FrancophonIA/ELRC3.0 huggingface dataset:
English: - on the level of endometrial hyperplasia, the trial on the 1 mg estradiol/0.1 mg NETA product indicates an adequate protective effect, albeit with an upper confidence limit of the hyperplasia rate estimate exceeding recommendation in the guideline.
Danish: - Med det aktuelle niveau af endometriehyperplasi tyder forsøget med 1 mg estradiol/0,1 mg norethisteronacetat-produktet på, at der er en tilstrækkelig beskyttende effekt, selvom den øvre konfidensgrænse på estimatet af hyperplasiraten overskrider anbefalingen i retningslinjerne.
English: The WHI trial reported a risk estimate of 1.24 (95%CI 1.01 - 1.54) after 5.6 years of use of oestrogenprogestagen combined HRT (CEE + MPA) in all users compared with placebo.
Danish: WHI-studiet rapporterede en estimeret risiko på 1,24 (95% konfidensinterval: 1,01 - 1,54) efter 5,6 års behandling med kombineret østrogen-gestagen (CEE + MPA) sammenlignet med placebo.
English: Vaginal haemorrhage
Danish: Vaginal hæmorrhagi
English: • If you get migraines or severe headaches
Danish: • Hvis De har migræne eller kraftig hovedpine
English: • If you have diabetes or gallstone disease
Danish: • Hvis De har sukkersyge eller galdestenssygdom
English: For oestrogen plus progestagen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with oestrogens alone.
Danish: For kombineret østrogen-gestagen behandling har adskillige epidemiologiske studier vist en generelt større risiko for brystcancer end ved østrogenbehandling alene.
English: • Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
Danish: • Aktuel eller tidligere idiopatisk venøs tromboembolisme (dyb venetrombose, lungeemboli)
English: It is unknown whether the increased risk also extends to other HRT products.
Danish: Det er uvist, om den øgede risiko også omfatter andre HRT-produkter.
English: All adverse reactions observed with a higher frequency in patients treated with Activelle compared to placebo and which on an overall judgement are possible related to treatment are presented below.
Danish: Alle de bivirkninger, der er observeret i randomiserede, kliniske studier, med en højere frekvens hos patienter behandlet med Activelle end ved behandling med placebo, og som ved overordnet vurdering menes at være relateret til behandlingen, er vist i tabellen herunder:
English: For other HRT products there are only limited data from trials examining the effects on the risk of cardiovascular disease.
Danish: Der findes kun begrænsede data for andre HRT-produkter fra studier, der har undersøgt effekten af risikoen for hjertesygdomme.
English: You may need to stop taking these tablets 4 to 6 weeks before the operation, to reduce the risk of a blood clot.
Danish: Hvis De skal have foretaget en operation, så tal med lægen, da det kan være nødvendigt at stoppe behandlingen 4 til 6 uger inden operationen, for at nedsætte risikoen for blodpropper.
English: For all HRT, an excess risk becomes apparent within a few years of use and increases with duration of intake but returns to baseline within a few (at most five) years after stopping treatment.
Danish: For alle HRT-produkter bliver en øget risiko tydelig efter få års behandling og stiger med behandlingsvarigheden, men den vender tilbage til udgangspunktet få år (højst 5) efter ophørt behandling.
English: There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65.
Danish: WHI-studiet viste nogen evidens for en øget risiko for mulig demens hos kvinder, som påbegyndte behandling med kontinuerlig, kombineret CEE og MPA efter 65 års alderen.
English: • Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura
Danish: • Hud og subkutane væv: Cloasma, erythema multiforme, erythema nodosum, vaskulær purpura
English: In the WHI study, the continuous combined conjugated equine oestrogen and medroxyprogesterone acetate (CEE + MPA) product used was associated with breast cancers that were slightly larger in size and more frequently had local lymph node metastases compared to placebo.
