FrancophonIA/ELRC3.0 huggingface dataset:
English: The preliminary results of a randomised controlled clinical trial, the ‘Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population' (BART) study, had shown that although the use of aprotinin was associated with less serious bleeding than either of the comparator drugs, an increase in 30 day all-cause mortality had been observed among patients receiving aprotinin compared to patients taking other medicines.
Danish: De foreløbige resultater af en randomiseret, kontrolleret klinisk undersøgelse “Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population” (BART) havde vist, at selvom brug af aprotinin var associeret med mindre alvorlig blødning end med nogen af sammenligningsstofferne, var der observeret højere dødelighed af alle årsager efter 30 dage hos patienter, der fik aprotinin, sammenlignet med patienter der fik andre lægemidler.
English: The CHMP considered also the adverse reactions profile, including new adverse events (some of which serious) associated with the use of EACA.
Danish: CHMP tog endvidere bivirkningsprofilen i betragtning, inklusive nye bivirkninger (af hvilke nogle er alvorlige) associeret med anvendelse af EACA.
English: The lysine analogues epsilon aminocaproic acid (EACA, also referred as aminocaproic acid) and tranexamic acid (TXA) inhibit more specifically the conversion of plasminogen to plasmin.
Danish: Lysinanalogerne epsilon-aminocapronsyre (EACA, der også benævnes aminocapronsyre) og tranexamsyre (TXA) hæmmer mere specifikt omdannelsen af plasminogen til plasmin.
English: Data available from randomised clinical trials and observational studies, including meta-analysis were considered.
Danish: Foreliggende data fra randomiserede, kliniske undersøgelser og observationsundersøgelser, inklusive metaanalyser, blev taget i betragtning.
English: Leukopenia, thrombocytopenia, BUN (blood urea nitrogen) increased and renal failure are adverse events which can be serious and have been reported, but these risks had not been considered in the current authorised product information.
Danish: Leukopeni, trombocytopeni, øget urinkvælstof og nyresvigt er bivirkninger, der kan være alvorlige og er blevet indberettet, men disse risici blev ikke taget i betragtning i de nuværende, godkendte produktoplysninger.
English: A list of indications for which the CHMP considered that the benefit risk balance remains positive is presented below.
Danish: Herunder er anført en liste over indikationer, for hvilke CHMP anså, at benefit/risk-forholdet forbliver positiv.
English: Several data sources informed the opinion of the Committee, including available data from clinical studies, published literature, spontaneous reports and other data submitted by marketing authorisation holders (MAHs) of medicinal products containing aprotinin, EACA or TXA.
Danish: Udvalgets udtalelse er baseret på en række datakilder, herunder foreliggende data fra kliniske undersøgelser, litteraturen, spontane indberetninger og andre data, der er indsendt af indehaverne af markedsføringstilladelserne for lægemidler indeholdende aprotinin, EACA og TXA.
English: On the basis of the above, the Committee recommended the variation to the terms of the marketing authorisation for the medicinal products containing aminocaproic acid referred to in Annex I for which the amendments to the product information are set out in annex III of the opinion.
Danish: På ovenstående grundlag anbefalede udvalget ændring af betingelserne for markedsføringstilladelserne for de i bilag I anførte lægemidler, der indeholder aminocapronsyre, for hvilke ændringerne af produktoplysningerne fremgår af bilag III til udtalelsen.
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Aminocaproic acid containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af indbringelse af antifibrinolytika Lægemidler, der indeholder aminocapronsyre (se bilag I)
English: • The Committee considered that evidence from randomised clinical trials and observational studies support the use of aminocaproic acid in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Danish: • Udvalget tog i betragtning, at evidens fra randomiserede, kliniske undersøgelser og observationsundersøgelser understøtter anvendelse af aminocapronsyre til patienter, der får foretaget dentale eller kirurgiske indgreb eller er i risiko for blødningskomplikationer.
English: • The Committee considered all data provided by the MAHs in writing, including data available from literature reviews.
Danish: • Udvalget tog alle skriftlige data fra indehaverne af markedsføringstilladelserne i betragtning, inklusive foreliggende data fra gennemgang af litteraturen.
