FrancophonIA/ELRC3.0 huggingface dataset:
English: The binding affinities of the major circulating metabolites of lasofoxifene were at least 31-fold and 18fold less than those of lasofoxifene for the estrogen receptor alpha and the estrogen receptor beta, respectively, indicating that these metabolites are unlikely to contribute to the pharmacologic activity of lasofoxifene.
Danish: Bindingsaffiniteter for de vigtigste cirkulerende metabolitter af lasofoxifen var mindst henholdsvis 31 og 18 gange mindre end bindingsaffiniteten for lasofoxifen til østrogenreceptor alpha og østrogenreceptor beta.
English: Common adverse reactions considered to be related to FABLYN therapy were muscle spasms, hot flush and vaginal discharge.
Danish: Almindelige bivirkninger relateret til Fablyn var muskeltrækninger, hedeture og vaginalt udflåd.
English: There were 0.48 events/100 patient years in the placebo group and 0.36 events/100 patient years among FABLYN-treated patients (HR = 0.75; 95% CI 0.51, 1.10, p = 0.140).
Danish: Der var 0,48 hændelser/100 patientår i placebo-gruppen og 0,36 hændelser/100 patientår blandt Fablyn-behandlede patienter (HR = 0,75; 95 % CI 0,51; 1,10 p = 0,140).
English: MARKETING AUTHORISATION NUMBER EU/1/08/500/001
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/08/500/001
English: To assess bone quality, bone biopsies were obtained from 71 postmenopausal women enrolled in BMD trials after 2 years of treatment.
Danish: For at vurdere knoglekvaliteten, blev der efter 2 års behandling taget knoglebiopsier fra 71 postmenopausale kvinder.
English: • Decreased pulse in feet, bruising
Danish: • Nedsat puls i fødderne, blå mærker
English: Venous Thromboembolic Events: The most serious adverse reaction related to FABLYN was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis).
Danish: Venøse Tromboemboliske hændelser (VTE): Den alvorligste bivirkning relateret til Fablyn var VTE (dyb venetrombose, lungeemboli og retinal venetrombose).
English: Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Danish: Aktuelle eller tidligere venøse tromboemboliske hændelser, herunder dyb venetrombose, lungeemboli og retinal venetrombose.
English: • if you have severe liver disease.
Danish: De har en alvorlig leversygdom.
English: • Dry mouth, flatulence (excessive amount of air or gases in the stomach or the intestine),
Danish: • Mundtørhed, luftafgang fra tarmen (meget luft i maven eller tarmen), mavepine
English: It is not known whether lasofoxifene is excreted in human milk.
Danish: Det vides ikke, om lasofoxifen udskilles i modermælken.
English: In fertility studies conducted in rats with lasofoxifene, slight effects on male reproductive performance occurred at ≥10 mg/kg/day (approximately 42 times the AUC in humans) as evidenced by decreases in copulation index, implantation sites, and fetuses sired.
Danish: I fertilitets-undersøgelser med rotter sås en lille påvirkning af hannernes reproduktive ydeevne ved doser ≥10 mg/kg/dag (ca. 42 gange AUC hos mennesker), hvilket kom til udtryk i en nedsættelse af parringsindeks, implantationssteder og fostre.
English: Increased incidence of imperforate anus, hypoplastic tail, edema and limb flexures noted in fetuses of pregnant rats dosed at 100 mg/kg (approximately 400 times the AUC in humans) were associated with increased embryo-fetal lethality and generalized failure to thrive.
Danish: En øget forekomst af analatresi, hypoplasti af halen, ødemer og fleksur af ekstremiteter blev observeret hos fostre af gravide rotter, der havde fået doser på 100 mg/kg (ca. 400 gange AUC hos mennesker), og var forbundet med en øget embryo-føtal letalitet og generel mistrivsel.
English: The expiry date refers to the last day of that month.
Danish: Brug ikke FABLYN efter den udløbsdato, der står på Udløbsdatoen (Exp) er den sidste dag i den nævnte måned..
