FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop taking DUAVIVE and see a doctor immediately if you get any of the following serious side effects:
Danish: Stop med at tage Duavive og kontakt straks lægen, hvis du får én eller flere af følgende alvorlige bivirkninger:
English: Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer' below).
Danish: Kvinderne skal instrueres i, hvilke ændringer i deres bryster, der bør rapporteres til læge eller sundhedspersonale (se "Brystcancer" nedenfor).
English: If you feel drowsy after taking this medicine, you should avoid driving or operating machines.
Danish: Hvis du føler dig træt, når du har taget dette lægemiddel, bør du undgå at føre motorkøretøj og betjene maskiner.
English: Glucuronidation is the major metabolic pathway.
Danish: Glukuronidation er den vigtigste metaboliseringsvej.
English: BZA is highly bound (98% - 99%) to plasma proteins in vitro, but does not bind to sex hormone binding globulin (SHBG).
Danish: Bazedoxifen er stærkt bundet (98 % - 99 %) til plasmaproteiner in vitro, men bindes ikke til kønshormonbindende globulin (SHBG).
English: • go for regular breast screening and cervical smear tests, as recommended by your doctor.
Danish: • Regelmæssigt at få foretaget mammografi og smear-test af livmoderhalsen som anbefalet af din læge
English: Tmax (hr)
Danish: Tmax (t)
English: On average, women with hepatic impairment showed a 4.3-fold increase in AUC compared with controls.
Danish: I gennemsnit viste kvinder med nedsat leverfunktion en stigning på 4,3 gange i AUC i forhold til kontrolpersonerne.
English: Incidence per 1,000 women in placebo arm over 5 years
Danish: Incidens pr. 1.000 kvinder i placebo-arm over 5 år
English: - Porphyria.
Danish: - Porfyri.
English: The following side effects have been observed when either conjugated oestrogens and/or bazedoxifene (the active ingredients in this medicine) has been used alone and may occur also with this medicine:
Danish: Følgende bivirkninger er observeret, når enten konjugerede østrogener og/eller bazedoxifen (de aktive stoffer i dette lægemiddel) har været brugt alene, og kan også forekomme med dette lægemiddel:
English: In case of overdose it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Danish: I tilfælde af overdosering anbefales det, at patienten monitoreres for tegn og symptomer på bivirkninger, og at der straks iværksættes passende symptomatisk behandling.
English: The major route of excretion of radiolabeled BZA is the faeces, and less than 1% of the dose is eliminated in urine.
Danish: Den vigtigste udskillelsesvej for radioaktivt mærket bazedoxifen er fæces, og mindre end 1 % af dosis elimineres i urinen.
English: Heart disease (heart attack)
Danish: Hjertesygdom (hjerteanfald)
English: Following intravenous administration of a 3 mg dose of BZA alone, the volume of distribution is 14.7 3.9 l/kg.
Danish: Efter intravenøs administration af en dosis på 3 mg bazedoxifen alene, er fordelingsvolumen 14,7  3,9 l/kg.
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1 antitrypsin, ceruloplasmin).
Danish: Andre plasmaproteiner kan være forhøjede (angiotensinogen/reninsubstrat, alfa-1-antitrypsin, ceruloplasmin).
English: For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used (see section 4.4).
Danish: Ved initiering og fortsættelse af behandling af postmenopausale symptomer skal den laveste, effektive dosis anvendes i kortest mulig tid (se pkt.
English: • A worsening of chorea (an existing neurological disorder characterised by involuntary spasmodic movements of the body)
Danish: • Forværring af chorea (en eksisterende neurologisk sygdom, der er kendetegnet ved ufrivillige, rykvise bevægelser af kroppen)
English: The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment.
Danish: Den øgede risiko bliver tydelig efter få års brug, men vender tilbage til baseline inden for få år (højst fem) efter behandlingsophør.
English: The following data are based on the findings in studies with bazedoxifene.
Danish: De følgende data er baseret på resultater fra studier med bazedoxifen.
English: This medicine contains 0.0088 mg sorbitol in each tablet.
Danish: Dette lægemiddel indeholder 0,0088 mg sorbitol pr. tablet.
English: Women 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, dyspnoea).
Danish: Kvinder skal informeres om, at de straks skal kontakte lægen, hvis de bliver opmærksomme på eventuelle symptomer på tromboemboli (f. eks. smertefuld hævelse af benet, pludselig smerte i brystet, dyspnø).
