FrancophonIA/ELRC3.0 huggingface dataset:
English: Viani Diskus and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for 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 long-acting beta-2-agonist.
Danish: Viani Diskus og tilknyttede navne (se bilag I) indeholder salmeterol og fluticasonpropionat, som er en fastdosiskombination af den langtidsvirkende beta-agonist salmeterol og det inhalerede corticosteroid fluticasonpropionat, og 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-2-agonist.
English: In several EU Member States Viani Diskus and associated names are approved through the Mutual Recognition Procedure (MRP).
Danish: Viani Diskus og tilknyttede navne er godkendt i en række EU-medlemsstater gennem proceduren for gensidig anerkendelse.
English: 4 July 2006 EMEA/306421/2006
Danish: 4. juli 2006 EMEA/306421/2006
English: Based on evaluation of the available data and the Rapporteur's assessment reports, the CHMP adopted an opinion on 27 April 2006 recommending the variation to the terms of the Marketing Authorisations with amendments to the Summary of Product Characteristics, Labelling and Package leaflet .
Danish: På grundlag af vurderingen af de foreliggende oplysninger og vurderingsrapporterne fra rapportøren vedtog CHMP den 27. april 2006 en udtalelse, hvori det anbefalede godkendelse af ændringen af markedsføringstilladelserne med ændringer i produktresumé, etikettering og indlægsseddel.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics, Labelling and Package Leaflet in the Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, og det ændrede produktresumé og den ændrede etikettering og indlægsseddel findes i bilag III.
English: On the basis of the grounds for referral, the point considered by the 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: Baseret på begrundelserne for indbringelsen var det punkt, som blev taget i betragtning af CPMP, hvorvidt det var hensigtsmæssigt at indføre initial vedligeholdelsesbehandling med fastdosiskombinationen af salmeterol og fluticasonpropionat for alle patienter med kronisk persisterende astma.
English: The RMS and CMSs rejected the type II variation based on the grounds that the overall risk/benefit was unfavourable for the initial maintenance therapy indication.
Danish: Referencemedlemsstaten og de berørte medlemsstater afviste type II-ændringen med den begrundelse, at det samlede benefit/risk-forhold var negativt for indikationen initial vedligeholdelsesbehandling.
English: The Marketing Authorisation Holders submitted a type II variation subject to the MRP in July 2004 to extend the indication to include initial maintenance therapy with the fixed dose combination in patients with chronic persistent asthma.
Danish: Indehaverne af markedsføringstilladelserne havde i juli 2004 indgivet ansøgning om en type IIændring i henhold til proceduren for gensidig anerkendelse med henblik på at udvide indikationen til at omfatte initial vedligeholdelsesbehandling med fastdosiskombinationen for patienter med kronisk persisterende astma.
English: Nucala received a marketing authorisation valid throughout the EU on 2 December 2015.
Danish: Nucala fik en markedsføringstilladelse med gyldighed i hele EU den 2. december 2015.
English: Further information on Nucala can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/nucala.
Danish: Yderligere information om Nucala findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/nucala.
English: Nucala is intended for long-term treatment.
Danish: Nucala er beregnet til langtidsbehandling.
English: As for all medicines, data on the use of Nucala are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Nucala løbende overvåget.
English: Other information about Nucala
Danish: Andre oplysninger om Nucala
English: The recommended dose is 100 mg in patients aged 12 years and above, and 40 mg in patients aged 6 to 11 years.
Danish: Den anbefalede dosis er 100 mg hos patienter i alderen 12 år og derover og 40 mg hos patienter i alderen 6-11 år.
English: The most common side effect with Nucala (which may affect more than 1 in 10 people) is headache.
Danish: Den hyppigste bivirkning ved Nucala (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine.
English: The European Medicines Agency decided that Nucala's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Nucala opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Nucala?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nucala?
English: Side effects reported with Nucala are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Nucala vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The second study involved 576 adults and adolescents given Nucala every 4 weeks for 28 weeks.
