FrancophonIA/ELRC3.0 huggingface dataset:
English: Doxorubicin accumulates in areas of the body where the blood vessels have an abnormal shape, such as within tumours, where its action is concentrated.
Danish: Doxorubicin akkumuleres i områder i kroppen, hvor blodkarrene har en unormal form, som f.eks. inden i tumorer, hvor dens virkning koncentreres.
English: What is Doxorubicin SUN?
Danish: Hvad er Doxorubicin SUN?
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union containing the same active substance, called Caelyx.
Danish: Det betyder, at det er identisk med et "referencelægemiddel" ved navn Caelyx, som allerede er godkendt i Den Europæiske Union (EU) og indeholder det samme aktive stof.
English: Doxorubicin SUN was assessed as a ‘hybrid generic medicine'.
Danish: Doxorubicin SUN blev vurderet som et "hybridt generisk lægemiddel".
English: Doxorubicin SUN was originally also expected to be used to treat AIDS-related Kaposi's sarcoma (a cancer of the blood vessels) but this indication was withdrawn during the evaluation process.
Danish: Doxorubicin SUN forventedes oprindeligt også anvendt til at behandle aidsrelateret Kaposis sarkom (kræft i blodkarrene), men denne indikation blev trukket tilbage under evalueringsproceduren.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af den sidste række spørgsmål på listen, var der fortsat visse uafklarede spørgsmål.
English: Doxorubicin SUN was to be used in combination with bortezomib (another anticancer medicine).
Danish: Doxorubicin SUN skulle anvendes i kombination med bortezomib (et andet lægemiddel mod cancer).
English: • advanced ovarian cancer (cancer of the ovary) in women whose previous treatment including a platinum-based anticancer medicine has stopped working;
Danish: • Fremskredet ovariecancer (æggestokkræft) hos kvinder, efter at en tidligere behandling med et platinbaseret lægemiddel mod cancer er ophørt med at virke.
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Doxorubicin SUN could not have been approved.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's lister med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Doxorubicin SUN ikke kunne være blevet godkendt.
English: Doxorubicin SUN was expected to be used to treat the following types of cancer in adults:
Danish: Doxorubicin SUN forventedes anvendt til behandling af følgende kræftformer hos voksne:
English: Doxorubicin SUN was expected to work in the same way as the reference medicine, Caelyx.
Danish: Doxorubicin SUN forventes at virke på samme måde som referencelægemidlet Caelyx.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Doxorubicin SUN.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige oplysninger til at underbygge ansøgningen om Doxorubicin SUN.
English: These included studies in patients with ovarian cancer and multiple myeloma to investigate the concentrations of doxorubicin in the blood produced by Doxorubicin SUN compared with Caelyx.
Danish: Disse omfattede undersøgelser hos patienter med ovariecancer og multipelt myelom af koncentrationerne i blodet af doxorubicin produceret af Doxorubicin SUN sammenlignet med Caelyx.
English: This included the total amount of doxorubicin and the amounts of liposome-encapsulated doxorubicin, free doxorubicin and doxorubicinol (the main metabolite of doxorubicin).
Danish: Dette omfattede den samlede mængde af doxorubicin og mængderne af liposomindkapslet doxorubicin, frit doxorubicin og doxorubicinol (hovedmetabolitten i doxorubicin).
English: On 20 Jul 2011, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Doxorubicin SUN, intended for the treatment of metastatic breast cancer, advanced ovarian cancer and progressive multiple myeloma.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Doxorubicin SUN til behandling af metastatisk brystcancer, fremskredet ovariecancer og progressivt multipelt myelom.
English: Based on the data submitted, the CHMP was of the opinion that the studies did not provide enough evidence to show that Doxorubicin SUN was similar to the reference medicine.
Danish: På baggrund af de indsendte data var CHMP af den opfattelse, at undersøgelserne ikke gav tilstrækkelig dokumentation til at påvise, at Doxorubicin SUN svarede til referencelægemidlet.
English: The active substance in Doxorubicin SUN and Caelyx, doxorubicin, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Danish: Det aktive stof i Doxorubicin SUN og Caelyx, doxorubicin, er et cytotoksisk lægemiddel, der tilhører gruppen af "anthracycliner".
English: Doxorubicin SUN was expected to be used on its own for this disease;
Danish: Doxorubicin SUN forventedes anvendt alene til behandling af denne sygdom.
English: What was Doxorubicin SUN expected to be used for?
Danish: Hvad forventedes Doxorubicin SUN anvendt til?
English: In Caelyx and Doxorubicin SUN, doxorubicin is contained (encapsulated) in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Danish: I Caelyx og Doxorubicin SUN er doxorubicin indeholdt (indkapslet) i "pegylerede liposomer" (bittesmå fedtsfærer, som er belagt med et kemikalie kaldet polyethylenglycol).
