FrancophonIA/ELRC3.0 huggingface dataset:
English: The full extent of the risks of dextropropoxyphene-containing medicine only became apparent when looking at complete forensic data and national mortality statistics, including toxicology data.
Danish: Det fuldstændige omfang af de risici, som lægemidler indeholdende dextropropoxyphen medfører, blev først klart, da man så på de samlede retsmedicinske data og på de nationale dødsstatistikker, herunder toksikologidata.
English: The CHMP concluded that the available data showed that dextropropoxyphene-containing medicines were weak painkillers, and only have limited effectiveness in the treatment of pain.
Danish: CHMP konkluderede, at de foreliggende data viste, at lægemidler indeholdende dextropropoxyphen var svage smertestillende midler og kun havde begrænset virkning ved behandlingen af smerte.
English: Following the re-examination, the Committee confirmed that the benefits of non-parenteral forms of dextropropoxyphene-containing medicines do not outweigh their risks and recommended their withdrawal.
Danish: Efter revurderingen bekræftede udvalget, at fordelene ved ikke-parenterale former for lægemidler indeholdende dextropropoxyphen ikke opvejer risiciene, og udvalget anbefalede deres tilbagetrækning.
English: During the re-examination, the CHMP looked again at the data it had previously received, taking into consideration the different forms of dextropropoxyphene-containing medicines.
Danish: Under revurderingen gennemgik CHMP igen de data, som det havde modtaget tidligere, og undersøgte de forskellige former for lægemidler, der indeholder dextropropoxyphen.
English: • Prescribers should carefully consider the best alternative treatments for patients currently taking dextropropoxyphene-containing medicines in line with national recommendations.
Danish: • De ordinerende læger skal nøje overveje de bedste alternative behandlinger til patienter, som i øjeblikket tager lægemidler, der indeholder dextropropoxyphen, i tråd med de nationale anbefalinger.
English: What were the conclusions of CHMP after the initial review?
Danish: Hvad konkluderede CHMP efter den indledende vurdering?
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of all medicines containing dextropropoxyphene, either on its own or in combination, do not outweigh their risks.
Danish: På baggrund af vurderingen af de tilgængelige data og den faglige drøftelse i udvalget konkluderede CHMP, at fordelene ved alle lægemidler, der indeholder dextropropoxyphen, både alene og som kombination, ikke opvejer risiciene.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of dextropropoxyphene do not outweigh its risks, and recommended that all marketing authorisations for dextropropoxyphene-containing medicines should be withdrawn throughout the European Union (EU).
Danish: EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved dextropropoxyphen ikke opvejer risiciene, og udvalget anbefalede en tilbagetrækning af alle markedsføringstilladelser for lægemidler, der indeholder dextropropoxyphen, i hele EU.
English: The CHMP also concluded that data from several Member States, specifically those from forensic centres and national mortality statistics, showed a significant number of deaths associated with overdose in patients taking dextropropoxyphene.
Danish: CHMP konkluderede også, at data fra flere medlemsstater, navnlig retsmedicinske data og nationale dødsstatistikker, viste et betydeligt antal dødsfald i forbindelse med en overdosis hos patienter, der tog dextropropoxyphen.
English: • Patients who have any dextropropoxyphene-containing medicines that they are no longer using are encouraged to take them to their pharmacist for safe disposal.
Danish: • Patienter, som er i besiddelse af lægemidler, der indeholder dextropropoxyphen, og som de ikke længere bruger, opfordres til at aflevere dem på apoteket, så de kan bortskaffes på en sikker måde.
English: • Patients who are currently receiving dextropropoxyphene-containing medicines should speak to their doctor at their next appointment to review their treatment.
Danish: • Patienter, som i øjeblikket får lægemidler, der indeholder dextropropoxyphen, bør ved næste besøg tale med deres læge om en ændring af behandlingen.
English: The CHMP noted that data from case reports of fatal overdose and from national poison centres underestimate the number of deaths from overdose with dextropropoxyphene-containing medicines.
Danish: CHMP bemærkede, at man i data fra case-rapporter og fra nationale giftinformationscentraler om dødelig overdosis undervurderer antallet af dødsfald som følge af en overdosis med lægemidler, der indeholder dextropropoxyphen.
English: The CHMP initially reviewed data presented by the companies that market dextropropoxyphenecontaining medicines, providing information on the efficacy and the safety of their medicines.
Danish: CHMP startede med at vurdere de data, der var fremlagt af de virksomheder, som markedsfører lægemidler indeholdende dextropropoxyphen, og som indeholdt oplysninger om lægemidlernes virkning og sikkerhed.
English: What were the conclusions of the CHMP following the re-examination?
