FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pifeltro 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 Pifeltro.
English: 1ml (200 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Danish: 12 (3 x 4) fyldte penne (multipakning)
English: Strength Pharmaceutical Form
Danish: 4 fyldte injektionssprøjter
English: 1ml (200 mg/ml) 4 pre-filled pens
Danish: 4 fyldte penne
English: The European Commission granted a marketing authorisation valid throughout the European Union for Avastin on 12 January 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Avastin den 12. januar 2005.
English: This is a summary of the European public assessment report (EPAR) for Avastin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Avastin.
English: The full EPAR for Avastin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Avastin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The first infusion of Avastin should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well.
Danish: Den første infusion af Avastin skal vare 90 minutter, men de efterfølgende infusioner kan gives hurtigere, hvis den første infusion blev tolereret godt.
English: The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated.
Danish: Dosis er mellem 5 og 15 mg pr. kilo legemsvægt hver anden eller tredje uge afhængigt af, hvilken type kræft der behandles.
English: What measures are being taken to ensure the safe and effective use of Avastin?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Avastin?
English: Avastin contains the active substance bevacizumab.
Danish: Avastin indeholder det aktive stof bevacizumab.
English: Other information about Avastin
Danish: Andre oplysninger om Avastin
English: The CHMP decided that Avastin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Avastin opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Avastin.
English: Cancer of the colon or rectum
Danish: Kræft i colon eller rectum
English: In all of the studies, the main measure of effectiveness was either overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
Danish: I alle undersøgelserne blev virkningen hovedsagelig målt på enten den samlede overlevelsestid (hvor længe patienterne levede) eller den progressionsfrie overlevelse (hvor lang tid patienterne levede, uden at deres sygdom forværredes).
English: Several studies have shown that Avastin is effective at treating the types of cancers for which it is approved.
Danish: Adskillige undersøgelser har vist, at Avastin er effektivt til behandling af de typer kræft, som lægemidlet er godkendt til.
English: As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, helping to slow down the growth of tumours.
Danish: Dette bevirker, at kræftcellerne ikke kan udvikle deres egen blodforsyning, og de får derfor mindre ilt og færre næringsstoffer, hvilket er med til at hæmme væksten af tumorer.
English: The third study involved 829 patients who had failed previous treatment including a fluoropyrimidine and irinotecan.
Danish: Den tredje undersøgelse omfattede 829 patienter, som ikke havde reageret på tidligere behandling, hvori der indgik fluoropyrimidin og irinotecan.
English: It is not intended to provide practical advice on how to use Avastin.
Danish: Det er ikke en praktisk vejledning i, hvordan Avastin bør anvendes.
English: What is Avastin and what is it used for?
Danish: Hvad er Avastin, og hvad anvendes det til?
English: Why has Avastin been approved?
Danish: Hvorfor blev Avastin godkendt?
English: Avastin can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer treatments.
Danish: Avastin udleveres kun efter recept, og behandlingen bør overvåges af en læge med erfaring i behandling af kræft.
English: Avastin is given in combination with paclitaxel and either the platinum-based medicine cisplatin or, if this cannot be used, another chemotherapy medicine, topotecan.
Danish: Avastin gives i kombination med paclitaxel og enten det platinbaserede lægemiddel cisplatin eller, hvis dette ikke kan anvendes, topotecan, et andet kemoterapilægemiddel.
English: • advanced or metastatic kidney cancer, in combination with interferon alfa-2a;
Danish: • fremskreden eller metastatisk nyrekræft, i kombination med interferon alfa-2a
English: What is the risk associated with Avastin?
Danish: Hvilken risiko er der forbundet med Avastin?
English: Avastin is used in combination with certain chemotherapy medicines in newly diagnosed patients when the cancer is advanced, or in previously treated patients whose cancer has come back (recurrent).
Danish: Avastin bruges i kombination med visse kræftlægemidler til nydiagnosticerede patienter med fremskreden kræft eller til tidligere behandlede patienter, hvis kræft er kommet igen (tilbagevendende).
