FrancophonIA/ELRC3.0 huggingface dataset:
English: Sequential treatment consisted of first-line capecitabine (1250 mg/m2 twice daily for 14 days), second-line irinotecan (350 mg/m2 on day
Danish: Kombinationsbehandlingen bestod af 1. linjebehandling med capecitabin (1.000 mg/m 2 to gange daglig i 14 dage) kombineret med irinotecan (250 mg/m 2 på dag 1) (XELIRI) og 2.
English: Each film-coated tablet contains 7 mg anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 7 mg vandfri lactose.
English: Encephalopathy:
Danish: Oversigt over indlægssedlen:
English: Renal impairment
Danish: DPD-mangel
English: Joint swelling, Bone pain, Facial pain, Musculoskeletal stiffness, Muscular weakness
Danish: Hævelse af led, Knoglesmerter, Ansigtssmerter, Muskuloskeletal stivhed,
English: Aluminium/aluminium blisters EU/1/12/763/013 30 film-coated tablets EU/1/12/763/014 60 film-coated tablets EU/1/12/763/015 120 film-coated tablets
Danish: EU/1/12/763/013 30 filmovertrukne tabletter EU/1/12/763/014 60 filmovertrukne tabletter EU/1/12/763/015 120 filmovertrukne tabletter
English: PVC/PVdC/aluminium blisters EU/1/12/763/016 30 film-coated tablets EU/1/12/763/017 60 film-coated tablets EU/1/12/763/018 120 film-coated tablets
Danish: EU/1/12/763/016 30 filmovertrukne tabletter EU/1/12/763/017 60 filmovertrukne tabletter EU/1/12/763/018 120 filmovertrukne tabletter
English: intravenous 2 hr
Danish: intravenøs 22 timer
English: 9/L or that the platelet count drops below
Danish: 9/l, eller antallet af blodplader falder til under 75 x 10
English: - PVC/PVdC/aluminium blisters 30 film-coated tablets: EU/1/12/763/016 60 film-coated tablets: EU/1/12/763/017 120 film-coated tablets: EU/1/12/763/018
Danish: 30 Filmovertrukne tabletter: EU/1/12/763/016 60 Filmovertrukne tabletter: EU/1/12/763/017 120 Filmovertrukne tabletter: EU/1/12/763/018
English: Maintain dose level
Danish: Fortsæt med samme dosis
English: Each film-coated tablet contains 25 mg anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 25 mg vandfri lactose.
English: Colon, colorectal and gastric cancer
Danish: Kolonkræft, kolorektalkræft og ventrikelkræft
English: - PVC/PVdC/aluminium blisters 30 film-coated tablets: EU/1/12/763/010 60 film-coated tablets: EU/1/12/763/011 120 film-coated tablets: EU/1/12/763/012
Danish: 30 Filmovertrukne tabletter: EU/1/12/763/010 60 Filmovertrukne tabletter: EU/1/12/763/011 120 Filmovertrukne tabletter: EU/1/12/763/012
English: Aluminium/aluminium blisters EU/1/12/763/007 30 film-coated tablets EU/1/12/763/008 60 film-coated tablets EU/1/12/763/009 120 film-coated tablets
Danish: EU/1/12/763/007 30 filmovertrukne tabletter EU/1/12/763/008 60 filmovertrukne tabletter EU/1/12/763/009 120 filmovertrukne tabletter
English: Ecansya 300 mg film-coated tablets - Aluminium/aluminium blisters 30 film-coated tablets: EU/1/12/763/007 60 film-coated tablets: EU/1/12/763/008 120 film-coated tablets: EU/1/12/763/009
Danish: 30 Filmovertrukne tabletter: EU/1/12/763/007 60 Filmovertrukne tabletter: EU/1/12/763/008 120 Filmovertrukne tabletter: EU/1/12/763/009
English: PVC/PVdC/aluminium blisters EU/1/12/763/010 30 film-coated tablets EU/1/12/763/011 60 film-coated tablets EU/1/12/763/012 120 film-coated tablets
Danish: EU/1/12/763/010 30 filmovertrukne tabletter EU/1/12/763/011 60 filmovertrukne tabletter EU/1/12/763/012 120 filmovertrukne tabletter
English: Each film-coated tablet contains 15 mg anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 15 mg vandfri lactose.
