FrancophonIA/ELRC3.0 huggingface dataset:
English: Arterial thromboembolic events may be lifethreatening or may have a fatal outcome.
Danish: Arterielle tromboemboliske hændelser kan være livstruende eller have dødeligt udfald.
English: Similar to acne treatment, percentages of improvement vary per study, and depend on the methods applied for evaluation of effects.
Danish: Ligesom ved acnebehandling varierer den procentuelle bedring mellem undersøgelserne og afhænger af de anvendte metoder til vurdering af virkningerne.
English: Grounds for PRAC recommendation Whereas
Danish: Begrundelse for PRAC's anbefaling
English: The IMS prescription data have limited value because they do not include a category of “contraception in the absence of acne”.
Danish: Ordinationsdata fra IMS har begrænset værdi, da de mangler kategorien “antikonception i fravær af acne”.
English: Misdiagnosis is a realistic possibility since TE has diffuse symptoms and is a rare event in population of healthy young women.
Danish: Fejldiagnose er en reel mulighed, da tromboemboliske hændelser giver diffuse symptomer og er en sjælden hændelse i populationen af raske unge kvinder.
English: Conclusions on safety
Danish: Konklusioner vedrørende sikkerhed
English: Acne without androgenic features
Danish: Acne uden androgene kendetegn
English: This is despite the fact that the study enrolment criteria overwhelmingly selected for patients in whom contraception would have been the original reason for consultation.
Danish: Dette på trods af, at undersøgelsens inklusionskriterier overvejende udvalgte patienter, hos hvem antikonception måtte formodes at have været den oprindelige grund til konsultationen.
English: Overall, VTE could be fatal in 1-2% of the cases.
Danish: Totalt er tromboemboli dødbringende i 1-2 % af tilfældene.
English: *calculated as the total number of cycles, n=21,196, minus the number of cycles, n=450, in which medication was missed.
Danish: *beregnet som samlet antal cyklusser, n=21 196, minus antal cyklusser, n=450, hvor medicineringen blev oversprunget.
English: As part of the risk minimisation measures the PRAC adopted an updated indication taking all the data into account, and making clear the conditions for which these products are indicated.
Danish: Som led i risikominimeringsforanstaltningerne vedtog PRAC en opdateret indikation, hvor alle data tages i betragtning, og hvor det præciseres, under hvilke betingelser, disse produkter er indiceret.
English: Post-marketing reporting
Danish: Indberetning efter markedsføring
English: Overall conclusion and conditions to the Marketing Authorisations The PRAC, having considered the matter as set out in the appended referral assessment report recommends that a. the marketing authorisation holders should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study;
Danish: Samlet konklusion og betingelser for markedsføringstilladelserne Efter gennemgang af sagen som beskrevet i den vedføjede vurderingsrapport om indbringelsen anbefaler PRAC, at a. indehaverne af markedsføringstilladelse sponsorerer en sikkerhedsundersøgelse efter markeds føring foruden opfølgende evaluering af resultaterne af denne undersøgelse,
English: This is expected in view of the differences in anti-androgenic properties of cyproterone, drospirenone and desogestrel.
Danish: Dette er forventeligt i betragtning af forskellene i antiandrogene egenskaber mellem cyproteron, drospirenon og desogestrel.
English: Weight and height were reported for 258 (26.7%) of 968 patients.
Danish: Vægt og højde blev oplyst for 258 (26,7 %) af 968 patienter.
English: Most reports were from patients between 18-35 years of age (66%).
Danish: Størstedelen af indberetningerne omhandlede patienter i alderen 18-35 år (66 %).
English: In the Cochrane review on treatment of hirsutism nine clinical studies qualified for inclusion.
Danish: I Cochrane-gennemgangen af behandling af hirsutisme fandtes ni undersøgelser egnede til inkludering.
English: They include benzoylperoxide, retinoids, antibiotics, salicylic acid, and azelaic acid.
Danish: Disse er benzoylperoxid, retinoider, antibiotika, salicylsyre og azelainsyre.