English: • metastatic breast cancer, in combination with paclitaxel or capecitabine;
Danish: • metastatisk brystkræft i kombination med paclitaxel eller capecitabin
English: For more information about treatment with Avastin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Avastin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: When the type of chemotherapy was taken into account, there was a tendency for patients given cisplatin-based treatment to live on average about 2 months longer than those given topotecan-based treatment, independently of giving Avastin as part of the treatment regimens.
Danish: Når typen af kemoterapi blev taget i betragtning, var der tendens til, at patienter, der modtog en cisplatinbaseret behandling, i gennemsnit levede ca. to måneder længere end patienter, som modtog en topotecanbaseret behandling, uafhængigt af om der blev givet Avastin som en del af behandlingsmåden.
English: The first two studies included patients whose cancer came back 6 months or more after previous treatment (‘platinum-sensitive disease'), while the third study was in patients with more aggressive cancer that had come back within 6 months of previous treatment (‘platinum-resistant disease').
Danish: De første to undersøgelser omfattede patienter, hvis kræft vendte tilbage 6 måneder eller mere efter forudgående behandling ("platinfølsom sygdom"), mens den tredje omfattede patienter med mere aggressiv kræft, der var vendt tilbage inden for 6 måneder efter forudgående behandling ("platinresistent sygdom").
English: Avastin must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies.
Danish: Avastin må ikke anvendes af personer, der er overfølsomme (allergiske) over for bevacizumab eller andre af indholdsstofferne eller over for lægemidler med ovarieceller fra kinesiske hamstre eller andre rekombinante antistoffer.
English: The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries).
Danish: De mest alvorlige bivirkninger er gastrointestinale perforationer (huller i tarmvæggen), hæmorrhagi (blødning) og arteriel tromboemboli (blodpropper i arterierne).
English: The active substance in Avastin, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Danish: Det aktive stof i Avastin, bevacizumab, er et protein af typen monoklonalt antistof, der er udformet, så det genkender og bindes til proteinet vaskulær endotelial vækstfaktor (VEGF), der cirkulerer i blodet og får blodkar til at vokse.
English: • cancer of the colon (large intestine) or rectum that is metastatic (has spread to other parts of the body), in combination with chemotherapy medicines that include a ‘fluoropyrimidine';
Danish: • kræft i colon (tyktarmen) eller rectum, som er metastatisk (har bredt sig til andre dele af kroppen), i kombination med kemoterapilægemidler, som omfatter et "fluoropyrimidin"
English: • advanced non-small cell lung cancer in patients whose cancer cells have a certain change (‘activating mutations') in the gene for a protein called EGFR, where it is given in combination with erlotinib;
Danish: • fremskreden ikke-småcellet lungekræft hos patienter, hvis kræftceller har visse ændringer ("aktiverende mutationer") i genet for et protein, der kaldes EGFR, hvor det gives sammen med erlotinib
English: • advanced non-small cell lung cancer in patients whose cancer cells are not mainly of the squamous type, where it is given with platinum-based chemotherapy;
Danish: • fremskreden ikke-småcellet lungekræft hos patienter, hvis kræftceller ikke hovedsageligt er af "pladecelletypen", hvor det gives sammen med platinbaseret kemoterapi
English: The most common side effects with Avastin are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Danish: De hyppigste bivirkninger ved Avastin er hypertension (forhøjet blodtryk), træthed eller asteni (kraftesløshed), diarré og mavesmerter.
English: In the second study, overall survival in patients given Avastin in combination with carboplatin and paclitaxel was 42.6 months, compared with 37.3 months in patients treated with carboplatin and paclitaxel only.
Danish: I den anden undersøgelse var den samlede overlevelse hos patienter, der fik Avastin sammen med carboplatin og paclitaxel 42,6 måneder sammenlignet med 37,3 måneder hos patienter i behandling med carboplatin og paclitaxel alene.
