FrancophonIA/ELRC3.0 huggingface dataset:
English: The change concerned an extension of indication to add the treatment of non-small cell lung cancer.
Danish: Ændringen vedrørte en udvidelse af indikationen til også at omfatte behandling af ikke-småcellet lungekræft.
English: In lung cancer, Erbitux is expected to work in the same way as it does in its existing indications.
Danish: Til lungekræft forventedes Erbitux at virke på samme måde, som det virker ved de nuværende indikationer.
English: It was to be used in patients who had not been treated before, when the tumour cells had a protein on their surface called epidermal growth factor receptor (EGFR).
Danish: Det skulle have været anvendt til patienter, som ikke tidligere var blevet behandlet, hvor tumorcellerne havde et overfladeprotein kaldet epidermal vækstfaktorreceptor (EGFR).
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Danish: Et monoklonalt antistof er en type protein, der er opbygget, så det genkender og binder sig til en bestemt struktur (kaldet et antigen) i kroppen.
English: What is happening with Erbitux for the treatment of cancer of the colon or rectum and cancers of the head and neck?
Danish: Hvad sker der med Erbitux til behandling af kræft i colon eller rectum og kræft i hoved og hals?
English: What was Erbitux expected to be used for?
Danish: Hvad forventedes Erbitux anvendt til?
English: In July 2009, the CHMP was concerned that the benefits of adding Erbitux to standard platinum-based chemotherapy were modest in terms of survival times, and that the medicine did not have a convincing effect on how long patients lived without their cancer getting worse.
Danish: I juli 2009 fandt CHMP grund til betænkelighed ved, at fordelene ved at tilføje Erbitux til standard platinbaseret kemoterapi var beskedne med hensyn til overlevelsestider, og at lægemidlet ikke havde en overbevisende effekt på, hvor lang tid patienterne levede, uden at deres kræft forværredes.
English: • metastatic cancer of the colon or rectum (large intestine).
Danish: • metastatisk kræft i colon eller rectum (tyktarmen).
English: Erbitux was also expected to be used to treat ‘non-small cell' lung cancer that was advanced (had started to spread) or metastatic.
Danish: Erbitux forventedes også anvendt til behandling af ‘ikke-småcellet' lungekræft, som var fremskreden (var begyndt at sprede sig) eller metastatisk.
English: These types of cancer affect the cells of the lining of the mouth or the throat, or of organs such as the larynx (voice box).
Danish: Disse former for kræft angriber cellerne i mund- og halsslimhinden eller i organer såsom larynx (strubehovedet).
English: Therefore, the CHMP was of the opinion that the benefits of Erbitux in the treatment of non-small cell lung cancer did not outweigh its risks.
Danish: CHMP var derfor af den opfattelse, at fordelene ved Erbitux til behandling af ikke-småcellet lungekræft ikke opvejede risiciene.
English: On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Erbitux.
Danish: Den 23. juli 2009 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgning om ændring af markedsføringstilladelsen for lægemidlet Erbitux.
English: Severe side effects were seen in some lung cancer patients who received Erbitux - these were similar to the side effects seen in patients treated with Erbitux for other types of cancer.
Danish: Der blev iagttages svære bivirkninger hos visse lungekræftpatienter, som fik Erbitux - disse svarede til de bivirkninger, der kunne observeres hos patienter behandlet med Erbitux for andre former for kræft.
English: In both studies, the combination of Erbitux with platinum-based chemotherapy was compared with platinum based chemotherapy without Erbitux.
Danish: I begge undersøgelser blev kombinationen af Erbitux med platinbaseret kemoterapi sammenlignet med platinbaseret kemoterapi uden Erbitux.
English: Erbitux was to be used in combination with platinum-based chemotherapy (a combination of anticancer medicines that includes a medicine such as cisplatin or carboplatin).
Danish: Erbitux skulle have været anvendt i kombination med platinbaseret kemoterapi (en kombination af lægemidler mod kræft, som omfatter et lægemiddel såsom cisplatin eller carboplatin).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Erbitux.
Danish: Virksomheden informerede CHMP om, at afslaget ikke får konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Erbitux.
