FrancophonIA/ELRC3.0 huggingface dataset:
English: The partial preservation of bone mass was achieved by reductions in the ovariectomy-induced increases in bone turnover, evaluated by biochemical markers of bone turnover and histomorphometric indices measured in cancellous and cortical bone.
Danish: Den delvise bevarelse af knoglemassen blev opnået ved en reduktion i den ooforektomi-inducerede stigning i knogleomsætningen, som blev evalueret ved biokemiske markører for knogleomsætning og histomorfometriske indekser målt i spongiøs og kortikal knogle.
English: There was no evidence of osteomalacia, peritrabecular or marrow fibrosis, cellular toxicity or woven bone in any of the bone-biopsy specimens in any of the treatment groups.
Danish: Der var ingen tegn på osteomalaci, peritrabekulær fibrose- eller marvfibrose, celletoksicitet eller ikke-lamellær knogle i nogen af knoglebiopsiprøverne hos nogen af behandlingsgrupperne.
English: Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Danish: Aktiv eller tidligere anamnese med venøse tromboemboliske hændelser, herunder dyb venetrombose, lungeemboli og retinal venetrombose.
English: If you feel drowsy after taking this medicine, you should avoid driving or operating machines.
Danish: Hvis du føler dig døsig efter at have taget dette lægemiddel, skal du undgå at køre bil eller motorcykel, lade være med at cykle og lade være med at arbejde med værktøj eller maskiner.
English: Bazedoxifene functions primarily as an oestrogen-receptor antagonist in uterine and breast tissues.
Danish: Bazedoxifen fungerer primært som en østrogenreceptorantagonist i uterint væv og brystvæv.
English: Bazedoxifene undergoes little or no cytochrome P450 (CYP)-mediated metabolism.
Danish: Bazedoxifen gennemgår en ringe eller ingen cytokrom P450 (CYP)-medieret metabolisme.
English: If you have signs of a blood clot in the legs or lungs, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing;
Danish: Hvis du får symptomer på en blodprop i benene eller lungerne, f.eks. smertefulde hævelser og rødme på benene, pludselige brystsmerter eller vejrtrækningsbesvær.
English: The disposition of a single 20 mg dose of bazedoxifene was compared in patients 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 bazedoxifen 20 mg, enkeltdosis, blev sammenlignet hos patienter med nedsat leverfunktion [Child-Pugh-klasse A (n=6), B (n=6) og C (n=6)] og forsøgsdeltagere med normal leverfunktion (n=18).
English: if you have any unexplained vaginal bleeding.
Danish: hvis du har en uforklaret blødning fra skeden.
English: The mean 10-year fracture probability of a major osteoporotic fracture for the entire study population was 11%.
Danish: For hele forsøgspopulationen var den gennemsnitlige 10-års-sandsynlighed for en omfattende osteoporose-fraktur 11 %.
English: The other ingredients are lactose monohydrate (see section 2 “CONBRIZA contains lactose”), microcrystalline cellulose, pre-gelatinised starch (maize), sodium starch glycolate, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide (E171) and macrogol 400.
Danish: - Øvrige indholdsstoffer: Lactosemonohydrat (se punkt 2 ”CONBRIZA indeholder lactose”) mikrokrystallinsk cellulose, prægelatineret stivelse (majs), natriumstivelsesglycolat, natriumlaurilsulfat,kolloid vandfri silica, magnesiumstearat, ascorbinsyre, hypromellose, titandioxid (E171) og macrogol 400.
English: The pharmacokinetics of a 20 mg single-dose of bazedoxifene were evaluated in a study in 26 healthy postmenopausal women.
Danish: Farmakokinetikken for bazedoxifen 20 mg, enkeltdosis, blev evalueret i et forsøg med 26 raske postmenopausale kvinder.
English: Repeated-dose studies in normally cycling rodents and cynomolgus monkeys revealed a marked stimulation of ovarian follicle growth without ovulation, leading to partly haemorrhagic-ovarian cysts and markedly elevated estradiol levels.
Danish: Forsøg med gentagne doser hos gnavere med normal cyklus og cynomolgusaber viste en tydelig stimulering af follikelvækst i ovariet uden ægløsning, hvilket medførte delvist hæmorragiske ovariecyster og tydeligt forhøjede østradiolniveauer.
