FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take your tablet at the usual time, take it within the next 12 hours.
Danish: Hvis De har glemt at tage en tablet på det sædvanlige tidspunkt, kan De tage den inden for de næste 12 timer.
English: Vulvovaginal mycotic infection, see also “Reproductive system and breast disorders
Danish: Vaginal mykotisk infektion, se også ” Det reproduktive system og mammae”
English: However, some CHMP members were of the opinion that the data provided are insufficient to support that it is not the case with 0.5 mg E2.
Danish: Nogle medlemmer af CHMP mente imidlertid, at de foreliggende data ikke var tilstrækkelige til at understøtte, at dette ikke er tilfældet med 0,5 mg E2.
English: How to take the first tablet Break the plastic tab and tip out the first tablet.
Danish: Sådan tager De den første tablet ud Knæk plastikspidsen af og vip den første tablet ud.
English: Therefore, data from higher dose of NETA or other progestogens may not be extrapolated to the NETA 0.1 mg dose.
Danish: Derfor kan data fra højere doser af NETA eller andre progestagener ikke ekstrapoleres til dosen på 0,1 mg NETA.
English: Post-marketing experience is subject to underreporting especially with regard to trivial and well known adverse drug reactions.
Danish: Post-marketing-erfaringer er påvirket af underrapportering specielt med hensyn til almindelige og velkendte uønskede bivirkninger.
English: Hypersensitivity, see also “Skin and subcutaneous tissue disorders
Danish: Hypersensitivitet Se også ”Hud og subkutane væv”
English: It is unknown whether the findings apply to younger postmenopausal women or other HRT products.
Danish: Det er uvist, om resultatet kan overføres til yngre postmenopausale kvinder eller andre HRT-produkter.
English: For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life.
Danish: Til behandling af postmenopausale symptomer bør HRT kun initieres for at lindre symptomer, som påvirker livskvaliteten negativt.
English: Blood clots in the deep veins
Danish: Blodpropper i dybtliggende vener
English: According to the European guideline, the endometrial biopsies should be classified, according to standardized criteria into the general classes of atrophic, proliferative, secretory, hyperplasia without atypia, hyperplasia with atypia, cancer and others.
Danish: I henhold til de europæiske retningslinjer skal endometriebiopsierne inddeles efter standardiserede kriterier i generelle klasser med atrofisk, proliferativ, sekretorisk, hyperplastisk uden atypia, hyperplastisk med atypia, cancer og andre.
English: The pharmacokinetics of estradiol is not influenced by norethisterone acetate.
Danish: Farmakokinetikken for østradiol påvirkes ikke af norethisteronacetat.
English: The most important metabolites are isomers of 5α-dihydro-NET and of tetrahydro-NET, which are excreted mainly in the urine as sulfate or glucuronide conjugates.
Danish: De vigtigste metabolitter er isomere af 5α-dihydro-NET og af tetrahydro-NET, som hovedsageligt udskilles med urinen som sulfat eller glukoronidkonjugater.
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Danish: T3-resinoptagelsen er nedsat, hvilket ses i det forhøjede TBG.
English: • Migraine or (severe) headache
Danish: • Migræne eller (stærk) hovedpine
English: Rarely, these conditions may come back or get worse during treatment with Activelle:
Danish: Disse tilstande kan i sjældne tilfælde komme tilbage eller forværres under behandling med Activelle:
English: The most frequently reported adverse reaction in the clinical trial with Activelle was vaginal bleeding.
Danish: Den hyppigst rapporterede bivirkning i det kliniske forsøg med Activelle er vaginalblødning.
English: The Cochrane review (Lethaby et al 2004) and analysis of available observational data (Anderson 2003, Beresford 97, Jain 2000, Hill 2000, Hully 98, MWS 2005, Newcomb 2003, Pike 97, Pukkala 2001, Weiderpass 99) suggest that addition of progestogen for at least 12 days per cycle reduces, but may not completely eliminate, the increased incidence of endometrial cancer caused by unopposed oestrogens; and that combined continuous HRT does not increase the risk of endometrial cancer.
Danish: Cochrane-gennemgangen (Lethaby et al. 2004) og en analyse af tilgængelige observationsdata (Anderson 2003, Beresford 97, Jain 2000, Hill 2000, Hully 98, MWS 2005, Newcomb 2003, Pike 97, Pukkala 2001, Weiderpass 99) tyder på, at tilføjelsen af progestagen i mindst 12 dage pr. cyklus nedsætter, men eliminerer ikke helt, den øgede incidens af endometriecancer forårsaget af østrogener alene, og at kombineret kontinuert HRT ikke øger risikoen for endometriecancer.
