FrancophonIA/ELRC3.0 huggingface dataset:
English: The metabolism of oestrogens and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepin) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Danish: Østrogen- og gestagenmetabolismen kan blive forøget ved samtidig indtagelse af stoffer, som er kendt for at påvirke lægemiddelmetaboliserende enzymer, specielt cytochrom P450 enzymer såsom antiepileptika (fx barbiturater, phenytoin, carbamazepin), eller bredspektret antibiotika (rifampicin, rifabutin, nevirapin og efavirenz).
English: The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to oestrogen-progestagen combined HRT (CEE + MPA) per 10,000 women years.
Danish: WHI-studiet estimerede ved opfølgning efter 5,6 år af kvinder i alderen 50-79 år, at yderligere 8 tilfælde af invasiv brystcancer pr. 10.000 kvindeår kunne skyldes kombineret østrogen-gestagen HRT (CEE + MPA).
English: • If you have high levels of fat in the blood (hypertriglyceridemia)
Danish: • Hvis De har forhøjet fedtindhold i blodet (hypertriglyceridæmi)
English: The addition of a progestagen for at least 12 days per cycle in non-hysterectomised women greatly reduces this risk.
Danish: Kombination med gestagen i mindst 12 cyklusdage reducerer i høj grad denne risiko hos ikkehysterektomerede kvinder.
English: • Significant increase in blood pressure
Danish: • Signifikant blodtryksforhøjelse
English: Norethisterone acetate: As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer.
Danish: Norethisteronacetat: Eftersom østrogener fremmer væksten af endometriet, vil ukonjugeret østrogen øge risikoen for endometriehyperplasi og cancer.
English: Physical (including pelvic and breast) examination should be guided by this and, by the contraindications and warnings for use.
Danish: bækken og bryst) bør sammenholdes med dette og med kontraindikationer og advarsler for brug.
English: However, the some members of the CHMP noted that this trial failed to demonstrate the endometrial safety of the combination of E2 1 mg and NETA 0.1 mg, as the upper limit of the two-sided 95% confidence interval of the observed frequency of endometrial hyperplasia was 2.90% and then exceeded the acceptable limit of 2%.
Danish: Nogle medlemmer af CHMP bemærkede imidlertid, at det i dette forsøg ikke lykkedes at påvise endometrie sikkerheden ved kombinationen af 1 mg E2 og 0,1 mg NETA, da den øvre grænse af det tosidige 95%-konfidensinterval for den observerede frekvens af endometriehyperplasi var 2,90 % og dermed overskred den acceptable grænse på 2 %.
English: Do not take Activelle
Danish: Tag ikke Activelle
English: According to this recommendation, the applicant provided data from a trial (KLIM/PD/7/USA) which studied endometrial safety of the combination of E2 1 mg and NETA 0.1 mg.
Danish: Ansøgeren skaffede i overensstemmelse med denne anbefaling data fra et forsøg (KLIM/PD/7/USA), hvor endometrie-sikkerheden ved kombinationen af 1 mg E2 og 0,1 mg NETA blev undersøgt.
English: Active substances that inhibit the activity of hepatic microsomal drug metabolizing enzymes e.g. ketoconazole, may increase circulating levels of the active substances in Activelle.
Danish: Aktive indholdsstoffer, som inhiberer aktiviteten af hepatiske, microsomale lægemiddelmetaboliserende enzymer fx ketoconazol, kan øge plasmakoncentrationen af de aktive indholdsstoffer i Activelle.
English: At high doses of norethisterone embryo-lethal effects were observed.
Danish: Ved høje doser af norethisteron er der observeret en letal effekt på embryoer.
English: System organ class
Danish: Organklasser
English: If you get breakthrough bleeding or spotting, it is usually nothing to worry about, especially during the first few months of taking HRT.
Danish: Hvis De oplever gennembrudsblødning eller pletblødning, er dette ikke usædvanligt specielt i løbet af de første få måneder af behandlingen med HRT.
English: 1 x 28 film-coated tablets 3 x 28 film-coated tablets
Danish: 1 x 28 filmovertrukne tabletter 3 x 28 filmovertrukne tabletter
English: cysts and polyps): Endometrial cancer
Danish: cyster og polypper): Endometriecancer
English: Patients with a history of VTE or known thrombophilic states have an increased risk of VTE.
Danish: Patienter, som tidligere har haft VTE eller med kendt trombofili, har en øget risiko for VTE.
