FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 x 28 dose Diskus or 1 x 60 dose Diskus or 2 x 60 dose Diskus or 3 x 60 dose Diskus or 10 x 60 dose Diskus
Danish: Inhalationspulver, afdelt 28 afdelte doser 60 afdelte doser 2 x 60 afdelte doser 3 x 60 afdelte doser 10 x 60 afdelte doser
English: When salmeterol and fluticasone propionate were administered in combination by the inhaled route, the pharmacokinetics of each component were similar to those observed when the drugs were administered separately.
Danish: Ved inhalation af salmeterol og fluticasonpropionat i kombination var hvert stofs farmakokinetik som når de blev givet enkeltvis.
English: The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4.
Danish: Fluticasonpropionat fjernes hurtigt fra den systemiske cirkulation via nedbrydning til et inaktivt carboxylsyrederivat ved hjælp af cytochrom P450-enzymet CYP3A4.
English: GOAL showed more patients treated with Seretide achieved asthma control than patients treated with ICS alone and this control was attained at a lower corticosteroid dose.
Danish: GOAL viste, at der var flere patienter i behandling med Seretide, der opnåede astmakontrol, end i gruppen, der kun fik inhalationssteroid og med en mindre dosis inhalationssteroid.
English: There is a counter on top of the Diskus which tells you how many doses are left.
Danish: Der er en dosistæller, der viser, hvor mange doser, der er tilbage.
English: Nervous System Disorders
Danish: Lidelser i det centrale og perifere nervesystem
English: The results of this study suggest that Seretide 50/100mcg bd 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: Undersøgelsesresultaterne antyder, at Seretide 50/100 mikrogram 2 gange daglig kan overvejes som første vedligeholdelsesbehandling hos patienter med moderat astma, hvor der er behov for hurtig astmakontrol (se pkt.
English: Seretide contains salmeterol and fluticasone propionate which have differing modes of action.
Danish: Seretide indeholder både salmeterol og fluticasonpropionat, der virker forskelligt, og beskrives herunder:
English: These effects include stomach pain, tiredness, loss of appetite, sickness, diarrhoea, weight loss, headache or drowsiness, low levels of potassium in your blood, low blood pressure and seizures.
Danish: Dette kan medføre mavesmerter, træthed, appetitløshed, kvalme, diarré, vægttab, hovedpine eller døsighed, lavt indhold af kalium i blodet, lavt blodtryk og krampeanfald.
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 en lille undersøgelse med raske personer og den lidt mindre potente CYP3A-hæmmer, ketoconazol, sås øget plasmakoncentration af fluticasonpropionat på 150 % efter en enkelt inhalation, og i forhold til fluticasonpropionat givet alene sås lavere plasmakortisolspejl.
English: • the CHMP considered that an initial maintenance therapy indication with the fixed dose combination of salmeterol and fluticasone propionate in patients with moderate persistent asthma in section 4.1 of the SPC is not acceptable as it could result in overtreatment particularly in patients who would have responded to inhaled corticosteroids alone.
Danish: • CHMP fandt det ikke acceptabelt, at produktresuméets afsnit 4.1 skal indeholde en generel anbefaling af initial vedligeholdelsesbehandling med fastdosiskombinationen af salmeterol og fluticasonpropionat hos patienter med moderat persisterende astma, da dette kan tænkes at føre til overbehandling af især patienter, som ville have responderet på inhalerede corticosteroider alene.
English: Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects.
Danish: Derfor skal samtidig brug undgås, med mindre fordelen for patienten opvejer risikoen for systemiske bivirkninger forårsaget af glukokortikoider.
English: - Rinse your mouth with water and spit it out as this may help prevent the occurrence of thrush and hoarseness.
Danish: Skyl munden med vand og spyt ud - eller børst tænder - for at modvirke svamp og hæshed.
English: PHARMACEUTICAL FORM Inhalation powder, pre-dispensed.
Danish: Inhalationspulver, afdelt.
English: In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly day-time symptoms the dose should be given in the morning.
Danish: I så fald anbefales det, at patienter med natlige symptomer tager Seretide om aftenen, og patienter med symptomer om dagen tager Seretide om morgenen.
English: These effects usually wear off with continued treatment, however, if you have used larger doses for a long period of time, you should contact your doctor or pharmacist for advice.