English: Aluminium/aluminium blisters EU/1/12/763/001 30 film-coated tablets EU/1/12/763/002 60 film-coated tablets EU/1/12/763/003 120 Film-coated tablets
Danish: EU/1/12/763/001 30 filmovertrukne tabletter EU/1/12/763/002 60 filmovertrukne tabletter EU/1/12/763/003 120 filmovertrukne tabletter
English: Gastrointestinal haemorrhage, Constipation, Upper abdominal pain, Dyspepsia, Flatulence, Dry mouth
Danish: Gastrointestinal blødning, Konstipation, Øvre abdominale smerter,
English: 1), and third-line combination of capecitabine (1000 mg/m 2 twice daily for 14 days) with oxaliplatin
Danish: linjebehandling med capecitabin (1.000 mg/m to gange dagligt i 14 dage) plus oxaliplatin (130 mg/m på dag 1).
English: - PVC/PVdC/aluminium blisters 30 film-coated tablets: EU/1/12/763/004 60 film-coated tablets: EU/1/12/763/005 120 film-coated tablets: EU/1/12/763/006
Danish: 30 Filmovertrukne tabletter: EU/1/12/763/004 60 Filmovertrukne tabletter: EU/1/12/763/005 120 Filmovertrukne tabletter: EU/1/12/763/006
English: Ecansya 500 mg film-coated tablets - Aluminium/aluminium blisters 30 film-coated tablets: EU/1/12/763/013 60 film-coated tablets: EU/1/12/763/014 120 film-coated tablets: EU/1/12/763/015
Danish: 30 Filmovertrukne tabletter: EU/1/12/763/013 60 Filmovertrukne tabletter: EU/1/12/763/014 120 Filmovertrukne tabletter: EU/1/12/763/015
English: Pyrexia, Oedema peripheral, Malaise, Chest pain
Danish: Perifere ødemer, Utilpashed, Brystsmerter
English: PVC/PVdC/aluminium blisters EU/1/12/763/004 30 film-coated tablets EU/1/12/763/005 60 film-coated tablets EU/1/12/763/006 120 film-coated tablets
Danish: EU/1/12/763/004 30 filmovertrukne tabletter EU/1/12/763/005 60 filmovertrukne tabletter EU/1/12/763/006 120 filmovertrukne tabletter
English: Headache, Lethargy Dizziness, Paraesthesia, Dysgeusia
Danish: Hud og subkutane væv Alopeci, Neglesygdomme
English: Hepatic impairment.
Danish: Nedre abdominale smerter,
English: Diabetes,
Danish: Kvalme,
English: Ecansya 150 mg film-coated tablets - Aluminium/aluminium blisters 30 film-coated tablets: EU/1/12/763/001 60 film-coated tablets: EU/1/12/763/002 120 Film-coated tablets: EU/1/12/763/003
Danish: 30 Filmovertrukne tabletter: EU/1/12/763/001 60 Filmovertrukne tabletter: EU/1/12/763/002 120 Filmovertrukne tabletter: EU/1/12/763/003
English: Elderly (see section 4.2):
Danish: Ældre (se pkt.
English: You may need to read it again.
Danish: De kan få brug for at læse den igen.
English: 4 years
Danish: 4 år
English: The potential risk for humans is unknown.
Danish: Den potentielle risiko for mennesker kendes ikke.
English: • At the request of the EMEA
Danish: • Efter anmodning fra EMEA
English: • if you could still become pregnant.
Danish: • hvis De stadig kan blive gravid.
