FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC considered that the use of fusafungine for oromucosal and nasal use is associated with serious adverse allergic reactions sometimes fatal.
Danish: PRAC vurderer, at brug af fusafungin i mundhulen og næsen er forbundet med alvorlige bivirkninger i form af allergiske reaktioner, der i visse tilfælde kan have dødelig udgang.
English: To include all possibly relevant cases, the MAH used the combined search of “Identified Risk Events Anaphylactic reaction hypersensitivity” for its data collection and analysis.
Danish: PRAC har anmodet indehaveren af markedsføringstilladelsen om at foretage en nærmere analyse af tilfældene med dødelig udgang samt en vurdering af årsagssammenhæng og stratificering efter alder. For at få alle relevante tilfælde med har indehaveren af markedsføringstilladelsen foretaget en kombineret søgning på "Identified Risk Events Anaphylactic reaction hypersensitivity" ("identificeret risiko hændelser anafylaktisk reaktion overfølsomhed") ved sin indsamling og analyse af data.
English: Fusafungine , used in the form of a spray, is indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth.
Danish: Fusafungin i sprayform er indiceret til lokal antibakteriel og antiinflammatorisk behandling af sygdomme i de øvre luftveje (sinuitis, rhinitis, rhinofaryngitis, angina, laryngitis).
English: Further risk minimisation measures such as additional amendments to the product information (further restriction of the indication and contra-indications, limitation of treatment duration, addition of the wording ‘do not inhale' in special warning and precautions for use, limitation of excipients), communication material (Direct Health Care Professional communication) and restriction to prescription only were therefore also considered during the discussions.
Danish: Under drøftelserne er yderligere risikominimerende foranstaltninger derfor blevet overvejet, herunder flere ændringer i produktinformationen (flere begrænsninger i indikationen og flere kontraindikationer, begrænsning af behandlingsvarigheden, tilføjelse af advarslen "må ikke inhaleres" under særlige advarsler og forsigtighedsregler vedrørende brugen, begrænsning af hjælpestofferne), kommunikationsmateriale (brev til sundhedspersoner) og indførelse af receptpligt.
English: Fusafungine is currently indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth.
Danish: Fusafungin er aktuelt indiceret til lokal antibakteriel og antiinflammatorisk behandling af sygdomme i de øvre luftveje (sinuitis, rhinitis, rhinofaryngitis, angina, laryngitis).
English: Further risk minimisation measures, as proposed by the MAH, such as additional amendments to the product information (further restriction of the indication and additional contra-indications, limitation of treatment duration, addition of the wording ‘do not inhale' in special warning and precautions for use, limitation of excipients), communication material (Direct Health Care Professional communication) and restriction to prescription only were also considered during the discussions.
Danish: Under drøftelserne er yderligere risikominimerende foranstaltninger blevet overvejet i henhold til forslag fra indehaveren af markedsføringstilladelsen, herunder flere ændringer i produktinformationen (flere begrænsninger i indikationen og flere kontraindikationer, begrænsning af behandlingsvarigheden, tilføjelse af advarslen "må ikke inhaleres" under særlige advarsler og forsigtighedsregler vedrørende brugen, begrænsning af hjælpestofferne), kommunikationsmateriale (brev til sundhedspersoner) og indførelse af receptpligt.
English: The PRAC reviewed all the available data submitted with regards to the clinical efficacy and safety of fusafungine-containing products.
Danish: PRAC har gennemgået alle de tilgængelige data, der er indsendt, hvad angår fusafungin-holdige produkters kliniske virkning og sikkerhed.
English: The PRAC reviewed all the available data submitted with regards to the clinical safety of fusafunginecontaining products.
Danish: PRAC har gennemgået alle de tilgængelige data, der er indsendt, hvad angår den kliniske sikkerhed ved fusafungin-holdige lægemidler.
English: 7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
Danish: 2000, Study report [NP07760] 7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
English: The PRAC reviewed all the available data submitted with regards to the clinical efficacy of fusafunginecontaining products.
Danish: PRAC har gennemgået alle de tilgængelige data, der er indsendt, hvad angår den kliniske virkning af fusafungin-holdige lægemidler.
English: Fusafungine was shown to be superior to placebo in the acute rhinopharyngitis indication regarding evolution of nasal symptom score after 4 days of treatment in adults in three pivotal studies Chabolle, 19995, Eccles 20006 and Bouter, 20027) and the pooled analysis of them (Grouin 20038).
Danish: I tre centrale undersøgelser (Chabolle 19995, Eccles 20006 og Bouter 20027) og i den samlede analyse af disse (Grouin 20038) er det påvist, at fusafungin har større virkning end placebo i indikationen akut rhinofaryngitis hos voksne med hensyn til scoren for udvikling af næsesymptomer efter 4 dages behandling.