Danish: Det andet studie omfattede 576 voksne og unge, der fik Nucala hver 4. uge i 28 uger.
English: An overview of Nucala and why it is authorised in the EU
Danish: En oversigt over Nucala, og hvorfor det er godkendt i EU
English: Why is Nucala authorised in the EU?
Danish: Hvorfor er Nucala godkendt i EU?
English: It is used with other medicines in patients whose asthma is severe and not well controlled with previous treatments.
Danish: Det anvendes sammen med andre lægemidler hos patienter med svær astma, der ikke har kunnet kontrolleres tilstrækkeligt ved tidligere behandlinger.
English: For more information about using Nucala, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Nucala, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: An additional study was carried out in children aged 6 years to 11 years which showed that a dose of 40 mg Nucala given under the skin produced comparable levels of active substance in the body to those seen with standard doses in adults.
Danish: Et yderligere studie med børn i alderen 6-11 år viste, at en dosis på 40 mg Nucala injiceret under huden gav et niveau af aktivt stof i kroppen, der svarede til det niveau, der sås ved standarddoser hos voksne.
English: Over half (37 of 69) of the patients given Nucala were able to reduce their daily corticosteroid dose by more than 50% to a dose of 5 mg or less, and 10 of them were able to stop corticosteroids altogether, compared with about a third of those given placebo (22 of 66, of whom 5 were able to stop corticosteroids).
Danish: Over halvdelen (37 ud af 69) af de patienter, der fik Nucala, kunne nedsætte deres daglige dosis af binyrebarkhormon med over 50 % til en dosis på 5 mg eller derunder, og 10 af dem kunne komme helt ud af behandlingen med binyrebarkhormon, sammenholdt med omkring en tredjedel af dem, der fik placebo (22 ud af 66, hvoraf 5 kunne holde op med at bruge binyrebarkhormon).
English: The medicine is given by injection under the skin of the upper arm, thigh or abdomen (belly) once every 4 weeks.
Danish: Lægemidlet gives ved injektion under huden i overarmen, låret eller maven én gang hver 4. uge.
English: What is Nucala and what is it used for?
Danish: Hvad er Nucala, og hvad anvendes det til?
English: This helps to reduce inflammation, resulting in a reduction in asthma attacks and improvement of symptoms.
Danish: Derved mindskes betændelsen, så astmaanfaldene reduceres, og symptomerne bedres.
English: In adults the reduction seen in severe asthma attacks and consequent need for hospital treatment was considered important and outweighed the low risk of side effects.
Danish: Reduktionen hos voksne af svære astmaanfald med et deraf følgende mindre behov for hospitalsbehandling anses for at være væsentlig og opvejer den lave risiko for bivirkninger.
English: In children, eosinophilic asthma is rare and the data available are therefore limited.
Danish: Eosinofil astma er en sjælden sygdom hos børn, og de tilgængelige data er derfor begrænsede.
English: Nucala contains the active substance mepolizumab.
Danish: Nucala indeholder det aktive stof mepolizumab.
English: What are the risks associated with Nucala?
Danish: Hvilke risici er der forbundet med Nucala?
English: By attaching to interleukin-5, mepolizumab blocks its action and thereby reduces the numbers of eosinophils.
Danish: Ved at binde sig til interleukin-5 blokerer mepolizumab dets virkning og nedsætter derved antallet af eosinofiler.
English: In eosinophilic asthma, symptoms are associated with having too many eosinophils (a type of white blood cell) in the blood and in phlegm in the lungs.
Danish: Symptomerne ved eosinofil astma hænger sammen med, at der er for mange eosinofiler (en type hvide blodlegemer) i blodet og slim i lungerne.
English: The first study involved 616 adults and adolescents given Nucala every 4 weeks for a year, in addition to their regular asthma medicines.
Danish: Det første studie omfattede 616 voksne og unge, der fik Nucala hver 4. uge i et år i tillæg til deres sædvanlige astmalægemidler.
English: The active substance in Nucala, mepolizumab, is a type of protein called a monoclonal antibody, which attaches to a specific substance in the body.
