natgillin/translations-raw huggingface dataset:
Resultaterne viser, at det samlede proteinindhold pr. ml er højere i BVDV-1-antigen-batcher end i BoHV-1-antigen-batcher.
These results show that the overall protein content per ml is higher in BVDV-1 antigen batches than in BoHV1 antigen batches.
I hele EU har man godkendt mange levende og inaktiverede IBR-markørvacciner, der benyttes med god virkning.
Several live and inactivated IBR marker vaccines are authorised and successfully used throughout the EU.
Bilag IV Betingelser for markedsføringstilladelserne
Annex IV Conditions of the marketing authorisations
Lægemiddelform Dyreart Indgivelsesvej
Animal species Route of administration
CattleMarker IBR Inactivated opfylder kriterierne for en effektiv IBR-markørvaccine og giver fyldestgørende terapeutisk udbytte.
CattleMarker IBR Inactivated fulfils the criteria for an effective IBR marker vaccine and provides the full therapeutic benefit.
I fremstillingsprocessen er man begyndt at anvende filtrering ved brug af tre membraner for at gøre antigen-præparaterne klarere.
A filtration step using three filtration membranes has been integrated into the production process for clarification of the antigen preparations.
Før CattleMarker IBR Inactivated markedsføres på det europæiske marked, skal resultaterne indsendes til og vurderes af de nationale kompetente myndigheder, der skal godkende dem.
Prior to placing CattleMarker IBR Inactivated on the EU market the results should be submitted to the national competent authorities to be assessed by the authorities to their satisfaction.
Videnskabelige konklusioner og begrundelser for udstedelse af markedsføringstilladelserne
Scientific conclusions and grounds for the granting of the marketing authorisations
− Bruge de eksisterende produkt/batch-tilbagekaldelsesprocedurer i henhold til god fremstillingspraksis.
− Utilise the existing GMP product/batch recall procedures.
Kalve, der har bekræftet BNP, skal også kontrolleres for MHC-I-alloantistoffer.
Any confirmed BNP calves will also be assessed for MHC-I alloantibodies.
− Indehaveren af markedsføringstilladelsen skal overveje udvikling af en metode til analyse af proteinindholdet i det endelige produkt.
− The marketing authorisation holder should consider the development a method for assaying the protein content in the finished product.
Produktet er også indiceret til aktiv immunisering af kviekalve i alderen 6 måneder og derover:
Active immunisation of female cattle from 6 months of age is also indicated:
Ovennævnte studieresultater skal indsendes til og vurderes af de nationale kompetente myndigheder, før CattleMarker IBR Inactivated lanceres på det europæiske marked, og senest 24 måneder efter Kommissionens afgørelse.
The abovementioned study results should be provided to the relevant national competent authorities for assessment prior to placing CattleMarker IBR Inactivated on the EU market and within 24 months of the Commission Decision.
Hos kviekalve virker vaccinen efter 2 uger eller 19 dage inden bedækning eller insemination, og beskyttelsens varighed er 12 måneder efter den primære vaccine.
Onset of protection for female cattle is 2 weeks or 19 days prior to breeding or insemination and duration is 12 months post primary vaccination.
I 2010 blev der på grund af disse bekymringer indbragt en sag for CVMP i henhold til artikel 78 i direktiv 2001/82/EF, hvor CVMP konkluderede, at der - selv om BNP's ætiologi stadig ikke var fastlagt - forelå evidens for, at PregSure BVD kunne være forbundet med BNP, og at produktets benefit/risk-forhold var ugunstigt.
In 2010, due to these concerns, a procedure under Article 78 of Directive 2001/82/EC was initiated in which the CVMP concluded that although the aetiology of BNP had yet to be determined there was evidence to suggest that PregSure BVD may be associated with BNP and that the benefit-risk balance for the product was unfavourable.