Danish: I WHI-studiet var behandling med kontinuerlig, kombineret og konjugeret equin østrogen og medroxyprogesteronacetat (CEE+MPA) forbundet med brystcancere, som var lidt større og lidt oftere havde lokale lymfeknudemetastaser sammenlignet med placebo.
English: - the endometrial safety of Activelle 0.5mg estradiol/0.1mg NETA product is sufficiently supported from the submitted data.
Danish: - Endometrie-sikkerheden ved produktet Activelle 0,5 mg estradiol/0,1 mg norethisteronacetat er tilstrækkeligt underbygget af de fremsendte data.
English: Animal studies have shown embryo-lethal effects of estradiol or estradiol valerate even at relatively low doses; malformations of the urogenital tract and feminization of male fetuses were observed.
Danish: Dyreforsøg har vist, at østradiol eller østradiolvalerat har en dødelig effekt på embryoer, selv ved meget lave doser; der er blevet observeret misdannelser af urogenitalkanalen og feminisering af hankønsfostre.
English: estradiol/norethisterone acetate
Danish: estradiol/norethisteronacetat
English: Clinically, an increased metabolism of oestrogens and progestagens may lead to decreased effect and changes in the uterine bleeding profile.
Danish: Forøget østrogen- og gestagenmetabolisme kan klinisk medføre en nedsat virkning og ændringer i blødningsprofilen.
English: Hungary - Noviana filmtabletta
Danish: Ungarn - Noviana filmtabletta
English: • Medicines used for tuberculosis (such as rifampicin, rifabutin)
Danish: • Medicin mod tuberkulose (fx rifampicin, rifabutin)
English: b. Duration-dependency of the proliferative effect of unopposed oestrogens
Danish: b. Varighedsafhængighed af den proliferative effekt af østrogener alene
English: For 1000 women who used oestrogen + progestagen combined HRT (CEE + MPA), the number of additional cases would be o Between 0 and 9 (best estimate = 4) for 5 years' use.
Danish: Ud af 1000 kvinder, som brugte kombineret østrogen-gestagen HRT (CEE + MPA), ville antallet af ekstra tilfælde over en periode på 5 år være mellem 0 og 9 (bedste skøn = 4).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DISPENSER LABEL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Keep the container in the outer carton, in order to protect from light
Danish: Opbevar beholderen i den ydre karton for at beskytte mod lys
English: Marketing authorisation holder and manufacturer
Danish: Indehaveren af markedsføringstilladelsen og fremstiller
English: Brown pigmented patches in the face, redness of the skin including inflammation on the hands or the legs (erythema multiforme), hump rose or a bruise-like rash.
Danish: Brune pigmentpletter i ansigtet, rødme på huden herunder inflammation på hænder og ben (erythema multiforme), knuderosen - ømme, røde knuder, oftest på ben og arme (erythema nodosum) eller udslet som blå mærker.
English: The dose-dependency of the proliferative effect of unopposed oestrogens on the endometrium was sustained by data from the KLIM/PD/11/USA trial for E2 (0.5 mg and 1 mg) and from Pickar et al for conjugated equine oestrogens (CEE, 0.3 to 0.625 mg).
Danish: Dosisafhængigheden af den proliferative effekt af østrogener alene på endometriet blev bekræftet af data fra KLIM/PD/11/USA-forsøget, hvad angik E2 (0,5 mg og 1 mg), og af data fra Pickar et al., hvad angik konjugerede ekvine østrogener (CEE, 0,3 til 0,625 mg).
English: • Medicines used for HIV infections (such as nevirapine, efavirenz, ritonavir and nelfinavir)
Danish: • Medicin mod HIV-infektion (fx nevirapin, efavirenz, ritonavir og nelfinavir)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON
English: The applicant/MAH was asked to demonstrate the endometrial safety of Activelle 0.5mg/0.1mg for the following reasons:
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen blev bedt om at påvise endometrie-sikkerheden ved Activelle 0,5 mg/0,1 mg af følgende årsager:
English: - The endometrial safety data was extrapolated from another combination containing 1.0 mg estradiol and 0.1mg norethisterone acetate (NETA).
