FrancophonIA/ELRC3.0 huggingface dataset:
English: When you close the Diskus, the lever automatically moves back to the original position, with the outer casing protecting the Diskus when not in use.
Danish: Når Diskus lukkes, går dosisknappen automatisk tilbage til startpositionen, hvor den ydre beholder er lukket og beskytter Diskus, når den ikke er i brug.
English: The primary endpoint in the GOAL study was the proportion of patients reaching asthma control (well-control of asthma).
Danish: Det primære endepunkt i GOAL-undersøgelsen var den andel af patienterne, der opnåede vellykket astmakontrol (velkontrolleret astma).
English: A clear benefit has not been shown as compared to inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing.
Danish: Der er ikke blevet vist en klar fordel i sammenligning med inhaleret fluticasonpropionat som første vedligeholdelsesbehandling, idet der mangler et eller to af kriterierne for sværhedsgraden.
English: Tel: +44 (0)1920 463993
Danish: Telefon +44 1920 463993
English: In several EU Member States Seretide Diskus and associated names (see Annex I) are approved through the Mutual Recognition Procedure (MRP).
Danish: Seretide Diskus og tilknyttede navne (se bilag I) er godkendt i en række EU-medlemsstater gennem proceduren for gensidig anerkendelse.
English: The mouthpiece is then placed in the mouth and the lips closed round it.
Danish: Derefter sættes mundstykket mellem tænderne, og læberne lukkes tæt om det.
English: If your symptoms are well controlled using Seretide Diskus twice daily, your doctor may decide to reduce your dose to once daily.
Danish: Hvis dine symptomer er velkontrollerede på Seretide i Diskus to gange daglig, kan din læge forsøge at nedsætte dosis til en gang daglig.
English: The wording also indicates the importance for stepping down to inhaled corticosteroids alone once asthma control is attained.
Danish: Af ordlyden fremgår også vigtigheden af nedtrapning til inhalerede corticosteroider alene, efter at astmakontrol er opnået.
English: Less than 5% of the dose is excreted in urine, mainly as metabolites.
Danish: Mindre end 5 % i urinen i form af metabolitter.
English: Additionally, hypokalaemia can occur and potassium replacement should be considered.
Danish: Ligeledes kan der opstå hypokaliæmi, og kaliumtilskud skal overvejes.
English: Each single dose of Seretide provides:
Danish: Hver dosis Seretide indeholder:
English: Data from six pivotal studies and two supporting studies have been presented to confirm the safety profile of salmeterol/FP when initiated as maintenance treatment.
Danish: Der er forelagt oplysninger fra seks hovedundersøgelser og to støttende undersøgelser til at underbygge sikkerheden af salmeterol/fluticasonpropionat anvendt som indledende vedligeholdelsesbehandling.
English: Side effects may also occur if you get an infection or at times of extreme stress (such as after a serious accident or if you have surgery).
Danish: Der kan også opstå bivirkninger, hvis du får en infektion eller udsættes for ekstremt stress (fx efter alvorlig ulykke eller hvis du skal opereres).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: Candidiasis of the mouth and throat
Danish: Candidiasis i mund og svælg
English: The CHMP considered the use of “Control of Asthma” as the primary efficacy variable a reliable parameter of the patient clinical status and, as such, clinically meaningful.
Danish: CHMP fandt, at anvendelse af ”astmakontrol” som primær virkningsvariabel er en pålidelig parameter for patienters kliniske tilstand og dermed klinisk relevant.
English: Seretide Diskus is also used for the regular treatment of the symptoms of severe Chronic Obstructive Pulmonary Disease (COPD).
Danish: Seretide Diskus kan også bruges til regelmæssig behandling af symptomerne ved svær kronisk obstruktiv lungesygdom (KOL).
English: Chronic Obstructive Pulmonary Disease (COPD)
Danish: Kronisk Obstruktiv Lungesygdom (KOL)
English: Do not store above 30°C.
Danish: Må ikke opbevares ved over 30°C.
English: - Very fast heart rate (tachycardia).
Danish: - Meget hurtig puls (takykardi).
English: Children 4 to 12 years of age Seretide 50/100 Diskus
Danish: Børn fra 4 til 12 år Seretide 50/100 Diskus
English: In general inhaled corticosteroids remain the first line treatment for most patients.
