FrancophonIA/ELRC3.0 huggingface dataset:
English: When Gluscan 500 is injected in the body, the radiolabelled fluodeoxyglucose is absorbed in the same way as glucose, the main source of energy for the cells.
Danish: Når Gluscan 500 indsprøjtes i kroppen, optages det radioaktivt mærkede fluordeoxyglukose på samme måde som glukose, der er cellernes vigtigste energikilde.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Gluscan 500 outweigh its risks, and therefore the marketing authorisation for Gluscan 500 should be granted in all concerned Member States.
Danish: På grundlag af en vurdering af de foreliggende data og den faglige drøftelse i udvalget er CHMP af den opfattelse, at den gavnlige virkning af Gluscan 500 er større end risiciene, og at der bør udstedes markedsføringstilladelse for Gluscan 500 i alle de berørte medlemsstater.
English: Advanced Accelerator Applications submitted Gluscan 500 to the French medicines regulatory agency for a decentralised procedure.
Danish: Advanced Accelerator Applications indgav en ansøgning om markedsføringstilladelse for Gluscan 500 til den franske lægemiddelkontrolmyndighed med henblik på en decentral procedure.
English: The grounds for the referral were concerns from the Spanish medicines regulatory agency that, while the use of fluodeoxyglucose (18F) with PET in the areas of cancer, cardiac and neurology medicine were well established, its use in the diagnosis of infectious and inflammatory conditions had not been shown to be sufficiently established in the European Union, and therefore the use of Gluscan 500 as a diagnostic radiopharmaceutical in the diagnosis of these conditions should not be authorised.
Danish: Årsagerne til indbringelsen var, at den spanske lægemiddelkontrolmyndighed, der fastslog, at anvendelsen af fluordeoxyglukose (18F) sammen med PET-scanning inden for kræft- og hjertemedicin og neurologi var veldokumenteret, var bekymret over, at anvendelsen til diagnosticering af infektiøse og inflammatoriske lidelser ikke var tilstrækkeligt dokumenteret i EU, og derfor burde anvendelsen af Gluscan 500 som diagnostisk radiofarmaceutisk lægemiddel til diagnosticering af disse lidelser ikke tillades.
English: London, 2 June 2009
Danish: London, den 2. juni 2009 Ref. dok.
English: The active substance in Gluscan 500, fluodeoxyglucose (18F), is a diagnostic radiopharmaceutical.
Danish: Det aktive stof i Gluscan 500, fluordeoxyglukose (18F), er et diagnostisk radiofarmaceutisk lægemiddel.
English: Questions and answers on the referral for Gluscan 500 solution for injection containing fludeoxyglucose (
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Gluscan 500 opløsning til injektion indeholdende fluordeoxyglukose (18F) 500MBq pr. ml
English: EU/1/08/502/001 Mepact
Danish: EU/1/08/502/001
English: 1 vial + 1 filter
Danish: 1 hætteglas + 1 filter
English: 4 mg Powder for concentrate for dispersion for infusion
Danish: 4 mg Pulver til koncentrat til infusionsvæske, dispersion i.v.
English: EMA Procedure Number
Danish: EMA's procedurenr.
English: Invented name
Danish: (Særnavn) Navn
English: Immediate Packaging
Danish: hætteglas
English: MA (EU) Number (Invented) name
Danish: MF (EU)-nummer Navn
English: Strength Pharmaceutical Form Route of administration
Danish: Styrke Lægemiddelform Administration Emballage
English: EU/1/19/1397/001 Bortezomib Fresenius Kabi
Danish: EU/1/19/1397/001
English: MA (EU) Numbers (Invented) name Strength
Danish: MF (EU)-nummer
English: Powder for solution for injection
Danish: 3,5 mg Pulver til injektionsvæske, opløsning
English: Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: Intravenous use, Subcutaneous use vial (glass)
Danish: Hætteglas (glas)
English: Immediate Packaging
Danish: Intravenøs anvendelse.
English: Pack size
Danish: Subkutan anvendelse.
