FrancophonIA/ELRC3.0 huggingface dataset:
English: In the PV population, 5 (13%) patients in the rituximab group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the rituximab group and 33 (92%) patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
Danish: I PV-populationen havde 5 (13%) patienter i rituximab-gruppen og 3 (8 %) patienter i standarddosis prednison-gruppen moderat sygdom, og 33 (87%) patienter i rituximabgruppen og 33 (92%) patienter i standarddosis prednison-gruppen havde svær sygdom i henhold til sygdomssværhedsgrad defineret ved Harman's kriterier.
English: Blitzima can be given alone or with other medicines called “chemotherapy”.
Danish: Blitzima kan anvendes alene eller sammen med kemoterapi.
English: You might get infections more easily during your treatment with Blitzima.
Danish: Risikoen for infektioner kan øges under behandling med Blitzima.
English: If you are being treated for non-Hodgkin's Lymphoma
Danish: a) Hvis du behandles for non-Hodgkin-lymfom
English: You must also do this for 12 months after your last treatment with Blitzima.
Danish: I skal fortsætte med sikker prævention i 12 måneder efter din sidste behandling med Blitzima.
English: +left ventricular failure, +supraventricular tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia severe cardiac disorders4
Danish: +venstre ventrikulært svigt, +supraventrikulær takykardi, +ventrikulær takykardi, +angina, +myokardieiskæmi, bradykardi,
English: Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Danish: Da der er begrænset viden om brug af Blitzima til børn og unge, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet inden medicinen gives, hvis du eller dit barn er under 18 år.
English: Disease‐free survivala Subgroup analysis
Danish: Varighed til ny lymfombehandling Sygdomsfri overlevelsea Analyse af undergrupper PFS
English: A total of 6/34 (18%) of rituximab treated patients from the maintenance therapy clinical trial developed ADA.
Danish: I alt 6 ud af 34 (18%) rituximab-behandlede patienter fra det kliniske studie med vedligeholdelsesbehandling udviklede ADA.
English: System organ class
Danish: Systemorganklass e
English: Blitzima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.
Danish: Blitzima er i kombination med kemoterapi indiceret til behandling af kronisk lymfatisk leukæmi (CLL) hos patienter, som ikke tidligere er behandlet, og til patienter med relaps/refraktær CLL.
English: Patients treated with rituximab in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
Danish: I alle studier havde patienter behandlet med rituximab i kombination med methotrexat en signifikant større reduktion i sygdomsaktivitetsscore (DAS28) end patienter behandlet med methotrexat alene(tabel 12).
English: The recommended dosage of Blitzima in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Danish: Den anbefalede dosis af Blitzima i kombination med kemoterapi til tidligere ubehandlede patienter og til relaps/refraktære patienter er 375 mg/m2 legemsoverflade, som gives på dag 0 af første behandlingsserie, efterfulgt af 500 mg/m2 legemsoverflade på dag 1 af hver af de følgende serier, i alt 6 serier.
English: A total of 6/34 (18%) of rituximab-treated patients from the maintenance therapy clinical trial developed ADA.
Danish: I alt 6 ud af 34 (18 %) rituximab-behandlede patienter fra det kliniske studie med vedligeholdelsesbehandling udviklede ADA.
English: Treatment with Blitzima uses four separate infusions given at weekly intervals.
Danish: Hvert behandlingsforløb Blitzimabestår af fire separate infusioner, der gives med én uges mellemrum.
English: What Blitzima is and what it is used for What you need to know before you use Blitzima How to use Blitzima
Danish: Virkning og anvendelse Det skal du vide, før du begynder at få Blitzima Sådan får du Blitzima
English: Blitzima is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Danish: Blitzima er, i kombination med CHOP-kemoterapi (cyclophosphamid, doxorubicin, vincristin og prednisolon), indiceret til behandling af patienter med CD20 positivt, diffust storcellet B-celle nonHodgkin-lymfom.
English: The recommended dose of Blitzima used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
Danish: Den anbefalede dosis af Blitzima til vedligeholdelsesbehandling hos patienter med recidiveret/ refraktært follikulært lymfom, som har responderet på induktionsbehandling, er 375 mg/m2 legemsoverfladeareal én gang hver 3. måned (startende 3 måneder efter den sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (8 infusioner i alt).
