FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Fluenz can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Fluenz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A risk management plan has been developed to ensure that Fluenz is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Fluenz anvendes så sikkert som muligt.
English: Other information about Fluenz
Danish: Andre oplysninger om Fluenz
English: Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season.
Danish: Hvert år kommer Verdenssundhedsorganisationen (WHO) med anbefalinger om, hvilke influenzastammer der bør medtages i vaccinerne i den kommende influenzasæson.
English: Children who have not been previously vaccinated against seasonal flu should be given a second dose after at least four weeks.
Danish: Børn, som ikke tidligere er blevet vaccineret mod sæsonbestemt influenza, skal have endnu en dosis efter mindst fire uger.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at ”lære” immunsystemet (kroppens naturlige forsvar), hvordan det skal beskytte sig mod en sygdom.
English: These virus strains need to be included in Fluenz before it can be used.
Danish: Disse virusstammer skal være medtaget i Fluenz, før det kan anvendes.
English: Fluenz contains strains of flu virus that have first been weakened so that they do not cause disease.
Danish: Fluenz indeholder influenzavirusstammer, der først er blevet svækket, så de ikke medfører sygdom.
English: It must also not be given to children who are receiving treatment with salicylates (painkillers such as aspirin).
Danish: Det må heller ikke gives til børn, der modtager behandling med salicylater (smertestillende midler såsom aspirin).
English: The immune system will then be able to respond more quickly when it is exposed to the virus again.
Danish: Dermed er immunsystemet i stand til at reagere hurtigere, næste gang det bliver udsat for den samme virus.
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 Fluenz.
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 Fluenz skal anvendes.
English: Fluenz influenza vaccine (live attenuated, nasal)
Danish: Influenzavaccine (levende svækket, nasal)
English: Fluenz is given as a nasal spray using a single-use nasal applicator (0.1 ml sprayed into each nostril).
Danish: Fluenz gives som næsespray ved hjælp af en nasal applikator til engangsbrug (0,1 ml sprøjtes ind i hvert næsebor).
English: It must only be used as a nasal spray and must not be injected.
Danish: Det må kun anvendes som næsespray og må ikke gives som indsprøjtning.
English: What measures are being taken to ensure the safe and effective use of Fluenz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fluenz?
English: The viruses used in Fluenz are grown in hens' eggs.
Danish: De vira, der anvendes i Fluenz, er dyrket i hønseæg.
English: It must also not be given to people with weakened immune systems due to conditions such as blood disorders, symptomatic HIV infection and cancer or as a result of certain medical treatments.
Danish: Det må heller ikke gives til personer med et svækket immunforsvar, der skyldes tilstande såsom blodsygdomme, symptomatisk hivinfektion og kræft, eller som skyldes visse medicinske behandlinger.
English: The flu strains were selected according to the influenza season.
Danish: Influenzastammerne blev udvalgt efter influenzasæsonen.
English: For more information about treatment with Fluenz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Fluenz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes defences against it.
Danish: Når en person får vaccinen, opfatter immunsystemet virussen som ”fremmed” og danner antistoffer mod den.
English: In the studies in children and adolescents, Fluenz reduced the number of flu cases caused by the three flu strains by between 62% and 100% compared with placebo and by between 35% and 53% compared with the comparator inactivated vaccine.
Danish: I undersøgelserne hos børn og unge reducerede Fluenz antallet af influenzatilfælde, som var forårsaget af de tre stammer, med mellem 62 % og 100 % sammenlignet med placebo og med mellem 35 % og 53 % sammenlignet med den inaktiverede sammenligningsvaccine.
English: Fluenz will be updated with weakened virus strains type A-H1N1, type A-H3N2 and type B for each season, according to recommendations for the northern hemisphere from the WHO and from the European Union.
Danish: Fluenz vil blive opdateret med svækkede virusstammer af type A-H1N1, type A-H3N2 og type B for hver sæson i henhold til WHO's og EU's anbefalinger for den nordlige halvkugle.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fluenz, 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 Fluenz, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Fluenz is used to prevent flu in children and adolescents from 24 months to less than 18 years old.
Danish: Fluenz anvendes til at forebygge influenza hos børn og unge, som er over 24 måneder, men under 18 år gamle.