English: Exacerbation of chorea
Danish: Forværring af chorea
English: If you forget to take a tablet, take it as soon as you remember.
Danish: Hvis du glemmer at tage en tablet, skal du tage den, så snart du kommer i tanke om det.
English: Oestrogen therapy will not prevent memory loss.
Danish: Østrogenbehandling forebygger ikke hukommelsestab.
English: During the menopause, the amount of the oestrogen produced by a woman's body drops.
Danish: I overgangsalderen falder mængden af østrogen, som kvindens krop producerer.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system; estrogens, combinations with other drugs; ATC code: G03CC07
Danish: Farmakoterapeutisk klassifikation: Urogenitalsystem og kønshormoner, østrogener, kombinationer med andre stoffer, ATC-kode: G03CC07
English: The concentrations of this glucuronide are approximately 10-fold higher than those of unchanged BZA in plasma.
Danish: Koncentrationerne af denne glukuronid er ca. 10 gange højere end koncentrationen af uforandret bazedoxifen i plasma.
English: Bazedoxifene-5-glucuronide is the major circulating metabolite.
Danish: Bazedoxifen-5-glukuronid er den vigtigste cirkulerende metabolit.
English: Growth potentiation of benign meningioma; fibrocystic breast disease
Danish: Vækstpotensering af benignt meningiom, fibrocystisk brystsygdom
English: Blood clots in a vein (thrombosis) DUAVIVE may increase the risk of blood clots.
Danish: Blodpropper i en vene (trombose) Duavive kan øge risikoen for blodpropper.
English: In postmenopausal women, a significant proportion of the circulating oestrogens exists as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active oestrogens.
Danish: Hos postmenopausale kvinder findes en betydelig del af de cirkulerende østrogener som sulfatkonjugater, især estronsulfat, som tjener som et cirkulerende reservoir for dannelse af flere aktive østrogener.
English: If such symptoms occur, patients should avoid driving or use of machines that requires accurate visual perception until symptoms have resolved, or until they have received medical advice that it is safe to do so.
Danish: Hvis sådanne symptomer forekommer, bør patienten undgå at føre motorkøretøj og betjene maskiner, der kræver et præcist syn, indtil symptomerne er forsvundet, eller indtil de har fået en lægelig vurdering af, at det er sikkert.
English: Call your doctor or pharmacist.
Danish: Kontakt din læge eller apoteket.
English: BZA is eliminated with a half-life of approximately 30 hours.
Danish: Bazedoxifen elimineres med en halveringstid på ca. 30 timer.
English: Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from 5 to 55 extra cases diagnosed in every 1,000 women between the ages of 50 and 65 years.
Danish: Afhængigt af varigheden for anvendelse af østrogen alene og den anvendte østrogendosis, varierede stigningen i risikoen for endometriecancer i epidemiologiske studier mellem 5-55 yderligere tilfælde diagnosticeret for hver 1.000 kvinder i alderen 50-65 år.
English: The distribution of exogenous oestrogens is similar to that of endogenous oestrogens.
Danish: Fordelingen af eksogene østrogener er den samme som for endogene østrogener.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • increased risk of developing blood clots [see “Blood clots in a vein (thrombosis)”]
Danish: • en øget risiko for at få blodpropper [se "Blodpropper i en vene (trombose)"]
English: • if any of your close relatives has ever had a blood clot in the leg, lung or another organ
Danish: • hvis du eller et af dine nære familiemedlemmer tidligere har haft en blodprop i benet, lungen eller et andet organ
English: In vitro and in vivo studies have shown that oestrogens are partially metabolised by cytochrome P450 enzymes, including CYP3A4.
Danish: In vitro- og in vivo-studier har vist, at østrogener delvist metaboliseres af CYP-enzymer, herunder CYP3A4.
English: • Increase in hair growth
Danish: • Øget hårvækst
English: A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56).
Danish: En meta-analyse fra 52 epidemiologiske studier viste en forhøjet risiko for ovariecancer hos kvinder, der er i hormonsubstitutionsbehandling, sammenlignet med kvinder, der aldrig har brugt HRT (RR 1,43, 95 %-KI 1,31-1,56).
English: The level of risk is dependent on duration of use (see section 4.4).
Danish: Risikoniveauet afhænger af varigheden af anvendelsen (se pkt.
English: - Undiagnosed genital bleeding.
