FrancophonIA/ELRC3.0 huggingface dataset:
English: Singulair is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma, in patients aged 6 months to 5 years.
Danish: Singulair er indiceret til behandling af astma som tillægsbehandling af patienter med mild til moderat persisterende astma, som ikke er tilstrækkeligt under kontrol med inhalerede kortikosteroider, og hvor korttidsvirkende β-agonister efter behov giver utilstrækkelig klinisk kontrol over astmaen hos patienter i alderen 6 måneder til 5 år.
English: Adult Patients 15 years and older (two 12-week studies; n=795)
Danish: (To 12-ugers undersøgelser; n=795)
English: SINGULAIR is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction.
Danish: SINGULAIR er også indiceret til forebyggelse af astma fra 2 år og ældre, hvor den dominerende årsag er anstrengelsesudløst bronkokonstriktion.
English: 4 mg Chewable tablets Oral
Danish: 4 mg Tyggetabletter Oral
English: • Always have your child take SINGULAIR as your doctor has told you.
Danish: • Barnet skal altid tage granulatet efter lægens anvisning.
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Granulat
English: • SINGULAIR may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.2).
Danish: • SINGULAIR kan muligvis også anvendes som et alternativ til lavdosis inhalerede kortikosteroider til patienter i alderen 2 til 5 år med mild persisterende astma, som ikke for nylig har haft så alvorlige astmaanfald, at oral steroidanvendelse var påkrævet, og som har vist, at de ikke er i stand til at anvende inhalerede kortikosteroider (se afsnit 4.2).
English: “Singulair may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids”
Danish: "Singulair kan muligvis også anvendes som et alternativ til lavdosis inhalerede kortikosteroider hos patienter i alderen 2 til 5 år med mild persisterende astma, som ikke for nylig har haft så alvorlige astmaanfald, at oral steroidanvendelse var påkrævet, og som har vist, at de ikke er i stand til at anvende inhalerede kortikosteroider.
English: NAME OF THE MEDICINAL PRODUCT SINGULAIR 4 MG CHEWABLE TABLETS
Danish: LÆGEMIDLETS NAVN SINGULAIR 4 mg tyggetabletter.
English: • SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.
Danish: • SINGULAIR er indiceret til behandling af astma som tillægsbehandling af patienter i alderen 2 til 5 år med mild til moderat persistende astma, som ikke er tilstrækkeligt under kontrol med inhalerede kortikosteroider, og hvor korttidsvirkende β-agonister efter behov giver utilstrækkelig klinisk kontrol med astmaen.
English: SINGULAIR 4 mg Granules montelukast
Danish: SINGULAIR 4 mg granulat montelukast (som montelukastnatrium)
English: 4 mg Chewable tablets Oral use
Danish: 4 mg Tyggetabletter Oral anvendelse 4 mg
English: "SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting β-agonists provide inadequate clinical control of asthma".
Danish: "SINGULAIR er indiceret til behandling af astma som tillægsbehandling af patienter i alderen 2 til 5 år med mild til moderat persisterende astma, som ikke er tilstrækkeligt under kontrol med inhalerede kortikosteroider, og hvor korttidsvirkende β-agonister efter behov giver utilstrækkelig klinisk kontrol med astmaen."
English: For children 6 months to 5 years of age
Danish: 6 - 14 år
English: • Keep this leaflet.
Danish: • Tag granulatet gennem munden.
English: "SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 6 months to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting β-agonists provide inadequate clinical control of asthma".
Danish: "SINGULAIR er indiceret til behandling af astma som tillægsbehandling af patienter i alderen 6 måneder til 5 år med mild til moderat persisterende astma, som ikke er tilstrækkeligt under kontrol med inhalerede kortikosteroider, og hvor korttidsvirkende β-agonister efter behov giver utilstrækkelig klinisk kontrol med astmaen."
English: SINGULAIR 4 mg chewable tablets montelukast
Danish: SINGULAIR 4 mg tyggetabletter montelukast
English: Granules 7 x 1 sachet 20 x 1 sachet 28 x 1 sachet 30 x 1 sachet
Danish: 20 x 1 brev
English: SINGULAIR may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.2).
Danish: SINGULAIR kan også være en alternativ behandlingsmulighed til lavdosis inhalationskorti-kosteroider til patienter i alderen 2-5 år med mild vedvarende astma, som ikke for nylig har haft alvorlig astmaanfald i anamnesen, hvor brug af oral kortikosteroid var påkrævet, og som har vist, at de ikke er i stand til at anvende inhalationskortikosteroider (se pkt.
English: Each sachet of granules contains montelukast sodium which corresponds to 4 mg of montelukast.
Danish: Hver pose granulat indeholder montelukastnatrium, som svarer til 4
English: Skin and subcutaneous tissue disorders eczematous dermatitis, rash
Danish: Hud og subkutane væv
English: • SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 6 months to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma.