English: • OTHER CONDITIONS
Danish: • ANDRE BETINGELSER
English: • When new information is received that may impact on the current Safety Specification,
Danish: • Når der modtages ny information, som kan påvirke den gældende sikkerhedsspecifikation,
English: Linearity/non-linearity:
Danish: Linearitet/non-linearitet:
English: In addition, an updated RMP should be submitted
Danish: Ligeledes skal en opdateret RMP indsendes
English: Children and adolescents below 18 years of age:
Danish: Børn og unge under 18 år:
English: The programme shall have both electronic and printed form, which are identical in terms of content.
Danish: Programmet skal have både elektroniske og printede skemaer, som har identisk indhold.
English: The programme shall convey the following key messages:
Danish: Programmet skal indeholde følgende primære budskaber:
English: Elderly women (65 years and older):
Danish: Ældre kvinder (65 år eller derover):
English: Do not take a double dose to make up for a forgotten tablet.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: • Web-based
Danish: • Web-baseret
English: • Change in appetite
Danish: • Ændring af appetitten
English: Do not use if box has been opened.
Danish: Må ikke anvendes, hvis pakningen har været åbnet.
English: • On CD
Danish: • På CD
English: • Not known: frequency cannot be estimated from the available data
Danish: • Bivirkninger, hvor hyppigheden ikke er kendt: Hyppigheden kan ikke bestemmes ud fra de tilgængelige data
English: Your doctor may recommend that you stop treatment at least 3 weeks prior to this time.
Danish: Deres læge kan anbefale, at De stopper behandlingen mindst 3 uger, inden De skal indlægges.
English: • References to authoritative international guidelines relevant for uterine surveillance.
Danish: • Referencer til myndigheders internationale guidelines, der er relevante for kontrol af uterus.
English: • if you have or have had breast cancer.
Danish: De har eller har haft brystkræft.
English: All histology findings were benign.
Danish: Alle histologiske fund var benigne.
English: Name and address of the manufacturer of the biological active substance Not applicable
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Ikke relevant.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: This binding results in the activation of some estrogenic pathways and a blockade of others.
Danish: Denne binding resulterer i aktivering af nogle østrogen-pathways og blokering af andre.
English: Pharmacovigilance system
Danish: Pharmacovigilancesystem
English: Although all of these tumours are believed to be the result of rodent-specific hormonal mechanisms, their relevance for humans is currently unknown.
Danish: Selvom alle disse tumorer anses for at være forårsaget af en gnaver-specifik hormonel mekanisme, er relevansen for mennesker ukendt.
English: Adult (postmenopausal women):
Danish: Voksne (postmenopausale kvinder):
English: In the event of overdose, general supportive measures should be initiated based on the patient's signs and symptoms.
Danish: I tilfælde af overdosering skal der initieres generelt understøttende behandling afhængigt af patientens symptomer.
English: It must be in line with authoritative international guidelines and supported by evidence published in peer reviewed medical journals.
Danish: Det skal overholde myndighedernes internationale guidelines samt understøttes af udgivelser i medicinske tidsskrifter, der anvender peer review.
English: Metabolism:
Danish: Metabolisme:
English: These changes are not considered to be clinically meaningful.
Danish: Disse ændringer vurderes ikke at være klinisk relevante.
English: Lasofoxifene is highly bound to proteins in human plasma (>99%).
Danish: Lasofoxifen er i høj grad bundet til proteiner i humant plasma (>99 %).
English: The overall incidence of vaginal bleeding was low (≤ 2.6% in all treatment groups).
Danish: Den totale forekomst af vaginalblødning var lav (≤ 2,6 % i alle behandlingsgrupper).
English: The increase was observed at 12 months, and did not significantly increase through 3 years.
Danish: Denne stigning blev set efter 12 måneder, og steg ikke signifikant gennem de 3 år.
English: These differences are not considered to be clinically meaningful.
Danish: Disse forskelle anses ikke for at være klinisk relevante.