English: The studies in adults showed that Fluenz may have some benefits compared with placebo but the results were inconsistent.
Danish: Undersøgelserne hos voksne viste, at Fluenz kan have nogle fordele sammenlignet med placebo, men resultaterne var ikke entydige.
English: It contains three live attenuated (weakened) influenza (flu) virus strains: A/California/7/2009 (H1N1)pdm09-like strain; A/Victoria/361/2011 (H3N2)-like strain; and B/Massachusetts/2/2012-like strain.
Danish: Den indeholder tre levende, svækkede influenzavirusstammer, nemlig A/California/7/2009 (H1N1)pdm09-lignende stamme, A/Victoria/361/2011 (H3N2)-lignende stamme og B/Massachusetts/2/2012-lignende stamme.
English: Fluenz must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins.
Danish: Fluenz må ikke anvendes til patienter, der er allergiske (overfølsomme) over for de aktive stoffer eller andre af indholdsstofferne, gentamicin (en type antibiotika), æg eller æggeproteiner.
English: Some studies also suggested that Fluenz was not as effective as the comparator inactivated vaccine in adults.
Danish: Nogle undersøgelser viste også, at Fluenz ikke var lige så effektiv som den inaktiverede sammenligningsvaccine hos voksne.
English: The CHMP therefore decided that Fluenz's benefits are greater than its risks in children and adolescents from 24 months to less than 18 years old and recommended that it be given marketing authorisation in this patient group.
Danish: Derfor besluttede CHMP, at fordelene ved Fluenz opvejer risiciene hos børn og unge i alderen 24 måneder til under 18 år, og anbefalede udstedelse af en markedsføringstilladelse for Fluenz for denne patientgruppe.
English: Nine main studies involving around 24,000 children and adolescents and four studies involving around 11,000 adults compared Fluenz with either placebo (a dummy vaccine) or another injectable flu vaccine containing inactivated (killed) viral material from the same three flu strains.
Danish: I ni hovedundersøgelser med ca. 24 000 børn og unge og fire undersøgelser med ca. 11 000 voksne sammenlignede man Fluenz med enten placebo (en virkningsløs behandling) eller en anden injicerbar influenzavaccine, som indeholdt inaktiveret (dræbt) virusmateriale fra de samme tre influenzastammer.
English: The most common side effects with Fluenz (seen in more than 1 patient in 10) are reduced appetite, headache, blocked or runny nose and malaise (feeling unwell).
Danish: De hyppigste bivirkninger ved Fluenz (som optræder hos flere end 1 ud af 10 patienter) er nedsat appetit, hovedpine, tilstoppet eller løbende næse og utilpashed.
English: Fluenz is a vaccine which is available as a nasal spray to protect against influenza A (sub-types H1N1 and H3N2) and influenza B.
Danish: Fluenz er en vaccine, der fås som næsespray, og som beskytter mod influenza A (undertype H1N1 og H3N2) og influenza B.
English: What is the risk associated with Fluenz?
Danish: Hvilken risiko er der forbundet med Fluenz?
English: The CHMP noted that the studies showed convincingly that Fluenz was more effective than placebo and the comparator inactivated vaccine in children and adolescents, but not in adults.
Danish: CHMP bemærkede, at undersøgelserne gav overbevisende dokumentation for, at Fluenz var mere effektivt end placebo og den inaktiverede sammenligningsvaccine hos børn og unge, men ikke hos voksne.
English: Why has Fluenz been approved?
Danish: Hvorfor blev Fluenz godkendt?
English: For the full list of all side effects reported with Fluenz, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Fluenz fremgår af indlægssedlen.
English: What benefit has Fluenz shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fluenz?
English: What is Fluenz?
Danish: Hvad er Fluenz?
English: The vaccine can only be obtained with a prescription.
Danish: Vaccinen udleveres kun efter recept og skal anvendes i overensstemmelse med de officielle anbefalinger.
English: The main measure of effectiveness was the number of laboratory-confirmed cases of flu caused by the three strains during the given flu season, although one of the studies in adults measured the number of cases of feverish illness (as opposed to confirmed flu cases).