Danish: Generelt er inhalationssteroider stadig førstevalgsbehandling for de fleste patienter.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, INDEHAVER AF MARKEDSFØRINGSTILLADELSE R I MEDLEMSSTATERNE
English: If your asthma gets worse or is not well controlled (you will feel wheezy and need more of your fast acting ‘rescue' medicine), do not increase the number of inhalations of Seretide you take.
Danish: Hvis din astma forværres eller er ikke er velkontrolleret (hvis din vejrtrækning er hvæsende, og du har brug for mere anfaldsmedicin), skal du ikke øge antallet af inhalationer af Seretide.
English: The disposition of fluticasone propionate is characterised by high plasma clearance (1150ml/min), a large volume of distribution at steady-state (approximately 300l) and a terminal half-life of approximately 8 hours.
Danish: Udskillelsen af fluticason er karakteriseret ved høj clearance (1150 ml/minut), stort fordelingsvolumen i steady-state (ca. 300 l) og en terminal halveringstid på ca. 8 timer.
English: Although the safety profile of salmeterol/fluticasone propionate is well known, the CHMP considered it not justified to expose the whole intended target population to an increased incidence of beta-agonists related adverse events.
Danish: Selv om at sikkerhedsprofilen for salmeterol/fluticasonpropionat er veldokumenteret, fandt CHMP det ikke berettiget at eksponere hele den tilsigtede målgruppe for øget forekomst af beta-agonistrelaterede bivirkninger.
English: These side effects are usually harmless and lessen as treatment continues.
Danish: Disse bivirkninger er oftest uskadelige og aftager ved fortsat behandling.
English: SLIDE: Hold your Diskus with the mouthpiece towards you.
Danish: KLARGØRING: Hold din Diskus med mundstykket ind imod dig.
English: When you first take Seretide Diskus out of the box, it will be in the closed position.
Danish: Når du tager Seretide Diskus ud af æsken, er den lukket.
English: Adults and adolescents 12 years and older:
Danish: Voksne og unge fra 12 år:
English: Treatment with Seretide should not be stopped abruptly in patients with asthma due to risk of exacerbation.
Danish: Behandling med Seretide bør ikke seponeres pludseligt hos astmapatienter på grund af risiko for forværring.
English: The absolute bioavailability of inhaled fluticasone propionate in healthy subjects varies between approximately 10-30% of the nominal dose depending on the inhalation device used.
Danish: Efter inhalation er den absolutte biotilgængelighed hos raske personer ca. 10-30 % af den nominelle dosis, afhængig af inhalatoren.
English: Other unidentified metabolites are also found in the faeces.
Danish: Andre, uidentificerbare metabolitter ses også i fæces.
English: A recommendation in section 4.2 “Posology and method of administration” was considered acceptable.
Danish: Det blev fundet acceptabelt at give en sådan anbefaling i afsnit 4.2 "Dosering og indgivelsesmåde".
English: Children and adolescents <16years taking high doses of fluticasone propionate (typically ≥ 1000mcg/day) may be at particular risk.
Danish: Børn og unge under 16 år, der får høje doser fluticasonpropionat (typisk > 1000 mikg/dag), er specielt i risikogruppen.
English: See your doctor immediately so they can review your condition and assess the medication you need to take.
Danish: Kontakt din læge øjeblikkelig, så du bliver undersøgt og lægen kan finde ud af, hvilken medicin, du skal have.
English: - Feeling shaky and fast or irregular heartbeat (palpitations).
Danish: - rysten og hurtig og uregelmæssig hjertebanken (palpitationer).
English: Seretide is not intended for the initial management of mild asthma.
Danish: Seretide er ikke beregnet til førstevalg til behandling af mild astma.
English: There are insufficient data on the use of salmeterol and fluticasone propionate during pregnancy and lactation in man to assess the possible harmful effects.
Danish: Der er utilstrækkelige oplysninger om brugen af salmeterol og fluticasonpropionat hos gravide og ammende kvinder til, at eventuel skadepåvirkning kan vurderes.
English: Ritonavir can greatly increase the concentration of fluticasone propionate in plasma.
Danish: Ritonavir kan i høj grad øge plasmakoncentrationen af fluticasonpropionat.
English: On 12 August 2005, the MAHs presented to the EMEA a referral under Article 6(13) of Commission Regulation (EC) No 1084/2003.