English: The recommended dosage of Blitzima for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Danish: Den anbefalede dosis af Blitzima til induktion af remission af GPA og MPA er 375 mg/m2 legemsoverfladeareal, administreret som intravenøs infusion, én gang ugentligt i 4 uger (4 infusioner i alt).
English: Blitzima is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Danish: Blitzima gives i kombination med binyrebarkhormon, for at behandle sygdommen granulomatose med polyangiitis (blev tidligere kaldt Wegeners granulomatose) og mikroskopisk polyangiitis.
English: The recommended dose of Blitzima used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 infusions in total).
Danish: Den anbefalede dosis af Blitzima til vedligeholdelsesbehandling hos tidligere ubehandlede patienter med follikulært lymfom, som har responderet på induktionsbehandling, er 375 mg/m2 legemsoverfladeareal én gang hver 2. måned (startende 2 måneder efter den sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (12 infusioner i alt).
English: For retreatment with Blitzima monotherapy for patients who have responded to previous treatment with Blitzima monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks (see section 5.1).
Danish: Til genbehandling med Blitzima monoterapi til patienter, som har responderet på tidligere behandling med Blitzima monoterapi for recidiveret/refraktært follikulært lymfom, er den anbefalede dosis: 375 mg/m2 legemsoverfladeareal, givet som en intravenøs infusion én gang ugentligt i 4 uger (se pkt.
English: The recommended dose of Blitzima in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Danish: Den anbefalede dosis af Blitzima i kombination med kemoterapi til induktionsbehandling hos tidligere ubehandlede patienter eller patienter med recidiveret/ refraktært follikulært lymfom er 375 mg/m2 legemsoverfladeareal pr. behandlingsserie i op til 8 serier.
English: EGIS Pharmaceuticals PLC pārstāvniecība Latvijā Tel: +371 67613859
Danish: EGIS PHARMACEUTICALS PLC atstovybė Tel: +370 5 231 4658
English: Initial treatment, in combination with chemotherapy In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
Danish: I et åbent, randomiseret studie blev 322 tidligere ubehandlede patienter med follikulært lymfom randomiseret til enten CVP-kemoterapi (cyklophosphamid 750 mg/m2, vincristin 1,4 mg/m2 op til maksimalt 2 mg på dag 1 og prednisolon 40 mg/m2 på dag 1-5) hver 3. uge i 8 serier eller til rituximab 375 mg/m2 i kombination med CVP (R-CVP).
English: Overall response rate* chi-squared test p value odds ratio (95% CI)
Danish: Samlet respons rate* chi-i-anden-test p-værdi odds ratio (95% KI) Komplet respons (CR/CRu) rate*
English: infusions separated by two weeks (on Day 1 and Day 15) followed by 500 mg IV every 6 months for 18 months) or azathioprine (administered orally at a dose of 2 mg/kg/day for 12 months, then 1.5 mg/kg/day for 6 months, and finally 1 mg/kg/day for 4 months (treatment discontinuation after these 22 months).
Danish: Til den tid og inden for højst 1 måned efter den sidste cyclophosphamid pulsbehandling blev patienterne randomiseret til at få enten rituximab (to 500 mg intravenøse infusioner med to ugers mellemrum (på dag 1 og dag 15) efterfulgt af 500 mg intravenøst hver 6. måned i 18 måneder) eller azathioprin (administreret oralt i en dosis på 2 mg/kg/dag i 12 måneder, derefter 1,5 mg/kg/dag i 6 måneder og til sidst 1 mg/kg/dag i 4 måneder (behandlingsophør efter disse 22 måneder)).
English: The recommended dose of Blitzima monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks.
Danish: Den anbefalede dosis af Blitzima monoterapi til induktionsbehandling hos voksne patienter med grad III-IV follikulært lymfom, som er resistente over for behandling med kemoterapi eller som er i deres anden eller efterfølgende recidiv efter kemoterapi, er 375 mg/m2 legemsoverfladeareal, givet som intravenøs infusion én gang ugentligt i 4 uger.
