FrancophonIA/ELRC3.0 huggingface dataset:
English: In this regard, the PRAC recommends as a condition to the marketing authorisations that the current formulations shall be replaced with formulations free from cow's milk proteins, within the agreed timeframe.
Danish: I den forbindelse anbefaler PRAC som en betingelse for markedsføringstilladelserne, at de gældende formuleringer erstattes af formuleringer uden komælksproteiner inden for den fastsatte tidsfrist.
English: In view of the above, the Croatian national competent authority (NCA) HALMED considered that the risk of serious allergic reactions in patients allergic to cow's milk treated for acute allergic conditions with intravenous/intramuscular (IV/IM) medicinal products containing as excipient lactose from bovine origin should be reviewed.
Danish: I lyset af ovennævnte overvejede den kroatiske kompetente nationale myndighed (NCA) HALMED, at risikoen for alvorlige allergiske reaktioner hos patienter, der er allergiske overfor komælk, som behandles for akutte allergiske symptomer med intravenøse/intramuskulære (IV/IM) lægemidler, der som hjælpestof indeholder laktose fra kvæg, skulle vurderes.
English: It was noted that in the European Union member states (EU MS), Norway and Iceland, at start of the procedure, medicinal products formulated with lactose of bovine origin and authorised for IV/IM use in acute allergic conditions, and therefore concerned by this procedure, were limited to certain strengths of methylprednisolone-containing products.
Danish: Det blev bemærket, at lægemidler formuleret med laktose fra kvæg, som er godkendt til IV/IM-anvendelse ved akutte allergiske reaktioner, og som derfor er berørt af denne procedure, i EU-medlemsstaterne Norge og Island ved procedurens start var begrænset til visse styrker af lægemidler indeholdende methylprednisolon.
English: To that effect, the PRAC recommends as a condition to the marketing authorisations that the MAHs shall replace the current formulations with formulations free from cow's milk proteins, within an agreed timeframe.
Danish: Med henblik herpå anbefaler PRAC som en betingelse for markedsføringstilladelserne, at indehaverne af markedsføringstilladelse skal erstatte de gældende formuleringer med formuleringer uden komælksproteiner inden for en nærmere fastsat tidsfrist.
English: Serious cases of allergic reactions have been reported in patients allergic to cow's milk administered Solu-Medrol for acute allergic conditions, including cases reporting a positive skin prick test for Solu-Medrol, a skin test for immunoglobulin E mediated allergic response.
Danish: Der er blevet rapporteret om alvorlige tilfælde af allergiske reaktioner hos patienter, der er allergisk over for komælksbaseret Solu-Medrol til anvendelse ved akutte allergiske reaktioner, herunder tilfælde af en positiv priktest for Solu-Medrol, en hudtest for immunoglobulin E-baseret allergisk reaktion.
English: In view of the above, the Committee considers that the benefit-risk balance of medicinal products containing lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions remains favourable subject to the agreed condition to the marketing authorisations, and taking into account the agreed amendments to the product information.
Danish: I lyset af ovennævnte vurderer udvalget, at benefit/risk-forholdet for lægemidler, der indeholder laktose fra kvæg, til intravenøs/intramuskulær (IV/IM) anvendelse ved akutte allergiske reaktioner, fortsat er positivt med forbehold for de aftalte betingelser i markedsføringstilladelserne, og under hensyn til de aftalte ændringer af produktinformationen.
English: When considering all the data submitted by the marketing authorisation holders (MAHs), in relation to the risk of serious allergic reactions in patients allergic to cow's milk treated for acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin, as well as data available in Eudravigilance and the literature, the PRAC was of the view that medicinal products containing lactose of bovine origin for IV/IM use in acute allergic conditions are associated with a risk of serious allergic reactions in patients allergic to cow's milk.
Danish: Når man sammenligner alle de data, der er indgivet af indehaverne af markedsføringstilladelse, i forhold til risikoen for alvorlige allergiske reaktioner hos patienter, der er allergiske over for komælk, og som blev behandlet for akutte allergiske reaktioner med lægemidler indeholdende methylprednisolon formuleret med laktose fra kvæg, samt oplysninger i Eudravigilance-databasen og i litteraturen, var PRAC af den opfattelse, at lægemidler, der indeholder laktose fra kvæg til IV/IM-anvendelse ved akutte allergiske reaktioner, er forbundet med en risiko for alvorlige allergiske reaktioner hos patienter, der er allergiske over for komælk.
