FrancophonIA/ELRC3.0 huggingface dataset:
English: EMA recommends new safety measures for Zydelig
Danish: EMA anbefaler nye sikkerhedsforanstaltninger for Zydelig
English: 1 For more information see here.
Danish: 1 Yderligere information findes her.
English: The review of Zydelig has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Danish: Eftersynet af Zydelig blev indledt den 11. marts 2016 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: Other excess deaths related mainly to respiratory events.
Danish: Andre ekstra dødsfald var hovedsageligt forbundet med respiratoriske hændelser.
English: To ensure that the medicine is used as safely as possible changes have been made to the way the medicine is used:
Danish: For at sikre at medicinen bruges så sikkert som muligt, er der foretaget ændringer i den måde, medicinen bruges på:
English: Patients who are already on treatment will have their treatment reviewed by their doctor.
Danish: Patienter, som allerede er i behandling, vil få deres behandling vurderet af lægen.
English: In case of neutropenia your doctor may stop your treatment with Zydelig.
Danish: I tilfælde af neutropeni kan din læge stoppe din behandling med Zydelig.
English: • Patients should be informed about the risk of serious infections with Zydelig.
Danish: • Patienter skal informeres om risikoen for alvorlige infektioner med Zydelig.
English: 18 March 2016 EMA/201814/2016
Danish: Den 23. marts 2016 EMA/309645/2016
English: More information on the approved uses of Zydelig can be found here.
Danish: Yderligere information om de godkendte anvendelser af Zydelig findes her.
English: You should contact your doctor straight away if you develop fever, cough or difficulty breathing.
Danish: Kontakt straks lægen, hvis du får feber, hoste eller vejrtrækningsbesvær.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Danish: Det sidste trin i eftersynsproceduren er Europa-Kommissionens vedtagelse af en retligt bindende beslutning med gyldighed i alle EU's medlemslande.
English: If you are taking Zydelig and have any questions or concerns speak to your doctor or pharmacist.
Danish: Hvis du tager Zydelig og har spørgsmål eller bekymringer, skal du tale med lægen eller apotekspersonalet.
English: • You should not stop Zydelig before speaking to your doctor.
Danish: • Du skal ikke holde op med at tage Zydelig, før du har talt med lægen.
English: Healthcare professionals will be informed in writing about the precautionary measures to be taken.
Danish: Sundhedspersonale er blevet skriftligt underrettet om de sikkerhedsforanstaltninger, der skal følges.
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended.
Danish: Regelmæssig klinisk og laboratoriemæssig monitorering for cytomegalovirus-infektion anbefales også.
English: However, these studies did not use the medicine in the same way as currently authorised.
Danish: Disse studier vurderede dog ikke lægemidlet i dets aktuelt godkendte brug.
English: Measures include close monitoring and use of antibiotics to prevent pneumonia
Danish: Sikkerhedsforanstaltningerne inkluderer tæt monitorering og brug af antibiotika til at forebygge lungebetændelse
English: Once the review is concluded, EMA will communicate further and provide guidance to patients and healthcare professionals.
Danish: Når undersøgelsen er gennemført, vil EMA kommunikere yderligere med råd til patienter og sundhedspersonale.
English: There have been reports of serious side effects in clinical studies with the cancer medicine Zydelig.
Danish: Der er blevet rapporteret alvorlige bivirkninger i kliniske studier med kræftmedicinen Zydelig.
English: These are provisional recommendations which the PRAC has issued, as a precaution, to protect patients while the medicine is being reviewed.
Danish: Disse er foreløbige anbefalinger udstedt af PRAC som en sikkerhedsforanstaltning for at beskytte patienterne, mens lægemidlet gennemgås.
English: Doctors should reevaluate each patient taking Zydelig first-line for CLL, and only continue treatment if the benefits outweigh the risks.
Danish: Læger skal reevaluere hver enkelt patient, som tager Zydelig som førstelinjebehandling for CLL, og kun fortsætte behandlingen, hvis fordelene opvejer risiciene.
English: While the review is ongoing the PRAC has made a set of provisional recommendations to protect public health.
Danish: Mens eftersynet foregår, har PRAC udstedt en række foreløbige anbefalinger for at beskytte den offentlige sundhed.
English: • Your doctor will order regular blood tests to minimise the risk of infections or neutropenia (low white blood cell count which may make you more likely to develop an infection).