English: c) Granulomatosis with polyangiitis or microscopic polyangiitis
Danish: c) Granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: Complete response (CR/CRu) rate* 48% 67% 53% 67% chi-squared test p value odds ratio (95% CI)
Danish: Samlet respons rate* chi-i-anden-test p-værdi odds ratio (95% KI) Komplet respons (CR/CRu) rate* chi-i-anden-test p-værdi odds ratio (95% KI)
English: , weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Danish: Metabolisme og ernæring hyperglykæmi, vægttab, perifert ødem, ansigtsødem, øget LD, hypocalcæmi
English: Your doctor may decide to stop your Blitzima treatment if these reactions are serious.
Danish: Hvis disse reaktioner er alvorlige, kan lægen vælge at stoppe behandlingen med Blitzima.
English: microscopic polyangiitis or pemphigus vulgaris must be given the patient alert card with each infusion.
Danish: Granulomatose med polyangiitis og mikroskopisk polyangiitis Patienter behandlet med Blitzima skal have udleveret patientkortet ved hver infusion.
English: Blitzima 500 mg concentrate for solution for infusion Rituximab
Danish: Blitzima 500 mg, koncentrat til infusionsvæske, opløsning Rituximab
English: Blitzima 100 mg concentrate for solution for infusion Rituximab
Danish: Blitzima 100 mg, koncentrat til infusionsvæske, opløsning Rituximab
English: Blitzima 500 mg concentrate for solution for infusion
Danish: Blitzima 500 mg koncentrat til infusionsvæske, opløsning
English: You may be asked not to take these other medicines 12 hours before you are given Blitzima.
Danish: 12 timer inden, du får Blitzima.
English: Blitzima 100 mg concentrate for solution for infusion
Danish: Blitzima 100 mg koncentrat til infusionsvæske, opløsning
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Blitzima infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Danish: Hos patienter med GPA eller MPA i sygdomsremission eller PV, bør præmedicinering i form af 100 mg methylprednisolon i.v.
English: Also do not breast-feed for 12 months after your last treatment with Blitzima.
Danish: Da Blitzima udskilles i mælken, må du ikke amme, mens du er i behandling med Blitzima samt i 12 måneder efter din sidste dosis af Blitzima.
English: Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma or chronic lymphocytic leukaemia
Danish: a) Hvis du behandles for non-Hodgkin-lymfom eller kronisk lymfatisk leukæmi
English: • What you need to know before having
Danish: • Hvad du skal vide, før du får Blitzima
English: Progression‐free survival (PFS)
Danish: Progressionsfri overlevelse (PFS)
English: immunosuppressive therapy and/or chemotherapy.
Danish: Induktionsbehandling i kombination med kemoterapi
English: After 14-21 days.
Danish: 14-21 dage.
English: The product has been authorised in the reference Member State (Slovak Republic) for 7 years.
Danish: Lægemidlet har været godkendt i referencemedlemsstaten (Den Slovakiske Republik) i 7 år.
English: Assessment of Quality and Efficacy issues
Danish: Vurdering af kvalitets- og effektivitetsaspekter
English: The National Competent Authority of the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holder:
Danish: Den nationale kompetente myndighed i referencemedlemsstaten skal sikre, at følgende betingelser opfyldes af indehaveren af markedsføringstilladelsen:
English: In addition to these quality points Spain also considered that the permitted level of residual formaldehyde was too high.
Danish: Ud over disse punkter vedrørende kvalitet vurderede Spanien også, at det tilladte niveau af restkoncentrationer af formaldehyd var for højt.
English: Slovak Republic1
Danish: Slovakiske Republik1
English: At the conclusion of the assessment phase of the procedure the concerned Member State Poland was prepared to grant an authorisation.
Danish: Efter procedurens vurderingsfase var den berørte medlemsstat Polen klar til at godkende lægemidlet.
English: The present referral follows an application for mutual recognition of the product in Poland and Spain.
Danish: Nærværende indbringelsesprocedure finder sted som følge af en ansøgning om gensidig anerkendelse af lægemidlet i Polen og Spanien.
English: There had been initial concerns related to whether the control parameters in place during production and on the finished product could ensure consistency of production.