English: Similar results for vaginal pH and MI were observed in the PEARL study.
Danish: Lignende resultater for vaginalt pH og MI sås i PEARL-studiet.
English: Pharmacovigilance Plan or risk minimisation activities
Danish: pharmacovigilance-plan eller risikominimeringsaktiviteter.
English: The programme materials shall be provided via the following means:
Danish: Programmaterialet skal være tilgængeligt som følger:
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: Som beskrevet i ”CHMP guideline on risk management systems for medicinal products for human use”, skal den opdaterede Risk Management Plan indsendes samtidig med den næste periodiske sikkerhedsopdateringsrapport (PSUR).
English: Most of the adverse reactions occurring during the studies were mild and generally did not require discontinuation of therapy.
Danish: De fleste bivirkninger, der blev set i studierne, var milde og krævede generelt ikke seponering af behandlingen.
English: Name and address of the manufacturer responsible for batch release Pfizer Manufacturing Deutschland GmbH
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Pfizer Manufacturing Deutschland GmbH
English: • Diabetes (typical symptoms are excessive thirst, frequent urination)
Danish: • Diabetes (de typiske symptomer er øget tørst, hyppig vandladning)
English: Hot flush occurred in about one in 11 patients and was most commonly reported during the first 6 months of treatment.
Danish: En ud af 11 patienter fik hedeture, som hyppigst blev set i de første 6 måneder af behandlingen.
English: Like all medicines, FABLYN can cause side effects, although not everybody gets them.
Danish: FABLYN kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: -All clinical fractures
Danish: -Alle kliniske frakturer
English: In each system organ class and frequency, adverse reactions are not presented in order of decreasing seriousness but in alphabetical order.
Danish: Indenfor hver organklasse og hyppighed er bivirkningerne ikke opstillet efter hvor alvorlige de er, men i alfabetisk rækkefølge.
English: This medicine does not require any special storage conditions.
Danish: Denne medicin kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: There are no adequate data from the use of lasofoxifene in pregnant women.
Danish: Der findes ikke tilstrækkelige data vedrørende brugen af lasofoxifen til gravide.
English: Based on 3- and 5-year human data in the clinical trials, the incidence of cancer during treatment with lasofoxifene was not higher than for placebo.
Danish: Baseret på 3- og 5-års humane data fra de kliniske studier var forekomsten af cancer under behandlingen med lasofoxifen ikke højere end for placebo.
English: Effects on lipid metabolism and cardiovascular risk:
Danish: Virkninger på lipidmetabolisme og kardiovaskulær risiko:
English: Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.
Danish: Der skal suppleres med calcium og/eller vitamin D, hvis det daglige indtag ikke er tilstrækkeligt.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen.
English: Abbreviations: n= number of patients; CI = Confidence Intervals a p < 0.0001; b p = 0.0004; c p = 0.0002; d p = 0.0020; e p = 0.0004
Danish: Forkortelser: n= antallet af patienter; CI = Konfidensinterval a p < 0,0001; b p = 0,0004; c p = 0,0002; d p = 0,0020; e p = 0,0004
English: The Manufacturer is Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Germany.
Danish: Fremstiller er: Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Tyskland.
English: Adverse reactions are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)).
Danish: Bivirkninger er anført efter organklasse og hyppighed (meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100) og sjælden (≥1/10.000 til <1/1.000)).
English: The disposition of lasofoxifene was evaluated in 758 subjects in conventional clinical pharmacology studies.
Danish: Lasofoxifens egenskaber blev evalueret hos 758 patienter i konventionelle kliniske farmakologistudier.
English: FABLYN Placebo Relative risk reduction (95% CI) vs. placebo
Danish: Fablyn Placebo Relativ risikoreduk tion (95% CI) vs. placebo
English: • if you are pregnant or breast-feeding.
Danish: • hvis De er gravid eller ammer.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/.
English: In addition, women taking FABLYN should be advised to move about periodically during prolonged travel.
