FrancophonIA/ELRC3.0 huggingface dataset:
English: Further, in all women emergency contraception should be taken as soon as possible after unprotected intercourse.
Danish: Hos alle kvinder bør indtagelse af postcoital antikonception desuden finde sted snarest muligt efter ubeskyttet samleje.
English: Grounds for the variation to the terms of the marketing authorisation Whereas
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelsen
English: For emergency contraception one tablet of 1.5 mg LNG needs to be taken, or two tablets of 0.75 mg LNG at once.
Danish: Til postcoital kontraception tages 1 tablet med 1,5 mg levonorgestrel eller 2 tabletter med 0,75 mg levonorgestrel samtidig.
English: This information should also be reflected in the package leaflet.
Danish: Disse oplysninger bør ligeledes afspejles i indlægssedlen.
English: While the analyses of data from the three randomised controlled trials in which 2,098 women received UPA indicate a weak effect of body weight or BMI on pregnancy rates, the open label study (n=1,241) indicated no such effect.
Danish: Skønt analyserne af data fra de tre randomiserede, kontrollerede undersøgelser, hvor 2 098 kvinder fik ulipristalacetat, tyder på en svag virkning af legemsvægt eller BMI på graviditetsraten, viste den åbne undersøgelse (n=1 241) ingen sådan virkning.
English: Ulipristal acetate (UPA) (30 mg) (ellaOne) is an orally synthetic progesterone receptor modulator, which acts via high affinity binding to the human progesterone receptor.
Danish: Ulipristalacetat (30 mg) (ellaOne) er en oral, syntetisk progesteron-receptormodulator med høj affinitet til den humane progesteronreceptor.
English: A trend was observed in the UPA group for increasing number of pregnancies with increasing weight or BMI.
Danish: I ulipristalacetat-grupperne var der tendens til tiltagende antal graviditeter med stigende vægt eller BMI.
English: A range of different factors have an impact on a woman´s fertility and the ability of emergency contraceptives to prevent a pregnancy, e.g. timing of intake of emergency contraception in relation to intercourse, conception probability, further acts of unprotected intercourse, age, ethnicity, previous infections of the genital tract, male fertility, etc.
Danish: En række forskellige faktorer har indvirkning på kvinders fertilitet og på postcoitale kontraceptivas evne til at forhindre graviditet, f.eks. tidspunktet for indtagelse af postcoital kontraception i forhold til samlejet, sandsynligheden for konception, yderligere ubeskyttede samlejer, alder, etnisk tilhørsforhold, tidligere infektioner af de kvindelige kønsveje, fertiliteten hos manden osv.
English: Levonorgestrel (LNG)
Danish: Levonorgestrel
English: All together, the current data are considered not robust enough to support the current recommendation of decreased efficacy in women with body weight above 75 kg and inefficacy in women with body weight above 80 kg as is currently included in the product information of one LNG-containing emergency contraceptive medicinal product (Norlevo).
Danish: Alt i alt anses de nuværende data for ikke for tilstrækkeligt solide til at støtte anbefalingen om nedsat virkning hos kvinder med legemsvægt over 75 kg og manglende virkning hos kvinder med legemsvægt over 80 kg, således som den angives i den nuværende produktinformation for det ene levonorgestrel-holdige postcoitale kontraceptivum (Norlevo).
English: The data are currently too limited and therefore insufficiently precise to draw definite conclusions whether efficacy is negatively influenced by increased body weight and BMI; for instance for the obese category (BMI ≥30) three pregnancies were reported in the first analysis, and eleven pregnancies in the second.
Danish: Dataene er på nuværende tidspunkt for begrænsede og derfor ikke tilstrækkeligt præcise til, at der kan drages afgørende konklusioner om, hvorvidt virkningen nedsættes af øget legemsvægt og BMI; f.eks. blev der for kategorien adipøs (BMI ≥30) indberettet 3 graviditeter i den første analyse og 11 graviditeter i den anden.
English: Considering the need to further characterise this risk, the MAHs are strongly recommended to investigate the pharmacodynamic effect (ovulation inhibition) of LNG in obese women in the future.
Danish: I betragtning af behovet for yderligere karakterisering af denne risiko anbefales det kraftigt, at markedsføringstilladelsesindehaverne undersøger den farmakodynamiske virkning (ovulationshæmning) af levonorgestrel hos adipøse kvinder i fremtiden.