English: 10 sprayers
Danish: 10 sprayflasker
English: EU/1/10/661/002
Danish: EU/1/10/661/002 FLUENZ -
English: Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029) 10
Danish: Reassortant influenzavirus* (levende svækket) fra følgende stammer**: A/California/7/2009 (H1N1)pdm09-lignende stamme (A/California/7/2009, MEDI 228029)
English: FFU*** ................................................................................................................................................per 0.2 ml dose
Danish: FFU*** .............................................................................................................................................................pr. 2 ml dosis
English: Nasal use sprayer (glass/PE) 0.2ml
Danish: Næsespray, suspension nasal anvendelse sprayflaske (glas/PE)
English: Adopted at the 4-8 July 2016 PRAC
Danish: Vedtaget på PRAC's møde 4.-8. juli 2016
English: • You are due to have a specific blood test (Chromogranin A)
Danish: • du skal have taget en særlig blodprøve (chromogranin A)
English: The frequency of these reactions is considered not known (cannot be estimated from the available data).
Danish: Hyppigheden af disse bivirkninger anses for ”ikke kendt” (kan ikke estimeres ud fra forhåndenværende data).
English: Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.
Danish: Tabletterne skal tages før måltider eller sammen med et måltid, afhængigt af den gastrointestinale tolerance.
English: If you cannot follow this instruction or have difficulty swallowing, please contact your doctor.
Danish: Hvis du ikke kan følge disse anvisninger eller har svært ved at synke, skal du kontakte lægen.
English: Post-marketing: The following ADRs have been reported during post-marketing surveillance.
Danish: Efter markedsføring: Følgende bivirkninger er indberettet ved overvågning efter markedsføring.
English: Ferrous sulfate - Mouth ulceration (EPITT no 18623)
Danish: Ferrosulfat - mundsår (EPITT nr. 18623)
English: To avoid this interference, [Product name] treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Danish: For at undgå denne interferens bør [særnavn] seponeres mindst 5 dage inden måling af CgA (se pkt.
English: Proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Elevated circulating levels of Chromogranin A (EPITT no 18614)
Danish: Protonpumpehæmmere: dexlansoprazol, esomeprazol, lansoprazol, omeprazol, pantoprazol, rabeprazol - forhøjet chromogranin A i blodet (EPITT nr. 18614)
English: Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route.
Danish: Ældre patienter og patienter med synkebesvær risikerer desuden øsofageale læsioner eller bronkial nekrose ved fejlsynkning.
English: Tell your doctor before taking this medicine, if:
Danish: 2 - Det skal du vide, før du begynder at tage [særnavn] Advarsler og forsigtighedsregler Før du tager denne medicin, skal du fortælle lægen, hvis:
English: Interference with laboratory tests
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Interferens med laboratorieprøver
English: The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Danish: Tabletterne må ikke suges, tygges eller falde hen i munden, men skal synkes hele med vand.
English: Do not suck, chew or keep the tablet in your mouth.
Danish: Du må ikke sutte på eller tygge tabletterne eller opløse dem i munden.
English: Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth but swallowed whole with water.
Danish: På grund af risiko for mundsår og misfarvning af tænderne må tabletterne ikke suges, tygges eller opløses i munden, man skal synkes hele med vand.
English: Gastrointestinal disorders: mouth ulceration* * in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth.
Danish: Mundsår* * ved ukorrekt administration, dvs. hvis tabletterne tygges, suges eller falder hen i munden.
English: Method of administration:
Danish: Administration
English: Due to the risk of mouth ulcerations and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen På grund af risikoen for oral ulceration og misfarvning af tænderne må tabletterne ikke suges, tygges eller falde hen i munden, men skal synkes hele med vand.
English: Not known (frequency cannot be estimated from the available data) Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth) Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects your mouth with your stomach) or bronchus (the major air passages of the lungs) if the tablet enters the airways.
Danish: Ikke kendt (kan ikke vurderes ud fra forhåndenværende data) Mundsår (i tilfælde af forkert brug, dvs. hvis tabletterne tygges, suges eller opløses i munden).
English: 3 - How to take [Product name] Swallow the tablet whole with water.
Danish: 3 - Sådan skal du tage [særnavn]
English: This was then compared with results reported in the scientific literature.
Danish: Dette blev så sammenlignet med resultaterne fra den videnskabelige litteratur.
English: The effects of Epostim were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Epostim blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Epostim was expected to be used in the following situations:
Danish: Epostim forventedes anvendt i følgende situationer:
English: What is Epostim?
Danish: Hvad er Epostim?
English: This means that Epostim was intended to be similar to a biological medicine that is already authorised in the European Union (also known as the ‘reference medicine') and contains the same active substance.
