FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC concluded that valproate and related substances should be contraindicated in prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate.
Danish: • PRAC konkluderede, at valproat og relaterede stoffer bør være kontraindiceret til forebyggelse af migræneanfald under graviditet og hos kvinder i den fødedygtige alder, som ikke anvender sikker prævention under behandlingen med valproat.
English: In addition, the PRAC considered the views of patients, families and carers, and the views of healthcare professionals for the understanding and the awareness of the risks associated with valproate in utero exposure.
Danish: Desuden tog PRAC de synspunkter i betragtning, der var udtrykt af patienter, familier og omsorgsgivere, og sundhedspersoners syn på kendskabet til og bevidstheden om risiciene ved eksponering in utero for valproat.
English: In addition, the views of patients, families and carers, and the view of healthcare professionals regarding the implications, the understanding and awareness of the risks associated with valproate in utero exposure were taken into account in the recommendation.
Danish: I anbefalingen blev der desuden taget hensyn til udtalelser fra patienter, familier og omsorgsgivere samt sundhedspersoners syn på konsekvenserne af, kendskabet til og bevidstheden om risiciene ved in utero-eksponering for valproat.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations subject to conditions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelse for ændring af markedsføringstilladelserne på visse betingelser samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering)
English: The CMDh considered the below PRAC recommendation with regard to valproate and related substances-containing medicinal products:
Danish: CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) har gennemgået nedenstående anbefaling fra PRAC for lægemidler indeholdende valproat og relaterede stoffer:
English: The European Commission issued a decision on 30 March 2010.
Danish: Europa-Kommissionen traf en afgørelse den 30. marts 2010.
English: Dr Harald Enzmann (Germany)
Danish: Dr. Harald Enzmann (Tyskland)
English: Dr Robert James Hemmings (United Kingdom)
Danish: Dr. Robert James Hemmings (Det Forenede Kongerige)
English: London, 30 March 2010 Doc.
Danish: London, den 30. marts 2010 Dok.
English: Co-rapporteur(s):
Danish: Co-rapportør(er):
English: However, the member states were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 30 July 2009.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og den svenske lægemiddelkontrolmyndighed henviste sagen til CHMP til voldgift den 30. juli 2009.
English: Bioequivalence studies are used to compare how a generic medicine is absorbed by the body in comparison to the reference medicine.
Danish: Bioækvivalensundersøgelser anvendes til at sammenligne, hvordan et generisk lægemiddel optages i kroppen i forhold til referencelægemidlet.
English: Questions and answers on the referral for Pantoprazole Bluefish pantoprazole 20 and 40 mg tablets
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Pantoprazole Bluefish pantoprazol 20- og 40-mg tabletter
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Bluefish.
Danish: Det Europæiske Lægemiddelagentur har afsluttet en voldgiftsprocedure som følge af uenighed blandt Den Europæiske Unions medlemsstater om godkendelsen af lægemidlet Pantoprazole Bluefish.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Pantoprazole Bluefish had been shown to be bioequivalent to the reference medicine, and therefore the marketing authorisation should be granted in Sweden and all concerned member states.
Danish: På basis af en vurdering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at Pantoprazole Bluefish havde vist sig at være bioækvivalent med referencelægemidlet, og at der kunne udstedes markedsføringstilladelse i Sverige og alle de berørte medlemsstater.
English: By blocking the pumps, pantoprazole reduces acid production.
Danish: Ved at blokere pumperne reducerer pantoprazol syreproduktionen.
English: These are tablets that pass through the stomach without being broken down until they reach the intestine.
Danish: Disse tabletter passerer gennem maven og bliver først nedbrudt, når de når ned i tarmene.
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Austria, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Norway, Poland, Portugal and Spain).
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Sverige) vurderer et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, som gælder både nationalt og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Østrig, Danmark, Tyskland, Finland, Frankrig, Ungarn, Irland, Italien, Nederlandene, Polen, Portugal og Spanien samt Norge).