English: • If bleeding continues after stopping HRT.
Danish: • Hvis blødningen fortsætter, efter De er stoppet med HRT behandlingen.
English: It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms.
Danish: Det substituerer den manglende østrogenproduktion hos menopausale kvinder og lindrer de menopausale symptomer.
English: Endometrial Safety
Danish: Endometrie-sikkerhed
English: However, a majority of CHMP members endorsed the applicant/MAH's approach to provide a very low dose alternative of combined continuous HRT.
Danish: Flertallet af CHMP-medlemmerne støttede dog den fremgangsmåde, ansøgeren/indehaveren af markedsføringstilladelsen havde benyttet for at få godkendt et lavdosis-alternativ til kombineret kontinuert HRT.
English: Pharmacotherapeutic group: Progestogens and estrogens, fixed combinations, ATC code: G03FA01
Danish: Farmakoterapeutisk gruppe: Gestagen og østrogen i faste kombinationer, ATC kode: G03FA01
English: Your doctor should aim to prescribe the lowest dose for the shortest time that gives you relief from your symptoms.
Danish: Deres læge vil ordinere så lav en dosis som muligt i den kortest mulige periode, som giver Dem symptomlindring.
English: In women with amenorrhea and not taking HRT or women transferring from another continuous combined HRT product, treatment with Activelle may be started on any convenient day.
Danish: Kvinder med amenoré, som ikke tager HRT, og kvinder, som skifter fra et andet kontinuerligt, kombineret HRT-produkt, kan starte behandlingen med Activelle når som helst.
English: • Diabetes mellitus with or without vascular involvement
Danish: • Diabetes med eller uden vaskulære komplikationer
English: The acute toxicity of estrogens is low.
Danish: Den akutte østrogen-toksicitet er lav.
English: • If any of the conditions listed in section 2,“Do not take Activelle”, occur.
Danish: • Hvis De får nogle af tilstandene, som er anført i afsnit 2, ”Det skal De vide, før De begynder at tage Activelle”
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, and ceruloplasmin).
Danish: Andre plasma proteiner kan være forhøjede (angiotensinogen/renin substrat, alpha-I-antitrypsin, ceruloplasmin).
English: The absolute risks calculated from the MWS and the WHI trial are presented below:
Danish: De endelige beregnede risici fra MWS- og WHI-studierne er beskrevet herunder:
English: Using other medicines Some medicines may reduce the effects of Activelle:
Danish: Følgende lægemidler kan nedsætte virkningen af Activelle:
English: One randomised controlled trial and epidemiological studies found a two- to threefold higher risk for users compared with non-users.
Danish: I et randomiseret, kontrolleret forsøg og epidemiologiske studier er der fundet en to-tre gange større risiko for brugere sammenlignet med ikke-brugere.
English: Oestrogen and progestagen for continuous combined hormone replacement therapy (HRT).
Danish: Østrogen og gestagen til kontinuerlig kombineret hormonsubstitutionsterapi (HRT).
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke blevet gennemført nogen studier for at undersøge virkningen på evnen til at føre motorkøretøjer eller betjene maskiner.
English: Two large clinical trials (WHI and HERS i.e. Heart and Estrogen/progestin Replacement Study) showed a possible increased risk of cardiovascular morbidity in the first year of use and no overall benefit.
Danish: To store kliniske studier (WHI og HERS, som er Heart and Estrogen/progestin Replacement Study) har vist en mulig øget risiko for kardiovaskulær morbiditet i det første behandlingsår og ingen generel fordel.
English: It should be taken into account that these conditions may recur or be aggravated during treatment with Activelle in particular:
Danish: Der skal tages specielt hensyn til, at især følgende tilstande kan vende tilbage eller forværres under behandling med Activelle:
English: Patients with terminal renal insufficiency should be closely observed, since it is expected that the level of circulating active ingredients in Activelle will increase.
Danish: Patienter med terminal nyresygdom bør nøje overvåges, idet det må forventes, at plasmakoncentrationen af de aktive stoffer i Activelle vil øges.
English: Generally recognised risk factors for VTE include a personal history or family history, severe obesity (Body Mass Index > 30 kg/m2) and systemic lupus erythematosus (SLE).
Danish: Almindeligt anerkendte risikofaktorer for VTE omfatter tidligere episoder hos patienten selv eller familiær disposition, svær overvægt (Body Mass Index >30 kg/m2) og systemisk lupus erythematosus (SLE).
