FrancophonIA/ELRC3.0 huggingface dataset:
English: Therecommendeddose is one tablet by mouth daily.Taking more than one tablet daily is not more effective and may carry additional risks.
Danish: Den anbefalede dosis er 1 tablet dagligt via munden.Det er ikke mere effektivt at tage mere end én tablet om dagen, og det kan medføre flere risici ved behandlingen.
English: Pharmacotherapeutic group: Selective estrogen receptor modulator, ATC code: G03XC02.
Danish: Farmakoterapeutisk klassifikation: Selektiv østrogenreceptormodulator, ATC-kode: G03XC02.
English: Urine parameters were pathologically changed.
Danish: Der sås en patologisk ændring af urinparametrene.
English: Based on in vitro bazedoxifene plasma protein binding characteristics, drug interactions with warfarin, digoxin and diazepam are unlikely.
Danish: Baseret på bazedoxifens in vitro plasmaproteinbindende egenskaber er interaktioner med warfarin, digoxin og diazepam ikke sandsynlige.
English: CONBRIZA has minor influence on the ability to drive and use machines.
Danish: CONBRIZA påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Bazedoxifene has not been studied in women with triglyceride levels 300 mg/dl (3.4 mmol/litre).
Danish: Bazedoxifen er ikke blevet undersøgt hos kvinder med triglyceridniveauer  300 mg/dl (> 3,4 mmol/l).
English: The bazedoxifene 40 mg dose was decreased to a 20 mg dose after approximately 4 years.
Danish: Bazedoxifen 40 mg dosis blev nedsat til en 20 mg dosis efter cirka 4 år.
English: Пфайзер Люксембург САРЛ, Клон България Тел.
Danish: Пфайзер Люксембург САРЛ, Клон България Teл.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Bazedoxifene is eliminated with a half-life of approximately 30 hours.
Danish: Bazedoxifen elimineres med en halveringstid på ca. 30 timer.
English: No data are available on the concomitant use with agents used in the treatment of early or advanced breast cancer.
Danish: Der foreligger ingen data vedrørende samtidig brug af stoffer, der bruges til behandling af tidlig eller fremskreden brystcancer.
English: Glucuronidation is the major metabolic pathway.
Danish: Glukuronidering er den vigtigste metaboliseringsvej.
English: Table 1: Effect of bazedoxifene on risk of vertebral fractures after 3 years of treatment Number of subjects
Danish: Tabel 1: Bazedoxifens virkning på risikoen for vertebrale frakturer efter 3 års behandling Antal forsøgsdeltagere
English: Swelling of the hands, feet and legs (peripheral oedema)
Danish: Hævede hænder, fødder og ben (perifert ødem)
English: Bazedoxifene is extensively metabolised in women.
Danish: Bazedoxifen metaboliseres i udstrakt grad hos kvinder.
English: CONBRIZA is only indicated for use in postmenopausal women (see section 4.3) and should not be used during breast-feeding.
Danish: CONBRIZA er kun indiceret til anvendelse af postmenopausale kvinder (se pkt 4.3) og bør ikke anvendes under amning.
English: Histomorphometric assessment revealed normal mineralisation, as evidenced by the presence of normal osteoid thickness, normal mineralisation lag time, and mineral apposition rate.
Danish: Histomorfometrisk vurdering viste normal mineralisering påvist ved tilstedeværelsen af normal osteoid tykkelse, normal mineraliseringslatenstid og mineraloptagelseshastighed.
English: The median T-score ranged from -0.6 to -1.4, depending on the skeletal site.
Danish: Medianen for T-scoren lå i området -0,6 til -1,4 afhængig af skeletområdet.
English: The mean pharmacokinetic parameters of bazedoxifene after multiple doses in healthy postmenopausal ambulatory women who were naturally postmenopausal or who had undergone bilateral oophorectomy are summarized in Table 2.