• Indehaveren af markedsføringstilladelsen skal sørge for, at det endelige produkt omfatter en ny specifikation af det maksimale samlede proteinindhold.
• The marketing authorisation holder shall include a new specification in the finished product of a maximum total protein content.
Det er de versioner af produktresumé, etikettering og indlægsseddel, som er foranstaltet i forbindelse med koordinationsgruppens sagsbehandling, der er gyldige.
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
• med henblik på at reducere forekomsten af aborter i forbindelse med BoHV-1-infektion, typisk i drægtighedsperiodens andet trimester, efter eksponering.
• to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
− Før vaccinen lanceres på markedet og derefter én gang årligt: sørge for målrettede kurser til sælgere og teknikere, der beskæftiger sig med CattleMarker IBR Inactivated, vedrørende produktets sikkerhedsprofil, BNP og pligten til lægemiddelovervågning.
− Prior to launch of the vaccine on the market and annually thereafter, provide specific training to the bovine sales and technical teams on the CattleMarker IBR Inactivated product safety profile, BNP and pharmacovigilance obligations.
− Benytte den eksisterende råmælk-praksis, der anvendes i BNP-tilfælde, og udarbejde yderligere risikominimeringsforanstaltninger for råmælk.
− Utilise the existing colostrum practices in case of BNP cases and develop further mitigation measure for colostrum.
Den potentielle risiko for udvikling af BNP ved den tilsigtede anvendelse af CattleMarker IBR Inactivated hænger sammen med sammensætningen og fremstillingen af vaccinen og mere specifikt med mængden af antigener, der ikke er relateret til det aktive stof (ANAS), ligesom det også er af betydning, at vaccinen anvendes til kviekalve, der skal vaccineres flere gange.
The potential risk deriving from the intended use of CattleMarker IBR Inactivated to trigger BNP is associated with the composition and manufacture of the vaccine and more specifically with the amount of Antigens Not related to the Active Substance (ANAS) and is also linked to the use of the vaccine in female cattle subject to repeated vaccinations.
I forbindelse med denne vurderingsprocedure, jf. artikel 78 i direktiv 2001/82/EF, skønner CVMP imidlertid, at forekomsten af PregSure BVD-forårsaget BNP ligger på omkring 0,01 %.
Nonetheless in the assessment in the frame of this procedure under Article 78 of Directive 2001/82/EC the frequency of the BNP caused by PregSure BVD was approximated to be around 0.01% by the CVMP.
Ansøger/markedsføringstilladelsens indehaver
Applicant/marketing authorisation holder
− Ud over det sædvanlige lægemiddelovervågningssystem til monitorering af dyr, der er vaccineret med CattleMarker IBR Inactivated: gennemføre grundige undersøgelser, hvis der ses uventet mortalitet blandt afkommet fra vaccinerede dyr efter dokumenteret brug af CattleMarker IBR Inactivated.
− In addition to the usual pharmacovigilance system for the monitoring of animals vaccinated with CattleMarker IBR Inactivated, to conduct thorough investigations for any unexplained mortality in the offspring of vaccinated animals following documented use of CattleMarker IBR Inactivated.
gE-deleterede IBR-vacciner som f.eks. CattleMarker IBR Inactivated er "DIVA-vacciner", der skelner mellem smittede og vaccinerede dyr.
gE deleted IBR vaccines such as CattleMarker IBR Inactivated are “DIVA vaccines”, differentiating infected from vaccinated animals.
Hos døde dyr: kontrol af, om knoglemarvshistopatologien viser tegn på trilineær hypoplasi.
If dead, bone marrow histopathology shows trilineage hypoplasia.
Derudover har indehaveren af markedsføringstilladelsen forpligtet sig til efter tilladelse til markedsføring at fastsætte et maksimalt proteinniveau for batchfrigivelse og gennemføre to yderligere studier til undersøgelse af mulige interaktioner ved CattleMarker IBR Inactivated-vaccination af dyr, der tidligere er blevet vaccineret med PregSure BVD eller andre vacciner.