English: What FABLYN looks like and contents of the pack FABLYN tablets are triangular, peach coloured, film-coated tablets marked with “Pfizer” on one side and “OPR 05” on the other.
Danish: FABLYN er en trekantet, ferskenfarvet, filmovertrukken tablet mærket med “Pfizer” på den ene side og “OPR 05” på den anden side.
English: These included, in some subjects, a small excess in the incidence of vaginal bleeding as well as endometrial cystic change viewed on ultrasound and histological benign cystic atrophy (a variant of atrophic endometrium).
Danish: Disse omfattede hos visse forsøgspersoner en mindre stigning i forekomsten af vaginalblødning såvel som cystiske endometrieforandringer, set ved ultralydsundersøgelser og histologisk påvist benign cystisk atrofi (en variant af atrofisk endometrium).
English: There were 0.51 events/100 patient-years for FABLYN-treated patients compared to 0.75 events/100 patient-years in placebo-treated patients (HR 0.68; 95% CI 0.50, 0.93, p= 0.016).
Danish: Der var 0,51 hændelser/100 patientår hos Fablyn-behandlede patienter sammenlignet med 0,75 hændelser/100 patientår hos placebobehandlede patienter (HR 0,68; 95 % CI 0,50; 0,93, p= 0,016).
English: • Abnormal or irregular beating of the heart, increased heart rate
Danish: • Unormal eller uregelmæssig hjertebanken, hurtig puls
English: Following oral administration of 14C-labeled lasofoxifene in solution to humans, approximately 72% of the radioactive dose was recovered by day 24 (approximately 66% in feces and 6% in urine).
Danish: Efter oral administration af en opløsning af 14C-mærket lasofoxifen i mennesker genfandtes ca. 72 % af den radioaktive dosis efter 24
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: In clinical trials, FABLYN-treated women had an increased risk of venous thromboembolic events (deep vein thrombosis and pulmonary embolism) compared to placebo.
Danish: I kliniske studier er der set en øget risiko for venøse tromboemboliske hændelser (dyb venetrombose og lungeemboli) hos Fablyn-behandlede kvinder sammenlignet med placebo.
English: Bone histomorphometry
Danish: Knoglehistomorfometri
English: Significantly fewer women experienced multiple radiographic vertebral fractures in the FABLYN treatment group versus the placebo group throughout 5 years of dosing (p < 0.0001).
Danish: I Fablyn gruppen fik signifikant færre kvinder multiple radiografisk verificerede rygsøjlefrakturer sammenlignet med placebogruppen gennem 5 års behandling (p < 0,0001).
English: It belongs to a group of medicines called Selective Estrogen Receptor Modulators (SERM).
Danish: FABLYN hører til den gruppe af ikke-hormonel medicin, der kaldes selektive østrogenreceptor-modulerende stoffer (SERM).
English: PHARMACEUTICAL PARTICULARS
Danish: FARMAKOLOGISKE EGENSKABER
English: FABLYN is used to treat osteoporosis in women after the menopause (postmenopausal osteoporosis) who are likely to break bones, especially in the spine, hips and wrists.
Danish: FABLYN anvendes til behandling af knogleskørhed hos kvinder, der har passeret overgangsalderen (postmenopausal knogleskørhed), og som har øget risiko for knoglebrud, især i rygsøjlen, hofterne eller håndleddene.
English: The duration of treatment in postmenopausal women was 12 months, 124 were exposed to FABLYN and 125 were exposed to placebo.
Danish: I alt 124 kvinder fik Fablyn og 125 fik placebo.
English: Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (> 5.6 mmol/l), lasofoxifene may be associated with a marked increase in serum triglycerides.
Danish: Begrænsede kliniske data tyder på, at lasofoxifen kan være forbundet med en stigning i triglyceridniveauet i serum hos patienter med tidligere oral østrogeninduceret hypertriglyceridæmi (>5,6 mmol/l).
