FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore the PRAC requested that a PASS will be conducted to evaluate the effectiveness of the risk minimisation activities.
Danish: Endvidere anmodede PRAC om, at der udføres en sikkerhedsundersøgelse efter godkendelse (PASS) til vurdering af effektiviteten af risikominimeringsforanstaltningerne,
English: Results indicated that after 6 month treatment the efficacy of CPA/EE (2mg/0.035mg) was superior and statistically significantly better than for LNG/EE.
Danish: Efter seks måneders behandling var virkningen af CPA/EE (2 mg/0,035 mg) statistisk signifikant bedre end af LNG/EE.
English: In study AI58, one patient on CPA/EE developed VTE.
Danish: I undersøgelse AI58 forekom der venøs tromboemboli hos én patient, der blev behandlet med CPA/EE.
English: In the INAS-SCORE study 20.2% of use is in contraception from a total of 1094 users of CPAcontaining preparations which represents 5.5% of the total study population.
Danish: I INAS-OC-undersøgelsen udgør antikonception 20,2 % af anvendelsen hos i alt 1 094 brugere af præparater indeholdende CPA, svarende til 5,5 % af hele undersøgelsespopulationen.
English: INAS-OC is a prospective, non-interventional, active surveillance study designed to assess the risk of short- and long-term use of YAZ (3 mg drospirenone/0.020mg ethinylestradiol), Yasmin (3 mg drospirenone/0.030mg ethinylestradiol) and of oral contraceptives and CPA/EE (2mg/0.035mg), conducted in 6 European countries and United States.
Danish: INAS-OC er en prospektiv, ikke-interventionel aktiv overvågningsundersøgelse til vurdering af risikoen ved kort- og langtidsanvendelse af YAZ (3 mg drospirenon/0,020mg ethinylestradiol), Yasmin (3 mg drospirenon/0,030mg ethinylestradiol) og af orale antikonceptionsmidler og CPA/EE (2 mg/0,035 mg).
English: The estimate is based on the calculated global patient exposure of 75,417,345 women-years and 968 received TE reports worldwide.
Danish: Dette tal er baseret på den beregnede globale patienteksponering på 75 417 345 kvindeår og 968 modtagne indberetninger om tromboemboli på verdensbasis.
English: In addition, with regard to CPA/EE (2mg/0.035mg) vs. non-use statistical significance is even not achieved.
Danish: For CPA/EE (2 mg/0,035 mg) sammenlignet med ingen anvendelse opnås ikke engang statistisk signifikans.
English: Thromboembolic events are known, rare adverse drug reactions associated with the use of estrogenprogestogen containing preparations including CPA/EE (2mg/0.035mg).
Danish: Tromboemboliske hændelser er kendte, sjældne bivirkninger, der er forbundet med anvendelse af præparater indeholdende østrogen-progestogen, herunder CPA/EE (2 mg/0,035 mg).
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products.
Danish: • PRAC fulgte proceduren i overensstemmelse med artikel 107, stk. 1, i direktiv 2001/83/EF for lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg),
English: However, based on the best evidence available, the authors concluded that the treatment containing cyproterone acetate improved acne better than a levonorgestrel-containing treatment; that treatment with cyproterone acetate showed better acne outcomes than one with desogestrel, but the studies produced conflicting results; and finally that drospirenone-containing treatment appeared to be more effective than norgestimate or nomegestrol acetate-containing treatment but less effective than treatment with cyproterone acetate.
Danish: Baseret på bedste foreliggende evidens konkluderede forfatterne dog, at præparatet med cyproteronacetat gav større bedring af acne end et præparat indeholdende desogestrel, men at undersøgelserne gav modstridende resultater.
English: These studies give some information regarding the use of CPA/EE (2mg/0.035mg) as a contraceptive.
Danish: Undersøgelserne giver visse oplysninger om anvendelsen af CPA/EE (2 mg/0,035 mg) som antikonceptionsmiddel.
English: In INAS-OC study 28.1% of use is in contraception, from a total of 1672 users of CPA-containing preparations enrolled in the study, representing 7.5% of the total study population.
Danish: I INAS-OC-undersøgelsen udgør antikonception 28,1 % af anvendelsen hos de af undersøgelsen omfattede 1 672 brugere af præparater indeholdende CPA, svarende til 7,5 % af den samlede undersøgelsespopulation.
English: Overall, there is no conclusive evidence for a higher VTE risk with CPA/EE (2mg/0.035mg) compared to COCs, including those containing levonogestrel.