Danish: • SINGULAIR er indiceret til behandling af astma som tillægsbehandling af patienter i alderen 6 måneder til 5 år med mild til moderat persisterende astma, som ikke er tilstrækkeligt under kontrol med inhalerede kortikosteroider, og hvor korttidsvirkende β-agonister efter behov giver utilstrækkelig klinisk kontrol med astmaen."
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your child's doctor or pharmacist.
Danish: Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller Deres barn får bivirkninger, som ikke er nævnt her.
English: • This medicine has been prescribed for your child. Do not pass it on to others.
Danish: Lad derfor være med at give det til andre.
English: Granules
Danish: • Udslæt
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
English: Nervous system disorders headache headache
Danish: Nervesystemet
English: Suspension (inactivated)
Danish: Suspension (inaktiveret)
English: ** Antibody micro agglutination-lytic reaction.
Danish: * Vævskulturinficerende dosis - 50 % (tissue culture infectious dose 50 %) ** Antistof mikroagglutinationsreaktion - lytisk reaktion (antibody micro agglutination-lytic reaction)
English: Most of these reactions last for 2 to 3 days.
Danish: De fleste af disse reaktioner varer i to-tre dage.
English: If necessary, the second dose can be given later but within 6 months after the first dose.
Danish: Den anden dosis kan om nødvendigt gives senere, men senest seks måneder efter den første dosis.
English: The vaccination course consists of 2 injections given 2 months apart.
Danish: Vaccinationsforløbet består af 2 injektioner, der gives med 2 måneders mellemrum.
English: Shingrix was assessed in two main studies in around 30,000 adults.
Danish: Shingrix blev vurderet i to hovedstudier hos omkring 30 000 voksne.
English: Further information on Shingrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Shingrix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It also contains an ‘adjuvant' which is made of substances to help strengthen the immune responses to the vaccine.
Danish: Det indeholder desuden et "adjuvans", der består af stoffer, som styrker immunreaktionen på vaccinen.
English: Overall, the vaccine effectiveness was similar across ages.
Danish: Overordnet havde vaccinen samme effektivitet på tværs af aldersgrupperne.
English: As for all medicines, data on the use of Shingrix is continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Shingrix løbende overvåget.
English: The studies also looked at the number of people who had post-herpetic neuralgia after vaccination.
Danish: Studierne så også på det antal personer, der fik postherpetisk neuralgi efter vaccinationen.
English: The most common side effects with Shingrix (which may affect more than 1 in 10 people) are reactions at the site of injection (such as pain, redness and swelling), chills, fever, muscle pain, tiredness, headache and side effects of the digestive system such as nausea, vomiting, diarrhoea and stomach pain.
Danish: De hyppigste bivirkninger ved Shingrix (som optræder hos mere end 1 ud af 10 personer) er reaktioner på injektionsstedet (såsom smerte, rødme og hævelse), kulderystelser, feber, muskelsmerter, træthed, hovedpine og bivirkninger fra fordøjelsessystemet såsom kvalme, opkastning, diarré og mavesmerter.
English: After a patient has had chickenpox, the virus can lie dormant in the nerves and become active again if the immune system (the body's natural defences) weakens due, for example, to ageing or to an illness.
Danish: Når en patient har haft skoldkopper, kan virusset ligge sovende i nerverne og blive aktivt igen, hvis kroppens naturlige forsvar (immunsystemet) svækkes som følge af f.eks. aldring eller sygdom.
English: For more information about using Shingrix, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Shingrix, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: It is available as a powder and a suspension to be mixed together by a doctor or a nurse before being injected into the upper arm muscle.
Danish: Det fås som et pulver med en suspension, der sammenblandes af lægen eller sygeplejersken, hvorefter det injiceres i musklen i overarmen.
English: Shingrix can only be obtained with a prescription and should be used according to official recommendations.
Danish: Shingrix udleveres kun efter recept og bør anvendes i henhold til officielle anbefalinger.
English: Shingrix (herpes zoster vaccine, recombinant, adjuvanted)
Danish: Shingrix (herpes zoster-vaccine, rekombinant, adjuveret)
English: Other information about Shingrix
Danish: Andre oplysninger om Shingrix
English: The European Medicines Agency therefore decided that Shingrix's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Shingrix opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Shingrix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Shingrix?
English: Side effects reported with Shingrix are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Shingrix vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: In both studies, the main measure of effectiveness was the number of people having shingles in the group receiving the vaccine compared with the group receiving placebo (a dummy vaccine).
Danish: I begge studier var det vigtigste mål for effektiviteten det antal personer, der fik helvedesild i den vaccinerede gruppe, sammenholdt med den gruppe, der fik virkningsløs vaccine (placebo).
