FrancophonIA/ELRC3.0 huggingface dataset:
English: Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic.
Danish: Navnlig bør fluoroquinoloner generelt undgås hos patienter, der tidligere har oplevet alvorlige bivirkninger ved behandling med fluoroquinolon- eller quinolon-antibiotika.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 14 February 2019 for Quinsair and on 11 March 2019 for other quinolone and fluoroquinolone antibiotics given by mouth and by injection, which is applicable in all EU countries.
Danish: CHMP's udtalelse blev sendt til Europa-Kommissionen, der vedtog en endelig juridisk bindende afgørelse med gyldighed i alle EU-lande den 14. februar 2019 for Quinsair og den 11. marts 2019 for andre quinolon- og fluoroquinolon-antibiotika, der indgives gennem munden og ved injektion.
English: • You should not take a fluoroquinolone medicine if you have ever had a serious side effect with a fluoroquinolone or a quinolone medicine and you should speak with your doctor immediately.
Danish: • Du bør ikke tage et fluoroquinolon-lægemiddel, hvis du tidligere har haft en alvorlig bivirkning ved behandling med et fluoroquinolon- eller quinolon-lægemiddel - fortæl det altid til lægen.
English: • Fluoroquinolones should generally not be used in patients who have had serious adverse reactions associated with the use of quinolone or fluoroquinolone medicines.
Danish: • Fluoroquinoloner bør generelt ikke anvendes hos patienter, der tidligere har oplevet alvorlige bivirkninger ved behandling med quinolon- eller fluoroquinolon-lægemidler.
English: • The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell.
Danish: • Alvorlige bivirkninger omfatter tendinitis, senebrud, artralgi, smerter i ekstremiteterne, gangforstyrrelser, neuropatier forbundet med paræstesi, depression, træthed, nedsat hukommelse, søvnforstyrrelser, nedsat hørelse og syn og forstyrret smags- og lugtesans.
English: o if you get pain, feel pins and needles, tingling, tickling, numbness or burning, or weakness especially in the legs or arms;
Danish: o hvis du oplever smerter, prikkende eller stikkende fornemmelse, snurren, kildren, følelsesløshed eller brændende fornemmelse, svaghed (navnlig i ben og arme)
English: • These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.
Danish: • Disse alvorlige bivirkninger omfatter betændte eller iturevne sener, muskelsmerter eller muskelsvaghed, ledsmerter eller hævede led, gangbesvær, prikkende og stikkende fornemmelse, brændende smerte, træthed, depression, problemer med hukommelse, søvn, syn og hørelse samt forstyrret smags- og lugtesans.
English: o if you get swelling in the shoulder, arms or legs, have walking difficulty, feel tired or depressed or have problems with your memory or with sleeping or you notice changes with your vision, taste, smell or hearing.
Danish: o hvis du oplever hævelse i skuldre, arme eller ben, gangbesvær, træthed eller nedtrykthed eller problemer med hukommelse, søvn, syn, hørelse eller forstyrret smags- eller lugtesans.
English: The doctor will consider stopping treatment if the condition does not show any improvement after 16 weeks.
Danish: Lægen vil overveje at stoppe behandlingen, hvis tilstanden ikke er forbedret efter 16 uger.
English: Dupixent received a marketing authorisation valid throughout the EU on 27 September 2017.
Danish: Dupixent fik en markedsføringstilladelse med gyldighed i hele EU den 27. september 2017.
English: Patientsor their carers may inject the medicine themselves if their doctor or nurse considers it appropriate.
Danish: Patienterne eller deres plejere kan selv injicere lægemidlet, hvis deres læge eller sygeplejerske finder det hensigtsmæssigt.
English: The medicine is for long-term use and the need to continue taking the medicine should be assessed by the doctor at least yearly.
Danish: Lægemidlet er til længerevarende brug, og behovet for at fortsætte med lægemidlet bør vurderes af lægen mindst en gang om året.
English: Further information on Dupixent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dupixent.
Danish: Yderligere information om Dupixent findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/dupixentema.europa.eu/medicines/human/EPAR/dupix ent.