English: In the meta-analysis including the three WHO studies, primarily including African and Asian women, no trend for a reduced efficacy with increasing body weight/BMI was observed (Table 1).
Danish: I metaanalysen af de tre WHOundersøgelser, der hovedsagelig omfattede afrikanske og asiatiske kvinder, sås ingen tendens til nedsat effektivitet med stigende legemsvægt/BMI (tabel 1).
English: Table 3: Meta-analysis on four clinical studies conducted with UPA
Danish: Tabel 3: Metaanalyse af fire kliniske undersøgelser med ulipristalacetat
English: Pregnancy rate 0.00% 1.23% 1.29% 2.57%
Danish: Graviditetsrate 0,00% 1,23% 1,29% 2,57%
English: Emergency contraceptives can be used to prevent an unintended pregnancy following an unprotected sexual intercourse or in case of failure of a contraceptive method.
Danish: Postcoitale kontraceptiva kan anvendes til at forhindre utilsigtet graviditet efter ubeskyttet samleje eller ved svigt af præventionsmidler.
English: The data are currently too limited and therefore insufficiently precise to draw definite conclusions whether efficacy is negatively influenced by increased body weight and BMI.
Danish: Dataene er på nuværende tidspunkt for begrænsede og derfor ikke tilstrækkelig præcise til, at der kan drages afgørende konklusioner om, hvorvidt virkningen påvirkes negativt af øget legemsvægt og BMI.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for the emergency contraceptive medicinal products containing LNG or UPA.
Danish: • udvalget fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for postcoitale kontraceptiva indeholdende levonorgestrel eller ulipristalacetat,
English: From these data there is no clear indication of an effect of weight or BMI on efficacy in general, or specifically among overweight or obese women.
Danish: Disse data giver ingen klar indikation af, at vægt eller BMI har betydning for virkningen i almindelighed eller hos overvægtige eller adipøse kvinder i særdeleshed.
English: Pregnancy rate 1.83% 0.99% 0.57% 1.17% Confidence
Danish: Graviditetsrate 1,83% 0,99% 0,57% 1,17% Sikkerhedsinterval
English: The products are indicated for emergency contraception within 72 hours (3 days) of unprotected sexual intercourse or contraceptive failure, and have been approved in more than 100 countries worldwide and used for more than 30 years.
Danish: Lægemidlerne, der er indiceret til postcoital kontraception inden for 72 timer (3 døgn) efter ubeskyttet samleje eller svigt af præventionsmidler, er godkendt i over 100 lande verden over og har været anvendt i over 30 år.
English: The use of emergency contraception is an occasional method that is far less effective compared with most contraceptive products used on a regular basis, e.g. combined hormonal contraceptives, gestagen-only pills and various long-acting methods like intra-uterine devices and implants.
Danish: Postcoital kontraception er en metode til lejlighedsvis brug og er langt mindre effektiv end de fleste antikonceptionsmidler til regelmæssig brug, f.eks. kombinerede hormonale kontraceptiva, piller med gestagen alene og forskellige langtidsvirkende metoder, såsom intrauterin spiral og intrauterint implantat.
English: Further, the data of the two meta-analyses should be reflected in section 5.1 of the SmPC.
Danish: Desuden bør dataene fra de to metaanalyser afspejles i produktresuméets afsnit 5.1.
English: Further, the data of the metaanalysis should be presented in section 5.1 of the SmPC.
Danish: Desuden bør dataene fra metaanalysen afspejles i produktresuméets afsnit 5.1.
English: The CHMP was requested to assess whether the efficacy of emergency contraceptives is affected in relation to body weight and/or body mass index (BMI) of the women.
Danish: CHMP blev anmodet om at vurdere, om virkningen af postcoitale kontraceptiva afhænger af kvindens legemsvægt og/eller legemsmasseindeks (BMI).
English: In the three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) no trend for a reduced efficacy with increasing body weight/BMI was observed, whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI.
Danish: I tre WHO-undersøgelser (Von Hertzen et al., 1998 and 2002, og Dada et al., 2010) sås ingen tendens til nedsat virkning med stigende legemsvægt/BMI, mens der i de to andre undersøgelser (Creinin et al., 2006 og Glasier et al., 2010) iagttoges nedsat antikonceptiv virkning med stigende legemsvægt eller BMI.
