FrancophonIA/ELRC3.0 huggingface dataset:
English: A letter will be sent to healthcare professionals, advising them of these changes.
Danish: Der vil blive sendt et brev til sundhedspersoner med oplysninger om disse ændringer.
English: CHMP confirms recommendations for use of Zydelig
Danish: CHMP bekræfter anbefalingerne vedrørende brug af Zydelig
English: Patients should be monitored for infection and given antibiotics during and after treatment
Danish: Patienterne bør overvåges for infektion og gives antibiotika under og efter behandlingen
English: Zydelig is a cancer medicine containing the active substance idelalisib.
Danish: Zydelig er et kræftlægemiddel, der indeholder det aktive stof idelalisib.
English: • You should not stop Zydelig without speaking to your doctor.
Danish: • Du bør ikke holde op med at tage Zydelig, før du har talt med lægen.
English: • Your doctor will regularly check you for signs of infections.
Danish: • Lægen vil kontrollere dig regelmæssigt for tegn på infektion.
English: If you are taking Zydelig and have any questions or concerns speak to your doctor, nurse or pharmacist.
Danish: Hvis du tager Zydelig og har spørgsmål eller bekymringer, skal du tale med lægen, sygeplejersken eller apotekspersonalet.
English: If you develop fever, cough or difficulty breathing you should contact your doctor straight away.
Danish: Hvis du får feber, hoste eller vejrtrækningsbesvær, skal du kontakte lægen med det samme.
English: Patients should be monitored for respiratory signs and symptoms.
Danish: Patienterne skal overvåges for respiratoriske tegn og symptomer.
English: However, following a review it has updated recommendations to minimise the risk of serious infections in patients treated with the medicine.
Danish: Efter en gennemgang har udvalget imidlertid ajourført sine anbefalinger med henblik på at minimere risikoen for alvorlige infektioner hos patienter, der behandles med lægemidlet.
English: 1 17p deletion or TP53 mutation, see http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp
Danish: 1 17p-deletion eller TP53-mutation, se http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp.
English: Your doctor may stop your treatment with Zydelig if your white blood cell count is too low.
Danish: Lægen kan standse din behandling med Zydelig, hvis antallet af hvide blodlegemer er for lavt.
English: The relevance of these results to the authorised use of Zydelig is therefore limited, but suggests a need to strengthen measures to minimise the risk of infection.
Danish: Disse resultaters relevans for den godkendte brug af Zydelig er derfor begrænset, men resultaterne peger på et behov for at styrke forsigtighedsreglerne for at minimere risikoen for infektion.
English: In its review the PRAC evaluated data from these studies, together with other available evidence as well as advice from experts in this field.
Danish: I forbindelse med gennemgangen vurderede PRAC dataene fra disse undersøgelser parallelt med anden tilgængelig evidens samt anvisninger fra eksperter på området.
English: Low white cell counts can indicate an increased risk of infection and treatment may need to be interrupted.
Danish: Et lavt antal hvide blodlegemer kan indikere øget risiko for infektion, og det kan være nødvendigt at afbryde behandlingen.
English: Patients receiving Zydelig should also be monitored for signs of infection and have regular blood tests to measure the level of white blood cells.
Danish: Patienter, der får Zydelig, bør også overvåges for tegn på infektion og få taget regelmæssige blodprøver for at måle niveauet af hvide blodlegemer.
English: • Patients should be informed about the risk of serious infections with Zydelig.
Danish: • Patienterne skal informeres om risikoen for alvorlige infektioner ved behandling med Zydelig.
English: The percentage of deaths in the treatment arms was 8% in the CLL study and 8% and 5% in the lymphoma studies, compared with 3%, 6% and 1% respectively in the placebo arms.
Danish: Andelen af dødsfald i behandlingsgrupperne var 8 % i CLL-undersøgelsen og 8 % og 5 % i lymfomundersøgelserne, mens den i placebogrupperne var henholdsvis 3 %, 6 % og 1 %.
English: The additional deaths were mainly caused by infections, including Pneumocystis jirovecii pneumonia and cytomegalovirus infections.
Danish: De ekstra dødsfald skyldtes primært infektioner, herunder Pneumocystis jirovecii-pneumoni og cytomegalovirus-infektioner.
English: • There have been reports of serious infections in clinical studies with the cancer medicine Zydelig.
Danish: • Der er blevet rapporteret alvorlige infektioner i kliniske undersøgelser af kræftlægemidlet Zydelig.
English: The CHMP has confirmed the recommendations from the PRAC review, and its opinion will now be sent to the European Commission for a final legally binding decision.