English: In addition, there are other known alternative pharmacological treatments for severe androgenic symptoms (especially hirsutism).
Danish: Derudover er der andre kendte farmakologiske behandlingsmuligheder for svære androgene symptomer (navnlig hirsutisme).
English: BMI for these patients was between 15 and 54 (mean 24, median 23), whereas BMI over 30 kg/m2 was documented in 33 (3.4%) of these reports.
Danish: BMI for patienterne var mellem 15 og 54 (gennemsnit 24, median 23), mens et BMI over 30 kg/m2 blev angivet i 33 (3,4 %) af indberetningerne.
English: The data on efficacy of CPA/EE in alopecia androgenetica, except for the mechanism of action, is limited to one small study (DeCecco L et al, 1987) in which some limited beneficial effects were noted.
Danish: Virkningen af CPA/EE ved alopecia androgenetica er, bortset fra virkningsmekanismen, kun omfattet af en enkelt lille undersøgelse (DeCecco L et al, 1987), hvor der blev fundet visse gavnlige virkninger af begrænset omfang.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations subject to conditions
Danish: Videnskabelige konklusioner og begrundelse for ændring af markedsføringstilladelserne på visse betingelser
English: The PRAC also recommended that the MAH should submit a full risk management plan (RMP) within 3 months following the decision of this procedure.
Danish: PRAC anbefalede desuden, at indehaveren af markedsføringstilladelsen indsender en komplet risikostyringsplan (RMP) senest tre måneder efter beslutningen om denne procedure.
English: Cegedim Promotional data show 32% of use in contraception only, while Longitudinal data show 3.4% use in contraception only; the Pharmalink Panel data for Germany show 53% of contraceptive use, of which 75% the reason given is for acne and 25% for other reasons.
Danish: Cegedim Promotional viser 32 % anvendelse til antikonception alene, mens Longitudinal data viser 3,4 % til antikonception alene; data fra Pharmalink Panel for Tyskland viser 53 % anvendelse til antikonception, hvoraf 75 % begrundes med acne og 25 % med andre forhold.
English: ANSM considered the risk of venous and arterial thromboembolism (VTE and ATE) to outweigh the benefits in treating acne.
Danish: ANSM anså risikoen for venøs og arteriel tromboemboli (VTE og ATE) for at overstige fordelene ved behandling af acne.
English: The MAH- of the originator product sponsored 10 phase-III clinical trials providing information on safety of these medicinal products.
Danish: Indehaveren af markedsføringstilladelsen for det oprindelige produkt forestod 10 kliniske fase IIIundersøgelser, der giver oplysninger om sikkerheden af disse lægemidler.
English: It also reduces androgen synthesis by a negative feedback effect on the hypothalamo-pituitary-ovarian axis.
Danish: Det nedsætter desuden androgensyntesen ved negativ feedbackvirkning på den hypothalamus-hypofysære-ovarielle akse.
English: When diagnosis is not made and no treatment is started, or when the thrombosis does not give any clear symptoms, the clot can move upwards to the lung (pulmonary embolism) or the brain (cerebral embolism).
Danish: Ved manglende diagnosticering og behandling eller i mangel af klare symptomer kan blodproppen bevæge sig opad til lungerne (lungeemboli) eller hjernen (hjerneemboli).
English: Seborrhoea
Danish: Seborré
English: Thromboembolic events are adverse events which usually occur in a vein of the leg (deep vein thrombosis).
Danish: Tromboemboliske hændelser er bivirkninger, der sædvanligvis optræder i en vene i benet (dyb venetrombose).
English: The PRAC considered that a Direct Healthcare Professional Communication (DHPC) was needed to communicate the outcome of the present review.
Danish: PRAC fandt behov for udsendelse af en direkte meddelelse til fagfolk i sundhedssektoren (DHPC) til formidling af resultatet af denne gennemgang.
English: The only difference in clinical outcome was a significantly improved Ferriman Gallwey (FG) score at 12 months when cyproterone acetate was compared with flutamide.