Danish: Det primære effektmål var antallet af laboratoriebekræftede influenzatilfælde, som var forårsaget af de tre stammer i den pågældende influenzasæson.
English: What is Fluenz used for?
Danish: Hvad anvendes Fluenz til?
English: How has Fluenz been studied?
Danish: Hvordan blev Fluenz undersøgt?
English: How is Fluenz used?
Danish: Hvordan anvendes Fluenz?
English: How does Fluenz work?
Danish: Hvordan virker Fluenz?
English: Alternative treatments should be used.
Danish: Der bør anvendes alternative behandlinger.
English: The physician educational programme should contain the following key elements:
Danish: Uddannelsesprogrammet for læger bør indeholde følgende nøgleelementer:
English: Co-administration should be avoided.
Danish: Samtidig administration bør undgås.
English: Date of first authorisation: 12 September 2013 Date of latest renewal: 24 April 2019
Danish: Dato for første markedsføringstilladelse: 12 september 2013 Dato for sidste fornyelse: 24 april 2019
English: At each investigation, the need for dose adjustment should be considered.
Danish: Ved hver undersøgelse bør behovet for dosisjustering overvejes.
English: - PSUR - Annual Reassessment
Danish: - PSUR - årlig revurdering
English: You may for example take one capsule in the morning and one in the evening.
Danish: Du kan f.eks. tage en kapsel om morgenen og en om aftenen.
English: This way, you will have to take fewer capsules at once.
Danish: På den måde skal du tage færre kapsler på samme tid.
English: The dose recommendations reflect the use in this population.
Danish: Dosisanbefalingerne afspejler anvendelsen i denne population.
English: The dose should be adjusted accordingly, as described above.
Danish: Dosis bør tilpasses som beskrevet ovenfor.
English: There is no experience in elderly patients.
Danish: Der er ingen erfaring med ældre patienter.
English: Make sure you see your doctor for these regular examinations at least once a year.
Danish: Sørg for at gå til læge og få foretaget disse undersøgelser mindst én gang om året.
English: However, absolute numbers of cases are small.
Danish: Det absolutte antal patienter er imidlertid lille.
English: If you take these medicines, take Orphacol at least 5 hours before or at least 5 hours after taking these other medicines.
Danish: Hvis du tager disse lægemidler, skal du tage Orphacol mindst 5 timer før eller mindst 5 timer efter, at du har taget de andre lægemidler.
English: Due to the rarity of the diseases, the information about the most serious and/or most frequently occurring adverse reactions is limited.
Danish: Grundet sygdommenes sjældenhed er oplysninger om de alvorligste og/eller hyppigst forekommende bivirkninger er begrænsede.
English: Patients should be monitored as follows: 3-monthly during the first year, 6-monthly during the subsequent three years and annually thereafter (see below).
Danish: Patienterne bør monitoreres som følger: hver 3. måned i det første år, hver 6. måned i de efterfølgende tre år og herefter årligt (se nedenfor).
English: Progress and results from the database will form the basis of the annual reassessments of the benefit/risk profile of Orphacol.
Danish: Fremskridt og resultater fra databasen vil udgøre grundlaget for de årlige revurderinger af Orphacols risk/benefit-profil.
English: You can help by reporting any side effects you may get.
Danish: Du kan hjælpe ved at indberette alle de bivirkninger, de får.
English: If you become pregnant during treatment with Orphacol, your doctor will decide which treatment and dose is best in your situation.
Danish: Hvis du bliver gravid under behandling med Orphacol, beslutter din læge, hvilken behandling og dosis der er bedst i din situation.
English: Other food such as fruit compote or yoghurt may be suitable for administration, but no data on the compatibility or palatability are available.
Danish: Andre fødevarer, f.eks. frugtkompot eller yoghurt, kan være velegnet til administration, men der foreligger ingen data vedrørende kompatibilitet eller velsmag.
English: This rarity also made the conduct of controlled clinical studies impossible.
Danish: Dette har også gjort det umuligt at udføre klinisk kontrollerede undersøgelser.
English: Pack sizes: 30, 60, 120.
Danish: Pakningsstørrelser: 30, 60, 120.
English: Please tell your doctor if you are taking ciclosporin.