Danish: Hvis du har taget for høj dosis over en lang periode, skal du dog kontakte din læge eller apotek for rådgivning.
English: Animal studies with salmeterol xinafoate have shown embryofoetal toxicity only at high exposure levels.
Danish: Dyreundersøgelser med salmeterolxinafoat har vist fosterskader - dog kun ved meget høje doser.
English: The management of asthma should normally follow a stepwise programme and patient response should be monitored clinically and by lung function tests.
Danish: Behandling af astma bør følge et trinvist skema og patienterne bør kontrolleres både klinisk og med lungefunktionsundersøgelse med henblik på dosistitrering.
English: There is also an increased risk of systemic side effects when combining fluticasone propionate with other potent CYP3A inhibitors (see 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction).
Danish: Der er også øget risiko for systemiske bivirkninger ved samtidig brug af fluticasonpropionat og andre potente CYP3A-hæmmere (se pkt.
English: Salmeterol produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting beta-2-agonists.
Danish: Salmeterol giver en længerevarende bronkodilatation end konventionelle korttidsvirkende ß2agonister, idet bronkodilatationen varer i mindst 12 timer.
English: You should ask your doctor for advice before taking Seretide whilst you are pregnant or breastfeeding.
Danish: Lægen vil vurdere, om du skal tage Seretide, hvis du er gravid eller ammer.
English: In animal studies foetal abnormalities occur after administration of beta-2-adrenoreceptor agonists and glucocorticosteroids (see 5.3 Preclinical Safety Data).
Danish: Hos dyr sker der fosterpåvirkning efter indgift af ß2-agonister og glukokortikosteroider (se pkt.
English: This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered.
Danish: Denne risiko bør altid tages i betragtning i stresssituationer, herunder kirurgiske indgreb, og relevant steroiddosis vurderes, eventuelt med bistand fra specialist.
English: The doctor will prescribe the lowest strength of Seretide Diskus that will best control your symptoms.
Danish: Din læge vil bestræbe sig på at ordinere den laveste dosis Seretide, som kan holde dine symptomer under kontrol.
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.
Danish: Derfor bør kombinationen af de to stoffer undgås, med mindre fordelen for patienten opvejer den øgede risiko for systemiske bivirkninger forårsaget af glukokortikoider.
English: The only safety concerns for human use derived from animal studies of salmeterol xinafoate and fluticasone propionate given separately were effects associated with exaggerated pharmacological actions.
Danish: De eneste sikkerhedsmæssige overvejelser, som dyreundersøgelser giver anledning til, er en forøget farmakologisk virkning af salmeterol og fluticasonpropionat.
English: Via A. Fleming, 2 37135 Verona Italy
Danish: 37135 Verona - Italien
English: Please tell your doctor if you are taking or have recently taken any other medicines, including those for asthma or any medicines obtained without a prescription.
Danish: Hvis du tager eller for nylig har taget andre lægemidler, bør du oplyse din læge eller apotek herom, også hvis der er tale om anden astmamedicin eller medicin i håndkøb.
English: Percentage of Patients Attaining *Well Controlled (WC) and **Totally Controlled (TC) Asthma over 12 months Salmeterol/FP
Danish: Patienter med astma, som i løbet af et år blev velkontrolleret*) eller hvor Total Kontrol**) blev opnået Salmeterol/fluticasonpropionat
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN Udfyldes nationalt
English: Patients should be given the strength of Seretide containing the appropriate fluticasone propionate dosage for the severity of their disease.
Danish: Patienterne skal have Seretide i den styrke fluticasonpropionat, der passer til sværhedsgraden af deres astma.
English: • the CHMP agreed that factual data from the GOAL study in particular the timing of reaching more rapidly control with Seretide than with ICS alone should be included in section 5.1 of the SPC and that some amendments in this section were necessary in line with the agreed recommendation in section 4.2.
Danish: • CHMP fandt, er der i produktresuméets afsnit 5.1 bør indsættes visse faktuelle oplysninger fra GOAL-undersøgelsen, navnlig vedrørende det tidsmæssige aspekt ved opnåelse af hurtigere kontrol ved hjælp af Seretide end med inhalerede corticosteroider alene, og at det er nødvendigt med visse ændringer i dette afsnit i henhold til den vedtagne anbefaling i afsnit anbefaler CHMP godkendelse af ansøgningen om ændring af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III.
