FrancophonIA/ELRC3.0 huggingface dataset:
English: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2).
Danish: Allogene T-celler, der er genetisk modificerede med retroviral vektorindkodning til en afkortet form af human lavaffinitets-nervevækstfaktorreceptor (ΔLNGFR) og herpes simplex I-virus-tymidinkinase (HSV-TK Mut2).
English: Human serum albumin Dimethyl sulfoxide
Danish: Dimethylsulfoxid
English: Posology
Danish: Almindelig
English: premature babies.
Danish: børn.
English: What was Blectifor expected to be used for?
Danish: Hvad forventedes Blectifor anvendt til?
English: What is Blectifor?
Danish: Hvad er Blectifor?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was doing so for commercial reasons.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skete af kommercielle grunde.
English: Furthermore, the proposed indication was not supported by the provided literature, and the target population was considered not sufficiently characterised.
Danish: Den angivne indikation var endvidere ikke understøttet i den forelagte litteratur, og målpopulationen blev ikke anset for at være tilstrækkelig karakteriseret.
English: Blectifor is a medicine that contains the active substance caffeine citrate.
Danish: Blectifor er et lægemiddel, der indeholder det aktive stof koffeincitrat.
English: Withdrawal of the marketing authorisation application for Blectifor (caffeine citrate)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Blectifor (koffeincitrat)
English: It was to be available as a solution for injection, which can also be given by mouth.
Danish: Det skulle gøres tilgængeligt som en injektionsvæske, der også kunne indgives oralt.
English: Additionally, the facility designated to test the stability of Blectifor was not certified to comply with good manufacturing practices (GMP).
Danish: Den facilitet, der var udpeget til at afprøve Blectifors stabilitet, var desuden ikke certificeret til at overholde god fremstillingspraksis.
English: Withdrawal of the marketing authorisation application for Blectifor (caffeine citrate) EMA/188385/2017
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Blectifor (koffeincitrat) EMA/188385/2017
English: On 9 March 2017, Viridian Pharma Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Blectifor, for the prevention of bronchopulmonary dysplasia.
Danish: Den 9. marts 2017 meddelte Viridian Pharma Ltd officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Blectifor til forebyggelse af bronchopulmonær dysplasi.
English: This leads to difficulty breathing and poor growth, and later in life can result in frequent infections of the airways and long-term lung problems.
Danish: Dette fører til vejrtrækningsproblemer og lav vækst og kan senere i livet forårsage hyppige luftvejsinfektioner og kroniske lungeproblemer.
English: Another concern was that the applicant did not demonstrate the so-called well-established use (systematic and documented use in the EU for more than 10 years) of caffeine citrate for the prevention of bronchopulmonary dysplasia.
Danish: Derudover udtrykte udvalget bekymring over, at ansøgeren ikke havde påvist en såkaldt "almindelig anerkendt anvendelse" (systematisk og dokumenteret anvendelse i EU i over 10 år) af koffeincitrat til forebyggelse af bronchopulmonær dysplasi.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Blectifor.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige oplysninger til at underbygge ansøgningen om Blectifor.
English: The company presented data from the published scientific literature mainly on the use of caffeine citrate for the treatment of primary apnoea in premature babies; several articles also provided data on the development of bronchopulmonary dysplasia in these patients.
Danish: Virksomheden fremlagde oplysninger fra offentliggjort videnskabelig litteratur, primært om anvendelsen af koffeincitrat til behandling af primær apnø hos for tidligt fødte børn, herunder også en række artikler med oplysninger om udviklingen af bronchopulmonær dysplasi hos disse patienter.
English: The active substance in Blectifor, caffeine citrate, is a stimulant of the nervous system and is currently authorised in the EU as Peyona for the treatment of a breathing disorder called primary apnoea in
Danish: Det aktive stof i Blectifor, nemlig koffeincitrat, stimulerer nervesystemet og er i øjeblikket godkendt i EU som Peyona til behandling af en åndedrætsforstyrrelse kaldet primær apnø hos for tidligt fødte
English: In addition, caffeine citrate may also have other effects in the lungs, such as reducing inflammation, which are expected to prevent the damage that leads to bronchopulmonary dysplasia.
Danish: Koffeincitrat kan endvidere have andre virkninger i lungerne, herunder ved at reducere inflammationen, hvilket forventes at forebygge den skade, der forårsager bronchopulmonær dysplasi.