Danish: Den eneste forskel i klinisk udfald var væsentligt bedre Ferriman Gallwey (FG) score ved 12 måneder med cyproteronacetat end med flutamid.
English: Non-fatal cases
Danish: Tilfælde uden dødelig udgang
English: The reporting frequency is less than the incidence of VTE as reported in epidemiological studies.
Danish: Indberetningshyppigheden er mindre end den hyppighed af venøs tromboemboli, der beskrives i epidemiologiske undersøgelser.
English: Contraceptive effect
Danish: Antikonceptiv virkning
English: In addition the PRAC stressed that these products should not be given concomitantly with other hormonal contraceptives.
Danish: Derudover understregede PRAC, at disse produkter ikke bør gives sideløbende med andre hormonale antikonceptionsmidler.
English: The calculations met the precision requirements of the Guideline on clinical investigation of steroid contraceptives in women2.
Danish: Beregningerne opfyldte kraven til præcision i vejledningen for klinisk undersøgelse af steroide antikonceptionsmidler hos kvinder2.
English: In women with androgenic sensitive skin conditions, the efficacy in moderate and severe acne with/without seborrhoea and/or hirsutism is demonstrated in more than 30 sponsored and nonsponsored trials, including comparative trials, uncontrolled trials, and pilot studies.
Danish: Hos kvinder med androgenfølsomme hudlidelser er der påvist virkning ved moderat og svær acne med eller uden seborré og/eller hirsutisme i over 30 sponsorerede og ikke sponsorerede undersøgelser, herunder sammenlignende undersøgelser, ukontrollerede undersøgelser og pilotundersøgelser.
English: The PRAC also agreed on the need of a risk management plan to be submitted as these medicinal products do not have an EU risk management plan in place.
Danish: PRAC vedtog ligeledes, at der bør forelægges en risikostyringsplan, da der ikke er nogen EUrisikostyringsplan i kraft for disse produkter.
English: The combined therapy with CPA/EE and CPA 10 mg has a different safety profile as reflected in the labelling of CPA 10 mg.
Danish: Den kombinerede behandling med CPA/EE og CPA 10 mg har en anden sikkerhedsprofil, som afspejles i produktinformationen for CPA 10 mg.
English: Age was reported for 877 of 968 (90.6%) patients.
Danish: Alderen blev oplyst for 877 af 968 (90,6 %) af patienterne.
English: Regarding acne without androgenic features, one study compared CPA/EE with systemic antibiotic tetracycline and showed similar efficacy (Greenwood R, et al., 1985).
Danish: For acne uden androgene kendetegn viste én undersøgelse samme virkning af CPA/EE som af systemisk antibiotisk tetracyklin (Greenwood R, et al., 1985).
English: No study collected such data and therefore this design limitation must be kept in mind when interpreting the data.
Danish: At dette ikke er sket i nogen af undersøgelserne, er en begrænsning, der må tages hensyn til ved fortolkning af oplysningerne.
English: These 968 cases comprise 7% of the total number of ADR reports received cumulatively through 30 Jan 2013 (n = 13,875 in total).
Danish: Disse 968 tilfælde udgør 7 % af det samlede antal bivirkningsindberetninger, der er modtaget kumulativt frem til den 30. januar 2013 (n = 13 875 i alt).
English: Compared with a corresponding reporting frequency ranging between 0.8 and 1.5 per 100,000 women-years during the previous six PSUR periods, there is no evidence of an overall increased reporting frequency of thrombotic /thromboembolic events.
Danish: Sammenlignet med den tilsvarende indberetningshyppighed på mellem 0,8 og 1,5 per 100 000 kvindeår i de foregående seks PSUR-perioder er der ikke tegn på en samlet stigning i indberetningshyppigheden for trombotiske/tromboemboliske hændelser.
English: In addition, co-suspected drugs, such as citalopram, thalidomide, olanzapine, antineoplastic agents, natalizumab, methylprednisolone sodium succinate, antibiotics or isotretinoin were reported for 20 (2.1%) patients.