English: Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis.
Danish: Langtidsbehandling med høje doser inhaleret kortikosteroid kan resultere i nedsat binyrebarkfunktion og akut binyrebarkinsufficiens.
English: The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.
Danish: Hos gravide bør gives den laveste effektive dosis af fluticasonpropionat til kontrol af astmaen.
English: If you accidentally take a larger dose, you may develop side effects such as your heart beating faster than usual, feeling shaky, headache, muscle weakness, aching joints and also a reduction of steroid hormones produced by the adrenal gland.
Danish: Hvis du ved en fejltagelse kommer til at tage en for stor dosis, kan du få bivirkninger som hurtigere hjertebanken end sædvanligt, rysten, hovedpine, muskeltræthed, ømme led og nedsat produktion af binyrebarkhormoner.
English: There is no need to adjust the dose in elderly patients or in those with renal impairment.
Danish: Specielle patientgrupper: Dosisjustering er ikke nødvendig hos ældre eller hos patienter med nedsat nyrefunktion.
English: Germany atmadisc Diskus
Danish: Atmadisc Diskus
English: The effects are slowing of growth in children and adolescents, thinning of the bones, cataract, glaucoma, weight gain, high blood pressure and rounded (moon shaped) face (Cushing's Syndrome).
Danish: Virkningerne hos børn og unge er nedsat vækst, fald i knogletæthed, sløret syn, øget tryk i øjet, vægtforøgelse, højt blodtryk, rundt ansigt (”måneansigt”) (Cushing's Syndrom).
English: Each dose contains 50 micrograms of salmeterol (as xinafoate) together with either 100, 250 or 500 micrograms of fluticasone propionate.
Danish: Hver blister indeholder 50 mikrogram salmeterol (som salmeterolxinafoat) sammen med 100, 250 eller 500 mikrogram fluticasonpropionat.
English: D-40789 Monheim Germany atmadisc 50µg/250µg Diskus 50/250
Danish: Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc 50µg/250µg Diskus 50/250
English: Product Name
Danish: Særnavn Navn
English: This may cause thinning of the bones, cataract, glaucoma, weight gain, rounded (moon shaped) face, high blood pressure and slowing of growth in children and adolescents.
Danish: Dette kan medføre fald i knogletæthed, sløret syn, øget tryk i øjet, vægtforøgelse, rundt ansigt (”måneansigt”), højt blodtryk og nedsat vækst hos børn og unge.
English: - The active substance(s) are 50 micrograms salmeterol (as xinafoate) and 100, 250 or 500
Danish: Seretide indeholder - De aktive stoffer er 50 mikrogram salmeterol som salmeterolxinafoat og 100, 250 eller 500
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Kontakt din læge eller apotek, hvis du har yderligere spørgsmål.
English: EFFICACY
Danish: VIRKNING
English: Uncommon effects: means that between 1 in 100 and 1 in 1000 people taking the medicine are affected.
Danish: Ikke almindelig bivirkning (det sker hos mellem 1 og 10 ud af 1.000 patienter): - Hududslæt.
English: The devices are packed in cartons which hold:
Danish: Medicinen leveres i æsker med:
English: The initial starting dose is 1 inhalation of 50 mcg salmeterol/100 mcg FP twice daily.
Danish: Startdosis er 1 inhalation af 50 mcg salmeterol/100 mcg fluticasonpropionat to gange dagligt.
English: There have been very rare reports of hyperglycaemia (see 4.4 Special Warnings and Precautions for Use).
Danish: I meget sjældne tilfælde er der set hyperglykæmi (se pkt.
English: Lactose monohydrate (which contains milk proteins).
Danish: Lactosemonohydrat (indeholder mælkeproteiner) 6.2 Uforligeligheder
English: For example, 100mcg of fluticasone propionate is approximately equivalent to 200mcg of beclomethasone dipropionate (CFC containing) or budesonide.
Danish: Fx svarer 100 mikg fluticasonpropionat til ca. 200 mikg beclometasondipropionat eller budesonid.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES <PÅ DEN YDRE EMBALLAGE> <OG> <PÅ DEN INDRE EMBALLAGE>
English: - Aching, swollen joints and muscle pain.
Danish: - Led- og muskelsmerter.
English: In cases of fluticasone propionate overdose Seretide therapy may still be continued at a suitable dosage for symptom control.