Danish: Bazedoxifens gennemsnitlige farmakokinetiske parametre efter multiple doser hos raske postmenopausale ambulante kvinder, der var naturligt postmenopausale, eller som havde fået foretaget bilateral ooforektomi, er opsummeret i tabel 2.
English: Following intravenous administration of a 3 mg dose of bazedoxifene, the volume of distribution is 14.7 ± 3.9 l/kg.
Danish: Efter intravenøs administration af bazedoxifen i en dosis på 3 mg er fordelingsvolumen 14,7 ± 3,9 l/kg.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter, skal du kontakte din læge, før du tager dette lægemiddel.
English: The recommended dose of CONBRIZA is one tablet once daily, at any time of day, with or without food (see section 5.2).
Danish: Den anbefalede dosis CONBRIZA er én tablet én gang dagligt på et hvilket som helst tidspunkt af dagen i forbindelse med et måltid eller imellem måltiderne (se pkt.
English: Mean ± SD pharmacokinetic parameters of bazedoxifene (n=23) Cmax (ng/ml)
Danish: Bazedoxifens gennemsnitlige farmakokinetiske parametre ± SD (n = 23) Cmax (ng/ml)
English: All subjects received calcium supplementation daily; most received 600 mg calcium (e.g., Caltrate) daily, while some received up to 1,200 mg daily.
Danish: Alle forsøgsdeltagere fik calcium-tilskud dagligt, idet de fleste fik 600 mg calcium (f.eks. Caltrate) dagligt, mens nogle fik op til 1.200 mg dagligt.
English: In vitro data suggest that bazedoxifene is unlikely to interact with co-administered medicinal products via CYP-mediated metabolism.
Danish: In vitro-data tyder på, at bazedoxifen sandsynligvis ikke interagerer med samtidigt administrerede lægemidler via CYP-medieret metabolisme.
English: Deep vein thrombosis*, thrombophlebitis superficial
Danish: Dyb venetrombose*, superficiel tromboflebitis
English: Each film-coated tablet contains 142.8 mg lactose (as monohydrate).
Danish: Hver filmovertrukket tablet indeholder 142,8 mg (som lactosemonohydrat).
English: There were no significant pharmacokinetic interactions between bazedoxifene and the following medicinal products: ibuprofen, atorvastatin, azithromycin, or an antacid containing aluminium and magnesium hydroxide.
Danish: Der var ingen signifikante farmakokinetiske interaktioner mellem bazedoxifen og følgende medicinske produkter: Ibuprofen, atorvastatin, azithromycin, eller et antacid indeholdende aluminium og magnesiumhydroxid.
English: CONBRIZA is supplied as a white to off-white, capsule-shaped, film-coated tablet marked with “WY20”.
Danish: CONBRIZA leveres som en hvid til offwhite, kapselformet, filmovertrukket tablet præget med “WY20”.
English: Since chronic progressive nephropathy and corticomedullar nephrocalcinosis are most likely rat-specific nephropathies, these findings are presumably not relevant for humans.
Danish: Eftersom kronisk progressiv nefropati og kortikomedullær nefrocalcinose mest sandsynligt er specifikke for rotter, er disse fund formentlig ikke relevante for mennesker.
English: These effects on bone remodeling lead to an increase in bone mineral density (BMD), which in turn contributes to a reduction in the risk of fractures.
Danish: Disse virkninger på knogleremodellering medfører øget knoglemineraltæthed (BMD), som atter medvirker til en nedsat risiko for frakturer.
English: Uncommon Frequency not known (cannot be estimated from available data)
Danish: Almindelig Ikke almindelig Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppe opstilles bivirkningerne efter, hvor alvorlige de er.
English: as it may increase your risk of getting blood clots.
Danish: da din risiko for at få blodpropper kan være øget.
English: The apparent oral clearance of bazedoxifene is approximately 4 to 5 l/h/kg.
Danish: Bazedoxifens tilsyneladende orale clearance er ca. 4 til 5 l/t/kg.