English: 20 July 2011
Danish: 20. juli 2011
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Danish: Resultatet af en sag indbragt i henhold til artikel 30 i direktiv 2001/83/EF
English: A European Commission issued a decision on 20 July 2011.
Danish: Europa-Kommissionen traf en afgørelse den 20. juli 2011.
English: The amended information to doctors and patients is available here.
Danish: De ændrede informationer for læger og patienter findes her.
English: What is Kytril?
Danish: Hvad er Kytril?
English: Kytril tablets should be swallowed whole with water.
Danish: Kytril tabletter sluges hele med vand.
English: Why was Kytril reviewed?
Danish: Hvorfor blev Kytril vurderet igen?
English: The active substance in Kytril, granisetron, is a ‘5HT3 antagonist'.
Danish: Det aktive stof i Kytril, granisetron, er en "5HT3-antagonist".
English: Kytril is authorised in the EU via national procedures.
Danish: Kytril er godkendt i EU efter nationale procedurer.
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Danish: Når 5HT binder sig til disse receptorer, forårsager det normalt kvalme og opkastning.
English: When used for treatment, further doses of the solution may be given at least 10 minutes apart, up to a maximum of 9 mg per 24 hours.
Danish: Når lægemidlet anvendes til behandling, kan yderligere doser af opløsningen gives med mindst 10 minutters mellemrum, op til maksimalt 9 mg pr. 24 timer.
English: On 3 June 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Kytril in the EU.
Danish: Den 3. juni 2010 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Kytril i EU.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the in the brain and the gut.
Danish: Det betyder, at det forhindrer et kemisk stof i kroppen kaldet 5-hydroxytryptamin (5HT også kendt som serotonin) i at binde sig til 5HT3receptorer i hjernen og tarmen.
English: Granisetron prevents the nausea and vomiting by blocking these receptors.
Danish: Granisetron forhindrer kvalme og opkastning ved at blokere disse receptorer.
English: Other sections harmonised by the CHMP include sections on special warnings, side effects and the medicines pharmacological properties.
Danish: De øvrige afsnit, som CHMP har harmoniseret, omfatter afsnit om særlige advarsler, bivirkninger og lægemidlets farmakologiske egenskaber.
English: The European Medicines Agency has completed a review of Kytril.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en vurdering af Kytril.
English: For the prevention of nausea and vomiting, the recommended dose is 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy.
Danish: Ved forebyggelse af kvalme og opkastning er den anbefalede dosis 1 mg to gange om dagen eller 2 mg én gang om dagen i op til en uge efter strålebehandling eller kemoterapi.
English: Kytril is also available in the EU under the trade name Kevatril.
Danish: Kytril fås også i EU under særnavnet Kevatril.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har medført, at lægemidlet kan anvendes på forskellige måder i medlemsstaterne, sådan som det fremgår af forskellene i produktresuméerne, etiketteringen og indlægssedlerne i de lande, hvor lægemidlet markedsføres.
English: Kytril must not be used in patients who are hypersensitive (allergic) to the active substance or to any of the excipients.
Danish: Kytril må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for det aktive stof eller et eller flere af hjælpestofferne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Kytril in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) har konkluderet, at der er behov for at harmonisere ordinationsoplysningerne for Kytril i Den Europæiske Union (EU).
English: The company that markets these medicines is Roche.
Danish: Disse lægemidler markedsføres af virksomheden Roche.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de fremlagte oplysninger og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméerne, etiketteringen og indlægssedlerne skulle harmoniseres inden for EU.
English: Kytril is an anti-emetic (a medicine that prevents nausea and vomiting).
Danish: Kytril er et antiemetikum (et lægemiddel mod kvalme og opkastning).
English: Kytril solution for injection is given into a vein at a dose of 1-3 mg (10-40 g/kg) for the prevention and treatment of nausea and vomiting in adults.
Danish: Kytril injektionsvæske, opløsning indgives i en vene med en dosis på 1-3 mg (10-40 g/kg) til forebyggelse og behandling af kvalme og opkastning hos voksne.
English: It is used to prevent nausea and vomiting following treatments for cancer such as chemotherapy and radiotherapy.
