FrancophonIA/ELRC3.0 huggingface dataset:
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 puffs 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: Seretide Evohaler is for inhalation use only.
Danish: Seretide Evohaler må kun anvendes til inhalation.
English: BATCH NUMBER
Danish: BATCHNUMMER Batch no
English: Children 4 to 12 years of age Seretide 25/50 Evohaler
Danish: Børn fra 4 til 12 år Seretide 25/50 Evohaler
English: Do not stop taking Seretide suddenly as this could make your asthma worse and could cause problems with the body's hormones.
Danish: Du må ikke stoppe behandlingen med Seretide pludseligt, da dette kan forværre dine symptomer og give problemer med kroppens hormoner.
English: There are no data available for use of Seretide inhaler in children aged under 4 years.
Danish: Der er ikke lavet undersøgelser med Seretide inhalationsspray til børn under 4 år.
English: GlaxoSmithKline ehf Thverholt 14, 105 Reykjavik Iceland
Danish: GlaxoSmithKline ehf Thverholt 14, 105 Reykjavik, Island
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: 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: Note: Seretide 25/50 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: A spacer device may be used to improve treatment with Seretide particularly with young children, if you or your child has difficultly co-ordinating breathing in through your mouth and pressing the can to release a puff at the same time.
Danish: Til små børn kan Seretide inhalationsspray bruges i en såkaldt spacer, det kan især være gavnligt, hvis du eller dit barn har svært ved at koordinere inhalationen med samtidig at skulle afgive et pust fra sprayen.
English: Symptomatic candidiasis can be treated with topical antifungal therapy whilst still continuing with the Seretide Evohaler.
Danish: Symptomatisk candidiasis kan behandles med topikale midler mod svamp samtidig med anvendelse af Seretide.
English: The maximum licensed dose of fluticasone propionate delivered by Seretide inhaler in children is 100mcg twice daily.
Danish: Den maksimale godkendte dosis fluticasonpropionat i Seretide spray til børn er 100 mikrogram to gange dagligt.
English: Pressurised container.
Danish: Trykbeholder.
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 4.2,
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 bruger Seretide hver dag som anvist, indtil din læge fortæller dig andet.
English: Seretide Evohaler 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 Evohaler 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: The recommendation included in section 4.2 allows a short term trial of Seretide Evohaler 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 Evohaler hos voksne patienter med moderat persisterende astma og tvingende behov for hurtig astmakontrol.
English: Seretide Evohaler 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: 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 betaagonistrelaterede bivirkninger,
English: Glaxo SmithKline Pharma GmbH Albert Schweitzer Gasse 6 1140 Wien
Danish: Glaxo SmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Østrig
English: The doctor will prescribe the lowest strength of Seretide Evohaler that will best control your symptoms.
Danish: Din læge vil bestræbe sig på at ordinere den laveste dosis Seretide Evohaler, som kan holde dine symptomer under kontrol.
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 have tuberculosis (TB).
Danish: Du bør ikke 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: What Seretide contains - The active substance(s) are 25 micrograms salmeterol (as xinafoate) and 50, 125 or 250
Danish: Seretide indeholder - De aktive stoffer er 25 mikrogram salmeterol som salmeterolxinafoat og 50, 125 eller 250
English: GlaxoSmithKline (Ireland) Limited Stonemasons Way Rathfarnham, Dublin 16
Danish: GlaxoSmithKline (Ireland) Limited (trading as: Allen & Hanbury) Stonemasons Way Rathfarnham
English: Do not store Seretide Evohaler in a cold place, as your medicine may not work as well.
Danish: Seretide må ikke opbevares koldt, da det kan forringe virkningen af medicinen.
English: Germany atmadisc
Danish: Atmadisc
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: 3705 LZ Zeist
Danish: Huis ter Heideweg 62, 3705 LZ Zeist, Nederlandene
English: Belgium GlaxoSmithKline s.a./n.v., Rue du Tilleul 13
Danish: Luxembourg GlaxoSmithKline s.a./n.v., Rue du Tilleul 13, B-1332 Genval, Belgien
English: D-40789 Monheim Germany atmadisc mite DosierAerosol FCKW-frei 25 µg/50 µg Druckgasinhalation, Suspension
Danish: Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc mite DosierAerosol FCKW-frei 25 µg/50 µg Druckgasinhalation, Suspension
English: - The other ingredient is Norflurane (HFA 134a).