Danish: - Udiagnosticeret genital blødning.
English: Red Iron oxide (E172)
Danish: Rød jernoxid (E172)
English: 28 modified-release tablets
Danish: 28 tabletter med modificeret udløsning
English: If any of the above conditions appear for the first time while taking this medicine, stop taking it at once and consult your doctor immediately.
Danish: Hvis en eller flere af de tilstande, der er nævnt ovenfor, forekommer for første gang, mens du tager dette lægemiddel, skal du straks stoppe med at tage det og øjeblikkeligt kontakte din læge.
English: Package leaflet: Information for the patient
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
English: DUAVIVE alleviates these symptoms after menopause.
Danish: Duavive lindrer disse symptomer efter overgangsalderen.
English: In addition, women taking CE/BZA should be advised to move about periodically during travel involving prolonged immobilisation.
Danish: Desuden bør kvinder, der tager konjugerede østrogener/bazedoxifen, rådes til at bevæge sig regelmæssigt under rejser, som indebærer langvarig immobilisering.
English: The clearance of BZA is 0.4 ±0.1 L/h/kg based on intravenous administration.
Danish: Bazedoxifen-clearance er 0,4 ± 0,1 l/t/kg baseret på intravenøs administration.
English: Estradiol only
Danish: Estradiol alene
English: It is not known whether bazedoxifene is excreted in human milk.
Danish: Det vides ikke, om bazedoxifen udskilles i modermælk.
English: DUAVIVE is a medicine that contains two active substances called conjugated oestrogens and bazedoxifene.
Danish: Duavive er et lægemiddel, der indeholder to aktive stoffer, som hedder konjugerede østrogener og bazedoxifen.
English: *WHI study in women with no uterus, which did not show an increase in risk of breast cancer
Danish: *WHI-studie med kvinder uden livmoder, som ikke viste en stigning i risikoen for brystcancer
English: If you have or have ever had liver disease and your liver function tests have not returned to normal.
Danish: - Hvis du har eller nogensinde har haft leversygdom, og dine levertal ikke er vendt tilbage til det normale.
English: Longterm exposure to CE/BZA for up to 2 years was evaluated; 3,322 women were exposed to CE/BZA for at least 1 year, and 1,999 women were exposed for 2 years.
Danish: Langvarig eksponering med konjugerede østrogener/bazedoxifen i op til 2 år blev vurderet; 3.322 kvinder blev eksponeret for konjugerede østrogener/bazedoxifen i mindst 1 år, og 1.999 kvinder blev eksponeret i 2 år.
English: • fluid retention due to cardiac or kidney problems
Danish: • væskeophobning på grund af hjerte- eller nyreproblemer
English: Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death.
Danish: Blodpropper kan være alvorlige, og hvis en blodprop kommer op til lungerne, kan det give brystsmerter, åndenød, kollaps eller endda død.
English: Blood triglycerides increased, alanine aminotransferase increased; aspartate aminotransferase increased
Danish: Forhøjede triglycerider , forhøjet alaninaminotransferase, forhøjet aspartataminotransferase
English: • Abrupt onset of abdominal pain and passage of bright red blood in the stool, with or without diarrhoea due to sudden blockage of an artery supplying the intestines (ischaemic colitis)
Danish: • Pludselige mavesmerter og klart rødt blod i afføringen, med eller uden diarré, som skyldes en pludselig blokering af en arterie, der forsyner tarmene (iskæmisk colitis)
English: On average, compared to women 51 to 64 years of age (n=8), women 65 to 74 years of age (n=8) showed a 1.5-fold increase in AUC, and women 75 years of age (n=8) showed a 2.6-fold increase in AUC.
Danish: I forhold til kvinder i alderen 51-64 år (n=8) udviste kvinder i alderen 65-74 år (n=8) i gennemsnit en stigning i AUC på 1,5 gange, og kvinder  75 år (n=8) udviste en stigning i AUC på 2,6 gange.
English: Blood triglycerides increased
Danish: Forhøjede blodtriglycerider
English: • Memory loss (dementia)
Danish: • Hukommelsestab (demens)
English: • a disease affecting the eardrum and hearing (otosclerosis)
Danish: • en sygdom, der påvirker trommehinden og hørelsen (otosklerose)
English: • regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.
Danish: • Regelmæssigt at undersøge dine bryster for at opdage eventuelle forandringer såsom fordybninger i huden, forandringer i brystvorterne og eventuelle knuder, som du kan se eller mærke.