Danish: CHMP bekræftede anbefalingerne fra PRAC's gennemgang, og udvalgets udtalelse blev sendt til Europa-Kommissionen, der traf en endelig juridisk bindende beslutning.
English: • You will have regular blood tests to check if you have a low white blood cell count, as a low count can put you at more risk of developing an infection.
Danish: • Du vil regelmæssigt få taget blodprøver for at se, om du har et lavt antal hvide blodlegemer, da dette kan betyde, at du har større risiko for at få en infektion.
English: Although the studies did not use the medicine in the same way as currently authorised, the review concluded that the risk of serious infection had some relevance to the authorised use.
Danish: Selvom lægemidlet i undersøgelserne ikke blev anvendt i henhold til den aktuelle godkendelse, blev det ved gennemgangen konkluderet, at risikoen for alvorlig infektion også havde en vis relevans i den godkendte anvendelse.
English: The review, which was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), was started because of deaths seen in 3 studies in which Zydelig was given to patient groups for whom it is not licensed, or in unlicensed combinations with other medicines.
Danish: Gennemgangen, der blev foretaget af EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC), blev iværksat, fordi der er set dødsfald i tre undersøgelser, hvor Zydelig blev givet til patientgrupper, som lægemidlet ikke er godkendt til, eller i ikkegodkendte kombinationer med andre lægemidler.
English: • If you are taking Zydelig, you will receive antibiotics to prevent a type of lung infection (Pneumocystis jirovecii pneumonia).
Danish: • Hvis du tager Zydelig, vil du få antibiotika for at forebygge en type lungeinfektion, der kaldes Pneumocystis jirovecii-pneumoni.
English: Because some infections have occurred after patients had finished their cancer treatment, you will have to keep taking these antibiotics for 2 to 6 months after stopping Zydelig.
Danish: Da nogle infektioner er opstået, efter at patienterne havde afsluttet deres kræftbehandling, skal du fortsætte antibiotikabehandlingen i 2-6 måneder, efter at behandlingen med Zydelig er afsluttet.
English: • These studies included patients with disease characteristics that were different from those covered by the currently approved indications for Zydelig and investigated use with treatment combinations that are not currently licensed and which may have influenced the infection rate.
Danish: • Disse undersøgelser omfattede patienter, hvis sygdomskarakteristika var anderledes end de sygdomskarakteristika, der er omfattet af de aktuelt godkendte indikationer for Zydelig, og vurderede brugen af behandlingskombinationer, der ikke er godkendt i øjeblikket, og som kan have haft indvirkning på infektionsraten.
English: Zydelig should also not be started in patients with any generalised infection.
Danish: Zydelig bør heller ikke initieres hos patienter med systemisk infektion.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for at vurdere sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended and specific guidance is included in the updated summary of product characteristics (SmPC).
Danish: Det anbefales også at overvåge patienterne klinisk og laboratoriemæssigt for cytomegalovirus-infektion, jf. den specifikke vejledning i det ajourførte produktresumé.
English: If the patient develops severe neutropenia, treatment with Zydelig may have to be interrupted, in line with the updated SmPC.
Danish: Hvis en patient udvikler svær neutropeni, kan det være nødvendigt at afbryde behandlingen med Zydelig, jf. det ajourførte produktresumé.
English: • In follicular lymphoma, Zydelig is used on its own in patients whose disease has not responded to two previous treatments.
Danish: • Ved follikulært lymfom anvendes Zydelig som enkeltstofbehandling hos patienter, hvis sygdom ikke har reageret på to tidligere behandlinger.
English: In the EU, Zydelig is authorised for the treatment of two cancers of white blood cells, chronic lymphocytic leukaemia and follicular lymphoma (one of a group of cancers called non-Hodgkin's lymphomas).
Danish: I EU er Zydelig godkendt til behandling af to typer blodkræft i de hvide blodlegemer, nemlig kronisk lymfatisk leukæmi og follikulært lymfom (der hører til den gruppe kræftsygdomme, der kaldes non-Hodgkins lymfom).
English: • Patients should also have regular checks of their blood counts to detect neutropenia.
Danish: • Patienterne skal også have tjekket deres blodtal regelmæssigt og kontrolleres for neutropeni.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 July 2016 EMA/488322/2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The CHMP (EMA's Committee for Medicinal Products for Human Use) has confirmed that the benefits of Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects.
Danish: Den 21. juli 2016 bekræftede CHMP (EMA's Udvalg for Humanmedicinske Lægemidler), at fordelene ved Zydelig (idelalisib) til behandling af blodkræfttyperne kronisk lymfatisk leukæmi (CLL) og follikulært lymfom opvejer risikoen for bivirkninger.