Danish: Desuden bør kvinder i behandling med Fablyn vejledes om jævnligt at bevæge sig under længerevarende rejser.
English: The programme shall include the full text of the SmPC.
Danish: Programmet skal inkludere produktresuméets fulde tekst.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG
English: Results from one-year trial in Asian subjects
Danish: Resultater fra 1-års-studie med asiatiske patienter
English: Table 2: Fracture incidence in postmenopausal women over 5 years
Danish: Tabel 2: Forekomsten af frakturer hos postmenopausale kvinder gennem 5 år
English: This must be investigated by your doctor before starting treatment.
Danish: Dette skal undersøges af Deres læge, inden De begynder at tage
English: Unexplained uterine bleeding.
Danish: Uforklaret uterin blødning.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Danish: • Inden for 60 dage efter, en vigtig milepæl er nået i forbindelse med pharmacovigilance eller risikominimering.
English: INFORMATION IN BRAILLE FABLYN
Danish: INFORMATION I BRAILLE-SKRIFT FABLYN
English: Overall, the reproductive and developmental effects observed in animals are consistent with the SERM class of compounds.
Danish: Overordnet set svarer de observerede virkninger på reproduktion og udvikling hos dyr til de virkninger, der er set med stoffer i SERM-klassen.
English: This programme should focus on interpretation of endometrial biopsy of women treated with FABLYN.
Danish: Dette program bør fokusere på fortolkning af endometriebiopsier fra kvinder i behandling med FABLYN.
English: Ingestion of a high fat meal does not change the oral bioavailability of lasofoxifene.
Danish: Indtagelse af et måltid med højt fedtindhold ændrer ikke den orale biotilgængelighed af lasofoxifen.
English: Lasofoxifene binds to both albumin and α1-acid glycoprotein; however, it does not affect the binding of either warfarin or propranolol.
Danish: Lasofoxifen bindes til både albumin og α1-acid glycoprotein, men påvirker ikke bindingen af hverken warfarin eller propranolol.
English: Film-coated tablet.
Danish: Filmovertrukken tablet.
English: Important information about some of the ingredients of FABLYN FABLYN contains lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i FABLYN FABLYN indeholder lactose.
English: Muscle spasms occurred in about one in 9 patients .
Danish: Muskelsitren sås hos 1 ud af 9 patienter.
English: • if you are allergic (hypersensitive) to lasofoxifene or any of the other ingredients of FABLYN.
Danish: • hvis De er overfølsom (allergisk) over for lasofoxifen eller et af de øvrige indholdsstoffer.
English: • The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding occurs.
Danish: • Behovet for at stoppe behandlingen med FABLYN og foretage undersøgelser, hvis der opstår uforudset uterusblødning.
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: Hvis De sidder for lang tid i den samme stilling, kan Deres blodcirkulation forværres, og det øger risikoen for blodpropper.
English: It also reduced markers of bone turnover.
Danish: Behandlingen nedsatte også knogleomsætningsmarkører.
English: There is no specific antidote for FABLYN.
Danish: Der findes ingen specifik antidot til Fablyn.
English: Effects on the endometrium:
Danish: Virkninger på endometriet:
English: Vertebral fractures are the most common type of osteoporotic fracture in postmenopausal women.
Danish: Rygsøjlefrakturer er den mest almindelige type fraktur som følge af osteoporose hos postmenopausale kvinder.
English: 5-year results from large, multinational fracture trial (PEARL)
Danish: 5-årsresultater fra stort, multinationalt frakturstudie (PEARL)
English: Postmenopausal women require an average of 1,500 mg/day of elemental calcium.
Danish: Postmenopausale kvinder behøver i gennemsnit 1500 mg calcium dagligt.
English: Warfarin - Lasofoxifene had no effect on the pharmacokinetics of R- and S- warfarin.
Danish: Warfarin - Lasofoxifen havde ingen virkning på farmakokinetikken af R- og S-warfarin.