English: The concurrent use of FABLYN and systemic estrogen or hormone therapy has not been studied and therefore concomitant use of FABLYN with systemic estrogens is not recommended.
Danish: Samtidig brug af Fablyn og systemisk behandling med østrogener eller hormoner er ikke undersøgt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains lasofoxifene tartrate, equivalent to 500 micrograms lasofoxifene.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder lasofoxifentartrat, svarende til 500 μg lasofoxifen.
English: • if you have severe kidney disease.
Danish: De har en alvorlig nyresygdom.
English: Common: Aspartate aminotransferase increased Uncommon: Alanine aminotransferase increased, blood glucose increased, smear cervix abnormal,
Danish: Abnormt cervix-smear, forhøjet alanin-aminotransferase, forhøjet blodsukker, forhøjede
English: • Very rare: affects less than 1 user in 10,000
Danish: • Meget sjældne bivirkninger: Forekommer hos færre end 1 ud af 10.000 patienter
English: Rare:
Danish: Ikke almindelig:
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: • Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: Due to the chronic nature of the disease process, FABLYN is intended for long-term use (see section 5.1).
Danish: Fablyn er beregnet til langtidsbrug på grund af sygdommens kroniske natur (se pkt.
English: -Radiographic vertebral fractures
Danish: Radiografisk verificerede rygsøjlefrakturer
English: Very common side effects:
Danish: Meget almindelige bivirkninger:
English: • Dry eye, hair loss, skin rash, night sweats, itching, feeling hot, weight gain
Danish: • Tørre øjne, hårtab, hududslæt, nattesved, kløe, varmefølelse, vægtøgning
English: Within this study, 12.9% of FABLYN-treated women and 12.3% of placebo-treated women discontinued therapy due to adverse events.
Danish: Behandlingen blev seponeret som følge af bivirkninger hos 12,9 % af de Fablyn-behandlede kvinder og 12,3 % af de placebobehandlede kvinder.
English: Oxidation, by multiple cytochrome P450s including CYPs 2D6 and 3A4/5, and conjugation of lasofoxifene are the two primary mechanisms of elimination of lasofoxifene from the systemic circulation.
Danish: Lasofoxifens 2 primære eliminationsveje er oxidering af en række cytochrome P450-systemer, herunder CYP 2D6 og 3A4/5, samt konjugering af lasofoxifen.
English: • Constipation
Danish: • Forstoppelse
English: SUBSTANCE AND MANUFACTURING AUTHORISATION
Danish: Indehaver af markedsføringstilladelsen og fremstiller
English: Table 1 lists adverse reactions occurring in the two osteoporosis treatment clinical trials that occurred at an incidence greater than placebo.
Danish: Tabel 1 indeholder de bivirkninger, der blev set i de to osteoporose-studier med en højere hyppighed blandt Fablyn-behandlede personer end blandt placebo-behandlede personer.
English: All clinical fractures Percentage of patients with clinical fracture n=2,852
Danish: Alle kliniske frakturer Procentdel af patienter med kliniske frakturer n=2852
English: Gender:
Danish: Køn:
English: In women with postmenopausal osteoporosis, FABLYN reduces the risk of both fractures of the spine (vertebral fractures) and non-spine fractures (non-vertebral fractures), but not hip fractures.
Danish: Hos kvinder med knogleskørhed efter overgangsalderen nedsætter FABLYN risikoen for brud i rygsøjlen (vertebrale brud) og brud i arme, ben og håndled, (ikke-vertebrale brud), men ikke hoftebrud.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Take special care with FABLYN
Danish: Vær ekstra forsigtig med at tage FABLYN
English: Rare side effects:
Danish: Sjældne bivirkninger:
English: There was no difference between FABLYN- and placebo-treated women in the incidences of endometrial carcinoma and endometrial hyperplasia.
Danish: Der var ingen forskel i forekomsten af endometriekarcinom og endometriehyperplasi mellem Fablyn- og placebobehandlede kvinder.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains lasofoxifene tartrate, equivalent to 500 microgram lasofoxifene.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder lasofoxifentartrat, svarende til 500 mikrogram lasofoxifen.