Danish: Overordnet er der ikke konklusiv evidens for en højere risiko for venøs tromboemboli med CPA/EE (2 mg/0,035 mg) end med kombinerede orale antikonceptionsmidler, herunder dem, der indeholder levonorgestrel.
English: Furthermore the PRAC requested that the protocol of a PASS should be submitted within the risk management plan submission, to evaluate the effectiveness of the risk minimization activities.
Danish: Endvidere anmodede PRAC om, at der i forbindelse med indsendelse af risikostyringsplanen forelægges en protokol til en sikkerhedsundersøgelse efter markedsføring (PASS) til vurdering af effektiviteten af risikominimeringstiltagene.
English: In conclusion the PRAC considered all currently available safety data for the CPA/EE (2mg/0.035mg) containing medicinal products and recommended that these products should be contraindicated in patients with history or hereditary predisposition of venous thrombosis.
Danish: Som konklusion tog PRAC alle foreliggende sikkerhedsdata for lægemidler indeholdende CPA/EE (2 mg/0,035 mg) i betragtning og anbefalede, at disse produkter gøres kontraindiceret, når venøs trombose forekommer i anamnesen eller som familiær disposition.
English: INAS-SCORE was initiated after the launch of Qlaira (dienogest/estradiol valerate, step down dose regimen) in Europe (September 2009) and USA (October 2010) and is a prospective noninterventional post-approval safety study conducted in Austria, France, Germany, Italy, Poland, Sweden, UK and the US.
Danish: Det er en prospektiv, ikke-interventionel sikkerhedsundersøgelse efter markedsføring i Østrig, Frankrig, Tyskland, Italien, Polen, Sverige, Det Forenede Kongerige og USA.
English: The combination of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) acts simultaneously as a hormonal contraceptive.
Danish: Kombinationen cyproteronacetat/ethinylestradiol (2 mg/0,035 mg) virker samtidigt som et hormonalt antikonceptionsmiddel.
English: The wording of the indication of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products varies between the EU Member States.
Danish: Ordlyden af indikationen for lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg) varierer mellem EU-medlemsstaterne.
English: The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience on the safety of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products, as well as stakeholders' submissions in particular with regards to the thromboembolic events.
Danish: PRAC gennemgik alle foreliggende data fra kliniske undersøgelser, farmakoepidemiologiske undersøgelser, den publicerede litteratur, erfaringer efter markedsføring vedrørende sikkerheden af lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg) samt oplysninger fra interesserede parter, navnlig om tromboemboliske hændelser.
English: As recent data have demonstrated, restarting or switching COC use after interruption is associated with an excess risk.
Danish: Som påvist for nylig er der ekstra risiko ved at genoptage eller overgå til behandling med kombinerede orale antikonceptionsmidler efter en pause.
English: The CMDh having considered the PRAC recommendation dated 16 May 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC reached a position on the variation to the terms of the marketing authorisations of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Danish: Efter gennemgang af PRAC's anbefaling dateret den 16. maj 2013 tog CMDh i henhold til artikel 107, stk. 1 og 2, i direktiv 2000/83/EF stilling til ændringerne af betingelserne for markedsføringstilladelserne for lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg), for hvilke de relevante afsnit af produktresuméet og indlægssedlen er gengivet i bilag III, og under de betingelser, der fremgår af bilag IV.
English: The estimate is based on the calculated patient exposure of 75,417,345 women-years and 789 reports of venous embolic and thrombotic events worldwide.
Danish: Tallet er baseret på den beregnede patienteksponering på 75 417 345 kvindeår og 789 indberetninger af venøse emboliske og trombotiske hændelser på verdensbasis.
English: With exception of study report AI58, no cases of VTEs or ATEs were reported in patients from the 10 MAH- sponsored clinical trials with (CPA/EE) (2mg/0.035mg).
Danish: Bortset fra undersøgelsesrapport AI58 blev der ikke indberettet tilfælde af venøs eller arteriel tromboemboli hos patienterne i de ti kliniske undersøgelser med (CPA/EE) (2 mg/0,035 mg), som var sponsoreret af indehaveren af markedsføringstilladelsen.
English: There were no cases reporting ATE with a fatal outcome.
Danish: Der var ingen tilfælde af arteriel tromboemboli med dødeligt udfald.
English: Off-label use would primarily equate to prescription of CPA/EE (2mg/0.035mg) as a contraceptive in patients with no requirement for acne treatment.