English: The grounds for the referral were concerns expressed by the Dutch, German, Irish and Italian medicines regulatory agencies regarding the bioequivalence study comparing Pantoprazole Bluefish and Pantecta.
Danish: Begrundelsen for indbringelsen var, at de nederlandske, tyske, irske og italienske lægemiddelkontrolmyndigheder havde givet udtryk for betænkeligheder vedrørende den bioækvivalensundersøgelse, hvor Pantoprazole Bluefish og Pantecta var blevet sammenlignet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Bluefish outweigh its risks, and the marketing authorisation can be granted in Sweden and in the following Member States of the European Union, Austria, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Poland, Portugal, Spain as well as in Norway.
Danish: EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Pantoprazole Bluefish opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Sverige og i EU-medlemsstaterne Østrig, Danmark, Tyskland, Finland, Frankrig, Ungarn, Irland, Italien, Nederlandene, Polen, Portugal og Spanien samt Norge.
English: The 20 mg tablets can be used for reflux disease to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth), for the long-term management and prevention of relapse in reflux oesophagitis (inflammation of the gullet, due to acid), for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
Danish: 20-mg-tabletterne kan anvendes ved reflukssygdom til behandling af symptomer som f.eks. halsbrand og sure opstød, langtidsbehandling og forebyggelse af tilbagefald af refluksøsofagitis (betændelse i spiserøret forårsaget af syre) og forebyggelse af mavesår, som kan være forårsaget af visse lægemidler mod smerter og betændelse kaldet ikke-selektive, ikke-steroide antiinflammatoriske lægemidler (NSAID'er), når patienten har behov for fortsat NSAID-behandling.
English: Bluefish Pharmaceuticals AB submitted Pantoprazole Bluefish to the Swedish medicines regulatory agency for a decentralised procedure.
Danish: Bluefish Pharmaceuticals AB indgav en ansøgning for Pantoprazole Bluefish til Sveriges lægemiddelkontrolmyndighed med henblik på en decentral procedure.
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Danish: Det virker ved at blokere "protonpumperne", som er proteiner i specialiserede celler i mavesækkens slimhinde, der pumper syre ind i maven.
English: What is Pantoprazole Bluefish?
Danish: Hvad er Pantoprazole Bluefish?
English: Pantoprazole Bluefish is a medicine used to treat diseases where the stomach produces too much acid.
Danish: Pantoprazole Bluefish er et lægemiddel, der anvendes til behandling af sygdomme, hvor der produceres for meget syre i maven.
English: The 40 mg tablets can be used for more severe acid diseases such as stomach ulcer, duodenal ulcer, Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach) and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcer.
Danish: 40-mg-tabletterne kan anvendes til sværere syrerelaterede sygdomme som f.eks. mavesår, duodenalsår og Zollinger-Ellison-syndrom (en tilstand, der skyldes oversekretion af syre i maven), og kan hjælpe med at udrydde en bakterie i maven kaldet Helicobacter pylori, som man ved kan forårsage mavesår.
English: Why was Pantoprazole Bluefish reviewed?
Danish: Hvorfor blev Pantoprazole Bluefish vurderet igen?
English: Pantoprozole Bluefish is a generic medicine based on the reference medicine Pantecta.
Danish: Pantoprozole Bluefish er et generisk lægemiddel, der er baseret på referencelægemidlet Pantecta.
English: The active substance in Pantoprazole Bluefish, pantoprazole, is a proton pump inhibitor.
Danish: Det aktive stof i Pantoprazole Bluefish, pantoprazol, er en protonpumpehæmmer.
English: Pantoprazole Bluefish is presented as gastro-resistant tablets.
Danish: Pantoprazole Bluefish fås som enterotabletter.
English: Company responses provided on: 21 September 2009, 26 October 2009 Opinion date:
Danish: 21. september 2009, 26. oktober 2009
English: This overview was last updated in 04-2018.
Danish: Denne oversigt blev sidst ajourført i 04-2018.
English: Bosulif received a marketing authorisation valid throughout the EU on 27 March 2013.