English: Use of CONBRIZA is not recommended in women at an increased risk for venous thromboembolic events.
Danish: Anvendelse af CONBRIZA hos kvinder med øget risiko for venøse tromboemboliske hændelser anbefales ikke.
English: There was one case of ovarian cancer in the 40 mg treatment group up to 5 years.
Danish: Der var 1 tilfælde af ovariecancer i 40 mgbehandlingsgruppen efter op til 5 år.
English: Blood triglycerides increased, alanine aminotransferase increased, aspartate aminotransferase increased.
Danish: Forhøjet indhold af triglycerider i blodet, forhøjet alaninaminotran sferase, forhøjet aspartataminotra nsferase
English: There have been post-marketing reports of ocular events other than retinal vein thrombosis.
Danish: Efter markedsføring er der rapporteret om okulære bivirkninger ud over retinal venetrombose.
English: Similar reductions in the rate of bone turnover have been observed in the osteoporosis prevention study.
Danish: Lignende fald i knogleomsætningen er blevet observeret i osteoporose-forebyggelsesforsøget.
English: The effects of bazedoxifene treatment on bone, uterus, and mammary gland were assessed in ovariectomized rats (0.15 to 1.5 mg/kg/day) and non-human primates [Cynomolgus macaques] (0.2 to 25.0 mg/kg/day).
Danish: Bazedoxifen-behandlingens virkninger på knogler, uterus og brystkirtler blev vurderet hos ooforektomerede rotter (0,15 til 1,5 mg/kg/dag) og ikke-menneskeaber [Cynomolgus macaques] (0,2 til 25,0 mg/kg/dag).
English: Bazedoxifene acts as both an oestrogen-receptor agonist and/or antagonist, depending upon the cell and tissue type and target genes.
Danish: Bazedoxifen virker som en østrogenreceptoragonist og/eller som en østrogenreceptorantagonist afhængigt af celle- og vævstype og mål-gener.
English: The metabolic disposition of bazedoxifene in postmenopausal women has been determined following oral administration of 20 mg of radio-labelled bazedoxifene.
Danish: Bazedoxifens metaboliske fordeling hos postmenopausale kvinder er blevet bestemt efter peroral administration af 20 mg radioaktivt mærket bazedoxifen.
English: CONBRIZA contains lactose
Danish: CONBRIZA indeholder lactose
English: The observation of benign, ovarian granulosa-cell tumours in female mice and rats administered bazedoxifene is a class effect of SERMs, related to its pharmacology in rodents when treated during their reproductive lives, when their ovaries are functional and responsive to hormonal stimulation.
Danish: Observationen af benigne granulosa-celletumorer i ovarierne hos hunmus og hunrotter, som fik administreret bazedoxifen, er en klasseeffekt af SERM, der er forbundet med bazedoxifens farmakologi hos gnavere ved behandling i den reproduktive del af deres liv, når deres ovarier fungerer og responderer på hormonal stimulering.
English: Do not store above 25ºC.
Danish: Må ikke opbevares ved temperaturer over 25ºC.
English: Systemic exposure (AUC) of bazedoxifene in these groups was 2.6 and 6.6 times that observed in postmenopausal women administered 20 mg/day for 14 days.
Danish: Den systemiske eksponering (AUC) for bazedoxifen hos disse grupper var 2,6 og 6,6 gange større end eksponeringen hos postmenopausale kvinder, som fik administreret 20 mg/dag i 14 dage.
English: Bazedoxifene belongs to a class of compounds known as selective estrogen receptor modulators (SERMs).
Danish: Bazedoxifen tilhører en klasse af stoffer, der går under betegnelsen selektive østrogenreceptormodulatorer (SERM).
English: In subjects with a fracture probability of 20% or greater (n = 618), the risk of non-vertebral fractures in bazedoxifene-treated subjects was decreased by 55% (95% CI: 18-76) compared to placebo-treated subjects.
Danish: Hos forsøgsdeltagere med en fraktursandsynlighed på 20 % eller derover (n = 618) faldt risikoen for non-vertebrale frakturer hos bazedoxifenbehandlede forsøgsdeltagere med 55 % (95 %-CI: 18-76) sammenlignet med placebo-behandlede deltagere.