English: Palpitations (awareness of your heart beat)
Danish: Hjertebanken (bevidsthed om din hjerterytme)
English: They are packed in PVC/Aclar blisters and are available in packs of 7, 28, 30, 84 or 90 tablets.
Danish: Tabletterne er pakket i PVC-/Aclar-blisterkort og fås i pakninger med 7, 28, 30, 84 og 90tabletter.
English: Bazedoxifene undergoes metabolism by uridine diphosphate glucuronosyltransferase (UGT) enzymes in the intestinal tract and liver (see section 5.2).
Danish: Bazedoxifen metaboliseres af uridindiphosphat-glukuronosyltransferase (UGT) -enzymer i tarmen og leveren (se pkt 5.2).
English: Paediatric population There is no relevant use of bazedoxifene in the paediatric population.
Danish: Pædiatrisk population Der er ingen relevant anvendelse af bazedoxifen i den pædiatriske population.
English: if you are immobile (unable to move) for some time, such as being wheel-chair bound, sitting for a prolonged period of timeor having to stay in bed while recovering from an operation or illness.
Danish: hvis du er ude af stand til at røre dig (immobil) i nogen tid, fordi du sidder i kørestol, skal sidde ned i et længere stykke tid eller er sengeliggende, mens du kommer dig efter en operation eller en sygdom.
English: CONBRIZA is associated with an increased risk of venous thromboembolism (VTE).
Danish: CONBRIZA er forbundet med en øget risiko for venøs tromboemboli (VTE).
English: The effect of bazedoxifene on BMD at other skeletal sites was similar.
Danish: Bazedoxifens virkning på BMD på andre dele af skelettet var den samme.
English: Limited clinical data (n=5) are available in subjects with moderate renal impairment (CrCl  50 ml/min).
Danish: Der er begrænsede tilgængelige kliniske data (n=5) for forsøgsdeltagere med moderat nedsat nyrefunktion (kreatininclearance  50 ml/min).
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om CONBRIZA, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: All subjects were to receive 1,200 mg of elemental calcium and 400 IU of vitamin D daily.
Danish: Alle skulle have 1.200 mg calcium og 400 IE vitamin D dagligt.
English: Retinal vein thrombosis*
Danish: Retinal venetrombose*
English: Like the rodent results, bazedoxifene treatment in non-human primates resulted in uterine and mammary gland atrophy without other histological differentiation from untreated animals.
Danish: I lighed med resultaterne for gnavere, resulterede bazedoxifen-behandlingen hos ikke-humane primater i atrofi af uterus og brystkirtler uden anden histologisk differentiering i forhold til ubehandlede dyr.
English: White to off-white, capsule-shaped, film-coated tablet debossed on one side with “WY20”.
Danish: Hvid til offwhite kapselformet, filmovertrukket tablet præget med “WY20” på den ene side.
English: CARTON TEXT
Danish: TEKST PÅ KARTON
English: Additionally, uterine wet weights were reduced compared with untreated animals and histologic evaluation demonstrated little to no difference from the untreated controls.
Danish: Yderligere reduceredes vådvægten af uterus sammenlignet med ubehandlede dyr, og histologisk undersøgelse viste kun ringe eller ingen forskel sammenlignet med ubehandlede kontrolgrupper.
English: The reduction in the incidence of vertebral fracture was similar among bazedoxifene and raloxifene treatment groups.
Danish: Reduktionen i incidensen af vertebral frakturer var sammenlignelig for bazedoxifen- og raloxifen-behandlingsgrupperne.
English: In subjects with 10-year fracture probabilities at or above 16%, bazedoxifene was associated with a significant decrease in the risk of all clinical fractures.
Danish: Hos forsøgsdeltagere med en 10-års-sandsynlighed for fraktur på 16 % eller derover var bazedoxifenbehandling forbundet med et signifikant fald i risikoen for alle kliniske frakturer.
