FrancophonIA/ELRC3.0 huggingface dataset:
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Holoclar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What information is still awaited for Holoclar?
Danish: Hvilke oplysninger afventes der stadig for Holoclar?
English: The Committee noted that that moderate to severe forms of limbal stem-cell deficiency are serious conditions which, if untreated, can lead to severe reduction or complete loss of vision.
Danish: Udvalget bemærkede, at moderat til svær mangel på limbale stamceller er en alvorlig tilstand, som uden behandling kan medføre svær synsnedsættelse eller fuldstændigt tab af synet.
English: What are the risks associated with Holoclar?
Danish: Hvilke risici er der forbundet med Holoclar?
English: Holoclar, comprising the cells and the membrane, is then sent back to the hospital, where it is immediately surgically implanted in the patient's eye.
Danish: Holoclar - som består af cellerne og membranen - sendes derefter retur til hospitalet, hvor det straks implanteres i patientens øje ved operation.
English: It consists of cells taken from the patient's limbus (at the edge of the cornea) and then grown in a laboratory so that they can be used to repair the damaged corneal surface.
Danish: Det består af celler, der tages fra patientens hornhinderand (limbus) og derefter dyrkes i laboratoriet, så de kan anvendes til at reparere den beskadigede overflade af hornhinden.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Holoclar, 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 Holoclar, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: In addition, the company that makes Holoclar will provide healthcare professionals with educational material on the safe use of this treatment, including on the selection and follow-up of patients and on reporting side effects.
Danish: Desuden skal virksomheden, der fremstiller Holoclar, udlevere oplysningsmateriale til sundhedspersoner om sikker brug af lægemidlet, herunder udvælgelse og opfølgning af patienterne og indberetning af bivirkninger.
English: For more information about treatment with Holoclar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Holoclar, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Before Holoclar is used, the damaged corneal surface tissue of the affected eye is removed.
Danish: Før Holoclar anvendes, fjernes det beskadigede område af hornhindeoverfladen i det pågældende øje.
English: The active substance in Holoclar is the patient's own limbal cells, which include cells from the surface of the cornea and limbal stem cells grown in a laboratory.
Danish: Det aktive stof i Holoclar er patientens egne limbale celler, dvs. celler fra hornhindeoverfladen og limbale stamceller dyrket i laboratoriet.
English: Patients with this condition do not have enough limbal stem cells which normally act as a regeneration system, replenishing the outer corneal cells when they get damaged and when they age.
Danish: Disse patienter har ikke tilstrækkeligt med limbale stamceller, der normalt virker som et gendannelsessystem og erstatter de yderste celler i hornhinden, når de bliver beskadiget eller ældet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Holoclar treatment was effective in restoring healthy corneal surfaces in patients with moderate or severe limbal stem-cell deficiency caused by burns as well as in improving their symptoms and vision.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at behandling med Holoclar var effektivt til at gendanne en sund hornhindeoverflade hos patienter med moderat til svær mangel på limbale stamceller efter forbrændinger, og at det gav bedring i deres symptomer og syn.
English: Holoclar ex vivo expanded autologous human corneal epithelial cells containing stem cells
Danish: Holoclar autologe ex vivo-ekspanderede humane corneaepitelceller indeholdende stamceller
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Danish: Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet.
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Holoclar fremgår af indlægssedlen.
English: For practical information about using Holoclar, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Holoclar, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Thawed cells are used to make Holoclar by growing them on a membrane made of a protein called fibrin.
Danish: Holoclar fremstilles ved dyrkning af optøede celler på en membran fremstillet af proteinet fibrin.
English: Once implanted in the eye, the corneal cells of Holoclar help to replace the corneal surface, while the limbal stem cells serve as a reservoir of new cells that continuously replenish the cornea.
Danish: Når hornhindecellerne i Holoclar er implanteret i øjet, gendanner de hornhindeoverfladen, mens de limbale stamceller virker som et reservoir, der til stadighed fornyer hornhinden.
English: Holoclar is a stem-cell treatment used in the eye to replace damaged cells on surface (epithelium) of the cornea, the transparent layer in front of the eye covering the iris (the coloured part).