English: Cetuximab has been designed to attach to EGFR, which can be found on the surface of some tumour cells.
Danish: Cetuximab er opbygget, så det binder sig til EGFR, der kan findes på overfladen af visse tumorceller.
English: • ‘squamous cell' cancers of the head and neck.
Danish: • ‘pladecelle-'kræft i hoved og hals.
English: What are the consequences of the refusal for patients in clinical trials using Erbitux?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Erbitux?
English: How is Erbitux expected to work?
Danish: Hvordan forventes Erbitux at virke?
English: Erbitux is a solution for infusion (drip into a vein) that contains the active substance cetuximab.
Danish: Erbitux er en opløsning til infusion (drop i en vene), der indeholder det aktive stof cetuximab.
English: The full European Public Assessment Report for Erbitux is available here.
Danish: Den fuldstændige EPAR for Erbitux findes her.
English: Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Danish: CHMP anbefalede derfor at give afslag på ansøgningen om ændring af markedsføringstilladelsen.
English: Erbitux can be used when the cancer is locally advanced (when the tumour has grown but has not spread), recurrent (when it has come back after previous treatment) or metastatic.
Danish: Erbitux kan anvendes, når kræften er lokalt fremskreden (når tumoren er vokset, men ikke har spredt sig), når kræften er recidiverende
English: Ref.: EMA/756630/2009 EMEA/H/C/264
Danish: Ref.: EMEA/756630/2009 EMEA/H/C/264
English: As the company had supplied the additional information requested, the ‘Exceptional Circumstances' ended on 10 March 2004.
Danish: Efter at virksomheden havde forelagt de anmodede supplerende oplysninger, blev de "særlige omstændigheder" ophævet den 10. marts 2004.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Agenerase to Glaxo Group Limited on 20 October 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Agenerase til Glaxo Group Limited den 20. oktober 2000.
English: Other information about Agenerase:
Danish: Andre oplysninger om Agenerase:
English: Agenerase was originally authorised under ‘Exceptional Circumstances', because, for scientific reasons, limited information was available at the time of approval.
Danish: Agenerase blev oprindelig godkendt "under særlige omstændigheder", da der af faglige årsager på godkendelsestidspunktet kun forelå begrænsede oplysninger.
English: The Committee recommended that Agenerase be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Agenerase.
English: It is available as cream capsules (50 and 150 mg) and as an oral solution (15 mg/ml).
Danish: Det fås som cremefarvede kapsler (50 og 150 mg amprenavir) og som oral opløsning (15 mg/ml).
English: Agenerase amprenavir EPAR summary for the public
Danish: Agenerase amprenavir EPAR - sammendrag for offentligheden
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse de faglige drøftelser (også en del af denne EPAR).
English: Agenerase is a medicine that contains the active substance amprenavir.
Danish: Agenerase er et lægemiddel, der indeholder det aktive stof amprenavir.
English: In children aged between four and 12 years and in patients who weigh less than 50 kg, the recommended dose of Agenerase depends on body weight.
Danish: Til børn mellem fire og 12 år og til patienter, der vejer under 50 kg, afhænger den anbefalede dosis Agenerase af legemsvægten.
English: Treatment with Agenerase should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandling med Agenerase bør startes af en læge med erfaring i behandling af hiv-infektion.
English: Because amprenavir is less easily absorbed with the oral solution than with the capsules, the two formulations are not interchangeable on a milligram-for-milligram basis.
Danish: Da amprenavir ikke optages lige så let fra den orale opløsning som fra kapslerne, kan de to formuleringer ikke erstatte hinanden milligram for milligram.
English: Agenerase does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Agenerase helbreder ikke hiv-infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: The full EPAR for Agenerase can be found here.
Danish: Den fuldstændige EPAR for Agenerase findes her: her.
English: The recommended dose of Agenerase for patients over 12 years of age is 600 mg twice a day, taken with 100 mg ritonavir twice a day and with other antiviral medicines.
Danish: Den anbefalede dosis til patienter over 12 år er 600 mg to gange dagligt, som tages sammen med 100 mg ritonavir to gange dagligt og med andre antivirale lægemidler.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Danish: Når enzymet blokeres, formerer viruset sig ikke normalt, så infektionen breder sig langsommere.