Furthermore, the MAH has made post authorisation commitments to set a maximum level of total proteins for batch release and to perform two additional studies in order to investigate possible interactions of vaccinations with CattleMarker IBR Inactivated in animals previously vaccinated with PregSure BVD or other vaccines.
Produktet er indiceret til aktiv immunisering af seronegative kalve i alderen 2 uger og derover med henblik på at reducere de kliniske tegn på IBR (navnlig pyreksi og depression) og spredning af virus, der skyldes BoHV-1-infektion.
The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection.
Det er bredt accepteret, at der er en sammenhæng mellem BNP og alloimmun reaktion over for antigener, der ikke er relateret til det aktive stof (ANAS) (f.eks. bovin nyrecellelinje-baserede antigener og de rester af antigenstoffer, som fremstillingsprocessen medfører).
An association between BNP and alloimune reaction to Antigens Not related to the Active Substance (ANAS) (e.g. bovine kidney cell line derived antigens and all antigenic substances remaining from the manufacturing process) is widely accepted.
Da der ikke er fundet nogen løsning på disse problemstillinger, er sagen blevet indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedurelægemidler til dyr (CMD(v)), jf. artikel 33, stk. 1, i direktiv 2001/82/EF.
These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
• Indehaveren af markedsføringstilladelsen skal gennemføre et kontrolleret laboratoriestudie for at få bekræftet, at hyperimmunisering af kvæg ved brug af CattleMarker IBR Inactivated ikke inducerer et signifikant alloantistofrespons over for MHC-I- og MDBK-celler, samt for at vurdere, om vaccination med andre kvægvacciner, der er fremstillet i bovine cellelinjer, som indeholder en stor mængde ANAS, og som efterfølgende boostes med CattleMarker IBR Inactivated, medfører en signifikant stigning i alloantistoftitre mod MHC-I og MDBK-celler.
• The marketing authorisation holder shall conduct a controlled laboratory study to confirm that hyperimmunisation of cattle with CattleMarker IBR Inactivated does not induce a significant alloantibody response to MHC-I and MDBK cells and also to assess if vaccination with other cattle vaccines produced on bovine cell lines and with high amount of ANAS followed by booster with CattleMarker IBR Inactivated leads to a significant increase in alloantibody titres against MHC-I and MDBK cells.
Der er fremlagt data til påvisning af, at CattleMarker IBR Inactivated i modsætning til PregSure BVD har en beskeden mængde immunologisk signifikante ANAS-rester i det endelige produkt fra fremstillingsprocessen i den bovin-baserede nyrecellelinje.
Data has been provided to demonstrate that CattleMarker IBR Inactivated, unlike PregSure BVD, has a reduced amount of immunologically significant amount of ANAS remaining from its manufacturing process on the bovine derived kidney cell line in the final product.
Vurdering af det generelle benefit/risk-forhold
Evaluation of the overall benefit-risk balance
Under den gensidige anerkendelsesprocedure gav Tyskland udtryk for bekymring, hvad angår den immunologiske sikkerhed ved CattleMarker IBR Inactivated, fordi produktet har samme sammensætning som PregSure BVD, en vaccine, som man har påvist inducerer langvarig allogen antistofrespons, hvilket har været forbundet med bovin neonatal pancytopeni (BNP), en neonatal alloimmun sygdom hos afkommet fra vaccinerede moderdyr.
During the MRP Germany raised a concern about the immunological safety of CattleMarker IBR Inactivated, as the composition of this product is similar to PregSure BVD, a vaccine which has been shown to induce a long-lasting allogeneic antibody response which has been associated with Bovine Neonatal Pancytopenia (BNP), a neonatal alloimmune disease, in the progeny of vaccinated dams.