English: As for all medicines, data on the use of Dupixent are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Dupixent løbende overvåget.
English: Anaphylaxis (sudden, severe allergic reaction) has been reported very rarely.
Danish: Anafylaksi (pludselig, svær allergisk reaktion) er meget sjældent indberettet.
English: Other information about Dupixent
Danish: Andre oplysninger om Dupixent
English: A further study was carried out in 251 adolescents aged from 12 to less than 18 years with moderate to severe atopic dermatitis.
Danish: Der blev gennemført et yderligere studie hos 251 unge i alderen 12 år til under 18 år med moderat til svær atopisk dermatitis.
English: What is Dupixent and what is it used for?
Danish: Hvad er Dupixent , og hvad anvendes det til?
English: An overview of Dupixent and why it is authorised in the EU
Danish: En oversigt over Dupixent og hvorfor det er godkendt i EU
English: Why is Dupixent authorised in the EU?
Danish: Hvorfor er Dupixent godkendt i EU?
English: What measures are being taken to ensure the safe and effective use of Dupixent?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dupixent?
English: There have been very rare cases of serum sickness (allergy to foreign proteins) and serum sickness-like reactions.
Danish: Der har været meget sjældne tilfælde af serumsygdom (allergi over for fremmede proteiner) og serumsygdomslignende reaktioner.
English: Dupixent or placebo was used on its own in the other two studies involving a total of 1,379 patients.
Danish: Dupixent eller placebo blev anvendt alene i de to andre studier med i alt 1.379 patienter.
English: The European Medicines Agency therefore decided that Dupixent's benefits are greater than its risks and it can be authorised in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Dupixent opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Dupixent are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Dupixent vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Regarding safety, Dupixent's side effects are generally mild and manageable.
Danish: Hvad sikkerheden angår, er bivirkningerne generelt lette og håndterbare.
English: For more information about using Dupixent, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Dupixent, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Dupixent is only for use in patients with a type of inflammation of the airways called ‘type 2 inflammation'.
Danish: Dupixent er kun til brug hos patienter med en type betændelse i luftvejene, der kaldes "type 2-inflammation".
English: What are the risks associated with Dupixent?
Danish: Hvilke risici er der forbundet med Dupixent?
English: By blocking the receptors, dupilumab prevents IL-4 and IL-13 from working and relieves disease symptoms.
Danish: Ved at blokere receptorerne forhindrer dupilumab IL-4 og IL-13 i at fungere og lindrer sygdomssymptomerne.
English: The active substance in Dupixent, dupilumab, is a monoclonal antibody (a type of protein) designed to block receptors (targets) for IL-4 and IL-13.
Danish: Det aktive stof i Dupixent, dupilumab, er et monoklonalt antistof (en type protein), der er designet til at blokere receptorer (mål) for IL-4 og IL-13.
English: Patients with atopic dermatitis and patients with asthma produce high levels of proteins called interleukin 4 and interleukin 13 (IL-4 and IL-13), which can cause inflammation of the skin and airways leading to the symptoms of these diseases.
Danish: Patienter med atopisk dermatitis og patienter med astma producerer et højt niveau af proteiner, der kaldes interleukin 4 og interleukin 13 (IL-4 og IL-13), og som kan forårsage betændelse i hud og luftveje, der fører til symptomerne på disse sygdomme.
English: After 12 weeks of treatment, Dupixent improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 320 ml (for 200 mg Dupixent) or 340 ml (for 300 mg Dupixent) compared with 180 ml and 210 ml for placebo.
Danish: Efter 12 ugers behandling forbedrede Dupixent patienternes FEV1 (den maksimale mængde luft, en person kan udånde på et sekund) med 320 ml (for 200 mg Dupixent) eller 340 ml (for 300 mg Dupixent) sammenlignet med 180 ml og 210 ml for placebo.
English: The most common side effects with Dupixent when used in treatment of atopic dermatitis are injectionsite reactions (such as redness, swelling and itching),which may affect more than 1 in 10 people, and conjunctivitis (redness and discomfort in the eye), blepharitis (inflammation of the eyelid) and cold sores, which may affect up to 1 in 10 people.
