FrancophonIA/ELRC3.0 huggingface dataset:
English: Similar results were obtained for the active mono-demethylated metabolite.
Danish: Lignende resultater blev opnået for den aktive mono-demethylerede metabolit.
English: Enzyme induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if a woman has stopped taking an enzyme inducer in the past 4 weeks.
Danish: Enzyminduktion aftager langsomt, og der kan muligvis forekomme virkninger på plasmakoncentrationen af ulipristalacetat, selvom en kvinde er ophørt med at tage en enzyminducer inden for de sidste 4 uger.
English: Ulipristal acetate is not a substrate for either OATP1B1 or OATP1B3.
Danish: Ulipristalacetat er ikke substrat for OATP1B1 eller OATP1B3.
English: Only condoms can protect you from sexually transmitted infections.
Danish: Kun kondomer beskytter mod seksuelt overførte infektioner.
English: There were no safety differences in these subjects in terms of incidence and severity of adverse reactions, change in duration or volume of menses or incidence of intermenstrual bleeding.
Danish: Der var ingen sikkerhedsmæssig forskel hos disse forsøgspersoner med hensyn til incidens og sværhedsgrad af uønskede hændelser, ændring i varighed eller volumen af menstruationen eller incidens af intermenstruel blødning.
English: P-glycoprotein (P-gp) substrates
Danish: P-glykoprotein (P-gp)-substrater
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days.
Danish: En mindre del af kvinderne (8,7 %) rapporterede intermenstruel blødning, der varede i 2,4 dage i gennemsnit.
English: During this time, it is recommended to use a breast pump in order to maintain milk production, but throw away your breast milk.
Danish: I løbet dette tidsrum anbefales det, at du anvender en brystpumpe, så du kan opretholde mælkeproduktionen, men mælken skal kasseres.
English: In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days.
Danish: Hos 18,5 % af kvinderne var der en forsinkelse på mere end 7 dage, og hos 4 % var forsinkelsen større end 20 dage.
English: The mono-demethylated metabolite is pharmacologically active.
Danish: Den mono-demethylerede metabolit er farmakologisk aktiv.
English: If you become pregnant despite taking ellaOne, you are encouraged to ask your doctor to register your pregnancy in an official registry.
Danish: Hvis du bliver gravid, selvom du har taget ellaOne, anbefales det, at du beder din læge om at registrere din graviditet i et officielt register.
English: <Not applicable.>
Danish: <Ikke relevant.>
English: It has minimal affinity to the androgen receptor and no affinity for the human estrogen or mineralocorticoid receptors.
Danish: Stoffet har minimal affinitet til androgen-receptoren og ingen affinitet til de humane østrogen- eller mineralkortikoidreceptorer.
English: ellaOne is not to be used for regular contraception
Danish: ellaOne må ikke anvendes som almindelig prævention
English: Randomised controlled trial
Danish: Randomiseret kontrolleret studie
English: In any case, women should be advised to adopt a regular method of contraception.
Danish: Kvinder skal under alle omstændigheder rådes til at bruge en almindelig svangerskabsforebyggelse.
English: If you take this medicine while you are breast-feeding a baby, do not breast-feed for one week after taking this medicine.
Danish: Hvis du tager dette lægemiddel, mens du ammer et spædbarn, må du ikke amme i en uge efter dette lægemiddel.
English: In such cases ritonavir might reduce plasma concentrations of ulipristal acetate.
Danish: I sådanne tilfælde kan ritonavir eventuelt reducere plasmakoncentrationen af ulipristalacetat.
English: The meta-analysis of the four clinical studies conducted with ulipristral acetate presented below excluded women who had further acts of unprotected intercourse.
Danish: Meta-analysen af fire kliniske studier udført med ulipristalacetat, der præsenteres herunder, udelukkede kvinder, som havde yderligere ubeskyttede samlejer.
English: Premenstrual syndrome
Danish: Præmenstruelt syndrom
English: After taking the tablet, it is normal for your next period to be a few days late.
Danish: Efter at du har taget tabletten, er det normalt, at din menstruation er nogle få dage forsinket.
English: The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is used for a longer period.
Danish: CYP3A4-inhibitoren ritonavir kan desuden have en inducerende virkning på CYP3A4, når ritonavir anvendes i længere tid.
