FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the amount of lactose in this medicine does not normally cause problems in lactose intolerant people.
Danish: Denne mængde lactose giver dog normalt ikke problemer hos patienter med lactose-intolerans.
English: If you are using high doses of Seretide for a long time, one of the active ingredients, fluticasone propionate, may stop the natural production of steroid hormones by the adrenal gland.
Danish: Hvis du bruger høje doser Seretide i lang tid, kan et af de aktive indholdsstoffer, fluticasonpropionat, stoppe din egen produktion af binyrebarkhormoner.
English: Immune System Disorders
Danish: Lidelser i immunsystemet
English: Seretide Asthma clinical trials
Danish: Kliniske afprøvninger med Seretide til astma
English: micrograms fluticasone propionate.
Danish: mikrogram fluticasonpropionat.
English: It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
Danish: Det er derfor vigtigt, at patienten undersøges jævnligt, og at der reduceres til den laveste dosis inhalationssteroid, der giver astmakontrol.
English: The CHMP had a concern that a general recommendation i.e. the therapeutic indication in the Summary of Product Characteristics (SPC), will result in over treatment particularly in patients who would have responded to inhaled corticosteroids alone.
Danish: CHMP var betænkelig over, at en generel anbefaling, dvs. den terapeutiske indikation i produktresuméet, kan frygtes at føre til overbehandling af især patienter, som ville have responderet på inhalerede corticosteroider alene.
English: Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Danish: Det bør overvejes at lægge systemiske kortikosteroider oven i behandlingen i stressperioder eller i forbindelse med operation.
English: - The other ingredient is lactose monohydrate (which contains milk proteins).
Danish: - Det øvrige indholdsstof er lactose (indeholder mælkesukker).
English: Co-treatment with other potent CYP3A inhibitors, such as itraconazole, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic side-effects.
Danish: Samtidig behandling med andre potente CYP3A-hæmmere, fx itraconazol, forventes også at øge følsomheden for fluticason og risikoen for systemiske bivirkninger.
English: Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
Danish: Øget brug af korttidsvirkende bronkodilatatorer betyder forværring, og patientens tilstand bør revurderes af en læge.
English: Patients with mild persistent asthma are not considered to be candidates for a combination therapy as IMT and patients with a more severe disease would deserve more intensive therapeutic approaches.
Danish: Patienter med mild persisterende astma betragtes ikke som egnede kandidater til kombinationsbehandling som initial vedligeholdelsesbehandling, og patienter med sværere sygdom kræver en mere intensiv behandlingsmetode.
English: Potentially serious hypokalaemia may result from systemic beta-2-agonist therapy but following inhalation at therapeutic doses plasma levels of salmeterol are very low.
Danish: Systemisk behandling med ß2-agonister kan resultere i potentielt alvorlig hypokaliæmi, men efter inhalation i terapeutiske doser er der meget lave plasmakoncentrationer af salmeterol.
English: Administration of Seretide to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Danish: Seretide bør kun gives til gravide, hvis den forventede fordel af behandlingen for moderen er større end en eventuel risiko hos fostret.
English: As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing.
Danish: Som ved anden inhalationsbehandling kan paradoks bronkospasme forekomme med akut øget hvæsen efter indtagelse af dosis.
English: Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, without the adverse effects observed when corticosteroids are administered systemically.
Danish: Fluticasonpropionat givet som inhalation i de anbefalede doser giver en glukokortikoid antiinflammatorisk effekt i lungerne, som formindsker symptomer på og forværring af astmaen uden de bivirkninger, der ses ved systemisk steroidbehandling.
English: To help prevent side effects occurring, your doctor will make sure you are on the lowest dose of Seretide that will control your asthma.
Danish: For at undgå bivirkninger vil din læge bestræbe sig på, at du får den laveste dosis Seretide, som kan kontrollere din astma.
English: There are no data available for use of Seretide in patients with hepatic impairment.
Danish: Der er ingen oplysninger om brug af Seretide hos patienter med nedsat leverfunktion.
English: United Kingdom Glaxo Wellcome UK Limited, Stockley Park West, Uxbridge, Middlesex UB11 1BT
Danish: Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West, Uxbridge, Middlesex UB11 1BT, Det Forenede Kongerige
English: It helps the airways in the lung to stay open making it easier for air to get in and out.