English: In the breast-density study, an ancillary study of the osteoporosis treatment study, 444 postmenopausal women (mean age = 59 years) with osteoporosis from all 4 treatment groups, were evaluated for mammographic breast density changes at 24 months.
Danish: I forsøget med brysttæthed, som var et supplerende forsøg til osteoporosebehandlingsforsøget, blev 444 postmenopausale kvinder (gennemsnitsalder = 59 år) med osteoporose fra alle 4 behandlingsgrupper vurderet med henblik på mammografiske ændringer i brysttæthed efter 24 måneder.
English: Bazedoxifene was not genotoxic or mutagenic in a battery of tests, including in vitro bacterial reverse mutation assay, in vitro mammalian cell forward mutation assay at the thymidine kinase (TK±) locus in L5178Y mouse lymphoma cells, in vitro chromosome aberration assay in Chinese hamster ovary (CHO) cells, and in vivo mouse micronucleus assay.
Danish: Bazedoxifen var ikke genotoksisk eller mutagent i en række test, herunder bakteriel omvendt mutationsanalyse in vitro, fremadrettet mutationsanalyse in vitro med celler fra pattedyr på thymidinkinase (TK±) locus i L5178Y-lymfomceller fra mus, kromosomaberrationsanalyse in vitro på ovarieceller fra kinesisk hamster (CHO), og mikronukleusanalyse in vivo på mus.
English: The median percent change from baseline of total cholesterol, LDL cholesterol and HDL cholesterol with bazedoxifene 20 mg were -3.75%, -5.36% and 5.10%, respectively, and were similar to that observed with raloxifene 60 mg.
Danish: Den mediane procentvise ændring af samlet kolesterol, LDL-kolesterol og HDL-kolesterol med bazedoxifen 20 mg i forhold til baseline var henholdsvis -3,75 %, -5,36 % og 5,10 % og var sammenlignelig med værdien for raloxifen 60 mg.
English: Median reductions from baseline over 25% for C-telopeptide and osteocalcin were observed with bazedoxifene therapy.
Danish: I forbindelse med bazedoxifen-behandling blev der for C-telopeptid og osteocalcin observeret mediane fald på over 25 % sammenlignet med baseline.
English: If this happens, you should avoid driving or operating machines until your doctor tells you that it is safe to do so.
Danish: Hvis det sker, må du ikke køre bil eller motorcykel eller arbejde med værktøj eller maskiner, før du har talt med din læge, om det er sikkert at gøre det.
English: Very common(may affect more than 1 in 10 people):
Danish: Meget almindelige(det sker hos flere end 1 ud af 10 patienter)
English: In rats, treatment with bazedoxifene for approximately one year partially prevented the effects of ovariectomy on numerous skeletal parameters (bone mineral content, bone mineral density, and architecture).
Danish: Hos rotter forebyggede bazedoxifen-behandling i ca. ét år delvist virkningerne af ooforektomi på flere parametre for bevægeapparatet (knoglemineralindhold, knoglemineraltæthed, knoglearkitektur).
English: Oestrous cycles and fertility were adversely affected in all bazedoxifene-treated female groups.
Danish: Brunstperioder og fertilitet blev påvirket negativt i alle bazedoxifen-behandlede hungrupper.
English: After 7 year study period the relative risk was 1.51 (see section 5.1).
Danish: Efter 7 års-forsøgsperioden var den relative risiko 1,51 (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS AND STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
English: In the osteoporosis treatment study, the incidence of breast-related adverse events in the bazedoxifene group was similar to placebo at 3 years.
Danish: I osteoporose-behandlingsforsøget var incidensen af brystrelaterede bivirkninger hos bazedoxifengruppen sammenlignelig med incidensen i placebogruppen ved 3 år.
English: Importantly, in both species, the administration of bazedoxifene had no deleterious effects on bone quality.
Danish: Først og fremmest havde administration af bazedoxifen ingen skadelige virkninger på knoglekvaliteten hos nogen af de to arter.
English: This study included mostly Caucasian (87.3%) subjects who were either osteoporotic without baseline vertebral fracture (BMD T-score at lumbar spine [LS] or femoral neck [FN] between -2.5 and -4.0) or osteoporotic, with at least 1 mild baseline vertebral fracture.