English: How was Doxorubicin SUN expected to work?
Danish: Hvordan forventes Doxorubicin SUN at virke?
English: Doxorubicin SUN is concentrate to be made up into a solution for infusion (drip into a vein).
Danish: Doxorubicin SUN er et koncentrat til fremstilling af en infusionsvæske, opløsning, (intravenøst drop).
English: What did the company present to support its application?
Danish: Hvilken dokumentation fremlagde virksomheden i forbindelse med ansøgningen til CHMP?
English: The recommended dose depends on the patient's height and weight.
Danish: Den anbefalede dosis afhænger af patientens højde og vægt.
English: Pazenir received a marketing authorisation valid throughout the EU on 6 May 2019.
Danish: Pazenir fik en markedsføringstilladelse med gyldighed i hele EU den 6. maj 2019.
English: Information on the reference medicine can also be found on the Agency's website.
Danish: Oplysninger om referencelægemidlet findes også på agenturets websted.
English: By keeping this structure intact, the cells cannot divide and they eventually die.
Danish: Ved at holde denne struktur intakt kan cellerne ikke dele sig og dør til sidst.
English: Further information on Pazenir can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pazenir.
Danish: Yderligere information vedrørende Pazenir findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/pazenir.
English: Paclitaxel has been available as a cancer medicine since 1993.
Danish: Paclitaxel har været tilgængeligt som kræftlægemiddel siden 1993.
English: The medicine is given once a day on days 1, 8 and 15 of each cycle.
Danish: Lægemidlet gives én gang dagligt på dag 1, 8 og 15 i hver cyklus.
English: ‘Metastatic' means that the cancer has spread to other parts of the body;
Danish: "Metastatisk" betyder, at kræften har spredt sig til andre dele af kroppen
English: It should not be interchanged with other medicines containing paclitaxel.
Danish: Det bør ikke udskiftes med andre lægemidler indeholdende paclitaxel.
English: Other information about Pazenir
Danish: Andre oplysninger om Pazenir
English: The medicine can only be obtained with a prescription.
Danish: Lægemidlet fås kun på recept.
English: What measures are being taken to ensure the safe and effective use of Pazenir?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pazenir?
English: This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
Danish: Dette gør det let at forberede en suspension af paclitaxel, der kan indgives i en vene.
English: Pazenir is used to treat the following cancers in adults:
Danish: Pazenir anvendes til behandling af følgende kræftformer hos voksne:
English: Pazenir is given as an infusion into a vein over a period of 30 minutes.
Danish: Pazenir gives som en infusion i en vene i løbet af 30 minutter.
English: An overview of Pazenir and why it is authorised in the EU
Danish: En oversigt over Pazenir, og hvorfor det er godkendt i EU
English: As for all medicines, data on the use of Pazenir are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Pazenir løbende overvåget.
English: What are the benefits and risks of Pazenir?
Danish: Hvilke fordele og risici er der forbundet med Pazenir?
English: What is Pazenir and what is it used for?
Danish: Hvad er Pazenir, og hvad anvendes det til?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Pazenir has been shown to be comparable to Abraxane.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pazenir er sammenligneligt med Abraxane.
English: Side effects reported with Pazenir are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Pazenir vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Pazenir also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Danish: Pazenir påvirker også andre celler end kræftceller, f.eks. blod- og nerveceller, hvilket kan give bivirkninger.
English: As for every medicine, the company provided studies on the quality of Pazenir.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Pazenir.
English: Pazenir should only be given under the supervision of a cancer doctor in clinics that are specialised in giving ‘cytotoxic' (cell-killing) medicines.
Danish: Pazenir bør kun gives under tilsyn af en kræftlæge på klinikker, der er specialiserede i at give "cytotoksiske" (celledræbende) lægemidler.
English: Why is Pazenir authorised in the EU?
Danish: Hvorfor er Pazenir godkendt i EU?
English: For more information about using Pazenir, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Pazenir, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Paclitaxel blocks a stage of cell division in which the cell's internal ‘skeleton' is dismantled to allow the cell to divide.
Danish: Paclitaxel blokerer det stadium af cellernes deling, hvor det indvendige "skelet" i cellen adskilles, så cellen kan dele sig.
English: There was no need for ‘bioequivalence' studies to investigate whether Pazenir is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Pazenir optages på samme måde som referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Abraxane, and do not need to be repeated for Pazenir.
Danish: Der er allerede gennemført studier af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Abraxane, og det er ikke nødvendigt at gentage disse med Pazenir.