Danish: Indehaverne af markedsføringstilladelsen indbragte i henhold til artikel 6, stk. 13, i Kommissionens forordning (EF) nr. 1084/2003 en sag for EMEA den 12. august 2005.
English: Rua Dr. António Loureiro Borges, 3, Arquiparque , Miraflores 1495131 Algés
Danish: Rua Dr. António Loureiro Borges, 3, Arquiparque , Miraflores 1495131 Algés, Portugal
English: Both salmeterol and fluticasone propionate are excreted into breast milk in rats.
Danish: Både salmeterol og fluticasonpropionat udskilles i brystmælk hos rotter.
English: Concomitant use of other beta-adrenergic containing drugs can have a potentially additive effect.
Danish: Samtidig brug af andre ß-adrenerge stoffer kan have en potentiel additiv effekt.
English: Very common, common and uncommon events were derived from clinical trial data.
Danish: Meget almindelige, almindelige og ikke almindelige bivirkninger er generelt fundet i kliniske undersøgelser.
English: Both non-selective and selective beta-blockers should be avoided unless there are compelling reasons for their use.
Danish: Både selektive og ikke-selektive ß-blokkere skal så vidt muligt undgås.
English: Instructions for proper use Your doctor, nurse or pharmacist should instruct you in the proper use of your inhaler.
Danish: Brugsanvisning Få lægen, sygeplejersken eller apoteket til at vise dig, hvordan du skal bruge din Diskus.
English: Once the counter shows 0, your inhaler is empty.
Danish: Når tælleren viser 0, er Diskus tom.
English: Patients should be regularly reassessed by a doctor, so that the strength of Seretide they are receiving remains optimal and is only changed on medical advice.
Danish: Patienterne skal kontrolleres jævnligt af en læge, så dosis forbliver optimal, og denne bør kun ændres af lægen.
English: Cases of Cushing's syndrome and adrenal suppression have been reported.
Danish: Der er rapporter om tilfælde af Cushings syndrom og binyrebarksuppression.
English: If an individual patient should require dosages outside the recommended regimen, appropriate doses of beta-agonist and/or corticosteroid should be prescribed.
Danish: Hvis en patient har brug for doser, der ligger uden for de anbefalede, bør der ordineres ß-agonister og/eller kortikosteroider.
English: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.
Danish: Det anbefales, at højden måles jævnligt på børn i langtidsbehandling med inhalerede kortikosteroider.
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: Derudover er der kun begrænsede oplysninger 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) ved inhalation i terapeutiske doser.
English: This may be either once at night if you have night-time symptoms or once in the morning if you have daytime symptoms.
Danish: Dosis kan tages enten om aftenen, hvis du får symptomer om natten, eller om morgenen, hvis du har symptomer om dagen.
English: Placebo-controlled clinical trials, over 6 and 12 months, have shown that regular use of Seretide 50/500 micrograms improves lung function and reduces breathlessness and the use of relief medication.
Danish: Placebo-kontrollerede kliniske forsøg over 6 og 12 måneder har vist, at fast behandling med Seretide 50/500 mikg forbedrer lungefunktionen og reducerer åndenød og brug af anfaldsmedicin.
English: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Danish: Salmeterol er en selektiv, langtidsvirkende (12 timer) ß2-agonist med en lang sidekæde, som bindes til receptorens exo-site.
English: BATCH NUMBER Lot
Danish: FREMSTILLERENS BATCHNUMMER Lot no
English: Seretide Diskus United Kingdom Seretide Accuhaler
Danish: Seretide Diskus Det Forenede Kongerige Seretide Accuhaler
English: There are no data available for human breast milk.
Danish: Der er ingen oplysninger om udskillelse i brystmælk hos kvinder.
English: These are the side effects reported by people taking Seretide.
Danish: Følgende bivirkninger er rapporteret af brugere af Seretide.
English: Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.
Danish: Således er klinisk signifikante interaktioner forårsaget af fluticasonpropionat ikke sandsynlige.
English: Salmeterol is one of a group of medicines called long-acting bronchodilators (effect lasting for at least 12 hours).
Danish: Salmeterol tilhører en gruppe lægemidler med langtidsvirkende bronkieudvidende effekt (virkningen holder sig i mindst 12 timer).
English: For pharmacokinetic purposes therefore each component can be considered separately.