English: These data, along with data on effects on endometrial hyperplasia, convincingly support the assumption that a continuous combined regimen protects the endometrium from both hyperplasia and neoplasia, a protective effect that seems to be both relative and absolute (i.e. conferring a lower risk than for untreated women) and that seems to increase with duration of intake.
Danish: Disse data understøtter sammen med data om effekten i forbindelse med endometriehyperplasi overbevisende antagelsen, at et kontinuert kombineret regimen beskytter endometriet mod både hyperplasi og neoplasi, hvilket er en beskyttende effekt, der synes at være både relativ og absolut (dvs. udgør en lavere risiko end risikoen hos ubehandlede kvinder), og som synes at øges med varigheden af behandlingen.
English: This systematic review therefore supports that a continuous combined low dose regimen, as in Activelle 0,5mg/0,1mg, would provide sufficient endometrial protection.
Danish: Denne systematiske gennemgang understøtter derfor, at et kontinuert kombineret lavdosisregimen, som i Activelle 0,5 mg/0,1 mg, vil beskytte endometriet tilstrækkeligt.
English: • If you have systemic lupus erythematosus (SLE, autoimmune collagen disease, which may affect many organ systems)
Danish: • Hvis De har systemisk lupus erythematose (SLE, en autoimmun bindevævssygdom der påvirker huden på hele kroppen, og som også kan påvirke flere organsystemer)
English: • If you have high blood pressure
Danish: • Hvis De har for højt blodtryk
English: Patients should be told to contact their doctors immediately when they are aware of a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnea).
Danish: Patienter skal opfordres til straks at søge læge ved mulige symptomer på tromboembolisme (f.eks. smertefuld hævelse af et ben, pludselige brystsmerter, dyspnø).
English: It states that “for a new combination of oestrogen/progestogen (e.g. new administration scheme or new strength) or a new progestogen in a fixed combination, endometrial data are required, except for a known progestogen, with the same administration route and the same progestogen dose as in known fixed combination with oestrogen, where data on endometrial safety can be extrapolated from the fixed combination if exposure to the oestrogen is similar or lower”.
Danish: Heri anføres det, at "der kræves endometrie-data om en ny kombination af østrogen/progestagen (f.eks. ny administrationsplan eller ny styrke) eller et nyt progestagen i en fast kombination, med undtagelse af hvis der er tale om et kendt progestagen med den samme administrationsvej og med den samme progestagendosis som i en kendt fast kombination med østrogen, hvor data om endometrie-sikkerhed kan ekstrapoleres fra den faste kombination, hvis eksponeringen for østrogenet er af tilsvarende størrelsesorden eller lavere".
English: Estradiol: The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.
Danish: Østradiol: Det aktive indholdsstof, syntetisk 17β-østradiol, er kemisk og biologisk identisk med det endogene humane østradiol.
English: For instructions on the use of the calendar pack, see “USER INSTRUCTIONS” at the end of the package leaflet.
Danish: Se ”BRUGERVEJLEDNING” til sidst i denne indlægsseddel for instruktion i brug af kalenderpakningen.
English: - Pickar J.H.
Danish: - Pickar J.H. et al.:
English: Taking the above arguments on board, the majority of CHMP members were of the opinion that the data presented demonstrate the importance of types of oestrogen-progestogen regimens for the association with endometrial cancer risk.
Danish: Ved gennemgang af ovennævnte argumenter fandt de fleste medlemmer af CHMP, at de præsenterede data påviser vigtigheden af typer af østrogen-progestagen-regimener med hensyn til sammenhængen med risikoen for endometriecancer.
English: • A history of, or risk factors for, thromboembolic disorders (see below)
Danish: • Anamnese på eller risikofaktorer for tromboembolisk sygdom (se nedenfor)
English: Given that there are studies demonstrating negative effects of combined HRT on the risk of breast cancer and cardiovascular complications, the general recommendation for HRT is to only treat women with severe symptoms, negatively affecting their quality of life.
Danish: Eftersom der i flere forsøg er påvist negative effekter af kombineret HRT mht. risikoen for brystcancer og kardiovaskulære komplikationer, er den generelle anbefaling, at HRT kun skal anvendes til behandling af kvinder med svære symptomer, der påvirker deres livskvalitet negativt.
English: Like other progestogens norethisterone causes virilization of female fetuses in rats and monkeys.
Danish: Som ved andre progestogener er norethisteron årsag til virilisering af hunkønsfostre hos rotter og aber.
English: The risk seems to be higher for women, who use oestrogen in combination with progestagen as compared to oestrogen alone.
Danish: Risikoen synes at være større hos kvinder, der bruger østrogen i kombination med gestagen sammenlignet med produkter med østrogen alene.
