrine disorders Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density
Danish: Det endokrine system Cushings syndrom, cushingoide træk, adrenal suppression, væksthæmning hos børn og unge, nedsat knoglemineraltæthed
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, der ordineres i længere perioder, specielt ved høje doser.
English: SMART was a multi-centre, randomised, double blind, placebo-controlled, parallel group 28-week study in the US which randomised 13,176 patients to salmeterol (50 micrograms twice daily) and 13,179 patients to placebo in addition to the patients' usual asthma therapy.
Danish: Salmeterol Multi-center Asthma Research Trial (SMART) SMART var et 28-ugers randomiseret, dobbeltblindt, placebokontrolleret studie med parallelle grupper i USA, hvor 13.176 patienter blev randomiseret til salmeterol (50 mikrogram to gange dagligt) og 13.179 patienter til placebo, i tillæg til patienternes sædvanlige astmabehandling.
English: There was no increase in pneumonia related deaths; deaths while on treatment that were adjudicated as primarily due to pneumonia were 7 for placebo, 9 for salmeterol, 13 for FP and 8 for salmeterol/fluticasone propionate.
Danish: Dødsfald under behandlingen, som blev bedømt som primært at skyldes pneumoni, var 7 for placebo, 9 for salmeterol, 13 for FP og 8 for salmeterol/fluticasonpropionat.
English: Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should therefore be avoided unless the benefits outweigh the potentially increased risk of systemic undesirable effects of salmeterol treatment (see section 4.5).
Danish: Samtidig behandling med ketoconazol eller andre potente CYP3A4-hæmmere bør derfor undgås, medmindre fordelene opvejer den øgede risiko for systemiske bivirkninger fra salmeterol (se pkt.
English: Afterwards, rinse your mouth with water and spit it out and/or brush your teeth.
Danish: Derefter skal du skylle munden med vand og spytte det ud og/eller børste tænder.
English: Following co-administration, increased incidences of transposed umbilical artery and incomplete ossification of occipital bone were found in rats at doses associated with known glucocorticoid
Danish: Efter samtidig administration er der observeret en øget forekomst af omlagt umbilikalarterie og ufuldstændig ossifikation af nakkebenet hos rotter ved doser, der er forbundet med kendte glukokortikoid-inducerede anomalier.
English: Before using your Aerivio Spiromax for the first time, you need to prepare it for use as follows:
Danish: Før du bruger Aerivio Spiromax første gang, skal du klargøre inhalatoren på følgende måde:
English: The following side effects have also been reported in patients with chronic obstructive pulmonary disease (COPD):
Danish: Følgende bivirkninger er derudover blevet rapporteret hos patienter med kronisk obstruktiv lungesygdom
English: The mean number of moderate to severe exacerbations per year was significantly reduced with salmeterol/fluticasone propionate (FP) as compared with treatment with salmeterol, FP and placebo (mean rate in the salmeterol/fluticasone propionate group 0.85 compared with 0.97 in the salmeterol group, 0.93 in the FP group and 1.13 in the placebo).
Danish: Det gennemsnitlige antal moderate til svære eksacerbationer pr. år var signifikant reduceret med salmeterol/fluticasonpropionat (FP), sammenlignet med salmeterol, FP og placebo (gennemsnitlig hyppighed i salmeterol/fluticasonpropionat-gruppen var 0,85 sammenlignet med 0,97 i salmeterol-gruppen, 0,93 i FPgruppen og 1,13 i placebogruppen).
English: You should always have your fast-acting
Danish: Hav altid din inhalator med hurtigtvirkende
English: The studies described were carried out with a previously authorised product available in three different strengths; the studies were not carried out with
Danish: Studierne blev udført med et tidligere godkendt præparat, tilgængeligt i tre forskellige styrker; studierne blev ikke udført med Aerivio Spiromax.
English: The dose of inhaled corticosteroid should always be reduced to the lowest dose at which effective control of asthma is maintained.
Danish: Dosis af det inhalerede kortikosteroid skal altid reduceres til den laveste dosis, der kan opretholde en effektiv astmakontrol.
English: You do not need to shake your inhaler.
Danish: Det er ikke nødvendigt at ryste inhalatoren.
English: Peak Inspiratory Flow Rate through the Spiromax Device A randomised, open-label cross-over study was performed in children and adolescents with asthma (aged 417 years), adults with asthma (aged 18-45 years), adults with chronic obstructive pulmonary disease (COPD) (aged older than 55 years) and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Danish: Maksimal inspiratorisk flowhastighed gennem Spiromax-inhalationsdevice Der blev udført et randomiseret, åbent overkrydsningsstudie hos børn og unge (4-17 år) med astma, voksne (18-45 år) med astma, voksne (over 55 år) med kronisk obstruktiv lungesygdom (KOL) og raske, frivillige personer (18-45 år) for at evaluere maksimal inspiratorisk flowhastighed (peak inspiratory flow rate, PIFR) samt andre relaterede inhalationsparametre efter inhalation af placebo gennem et Spiromax-inhalationsdevice sammenlignet med inhalation gennem et allerede markedsført multidosis pulver-inhalationsdevice.
English: If you stop using Aerivio Spiromax
Danish: Hvis du holder op med at bruge Aerivio Spiromax
English: • Chronic obstructive pulmonary disease (COPD), to reduce the number of flare ups of symptoms.
Danish: • kronisk obstruktiv lungesygdom (KOL), for at nedsætte hyppigheden af anfald med forværring af dine
English: Then breathe out gently (do not breathe out through the inhaler).
Danish: Pust roligt ud (pust ikke ud gennem inhalatoren).