Danish: - Dataene vedrørende endometrie-sikkerheden blev ekstrapoleret fra en anden kombination, der indeholdt 1,0 mg estradiol og 0,1 mg norethisteronacetat (NETA).
English: Activelle is a continuous combined hormone replacement therapy intended for use in women with an intact uterus.
Danish: Activelle er et kombineret HRT-produkt til kontinuerlig behandling af kvinder med intakt uterus.
English: • Porphyria
Danish: • Porfyri.
English: Pregnancy and breast-feeding Do not take Activelle if you are pregnant or breast-feeding.
Danish: Tag ikke Activelle, hvis De er gravid eller ammer.
English: During treatment periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Danish: Rutinemæssig kontrol anbefales under behandlingen; hvor ofte og hvordan afhænger af den enkelte kvinde.
English: There is no evidence from randomised controlled trials of cardiovascular benefit with continuous combined conjugated oestrogens and medroxyprogesterone acetate (MPA).
Danish: Der er i randomiserede, kontrollerede forsøg ikke vist kardiovaskulære fordele ved kontinuerlig behandling med kombineret, konjugeret østrogen og medroxyprogesteronacetat (MPA).
English: Before you start treatment and regularly during treatment, your doctor will evaluate whether Activelle is a suitable treatment for you.
Danish: Før De starter på behandlingen og med jævne mellemrum under denne, vil Deres læge vurdere, om Activelle er en velegnet behandling til Dem. Deres læge vil oplyse Dem om, hvor ofte De bør komme til kontrol, på baggrund af Deres generelle helbredstilstand.
English: Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting unless you have had your womb removed.
Danish: Hvis De glemmer at tage en tablet, kan det øge risikoen for gennembrudsblødning eller pletblødning, medmindre De har fået fjernet livmoderen.
English: A randomised placebo-controlled trial, the Women's Health Initiative study (WHI), and epidemiological studies, including the Million Women Study (MWS), have reported an increased risk of breast cancer in women taking oestrogens, oestrogen-progestagen combinations or tibolone for HRT for several years (see section 4.8).
Danish: Et randomiseret, placebokontrolleret forsøg, WHI-studiet (the Women's Health Initiative study) og epidemiologiske studier inklusive MWS-studiet (the Million Women Study) har vist, at kvinder, der tager østrogen, østrogen-gestagen kombinationer eller tibolon som HRT i flere år, har en øget risiko for brystcancer (se pkt.
English: • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
Danish: • Aktuel eller nylig arteriel trombolisk sygdom (f.eks. angina, myokardieinfarkt)
English: If VTE develops after initiating therapy, the drug should be discontinued.
Danish: Hvis der opstår VTE efter start af behandlingen, bør lægemidlet seponeres.
English: In women transferring from sequential HRT regimens, treatment should start right after their withdrawal bleeding has ended.
Danish: Kvinder, der skifter fra sekventiel HRT, bør starte lige efter ophør af den cykliske blødning.
English: • Medicines used for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
Danish: • Medicin mod epilepsi (fx barbiturater, phenytoin og carbamazepin)
English: Turn the inner disc to set the day of the week opposite the little plastic tab.
Danish: Sådan sætter De ugedagsskiven Drej midterskiven, således at ugedagen står ud for den lille plastikspids.
English: • Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer
Danish: • Risikofaktorer for østrogenafhængige tumorer, f.eks. forekomst af brystcancer i nær familie
English: et al, the relationship between treatment duration and incidence of hyperplasia was also observed with the low dose of 0.3 mg CEE.
Danish: I Pickar J.H. et al. blev der også observeret en sammenhæng mellem behandlingsvarigheden og incidensen af hyperplasi ved administration af den lave dosis på 0,3 mg konjugerede ekvine østrogener.