English: The active substance in Agenerase, amprenavir, is a protease inhibitor.
Danish: Det aktive stof i Agenerase, amprenavir, er en proteasehæmmer.
English: What is the risk associated with Agenerase?
Danish: Hvilken risiko er der forbundet med Agenerase?
English: In adults, Agenerase capsules are usually given with low-dose ritonavir (another antiviral medicine).
Danish: Til voksne gives Agenerase-kapsler sædvanligvis sammen med lave doser af ritonavir (et andet antiviralt lægemiddel).
English: If ritonavir is not used, Agenerase is taken at a higher dose (1,200 mg twice a day).
Danish: Hvis patienten ikke skal have ritonavir, skal der bruges større dosis Agenerase (1 200 mg to gange dagligt).
English: Ritonavir is another protease inhibitor that is used as a ‘booster'.
Danish: Ritonavir er en anden proteasehæmmer, der bruges som "forstærker".
English: Agenerase, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Agenerase anvendes i kombination med andre antivirale lægemidler, mindsker det hiv-mængden i blodet og holder den nede.
English: Doctors should prescribe Agenerase after they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
Danish: Lægen bør først ordinere Agenerase efter at have undersøgt, hvilken antiviral medicin patienten tidligere har fået og efter at have vurderet sandsynligheden for, at medicinen virker på den pågældende virus.
English: In the studies of adults who had not previously taken protease inhibitors, Agenerase taken without ritonavir was more effective than placebo but less effective than indinavir.
Danish: I undersøgelsen af voksne, der tidligere havde fået proteasehæmmere, var Agenerase uden ritonavir mere effektivt end placebo men ikke så effektivt som indinavir.
English: Agenerase should not be used in people who may be hypersensitive (allergic) to amprenavir or any of the other ingredients.
Danish: Agenerase bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for amprenavir eller andre af indholdsstofferne.
English: For the full list of all side effects reported with Agenerase, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Agenerase fremgår af indlægssedlen.
English: In adults who had taken protease inhibitors in the past, Agenerase boosted with ritonavir was as effective as other protease inhibitors in reducing viral loads after 16 weeks of treatment: around two thirds of the patients in both groups had viral loads below 400 copies/ml.
Danish: I undersøgelsen af voksne, der tidligere havde fået proteasehæmmere, var Agenerase, forstærket med ritonavir, lige så effektivt som andre proteasehæmmere til at nedsætte virusindholdet efter 16 ugers behandling: Ca. to tredjedele af patienterne i begge grupper havde et virusindhold på mindre end 400 kopier/ml..
English: Agenerase should only be used in patients who have previously been treated with the same type of medicine as Agenerase (protease inhibitors).
Danish: Agenerase bør kun anvendes til patienter, der tidligere er blevet behandlet med medicin af samme type som Agenerase (proteasehæmmere).
English: Why has Agenerase been approved?
Danish: Hvorfor blev Agenerase godkendt?
English: Agenerase is used in combination with other antiviral medicines to treat patients over four years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Agenerase anvendes sammen med andre antivirale lægemidler til behandling af patienter over fire år, som er inficeret med humant immundefektvirus type 1(hiv-1).
English: It slows down the rate at which amprenavir is broken down, increasing the levels of amprenavir in the blood.
Danish: Den mindsker nedbrydningshastigheden af amprenavir, der derfor får højere koncentration i blodet.
English: The most common side effects with Agenerase (seen in more than 1 patient in 10) are hypercholesterolaemia (high blood cholesterol levels), headache, diarrhoea, flatulence (gas), nausea (feeling sick), vomiting, rash and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Agenerase (som optræder hos flere end 1 ud af 10 patienter) er hyperkolesterolæmi (forhøjet koncentration af kolesterol i blodet), hovedpine, diarré, tarmluft, kvalme, opkastning, udslæt og træthed.
English: As with other anti-HIV medicines, patients taking Agenerase may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Danish: Som med anden hiv-medicin kan patienter, der får Agenerase, få lipodystrofi (ændret fedtfordeling i kroppen), osteonekrose (knoglevævsdød) eller immunreaktiveringssyndrom (infektionslignende symptomer, der skyldes, at immunsystemet genvinder sin funktion).