Danish: I forsøget indgik overvejende kaukasiske (87,3 %) forsøgsdeltagere, som havde enten osteoporose uden vertebral fraktur ved baseline (BMD T-score ved columna lumbalis eller collum femoris på mellem -2,5 og -4,0) eller osteoporose med mindst en mild vertebral fraktur ved baseline.
English: Patients may experience visual symptoms such as visual acuity disturbance or blurred vision.
Danish: Patienter kan opleve synsforstyrrelser som f.eks. nedsat synsskarphed eller sløret syn.
English: Little or no cytochrome P450-mediated metabolism is evident.
Danish: Kun ringe eller ingen cytokrom P450-medieret metabolisme er påvist.
English: Systemic exposure (AUC) to bazedoxifene in these groups was 35 and 69 times that in postmenopausal women administered 20 mg/day for 14 days.
Danish: Den systemiske eksponering (AUC) for bazedoxifen hos disse grupper var 35 og 69 gange større end eksponeringen hos postmenopausale kvinder, som fik administreret 20 mg/dag i 14 dage.
English: This medicine should be taken with an adequate amount of calcium and vitamin D. Consult your doctor to see if your dietary calcium and vitamin D intake is adequate and whether you need calcium and vitamin D supplementation.
Danish: Spørg din læge for at finde ud af, om dit indtag af calcium og D-vitamin via kosten er tilstrækkeligt, og om du har brug for supplerende calcium og D-vitamin.
English: Paediatric population The pharmacokinetics of bazedoxifene have not been studied in the paediatric population.
Danish: Pædiatrisk population Bazedoxifens farmakokinetik er ikke blevet undersøgt hos den pædiatriske population.
English: In monkeys, treatment with bazedoxifene for 18 months resulted in the partial preservation of cortical and cancellous bone mass as determined by BMD measurements.
Danish: Hos aber resulterede en 18-måneders behandling med bazedoxifen i delvis bevarelse af den kortikale og den spongiøse knoglemasse som bestemt ved måling af BMD.
English: After 7 years of treatment with bazedoxifene the increases in BMD relative to placebo remained statistically significant at the femoral neck, femoral trochanter, and total hip.
Danish: Efter 7 års behandling med bazedoxifen forblev stigningerne i BMD at være statistisk signifikante i collum femoris, trochanter femoris og hele hoften sammenlignet med placebo.
English: There was a significant reduction in the incidence of new vertebral fractures after 3 years of treatment with bazedoxifene 20 mg (42%), bazedoxifene 40 mg (37%) and raloxifene 60 mg (42%) compared to placebo.
Danish: Der var en signifikant reduktion i incidensen af nye vertebrale frakturer efter 3 års behandling med bazedoxifen 20 mg (42 %), bazedoxifen 40 mg (37 %) og raloxifen 60 mg (42 %) sammenlignet med placebo.
English: Bazedoxifene is rapidly absorbed with a tmax of approximately 2 hours and exhibits 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.
Danish: Bazedoxifen absorberes hurtigt med en tmax på ca. 2 timer og udviser en lineær stigning i plasmakoncentrationer ved enkeltdoser fra 0,5 mg op til 120 mg og multiple daglige doser fra 1 mg til 80 mg. Bazedoxifens absolutte biotilgængelighed er ca. 6 %.
English: In a 2-year carcinogenicity study in rats, an increased incidence of benign, ovarian granulosa-cell tumours was observed in female rats at dietary concentrations of 0.03 and 0.1%.
Danish: I et 2-årigt karcinogenicitetsforsøg med rotter blev der observeret en øget incidens af benigne granulosa-celletumorer i ovarierne hos hunrotter ved koncentrationer i kosten på 0,03 og 0,1 %.
English: Tlf: +47 67 526 100
Danish: Pfizer AS Tlf:+47 67 526 100
English: Mean changes in mammographic breast density in the bazedoxifene 20 mg group were significantly reduced from baseline (-1.45 percentage points, p<0.05) while no changes were observed in the placebo group (-0.15 percentage points).
Danish: Gennemsnitsændringerne i mammografisk brysttæthed i bazedoxifen 20 mg-gruppen var signifikant reduceret i forhold til baseline (-1,45 procentpoint, p<0,05), mens der ikke blev observeredet nogen ændringer i placebo-gruppen (-0,15 procentpoint).