English: No dose adjustment for FABLYN is necessary for patients with mild or moderate hepatic insufficiency.
Danish: Dosisjustering af Fablyn er ikke nødvendig hos patienter med mild til moderat leverinsufficiens.
English: It must not be taken by women of child-bearing potential, pregnant women and lactating women (see section 4.6).
Danish: Fablyn må ikke anvendes til kvinder i den fødedygtige alder, gravide eller ammende kvinder (se pkt.
English: Tablet coating:
Danish: Tabletovertræk:
English: The pharmacokinetics of lasofoxifene have not been evaluated in a paediatric population.
Danish: Lasofoxifens farmakokinetik er ikke undersøgt hos børn.
English: FABLYN significantly decreased the incidence of all clinical fractures from 12.1% for placebo to 9.3% for FABLYN (relative risk reduction = 25%, p = 0.0004).
Danish: Fablyn nedsatte signifikant forekomsten af alle kliniske frakturer fra 12,1 % for placebo til 9,3 % for Fablyn (relativ reduktion af risiko = 25 %, p = 0,0004).
English: Non-vertebral fractures Percentage of patients with non-vertebral fracture n=2,852
Danish: Non-vertebrale frakturer Procentdel af patienter med non-vertebrale frakturer n=2852
English: Ear discomfort, inner ear disorder, vertigo positional Cardiac disorders
Danish: Sjælden: Positionel vertigo, sygdom i det indre øre, ubehag i øret Hjerte
English: What FABLYN contains
Danish: FABLYN indeholder:
English: FABLYN significantly decreased the incidence of non-vertebral fractures from 10.4% for placebo to 8.1% for FABLYN (relative risk reduction = 24%, p = 0.0020).
Danish: Fablyn nedsatte signifikant forekomsten af non-vertebrale frakturer fra 10,4 % for placebo til 8,1 % for Fablyn (relativ reduktion af risiko = 24 %, p = 0,0020).
English: The effects of FABLYN on fracture incidence (table 2) were examined through 5 years; and BMD and bone biomarkers in postmenopausal women with osteoporosis were examined through 3 years in the PEARL study.
Danish: BMD og knoglebiomarkører hos postmenopausale kvinder med osteoporose blev undersøgt gennem 3 år i PEARLstudiet.
English: FABLYN significantly decreased the incidence of new radiographic vertebral fractures (excluding worsening of previous fractures) from 9.3% for placebo to 5.6% for FABLYN (relative risk reduction = 41%, p < 0.0001).
Danish: Fablyn nedsatte signifikant forekomsten af nye radiografisk verificerede rygsøjlefrakturer (undtagen forværring af tidligere frakturer) fra 9,3 % for placebo til 5,6 % for Fablyn (relativ reduktion af risiko = 41 %, p < 0,0001).
English: Lactose anhydrous
Danish: Lactosemonohydrat
English: In clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding, in accordance with guidelines for postmenopausal women (see section 4.4).
Danish: Ifølge klinisk praksis og retningslinjer for postmenopausale kvinder, vil disse benigne fund ikke berettige til yderligere undersøgelser hos kvinder uden vaginalblødning (se pkt.
English: Uncommon: Alopecia, erythema, night sweats, pruritus Rare:
Danish: Alopeci, erytem, nattesved, pruritus
English: • Common: affects 1 to 10 users in 100
Danish: • Almindelige bivirkninger: Forekommer hos mellem 1 og 10 ud af 100 patienter
English: Metabolism and nutrition disorders Uncommon: Diabetes mellitus Rare:
Danish: Infektioner og parasitære sygdomme Ikke almindelig:
English: Safety and efficacy of lasofoxifene have not been evaluated in patients with hepatic insufficiency with liver function test > 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
Danish: Sikkerhed og effekt af lasofoxifen er ikke undersøgt hos patienter med leverinsufficiens med leverfunktionstest >1,5 ULN.