English: Safety and efficacy have not been evaluated further in patients with hepatic insufficiency.
Danish: Sikkerhed og virkning er ikke blevet yderligere vurderet hos patienter med leverinsufficiens.
English: Histological assessment of bone biopsies from all treatment groups revealed formation of normal lamellar bone in all treated subjects.
Danish: Histologisk vurdering af knoglebiopsierne fra alle behandlingsgrupperne viste, at der hos alle behandlede forsøgsdeltagere var dannet normalt lamellært knoglevæv.
English: In subjects treated with bazedoxifene, the incidence of fractures was related to the baseline fracture risk: the higher the fracture risk, the greater the benefit with bazedoxifene treatment.
Danish: Hos de forsøgsdeltagere, der var blevet behandlet med bazedoxifen, var frakturincidensen relateret til risikoen for fraktur ved baseline: Jo højere frakturrisiko, desto større var den gavnlige effekt af behandlingen med bazedoxifen.
English: The efficacy of bazedoxifene was established in two multicentre, double-blind, randomised, placeboand active-control, Phase 3 trials: 3-year osteoporosis treatment trial and a 2-year osteoporosis prevention trial.
Danish: Virkningen af basedoxifen blev fastslået i to dobbeltblindede, randomiserede, placebo- og aktivt kontrollerede, multicenter-, fase 3-forsøg: et 3-årigt osteoporose-behandlingsforsøg og et 2-årigt osteoporose-forebyggelsesforsøg.
English: The active substance is bazedoxifene.
Danish: - Aktivt stof: Bazedoxifen.
English: The risk factors associated with VTE cases in clinical trials included: advanced age, obesity, immobilisation, surgery, major trauma and malignancy.
Danish: I kliniske forsøg omfattede risikofaktorerne forbundet med VTE-hændelser: fremskreden alder, adipositas, immobilisering, kirurgi, større traume og malign sygdom.
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 kartonen og blisterkortet efter EXP. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: CONBRIZA is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.
Danish: CONBRIZA er indiceret til behandling af postmenopausal osteoporose hos kvinder med øget risiko for fraktur.
English: The major route of excretion of radio-labelled bazedoxifene is the faeces, and less than 1% of the dose is eliminated in urine.
Danish: Størstedelen af radioaktivt mærket bazedoxifen udskilles gennem fæces, og mindre end 1 % af dosen udskilles gennem urinen.
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 2.3-fold increase in AUC.
Danish: Sammenlignet med kvinder i alderen 51 til 64 år (n=8) havde kvinder i alderen 65 til 74 år (n=8) en gennemsnitlig stigning i AUC på 1,5, og kvinder i alderen  75år (n=8) havde en gennemsnitlig stigning i AUC på 2,3.
English: If you forget to take CONBRIZA
Danish: Hvis du har glemt at tage CONBRIZA
English: Cerebrovascular effects
Danish: Cerebrovaskulære virkninger
English: PVC/Aclar blister packs of 7, 28, 30, 84, and 90 film-coated tablets.
Danish: PVC/Aclar-blisterpakninger med 7, 28, 30, 84 og 90 filmovertrukne tabletter.
English: Osteoporosis prevention trial
Danish: Osteoporose-forebyggelsesforsøget
English: Studies in rats have shown adverse effects on fertility (see section 5.3).
Danish: Forsøg med rotter har vist uønskede virkninger på fertilitet (se pkt.
English: The treatment effect was similar among those with and without prevalent vertebral fractures (Table 1).
Danish: Behandlingseffekten var sammenlignelig for forsøgsdeltagere med og forsøgsdeltagere uden prævalente udbredte vertebrale frakturer (tabel 1).
English: In a 30-day study, bazedoxifene increased hormone-binding globulin concentrations, including corticosteroid-binding globulin (CBG), sex hormone-binding globulin (SHBG) and thyroxine-binding globulin (TBG).