Danish: Ikke godkendt anvendelse vil primært være ordination af CPA/EE (2 mg/0,035 mg) som antikonceptionsmiddel, hvor der ikke er behov for acnebehandling.
English: Direct questioning of the prescribing physician would be needed to ascertain this true proportion.
Danish: For med sikkerhed at fastslå den sande andel måtte man have udspurgt den ordinerende læge direkte.
English: Only one study evaluated the efficacy of CPA/EE (2mg/0.035mg) versus placebo.
Danish: Kun i én undersøgelse blev virkningen af CPA/EE (2 mg/0,035 mg) vurderet i forhold til placebo.
English: In these studies VTE risk among CPA/EE users was compared to the VTE risk of non-use as well as of various types of combined oral contraceptives (COCs).
Danish: I disse undersøgelser blev risikoen for venøs tromboemboli ved anvendelse af CPA/EE sammenlignet med risikoen for venøs tromboemboli uden sådan anvendelse og ved anvendelse af forskellige typer kombinerede orale antikonceptionsmidler.
English: This is the case in 54% of the 60% of prescriptions written by general practitioners (i.e. 32.4% of all prescriptions) and in 75% of the 36% of prescriptions written by gynaecologists (27.8% of all prescriptions), which implies that around 60% of all French prescriptions for CPA/EE (2mg/0.035mg) relate to contraception and therefore would be off-label use taking into account the indication only in acne in France.
Danish: Dette er tilfældet i 54 % af de 60 % af ordinationerne, der udskrives i almen praksis (dvs. 32,4 % af alle ordinationer) og i 75 % af de 36 % af ordinationerne, der udskrives af gynækologer (27,8 % af alle ordinationer).
English: For the condition of alopecia in view of the overall available safety data, in particular in relation to the risk of serious thromboembolic events, and very limited efficacy data, the PRAC concluded that the benefit-risk balance is not favourable and therefore these medicinal products should no longer be indicated in this therapeutic indication.
Danish: For alopeci tog PRAC i betragtning de foreliggende overordnede sikkerhedsdata, navnlig risikoen for alvorlige tromboemboliske hændelser og de meget begrænsede data om virkning, hvorfor udvalget konkluderede, at benefit/risk-forholdet ikke er gunstigt, og at disse lægemidler ikke fortsat bør være indiceret til denne terapeutiske indikation.
English: In comparison with other medical treatment options, no clinical differences in hirsutism were detected when CPA/EE (2mg/0.035mg) was compared to other medicinal products (spironolactone, finasteride, GnRH analogues, ketoconazole).
Danish: Der blev ikke fundet kliniske forskelle i hirsutisme mellem CPA/EE (2 mg/0,035 mg) og andre lægemidler (spironolakton, finasterid, GnRH-analoger, ketoconazol).
English: Hormone preparations containing CPA/EE (2mg/0.035mg) are part of the comparator arms in these studies.
Danish: Hormonpræparater indeholdende CPA/EE (2 mg/0,035 mg) indgår i sammenligningsarmene i disse undersøgelser.
English: • The PRAC also noted the available data concerning the hormonal contraceptive effect of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products.
Danish: • PRAC tog ligeledes til efterretning de foreliggende data om den hormonale antikonceptive virkning af lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg),
English: Healthcare professionals enrolled CPA/EE (2mg/0.035mg) users into the studies due to the fact that in many European countries CPA/EE (2mg/0.035mg) mentions contraception in women requiring treatment for androgen dependent skin conditions.
Danish: I undersøgelserne indgik brugere af CPA/EE (2mg/0,035mg), da antikonception til kvinder med behov for behandling af androgenafhængige hudlidelser i mange europæiske lande er en indikation for CPA/EE (2 mg/0,035 mg).
English: A total of 1672 users of CPA/EE (2mg/0.035mg) -containing preparations were enrolled in the study representing 7.5% of the total study population.
Danish: I alt omfattede undersøgelsen 1 672 brugere af præparater indeholdende CPA/EE (2 mg/0,035 mg), svarende til 7,5 % af hele undersøgelsespopulationen.
English: • The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience on the safety of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products, as well as stakeholders' submissions in particular with regards to the risk of thromboembolic events.
Danish: • PRAC gennemgik alle foreliggende data fra kliniske undersøgelser, farmakoepidemiologiske undersøgelser, den publicerede litteratur, erfaringer efter markedsføring vedrørende sikkerheden af lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg) samt oplysninger fra interesserede parter, navnlig om risikoen for tromboemboliske hændelser,
English: • The PRAC also considered that in view of the currently available safety data in order to maintain a favourable benefit/risk for the indications referred above cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products should be contraindicated in patients with history or hereditary predisposition of venous thrombosis.