Danish: • Din læge vil ordinere regelmæssige blodprøver for at mindske risikoen for infektioner eller neutropeni (lavt antal hvide blodlegemer, som kan gøre det mere sandsynligt, at du udvikler en infektion).
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Danish: Eftersynet foretages af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for at vurdere sikkerhedsspørgsmål vedrørende lægemidler til mennesker.
English: • a type of non-Hodgkin lymphoma called follicular lymphoma where it is used on its own.
Danish: • en form for non-Hodgkin lymfom kaldet follikulært lymfom, hvor det bruges alene.
English: Once the PRAC review is concluded any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt a final opinion.
Danish: Når PRAC-eftersynet er gennemført, vil eventuelt yderligere anbefalinger blive sendt til Udvalget for Humanmedicinske Lægemidler (CHMP), der er ansvarlig for spørgsmål vedrørende medicin til mennesker, og som vil træffe en endelig afgørelse.
English: Most deaths related to infections such as Pneumocystis jirovecii pneumonia and cytomegalovirus infections.
Danish: De fleste dødsfald var forbundet med infektioner som f.eks. Pneumocystis jirovecii pneumoni og cytomegalovirus-infektioner.
English: • Patients should also have regular checks of their blood counts to detect neutropenia.
Danish: • Patienter skal også have regelmæssig kontrol af deres blodtal til påvisning af neutropeni.
English: • Studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indication and investigated a combination of medicines not currently approved.
Danish: • Studierne af non-Hodgkin lymfom omfattede patienter med sygdomskarakteristika, der var forskellige fra dem, der er dækket under de aktuelt godkendte indikationer og undersøgte en kombination af lægemidler, der aktuelt ikke er godkendt.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) to ensure that it continues to be used as safely as possible.
Danish: Den 17. marts 2016 udstedte EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) foreløbige råd til læger og patienter, som bruger kræftlægemidlet Zydelig (idelalisib) for at sikre, at det fortsat bruges så sikkert som muligt.
English: • Further details on these provisional measures will be provided in writing to healthcare professionals and the product information will be updated accordingly.
Danish: • Yderligere detaljer om disse foreløbige sikkerhedsforanstaltninger er blevet sendt i skriftligt form til sundhedspersonale, og produktinformationen er blevet opdateret, så den afspejler de ovennævnte sikkerhedsforanstaltninger.
English: • Further information on Zydelig will be provided as necessary.
Danish: • Yderlige information om Zydelig vil blive givet efter behov.
English: The clinical trials, which have now been stopped, involved patients with CLL and indolent non-Hodgkin lymphoma.
Danish: Disse kliniske forsøg, som nu er blevet stoppet, omfattede patienter med CLL og indolent non-Hodgkin lymfom.
English: Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called nonHodgkin lymphoma).
Danish: Zydelig er aktuelt godkendt i EU til behandling af to typer blodkræft kaldet kronisk lymfatisk leukæmi (CLL) og follikulært lymfom (én af en gruppe kræftformer kaldet non-Hodgkin lymfom).
English: • All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and should be monitored for respiratory signs and symptoms.
Danish: • Alle patienter skal have profylaktisk behandling for P. jirovecii pneumoni under behandling med Zydelig og monitoreres for respiratoriske tegn og symptomer.
English: • If you are taking Zydelig, you will receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia) and be monitored for signs of infections.
Danish: • Hvis du tager Zydelig, vil du få antibiotika for at forebygge en speciel type lungebetændelse (Pneumocystis jirovecii pneumoni), og du vil blive overvåget for tegn på infektioner.
English: The PRAC recommends that all patients treated with Zydelig should receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia).
Danish: PRAC anbefalede, at alle patienter i behandling med Zydelig skal have antibiotika for at forebygge en speciel type lungebetændelse (Pneumocystis jirovecii pneumoni).
English: Patients should also be monitored for infection and have regular blood tests for white cell counts because low counts can increase their risk of infection.
Danish: Patienterne skal også monitoreres for infektioner og have regelmæssige blodprøver til monitorering af deres neutrofiltal, da et lavt tal kan øge deres risiko for infektion.
English: • Further information on the review of Zydelig will be provided as necessary and once the review is concluded.
Danish: • Yderligere information om eftersynet af Zydelig vil blive givet efter behov, og når dette er gennemført.
English: These will now be forwarded to the European Commission (EC), which will issue a provisional legally binding decision applicable in all EU Members States.