Danish: Derfor kan hvert stof betragtes for sig rent farmakokinetisk.
English: It is also highlighted that Seretide is not appropriate as IMT in patients with mild and severe asthma and that in general inhaled corticosteroids remain the first line treatment for most patients.
Danish: Desuden bliver det fremhævet, at Seretide ikke er hensigtsmæssigt som initial vedligeholdelsesbehandling hos patienter med let og svær astma, og at inhalerede corticosteroider generelt stadig er førstevalgsbehandlingen til de fleste patienter.
English: Therefore the CHMP considered it acceptable to give guidance to physicians as to the most appropriate dose strategy for initiating maintenance therapy with the fixed dose combination.
Danish: CHMP anså det derfor for acceptabelt at vejlede lægerne i den mest hensigtsmæssige strategi for doseringen ved indledning af en vedligeholdelsesbehandling med fastdosiskombinationen.
English: Salmeterol acts locally in the lung therefore plasma levels are not an indication of therapeutic effects.
Danish: Da salmeterol virker lokalt i lungerne, er plasmakoncentrationer ikke en indikator for terapeutisk effekt.
English: Throat irritation Hoarseness/dysphonia Paradoxical bronchospasm
Danish: Hæshed/dysfoni Paradoks bronkospasme
English: Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected.
Danish: Der findes ikke data om denne interaktion ved inhaleret fluticasonpropionat, men en udpræget højere plasmakoncentration af fluticasonpropionat er forventelig.
English: - Breathing difficulties or wheezing (bronchospasm) worsens immediately after taking Seretide.
Danish: - Åndenød eller hvæsende vejrtrækning (bronkospasme) kan forværres umiddelbart efter du har taget Seretide.
English: Sliding the lever of the Diskus opens a small hole in the mouthpiece and opens a blister in a foil strip, ready for you to inhale the powder.
Danish: Ved at skubbe dosisknappen på Diskus åbnes et lille hul i mundstykket, og der åbnes en blister i folien, som nu er klar til inhalation.
English: The remainder of the inhaled dose may be swallowed but contributes minimally to systemic exposure due to the low aqueous solubility and pre-systemic metabolism, resulting in oral availability of less than 1%.
Danish: Resten af den inhalerede dosis bliver formentlig slugt, men bidrager minimalt til den systemiske påvirkning på grund af lav vandopløselighed og præsystemisk metabolisme, så den perorale biotilgængelighed er under 1 %.
English: This amount does not normally cause problems in lactose intolerant people.
Danish: Denne mængde giver normalt ikke problemer hos laktose-intolerante patienter.
English: - Seretide may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time.
Danish: - Seretide kan påvirke den naturlige produktion af binyrebarkhormoner i kroppen, især efter indtagelse af høje doser over lang tid.
English: GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760, Tres Cantos, Madrid Spain
Danish: GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760, Tres Cantos, Madrid, Spanien
English: Be careful not to confuse your Seretide inhaler with your ‘rescue' inhaler.
Danish: Vær opmærksom på ikke at forveksle Seretide med din anfaldsmedicin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Udfyldes nationalt
English: The foil protects the powder for inhalation from the effects of the atmosphere.
Danish: Blistrene beskytter inhalationspulveret imod luftens påvirkning.
English: To work properly in controlling asthma and treating COPD symptoms, Seretide must be taken every day as directed by your doctor.
Danish: For at få kontrol over din astma og for at behandle symptomer på KOL, skal du tage Seretide hver dag som anvist af din læge.
English: OPEN: to open your Diskus, hold the outer case in one hand and put the thumb of your other hand on the thumbgrip.
Danish: SÅDAN ÅBNES DISKUS: Hold Diskus med den ene hånd og sæt tommelfingeren på fingergrebet.
English: Fluticasone propionate:
Danish: Fluticasonpropionat:
English: CHMP considered it not acceptable to expose the whole target population to beta-agonists related adverse events.
Danish: CHMP fandt det ikke berettiget at eksponere hele den tilsigtede målgruppe for beta-agonistrelaterede bivirkninger,
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 3A4 in the gut and liver.
Danish: Under normale omstændigheder opnås lave plasmakoncentrationer af fluticasonpropionat ved inhalation på grund af en betragtelig first pass metabolisme og høj systemisk clearance afhjulpet af cytokrom P450 3A4 i tarm og lever.