Danish: Holoclar er et lægemiddel, der indeholder stamceller og anvendes til at erstatte beskadigede celler på overfladen (epitelet) af øjets hornhinde, det gennemsigtige lag, der dækker øjets forside og regnbuehinden.
English: How is Holoclar used?
Danish: Hvordan anvendes Holoclar?
English: It is used in adult patients with moderate to severe limbal stem-cell deficiency caused by burns, including chemical burns, to the eyes.
Danish: Det anvendes hos voksne patienter med moderat til svær mangel på limbale stamceller efter forbrænding eller ætsning af øjnene.
English: What benefits of Holoclar have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Holoclar?
English: The conclusion on the benefit-risk balance of Holoclar is based on results of two retrospective studies (using past medical records), and the company is to provide further data from a prospective study (that records outcomes during the course of the study).
Danish: Konklusionen om benefit/risk-forholdet for Holoclar er baseret på resultaterne af to undersøgelser af allerede eksisterende patientjournaler (retrospektive undersøgelser).
English: One year after Holoclar implantation, 75 out of 104 patients studied (72%) were judged to have had successful implants based on the presence of stable corneal surface with no surface defects and little or no ingrown blood vessels (a common feature of limbal stem-cell deficiency).
Danish: Et år efter implantationen af Holoclar blev 75 af de 104 undersøgte patienter (72 %) bedømt til at have fået et vellykket implantat.
English: How does Holoclar work?
Danish: Hvordan virker Holoclar?
English: Holoclar must only be used by an appropriately trained and qualified eye surgeon in a hospital, and must only be given to the patient whose limbal cells were used to manufacture the medicine.
Danish: Holoclar må kun anvendes af en tilstrækkeligt oplært og kvalificeret øjenkirurg på et hospital.
English: Holoclar was shown to be effective in restoring a stable corneal surface in patients with moderate or severe limbal stem-cell deficiency caused by burns in a retrospective study using patients' past medical records.
Danish: Det fremgik, at Holoclar var effektivt til at gendanne en stabil hornhindeoverflade hos patienter med moderat til svær mangel på limbale stamceller efter forbrændinger.
English: Antibiotics to prevent eye infection should be given to patients after limbal tissue has been taken from them.
Danish: Efter at have fået udtaget limbalt væv skal patienten have antibiotika for at forebygge øjeninfektion.
English: They had concerns with the way the data were analysed.
Danish: Außerdem hatte der Ausschuss Bedenken bezüglich der Art und Weise, wie die Daten analysiert wurden.
English: The studies measured how long it would take before the disease would progress.
Danish: In den Studien wurde gemessen, wie lange es dauerte, bis die Krankheit fortschritt.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF APPLICATION FOR A VARIATION OF MARKETING AUTHORISATION for DEPOCYTE
Danish: FRAGEN UND ANTWORTEN ZUR RÜCKNAHME EINES ANTRAGS AUF ÄNDERUNG DER GENEHMIGUNG FÜR DAS INVERKEHRBRINGEN von DEPOCYTE
English: The evaluation was finished and the CHMP would have given a negative opinion.
Danish: Die Beuteilung war abgeschlossen, und der CHMP hätte ein negatives Gutachten abgegeben.
English: International Non-proprietary Name (INN): cytarabine
Danish: Internationaler Freiname (INN): Cytarabin
English: Cytarabine has been used as an anti-cancer medicine since the 1970s.
Danish: Cytarabin wird seit den 1970er Jahren als Krebsmedikament eingesetzt.
English: What is DepoCyte?
Danish: Was ist DepoCyte?
English: There are no consequences for DepoCyte's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.
Danish: Es ergeben sich keine Konsequenzen für die Anwendung von DepoCyte in den Indikationen, für die es bereits zugelassen ist und bei denen das bekannte Nutzen-/Risikoprofil unverändert bleibt.
English: DepoCyte helps control the symptoms of the disease.
Danish: DepoCyte hilft, die Symptome der Krankheit zu bekämpfen.