English: Of these, 43 had HIV that was resistant to four other protease inhibitors.
Danish: Hos 43 heraf var hiv resistent over for fire andre proteasehæmmere.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Agenerase benefits are greater than its risks, but noted that the benefit of Agenerase taken with ritonavir has not been demonstrated in patients who have not taken protease inhibitors in the past.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Agenerase opvejer risiciene, men at Agenerase ikke er påvist at have nogen fordel, når det anvendes sammen med ritonavir hos patienter, der ikke tidligere har fået proteasehæmmere.
English: This allows a lower dose of amprenavir to be used for the same effect.
Danish: På denne måde fås samme virkning med en lavere dosis amprenavir.
English: Agenerase boosted with ritonavir must not be taken by patients who have severe problems with their liver, or by patients taking rifampicin (used to treat tuberculosis) or medicines that are broken down in the same way as ritonavir, such as flecainide and propafenone (used to correct irregular heartbeat).
Danish: Agenerase forstærket med ritonavir må heller ikke anvendes af patienter, der har alvorlige leversygdomme, eller af patienter, der får rifampicin (anvendes til behandling af tuberkulose) eller lægemidler, der nedbrydes på samme måde som ritonavir, f.eks. flecainid og propafenon (anvendes til behandling af uregelmæssig hjerterytme).
English: What is Agenerase?
Danish: Hvad er Agenerase?
English: What benefit has Agenerase shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Agenerase?
English: In the patients with HIV that was resistant to four other protease inhibitors, patients taking Agenerase with ritonavir had a greater fall in viral load after four weeks than those continuing to take their previous protease inhibitors.
Danish: Patienter, hos hvem hiv var resistent over for fire andre proteasehæmmere, opnåede efter fire uger større fald i virusindholdet ved at få Agenerase kombineret med ritonavir end ved at fortsætte med de proteasehæmmere, de tidligere havde fået.
English: See the Package Leaflet for the full list of these medicines.
Danish: En fuldstændig liste over sådanne lægemidler fremgår af indlægssedlen.
English: The main measures of effectiveness were the number of patients with undetectable levels of HIV in the blood (viral load) and the change in viral load after treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på den andel af patienterne, hos hvem der efter behandling ikke fandtes påviselige mængder af hiv i blodet og ændringen af virusindholdet i blodet efter behandling.
English: What is Agenerase used for?
Danish: Hvad anvendes Agenerase til?
English: How has Agenerase been studied?
Danish: Hvordan blev Agenerase undersøgt?
English: Agenerase boosted with low-dose ritonavir has been compared with other protease inhibitors in 206 adults who had taken protease inhibitors in the past.
Danish: Virkningen af Agenerase forstærket med lave doser af ritonavir blev desuden sammenlignet med virkningen af andre proteasehæmmere hos 206 voksne, der tidligere havde fået proteasehæmmere.
English: Agenerase must not be used in patients who are taking St John's wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Agenerase and are harmful at high levels in the blood.
Danish: Amprenavir må ikke anvendes til patienter, der får perikum (et naturlægemiddel, der anvendes til behandling af depression) eller lægemidler, der nedbrydes på samme måde som Agenerase og er skadelige, hvis koncentrationen i blodet bliver for høj.
English: Taking Agenerase with ritonavir should be avoided in children.
Danish: Hos børn bør der ikke anvendes ritonavir sammen med Agenerase.
English: Agenerase reduced viral loads in children and adolescents, although very few of those who had taken protease inhibitors in the past responded to treatment and there were very few children aged below four years.
Danish: Agenerase mindskede også virusindholdet hos børn og unge, selvom meget få af de børn, der tidligere havde fået proteasehæmmere, responderede på behandlingen.
English: How is Agenerase used?
Danish: Hvordan anvendes Agenerase?
English: Agenerase without ritonavir has also been studied in 268 HIV-infected children and adolescents aged between six months and 18 years, all of whom had previously taken treatment for HIV infection, and 135 of whom had been treated with protease inhibitors.