English: Because Pazenir 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: Da Pazenir er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: • metastatic breast cancer, when the first treatment has stopped working and standard treatment including an anthracycline (another type of cancer medicine) is not suitable.
Danish: • metastatisk brystkræft, hvor den første behandling er holdt op med at virke, og standardbehandling, herunder antracykliner (en anden form for kræftlægemiddel), ikke er egnet.
English: In metastatic breast cancer, Pazenir is given on its own every three weeks.
Danish: Ved metastatisk brystkræft gives Pazenir alene hver tredje uge.
English: In non-small cell lung cancer, treatment is carried out in 3-week cycles with Pazenir given on days 1, 8 and 15 of each cycle and carboplatin given on day 1 immediately after Pazenir.
Danish: Ved ikkesmåcellet lungekræft forløber behandlingen over 3-ugers cyklusser, hvor Pazenir gives på dag 1, 8 og 15 i hver cyklus, og carboplatin gives på dag 1 umiddelbart efter Pazenir.
English: For more information on generic medicines, see the question-and-answer document here.
Danish: Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med spørgsmål og svar her.
English: This means that Pazenir contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Abraxane.
Danish: Det betyder, at Pazenir indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Abraxane.
English: This is because Pazenir is given by infusion into a vein and the nanoparticles it contains rapidly separate into its constituent parts in the same way as Abraxane's.
Danish: Dette skyldes, at Pazenir gives ved infusion i en vene, og at de nanopartikler, det indeholder, hurtigt udskilles i dets enkeltdele på samme måde som i Abraxane.
English: Immediately after giving Pazenir, gemcitabine should be given.
Danish: Gemcitabin bør gives straks efter Pazenir.
English: Therefore, the Agency's view was that, as for Abraxane, the benefits of Pazenir outweigh the identified risks and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Pazenir opvejer de identificerede risici som for Abraxane, og at det kan godkendes til anvendelse i EU.
English: • non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.
Danish: • ikkesmåcellet lungekræft, som en første behandling i kombination med kræftlægemidlet carboplatin, når operation eller stråleterapi ikke er mulige.
English: How has Pazenir been studied?
Danish: Hvordan er Pazenir blevet undersøgt?
English: In metastatic adenocarcinoma of the pancreas, Pazenir is given in 4-week treatment cycles.
Danish: Til metastatisk adenokarcinom i bugspytkirtlen gives Pazenir i 4-ugers behandlingscyklusser.
English: • metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine;
Danish: • metastatisk adenokarcinom i bugspytkirtlen som første behandling i kombination med et andet kræftlægemiddel, gemcitabin
English: The active substance in Pazenir, paclitaxel, belongs to the group of cancer medicines known as the ‘taxanes'.
Danish: Det aktive stof i Pazenir, paclitaxel, tilhører en gruppe af kræftlægemidler, der kaldes taxaner.
English: In Pazenir, as in its reference medicine Abraxane, paclitaxel is attached to a human protein called albumin in tiny particles known as ‘nanoparticles'.
Danish: I Pazenir, som i referencelægemidlet Abraxane, er paclitaxel bundet til et humant protein kaldet albumin i små partikler kaldet "nanopartikler".
English: Pazenir contains the active substance paclitaxel attached to a human protein called albumin and is a ‘generic medicine'.
Danish: Pazenir, der indeholder det aktive stof paclitaxel bundet til et humant protein kaldet albumin, er et "generisk lægemiddel".
English: How is Pazenir used?
Danish: Hvordan anvendes Pazenir?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pazenir 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 Pazenir.
English: How does Pazenir work?
Danish: Hvordan virker Pazenir?
English: Pictures of rash according to different grades
Danish: Billeder af udslæt inddelt efter sværhedsgrad
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:
Danish: Medlemslandet skal sørge for, at alle betingelser og begrænsninger vedrørende sikker og effektiv anvendelse af lægemidlet beskrevet nedenfor er implementeret:
English: Rash and Severe Cutaneous Adverse Reactions safety data from Phases 2 and 3 Incidence of rash and severe cutaneous reactions Grading and management of rash and severe cutaneous reactions, particularly with respect to criteria for the continuation or discontinuation of telaprevir and the other
Danish: Brochuren med information til læger skal indeholde følgende centrale punkter: Sikkerhedsdata om udslæt og svære kutane bivirkninger fra fase 2-og 3 Incidens af udslæt og svære kutane reaktioner Inddeling og behandling af udslæt og svære kutane reaktioner, især mhp.