Danish: - Det øvrige indholdsstof er norfluran.
English: D-40789 Monheim Germany atmadisc Dosier-Aerosol FCKW-frei 25 µg/125 µg Druckgasinhalation, Suspension
Danish: Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc Dosier-Aerosol FCKW-frei 25 µg/125 µg Druckgasinhalation, Suspension
English: METHOD AND ROUTE(S) OF ADMINISTRATION Shake well before use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Læs indlægssedlen inden brug.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications 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-agonist.
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer Astma Til behandling af astma, hvor behandling med et kombinationsprodukt (langtidsvirkende ß2-agonist og inhalationssteroid) er hensigtsmæssig: - hos patienter, der ikke er velkontrollerede på inhalationssteroid og korttidsvirkende ß2-agonist ved behov,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single actuation of Seretide provides:
Danish: Hver dosis Seretide indeholder:
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: [See Annex I - To be completed nationally]
Danish: Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelse <[Se bilag I - Udfyldes nationalt]>
English: Belgium GlaxoSmithKline s.a./n.v.
Danish: Nederlandene GlaxoSmithKline B.V.
English: Box 24 FIN-02231, Espoo Finland
Danish: GlaxoSmithKline Oy, Piispansilta 9A, P.O. Box 24, FIN-02231 Espoo, Finland
English: Just after starting to breathe in through their mouth, patients should press down on the top of the inhaler to release Seretide, while still breathing in steadily and deeply.
Danish: Beholderen skal trykkes ned i starten af en indånding gennem munden, og dosis inhaleres roligt og dybt.
English: No ICS (SABA alone) Low dose ICS ( ≤500mcg BDP or equivalent/day) Medium dose ICS (>500-1000mcg BDP or equivalent/day) Pooled results across the 3 treatment levels *Well controlled asthma; occasional symptoms or SABA use or less than 80% predicted lung function plus no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy **Total control of asthma; no symptoms, no SABA use, greater than or equal to 80% predicted lung function, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy.
Danish: **) Total kontrol blev defineret som: ingen symptomer, ingen brug af korttidsvirkende ß2-agonister (behovsmedicin), ≥ 80 % af forventet lungefunktion, ingen natlig opvågnen, ingen eksacerbationer og ingen bivirkninger, der førte til ændring i behandlingen.
English: D-40789 Monheim Germany atmadisc forte DosierAerosol FCKW-frei 25 µg/250 µg Druckgasinhalation, Suspension
Danish: Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc forte DosierAerosol FCKW-frei 25 µg/250 µg
English: Seretide 25/50 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma.
Danish: Det anbefales at finde den mest hensigtsmæssige dosis inhalationssteroid, før der anvendes en fast kombination hos patienter med svær astma.
English: Therefore, it must be taken every day as directed by your doctor.
Danish: For at få kontrol over din astma skal du tage Seretide hver dag som anvist af din læge.
English: Seretide Evohaler and associated names (see Annex I) 25/125 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Danish: Seretide Evohaler og andre navne (se bilag I) 25/125 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
English: Seretide Evohaler and associated names (see Annex I) 25/50 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Danish: Seretide Evohaler og andre navne (se bilag I) 25/50 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Seretide Evohaler and associated names (see Annex I) 25/125 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) Seretide Evohaler og andre navne (se bilag I) 25/125 mikrogram/dosis inhalationsspray {(sær)navn og tilhørende navne (Se bilag I) styrke lægemiddelform} [Se bilag I - Udfyldes nationalt]
English: Seretide Evohaler and associated names (see Annex I) 25/250 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Danish: Seretide Evohaler og andre navne (se bilag I) 25/250 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
English: Patients should be made aware that Seretide Evohaler must be used daily for optimum benefit, even when asymptomatic.