Danish: Bosulif fik en markedsføringstilladelse med gyldighed i hele EU den 27. marts 2013.
English: Further information on Bosulif can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Bosulif findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Every year, the Agency will review any new information that becomes available and this summary will be updated as necessary.
Danish: Hvert år gennemgår Det Europæiske Lægemiddelagentur alle nye oplysninger, der bliver tilgængelige, og ajourfører om nødvendigt denne oversigt.
English: Bosulif has been given ‘conditional authorisation'.
Danish: Bosulif har fået en "betinget godkendelse".
English: Bosulif was not compared with another treatment.
Danish: Bosulif blev ikke sammenlignet med nogen anden behandling.
English: The recommended dose is 400 mg once a day for newly diagnosed patients, and 500 mg once a day for patients who have already been treated with other medicines.
Danish: Den anbefalede dosis er 400 mg én gang dagligt til nydiagnosticerede patienter, og 500 mg én gang dagligt til patienter, som før er blevet behandlet med andre lægemidler.
English: The doctor may increase the dose up to 600 mg once a day or reduce it or interrupt treatment according to how the medicine is working and the side effects the patient has.
Danish: Lægen kan øge dosis til 600 mg én gang dagligt, eller sætte den ned eller afbryde behandlingen, alt efter hvordan lægemidlet virker, og hvilke bivirkninger patienten får.
English: As for all medicines, data on the use of Bosulif are continuously monitored.
Danish: Som for alle lægemidler overvåges data vedrørende brugen af Bosulif løbende.
English: The side effects of the medicine are considered to be manageable.
Danish: Lægemidlets bivirkninger anses for at kunne behandles.
English: Bosulif must not be used in patients with reduced liver function.
Danish: Bosulif må ikke anvendes af patienter med svært nedsat leverfunktion.
English: What measures are being taken to ensure the safe and effective use of Bosulif?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bosulif?
English: The European Medicines Agency therefore decided that the benefits of Bosulif are greater than in its risks and recommended that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Bosulif opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Bosulif are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Bosulif vurderes omhyggeligt, og der træffes de nødvendige forholdsregler til beskyttelse af patienterne.
English: An overview of Bosulif and why it is authorised in the EU
Danish: En oversigt over Bosulif og hvorfor det er godkendt i EU
English: What is Bosulif and what is it used for?
Danish: Hvad er Bosulif, og hvad anvendes det til?
English: Other information about Bosulif
Danish: Andre oplysninger om Bosulif
English: After one year of treatment, 47% (116 out of 246) of patients treated with Bosulif had a major molecular response, compared with 37% (89 out of 241) of patients treated with imatinib.
Danish: Efter ét års behandling havde 47 % (116 ud af 246) af de patienter, der blev behandlet med Bosulif, afgørende molekylær respons, sammenholdt med 37 % (89 ud af 241) af dem, der blev behandlet med imatinib.
English: Why is Bosulif authorised in the EU?
Danish: Hvorfor blev Bosulif godkendt i EU?
English: What are the risks associated with Bosulif?
Danish: Hvilke risici er der forbundet med Bosulif?
English: For more information about using Bosulif, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Bosulif, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Effectiveness was also measured in other ways including ‘haematological response' (a return to normal of the number of white cells in the blood).
Danish: Virkningen blev desuden bedømt på andre måder, bl.a. ved "hæmatologisk respons", dvs. at antallet af hvide blodlegemer igen blev normalt.
English: The active substance in Bosulif, bosutinib, is a tyrosine kinase inhibitor.
Danish: Det aktive stof i Bosulif, bosutinib, er en tyrosinkinasehæmmer.
English: A second study in 536 newly diagnosed CML patients in the ‘chronic phase' compared Bosulif with imatinib.
Danish: I endnu et studie med 536 nydiagnosticerede CML-patienter i "kronisk fase" blev Bosulif sammenlignet med imatinib.
English: What information is still awaited for Bosulif?
Danish: Hvilke oplysninger afventes der stadig for Bosulif?