Danish: Derudover blev der indberettet samtidigt mistænkte lægemidler såsom citalopram, thalidomid, olanzapin, antineoplastiske midler, natalizumab, methylprednisolonnatriumsuccinat, antibiotika eller isotretinoin for 20 (2,1 %) af patienterne.
English: 88 (9.1%) ADR reports referred to patients less than 18 years of age, 639 (66%) patients were between 18 and 35 years of age and 150 (15.5%) reports referred to patients older than 35 years of age.
Danish: 88 (9,1 %) af bivirkningsindberetningerne omhandlede patienter under 18 år, 639 (66 %) 18-35 år, og 150 (15,5 %) over 35 år.
English: In total, 76 (7.9%) of 968 ADR reports with TE events reported fatal outcomes; 66 were medically confirmed and 10 were non-medically confirmed consumer reports.
Danish: Der var i alt 76 (7,9 %) dødstilfælde ud af 968 bivirkningsindberetninger med tromboemboliske hændelser; 66 var lægeligt bekræftede, mens 10 var ikke-lægeligt bekræftede forbrugerindberetninger.
English: In none of the 118 identified clinical studies described in the scientific literature a venous or arterial thromboembolic/cardiovascular event during course of the study was reported.
Danish: Ingen af de 118 fundne kliniske undersøgelser i den videnskabelige litteratur nævner venøse eller arterielle tromboemboliske/kardiovaskulære hændelser i perioden omfattet af den pågældende undersøgelse.
English: For the treatment of hirsutism alone (mostly in PCOS patients), 13 studies demonstrated efficacy versus other treatments.
Danish: Til behandling af hirsutisme alene (hovedsagelig hos patienter med polycystisk ovariesyndrom) er virkningen godtgjort i 13 undersøgelser, hvor der blev sammenlignet med andre behandlinger.
English: Furthermore, the data do not systematically provide information on the medical history of the patient (e.g. history of acne or hyperandrogenic symptoms) or clinical findings as doctors tend to fill out the minimum mandatory information for the IMS.
Danish: Desuden gives der ikke systematisk oplysninger om patienternes anamnese (f.eks. om acne eller hyperandrogene symptomer) eller kliniske af undersøgelsesresultater, da lægerne er tilbøjelige til at begrænse sig til de obligatoriske mindsteoplysninger til IMS.
English: It is evident that in the current approved indications in EU, off-label use is observed.
Danish: Ikke godkendt anvendelse bliver klart praktiseret ved de nuværende godkendte indikationer i EU.
English: The effects on hirsutism and seborrhoea have mainly been studied in the context of treatment of acne and/or polycystic ovary syndrome (PCOS).
Danish: Virkningerne på hirsutisme og seborré er hovedsagelig undersøgt i forbindelse med behandling af acne og /eller polycystisk ovariesyndrom (PCOS).
English: In addition information in the section on circulatory disorders on the switch or restart was recommended by PRAC.
Danish: PRAC anbefalede supplerende oplysninger i afsnittet om kredsløbsforstyrrelser ved skift til eller genoptagelse af behandlingen.
English: The primary outcomes of interest are cardiovascular events, in particular the incidence of VTE and ATE, during oral contraception use.
Danish: De primære udfald af interesse er kardiovaskulære hændelser, navnlig forekomsten af venøs og arteriel tromboemboli ved brug af oral antikonception.
English: The updated total number of cases through 6 Mar 2013 amounts to 1143 reports with TE.
Danish: Det således opdaterede samlede antal tilfælde frem til den 6. marts 2013 er 1 143 indberetninger med tromboemboli.
English: Epidemiological studies have suggested an association between the use of COCs in general and an increased risk of arterial thrombotic and thromboembolic diseases such as myocardial infarction, and of cerebrovascular accidents.
Danish: Epidemiologiske undersøgelser har peget på en sammenhæng mellem anvendelse af kombinerede orale antikonceptionsmidler generelt og øget risiko for arterielle trombotiske og tromboemboliske sygdomme såsom myokardieinfarkt og cerebrovaskulære hændelser.