English: The Member States shall agree to the final healthcare educational pack with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Danish: Medlemslandene skal sammen med indehaveren af markedsføringstilladelsen vedtage det endelige indhold i uddannelsesmaterialet om behandlingen før markedsføringen af lægemidlet inden for deres
English: The Member States shall ensure that the MAH provides to all physicians who are expected to prescribe or use INCIVO a healthcare professional educational pack containing the following:
Danish: Medlemslandene skal sikre, at indehaveren af markedsføringstilladelsen forsyner alle læger, som forventes at ordinere eller anvende INCIVO, med uddannelsesmateriale til sundhedspersonale, der
English: EU Number
Danish: EU-nummer
English: 250 µg Solution for injection
Danish: 250 µg Injektionsvæske, opløsningIntravenøs anvendelse
English: Invented name
Danish: Særnavn
English: 5 capsules
Danish: 5 kapsler
English: Packaging Content (concentration) Package size
Danish: Indhold Pakningsstørrelse
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Indgivelsesvej
English: Intravenous use vial (glass) 5 ml
Danish: 5 ml
English: 1 vial
Danish: Emballage
English: Prohippur was not studied directly in patients with these conditions.
Danish: Prohippur er ikke undersøgt direkte hos patienter med disse sygdomme.
English: What was the recommendation of the CHMP at that time?
Danish: Hvad anbefalede CHMP på det pågældende tidspunkt?
English: The withdrawal letter is available here.
Danish: Brevet om tilbagetrækningen kan ses her
English: The conditions are caused by a lack of enzymes needed to remove them.
Danish: Sygdommene skyldes en mangel på enzymer, der er nødvendige for at fjerne stofferne.
English: What was Prohippur expected to be used for?
Danish: Hvad forventedes Prohippur anvendt til?
English: At the time of the withdrawal, the CHMP had some concerns.
Danish: På tidspunktet for tilbagetrækningen havde CHMP visse betænkeligheder.
English: Prohippur was expected to be used to treat the following inherited disorders:
Danish: Prohippur skulle anvendes til behandling af følgende arvelige sygdomme:
English: What is Prohippur?
Danish: Hvad er Prohippur?
English: Both glycine and ammonia are harmful in high amounts and can cause severe brain damage.
Danish: Både glycin og ammoniak er skadelige i store mængder og kan forårsage alvorlig hjerneskade.
English: Prohippur is a medicine containing the active substance sodium benzoate.
Danish: Prohippur er et lægemiddel, der indeholder det aktive stof natriumbenzoat.
English: Prohippur also helps remove excess nitrogen from the body, thereby lowering levels of ammonia.
Danish: Prohippur hjælper også med at fjerne det overskydende nitrogen fra kroppen, hvorved niveauet af ammoniak sænkes.
English: It was to be available as granules.
Danish: Det skulle markedsføres som granulat.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Prohippur did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Prohippur ikke opvejede risiciene.
English: If you are in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der behandler dig.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, som virksomheden havde fremlagt, og udarbejdet en liste med spørgsmål.
English: Finally, the CHMP had questions about the high levels of a substance in Prohippur (butylated methacrylate copolymer), the method of administration and quality control of the medicine in general.
Danish: Endelig havde CHMP spørgsmål til det høje indhold af et bestemt stof i Prohippur (butyleret methacrylatcopolymer), indgivelsesmåden og kvalitetskontrollen af lægemidlet generelt.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it needed more time to prepare adequate answers to questions raised by the CHMP.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den havde brug for mere tid til at besvare de spørgsmål, som CHMP havde stillet.
English: Prohippur was designated an ‘orphan medicine' (a medicine to be used in rare diseases) for non-ketotic hyperglycinaemia on 11 September 2002 and for urea cycle disorders on 14 July 2016, 29 August 2016 and 18 November 2016.
Danish: Prohippur blev udpeget som "lægemiddel til sjældne sygdomme" mod ikke-ketotisk hyperglycinæmi den 11. september 2002 og mod defekt urinstofcyklus den 14. juli 2016, 29. august 2016 og 18. november 2016.
English: The company had not responded to the last round of questions at the time of the withdrawal.
Danish: Virksomheden havde endnu ikke besvaret den sidste række spørgsmål, da ansøgningen blev trukket tilbage.
English: The active substance in Prohippur, sodium benzoate, helps reduce harmful levels of glycine by attaching to glycine and forming a substance that is more easily removed by the kidneys.
Danish: Det aktive stof i Prohippur, natriumbenzoat, hjælper med at reducere de skadelige niveauer af glycin ved at binde til glycin og danne et stof, der lettere udskilles af nyrerne.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse?
English: On 3 April 2018, Lucane Pharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Prohippur, for the treatment of non-ketotic hyperglycinaemia and urea cycle disorders.
Danish: Den 3. april 2018 meddelte Lucane Pharma officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Prohippur til behandling af ikke-ketotisk hyperglycinæmi og defekt urinstofcyklus.