English: The bazedoxifene component of this medicine has been reported to cause problems with eyesight such as blurred vision.
Danish: Det er blevet rapporteret, at bazedoxifen-komponenten i dette lægemiddel har forårsaget problemer med synet som f. eks. sløret syn.
English: Bazedoxifene
Danish: Bazedoxifen
English: Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see section 4.8).
Danish: Visse andre studier, herunder WHI-studiet, tyder på, at brug af kombinerede HRT-præparater kan være forbundet med en tilsvarende eller lidt mindre risiko (se pkt.
English: There were no significant pharmacokinetic interactions between bazedoxifene and the following medicinal products: ibuprofen, atorvastatin and azithromycin or an antacid containing aluminium and magnesium hydroxide.
Danish: Der er ingen væsentlige farmakokinetiske interaktioner mellem bazedoxifen og følgende lægemidler: Ibuprofen, atorvastatin og azithromycin eller en antacidum indeholdende aluminium- og magnesiumhydroxid.
English: Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
Danish: Almindeligt anerkendte risikofaktorer for VTE omfatter brug af østrogener, høj alder, større operative indgreb, langvarig immobilisering, svær overvægt (BMI > 30 kg/m2), graviditet/postpartum-periode, systemisk lupus erythematosus (SLE) og cancer.
English: See package leaflet for further information.
Danish: Se indlægssedlen for at få yderligere oplysninger.
English: The disposition of a single 20 mg dose of bazedoxifene was compared in women with hepatic impairment (Child-Pugh Class A [n=6], B [n=6], and C [n=6]) and subjects with normal hepatic function (n=18).
Danish: Fordelingen af en enkelt dosis bazedoxifen på 20 mg blev sammenlignet hos kvinder med nedsat leverfunktion (Child-Pugh-klasse A [n=6], B [n=6] og C [n=6]) og hos forsøgspersoner med normal leverfunktion (n=18).
English: Based on available data no dosage adjustment is necessary based on age (see section 5.2).
Danish: Ud fra de foreliggende data er dosistilpasning ikke nødvendig på grund af alder (se pkt.
English: Conjugated oestrogens is a medicine that belongs to a group of medicines called hormone replacement therapy (HRT).
Danish: Konjugerede østrogener er et lægemiddel, der hører til en gruppe af lægemidler, som benævnes hormonsubstitutionsbehandling (HRT).
English: Changes in weight (increase or decrease)
Danish: Vægtændringer (stigning eller nedgang)
English: DUAVIVE is indicated for the treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.
Danish: Duavive er indiceret til behandling af symptomer på østrogenmangel hos postmenopausale kvinder, med intakt uterus (med mindst 12 måneder fra sidste menstruation), hvor behandling med syntetisk gestagen ikke er hensigtsmæssig.
English: There is no consensus about the possible role of varicose veins in VTE.
Danish: Der er ingen konsensus vedrørende en mulig sammenhæng mellem varicer (åreknuder) og VTE.
English: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Danish: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgien.
English: Exacerbation of epilepsy
Danish: Forværring af epilepsi
English: Adverse reactions were categorised as very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from available data).
Danish: Bivirkninger blev kategoriseret som meget almindelige (≥ 1/10); almindelige (≥ 1/100 til < 1/10), ikke almindelige (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til <1/1.000), meget sjældne (< 1/10,000) eller ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: Patients with known thrombophilic states have an increased risk of VTE and hormone therapy may add to this risk.
Danish: Patienter med kendte trombofili-sygdomme har en øget risiko for VTE, og hormonbehandling kan øge denne risiko.
English: In women with no personal history of VTE but with a first-degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).
Danish: Kvinder, der ikke selv har VTE i anamnesen, men som har en slægtning i den nærmeste familie med trombose i en tidlig alder, kan der tilbydes screening efter nøje rådgivning med hensyn til begrænsningerne vedrørende denne (kun en del af de trombofile sygdomme/defekter identificeres ved screening).
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Erythema multiforme: symptoms may include skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.
Danish: • Erythema multiforme: Symptomer kan omfatte hududslæt med lyserøde eller røde pletter, især på håndfladen eller fodsålen, som kan danne blærer.
English: If you have a rare blood problem called porphyria, which is passed down in families (inherited).