CattleMarker IBR Inactivated, en injicerbar emulsion til kvæg, er en inaktiveret infektiøs bovin rhinotracheitis (IBR)-vaccine, der indeholder glykoprotein E (gE)-negativ bovin herpesvirus 1 (BoHV-1) af Difivac-stammen.
CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated) is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac.
Hos levende dyr: kontrol af, om der er tegn på omfattende trombocytopeni (med eller uden neutropeni, lymfopeni og non-regenerativ anæmi).
If alive, profound thrombocytopenia (with or without neutropenia, lymphopenia and nonregenerative anaemia).
Tidligere har først epidemiologiske data og sidenhen hurtigt voksende lægemiddelovervågningsdata påvist en hyppigere forekomst af denne alloimmune reaktion mellem moderdyret og fosteret.
In the past initially epidemiological information and then rapidly increasing pharmacovigilance data documented an increase of the frequency of this alloimmune reaction between the dam and the foetus and finally a close relationship between the occurrences of BNP and the repeated vaccination of dams with PregSure BVD was established.
Indehaveren af markedsføringstilladelsen har foreslået at foretage lægemiddelovervågning efter tilladelse af markedsføring ved at anvende sit sædvanlige lægemiddelovervågningssystem til monitorering af dyr, der er vaccineret med CattleMarker IBR Inactivated.
The MAH proposed a post-marketing pharmacovigilance surveillance program utilising its usual pharmacovigilance system for the monitoring of animals vaccinated with CattleMarker IBR Inactivated.
Begrundelser for udstedelse af markedsføringstilladelserne
Grounds for the granting of the marketing authorisations
Seronegative kalve i alderen 2 uger og derover opnår beskyttelse 2 uger efter administration af den primære vaccine, og de vil være beskyttet 6 måneder frem.
Onset and duration of protection for the seronegative cattle form 2 weeks of age is 2 weeks and 6 months respectively after completion of the primary vaccination
vurderes at stå i rimeligt forhold til BNP-risikoen og skønnes at være den mest effektive måde at imødegå den på.
The proposed measures, which will be included in a risk management plan, are considered proportionate and the most efficient way to tackle the BNP risk.
• med henblik på at reducere de kliniske tegn på IBR (navnlig pyreksi og varigheden af dyspnø) og spredning af virus, der skyldes BoHV-1-infektion
• to reduce the clinical signs (pyrexia and duration of dyspnoea) of infectious bovine rhinotracheitis (IBR) and virus shedding caused by BoHV-1 infection;
Benefit/risk-forholdet for CattleMarker IBR Inactivated, en injicerbar emulsion til kvæg, vurderes generelt at være positivt, forudsat at der gennemføres supplerende studier og yderligere foranstaltninger som angivet i risikostyringsplanen.
Overall, the benefit-risk balance for CattleMarker IBR Inactivated emulsion for injection is considered positive, subject to the conduct of additional studies and the implementation of further measures specified in a RMP.
• Indehaveren af markedsføringstilladelsen skal gennemføre et studie til vurdering af CattleMarker IBR Inactivated-vaccinens potentielle boostereffekt på et eventuelt MHC-I- eller opsoniserende alloantistofrespons hos kvæg, der tidligere er blevet vaccineret med PregSure BVD.
• The marketing authorisation holder shall conduct a study to assess the potential booster of CattleMarker IBR Inactivated on any MHC-I or opsonizing alloantibody responses in cattle previously vaccinated using PregSure BVD.
CattleMarker IBR Inactivated fremstilles i samme bovine cellelinje og tilføres den samme højpotente adjuvans, Procision-A, som PregSure BVD.
CattleMarker IBR Inactivated is produced on the same bovine cell line and is adjuvanted with the same highly potent adjuvant, Procision-A, as PregSure BVD.
I et hyperimmuniseringsundersøgelse bevirkede gentagne injektioner af CattleMarker IBR Inactivated ikke udvikling af alloantistoffer i samme omfang som PregSure BVD ved hyperimmunisering af dyr.