English: The study compared the effect of adding Avastin to chemotherapy using paclitaxel plus cisplatin or topotecan to results in patients given chemotherapy alone.
Danish: I undersøgelsen sammenlignedes virkningen af at tilføje Avastin til kemoterapi med paclitaxel plus cisplatin eller topotecan med resultater hos patienter, der blev behandlet med kemoterapi alene.
English: • Recurrent disease: three studies with Avastin in recurrent ovarian, fallopian tube and peritoneal cancers were performed in a total of 1,518 patients.
Danish: • Tilbagevendende sygdom: Der er blevet gennemført tre undersøgelser med Avastin i forbindelse med tilbagevendende kræft i æggestokkene, æggelederne og bughinden hos i alt 1.518 patienter.
English: For practical information about using Avastin, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Avastin, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Avastin is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Danish: Avastin leveres som et koncentrat, der blandes til en infusionsvæske, opløsning, til indgivelse (drop) i en vene.
English: In the first study, average progression-free survival was 12.4 months when Avastin was added to carboplatin and gemcitabine, compared with 8.4 months when placebo was added.
Danish: I den første undersøgelse var den gennemsnitlige progressionsfrie overlevelsestid 12,4 måneder, når Avastin blev tilføjet til carboplatin og gemcitabin sammenlignet med 8,4 måneder, når placebo blev tilføjet.
English: In the third study in patients with more aggressive cancer, progression-free survival was 6.7 months when Avastin was added to paclitaxel, topotecan, or pegylated liposomal doxorubicin, compared with 3.4 months when these chemotherapies were used on their own.
Danish: I den tredje undersøgelse af patienter med mere aggressiv kræft var den progressionsfrie overlevelse 6,7 måneder, når Avastin blev tilføjet til paclitaxel, topotecan eller pegyleret liposomalt doxorubicin, sammenholdt med 3,4 måneder ved anvendelse af disse kemoterapimidler alene.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Avastin have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er anført anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Avastin.
English: For the full list of all side effects reported with Avastin, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Avastin fremgår af indlægssedlen.
English: Results showed that the average overall survival was 16.8 months with chemotherapy including Avastin compared with 12.9 months on chemotherapy alone.
Danish: Resultaterne viste, at den gennemsnitlige samlede overlevelsestid var 16,8 måneder med kemoterapi i kombination med Avastin, sammenlignet med 12,9 måneder med kemoterapi alene.
English: In advanced or metastatic kidney cancer, Avastin plus interferon alfa-2a has been shown to increase progression-free survival in one study in 649 patients: the average progression-free survival was 10.2 months in the patients receiving Avastin plus interferon alfa-2a and 5.4 months in those receiving interferon alfa-2a.
Danish: Hos patenter med fremskreden eller metastatisk nyrekræft har Avastin plus interferon alfa-2a i en undersøgelse med 649 patienter vist sig at øge den progressionsfrie overlevelse: Den gennemsnitlige progressionsfrie overlevelse var 10,2 måneder hos patienter, der fik Avastin plus interferon alfa-2a og 5,4 måneder hos dem, der fik interferon alfa-2a.
English: Overall survival was 12.9 months in patients adding Avastin and 10.8 months in those receiving chemotherapy alone.
Danish: Den samlede overlevelsestid var 12,9 måneder hos patienter, som fik tilføjet Avastin, og 10,8 måneder hos patienter, som fik kemoterapi alene.
English: In the first study (722 patients), progression-free survival was 11.4 months in patients receiving Avastin with paclitaxel, compared with 5.8 months in those receiving paclitaxel alone.
Danish: I den første undersøgelse (722 patienter) var den progressionsfrie overlevelsestid 11,4 måneder hos patienter, som fik Avastin sammen med paclitaxel sammenlignet med 5,8 måneder hos dem, der fik paclitaxel alene.