English: Specific populations
Danish: Specifikke populationer
English: See leaflet for further information
Danish: Se indlægssedlen for yderligere oplysninger
English: The majority of women (74.6%) in the phase III studies had their next menstrual period at the expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than expected and 18.5% had a delay of more than 7 days beyond the anticipated onset of menses.
Danish: I fase III-studierne fik flertallet af kvinderne (74,6 %) deres næste menstruation på det forventede tidspunkt eller inden for ± 7 dage, mens 6,8 % fik menstruation mere end 7 dage tidligere end forventet, og 18,5 % oplevede en forsinkelse på mere end 7 dage i forhold til det forventede tidspunkt for menstruationsstart.
English: If you have taken emergency contraception and you do not use a regular contraceptive method (or do not have a contraceptive method that suits you), talk to your doctor or family planning clinic for advice.
Danish: Hvis du har taget nødprævention, og du ikke benytter en almindelig præventionsmetode (eller hvis du ikke bruger prævention, der passer til dig), skal du tale med din læge eller en klinik for familieplanlægning.
English: You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.
Danish: Du rådes til at tale med din læge eller sundhedspersonalet, hvis du er bekymret over eventuelle problemer i forbindelse med brug af nødprævention
English: Ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1 mg/kg) and in monkeys.
Danish: Ulipristalacetat har en embryoletal virkning hos rotter, kaniner (ved gentagne doser over 1 mg/kg) og aber på grund af dets virkningsmekanisme.
English: Hormonal contraceptives
Danish: Hormonale kontraceptiva
English: Post-marketing experience: the adverse reactions spontaneously reported in post-marketing experience were similar in nature and frequency to the safety profile described during the phase III program.
Danish: Erfaringer efter markedsføring: De spontant indberettede bivirkninger efter markedsføring svarede i art og hyppighed til den sikkerhedsprofil, der blev beskrevet i fase III-programmet.
English: Dry throat
Danish: Tør hals
English: In vitro data indicate that ulipristal acetate and its active metabolite do not significantly inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, at clinically relevant concentrations.
Danish: In vitro-data indikerer, at ulipristalacetat og dets aktive metabolit ikke i væsentlig grad hæmmer CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 og 3A4 i klinisk relevante koncentrationer.
English: Potential for ulipristal acetate to affect other medicinal products
Danish: Potentiel risiko for, at ulipristalacetat kan påvirke andre lægemidler
English: A post-marketing observational study evaluating efficacy and safety of ellaOne in adolescents aged 17 and younger showed no difference in the safety and efficacy profile compared to adult women aged 18 and older.
Danish: Et post marketing-overvågningsstudie, der evaluerede ellaOnes virkning og sikkerhed hos unge under 17 år eller yngre, viste ingen forskelle i sikkerheds- og virkningsprofilen sammenlignet med voksne kvinder i alderen 18 år og derover.
English: Therefore it is important you use condoms until your next period.
Danish: Det er derfor vigtigt, at du bruger kondom, indtil din næste menstruation.
English: If you have used any of the medicines listed below during the last 4 weeks, ellaOne may be less suitable for you.
Danish: Hvis du har taget et eller flere af nedenstående lægemidler inden for de sidste 4 uger, kan ellaOne være mindre egnet til dig.
English: See section “Pregnancy, breast-feeding and fertility” for more information.
Danish: Se punktet ”Graviditet, amning og frugtbarhed” for at få yderligere oplysninger.
English: During this time it is recommended to express and discard the breast milk in order to stimulate lactation.
Danish: I denne periode anbefales det at malke mælken ud og kassere den for at stimulere mælkesekretionen.
English: Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via high-affinity binding to the human progesterone receptor.
Danish: Ulipristalacetat er en oralt aktiv syntetisk selektiv progesteron-receptormodulator, der virker gennem højaffinitetsbinding til den humane progesteron-receptor.
English: Excipients with known effect Each tablet contains 237 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder 237 mg lactose (som monohydrat).
English: Laboratorios León Farma S.A. C/ La Vallina, s/n Pol. Ind. Navatejera 24008 Navatejera, León Spain
Danish: Laboratorios León Farma S.A. C/ La Vallina, s/n Pol. Ind. Navatejera 24008 Navatejera, León Spanien
English: - if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for ulipristalacetat eller et af de øvrige indholdsstoffer i ellaOne (angivet i punkt 6).
