FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Rydapt will complete three further studies to provide the Agency with evidence to support the effectiveness of the medicine in elderly patients with AML.
Danish: Den virksomhed, der markedsfører Rydapt, skal gennemføre tre supplerende undersøgelser og fremsende dokumentation til agenturet til understøttelse af lægemidlets virkning hos ældre patienter med AML.
English: For mast cell disorders, the starting dose is 100 mg (four capsules) twice daily; treatment is continued for as long as the patient benefits.
Danish: Ved mastcelleforstyrrelser er startdosis 100 mg (fire kapsler) to gange dagligt, og behandlingen fortsættes, så længe patienten har gavn af den.
English: Another main study involving 116 patients with mast cell disorders also showed benefit.
Danish: En anden hovedundersøgelse af 116 patienter med mastcelleforstyrrelser viste, at disse patienter også havde gavn af Rydapt.
English: For more information about treatment with Rydapt, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rydapt, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The usual starting dose is 50 mg (two capsules) twice a day for AML, on days 8 to 21 of a 28-day treatment cycle, and then every day once the disease has responded.
Danish: Ved AML er den sædvanlige startdosis 50 mg (to kapsler) to gange dagligt dag 8-21 i en 28-dages behandlingscyklus, og derefter hver dag, når sygdommen har reageret på behandlingen.
English: Rydapt must not be given to patients taking certain other medicines that affect the way it is handled in the body.
Danish: Rydapt må ikke gives til patienter, der får visse andre lægemidler, som kan påvirke kroppens reaktion på Rydapt.
English: In mast cell disorders there was also important evidence of effectiveness.
Danish: Ved mastcelleforstyrrelser var der også væsentlig evidens for virkningen.
English: Rydapt also blocks a mutated form of another enzyme, KIT kinase, which plays an important role in stimulating the abnormal growth of mast cells in patients with mast cell disorders.
Danish: Rydapt blokerer også for en muteret form af et andet enzym, KIT-kinase, der spiller en vigtig rolle for stimulationen af mastcellernes unormale vækst hos patienter med mastcelleforstyrrelser.
English: It is used with other cancer medicines (chemotherapy) initially and on its own once the chemotherapy is completed if the disease has responded to treatment.
Danish: Det bruges indledningsvis sammen med andre kræftlægemidler (kemoterapi) og derefter som enebehandling, når kemoterapien er afsluttet, og hvis sygdommen har reageret på behandlingen.
English: This means that it blocks the action of certain enzymes known as receptor tyrosine kinases.
Danish: Det vil sige, at stoffet blokerer aktiviteten af bestemte enzymer kaldet receptortyrosinkinase-enzymer.
English: One main study, involving 717 such patients, compared Rydapt with placebo (a dummy treatment) initially as an addition to other cancer medicines, followed by treatment with Rydapt or placebo alone in those whose disease responded.
Danish: I en hovedundersøgelse med 717 AML-patienter med FLT3-mutation blev Rydapt sammenlignet med placebo (et uvirksomt stof), først som tillægsbehandling til andre kræftlægemidler, og derefter med Rydapt eller placebo som enebehandling hos de patienter, hvis sygdom reagerede på behandlingen.
English: By blocking the abnormal FLT3 enzyme, Rydapt helps to bring about the death of the abnormal cells and control the spread of the cancer.
Danish: Ved at blokere det unormale FLT3-enzym hjælper Rydapt med at få de unormale celler til at dø og forhindre, at kræften spreder sig.
English: What benefits of Rydapt have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Rydapt?
English: The active substance in Rydapt, midostaurin, is a ‘tyrosine kinase inhibitor'.
Danish: Det aktive stof i Rydapt, midostaurin, er en såkaldt "tyrosinkinasehæmmer".
English: How is Rydapt used?
Danish: Hvordan anvendes Rydapt?
English: The study looked at the response to Rydapt treatment in patients with aggressive systemic mastocytosis, systemic mastocytosis associated with blood cancer, or mast cell leukaemia.
