FrancophonIA/ELRC3.0 huggingface dataset:
English: The paediatric patients received 4 mg/kg monthly intramuscular dose of fulvestrant.
Danish: De pædiatriske patienter fik en intramuskulær dosis fulvestrant på 4 mg/kg hver måned.
English: Neoadjuvant treatment for up to 16 weeks in breast cancer patients with either Faslodex 500 mg or Faslodex 250 mg did not result in clinically significant changes in serum bone-turnover markers.
Danish: Neoadjuverende behandling med enten Faslodex 500 mg eller Faslodex 250 mg, til brystkræftpatienter i op til 16 uger, resulterede ikke i klinisk signifikante ændringer af knogle-turnover-markører i serum.
English: - The other ingredients (excipients) are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.
Danish: - Øvrige indholdsstoffer (hjælpestoffer): ethanol (96 procent), benzylalkohol, benzylbenzoat og renset ricinusolie.
English: Faslodex contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Danish: Faslodex indeholder 10 % w/v ethanol (alkohol), dvs. op til 500 mg per injektion, hvilket svarer til 10 ml øl eller 4 ml vin.
English: Two clear type 1 glass pre-filled syringes with polystyrene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Faslodex solution for injection.
Danish: To klare type 1 fyldte glas-injektionssprøjter med et polystyren pumpestempel, der er lukket med sikkerhedsforsegling, hver indeholdende 5 ml Faslodex-opløsning til injektion.
English: Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and p-value
Danish: Progressionsfri overlevelse Antal PFS-hændelser (%) PFS hazard ratio (95 % CI) og p-værdi
English: Faslodex contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml.
Danish: Faslodex indeholder 500 mg benzylalkohol per injektion, hvilket svarer til 100 mg/ml.
English: • Expel excess gas from the syringe.
Danish: • Fjern overskydende luft fra sprøjten.
English: 1 pre-filled syringe (5 ml) 1 safety needle
Danish: 1 fyldt injektionssprøjte (5 ml) 1 beskyttet kanyle
English: Faslodex should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Danish: Anvend Faslodex med forsigtighed til patienter med meget nedsat nyrefunktion (kreatinin clearance < 30 ml/min).
English: For detailed instructions for administration, see section 6.6.
Danish: 6.6. for detaljeret administrationsinstruktion.
English: Ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.
Danish: Ethanol (96 procent), benzylalkohol, benzylbenzoat og renset ricinusolie.
English: For the subgroup of patients with disease limited to non-visceral metastasis (n=208), the HR was 0.592 (95% CI: 0.419, 0.837) for the Faslodex arm compared to the anastrozole arm. For the subgroup of patients with visceral metastasis (n=254), the HR was 0.993 (95% CI: 0.740, 1.331) for the Faslodex arm compared to the anastrozole arm.
Danish: For undergruppen af patienter med sygdom, der var begrænset til ikke-viscerale metastaser (n=208), var hazard ratio 0,592 (95 % CI: 0,419; 0,837) for Faslodex-armen sammenlignet med anastrozol-armen.
English: Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Hazard ratio 95% CI p-value
Danish: Sammenligning mellem grupper (Faslodex 500 mg/Faslodex 250 mg) Hazard ratio
English: Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with Faslodex injection.
Danish: I forbindelse med administration af Faslodex, er bivirkninger, relateret til injektionsstedet, herunder iskias, neuralgi, neuropatiske smerter og perifer neuropati, observeret og rapporteret.
English: Do not use Faslodex: - if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant or breast-feeding - if you have severe liver problems
Danish: Brug ikke Faslodex - hvis du er allergisk over for fulvestrant eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Faslodex 250 mg solution for injection.
Danish: Faslodex 250 mg injektionsvæske, opløsning.
English: Store and transport in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab og transporteres nedkølet (2 °C-8 °C).
English: 2 pre-filled syringes (5 ml each) 2 safety needles
Danish: 2 fyldte injektionssprøjter (5 ml i hver) 2 beskyttede kanyler
English: Hepatic failure c, f
Danish: neuralgi c, f
English: Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Danish: Anæmi inkluderer de følgende PTs: anæmi, nedsat hæmoglobin, nedsat hæmatokrit.
English: All Patients -AE subgroup (n=423) -AI subgroup (n=313) OS
Danish: Alle patienter -AE-undergruppe (n=423) -AI-undergruppe (n=313) OS
English: One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Danish: En fyldt injektionssprøjte indeholder 250 mg fulvestrant i 5 ml opløsning.