English: Take the tablet without delay.
Danish: Tag tabletten hurtigst muligt.
English: Although no teratogenic potential has been observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
Danish: Selvom der ikke blev observeret noget teratogent potentiale, er dataene fra dyrestudier utilstrækkelige for så vidt angår reproduktionstoksicitet (se pkt.
English: The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea.
Danish: De almindeligst rapporterede bivirkninger var hovedpine, kvalme, abdominalsmerter og dysmenoré.
English: At these repeated doses, the safety for a human embryo is unknown.
Danish: Sikkerheden for et menneskeligt embryo ved disse gentagne doser kendes ikke.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours).
Danish: Du skal tage tabletten hurtigst muligt efter samlejet og inden for højst 5 dage (120 timer).
English: MORE ABOUT REGULAR CONTRACEPTION
Danish: MERE OM ALMINDELIG PRÆVENTION
English: How ellaOne works ellaOne contains the substance ulipristal acetate which acts by modifying the activity of the natural hormone progesterone which is necessary for ovulation to occur.
Danish: Sådan virker ellaOne ellaOne indeholder stoffet ulipristalacetat, som virker ved at ændre aktiviteten af det naturlige hormon progesteron, som er nødvendigt for ægløsning.
English: Two trials provide efficacy data on ellaOne used up to 120 hours after unprotected intercourse.
Danish: To studier giver effektdata for ellaOne anvendt i op til 120 timer efter ubeskyttet samleje.
English: The timing of ovulation cannot be predicted and therefore the tablet should be taken as soon as possible after unprotected intercourse.
Danish: Tidspunktet for ægløsning kan ikke forudsiges, og derfor skal tabletten tages hurtigst muligt efter et ubeskyttet samleje.
English: As a result, this medicine works by postponing ovulation.
Danish: Som følge heraf virker dette lægemiddel ved at forsinke ægløsningen.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDEL SAMT AFFALD HERAF
English: ellaOne does not work if you are already pregnant
Danish: ellaOne virker ikke, hvis du allerede er gravid
English: - If you are using one of the medicines that may prevent ellaOne from working properly (see section 2 “What you need to know before you take ellaOne”) or if you have used one of these medicines in the past 4 weeks, ellaOne may work less effectively for you.
Danish: - Hvis du tager et af de lægemidler, der kan forhindre, at ellaOne virker effektivt (se punkt 2 ”Det skal du vide, før du begynder at tage ellaOne”), eller hvis du har taget et af disse lægemidler inden for de seneste 4 uger, kan ellaOne være mindre effektivt for dig.
English: No differences in safety or efficacy have been shown compared to adult women aged 18 and older (see section 5.1).
Danish: Der er ikke observeret nogen forskelle i sikkerhed eller virkning sammenlignet med voksne kvinder i alderen 18 år og opefter (se pkt.
English: In vitro data indicate that this is predominantly mediated by CYP3A4, and to a small extent by CYP1A2 and CYP2A6.
Danish: In vitro-data indikerer, at dette hovedsageligt medieres af CYP3A4 og i mindre grad af CYP1A2 og CYP2A6.
English: - CYP3A4 inhibitors
Danish: - CYP3A4-inhibitorer
English: Such high doses were well-tolerated; however, these women had a shortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and in some women, the duration of bleeding was prolonged, although not excessive in amount (spotting).
Danish: Disse kvinder havde dog en kortere menstruationscyklus (uterin blødning skete 2-3 dage tidligere end forventet), og hos nogle kvinder varede blødningen længere, men var ikke kraftig (pletblødning).
English: This medicine may make regular hormonal contraceptives, like pills and patches, temporarily less effective.
Danish: Dette lægemiddel kan midlertidigt gøre almindelige hormonbaserede præventionstyper, såsom ppiller, mindre effektive.
English: Emergency contraception does not protect against sexually transmitted infections
Danish: Nødprævention beskytter ikke mod seksuelt overførte infektioner.
English: If you have been told by your doctor or other healthcare professional that you have an intolerance to some sugars, tell your pharmacist before taking this medicine.
Danish: Hvis din læge eller andre sundhedspersoner har fortalt dig, at du ikke tåler visse sukkerarter, skal du fortælle det til apotekspersonalet, inden du tager denne medicin.