Danish: • på baggrund af de aktuelt foreliggende sikkerhedsdata og for at opretholde et positivt benefit/riskforhold for ovennævnte indikationer fandt PRAC desuden, at lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg) bør være kontraindiceret hos patienter med anamnese med eller familiær disposition for venøs trombose.
English: The contraceptive effect of CPA/EE (2mg/0.035mg) was investigated in several studies at the time of authorisation.
Danish: Den antikonceptive virkning af CPA/EE (2 mg/0,035 mg) var genstand for flere undersøgelser på godkendelsestidspunktet.
English: The IMS Prescriptions Insight Data for France (ANSM benefit/risk review, 5 Feb 2013) suggest that CPA/EE (2mg/0.035mg) containing medicines are prescribed for contraception.
Danish: Oplysningerne fra IMS Prescriptions Insight Data for Frankrig viser, at lægemidler indeholdende CPA/EE (2 mg/0,035 mg) udskrives som antikonception (ANSM's gennemgang af benefit/risk-forhold af 5. februar 2013).
English: These studies investigate the safety of the combined oral contraceptives YAZ (3 mg drospirenone/0.020mg ethinylestradiol) and Qlaira (dienogest/estradiol valerate, step down dose regimen) respectively.
Danish: Disse undersøgelser vedrører henholdsvis sikkerheden af de kombinerede orale antikonceptionsmidler YAZ (3 mg drospirenon/0,020mg ethinylestradiol) og Qlaira (dienogest/estradiolvalerat, nedtrapningsdosering).
English: In this study almost 67% of women prescribed CPA-containing preparations remembered after the discussion with their healthcare professional that their individual prescription was written for acne and/or PCOS, indicating that the skin condition was discussed during the counselling and was mentioned as the main reason to prescribe CPA/EE (2mg/0.035mg).
Danish: Af de kvinder, der fik ordineret præparater indeholdende CPA i undersøgelsen, huskede næsten 67 % efter samtalen med deres sundhedsperson, at de havde fået præparatet ordineret for acne og/eller polycystisk ovariesyndrom, og angav, at hudlidelsen blev drøftet under samtalen og nævnt som hovedbegrundelse for ordinationen af CPA/EE (2 mg/0,035 mg).
English: These studies (INAS-OC and INAS-SCORE) investigate the safety of the combined oral contraceptive drugs YAZ (3 mg drospirenone/0.020mg ethinylestradiol) and Qlaira (dienogest/estradiol valerate, step down dose regimen) respectively.
Danish: Disse undersøgelser (INAS-OC og INAS-SCORE) vedrører sikkerheden af henholdsvis det kombinerede orale antikonceptionsmiddel YAZ (3 mg drospirenon/0,020mg ethinylestradiol) og Qlaira (dienogest/østradiolvalerat, nedtrapningsdosering).
English: Overall summary of the scientific evaluation of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal product(s) by PRAC
Danish: Samlet resumé af PRAC's videnskabelige vurdering af lægemidler indeholdende cyproteronacetat/ethinylestradiol (2mg/0,035mg)
English: CPA/EE (2mg/0.035mg) containing medicinal products have anti-androgenic effects.
Danish: Lægemidler indeholdende CPA/EE (2 mg/0,035 mg) vides at have antiandrogene virkninger.
English: Data from these two studies indicate that, even where the primary reason for consultation is almost certainly contraception, 63% of prescriptions for CPA/EE (2mg/0.035mg) could be linked by the patients themselves to acne and/or other hyper-androgenous conditions.
Danish: De to undersøgelser viser, at selv når den primære anledning til konsultationerne med stor sikkerhed er antikonception, bliver 63 % af ordinationerne af CPA/EE (2 mg/0,035 mg) af patienterne selv sat i forbindelse med acne og/eller andre hyperandrogene lidelser.
English: It also noted the available data concerning the hormonal contraceptive effect of CPA/EE (2mg/0.035mg) containing medicinal products.
Danish: Udvalget tog ligeledes i betragtning de foreliggende data om den hormonale antikonceptive virkning af lægemidler indeholdende CPA/EE (2 mg/0,035 mg).
English: The MAH commented that data from these two studies indicate that, even where the primary reason for consultation is almost certainly contraception, 63% of prescriptions for CPA/EE (2mg/0.035mg) could be linked by the patients themselves to acne and/or other hyperandrogenous conditions.