English: Of these, 52 patients were considered to have an unmet medical need, because disease resistance or the risk of severe side effects made other tyrosine kinase inhibitors unsuitable.
Danish: 52 af disse patienter blev anset for at have et uopfyldt medicinsk behov, fordi andre tyrosinkinasehæmmere var uegnede på grund af sygdommens upåvirkelighed eller risikoen for alvorlige bivirkninger.
English: Among these patients, 36 had chronic phase CML and 16 had either accelerated or blast phase CML.
Danish: Af disse patienter havde 36 kronisk myeloid leukæmi i kronisk fase, mens 16 havde det enten i accelereret fase eller blastfase.
English: It blocks the action of enzymes known as Src and Bcr-Abl tyrosine kinases found on leukaemia cells where they are involved in stimulating the cells to divide uncontrollably.
Danish: Det blokerer virkningen af enzymerne Src- og Bcr-Abl-tyrosinkinase, som findes på leukæmiceller, og som stimulerer cellerne til at dele sig ukontrolleret.
English: Bosulif is also used to treat newly diagnosed patients who are in the ‘chronic phase' of CML.
Danish: Bosulif anvendes også til behandling af nydiagnosticerede patienter, som er i den "kroniske fase" af kronisk myeloid leukæmi.
English: For more information about treatment with Bosulif, read the package leaflet (also part of the EPAR) or contact a doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Bosulif, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Bosulif is a cancer medicine that is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in adults with a special chromosome in their cells called the Philadelphia chromosome.
Danish: Bosulif er et kræftlægemiddel, der anvendes til behandling af kronisk myeloid leukæmi (CML, kræft i de hvide blodlegemer) hos voksne, der har det særlige Philadelphia-kromosom i deres celler.
English: Studies have shown that Bosulif is effective at reducing the proportion of white blood cells with the Philadelphia chromosome.
Danish: Studierne viser, at Bosulif er effektivt til at nedsætte andelen af hvide blodlegemer med Philadelphiakromosom.
English: Bosulif treatment was effective in patients with an unmet medical need: 18 out of 36 patients with chronic phase CML had a ‘major cytogenetic response', while 7 out of the 16 patients with advanced (accelerated or blast phase) CML also had a sufficient response based on other measurements.
Danish: Behandlingen med Bosulif virkede hos patienter med et uopfyldt behandlingsbehov: 18 ud af 36 patienter med kronisk myeloid leukæmi i kronisk fase opnåede "afgørende cytogenetisk respons", og 7 ud af 16 patienter med fremskreden (accelereret fase eller blastfase) kronisk myeloid leukæmi opnåede ligeledes tilstrækkelig respons, bedømt på andre målinger.
English: Bosulif was investigated in one main study involving 570 patients with Ph+ CML who had previously been treated with at least one tyrosine kinase inhibitor.
Danish: Bosulif var omfattet af ét hovedstudie, hvori der deltog 570 patienter med kronisk myeloid leukæmi af typen Ph+, som tidligere var behandlet med mindst én tyrosinkinasehæmmer.
English: How is Bosulif used?
Danish: Hvordan anvendes Bosulif?
English: Bosulif has been shown to improve the condition of patients with CML, including by reducing the number of cancer cells with the Philadelphia chromosome and returning white blood cell levels to normal.
Danish: Det er påvist, at Bosulif forbedrer tilstanden hos patienter med kronisk myeloid leukæmi, bl.a. ved at reducere antallet af kræftceller med Philadelphia-kromosom og gøre antallet af hvide blodlegemer normalt igen.
English: The most serious side effects (which may affect more than 1 in 20 people) include thrombocytopenia, anaemia, diarrhoea, rash, neutropenia (low levels of neutrophils, a type of white blood cell) and blood tests suggesting damage to the liver and pancreas.
Danish: De mest alvorlige bivirkninger (som kan forekomme hos mere end 1 ud af 20 personer) er for lavt antal blodplader (trombocytopeni), anæmi, diarré, udslæt, for lavt antal hvide blodlegemer af typen neutrofile (neutropeni) samt blodprøver, der tyder på beskadigelse af lever og bugspytkirtel.