English: In these babies, the continuous high pressure and high concentration of the oxygen supplied through mechanical ventilation may cause inflammation and injury to the lungs and prevent normal development of the alveoli (air sacs in the lungs).
Danish: Hos disse nyfødte børn kan det fortsat høje tryk og den fortsat høje koncentration af ilten, der tilføres via mekanisk ventilation, forårsage inflammation og skade på lungerne og hindre normal udvikling af alveolerne (luftsække i lungerne).
English: In the prevention of bronchopulmonary dysplasia, caffeine citrate is expected to act mainly by stimulating the part of the brain that controls breathing, which is thought to help babies breathe on their own and reduce the time spent on mechanical ventilation.
Danish: I forbindelse med forebyggelse af bronchopulmonær dysplasi forventes koffeincitrat primært at virke ved at stimulere den del af hjernen, som kontrollerer åndedrættet, der menes at hjælpe spædbørn med at trække vejret selv og reducere tiden på mekanisk ventilation.
English: The Committee considered that the role of caffeine citrate in the prevention of the disease had not been sufficiently demonstrated, and no definite conclusion on the effect of caffeine citrate for the prevention of bronchopulmonary dysplasia could be drawn.
Danish: Udvalget mente ikke, at koffeincitrats rolle i forebyggelsen af sygdommen var blevet tilstrækkelig dokumenteret, og at der kunne drages en endelig konklusion om virkningen af koffeincitrat til forebyggelse af bronchopulmonær dysplasi.
English: Blectifor was expected to be used to prevent bronchopulmonary dysplasia, a lung disease affecting premature babies who have been on prolonged mechanical ventilation (using a machine that supplies oxygen to support breathing).
Danish: Blectifor forventedes anvendt til forebyggelse af bronchopulmonær dysplasi, en lungesygdom, der rammer for tidligt fødte børn, som gennem længere til har været på mekanisk ventilation (ved brug af en maskine, der leverer ilt til støtte for vejrtrækningen).
English: Blectifor was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 April 2014 for the prevention of bronchopulmonary dysplasia.
Danish: Blectifor blev udpeget som "lægemiddel til sjældne sygdomme" den 11. april 2014 til forebyggelse af bronchopulmonær dysplasi.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 March 2017 EMA/188385/2017 EMEA/H/C/004100
Danish: marts 2017 EMA/188385/2017 EMEA/H/C/004100
English: Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that, based on the data submitted by the company, Blectifor could not have been approved for the prevention of bronchopulmonary dysplasia.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP haft visse betænkeligheder og var af den foreløbige opfattelse, at Blectifor ud fra de oplysninger, som virksomheden havde fremlagt, ikke kunne være blevet godkendt til forebyggelse af bronchopulmonær dysplasi.
English: How does Blectifor work?
Danish: Hvordan virker Blectifor?
English: EU/1/18/1350/001 Vantobra
Danish: EU/1/18/1350/001
English: 56 ampoules + 1 administration device
Danish: 56 ampuller x 1 administrationsanordning
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Indhold
English: 170 mg Nebuliser solution Inhalation use ampoule (LDPE)
Danish: 170 mg Nebuliser opløsning
English: 1.7 ml
Danish: Til inhalation ampul (PE) 1,7 ml
English: The animals return to normal the next day.
Danish: Alle dyr vil vende tilbage til deres normale tilstand igen den følgende dag.
English: This was regarded as the worst case scenario using the most susceptible animals.
Danish: Dette blev betragtet som det værst tænkelige scenario, når man brugte de mest modtagelige dyr.
English: Thereby the following instructions should be used:
Danish: Følgende blandingsanvisning bør bruges:
English: The youngest age for the two products to be used simultaneously is thus four weeks of age.
Danish: Den yngste alder, som de to lægemidler skal anvendes i samtidig, er således 4 uges alderen.
English: 3) the minimum efficacious titre is 4.0 TCID50
Danish: 3) den minimale effektive titer er 4,0 TCID50
English: The marketing authorisation holder has complied with these requirements with the design of this study.
Danish: Indehaveren af markedsføringstilladelsen har overholdt disse krav med tilrettelæggelsen af denne undersøgelse.
English: Following the absence of agreement between the Reference Member State (the United Kingdom acted on behalf of France as the Reference Member State in a work-sharing arrangement) and one of the Concerned Member States (Spain) at day 90 of the CMDv procedure, the matter was referred to the CVMP on 2 October 2009.