Danish: De hyppigste bivirkninger ved Dupixent ved behandling af atopisk dermatitis er reaktioner på injektionsstedet (såsom rødme, hævelse og kløe), som kan forekomme hos mere end 1 ud af 10 personer, og konjunktivitis (rødme og ubehag i øjet), blefaritis (betændelse i øjenlåget) og forkølelsessår, som kan forekomme hos op til 1 ud af 10 personer.
English: Dupixent can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the conditions Dupixent is used to treat.
Danish: Dupixent fås kun på recept, og behandlingen bør iværksættes af en læge med erfaring i diagnosticering og behandling af de sygdomme, som Dupixent anvendes til.
English: For all other asthma patients, the first dose is two injections of 200 mg in two different sites.
Danish: For alle andre astmapatienter er den første dosis to injektioner på 200 mg to forskellige steder.
English: In adolescents weighing less than 60 kg, the 200-mg injection is used.
Danish: Hos unge på under 60 kg anvendes injektionen på 200 mg.
English: The most common side effect with Dupixent when used in treatment of asthma is redness at the site of injection.
Danish: Den hyppigste bivirkning ved Dupixent ved behandling af astma er rødme på injektionsstedet.
English: In the first study, involving 1,902 patients, the number of severe flare-ups per year was 0.46 in patients taking 200 mg Dupixent and 0.52 in patients taking 300 mg Dupixent, compared with 0.87 or 0.97 in patients given placebo.
Danish: I det første studie med 1.902 patienter var antallet af svære forværringer pr. år 0,46 hos patienter, der fik 200 mg Dupixent, og 0,52 hos patienter, der fik 300 mg Dupixent, sammenlignet med 0,87 eller 0,97 hos patienter, der fik placebo.
English: Dupixent is a medicine used to treat patients aged 12 years or over with moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry).
Danish: Dupixent er et lægemiddel til behandling af patienter på 12 år og derover med moderat til svær atopisk dermatitis (også kaldet atopisk eksem, hvor huden er kløende, rød og tør).
English: In the first study, which involved 740 patients, participants were given Dupixent or placebo, both in combination with a topical corticosteroid (a medicine for inflammation applied to the skin).
Danish: I det første studie, som omfattede 740 patienter, fik deltagerne Dupixent eller placebo, begge i kombination med et topisk binyrebarkhormon (et lægemiddel mod betændelse, der påføres huden).
English: Dupixent has been shown to reduce the extent and severity of atopic dermatitis in patients with moderate to severe disease, for whom available therapies are limited.
Danish: Dupixent har vist sig at reducere omfanget og sværhedsgraden af atopisk dermatitis hos patienter med moderat til svær sygdom, for hvem der kun findes begrænsede behandlingsmuligheder.
English: Dupixent was more effective than placebo (a dummy treatment) at reducing the extent and severity of atopic dermatitis in 3 main studies in patients with moderate to severe disease.
Danish: Dupixent var mere effektivt end placebo (en virkningsløs behandling) til at reducere omfanget og sværhedsgraden af atopisk dermatitis i 3 hovedstudier hos patienter med moderat til svær sygdom.
English: Dupixent is available as pre-filled syringes containing 200 mg or 300 mg dupilumab in a solution for injection under the skin, usually in the thigh or belly.
Danish: Dupixent fås som fyldte sprøjter, der indeholder 200 mg eller 300 mg dupilumab i en opløsning til injektion under huden, normalt i låret eller maven.
English: For the full list of side effects and restrictions of Dupixent, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Dupixent fremgår af indlægssedlen.
English: How is Dupixent used?
Danish: Hvordan anvendes Dupixent?
English: For severe asthma, in patients taking corticosteroids by mouth or patients who also have atopic dermatitis, the first dose is two injections of 300 mg in two different sites.
Danish: Ved svær astma hos patienter, der tager binyrebarkhormon gennem munden, eller patienter, der også har atopisk dermatitis, er den første dosis to injektioner på 300 mg to forskellige steder.