English: In addition to cardiac surgery, the CHMP considered that sufficient evidence is available on the safety and efficacy of EACA in other indications, including in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Danish: Udover hjerteoperation tog CHMP i betragtning, at der er tilstrækkelig evidens om sikkerheden og virkningen af EACA til andre indikationer, inklusive til patienter, der får foretaget dentale eller kirurgiske indgreb, eller er i risiko for blødningskomplikationer.
English: The CHMP recommended that information on leukopenia, thrombocytopenia, BUN increased and renal failure should be appropriately reflected through warnings and recommendations in the product information.
Danish: CHMP anbefalede, at information om leukopeni, trombocytopeni, øget urinkvælstof og nyresvigt bør være korrekt oplyst i advarsler og anbefalinger i produktoplysningerne.
English: Antifibrinolytics (e.g. aprotinin, aminocaproic acid and tranexamic acid), are a class of haemostatic agents used to prevent excessive blood loss.
Danish: Antifibrinolytika (f.eks. aprotinin, aminocapronsyre og tranexamsyre) er en klasse af hæmostatiske midler til forebyggelse af ekscessivt blodtab.
English: • In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of EACA, and considering the adverse reactions profile (some of which serious) associated with the use of EACA, the CHMP considered that for some of the therapeutic indications the benefits no longer outweigh the risks and therefore they should be removed.
Danish: • På baggrund af de identificerede, alvorlige begrænsninger ved dataene om virkningen, foreliggende ny evidens og/eller aktuel medicinsk viden om anvendelse af EACA samt bivirkningsprofilen (af hvilke nogle bivirkninger er alvorlige) associeret med anvendelse af EACA taget i betragtning, overvejede CHMP, at for visse af de terapeutiske indikationer opvejer fordelene ikke længere risiciene, og disse indikationer bør derfor slettes.
English: In view of the identified serious limitations of the efficacy data, the available new evidence and/or current medical knowledge on the use of EACA, and considering the adverse reactions profile (some of which serious) associated with the use of EACA, the CHMP considered that some of these indications should be removed.
Danish: På baggrund af de identificerede, alvorlige begrænsninger ved dataene om virkningen, foreliggende ny evidens og/eller aktuel medicinsk viden om anvendelse af EACA samt bivirkningsprofilen (af hvilke nogle bivirkninger er alvorlige) for anvendelse af EACA taget i betragtning, overvejede CHMP, at nogle af disse indikationer burde slettes.
English: Aminocaproic acid has also been associated with hypotension, nasal and conjunctival congestion, gastrointestinal disturbances (diarrhoea, nausea, vomiting, abdominal pain), dizziness, headache, tinnitus and ejaculation disorders; blood disorders (agranulocytosis, coagulation disorders), muscular damage, convulsions, anaphylactic reactions, renal impairment, and thrombotic complications.
Danish: Aminocapronsyre har også været associeret med hypotension, tilstoppet næse og konjunktiva, gastrointestinale forstyrrelser (diarré, kvalme, opkastning, abdominalsmerter), svimmelhed, hovedpine, tinnitus, ejakulationsforstyrrelser, blodsygdomme (agranulocytose, koagulationsforstyrrelser), muskelskader, krampeanfald, anafylaktiske reaktioner, nedsat nyrefunktion og trombotisk komplikation.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations for aminocaproic acid containing medicinal products presented by the EMA
Danish: Videnskabelige konklusioner og begrundelse for ændring af betingelserne i markedsføringstilladelserne for lægemidler indeholdende aminocapronsyre fremlagt af EMA
English: patients of all ages in haemorrhage caused by local or general fibrinolysis, including in Postsurgical haemorrhages in: - urology (surgery of the bladder and prostate) - gynaecology (cervical surgery), in patients where tranexamic acid is not available or not tolerated - obstetrics (post-partum and post-miscarriage haemorrhages) after correction of the coagulation defect - heart surgery (with or without bypass placement)
Danish: patienter i alle aldre, der får blødning forårsaget af lokal eller generel fibrinolyse, inklusive ved postoperativ blødning ved: - urologi (operation i blære og prostata) - gynækologi (operation i livmoderhalsen) hos patienter, hvor tranexamsyre ikke er til rådighed eller ikke tåles - obstetrik (blødning postpartum og efter abort) efter korrektion af koagulationsdefekten - hjerteoperation (med eller uden anlæggelse af bypass)
English: Grounds for amendment of the marketing authorisations of aminocaproic acid containing medicinal products listed in Annex I
Danish: Begrundelser for ændring af markedsføringstilladelserne til de i bilag I anførte lægemidler, der indeholder aminocapronsyre
English: Whereas
Danish: Følgende noteres:
English: In particular the therapeutic indications were updated to reflect current scientific knowledge on the use of EACA; other changes to the product information were inclusion of information on leukopenia, thrombocytopenia, blood urea nitrogen increased and renal failure as warnings and recommendations.