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 astmasymptomer er potentielt livstruende og patienten skal snarest tilses af en læge.
English: This combination of salmeterol and fluticasone propionate when used regularly prevents asthma attacks occurring.
Danish: Denne kombination af salmeterol og fluticasonpropionat forebygger astmaanfald ved regelmæssig brug.
English: Administration of Seretide to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Danish: Seretide bør kun gives til kvinder, der ammer, hvis den forventede fordel af behandlingen for moderen er større end en eventuel risiko hos barnet.
English: Well Controlled asthma was achieved more rapidly with Seretide than with ICS alone.
Danish: Velkontrolleret astma blev opnået hurtigere med Seretide end med inhalationssteroid alene.
English: If you forget to take Seretide
Danish: Hvis du glemmer at tage Seretide
English: - Uneven heartbeat or heart gives an extra beat (arrhythmias).
Danish: - Uregelmæssig hjerterytme, eller hvis hjertet slår et ekstra slag (arytmi).
English: Do not breathe into your Diskus inhaler.
Danish: Pust ikke ind i Diskus.
English: Pre-Study Treatment
Danish: Behandling før afprøvningen
English: Glaxo SmithKline Pharma GmbH, Albert-Schweitzer-Gasse 6 A-1140 Wien
Danish: Glaxo SmithKline Pharma GmbH, Albert-Schweitzer-Gasse 6, A-1140 Wien, Østrig
English: - Hold the Diskus away from your mouth, breathe out as far as is comfortable.
Danish: Hold Diskus væk fra munden, pust helt ud.
English: There are no data available from clinical trials on overdose with Seretide, however data on overdose with both drugs are given below:
Danish: Der er ingen oplysninger om overdosering i de kliniske afprøvninger, men med de to stoffer givet hver for sig er der set følgende:
English: Very rare events were derived from postmarketing spontaneous data.
Danish: Meget sjældne bivirkninger er generelt fundet fra indberetninger efter markedsføring.
English: This is to reduce the risk of affecting the function of your adrenal gland.
Danish: Derved nedsættes risikoen for påvirkning af din egen hormonproduktion.
English: GlaxoSmithKline (Ireland) Limited (trading as: Allen & Hanbury) Stonemasons Way, Rathfarnham, Dublin 16
Danish: GlaxoSmithKline (Ireland) Limited (trading as: Allen & Hanbury) Stonemasons Way, Rathfarnham, Dublin 16, Irland
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 28 doses
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 28 eller 60 doser
English: Both hoarseness and incidence of candidiasis may be relieved by gargling with water after using the product.
Danish: Forekomsten af både hæshed og candidiasis kan nedsættes ved gurgling med vand efter inhalation af produktet.
English: If you stop taking Seretide
Danish: Hvis du holder op med at tage Seretide
English: A subpopulation from the GOAL study (Gaining Optimal Asthma ControL study) i.e. stratum 1, addendum, step 1 (patients without ICS at entry who fulfilled the criteria for moderate persistent asthma and who are randomised to Seretide 50/100 or FP 100 mcg), can be considered as an adequate target population to assess the adequacy of Seretide as IMT.
Danish: En undergruppe fra GOAL-undersøgelsen (Gaining Optimal Asthma Control study), dvs. stratum 1, addendum, fase 1 (patienter, der ikke fik inhaleret corticosteroid ved indledningen af undersøgelsen, og som opfyldte kriterierne for moderat persisterende astma og er blevet randomiseret til Seretide 50/100 eller fluticasonpropionat 100 mcg), kan anses som en passende målgruppe til vurderingen af hensigtsmæssigheden af Seretide som initial vedligeholdelsesbehandling.
English: The pharmacological side effects of beta-2-agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Danish: De farmakologiske bivirkninger ved ß2-agonister, fx tremor, palpitationer og hovedpine, er rapporteret, men synes at være forbigående og aftagende ved regelmæssig behandling.
English: If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig, eller du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du fortælle det til din læge eller apotek.
English: Seretide Diskus contains up to 12.5 milligrams of lactose in each dose.
Danish: Seretide i Diskus indeholder op til 12,5 mg lactose pr. dosis.
English: Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone.
Danish: Når der er opnået astmakontrol, revurderes behandlingen, og det overvejes, om patienterne skal trappes ned til behandling med inhalationssteroid alene.