English: Dupixent is also used to treat severe asthma in patients aged 12 years or over whose asthma is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma.
Danish: Dupixent anvendes også til at behandle svær astma hos patienter i alderen 12 år eller derover, når den ikke kan kontrolleres tilstrækkeligt med en kombination af højdosis-binyrebarkhormon, der tages ved inhalation, plus et andet lægemiddel, der anvendes til at forebygge astma.
English: The second study, involving 210 patients, showed that in 70% of patients given Dupixent their condition improved to the extent that they could reduce their dose of corticosteroids taken by mouth compared with 42% of those given placebo.
Danish: Det andet studie med 210 patienter viste, at blandt de patienter, der fik Dupixent, blev tilstanden hos 70 % forbedret i et sådant omfang, at de kunne reducere deres dosis af binyrebarkhormon indtaget gennem munden, sammenlignet med 42 % blandt dem, der fik placebo.
English: This is followed by one 300 mg injection every two weeks.
Danish: Dette efterfølges af en injektion på 300 mg hver anden uge.
English: For atopic dermatitis, the first dose in adults and adolescents weighing 60 kg or more is two injections of 300 mg in two different sites.
Danish: Ved atopisk dermatitis er den første dosis hos voksne og unge på 60 kg og derover to injektioner på 300 mg to forskellige steder.
English: Dupixent was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving patients with asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and other medicines.
Danish: Dupixent viste sig at reducere antallet af forværringer (eksacerbationer) af astma under behandlingen i to hovedstudier med patienter med astma, der ikke var tilstrækkeligt kontrolleret med en kombination af en høj dosis af inhaleret binyrebarkhormon og andre lægemidler.
English: This is followed by one 200-mg injection every two weeks.
Danish: Dette efterfølges af en injektion på 200 mg hver anden uge.
English: What benefits of Dupixent have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Dupixent?
English: How does Dupixent work?
Danish: Hvordan virker Dupixent?
English: In the treatment of asthma, Dupixent has been shown to reduce the number of asthma flare-ups and the need for oral corticosteroid treatment.
Danish: I forbindelse med behandling af astma har Dupixent vist sig at reducere antallet af astmaforværringer og behovet for behandling med binyrebarkhormon taget gennem munden.
English: In this study, after 16 weeks atopic dermatitis had cleared up or almost cleared up in around 24% of those given Dupixent every 2 weeks compared with around 2% of those given placebo.
Danish: I dette studie var den atopiske dermatitis forsvundet eller næsten forsvundet efter 16 uger hos ca. 24 % af de patienter, der fik Dupixent hver anden uge, sammenlignet med ca. 2 % af dem, der fik placebo.
English: After 16 weeks of treatment, 39% of patients treated with Dupixent every two weeks in the first study showed clearing or almost clearing of their atopic dermatitis compared with 12% of patients on placebo.
Danish: Efter 16 ugers behandling oplevede 39 % af de patienter, der blev behandlet med Dupixent hver anden uge i det første studie, at deres atopiske dermatitis forsvandt eller næsten forsvandt sammenlignet med 12 % af de patienter, der fik placebo.
English: Taking the results of the other two studies together, 37% of patients treated with Dupixent every two weeks had clearing or almost clearing of their atopic dermatitis compared with 9% of patients on placebo.
Danish: Når resultaterne fra de to andre studier blev lagt sammen, oplevede 37 % af de patienter, der blev behandlet med Dupixent hver anden uge, at deres atopiske dermatitis forsvandt eller næsten forsvandt sammenlignet med 9 % af de patienter, der fik placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dupixent 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 Dupixent.
English: The quality of the product is considered satisfactory.
Danish: Produktets kvalitet anses for tilfredsstillende.
English: It is currently authorised in 12 European Union (EU) Member States (MS).
Danish: Det er nu godkendt i 12 medlemsstater i EU.
English: The mechanism of resistance was also harmonised.
Danish: Også resistensmekanismen blev harmoniseret.
English: Section 1, 6.3 and 6.4 have only been partially harmonised as it is considered that these should be adapted nationally.
