FrancophonIA/ELRC3.0 huggingface dataset:
English: gE deleted IBR vaccines such as CattleMarker IBR Inactivated are “DIVA vaccines”, differentiating infected from vaccinated animals.
Danish: gE-deleterede IBR-vacciner som f.eks. CattleMarker IBR Inactivated er "DIVA-vacciner", der skelner mellem smittede og vaccinerede dyr.
English: If dead, bone marrow histopathology shows trilineage hypoplasia.
Danish: Hos døde dyr: kontrol af, om knoglemarvshistopatologien viser tegn på trilineær hypoplasi.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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).
English: 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.
Danish: 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.
English: • 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.
Danish: • 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.
English: 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.
Danish: 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.
English: Evaluation of the overall benefit-risk balance
Danish: Vurdering af det generelle benefit/risk-forhold
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: If alive, profound thrombocytopenia (with or without neutropenia, lymphopenia and nonregenerative anaemia).
Danish: Hos levende dyr: kontrol af, om der er tegn på omfattende trombocytopeni (med eller uden neutropeni, lymfopeni og non-regenerativ anæmi).
English: 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.
Danish: Tidligere har først epidemiologiske data og sidenhen hurtigt voksende lægemiddelovervågningsdata påvist en hyppigere forekomst af denne alloimmune reaktion mellem moderdyret og fosteret.
English: The MAH proposed a post-marketing pharmacovigilance surveillance program utilising its usual pharmacovigilance system for the monitoring of animals vaccinated with CattleMarker IBR Inactivated.
Danish: 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.
English: Grounds for the granting of the marketing authorisations
Danish: Begrundelser for udstedelse af markedsføringstilladelserne
English: 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
Danish: 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.
English: 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.
Danish: vurderes at stå i rimeligt forhold til BNP-risikoen og skønnes at være den mest effektive måde at imødegå den på.
English: • to reduce the clinical signs (pyrexia and duration of dyspnoea) of infectious bovine rhinotracheitis (IBR) and virus shedding caused by BoHV-1 infection;
Danish: • 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
English: 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.
Danish: 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.
English: • 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.
Danish: • 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.
English: 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.
Danish: CattleMarker IBR Inactivated fremstilles i samme bovine cellelinje og tilføres den samme højpotente adjuvans, Procision-A, som PregSure BVD.
English: 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.
Danish: I et hyperimmuniseringsundersøgelse bevirkede gentagne injektioner af CattleMarker IBR Inactivated ikke udvikling af alloantistoffer i samme omfang som PregSure BVD ved hyperimmunisering af dyr.
English: 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.
Danish: 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.
English: • A range of quality and risk mitigation and surveillance measures has been proposed by the MAH
Danish: • Indehaveren af markedsføringstilladelsen har foreslået en række kvalitetssikrings-, risikominimerings- og overvågningsforanstaltninger, som vil blive inkluderet i risikostyringsplanen.
English: 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.
Danish: Risikostyringsplanen skal revideres med det samme, hvis der opstår problemer.
English: 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.
Danish: Fremstillingsprocessen for CattleMarker IBR Inactivated giver imidlertid færre ANAS-rester (f.eks. MDBK-cellerester) end fremstillingsprocessen for PregSure BVD.
English: 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.
Danish: 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.
English: 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).
Danish: CattleMarker IBR Inactivated indeholder den samme adjuvans, Procision-A, som PregSure BVD, og i virusfremstillingen benyttes også en bovin-baseret nyrecellelinje (MDBK).
English: 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.
Danish: CattleMarker IBR Inactivated har den samme højpotente adjuvans, Procision-A, og produceres i den samme bovinbaserede nyrecellelinje (MDBK) som PregSure BVD.
English: 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.
Danish: Disse foranstaltninger står i rimeligt forhold til BNP-risikoen og omfatter al den aktuelle viden om BNP, der er indsamlet fra PregSure BVD-hændelser.