English: The increase from baseline in lumbar spine BMD at 7 years in the bazedoxifene 20 mg group was not statistically greater than in the placebo group.
Danish: Efter 7 år var stigningen fra baseline i BMD i columna lumbalis i bazedoxifen 20mg-gruppen ikke statistisk højere end i placebogruppen.
English: Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Danish: Hver filmovertrukken tablet indeholder bazedoxifenacetat svarende til 20 mg bazedoxifen.
English: No dose adjustment is required for mild or moderate renally impaired patients.
Danish: Det er ikke nødvendigt at tilpasse dosis hos patienter med let til moderat nedsat nyrefunktion.
English: In order for this medicine to treat osteoporosis, it must be taken daily.
Danish: Dette lægemiddel skal tages hver dag for at behandle knogleskørhed.
English: CONBRIZA 20 mg film-coated tablets Bazedoxifene
Danish: CONBRIZA 20 mg filmovertrukne tabletter Bazedoxifen
English: In 6-month carcinogenicity studies in transgenic mice, there was an increased incidence of benign, ovarian granulosa-cell tumours in female mice given 150 or 500 mg/kg/day.
Danish: I 6-måneders karcinogenicitetsforsøg med transgene mus var der øget incidens af benigne granulosacelletumorer i ovarierne hos hunmus, der fik 150 eller 500 mg/kg/dag.
English: The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs, such as rifampicin, phenobarbital, carbamazepine, and phenytoin, potentially leading to decreased systemic concentrations of bazedoxifene.
Danish: Metabolisering af bazedoxifen kan øges ved samtidig anvendelse af lægemidler, der er kendt for at inducere UGT'er, såsom rifampin, phenobarbital, carbamazepin og phenytoin.
English: If you have signs of a blood clot in the eye (retinal vein), such as one sided visual disturbance or visual impairment or blurring or loss of vision in one eye.
Danish: Hvis du får symptomer på en blodprop i øjet (i nethindens blodkar), f.eks. ensidige synsforstyrrelser eller forringet syn eller sløret syn eller synstab på ét øje.
English: Bazedoxifene caused corticomedullar nephrocalcinosis and enhanced spontaneous chronic progressive nephropathy (CPN) in male rats.
Danish: Bazedoxifen forårsagede kortikomedullær nefrocalcinose og øgede spontan kronisk progressiv nefropati hos hanrotter.
English: These reports include visual acuity reduced, blurred vision, photopsia, visual field defect, visual impairment, dry eye, eyelid oedema, blepharospasm, eye pain and eye swelling.
Danish: Disse rapporter omfatter nedsat synsskarphed, sløret syn, fotopsi, synsfeltforstyrrelser, unormalt syn, tørre øjne, øjenlågsødem, blefarospasme, smerter i øjnene, hævede øjne.
English: Lactose monohydrate Microcrystalline cellulose Pregelatinised starch (maize) Sodium starch glycolate Sodium lauryl sulfate
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Prægelatineret stivelse (majs) Natriumstivelsesglycolat Natriumlaurilsulfat Kolloid vandfri silica Magnesiumstearat Ascorbinsyre
English: The effect on triglycerides in the bazedoxifene 20 mg and raloxifene 60 mg groups was similar to placebo.
Danish: Virkningen på triglycerider hos bazedoxifen 20 mg- og raloxifen 60 mg-grupperne var sammenlignelig med virkningen hos placebo-gruppen.
English: The safety of CONBRIZA has been evaluated in two multicentre, double-blind, randomised, placeboand active-control, Phase 3 trials: 7,492 evaluable postmenopausal women in a three-year osteoporosis treatment trial (1,886 women received bazedoxifene 20 mg; 1,872 women received bazedoxifene 40 mg; 1,849 women received raloxifene; 1,885 women received placebo) and 1,583 evaluable postmenopausal women in a 2-year osteoporosis prevention trial (321 women received bazedoxifene 10 mg; 322 women received bazedoxifene 20 mg; 319 women received bazedoxifene 40 mg; 311 women received raloxifene; 310 women received placebo).