English: All Patients -AE subgroup (n=423) -AI subgroup (n=313)
Danish: Alle patienter -AE-undergruppe (n=423) -AI-undergruppe (n=313)
English: Vaginal moniliasis f, leukorrhea
Danish: Vaginal blødning Ikke almindelig Vaginal candidiasis f, leukoré
English: One clear type 1 glass pre-filled syringe with polystyrene plunger rod, fitted with a tamper-evident closure, containing 5 ml Faslodex solution for injection.
Danish: En klar type 1 fyldt glas-injektionssprøjte med et polystyren pumpestempel, der er lukket med sikkerhedsforsegling, indeholdende 5 ml Faslodex opløsning til injektion.
English: Caution should be taken while administering Faslodex at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and
Danish: Der bør udvises forsigtighed ved administration af Faslodex i det dorsogluteale injektionsområde på grund af den nært underliggende iskiasnerve (se pkt.
English: - previous problems with blood clots - osteoporosis (loss of bone density) - alcoholism
Danish: - knogleskørhed (nedsat mineralindhold i knoglerne) - alkoholisme
English: Faslodex contains 10% w/v ethanol (alcohol) as an excipient, i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Danish: Faslodex indeholder 10 % vægt/volumen ethanol (alkohol) som hjælpestof, dvs. op til 500 mg pr. injektion, svarende til 10 ml øl eller 4 ml vin pr. injektion.
English: However, since asthenia has been reported very commonly with Faslodex, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
Danish: Derfor skal patienter, som oplever denne bivirkning, være forsigtige, når de fører motorkøretøj eller betjener maskiner.
English: What Faslodex looks like and contents of the pack Faslodex is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection.
Danish: Faslodex er en klar, farveløs til gul, viskøs væske i en fyldt injektionssprøjte lukket med en sikkerhedsforsegling indeholdende 5 ml opløsning til injektion.
English: Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Danish: Udslæt inkluderer de følgende PTs: udslæt, makulopapuløst udslæt, kløende udslæt, erytematøst udslæt, papulært udslæt, dermatitis, acneiform dermatitis, toksisk hududslæt.
English: AstraZeneca AB, o.z.
Danish: Slovenská republika AstraZeneca AB o.z.
English: This study compared the efficacy and safety of Faslodex 500 mg (n=362) with Faslodex 250 mg (n=374).
Danish: I dette studie blev virkning og sikkerhed af Faslodex 500 mg (n=362)
English: Intramuscular use.
Danish: Til intramuskulært brug
English: Solution for injection in a pre-filled syringe.
Danish: Injektionsvæske, opløsning i en fyldt injektionssprøjte.
English: What Faslodex is and what it is used for What you need to know before you use Faslodex How to use Faslodex
Danish: Det skal du vide, før du begynder at bruge Faslodex Sådan skal du bruge Faslodex Bivirkninger
English: The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.
Danish: Den anbefalede dosis er 500 mg givet med 1 måneds interval.
English: Elevated hepatic enzymes (ALT, AST, ALP)
Danish: Meget almindelig Forhøjede leverenzymer (ALAT, ASAT, alkalisk fosfatase)
English: Excipients with known effect (per 5 ml) Ethanol (96%, 500 mg) Benzyl alcohol (500 mg) Benzyl benzoate (750 mg)
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på (pr. 5 ml) Ethanol (96 %, 500 mg)
English: There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Danish: Der er ingen data vedrørende patienter med svært nedsat leverfunktion (se pkt.
English: NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Faslodex at the dorsogluteal injection site (see section 4.4).
Danish: BEMÆRK: Der bør udvises forsigtighed ved administration af Faslodex i det dorsogluteale injektionsområde på grund af den nært underliggende iskiasnerve (se pkt.
English: • Anaphylactic reactions
Danish: • Anafylaktisk reaktion/shock
English: Severe hepatic impairment (see sections 4.4 and 5.2).
Danish: 4.3, 4.4 og 5.2).
English: • Joint and musculoskeletal pain
Danish: • Smerter i led, muskler og knogler
English: When Faslodex is used in combination with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Danish: Se også produktresuméet for palbociclib, når Faslodex anvendes i kombination med palbociclib.
English: Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Danish: Faslodex skal anvendes med forsigtighed til patienter med let til moderat nedsat leverfunktion (se pkt.
English: • Pull shield straight off needle to avoid damaging needle point.
Danish: • Kanylens beskyttelseshylster trækkes af i længderetningen for at hindre beskadigelse af kanylens spids.