Danish: Det betyder, at Epostim skulle være identisk med et biologisk lægemiddel, som allerede er godkendt i Den Europæiske Union (også kaldet "referencelægemidlet"), og som indeholder det samme aktive stof.
English: Epostim was developed as a ‘biosimilar' medicine.
Danish: Epostim blev udviklet som et "biosimilært" lægemiddel.
English: Withdrawal of the marketing authorisation application for Epostim (epoetin alfa)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Epostim (epoetin alfa)
English: This study is still ongoing and aims to show that Epostim has the same effect on maintaining haemoglobin levels as Eprex.
Danish: Denne undersøgelse er endnu ikke afsluttet, og den tager sigte på at vise, at Epostim har samme virkning på fastholdelsen af hæmoglobinniveauerne som Eprex.
English: What was Epostim expected to be used for?
Danish: Hvad forventedes Epostim anvendt til?
English: For more information on biosimilar medicines, see the question-and-answer document here.
Danish: Yderligere oplysninger om biosimilære lægemidler fås i dokumentet med spørgsmål og svar her.
English: The company informed the CHMP that here are no consequences for patients currently in clinical trials using Epostim.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som for øjeblikket deltager i kliniske undersøgelser med Epostim.
English: The reference medicine for Epostim is Eprex.
Danish: Referencelægemidlet for Epostim er Eprex.
English: On 15 March 2011, Reliance GeneMedix Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Epostim to be used to treat anaemia and stimulate red blood cell production.
Danish: Den 15. marts 2011 meddelte Reliance GeneMedix Plc officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Epostim til behandling af anæmi og til at stimulere dannelsen af røde blodlegemer.
English: The epoetin alfa in Epostim is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Danish: Epoetin alfa i Epostim fremstilles ved hjælp af en metode, der kaldes "rekombinant DNAteknologi", dvs. det fremstilles af en celle, som har modtaget et gen (DNA), der sætter den i stand til at danne epoetin alfa.
English: In a main study in 75 adults with anaemia caused by kidney problems, patients were treated with Epostim and their blood levels of haemoglobin (a protein in red blood cells) measured to see how much their anaemia improved.
Danish: I en hovedundersøgelse af 75 voksne med anæmi som følge af nyreproblemer blev patienterne behandlet med Epostim, og deres niveauer af hæmoglobin (et protein i de røde blodlegemer) i blodet blev målt for at se, hvor stor en forbedring der skete med deres anæmi.
English: A second main study in 188 kidney patients compared Epostim with the reference medicine Eprex.
Danish: I en anden hovedundersøgelse af 188 nyrepatienter sammenlignede man Epostim med referencelægemidlet Eprex.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin.
Danish: Patienter i kemoterapi og patienter med nyresvigt kan få anæmi, fordi de enten mangler erytropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på erytropoietin.
English: Epostim is a solution for injection that contains the active substance epoetin alfa.
Danish: Epostim er en injektionsvæske, opløsning, som indeholder det aktive stof epoetin alfa.
English: How is Epostim expected to work?
Danish: Hvordan forventes Epostim at virke?
English: • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce their need for blood transfusions;
Danish: • til behandling af anæmi hos voksne patienter, der får kemoterapi for visse kræftformer, og til at mindske deres behov for blodtransfusioner,
English: • to increase the amount of blood that can be taken from patients who are going to need the blood after surgery (autologous blood transfusion);
Danish: • til at øge den mængde blod, der kan tappes fra patienter, som får brug for blod efter en operation (autolog blodtransfusion),
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly);
Danish: • til behandling af anæmi (mangel på røde blodlegemer), som giver symptomer hos voksne og børn med "kronisk nyresvigt" (langvarig, fremadskridende nedsættelse af nyrefunktionen),
English: Erythropoietin is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Danish: Erythropoietin anvendes ligeledes før en operation for at øge mængden af røde blodlegemer og minimere konsekvenserne af blodtabet.
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 med Epostim eller i programmer for anvendelse af Epostim med særlig udleveringstilladelse?
English: The active substance in Epostim, epoetin alfa, is a copy of human erythropoietin and was expected to work in exactly the same way as the natural hormone to stimulate red blood cell production.
Danish: Det aktive stof i Epostim, epoetin alfa, er en kopi af det menneskelige erytropoietin og forventedes at have nøjagtigt samme stimulerende virkning på produktionen af røde blodlegemer som det naturlige hormon.
English: • to reduce the need for blood transfusions in non-iron deficient patients who are about to undergo major orthopaedic (bone) surgery.
Danish: • til at reducere behovet for blodtransfusioner hos patienter, som ikke lider af jernmangel, og som står over for at skulle have en større ortopædisk operation (knoglekirurgi).
English: A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Danish: Hormonet erytropoietin stimulerer knoglemarven til at producere røde blodlegemer.
