FrancophonIA/ELRC3.0 huggingface dataset:
English: Reconstitute vedolizumab with 4.8 mL of sterile water for injections at room temperature (20 °C-25 °C), using a syringe with a 21-25 gauge needle.
Danish: Vedolizumab rekonstitueres med 4,8 ml sterilt vand til injektionsvæske ved stuetemperatur (20 °C-25 °C).
English: In-use stability of the diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection in infusion bag has been demonstrated for 12 hours at 20°C-25°C or 24 hours at 2°C-8°C.
Danish: senere anvendelse af opløsningen fortyndet i natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning i infusionsposen er påvist i 12 timer ved 20 °C-25 °C eller 24 timer ved 2 °C-8 °C.
English: NAME OF THE MEDICINAL PRODUCT Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab
Danish: LÆGEMIDLETS NAVN Entyvio 300 mg pulver til koncentrat til infusionsvæske, opløsning.
English: • prickling or tingling
Danish: • kuldegysninger eller skælven
English: • high fever or rash
Danish: • høj feber eller udslæt
English: Mucosal healing Durable clinical remission#
Danish: Mucosaheling Vedvarende klinisk remission#
English: Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab
Danish: Entyvio 300 mg pulver til koncentrat til infusionsvæske, opløsning.
English: The combined in-use stability of Entyvio in the vial and infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection is a total of 12 hours at 20°C-25°C or 24 hours at 2°C-8°C.
Danish: senere anvendelse for Entyvio i hætteglasset og infusionsposen med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning er i alt 12 timer ved 20 °C-25 °C eller 24 timer ved 2 °C-8 °C.
English: In these patients, clinical remission was achieved in 25% of patients at week 28 and week 52.
Danish: Blandt disse patienter var der opnået klinisk remission hos 25 % af patienterne i uge 28 og uge 52.
English: Vedolizumab Every 8 weeks n = 154
Danish: Vedolizumab Hver 8. uge n = 154
English: Respiratory tract infection, Vulvovaginal candidiasis, Oral candidiasis, Herpes zoster
Danish: Bronkitis, gastroenteritis, øvre luftvejsinfektion, influenza, sinusitis, faryngitis Ikke almindelig Luftvejsinfektion, vulvovaginal candidiasis, oral candidiasis, herpes zoster
English: The risk of malignancy is increased in patients with ulcerative colitis and Crohn's disease.
Danish: Hos patienter med colitis ulcerosa og Crohns sygdom er risikoen for malignitet øget.
English: TNFα Antagonist(s) Naïve^
Danish: Naive til TNFα-antagonistbehandling^
English: Vedolizumab Every 4 weeks n = 125
Danish: Vedolizumab Hver 4. uge n = 125
English: In these patients, clinical remission was achieved in 23% of patients at week 28 and 32% of patients at week 52.
Danish: Blandt disse patienter blev der opnået klinisk remission hos 23 % af patienterne i uge 28 og hos 32 % af patienter i uge 52.
English: Adverse Reaction(s)
Danish: Bivirkning(er)
English: Vedolizumab Every 4 weeks n = 154
Danish: Vedolizumab Hver 4. uge n = 154
English: Storage Condition Refrigerator (2 °C-8 °C)
Danish: Opbe varings forhold Køleskab (2 °C-8 °C)
English: In these patients, clinical remission was achieved in 46% of patients by 28 weeks and 41% of patients by 52 weeks.
Danish: Blandt disse patienter blev der opnået klinisk remission hos 46 % af patienterne i uge 28 og hos 41 % af patienterne i uge 52.
English: • tiredness
Danish: • tarmluft
English: including corticosteroids, immunomodulators, and/or TNFα antagonists (including primary non-responders).
Danish: Inkluderede patienter har ikke responderet på mindst én konventionel behandling, herunder kortikosteroider, immunmodulatorer og/eller TNFα-antagonister (herunder primære non-respondere).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 300 mg of vedolizumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 300 mg vedolizumab.