English: • The PRAC reviewed the totality of the data provided by the marketing authorisation holders, in relation to the risk of serious allergic reactions in patients allergic to cow's milk treated for acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin, as well as data available in Eudravigilance and the literature.
Danish: • PRAC vurderede helheden af de leverede data fra indehaverne af markedsføringstilladelserne i forhold til risikoen for alvorlige allergiske reaktioner hos patienter, der er allergiske over for komælk, som blev behandlet for akutte allergiske symptomer med lægemidler indeholdende methylprednisolon formuleret med laktosefra kvæg samt oplysninger i Eudravigilance-databasen og i litteraturen.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for medicinal products containing lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions.
Danish: Som konsekvens heraf anbefaler udvalget, at der sker ændring af betingelserne for markedsføringstilladelserne til lægemidler, der indeholder laktose fra kvæg, til intravenøs/intramuskulær (IV/IM) anvendelse ved akutte allergiske reaktioner.
English: • The PRAC considers that, in patients allergic to cow's milk, a risk of serious allergic reactions, including anaphylactic reactions, is associated to IV/IM treatment of acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin.
Danish: • PRAC vurderer, at der hos patienter, der er allergiske over for komælk, er knyttet en risiko for alvorlige allergiske symptomer, herunder anafylaktiske reaktioner, til brugen af IV/IMbehandling af akutte allergiske symptomer med lægemidler indeholdende methylprednisolon formuleret med laktose fra kvæg.
English: The PRAC noted that the lactose used in these products is produced in accordance with the European Pharmacopoeia (Ph.
Danish: PRAC bemærkede, at den laktose, der anvendes i disse lægemidler, produceres i overensstemmelse med den relevante monografi i Den Europæiske Farmakopé, som ikke indeholder spor af mælkeproteiner.
English: • The PRAC also notes that due to the limitations inherent to the emergency settings in which methylprednisolone-containing products are commonly used, these routine measures may not entirely eliminate the risk.
Danish: • PRAC bemærker endvidere, at disse rutinemæssige foranstaltninger ikke kan eliminere risikoen helt på grund af begrænsningerne i forbindelse med de katastrofesituationer, hvor lægemidler indeholdende methylprednisolon ofte anvendes.
English: Therefore the CMDh recommends the variation to the terms of the marketing authorisations for medicinal products containing lactose of bovine origin for IV/IM use in acute allergic conditions.
Danish: Derfor anbefaler CMDh, at der sker ændring af betingelserne for markedsføringstilladelserne til lægemidler, der indeholder laktose fra kvæg, til (IV/IM) anvendelse ved akutte allergiske reaktioner.
English: Thus, data currently available does not allow establishing a safe IV/IM intake threshold for patients allergic to cow's milk and the risk of serious allergic reactions in these patients applies to all products formulated with Ph. Eur.
Danish: Således er det ikke muligt på baggrund af de foreliggende data at fastlægge en sikker IV/IM-grænse for indtag hos patienter, der er allergiske over for komælk, og risikoen for alvorlige allergiske reaktioner hos disse patienter gælder for alle lægemidler, der er formuleret i overensstemmelse med Den Europæiske Farmakopé for laktose til IV/IM-anvendelse ved akutte allergiske reaktioner.
English: The CMDh, as a consequence, considers that the benefit-risk balance of medicinal products containing lactose of bovine origin for IV/IM use in acute allergic conditions remains favourable subject to the amendments to the product information and to the condition described above.
Danish: CHMP finder følgeligt, at benefit/risk-forholdet for lægemidler, der indeholder laktose fra kvæg, til intravenøs/intramuskulær (IV/IM) anvendelse ved akutte allergiske reaktioner, fortsat er positivt, under forudsætning af at de nævnte ændringer indføres i produktinformationen og i henhold til ovennævnte betingelser.
English: It is also approved in Norway and Iceland.
Danish: Det er desuden godkendt i Norge og Island.
English: The final opinion was converted into a Decision by the European Commission on 03.09.2007.
Danish: Den endelige udtalelse blev omarbejdet til en beslutning af Europa-Kommissionen den 03.09.2007.
