FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Adcetris?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Adcetris?
English: Patients should be monitored during and after the infusion for certain side effects and they should have full blood counts (tests of the number of blood cells) before every dose of Adcetris.
Danish: Patienterne bør under og efter infusionen overvåges for visse bivirkninger og have foretaget en komplet blodtælling (optælling af antallet af blodceller) før hver dosis af Adcetris.
English: After 2 years, 82% of patients given Adcetris survived without their disease getting worse, compared with 77% of patients given bleomycin.
Danish: Efter 2 år overlevede 82 % af de patienter, der fik Adcetris, uden forværring af sygdommen, sammenlignet med 77 % af de patienter, der fik bleomycin.
English: Therefore, the Agency decided that the benefits of Adcetris are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Adcetris opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Further information on the orphan designations can be found on the European Medicines Agency's website (Hodgkin's lymphoma: 15 January 2009; Anaplastic large cell lymphoma: 15 January 2009; Cutaneous T-cell lymphoma: 11 January 2012).
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes på Det Europæiske Lægemiddelagenturs websted (Hodgkins lymphom: 15. januar 2009, anaplastisk storcellet lymfom: 15. januar 2009, kutant T-cellelymfom: 11. januar 2012).
English: A complete response was observed in 33% of patients (34 out of 102).
Danish: Fuldstændig respons blev iagttaget hos 33 % af patienterne (34 ud af 102).
English: Side effects reported with Adcetris are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Adcetris vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: In these patients, who generally have poor outcomes and lack suitable treatments, Adcetris could lead to a cure or could enable them to undergo potentially curative treatments.
Danish: Hos disse patienter, som generelt oplever dårlige resultater, og til hvem der mangler egnede behandlinger, kunne Adcetris føre til helbredelse eller sætte dem i stand til at gennemføre potentielt helbredende behandlinger.
English: The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment.
Danish: Virkningen blev hovedsagelig målt på procentdelen af patienter, der udviste fuldstændig eller delvis respons på behandlingen.
English: This means that there is more evidence to come, especially about the medicine's long-term effects, which are needed to confirm the positive benefit-risk balance.
Danish: Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet, især yderligere oplysninger om dets langtidsvirkninger, som er nødvendige for at få bekræftet, at fordelene opvejer risiciene.
English: Adcetris is also used to treat adults with two other lymphomas:
Danish: Adcetris anvendes desuden til behandling af voksne med to andre typer lymfom:
English: The recommended dose depends on body weight and whether Adcetris is given with other cancer medicines.
Danish: Den anbefalede dosis afhænger af kropsvægten, og om Adcetris gives sammen med andre kræftlægemidler.
English: Adcetris must not be used together with bleomycin (another cancer medicine) as this combination is damaging to the lungs.
Danish: Adcetris må ikke anvendes sammen med bleomycin (et andet kræftmiddel), da denne kombination er skadelig for lungerne.
English: In this study, the average time patients lived before their disease got worse was around 43 months in those given Adcetris, compared with around 24 months in those given placebo.
Danish: I dette studie var den gennemsnitlige periode, patienterne levede, før sygdommen blev værre, omkring 43 måneder hos dem, som fik Adcetris, sammenlignet med omkring 24 måneder hos dem, der fik placebo.
English: What is Adcetris and what is it used for?
Danish: Hvad er Adcetris, og hvad anvendes det til?
English: The proportion of patients whose disease responded to treatment for at least 4 months was 56% of those given Adcetris (36 of 64 patients) and 13% of those given alternative treatments (8 of 64 patients).
Danish: Andelen af patienter, hvis sygdom udviste respons på behandlingen i mindst fire måneder, var på 56 % hos dem, der fik Adcetris (36 ud af 64 patienter) og på 13 % hos dem, der fik andre behandlinger (8 ud af 64 patienter).
English: What information is still awaited for Adcetris?
Danish: Hvilke oplysninger afventes der stadig for Adcetris?