Danish: Indehaveren af markedsføringstilladelsen kommenterede dette med, at de to undersøgelser viser, at selv når den primære anledning til konsultationerne med stor sikkerhed er antikonception, kan 63 % af patienterne selv kæde ordinationerne af CPA/EE (2 mg/0,035 mg) sammen med acne og/eller andre hyperandrogene lidelser.
English: Cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products are known to increase risk of thromboembolic events (TE).
Danish: Lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg) vides at øge risikoen for tromboemboliske hændelser (TE).
English: There are two large, ongoing post-marketing surveillance studies which yield incidental data on the use of CPA/EE (2mg/0.035mg) containing medicinal products.
Danish: Sikkerheds- og overvågningsundersøgelser efter markedsføring Der pågår to store overvågningsundersøgelser efter markedsføring, hvorfra der kan hentes episodiske oplysninger om brugen af lægemidler indeholdende CPA/EE (2 mg/0,035 mg).
English: A total of 789 (81.5%) of 968 retrieved cases reported one or more VTEs in association with CPA/EE (2mg/0.035mg) use.
Danish: Af 968 indberettede tilfælde omfattede i alt 789 (81,5 %) en eller flere venøse tromboemboliske hændelser i forbindelse med anvendelse af CPA/EE (2 mg/0,035 mg).
English: The PRAC concluded that the risk-benefit balance of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal product(s) in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age remains favourable subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and additional risk minimisation measures agreed.
Danish: PRAC konkluderede, at benefit/risk-forholdet fortsat er gunstigt for lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg) til behandling af moderat til svær acne i forbindelse med androgenfølsomhed (med eller uden seborré) og/eller hirsutisme hos kvinder i den fødedygtige alder, under forudsætning af de vedtagne begrænsninger, advarsler, andre ændringer i produktinformationen, supplerende lægemiddelovervågningstiltag og supplerende risikominimeringsforanstaltninger.
English: A total of 52 (5.4%) of 968 retrieved cases reported one or more ATEs in association with CPA/EE (2mg/0.035mg) use.
Danish: Af 968 indberettede tilfælde omfattede de 52 (5,4 %) en eller flere arterielle tromboembolier i forbindelse med anvendelse af CPA/EE (2 mg/0,035 mg).
English: In this study, around 60% of women prescribed a CPA/EE-containing preparation specifically reported in the baseline questionnaire that their CPA/EE (2mg/0.035mg) prescription was due to acne and/or polycystic ovary syndrome (PCOS).
Danish: 60 % af de deltagende kvinder, der fik ordineret et præparat indeholdende CPA/EE, oplyste udtrykkeligt i spørgeskemaet ved baseline, at deres ordination af CPA/EE (2 mg/0,035 mg) skyldtes acne og/eller polycystisk ovariesyndrom (PCOS).
English: The CMDh, having considered the PRAC recommendation dated 16 May 2013 with regards to the cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products, agrees with the recommendation therein as stated below:
Danish: CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer (human)) har gennemgået PRAC's (Det Rådgivende Udvalg for Risikovurdering inden for Lægemiddelvurdering) anbefaling af 16. maj 2013 for lægemidler indeholdende cyproteronacetat/ethinylestradiol (2mg/0,035mg) og kan tilslutte sig anbefalingen, således som det fremgår af følgende:
English: In this study, around 60% of women prescribed a CPA-containing preparation specifically reported in the baseline questionnaire that their CPA/EE (2mg/0.035mg) prescription was due to acne and/or PCOS.
Danish: I spørgeskemaet ved baseline i undersøgelsen angav 60 % af de kvinder, der fik ordineret et præparat indeholdende CPA, udtrykkeligt, at deres ordination af CPA/EE (2 mg/0,035 mg) skyldtes acne og/eller polycystisk ovariesyndrom (PCOS).
English: French assessment report February 2013 Rationale for the triggering of procedure under Article 107i of Directive 2001/83/EC on cyproterone/ethinylestradiol (2mg/0.035mg) presented by ANSM, France history of VTE before prescribing EE-containing medicinal products (e.g. combined oral contraceptives (COC)) is, therefore, recommended in the product information of the products.
Danish: Fransk vurderingsrapport af februar 2013: Rationalet for at udløse en procedure i henhold til artikel 107, stk. 1, i direktiv 2001/83/EF vedrørende cyproteron/ethinylestradiol (2mg/0,035mg), forelagt af ANSM, Frankrig
English: Fatal cases
Danish: Dødstilfælde