English: The letter from the Company notifying the EMEA of the withdrawal of DepoCyte is available here.
Danish: Das Schreiben, mit dem das Unternehmen die EMEA von der Rücknahme des Antrags für DepoCyte in Kenntnis setzt, finden Sie hier.
English: What were the main concerns of the CHMP?
Danish: Was waren die wesentlichen Bedenken des CHMP?
English: Following CHMP opinion, it usually takes around 6 weeks for the European Commission to update the licence.
Danish: Gutachten des CHMP dauert es in der Regel 6 Wochen, bis die Europäische Kommission die Zulassung aktualisiert.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Sollten Sie an einer klinischen Studie oder an einem derartigen “Compassionate-Use”-Programm teilnehmen und weitere Informationen zu Ihrer Behandlung benötigen, wenden Sie sich an Ihren behandelnden Arzt.
English: What was the recommendation of the CHMP at that time?
Danish: Wie lautete die Empfehlung des CHMP zu diesem Zeitpunkt?
English: What is happening for DepoCyte for the treatment of lymphomatous meningitis?
Danish: Was geschieht mit DepoCyte zur Behandlung der lymphomatösen Meningitis?
English: The CHMP had concerns that the studies presented by the Company had not sufficiently shown that Depocyte was as effective as, or more effective than intrathecal methotrexate.
Danish: Der CHMP äußerte Bedenken dahingehend, die vom Unternehmen vorgelegten Studien hätten nicht ausreichend belegt, dass Depocyte genauso wirksam oder wirksamer als intrathekal verabreichtes Methotrexat sei.
English: On 28 June 2006, SkyePharma PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for DepoCyte 50 mg suspension for injection, in the intrathecal treatment of solid tumour neoplastic meningitis.
Danish: Am 28. Juni 2006 teilte SkyePharma PLC dem Ausschuss für Humanarzneimittel (CHMP) offiziell mit, dass das Unternehmen seinen Antrag für eine neue Indikation für DepoCyte 50 mg Injektionssuspension zur intrathekalen Behandlung der durch solide Tumoren verursachten neoplastischen Meningitis zurückzieht.
English: DepoCyte was compared with methotrexate (another anti-cancer medicine), both medicines being administered intrathecally.
Danish: DepoCyte wurde mit Methotrexat (einem anderen Krebsmedikament) verglichen, und beide Medikamente wurden intrathekal verabreicht.
English: The company presented the results of two studies, involving 164 patients with solid tumour neoplastic meningitis.
Danish: Das Unternehmen legte die Ergebnisse von zwei Studien an 164 Patienten mit neoplastischer Meningitis infolge von soliden Tumoren vor.
English: What documentation has been presented by the Company to support the application to the CHMP?
Danish: Welche Unterlagen hat das Unternehmen dem CHMP zur Stützung des Antrags vorgelegt?
English: DepoCyte was to be injected intrathecally.
Danish: DepoCyte sollte intrathekal injiziert werden.
English: How far into the evaluation was the application when it was withdrawn?
Danish: In welchem Stadium der Beurteilung befand sich der Antrag zum Zeitpunkt der Rücknahme?
English: What were the reasons given by the Company to withdraw the application?
Danish: Aus welchen Gründen hat das Unternehmen den Antrag zurückgezogen?
English: DepoCyte is a suspension for injection that contains 50 mg of the active substance cytarabine.
Danish: DepoCyte ist eine Injektionssuspension, die 50 mg des arzneilich wirksamen Bestandteils Cytarabin enthält.
English: DepoCyte contains cytarabine in a special formulation: the active substance is contained in liposomes (small fatty particles) from which it is slowly released.
Danish: DepoCyte enthält Cytarabin in einer besonderen Darreichungsform: der arzneilich wirksame Bestandteil ist in Liposomen (kleinen Fettpartikeln) enthalten, aus denen er langsam freigesetzt wird.
English: The active substance in DepoCyte, cytarabine, is an anti-cancer agent.
Danish: Der arzneilich wirksame Bestandteil in DepoCyte, Cytarabin, ist ein Mittel gegen Krebs.