Danish: Undersøgelsen vurderede reaktionen på behandling med Rydapt hos patienter med aggressiv systemisk mastocytose, systemisk mastocytose forbundet med blodkræft eller mastcelleleukæmi.
English: The commonest severe side effects were tiredness, sepsis (blood poisoning), pneumonia (lung infection), febrile neutropenia and diarrhoea.
Danish: De hyppigste alvorlige bivirkninger var træthed, sepsis (blodforgiftning), pneumoni (lungebetændelse), febril neutropeni og diarré.
English: For the full list of all side effects reported with Rydapt, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rydapt fremgår af indlægssedlen.
English: For practical information about using Rydapt, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Rydapt, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In patients with an FLT3 mutation, an abnormal form of the FLT3 tyrosine kinase stimulates the survival and growth of AML cells.
Danish: Hos patienter med en FLT3-mutation stimulerer en unormal udgave af FLT3-tyrosinkinase-enzymet AML-cellernes overlevelse og vækst.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rydapt have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Rydapt.
English: The most frequent severe side effects were febrile neutropenia, lymphopenia (low counts of lymphocytes, a particular type of white blood cell), infections at the site of a catheter (a tube inserted in a vein), exfoliative dermatitis, high blood sugar and nausea (feeling sick).
Danish: De hyppigste alvorlige bivirkninger er febril neutropeni, lymfopeni (lavt antal lymfocytter, en særlig type hvide blodlegemer), infektion på indstiksstedet for kateteret (lille plasticslange anlagt i en blodåre), eksfoliativ dermatitis, højt blodsukker og kvalme.
English: When used to treat AML, the most common side effects with Rydapt (which may affect more than 1 in 10 people) are febrile neutropenia (fever and low white blood cell count, seen in nearly all patients), exfoliative dermatitis (inflamed, peeling skin), vomiting, headache, petechiae (tiny blood spots under the skin) and fever.
Danish: Når Rydapt anvendes til behandling af AML, er de hyppigste bivirkninger (der kan forekomme hos mere end 1 ud af 10 personer) febril neutropeni (feber og lavt antal hvide blodlegemer (ses hos næsten alle patienter)), betændt, afskallende hud (eksfoliativ dermatitis), opkastning, hovedpine, petekkier (små mørkerøde pletter under huden) og feber.
English: Rydapt is also used on its own in adults with the following disorders of a type of white blood cell known as mast cell: aggressive systemic mastocytosis, systemic mastocytosis associated with a haematological neoplasm (blood cancer), and mast cell leukaemia.
Danish: Rydapt anvendes også som enebehandling hos voksne med følgende forstyrrelser i de såkaldte mastceller, en type hvide blodlegemer: aggressiv systemisk mastocytose, systemisk mastocytose forbundet med hæmatologiske neoplasmer (blodkræft) samt mastecelle-leukæmi.
English: Rydapt is only given when the AML has a particular genetic change called an FLT3 mutation.
Danish: Rydapt gives kun til AML-patienter, der har en bestemt genetisk forandring kaldet FLT3-mutation.
English: Rydapt is a cancer medicine used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a cancer of white blood cells.
Danish: Rydapt anvendes til at behandle patienter med nydiagnosticeret akut myeloid leukæmi (AML), en form for kræft i de hvide blodlegemer.
English: When used for mast cell disorders, the commonest side effects (affecting one third or more of all patients) were nausea, vomiting, diarrhoea, peripheral oedema (swelling of the ankles and feet) and tiredness.
Danish: Når Rydapt anvendes til behandling af mastcelleforstyrrelser, er de hyppigste bivirkninger (der forekommer hos mindst en tredjedel af alle patienter) kvalme, opkastning, diarré, perifert ødem (hævede ankler og fødder) og træthed.
English: Rydapt has been shown to improve survival in patients with AML associated with an FLT3 mutation.
Danish: Det er påvist, at Rydapt forbedrer overlevelsen hos AML-patienter, der har en FLT3-mutation.