Danish: Den holder luftvejene i lungerne åbne, således at luften lettere passerer, og det bliver nemmere at trække vejret.
English: Angioedema (mainly facial and oropharyngeal oedema), Respiratory symptoms (dyspnoea and/or bronchospasm), Anaphylactic reactions
Danish: Angioødem (primært i ansigt og svælg), luftvejssymptomer (dyspnøe og/eller bronkospasme), anafylaktiske reaktioner
English: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-roi Cedex, France
Danish: Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-roi Cedex, Frankrig
English: Fluticasone propionate is one of a group of medicines called corticosteroids which reduces swelling and irritation in the lungs.
Danish: Fluticasonpropionat tilhører en gruppe lægemidler, der hedder binyrebarkhormoner, som hæmmer hævelse og irritation i lungerne.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DISKUS LABEL
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: You must use your fast acting ‘rescue' medicine (such as salbutamol) for this purpose which you should carry with you at all times.
Danish: Mod dette skal du bruge den hurtigvirkende anfaldsmedicin (fx salbutamol), som du altid bør have på dig.
English: *Very Common Common
Danish: *) Meget almindelig
English: If you find it difficult to breathe or your wheezing gets worse after taking Seretide, stop using it immediately and tell your doctor straightaway so they can assess your treatment.
Danish: Hvis du får åndenød, eller din hvæsende vejrtrækning bliver værre, efter brug af Seretide, skal du straks holde op med at tage Seretide og kontakte din læge, så din behandling kan blive taget op til revision.
English: The MAHs were of the opinion that the issues identified during the MRP were issues of clinical management and as such cannot be addressed by conducting further clinical trials.
Danish: Indehaverne af markedsføringstilladelserne var af den opfattelse, at de rejste spørgsmål under proceduren for gensidig anerkendelse angik den kliniske behandling og derfor ikke kunne afklares gennem yderligere kliniske undersøgelser.
English: Psychiatric Disorders Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children)
Danish: Uro, søvnforstyrrelser og ændret adfærd, herunder hyperaktivitet og irritabilitet (især hos børn)
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C
Danish: Må ikke opbevares over 30ºC
English: The maximum licensed dose of fluticasone propionate delivered by Seretide Diskus in children is 100mcg twice daily.
Danish: Den maksimale godkendte dosis af fluticasonpropionat i Seretide i Diskus til børn er 100 mikg 2 gange dagligt.
English: HOW TO TAKE SERETIDE
Danish: HVORDAN DU TAGER SERETIDE
English: Symptomatic candidiasis can be treated with topical antifungal therapy whilst still continuing with the Seretide Diskus.
Danish: Symptomatisk candidiasis kan behandles med topikale midler mod svamp samtidig med anvendelse af Seretide.
English: [See Annex I - To be completed nationally]
Danish: <[Se bilag I - Udfyldes nationalt]>
English: If you notice these symptoms or they appear suddenly after taking Seretide, tell your doctor immediately as you could be allergic to Seretide.
Danish: Hvis du får nogle af disse symptomer, eller de opstår lige efter brug af Seretide, skal du straks kontakte din læge, da du kan være overfølsom over for Seretide.
English: POSSIBLE SIDE EFFECTS
Danish: HVILKE MULIGE BIVIRKNINGER HAR SERETIDE
English: Tell your doctor, but do not stop taking Seretide unless they tell you to do so.
Danish: Tal med lægen om det, men hold ikke op med at tage Seretide uden samråd med lægen.
English: In line with above arguments, the CHMP was not in agreement with a general recommendation for IMT of the fixed dose combination in section 4.1. but considered it acceptable to include guidance for a short term trial of initial maintenance therapy with Seretide in section 4.2.
Danish: Som konsekvens heraf var CHMP ikke enig i, at afsnit 4.1 skulle indeholde en generel anbefaling om initial vedligeholdelsesbehandling med fastdosiskombinationen, men fandt det acceptabelt, der at der i afsnit 4.2 indsættes en vejledning i forsøgsvis initial kortvarig vedligeholdelsesbehandling med Seretide.
English: 60 doses
Danish: 60 afdelte doser.