In a hyperimmunisation study, repeated injections of CattleMarker IBR Inactivated did not trigger the production of alloantibodies at a level similar to this of animals hyperimmunised with PregSure BVD.
I et hyperimmuniseringsundersøgelse er det blevet påvist, at disse ANAS-rester, som fremstillingsprocessen for CattleMarker IBR Inactivated medfører, ikke bevirker udvikling af alloantistoffer i samme omfang som PregSure BVD ved hyperimmunisering af dyr.
In a hyperimmunisation study it has been demonstrated that these remaining ANAS from the manufacturing process of CattleMarker IBR Inactivated did not trigger the production of alloantibodies at a level similar to this of animals hyperimmunised with PregSure BVD.
• Indehaveren af markedsføringstilladelsen har foreslået en række kvalitetssikrings-, risikominimerings- og overvågningsforanstaltninger, som vil blive inkluderet i risikostyringsplanen.
• A range of quality and risk mitigation and surveillance measures has been proposed by the MAH
Risikostyringsplanen skal revideres med det samme, hvis der opstår problemer.
Updates to the risk management plan should be proposed as required as soon as any issues arise, otherwise the risk management plan should be reviewed on a yearly basis at least, in conjunction with the PSUR submission.
Fremstillingsprocessen for CattleMarker IBR Inactivated giver imidlertid færre ANAS-rester (f.eks. MDBK-cellerester) end fremstillingsprocessen for PregSure BVD.
However the manufacturing process of CattleMarker IBR Inactivated leads to an amount of remnant of ANAS (e.g. MDBK cell debris) lower than the one of PregSure BVD.
Hyppigheden af BNP, der skyldes PregSure BVD-vaccination, er dog ikke blevet sikkert fastlagt, idet denne varierer fra 5 % til 0,004 % alt efter kilde.
The frequency of this condition had been dramatically exacerbated by PregSure BVD vaccination in the 2000's leading to the characterisation of a strong association between the occurrence of BNP and the use of Pregsure BVD; however the frequency of BNP disease caused by PregSure BVD vaccination has not been solidly determined, varying from 5% to 0.004% according to the source; the CVMP approximated this frequency to be around 0.01% during the Article 78 procedure.
CattleMarker IBR Inactivated indeholder den samme adjuvans, Procision-A, som PregSure BVD, og i virusfremstillingen benyttes også en bovin-baseret nyrecellelinje (MDBK).
CattleMarker IBR Inactivated contains the same adjuvant Procision-A as PregSure BVD and the virus production also utilises a bovine-derived kidney cell line (MDBK).
CattleMarker IBR Inactivated har den samme højpotente adjuvans, Procision-A, og produceres i den samme bovinbaserede nyrecellelinje (MDBK) som PregSure BVD.
CattleMarker IBR Inactivated has the same highly potent adjuvant, Procision-A, and is grown on the same bovine-derived kidney cell line (MDBK) as PregSure BVD.
Disse foranstaltninger står i rimeligt forhold til BNP-risikoen og omfatter al den aktuelle viden om BNP, der er indsamlet fra PregSure BVD-hændelser.
The MAH committed to conducting thorough investigations for any unexplained mortality in the offspring of vaccinated animals following documented use of vaccinesThese measures are proportionate to the BNP risk and include all the current knowledge on BNP gathered from the PregSure BVD incident.
− Udarbejde en beredskabsplan for at være forberedt, hvis der mod forventning rapporteres om BNP-tilfælde efter brug af CattleMarker IBR Inactivated hos moderdyr.
− Provide a contingency plan in the unlikely circumstance that BNP reports occur that involve CattleMarker IBR Inactivated vaccinated dams.
Rumænien Zoetis Belgium SA Rue Laid Burniat 1
Romania Zoetis Belgium SA Rue Laid Burniat 1
Endelig synes BNP-risikoen ved CattleMarker IBR Inactivated at være signifikant lavere end ved PregSure BVD, når man sammenligner offentliggjorte data om alloantistofrespons forårsaget af andre markedsførte vacciner.