Danish: I en 30-dages undersøgelse øgede bazedoxifen koncentrationerne af hormonbindende globulin, herunder kortikosteroidbindende globulin (CBG), kønshormonbindende globulin (SHBG) og thyroxinbindende globulin (TBG).
English: If you stop taking CONBRIZA
Danish: Hvis du holder op med at tage CONBRIZA
English: Impaired renal function showed little or no influence on bazedoxifene pharmacokinetics, and no dosing adjustment is required.
Danish: Nedsat nyrefunktion havde kun ringe eller ingen indflydelse på bazedoxifens farmakokinetik, og dosisjustering er ikke nødvendig.
English: The treatment effect on lipids was similar in the osteoporosis prevention study.
Danish: Behandlingens virkning på lipider var tilsvarende i osteoporose-forebyggelsesforsøget.
English: The majority of adverse reactions occurring during the clinical trials were mild to moderate in severity and did not lead to discontinuation of therapy.
Danish: Sværhedsgraden af de fleste af de bivirkninger, der forekom under de kliniske forsøg, var let til moderat og medførte ikke seponering af behandlingen.
English: Elderly patients No dose adjustment is necessary based on age (see section 5.2).
Danish: Ældre patienter Dosisjustering på grund af alder er ikke nødvendig (se pkt.
English: Patients with hepatic impairment showed a 4.3-fold increase in area under the curve (AUC) [on average] compared with controls.
Danish: Patienter med nedsat leverfunktion viste en stigning på [gennemsnitligt] 4,3 gange i arealet under kurven (AUC) sammenlignet med kontrolgrupperne.
English: Other medicines and CONBRIZA
Danish: Brug af anden medicin sammen med CONBRIZA
English: Effects on thyroid and ovarian malignancies
Danish: Virkning på thyroidea- og ovariecancer
English: No dose adjustment is necessary based on age.
Danish: Dosisjustering på grund af alder anbefales ikke.
English: Negligible amounts of bazedoxifene were eliminated in urine.
Danish: Minimale mængder bazedoxifen blev udskilt i urinen.
English: The increases in BMD relative to placebo remained statistically significant at all skeletal sites throughout the 5 years of treatment with bazedoxifene.
Danish: Stigningerne i BMD sammenlignet med placebo vedblev at være statistisk signifikante i på alle skeletområder gennem de 5 års behandling med bazedoxifen.
English: Bazedoxifene has not been studied in premenopausal women.
Danish: Bazedoxifen er ikke blevet undersøgt hos præmenopausale kvinder.
English: The most frequent drug-related adverse reactions in double-blind, randomised studies were hot flushes and muscle spasms (includes leg cramps).
Danish: De hyppigst forekommende lægemiddelrelaterede bivirkninger i dobbeltblindede, randomiserede forsøg var hedeture og muskelspasmer (herunder kramper i benene).
English: CONBRIZA 20 mg film-coated tablets
Danish: CONBRIZA 20 mg filmovertrukne tabletter
English: Osteoporosis treatment trial
Danish: Osteoporose-behandlingsforsøget
English: Treatment of rats at maternally toxic doses 1 mg/kg/day (0.3 times the human exposure) resulted in reduced numbers of live foetuses and/or reductions in foetal body weights.
Danish: Behandling af rotter med maternelt toksiske doser  1 mg/kg/dag ( 0,3 gange den humane eksponering) resulterede i et lavere antal levende fostre og/eller lavere legemsvægt hos fostrene.
English: What you need to know before you take CONBRIZA
Danish: Det skal du vide, før du begynder at tage CONBRIZA
English: This is because sitting for a long time in the same position may prevent good blood circulation and may increase your risk of blood clots.
Danish: Det bør du gøre, fordi blodomløbet kan hæmmes, når man sidder ned i lang tid i samme stilling, og det kan øge risikoen for blodpropper.
English: There were no cases on thyroid cancer in the 40 mg treatment group up to 5 years.