Danish: Punkt 1, 6.3 og 6.4 er kun delvis blevet harmoniseret, da udvalget fandt, at de bør tilpasses nationalt.
English: Overall summary of the scientific evaluation of Amoxil and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Amoxil og relaterede navne (se bilag I)
English: The breakpoint table was updated based on EUCAST (version 4) dated 01 January 2014.
Danish: Tabellen over afskæringspunkter blev ført ajour på grundlag af EUCAST (version 4) dateret 1. januar 2014.
English: As a result of this harmonisation procedure, the Module 3 was substantially updated and revised to include data which has become available during the years since the first marketing authorisation.
Danish: Som resultat af denne harmoniseringsprocedure blev modul 3 væsentligt ajourført og revideret, idet der blev tilføjet data, som er blevet tilgængelige i årene siden den første markedsføringstilladelse.
English: However, in some patient groups (especially in infants and children) drug administration every 8 hours may give rise to some problems of compliance.
Danish: Hos nogle patientgrupper (navnlig spædbørn og børn) kan der dog være compliance-problemer ved administration hver 8. time.
English: Available data in animal and human do not suggest a reproductive toxicity.
Danish: De foreliggende data fra dyr og mennesker tyder ikke på reproduktionstoksicitet.
English: Quality aspects
Danish: Aspekter vedrørende kvalitet
English: However, when considering the different sites of infection, insufficient data is available to support these potential indications.
Danish: I betragtning af de forskellige infektionssteder er dataene imidlertid utilstrækkelige til at underbygge disse mulige indikationer.
English: The wording on the pharmacotherapeutic group, mechanism of action and ATC code was harmonised.
Danish: Ordlyden vedrørende farmakoterapeutisk gruppe, virkningsmekanisme og ATC-kode blev harmoniseret.
English: The first amoxicillin-containing product was authorised in 1972 and Amoxil has been since authorised in the EU through national procedures.
Danish: Efter at det første amoxicillinprodukt blev godkendt i 1972, er Amoxil siden blevet godkendt i EU ved nationale procedurer.
English: Furthermore the committee considered the advice of the Infectious Diseases Working Party.
Danish: Udvalget tog endvidere anvisningerne fra arbejdsgruppen vedrørende infektionssygdomme i betragtning
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), the European Commission notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product information and thus to harmonise its divergent product information across the EU.
Danish: På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne ved godkendelsen af ovenstående produkter (og relaterede navne), foretog Europa-Kommissionen en officiel indbringelse for Det Europæiske Lægemiddelagentur i medfør af artikel 30 i direktiv 2001/83/EF for at få ophævet divergenserne mellem de nationalt godkendte produktinformationer og dermed harmonisere dem i EU.
English: Therefore, these two possible regimens have been reflected in order for the prescriber to tailor the dosing regimen to the needs of the patient and to improve patient compliance.
Danish: Derfor er begge disse to mulige regimer angivet, så den ordinerende læge kan tilpasse doseringsregimet til patientens behov og forbedre compliance.
English: Infections of the female genital tract are both aetiologically and clinically diverse.
Danish: Infektioner i de kvindelige kønsveje er både ætiologisk og klinisk meget forskelligartede.
English: The use of parenteral formulation showed similar results to the oral formulation.
Danish: Den parenterale formulering gav resultater svarende til den orale formulering.
English: The treatment of acute skin infections was effective in about 60-90% of patients depending on the study.
Danish: Behandlingen af akutte hudinfektioner var effektiv hos 60-90 % af patienterne, afhængigt af undersøgelsen.
English: Recent guidelines (Public Health England guideline 2015, Infectious Diseases Society of America guidelines 2014 and Surgical Society Infections guideline 2011) recommend antibiotics other than amoxicillin for the treatment of most skin and soft tissue infections.
Danish: I nyere retningslinjer (Public Health England guideline 2015, Infectious Diseases Society of America guidelines 2014 og Surgical Society Infections guideline 2011) anbefales andre antibiotika end amoxicillin til de fleste infektioner i hud og underliggende væv.