Danish: Det anvendes til at forebygge kvalme og opkastning efter behandling for kræft, f.eks. kemoterapi og strålebehandling.
English: Questions and answers on Kytril and associated names (granisetron, 1 and 2 mg tablets, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml solution for injection)
Danish: Spørgsmål og svar vedrørende Kytril og relaterede navne (granisetron 1 og 2 mg tabletter, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml injektionsvæske, opløsning)
English: Questions and answers on Kytril and associated names (granisetron, 1 and 2 mg tablets, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml solution for injection) EMA/585560/2011
Danish: Spørgsmål og svar vedrørende Kytril og relaterede navne (granisetron 1 og 2 mg tabletter, 3 mg/ml, 3 mg/5 ml, 1 mg/ml, 3 mg/3 ml injektionsvæske, opløsning) EMA/660559/2011
English: The CHMP recommended that Kytril tablets and solution for injection can be used in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy, and also for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Danish: CHMP anbefalede, at Kytril tabletter og injektionsvæske, opløsning, kan anvendes til voksne til forebyggelse og behandling af akut kvalme og opkastning i tilknytning til kemoterapi og strålebehandling og også mod forsinket kvalme og opkastning i tilknytning til kemoterapi og strålebehandling.
English: Kytril was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentrale procedurer (CMD(h)), at Kytril skulle harmoniseres.
English: The solution for injection can also be used in children aged two years above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.
Danish: Injektionsvæske, opløsning, kan også anvendes til børn på 2 år og derover til forebyggelse og behandling af akut kvalme og opkastning i tilknytning til kemoterapi.
English: In addition, the solution for injection can be used in adults for the prevention and treatment of nausea and vomiting following surgery.
Danish: Derudover kan injektionsvæske, opløsning, anvendes til voksne til forebyggelse og behandling af kvalme og opkastning efter operation.
English: 1 vial
Danish: 1 fyldt pen
English: 10 (2 x 5) prefilled pens (multipack)
Danish: 10 (2 x 5) fyldte penne (multipakning)
English: 5 (5 x 1) vials (multipack)
Danish: 5 (5 x 1) hætteglas (multipakning)
English: 25 (5 x 5) cartridges (multipack)
Danish: 25 (5 x 5) cylinderampuller (multipakning)
English: Eculizumab should be given to a pregnant woman only if clearly needed.
Danish: Eculizumab bør kun gives til en gravid kvinde hvis der er et klart behov for det.
English: • No clinical data on exposed pregnancies is available.
Danish: • der foreligger ingen kliniske data om eksponering under graviditet.
English: The patient safety card should contain:
Danish: Patientsikkerhedskortet bør indeholde:
English: • Warning to seek immediate medical care if above are present
Danish: • advarsel om straks at søge lægehjælp hvis ovenstående er tilstede
English: Vaccination reminders are sent to the prescribers.
Danish: Påmindelser om vaccination bliver sendt til de ordinerende læger.
English: All patients being treated with eculizumab receive a patient safety card
Danish: Alle patienter der behandles med eculizumab modtager et patientsikkerhedskort
English: • Signs and symptoms of infection and sepsis
Danish: • Tegn og symptomer på infektion og sepsis
English: • Contact details where a health care practitioner can receive further information
Danish: • kontaktinformationer hvor sundhedspersonale kan modtage yderligere informationer.
English: • Signs and symptoms of severe infection and the need to obtain urgent medical care
Danish: • tegn og symptomer på svær infektion og behovet for at modtage akut lægehjælp
English: All healthcare practitioners who may prescribe eculizumab receive the appropriate educational material.
Danish: Alle ordinerende læger, som kan udskrive eculizumab, modtager det relevante uddannelsesmateriale
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: Medlemslandene skal sikre, at alle betingelser eller begrænsninger mht. sikker og effektiv anvendelse af nedenstående beskrevne lægemiddel implementeres
English: • Patient's/carer's information brochures
Danish: • patientens/plejerens informationsbrochure
English: • Enrolment in the PNH and aHUS registries
Danish: • indskrivning i PNH og aHUS registrene
English: • Patient safety card
Danish: • patientsikkerhedskort.