English: Stop taking Activelle
Danish: Stop med at tage Activelle
English: Dementia
Danish: Demens
English: Fluid retention, see also “General disorders and administration site conditions
Danish: Væskeophobning Se også ”Almene symptomer og reaktioner på administrationsstedet”
English: Depending on the duration of treatment and oestrogen dose, the reported increase in endometrial cancer risk among unopposed oestrogen users varies from 2-to 12-fold greater compared with non-users.
Danish: Afhængig af behandlingsvarigheden og østrogendosis varierer den rapporterede stigning i risikoen for endometriecancer mellem 2 og 12 gange for kvinder, som bruger østrogen alene sammenlignet med kvinder, som ikke bruger HRT.
English: Therefore, it is uncertain whether these findings also extend to other HRT products.
Danish: Det er derfor usikkert, om resultaterne også gælder for andre HRT-produkter.
English: • Investigations: Weight decreased, blood pressure increased
Danish: • Undersøgelser: Vægttab, forhøjet blodtryk
English: • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
Danish: • Kendt eller mistanke om østrogenafhængige tumorer (f.eks. endometriecancer)
English: The MWS reported that, compared to never users, the use of various types of oestrogen-progestagen combined HRT was associated with a higher risk of breast cancer (RR = 2.00, 95%CI 1.88 - 2.12) than use of oestrogens alone (RR = 1.30, 95%CI 1.21 - 1.40) or use of tibolone (RR=1.45, 95%CI
Danish: MWS-studiet rapporterede, at sammenlignet med kvinder, som aldrig har anvendt HRT, er behandling med forskellige østrogen-gestagen kombinerede HRT-produkter forbundet med en større risiko for brystcancer (RR=2,00; 95% konfidensinterval: 1,88 - 2,12) end behandling med østrogen alene (RR=1,30; 95% konfidensinterval: 1,21 - 1,40) eller behandling med tibolon (RR=1,45; 95% konfidensinterval: 1,25 - 1,68).
English: • Unexplained migraine-type headaches, with or without disturbed vision.
Danish: Hvis De får: - Migræne-lignende hovedpine uden nogen kendt årsag med eller uden synsforstyrrelser.
English: Treatment with unopposed oestrogens for long periods of time also increases the risk of cancer of the lining of the womb (endometrial cancer).
Danish: Behandling kun med østrogen i en længere behandlingsperiode øger også risikoen for kræft i livmoderslimhinden (endometriecancer).
English: • If you have further questions, ask your doctor or pharmacist
Danish: Er De i tvivl, så spørg lægen eller apoteket.
English: There is no consensus about the possible role of varicose veins in VTE.
Danish: Der er ingen konsensus omkring sammenhængen mellem åreknuder og VTE.
English: Keep the container in the outer carton in order to protect from light.
Danish: Opbevar kalenderpakken i den ydre karton for at beskytte mod lys.
English: • Nervous system disorders: Dizziness
Danish: • Nervesystemet: Svimmelhed
English: -The endometrial safety of the combination of oestrogen and progestogen for the new ratio of 0.5mg/0.1mg cannot be extrapolated from the already licensed dose of Activelle, which contains 1mg estradiol and 0.5mg NETA.
Danish: - Endometrie-sikkerheden ved kombinationen af østrogen og progestagen i et nyt forhold på 0,5 mg/0,1 mg kan ikke ekstrapoleres fra den allerede godkendte dosis af Activelle, som indeholder 1 mg E2 og 0,5 mg NETA.
English: For oestrogen-only HRT, estimates of relative risk (RR) from a reanalysis of original data from 51 epidemiological studies (in which >80% of HRT use was oestrogen-only HRT) and from the epidemiological Million Women Study (MWS) are similar at 1.35 (95%CI 1.21 - 1.49) and 1.30 (95%CI 1.21 - 1.40), respectively.