English: Chest discomfort, feeling drunk, hyperthermia, inflammation, mass, oedema, polyp Investigations
Danish: Sjælden: Følelse af beruselse, hypertermi, inflammation, polyp, thorakalt ubehag, udfyldning, ødem Undersøgelser
English: • Very common: affects more than 1 user in 10
Danish: • Meget almindelige bivirkninger: Forekommer hos flere end 1 ud af 10 patienter.
English: Safety and efficacy of FABLYN have not been evaluated in patients with liver function test > 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
Danish: Sikkerhed og effekt af Fablyn er ikke undersøgt hos patienter med leverfunktionstest >1,5 ULN.
English: Within this study, 3.2% of FABLYN-treated women and 8.0% of placebo-treated women discontinued therapy due to adverse events.
Danish: Behandlingen blev seponeret som følge af bivirkninger hos 3,2 % af de Fablyn-behandlede og 8,0 % af de placebobehandlede kvinder.
English: In women with a prevalent vertebral fracture at baseline, FABLYN significantly reduced the incidence of new vertebral radiographic fractures from 14.2% for placebo to 8.7% for FABLYN (relative risk reduction = 42%, p = 0.0004).
Danish: Hos kvinder med en prævalent rygsøjlefraktur ved baseline reducerede Fablyn signifikant forekomsten af nye radiografisk verificerede rygsøjlefrakturer fra 14,2 % for placebo til 8,7 % for Fablyn (relativ reduktion af risiko = 42%, p = 0,0004).
English: In women without any prevalent vertebral fractures at baseline, the incidence of new radiographic vertebral fractures was significantly reduced from 7.4% for placebo to 4.4% for FABLYN (relative risk reduction = 41%, p = 0.0002).
Danish: Hos kvinder uden prævalent rygsøjlefraktur ved baseline var forekomsten af nye radiografisk verificerede rygsøjlefrakturer signifikant reduceret fra 7,4 % for placebo til 4,4% for Fablyn (relativ reduktion af risiko = 41 %, p = 0,0002).
English: • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: • Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: As a consequence of these benign effects, more FABLYN-treated patients had a diagnostic uterine procedure compared to placebo-treated patients in the PEARL trial (see section 5.1).
Danish: Disse cystiske fund medførte en forøgelse af den gennemsnitlige endometrietykkelse på ca. 1,5 mm. Som følge af disse benigne påvirkninger fik flere Fablyn-behandlede end placebo-behandlede patienter foretaget en diagnostisk undersøgelse af uterus under PEARL-studiet (se pkt.
English: • Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs.
Danish: • På baggrund af de kliniske studier er de morfologiske forandringer, forårsaget af FABLYN,
English: Arthritis infective, bronchitis, cellulitis, cervicitis, diverticulitis, fungal infection, furuncle, genital candidiasis, herpes simplex ophthalmic, impetigo, labyrinthitis,
Danish: Sjælden: Bronkitis, cellulitis, cervicitis, diverticulit, furunculus, genital candidiasis, herpes simplex,
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 7 tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER - 7 tabletter
English: Chronic obstructive pulmonary disease, pulmonary granuloma, vasomotor rhinitis Gastrointestinal disorders
Danish: Sjælden: Kronisk obstruktiv lungesygdom, lungegranulom, vasomotorisk rinit Mave-tarm-kanalen
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 30 tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER - 30 tabletter
English: • if you are immobile for some time, such as, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an illness, as these may increase your risk of blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
Danish: • hvis De ikke har mulighed for at bevæge Dem i et stykke tid, som f.eks. hvis De skal indlægges, eller hvis De skal ligge i sengen efter en operation eller en sygdom.
English: FABLYN must not be taken by women of childbearing potential (see section 4.3).
Danish: Fablyn må ikke anvendes til kvinder i den fødedygtige alder (se pkt.
