FrancophonIA/ELRC3.0 huggingface dataset:
English: The first main study involved 561 healthy adults, while the second study involved around 3,600 adults including those at higher risk of flu (such as people with a long-term illness or a weakened immune system).
Danish: Den første undersøgelse omfattede 561 raske voksne, mens den anden omfattede omkring 3 600 voksne, herunder personer med høj risiko for at få influenza (såsom personer med langvarig sygdom eller et svækket immunsystem).
English: The Committee noted that Vepacel produced a good antibody response in healthy adults and an acceptable response in healthy adults aged 60 and over and in patients with a weakened immune system or long-term illness.
Danish: Udvalget bemærkede, at Vepacel gav en god antistofrespons hos raske voksne samt en acceptabel respons hos raske voksne på 60 år og derover og hos patienter med svækket immunforsvarssystem eller langvarig sygdom.
English: The most common side effects with Vepacel (seen in more than 1 person in 10) in adults are headache, fatigue (tiredness) and pain at the site of injection.
Danish: De hyppigste bivirkninger ved Vepacel (som optræder hos flere end 1 ud af 10 patienter) hos voksne er hovedpine, træthed og smerter på injektionsstedet.
English: All of the studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') against H5N1.
Danish: I samtlige undersøgelser så man nærmere på vaccinens evne til at udløse dannelsen af antistoffer ("immunogenicitet") mod H5N1.
English: The CHMP decided that the benefits of Vepacel are greater than its risks and recommended that it be granted a marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Vepacel opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Vepacel.
English: Vepacel has also been studied in a main study involving 657 healthy children aged 6 months to 17 years, who were given two doses of Vepacel, three weeks apart.
Danish: Vepacel er også blevet undersøgt i en hovedundersøgelse, der omfattede 657 raske børn i alderen seks måneder til 17 år, som fik to doser af Vepacel med tre ugers mellemrum.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vepacel, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vepacel, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Vaccination with Vepacel in adults produced an antibody response that met these criteria.
Danish: Vaccination med Vepacel hos voksne bevirker en antistofrespons, som opfylder disse kriterier.
English: The viruses used in Vepacel are grown in mammal cells (‘vero cells'), as opposed to hen's eggs.
Danish: De vira, der anvendes i Vepacel, dyrkes i pattedyrceller ("veroceller") i modsætning til hønseæg.
English: This is a type of vaccine to be used to protect against a new strain of flu that may cause a future influenza pandemic.
Danish: Det er en vaccinetype, som anvendes til at beskytte mod en ny influenzastamme, der eventuelt kan forårsage en influenzapandemi i fremtiden.
English: The vaccine has been developed so that it can be used before or during a flu pandemic to provide protection against the H5N1 virus.
Danish: Vaccinen er blevet udviklet, så den kan anvendes før eller under en influenzapandemi til beskyttelse mod denne H5N1virus.
English: Why has Vepacel been approved?
Danish: Hvorfor blev Vepacel godkendt?
English: This may help to provide protection in the event of a pandemic caused by a new strain of the H5N1 virus.
Danish: Dette kan medvirke til at opnå beskyttelse i tilfælde af en pandemi forårsaget af en ny stamme af H5N1-virus.
English: This vaccine contains a strain of the H5N1 virus.
Danish: Denne vaccine indeholder en stamme af H5N1-virus.
English: Health experts are concerned that a future flu pandemic could be caused by a strain of the H5N1 virus.
Danish: Sundhedseksperter er bekymrede for, at en kommende influenzapandemi kan forårsages af en stamme af H5N1-virus.
English: The booster vaccination (one year after the 2-dose vaccination with Vepacel) also produced a strong antibody response against the strains used in the booster and in Vepacel.
Danish: Boostervaccinationen (ét år efter todosisvaccinationen med Vepacel) fremkaldte også en kraftig antistofrespons mod de stammer, der anvendes i boosteren og i Vepacel.
English: What is Vepacel?
Danish: Hvad er Vepacel?
English: The Committee also noted that Vepacel produced a reasonable antibody response against other H5N1 strains that could potentially cause a flu pandemic.
Danish: Udvalget bemærkede også, at Vepacel medførte en rimelig antistofrespons mod andre H5N1-stammer, som potentielt kunne forårsage en influenzapandemi.
English: In both studies, participants were given two doses of Vepacel followed by a booster dose (given after six months, one year or two years) of a vaccine containing different strengths of the same H5N1 flu strain as in Vepacel or a different H5N1 flu strain.