English: • throat and mouth yeast infection
Danish: • svampeinfektion i svælg og mund
English: Do not store any unused portion of the reconstituted solution or infusion solution for reuse.
Danish: Ikke anvendte rester af den rekonstituerede opløsning eller infusionsopløsningen må ikke opbevares og anvendes igen.
English: Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
Danish: Inde have ren af marke ds føringstilladelsen Takeda Pharma A/S
English: Do not freeze the reconstituted solution in the vial or the diluted solution in the infusion bag.
Danish: Den rekonstituerede opløsning i hætteglasset og den fortyndede opløsning i infusionsposen må ikke nedfryses.
English: Very rare
Danish: Meget sjælden Sløret syn
English: • swelling
Danish: • halsbrand
English: In these patients, clinical remission was achieved in 45% of patients by 28 weeks and 36% of patients by 52 weeks.
Danish: Blandt disse patienter var der opnået klinisk remission hos 45% af patienterne i uge 28 og hos 36 % af patienterne i uge 52.
English: Remove flip-off cap from the vial and wipe with alcohol swab.
Danish: Fjern vippehætten fra hætteglasset, og tør af med en spritserviet.
English: TNFα Antagonist(s) Failure¶
Danish: Manglende respons på TNFα-antagonist¶
English: Possible side effects
Danish: Tabel over bivirkning
English: TNFα Antagonist(s) Failure¶,‡
Danish: Manglende respons på TNFα-antagonist¶,‡
English: Oropharyngeal pain, Nasal congestion, Cough
Danish: Orofaryngeale smerter, tilstoppet næse, hoste
English: Age does not impact the vedolizumab clearance in ulcerative colitis and Crohn's disease patients based on the population pharmacokinetic analyses.
Danish: Vedolizumabs clearance hos patienter med colitis ulcerosa og Crohns sygdom baseret på farmakokinetiske populationsanalyser påvirkes ikke af alder. Der er ikke udført formelle studier for at undersøge effekterne af nedsat nyre- eller leverfunktion på vedolizumabs farmakokinetiske egenskaber.
English: D.
Danish: Hyppighe d
English: • chest infection
Danish: • halsbetændelse
English: TNFα Antagonist(s) Failure‡
Danish: Manglende respons på TNFα-antagonist‡
English: TNFα Antagonist(s) Naïve
Danish: Naive til TNFα-antagonistbehandling
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: Takeda Italia S.p.A. Tel.: +39 06 502601
Danish: Tel.: +39 06 502601
English: Tlf.
Danish: SN:
English: • anal infection
Danish: • analinfektion
English: • vaginal infection
Danish: Vaskulære sygdomme
English: Folliculitis
Danish: Dosering
English: TNFα Antagonist(s) Failure
Danish: Manglende respons på TNFα-antagonistbehandling
English: The CHMP concluded
Danish: konkluderede CHMP, at
English: Grounds for variation to the terms of the marketing authorisations
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelserne
English: Annex II Scientific conclusions and grounds for variation to the terms of the Marketing Authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne
English: The contraindication in this patient population was also further defined by inclusion of age specific %CD4+ for HIV-infected patients.
Danish: Kontraindikationen hos denne patientpopulation blev desuden nærmere afgrænset ved, at den aldersspecifikke % CD4+ for HIV-smittede patienter indgår.
English: There is an estimated theoretical risk of severe malformations attributed to the rubella containing vaccine that varies between 0.5% and 1.3%.
Danish: Den beregnede teoretiske risiko for svære misdannelser ved vaccination mod røde hunde er mellem 0,5 % og 1,3 %.
English: • that vaccination with MMRV vaccines may be considered in patients with selected immune deficiencies when the benefit outweighs the risk of vaccination.
