FrancophonIA/ELRC3.0 huggingface dataset:
English: A review of the product information was undertaken to specify the agreed target population and update the clinical part of the product information to ensure that the information to healthcare professionals and patients is up to date.
Danish: Der blev foretaget en gennemgang af produktoplysningerne for at specificere den pågældende målgruppe og opdatere den kliniske del af produktoplysningerne med det formål at sikre, at informationen til sundhedspersonale og patienter er opdateret.
English: Taking into account all the data available on the efficacy and safety of aprotinin to date, the CHMP considered that there is clear evidence of a patient population in which the efficacy of systemic aprotinin clearly outweighs its risks.
Danish: Når alle de hidtil foreliggende data om virkningen og sikkerheden af aprotinin tages i betragtning, fandt CHMP klar evidens for en patientpopulation, hos hvilken virkningen af systemisk aprotinin klart overstiger dets risici.
English: There is no evidence of an association between aprotinin and perioperative mortality from randomised clinical trials when the BART study is excluded.
Danish: Der er ingen tegn på en sammenhæng mellem aprotinin og den perioperative mortalitet i randomiserede kliniske undersøgelser, når der ses bort fra BART-undersøgelsen.
English: On the basis of the above, the Committee recommended the lifting of the suspension and the amendment of the marketing authorisations for the medicinal products containing aprotinin 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 ophævelse af suspenderingen og ændring af markedsføringstilladelserne for de i bilag 1 anførte lægemidler indeholdende aprotinin, for hvilke ændringerne af produktoplysningerne fremgår af bilag III til udtalelsen.
English: Overall, the CHMP considered that the BART study was not designed to reliably determine the risk of death associated with aprotinin in relation to EACA or TXA and the results of higher mortality initially observed in aprotinin treated patients may be due to chance.
Danish: Samlet set fandt CHMP, at BART-undersøgelsen ikke var designet til på pålidelig vis at bestemme dødsrisikoen associeret med aprotinin i forhold til EACA eller TXA, og den højere mortalitet, der blev iagttaget hos patienter behandlet med aprotinin, kunne skyldes en tilfældighed.
English: The reduction of the need for resurgery after coronary artery bypass grafting (CABG) demonstrated for aprotinin is considered to be a benefit of high clinical relevance.
Danish: Den for aprotinin påviste reduktion af behovet for reoperation efter koronar bypassoperation anses for at være en fordel af høj klinisk relevans.
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: Reduction in massive bleeding, transfusion need and risk for re-surgery due to bleeding are considered meaningful clinically important effects of aprotinin, and when considering the overall data on the known risks, the CHMP considered that the balance is clearly positive in the identified patient population.
Danish: Reduktion i massiv blødning, transfusionsbehov og risiko for reoperation på grund af blødning anses for meningsfulde, klinisk vigtige virkninger af aprotinin, og på grundlag af den samlede mængde data om de kendte risici fandt CHMP, at risk/benefit-forholdet er klart positivt til den fastlagte patientpopulation.
English: A restricted distribution of aprotinin is envisaged with aprotinin available only to centres that perform cardiac surgery on cardio-pulmonary bypass and that commit to participate in the registry.
Danish: Udleveringen af aprotinin vil blive begrænset til centre, der udfører hjertekirurgi eller kardiopulmonal bypass, og som forpligter sig til at deltage i registret.
English: Therefore, taking the totality of data into account it is judged that the previous signal for an increased mortality associated with the use of aprotinin is refuted provided that aprotinin is given in the identified target population and the recommendations for its use are followed.
Danish: Når samtlige data tages i betragtning, anses det tidligere signal om øget dødelighed i forbindelse med anvendelse af aprotinin at være tilbagevist, forudsat at aprotinin anvendes hos den udpegede målpopulation og i overensstemmelse med anbefalingerne.
English: The CHMP considered that a clarification should be included in the wording of the indication to reflect that the product should be used in patients undergoing CPB in the course of ‘isolated CABG' surgery, as efficacy and safety of aprotinin in more extensive surgery has not been sufficiently characterised.