Danish: En revurdering af de oprindelige data fra 51 epidemiologiske studier (hvor >80% af HRTbehandlingen var østrogen alene) og fra det epidemiologiske MWS (Million Women Study) viser samme relative risiko (RR), henholdsvis 1,35 (95% konfidensinterval: 1,21 - 1,49) og 1,30 (95% konfidensinterval: 1,21 - 1,40).
English: If you stop taking Activelle
Danish: Hvis De holder op med at tage Activelle
English: France - Activelle 0,5 mg/0,1 mg comprimé pelliculé Germany - Noviana
Danish: Frankrig - Activelle 0,5 mg/0,1 mg comprimé pelliculé Tyskland - Noviana
English: Take special care with Activelle
Danish: Vær ekstra forsigtig med at tage Activelle
English: • Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users (For further information, see sections 4.3 and 4.4)
Danish: • Vene tromboembolisme, dvs. dyb venetrombose i underekstremitet eller bækken og lungeemboli, forekommer hyppigere blandt brugere af HRT end hos ikke-brugere, (se pkt.
English: This risk increases with the duration of intake of HRT, but returns to normal within a few (at most five) years of having stopped HRT.
Danish: Risikoen øges med behandlingsvarigheden, men vender tilbage til udgangspunktet inden for få (højst 5) års ophør.
English: • If you are allergic (hypersensitive) to estradiol, norethisterone acetate or any of the other ingredients of Activelle (listed in section 6,“Further information”).
Danish: Start ikke med Activelle: - Hvis De er overfølsom (allergisk) over for estradiol, norethisteronacetat eller et af de øvrige indholdsstoffer i Activelle tabletter (se pkt.
English: • Go for regular breast screening (mammography) and cervical smear tests.
Danish: • Regelmæssigt får foretaget brystscreening (mammografi) og får taget en celleskrabning fra livmoderhalsen (smeartest)
English: There is no evidence of beneficial effects on the risks of cardiovascular disease with HRT in the menopause.
Danish: Der er ingen bevis for, at HRT i menopausen har en gunstig indflydelse på risikoen for hjertesygdomme.
English: In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported, and are by an overall judgement considered possibly related to Activelle 1 mg/0.5 mg treatment.
Danish: Udover ovennævnte uønskede bivirkninger er de bivirkninger, som er opstillet nedenfor, blevet rapporteret spontant, og efter en overordnet vurdering betragtes de som muligvis relateret til behandlingen med Activelle 1 mg/0,5 mg. Rapporteringshyppigheden af disse uønskede bivirkninger er meget sjælden (<1/10.000 patienter pr. år).
English: The following adverse reactions have been reported in the literature in association with oestrogen/progestagen treatment:
Danish: Der er blevet rapporteret følgende bivirkninger i litteraturen i forbindelse med østrogenprogesteronbehandling:
English: The results of most epidemiological studies to date relevant to inadvertent foetal exposure to combinations of oestrogens and progestagens indicate no teratogenic or foetotoxic effect.
Danish: Til dato har de fleste epidemiologiske studier ikke indiceret en teratogen eller foetotoksisk effekt ved uforvaren påvirkning af fostre med østrogen-gestagen kombinationer.
English: It is not yet known whether other types of HRT increase the risk in the same way.
Danish: Det er usikkert, hvorvidt andre typer HRT-præparater ligeledes øger denne risiko.
English: After administration of two Activelle tablets, the average peak plasma concentration was 24 pg/ml (CV 38 %).
Danish: Den maksimale gennemsnitlige plasmakoncentration var på 24 pg/ml (CV 38 %) efter administration af to Activelle tabletter.
English: • Untreated endometrial hyperplasia
Danish: • Ubehandlet endometriehyperplasi
English: a. Dose-dependency of the proliferative effect of unopposed oestrogens
Danish: a. Dosisafhængighed af den proliferative effekt af østrogener alene
English: According to evidence from a large number of epidemiological studies and one randomised placebocontrolled trial, the Women's Health Initiative (WHI), the overall risk of breast cancer increases with increasing duration of HRT use in current or recent HRT users.