Danish: I begge undersøgelser fik deltagerne to doser Vepacel efterfulgt af en boosterdosis (som blev givet henholdsvis seks måneder, et år eller to år efter) af en vaccine, der indeholdt forskellige styrker af den samme H5N1-influenzastamme som i Vepacel eller en anden H5N1influenzastamme.
English: The study in children showed that vaccination with Vepacel brought about similar levels of antibodies to those seen in adults: at 21 days after the second injection, 85.4% of children aged 9 to 17 years, 72.9% of children aged 3 to 8 years and 68.8% of children aged 6 to 35 months had levels of antibodies that would protect them against H5N1.
Danish: Undersøgelsen af børn viste, at vaccination med Vepacel medførte en lignende mængde antistoffer som den, der sås hos voksne: 21 dage efter den anden injektion havde 85,4 % af børnene i alderen ni til 17 år, 72,9 % af børnene i alderen tre til otte år og 68,8 % af børnene i alderen seks til 35 måneder dannet nok antistoffer til at være beskyttet mod H5N1.
English: Some children also received a booster dose of a vaccine containing a different H5N1 flu strain after one year.
Danish: Enkelte børn fik desuden en boosterdosis af en vaccine, der indeholdt en anden H5N1-influenzastamme, ét år efter.
English: For the full list of all side effects reported with Vepacel, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Vepacel fremgår af indlægssedlen.
English: In the second main study, 85.8% of healthy adults under 60 and 80.2% of healthy adults aged 60 and over had protective levels of antibodies.
Danish: I den anden hovedundersøgelse havde 85,8 % af de raske voksne under 60 år og 80,2 % af de raske voksne på 60 år og derover beskyttende mængder antistoffer.
English: Vepacel is a vaccine for use in adults and children from 6 months of age to protect against flu caused by the H5N1 (“bird flu”) subtype of the influenza A virus.
Danish: Vepacel er en vaccine til beskyttelse af voksne og børn i alderen seks måneder og derover mod influenza forårsaget af H5N1-undertypen af influenzavirus A (fugleinfluenza).
English: In both studies, patients who received Vepacel and a booster with a different H5N1 flu strain produced antibodies that could react with several strains of H5N1 virus.
Danish: I begge undersøgelserne dannede de patienter, der fik Vepacel og en booster med en anderledes H5N1-influenzastamme, antistoffer, som kunne reagere med forskellige stammer af H5N1-virus.
English: How has Vepacel been studied?
Danish: Hvordan blev Vepacel undersøgt?
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Danish: Når en person får vaccinen, opfatter immunsystemet virusdelene som "fremmede" og danner antistoffer mod dem. Immunsystemet kan således danne antistoffer hurtigere, når det eksponeres for samme virus igen.
English: In the first main study, at 21 days after the second injection, 72.5% of adults under 60 and 74.1% of adults aged 60 and over had levels of antibodies that would protect them against H5N1.
Danish: I den første hovedundersøgelse havde 72,5 % af de voksne under 60 år og 74,1 % af de voksne på 60 år og derover antistofmængder, som ville beskytte dem mod H5N1, 21 dage efter den anden injektion.
English: The use of Vepacel was later extended to children from 6 months of age since the vaccine was shown to produce a good antibody response also in this population, with a safety profile similar to that seen in adults.
Danish: Med en sikkerhedsprofil svarende til den, der ses hos voksne, blev anvendelsen af Vepacel senere udvidet til at omfatte børn i alderen seks måneder og derover, idet vaccinen også viste sig at fremkalde en god antistofrespons hos denne population.
English: What is Vepacel used for?
Danish: Hvad anvendes Vepacel til?
English: How is Vepacel used?
Danish: Hvordan anvendes Vepacel?
English: What benefit has Vepacel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Vepacel?
English: It was decided that a re-inspection would be done after one year to assess the progress in eliminating the major deficiencies.
Danish: Det blev besluttet, at der skulle foretages en fornyet inspektion efter et år for at vurdere fremskridtene i afhjælpningen af de større mangler.
English: During the previous inspection (January 2014) a number of major deficiencies were already identified.
Danish: Ved den foregående inspektion (januar 2014) var der allerede konstateret en række mangler.
English: A shortage of supply was expected from November 2015.
Danish: Manglende tilførsel blev forventet fra november 2015.
English: As such it is consequently inspected against EU-GMP guidelines.
Danish: Som sådant inspiceres det derfor i henhold til EU's GMP-retningslinjer.