Danish: For at opnå fuld effekt skal Seretide tages hver dag - også i perioder uden symptomer.
English: INSTRUCTIONS ON USE
Danish: ANVENDELSESMÅDE Omrystes.
English: Seretide is supplied to you in a metered dose inhaler which delivers your medicine in a pressurised suspension for you to inhale.
Danish: Seretide inhalationsspray er en suspension, som skal omrystes før brug.
English: Patients should be instructed in the proper use of their inhaler (see patient information leaflet) During inhalation, the patient should preferably sit or stand.
Danish: Patienten skal instrueres godt i, hvordan sprayen skal bruges, som beskrevet i indlægssedlen i pakningen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xiapex on 28 February 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xiapex den 28. februar 2011.
English: This weakens and disrupts the cord or plaque.
Danish: Dette svækker og nedbryder strengen eller plakken.
English: This is a summary of the European public assessment report (EPAR) for Xiapex.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xiapex.
English: The full EPAR for Xiapex can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Xiapex findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Xiapex
Danish: Andre oplysninger om Xiapex
English: A risk management plan has been developed to ensure that Xiapex is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Xiapex anvendes så sikkert som muligt.
English: Injection site reactions were very common, occurring in the vast majority of patients.
Danish: Reaktioner på injektionsstedet var meget almindelige og forekom hos langt størstedelen af patienterne.
English: The patients were treated with three injections and their hands were examined three months after the last injection to see how much the finger joints could be straightened out.
Danish: Patienterne blev behandlet med tre injektioner, og deres hænder blev undersøgt tre måneder efter den sidste injektion for at se, hvor meget deres fingerled kunne rettes ud.
English: Up to 2 cords or 2 affected joints in the same hand can be treated at a time.
Danish: Optil to strenge eller to berørte led i samme hånd kan behandles samtidig.
English: If injection and finger extension have not brought about a satisfactory response, the procedure may be repeated at monthly intervals up to a maximum of 3 injections per cord.
Danish: Hvis injektion og fingerudstrækning ikke giver et tilfredsstillende resultat, kan proceduren gentages med en måneds mellemrum og med maksimalt tre injektioner pr. streng.
English: In the second study the figures were 44% (20 out of 45) for the Xiapex group and 5% (1 out of 21) for the placebo group.
Danish: I den anden undersøgelse var tallene 44 % (20 ud af 45) for Xiapexgruppen og 5 % (1 ud af 21) for placebogruppen.
English: Dupuytren's contracture is a condition where one or more fingers are bent forwards toward the palm and cannot be fully straightened.
Danish: Dupuytrens kontraktur er en tilstand, hvor en eller flere fingre krummer indad mod håndfladen og ikke kan strækkes fuldstændigt ud.
English: The most common side effects seen with Xiapex were local injection site reactions such as swelling, bruising, bleeding and pain.
Danish: De hyppigste bivirkninger ved Xiapex var lokale reaktioner på injektionsstedet, såsom hævelse, blå mærker, blødning og smerter.
English: Xiapex collagenase clostridium histolyticum
Danish: Xiapex kollagenase clostridium histolyticum
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xiapex.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Xiapex skal anvendes.
English: The company must carry out an educational programme for doctors on the correct use and the potential side effects associated with the medicine.
Danish: Virksomheden skal gennemføre uddannelsesprogrammer for læger i lægemidlets korrekte brug og de potentielle bivirkninger.
English: Around 24 hours after the injection, the finger can then be straightened by the doctor, by performing a ‘finger extension procedure' whereby it is stretched out for around 10 to 20 seconds to help disrupt the cord.
Danish: Ca. 24 timer efter injektionen kan lægen rette fingeren ud ved at udføre en "fingerudstrækningsprocedure", hvor fingeren strækkes ud i ca. 10-20 sekunder, hvilket er med til at nedbryde strengen.
English: Xiapex contains a mixture of two ‘collagenases', enzymes that break up collagen.
Danish: Xiapex indeholder en blanding af to "kollagenaser", som er enzymer, der nedbryder kollagen.
English: For patients with Peyronie's disease, Xiapex is given for up to 4 treatment cycles each lasting about 6 weeks.