English: Instructions for administration
Danish: Administrationsinstruktioner
English: • Back pain*
Danish: • Rygsmerter*
English: Injection site haemorrhage f, injection site haematoma f, neuralgia c,f
Danish: Ikke almindelig Blødning ved injektionsstedet f, hæmatom ved injektionsstedet f,
English: Joint and musculoskeletal pain
Danish: Smerter i led, muskler og knogler
English: • Hot flushes
Danish: • Hududslæt
English: PFS Median [months (95% CI)] Number of OS Events* OS Hazard Ratio (95% CI) and p-value
Danish: Antal OS-hændelser* OS-hazard ratio (95 % CI) og p-værdi
English: Reduced platelet count
Danish: Nedsat antal blodplader
English: Vaginal haemorrhage
Danish: Mave-tarm-kanalen
English: CBR Odds Ratio (95% CI) and p-value
Danish: Klinisk benefit rate Klinisk benefit rate-odds ratio (95 % CI) og p-værdi
English: This should be analysed separately.
Danish: Dette bør analyseres separat.
English: The issue of language was raised.
Danish: Spørgsmålet om sprog blev rejst.
English: Mexico plans to recognise unilaterally EU centralised authorisations.
Danish: Mexico har planer om ensidigt at anerkende EU's centraliserede godkendelser.
English: As part of that work, the Agency had launched the ESVAC project in September 2009.
Danish: Som led i dette arbejde iværksatte agenturet ESVAC-projektet i september 2009.
English: • Revised draft agenda version 4.0.
Danish: • Revideret udkast til dagsorden version 4.0.
English: The report concluded that, in general, performance was stable over the last two years.
Danish: Rapportens konklusion var, at resultaterne generelt har været stabile i de forgangne to år.
English: Rapporteurship arrangements could be reviewed after that time.
Danish: Rapportørordningen vil kunne revideres efter dette tidspunkt.
English: The procedure concerns any incomplete and/or incorrect declarations of interests.
Danish: Proceduren vedrører ufuldstændige og/eller fejlagtige interesseerklæringer.
English: The Board stressed the importance of transparency in this context.
Danish: Bestyrelsen understregede vigtigheden af gennemsigtighed i denne sammenhæng.
English: Visit of Commissioner John Dalli
Danish: Besøg af kommissær John Dalli
English: The Board had divergent views about the two approaches.
Danish: Bestyrelsen havde forskellige holdninger til de to tilgange.
English: • The renewed EU strategy 2011-14 for social corporate responsibility.
Danish: • den fornyede EU-strategi 2011-14 for virksomhedernes sociale ansvar.
English: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
Danish: Europæisk overvågning af veterinært forbrug af antimikrobielle stoffer (ESVAC)
English: 7 June 2012
Danish: Den 7. juni 2012
English: No additional conflicts of interests were declared.
Danish: Der blev ikke afgivet yderligere erklæringer om interessekonflikt.
English: This is important to ensure that correct risk levels are generated by the system.
Danish: Dette er vigtigt for at sikre, at systemet genererer det rette risikoniveau.
English: Discharge for the budget 2010
Danish: Decharge for budgettet for 2010
English: b.) Overview of nominations received
Danish: b) Oversigt over modtagne udnævnelser
English: Appointment of Michael Lenihan as the Agency's accounting officer
Danish: Udnævnelse af Michael Lenihan til agenturets regnskabsfører
English: This was the last meeting for those civil-society representatives who attended as observers today.
Danish: Dette var det sidste møde for de civilsamfundsrepræsentanter, der deltog som observatører.
English: The European Parliament rapporteur for the discharge of EU agencies visited the Agency on 10 February.
Danish: Europa-Parlamentets ordfører for decharge for EU's agenturer besøgte agenturet den 10. februar.
English: Interpretation will be discontinued, starting from the June 2012 meeting, resulting in savings of around EUR 25,000 per year.
Danish: Tolkning afskaffes fra og med mødet i juni 2012, hvilket betyder en besparelse på ca. 25 000 EUR årligt.
English: The annual bilateral between the European Commission/the Agency and the US Food and Drug Administration (FDA) took place from 5 to 7 March.
Danish: Det årlige møde med Kommissionen/agenturet og USA's »Food and Drug Administration« (FDA) fandt sted den 5.-7. marts.
English: Public hearings should initially cover a limited number of aspects only, but may over time be expanded to cover more complex issues.
Danish: Offentlige høringer bør i princippet kun dække et begrænset antal aspekter, men over tid kunne udvides til at dække mere komplekse områder.