English: In the already licensed dose of Activelle, the ratio between NETA and E2 is 1:2, while this ratio is 1:5 in the new strength of Activelle.
Danish: Forholdet mellem NETA og E2 er 1:2 i den allerede godkendte dosis af Activelle, mens dette forhold er 1:5 i den nye styrke af Activelle.
English: There was no significant difference in the rate of endometrial hyperplasia of continuous oestrogenprogestogen combinations in comparison with placebo after 12 and 24 months.
Danish: Der var ingen signifikant forskel i raten af endometriehyperplasi ved administration af kontinuerte østrogenprogestagen-kombinationer i forhold til ved administration af placebo efter 12 og 24 måneder.
English: Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause.
Danish: Hormonsubstitutionsbehandling (HRT) mod symptomer på østrogenmangel hos postmenopausale kvinder mere end 1 år efter menopausen.
English: The number of additional cases of breast cancer in women who use HRT is broadly similar for women who start HRT irrespective of age at start of use (between the ages of 45-65) (see section 4.4).
Danish: Det ekstra antal tilfælde af brystcancer hos kvinder, som bruger HRT, er stort set det samme uanset alder ved start af HRT-behandlingen (mellem 45 og 65 år) (se pkt.
English: • If bleeding starts after taking HRT for a while
Danish: • Hvis blødningen starter, efter De har taget HRT et stykke tid
English: It can also be noticed that the monitoring of the endometrial thickness by pelvic ultrasound showed a significant increase, even with 0.5 mg E2, which was not reported in the placebo group.
Danish: Det ses også, at monitoreringen af endometriets tykkelse ved hjælp af ultralydsscanning af bækkenet viste en signifikant stigning, selv med 0,5 mg E2, hvilket der ikke blev rapporteret om i placebogruppen.
English: Before initiating or reinstituting HRT, a complete personal and family medical history should be taken.
Danish: Før behandling med HRT startes eller genoptages, bør der optages en komplet anamnese og indhentes oplysninger om familiær disposition.
English: The addition of a progestagen reduces, but does not completely eliminate, the oestrogen-induced risk of endometrial hyperplasia in nonhysterectomised women.
Danish: Tilsætningen af gestagen reducerer i høj grad men eliminerer ikke fuldstændigt den østrogeninducerede risiko for endometriehyperplasi hos ikkehysterektomerede kvinder.
English: Post marketing experience:
Danish: Post-marketing-erfaringer
English: Stop taking HRT until your doctor says you can take it again.
Danish: Stop behandlingen med HRT, indtil lægen siger, De kan starte igen.
English: Other medicines may increase the effects of Activelle: • Medicines containing ketoconazole (a fungicide).
Danish: Andre lægemidler, som kan øge effekten af Activelle: - Medicin der indeholder et ketokonazol (et svampemiddel).
English: It is well established that the use of unopposed oestrogens in women with an intact uterus is associated with a gradually increasing incidence of hyperplasia with duration of treatment.
Danish: Det er velkendt, at brugen af østrogener alene til kvinder med en intakt uterus er forbundet med en gradvist stigende incidens af hyperplasi med varigheden af behandlingen.
English: • Vascular disorders: Hypertension aggravated
Danish: • Vaskulære sygdomme: Forværret hypertension
English: Do not refrigerate
Danish: Må ikke opbevares i køleskab
English: • For women not using HRT, about 32 in every 1000 are expected to have breast cancer diagnosed between the ages of 50 and 64 years.
Danish: • For kvinder, der ikke anvender HRT, kan ca. 32 ud af 1000 forvente en brystcancer-diagnose i alderen 50-64 år.
English: Activelle will not cause regular monthly bleeding, but when first starting the tablets, many women experience slight vaginal bleeding or spotting.
Danish: Activelle giver ikke regelmæssige månedlige blødninger, men mange kvinder oplever en smule vaginal blødning eller pletblødning, når de starter tabletbehandlingen.
English: Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
Danish: Ritonavir og nelfinavir kan, selvom de er kendt som stærke inhibitorer, tværtimod udøve forstærkende egenskaber, når de anvendes sideløbende med steroidhormoner.
English: For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.
Danish: Både ved initial og kontinuerlig behandling af postmenopausale symptomer bør den laveste, effektive dosis og det korteste tidsrum vælges (se også pkt.
English: Activelle is not indicated during pregnancy.
Danish: Activelle er kontraindiceret ved graviditet.
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn og adresse} <{tlf}>
English: Taking into account the points above, the some CHMP were of the opinion that endometrial safety of Activelle 0.5 mg/0.1 mg could not be supported by the KLIM/PD/7/USA trial.