Danish: CHMP fandt, at det i ordlyden af indikationen bør præciseres, at produktet er til anvendelse hos patienter, der underkastes kardiopulmonal bypass som led i “enkeltstående koronar bypassoperation”, da virkningen og sikkerheden af aprotinin ved mere omfattende kirurgiske indgreb ikke er tilstrækkeligt karakteriseret.
English: The CHMP noted that since the initial review in 2007, more data has become available, in particular the final study results, and more importantly new analysis of the BART study.
Danish: CHMP bemærkede, at der siden den indledende gennemgang i 2007 er forelagt flere data, især de endelige resultater af undersøgelsen, og ikke mindst en ny analyse af BART-undersøgelsen.
English: The CHMP considered that a registry should be conducted by MAHs of aprotinin containing medicinal products affected by this review.
Danish: CHMP fandt, at indehaverne af markedsføringstilladelserne for aprotininholdige lægemidler, der omfattes af denne gennemgang, bør føre et register.
English: Scientific conclusions and grounds for lifting of the suspension and amendment of the marketing authorisations for aprotinin containing medicinal products presented by the EMA
Danish: Videnskabelige konklusioner og begrundelser for ophævelse af suspenderingen og ændring af markedsføringstilladelserne for lægemidler indeholdende aprotinin fremlagt af EMA
English: The CHMP noted that since the initial review in 2007, more data has become available, such as new observational studies, the final study results of the BART study, and more importantly new analyses of the BART study.
Danish: CHMP bemærkede, at der siden den indledende gennemgang i 2007 er forelagt flere data, som f.eks. nye observationsundersøgelser, de endelige resultater af BART-undersøgelsen, og ikke mindst nye analyser af BART-undersøgelsen.
English: The CHMP considered that the efficacy of aprotinin has been clearly demonstrated in prospective randomised trials and meta-analysis of clinical trials which show that aprotinin reduces the incidence of massive bleeding, reduces the need for transfusion of blood products and reduces the need for resurgery for bleeding in patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB).
Danish: CHMP fandt, at aprotinins virkning er klart påvist i prospektive, randomiserede undersøgelser, og en metaanalyse af kliniske undersøgelser, som viser, at aprotinin reducerer forekomsten af massiv blødning, mindsker behovet for transfusion af blodprodukter og nedsætter behovet for reoperation hos patienter, der får foretaget hjerteoperation med behov for kardiopulmonal bypass (CPB).
English: The CHMP noted that the findings from other randomised clinical trials and meta-analysis of randomised clinical trials (when the BART study is excluded) do not provide evidence of an association between aprotinin and perioperative mortality.
Danish: CHMP bemærkede, at resultaterne af andre randomiserede, kliniske forsøg og metaanalyse af randomiserede, kliniske forsøg (bortset fra BART) ikke giver holdepunkt for en sammenhæng mellem aprotinin og perioperativ dødelighed.
English: Taking the totality of data into account it is judged that the previous signal for an increased mortality associated with the use of aprotinin should be refuted provided that the drug is given in the identified target population of adult patients at high risk of major blood loss undergoing isolated coronary artery bypass graft (CABG) surgery and the recommendations for its use are followed.
Danish: • Når samtlige data tages i betragtning, anses det tidligere signal om øget dødelighed i forbindelse med anvendelse af aprotinin at være tilbagevist, forudsat at aprotinin anvendes hos den udpegede målpopulation af voksne patienter, der har høj risiko for større blodtab under enkeltstående koronar bypassoperation (CABG), og at det bruges som anbefalet.
English: Grounds for lifting of the suspension and amendment of the marketing authorisations of aprotinin containing medicinal products listed in Annex I
Danish: Begrundelser for ophævelse af suspenderingen og ændring af markedsføringstilladelserne for de i bilag I angivne lægemidler indeholdende aprotinin
English: • The Committee considered that the available randomised clinical trial and meta-analysis of clinical trials (when the BART study is excluded) do not give evidence of an association between aprotinin and perioperative mortality.