English: • Details of the PNH and aHUS registries and how to enter patients
Danish: • detaljer omkring PNH og aHUS registrene og hvordan man indskriver patienter
English: The educational material should be agreed with the National Competent Authority and should contain the following:
Danish: Uddannelses materialet skal aftales med den ansvarlige nationale myndighed, og skal indeholde følgende elementer:
English: Drug distribution will only be possible after written confirmation that the patient has effectively received meningococcal vaccination and/or antibiotic prophylaxis.
Danish: Udlevering af lægemidlet kun vil være muligt efter skriftlig bekræftelse af, at patienten har modtaget en effektiv meningokok-vaccine og/eller profylaktisk antibiotisk behandling
English: • All patients must be monitored for signs of meningitidis
Danish: • alle patienter skal monitoreres for tegn på Neisseria meningitidis-infektion
English: The MAH shall agree the details of a controlled drug distribution system and educational material including a patient safety card with each National CompetentAuthority and must implement such programmes nationally to ensure that:
Danish: Indehaveren af markedsføringstilladelsen skal aftale de nærmere enkeltheder i et kontrolleret lægemiddel udleveringssystem og uddannelsesmateriale, inklusive et patientsikkerhedskort, med den ansvarlige nationale myndighed og gennemføre et nationalt program der sikrer at:
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
Danish: Betingelser eller begrænsninger vedrørende sikker og effektiv anvendelse af lægemidlet, som skal implementeres af medlemslandene.
English: • The patient safety card and the need to carry it on their person and tell any treating healthcare professional that they are being treated with eculizumab
Danish: • patientsikkerhedskortet og behovet for at patienterne bærer dette på sig, og informerer eventuelt behandlende sundhedspersonale, om at de er i behandling med eculizumab
English: The patient's/carer's guides should be indication specific and contain the following key messages:
Danish: Patientens/plejerens vejledninger bør være specifikke for indikationen og indeholde følgende centrale budskaber:
English: The MAH shall send annually to prescribers and pharmacists who prescribe/dispense eculizumab, a reminder about the need for (re)-vaccination against Neisseria meningitidis for patients on eculizumab.
Danish: Indehaveren af markedsføringstilladelsen skal årligt sende en påmindelse til læger og farmaceuter, som ordinere/udlevere eculizumab, om behovet for (re-)vaccination imod Neisseria meningitidis, af patienter der modtager eculizumab.
English: • The need to explain to and ensure understanding of by patients/carers: o the risks of treatment with eculizumab o the signs and symptoms of sepsis/severe infection and what action to take o the patient's/carer's guides and their contents o the need to carry the patient safety card and to tell any healthcare practitioner that he/she is receiving treatment with eculizumab o the requirement for pre-treatment vaccinations/antibiotic prophylaxis o the enrolment in the registries
Danish: • behovet for at forklare, og sikre at patienter/plejere har forstået: o risikoen ved behandling med eculizumab o tegn og symptomer på sepsis/svær infektion og hvilken handling de skal foretage o patientens/plejerens vejledninger og disses indhold o behovet om at bære patientsikkerhedskortet og fortælle eventuelt sundhedspersonale at han/hun modtager behandling med eculizumab o kravet om vaccinationer/profylaktisk antibiotisk behandling før behandling o indskrivning i registrene
English: • The risk of developing antibodies to eculizumab
Danish: • risikoen for at udvikle antistoffer mod eculizumab
English: The physician's guides to prescribing should be indication specific and contain the following key messages:
Danish: Lægens vejledning til ordination bør være specifik for indikationen og indeholde følgende centrale budskaber:
English: • The importance of meningococcal vaccination prior to treatment and/or to receive antibiotic prophylaxis
Danish: • vigtigheden af meningokok-vaccination forud for behandling og/eller at modtage profylaktisk antibiotisk behandling
English: • Physician's guides to prescribing
Danish: • lægens vejledning til ordination
English: • The need for patients to be vaccinated against Neisseria meningitidis two weeks prior to receiving eculizumab and/or to receive antibiotic prophylaxis
Danish: • behovet for at patienter vaccineres mod Neisseria meningitidis-infektion to uger før de modtager eculizumab og/eller at de modtager profylaktisk antibiotisk behandling
English: Breast-feeding should be discontinued during and up to five months after treatment.