Danish: Sikkerheden ved CONBRIZA er blevet evalueret i to dobbeltblindede, randomiserede, placebo- og aktivt kontrollerede, multicenter-, fase 3-forsøg: et treårigt osteoporose-behandlingsforsøg med 7.492 evaluerbare postmenopausale kvinder (1.886 kvinder fik bazedoxifen 20 mg, 1.872 kvinder fik bazedoxifen 40 mg, 1.849 kvinder fik raloxifen, og 1.885 kvinder fik placebo) og et toårigt osteoporose-forebyggelsesforsøg med 1.583 evaluerbare postmenopausale kvinder (321 kvinder fik bazedoxifen 10 mg, 322 kvinder fik bazedoxifen 20 mg, 319 kvinder fik bazedoxifen 40 mg, 311 kvinder fik raloxifen, og 310 kvinder fik placebo).
English: Effects on lipid metabolism and cardiovascular system In the osteoporosis treatment study after 3 years of treatment, bazedoxifene 20 mg and raloxifene 60 mg exhibited significant reductions in serum total cholesterol, low-density lipoprotein (LDL) cholesterol and a significant increase in high-density lipoprotein (HDL) cholesterol compared to placebo.
Danish: Virkning på lipidmetabolismen og det kardiovaskulære system I osteoporose-behandlingsforsøget viste bazedoxifen 20 mg og raloxifen 60 mg efter 3 års behandling signifikante fald i det samlede kolesterolindhold i serum, lavdensitetslipoprotein (LDL)-kolesterol og en signifikant stigning i højdensitetslipoprotein (HDL)-kolesterol sammenlignet med placebo.
English: After 3 years the relative risk was 1.63 and after a 5 year study period the relative risk was 1.50.
Danish: Efter 3 år var den relative risiko 1,63 og efter en 5-års forsøgsperiode 1,50 (se pkt.
English: In an 18-month bone efficacy study in aged ovariectomized cynomolgus monkeys, bazedoxifene, administered orally to monkeys at dosages of 0, 0.2, 0.5, 1, 5, or 25 mg/kg/day, resulted in exposures, based on surface area (mg/m2) of approximately 0.2 to 24 times the clinical dose of 20 mg. Renal cell carcinomas were observed in this study.
Danish: I en 18-måneders undersøgelse af effekten på knoglerne hos gamle cynomolgusaber uden æggestokke blev bazedoxifen administreret oralt til aberne i doser på 0, 0,2, 0,5, 1, 5 eller 25 mg/kg/dag, og resultatet var eksponeringer - baseret på overfladeareal (mg/m2) - på cirka 0,2 til 24 gange den kliniske dosis på 20 mg. Nyrecellecancer blev set i denne undersøgelse.
English: The increase in LS BMD with bazedoxifene 20 mg and raloxifene 60 mg, compared with placebo, was significant at 6 months (1.14% and 1.26%, respectively) and was maintained through 2 years (1.41% and 1.49%, respectively).
Danish: Stigningen i BMD i columna lumbalis med bazedoxifen 20 mg og raloxifen 60 mg sammenlignet med placebo var signifikant ved 6 måneder (henholdsvis 1,14 % og 1,26 %), og den blev opretholdt gennem 2 år (henholdsvis 1,41 % og 1,49 %).
English: Dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids).
Danish: Tørre øjne, øjensmerter, nedsat synsskarphed, synsforringelse, unormal, ufrivillig blinken eller muskelsammentrækninger i øjenlågene (blefarospasme).
English: It is contraindicated in women of child-bearing potential (see section 4.3).
Danish: Det er kontraindiceret til kvinder i den fertile alder (se pkt.
English: BMD was preserved in bazedoxifene 20 mg and raloxifene 60 mg-treated subjects, while significant loss in BMD was observed in patients receiving placebo.
Danish: BMD blev opretholdt hos forsøgsdeltagere, der blev behandlet med bazedoxifen 20 mg og raloxifen 60 mg, mens der blev observeret signifikante BMD-tab hos patienter, der fik placebo.
English: Discontinuation from the study was required when excessive bone loss or incident vertebral fractures occurred.
Danish: Det var påkrævet at afbryde forsøget i de tilfælde, hvor der forekom et usædvanligt stort knogletab eller der pludselig opstod vertebrale frakturer.