English: Since Bosulif has been granted a conditional approval, the company that markets Bosulif will carry out and submit the results of a larger study with Bosulif in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom dasatinib, imatinib and nilotinib are not considered appropriate treatment options.
Danish: Da Bosulif har fået en betinget godkendelse, skal den virksomhed, der fremstiller Bosulif, udføre og forelægge resultaterne af et større studie med Bosulif hos patienter med kronisk myeloid leukæmi af typen Ph+, der tidligere er blevet behandlet med en eller flere tyrosinkinasehæmmere, og til hvem imatinib, nilotinib og dasatinib ikke anses for egnede.
English: The most common side effects with Bosulif (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), thrombocytopenia (low blood platelet counts), abdominal pain (belly ache), vomiting, rash, anaemia (low red blood cell counts), tiredness, fever and increased levels of liver enzymes.
Danish: De hyppigste bivirkninger med Bosulif (som kan forekomme hos mere end 1 ud af 5 personer) er diarré, kvalme, for lavt antal blodplader (trombocytopeni), mavesmerter, opkastning, udslæt, for lavt antal røde blodlegemer (anæmi), træthed, feber og forhøjede leverenzymer.
English: The main measure of effectiveness was the number of patients who had a ‘major molecular response' (where the amount in the bone marrow of BCR-ABL, the protein produced by the Philadelphia chromosome, is greatly lowered).
Danish: Virkningen blev hovedsageligt bedømt på antallet af patienter, der opnåede "afgørende molekylær respons" (stærk nedsættelse af knoglemarvens indhold af proteinet BCR-ABL, der produceres af Philadelphia-kromosomet).
English: It is used to treat three stages of CML called ‘chronic phase', ‘accelerated phase' and ‘blast phase' in patients who have already been treated with one or more tyrosine kinase inhibitors (medicines for CML which work in a similar way to Bosulif), and when the tyrosine kinase inhibitors called dasatinib, imatinib and nilotinib are not suitable.
Danish: Det anvendes til at behandle tre faser af kronisk myeloid leukæmi, hhv. "kronisk fase", "accelereret fase" og "blastfase", hos patienter, der allerede er behandlet med et eller flere lægemidler mod kronisk myeloid leukæmi (tyrosinkinasehæmmere), som virker på samme måde som Bosulif, og når tyrosinkinasehæmmerne dasatinib, imatinib og nilotinib ikke er egnede.
English: For the full list of all side effects reported with Bosulif, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Bosulif fremgår af indlægssedlen.
English: By blocking their action, Bosulif helps to control cell division, thereby controlling the growth and spread of the leukaemia cells in CML.
Danish: Ved at blokere virkningen af enzymerne medvirker Bosulif til at kontrollere leukæmicellernes deling, vækst og spredning ved kronisk myeloid leukæmi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bosulif 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 Bosulif.
English: The main measure of effectiveness was the number of patients who had at least a ‘major cytogenetic response' (where the proportion of white blood cells with the Philadelphia chromosome fell below 35%) after six months of Bosulif treatment.
Danish: Virkningen blev hovedsageligt på antallet af patienter, der efter seks måneders behandling med Bosulif som minimum udviste "afgørende cytogenetisk respons" (dvs. at andelen af hvide blodlegemer med Philadelphia-kromosom faldt til under 35 %).
English: How does Bosulif work?
Danish: Hvordan virker Bosulif?
English: What benefits of Bosulif have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Bosulif?
English: It can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of CML.
Danish: Bosulif leveres som tabletter i styrkerne 100, 400 og 500 mg. Lægemidlet udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i diagnosticering og behandling af kronisk myeloid leukæmi.
English: London, 23 October 2008 Doc.
Danish: London, den 23. oktober 2008 Dok.
English: Pain was measured by the patients on an 11-point scale.
Danish: Smerten blev målt af patienterne ved hjælp af en 11-points skala.