Danish: Amning bør undlades under behandling og i fem måneder efter behandling
English: • The risk of infusion reactions including anaphylaxis and advice on post-infusion monitoring
Danish: • risikoen for reaktioner som følge af infusion, inklusive anafylaktisk shock, og rådgivning omkring post-infusion monitorering
English: • That eculizumab may be teratogenic and the need for effective contraception in women of childbearing potential during and up to five months after treatment, and that breast-feeding should be discontinued during and up to five months after treatment.
Danish: • at eculizumab kan være teratogent og behovet for sikker antikonception til kvinder i den fertile alder under behandlingen og i fem måneder efter behandlingen og at amning bør undlades under behandling og i fem måneder efter behandling
English: • The risk of infusion reactions with eculizumab, including anaphylaxis, and the need for clinical monitoring post-infusion
Danish: • risikoen for reaktioner som følge af infusion, inklusive anafylaktisk shock, og behovet for klinisk post-infusion monitorering
English: The need for effective contraception in women of childbearing potential during and up to five months after treatment.
Danish: Behovet for sikker antikonception til kvinder i den fertile alder under behandlingen og i fem måneder efter behandlingen.
English: • Statement that the patient is receiving eculizumab
Danish: • meddelelse om at patienten er i behandling med eculizumab
English: • The requirement to vaccinate children against pneumococcus and haemophilus before eculizumab treatment
Danish: • kravet om at børn vaccineres mod pneumokokinfektioner og Haemophilus influenzae før behandling med eculizumab
English: • The need for children to be vaccinated against pneumococcus and haemophilus before eculizumab treatment
Danish: • behovet for at børn vaccineres mod pneumokokinfektioner og Haemophilus influenzae før behandling med eculizumab
English: • Risk of severe thrombotic microangiopathic complications following eculizumab discontinuation and postponement of administration, its signs, symptoms, monitoring and management (aHUS only)
Danish: • risikoen for alvorlige komplikationer som følge af trombotisk mikroangiopati efter seponering og udsættelse af administration af eculizumab, tegn, symptomer, monitorering og håndtering (kun aHUS)
English: • Summary of product characteristics
Danish: • Produktresumé
English: • Risk of serious haemolysis following eculizumab discontinuation and postponement of administration, its criteria, the required post-treatment monitoring and its proposed management (PNH only)
Danish: • risikoen for svær hæmolyse efter seponering og udsættelse af administration af eculizumab, kriterier forbundet hermed, den påkrævede post-behandlings monitorering og den foreslåede håndtering heraf (kun PNH)
English: • Risk of severe haemolysis (in PNH) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
Danish: • risikoen for svær hæmolyse (i PNH) efter seponering/udsættelse af administration af eculizumab, tegn og symptomer forbundet hermed og anbefaling om at konsultere den ordinerende læge før seponering/udsættelse af administration af eculizumab
English: • Risk of severe thrombotic microangiopathic complications (in aHUS) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
Danish: • risikoen for alvorlige komplikationer som følge af trombotisk mikroangiopati (i aHUS) efter seponering/udsættelse af administration af eculizumab, tegn og symptomer forbundet hermed og anbefaling om at konsultere den ordinerende læge før seponering/udsættelse af administration af eculizumab
English: It was to be available as tablets (15, 30 and 45 mg).
Danish: Det skulle have været leveret som tabletter (15, 30 og 45 mg).
English: It was to be used in addition to diet and exercise.
Danish: Det skulle have været anvendt sammen med diæt og motion.
English: The withdrawal letter is available here.
Danish: Brevet om tilbagetrækningen findes her.
English: As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Danish: Derved reduceres mængden af blodglukose, og dette medvirker til at regulere type 2-diabetes.
English: The active substance in Pioglitazone ratiopharm, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Pioglitazone ratiopharm, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: This means that Pioglitazone ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Pioglitazone ratiopharm er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU) kaldet Actos.