English: Why is Adcetris authorised in the EU?
Danish: Hvorfor blev Adcetris godkendt i EU?
English: The data on these patients showed that 55% of patients (22 out of 40) responded to treatment.
Danish: Dataene for disse patienter viste, at 55 % af dem (22 ud af 40) responderede på behandlingen.
English: For 23% of these patients (9 out of 40) a complete response was observed.
Danish: Hos 23 % af disse patienter (9 ud af 40) iagttoges en fuldstændig respons.
English: Adcetris can only be obtained with a prescription, and it should be given under the supervision of a doctor who has experience in the use of cancer treatments.
Danish: Adcetris udleveres kun efter recept, og det bør gives under opsyn af en læge med erfaring i kræftbehandlinger.
English: • when patients have had an autologous stem cell transplant but are considered to be at increased risk of the cancer coming back or not responding;
Danish: • hvis patienten har gennemgået en autolog stamcelletransplantation, men anses for at have en forhøjet risiko for, at kræften vender tilbage eller ikke responderer
English: When given with other cancer medicines, patients may also be given a medicine to help prevent neutropenia (low white blood cell count).
Danish: Ved kombinationsbehandling, kan patienten også gives et lægemiddel til forebyggelse af neutropeni (lavt antal hvide blodlegemer).
English: In this study, 86% of patients (50 out of 58) responded partially or completely to treatment and this response was complete for 59% (34 out of 58).
Danish: I dette studie responderede 86 % af patienterne (50 ud af 58) fuldstændigt eller delvist på behandlingen, og der var fuldstændig respons hos 59 % (34 ud af 58).
English: For the full list of all side effects with Adcetris, including side effects when used with doxorubicin, vinblastine and dacarbazine, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Adcetris, herunder bivirkninger ved anvendelse med doxorubicin, vinblastin og dacarbazin, fremgår af indlægssedlen.
English: Adcetris is a cancer medicine used to treat adults with Hodgkin's lymphoma (HL, a type of cancer that originates from blood cells in the lymphatic system, a part of the immune system).
Danish: Adcetris er et kræftlægemiddel, som anvendes til behandling af voksne med Hodgkins lymfom (en type kræft, der udgår fra blodceller i lymfesystemet, en del af immunsystemet).
English: The study compared treatment with Adcetris and treatment with another appropriate medicine (methotrexate or bexarotene).
Danish: I studiet blev behandling med Adcetris sammenlignet med behandling med et andet egnet lægemiddel (methotrexat eller bexaroten).
English: What are the risks associated with Adcetris?
Danish: Hvilke risici er der forbundet med Adcetris?
English: In this study, 75% of patients (76 out of 102) responded partially or completely to treatment.
Danish: I dette studie responderede 75 % af patienterne (76 ud af 102) fuldstændigt eller delvist på behandlingen.
English: Adcetris contains the active substance brentuximab vedotin.
Danish: Adcetris indeholder det aktive stof brentuximab vedotin.
English: The active substance in Adcetris, brentuximab vedotin, is made up of a CD30 monoclonal antibody (a type of protein that attaches to CD30).
Danish: Det aktive stof i Adcetris, brentuximab vedotin, er et monoklonalt CD30-antistof (en type protein, der binder sig til CD30).
English: Adcetris is used when the tumour cells are CD30-positive (when they have a protein called CD30 on their surface) and is given:
Danish: Adcetris anvendes, når tumorcellerne er CD30-positive (når de har proteinet CD30 på deres overflade).
English: Previously untreated patients with advanced HL also benefited from Adcetris used in combination with other cancer medicines.
Danish: Tidligere ubehandlede patienter med fremskredent Hodgkins lymfom havde også gavn af Adcetris anvendt i kombination med andre kræftlægemidler.
English: The monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells, and once inside the cancer cells, it stops them from dividing, and the cancer cells eventually die.