English: Rydapt has been shown to be of benefit in patients with AML associated with an FTL3 mutation.
Danish: Det er påvist, at Rydapt har gavnlig effekt hos AML-patienter, der har en FTL3-mutation.
English: Co. Dublin, Ireland
Danish: Co. Dublin, Irland
English: The recommendations of the Inspectors were followed: immediately or according to an agreed timetable.
Danish: Inspektørernes anbefalinger var blevet fulgt op, enten umiddelbart eller ifølge en aftalt tidsplan.
English: The full reports of the external consultant (15.4.1999 / 4.6.1999) were provided.
Danish: Den eksterne konsulents fuldstændige rapporter (15.4.1999 / 4.6.1999) blev fremlagt.
English: The other cases were classified as “unlikely related”.
Danish: De øvrige tilfælde blev klassificeret som "sandsynligvis ingen relation".
English: Special requirements according to national prescriptions.
Danish: Specielle krav efter nationale forskrifter.
English: The number of reported cases increased to approx. 7,000.
Danish: Antallet af indberettede tilfælde steg til omkring 7 000.
English: The manufacturer proposes the following main modifications:
Danish: Fremstilleren foreslår følgende ændringer:
English: This will induce an immunity lasting for 6 months.
Danish: Dette vil inducere en immunitet, som varer i 6 måneder.
English: The full report of the last official GMP-inspection (13.7.1998) was presented.
Danish: Den fuldstændige rapport om den seneste officielle GMP-inspektion (13.7.1998) blev forelagt.
English: No precautions are required.
Danish: Ingen særlige forholdsregler nødvendige.
English: Authorisation year + number
Danish: Tilladelse år + antal
English: The disease problems occurring on both groups of farms were comparable .
Danish: De sygdomsproblemer, der opstod i de to grupper af bedrifter, var sammenlignelige.
English: SCIENTIFIC CONCLUSIONS PRESENTED BY THE EMEA
Danish: VIDENSKABELIGE KONKLUSIONER FREMLAGT AF EMEA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT see Annex II
Danish: VETERINÆRLÆGEMIDLETS NAVN Se bilag II.
English: No microbial growth
Danish: Ingen mikrobiel vækst
English: The recommendations of the external consultant were also implemented.
Danish: Den eksterne konsulents anbefalinger var ligeledes blevet fulgt op.
English: Booster vaccinations are performed every 6 months.
Danish: Boostervaccinationer foretages hver 6. måned.
English: Test results:
Danish: Testresultater:
English: The possibility of BVD cross-contamination in general was investigated, but was estimated highly unlikely.
Danish: Muligheden for BVD-krydskontaminering generelt blev undersøgt, men vurderedes som højst usandsynlig.
English: Of these cases, so far only 6 were handed from LTO to Bayer or Hoechst.
Danish: Af disse er hidtil kun 6 gået videre fra LTO til Bayer eller Hoechst.
English: In the beginning of 1999 field problems in cattle accompanied with high mortality were reported by The Netherlands.
Danish: I begyndelsen af 1999 indberettede Nederlandene tilfælde af kvægsygdom ledsaget af høj dødelighed.
English: Contact Belgium:
Danish: Kontaktperson i Belgien:
English: On 9 March 1999 a rapid alert was sent by the Netherlands to all the Member States.
Danish: Den 9. marts 1999 underrettede Nederlandene alle medlemsstaterne efter proceduren for hurtig varsling.
English: No. 552/96 Dev
Danish: Nr. 552/96 Dev
English: The freeze-dried product should be reconstituted just prior to use.
Danish: Det frysetørrede produkt bør færdiggøres lige før brug.
English: Both products have different names because of co-marketing, but are equal in composition.
Danish: De to produkter har forskellige navne, da de markedsføres af to forskellige virksomheder, men deres sammensætning er ens.