English: Pharmaceutical Form Route of Administration
Danish: Farmaceutisk form Indgivelsesvej Emballage
English: 10 vials + 10 pre-filled syringes with attached needle
Danish: 10 hætteglas + 10 forfyldte sprøjter med påmonteret kanyle
English: 1 vial + 1 pre-filled syringe + 2 separate needles
Danish: 1 hætteglas + 1 forfyldt sprøjte + 2 separate kanyler
English: 1 vial + 1 pre-filled syringe + 1 separate needle
Danish: 1 hætteglas + 1 forfyldt sprøjte + 1separate kanyle
English: 1 vial + 1 pre-filled syringe without needle
Danish: 1 hætteglas + 1 forfyldt sprøjte uden påmonteret kanyle
English: 1 vial + 1 pre-filled syringe with attached needle
Danish: 1 hætteglas + 1 forfyldt sprøjte med påmonteret kanyle
English: 06 March 2012
Danish: Den 6. marts 2012
English: The European Commission issued a decision on 06 March 2012.
Danish: Europa-Kommissionen traf en afgørelse den 6. marts 2012.
English: What is Norditropin?
Danish: Hvad er Norditropin?
English: 1 In May 2011 the marketing authorisations of the concerned products were withdrawn in Estonia, and in June 2011 the marketing authorisations of the concerned products were withdrawn in Latvia.
Danish: 1 I maj 2011 blev markedsføringstilladelserne for de pågældende produkter trukket tilbage i Estland, og juni 2011 blev markedsføringstilladelserne for de pågældende produkter trukket tilbage i Letland.
English: On 20 April 2011, Denmark referred the matter to the CHMP for arbitration.
Danish: Den 20. april 2011 henviste Danmark sagen til CHMP med henblik på voldgift.
English: Why was Norditropin reviewed?
Danish: Hvorfor blev Norditropin vurderet igen?
English: The Committee looked at the study presented by the company to support the new indication.
Danish: Udvalget gennemgik den undersøgelse, virksomheden havde forelagt til støtte for den nye indikation.
English: The Committee concluded that the change to the marketing authorisation cannot be granted.
Danish: CHMP konkluderede, at ændringen af markedsføringstilladelsen ikke kan godkendes.
English: The company that makes the medicine is NovoNordisk.
Danish: Den virksomhed, der markedsfører disse lægemiddel, er NovoNordisk.
English: Norditropin is authorised under a mutual recognition procedure based on an initial authorisation granted by Denmark.
Danish: Norditropin er godkendt ved en gensidig anerkendelsesprocedure, der er baseret på den oprindelige godkendelse i Danmark.
English: In May 2010, the company applied for an additional indication in Denmark and in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Danish: I maj 2010 ansøgte virksomheden om en ny indikation i Danmark og i følgende medlemsstater: Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Estland, Finland, Frankrig, Tyskland,
English: The CHMP therefore recommended that the new indication for Norditropin and associated names should not be granted in Denmark or in the concerned Member States.
Danish: CHMP anbefalede derfor, at den nye indikation for Norditropin og relaterede navne ikke godkendes i Danmark eller i de berørte medlemsstater.
English: Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom1.
Danish: Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige.1.
English: The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names.
Danish: Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure for Norditropin og relaterede navne.
English: The Member States cited methodological weaknesses in the study presented, the wide range of doses used and insufficient data (e.g. missing data on body composition measurements).
Danish: Medlemsstaterne henviste til metodesvagheder i den forelagte undersøgelse, den store forskel i de anvendte doser og utilstrækkelige data (f.eks. manglende data om bestemmelser af kropssammensætning).
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that the data were insufficient and that the study presented, which was an observational study, did not meet required methodological standards.
Danish: Efter vurderingen af de foreliggende data og efter den videnskabelige drøftelse i udvalget fandt CHMP, at data var utilstrækkelige, og at den forelagte undersøgelse (som var en observationsundersøgelse) ikke opfyldte de metodemæssige normer.
English: Although somatropin medicines are already approved in EU Member States for use in Prader-Willi syndrome, the Member States were unable to reach agreement on whether to accept this indication for Norditropin.
Danish: Skønt lægemidler indeholdende somatropin allerede er godkendt i EU's medlemsstater til Prader-Willis syndrom, kunne medlemsstaterne ikke nå til enighed om at godkende denne indikation for Norditropin.
English: Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Danish: Væksthormon fremmer væksten hos børn og unge og har desuden betydning for stofskiftet af proteiner, fedtstoffer og kulhydrater.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a requested change to the marketing authorisation for these medicines to include a new indication for use in children with Prader-Willi syndrome.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) blev anmodet at fungere som voldgift vedrørende en ansøgning om ændring af markedsføringstilladelsen for disse lægemidler med henblik på tilføjelse af en ny indikation: anvendelse hos børn med Prader-Willis syndrom.