English: Arthropathy, bursitis, clubbing, coccydynia, costochondritis, dactylitis, exostosis, extremity contracture, haemarthrosis, joint stiffness, muscle contracture, muscle twitching, musculoskeletal discomfort, pain in jaw, periarthritis, rheumatoid arthritis,
Danish: Sjælden: Artropati, bursitis, coccygodyni, costochondritis, dactylitis, exostose, hæmartrose, kontraktur af ekstremitet, ledstivhed, muskelkontraktur, muskeltrækninger, muskuloskeletale gener, periartrit, rheumatoid artrit, rotator cuff-syndrom, smerter i kæbe, tendosynovitis, trommestikfingre Nyrer og urinveje Ikke almindelig:
English: 5′ nucleotidase increased, blood albumin decreased, blood creatinine abnormal, blood triglycerides increased, blood urine present, bone density decreased, chest X-ray abnormal, electrocardiogram T wave abnormal, gamma-glutamyltransferase increased, hepatitis B surface antigen positive, high density lipoprotein decreased, low density lipoprotein increased, pedal pulse decreased, platelet count decreased, ultrasound breast
Danish: Sjælden: Abnorm EKG T-bølge, abnormt fund ved røntgen af thorax, abnorm serumkreatinin, abnorm ultralydsundersøgelse af bryst, abnorm ultralydsundersøgelse af ovarier blod i urinen, forhøjet 5′-nukleotidase, forhøjet gamma-glutamyltransferase, forhøjet low density lipoprotein, forhøjede serumtriglycerider, nedsat fodpuls, nedsat high density lipoprotein, nedsat knogletæthed, nedsat serumalbumin, nedsat trombocyttal, positiv test for hepatitis Boverfladeantigen,
English: NAME OF THE MEDICINAL PRODUCT FABLYN 500 microgram film-coated tablets.
Danish: LÆGEMIDLETS NAVN FABLYN 500 mikrogram Filmovertrukne tabletter.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FABLYN 500 microgram film-coated tablets lasofoxifene
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) FABLYN 500 mikrogram filmovertrukne tabletter lasofoxifen
English: How to FABLYN
Danish: FABLYN.
English: Take your next tablet and continue as before.
Danish: Fortsæt blot med den sædvanlige dosis.
English: Uncommon: Urinary tract infection, vaginal candidiasis, vaginal infection, vulvovaginitis Rare:
Danish: Vaginal candidiasis, vaginal infektion, vulvovaginitis, urinvejsinfektion,
English: • Breast stiffening, breast pain, vaginal bleeding, genital itching
Danish: • Ubehag i brystet, brystsmerter, blødning fra skeden, kløe i kønsorganerne
English: • Rare: affects 1 to 10 users in 10,000
Danish: • Sjældne bivirkninger: Forekommer hos mellem 1 og 10 ud af 10.000 patienter
English: New radiographic vertebral fractures Percentage of patients with new fracture n=2,748
Danish: Nye radiografisk verificerede rygsøjlefrakturer Procentdel af patienter med nye frakturer n=2748
English: Pregnancy and breast-feeding
Danish: Metabolisme og ernæring
English: Proton pump inhibitors - Data on the effect of concomitant administration of proton pump inhibitors (PPIs) with lasofoxifene is not available; thus, use of these agents with lasofoxifene should be considered with caution.
Danish: Protonpumpehæmmere - Der findes ikke oplysninger om samtidig brug af protonpumpehæmmere og lasofoxifen.
English: Subjects with severe hepatic impairment have not been studied (see section 4.4).
Danish: Der er ikke foretaget undersøgelser på personer med svær leverinsufficiens (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 28 tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER - 28 tabletter
English: Lactose monohydrate
Danish: Almindelig Hyperhidrose
English: No dose adjustment is required in patients with mild to moderate hepatic insufficiency (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med mild til moderat leverinsufficiens (se pkt.
English: HOW TO TAKE FABLYN
Danish: SÅDAN SKAL DE TAGE FABLYN