Danish: Til patienter med Peyronies sygdom gives Xiapex i op til 4 behandlingsserier, der hver er af ca. 6 ugers varighed.
English: When injected into a cord or a plaque, the collagenases break up the collagen fibres.
Danish: Når det injiceres i en streng eller en plak, nedbryder kollagenaserne kollagenfibrene.
English: Among patients who completed the first study, 64% (130 out of 203) of those receiving Xiapex could straighten their fingers to an angle of 5 degrees or less compared with 7% (7 out of 103) of patients receiving placebo.
Danish: Blandt de patienter, som afsluttede den første undersøgelse, kunne 64 % (130 ud af 203) af dem, der fik Xiapex, rette deres fingre ud med en vinkel på højst 5 grader, sammenlignet med 7 % (7 ud af 103) af de patienter, der fik placebo.
English: These reactions were mostly mild to moderate in severity and generally subsided within one to two weeks.
Danish: Disse reaktioner var for det meste af let til moderat sværhedsgrad og forsvandt som regel efter 1-2 uger.
English: Patients received up to 4 treatment cycles, each involving two injections and subsequent modeling procedures, and the effects were measured on follow-up after 1 year.
Danish: Patienterne fik op til 4 behandlingsserier, hver bestående af to indsprøjtninger og efterfølgende modellering, og virkningerne blev målt ved opfølgning efter et år.
English: Xiapex was shown to be more effective at treating Dupuytren's contracture than placebo.
Danish: Xiapex viste sig at være mere effektivt til behandling af Dupuytrens kontraktur end placebo.
English: The cords in the palm of patients with Dupuytren's contracture and the plaques in Peyronie's disease are made of fibres of a protein called collagen.
Danish: Strengene i håndfladen hos patienter med Dupuytrens kontraktur og plakkene ved Peyronies sygdom består af fibre af et protein, der kaldes kollagen.
English: Xiapex was also more effective than placebo in treating Peyronie's disease, producing a 38% and 31% improvement in abnormal curvature in the two studies, compared with 21% and 15% respectively for placebo.
Danish: Xiapex var også mere effektivt end placebo til behandling af Peyronies sygdom og medførte en forbedring på 38 % og 31 % i den abnorme krumning i de to undersøgelser, sammenholdt med hhv. 21 % og 15 % med placebo.
English: The CHMP decided that Xiapex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Xiapex opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Xiapex.
English: Xiapex must not be used to treat Peyronie's disease if the plaque affects the urethra (the tube that carries urine and semen to the outside).
Danish: Xiapex må ikke anvendes til behandling af Peyronies sygdom, hvis plakken inddrager urinrøret (det rør, der fører urin og sæd ud af kroppen).
English: For more information about treatment with Xiapex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xiapex, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xiapex, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Xiapex, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: For Peyronie's disease, Xiapex was compared with placebo in two further studies involving 832 men.
Danish: Ved Peyronies sygdom blev Xiapex sammenlignet med placebo i yderligere to undersøgelser med deltagelse af 832 mænd.
English: In each cycle, the dose of Xiapex is injected into the plaque causing the deformity followed by a second injection given 1 to 3 days after the first.
Danish: I hver behandlingsserie injiceres Xiapex i plakken, der er årsag til deformiteten, hvorefter der gives endnu en injektion 1-3 dage efter den første.
English: Patients should subsequently continue modeling procedures daily at home as instructed for the rest of the cycle.
Danish: Patienten skal derefter hver dag hjemme selv fortsætte med modelleringen, idet han følger anvisningerne i resten af behandlingsserien.
English: It is caused by a thickening of the tissues under the skin of the palm that form ‘cords' pulling down on the fingers.
Danish: Det skyldes en fortykkelse i vævet under håndfladens hud, som danner "strenge", der trækker fingrene indad.
English: For more information on the use of Xiapex, including instructions on finger extension and penile modeling procedures, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Xiapex, herunder instruktioner om fremgangsmåden ved fingerudstrækning og ved modellering af penis, fremgår af produktresuméet (også en del af EPAR).