English: According to calculations from the trial data, it is estimated that:
Danish: Beregninger fra disse forsøgsdata giver anledning til følgende estimater:
English: This study focused on prevention of osteoporosis but endometrial safety of unopposed E2 0.5 mg or 1 mg during 2 years was also assessed.
Danish: I dette forsøg blev der fokuseret på forebyggelsen af osteoporose, men endometrie-sikkerheden ved 0,5 mg eller 1 mg E2 alene blev også vurderet gennem 2 år.
English: • Psychiatric disorders: Insomnia, anxiety, libido decreased, libido increased
Danish: • Psykiske forstyrrelser: Søvnløshed, nervøsitet, nedsat libido, øget libido
English: The CHMP noted that the applicant had provided the following arguments to support the endometrial safety of Activelle 0.5 mg/0.1 mg:
Danish: CHMP bemærkede, at ansøgeren var kommet med følgende argumenter til understøttelse af endometrie-sikkerheden ved Activelle 0,5 mg/0,1 mg:
English: Both considered the endometrial safety of Activelle 0.5 mg/0.1 mg to be insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/CHMP/021/97 rev 1).
Danish: Begge mente, at endometrie-sikkerheden ved Activelle 0,5 mg/0,1 mg ikke var tilstrækkeligt påvist i henhold til CHMP's retningslinjer for HRT-produkter (EMEA/CHMP/021/97 ver. 1).
English: - Pooled data from several recently authorized sequential and continuous oestrogen/progestin HRT combinations in Europe show that the incidence of hyperplasia or more serious adverse endometrial outcomes was approximately 0.26% during the first year of treatment, that is well under the observed hyperplasia incidence of 0.8% in the KLIM/PD/7/USA trial.
Danish: - Sammenlagte data fra flere for nylig godkendte sekventielle eller kontinuerte hormonsubstitutionsbehandlinger med østrogen/progestin-kombinationer i Europa viser, at incidensen af hyperplasi eller mere alvorlige uønskede endometriske udfald var ca. 0,26 % i det første år med behandling, hvilket er et pænt stykke under den observerede incidens af hyperplasi på 0,8 % i KLIM/PD/7/USA-forsøget.
English: On the basis of all these data, the majority of the CHMP was of the opinion that Activelle 0.5 mg estradiol/0.1 mg NETA is safe in terms of endometrial hyperplasia and neoplasia risk and that it offers a needed low-dose hormone replacement alternative with a positive benefit-risk.
Danish: På baggrund af alle disse data var de fleste medlemmer af CHMP af den opfattelse, at Activelle 0,5 mg estradiol/0,1 mg norethisteronacetat er sikker med hensyn til risikoen for endometriehyperplasi og neoplasi, og at det er en nødvendig alternativ lavdosis-hormonsubstitutionsbehandling med flere fordele end risici.
English: If you ever have had angina or heart attack, you should talk to your doctor about the risks and benefits of HRT.
Danish: Hvis De tidligere har haft hjertekramper eller hjerteanfald, bør De tale med Deres læge om fordele og ulemper ved HRT.
English: • If your blood pressure goes up while you're taking Activelle
Danish: • Hvis Deres blodtryk øges under behandling med Activelle
English: In this review, progestogen addition as continuous therapy was more effective than sequential therapy in reducing the risk of endometrial hyperplasia at longer duration of treatment.
Danish: I denne gennemgang viste det sig, at tilføjelsen af progestagen som kontinuert behandling var mere effektiv end sekventiel behandling, idet det nedsatte risikoen for endometriehyperplasi ved længerevarende behandling.
English: Vulvovaginal mycotic infection
Danish: Vaginal mykotisk infektion
English: It is uncertain whether long-term use of combined HRTs confers to a different risk than oestrogen-only products.
Danish: Det er uvist om langtidsbehandling med kombinerede HRT-produkter udgør en anden risiko end for rene østrogenprodukter.
English: Activelle is prescribed to relieve unpleasant symptoms like hot flushes, night sweats and vaginal dryness, which occur when the oestrogen levels decline and the periods stop (menopause).
Danish: Activelle ordineres for at behandle symptomer som hedeture, nattesved og tørre slimhinder i skeden, når østrogenniveauet falder og menstruationerne ophører (overgangsalderen).
English: After you have used all 28 tablets in a calendar pack, go straight to using the next pack.
Danish: Når alle 28 tabletter i en kalenderpakning er taget, fortsættes behandlingen næste dag med en ny kalenderpakning.