Danish: Hvad konkluderede CHMP efter revurderingen?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Metalyse on 23 February 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Metalyse den 23. februar 2001.
English: This document is a summary of the European Public Assessment Report (EPAR) for Metalyse.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Metalyse.
English: If treatment is necessary in these patients, facilities for resuscitating them must be readily available.
Danish: Hvis det er nødvendigt at behandle disse patienter, skal der være adgang til genoplivningsfaciliteter.
English: The full EPAR for Metalyse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Metalyse findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It contains the active substance tenecteplase.
Danish: Det indeholder det aktive indholdsstof tenecteplase.
English: Around 94% of patients who received either medicine were alive 30 days after treatment.
Danish: Ca. 94 % af de patienter, der fik lægemidlet, var i live efter 30 dages behandling.
English: Other information about Metalyse:
Danish: Andre oplysninger om Metalyse:
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 Metalyse.
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 Metalyse skal anvendes.
English: Based on this and all other available data, the Committee decided that Metalyse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Baseret herpå og og på de tilgængelige data besluttede udvalget, at fordelene ved Metalyse opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: The dose to be given is adjusted according to the patient's weight (see the package leaflet).
Danish: Doseringen tilpasses patientens vægt (se indlægssedlen).
English: The patients were given either medicine within six hours of their symptoms appearing in addition to either aspirin or heparin.
Danish: Patienterne fik noget af lægemidlet inden for seks timer, efter at deres symptomer opstod, ud over enten aspirin eller heparin.
English: Tenecteplase is made by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Danish: Tenecteplase produceres via en metode, der er kendt som ”rekombinant DNA-teknologi”: Det fremstilles af en celle, som har modtaget et gen (DNA), der sætter den i stand til at producere dette stof.
English: For more information about treatment with Metalyse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Metalyse, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP noted that while Metalyse was as effective as alteplase in preventing death, it caused less serious bleeding, which meant that fewer blood transfusions were required.
Danish: CHMP konkluderede, at selvom Metalyse er ligeså effektivt som alteplase til at forebygge dødsfald, forårsager det færre blødninger, hvilket betyder, at der er brug for færre blodtransfusioner.
English: The main measure of effectiveness was the number of patients who were alive 30 days after treatment.
Danish: Virkningen blev hovedsagelig bedømt på antallet af patienter, der var i live efter 30 dages behandling.
English: Treatment with Metalyse should be started as soon as possible after the start of heart attack symptoms.
Danish: Behandling med Metalyse skal indledes så hurtigt som muligt, efter at symptomerne på hjertetilfældet opstår.
English: In addition to Metalyse, the patient should also be treated with other medicines that are used to prevent blood clots such as aspirin and heparin.
Danish: Ud over Metalyse skal patienten også behandles med andre lægemidler, der anvenders til at forebygge blodpropper, såsom aspirin og heparin.
English: The most common bleedings (seen in between 1 and 10 patients in 100) are epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), ecchymosis (bleeding beneath the skin), urogenital haemorrhage (bleeding from the structures that carry urine or from the genital area), bleeding at the injection site, and bleeding at puncture site.
Danish: De hyppigste blødninger (optræder hos mellem 1 og 10 patienter ud af 100) er epistaxis (næseblod), gastrointestinale blødninger (blødninger i mave eller tarm), ekkymose (blødning under huden), urogenital blødning (blødning fra urinvejene eller fra det genitaleområde), blødning på injektionsstedet og blødning på punkturstedet.
English: Metalyse is a powder and a solvent that are made up into a solution for injection.
Danish: Metalyse er pulver og solvens, der blandes til en opløsning til injektion.
English: Metalyse should be prescribed by doctors who have experience in the use of thrombolytic treatments (treatments to dissolve blood clots).
Danish: Metalyse skal ordineres af læger, som har erfaring med trombolytisk behandling (behandling til opløsning af blodpropper).
English: It works by converting a protein in the clots called plasminogen into its active form, plasmin, which breaks down the fibrous protein holding the clot together.
Danish: Det virker ved at omdanne et protein i blodpropperne kaldet plasminogen til dets aktive form, plasmin, som nedbryder fiberproteinet, der holder blodproppen sammen.
English: What is the risk associated with Metalyse?
Danish: Hvilken risiko er der forbundet med Metalyse?
English: Metalyse was compared with alteplase (another medicine used to treat heart attacks) in one main study involving about 17,000 adults who were having a heart attack.
Danish: Metalyse blev sammenlgnet med alteplase (et andet lægemidddel, som anvendes til behandling af hjertetilfælde) i en hovedundersøgelse, som omfattede ca. 17 000 voksne, der havde haft et hjertetilfælde.
English: It is used to dissolve the blood clots that have formed inside the blood vessels supplying the heart.