English: − Provide a contingency plan in the unlikely circumstance that BNP reports occur that involve CattleMarker IBR Inactivated vaccinated dams.
Danish: − Udarbejde en beredskabsplan for at være forberedt, hvis der mod forventning rapporteres om BNP-tilfælde efter brug af CattleMarker IBR Inactivated hos moderdyr.
English: Romania Zoetis Belgium SA Rue Laid Burniat 1
Danish: Rumænien Zoetis Belgium SA Rue Laid Burniat 1
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1
Danish: Storbritannien Zoetis Belgium SA Rue Laid Burniat 1
English: Germany Zoetis Belgium SA Rue Laid Burniat 1
Danish: Tyskland Zoetis Belgium SA Rue Laid Burniat 1
English: other non-immune diseases/conditions with similar clinical signs included in the differential diagnosis (such as BVD, nitrofuran treatment) should be excluded.
Danish: 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.
English: 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.
Danish: 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.
English: • The MAH has provided data demonstrating that the risk that repeated injections with the vaccine
Danish: • 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.
English: Further information on Tagrisso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Tagrisso findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 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.
Danish: Patienten bør tage 80 mg én gang dagligt, så længe sygdommen bedres eller holder sig stabil, og bivirkningerne er tålelige.
English: This was switched to a full marketing authorisation on 24 April 2017.
Danish: Den blev ændret til en fuldgyldig markedsføringstilladelse den 24. april 2017.
English: Tagrisso received a conditional marketing authorisation valid throughout the EU on on 2 February 2016.
Danish: Tagrisso fik en betinget markedsføringstilladelse med gyldighed i hele EU den 2. februar 2016.
English: As for all medicines, data on the use of Tagrisso are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Tagrisso løbende overvåget.
English: Tagrisso was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Danish: Tagrisso fik oprindeligt en "betinget godkendelse", fordi der var flere videnskabelige beviser på vej om lægemidlet.
English: In these studies, Tagrisso was not compared with any other treatment.
Danish: I disse studier blev Tagrisso ikke sammenlignet med andre behandlinger.
English: Patients with EGFR mutations have a poor prognosis and limited treatment options; therefore there is a high unmet medical need.
Danish: Patienter med EGFR-mutationer har en dårlig prognose og begrænsede behandlingsmuligheder; der er derfor et stort uopfyldt medicinsk behov.
English: Other information about Tagrisso
Danish: Andre oplysninger om Tagrisso
English: It is used in patients who have mutations (changes) in a gene for a protein called EGFR.
Danish: Det anvendes hos patienter, der har mutationer (forandringer) i genet for et protein, der hedder EGFR.
English: If certain side effects develop the doctor may decide to reduce the dose or stop treatment.
Danish: Ved visse bivirkninger kan lægen beslutte at nedsætte dosis eller stoppe behandlingen.
English: It blocks the activity of EGFR, which normally controls growth and division of cells.
Danish: Det blokerer aktiviteten af EGFR, som normalt kontrollerer cellers vækst og deling.
English: It contains the active substance osimertinib.
Danish: Det indeholder det aktive stof osimertinib.
English: Before starting treatment, doctors should use a genetic test to confirm that the patient has an EGFR mutation.
Danish: Før påbegyndelse af behandling bør lægerne foretage en genetisk analyse for at bekræfte, at patienten har en EGFR-mutation.
English: Treatment with Tagrisso should be started and supervised by a doctor who is experienced in the use of cancer medicines.
Danish: Behandlingen med Tagrisso skal påbegyndes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: In patients with T790 mutation, the medicine may be given after other treatments.
Danish: Hos patienter med T790-mutation, kan lægemidlet gives efter andre behandlinger.
English: For more information about using Tagrisso, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Tagrisso, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency therefore concluded that Tagrisso's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Tagrisso opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Tagrisso?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tagrisso?
English: An overview of Tagrisso and why it is authorised in the EU
Danish: En oversigt over Tagrisso, og hvorfor det er godkendt i EU
English: Side effects reported with Tagrisso are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Tagrisso vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Tagrisso is available as 40 and 80 mg tablets.