Danish: • vaccination med MMRV-vacciner kan overvejes hos patienter med udvalgte immundefekter, når fordelene overstiger risikoen ved vaccination.
English: Based on the above, Belgium national competent authorities triggered a referral under Article 31 of Directive 2001/83/EC on 9 March 2012, requesting the CHMP to review the benefit/risk of these vaccines in the above mentioned populations, i.e. pregnant women and subjects with immune deficiencies.
Danish: På dette grundlag indledte Belgiens nationale kompetente myndigheder den 9. marts 2012 en indbringelse i henhold til artikel 31 i direktiv 2001/83/EF og anmodede CHMP om at gennemgå benefit/risk-forholdet for disse vacciner til ovennævnte populationer, dvs. gravide kvinder og personer med immundefekt.
English: Vaccination with these MMRV vaccines is contraindicated in pregnant women and in immunocompromised subjects.
Danish: Vaccination med disse MMRV-vacciner er kontraindiceret hos gravide kvinder og hos immunkompromitterede personer.
English: Moreover, a warning should be added as vaccination may be considered in patients with selected immune deficiencies (e.g. IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases), if the benefit outweighs the risk of vaccination.
Danish: Desuden bør der indsættes en advarsel, da vaccination kan overvejes hos patienter med udvalgte immundefekter (f.eks. IgGunderklassedefekter, kongenit neutropeni, kronisk granulomatøs sygdom og sygdomme med komplementdefekt), hvis fordelen overstiger risikoen ved vaccination.
English: The CHMP acknowledged that MMRV vaccines should remain contraindicated in patients with severely impaired humoral and/or cellular immune systems such as severe combined immunodeficiency (SCID) and agammaglobulinemia.
Danish: CHMP tilsluttede sig, at MMRV-vacciner fortsat bør være kontraindicerede hos patienter med svært nedsat humoral og/eller cellulær immunitet såsom ved svær kombineret immundefekt (SCID) og agammaglobulinæmi.
English: • that the data were sufficient to amend the product information to mention that pregnancy should be avoided for 1 month (instead of 3 months) following vaccination.
Danish: • oplysningerne var tilstrækkelige til at ændre produktinformationen, således at det anføres, at graviditet bør undgås i 1 måned efter vaccination (i stedet for 3 måneder).
English: The product information is therefore amended accordingly to reflect that pregnancy should be avoided for 1 month following vaccination instead of 3 months.
Danish: Produktinformationen ændres tilsvarende, så den afspejler, at graviditet bør undgås i 1 måned efter vaccination i stedet for i 3 måneder.
English: However, it was noted by the CHMP that the data from post-marketing surveillance and pregnancy registry were limited due to the current contraindication in the product information and were too poorly documented to draw any conclusion.
Danish: CHMP bemærkede dog, at der kun forelå begrænsede oplysninger fra lægemiddelovervågning efter markedsføring og fra graviditetsregistre på grund af den nuværende kontraindikation i produktinformationen, og at oplysningerne var for dårligt dokumenteret til, at der kan drages konklusioner.
English: In addition, published data also indicated that some groups of individuals other than pregnant women could benefit from a MMRV vaccine and therefore the contraindication for immunocompromised subjects needed to be reviewed.
Danish: Desuden tydede publicerede data på, at visse andre grupper af personer end gravide kvinder kunne have gavn af en MMRV-vaccine, hvorfor kontraindikationen for immunkompromitterede personer burde gennemgås på ny.
English: Because of this theoretical teratogenic risk, the World Health Organization (WHO) recommended in 2011 that vaccination against rubella should be avoided in principle in pregnant women and women who intend to become pregnant should be advised to delay for 1 month following rubella vaccination1.
Danish: På grund af denne teoretiske teratogene risiko anbefalede WHO i 2011, at vaccination mod røde hunde i princippet bør undgås hos gravide, og at kvinder, der planlægger graviditet, bør tilrådes at udsætte denne i en måned efter vaccination mod røde hunde
English: The CHMP considered that the contraindication should be harmonised and adjusted according to WHO guidance and scientific data and that although these vaccines are generally contraindicated in immunocompromised subjects, some individuals may benefit from vaccination.