Danish: Ved overdosering af fluticasonpropionat kan behandling med Seretide fortsættes i laveste effektive dosis.
English: The signs and symptoms of salmeterol overdose are tremor, headache and tachycardia.
Danish: Salmeterol: Tremor, hovedpine og takykardi.
English: Rinsing the mouth out with water and spitting it out immediately after taking each puff may help.
Danish: Dette kan afhjælpes ved at skylle munden og spytte ud lige efter hver inhalation.
English: Push your thumb away from you as far as it will go and you hear a click.
Danish: Skub med tommelfingeren fingergrebet helt i bund - til det siger klik.
English: The dose can then be inhaled and the device closed.
Danish: Dosis kan nu inhaleres.
English: The time on treatment for 50% of subjects to achieve a first individual Well Controlled week was 16 days for Seretide compared to 37 days for the ICS group.
Danish: Der gik 16 dage med behandling med Seretide, før 50% af patienterne opnåede velkontrolleret astma i sammenligning med 37 dage for den gruppe, der fik inhalationssteroid alene.
English: Only take these medicines whilst on Seretide, if told to do so by your doctor.
Danish: Når du tager Seretide, må du kun tage disse lægemidler efter lægens anvisning.
English: SE-169 29 Solna Sweden
Danish: GlaxoSmithKline AB Box 516, SE-169 29 Solna Sverige
English: D-40789 Monheim Germany atmadisc mite 50µg/100µg Diskus
Danish: Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc mite 50µg/100µg Diskus
English: Belgium GlaxoSmithKline s.a./n.v., Rue du Tilleul 13,
Danish: Luxembourg GlaxoSmithKline s.a./n.v., Rue du Tilleul 13,
English: 1 x Diskus 28 inhalations or 1, 2, 3 or 10 x Diskus each containing 60 inhalations Not all pack sizes may be marketed.
Danish: 1, 2, 3 eller 10 Diskus med 60 doser.
English: Musculoskeletal & Connective Tissue Disorders
Danish: Muskuloskeletale-, bindevævs-og knoglelidelser
English: The Netherlands GlaxoSmithKline B.V. Huis ter Heideweg 62, 3705 LZ Zeist
Danish: Huis ter Heideweg 62, 3705 LZ Zeist, Nederlandene
English: Wipe the mouthpiece of the Diskus with a dry tissue to clean it.
Danish: Rengøring af Diskos Tør mundstykket af med en tør klud.
English: • the CHMP agreed, however, that a recommendation for a short term trial with the fixed dose combination of salmeterol and fluticasone propionate as initial maintenance therapy in adults and adolescents with moderate persistent asthma for whom rapid control of asthma is essential, in section 4.2 of the SPC is acceptable.
Danish: • CHMP fandt det dog acceptabelt, at produktresuméets afsnit 4.2 indeholder en anbefaling om kortvarig forsøgsvis brug af fastdosiskombinationen af salmeterol og fluticason som initial vedligeholdelsesbehandling af voksne og unge patienter med moderat persisterende astma og tvingende behov for hurtig astmakontrol,
English: Metabolism & Nutrition Disorders
Danish: Metaboliske og ernæringsmæssige lidelser Hyperglykæmi
English: Some types of antiviral and antifungal medication (such as ritonavir, ketoconazole and itraconazole) may increase the amount of fluticasone propionate in your body and therefore increase your risk of having side effects.
Danish: Seretide bør ikke tages sammen med beta-blokkere (fx atenolol, propranolol, sotalol), med mindre din læge har ordineret det. Nogle typer medicin mod virus og svamp (fx ritonavir, ketoconazol og itraconazol) kan øge mængden af fluticasonpropionat i kroppen og derved øge risikoen for bivirkninger.
English: D-40789 Monheim Germany atmadisc forte 50µg/500µg Diskus
Danish: Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc forte 50µg/500µg Diskus
English: Very Common effects: this means that more than 1 in 10 people taking the medicine are affected.
Danish: Meget almindelig bivirkning (det sker hos flere end 1 ud af 10 patienter): - Hovedpine, aftager som regel ved fortsat behandling.
English: In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations).
Danish: I dyrereproduktionsundersøgelser er der set misdannelser (hareskår, knogledeformiteter) efter administration af glukokortikoider.
English: The Diskus device holds blisters containing Seretide in powder form.