English: It is important to take Seretide as your doctor recommended.
Danish: Det er vigtigt kun at tage Seretide efter lægens anvisning.
English: A short term trial of Seretide may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential.
Danish: Det kan overvejes at forsøge kortvarigt med Seretide som første vedligeholdelsesbehandling hos voksne og unge med moderat astma (defineret som patienter med daglige symptomer, daglig brug for behovsmedicin og moderat til alvorlig begrænset peakflow), hvor der er brug for hurtig indsættende astmakontrol.
English: Note: Seretide 50/100 microgram strength is not appropriate in adults and children with severe asthma.
Danish: Seretide 50/100 mikrogram er uegnet til voksne og børn med alvorlig astma.
English: Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles).
Danish: Hjertearytmier, herunder atrieflimren, supraventrikulær takykardi og ekstrasystoli
English: Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients.
Danish: Fluticasonpropionat kan medføre hæshed og candidiasis (trøske) i mund og svælg hos nogle patienter.
English: If Seretide therapy has to be withdrawn due to overdose of the beta agonist component of the drug, provision of appropriate replacement steroid therapy should be considered.
Danish: Hvis Seretide skal seponeres på grund af overdosering af ß-agonist-delen, skal der tages højde for fortsat steroidbehandling.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Inhalation use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Læs indlægssedlen inden brug Til inhalation
English: The recommendation included in section 4.2 allows a short term trial of Seretide Diskus in adults and adolescents with moderate persistent asthma for whom rapid control of asthma is essential.
Danish: Den i afsnit 4.2 indføjede anbefaling giver mulighed for kortvarig forsøgsvis brug af Seretide Diskus hos voksne patienter med moderat persisterende astma og tvingende behov for hurtig astmakontrol.
English: The MAH's proposed therapeutic indication to include “patients with persistent asthma not adequately controlled on "as needed" inhaled shortacting beta-2-agonists alone who exhibit a combination of at least two of the following clinical features of asthma: airflow limitation, daily use of rescue medication, daily symptoms (day-time and/or night-time)” was not considered acceptable as it does not effectively identify a population in need of combination therapy.
Danish: Forslaget fra indehaverne af markedsføringstilladelserne om at lade den terapeutiske indikation omfatte “patienter med persisterende astma, som ikke kan kontrolleres tilstrækkeligt alene med de efter behov inhalerede korttidsvirkende beta-2-agonister og som frembyder mindst to af følgende kliniske tegn på astma: begrænset luftflow, daglig brug af livsvigtig medicin, daglige symptomer (om dagen og/eller om natten)" blev ikke fundet acceptabelt, da det ikke effektivt identificerer en patientgruppe med behov for kombinationsbehandling.
English: HOW TO STORE SERETIDE
Danish: HVORDAN DU OPBEVARER SERETIDE
English: Seretide Diskus and associated names (see Annex I of Opinion) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist (LABA) salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate (FP) indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate:patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and longacting beta-2-agonist.
Danish: Seretide Diskus og tilknyttede navne (se bilag I til udtalelsen) indeholder salmeterol og fluticasonpropionat, som er en fastdosiskombination af den langtidsvirkende beta-agonist salmeterol og det inhalerede corticosteroid fluticasonpropionat, der er indiceret til standardbehandling af astma, når det er hensigtsmæssigt at anvende et kombinationsprodukt (langtidsvirkende beta-2-agonist og inhaleret corticosteroid): - hos patienter, som ikke kan kontrolleres tilstrækkeligt med inhalerede corticosteroider og inhaleret korttidsvirkende beta-2-agonist givet efter behov, eller - hos patienter, der allerede kontrolleres tilstrækkeligt med både inhaleret corticosteroid og langtidsvirkende beta-2agonist.
English: - Hold your breath for about 10 seconds or for as long as is comfortable.
Danish: Hold vejret i 5-10 sekunder.
English: The main objection relating to the identification of the patient population especially those patients who would respond to inhaled corticosteroids alone had not been adequately identified.
Danish: Hovedindvendingen vedrørte identificeringen af patientgruppen, specielt savnedes tilstrækkelig afgrænsning af de patienter, som responderede på inhalerede corticosteroider alene.