Danish: CHMP fandt, at kontraindikationen bør harmoniseres og tilpasses i henhold til WHO-vejledningen og videnskabelige oplysninger, og at nogle individer kan have gavn af vaccination, uanset at disse vacciner generelt er kontraindiceret hos immunkompromitterede personer.
English: Monovalent and multivalent measles, mumps, rubella and/or varicella containing vaccines (MMRV) are live attenuated vaccines which are indicated in vaccination of adults and children against these viruses.
Danish: Monovalente og multivalente vacciner mod mæslinger, fåresyge, røde hunde og/eller skoldkopper (MMRV) er levende, svækkede vacciner, som er indiceret til vaccination af voksne og børn mod de pågældende vira.
English: Having considered all available data, the CHMP is of the opinion that MMRV vaccination should continue to be contraindicated in pregnant women.
Danish: På grundlag af alle de foreliggende data er CHMP af den opfattelse, at MMRV-vaccination fortsat bør være kontraindiceret hos gravide kvinder.
English: Overall summary of the scientific evaluation of the measles, mumps, rubella and varicella containing vaccines (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af vacciner mod mæslinger, fåresyge, røde hunde og skoldkopper (se bilag I)
English: For completeness, the CHMP also recommended the update of the product information to reflect the most recent published data regarding vaccination against rubella in pregnant women.
Danish: For fuldstændighedens skyld anbefalede CHMP desuden, at produktinformationen opdateres, så den er i overensstemmelse med de seneste publicerede data om vaccination mod røde hunde hos gravide kvinder.
English: However, the CHMP concluded that the current contraindication for use of MMRV vaccines in immunocompromised subjects should be amended to clarify that, according to WHO guidelines and scientific data, for HIV-infected patients age specific %CD4+ is to be included.
Danish: CHMP konkluderede imidlertid, at den nuværende kontraindikation for anvendelse af MMRV-vacciner hos immunkompromitterede personer bør korrigeres, så det præciseres, at for HIV-smittede patienter bør den aldersspecifikke % CD4+ indgå i overensstemmelse med WHO-vejledningen og videnskabelige data.
English: On the basis of the most recent published data on rubella containing vaccines, in particular for pregnant women Belgium national competent authorities considered it was justified to review whether monovalent and multivalent MMRV vaccines should remain contraindicated in pregnant women as vaccination in some individual cases may outweigh the risk.
Danish: På grundlag af de seneste publicerede oplysninger om vacciner mod røde hunde, navnlig til gravide kvinder, fandt de belgiske nationale kompetente myndigheder behov for en vurdering af, om monovalente og multivalente MMRV-vacciner fortsat burde være kontraindiceret til gravide kvinder, da fordelen ved vaccination i enkelte tilfælde kunne tænkes at overstige risikoen.
English: When considering the data from studies in the literature and the data from post-marketing surveillance the CHMP concluded that although a theoretical risk cannot be excluded, no case of CRS has been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated against rubella.
Danish: Efter gennemgang af litteraturdata fra sådanne undersøgelser og lægemiddelovervågningsdata efter markedsføring konkluderede CHMP, at skønt en teoretisk risiko ikke kan udelukkes, er der ikke indberettet noget tilfælde af CRS hos over 3 500 modtagelige kvinder, som uforvarende var i de tidlige stadier af graviditet, da de blev vaccineret mod røde hunde.
English: Regarding the contraindication on immunocompromised subjects, an assessment of the safety of MMRV vaccines (based on experience to date) in subjects with various types of immune deficiencies (e.g. T-cell defects, sub-class deficiencies etc.) was provided by the Marketing Authorisation Holders (MAHs).