Danish: Det anvendes til at opløse de blodpropper, som er opstået i de blodkar, der forsyner hjertet
English: Metalyse is used to treat adults suspected of having an acute myocardial infarction (heart attack) within six hours of the first symptoms appearing.
Danish: Metalyse anvendes til at behandle voksne, som formodes at have haft et akut myokardieinfarkt (hjertetilfælde), inden for 6 timer efter de første symptomer.
English: Metalyse should not be used in patients who have or have had recent bleeding problems or major surgery, or have a disease which may cause bleeding (such as a past stroke or severe high blood pressure).
Danish: Metalyse må ikke anvendes til patienter, der har eller for nylig har haft blødningsproblemer eller som har gennemgået en stor operation, eller til patienter, der har en sygdom, som kan forårsage blødninger (for eksempel slagtilfælde eller stærkt forhøjet blodtryk).
English: Metalyse was as effective as alteplase in keeping patients alive after a heart attack.
Danish: Metalyse var lige så virksomt som alteplase, når det gælder om at holde folk i live efter et hjertetilfælde.
English: Metalyse is given once as a single injection into a vein over around 10 seconds.
Danish: Metalyse gives én gang som engangsinjektion i en vene i løbet af 10 sekunder.
English: Why has Metalyse been approved?
Danish: Hvorfor blev Metalyse godkendt?
English: Metalyse should not be used in people who have had an anaphylactic reaction (a severe, lifethreatening allergic reaction) to tenecteplase, gentamicin (an ingredient found in the medicine) or any of the other ingredients.
Danish: Metalyse må ikke anvendes af personer, der har haft en anafylaktisk reaktion (en svær livstruende allergisk reaktion over for tenecteplase, gentamicin (at indholdsstof i lægemidlet) eller et eller flere af de øvrige indholdsstoffer.
English: The active substance in Metalyse, tenecteplase, is a modified copy of the human enzyme ‘tissue plasminogen activator', which the body uses to break down clots.
Danish: Det aktive stof i Metalyse, tenecteplase, er en modificeret form af et naturligt enzym, human plasminogenaktivator, som kroppen anvender til at nedbryde blodpropper.
English: For the full list of all side effects reported with Metalyse, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Metalyse fremgår af indlægssedlen.
English: The most common side effect with Metalyse was haemorrhage (bleeding).
Danish: De hyppigste bivirkninger af Metalyse er blødninger.
English: What is Metalyse?
Danish: Hvad er Metalyse?
English: With the blood clot broken down, blood can flow more easily into the heart muscle, allowing the heart to keep working and helping to save the patient's life.
Danish: Når blodproppen er nedbrudt, kan blodet lettere flyde ind i hjertemusklen.
English: What benefit has Metalyse shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Metalyse?
English: How has Metalyse been studied?
Danish: Hvordan blev Metalyse undersøgt?
English: What is Metalyse used for?
Danish: Hvad anvendes Metalyse til?
English: How is Metalyse used?
Danish: Hvordan anvendes Metalyse?
English: How does Metalyse work?
Danish: Hvordan virker Metalyse?
English: • The handling of ChondroCelect and its preparation for the implantation
Danish: • Håndtering af ChondroCelect og præparering af dette til implantation
English: • The surgical checklist to be completed at the operating theatre immediately prior to the first incision confirming the right patient, the right product, the right side of the implantation, and the type of biological membrane and fibrin sealant to be used in the procedure.
Danish: • Den kirurgiske tjekliste, som skal udfyldes på operationsstuen umiddelbart forud for første incision, hvorpå det bekræftes, at det er den rigtige patient, det rigtige lægemiddel, den rigtige side af implantationen, og hvilken type biologisk membran og fibrinforsegling der vil blive
English: The Marketing Authorisation Holder (MAH) shall ensure that the medicinal product will be distributed only to Healthcare Establishments that meet criteria described in the Risk Management Plan.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at lægemidlet kun udleveres til hospitaler og sundhedsinstitutioner, som opfylder de kriterier, der er beskrevet i risikostyringsplanen.
English: • The need for screening of donors using patient questionnaire and laboratory tests for hepatitis C,
Danish: • Behovet for screening af donorer ved hjælp af patientspørgeskema og laboratorieprøver for hepatitis C, hepatitis B, HIV og syfilis
English: • The implantation procedure by knee-joint arthrotomy
Danish: • Implantationsproceduren ved artrotomi i knæled
English: The educational programme for healthcare professionals contains the following components:
Danish: Uddannelsesprogrammet for sundhedspersonale indeholder følgende komponenter:
English: • Training material for other Healthcare Professionals • Informed consent for the patients to be signed prior to the treatment with ChondroCelect
Danish: • Undervisningsmateriale for andet sundhedspersonale • Erklæring om informeret samtykke, som patienter skal underskrive forud for behandling med
English: The training materials for Surgeons shall include the following key messages and components:
Danish: Undervisningsmaterialerne for kirurger skal omfatte følgende centrale budskaber og komponenter:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL INDFØRES
English: The Marketing Authorisation Holder (MAH) shall ensure, prior to the distribution of the product to a particular Healthcare Establishment, that all surgeons and other healthcare professionals involved in the handling and administration of ChondroCelect or its components, as well as those involved in follow-up of patients treated with ChondroCelect in the Healthcare Establishment, receive training as per the educational programme described in the Risk Management Plan.