Danish: Fortæl det til lægen, hvis du tager ciclosporin.
English: As a precautionary measure, pregnant women and their unborn children should be closely monitored.
Danish: Som en sikkerhedsforanstaltning bør gravide kvinder og deres ufødte børn monitoreres nøje.
English: If itching and/or diarrhoea last for more than three days, tell your doctor.
Danish: Hvis kløen og/eller diarréen varer i mere end tre dage, skal du fortælle det til lægen.
English: There is a limited amount of data (less than 20 pregnancy outcomes) from the use of cholic acid in pregnant women.
Danish: Der foreligger begrænsede data (mindre end 20 graviditetsudfald) vedrørende brug af cholsyre til gravide kvinder.
English: Ciclosporin (a medicine used to suppress the immune system) may also change the effect of Orphacol.
Danish: Ciclosporin (et lægemiddel, som bruges til at undertrykke immunsystemet) kan også ændre Orphacols virkning.
English: If your doctor has prescribed a dose which requires you to take more than one capsule per day, you and your doctor can decide how this will be taken during the day.
Danish: Hvis din læge har ordineret en dosis, som kræver, at du tager flere kapsler hver dag, kan du og din læge beslutte, hvordan det skal ske i løbet af dagen.
English: The dose will then be further adjusted by your doctor depending on your body's response.
Danish: Dosis justeres derefter yderligere af din læge, afhængigt af hvordan din krop reagerer på medicinen.
English: Please consult your doctor if you plan to become pregnant.
Danish: Tal med din læge, hvis du har planer om at blive gravid.
English: PVC/PVDC-aluminium blister of 10 capsules.
Danish: PVC/PVDC-aluminiumsblisterkort med 10 kapsler.
English: PC: {number}
Danish: PC: {nummer}
English: There is a risk of permanently damaging your liver if you stop taking Orphacol.
Danish: Der er risiko for permanent skade på leveren, hvis du holder op med at tage Orphacol.
English: Take a pregnancy test as soon as you suspect you may be pregnant.
Danish: Tag en graviditetstest, så snart du har mistanke om, at du er gravid.
English: Taking Orphacol at regular times with a meal will help you remember to take this medicine, and may help your body to better take it up.
Danish: Hvis du tager Orphacol regelmæssigt sammen med et måltid, vil det hjælpe dig med at huske at tage medicinen, og det kan hjælpe din krop med at optage den bedre.
English: SN: {number} NN: {number}
Danish: SN: {nummer} NN: {nummer}
English: The frequency of these reactions is not known (cannot be estimated from the available data).
Danish: Hyppigheden af disse bivirkninger er ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is very important to continue taking Orphacol during pregnancy.
Danish: Det er meget vigtigt at fortsætte med at tage Orphacol under graviditeten.
English: As a precaution, you and your unborn child should be closely monitored during pregnancy.
Danish: Som en sikkerhedsforanstaltning skal du og dit ufødte barn overvåges nøje under graviditeten.
English: Reports on recruitment progress of the patient surveillance database will be analysed and reported to the CHMP at the time of PSURs (for safety) and of the Annual Reassessments (for efficacy and safety).
Danish: Rapporter om rekrutteringsfremskridt i patientovervågningsdatabasen vil blive analyseret og indberettet til CHMP på tidspunktet for PSUR'er (sikkerhed) og på tidspunktet for de årlige revurderinger (virkning og sikkerhed).
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende ig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Administration of these medicinal products is expected to reduce the effect of cholic acid.
Danish: Administration af disse lægemidler forventes at reducere virkningen af cholsyre.
English: In adults, the daily dose should not exceed 500 mg.
Danish: Hos voksne må den daglige dosis ikke overstige 500 mg.
English: The lowest dose of cholic acid that effectively reduces the bile acid metabolites to as close to zero as possible should be chosen.
Danish: Den laveste dosis cholsyre, som effektivt reducerer galdesyremetabolitterne til så tæt på nul som muligt, bør vælges.
English: Capsules must be swallowed whole with water.
Danish: Kapslerne skal sluges hele med vand.
English: Do not use Orphacol after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke Orphacol efter den udløbsdato, der står på pakningen eller blisteren.