English: Therefore, at present the positive benefit-risk cannot be confirmed.
Danish: Derfor kan et positivt benefit/risk-forhold på nuværende tidspunkt ikke bekræftes.
English: The main concern identified was potential for particulate contamination.
Danish: Det konstaterede hovedproblem var potentialet for kontaminering med partikler.
English: CHMP opinion Whereas
Danish: CHMP's udtalelse
English: This has to be applied to the sponge which is thereafter implanted into patients.
Danish: Dette skal påføres på svampen, som herefter implanteres i patienten.
English: From a public health perspective, there was no indication of risks to patients linked to the inspection findings.
Danish: Fra et offentligt sundhedsperspektiv var der ingen tegn på risici for patienterne forbundet med inspektionsresultaterne.
English: Several such products are available, both derived from human donor tissue and from ceramics.
Danish: Flere sådanne produkter er til rådighed, både fra humant donorvæv og af keramisk art.
English: The latest batch was released in January 2015 into the EU market, thus prior to the above inspection.
Danish: Den seneste batchfrigivelse til EU-markedet fandt sted i januar 2015, hvilket således var før ovennævnte inspektion.
English: • There is no alternative manufacturing site authorised within the marketing authorisation dossier;
Danish: • der er ikke anført noget alternativt godkendt fremstillingssted i markedsføringstilladelsen
English: This action determined that no new batches of InductOs could be produced nor released in the EU.
Danish: Det blev herunder fastslået, at ingen nye batcher af InductOs kunne produceres eller frigives i EU.
English: The final statement of non-compliance was issued and entered in the Community database by the Netherlands (IGZ) in accordance with Article 111 (7) of Directive 2001/83/EC on 23 July 2015.
Danish: Den endelige erklæring om manglende overensstemmelse blev udstedt og indført i Fællesskabets database af Nederlandene (IGZ) i henhold til artikel 111, stk. 7, i direktiv 2001/83/EF den 23. juli 2015.
English: No other ‘morphogenetic proteins' (such as InductOs) are available in the EU but substances known as ‘graft extenders' reduce the required amount of bone graft (but not completely replace the grafts).
Danish: Der er ingen andre "morfogenetiske proteiner" (såsom InductOs) på markedet i EU, men såkaldte "graft extenders" nedsætter mængden af krævet knogletransplantat (men erstatter ikke nødvendigvis helt transplantatet).
English: Consequently, the Netherlands issued a draft statement of GMP non -compliance for this manufacturer which is the only existent one.
Danish: Nederlandene udstedte derfor udkast til en erklæring om manglende GMP-overensstemmelse for denne producent, som er den eneste, der findes.
English: On 23 July, the CHMP considered the need to take provisional measures to be applied immediately, notably a withdrawal from the market and/or suspension of the marketing authorisation, as requested by the EC.
Danish: Den 23. juli tog CHMP stilling til nødvendigheden af øjeblikkelige, midlertidige foranstaltninger, dvs. tilbagetrækning fra markedet og/eller suspendering af markedsføringstilladelsen som anmodet af Kommissionen.
English: The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (absorbable collagen sponge, ACS).
Danish: Sættet består af et pulver indeholdende det aktive stof, dibotermin alfa, en solvens og en matrix (resorberbar kollagensvamp, ACS).
English: ACS has been classified as an excipient of InductOs.
Danish: ACS er klassificeret som et hjælpestof i InductOs.
English: Therefore, and taking into account the assessment of the latest PSUR for InductOs dated April 2015 showing no signals in this regard, the CHMP was of the view that there was no need to adopt provisional measures for InductOs.
Danish: Derfor og i betragtning af vurderingen af den seneste PSUR for InductOs dateret april 2015, der ikke viste signaler af denne art, var CHMP af den opfattelse, at der ikke var behov for midlertidige foranstaltninger for InductOs.
English: An Article 20 of Regulation (EC) No 726/2004 was initiated by the EC on 23 July 2015 for the above concerns and their impact on the benefit-risk balance of InductOs to be determined and to decide if the relevant marketing authorisation should be maintained, varied, suspended or revoked.
Danish: Kommissionen indledte den 23. juli 2015 en procedure i henhold til artikel 20 i forordning (EF) nr. 726/2004 vedrørende ovennævnte betænkeligheder og deres betydning for benefit/risk-forholdet af InductOs med henblik på, om markedsføringstilladelsen skulle opretholdes, ændres, suspenderes eller inddrages.