English: Subsequent studies (Lidegaard et al. 2003, Seaman et al. 2004), the latter addressing the issue of confounding, concluded that the absolute risk of VTE among women taking CPA/EE is not significantly greater than for women on COCs.
Danish: Efterfølgende undersøgelser (Lidegaard et al. 2003, Seaman et al. 2004), hvoraf sidstnævnte omhandler konfunderingsproblemet, konkluderede, at den absolutte risiko for venøs tromboemboli blandt CPA/EE-brugere ikke er nævneværdigt større end blandt kvinder, der bruger kombinerede orale antikonceptionsmidler.
English: Two large, ongoing post-marketing surveillance studies (INAS-OC and INAS-SCORE) yield incidental data on the use of CPA/EE.
Danish: To igangværende overvågningsundersøgelser efter markedsføring (INAS-OC and INAS-SCORE) giver som biresultat oplysninger om anvendelsen af CPA/EE.
English: Cohort studies
Danish: Kohorteundersøgelser
English: In both studies all enrolled women receiving a prescription for an oral contraceptive were questioned about the reason for the prescription at baseline (after having received the prescription).
Danish: Alle de kvinder, der fik ordineret et oralt antikonceptionsmiddel,blev i begge undersøgelser ved baseline (efter ordinationen) udspurgt om begrundelsen for ordinationen.
English: The PRAC also recommended further changes to the product information including that the need to continue treatment should be evaluated periodically knowing that the time to relief of symptoms is at least three months.
Danish: PRAC anbefalede desuden yderligere ændringer af produktinformationen, herunder angivelse af, at behovet for fortsat behandling bør vurderes regelmæssigt på baggrund af, at tiden til lindring af symptomer er mindst tre måneder,
English: No age was reported for 91 (9.4%) patients.
Danish: For 91 (9,4 %) af patienterne blev alder ikke oplyst.
English: Concomitant medications
Danish: Samtidig medicinering
English: More recent studies assessing the VTE risk in users of various COCs and CPA/EE (including Lidegaard 2009, Hylckama 2009) had major methodological flaws (missing data for confounders) that raise questions about the validity of their conclusions.
Danish: Nyere undersøgelser til vurdering af risikoen for venøs tromboemboli hos brugere af forskellige kombinerede orale antikonceptionsmidler og CPA/EE (herunder Lidegaard, 2009, og Hylckama, 2009) havde væsentlige metodefejl (manglende oplysninger om konfunderende faktorer), der rejser tvivl om validiteten af konklusionerne.
English: Furthermore PRAC agreed on other changes to the product information, additional pharmacovigilance activities and risk minimisation measures to address the risk of thromboembolic events.
Danish: PRAC vedtog desuden andre ændringer af produktinformationen, supplerende lægemiddelovervågning og risikominimeringsforanstaltninger over for tromboemboliske hændelser.
English: In addition, usage patterns of CPA/EE and COCs for oral contraception may differ significantly.
Danish: Desuden kan der være betydelig forskel på anvendelsesmønsteret for CPA/EE og for kombinerede orale antikonceptionsmidler.
English: In a recent study (Lidegaard, 2012) the comparative analyses of the relative risk for thrombotic stroke and myocardial infarction between the various progestins, including levonorgestrel, and non-use are in the same magnitude and do not show differences between the various progestins.
Danish: En nyere undersøgelse (Lidegaard, 2012) viser, at den relative risiko for trombotiske slagtilfælde og myokardieinfarkt med de forskellige progestiner, herunder levonorgestrel, er af samme størrelsesorden som uden anvendelse, og at der ikke er forskel mellem de forskellige progestiner.
English: Alternative treatments for moderate to severe acne are long-term antibiotics (topical or systemic), keratolytics and retinoids (topical or systemic, with known risks of teratogenicity and subject to a pregnancy prevention plan and regular liver function testing).
Danish: Andre behandlingsmuligheder for moderat til svær acne er antibiotisk langtidsbehandling (topisk eller systemisk), keratolytika og retinoider (topiske eller systemiske, som er kendt for at være teratogene og forudsætter en antikonceptionsplan og regelmæssige leverfunktionsprøver).