Danish: Det aktive stof i Nucala, mepolizumab, er et såkaldt monoklonalt antistof, dvs. et protein, der binder sig til et specifikt stof i kroppen.
English: The benefits of Nucala in severe eosinophilic asthma that is not well controlled by previous treatment have been shown in three main studies, in which it was compared with a placebo (dummy) injection.
Danish: Fordelene ved Nucala til behandling af svær eosinofil astma, der ikke har kunnet kontrolleres tilstrækkeligt ved tidligere behandlinger, er påvist i tre hovedstudier, hvor det blev sammenlignet med injektioner af placebo (ikke-aktivt stof).
English: For the full list of side effects and restrictions with Nucala, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Nucala fremgår af indlægssedlen.
English: Nucala is an asthma medicine used to treat patients aged 6 years and above with a particular type of asthma called eosinophilic asthma.
Danish: Nucala er et astmalægemiddel til behandling af patienter i alderen 6 år og derover med en særlig type astma, der kaldes eosinofil astma.
English: Reactions at the site of injection and back pain are common, affecting up to 1 patient in 10.
Danish: Reaktioner ved injektionsstedet og rygsmerter er almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter).
English: Mepolizumab attaches to a substance called interleukin-5 which encourages the production and survival of eosinophils.
Danish: Mepolizumab binder sig til stoffet interleukin-5, der øger produktionen og overlevelsen af eosinofiler.
English: The reduction in eosinophil levels in the blood achieved in children was also comparable with that seen with standard doses in adults.
Danish: Desuden svarede den reduktion i eosinofil-koncentrationen, der sås i blodet hos børn, til den reduktion, der sås ved standarddoserne hos voksne.
English: Nucala can only be obtained with a prescription and should be prescribed by a doctor experienced in identifying and treating severe eosinophilic asthma.
Danish: Lægemidlet Nucala fås kun på recept og bør ordineres af en læge med erfaring i at identificere og behandle eosinofil astma.
English: The Agency concluded that the data available indicate that Nucala acts in a similar way in adults and children and the results in adults therefore also apply to children with eosinophilic asthma.
Danish: Da de tilgængelige data viser, at Nucala virker på samme måde hos voksne som hos børn, vurderede agenturet, at resultaterne fra voksne også gælder børn med eosinofil astma.
English: Nucala is available as a solution in a prefilled pen or syringe or as a powder that comes in a vial and is made up into an injection.
Danish: Nucala fås som en opløsning i en fyldt pen eller sprøjte eller som pulver i et hætteglas, der blandes til en opløsning til injektion.
English: In addition, a reduction in corticosteroid dose was considered clinically relevant, given the potential complications of long-term corticosteroid treatment.
Danish: Desuden vurderes reduktionen i forbruget af binyrebarkhormon at være klinisk relevant, da der kan opstå potentielle komplikationer ved langvarig behandling med binyrebarkhormon.
English: How is Nucala used?
Danish: Hvordan anvendes Nucala?
English: The patient and carer can use Nucala prefilled pen or syringe themselves once they have been trained, whereas the vial is only for use by a healthcare professional.
Danish: De fyldte Nucala-penne eller -sprøjter kan anvendes af patienten og omsorgsgiveren efter passende instruktion, mens hætteglasset kun er til brug for sundhedspersoner.
English: What benefits of Nucala have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Nucala?
English: How does Nucala work?
Danish: Hvordan virker Nucala?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nucala have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nucala.
English: The third study involved 135 mostly adult patients with eosinophilic asthma severe enough to need regular treatment by mouth with corticosteroids (potent anti-inflammatory medicines such as prednisone and prednisolone), and the main measure of effectiveness was how much the corticosteroid dose could be reduced using Nucala for 24 weeks compared with placebo.
Danish: Det tredje studie omfattede 135 patienter (primært voksne) med eosinofil astma, der var tilstrækkeligt svær til at skulle behandles regelmæssigt med binyrebarkhormon gennem munden (stærk antiinflammatorisk medicin som f.eks. prednison og prednisolon).