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Danish: Andre bundne proteiner kan være forhøjet i serum, fx kortikoidbindende globulin (CBG), sexshormonbindende globulin (SHBG), hvilket medfører en forøgelse af henholdsvis cirkulerende kortikosteroider og af sexshormoner.
English: Driving and using machines Activelle does not affect the use of any machines or the ability to drive safely.
Danish: Trafik- og arbejdssikkerhed Activelle påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Other conditions
Danish: Andre forhold
English: Important information about some of the ingredients of Activelle: Activelle contains lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Activelle Activelle indeholder lactose.
English: LIST OF EXCIPIENTS Activelle contains lactose.
Danish: LISTE OVER HJÆLPESTOFFER Activelle indeholder lactose.
English: Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.
Danish: Det at glemme en dosis øger sandsynligheden for gennembrudsblødning eller pletblødning.
English: Data on a limited number of exposed pregnancies indicate adverse effects of norethisterone on the foetus.
Danish: Data på et begrænset antal graviditeter, hvor kvinden har været udsat for hormonbehandling, indicerer bivirkninger af norethisteron på fostret.
English: However, the CHMP noted that the strengths studied did not include E2 0.5 mg/NETA 0.1 mg.
Danish: CHMP bemærkede dog, at de undersøgte styrker ikke omfattede 0,5 mg E2/0,1 mg NETA.
English: If you forget to take Activelle
Danish: Hvis De har glemt at tage Activelle
English: The applicant was asked to provide any additional data, from clinical and observational studies, of relevance for the effects of continuous oestrogen-progestogen combined products on endometrial hyperplasia or endometrial cancer.
Danish: Ansøgeren blev bedt om at fremskaffe eventuelle yderligere data fra kliniske forsøg og observationsforsøg, som var relevante for effekten af kontinuerte kombinerede østrogen-progestagenprodukter i forbindelse med endometriehyperplasi eller endometriecancer.
English: Results from two clinical studies showed that women, who used another type of oestrogen/progestagen combination than the one in Activelle, had a slightly increased risk of cardiovascular disease in the first year of use.
Danish: Resultater fra to store kliniske studier har vist, at kvinder, som anvendte en anden type østrogen/gestagen-kombination end Activelle, havde en let øget risiko for hjertesygdomme i det første behandlingsår.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: For other HRT products there are only limited data from randomised controlled trials examining effects in cardiovascular morbidity or mortality.
Danish: For andre HRT-produkter er der kun begrænsede data fra randomiserede, kontrollerede forsøg, der undersøger effekten ved kardiovaskulær morbiditet og mortalitet.
English: Patients with any of the following rare hereditary diseases should not take this medicine: galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Danish: Medicinen bør ikke tages af patienter med følgende arvelige og sjældne sygdomme: galactoseintolerans, lactasemangel eller glucose/galactosemalabsorption.
English: • Otosclerosis
Danish: • Otosklerose.
English: • Eye disorders: Visual disturbances
Danish: • Øjne: Synsforstyrrelser
English: - The endometrial safety data is not in accordance with the European guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in post menopausal women (EMEA/CHMP/021/97 rev1).
Danish: - Dataene vedrørende endometrie-sikkerheden er ikke i overensstemmelse med de europæiske retningslinjer for klinisk undersøgelse af lægemidler til hormonsubstitutionsbehandling af symptomer på østrogenmangel hos postmenopausale kvinder (EMEA/CHMP/021/97 ver. 1).
English: HRT, especially oestrogen-progestagen combined treatment, may increase the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Danish: HRT, specielt kombineret østrogen-gestagen-behandling, kan øge densiteten af brystvævet på mammografibilleder, hvilket vanskeliggør den radiologiske diagnostik af brystcancer.
English: Breakthrough bleeding and spotting may occur during the first months of treatment.
Danish: Gennembrudsblødning og pletblødning kan forekomme i løbet af de første måneder af behandlingen.
English: Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels (by radio-immunoassay).
Danish: Østrogener øger thyroxinbindende globulin (TBG), hvilket medfører en øget totalmængde thyreoideahormon målt ved protein-bundet jodid (PBI), T4 niveauer (ved kolonne- eller radioimmunanalyse) eller T3 niveauer (radio-immunanalyse).
English: In the MWS, the relative risk of breast cancer with conjugated equine oestrogens (CEE) or estradiol (E2) was greater when a progestagen was added, either sequentially or continuously, and regardless of type of progestagen.