Danish: Forud for udleveringen af lægemidlet til en bestemt sundhedsinstitution skal indehaveren af markedsføringstilladelsen sikre, at følgende personer modtager uddannelse som anført i uddannelsesprogrammet, der er beskrevet i risikostyringsplanen: Alle kirurger og andet sundhedspersonale, som er inddraget i håndteringen og administrationen af ChondroCelect og komponenterne heri, samt de personer, som er inddraget i opfølgningen af de patienter, der er blevet behandlet med ChondroCelect i sundhedsinstitutionen.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL INDFØRES AF MEDLEMSSTATERNE
English: The training material for other Healthcare Professionals shall include the following key messages and components:
Danish: Undervisningsmaterialerne for andet sundhedspersonale skal omfatte følgende centrale budskaber og komponenter:
English: This summary was last updated in 01-2011.
Danish: Dette sammendrag blev sidst ajourført i 01-2011.
English: The marketing authorisation is valid for
Danish: Markedsføringstilladelsen er
English: What is the risk associated with Prevenar?
Danish: Hvilken risiko er der forbundet med Prevenar?
English: This is a summary of the European public assessment report (EPAR) for Prevenar.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Prevenar.
English: The additional studies showed that Prevenar was safe and effective in children up to the age of five years.
Danish: De yderligere undersøgelser viste, at Prevenar var sikkert og effektivt til børn i alderen op til fem år.
English: The full EPAR for Prevenar can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Prevenar findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Prevenar is a vaccine.
Danish: Prevenar er en vaccine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar to Wyeth Lederle Vaccines S.A. on 2 February 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prevenar til Wyeth Lederle Vaccines S.A. den 2. februar 2001.
English: The vaccination schedule to be used depends on the age of the child and should be based on official
Danish: Det vaccinationsprogram, der skal anvendes, afhænger af barnets alder og bør være baseret på
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
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 anvendelsesbetingelserne for Prevenar.
English: For the full list of all side effects reported with
Danish: Den fuldstændige liste over de indberettede bivirkninger for
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium again.
Danish: Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, hvis det udsættes for samme bakterie igen.
English: For more information about treatment with Prevenar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Prevenar, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Prevenar was given at two, four, six and 12 to 15 months of age.
Danish: Prevenar blev givet, da børnene var to, fire, seks og 12-15 måneder gamle.
English: A fourth dose (booster) is recommended in the second year of life.
Danish: Det anbefales at give en fjerde dosis (boosterdosis) i barnets andet leveår.
English: Alternatively, when Prevenar is given as part of a ‘universal infant immunisation programme' (when all infants in an area are vaccinated at around the same time), two doses can be given with an interval of at least two months, followed by a booster at 11 to 15 months of age.
Danish: Alternativt kan der, når Prevenar gives inden for et almindeligt immuniseringsprogram (når alle spædbørn i et område vaccineres omtrent samtidigt), gives to doser med et interval på mindst to måneder, efterfulgt af en booster ved 1115-måneders alderen.
English: The CHMP decided that Prevenar's benefits are greater than its risks and recommended that Prevenar
Danish: CHMP konkluderede, at fordelene ved Prevenar opvejer risiciene og anbefalede udstedelse af
English: A third dose is recommended in the second year of life.
Danish: Det anbefales at give en tredje dosis i barnets andet leveår.
English: The most common side effects with Prevenar (seen in more than 1 patient in 10) are vomiting, diarrhoea, loss of appetite, reactions at the site of the injection (redness, hardening, swelling or pain), fever, irritability, drowsiness and restless sleep.
Danish: De hyppigste bivirkninger ved Prevenar (der ses hos flere end 1 ud af 10 patienter) er opkastning, diarré, appetitløshed, reaktioner på injektionsstedet (rødme, hårdhed, hævelse eller smerte), feber, irritabilitet, døsighed og urolig søvn.
English: Prevenar contains the polysaccharides from different types of S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F).
Danish: Prevenar indeholder polysakkarider fra forskellige typer af S. pneumoniae (serotype 4, 6B, 9V, 14, 18C, 19F og 23F).