English: 1995 13 June REGNL 8800
Danish: 1995 13. juni REGNL 8800
English: Serious adverse drug reactions were reported in 451 Dutch field cases.
Danish: Alvorlige bivirkninger blev indberettet i 451 konkrete tilfælde i Nederlandene.
English: Contamination Approx. amount of BVD virus per dose as determined by:
Danish: Kontaminering Approx. mængde BVD-virus pr. dosis som bestemt ved:
English: Original batch documentation was supplied.
Danish: Den originale batchdokumentation blev ligeledes forelagt.
English: - the Committee considered the referral made under article 23 a (2) of Council Directive 81/851/EEC as amended regarding safety issues related to the use of the products listed in Annex II of the Opinion;
Danish: - udvalget har behandlet indbringelsen i henhold til artikel 23a, stk. 2, i Rådets direktiv 81/851/EØF med senere ændringer, vedrørende sikkerhedsspørgsmål i forbindelse med anvendelsen af de produkter, der er anført i bilag II til udtalelsen;
English: The results of the quality control testing complied with the requirements.
Danish: Resultaterne af kvalitetskontrolafprøvningen opfyldte kravene.
English: OVERVIEW OF SAFETY ASPECTS
Danish: OVERSIGT OVER SIKKERHEDSASPEKTER
English: Cattle
Danish: Kvæg.
English: The proposed modifications of production and quality control are fully assessed and considered sufficiently validated.
Danish: De foreslåede ændringer af produktionsprocessen og kvalitetskontrolmetoden er fuldt vurderet og anses for tilstrækkeligt validerede.
English: These calves must receive their first booster vaccination at the age of 6 months.
Danish: Disse kalve skal have deres første boostervaccine i en alder af 6 måneder.
English: Strength (mg)/ pharmaceutical form
Danish: Styrke (mg)/ Lægemiddelform
English: GROUNDS FOR RECOMMENDING THE VARIATIONS OF THE MARKETING AUTHORISATIONS:
Danish: BEGRUNDELSE FOR AT ANBEFALE ÆNDRINGER AF MARKEDSFØRINGSTILLADELSERNE:
English: The vaccination scheme consists of basic immunisation and booster vaccinations.
Danish: Vaccinationsprogrammet består af basis-immunisering og boostervaccinationer.
English: The PCR method validation (sensitivity, specificity and reproducibility) was provided.
Danish: Valideringen af PCR-metoden (sensitivitet, specificitet og reproducerbarhed) er fremsendt til udvalget.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER FOR SALG, UDLEVERING OG/ELLER BRUG
English: 2/2 calves well complies complies complies
Danish: 2/2 calves well
English: The Polymerase Chain Reaction (PCR) for testing of raw materials is well-described in a Standard Operation Procedure (SOP).
Danish: Polymerasekædereaktionen (PCR) til afprøvning af råvarer er udtømmende beskrevet i en standardoperationsprocedure (SOP).
English: The MSV, WSV, MCS and WCS were excluded as the source of the vaccine contamination with BVD virus.
Danish: MSV, WSV, MCS og WCS blev udelukket som kilde til vaccineforureningen med BVD-virus.
English: National authority
Danish: National myndighed
English: 13 February REGNL 8427
Danish: 13. februar REGNL 8427
English: OVERVIEW OF ANALYTICAL ASPECTS
Danish: OVERSIGT OVER ANALYTISKE ASPEKTER
English: The trypsin used in the manufacturing is incubated below pH 2 and additionally gamma-irradiated.
Danish: Den i fremstillingen anvendte trypsin bliver inkuberet under pH 2 og endvidere gammabestrålet.
English: The Dutch Agricultural and Horticultural Organisation (Land- en Tuinbouw-Organisatie, LTO) has asked approx. 45.000 cattle farmers to report any health problems occurring after IBR-vaccination to the “Gezondheidsdienst” (GD).
Danish: Den nederlandske landbrugs- og gartneriorganisation (Land- en Tuinbouw-Organisatie, LTO) har anmodet omkring 45 000 kvægbrugere om at indberette ethvert dyresundhedsproblem, der måtte opstå efter IBR-vaccination, til “Gezondheidsdienst” (GD).