English: An overview of Shingrix and why it is authorised in the EU
Danish: En oversigt over Shingrix og hvorfor det er godkendt i EU
English: Shingrix has been shown to be highly effective at preventing shingles and post-herpetic neuralgia across all age groups older than 50 years for at least 4 years after vaccination.
Danish: Shingrix er påvist at være yderst effektivt til at forebygge helvedesild og postherpetisk neuralgi hos alle aldersgrupper over 50 år i mindst fire år efter vaccinationen.
English: Why is Shingrix authorised in the EU?
Danish: Hvorfor blev Shingrix godkendt i EU?
English: Looking at the results for adults in this age group from both studies together, 25 adults out of 8,250 who received Shingrix had shingles within 4 years after vaccination compared with 284 out of 8,346 who received placebo.
Danish: Når man ser på resultaterne for voksne i denne aldersgruppe fra begge studier tilsammen, var der ud af de 8 250, som blev behandlet med Shingrix, 25 voksne, som fik helvedesild inden for fire år efter vaccinationen, sammenholdt med 284 ud af de 8 346, der blev behandlet med placebo.
English: In the first study with adults aged 50 years and over, 7,695 received Shingrix and 7,710 received placebo.
Danish: I det første studie med voksne over 50 år fik 7 695 Shingrix, og 7 710 fik placebo.
English: The second study involved adults aged 70 and over who received either Shingrix or placebo.
Danish: Det andet studie omfattede voksne over 70 år, som enten fik Shingrix eller placebo.
English: This indicates that Shingrix prevented 97% of shingles cases and 100% of cases of post-herpetic neuralgia in this study.
Danish: Det viser, at Shingrix forebyggede 97 % af tilfælde af helvedesild og 100 % af tilfælde af postherpetisk neuralgi i dette studie.
English: What is Shingrix and what is it used for?
Danish: Hvad er Shingrix, og hvad anvendes det til?
English: Shingrix contains small amounts of the surface antigens (proteins from the surface) of the virus to stimulate the body to make antibodies against the virus.
Danish: Shingrix indeholder små mængder proteiner fra virussets overflade (overfladeantigener), der stimulerer kroppen til at danne antistoffer mod virusset.
English: For the full list of side effects and restrictions with Shingrix, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Shingrix fremgår af indlægssedlen.
English: Side effects related to the use of Shingrix seemed to be mostly temporary and were manageable with standard care.
Danish: Bivirkningerne ved Shingrix syntes for det meste at være midlertidige og kunne håndteres med standardbehandling.
English: Shingrix has been shown to be effective at preventing shingles and post-herpetic neuralgia.
Danish: Shingrix er påvist at være effektivt til at forebygge helvedesild og postherpetisk neuralgi.
English: What are the risks associated with Shingrix?
Danish: Hvilke risici er der forbundet med Shingrix?
English: This indicates that Shingrix prevented 91% of shingles cases and 89% of cases of post-herpetic neuralgia in adults aged 70 years and older.
Danish: Det vil sige, at Shingrix forebyggede 91 % af tilfælde af helvedesild og 89 % af tilfælde af postherpetisk neuralgi hos voksne over 70 år.
English: Shingrix has been designed to prevent shingles in people who have been in contact with the varicella zoster virus (the virus that causes chickenpox) and have already developed antibodies against the virus.
Danish: Shingrix er udviklet til at forebygge helvedesild hos personer, der har været i kontakt med det virus, der medfører skoldkopper (varicella zoster-virusset) og allerede har dannet antistoffer mod virusset.
English: Shingrix is a vaccine used to protect adults aged 50 years and over against shingles (herpes zoster) and post-herpetic neuralgia (long-lasting nerve pain following shingles).
Danish: Shingrix er en vaccine, der anvendes til at beskytte voksne over 50 år mod helvedesild (herpes zoster) og langvarige smerter efter helvedesild (postherpetisk neuralgi).
English: Patients given Shingrix will be able to produce antibodies against the virus more quickly when the virus is reactivated and they will therefore have protection against the disease.
Danish: Når patienter har fået Shingrix, kan de hurtigere danne antistoffer mod virusset, når dette bliver aktivt igen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Shingrix 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 Shingrix.
English: After just over 3 years on average, 6 adults had had shingles in the Shingrix group compared with 210 in the placebo group.
Danish: Efter gennemsnitligt lige over tre år havde seks voksne i Shingrix-gruppen haft helvedesild, sammenholdt med 210 i placebogruppen.
English: After almost 4 years, nobody had had post-herpetic neuralgia in the Shingrix group compared with 18 in the placebo group.
Danish: Efter næsten fire år havde ingen i Shingrix-gruppen fået postherpetisk neuralgi, sammenholdt med 18 i placebogruppen.
English: How is Shingrix used?
Danish: Hvordan anvendes Shingrix?
English: How does Shingrix work?