Danish: Det monoklonale antistof bringer monomethylauristatin E frem til de CD30-positive kræftceller, og når det er kommet ind i kræftcellerne, hindrer det cellerne i at dele sig, så de til sidst dør.
English: The monoclonal antibody is attached to monomethyl auristatin E, a cytotoxic (cell-killing) molecule.
Danish: Det monoklonale antistof er bundet til monomethylauristatin E, der er et cytotoksisk (celledræbende) molekyle.
English: The company that markets the medicine will carry out a study on the benefits of the medicine in sALCL patients and a safety study in a larger population of HL and sALCL patients.
Danish: Virksomheden, der markedsfører lægemidlet, vil gennemføre et studie af lægemidlets fordele hos patienter med systemisk anaplastisk storcellet lymfom samt et sikkerhedsstudie hos en større gruppe patienter med Hodgkins lymfom og systemisk anaplastisk storcellet lymfom.
English: • CD30-positive cutaneous T-cell lymphoma (CTCL), a lymphoma of T lymphocytes that initially affects the skin, in patients who have received at least one previous treatment.
Danish: • CD30-positivt kutant T-cellelymfom (CTCL), som er et lymfom i T-lymfocytterne, som først påvirker huden, hos patienter, der har modtaget mindst en tidligere behandling.
English: In a main study of 1334 patients with CD30-positive HL who had not received previous treatment, Adcetris was compared with bleomycin (another HL medicine) when each was given with other cancer medicines (doxorubicin, vinblastine and dacarbazine).
Danish: I et hovedstudie med 1 334 patienter med CD30-positiv Hodgkins lymfom, som ikke var blevet behandlet tidligere, blev Adcetris sammenlignet med bleomycin (et andet lægemiddel mod Hodgkins lymfom), idet hvert lægemiddel blev givet sammen med andre kræftlægemidler (doxorubicin, vinblastin and dacarbazin).
English: How is Adcetris used?
Danish: Hvordan anvendes Adcetris?
English: • systemic anaplastic large cell lymphoma (sALCL, a CD30-positive cancer of white blood cells called T lymphocytes), when the cancer has come back or has not responded to other treatments;
Danish: • systemisk anaplastisk storcellet lymfom (forkortet sALCL, en CD30-positiv kræftform, som udgår fra de hvide blodlegemer af typen T-lymfocytter), hvis sygdommen er vendt tilbage eller ikke har responderet på andre behandlinger
English: • when the cancer has come back or has not responded to at least two other therapies and when autologous stem cell transplant or multi-agent chemotherapy (a combination of cancer medicines) cannot be used.
Danish: • hvis sygdommen er vendt tilbage eller ikke har responderet på mindst to andre behandlinger, og hvis det ikke er muligt at anvende autolog stamcelletransplantation eller kombinationskemoterapi
English: In addition, giving Adcetris to patients who have had a stem cell transplant and are considered at risk of the cancer progressing or coming back, resulted in a clear clinical benefit.
Danish: Endvidere viste det sig, at patienter, som havde fået en stamcelletransplantation, og som havde øget risiko for, at kræften ville udvikle sig eller vende tilbage, opnåede en tydelig klinisk fordel ved behandlingen med Adcetris.
English: Adcetris has been shown to be of benefit in CD30-positive cutaneous T-cell lymphoma in a main study in 128 patients with CD30-positive CTCL who had had at least one previous treatment.
Danish: Det er blevet påvist, at Adcetris er gavnligt ved CD30-positivt kutant T-cellelymfom i et hovedstudie, der omfattede 128 patienter med CD30-positivt kutant T-cellelymfom, som havde gennemgået mindst en tidligere behandling.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adcetris have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Adcetris.
English: For the full list of all restrictions with Adcetris, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: In addition, the company provided data on 40 patients with CD30-positive HL, whose cancer had come back or had not responded to at least 2 prior therapies and who were not eligible for autologous stem cell transplant or multi-agent chemotherapy.