English: A recent published study comparing CPA/EE (2mg/0.035mg) and drospirenone/EE, and desogestrel/EE showed that after 6 months these medicinal products were equally efficacious but after 12 months CPA/EE (2mg/0.035mg) showed the strongest anti-androgenic effect, followed by drospirenone/EE, and desogestrel/EE as the weakest.
Danish: En nyere publiceret undersøgelse, der sammenligner CPA/EE (2 mg/0,035 mg), drospirenon/EE og desogestrel/EE, viste, at disse lægemidler efter seks måneder var lige effektive, men efter 12 måneder havde CPA/EE (2 mg/0,035 mg) stærkest antiandrogen virkning, efterfulgt af drospirenon/EE og desogestrel/EE som det svageste.
English: In view of the risks of VTE and ATE the PRAC considered there was a need to ensure that all relevant information for the safe use of these products should be applied across authorised products and therefore agreed on the wording for all relevant sections dealing with the risk of VTE/ATE.
Danish: På baggrund af risiciene for venøs tromboemboli og arteriel tromboemboli fandt PRAC behov for at sikre, at al relevant information om sikker anvendelse af disse produkter bringes i anvendelse for alle godkendte produkter, og vedtog derfor en ordlyd for alle relevante afsnit, der omhandler risikoen for venøs og arteriel tromboemboli.
English: In addition the PRAC stressed that these products should not be given concomitantly with other hormonal contraceptives and also that the need to continue treatment should be evaluated periodically knowing that the time to relief of symptoms is at least three months.
Danish: Desuden understregede PRAC, at produkterne ikke bør gives sideløbende med andre hormonale antikonceptionsmidler, og at behovet for fortsat behandling jævnligt bør vurderes på baggrund af, at tiden til lindring af symptomer er mindst tre måneder.
English: Guideline on clinical investigation of steroid contraceptives in women.
Danish: 2 Guideline on clinical investigation of steroid contraceptives in women (Retningslinjer for klinisk undersøgelse af steroide antikonceptionsmidler hos kvinder).
English: Treatment of hirsutism
Danish: Behandling af hirsutisme
English: The overall global spontaneous reporting rate for all cases reporting any thrombotic /thromboembolic event is 1.3 per 100,000 women-years.
Danish: Den samlede globale, spontane indberetningshyppighed for alle tilfælde af trombotiske/tromboemboliske hændelser er 1,3 per 100 000 kvindeår.
English: Due to the observational nature of these two studies comparing newly marketed combined oral contraceptives with a comparator group there was no restriction of the comparator group to specific oral hormonal combinations.
Danish: Da begge undersøgelser er observationsundersøgelser, der sammenligner nylancerede kombinerede orale antikonceptionsmidler med et andet præparat, er sammenligningsgruppen ikke pålagt begrænsninger til nærmere bestemte orale hormonkombinationspræparater.
English: Known risk factors for VTE include history of VTE, pregnancy, trauma, surgery, immobilisation (e.g. after surgery or long flights), obesity and smoking (i.e. all situations of a prothrombotic state).
Danish: Kendte risikofaktorer for venøs tromboemboli er tidligere venøs tromboemboli, graviditet, traumer, immobilisering (f.eks. efter operationer eller lange flyrejser), fedme og rygning (dvs. situationer svarende til en protrombotisk tilstand).
English: The MAH provided an overview of 6 cohort studies (of which 2 with additional nested case-control analyses) and 7 case-control studies assessing the VTE risk associated with CPA/EE and one cohort study assessing the ATE risk associated with CPA/EE.
Danish: Indehaveren af markedsføringstilladelsen fremlagde en oversigt over 6 kohorteundersøgelser (heraf to med supplerende indlejrede case-kontrolanalyser), 7 case-kontrolundersøgelser til vurdering af risikoen for venøs tromboemboli forbundet med CPA/EE og 1 kohorteundersøgelse til vurdering af risikoen for arteriel tromboemboli forbundet med CPA/EE.