English: What was DepoCyte expected to be used for?
Danish: Wofür sollte DepoCyte angewendet werden?
English: DepoCyte is injected directly into the nervous system, in the space between the lining of the spinal cord and brain (intrathecal injection).
Danish: DepoCyte wird direkt in das Nervensystem, d. h. in den Raum zwischen den Hirn- und Rückenmarkshäuten, gespritzt (intrathekale Injektion).
English: The application was at Day 90 when the Company withdrew.
Danish: Als der Antrag vom Unternehmen zurückgezogen wurde, war im Antragsverfahren Tag 90 erreicht.
English: It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group of anti-metabolites.
Danish: Es ist ein Zytostatikum (ein Medikament, das Zellen abtötet, die sich teilen, wie z. B. Krebszellen) aus der Gruppe der Antimetabolite.
English: How is DepoCyte expected to work?
Danish: Wie soll DepoCyte wirken?
English: Therefore, at the time of the withdrawal, the CHMP's view was that it had not been shown that the benefits of DepoCyte in the treatment of solid tumour neoplastic meningitis were greater that its risks.
Danish: Aus diesem Grund vertrat der CHMP zum Zeitpunkt der Rücknahme des Antrags die Ansicht, es sei nicht belegt worden, dass der Nutzen von DepoCyte bei der Behandlung der durch solide Tumoren verursachten neoplastischen Meningitis gegenüber den Risiken überwiegt.
English: DepoCyte is used to treat lymphomatous meningitis: this is a condition where lymphoma tumour cells have spread to the membranes that surround the nervous system (meninges).
Danish: DepoCyte wird zur Behandlung der lymphomatösen Meningitis angewendet, einer Erkrankung, bei der die Zellen eines Lymphknotentumors in die Membranen eingedrungen sind, die das Nervensystem umgeben (Meninges - Hirn- und Rückenmarkshäute).
English: The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
Danish: Wenn der CHMP einen Antrag auf eine Änderung der Genehmigung für das Inverkehrbringen erhält, braucht der Ausschuss in der Regel bis zu 90 Tage, um ein Gutachten abzugeben.
English: London, 29 June 2006 Doc.Ref.
Danish: London, 29. Juni 2006 Dok.-Ref. EMEA/349175/2006
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DepoCyte?
Danish: „Compassionate-Use“-Programmen mit DepoCyte?
English: The company has informed the CHMP that the decision has no consequences for patients enrolled in clinical trials or compassionate use programmes.
Danish: Das Unternehmen hat den CHMP darüber informiert, dass die Entscheidung keine Konsequenzen für Patienten hat, die an klinischen Studien oder „Compassionate-Use“-Programmen (Programmen, bei denen Ärzte ein Arzneimittel zur Behandlung einer bestimmten Erkrankung für einen ihrer Patienten beantragen können, bevor dieses Mittel vollständig genehmigt wurde) teilnehmen.
English: DepoCyte was to be used in the treatment of solid tumour neoplastic meningitis: this is a disease where cancer cells, originally from a solid tumour (such as lung or breast cancer), spread to the membranes of the nervous system.
Danish: Dies ist eine Erkrankung, bei der sich Krebszellen aus einem soliden (festen) Tumor (wie z. B. Lungen- oder Brustkrebs) auf die Membranen des Nervensystems ausbreiten.
English: Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that DepoCyte could not be approved for the intrathecal treatment of solid tumour neoplastic meningitis.
Danish: Der Ausschuss war der vorläufigen Ansicht, dass DepoCyte nicht zur intrathekalen Behandlung der durch solide Tumoren verursachten neoplastischen Meningitis zugelassen werden könne.
English: 06 August 2014
Danish: Den 6. august 2014
English: The European Commission issued a decision on 06 August 2014.
Danish: Europa-Kommissionen traf en beslutning den 6. august 2014.
English: What is Dexamed?
Danish: Hvad er Dexamed?
English: Why was Dexamed reviewed?
Danish: Hvorfor blev Dexamed vurderet igen?