English: N pregnancies 0
Danish: N total N graviditeter
English: In an open-label clinical trial, which enrolled women who presented for emergency contraception and were treated with ulipristal acetate between 48 and 120 hours after unprotected intercourse, a pregnancy rate of 2.1% (26/1241) was observed.
Danish: I et open label klinisk studie, som rekrutterede kvinder, der henvendte sig for at få behandling med nødprævention og blev behandlet med ulipristalacetat mellem 48 og 120 timer efter ubeskyttet samleje, var den observerede graviditetsrate 2,1 % (26/1241).
English: Most findings in general toxicity studies were related to its mechanism of action as a modulator of progesterone and glucocorticoid receptors, with antiprogesterone activity observed at exposures similar to therapeutic levels.
Danish: I generelle toksicitetsstudier var de fleste fund relateret til stoffets virkningsmekanisme som modulator af progesteron- og glukokortikoid-receptorer, og der sås antiprogesteron-aktivitet ved eksponeringer svarende til terapeutiske niveauer.
English: If ovulation has already occurred, it is no longer effective.
Danish: Det er ikke længere effektivt, hvis ægløsningen allerede er sket.
English: When used for emergency contraception the mechanism of action is inhibition or delay of ovulation via suppression of the luteinising hormone (LH) surge.
Danish: Når det anvendes som nødprævention er virkningsmekanismen hæmning eller forsinkelse af ægløsning via suppression af luteiniserende hormon (LH)-bølgen.
English: The clinical relevance of this interaction for single dose administration of ulipristal acetate as emergency contraception is not known.
Danish: Den kliniske relevans af denne interaktion ved indgivelse af en enkelt dosis ulipristalacetat som akut svangerskabsforebyggelse kendes ikke.
English: Speak to your doctor or pharmacist before using ellaOne when you use (or have recently used) any of the medicines stated above.
Danish: Tal med lægen eller apotekspersonalet, før du tager ellaOne, hvis du tager (eller fornylig har taget) et eller flere af de lægemidler, der er nævnt ovenfor.
English: If you have used certain other medicines in the last 4 weeks, in particular for epilepsy, tuberculosis, HIV infection or herbal medicines containing St. John´s wort (see leaflet), ellaOne may work less effectively.
Danish: Hvis du har taget en bestemt type medicin inden for de sidste 4 uger, især medicin til behandling af epilepsi, tuberkulose, hiv-infektion eller naturlægemidler, der indeholder perikon (se indlægssedlen), kan ellaOne være mindre effektivt.
English: Ulipristal acetate also has high affinity for the glucocorticoid receptor and in vivo, in animals, antiglucocorticoid effects have been observed.
Danish: Ulipristalacetat har også høj affinitet til glukokortikoid-receptoren, og der er observeret antiglukokortikoid-virkning hos dyr in vivo.
English: Adolescents:
Danish: Unge:
English: Odds ratio [95% CI] of pregnancy risk, ulipristal acetate vs levonorgestrel2
Danish: Odds ratio [95 % CI] for graviditetsrisiko, ulipristalacetat kontra levonorgestrel2
English: ellaOne does not work if you are already pregnant.
Danish: ellaOne virker ikke, hvis du allerede er gravid.
English: A rapid return of fertility is likely following treatment with ulipristal acetate for emergency contraception.
Danish: Fertiliteten genoprettes sandsynligvis hurtigt efter behandling med ulipristalacetat som nødprævention.
English: After single dose administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not likely.
Danish: Efter enkeltdosisadministration er induktion af CYP1A2 og CYP3A4 forårsaget af ulipristalacetat eller dets aktive metabolit ikke sandsynlig.
English: What you need to know before you take ellaOne Do not take ellaOne
Danish: Det skal du vide, før du begynder at tage ellaOne Tag ikke ellaOne
English: This medicine will not protect you against HIV infection or any other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis).
Danish: Dette lægemiddel beskytter ikke mod hiv-infektion eller andre seksuelt overførte sygdomme (f.eks. klamydia, genital herpes, kønsvorter, gonorré, hepatitis B og syfilis).
English: Emergency contraception
Danish: Nødprævention
English: Each carton contains one blister.
Danish: Hvert karton indeholder ét blisterkort.
English: Concomitant use is therefore not recommended (see section 4.4).