English: The CHMP also considers that no product is recommended to be recalled from the market, as the current product on the market was released under a valid GMP certificate in January 2015.
Danish: CHMP finder desuden, at intet produkt bør anbefales trukket tilbage fra markedet, da det produkt, der er på markedet, blev frigivet i henhold til et gyldigt GMP-certifikat i januar 2015.
English: However the CHMP also noted that although the findings may not pose a risk to patients, the sponge should not include any other unwanted components/contaminants and the MAH must undertake efforts to remove these and comply with the legal obligations.
Danish: CHMP bemærkede dog også, at skønt resultaterne muligvis ikke udgør en risiko for patienterne, bør svampen ikke indeholde uønskede komponenter/kontaminanter, og indehaveren af markedsføringstilladelsen skal bestræbe sig på at fjerne disse og opfylde de lovbestemte forpligtelser.
English: Given the findings, the CHMP considered that the quality of InductOs cannot be assured at present due to the lack of GMP compliance of the ACS issued on 23 July 2015.
Danish: På baggrund af disse forhold fandt CHMP, at kvaliteten af InductOs på nuværende tidspunkt ikke kan sikres pga. manglende GMP-overensstemmelse af ACS pr. 23. juli 2015.
English: It was noted that alternative treatments are available, including the use of autogenous bone grafts, which are usually harvested from the iliac crest.
Danish: Det blev bemærket, at der findes behandlingsalternativer, herunder brug af autogene knogletransplantater, sædvanligvis hidrørende fra crista iliaca.
English: Healthcare professionals using InductOs were advised to follow the instructions in the product information as usual and a Direct Health Care Professional Communication (DHPC) was adopted and agreed to be distributed on 12 August by the MAH.
Danish: Sundhedspersoner, der anvendte InductOs, blev henvist til at følge anvisningerne i produktinformationen som sædvanlig, og der blev vedtaget en direkte henvendelse til sundhedspersoner (DHPC), som blev udsendt den 12. august af indehaveren af markedsføringstilladelsen.
English: No further product was released after the GMP non-compliance certificate was issued and the latest information on stock indicates that InductOs will be available until end of December 2015.
Danish: Intet yderligere produkt er frigivet efter udstedelsen af certifikatet om manglende GMP-overensstemmelse, og den seneste lageropgørelse viser, at InductOs vil være til rådighed indtil udgangen af december 2015.
English: As mentioned above, the April 2015 inspection found that the corrective action plan failed and the contamination of ACS with particulate matter was not under control and quality system not aiming for continuous improvement.
Danish: Som anført ovenfor blev det ved inspektionen i april 2015 konstateret, at udbedringsplanen havde slået fejl, at kontamineringen af ACS med partikler ikke var under kontrol, og at kvalitetssystemet ikke var målrettet mod løbende forbedring.
English: For the suspension to be lifted, the marketing authorisation(s) holder(s) should have a valid GMP compliance statement for the manufacturer of the ACS, fulfilling the requirements set out in Article 46 of Directive 2001/83/EC.
Danish: For at suspenderingen kan hæves, skal indehaveren af markedsføringstilladelsen være i besiddelse af en gyldig erklæring om overensstemmelse med GMP for producenten af ACS i overensstemmelse med kravene i artikel 46 i direktiv 2001/83/EF.
English: InductOs, is a kit for implant, authorised centrally since 2002 for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
Danish: InductOs er et implantationssæt, der har været godkendt centralt siden 2002 til kirurgisk fusion af lumbale corpora i ét niveau som alternativ til autogen knogletransplantation hos voksne med degenerativ diskussygdom, som har fået mindst seks måneders ikke-operativ behandling for sygdommen.
English: On the basis of the above and taking into account that InductOs has no alternative ACS manufacturing site authorised:
Danish: På dette grundlag, og fordi der for InductOs ikke er godkendt et alternativt fremstillingssted for ACS:
English: The Committee, as a consequence, concluded that
Danish: Ud fra følgende betragtninger:
English: The CHMP, having considered all the data provided by the MAH, considers that there is no apparent identified safety concern nor seems to have risk to patients associated with the contamination of the ACS with particulate matter.
Danish: Efter gennemgang af alle data fra markedsføringstilladelsesindehaveren finder CHMP, at der ikke er nogen åbenbar konstateret sikkerhedsmæssig betænkelighed eller tilsyneladende risiko for patienterne forbundet med kontamineringen af ACS med partikler.