Danish: Hvordan virker Shingrix?
English: After 4 years, 4 adults had had post-herpetic neuralgia in the Shingrix group compared with 36 in the placebo group.
Danish: Efter næsten fire år havde fire voksne i Shingrix-gruppen haft postherpetisk neuralgi, sammenholdt med 36 i placebogruppen.
English: What benefits of Shingrix have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Shingrix?
English: Shingles is a painful, blistering rash caused by the reactivation of the virus that causes chickenpox.
Danish: Det forårsages af fornyet aktivering af det virus, der giver skoldkopper.
English: 1 Previously known as Incruse.
Danish: 1 Tidligere kendt som Incruse.
English: Further information on Incruse Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Incruse Ellipta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Incruse Ellipta received a marketing authorisation valid throughout the EU on 28 April 2014.
Danish: Incruse Ellipta fik en markedsføringstilladelse med gyldighed i hele EU den 28. april 2014.
English: The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Danish: Det primære mål for virkningen var ændringer i patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde, som en person kan udånde på et sekund).
English: Incruse Ellipta was investigated in four main studies involving over 4,000 patients.
Danish: Incruse Ellipta er undersøgt i fire hovedstudier med over 4.000 patienter.
English: The studies also showed an improvement in symptoms such as breathlessness and wheezing.
Danish: Studierne viste desuden en bedring af symptomer som f.eks. åndenød og hvæsende vejrtrækning.
English: As for all medicines, data on the use of Incruse Ellipta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Incruse Ellipta løbende overvåget.
English: Incruse Ellipta0F (umeclidinium bromide) EMA/593792/2018
Danish: Incruse Ellipta0F (umeclidiniumbromid) EMA/593792/2018
English: Side effects reported with Incruse Ellipta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Incruse Ellipta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: A double dose of Incruse Ellipta only showed small improvements compared with a single dose, which were not considered relevant.
Danish: En dobbelt dosis Incruse Ellipta gav i forhold til en enkelt dosis kun små forbedringer, der ikke blev anset for at være klinisk relevante.
English: Incruse Ellipta is used for maintenance (regular) treatment.
Danish: Incruse Ellipta anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: As medicines of the same class as Incruse Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets Incruse Ellipta will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.
Danish: Da lægemidler af samme klasse som Incruse Ellipta kan påvirke hjertet og blodkarrene i hjernen, skal den virksomhed, der markedsfører lægemidlet, gennemføre et langtidsstudie med patienter for at indsamle yderligere oplysninger om lægemidlets sikkerhed sammenholdt med tiotropium.
English: Results showed that Incruse Ellipta improved lung function by an average FEV1 of 127 ml more than placebo after 12 weeks of treatment and by 115 ml more than placebo after 24 weeks of treatment.
Danish: Resultaterne viste, at behandling med Incruse Ellipta medførte en forbedring af lungefunktionen med en gennemsnitlig stigning i FEV1 på 127 ml mere end placebo efter 12 ugers behandling og på 115 ml mere end placebo efter 24 ugers behandling.
English: Incruse Ellipta1 (umeclidinium bromide)
Danish: Incruse Ellipta1 (umeclidiniumbromid)
English: It works by blocking some receptors called muscarinic receptors, which control the contraction of muscles.
Danish: Det virker ved at blokere virkningen af de såkaldte muskarine receptorer, der styrer musklernes sammentrækning.
English: The most common side effects with Incruse Ellipta (which may affect up to 1 in 10 people) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), cough, urinary tract infection (infection of the structures that carry urine), and tachycardia (increased heart rate).
Danish: De hyppigste bivirkninger ved Incruse Ellipta (der kan forekomme hos op til 1 ud af 10 patienter) er hovedpine, betændelse i næse og svælg, infektioner i de øvre luftveje (næse og svælg), bihulebetændelse, hoste, urinvejsinfektion og øget hjertefrekvens.
English: Other information about Incruse Ellipta
Danish: Andre oplysninger om Incruse Ellipta
English: In the study comparing Incruse Ellipta with tiotropium, FEV1 improvements over 24 weeks were similar for both medicines.
Danish: I det studie, hvor Incruse Ellipta blev sammenlignet med tiotropium, var forbedringen af FEV1 i løbet af 24 uger den samme for begge lægemidler.
English: What measures are being taken to ensure the safe and effective use of Incruse Ellipta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Incruse Ellipta?
English: The Agency also noted that there were no major safety concerns with Incruse Ellipta, with side effects being manageable and similar to other medicines of the same class (antimuscarinic bronchodilators).
Danish: Agenturet bemærkede desuden, at der ikke var større sikkerhedsmæssige problemer med Incruse Ellipta, idet bivirkningerne kan behandles og svarer til bivirkningerne ved andre lægemidler af samme klasse (antimuskarine bronkodilatorer).