Danish: Der havde indledningsvis været betænkeligheder i forbindelse med, hvorvidt de kontrolparametre der anvendes under produktionen og på det færdige produkt kunne sikre ensartethed i produktionen.
English: Murgašova 5 949 01 Nitra Slovak
Danish: Murgašova 5 949 01 Nitra Den Slovakiske Republik
English: NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, VETERINÆRLÆGEMIDLETS STYRKE, DYREART, INDGIVELSESVEJE, TILBAGEHOLDELSESTID OG ANSØGER/INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: In particular, it was requested to confirm that this vaccine covered the whole range of Apx toxins.
Danish: Der blev navnlig fremsat krav om bekræftelse af, at denne vaccine dækkede hele rækken af Apx-toksiner.
English: In addition, reports of the field studies were provided.
Danish: Der blev endvidere fremsendt rapporter over feltundersøgelserne.
English: Requirements for combined veterinary vaccines http://www.emea.europa.eu/pdfs/vet/iwp/005297en.pdf CVMP Note for guidance: Field trials with veterinary vaccines - http://www.emea.europa.eu/pdfs/vet/iwp/085299en.pdf
Danish: 2 CVMP's vejledningsnotat: Krav til kombinerede veterinære vaccinerhttp://www.emea.europa.eu/pdfs/vet/iwp/005297en.pdf 3 CVMP's vejledningsnotat: Feltundersøgelser af veterinære vacciner http://www.emea.europa.eu/pdfs/vet/iwp/085299en.pdf
English: There were no details of the statistical methods used, nor were there full reports of the field trials.
Danish: Der fremgik ingen beskrivelse af, hvilke statistiske metoder der var brugt, og der forelå heller ikke komplette rapporter over feltundersøgelserne.
English: Pigs Intramuscularly deep into the neck muscle.
Danish: Svin Intramuskulært dybt i nakkemusklen.
English: The justification to include the P.multocida component in the vaccine had been accepted by the Committee during the referral procedure.
Danish: Begrundelsen for at medtage P.multocidakomponenten i vaccinen var blevet accepteret af udvalget under indbringelsesproceduren.
English: The onset of immunity is stated as 14 days and the duration of immunity as 6 months.
Danish: Immuniteten indtræder efter 14 dage og varer 6 måneder.
English: Since formaldehyde is listed in Annex II of the MRL Council Regulation (EEC) No 2377/90 it has been accepted that it is not necessary for the protection of public health to establish a maximum residue limit.
Danish: Da formaldehyd fremgår af listen i bilag II i Rådets forordning (EØF) nr. 2377/90 om maksimalgrænseværdier for restkoncentrationer, er det blevet accepteret, at det ikke er nødvendigt for beskyttelse af folkesundheden at fastsætte en maksimalgrænseværdi for restkoncentrationer.
English: (*) Mean titre of agglutination antibodies after vaccination in rabbits
Danish: (*) Middeltiter af agglutinerende antistoffer efter vaccination hos kaniner
English: According to the provided data only batches clearly above the minimum potency were used.
Danish: Ifølge de fremlagte data blev kun batcher, der klart lå over minimumsstyrken, anvendt.
English: Quality issues:
Danish: Kvalitetsaspekter:
English: However, in these particular studies a serological response was induced but a correlation between efficacy (clinical signs) and potency could not be shown.
Danish: I disse bestemte undersøgelser blev der dog fremkaldt en serologisk respons, men der kunne ikke påvises nogen korrelation mellem effektivitet (kliniske tegn) og styrke.
English: It was noted that all three Apx toxigenic groups are represented in the vaccine.
Danish: Det blev bemærket, at alle de tre Apx-toksigene grupper er repræsenteret i vaccinen.
English: (0062) allows levels residual formaldehyde above 0.5 g/L provided the level has been shown to be safe.
Danish: I Den Europæiske Farmakopé (0062) tillades der en restkoncentration af formaldehyd på over 0,5 g/L, forudsat at det er blevet påvist, at niveauet er sikkert.
English: Spain raised objections which have led to the present referral procedure as it was considered that the authorisation of this veterinary medicinal product may present a potential serious risk to human or animal health or to the environment on the grounds of concerns over Quality and Efficacy.