Danish: Eftersom der ikke blev opnået enighed mellem referencemedlemsstaten (Det Forenede Kongerige repræsenterede Frankrig som referencemedlemsstat i en arbejdsdelingsordning) og en af de berørte medlemsstater (Spanien) på dag 90 i CMDv-proceduren, blev sagen indbragt for CVMP den 2. oktober 2009.
English: In isolated cases hypersensitivity reactions may occur.
Danish: Overfølsomhedsreaktioner kan forekomme i sjældne tilfælde.
English: List of the names, pharmaceutical forms, strengths of the Veterinary medicinal product, animal species, routes of administration, withdrawal period, marketing authorisation holders in the Member states
Danish: LISTE OVER VETERINÆRLÆGEMIDLETS NAVNE, LÆGEMIDDELFORMER, STYRKER, DYREARTER, ADMINISTRATIONSVEJ, TILBAGEHOLDELSESTID, INDEHAVER AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSSTATERNE
English: The general claim to reduce viraemia has only been demonstrated in laboratory studies.
Danish: Den generelle påstand om en reduktion af viræmi er kun blevet påvist i laboratorieundersøgelser.
English: 2) the apparent drop over 1 hour from the titre at release (6.4/6.2 TCID50) is 0.12/
Danish: 2) det umiddelbare fald over 1 time i titeren ved frigivelse (6,4/6,2 TCID50) er 0,12/
English: Koerverstraat 35 5831 AN Boxmeer The Netherlands
Danish: 5831 AN Boxmeer The Netherlands
English: Given that a lack of interference has been demonstrated a specific time point the duration of immunity remains the same as originally proven.
Danish: Eftersom den manglende interferens er blevet påvist, er et specifikt tidspunkt for immunitetsvarigheden det samme som det oprindeligt påviste.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PORCILIS M HYO (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN VIDENSKABELIGE VURDERING AF PORCILIS M HYO (SE BILAG I)
English: 1) the claimed in-use shelf life for the “mixed” product is one hour;
Danish: 1) den angivne holdbarhed ved brug for det "blandede" lægemiddel er 1 time
English: The inactivated vaccine is a suspension for injection.
Danish: Den inaktiverede vaccine er en injektionsvæske, suspension.
English: Before using the vaccine allow it to reach room temperature (15-25C) and shake well before use.
Danish: Før vaccinen anvendes, skal den have rumtemperatur (15-25C) og omrystes grundigt.
English: 6.2 Incompatibilities Do not mix with any other veterinary medicinal product except with Porcilis PRRS.
Danish: 6.2 Uforligeligheder Må ikke blandes med andre veterinærlægemidler med undtagelse af Porcilis PRRS.
English: and EU guidelines require safety studies to use animals which are seronegative for the antigens of the vaccine components.
Danish: Ph.Eur.- og EUretningslinjerne kræver sikkerhedsundersøgelser for at anvende dyr, der er seronegative over for antigenerne i vaccinens komponenter.
English: 4) this means that in the worst case scenario of a batch at the end of shelf being mixed there will be no statistically significant drop below the minimum titre over the claimed in-use shelf life of 1 hour.
Danish: 4) det betyder, at der i det værst tænkelige scenario, hvor man blander et batch, hvis holdbarhed er ved at være udløbet, ikke vil være noget statistisk signifikant fald under minimumstiter i den angivne holdbarhed ved brug på 1 time.
English: The first injection can be given from an age of 1 week onwards.
Danish: Første vaccination kan gives fra 1uges alderen.
English: After mixing with Porcilis PRRS: 1 hour (at room temperature)
Danish: Efter blanding med Porcilis PRRS: 1 time (ved stuetemperatur)
English: Intervet International B.V. represented by Intervet UK Ltd Walton Manor Walton
Danish: represented by Intervet UK Ltd Walton Manor Walton
English: 4.6 Adverse reactions (frequency and seriousness) A mean transient temperature increase in body temperature of about 0.3C, in individual pigs up to 2.0C, may occur on the first 1 to 2 days after vaccination.
Danish: 4.6 Bivirkninger (hyppighed og sværhedsgrad) En forbigående gennemsnitlig stigning i legemstemperaturen på ca. 0,3C, hos nogle svin op til 2,0C, kan forekomme 1 til 2 døgn efter vaccination.