Danish: • Udvalget bemærkede, at resultaterne af andre randomiserede, kliniske forsøg og metaanalyse af kliniske forsøg (bortset fra BART) ikke giver holdepunkt for en sammenhæng mellem aprotinin og perioperativ dødelighed.
English: Aprotinin was already indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in those patients undergoing CPB in the course of CABG who were at an increased risk for blood loss and blood transfusion.
Danish: Aprotinin var i forvejen indiceret til profylaktisk anvendelse med henblik på reduktion af perioperativt blodtab og transfusionsbehov hos patienter, som sættes i kardiopulmonal bypass under koronar bypassoperation og har øget risiko for blodtab og blodtransfusionsbehov.
English: New observational studies are now available and results showed that aprotinin did not affect in-hospital mortality, with one study reporting a statistically significant mortality ‘benefit' for aprotinin in high-risk cardiac surgery patients, compared with TXA.
Danish: Der blev rejst metodologisk tvivl ved en tredje observationsundersøgelse, hvor en supplerende analyse heller ikke viste signifikant sammenhæng mellem aprotinin og mortaliteten under syv dages indlæggelse, Der foreligger nu nye observationsundersøgelser, og resultaterne viste, at aprotinin ikke påvirkede dødeligheden under indlæggelse, hvor én undersøgelse rapporterede om en statistisk signifikant "dødelighedsfordel" ved aprotinin hos højrisikopatienter efter hjerteoperation i sammenligning med TXA.
English: The results of re-analysis of two of these studies did not show a statistically significant association between aprotinin treatment and myocardial infarction, and other cardiovascular endpoints; methodological questions were raised over a third observational study where a supplementary analysis also did not show a significant association between aprotinin and seven-day in-hospital mortality.
Danish: Reanalyse at to af disse undersøgelser viste ikke statistisk signifikant sammenhæng mellem behandling med aprotinin og myokardieinfarkt eller andre kardiovaskulære endepunkter.
English: The proposed indication is for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Danish: Den ansøgte indikation er profylaktisk anvendelse til mindskelse af blodtab og blodtransfusionsbehov hos voksne patienter, der har høj risiko for større blodtab under enkeltstående kardiopulmonal bypassoperation (dvs. en koronararteriebypassoperation, der ikke er kombineret med anden kardiovaskulær kirurgi).
English: prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Danish: profylaktisk anvendelse for at reducere blodtab og blodtransfusion hos voksne patienter i højrisiko for kraftigt blodtab, der får foretaget enkeltstående koronar bypassoperation (dvs. koronar bypassoperation, der ikke kombineres med anden kardiovaskulær operation).
English: Aprotinin is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Danish: Aprotinin er indiceret til profylaktisk anvendelse for at reducere blodtab og blodtransfusion hos voksne patienter i højrisiko for kraftigt blodtab, der får foretaget enkeltstående koronar bypassoperation (dvs. koronar bypassoperation, der ikke kombineres med anden kardiovaskulær operation).
English: The off-label use is a safety risk.
Danish: Off-label-anvendelsen er en sikkerhedsrisiko.
English: More than 90 % of these reports were considered mild.
Danish: Mere end 90% af disse rapporter blev anset som milde.
English: In either case, the original treatment regimen should be maintained.
Danish: I begge tilfælde bør den oprindelige behandlingsplan opretholdes.
English: It may take longer than one month for you to notice an improvement.
Danish: Der kan gå mere end en måned, før De mærker en bedring.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/351/001-003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/351/001-003
English: All or any of these problems can cause personal distress or relationship difficulties.
Danish: Et eller flere af disse problemer kan give personlige problemer eller problemer i parforholdet.
English: Long-term safety, including breast cancer
Danish: Langsigtet sikkerhed, herunder brystcancer
English: Tuck flap here to close.
Danish: Isæt flap her for at lukke.
English: What about sunbathing?
Danish: Hvad med solbadning?
English: For example: If you decide to start treatment on a Monday, then you have to change your patch always on a Thursday and a Monday.
Danish: For eksempel: Hvis De beslutter at starte behandlingen en mandag, skal De altid skifte plastret om torsdagen og om mandagen.