English: This medicine if not recommended for use in children below 4 years of age.
Danish: En inhalation to gange daglig Dette lægemiddel anbefales ikke til børn under 4 år.
English: CLOSE: - To close the Diskus, slide the thumbgrip back towards you, as far as it will go.
Danish: SÅDAN LUKKES DISKUS: Skub fingergrebet tilbage mod dig selv, så langt som muligt - indtil det siger klik.
English: Your doctor will need to know if you have recently been treated with corticosteroids (orally or by injection).
Danish: Fortæl din læge, hvis du for nyligt har været behandlet med binyrebarkhormoner (tabletter eller indsprøjtninger).
English: Your doctor will check you regularly for any of these side effects and to make sure you are taking the lowest dose of Seretide to control your asthma.
Danish: Din læge skal undersøge dig regelmæssigt for disse bivirkninger og sørge for, at du får den laveste dosis Seretide, hvor din astma er under kontrol.
English: This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.
Danish: Det kræver ikke særlige forholdsregler, idet den normaliseres på nogle få døgn jf. plasmakoncentrationsmålinger.
English: Seretide contains lactose up to 12.5 milligram /dose.
Danish: Seretide indeholder op til 12,5 mg laktose pr. dosis.
English: A dose indicator on the Diskus indicates the number of doses left.
Danish: Diskus er forsynet med dosistæller, som viser det resterende antal doser.
English: Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as other inhaled steroids at approximately half the microgram daily dose.
Danish: Lægen skal være opmærksom på, at hos astmapatienter er fluticasonpropionat dobbelt så effektiv som andre steroider til inhalation.
English: A twelve month study (Gaining Optimal Asthma ControL, GOAL), in 3416 adult and adolescent patients with persistent asthma, compared the safety and efficacy of Seretide versus inhaled corticosteroid (Fluticasone Propionate) alone to determine whether the goals of asthma management were achievable.
Danish: I en klinisk afprøvning, (Gaining Optimal Asthma ControL, GOAL), som løb over et år med 3416 voksne og unge patienter med persisterende astma, blev sikkerhed og effekt sammenlignet ved Seretide og inhalationssteroid alene (fluticasonpropionat) for at finde ud af, om målene for astmabehandling er realistiske.
English: It is very important that you take your Seretide every day as directed, until you are advised to stop by your doctor.
Danish: Det er meget vigtigt, at du tager Seretide hver dag som ordineret, og at du ikke ophører med det uden at have aftalt det med din læge.
English: The MAHs have demonstrated in a series of substantial and well conducted clinical studies that in patients with moderate chronic persistent asthma poorly controlled on a short acting β-agonist alone the introduction of combination therapy with salmeterol and fluticasone is more effective in improving disease control than the introduction of salmeterol or fluticasone alone.
Danish: Indehaverne af markedsføringstilladelsen har gennem en række omfattende og veltilrettelagte kliniske undersøgelser påvist, at det hos patienter med moderat kronisk persisterende astma, som ikke kontrolleres tilstrækkeligt med en korttidsvirkende beta-agonist alene, med henblik på at opnå en bedre sygdomskontrol er mere effektivt at gennemføre en kombinationsbehandling med salmeterol og fluticason end med salmeterol eller fluticason alene.
English: Seretide is indicated for the symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Danish: Til symptomatisk behandling af svær KOL (FEV1 <50 % af forventet) og tilbagevendende forværringer, hvor fast behandling med bronkodilatator ikke er tilstrækkelig.
English: - Feeling anxious, disturbed sleep and behavioural changes, such as being unusually active and irritable (mainly in children).
Danish: - Uro, søvnforstyrrelse og ændret adfærd, herunder hyperaktivitet og irritabilitet (især hos børn).
English: Seretide Diskus should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Danish: I så fald skal Seretide straks seponeres, patienten undersøges, og om nødvendigt gives anden behandling.
English: The preferred antidotes are cardioselective beta-blocking agents, which should be used with caution in patients with a history of bronchospasm.
Danish: Antidot: En kardioselektiv ß-blokker, som skal gives med forsigtighed til patienter med tidligere bronkospasme.
English: The renal clearance of fluticasone propionate is negligible.