English: Replies to the Court are being prepared.
Danish: Svar til Revisionsretten er under udarbejdelse.
English: The rapporteur did not indicate whether or not she would recommend granting the discharge for the Agency.
Danish: Ordføreren fortalte ikke, om hun ville anbefale en decharge for agenturet.
English: Instead, policies adopted by the Agency should be used as a reference when developing national policies in this domain.
Danish: I stedet bør de politikker, som agenturet vedtager, bruges som reference til udarbejdelsen af nationale politikker på området.
English: The hearings should see a 'real public participation'.
Danish: Høringerne bør opfattes som »offentlighedens reelle deltagelse«.
English: Organisational changes
Danish: Organisatoriske ændringer
English: d.) Project 2014
Danish: d) Projekt 2014
English: Cooperation with the Mexican authorities
Danish: Samarbejde med de mexicanske myndigheder
English: The budget for 2013 is €239.1 million (2012: € 222.5 million), of which the forecast fee revenue is €181.9 million.
Danish: Budgettet for 2013 er på 239,1 mio. EUR (2012: 222,5 mio. EUR), hvoraf den forventede indtægt fra gebyrer er 181,9 mio. EUR.
English: This means that adopted minutes will be published irrespective of whether a procedure is finished or still ongoing.
Danish: Dette betyder, at vedtagne referater offentliggøres, uanset om en procedure er afsluttet eller ej.
English: The Management Board was informed of the ongoing evaluation of the European Medicines Agency and the European Aviation Safety Agency (EASA).
Danish: Bestyrelsen blev informeret om den igangværende evaluering af Det Europæiske Lægemiddelagentur og Det Europæiske Luftfartssikkerhedsagentur (EASA).
English: c.) Information and communications technology
Danish: c) Informations- og kommunikationsteknologi
English: The European Commission provided an update on legislative and policy developments, including the following:
Danish: Europa-Kommissionen orienterede om den politiske og lovgivningsmæssige udvikling, herunder følgende:
English: Other members and alternates wishing to participate in these groups were invited to do so.
Danish: Andre medlemmer og suppleanter, der ønskede at deltage i grupperne, blev opfordret til at gøre det.
English: It was proposed to limit this impact by introducing the notion of 'department of an academic institution'.
Danish: Det blev foreslået at begrænse disse følger ved at indføre begrebet »afdeling i en akademisk institution«.
English: This puts significant strain on the Agency and the national competent authorities.
Danish: Dette lagde et stort pres på agenturet og de nationale kompetente myndigheder.
English: John Dalli, Commissioner for Health, visited the Agency on 6 February 2012.
Danish: John Dalli, kommissær med ansvar for sundhed, besøgte agenturet den 6. februar 2012.
English: The Board also noted the changed structure of the work programme, which now follows the three strategic areas of the Agency's five-year strategy document.
Danish: Bestyrelsen tog også den ændrede struktur i arbejdsprogrammet, der nu følger de tre strategiske områder i agenturets femårsstrategidokument, til efterretning.
English: The Agency is stepping up its communications activities.
Danish: Agenturet har udvidet sine kommunikationsaktiviteter.
English: The additional posts reflect the increase in workload in the period 2010 to 2012.
Danish: De nye stillinger afspejler den stigende arbejdsbyrde i perioden 2010-2012.
English: • The finalisation of the eHealth Network with good representation from national authorities.
Danish: • færdiggørelse af det elektroniske sundhedsnetværk (»eHealth Network«) med tilstrækkelig repræsentation af nationale myndigheder.
English: In addition, a new sector for international and European cooperation has been established, to respond to the growing levels of interaction and activities in this area.
Danish: Der er desuden oprettet en ny sektor for internationalt og europæisk samarbejde som reaktion på det øgede samspil og antal aktiviteter på dette område.
English: List of written procedures during the period 15 September 2011 to 30 November 2011
Danish: Liste over skriftlige procedurer i perioden fra den 15. september 2011 til den 30. november 2011
English: The first meeting of the network is planned for May 2012.
Danish: Netværkets første møde planlægges til maj 2012
English: The European Commission representative made the remark that the Commission does not generally receive many applications for such posts from European organisations representing patients and healthcare professionals.
Danish: Europa-Kommissionens repræsentant bemærkede, at Kommissionen normalt ikke modtager mange ansøgninger til sådanne stillinger fra europæiske organisationer, der repræsenter patienter og sundhedsmedarbejdere.