Danish: Med henblik på kontraindikationen for immunkompromitterede personer fremlagde indehaverne af markedsføringstilladelsen en sikkerhedsvurdering af MMRV-vacciner (baseret på de hidtidige erfaringer) hos personer med forskellige typer immundefekter (f.eks. T-celledefekter, underklassedefekter osv.).
English: • the CHMP reviewed all available data regarding use in pregnant women and in immunocompromised patients of rubella containing vaccines, including the most recent publications and data from post-marketing surveillance for monovalent and multivalent measles, mumps, rubella and varicella vaccines.
Danish: • CHMP gennemgik alle foreliggende data om anvendelse af vacciner mod røde hunde hos gravide kvinder og immunkompromitterede patienter, herunder de seneste publikationer og data fra lægemiddelovervågning efter markedsføring for monovalente og multivalente vacciner mod mæslinger, fåresyge, røde hunde og skoldkopper,
English: Data provided from post marketing surveillance and published literature did not show any safety concern with respect to spontaneous abortion or congenital malformations in pregnant women that were inadvertently vaccinated with MMRV vaccines and no case of CRS or CVS have been reported.
Danish: Oplysninger fra lægemiddelovervågning efter markedsføring og den publicerede litteratur gav ikke anledning til sikkerhedsmæssige betænkeligheder vedrørende spontanabort eller medfødte misdannelser hos gravide kvinder, som utilsigtet er vaccineret med MMRV-vacciner, og der ikke indberettet tilfælde af CRS eller CVS.
English: • the CHMP considered the referral under Article 31 of Directive 2001/83/EC for monovalent and multivalent measles, mumps, rubella and varicella containing vaccines.
Danish: • CHMP behandlede den indbringelse, der var foretaget i henhold til artikel 31 i direktiv 2001/83/EF, for monovalente og multivalente vacciner mod mæslinger, fåresyge, røde hunde og skoldkopper,
English: Therefore, the CHMP recommended the variation to the terms of the marketing authorisations for which the relevant sections of the summaries of product characteristics and package leaflets are set out in Annex III for monovalent and multivalent measles, mumps, rubella and varicella containing vaccines (see Annex I).
Danish: CHMP anbefalede følgelig ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé og indlægsseddel fremgår af bilag III for monovalente og multivalente vacciner mod mæslinger, fåresyge, røde hunde og skoldkopper (jf. bilag I).
English: Available on http://www.who.int/wer/2011/wer8629.pdf 29(86) Ref Type: Internet Communication
Danish: tilgængelig på http://www.who.int/wer/2011/wer8629.pdf 29(86) Ref Type: Internetmeddelelse indholdet af rubella-IgM efter vaccination når sit maksimum omkring 30 dage efter vaccinationen, og også IgG er til stede i påviselige mængder.
English: Evidence from post marketing surveillance and published literature that focused on risk of spontaneous abortion, miscarriage, stillbirth, immaturity and low birth weight in women susceptible to measles, mumps, rubella and/or varicella, risk of malformation and congenital rubella syndrome (CRS) in offspring of such women, and risk of congenital varicella syndrome (CVS) were considered for the review of the contraindication on pregnancy.
Danish: Ved gennemgangen af kontraindikationen graviditet tog udvalget hensyn til evidensen fra lægemiddelovervågning efter markedsføring og fra den publicerede litteratur vedrørende risikoen for spontanabort, dødfødsel, immaturitet og lav fødselsvægt hos kvinder, der er modtagelige for mæslinger, fåresyge, røde hunde og/eller skoldkopper, risikoen for misdannelser og kongenit rubellasyndrom (CRS) hos børn af sådanne kvinder og risikoen for kongenit varicellasyndrom (CVS).
English: The CHMP also considered that the most recent published data regarding vaccination against rubella in pregnant women should be reflected in the summary of product characteristics of the monovalent rubella vaccines and multivalent MMR vaccines.