Danish: - Hvis du har en sjælden blodsygdom, der kaldes porfyri, som nedarves i familien.
English: For women who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.
Danish: For kvinder, som i 5 år bruger HRT, der kun indeholder østrogen, ses der en lille eller ingen øget risiko for brystkræft.
English: *no differentiation was made between ischaemic and haemorrhagic stroke.
Danish: *der blev ikke differentieret mellem isklæmisk og hæmoragisk apopleksi.
English: CE/BZA was evaluated in 4,868 post-menopausal women who participated in 5 phase 3 trials.
Danish: Sikkerheden af konjugerede østrogener/bazedoxifen blev vurderet hos 4.868 post-menopausale kvinder, der deltog i 5 fase III studier.
English: Therapy should be discontinued in case a contraindication is discovered (e.g., venous thromboembolism, stroke, and pregnancy) and in the following situations:
Danish: Behandlingen skal seponeres, hvis der indentificeres en kontraindikation (f. eks. venøs tromboemboli, apopleksi og graviditet), samt ved følgende situationer:
English: - Patients with terminal renal insufficiency should be closely monitored, since it is expected that the level of circulating oestrogens components of CE/BZA will be increased.
Danish: - Patienter med terminal nyreinsufficiens skal monitoreres nøje, da det forventes, at niveauet af cirkulerende østrogenkomponeneter fra konjugerede østrogener/bazedoxifen vil øges.
English: Do not take this medicine if you are breast-feeding.
Danish: Tag ikke dette lægemiddel, hvis du ammer.
English: The pharmacokinetics of a 20 mg single dose of BZA were evaluated in a study in 26 healthy postmenopausal women.
Danish: De farmakokinetiske egenskaber ved en enkeltdosis på 20 mg bazedoxifen blev vurderet i et studie med 26 raske postmenopausale kvinder.
English: If you stop taking DUAVIVE
Danish: Hvis du holder op med at tage Duavive
English: - Jaundice or deterioration in liver function - Significant increase in blood pressure -New onset of migraine-type headache
Danish: - Gulsot eller forværring i leverfunktion - Væsentlig blodtryksstigning - Nyopstået migrænelignende hovedpine.
English: The additional risk of ischaemic stroke over five years of use was assessed in the largest randomised trial in women without a uterus (WHI) from 50-59 years of age.
Danish: Den yderligere risiko for iskæmisk apopleksi ved mere end fem års anvendelse blev vurderet i det største randomiserede studie med kvinder uden livmoder (WHI) i alderen 50-59 år.
English: Following administration of BZA alone, a linear increase in plasma concentrations for single doses from 0.5 mg up to 120 mg and multiple daily doses from 1 mg to 80 mg was observed.
Danish: Efter administration af bazedoxifen alene blev der observeret en lineær stigning i plasmakoncentrationerne for enkeltdoser fra 0,5 mg op til 120 mg og flere daglige doser fra 1-80 mg.
English: This change in BMD was similar to that shown with bazedoxifene 20 mg alone (+1.35%) and less than that seen with CE 0.45 mg/ medroxyprogesterone 1.5 mg (+2.58%) in the same study.
Danish: Denne ændring i BMD svarede til den, der sås med bazedoxifen 20 mg alene (+1,35 %), og var mindre end den, der sås med konjugerede østrogener 0,45 mg/medroxyprogesteron 1,5 mg (+2,58 %) i samme studie.
English: Skin and subcutaneous tissue
Danish: Hud og subkutane væv
English: Pharmacokinetic studies for CE/BZA were conducted in healthy postmenopausal women who were naturally postmenopausal or who had undergone bilateral oophorectomy.
Danish: Farmakokinetiske studier vedrørende konjugerede østrogener/bazedoxifen blev udført hos raske postmenopausale kvinder, der var naturligt post-menopausale, eller som havde fået foretaget bilateral oophorektomi.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicinal product.
Danish: Hvis du har fået at vide af din læge, at du ikke tåle visse sukkerarter, skal du kontakte lægen, inden du begynder at tage dette lægemiddel.
English: Women already on chronic anticoagulant treatment require careful consideration of the benefit risk of use of hormone therapy.
Danish: Hos kvinder, der allerede er i kronisk antikoagulations-behandling, kræver brug af hormonbehandling en nøje overvejelse af benefit/risk.
English: - Untreated endometrial hyperplasia.
Danish: - Ubehandlet endometriehyperplasi.