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) BMI (kg/m2)
Danish: Tabel 1: Metaanalyse af tre WHO-undersøgelser (Von Hertzen et al., 1998 og 2002; Dada et al., 2010) BMI (kg/m2)
English: Therefore, even if data from some studies suggest a lower ability of LNG-containing emergency contraceptives to prevent pregnancies in women of higher weight/BMI, this is only one factor influencing the effect and it is difficult to define a certain cut-off for weight/BMI at which no effect is present.
Danish: Selv om data fra nogle undersøgelser tyder på lavere evne af levonorgestrel-holdige postcoitale kontraceptiva til at forhindre graviditet hos kvinder med større vægt/BMI, er dette kun én faktor med indflydelse på virkningen, og det er vanskeligt at fastlægge et bestemt afskæringspunkt for vægt/BMI, hvor der ikke nogen virkning.
English: N pregnancies 11
Danish: N graviditeter
English: In addition the CHMP is of the opinion that conducting a pharmacodynamic/pharmacokinetic (PD/PK) study may provide some information which may help to further characterise the risk of decreased efficacy in women with high body weight/BMI and ovulation inhibition.
Danish: Derudover er CHMP af den opfattelse, at en farmakodynamisk/farmakokinetisk undersøgelse muligvis vil kunne give oplysninger til yderligere karakterisering af risikoen for nedsat virkning hos kvinder med høj legemsvægt/højt BMI og ovulationshæmning.
English: The product is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Danish: Lægemidlet er indiceret til postcoital kontraception inden for 120 timer (5 døgn) efter ubeskyttet samleje eller svigt af præventionsmidler.
English: Further, since the limited data available do not support with any certainty the conclusion that their contraceptive effect is reduced in women with high bodyweight, no adjustment of the dose is recommended at this stage, and any information that already is included in the section 4.2 of the SmPC making reference to effect and body weight should be removed.
Danish: Da de begrænsede foreliggende data endvidere ikke med sikkerhed støtter konklusionen om nedsat antikonceptiv virkning hos kvinder med høj legemsvægt, anbefales der i dette stade ingen dosisjustering, og eventuelle oplysninger herom i produktresuméets afsnit 4.2 med omtale af virkning og legemsvægt bør slettes.
English: Table 2: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010
Danish: Tabel 2: Metaanalyse af undersøgelserne udført af Creinin et al., 2006 og Glasier et al., 2010
English: • The CHMP concluded that the available data is limited and does not support a definite conclusion that increased bodyweight reduces efficacy of emergency contraceptives medicinal products containing LNG or UPA.
Danish: • CHMP konkluderede, at de foreliggende data er begrænsede og ikke støtter en endelig konklusion om, at øget legemsvægt nedsætter virkningen af postcoitale kontraceptiva indeholdende levonorgestrel eller ulipristalacetat.
English: During the data submission an analysis was provided on three WHO studies (Von Hertzen et al., 1998 1 and 2002 2; Dada et al., 2010 3) as well as an analysis on two other studies (Creinin et al., 2006 4; Glasier et al., 2010 5).
Danish: Ved indsendelsen af data blev der forelagt en analyse af tre WHO-undersøgelser (Von Hertzen et al., 1998 1 og 2002 2; Dada et al., 2010 3) og en analyse af to andre undersøgelser (Creinin et al., 2006 4; Glasier et al., 2010 5).
English: The CHMP proposed that a warning in section 4.4 of the summary of product characteristics (SmPC) is an appropriate routine risk minimisation measure to reflect that limited and inconclusive data are present regarding a possible reduced efficacy in women with a high body weight/BMI.
Danish: CHMP fremførte, at en advarsel i produktresuméets afsnit 4.4 er en passende rutinemæssig risikominimeringsforanstaltning til at afspejle de begrænsede og inkonklusive foreliggende data om mulig nedsat virkning hos kvinder med høj legemsvægt/højt BMI.
English: The CHMP concluded that a warning in section 4.4 of the SmPC is appropriate to indicate that limited and inconclusive data are present regarding a possible reduced efficacy in women with a high body weight/BMI and that in all women emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI.
Danish: CHMP konkluderede, at produktresuméets afsnit 4.4 bør indeholde en advarsel om, at der foreligger begrænsede og inkonklusive data om en mulig nedsat virkning hos kvinder med høj legemsvægt/højt BMI, og at postcoital kontraception hos alle kvinder bør tages snarest muligt efter ubeskyttet samleje uanset kvindens vægt eller BMI.