Danish: Disse er sendt til Europa-Kommissionen (EC), som udstedte en foreløbig retlig bindende beslutning med gyldighed i alle EU's medlemslande den 23. marts 2016.
English: The review started after a higher rate of serious adverse events was seen in three clinical trials among patients receiving Zydelig compared with placebo (a dummy treatment).1 The adverse events included deaths related to infections such as pneumonia.
Danish: Eftersynet begyndte efter der blev konstateret en højere forekomst af alvorlige uønskede hændelser (SAE'er) i tre kliniske forsøg hos patienter, som fik Zydelig sammenlignet med placebo (en uvirksom behandling).1 De uønskede hændelser omfattede dødsfald i forbindelse med infektioner, f.eks. pneumoni.
English: Zydelig should not be started in patients with a generalised infection.
Danish: Zydelig bør ikke initieres hos patienter med systemisk infektion.
English: • No new patients with chronic lymphocytic leukaemia (CLL) will be started on Zydelig if they have not received previous treatment for their cancer.
Danish: • Zydelig vil ikke blive indledt hos nye patienter med kronisk lymfatisk leukæmi (CLL), hvis de ikke tidligere har fået behandling for deres kræftsygdom.
English: Zydelig must not be started in patients with any evidence of ongoing systemic infection.
Danish: Zydelig bør ikke initieres hos patienter med evidens for aktuel systemisk infektion.
English: • Zydelig can continue to be used in combination, only with rituximab, in CLL patients who have received at least one prior therapy, and as monotherapy in patients with follicular lymphoma that is refractory to two lines of treatment.
Danish: • Zydelig kan fortsat anvendes i kombination, men kun med rituximab, hos CLL-patienter, som har fået mindst én tidligere behandling, og som monoterapi hos patienter med follikulært lymfom, som er refraktært til to tidligere behandlinger.
English: In case the patient has moderate or severe neutropenia treatment with Zydelig may have to be interrupted, in line with the updated summary of product characteristics (SmPC).
Danish: Hvis patienten har moderat til svær neutropeni, kan det være nødvendigt at afbryde behandlingen med Zydelig i overensstemmelse med det opdaterede produktresumé.
English: • As a precaution and while a thorough review is ongoing, Zydelig should not be started as first-line treatment in patients with CLL who have the 17p deletion or TP53 mutation.
Danish: • Som en sikkerhedsforanstaltning, og mens der foregår et grundigt eftersyn, bør Zydelig ikke initieres som førstelinjebehandling til patienter med CLL, som har 7p-deletion eller TP53-mutation.
English: It should also not be started in previously untreated patients with CLL whose cancer cells have certain genetic mutations (17p deletion or TP53 mutation).
Danish: Det bør heller ikke initieres hos tidligere ubehandlede patienter med CLL, hvis kræftceller har visse genetiske mutationer (17p-deletion eller TP53-mutation).
English: • Increased rates of serious adverse effects including deaths were seen in 3 clinical trials in the treatment arm evaluating the addition of Zydelig to standard therapy in first-line CLL and relapsed indolent non-Hodgkin lymphoma.
Danish: • Der blev konstateret en øget forekomst af alvorlige uønskede hændelser, inklusive dødsfald, i 3 kliniske forsøg i behandlingsarmen, der vurderede tilføjelsen af Zydelig til standardbehandlingen ved førstelinjebehandling af CLL og indolent non-Hodgkin lymfom, som er refraktært.
English: • chronic lymphocytic leukaemia in patients who have received previous treatment as well as in previously untreated patients who have certain genetic mutations (17p deletion or TP53 mutation) in their cancer cells.
Danish: • kronisk lymfatisk leukæmi hos patienter, som har fået tidligere behandling samt hos tidligere ubehandlede patienter, som har visse genetiske mutationer (17p-deletion eller TP53-mutation) i deres kræftceller.
English: The clinical trial in CLL involved patients who had not received previous treatment, some of whom had the 17p deletion or TP53 mutation; however, it also investigated a combination of medicines which is currently not approved.
Danish: Det kliniske forsøg med CLL omfattede patienter, som ikke tidligere havde modtaget behandling, af hvilke nogle havde 17p-deletion eller TP53-mutation.
English: No meeting in August
Danish: Intet møde i august
English: A need for this type of meeting may emerge, for example, in the event of a pandemic-influenza outbreak.
Danish: Der vil kunne opstå behov for denne form for møde f.eks. i tilfælde af et udbrud af pandemisk influenza.