Danish: Spanien gjorde indsigelser, som har ført til denne indbringelsesprocedure, idet det vurderedes, at godkendelse af dette veterinærmedicinske lægemiddel kan udgøre en potentiel alvorlig risiko for menneskers eller dyrs sundhed eller for miljøet på baggrund af betænkeligheder i forbindelse med lægemidlets kvalitet og effektivitet.
English: The Apx toxins present in the product (Apx I, Apx II and Apx III) are appropriate to providing protection against the serotypes present in the Member States where the product is intended to be used.
Danish: De Apx-toksiner, der findes i lægemidlet (Apx I, Apx II og Apx III), er egnede til at yde beskyttelse mod de serotyper, der findes i de medlemsstater, hvor lægemidlet skal anvendes.
English: Republic
Danish: Republik
English: Marketing Authorisation granted
Danish: Markedsføringstilladelse udstedt
English: It was shown that all comparator products contain the same range of Apx antigens as the current product, therefore a comparison could be justified on this basis.
Danish: Det blev vist, at alle de sammenlignelige produkter indeholder de samme række Apx-antigener som det aktuelle produkt, og der var derfor grundlag for en sammenligning.
English: This was considered important as pathological changes caused by P.multocida are not specific for infection with this organism.
Danish: Dette blev betragtet som betydningsfuldt, idet patologiske forandringer forårsaget af P. multocida ikke er specifikke for infektion med denne organisme.
English: Additional information supporting the close antigenic relationship between APP Serotype 9 and 11 have also been presented.
Danish: Der er også fremført yderligere informationer til støtte for det tætte antigene forhold mellem APP serotype 9 og 11.
English: The potency test for P. multocida should be able to distinguish potent and subpotent batches.
Danish: Styrketesten for P. multocida skal kunne skelne mellem potente og lavpotente batcher.
English: Pharmaceutical form
Danish: Særnavn Lægemiddelform
English: Based on an interpretation of the specific monograph that is supported by EDQM it was considered that the applicant has met these requirements through the use of the challenge strains used.
Danish: På baggrund af en fortolkning af den specifikke monografi, som støttes af EDQM, vurderedes det, at ansøgeren har opfyldt kravene ved brug af de anvendte challengestammer.
English: In particular the Applicant/MAH should clarify to what extent they could be considered to meet the criteria of minimum potency for P.multocida.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen skal navnlig præcisere, i hvilket omfang disse kan anses for at opfylde minimumskriterierne for styrke for P.multocida.
English: This differentiation is based on identification of characteristic lesions by experienced veterinary staff at slaughterhouses.
Danish: Differentieringen bygger på identificering af karakteristiske læsioner foretaget af erfarne dyrlæger på slagterier.
English: The applicant has provided supporting opinions from EDQM and the Chairman of Group 15V which supports this interpretation.
Danish: Ansøgeren har forelagt understøttende udtalelser fra European Directorate for the Quality of Medicines (EDQM) og formanden for gruppe 15V, som støtter denne fortolkning.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF APPM RESPIPHARM
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF APPM RESPIPHARM 1.
English: Whilst these lesions are not specific for the pathogen in question they provide a basis for differentiation in terms of the specificity of respiratory lesions which have different pathology and are supported in questionable cases by bacterial isolation.
Danish: Selv om disse læsioner ikke er specifikke for det pågældende patogen, danner de grundlag for differentiering med hensyn til specificiteten af luftvejslæsioner, som har forskellig patologi og i tvivlsomme tilfælde støttes af bakterieisolation.
English: Pregnant sows: Vaccine dose: 3 ml
Danish: Drægtige søer: Vaccinedosis: 3 ml
English: In brief, concerns were raised that the composition of Actinobacillus pleuropneumoniae serotypes in the vaccine (2, 9 and 11) were not based on the epizoological situation in Spain, where the most prevalent serotypes are 2, 4 and 7.
Danish: Der blev kort fortalt givet udtryk for betænkeligheder ved, at sammensætningen af Actinobacillus pleuropneumoniae-serotyper i vaccinen (2, 9 og 11) ikke var baseret på den epizoologiske situation i Spanien, hvor der er størst forekomst af serotype 2, 4 og 7.