Danish: I MWS-studiet var den relative risiko for brystcancer med konjugeret equin østrogen (CEE) eller estradiol (E2) større, når behandlingen var kombineret med gestagen, hvad enten dette var sekventielt eller kontinuerligt og uanset typen af gestagen.
English: • Myocardial infarction and stroke
Danish: • Myokardieinfarkt og slagtilfælde
English: By Week 3, the decrease in mean number of moderate to severe hot flushes for the 0.5 mg estradiol treatment group was statistically significant (p≤0.001) when compared to the placebo group.
Danish: Ved 3. uge sås et fald i det gennemsnitlige antal moderate til svære hedestigninger i behandlingsgruppen med 0,5 mg østradiol, som var statistisk signifikant (p≤0,001) sammenlignet med placebogruppen.
English: It is a lower strength with a lower oestrogen/progestogen ratio than the currently approved Activelle, which contains 1 mg E2 and 0.5 mg NETA.
Danish: Det har en lavere styrke med et mindre forhold mellem østrogen og progestagen end det aktuelt godkendte Activelle, som indeholder 1 mg E2 og 0,5 mg NETA.
English: However, some CHMP members considered that even if the observed hyperplasia incidence with the new dose E2 0.5 mg/NETA 0.1 mg should be lower than that observed with the E2 1mg/NETA 0.1mg combination, it is not unequivocally demonstrated that it will be in an acceptable range regarding the European guideline.
Danish: Nogle medlemmer af CHMP mente dog, at selv hvis den observerede incidens af hyperplasi med den nye dosis på 0,5 mg E2/0,1 mg NETA skulle være lavere end den observerede incidens med kombinationen på 1 mg E2/0,1 mg NETA, er det ikke påvist entydigt, at den vil ligge i et acceptabelt interval i henhold til de europæiske retningslinjer.
English: CONTENT BY WEIGHT, BY VOLUME OR BY UNIT 28 film-coated tablets
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 28 filmovertrukne tabletter
English: Activelle contains lactose monohydrate.
Danish: Activelle indeholder laktosemonohydrat.
English: • New onset of migraine-type headache
Danish: • Nye anfald af migrænelignende hovedpine
English: A switch to a higher dose product, e.g. Activelle 1 mg/0.5 mg tablets, should be considered if the response after three months is insufficient for satisfactory symptom relief.
Danish: Skift til kombinationsprodukt med højere dosis som f.eks Activelle 1 mg/0,5 mg tabletter kan foretages, såfremt der efter 3 måneders behandling ikke er opnået tilfredsstillende symptomlindring.
English: 28 film-coated tablets 3 x 28 film-coated tablets Not all pack sizes may be marketed.
Danish: 3 x 28 filmovertrukne tabletter Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: c. Continuous combined therapy versus sequential therapy in the prevention of endometrial hyperplasia or carcinoma
Danish: c. Kontinuert kombineret behandling i forhold til sekventiel behandling til forebyggelse af endometriehyperplasi eller -karcinom
English: HRT is associated with a higher relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Danish: HRT forbindes med en relativ øget risiko for at udvikle venøs tromboembolisme (VTE) dvs. dyb venetrombose eller lungeemboli.
English: Activelle is a continuous combined HRT product containing 17β-estradiol and norethisterone acetate with the intent of avoiding the regular withdrawal bleeding associated with cyclic or sequential HRT.
Danish: Activelle er et kombineret HRT-produkt til kontinuerlig behandling, som indeholder 17β-østradiol og norethisteronacetat til at undgå de regelmæssige blødninger, der forekommer ved cyklisk eller sekventiel HRT.
English: Bleeding with Activelle
Danish: Blødning med Activelle
English: Women with pre-existing hypertriglyceridemia should be followed closely during oestrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
Danish: Kvinder med tidligere hypertriglyceridæmi bør følges nøje under østrogen- eller hormonsubstitutionsbehandling, da der er set sjældne tilfælde af massiv forhøjelse af plasmatriglycerider, som har medført pankreatitis i forbindelse med østrogenbehandling.
English: According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT about 5 in every 1000 are expected to have endometrial cancer diagnosed between the ages of 50 and 65.
Danish: Ifølge resultater fra epidemiologiske studier er det bedste estimat, at 5 kvinder ud af 1000, som ikke bruger HRT, risikerer at få diagnosticeret en endometriecancer mellem deres 50. og 65. år.