English: NATIONAL COMPETENT AUTHORITIES NATIONAL COMPETENT AUTHORITIES 3,500 EUROPEAN EXPERTS 3,500 EUROPEAN EXPERTS
Danish: NATIONALE KOMPETENTE MYNDIGHEDER NATIONAL COMPETENT AUTHORITIES 3 500 EUROPÆISKE EKSPERTER 3,500 EUROPEAN EXPERTS
English: The certificate of compliance is valid throughout the European Community.
Danish: Certifikatet er gyldigt i hele Det Europæiske Fællesskab.
English: 3 Final accounts 2004.
Danish: 3 Det endelige regnskab for 2004.
English: The Agency will be able to organise meetings within 24 hours, on any day of the week.
Danish: Agenturet vil kunne tilrettelægge møder inden for 24 timer på enhver dag i ugen.
English: 301 Evaluations 302 Translation 303 Studies and consultants 304 Publications 305 Community programmes
Danish: 301 Evalueringer 302 Oversættelse 303 Undersøgelser og konsulenter 304 Publikationer 305 Fællesskabsprogrammer
English: A pilot project for the introduction of Internet telephony (voice over IP) will be started.
Danish: Der vil blive iværksat et pilotprojekt for indførelse af internettelefon (voice over IP).
English: 18 Staff insurances
Danish: 18 Personaleforsikringer
English: Efficient handling of the process is, therefore, essential.
Danish: Det er derfor af afgørende betydning, at processen håndteres effektivt.
English: Evaluating risk-management plans (RMPs).
Danish: Evaluering af risikostyringsplaner (RMP).
English: Experience obtained so far will be reviewed and opportunities for improvement will be identified.
Danish: De hidtil indhøstede erfaringer vil blive gennemgået, og muligheder for forbedringer vil blive afdækket.
English: 300 Meetings
Danish: 300 Møder
English: Small and medium-sized enterprises
Danish: Små og mellemstore virksomheder
English: Existing facilities and services for videoconferencing over the Internet will be extended and improved.
Danish: De eksisterende faciliteter og tjenester til videokonferencer via internettet vil blive udbygget og forbedret.
English: The EMEA is deeply committed to being a transparent, open and accessible organisation.
Danish: Det ligger EMEA stærkt på sinde at være en gennemsigtig, åben og tilgængelig organisation.
English: Implement and strengthen the European risk-management strategy in close cooperation with the Member States;
Danish: Gennemføre og styrke den europæiske strategi for risikostyring i tæt samarbejde med medlemsstaterne
English: The priorities and key objectives for 2006 can be summarised as follows:
Danish: De prioriterede indsatsområder og de vigtigste målsætninger for 2006 kan sammenfattes således:
English: Meeting forecasts for 2006 again point to a significant increase in the number of meetings and delegate-days.
Danish: Skønnene for 2006 tyder igen på en betydelig stigning i antallet af møder og delegeret-dage.
English: Community programmes
Danish: Fællesskabsprogrammer
English: A twoyear rolling work plan on the detailed initiatives to be undertaken up to mid 2007 has been established.
Danish: Der er fastlagt en toårig rullende arbejdsplan for de detaljerede initiativer, der skal iværksættes indtil midten af 2007.
English: MANAGEMENT BOARD MANAGEMENT BOARD Chairman: Hannes Wahlroos Chairman: Hannes Wahlroos
Danish: BESTYRELSE MANAGEMENT BOARD Formand: Hannes Wahlroos Chairman: Hannes Wahlroos
English: This should result in a more intensive drug-monitoring system.
Danish: Dette skulle resultere i et mere intensivt lægemiddelovervågningssystem.
English: The Agency will also continue its work with the World Health Organization, Codex Alimentarius and OIE.
Danish: Agenturet vil også videreføre sit arbejde med Verdenssundhedsorganisationen, Codex Alimentarius og OIE.
English: Safety of medicines has been the Agency's priority for a number of years.
Danish: Lægemiddelsikkerhed har været en prioriteret opgave for agenturet i en årrække.
English: Emphasis will be placed on full implementation of the new Community legislation and on the monitoring of this implementation.
Danish: Der vil blive lagt vægt på fuldstændig gennemførelse af den nye fællesskabslovgivning og på overvågning af denne gennemførelse.
English: Implementation of the Management Board decision on access to the Agency's documents, ensuring the widest possible public access.
Danish: Gennemførelse af bestyrelsens beslutning om adgang til agenturets dokumenter, hvilket sikrer størst mulig offentlig adgang.