English: On 22 May 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamed (dexamfetamine sulphate).
Danish: Den 22. maj 2014 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelsen af lægemidlet Dexamed (dexamfetaminsulfat).
English: These conclusions were supported by a group of experts in childhood and adolescent behavioural problems consulted by the CHMP.
Danish: Disse konklusioner blev støttet af en gruppe af eksperter i adfærdsproblemer hos børn og unge, som CHMP rådførte sig med om sagen.
English: This is a procedure where one European country (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other European countries (the ‘concerned Member States', in this instance Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain, and Sweden).
Danish: Ved denne procedure vurderer én medlemsstat (“referencemedlemsstaten”, her Det Forenede Kongerige) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de “berørte medlemsstater”, her Danmark, Finland, Irland, Luxembourg, Nederlandene, Norge, Spanien og Sverige).
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 10 June 2013.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Det Forenede Kongeriges lægemiddelstyrelse indbragte den 10. juni 2013 sagen for CHMP med henblik på voldgift.
English: Dexamed is a medicine that contains the active substance dexamfetamine sulphate.
Danish: Dexamed er et lægemiddel, der indeholder det aktive stof dexamfetaminsulfat.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Dexamed outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following countries: Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain and Sweden.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Dexamed opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i følgende lande: Danmark, Finland, Irland, Luxembourg, Nederlandene, Norge, Spanien og Sverige.
English: Kohne Pharma GmbH submitted Dexamed to the UK medicines regulatory agency for a decentralised procedure.
Danish: Kohne Pharma GmbH søgte godkendelse af Dexamed hos Det Forenede Kongeriges lægemiddelstyrelse ved en decentral procedure.
English: Educational material will be provided to doctors to help them decide if treatment with Dexamed is appropriate and to monitor patients receiving the medicine.
Danish: Lægerne vil få udleveret oplysningsmateriale, der støtter dem i afgørelsen af, om behandling med Dexamed er hensigtsmæssig, og i overvågningen af patienter, der får lægemidlet.
English: Furthermore, the company that markets Dexamed will conduct additional studies on the risk of abuse for this medicine.
Danish: Den virksomhed, der markedsfører Dexamed, skal derudover udføre supplerende undersøgelser af risikoen for misbrug af lægemidlet.
English: Educational material will also be given to pharmacists, parents and carers to help them identify any potential abuse or improper use of Dexamed.
Danish: Apoteker, forældre og omsorgsgivere vil desuden få udleveret oplysningsmateriale, der skal hjælpe dem til at opdage eventuelt misbrug eller forkert brug af Dexamed.
English: The CHMP also noted that evidence from studies and clinical practice is available to show that dexamfetamine is effective in ADHD, including in patients in whom other treatments have failed.
Danish: CHMP bemærkede endvidere, at undersøgelser og klinisk praksis viser, at dexamfetamin er effektivt ved ADHD, også hos patienter, hos hvem andre behandlinger har slået fejl.
English: It is to be available as tablets (5 mg) for the treatment of children between 6 and 17 years of age who have attention deficit hyperactivity disorder (ADHD) and in whom methylphenidate (another medicine for ADHD) was not effective (second-line treatment).
Danish: Det skal leveres som tabletter (5 mg) til andetvalgsbehandling af børn mellem 6 og 17 år med hyperaktiv opmærksomhedsforstyrrelse (ADHD) efter manglende virkning af methylphenidat, der er et andet lægemiddel mod ADHD.
English: ADHD is a condition that mainly affects children, resulting in a persistent inability to concentrate, hyperactivity and impulsive behaviour.
Danish: ADHD optræder især hos børn og medfører vedholdende nedsat koncentrationsevne, overaktivitet og impulsiv adfærd.
English: These measures include starting and regularly monitoring treatment with Dexamed under the supervision of a doctor experienced in treating childhood and adolescent behaviour disorders.
Danish: Til disse foranstaltninger hører, at behandlingen med Dexamed skal påbegyndes og efterfølgende regelmæssigt overvåges af en læge med erfaring i behandling af adfærdsforstyrrelser hos børn og unge.