English: The Rapporteur and Co-Rapporteur appointed were Dr Julia Dunne and Dr Ingemar Persson, respectively.
Danish: Som rapportør og medrapportør udpegedes henholdsvis dr. Julia Dunne og dr. Ingemar Persson.
English: The Member States' competent authorities will continue to keep the product under regular review.
Danish: De kompetente myndigheder fører løbende opsyn med produktet.
English: E-mail: mail@emea.eu.int http://www.emea.eu.int©.EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Danish: E-mail: mail@emea.europa.eu http://www.emea.europa.eu©.EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 31 OF COUNCIL DIRECTIVE 2001/83/EC, AS AMENDED, FOR
Danish: SAMMENDRAG AF UDTALELSEN VEDRØRENDE INDBRINGELSEN I HENHOLD TIL ARTIKEL 31 I RÅDETS DIREKTIV 2001/83/EØF, MED SENERE ÆNDRINGER, FOR
English: The 4 issues raised in the referral concerned the analyses of the Early Prostate Cancer Programme (EPC):
Danish: De fire spørgsmål, der blev rejst i indbringelsen, vedrørte analyserne af undersøgelserne i Early Prostate Cancer Programme (EPC):
English: To address this concern, a new epidemiological study will be performed, as part of an agreed Risk Management Plan.
Danish: Med henblik på denne betænkelighed skal der gennemføres en ny epidemiologisk undersøgelse som led i en godkendt risikostyringsplan.
English: International Non-Proprietary Name (INN): bicalutamide
Danish: Internationalt fællesnavn (INN): bicalutamid
English: Oral explanations were given on 22 May 2007.
Danish: Mundtlige forklaringer blev fremsat den 22. maj 2007.
English: The referral procedure started on 27 July 2006.
Danish: Henvisningsproceduren blev indledt den 27. juli 2006.
English: * Note: The information given in this document and Annexes reflect only the CHMP Opinion dated 24 May 2007.
Danish: * Bemærkning: Oplysningerne i nærværende dokument og de tilhørende bilag afspejler udelukkende CHMP's udtalelse af 24. maj 2007.
English: On 27 July 2006, Belgium presented a referral to the EMEA under Article 31 of Directive 2001/83, as amended.
Danish: Den 27. juli 2006 foretog Belgien en indbringelse for EMEA i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer.
English: Written explanations were provided by the Marketing Authorisation Holders on 20 October 2006, 22 March 2007 and on 15 May 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 20. oktober 2006, den 22. marts 2007 og den 15. maj 2007.
English: London, 16 August 2007 EMEA/378451/2007
Danish: London, den 16. august 2007 EMEA/378451/2007
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended relevant sections of the Summary of Product Characteristics in the Annex III, and the conditions of the marketing authorisations in the Annex IV.
Danish: Listen over de berørte produktnavne findes i bilag I. De faglige konklusioner fremgår af bilag II, de relevante punkter af produktresuméet af bilag III, og betingelserne for markedsføringstilladelserne af bilag IV.
English: - the lack of an overall survival benefit versus adverse events in ‘locally advanced prostate cancer'; - statistical concerns regarding multiplicity; - the standard of care for the placebo group in the relevant studies; - the number of deaths due to cardiac failure.
Danish: - den manglende fordel i total overlevelse, sammenholdt med bivirkningerne, ved "lokal avanceret prostatacancer", - statistiske betænkeligheder vedrørende multiplicitet, - behandlingsstandarden for placebogruppen i de pågældende undersøgelser, - antallet af dødsfald som følge af hjertesvigt.
English: Bicalutamide 150 mg is marketed in the EU following national and Mutual Recognition application procedures.
Danish: Bicalutamid, 150 mg, markedsføres i EU efter nationale ansøgninger og ansøgninger i henhold til den gensidige anerkendelsesprocedure.
English: Locally advanced prostate cancer refers to larger tumours or tumours with spread to lymph nodes, but not involving spread to other organs.
Danish: Ved lokal avanceret prostatacancer forstås større tumorer eller tumorer med spredning til lymfeknuder, men uden spredning til andre organer.
English: Bicalutamide 150 mg-containing medicinal products (See Annex 1)
Danish: Lægemidler indeholdende bicalutamid, 150 mg (se bilag 1).