English: The marketing authorisation holder examined the repeated administration of a single dose of each vaccine administered simultaneously at an interval of 14 days in animals of 4 weeks of age.
Danish: Indehaveren af markedsføringstilladelsen undersøgte den gentagne indgivelse af en enkeltdosis af hver vaccine indgivet samtidig med et interval på 14 dage hos dyr, der er 4 uger gamle.
English: CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
Danish: CVMP's retningslinjer for krav til data til støtte for veterinære vacciners stabilitet ved brug (Guideline on data requirements to support in-use stability claims for veterinary vaccines) (EMEA/CVMP/IWP/250147/2008CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
English: The guideline on data requirements to support in-use stability claims for veterinary vaccines*, states that “For inactivated vaccines, if the proposed in-use shelf-life is within one working day (maximum 10 hours) it is acceptable to omit the potency testing from the in-use shelf-life stability study.”
Danish: I retningslinjerne for krav til data til støtte for veterinære vacciners stabilitet ved brug (Guideline on data requirements to support in-use stability claims for veterinary vaccines)* står der, at "for inaktiverede vacciner er det, hvis den foreslåede holdbarhed ved brug er højst én arbejdsdag (maksimalt 10 timer), acceptabelt at udelade styrketesten fra undersøgelsen af stabilitet under holdbarhed ved brug."
English: The marketing authorisation holder Intervet International BV submitted a Type II variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the veterinary medicinal product Porcilis M Hyo in the framework of Article 6 of Commission Regulation (EC) No 1084/2003.
Danish: Indehaveren af markedsføringstilladelsen, Intervet International BV, indsendte en ansøgning om en type II-ændring af markedsføringstilladelserne for veterinærlægemidlet Porcilis M Hyo i henhold til proceduren for gensidig anerkendelse inden for rammerne af artikel 6 i Kommissionens forordning (EF) nr. 1084/2003.
English: It is indicated for finishing pigs from 1 week of age.
Danish: Det er indiceret til slagtesvin fra 1 uges alderen.
English: While it was suggested that the provided data was not adequate because the animals had not received a single M Hyo vaccination at 1 week of age within the design of this study and therefore the safety of the overall schedule was unproven, the marketing authorisation holder has proven the worst case scenario of a repeated dose of simultaneous vaccination with the two vaccines in susceptible animals (seronegative) of the minimum age.
Danish: Mens det blev anført, at de fremlagte data ikke var tilstrækkelige, eftersom dyrene ikke havde fået en enkelt M Hyo-vaccination i 1 uges alderen i forbindelse med denne undersøgelses tilrettelæggelse, og at den samlede vaccinationsplan sikkerhed således ikke var påvist, havde indehaveren af markedsføringstilladelsen påvist det værst tænkelige scenario med en gentagen dosis af samtidig vaccinering med de to vacciner hos modtagelige (seronegative) dyr i minimumsalderen.
English: A transient swelling/redness (max. diameter 5 cm) may occur at the injection site diminishing over a period of maximally 14 days.
Danish: 5 cm i diameter) kan forekomme på injektionsstedet men forsvinder i løbet af maksimalt 14 dage.
English: Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae and dl--tocopherol acetate as adjuvant.
Danish: Porcilis M Hyo er et immunologisk veterinærlægemiddel, der indeholder Mycoplasma hyopneumoniae og dl--tocopherolacetat som adjuvans.
English: Nevertheless absence of immunological interference has not been inferred but has been clearly demonstrated by providing laboratory challenge data which showed that there is not significant difference in protection between animals vaccinated with the mixed products and those vaccinated with single products.
Danish: Det er ikke blevet konkluderet, at der ikke er immunologisk interferens, men det er tydeligt påvist ved hjælp af laboratoriechallengedata, som viste, at der ikke er nogen signifikant forskel i beskyttelsen af dyr, der er vaccineret med det blandede lægemiddel, og dyr, der er vaccineret med de enkelte lægemidler.
English: Vaccinate pigs twice with a three week interval.
Danish: Grisene vaccineres to gange med tre ugers interval.
English: It should be administered intramuscularly (2 ml in the neck).
Danish: Vaccinen bør gives intramuskulært (2 ml i halsen).
English: In addition, it is considered that potency of the Porcilis M Hyo component after mixing should have been analysed in order to the exclude a quality interference right after mixing (at t=0) and after the proposed in-use shelf life.