English: Treatment should be stopped earlier if there are clear indicators of severe hepatic failure.
Danish: Behandlingen bør ophøre tidligere, hvis der er klare indikatorer for svært leversvigt.
English: Your doctor will prescribe laboratory tests on your blood, urine and liver for you when you start treatment and regularly thereafter.
Danish: Din læge vil sørge for laboratorietest af blod-, urin- og leverprøver, når du starter behandlingen, og derefter med jævne mellemrum.
English: In the case of an accidental overdose, treatment should be continued at the recommended dose after normalisation of clinical signs and/or biological abnormalities.
Danish: I tilfælde af en utilsigtet overdosis bør behandling fortsættes med den anbefalede dosis efter normalisering af de kliniske tegn og/eller biologiske abnormiteter.
English: Familial hypertriglyceridemia
Danish: Familiær hypertriglyceridæmi
English: No pharmacokinetic study data for Orphacol are available.
Danish: Der foreligger ingen farmakokinetiske undersøgelsesdata for Orphacol.
English: It is extremely important that pregnant women continue their therapy during pregnancy.
Danish: Det er meget vigtigt, at gravide kvinder fortsætter behandlingen under graviditeten.
English: The available non-clinical data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Danish: De tilgængelige ikke-kliniske data i litteraturen viser ingen særlig risiko for mennesker vurderet ud fra undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, carcinogenicitet og reproduktionstoksicitet.
English: This medicine has been authorised under “Exceptional Circumstances”.
Danish: Dette lægemiddel er godkendt under "særlige omstændigheder".
English: 30 hard capsules 60 hard capsules 120 hard capsules
Danish: 30 hårde kapsler 60 hårde kapsler 120 hårde kapsler
English: The studies have however not been conducted to the same level of detail as for a pharmaceutical agent, as cholic acid is a physiological substance in animals and humans.
Danish: Der er dog ikke udført undersøgelser med samme detaljeringsgrad som for et lægemiddelstof, da cholsyre er et fysiologisk stof, som findes i dyr og mennesker.
English: Regular and fixed times of administration support the patient's or caregiver's compliance.
Danish: Regelmæssige og faste tidspunkter for administration understøtter compliance.
English: He will assess your laboratory test results and advise you when you should resume your treatment with your normal dose.
Danish: Han vurderer dine laboratorieresultater og rådgiver dig om, hvornår du skal fortsætte behandlingen med den normale dosis.
English: Episodes of symptomatic overdose have been reported, including accidental overdose.
Danish: Der er rapporteret om episoder med symptomatisk overdosering, herunder utilsigtet overdosering.
English: Administered orally, bile acids and salts generally have only a minor toxic potential.
Danish: Galdesyrer og salte, som administreres oralt, har generelt kun mindre toksisk potentiale.
English: Diarrhoea, increased transaminases and pruritus have been associated with overdosage and disappeared after dose reduction.
Danish: Diarré, forhøjede transaminaser og pruritus har været forbundet med overdosering og forsvandt efter dosisreduktion.
English: CTRS commits to monitor the safety and efficacy in patients treated with Orphacol from a patient surveillance database for which the protocol has been endorsed by the CHMP and is documented in the Orphacol RMP.
Danish: CTRS forpligter sig til at monitorere sikkerhed og virkning hos patienter, der behandles med Orphacol, ud fra en patientovervågningsdatabase, for hvilken protokollen er blevet godkendt af CHMP og er dokumenteret i risikostyringsprogrammet for Orphacol.
English: Additional or more frequent investigations should be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Danish: Yderligere eller hyppigere undersøgelser bør foretages for at monitorere behandlingen i perioder med hurtig vækst, sygdom og graviditet (se pkt.
English: The daily dose may be divided if it consists of more than one capsule in order to mimic the continuous production of cholic acid in the body and to reduce the number of capsules that need to be taken per administration.
Danish: Hvis den daglige dosis består af mere end én kapsel, kan dosis opdeles for at efterligne den kontinuerlige produktion af cholsyre i kroppen og reducere det antal kapsler, der skal tages pr. administration.
English: They are contained in blisters of 10 capsules each.
Danish: De fås i blisterkort med 10 kapsler i hvert.