Danish: I betragtning af ovennævnte punkter var nogle medlemmer af CHMP af den mening, at endometriesikkerheden ved Activelle 0,5 mg/0,1 mg ikke kunne understøttes af KLIM/PD/7/USA-forsøget.
English: The objective of this study was to determine the endometrial safety of 2 years of treatment with low CEE doses (0.3, 0.45 and 0.625 mg).
Danish: Formålet med dette forsøg var at bestemme endometrie-sikkerheden ved 2 års behandling med lave doser af konjugerede ekvine østrogener (0,3 mg, 0,45 mg og 0,625 mg).
English: Personal or strong family history of thromboembolism, or recurrent spontaneous abortion, should be investigated in order to exclude a thrombophilic predisposition.
Danish: Anamnestisk, familiær disposition til tromboembolisme eller gentagne spontane aborter bør undersøges for at udelukke prædisponering for trombofili.
English: • Leiomyoma (uterine fibroids) or endometriosis
Danish: • Leiomyom (uterusfibromer) eller endometriose
English: In this study, the upper limit of the two-sided 95% CI of the incidence of endometrial hyperplasia was higher than the upper limit of 2%, and is therefore not considered acceptable.
Danish: I dette forsøg var den øvre grænse på det tosidige 95 %-konfidensinterval for incidensen af endometriehyperplasi højere end den øvre grænse på 2 % og anses derfor ikke for at være acceptabel.
English: • If you develop yellow skin or eyes (jaundice) or other liver problems
Danish: • Hvis De bliver gul i øjnene eller huden (gulsot) eller får andre leverproblemer
English: The only trial that studied the 0.1 mg NETA dose was the Novo Nordisk study KLIM/PD/7/USA , which some CHMP members considered to be inconclusive.
Danish: Det eneste forsøg, hvor dosen på 0,1 mg NETA blev undersøgt, var Novo Nordisks forsøg KLIM/PD/7/USA, som nogle medlemmer af CHMP ikke mente var entydigt.
English: • Epilepsy
Danish: • Epilepsi
English: You may find it helpful to make a note of any bleedings in a diary.
Danish: Det kan derfor være en hjælp for Dem at notere i en kalender, hvis De har haft en blødning.
English: Metabolism of 17β-estradiol, occurs mainly in the liver and gut but also in target organs, and involves the formation of less active or inactive metabolites, including estrone, catecholestrogens and several oestrogen sulphates and glucuronides.
Danish: Omdannelsen af 17β-østradiol sker hovedsageligt i lever og tarmsystem, men også i effektorganer og inkluderer dannelse af mindre aktive eller inaktive metabolitter herunder estron, katekoløstrogener og adskillige østrogensulfater og glukoronider.
English: - the addition of a progestogen for 12 days of a monthly treatment cycle is considered sufficient to protect the endometrium from an excess risk of hyperplasia (and ultimately endometrial cancer), and even longer periods, and a continuous combination will confer increasing protective effects.
Danish: - Tilføjelsen af et progestagen i 12 dage eller endda i længere perioder af en månedlig behandlingscyklus anses for at være tilstrækkeligt til at beskytte endometriet mod en forhøjet risiko for hyperplasi (og ultimativt endometriecancer), og en kontinuert kombination vil bidrage med en større beskyttende effekt.
English: This observation is also consistent with the known pharmacodynamic effects of added progestogens on the endometrium, e.g. down regulation of oestrogen receptor (ER) levels and endometrial atrophy.
Danish: Denne observation er også i overensstemmelse med de kendte farmakodynamiske effekter på endometriet af tilføjede progestagener, f.eks. nedregulering af østrogenreceptorniveauer (ER-niveauer) og endometrieatrofi.
English: According to the guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women (EMEA/CHMP/021/97 Rev. 1) endometrial safety has to be demonstrated unequivocally before approval.
Danish: I henhold til retningslinjerne for klinisk undersøgelse af lægemidler til hormonsubstitutionsbehandling af symptomer på østrogenmangel hos postmenopausale kvinder (EMEA/CHMP/021/97 ver. 1), skal endometrie-sikkerheden påvises entydigt før godkendelse.
English: • Other ingredients are: Lactose monohydrate, maize starch, hydroxypropylcellulose, magnesium stearate, hypromellose, triacetin and talc.
Danish: - Øvrige indholdsstoffer: Lactose monohydrat, majsstivelse, hydroxypropylcellulose, magnesiumstearat, hypromellose, triacetin og talcum.