Danish: Desuden var man af den opfattelse, at Porcilis M Hyo-komponentens styrke efter blanding skulle have været analyseret for at udelukke en kvalitetsinterferens lige efter blandingen (ved t=0) og efter den foreslåede holdbarhed ved brug.
English: After opening: 3 hours.
Danish: 6.3 Opbevaringstid 3 år Efter anbrud: 3 timer.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Danish: Der foreligger ingen oplysninger om sikkerhed og effekt af vaccinen ved samtidig brug med noget andet lægemiddel til dyr bortset fra det, der er nævnt ovenfor.
English: Since the protective immunity against lung lesion score is not altered by the mixed administration, the marketing authorisation holder considered that all the other efficacy parameters will also not be altered, and therefore, no more data are required in support of the duration of immunity for the mixed administration.
Danish: Eftersom scoren for beskyttende immunitet mod lungelæsion ikke ændres med indgivelsen af det blandede lægemiddel, var indehaveren af markedsføringstilladelsen af den opfattelse, at alle de andre virkningsparametre heller ikke ændrer sig, og at det derfor ikke er nødvendigt med flere data til støtte for immunitetsvarigheden for det blandede lægemiddel.
English: The National Competent Authority of Spain was concerned that some aspects regarding the quality, safety and the efficacy after mixing the two products (Porcilis PRRS and Porcilis M Hyo) were not adequately justified.
Danish: Spaniens nationale kompetente myndigheder havde betænkeligheder med hensyn til, at nogle aspekter af kvalitet, sikkerhed og virkning efter blandingen af de to lægemidler (Porcilis PRRS og Porcilis M Hyo) ikke var tilstrækkeligt dokumenteret.
English: For simultaneous use with Porcilis PRRS in finishing pigs from 4 weeks of age (3 weeks after priming) the vaccine may be used for reconstitution shortly before vaccination.
Danish: Ved samtidig brug med Porcilis PRRS til slagtesvin fra 4-ugers alderen (3 uger efter første vaccination) kan vaccinen anvendes til rekonstitution kort tid før vaccination,.
English: No information is available on the safety and efficacy of the use of Porcilis M Hyo mixed with Porcilis PRRS in breeding animals or during pregnancy.
Danish: Der foreligger ingen oplysninger om sikkerhed og effekt ved brug af Porcilis M Hyo blandet med Porcilis PRRS til avlsdyr eller under drægtighed.
English: This is at three weeks after the first injection with Porcilis M Hyo which is to be given from one week of age onwards.
Danish: Dette sker tre uger efter den første injektion med Porcilis M Hyo, som skal gives fra 1 uges alderen.
English: Safety and efficacy data are available in pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis PRRS.
Danish: Der foreligger oplysninger om sikkerhed og effektt i grise fra 4 ugers alderen, som dokumenterer, at vaccinen kan blandes med Porcilis PRRS.
English: Whereas: - the CVMP considered that stability of the mixed product up to 1 hour after mixing as claimed on the Summary of Product Characteristics was supported by the data provided, - the CVMP considered that the safety and efficacy of the mixed vaccine regarding the Mycoplasma hyopneumoniae component were sufficiently supported by the data provided, the CVMP has recommended the granting of the variation of the Marketing Authorisations for Porcilis M Hyo and associated names (see Annex I).
Danish: Ud fra følgende betragtninger: - CVMP var af den opfattelse, at stabiliteten af det blandede lægemiddel i op til 1 time efter blandingen, som angivet i produktresuméet, blev underbygget af de fremlagte data, - CVMP var af den opfattelse, at den blandede vaccines sikkerhed og virkning med hensyn til Mycoplasma hyopneumoniae-komponenten blev underbygget af de fremlagte data, anbefalede CVMP godkendelse af ændringen af markedsføringstilladelserne for Porcilis M Hyo og tilknyttede navne (se bilag I).
English: 4.9 Amounts to be administered and administration route Intramuscular injection in pigs of 2 ml per animal in the neck in the area behind the ear.
Danish: 4.9 Dosering og indgivelsesmåde 2 ml pr. gris ved intramuskulær injektion i halsmuskulaturen bag dyrets øre.
English: A single dose (2 ml) of Porcilis M Hyo mixed with Porcilis PRRS is given intramuscularly in the neck.
Danish: En enkelt dosis (2 ml) af Porcilis M Hyo blandet med Porcillis PRRS gives ved intramuskulær injektion i nakken.