English: Its authorised indications include the treatment of patients with locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Danish: De godkendte indikationer er lokal avanceret prostatacancer som umiddelbar behandling, enten alene eller i kombination med anden behandling, eller som adjuverende behandling til radikal prostatektomi eller strålebehandling.
English: Bicalutamide is an oral anti-androgen used in the management of prostate cancer.
Danish: Bicalutamid er et peroralt antiandrogen, der anvendes til behandling af prostatacancer.
English: The reasons for referral concerned a review of the benefit/risk profile of medicinal products containing bicalutamide 150 mg.
Danish: Begrundelsen for indbringelsen fremgik af en gennemgang af risk/benefit-profilen af lægemidler indeholdende bicalutamid, 150 mg.
English: In view of the available data, the CHMP concluded that a potential association between the use of bicalutamide 150 mg and heart failure cannot be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains.
Danish: På baggrund af de foreliggende oplysninger konkluderede CHMP, at en sammenhæng mellem brugen af bicalutamid, 150 mg, og hjertesvigt ikke kan udelukkes, og fandt derfor, at der fortsat er behov for nærmere at undersøge den kardiovaskulære morbiditet og mortalitet.
English: The CHMP considered that bicalutamide 150 mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to treatment of patients at high risk of disease progression.
Danish: CHMP fandt, at bicalutamid, 150 mg, er effektivt til behandling af lokal avanceret prostatacancer, men at indikationen bør indskrænkes til patienter med høj risiko for progression af sygdommen,
English: Based on evaluation of the available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of bicalutamide 150 mg-containing medicinal products remains favourable, and therefore adopted an opinion on 24 May 2007 recommending the maintenance or the granting, as appropriate, of the Marketing Authorisations with amendments to the relevant sections of the Summary of Product Characteristics, for bicalutamide 150 mg-containing medicinal products.
Danish: Udvalget vedtog derfor den 24. maj 2007 en udtalelse, der anbefaler opretholdelse eller, i givet fald, udstedelse af markedsføringstilladelse, med ændringer i de relevante punkter af produktresumeet, for produkter indeholdende bicalutamid, 150 mg.
English: The Member States shall ensure that the following conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at følgende betingelser eller begrænsninger i forhold til sikker og korrekt anvendelse af lægemidlet beskrevet herunder bliver implementeret:
English: • The need for intake of the 15 mg and 20 mg tablets with food
Danish: • Behovet for at tage 15 mg og 20 mg tabletterne sammen med mad
English: • Necessity to carry the Patient alert card with them at all times
Danish: • Nødvendigheden af altid at have patientkortet på sig
English: • The educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Xarelto and providing guidance on how to manage that risk.
Danish: • Dette uddannelsesmateriale skal øge opmærksomheden om den potentielle risiko for blødning ved behandling med Xarelto og give vejledning i, hvorledes denne risiko håndteres.
English: • The content and format of the educational material, together with a communication plan, should be agreed with the MAH prior to distribution of the educational pack and launch of the new indication.
Danish: • Indhold og udformning af uddannelsesmaterialet samt en kommunikationsplan skal godkendes sammen med indehaveren af markedsføringstilladelsen inden uddannelsesmaterialet distribueres og den nye indikation lanceres.
English: The need for intake of the 15 mg and 20 mg tablets with food Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals that they are taking Xarelto if they need to have any surgery or invasive procedure.
Danish: Behovet for at tage 15 mg og 20 mg tabletterne sammen med mad Nødvendigheden af altid at have patientkortet på sig Behovet for at oplyse sundhedspersonalet om, at man tager Xarelto, hvis man skal opereres eller have foretaget andre former for indgreb.
English: • Signs or symptoms of bleeding and when to seek attention from a health care provider.
Danish: • Tegn eller symptomer på blødning, og hvornår man skal kontakte sundhedspersonalet
English: • The Prescriber Guide should contain the following key safety messages: Details of populations potentially at higher risk of bleeding Recommendations for dose reduction in at risk populations Guidance regarding switching from or to rivaroxaban treatment The need for intake of the 15 mg and 20 mg tablets with food Management of overdose situations The use of coagulation tests and their interpretation That all patients should be provided with a Patient alert card and be counselled about:
Danish: Vejledningen til den ordinerende læge skal indeholde følgende hovedpunkter om sikkerhed: Oplysning om populationer med potentielt højere risiko for blødninger Anbefalinger til dosisnedsættelse i risikopopulationer Vejledning om skift fra eller til rivaroxaban-behandling Behovet for at tage 15 mg og 20 mg tabletterne sammen med mad Håndtering af tilfælde af overdosering Brugen af koagulationstests og tolkning af samme At alle patienter skal have udleveret et patientkort og modtage vejledning i:
English: • The need to inform Health Care Professionals that they are taking Xarelto if they need to have any surgery or invasive procedure.