English: estradiol/norethisterone acetate Oral use
Danish: estradiol/norethisteronacetat Oral anvendelse
English: One large randomised clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischaemic stroke in healthy women during treatment with continuous combined conjugated oestrogens and MPA.
Danish: Et stort randomiseret klinisk forsøg (WHI-studiet) viste som sekundært resultat en øget risiko for iskæmisk slagtilfælde hos raske kvinder i kontinuerlig behandling med kombineret, konjugeret østrogen og MPA.
English: BATCH NUMBER Batch
Danish: FREMSTILLERENS BATCHNUMMER Batch:
English: Moreover, one endometrial sample from a woman who received the E2 1 mg/NETA 0.1 mg combination was evaluated as “disordered proliferative” state.
Danish: Derudover blev en prøve af endometriet fra en kvinde, der fik kombinationen 1 mg E2/0,1 mg NETA, vurderet til at være i et "forstyrret proliferativt" stadium.
English: In conclusion, the CHMP agreed that the proliferative effect of unopposed oestrogens on endometrium is dependent on the dose of oestrogens.
Danish: CHMP konkluderede, at den proliferative effekt på endometriet af østrogener alene er afhængig af dosis af østrogener.
English: In a systematic review of 30 randomized controlled trials, unopposed moderate or high dose oestrogen therapy, when compared to placebo, was associated with a significant increase in rates of endometrial hyperplasia with increasing rates at longer duration of treatment (Lethaby et al. Cochrane database of systematic reviews 2004;3).
Danish: I en systematisk gennemgang af 30 randomiserede kontrollerede forsøg blev det observeret, at behandling med moderate eller høje doser østrogen alene sammenlignet med placebo var forbundet med en signifikant stigning i raterne af endometriehyperplasi med stigende rater ved længere varighed af behandlingen (Lethaby et al., Cochrane-database med systematiske gennemgange 2004;3).
English: If pregnancy occurs during medication with Activelle, treatment should be withdrawn immediately.
Danish: Hvis graviditet konstateres under behandling med Activelle, skal hormonbehandlingen straks seponeres.
English: Where prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT four to six weeks earlier, if possible.
Danish: Hvis patienten skal immobiliseres i længere tid efter elektiv kirurgi, især ved abdominalkirurgi eller ortopædkirurgi i benene, bør man vurdere om det er muligt at stoppe HRT- behandlingen midlertidigt 4-6 uger før operationen.
English: Do not use Activelle after the expiry date which is stated on the label and outer carton after “EXP”.
Danish: Brug ikke Activelle efter den udløbsdato, der står på pakningen.
English: If you are anxious for the risk of breast cancer, you should talk to your doctor about the risks and benefits of HRT.
Danish: Hvis De er bekymret over risikoen for at få brystkræft, bør De diskutere fordele og ulemper ved HRT med Deres læge.
English: o About 16 cases of invasive breast cancer would be diagnosed in 5 years.
Danish: Ud af 1000 kvinder i placebogruppen ville ca. 16 tilfælde af invasiv brystcancer kunne diagnosticeres inden for 5 år
English: Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
Danish: For kvinder, som allerede er i antikoagulationsbehandling, skal fordelene ved en HRT-behandling nøje afvejes mod risikoen.
English: Long-term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies.
Danish: Langtidsbehandling (mindst 5-10 år) af hysterektomerede kvinder med østrogen alene har i nogle epidemiologiske studier været forbundet med en øget risiko for ovariecancer.
English: The sample size of the KLIM/PD/11/USA study may be considered too small to draw any definite conclusion regarding endometrial safety of E2 0,5 mg, even for 2 yeartreatment.
Danish: Stikprøvestørrelsen i KLIM/PD/11/USA-forsøget kan anses for at være for lille til at drage en klar konklusion med hensyn til endometrie-sikkerheden ved 0,5 mg E2, selv ved behandling i 2 år.
English: USER INSTRUCTIONS
Danish: BRUGERVEJLEDNING
English: DK-2880 Bagsvaerd Denmark
Danish: DK-2880 Bagsvaerd Danmark
English: As for the KLIM/PD/11/USA trial, sample size may be considered too low to draw definite conclusion with regard to endometrial safety.
Danish: Stikprøvestørrelsen kan som i KLIM/PD/11/USA-forsøget anses for at være for lille til at drage en klar konklusion med hensyn til endometrie-sikkerheden.
English: • Hypersensitivity to the active substances or to any of the excipients
Danish: • Overfølsomhed over for de aktive indholdsstoffer eller hjælpestofferne