Danish: Samtidig brug kan derfor ikke anbefales (se pkt.
English: Results in vivo with the P-gp substrate fexofenadine were inconclusive.
Danish: In vivo-resultater med P-gp-substratet fexofenadin var inkonklusive.
English: In the absence of specific studies, no alternate dose recommendations for ulipristal acetate can be made.
Danish: På grund af manglen på specifikke studier kan der ikke gives nogen alternativ dosisanbefaling for ulipristalacetat.
English: If you have sex again after taking ellaOne
Danish: Hvis du har sex igen efter at have taget ellaOne
English: 92320 CHATILLON France
Danish: 92320 CHATILLON Frankrig
English: Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing is similar to the safety profile in adults during the phase III program (see section 4.2).
Danish: Unge: Sikkerhedsprofilen observeret hos kvinder under 18 år i studier og efter markedsføring svarer til sikkerhedsprofilen hos voksne i fase III-programmet (se pkt.
English: Women who become pregnant after taking ulipristal acetate should contact their doctor (see section 4.6).
Danish: Kvinder, som bliver gravide efter at have taget ulipristalacetat, skal kontakte deres læge (se pkt.
English: Disorientation
Danish: Desorientering
English: - CYP3A4 inducers
Danish: - CYP3A4-induktorer
English: In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed.
Danish: I tilfælde, hvor den næste menstruation er mere end 7 dage forsinket, hvis menstruationen forløber anderledes end sædvanligt, eller hvis der er symptomer, som antyder graviditet, eller i tvivlstilfælde, skal der udføres en graviditetsprøve.
English: Somnolence Migraine
Danish: Søvnighed Migræne
English: This is especially important if you have severe abdominal (stomach) pain or bleeding or if you have previously had a pregnancy outside the womb, tubal surgery or long term (chronic) genital infection.
Danish: Dette er især vigtigt, hvis du oplever svære mavesmerter eller blødning, eller hvis du tidligere har haft en graviditet uden for livmoderen, er blevet opereret i æggestokkene eller har haft en langvarig (kronisk) kønssygdom.
English: No pharmacokinetic studies with ulipristal acetate have been performed in females with impaired renal or hepatic function.
Danish: Der er ikke foretaget farmakokinetiske studier af ulipristalacetat hos kvinder med nedsat nyre- eller leverfunktion.
English: Pharmacodynamic data show that even when taken immediately before ovulation is scheduled to occur (when LH has already started to rise), ulipristal acetate is able to postpone follicular rupture for at least 5 days in 78.6% of cases (p<0.005 vs. levonorgestrel and vs. placebo)
Danish: Farmakodynamiske data viser, at ulipristalacetat, selvom det tages umiddelbart før ægløsning (når LH er begyndt at stige), kan udsætte follikelruptur i mindst 5 dage i 78,6 % af tilfældene (p<0,005 vs. levonorgestrel og vs. placebo) (se tabellen).
English: Results from two independent randomised controlled trials (see Table) showed the efficacy of ulipristal acetate to be non-inferior to that of levonorgestrel in women who presented for emergency contraception between 0 and 72 hours after unprotected intercourse or contraceptive failure.
Danish: Resultater fra to uafhængige randomiserede kontrollerede studier (se tabel) viste, at virkningen af ulipristalacetat ikke var ringere end levonorgestrel hos kvinder, der henvendte sig med henblik på at blive behandlet med nødprævention mellem 0 og 72 timer efter ubeskyttet samleje eller svigt af svangerskabsforebyggelse.
English: Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, and high density lipoprotein.
Danish: Ulipristalacetat binder i høj grad (> 98 %) til plasmaproteiner, herunder albumin, alpha-1-syreglykoprotein og højdensitetslipoprotein.
English: Vaginal Ring
Danish: Vaginalring
English: Do not use this medicine after the expiry date which is on the carton and on the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen eller blisterkortet efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Do not take this medicine together with another emergency contraceptive pill that contains levonorgestrel.
Danish: Du må ikke tage dette lægemiddel sammen med en anden nødpræventionspille, som indeholder levonorgestrel.
English: The effect of breast-feeding your baby in the week after taking this medicine is not known.
Danish: Det vides ikke, hvordan dette lægemiddel påvirker dit barn i ugen efter, at du har taget dette lægemiddel.
English: Daily methods
Danish: Daglige metoder