English: In metastatic cancer of the colon or rectum, Avastin used with chemotherapy including a fluoropyrimidine has been shown to increase overall and progression-free survival in three main studies.
Danish: Ved metastatisk kræft i colon eller rectum er det i tre hovedforsøg blevet påvist, at Avastin sammen med kemoterapi, inklusive fluoropyrimidin, øger den samlede og progressionsfrie overlevelse.
English: • In advanced, metastatic or recurrent lung cancer, Avastin plus platinum-based chemotherapy has been shown to increase overall survival in one study in 878 patients: the average overall survival was 12.3 months in the patients taking Avastin with platinum-based chemotherapy, and 10.3 months for those taking chemotherapy alone.
Danish: • Ved fremskreden, metastatisk eller tilbagevendende lungekræft har Avastin plus platinbaseret kemoterapi i et forsøg med 878 patienter vist sig at øge den samlede overlevelse: Den gennemsnitlige samlede overlevelsestid var 12,3 måneder hos patenter, som fik Avastin sammen med platinbaseret kemoterapi og 10,3 måneder hos dem, der kun fik kemoterapi.
English: In metastatic breast cancer, Avastin has been shown to increase progression-free survival in two main studies.
Danish: Til metastatisk brystkræft har Avastin i to hovedundersøgelser vist sig at øge den progressionsfrie overlevelsestid.
English: Avastin is a cancer medicine used to treat adults with the following types of cancer, in combination with other cancer medicines:
Danish: Avastin et kræftlægemiddel og anvendes sammen med andre kræftlægemidler til behandling af voksne med følgende kræftformer:
English: What benefits of Avastin have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Avastin?
English: • cancer of the cervix (the neck of the womb) that is persistent, recurrent or metastatic.
Danish: • livmoderhalskræft, som er vedvarende, tilbagevendende eller metastatisk.
English: In the second study (1,237 patients), when Avastin was added to capecitabine, the average progression-free survival was 8.6 months, compared with 5.7 months in those receiving capecitabine with placebo.
Danish: I den anden undersøgelse (1 237 patienter), når Avastin blev føjet til capecitabin, var den gennemsnitlige progressionsfrie overlevelsestid 8,6 måneder sammenlignet med 5,7 måneder hos dem, der fik capecitabin sammen med placebo.
English: By attaching to VEGF, Avastin stops it having an effect.
Danish: VEGF's effekt standses, når Avastin binder sig til VEGF.
English: How is Avastin used?
Danish: Hvordan anvendes Avastin?
English: • Newly diagnosed disease (including advanced disease, first-line treatment): in newly diagnosed ovarian, fallopian tube and peritoneal cancer, Avastin, in combination with carboplatin and paclitaxel, has been shown to increase progression-free survival in two main studies involving 3,401 patients: the average progression-free survival was 19.3 months in patients adding Avastin versus 16.9 months with carboplatin and paclitaxel alone in one study, and 14.7 months versus 10.6 months in the second study.
Danish: • Nydiagnosticeret sygdom (inklusive fremskreden sygdom, førstelinjebehandling): Ved nydiagnosticeret kræft i æggestokkene, æggelederne og bughinden har Avastin sammen med carboplatin og paclitaxel i et forsøg med 3.401 patienter vist sig at øge den progressionsfrie overlevelsestid: Den gennemsnitlige progressionsfrie overlevelsestid var 19,3 måneder hos patienter, der fik Avastin versus 16,9 måneder med carboplatin og paclitaxel alene i en undersøgelse og 14,7 måneder versus 10,6 måneder i den anden undersøgelse.
English: • In patients with a certain subtype of non-small cell lung cancer with activating mutations in the EGFR gene, Avastin plus erlotinib has been shown to increase progression-free survival in one study in 152 patients: patients on Avastin plus erlotinib had progression-free survival of 16.0 months on average compared with 9.7 months in patients given erlotinib alone.