Danish: Virksomheden fremlagde derudover oplysninger om 40 patienter med CD30-positiv Hodgkins lymfom, hvis sygdom var vendt tilbage eller ikke havde responderet på mindst to forudgående behandlinger, og som var uegnede til autolog stamcelletransplantation eller kombinationskemoterapi.
English: The European Medicines Agency noted that, despite limited data and studies that did not compare Adcetris with a control treatment, Adcetris was considered beneficial for patients with HL and sALCL whose cancer had come back or had not responded to therapy.
Danish: Selv om der kun forelå begrænsede data og studier, hvor Adcetris ikke blev sammenlignet med en kontrolbehandling, anså Det Europæiske Lægemiddelagentur Adcetris for at være til gavn for patienter med Hodgkins lymfom og systemisk anaplastisk storcellet lymfom, hvis kræftsygdom var vendt tilbage, eller som ikke havde responderet på behandling.
English: In another main study, Adcetris was compared with placebo (a dummy treatment) in 329 patients with CD30-positive HL who had received an autologous stem cell transplant and who were at increased risk of their cancer progressing or coming back.
Danish: I et andet hovedstudie blev Adcetris sammenlignet med placebo (en virkningsløs behandling) hos 329 patienter med CD30-positiv Hodgkins lymfom, som havde modtaget en autolog stamcelletransplantation, og som havde øget risiko for, at kræften ville udvikle sig eller vende tilbage.
English: What benefits of Adcetris have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Adcetris?
English: Adcetris was studied in 58 sALCL patients whose cancer had come back or had not responded to treatment.
Danish: Adcetris blev undersøgt hos 58 patienter med systemisk anaplastisk storcellet lymfom, hvis kræftsygdom var vendt tilbage eller ikke havde responderet på behandling.
English: The doctor may interrupt or stop treatment, or reduce the dose, if the patient develops certain serious side effects.
Danish: Hvis patienten får visse alvorlige bivirkninger, kan lægen afbryde eller standse behandlingen.
English: How does Adcetris work?
Danish: Hvordan virker Adcetris?
English: • when the cancer has come back or has not responded to an autologous stem cell transplant (a transplant of the patient's own blood-producing cells);
Danish: • hvis kræften er vendt tilbage eller ikke har responderet på en autolog stamcelletransplantation
English: In patients with CTCL, a clinically significant benefit was seen over treatment with bexarotene or methotrexate.
Danish: Hos patienter med CD30-positivt kutant Tcellelymfom sås der en klinisk signifikant fordel i forhold til bexaroten og methotrexat.
English: In another main study, Adcetris was used in 102 patients with CD30-positive HL, who had previously received an autologous stem cell transplant and whose cancer had come back or had not responded to previous treatment.
Danish: Adcetris indgik i et andet hovedstudie med 102 patienter med CD30-positiv Hodgkins lymfom, som tidligere havde modtaget en autolog stamcelletransplantation, og hvis kræftsygdom var vendt tilbage eller ikke havde responderet på tidligere behandling.
English: • together with doxorubicin, vinblastine and dacarbazine (other cancer medicines) in HL patients who have stage IV disease (advanced cancer that has spread to other parts of the body) that has not been treated before;
Danish: • sammen med doxorubicin, vinblastin og dacarbazin (andre kræftlægemidler) til patienter med
English: EU number
Danish: MF (EU)-nummer
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelfor m
English: Side effects are similar in children.
Danish: Bivirkningerne er de samme hos børn.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 12 August 2010.
Danish: Efter at virksomheden havde forelagt de supplerende oplysninger, det var blevet anmodet om, blev de "særlige omstændigheder" ophævet den 12. august 2010.
English: This will help to protect against the disease caused by the virus.
Danish: Dette er med til at beskytte mod de sygdomme, som kan forårsages af virussen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pandemrix on 20 May 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pandemrix den 20. maj 2008.
English: Pandemrix was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Danish: Pandemrix blev oprindeligt godkendt under ”særlige omstændigheder”, da der af videnskabelige årsager kun forelå begrænsede oplysninger på godkendelsestidspunktet.