Danish: Andre ændringer til produktoplysningerne var inklusion af information om leukopeni, trombocytopeni, øget urinkvælstof og nyresvigt i form af advarsler og anbefalinger.
English: These member states were not able to reach an agreement.
Danish: Disse medlemslande kunne ikke nå til enighed.
English: The European Commission issued a decision on 6 February 2009.
Danish: Europa-Kommissionen traf en afgørelse den 6. februar 2009.
English: Questions and answers on the referral for
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Danish: Artikel 29 i direktiv 2001/83/EF, med senere ændringer, indbringelse på grund af potentiel alvorlig risiko for folkesundheden
English: London, 09 February 2009 Doc.
Danish: London, den 9. februar 2009 Dok.
English: On 6 October 2008, the Dutch regulatory agency referred the matter to the CHMP.
Danish: Den 6. oktober 2008 henviste den nederlandske kontrolmyndighed sagen til CHMP.
English: What is Implanon?
Danish: Hvad er Implanon?
English: The company wanted the renewal of authorisation to be recognised in all the EU Member States, as well as Norway and Iceland where the product is already authorised.
Danish: Virksomheden ønskede, at fornyelsen af tilladelsen skulle anerkendes i alle EU-medlemslande samt i Norge og Island, hvor produktet allerede er tilladt.
English: Implanon subdermal implant etonogestrel 68 mg
Danish: Implanon subkutant implantat etonogestrel 68 mg
English: Additionally, the data on effectiveness in obese women in particular in the third year of use was considered insufficient.
Danish: Desuden blev dataene vedrørende virkningen hos overvægtige kvinder, især i det tredje brugsår, anset for utilstrækkelige.
English: It is presented as a small rod that is implanted by a doctor or a nurse using a special applicator just under the skin of the upper arm.
Danish: Det har form som en lille stav, der indsættes af lægen eller en sygeplejerske ved hjælp af en særlig applikator lige under huden på overarmen.
English: This changes the body's hormonal balance and help to prevent ovulation.
Danish: Dette ændrer kroppens hormonbalance og hjælper med at forebygge ægløsning.
English: Why was Implanon reviewed?
Danish: Hvorfor blev Implanon vurderet igen?
English: The CHMP also endorsed the changes to the product information for the medicine as agreed by the Coordination Group for the Mutual and Decentralised Procedures.
Danish: CHMP tilsluttede sig også ændringerne i produktoplysningerne for lægemidlet som godkendt af koordinationsgruppen for gensidig anerkendelse og decentraliserede procedurer.
English: The review was carried out under an ‘Article 29' referral1.
Danish: Revurderingen fandt sted inden for rammerne af en indbringelsesprocedure i henhold til artikel 29.1
English: The active substance in Implanon, etonogestrel, is a synthetic female hormone resembling progesterone.
Danish: Det aktive stof i Implanon, etonogestrel, er et syntetisk kvindeligt hormon, der ligner progesteron.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Implanon.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for Implanon.
English: N.V. Organon submitted Implanon for a second renewal of the marketing authorisation through mutual recognition on the basis of the initial authorisation granted by the Netherlands on 25 August 1998.
Danish: Organon indsendte ansøgning om endnu en fornyelse af marketingtilladelsen for Implanon gennem proceduren for gensidig anerkendelse på baggrund af den første tilladelse, der blev udstedt af Nederlandene den 25. August 1998.
English: Implanon is a female contraceptive.
Danish: Implanon er et svangerskabsforebyggende middel til kvinder.
English: The grounds for the referral were concerns regarding the side effects related to insertion and removal of the implant, the risk of breast cancer, the incidence of irregular bleedings leading to premature removal of the implant.
Danish: Begrundelserne for indbringelsen var bekymring med hensyn til bivirkninger relateret til indsættelse og fjernelse af implantatet, risikoen for brystcancer samt forekomsten af menstruationsforstyrrelser, der kunne føre til fjernelse af implantatet før tid.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Implanon outweigh its risks, and therefore the renewal of the marketing authorisation for Implanon should be granted in all concerned member states.