English: Pharmacotherapeutic group: Selective Estrogen Receptor Modulator (SERM), ATC code: {not yet assigned}
Danish: Farmakoterapeutisk klassifikation: Selektiv østrogenreceptormodulator (SERM), ATC-kode: {not yet assigned}
English: NAME OF THE MARKETING AUTHORISATION HOLDER Eberth
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Eberth
English: The MAH shall also provide access to educational programme for pathologists.
Danish: Indehaveren af markedsføringstilladelsen skal også give adgang til uddannelsesprogrammer for patologer.
English: -Non-vertebral fractures
Danish: -Non-vertebrale frakturer
English: This analysis included 2,049 postmenopausal women consisting of 85.5% Caucasian, 8.6% Hispanic, 3.4% Asian, and 1.9% African American.
Danish: Denne analyse inkluderede 2049 postmenopausale kvinder, bestående af 85,5 % kaukasiske, 8,6 % latin-amerikanske, 3,4 % asiatiske og 1,9 % afro-amerikanske kvinder.
English: In some asymptomatic patients, hot flushes may occur upon beginning therapy.
Danish: Nogle asymptomatiske patienter kan muligvis opleve hedeture efter start af behandling.
English: Excipient: Each film-coated tablet contains 71.34 mg lactose.
Danish: Hjælpestoffer: Hver filmovertrukken tablet indeholder 71,34 mg lactose.
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all healthcare professionals who are expected to prescribe FABLYN or order gynaecological ultrasound of patients treated with FABLYN, are provided with access to risk minimisation educational programme.
Danish: Indehaveren af markedsføringstilladelsen skal inden lanceringstidspunktet sikre, at alle læger, som forventes at udskrive FABLYN eller anvende gynækologisk ultralyd på patienter behandlet med FABLYN, har adgang til et risikominimerings-uddannelsesprogram.
English: The results of a phase 1 study in Japanese and Caucasian women was consistent with the population pharmacokinetic analysis and showed no discernible difference in lasofoxifene pharmacokinetics in these two populations.
Danish: Resultaterne fra et fase 1-studie hos japanske og kaukasiske kvinder stemmer overens med den populationsfarmakokinetiske analyse og viser ingen forskelle i lasofoxifens farmakokinetik mellem disse 2 populationer.
English: This decrease was observed through the first year and was maintained through 5 years.
Danish: Denne reduktion blev set gennem det første år og blev fastholdt gennem 5 år.
English: Any unexplained vaginal bleeding should be investigated as clinically indicated.
Danish: Alle tilfælde af uforklaret vaginalblødning skal undersøges, hvis det er klinisk indiceret.
English: • if you are taking FABLYN, you should walk around or exercise your legs and feet at regular intervals when traveling long distances.
Danish: • hvis De tager FABLYN, bør De motionere (f.eks. gå ture) eller lave regelmæssige øvelser med Deres ben og fødder, hvis De rejser over lange afstande.
English: In this study, FABLYN significantly increased spine and hip (total hip and all subcomponents of the hip) BMD by 2 to 4%.
Danish: I dette studie øgede Fablyn signifikant rygsøjle- og hofte-BMD (total hofte og alle subkomponenter af hoften) med 2 til 4 %.
English: Mean international normalized ratio (INR) AUC and maximum value of INR after single-dose warfarin administration with lasofoxifene were approximately 8% and 16% lower, respectively, than after warfarin alone.
Danish: Gennemsnitlig international normalized ratio (INR)-AUC og maksimal værdi af INR efter en enkeltdosis warfarin, administreret sammen med lasofoxifen, var henholdsvis ca. 8 % og 16 % lavere end efter warfarin alene.
English: Effects on vulvar and vaginal atrophy (VVA):
Danish: Virkninger på vulvovaginal atrofi (VVA):
English: Further information
Danish: YDERLIGERE OPLYSNINGER