English: AR8/005/01+02 Issue Date
Danish: Licence No. AR8/005/01+02 Udstedelsesdato
English: 5.10 Withdrawal period
Danish: 5.10 Tilbageholdelsestid
English: These batches are suspected to relate to the later Dutch field cases ('case 2').
Danish: Disse batcher mistænkes for at stå i forbindelse med de nyeste konkrete tilfælde i Nederlandene ('case 2').
English: - the Committee assessed the quality control data of three representative batches manufactured according to the proposed measures and considered the new quality control tests being sufficiently validated;
Danish: - udvalget har vurderet kvalitetskontroldata vedrørende tre repræsentative batcher, der er fremstillet i overensstemmelse med de foreslåede foranstaltninger, og mener, at de nye kvalitetskontrolprøver må anses for at være fyldestgørende valideret;
English: A great part of the master cell seed, working cell seed and master seed virus were used in a research project.
Danish: * En stor del af den pågældende master cell seed, working cell seed og master seed virus blev anvendt i et forskningsprojekt.
English: ANNEX II LIST OF NAMES OF THE MEDICINAL PRODUCTS, MARKETING AUTHORISATION HOLDERS, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, PACKING AND PACKAGE SIZES IN THE MEMBER STATES.
Danish: LISTE OVER LÆGEMIDLETS NAVNE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, EMBALLAGE OG PAKNINGSSTØRRELSER I MEDLEMSSTATERNE
English: Identity
Danish: Identitet
English: Not recorded.
Danish: Ikke optegnet.
English: 1.2 mg pH-stabiliser: HEPES Na
Danish: pH-stabilisator: HEPES Na
English: Beef cattle and fattening bulls are vaccinated preferably just prior to housing (crowding) or at transfer to new groups.
Danish: Kødkvæg og fedekalve vaccineres fortrinsvis lige før de sættes på stald ( sættes sammen ) eller ved overførsel til nye grupper.
English: As with other vaccines, vaccination may not completely prevent but does reduce risk of infection.
Danish: Som gældende for andre vacciner, vil vaccination med vaccinen måske ikke fuldstændig forebygge IBR virus infektion, men nedsætte risikoen for infektion.
English: ANNEX I SCIENTIFIC CONCLUSIONS AND GROUNDS TO VARY THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA.
Danish: BILAG I VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSE FOR AT ÆNDRE MARKEDSFØRINGSTILLADELSERNE FREMLAGT AF EMEA
English: To prepare the vaccine for inoculation, approximately a quarter of the solvent is transferred to the lyophilisate with a sterile syringe, then mixed and finally transferred back into the remaining solvent.
Danish: For at færdiggøre vaccinen overføres ca en fjerdedel af solvensen til lyophilisatet med en steril sprøjte, omryst, og bring det derefter tilbage til den resterende solvens.
English: Evaluation by veterinarians at farms concerned demonstrated that often no data were available to support a relation with the vaccines or the farmers were not willing to give them.
Danish: En evaluering foretaget af veterinærsagkyndige på berørte bedrifter viste, at det i mange tilfælde ikke var muligt at fremskaffes data, der kunne understøtte en formodning om en sammenhæng med vaccinerne, eller at kvægbrugerne ikke var indstillet på at udlevere dem.
English: No other serum than foetal calf serum is used in the manufacturing.
Danish: Der anvendtes intet andet serum end føtalt kalveserum ved fremstillingen.
English: Using FPLC preparation and ultrafiltration to concentrate virus and to eliminate antibodies, viable BVD virus types 1 and 2 was detected in this batch.
Danish: Ved anvendelse af FPLCpræparation og ultrafiltrering til koncentrering af virus og eliminering af antistoffer påvistes levedygtig BVD-virus type 1 og 2 i denne batch.