Danish: På basis af en vurdering af de tilgængelige data og de faglige drøftelser i udvalget er CHMP af den opfattelse, at fordelene ved Implanon er større end risiciene, og at fornyelsen af markedsføringstilladelsen for Implanon derfor bør udstedes i alle berørte medlemslande.
English: Once implanted, the rod releases a small amount of etonogestrel continuously into the bloodstream.
Danish: Når staven er sat ind under huden, afgiver den hele tiden en lille mængde etonogestrel til blodbanen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Implanon outweigh its risks, and that the marketing authorisation granted in the Netherlands can be recognised in other Member States of the European Union.
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Implanon er større end risiciene, og at den markedsføringstilladelse, der er udstedt i Nederlandene, kan anerkendes i de øvrige EU-medlemsstater.
English: Implanon can protect for up to three years; at the end of this period the implant must be removed.
Danish: Implanons beskyttende virkning kan holde i op til tre år.
English: Name Strength
Danish: Navn Styrke
English: Pharmaceutical form Route of administration Immediate Packaging Content Pack size EU/1/13/873/001 Xofigo 1100 kBq/mL Solution for injection Intravenous use
Danish: EU/1/13/873/001 Xofigo 1.100 kBq/ml
English: Package size l t o r
Danish: Pakningsstørrelse t r
English: EU Number
Danish: EU nr.
English: Action is needed in the following circumstances:
Danish: Det er nødvendigt at reagere ved følgende omstændigheder:
English: It is not known how commonly they occur.
Danish: Det vides ikke, hvor ofte de forekommer.
English: Your doctor can advise you what would be best.
Danish: Din læge kan rådgive dig om hvad der er bedst.
English: Date of first authorisation: 23 june 2017
Danish: Dato for første markedsføringstilladelse: 23. juni 2017
English: PML is probably caused by a combination of factors.
Danish: PML skyldes sandsynligvis en kombination af forskellige faktorer.
English: A risk to newborns or infants cannot be excluded.
Danish: En risiko for nyfødte eller spædbørn kan ikke udelukkes.
English: 9/L, then treatment must be stopped immediately.
Danish: 9/l, skal behandlingen straks afbrydes.
English: Most patients (91%) were <65 years of age.
Danish: De fleste patienter (91 %) var <65 år.
English: Response to Skilarence can be generally seen as early as week 3 and improves over time.
Danish: Respons på Skilarence ses generelt allerede i uge 3, og forbedres over tid.
English: Summary of clinical efficacy after 16 weeks treatment in Study 1102 Assessment
Danish: Opsummering af klinisk effekt efter 16 ugers behandling i studie 1102 Hodnocení
English: Symptomatic treatment is indicated in the case of an overdose.
Danish: Symptomatisk behandling er indiceret i tilfælde af overdosering.
English: Take your tablets during or immediately after a meal.
Danish: Tag dine tabletter under eller umiddelbart efter et måltid.
English: White blood cells help your body to fight infections.
Danish: Hvide blodlegemer hjælper din krop med at bekæmpe infektioner.
English: Immunosuppression is a risk factor for the use of live vaccines.
Danish: Immunosuppression er en risikofaktor for anvendelsen af levende vacciner.
English: In particular, tell your doctor if you are taking the following:
Danish: Fortæl især lægen, hvis du tager følgende:
English: The risk of vaccination should be weighed against the benefit.
Danish: Risikoen ved vaccination bør afvejes mod fordelene.
English: You must avoid using other products that contain fumarates to prevent taking too much.
Danish: Du skal undgå at tage andre produkter, der indeholder fumarater for at undgå, at du tager for meget.
English: A modified or weakened immune system as well as genetic or environmental factors can also constitute risk factors.
Danish: Et modificeret eller svækket immunforsvar samt genetiske eller miljømæssige faktorer kan også udgøre risikofaktorer.
English: Children and adolescents below the age of 18 years should not take this medicine because it has not been studied in this age group.
Danish: Dette lægemiddel bør ikke anvendes af børn og unge under 18 år, da det ikke er blevet undersøgt i denne aldersgruppe.
English: A previous infection with JCV is considered a prerequisite for the development of PML.