English: All patients treated with Zydelig should be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia during treatment and this should be continued for up to 6 months after treatment with Zydelig has stopped.
Danish: Alle patienter, der behandles med Zydelig, bør have forebyggende medicin mod Pneumocystis jiroveciipneumoni under behandlingen, og denne profylakse bør fortsætte i op til 6 måneder efter, at behandlingen med Zydelig afsluttes.
English: • Increased rates of serious adverse effects including deaths were seen in the treatment arm of 3 clinical trials2 evaluating the addition of Zydelig to standard therapy in first-line treatment of CLL and relapsed indolent non-Hodgkin lymphoma.
Danish: • Der er konstateret øget forekomst af alvorlige uønskede hændelser, herunder dødsfald, hos behandlingsgruppen i tre kliniske undersøgelser2, der vurderede tilføjelsen af Zydelig til standardterapi ved førstelinjebehandling af CLL og recidiveret indolent non-Hodgkins lymfom.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Danish: PRAC's anbefalinger blev sendt til Udvalget for Lægemidler til Mennesker (CHMP), som er ansvarlig for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets udtalelse den 21. juli 2016.
English: In addition, following an interim precautionary recommendation not to start Zydelig treatment in previously untreated patients with CLL that has certain genetic mutations1, the CHMP now concludes that treatment with Zydelig can again be started in these patients provided they alternative treatments are not suitable and provided that the measures to prevent infection are followed.
Danish: Efter midlertidigt at have anbefalet, at behandling med Zydelig af forsigtighedshensyn ikke bør initieres hos tidligere ubehandlede patienter med CLL, der har visse genetiske mutationer1, har CHMP desuden konkluderet, at behandling med Zydelig atter kan initieres hos disse patienter, forudsat at anden behandling ikke er egnet, og forudsat at forsigtighedsreglerne til forebyggelse af infektion følges.
English: • All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and for 2 to 6 months after stopping treatment.
Danish: • Alle patienter skal have profylakse mod P. jirovecii-pneumoni under behandling med Zydelig og 26 måneder efter behandlingens afslutning.
English: • In chronic lymphocytic leukaemia, Zydelig is used in combination with another medicine (rituximab) in patients who have received at least one previous treatment and in previously untreated patients who have genetic mutations in their cancer cells called 17p deletion or TP53 mutation and who are not eligible for other therapies.
Danish: • Ved kronisk lymfatisk leukæmi anvendes Zydelig i kombination med et andet lægemiddel (rituximab) hos patienter, der har fået mindst én tidligere behandling, samt hos tidligere ubehandlede patienter, der har genetiske mutationer i deres kræftceller (såkaldt 17p-deletion eller TP53-mutation), og hvor andre behandlinger ikke er egnede.
English: • Provided that strengthened measures are followed to minimise the risk of infection (see below), Zydelig can continue to be used in combination 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: • Forudsat at der træffes styrkede forsigtighedsregler for at minimere risikoen for infektion (se nedenfor), kan Zydelig fortsat anvendes i kombination med rituximab til behandling af CLLpatienter, der har fået mindst én tidligere behandling, samt som monoterapi til behandling af patienter med follikulært lymfom, der har udvist refraktaritet over for to behandlingslinjer.
English: • Zydelig may also be used in combination with rituximab, as first line treatment in CLL in the presence of 17p deletion or TP53 mutation provided patients cannot take any alternative treatment and provided again that the below measures are followed to reduce the risk of infection.
Danish: • Zydelig kan også anvendes i kombination med rituximab som førstelinjebehandling af CLL med tilstedeværelse af 17p-deletion eller TP53-mutation, forudsat at patienten ikke kan få anden behandling, og forudsat at nedstående forsigtighedsregler følges for at reducere risikoen for infektion.
English: Zydelig must not be started in patients with any evidence of ongoing systemic infection.
Danish: Zydelig må ikke initieres hos patienter med symptomer på systemisk infektion.
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.
Danish: CHMP's udtalelse blev fremsendt til EuropaKommissionen, som traf en endelig juridisk bindende beslutning den 15. september 2016.
English: GS-US-313-0124 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated iNHL;
Danish: GS-US-313-0124: en randomiseret, dobbeltblindet, placebokontrolleret fase 3-undersøgelse til vurdering af virkningen af og sikkerheden ved idelalisib i kombination med rituximab til behandling af tidligere behandlet iNHL.
English: GS-US-313-0125 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated iNHL;
Danish: GS-US-313-0125: en randomiseret, dobbeltblindet, placebokontrolleret fase 3-undersøgelse til vurdering af virkningen af og sikkerheden ved idelalisib i kombination med bendamustin og rituximab til behandling af tidligere behandlet iNHL.