English: Nevertheless, such calves are considered to be fully susceptible for BVD virus infection.
Danish: Sådanne kalve anses imidlertid for at være fuldt modtagelige for BVD-virusinfektion.
English: Other Bulks TV 3294
Danish: Andre bulk TV 3294
English: Calves may be vaccinated beginning from their 3rd week of life, irrespective of the status of maternal antibodies.
Danish: Kalve kan vaccineres fra deres 3. leveuge uanset status af maternelle antistoffer.
English: Therefore the manufacturer is required to provide to the CVMP before 15 April 2000 the data of validation studies of γ-irradiation of foetal calf serum used in the manufacture; 1) showing the reduction of Bovine Viral Diarrhoea virus by at least 106 and 2) establishing the exact dose of irradiation received by the serum.
Danish: Fremstilleren skal derfor inden den 15. april 2000 forelægge CVMP data vedrørende valideringsundersøgelserne af γ-bestrålingen af det ved fremstillingen anvendte føtale kalveserum, 1) som viser en reduktion af BVD-virus med mindst 106 og 2) som bestemmer den præcise strålingsdosis, som serummet har modtaget.
English: Interferon sensitive products should not be applied intranasally following 5 days after intranasal vaccination.
Danish: Interferon følsomme produkter bør ikke bruges intranasalt de første 5 dage efter intranasal vaccination.
English: The needles and syringes used for application of the vaccine must not be sterilised by chemical desinfectants as this may impair the efficacy of the vaccine.
Danish: Sprøjter og kanyler, der bruges til indgivelse af vaccinen, må ikke være steriliserede af kemiske desinfektionsmidler, da vaccinen herved kan svækkes.
English: According to an independent commission of international BVD experts it is difficult to assess the probability that cattle vaccinated with IBR-vaccine contaminated with a small amount of live BVD virus become diseased, because various factors are involved that determine whether or not BVD emerges.
Danish: Ifølge et uafhængigt udvalg af internationale BVD-eksperter er det vanskeligt at vurdere sandsynligheden for, at kvæg, der er vaccineret med IBR-vaccine, som er kontamineret med en lille mængde levende BVD-virus, angribes af sygdom, fordi der er flere forskellige faktorer, der er afgørende for, om BVD bryder ud eller ej.
English: - The implementation of the recommendations of an external inspecting consultant.
Danish: - Gennemførelse af en ekstern tilsynsførende sagkyndigs anbefalinger.
English: microscopical inspection typical for MDBKcells complies
Danish: Mikroskopisk inspektion Typisk for MDBKceller
English: However, re-evaluation revealed that the presence of a rather high level of BVD antibodies in this serum masked the presence of contaminating BVD-virus and limited its multiplication.
Danish: Ved en ny evaluering viste det sig imidlertid, at forekomsten af et forholdsvis højt indhold af BVD-antistoffer i dette serum tilslørede forekomsten af forurenende BVD-virus og begrænsede dens formering.
English: The Marketing Authorisation Holders are required to send to the National Competent Authorities exactly the same documentation (in particular SP-017, SO D-20, SO D-107, SO D-076, SO D-127, SO D-123 and FC-IBM which were fully assessed and considered sufficiently validated by the CVMP to support the recommended changes) in order to initiate the corresponding variations to the National Marketing Authorisations.
Danish: Indehaverne af markedsføringstilladelserne skal forelægge de nationale kompetente myndigheder præcist den samme dokumentation (især SP-017, SO D-20, SO D-107, SO D-076, SO D-127, SO D123 og FC-IBM, som er blevet fuldt vurderet og valideret af CVMP som støtte for de anbefalede ændringer) med henblik på indførelse af tilsvarende ændringer i de nationale markedsføringstilladelser.
English: Vaccination with 50 doses of such a contaminated batch of vaccine concerned did not result in an infection of susceptible cattle.
Danish: Vaccination med 50 doser af den pågældende kontaminerede vaccinebatch fremkaldte ingen infektion i modtageligt kvæg.