English: • Integra LifeSciences Corporation site is not in compliance with EU GMP for the manufacture of the absorbable collagen sponge (ACS), part of the medicinal product, InductOs;
Danish: • Integra LifeSciences Corporation's produktionssted er ikke i overensstemmelse med EU's GMPregler ved fremstilling af den resorberbare kollagensvamp (ACS), der er en del af lægemidlet InductOs
English: - The CHMP considers that at present the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC, are incorrect;
Danish: - finder CHMP, at de oplysninger og dokumenter, der er fremlagt i henhold til artikel 8, stk. 3, i direktiv 2001/83/EF, er ukorrekte
English: At that time, following a corrective action plan, restricted GMP certificate valid until January 2015 was issued.
Danish: På daværende tidspunkt blev der i henhold til en udbedringsplan udstedt et begrænset GMP-certifikat med gyldighed indtil januar 2015.
English: The CHMP noted that, following the inspection in April 2015, no batches of InductOs had been released in the EU as recommended by the inspectors.
Danish: CHMP bemærkede, at der efter inspektionen i april 2015 som anbefalet af inspektørerne ikke var frigivet batcher af InductOs i EU.
English: As a consequence, the CHMP recommends the suspension of the marketing authorisation for InductOs in accordance with Article 116, second paragraph of the said Directive.
Danish: Som følge heraf anbefaler CHMP suspendering af markedsføringstilladelsen for InductOs i medfør af artikel 116, andet afsnit, i nævnte direktiv.
English: On 23 July 2015, the CHMP also adopted a list of questions to be addressed by the MAH.
Danish: Den 23. juli 2015 vedtog CHMP desuden en række spørgsmål til indehaveren af markedsføringstilladelsen.
English: InductOs is also indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Danish: InductOs er desuden indiceret til behandling af akutte tibiafrakturer hos voksne som supplement til sædvanlig behandling med reduktion af åbne frakturer og fiksation med intramedullært søm uden reaming.
English: Standard of care in the EU consists of surgical intervention using reamed or unreamed intramedullary nailing with locking screws.
Danish: Standardbehandlingen i EU er operation med intramedullært søm med eller uden reaming med låseskruer.
English: USA), was inspected last in April 2015 by the Netherlands and Spain and found to be not compliant with the legal requirements and/or the principles and guidelines of GMP as provided for by Union law.
Danish: Producenten af ACS, Integra LifeSciences Corporation (ILS), der har hjemsted i et tredjeland (USA), blev inspiceret i slutningen af april 2015 af Nederlandene og Spanien og fundet uoverensstemmende med de lovbestemte krav og/eller de GMP-principper og -retningslinjer, der er fastsat i EUlovgivningen.
English: The CHMP is therefore of the opinion that the marketing authorisation(s) for InductOs should be suspended in accordance with Article 116, second paragraph of the said Directive.
Danish: CHMP anbefaler derfor suspendering af markedsføringstilladelsen/-tilladelserne for InductOs i medfør af artikel 116, andet afsnit, i nævnte direktiv.
English: - The CHMP considers that the absence of GMP compliance of the manufacturing site of the absorbable collagen sponge, part of the medicinal product precludes at present the confirmation of the benefit-risk of InductOs;
Danish: - finder CHMP, at benefit/risk-forholdet for InductOs på nuværende tidspunkt ikke kan bekræftes pga. den manglende GMP-overensstemmelse på fremstillingsstedet for den resorberbare kollagensvamp, der er en del af lægemidlet.
English: For the treatment of tibia fractures, fixation with a reamed nail instead of InductOs plus unreamed nail fixation is an alternative option.
Danish: Til behandling af tibiafrakturer kan fiksation med søm med reaming anvendes som behandlingsalternativ til InductOs kombineret med søm uden reaming.
English: This is more likely in areas exposed to the sun.
Danish: Dette sker oftere i områder, der er udsat for sol.
English: This is because it is not known if there is a risk to your baby.
Danish: Dette skyldes, at det ikke er afklaret, om der er en risiko for dit barn.
English: • You can take this medicine with or without food.
Danish: • Du kan tage dette lægemiddel med eller uden mad.
English: • Diarrhoea - this may come and go during treatment.
Danish: • Diarré - dette kan komme og gå under behandlingen.
English: Most cases can be treated but some cases have been fatal.
Danish: De fleste tilfælde kan behandles, men nogle har været dødelige.
English: • Drink the liquid straight away.
Danish: • Drik straks væsken.