English: In particular, limited but inconclusive data suggest that there may be reduced efficacy of these medicinal products with increased body weight in women.
Danish: Navnlig tyder begrænsede og inkonklusive data på, at virkningen af disse lægemidler kan være nedsat ved højere legemsvægt hos kvinder,
English: Both meta-analyses excluded off-label use of LNG-containing of emergency contraceptives, i.e. intake later than 72 hours after unprotected intercourse and women who had further acts of unprotected intercourse.
Danish: Begge metaanalyser ekskluderede ikke-godkendt brug af levonorgestrel-holdige postcoitale kontraceptiva, dvs. indtagelse senere end 72 timer efter ubeskyttet samleje, samt kvinder, som havde yderligere ubeskyttede samlejer.
English: Eight relevant studies with LNG-containing emergency contraceptives are available in public literature.
Danish: I litteraturen foreligger otte relevante undersøgelser med levonorgestrel-holdige postcoitale kontraceptiva.
English: • The Committee reviewed all data from clinical studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs), on the efficacy of emergency contraceptive medicinal products containing LNG or UPA, in particular with regards to a possible effect of high weight/BMI of women.
Danish: • udvalget gennemgik alle foreliggende data fra kliniske undersøgelser, den publicerede litteratur og erfaringer efter markedsføring, herunder besvarelserne fra markedsføringstilladelsesindehaverne, om virkningen af postcoitale kontraceptiva indeholdende levonorgestrel eller ulipristalacetat, navnlig hvad angår en mulig betydning af høj vægt/højt BMI hos kvinden,
English: There are limited and inconclusive data from clinical trials that evaluated the effect of high body weight/high BMI on the contraceptive efficacy.
Danish: Der findes kun begrænsede og inkonklusive data fra kliniske undersøgelser, hvor virkningen af høj legemsvægt/højt BMI på den antikonceptive virkning blev vurderet.
English: Interval
Danish: Ulipristalacetat
English: The CHMP reviewed all data from clinical studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs), on the efficacy of emergency contraceptive medicinal products containing LNG or UPA, in particular with regards to the relation of high weight/BMI of women.
Danish: CHMP gennemgik alle foreliggende data fra kliniske undersøgelser, den publicerede litteratur og erfaringer efter markedsføring, som var forelagt af markedsføringstilladelsesindehaverne om effektiviteten af postcoitale kontraceptiva indeholdende levonorgestrel eller ulipristalacetat, navnlig vedrørende sammenhængen med høj vægt/højt BMI hos kvinden.
English: excluded intake later than 72 hours after unprotected intercourse (i.e. off-label use of LNG) and women who had further acts of unprotected intercourse.
Danish: Begge metaanalyser ekskluderede indtagelse senere end 72 timer efter ubeskyttet samleje (dvs. ikke godkendt anvendelse af levonorgestrel) samt kvinder, som havde yderligere ubeskyttede samlejer.
English: For UPA-containing emergency contraceptive products (ellaOne) it is concluded that limited and inconclusive data suggest that there may be reduced efficacy of UPA with increased body weight in women.
Danish: For ulipristalacetat-holdige postcoitale antikonceptiva (ellaOne) konkluderes det, at begrænsede og inkonklusive data tyder på, at virkningen af ulipristalacetat kan aftage med stigende legemsvægt.
English: The emergency contraceptives can be divided into levonorgestrel (LNG)- and ulipristal acetate (UPA)-containing emergency contraceptives and they act by inhibiting and/or delaying ovulation.
Danish: Postcoitale kontraceptiva kan inddeles i midler indeholdende levonorgestrel og midler indeholdende ulipristalacetat og virker ved at hindre og/eller forsinke ovulationen.
English: The Committee concluded that the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA remains positive for all women regardless of body weight/BMI, subject to the warnings and changes to the product information agreed.
Danish: Udvalget konkluderede, at benefit/risk-forholdet for postcoitale kontraceptiva indeholdende levonorgestrel eller ulipristalacetat fortsat er positivt for alle kvinder uanset legemsvægt/BMI under forudsætning af de vedtagne advarsler og ændringer af produktinformationen.
English: • The Committee considered that in view of the currently available data, the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA is favourable, subject to warnings and other changes to the product information.