Danish: • Hos patienter med en bestemt undertype ikkesmåcellet lungekræft med aktiverende mutationer i EGFR-genet har Avastin plus erlotinib i en undersøgelse med 152 patienter vist sig at øge den progressionsfrie overlevelsestid: Patienter, der fik Avastin plus erlotinib havde i gennemsnit en progressionsfri overlevelsestid på 16,0 måneder sammenlignet med 9,7 måneder hos patienter, der kun fik erlotinib.
English: Non-small cell lung cancer
Danish: Ikkesmåcellet lungekræft
English: • epithelial cancer of the ovary, cancer of the fallopian tube (that connect the ovaries to the womb) or the peritoneum (the membrane lining the abdomen).
Danish: • kræft i æggestokkenes overfladeceller (epitel), kræft i æggelederne (der forbinder æggestokkene med livmoderen) eller bughinden (peritoneum, den indvendige membran, der beklæder bughulen).
English: The first two studies involved patients whose metastatic disease was being treated for the first time (‘first-line' treatment): in the first study (923 patients),the average overall survival was 20.3 months in patients adding Avastin and 15.6 months in those receiving chemotherapy alone; in the second study in 1,401 patients, progression-free survival was 9.4 months in patients adding Avastin and 8.0 months in those receiving chemotherapy alone.
Danish: De første to undersøgelser involverede patienter, hvis metastatiske sygdom blev behandlet for første gang (førstelinjebehandling): I den første undersøgelse (923 patienter) var den gennemsnitlige samlede overlevelsestid 20,3 måneder hos patienter, som fik tilføjet Avastin og 15,6 måneder hos hos patienter, som fik kemoterapi alene.
English: How does Avastin work?
Danish: Hvordan virker Avastin?
English: In cancer of the cervix, Avastin has been shown to increase overall survival in one main study involving 452 patients with advanced persistent, recurrent or metastatic cancer of the cervix.
Danish: Ved livmoderhalskræft har Avastin i en hovedundersøgelse med 452 patienter med fremskreden, vedvarende, tilbagevendende eller metastatisk livmoderhalskræft vist sig at øge den samlede overlevelse.
English: Cervical cancer
Danish: Livmoderhalskræft
English: Ovarian, fallopian tube and peritoneal cancer
Danish: Kræft i æggestokkene, æggelederne og bughinden
English: The recommended dose is two tablets (40 mg) once a day.
Danish: Den anbefalede dosis er to tabletter (40 mg) én gang dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Generics on 9 January 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tadalafil Generics den 9. januar 2017.
English: This is a summary of the European public assessment report (EPAR) for Talmanco.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Talmanco.
English: Patients with mild or moderate kidney or liver problems should be started on a lower dose.
Danish: Patienter med milde eller moderate nyre- eller leverproblemer bør starte med en lavere dosis.
English: The full EPAR for Talmanco can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Talmanco findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Talmanco
Danish: Andre oplysninger om Talmanco
English: The Committee recommended that Talmanco be approved for use in the EU.
Danish: Udvalget anbefalede, at Talmanco godkendes til anvendelse i EU.
English: As for every medicine, the company provided studies on the quality of Talmanco.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Talmanco.
English: Talmanco is a ‘generic medicine'.
Danish: Talmanco er et "generisk lægemiddel".
English: The name of the medicine was changed to Talmanco on 1 March
Danish: Lægemidlets navn blev ændret til Talmanco den 1. marts 2017.
English: Talmanco is not recommended for patients with severe kidney or liver problems.
Danish: Talmanco anbefales ikke til patienter med svære nyre- eller leverproblemer.
English: Previously known as Tadalafil Generics.
Danish: Tidligere kaldet Tadalafil Generics.
English: Therefore, the CHMP's view was that, as for Adcirca, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Adcirca.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Adcirca, and do not need to be repeated for Talmanco.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i den godkendte anvendelse med referencelægemidlet, Adcirca, og det er ikke nødvendigt at gentage disse med Talmanco.