English: • The split of the amended proposal into two proposals: 'information to patients' and 'pharmacovigilance'.
Danish: • opdeling af det ændrede forslag i to dele: »oplysninger til patienter« og »lægemiddelovervågning«.
English: Members agreed that all parts of agendas and minutes should be published.
Danish: Medlemmerne vedtog, at alle dele af dagsordener og referater skal offentliggøres.
English: The use of case stories was suggested, as this is a useful tool to increase understanding of the matters raised.
Danish: Det blev foreslået at anvende case stories, da dette udgør et nyttigt værktøj til at højne forståelsen af de rejste spørgsmål.
English: The Management Board decided to extend the pilot phase for one further year.
Danish: Bestyrelsen besluttede at forlænge pilotfasen med et år.
English: The final policy will be sent to the Board, together with a request for its members to complete a new declaration of interests.
Danish: Den endelige politik sendes til bestyrelsen sammen med en anmodning til medlemmerne om at udfylde en ny interesseerklæring.
English: The meeting concluded that this debate needs to continue and pilots should proceed as planned for in the 2012 work programme.
Danish: Deltagerne konkluderede, at drøftelserne bør fortsætte, og at pilotprojekterne videreføres som planlagt i arbejdsprogrammet for 2012.
English: c.) Breach of trust policy
Danish: c) Politik for tillidsbrud
English: The paper will be discussed by the newly created PRAC, and a final proposal will be submitted to the Board later this year.
Danish: Dokumentet vil blive diskuteret af det nyligt oprettede PRAC, og et endeligt forslag vil blive indgivet til bestyrelsen senere på året.
English: • clarification on the involvement in academic trials and in publicly funded research/development initiatives;
Danish: • præcisering af deltagelse i akademiske undersøgelser og offentligt finansierede forsknings/udviklingsinitiativer
English: After initial experience, the process needs to be evaluated, to verify if the expected results are being achieved.
Danish: Efter de første erfaringer skal processen evalueres for at vurdere, om man har opnået de forventede resultater.
English: The amendments concern:
Danish: Ændringerne vedrørte:
English: At the same time, the Agency will nominate a contact who will provide permanent support to patient representatives, to facilitate their participation in the work of the Committee.
Danish: Samtidig vil agenturet udnævne en kontaktperson, som skal yde løbende støtte til patientrepræsentanterne for at lette deres deltagelse i udvalgets arbejde.
English: The Board was informed that Luc Verhelst took office as the Head of the Agency's Information and Communications Technology Unit.
Danish: Bestyrelsen blev informeret om, at Luc Verhelst er blevet ansat som chef for agenturets enhed for informations- og kommunikationsteknologi.
English: The number of national experts would remain unchanged, with 15 FTEs expected.
Danish: Antallet af nationale eksperter forbliver uændret, nemlig 15 FTÆ.
English: • the definitions of ownership of a patent and (principal) investigator;
Danish: • definitioner af ejerskab til et patent og (hoved)investigator
English: Pharmacovigilance Risk Assessment Committee a.) Consultation procedure on final composition
Danish: Udvalget for Risikovurdering inden for Lægemiddelovervågning a) Høringsprocedure om endelig sammensætning
English: A group has been set up to propose alternatives at the June meeting.
Danish: Der blev nedsat en gruppe, som på mødet i juni vil fremlægge alternative muligheder.
English: The Agency wishes to launch a debate with all stakeholders on the appropriateness of introducing such a concept in the European Union (EU), including a consideration of appropriate incentives to support the development of new medicines.
Danish: Agenturet ønsker at indlede en debat med alle berørte parter om hensigtsmæssigheden af at indføre dette begreb i EU, herunder overvejelser om hensigtsmæssige incitamenter til at støtte udviklingen af nye lægemidler.
English: It is also planned to set up a team of scientific writers to deliver high-quality scientific articles for publication in scientific journals.
Danish: Der er også planer om at nedsætte et hold videnskabelige forfattere, som skal udarbejde videnskabelige artikler af høj kvalitet til offentliggørelse i videnskabelige tidsskrifter.
English: The Board set up a new group of topic coordinators with responsibility for the Agency's work programme and budget.
Danish: Bestyrelsen nedsatte en ny gruppe emnekoordinatorer med ansvar for agenturets arbejdsprogram og budget.
English: This included 62 applications for new medicines, an increase of 35% as compared to 2010.
Danish: Dette omfattede 62 ansøgninger vedrørende nye lægemidler, en stigning på 35 % sammenlignet med 2010.