English: The peer-review process of the first phase of assessment will be strengthened and monitored.
Danish: Peer review-processen som led i den første vurderingsfase vil blive styrket og overvåget.
English: EUROPEAN UNION INSTITUTIONS EUROPEAN UNION INSTITUTIONS
Danish: EU-INSTITUTIONER EUROPEAN UNION INSTITUTIONS
English: The number of parallel-distribution notifications is forecast to increase by a further 14% in 2006, reaching 750.
Danish: Antallet af anmeldelser af paralleldistribution forventes at stige med yderligere 14 % i 2006 og dermed at nå op på 750.
English: This is a challenging legislative initiative, requiring new expertise on medicines and diseases not encountered in Europe.
Danish: Der er tale om et udfordrende lovgivningsinitiativ, som kræver ny ekspertise inden for lægemidler og sygdomme, der ikke er konstateret i Europa.
English: This is in line with the Agency's priorities in the area of safety of medicinal products.
Danish: Dette er i overensstemmelse med agenturets prioriteter i forbindelse med lægemidlers sikkerhed.
English: The first production version of EudraGMP will be ready for use in the third quarter of 2006.
Danish: Den første produktionsversion af EudraGMP vil være klar til ibrugtagning i tredje kvartal af 2006.
English: The number of meetings is forecast to increase by 5% and the number of reimbursed delegates by 33%.
Danish: Antallet af møder forventes at stige med 5 % og antallet af delegerede, der modtager godtgørelse, med 33 %.
English: A pilot exercise for web meetings will run during the first half of 2006 to examine the potential benefits of this approach.
Danish: Et pilotforsøg med webmøder vil blive gennemført i løbet af første halvår af 2006 for at undersøge de potentielle fordele ved en sådan strategi.
English: Secure and reliable communication within the EU regulatory network is assured through EudraNet and the infrastructure supporting the systems.
Danish: En sikker og pålidelig kommunikation inden for EU's reguleringsnetværk sikres via EudraNet og den infrastruktur, der understøtter systemerne.
English: This will be done by identifying areas where expertise needs to be reinforced and developed.
Danish: Dette vil blive gjort ved at afdække områder, hvor sagkundskaben bør styrkes og udvikles.
English: The Agency also expects good progress on external evaluations carried out by Canada by the end of the year.
Danish: Agenturet forventer også, at der inden udgangen af året vil være opnået gode fremskridt i forbindelse med de af Canada foretagne eksterne vurderinger.
English: By the end of the year, advanced query facilities will be provided.
Danish: Inden udgangen af året vil avancerede forespørgselsfaciliteter bliver gjort tilgængelige.
English: AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Total grade AD AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Total grade AST Total Staff
Danish: AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Lønklasse AD i alt AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Lønklasse AST i alt Personaleressourcer i alt
English: This will also result in a higher demand on the Member States' national competent authorities to provide the necessary competences in these scientific areas.
Danish: Dette vil også stille større krav til medlemsstaternes nationale kompetente myndigheder om at stille de nødvendige kompetencer til rådighed på disse videnskabelige områder.
English: Its ability to address and manage safety issues has now been strengthened, through provisions in the new legislation and the adoption of the Agency's long-term strategy.
Danish: Dets mulighed for at behandle og styre sikkerhedsrelaterede problemstillinger er nu blevet styrket gennem bestemmelser i den nye lovgivning og vedtagelsen af agenturets langsigtede strategi.
English: A significant increase (64%) in validated parallel-distribution notifications was observed in 2005, due to the implementation of Community legislation on parallel distribution (mandatory EMEA notification procedure).
Danish: Der blev i 2005 iagttaget en markant stigning (64 %) i antallet af validerede anmeldelser af paralleldistribution som følge af gennemførelsen af fællesskabslovgivning om paralleldistribution (obligatorisk EMEA-anmeldelsesprocedure).
English: The European Commission has issued new regulations on transparency and will be reviewing European copyright laws.
Danish: Europa-Kommissionen har udstedt nye forordninger om gennemsigtighed og vil gennemgå den europæiske ophavsret.
English: Appropriation/Budget 2005 as of 31 December 2005.
Danish: Bevilling/budget for 2005 pr. 31. december 2005.
English: The Agency will implement the new legislation and guidelines concerning SMEs.
Danish: Agenturet vil gennemføre den nye lovgivning og de nye retningslinjer vedrørende SMV.