Danish: Udskillelsen af fluticasonpropionat gennem nyrerne er negligeabel.
English: In addition to the update in section 4.2 of the SPC, some factual data from the GOAL study in particular the timing of reaching more rapidly control with Seretide than with ICS alone have been included in section 5.1 “Pharmacodynamic properties” of the SPC.
Danish: Foruden ajourføringen af produktresuméets afsnit 4.2 er der i afsnit 5.1 "Farmakodynamiske egenskaber" indsat visse faktuelle oplysninger fra GOAL-undersøgelsen, navnlig vedrørende det tidsmæssige aspekt ved opnåelse af hurtigere kontrol med Seretide end med inhalerede corticosteroider alene.
English: In patients with asthma or COPD a lesser degree of systemic exposure to inhaled fluticasone propionate has been observed.
Danish: Astmapatienter og patienter med KOL er i mindre grad udsat for systemisk påvirkning efter inhalation af fluticasonpropionat.
English: The main part of the dose is excreted in faeces as metabolites and unchanged drug.
Danish: Hovedparten udskilles i fæces som metabolitter eller uomdannet.
English: Your doctor will supervise your treatment more closely if you have medical conditions such as heart disease including an irregular or fast heart beat, overactive thyroid gland, high blood pressure, diabetes mellitus (Seretide may increase your blood sugar), low potassium in your blood or if you are being, or have been treated for tuberculosis (TB).
Danish: Vær særlig forsigtig med at anvende Seretide - hvis du lider af hjertesygdomme, herunder uregelmæssig eller hurtig hjertebanken, eller forøget hormonproduktion fra skjoldbruskkirtlen, forhøjet blodtryk, sukkersyge (Seretide kan forhøje dit blodsukker), lavt indhold af kalium i blodet, eller hvis du er eller har været i behandling for tuberkulose (tb).
English: Nevertheless the CHMP acknowledged that current clinical guidelines (e.g. the Global Initiative for Asthma (GINA) guidelines) describe circumstances which could lead to the initiation of maintenance therapy with the combination.
Danish: Global Initiative for Asthma (GINA)) beskriver omstændigheder, der kan føre til, at vedligeholdelsesbehandling indledes med kombinationen.
English: No studies of the effect on the ability to drive and use machines have been performed.
Danish: Seretides effekt på evnen til at køre bil eller betjene maskiner er ikke undersøgt.
English: Seretide does not work in controlling sudden attacks of breathlessness and wheezing where you would need to use your fast acting ‘rescue' medication.
Danish: Seretide virker ikke på pludselige anfald af åndenød og hvæsende vejrtrækning, hvor du skal bruge den hurtigvirkende anfaldsmedicin, som du altid bør have på dig.
English: Salmeterol xinafoate and fluticasone propionate
Danish: Salmeterol som salmeterolxinafoat og fluticasonpropionat
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-induced abnormalities.
Danish: Efter samtidig indgift af begge stoffer er set øget frekvens af omlagt navlearterie og ufuldstændig forbening af nakkebenet hos rotter ved doser, der typisk sættes i forbindelse med glukokortikoid-inducerede abnormiteter.
English: The MAHs applied for a type II variation subject to MRP to extend the current approved indications to include initial maintenance therapy (IMT) with the fixed dose combination in patients with chronic persistent asthma.
Danish: Indehaverne af markedsføringstilladelsen ansøgte om en type II-ændring gennem proceduren for gensidig anerkendelse med henblik på at udvide de nu godkendte indikationer til også at omfatte initial vedligeholdelsesbehandling af patienter med kronisk persisterende astma med fastdosiskombinationen.
English: The issue to be considered by CHMP was whether it is appropriate to introduce initial maintenance therapy with the fixed dose combination of salmeterol and fluticasone propionate in all patients with chronic persistent asthma.
Danish: Det spørgsmål, som Udvalget for Humanmedicinske Lægemidler (CHMP) skulle overveje, var, hvorvidt det var hensigtsmæssigt at indføre initial vedligeholdelsesbehandling af alle patienter med kronisk persisterende astma med fastdosiskombinationen af salmeterol og fluticasonpropionat.
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Danish: ANVENDELSESMÅDE Læs indlægssedlen inden brug