English: The main measure of effectiveness in these studies was the number of severe attacks (exacerbations) of asthma that occurred during treatment, which was reduced by about half in patients given Nucala.
Danish: Det vigtigste mål for virkningen i disse studier var antallet af svære astmaanfald (akut symptomforværring), der sås under behandlingen.
English: This summary was last updated in September 2007.
Danish: Dette sammendrag blev sidst ajourført i 09-2007.
English: All horses should be revaccinated every three months to maintain immunity.
Danish: Alle heste skal revaccineres hver tredje måned for at opretholde immuniteten.
English: This makes it suitable for use in a vaccine.
Danish: Det gør den egnet til brug i en vaccine.
English: In very rare cases depression may develop.
Danish: I meget sjældne tilfælde kan der udvikles depression.
English: The withdrawal period is zero days.
Danish: Tilbageholdelsestiden er 0 døgn.
English: An increase in body temperature of up to 2°C may occur on the day of vaccination.
Danish: Der kan komme temperaturforhøjelse på indtil 2°C på vaccinationsdagen.
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysninger om udleveringsbestemmelser for produktet findes på etiketten/yderemballagen.
English: Equilis StrepE is a vaccine.
Danish: Equilis StrepE er en vaccine.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EQUILIS StrepE EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) EQUILIS StrepE EPAR - sammendrag for offentligheden
English: The effectiveness of Equilis StrepE has been studied in safety studies and one main field study.
Danish: Virkningen af Equilis StrepE blev undersøgt i sikkerhedsundersøgelser og i én hovedundersøgelse, der var en feltundersøgelse.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Danish: Vacciner virker ved at "lære" immunsystemet (organismens naturlige forsvar), hvordan det skal forsvare organismen mod sygdomme.
English: Only healthy horses which are at risk of infection should be vaccinated.
Danish: Kun raske heste, der er udsat for infektionsfare, bør vaccineres.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the bacteria.
Danish: Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, når det møder de samme bakterier igen.
English: After injection, swelling will develop at the injection site within four hours and the injection site may become warm or painful.
Danish: Efter injektion vil der komme hævelse på injektionsstedet i løbet af fire timer, og injektionsstedet kan blive varmt eller smertefuldt.
English: The horses had not had any disease including strangles in the past and had never been vaccinated.
Danish: Hestene havde ikke tidligere haft sygdom med kværke og var aldrig blevet vaccineret.
English: Other information about Equilis StrepE:
Danish: Andre oplysninger om Equilis StrepE:
English: The vaccine is given as a 0.2-ml injection into the inside of the upper lip.
Danish: Vaccinen gives som en indsprøjtning af 0,2 ml i indersiden af overlæben.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Equilis StrepE to Intervet International B.V. on 7 May 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Equilis StrepE til Intervet International B.V.
English: This is the first vaccine to be licensed for horses in the EU against strangles.
Danish: Denne vaccine er den første, der godkendes i EU mod kværke hos heste.
English: When a horse is given the vaccine, the immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Danish: Når hesten får vaccinen, opfatter dens immunsystem bakterierne som "fremmede" og producerer antistoffer mod dem.
English: This is a highly contagious disease and a common bacterial infection in horses.
Danish: Sygdommen er stærkt smitsom og er en udbredt bakteriel infektion hos heste.
English: Horses from four months of age should receive a second injection after four weeks.
Danish: Heste over fire måneder skal revaccineres efter fire uger.
English: No adjuvant or preservative is included.
Danish: Der er ikke tilsat adjuvans (forstærkningsmiddel) eller konserveringsstof.
English: The vaccine is provided together with the solvent, applicator and a syringe with needle.
Danish: Vaccinen leveres sammen med solvens (opløsningsvæske), en applikator og en sprøjte med kanyle.
English: In strangles, the lymph nodes in the head can become large enough to block the airway, causing the horse to have difficulty breathing.