English: This document is a summary of the European Public Assessment Report (EPAR) for Pandemrix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pandemrix.
English: The full EPAR for Pandemrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pandemrix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A second dose may be given after an interval of at least three weeks.
Danish: Efter et interval på mindst tre uger kan der gives en yderligere dosis.
English: Pandemrix is given according to official recommendations.
Danish: Pandemrix gives i overensstemmelse med de officielle anbefalinger.
English: A risk management plan has been developed to ensure that Pandemrix is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pandemrix anvendes så sikkert som muligt.
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: The CHMP noted that a single dose was able to trigger immunity to a satisfactory level in adults (including the elderly), adolescents and children from 10 years of age.
Danish: CHMP bemærkede, at en enkelt dosis var i stand til at fremkalde en tilfredsstillende immunrespons hos voksne (herunder ældre), unge og børn fra og med 10-årsalderen.
English: Vaccination should be postponed in subjects with severe fever or an acute (short-lived) infection.
Danish: Vaccinen skal udsættes hos personer med høj feber eller en akut (kortvarig) infektion.
English: Pandemrix influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Danish: Pandemrix influenzavaccine (H1N1)v (split virion, inaktiveret, adjuveret)
English: It should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccine is not available and if immunisation against (H1N1)v is considered necessary.
Danish: Det bør kun anvendes, hvis den anbefalede trivalente/quadrivalente sæsoninfluenzavaccine ikke er til rådighed, og hvis immunisering mod (H1N1)v anses for at være nødvendig.
English: Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with a solvent.
Danish: Inden brug skal vaccinen gøres klar ved at blande en suspension, der indeholder viruspartiklerne, med en solvens.
English: It contains parts of influenza (flu) viruses that have been inactivated.
Danish: Den indeholder dele af influenzavira, som er blevet inaktiveret.
English: For more information about treatment with Pandemrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pandemrix, 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 Pandemrix.
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 Pandemrix.
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Danish: Solvensen indeholder et ‘adjuvans' (en olieholdig forbindelse), som giver en bedre immunrespons.
English: In all of the studies, the vaccine was shown to bring about protective levels of antibodies to a satisfactory level, in line with the criteria laid down by the CHMP.
Danish: I alle undersøgelserne viste vaccinen sig at frembringe en tilstrækkelig beskyttende mængde antistoffer i overensstemmelse med de kriterier, som er fastsat af CHMP.
English: The resulting ‘emulsion' is then injected.
Danish: Den emulsion, der dannes, kan derefter indsprøjtes.
English: Other information about Pandemrix
Danish: Andre oplysninger om Pandemrix
English: What measures are being taken to ensure the safe and effective use of Pandemrix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pandemrix?
English: Six main studies have been carried out that looked at the ability of a two-dose schedule of the vaccine to trigger an immune response in the following groups (the numbers given are for those who received Pandemrix in the studies):
Danish: Der er blevet foretaget seks hovedundersøgelser, hvor det blev undersøgt, med hvilken effekt et todosisskema af vaccinen kunne fremkalde en immunrespons hos følgende grupper (tallene angiver, hvor mange der modtog Pandemrix i forbindelse med undersøgelserne):
English: Pandemrix is a vaccine.
Danish: Pandemrix er en vaccine.
English: Following rare cases of narcolepsy (a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly) among people given the vaccine, it was concluded that Pandemrix should only be used if the recommended seasonal influenza vaccine is not available and if immunisation against H1N1 is still needed.
Danish: På grund af sjældne tilfælde af narkolepsi (en sjælden søvnforstyrrelse, hvor personen pludselig og uventet falder i søvn) blandt de vaccinerede personer konkluderede CHMP, at Pandemrix kun bør anvendes, hvis den anbefalede sæsoninfluenzavaccine ikke er til rådighed og der stadig er behov for immunisering mod H1N1.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pandemrix, 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 Pandemrix, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.