Danish: CHMP fandt desuden, at de seneste publicerede data om vaccination mod røde hunde hos gravide kvinder bør afspejles i produktresuméet for monovalente vacciner mod røde hunde og multivalente MMR-vacciner, og
English: Based on the low theoretical teratogenic risk and the fact that no case of CRS has been reported, it should also be mentioned in the SmPC that inadvertent vaccination of unknowingly pregnant women with monovalent or multivalent mumps, measles and rubella containing vaccines should not be a reason for termination of pregnancy.
Danish: På grund af den lave teoretiske teratogene risiko og det forhold, at der ikke er indberettet nogen tilfælde af CRS, bør det desuden anføres i produktresuméet, er der ikke grund til at afbryde graviditeten hos kvinder, der uvidende om deres graviditet er blevet vaccineret med monovalente eller multivalente vacciner mod fåresyge, mæslinger og røde hunde.
English: Taking into account that rubella and varicella vaccination induce a fast immune response that make post-exposure prophylaxis possible, based on available evidence and as reflected in WHO recommendation, the CHMP considered that there are sufficient data to reduce the period post-vaccination where pregnancy should be avoided.
Danish: Ud fra den foreliggende evidens inducerer vaccination mod røde hunde og skoldkopper en hurtig immunrespons, der muliggør profylakse efter eksponering, hvilket afspejler sig i anbefalingen fra WHO.
English: • that the data provided were too limited and poorly documented to draw any conclusion and therefore without any sufficient data monovalent and multivalent MMRV vaccines should remain contraindicated during pregnancy.
Danish: • de forelagte oplysninger data var for begrænsede og for mangelfuldt dokumenterede til, at der kunne drages nogen konklusion.
English: However, we want to take this a step forward.
Danish: Vi ønsker imidlertid at gå skridtet videre.
English: The implementation strategy concentrates on a number of projects with high European added value.
Danish: Gennemførelsesstrategien fokuserer på en række projekter med stor europæisk merværdi.
English: The implementation of Article 5(3) and Article 107(2) procedures which are new legal provisions will be monitored carefully.
Danish: Gennemførelsen af procedurerne i artikel 5, stk. 3, og artikel 107, stk. 2, som er nye lovbestemmelser, vil blive fulgt nøje.
English: 2.11 Coordination group
Danish: 2.11 Koordineringsgruppe
English: The Agency will concentrate its efforts in three areas:
Danish: Agenturet vil koncentrere sin indsats om følgende tre områder:
English: This database is in the first stages of the design process.
Danish: Denne database er i første fase af designprocessen.
English: Generic, hybrid products, etc.
Danish: Generiske produkter, hybridprodukter osv.
English: 303 Studies and consultants 304 Publications
Danish: 303 Undersøgelser og konsulenter 304 Publikationer
English: With this in view, a number of guidance documents will be developed.
Danish: Der vil til dette formål blive udarbejdet en række vejledningsdokumenter.
English: This will result from routine maintenance activities.
Danish: Dette sker på basis af rutinemæssige vedligeholdelsesaktiviteter.
English: 1.6 Preparations for future enlargement
Danish: 1.6 Forberedelser til fremtidige udvidelser
English: The priorities and key objectives for 2007 can be summarised as follows:
Danish: Prioriteterne og hovedmålene for 2007 kan sammenfattes som følger:
English: Work on the next version will be postponed to 2009.
Danish: Arbejdet med den næste udgave udsættes til 2009.
English: 302 Translation
Danish: 302 Oversættelse
English: European public assessment report (EPAR).
Danish: Europæisk offentlig vurderingsrapport (EPAR).
English: System or process 2007 milestones
Danish: System eller proces Milepæle for 2007
English: Incentives are provided because such medicines might, for economic reasons, not otherwise be developed.
Danish: Det er nødvendigt med incitamenter, da denne form for medicin af økonomiske årsager ellers ikke vil blive udviklet.