Danish: Agenerase er desuden blevet undersøgt hos 268 hiv-inficerede børn og unge i alderen seks måneder til 18 år.
English: Patients who have problems with their liver may be at an elevated risk of liver damage when taking Agenerase.
Danish: Hos patienter med leverproblemer kan anvendelse af Agenerase øge risikoen for leverskade.
English: The oral solution is for patients who cannot swallow the capsules but it cannot be given with ritonavir.
Danish: Patienter, der ikke kan synke kapslerne, kan i stedet anvende Agenerase i oral opløsning.
English: Agenerase without ritonavir has also been compared with placebo (a dummy treatment) and with invirase (another protease inhibitor) in 736 HIV-infected adults who had not previously been treated with protease inhibitors.
Danish: Agenerase har i kombination med andre antivirale lægemidler, men uden ritonavir, været genstand for to hovedundersøgelser af 736 voksne, der var inficeret med hiv, og som ikke tidligere var blevet behandlet med proteasehæmmere.
English: How does Agenerase work?
Danish: Hvordan virker Agenerase?
English: The dose of Agenerase should be reduced in patients who have problems with their liver, and it should be taken without ritonavir by patients who have severe liver problems.
Danish: Til patienter med svære leverproblemer bør Agenerase anvendes uden ritonavir.
English: See section 6.6 for information on administration.
Danish: 6.6 for information om administration.
English: Once Daily
Danish: 1 gang dagligt
English: Lyrica and certain other medicines may influence each other (interaction).
Danish: Lyrica og anden medicin kan påvirke hinanden (interaktion).
English: • Your doctor will tell you to take Lyrica either twice or three times a day.
Danish: • Din læge vil fortælle, at du enten skal tage Lyrica 2 gange eller 3 gange dagligt.
English: If you are an elderly patient (over 65 years of age), you should take Lyrica normally except if you have problems with your kidneys.
Danish: Hvis du er ældre (over 65 år), skal du tage Lyrica som normalt, medmindre du har nyreproblemer.
English: Lyrica is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Danish: Lyrica er ikke beregnet til at blive brugt alene, men skal altid anvendes i kombination med anden behandling mod epilepsi.
English: Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Danish: Lyrica bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (hvis fordelene for moderen klart opvejer den mulige risiko for fosteret/det nyfødte barn).
English: The body is also marked with a black band.
Danish: Underdelen er også mærket med et sort bånd.
English: Your doctor will prescribe Lyrica for you to help treat your epilepsy when your current treatment is not controlling your condition.
Danish: Din læge vil udskrive Lyrica til behandling af din epilepsi, hvis din nuværende behandling ikke kan kontrollere din tilstand.
English: Pregabalin oral bioavailability is estimated to be  90% and is independent of dose.
Danish: Biotilgængeligheden af oral pregabalin anslås at være  90%, og er ikke dosisafhængig.
English: Oral Solution Pfizer Service Company Hoge Wei 10
Danish: Oral opløsning Pfizer Service Company Hoge Wei 10
English: Continue taking Lyrica until your doctor tells you to stop.
Danish: Fortsæt med at tage Lyrica, indtil din læge beder dig om at stoppe.
English: Pregabalin binds to an auxiliary subunit (2- protein) of voltage-gated calcium channels in the central nervous system.
Danish: Pregabalin bindes til en hjælpeundergruppe (2- protein) i de spændingsafhængige calciumkanaler i centralnervesystemet.
English: Lyrica oral solution contains small amounts of ethanol (alcohol), less than 100 mg/ml.
Danish: Lyrica indeholder en lille mængde alkohol (ethanol), mindre end 100 mg/ml.
English: Central nervous system influencing medical products Pregabalin may potentiate the effects of ethanol and lorazepam.
Danish: Lægemidler, der påvirker centralnervesystemet Pregabalin kan potensere virkningerne af ethanol og lorazepam.
English: You should take Lyrica in addition to your current treatment.
Danish: Du skal tage Lyrica sammen med din nuværende behandling.
English: Lyrica is for oral use only.
Danish: Lyrica er kun til oral anvendelse.