English: Always make sure your patch is covered by clothing.
Danish: Sørg altid for, at plastret er dækket af tøj.
English: This will mean that you wear one patch for 3 days and the other for 4 days.
Danish: Det betyder, at De bruger det ene plaster i 3 dage og det andet i 4 dage.
English: The site should not be oily, damaged, or irritated.
Danish: Området må ikke være fedtet, beskadiget eller irriteret.
English: The adverse reaction most often reported (30.4 %) was application site reactions.
Danish: Den hyppigst rapporterede bivirkning (30,4%) var reaktioner på applikationsstedet.
English: Less than 1 % of patients withdrew from the studies because of any of these reactions.
Danish: Mindre end 1% trak sig ud af forsøget på grund af nogle af disse reaktioner.
English: Serum levels of androgens fall as women age.
Danish: Serumniveauerne af androgener falder med alderen hos kvinder.
English: Use of the patch should be discontinued if this occurs.
Danish: Brug af plastret bør ophøre, hvis dette forekommer.
English: Change the patch only on these two days.
Danish: Skift kun plastret på disse to dage.
English: Patients should be advised to self assess for androgenic undesirable effects.
Danish: Patienterne bør rådes til også selv at vurdere, om de får uønskede androgene bivirkninger.
English: Use Livensa only as long as you experience a positive effect of the treatment.
Danish: Anvend kun Livensa, så længe De oplever en positiv virkning af behandlingen.
English: Information to appear on the inside of the flap
Danish: Information på indersiden af flappen
English: There is no information on the safety of Livensa beyond 12 months.
Danish: Der foreligger ingen oplysninger om Livensas sikkerhed ud over 12 måneder.
English: There are limited data about the use in women above the age of 60.
Danish: Der er begrænsede data om anvendelse hos kvinder over 60 år.
English: Each patch surface is stamped with T001.
Danish: Overfladen på hvert plaster er påtrykt T001.
English: Binding to albumin is of relatively low affinity and is reversible.
Danish: Bindingen til albumin har relativt lav affinitet og er reversibel.
English: Livensa is used to treat HSDD.
Danish: Livensa anvendes til behandling af HSDD.
English: o Sunday + Wednesday
Danish: o Søndag + onsdag
English: Frequencies are defined as 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), or very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret som meget almindelige (≥ 1/10), almindelige (≥ 1/100 til < 1/10), ikke almindelige (≥ 1/1.000 til < 1/100), sjældne (≥ 1/10.000 til < 1/1.000) eller meget sjældne (< 1/10.000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: Your doctor will advise you on what you should do.
Danish: Deres læge vil rådgive Dem om det.
English: It is a CHMP concern that the data from the THIN (The Health Improvement Database) study suggests that approx 70% of the users are outside indication.
Danish: CHMP anser det for bekymrende, at data fra THIN-undersøgelsen (The Health Improvement Database) indikerer, at ca. 70% af brugerne ikke er omfattet af indikationen.
English: Keep in mind that estrogens should be administered for the shortest possible duration.
Danish: Vær opmærksom på at østrogen skal tages i en så kort periode som muligt.
English: There is little information on long-term safety, including effects on breast tissue, the cardiovascular system and increase in insulin resistance.
Danish: Der foreligger kun få oplysninger om den langsigtede sikkerhed, herunder effekten på brystvæv, det kardiovaskulære system og øget insulinresistens.
English: Decide which two days each week you are going to change your patch, and change the patch on the same two days each week.
Danish: Beslut, hvilke to ugedage De vil skifte plastret, og skift plastret de samme to dage hver uge.
English: Grounds for one additional renewal
Danish: Begrundelse for en ekstra fornyelse
English: Continue to use for as long as your doctor prescribes.
Danish: Fortsæt brugen, så længe lægen ordinerer det.
English: Like all medicines, Livensa can cause side effects, although not everybody gets them.
Danish: Livensa kan som al anden medicin Livensgive bivirkninger, men ikke alle får bivirkninger.