Finally, by comparison with published data on alloantibody response triggered by other marketed vaccines, the BNP risk for CattleMarker IBR Inactivated appears to be significantly lower than this for PregSure BVD.
CVMP anbefaler derfor udstedelse af markedsføringstilladelse for CattleMarker IBR Inactivated, en injicerbar emulsion til kvæg, forudsat at de betingelser, der vedrører markedsføringstilladelserne, overholdes, jf. bilag IV.
which will be included in a risk management plan and are deemed adequate and proportionate to the identified risk of development of BNP; the CVMP has recommended the granting of the marketing authorisation for CattleMarker IBR Inactivated emulsion for injection for cattle subject to conditions affecting the marketing authorisations as set out in Annex IV.
Storbritannien Zoetis Belgium SA Rue Laid Burniat 1
Belgium Zoetis Belgium SA Rue Laid Burniat 1
Tyskland Zoetis Belgium SA Rue Laid Burniat 1
Germany Zoetis Belgium SA Rue Laid Burniat 1
Ifølge definitionen af bovin neonatal pancytopeni kan en kalv få stillet denne diagnose, hvis følgende tre kriterier er opfyldt: 1) Kalven skal være under en 1 måned gammel, 2) kalven skal have pancytopeni forbundet med knoglemarvsaplasi og 3) andre ikke-immune sygdomme/tilstande med lignende kliniske tegn i differentialdiagnosen (f.eks. BVD, nitrofuran-behandling) skal udelukkes.
other non-immune diseases/conditions with similar clinical signs included in the differential diagnosis (such as BVD, nitrofuran treatment) should be excluded.
Tyskland mener imidlertid, at den foreslåede håndtering af risiciene er utilstrækkelig, og at indehaveren af markedsføringstilladelsen bør iværksætte en omfattende undersøgelse efter tilladelse til markedsføring.
The potential risk of recurrence of BNP linked to the use of this vaccine in pregnant cows has been addressed by the MAH; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by the MAH.
• Indehaveren af markedsføringstilladelsen har fremlagt data, der påviser, at risikoen for BNP er signifikant lavere ved gentagne vaccinationer med CattleMarker IBR Inactivated end ved brug af PregSure BVD.
• The MAH has provided data demonstrating that the risk that repeated injections with the vaccine
Yderligere information vedrørende Tagrisso findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Tagrisso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Patienten bør tage 80 mg én gang dagligt, så længe sygdommen bedres eller holder sig stabil, og bivirkningerne er tålelige.
The patient should take 80 mg once a day for as long as the disease improves or remains stable and the side effects are tolerable.
Den blev ændret til en fuldgyldig markedsføringstilladelse den 24. april 2017.
This was switched to a full marketing authorisation on 24 April 2017.
Tagrisso fik en betinget markedsføringstilladelse med gyldighed i hele EU den 2. februar 2016.
Tagrisso received a conditional marketing authorisation valid throughout the EU on on 2 February 2016.
Som for alle lægemidler bliver data vedrørende brugen af Tagrisso løbende overvåget.
As for all medicines, data on the use of Tagrisso are continuously monitored.
Tagrisso fik oprindeligt en "betinget godkendelse", fordi der var flere videnskabelige beviser på vej om lægemidlet.
Tagrisso was originally given ‘conditional approval' because there was more evidence to come about the medicine.
I disse studier blev Tagrisso ikke sammenlignet med andre behandlinger.
In these studies, Tagrisso was not compared with any other treatment.
Patienter med EGFR-mutationer har en dårlig prognose og begrænsede behandlingsmuligheder; der er derfor et stort uopfyldt medicinsk behov.
Patients with EGFR mutations have a poor prognosis and limited treatment options; therefore there is a high unmet medical need.