English: 2 GS-US-312-0123 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated CLL;
Danish: GS-US-312-0123: en randomiseret, dobbeltblindet, placebokontrolleret fase 3-undersøgelse til vurdering af virkningen af og sikkerheden ved idelalisib i kombination med bendamustin og rituximab til behandling af tidligere ubehandlet CLL.
English: player
Danish: afspiller
English: Emphasise that patients should persist with the treatment.
Danish: Lægge vægt på, at patienter skal fortsætte med behandlingen.
English: That cough decreases with repeated use of the product and should stabilize after the first month or so.
Danish: At hoste aftager med gentagen anvendelse af produktet og bør være stabiliseret efter ca. en måned.
English: The Member States shall ensure that all physicians who are expected to prescribe or use Colobreathe are provided with a healthcare professional and patient educational pack containing the following:
Danish: Medlemsstaterne skal sikre, at alle læger, som forventes at ordinere eller anvende Colobreathe, tilvejebringes en sundhedspersonale- og patientuddannelsespakke, der indeholder følgende:
English: These are only of nuisance value for most patients
Danish: At disse sædvanligvis kun er en mindre gene for de fleste patienter.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
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 VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, DER SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
English: • “Physician DVD” information in “leaflet form” for those physicians who do not have access to a
Danish: • ”Læge-DVD”-information i ”brochure-form” for de læger, der ikke har adgang til en DVD
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member States shall agree the final healthcare professional and patient educational pack with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Danish: Medlemsstaterne skal blive enige om den endelige sundhedspersonale- og patientuddannelsespakke med indehaveren af markedsføringstilladelsen (MAH) før lancering af produktet indenfor deres territorie.
English: lamivudine
Danish: lamivudin
English: In children weighing less than 25 kg the recommended dose depends on their weight.
Danish: Hos børn på under 25 kg afhænger den anbefalede dosis af deres vægt.
English: An oral solution of lamivudine can be used to achieve the appropriate dose.
Danish: En oral opløsning kan anvendes til at opnå en passende dosis.
English: Patients who cannot swallow tablets should use an oral solution of lamivudine, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it.
Danish: Patienter, der ikke kan synke tabletter, bør anvende den orale opløsning af lamivudin, eller alternativt knuse tabletterne og komme dem i lidt mad eller drikke, umiddelbart inden de synker det.
English: It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Danish: Det virker ved at blokere revers transkriptase, et enzym, som hiv bruger til at fremskaffe den genetiske information, der skal til for at danne flere vira, når først cellen er angrebet.
English: For more information about treatment with Lamivudine Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lamivudine Teva Pharma B.V., kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Lamivudine Teva Pharma B.V.
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 Lamivudine Teva Pharma B.V.
English: The full EPAR for Lamivudine Teva Pharma B.V. can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Therefore, the CHMP's view was that, as for Epivir, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Epivir.
English: Lamivudine Teva Pharma B.V. is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Danish: anvendes i kombination med andre antivirale lægemidler til behandling af voksne og børn, der er smittet med humant immundefektvirus (hiv), som er den virus, der forårsager erhvervet immundefekt syndrom (AIDS).
English: This means that Lamivudine Teva Pharma B.V. is similar to a ‘reference medicine' already authorised in the European Union (EU) called Epivir.
Danish: er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), kaldet Epivir.
English: Lamivudine Teva Pharma B.V. does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Danish: helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: Lamivudine Teva Pharma B.V., taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: tages i kombination med andre antivirale lægemidler, nedsætter det mængden af hiv i blodet og holder det på et lavt niveau.
English: The active substance in Lamivudine Teva Pharma B.V., lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Danish: Det aktive stof i Lamivudine Teva Pharma B.V., lamivudin, er en nukleosid revers transkriptasehæmmer (NRTI).
English: This is a summary of the European public assessment report (EPAR) for Lamivudine Teva Pharma B.V.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lamivudine Teva Pharma B.V.
English: What measures are being taken to ensure the safe and effective use of Lamivudine Teva Pharma B.V.?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lamivudine Teva Pharma B.V.
English: The recommended dose of Lamivudine Teva Pharma B.V. for adults and children weighing at least 25 kg is 300 mg a day.
Danish: til voksne og børn på 25 kg og derover er 300 mg dagligt.
English: Because Lamivudine Teva Pharma B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Lamivudine Teva Pharma B.V. tablets should ideally be swallowed without crushing.
Danish: Lamivudine Teva Pharma B.V.-tabletterne skal helst synkes hele.