Danish: • Behovet for at oplyse sundhedspersonalet om, at man tager Xarelto, hvis man skal opereres eller have foretaget andre former for indgreb.
English: • The MAH shall provide an educational pack, targeting all physicians who are expected to prescribe/use Xarelto prior to the launch of the new indication for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
Danish: • Indehaver af markedsføringstilladelsen skal fremstille uddannelsesmateriale rettet mod de læger, som forventes at ordinere/anvende Xarelto, inden lanceringen af den nye indikation til behandling af dyb venetrombose (DVT) samt forebyggelse af recidiverende DVT og lungeemboli (PE) efter akut DVT hos voksne.
English: • The MAH shall provide an educational pack, targeting all physicians who are expected to prescribe/use Xarelto prior to the launch of the new indication for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors.
Danish: • Indehaver af markedsføringstilladelsen skal fremstille uddannelsesmateriale rettet mod de læger, som forventes at ordinere/anvende Xarelto, inden lanceringen af den nye indikation til forebyggelse af apopleksi og systemisk emboli hos voksne patienter med ikke-valvulær atrieflimren med én eller flere risikofaktorer.
English: Date of first authorisation: 08 December 2016
Danish: Dato for første markedsføringstilladelse: 8. december 2016
English: You must continue to take precautions to avoid this.
Danish: De skal fortsat tage forholdsregler for at undgå dette.
English: You must use an effective method of contraception to avoid becoming pregnant.
Danish: De skal anvende en effektiv præventionsmetode for at undgå at blive gravid.
English: <For inner carton of multipack:> Component of a multipack, can't be sold separately.
Danish: <til inderkarton af multipakning> En del af en multipakning, må ikke sælges separat.
English: If no alternative treatment is available, prolonged dose intervals may be used as follows:
Danish: Hvis der ikke er andre alternative behandlinger tilgængelige, kan forlængede doseringsintervaller anvendes på følgende måde:
English: • Talk to your doctor or pharmacist if you are over 65.
Danish: • Kontakt lægen eller eller apotekspersonalet, hvis De er over 65 år.
English: If you miss a dose, work out how long since you should have taken it.
Danish: Hvis De har glemt en dosis, skal De finde ud af, hvor lang tid der er gået, siden De skulle have taget den.
English: In addition, 61% of patients had normal ALT at week 48.
Danish: Ydermere havde 61% af patienterne normale ALAT-værdier ved uge 48.
English: • If you have HBV your doctor may offer you an HIV test to see if you have both HBV and HIV.
Danish: • Hvis De har HBV, kan Deres læge tilbyde Dem en HIV-test for at se, om De har både HBV og HIV.
English: • tacrolimus (for suppression of the immune system),
Danish: • tacrolimus (for undertrykkelse af immunsystemet),
English: CARTON FOR BLISTER
Danish: KARTON TIL BLISTER
English: If this is unavoidable, your doctor will monitor your kidney function once a week.
Danish: Hvis dette ikke kan undgås, vil Deres læge overvåge Deres nyrefunktion en gang om ugen.
English: • It is very important to tell your doctor if you are taking other medicines that may damage your kidneys.
Danish: • Det er meget vigtigt at fortælle Deres læge det, hvis De tager anden medicin, som kan skade Deres nyrer.
English: If you are an adult, your doctor may advise you to take the tablets less often.
Danish: Hvis De er voksen, kan Deres læge måske råde Dem til at tage tabletterne mindre hyppigt.
English: BMD Z-scores were not adjusted for height and weight.
Danish: BMD Z-score blev ikke justeret for højde og vægt.
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.
Danish: Ved langvarig behandling på mere end 2 år tilrådes regelmæssig revurdering for at bekræfte, at det fortsat er hensigtsmæssigt for patienten at fortsætte den valgte behandling.