Danish: Tagrisso fås som tabletter (40 mg og 80 mg).
English: The most common side effects with Tagrisso (which may affect more than 1 in 10 people) are diarrhoea, rash, dry skin, paronychia (nail bed infection), itching, stomatitis (inflammation of the lining of the mouth) and a decrease in the levels of white blood cells and platelets.
Danish: De hyppigste bivirkninger ved Tagrisso (som kan forekomme hos mere end 1 ud af 10 patienter) er diarré, udslæt, tør hud, infektion af neglelejet, kløe, betændelse i mundslimhinden og nedsat antal hvide blodlegemer og blodplader.
English: If a patient has mutations known as an ‘activating mutations', Tagrisso is given as the first treatment.
Danish: Hvis en patient har såkaldte aktiverende mutationer, gives Tagrisso som den første behandling.
English: Regarding safety, the adverse effects with Tagrisso are similar to other medicines of the same class and are considered acceptable.
Danish: Hvad angår sikkerheden, svarede bivirkningerne ved Tagrisso til bivirkningerne ved andre lægemidler i samme klasse, og de anses for acceptable.
English: In patients taking Tagrisso, the cancer did not get worse for around 10.1 months compared with 4.4 months in patients on chemotherapy.
Danish: Hos de patienter, som fik Tagrisso, blev kræften ikke værre i ca. 10,1 måneder sammenholdt med 4,4 måneder hos de patienter, som fik kemoterapi.
English: In lung cancer cells, EGFR is often overactive, causing uncontrolled growth of cancer cells.
Danish: I lungekræftceller er EGFR ofte overaktivt, hvilket får kræftcellerne til at vokse ukontrolleret.
English: Why is Tagrisso authorised in the EU?
Danish: Hvorfor blev Tagrisso godkendt i EU?
English: What is Tagrisso and what is it used for?
Danish: Hvad er Tagrisso, og hvad anvendes det til?
English: Tagrisso is medicine for treating a lung cancer called non-small cell lung cancer (NSCLC) when the cancer is advanced or has spread.
Danish: Tagrisso er et lægemiddel til behandling af en type lungekræft, der kaldes ikke-småcellet lungekræft (NSCLC), når kræften er fremskreden eller har spredt sig.
English: In two studies involving 411 previously treated patients who had T790 mutations, the overall response rates (the proportion of patients whose tumours shrank) with Tagrisso was 66% and the average length of time the response lasted was 12.5 months.
Danish: I to studier med deltagelse af 411 patienter, der tidligere var blevet behandlet, og som havde T790mutationer, var de samlede responsrater (andelen af patienter, hvis tumorer skrumpede) ved behandling med Tagrisso 66 %, og responsen varede i gennemsnit 12,5 måneder.
English: What are the risks associated with Tagrisso?
Danish: Hvilke risici er der forbundet med Tagrisso?
English: The active substance in Tagrisso, osimertinib, is a type of cancer medicine called tyrosine kinase inhibitor.
Danish: Det aktive stof i Tagrisso, osimertinib, er et kræftlægemiddel af typen "tyrosinkinasehæmmer".
English: By blocking EGFR, osimertinib helps to reduce the growth and spread of the cancer.
Danish: Ved at blokere EGFR medvirker osimertinib til at nedsætte kræftens vækst og spredning.
English: Finally, in a study of 556 patients with activating mutations, patients taking Tagrisso as a first treatment lived for 18.9 months without their disease getting worse compared with 10.2 months in patients receiving treatment with other medicines (either erlotinib or gefitinib).
Danish: Endelig har et studie med deltagelse af 556 patienter med aktiverende mutationer påvist, at patienter, der behandles med Tagrisso som første behandling, levede op til 18,9 måneder uden sygdomsforværring sammenholdt med 10,2 måneder hos patienter, der fik behandling med andre lægemidler (enten erlotinib eller gefinitib).