Danish: En tidligere infektion med JCV betragtes som en forudsætning for udvikling af PML.
English: No specific antidote is known.
Danish: Der kendes ingen specifik modgift.
English: In any case blood counts should be monitored until values have returned to the normal range.
Danish: Under alle omstændigheder skal der holdes øje med blodtællingen, indtil værdierne er vendt tilbage til det normale område.
English: One-sided 97.5% repeated CI (lower limit)
Danish: Ensidet 97,5 % gentaget CI (nedre grænse)
English: Certain types of vaccines (live vaccines) may cause infection if used during treatment with Skilarence.
Danish: Visse typer vacciner (levende vaccine) kan forårsage infektion, hvis de anvendes under behandling med Skilarence.
English: Tell your doctor if you have or have had problems with your stomach or intestines.
Danish: Fortæl din læge, hvis du har eller har haft problemer med maven eller tarmene.
English: Skilarence is for oral use.
Danish: Skilarence er til oral anvendelse.
English: You may not need the maximum dose of 720 mg per day.
Danish: Du vil ikke nødvendigvis have brug for den maksimale dosis på 720 mg pr. dag.
English: Reddening of the face or body (flushing) is a very common side effect which may affect more than 1 in 10 people.
Danish: Rødmen på ansigtet eller kroppen (blussen) er en meget almindelig bivirkning, som kan påvirke mere end 1 ud af 10 personer.
English: To improve tolerability, it is recommended to begin treatment with a low initial dose with subsequent gradual increases.
Danish: For at forbedre tolerancen anbefales det at begynde behandlingen med en lav startdosis med efterfølgende gradvise stigninger.
English: The only adverse reactions that led to discontinuation of treatment in >5% of patients were gastrointestinal reactions.
Danish: De eneste bivirkninger, som førte til seponering af behandlingen hos >5 % af patienterne var gastrointestinale reaktioner.
English: Blood sampling for safety clinical laboratory tests at follow-up visits was only performed in case of abnormalities at the preceeding visit.
Danish: Blodprøvetagning til sikkerhedskliniske laboratorieprøver ved opfølgende besøg blev kun udført i tilfælde af abnormiteter ved det foregående besøg.
English: You will have blood and urine tests before treatment and then regularly during your treatment to make sure that you are not getting these complications and can continue to take this medicine.
Danish: Du vil få taget blod-og urinprøver før behandling og derefter regelmæssigt under behandlingen for at sikre, at du ikke får disse komplikationer og kan fortsætte med at tage denne medicin.
English: Your doctor will start your treatment with a low dose (using 30 mg Skilarence tablets).
Danish: Din læge vil starte din behandling med en lav dosis (med 30 mg Skilarence-tabletter).
English: Talk to your doctor if you think you may have an infection.
Danish: Tal med din læge, hvis du mener, at du muligvis har en infektion.
English: Skilarence may reduce the number of your white blood cells.
Danish: Skilarence kan reducere antallet af hvide blodlegemer.
English: Talk to your doctor if you get any of the following side effects.
Danish: Tal med din læge, hvis du får nogen af de følgende bivirkninger.
English: Do not take Skilarence if you are pregnant or trying to become pregnant, as Skilarence may harm your baby.
Danish: Tag ikke Skilarence, hvis du er gravid eller forsøger at blive gravid, da Skilarence kan skade barnet.
English: The benefits of treatment with Skilarence were also supported by patient self-perceived improvements in their quality of life.
Danish: Fordelene ved behandling med Skilarence blev også understøttet af patienternes egen opfattelse af forbedringer i livskvalitet.
English: Dimethyl fumarate works on cells of the immune system (the body's natural defences).
Danish: Dimethylfumarat virker på celler i immunsystemet (kroppens naturlige forsvar).
English: Psoriasis is a disease causing thickened, inflamed, red areas on the skin, often covered by silvery scales.
Danish: Psoriasis er en sygdom, der forårsager fortykkede, betændte, røde områder på huden, ofte dækket af sølvfarvede skæl.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from available data).
Danish: Hyppigheden af bivirkninger defineres ved hjælp af følgende kategorier: Meget almindelig (≥ 1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The tablets are packed in PVC/PVDC-aluminium blisters.
Danish: Tabletterne er pakket i PVC/PVDC-aluminiumblister.