Danish: • udvalget fandt på baggrund af de foreliggende data, at benefit/risk-forholdet er positivt for postcoitale kontraceptiva indeholdende levonorgestrel eller ulipristalacetat under forudsætning af advarsler og andre ændringer af produktinformationen.
English: The information in the SmPC should also be reflected in the package leaflet.
Danish: Oplysningerne i produktresuméet bør ligeledes afspejles i indlægssedlen.
English: Pregnancy rate 1.56% 0.96% 2.36% 5.19% Confidence
Danish: Graviditetsrate 1,56% 0,96% 2,36% 5,19% Sikkerhedsinterval 0,04 - 8,40 0,44 - 1,82 1,02 - 4,60 2,62 - 9,09
English: The Committee, as a consequence, concluded that the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA remains positive, subject to the warnings and changes to the product information agreed.
Danish: konkluderede udvalget, at benefit/risk-forholdet for postcoitale kontraceptiva indeholdende levonorgestrel eller ulipristalacetat fortsat er positivt under forudsætning af de vedtagne advarsler og ændringer af produktinformationen.
English: Overall for of LNG-containing emergency contraceptives it is concluded that there is limited data on the effect of high body weight/high BMI on the contraceptive efficacy.
Danish: Overordnet konkluderedes det for levonorgestrel-holdige postcoitale kontraceptiva, at der kun findes begrænsede data om betydningen af høj vægt/højt BMI for den antikonceptive virkning.
English: For LNG-containing emergency contraceptives overall it is concluded that there is limited and inconsistent data on the effect of high body weight/high BMI on the contraceptive efficacy.
Danish: For levonorgestrel-holdige postcoitale kontraceptiva konkluderes det overordnet, at der kun findes begrænsede og ikke samstemmende data om indvirkningen af høj vægt/højt BMI på den antikonceptive virkning.
English: This summary was last updated in 10-2017.
Danish: Dette sammendrag blev sidst ajourført i 10-2017.
English: The third study involved 59 children aged two to 12 years.
Danish: Den tredje undersøgelse omfattede 59 børn i alderen 2-12 år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nuwiq on 24 July 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nuwiq den 24. juli 2014.
English: The main measure of effectiveness was based on patients' assessment of how well treatment worked.
Danish: Behandlingens virkning blev hovedsagelig målt på patienternes vurdering af, hvor godt behandlingen virkede.
English: The full EPAR for Nuwiq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Nuwiq findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Nuwiq.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nuwiq.
English: Nuwiq is intended for either short-term or long-term use.
Danish: Nuwiq er beregnet til enten kortvarig eller langvarig brug.
English: Other information about Nuwiq
Danish: Andre oplysninger om Nuwiq
English: Simoctocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Danish: Simoctocog alfa dannes ved hjælp af en metode kaldet "rekombinant DNA-teknologi", dvs. det fremstilles af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere det.
English: Patients or their carers may be able to administer Nuwiq themselves at home once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsgiver har mulighed for selv at indgive Nuwiq hjemme efter at have fået passende instruktion.
English: Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and may in some cases become severe.
Danish: Der er indberettet allergiske reaktioner over for faktor VIII-lægemidler, som i visse tilfælde kan være alvorlige.
English: The Agency decided that Nuwiq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP konkluderede, at fordelene ved Nuwiq opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Nuwiq?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nuwiq?
English: It contains the active substance simoctocog alfa (human coagulation factor VIII).
Danish: Det indeholder det aktive stof simoctocog alfa (human koagulationsfaktor VIII).
English: In such cases, a specialised haemophilia centre should be contacted.
Danish: I så fald bør man kontakte en specialafdeling for hæmofili.
English: Treatment with Nuwiq was rated as ‘excellent' or ‘good' for 94% of bleeding episodes.
Danish: Behandlingen med Nuwiq blev bedømt som "udmærket" eller "god" ved 94 % af blødningsepisoderne.
English: The dose and duration of treatment depend on whether Nuwiq is used to treat or prevent bleeding, or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Danish: Dosis og varighed af behandlingen afhænger af, om Nuwiq skal anvendes til behandling eller til forebyggelse af blødning eller under operation, og af patientens faktor VIII-niveauer, sygdommens sværhedsgrad, blødningens omfang og beliggenhed samt patientens tilstand og kropsvægt.