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Livensa remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Danish: Baseret på data, der er blevet tilgængelige siden den første markedsføringstilladelse, anser CHMP risk/benefit-forholdet af Livensa for stadig at være positivt men mener, at sikkerhedsprofilen skal overvåges nøje af de følgende årsager:
English: Hirsutism was also very commonly reported.
Danish: Det var også meget almindeligt at hirsutisme blev rapporteret.
English: ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
Danish: BILAG IV BEGRUNDELSE FOR EN EKSTRA FORNYELSE
English: What if your patch becomes loose, lifts at the edges or falls off?
Danish: Hvad, hvis plastret går løs, løsnes i kanterne eller falder af?
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 oC.
English: The mode of administration of Livensa makes overdose unlikely.
Danish: Måden, Livensa administreres på, gør overdosering usandsynlig.
English: There was no evidence of accumulation of testosterone over 52 weeks of treatment.
Danish: Der var ingen tegn på akkumulering af testosteron over 52 ugers behandling.
English: Toxicological studies of testosterone have only revealed effects which can be explained based on the hormone profile.
Danish: Toksikologiske forsøg med testosteron har kun vist virkninger, som kan forklares på grundlag af hormonprofilen.
English: Total satisfying sexual activity (primary endpoint), sexual desire, and distress associated with low sexual desire (secondary endpoints) were evaluated with validated instruments.
Danish: Fuldstændig tilfredsstillende seksuel aktivitet (primært endpoint), seksuel lyst og bekymring forbundet med lav seksuel lyst (sekundære endpoints) blev vurderet med validerede værktøjer.
English: Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Danish: Niveauerne af frie thyroideahormoner er imidlertid uændret, og der er ingen klinisk evidens for dysfunktion af thyroidea.
English: Testosterone has been found to be nongenotoxic.
Danish: Testosteron er påvist at være ikke-genotoksisk.
English: In women, circulating testosterone is primarily bound in the serum to SHBG (65-80 %) and to albumin (20-30 %) leaving only about 0.5-2 % as the free fraction.
Danish: Hos kvinder er cirkulerende testosterom primært bundet i serum til SHBG (65-80%) og til albumin (20-30%), hvilket kun giver 0,5-2% som fri fraktion.
English: DHT = dihydrotestosterone, SHBG = sex hormone binding globulin SEM = Standard Error of the Mean
Danish: DHT = dihydrotestosteron, SHBG = kønshormonbindende globulin SEM = Standard Error of the Mean
English: The usual dose is one patch twice weekly (each 3 to 4 days), see below ‘How and when to change your patch'.
Danish: Den sædvanlige dosis er et plaster to gange ugentligt (hver 3. eller 4. dag), se nedenfor ‘Sådan og på dette tidspunkt skiftes plasteret'.
English: Tell your doctor if you are taking blood-thinning (anticoagulant) treatment.
Danish: Fortæl det altid til lægen, hvis De tager blodfortyndende (antikoagulerende) medicin.
English: Paediatric population There is no relevant use of Livensa in the paediatric population.
Danish: Pædiatrisk population Der ingen relevant brug af Livensa i den pædiatriske population.
English: Avoid touching the sticky side of the patch with your fingers.
Danish: Undgå at røre ved plasterets klæbende side med fingrene.
English: If you have not experienced a positive effect of Livensa within 3-6 months, you should inform your doctor, who will suggest that treatment be discontinued.
Danish: Hvis De ikke har mærket nogen positiv virkning af Livensa i løbet af 3-6 måneder, bør De fortælle deres læge det, og han/hun vil foreslå, at behandlingen afbrydes.
English: If you forget to change your patch
Danish: Hvis De har glemt at skifte plastret
English: As the efficacy and safety of Livensa have not been evaluated in studies of longer duration than 1 year, it is recommended that an appraisal of the treatment is undertaken every 6 months.
Danish: Da virkningen og sikkerheden af Livensa ikke er blevet vurderet i forsøg af længere varighed end 1 år, anbefales det at foretage en vurdering af behandlingen hver 6. måned.