Danish: I et større antal epidemiologiske studier og et randomiseret placebokontrolleret studie, WHI (the Women's Health Initiative) er det evident, at den samlede risiko for brystcancer øges med stigende behandlingsvarighed hos kvinder, som er eller lige har været i HRT- behandling.
English: Member State Marketing Authorisation Holder
Danish: Indehaver af markedsførings tilladelse
English: • Reproductive system and breast disorders: Hyperplasia endometrial, vulvovaginal pruritus
Danish: • Det reproduktive system og mammae: Fortykkelse af endometrieslimhinden, vaginal pruritus
English: Overdose may be manifested by nausea and vomiting.
Danish: Symptomer på overdosering kan være kvalme og opkastning.
English: At doses higher than normally used in OC and HRT formulations masculinisation of female foetuses was observed.
Danish: Ved doseringer, der er højere end normalt for orale contraceptiva og HRT-produkter, er der observeret en maskulinisering af hunkønsfostre.
English: 11% of women at month 1, 15% of women at month 4 and 11 % of women at the end of the 6 month trial reported bleeding or spotting.
Danish: Ved afslutningen af forsøget på 6 måneder blev der rapporteret gennembrudsblødning eller pletblødning hos 11% af kvinderne i den 1. måned, hos 15% af kvinderne i den 4. måned og hos 11% af kvinderne ved afslutningen af forsøget.
English: From a clinical study there is some evidence for an increased risk of dementia among women older than 65 years, who started using another type of oestrogen/progestagen combination than the one in Activelle.
Danish: Resultater fra et klinisk forsøg tyder på, at der er en øget risiko for tab af intellektuelle evner (demens) hos kvinder over 65 år, der har været i behandling med andre typer østrogen/gestagen-kombinationer end Activelle.
English: • Undiagnosed genital bleeding
Danish: • Udiagnosticeret genitalblødning
English: 6.5 Nature and contents of container 1 x 28 tablets or 3 x 28 tablets in calendar dial packs.
Danish: 1 x 28 tabletter eller 3 x 28 tabletter i kalenderpakning.
English: Adding a progestagen, such as in Activelle, greatly reduces this increased risk.
Danish: Østrogenbehandling i kombination med gestagen, som f.eks. med Activelle, reducerer denne risiko markant.
English: - For the calculation of the incidence rate of endometrial hyperplasia and the two-sided 95 % confidence interval, in case of insufficient tissue obtained by biopsy and endometrial thickness ≥ 5 mm, the biopsy should be repeated or patient excluded from the calculation.
Danish: - Hvad angår beregningen af incidensraten af endometriehyperplasi og det tosidige 95 %konfidensinterval, skal biopsien gentages eller patienten ikke medtages i beregningen, i de tilfælde hvor der ikke er udtaget nok væv ved biopsien og endometriets tykkelse ≥ 5 mm. I det aktuelle forsøg var der i 7 prøver ikke væv nok og en endometrietykkelse > 4 mm (skæringspunktet for endometriets tykkelse var 4 mm).
English: Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I - To be completed nationally]
Danish: Activelle og tilhørende navne (Se bilag I) 0,5 mg/0,1 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
English: Therapy should be discontinued in case a contra-indication (see section 4.3) is discovered and in the following situations:
Danish: Behandlingen bør ophøre, såfremt en kontraindikation (se pkt.
English: Back pain Neck pain Pain in extremity
Danish: Rygsmerter Nakkesmerter Smerter i ekstremiteterne
English: Medicines should not be disposed of via waste water or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Heart disease
Danish: Hjertesygdomme
English: Check with your doctor or pharmacist if you are unsure.
Danish: Spørg lægen eller apoteket, hvis der er noget, De er i tvivl om eller føler Dem usikker på.
English: Adding a progestagen to oestrogen-only therapy greatly reduces this increased risk.
Danish: Tilføjelsen af progesteron reducerer i høj grad den øgede risiko.