Danish: Diskus indeholder folieblisterbånd med Seretide inhalationspulver.
English: If you are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate or to the other ingredient lactose monohydrate.
Danish: Du bør ikke anvende Seretide - hvis du er overfølsom over for salmeterol, fluticasonpropionat eller lactose.
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Danish: Dosis skal titreres til laveste effektive dosis.
English: Muscle cramps Arthralgia Myalgia
Danish: Muskelkramper Artralgi.
English: Do not use Seretide to treat a sudden attack of breathlessness or wheezing as it will not help you immediately.
Danish: Seretide virker ikke på pludselige anfald af åndenød og hvæsende vejrtrækning, den har ikke en øjeblikkelig virkning.
English: In the subset of steroid naive asthmatics the time to an individual Well Controlled week was 16 days in the Seretide treatment compared to 23 days following treatment with ICS.
Danish: I en undergruppe bestående af patienter, der ikke før havde fået steroider, gik der 16 dage, før patienterne var velkontrollerede, hvorimod der gik 23 dage med inhalationssteroid alene.
English: Seretide COPD clinical trials
Danish: Kliniske afprøvninger med Seretide til KOL
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom.
Danish: Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom.
English: The possible side effects associated with Seretide are unlikely to affect your ability to drive or use machines.
Danish: Bilkørsel og betjening af maskiner Seretide påvirker ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
English: Respiratory, Thoracic & Mediastinal Disorders
Danish: Lidelser i luftveje, thorax og mediastinum Svælgirritation.
English: For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician.
Danish: Seponering hos patienter med KOL kan føre til symptomer og bør kun ske i samråd med lægen.
English: The lever will return to its original position and is reset.
Danish: Dosisknappen går automatisk tilbage til startposition.
English: Headache Tremor
Danish: Hovedpine
English: There is no incidence of additional adverse events following concurrent administration of the two compounds.
Danish: Der er ikke set yderligere bivirkninger ved samtidig brug af de to stoffer.
English: - Muscle cramps.
Danish: - Muskelkramper.
English: There is a linear increase in systemic exposure with increasing inhaled dose.
Danish: Forøgelsen af den systemiske påvirkning er ligefrem proportional med størrelsen af dosis.
English: EXPIRY DATE
Danish: UDLØBSDATO Anvendes senest
English: - Headache, although this side effect usually lessens as treatment continues.
Danish: Disse virkninger forsvinder som regel ved fortsat behandling.
English: please tell your doctor or pharmacist.
Danish: Tal med din læge om dette.
English: Adverse events which have been associated with salmeterol fluticasone propionate are given below, listed by system organ class and frequency.
Danish: Bivirkningerne er inddelt i henhold til organklasser og efter hyppighed.
English: Seretide is indicated in the regular treatment of asthma where use of a combination product (longacting 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 long-acting beta-2
Danish: Til behandling af astma, hvor behandling med en kombinationsprodukt (langtidsvirkende ß2-agonist og inhalationssteroid) er hensigtsmæssig: - hos patienter, der ikke er velkontrollerede på inhalationssteroid og korttidsvirkende ß2-agonist ved behov,
English: Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk.
Danish: Patienter, der har været i behandling med høje doser steroider, er i risiko for nedsat binyrebarkfunktion i længere tid.
English: Endocrine Disorders Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density, Cataract, Glaucoma
Danish: Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, nedsat knogletæthed, katarakt, glaukom
English: Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Danish: Eventuel systemisk påvirkning kan omfatte Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, fald i knogletæthed, katarakt og glaukom.
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: Akut binyrebarkinsufficiens kan opstå på grund af traume, operation, infektion eller for hurtig nedsættelse af dosis og kan føre til spisevægring, mavesmerter, vægttab, træthed, hovedpine, kvalme, opkastning, hypotension, opmærksomhedstab, hypoglykæmi og kramper.
English: Box 24 FIN-02231 Espoo Finland
Danish: GlaxoSmithKline Oy, Piispansilta 9A, P.O. Box 24, FIN-02231 Espoo, Finland
English: There have been very rare reports of increases in blood glucose levels (see 4.8 Undesirable Effects) and this should be considered when prescribing to patients with a history of diabetes mellitus.
Danish: 4.8 ”Bivirkninger”), som skal tages med i overvejelserne, når medicinen udskrives til diabetes-patienter.