Danish: Der var ingen tilfælde af thyroideacancer i 40 mg-behandlingsgruppen efter op til 5 år.
English: Effects on the breast
Danish: Virkning på brystet
English: In a post-hoc analysis, the 10-year fracture probability as an index of baseline fracture risk was determined.
Danish: I en post hoc-analyse blev 10-års-sandsynligheden for fraktur bestemt som et indeks af risikoen for fraktur ved baseline.
English: Allergic reaction (including hypersensitivity and urticaria) Rash, itching
Danish: Allergiske reaktioner (inklusive overfølsomhed og nældefeber) Udslæt, kløe
English: In clinical trials, the highest rate of VTE was observed during the first year of treatment, with a relative risk of 2.69 compared to placebo.
Danish: I kliniske forsøg blev den højeste VTE-rate observeret i det første behandlingsår med en relativ risiko på 2,69 sammenlignet med placebo.
English: When determining the choice of CONBRIZA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Danish: Når der for den enkelte postmenopausale kvinde skal vælges mellem CONBRIZA eller andre behandlinger, herunder østrogen, skal menopausale symptomer, virkning på uterint væv og brystvæv samt kardiovaskulære fordele og ulemper tages med i overvejelserne (se pkt.
English: Urticaria, rash, pruritus
Danish: subkutane væv udslæt, pruritus
English: a of subjects with ≥1 new vertebral fracture Kaplan-Meier rate estimates p-value=0.015
Danish: a forsøgsdeltagere med ≥ 1 ny vertebral fraktur Kaplan-Meier hyppighedsestimater p-værdi = 0,015 p-værdi = 0,22 p-værdi = 0,035
English: Latvijā Pfizer Luxembourg SARL filiāle Latvijā
Danish: Pfizer Luxembourg SARL filialas Lietuvoje
English: Bazedoxifene decreases bone resorption and reduces biochemical markers of bone turnover to the premenopausal range.
Danish: Bazedoxifen nedsætter knogleresorption og reducerer biokemiske markører for knogleomsætning til det præmenopausale område.
English: Female rats were administered daily doses of 0.3 to 30 mg/kg (0.03 to 8 times the human exposure) prior to and during mating with untreated males.
Danish: Hunrotter fik administreret daglige doser på 0,3 til 30 mg/kg (0,03 til 8 gange den humane eksponering) før og under parring med ubehandlede hanrotter.
English: When single doses of 20 mg bazedoxifene were administered with a high-fat meal, Cmax and AUC increased by 28% and 22%, respectively.
Danish: Når bazedoxifen blev administreret i enkeltdoser på 20 mg sammen med et fedtrigt måltid, steg Cmax og AUC med henholdsvis 28 % og 22 %.
English: An additional study evaluating the effects of a standardized medium-fat meal on the pharmacokinetics of bazedoxifene at steady-state showed a 42% and 35% increase in Cmax and AUC, respectively, when 20 mg bazedoxifene was administered with food.
Danish: Et yderligere forsøg med henblik på at vurdere virkningen af et standardiseret mellemfedt måltid på bazedoxifens farmakokinetik ved steady state viste en stigning på 42 % og 35 % i henholdsvis Cmax og AUC ved administration af 20 mg bazedoxifen sammen med et måltid.
English: In a post-hoc analysis, the relative risk of non-vertebral fractures in bazedoxifene-treated subjects decreased with increased fracture probability.
Danish: I en post hoc-analyse faldt den relative risiko for non-vertebrale frakturer hos bazedoxifen-behandlede forsøgsdeltagere med øget fraktursandsynlighed.
English: On average, patients with hepatic impairment showed a 4.3-fold increase in AUC compared with controls.
Danish: Patienter med nedsat leverfunktion viste i gennemsnit en stigning i AUC på 4,3 sammenlignet med kontrolgrupperne.
English: Vision disorders/Ocular events
Danish: Synsforstyrrelser/okulære hændelser