Danish: Ved kværke kan lymfeknuderne i hovedet blive så store, at de blokerer luftvejene og bevirker, at hesten har svært ved at ånde.
English: They also had fewer abscesses and fewer lymph nodes affected.
Danish: Hestene havde også færre bylder, og færre lymfeknuder var berørt.
English: Equilis StrepE is only for use in healthy horses that are at risk of S. equi infection due to contact with horses from areas where the bacterium is known to be present.
Danish: Equilis StrepE er kun til brug hos raske heste, som er udsat for smitte med S. equi ved kontakt med heste fra områder, hvor bakterien vides at forekomme.
English: Equilis StrepE is a vaccine which contains the active substance live deletion mutant Streptococcus equi bacteria.
Danish: Equilis StrepE er en vaccine, der som aktivt stof indeholder en levende deletionsmutant af bakterien Streptococcus equi.
English: The bacterium strain included in Equilis StrepE has had some genes removed, so that it grows less well inside the horse's body and is less likely to cause disease.
Danish: Bakteriestammen i StrepE har fået fjernet visse gener, så den ikke så let kan vokse i hestens krop og har vanskeligt ved at fremkalde sygdom.
English: The reaction is greatest at two to three days after injection, but the area affected should not be larger than 3 by 8 cm.
Danish: Denne reaktion er mest udtalt to-tre dage efter injektionen, men det berørte område bør ikke være større end 3 gange 8 cm. Hævelsen forventes at svinde i løbet af tre uger og skulle ikke påvirke hestens appetit eller medføre gener.
English: Equilis StrepE contains small amounts of a type of bacterium called S. equi.
Danish: Equilis StrepE indeholder små mængder af bakterier af arten S. equi.
English: In rare cases, loss of appetite, fever and shivering may be observed.
Danish: I sjældne tilfælde kan ses manglende ædelyst, feber og staldkrampe.
English: What is the risk associated with Equilis StrepE?
Danish: Hvilken risiko er der forbundet med Equilis StrepE ?
English: Equilis StrepE is available as a lyophilisate (freeze-dried pellet) which is made up into a suspension for injection.
Danish: Equilis StrepE leveres som et lyofilisat (en frysetørret pellet), der benyttes til at fremstille en injektionsvæske (suspension).
English: Equilis StrepE is used to vaccinate horses against the respiratory disease caused by the bacteria Streptococcus equi.
Danish: Equilis StrepE anvendes til vaccination af heste med den luftvejssygdom, der forårsages af bakterien Streptococcus equi.
English: Equilis StrepE reduces the clinical signs of disease and the occurrence of lymph node abscesses (collections of pus).
Danish: Equilis StrepE mindsker sygdommens kliniske tegn og forekomsten af bylder i lymfeknuderne (pusansamling).
English: Fewer of the horses receiving Equilis StrepE had symptoms of strangles.
Danish: Når hestene fik Equilis StrepE, fik færre af dem symptomer på kværke.
English: The studies demonstrated that Equilis StrepE is effective in the active immunisation of horses from 4 months of age against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Danish: Undersøgelserne viser, at Equilis StrepE er effektiv til vaccination af heste over fire måneder mod Streptococcus equi med henblik på at begrænse de kliniske symptomer og forekomsten af bylder i lymfeknuderne.
English: as the local and systemic reactions observed after single, repeated dose and overdose treatment were considered acceptable.
Danish: Resultaterne af sikkerhedsundersøgelserne viser, at Equilis StrepE er sikker for heste over fire måneder, da de lokale og almene reaktioner efter enkeltdoser, gentagne doser og overdoser blev anset for acceptable.
English: How has Equilis StrepE been studied?
Danish: Hvordan blev Equilis StrepE undersøgt?
English: In case of accidental self-injection, which can cause inflammation with severe pain and swelling, seek medical advice immediately and show the Package Leaflet or the label to the doctor, even if only a small amount has been injected.
Danish: Der skal straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen, selv om den injicerede mængde er ganske lille.