natgillin/translations-raw huggingface dataset:
• De anbefalede tiltag for at nedsætte risikoen for venøs tromboemboli baseret på produktresuméet,
• The approaches recommended for mitigation of risk of venous thromboembolism based on the
Der blev udført flere diagnostiske uterine procedurer på Fablyn-behandlede patienter som følge af vaginal blødning (som beskrevet i protokollen) og asymptomatiske endometriefund (f.eks. mistanke om uteruspolypper, endometrietykkelse).
Diagnostic uterine procedures were performed in a greater number of FABLYN-treated patients as a result of vaginal bleeding (as mandated by the protocol) and asymptomatic endometrial findings (e.g., suspected uterine polyps, endometrial thickness).
Ældre:
Elderly:
Kvinderne i dette studie var i gennemsnit 67 år (interval 59 til 80) og i gennemsnit var der gået 20 år siden menopausen.
Women enrolled in this study had a median age of 67 years (range 59 to 80) and a median time since menopause of 20 years.
Lasofoxifen og dets metabolitter udskilles primært i fæces med kun en mindre del af det lasofoxifen-relaterede materiale udskilt i urinen.
Lasofoxifene and its metabolites are primarily excreted in feces, with a minor component of urinary excretion of active substance-related material.
Flere Fablyn-behandlede patienter (7,0 %) end placebobehandlede patienter (2,7 %) fik foretaget en diagnostisk procedure.
More FABLYN-treated patients (7.0%) had a diagnostic procedure compared to placebo-treated patients (2.7%).
Disse bivirkninger kan forekomme som vist nedenfor:
These side effects may occur with certain frequencies, which are defined as follows:
• Øvrige indholdsstoffer: vandfrit lactose; mikrokrystalliseret cellulose; croscarmellose natrium; silica; kolloid vandfri silica; magnesiumstearat; sunset yellow FCF (E110); hypromellose; lactosemonohydrat; titandioxid (E171)og triacetin.
• The other ingredients are lactose anhydrous; microcrystalline cellulose; croscarmellose sodium; silica, colloidal anhydrous; magnesium stearate; sunset yellow FCF aluminium lake (E110); hypromellose; lactose monohydrate; titanium dioxide (E171) and triacetin.
• Træthed, unormal eller kraftig blødning, som oftest fra næsen
• Tiredness, abnormal or excessive bleeding commonly from the nose
Tabletterne findes i blisterpakninger med 7, 28 eller 30 tabletter, og i beholder med 90 tabletter.
The tablets are provided in blister packs containing 7, 28 or 30 tablets, and in bottle packs containing 90 tablets.
Placebobehandlede kvinder havde et fald i den gennemsnitlige endometrietykkelse på 0,7 mm fra baseline over 3 år, mens Fablyn-behandlede kvinder havde en gennemsnitlig stigning på 1,4 mm.
Placebo-treated women had a 0.7 mm mean decrease from baseline in endometrial thickness over 3 years, whereas the FABLYN-treated women had a 1.4 mm mean increase.
Lasofoxifen blev undersøgt som en enkeltdosis på 0,25 mg hos raske frivillige og frivillige med mild eller moderat leverinsufficiens.
Lasofoxifene was studied, as a single 0.25 mg dose, in healthy subjects and subjects with mild or moderate hepatic impairment.
Lasofoxifen udviser lineær farmakokinetik over et bredt dosisområde efter administration af enkeltdosis (op til 100 mg) og flerdosis (op til 20 mg en gang dagligt).
Lasofoxifene exhibits linear pharmacokinetics over a wide dose range following single-dose (up to 100 mg) and multiple-dose (up to 20 mg once daily) administration.
Virkninger på brystvæv:
Effects on breast:
Ketoconazol - Den stærke CYP3A4/5-inhibitor ketoconazol øger den systemiske eksponering for lasofoxifen med 20 %, hvilket ikke vurderes at være klinisk relevant.
Ketoconazole - The strong CYP3A4/5 inhibitor ketoconazole increased the systemic exposure of lasofoxifene by 20% which is not considered to be clinically meaningful.
• hvis De har eller har haft blodpropper, f.eks. i blodåre, lunger eller øjne (blodprop i benene,
• if you currently have or previously had blood clots, for example in your veins, lungs or eyes
I det samme studie var der efter 5 år ingen stigning i risikoen for apopleksi, herunder hæmoragisk, iskæmisk, embolisk apopleksi, ikke-specificeret apopleksi og transitorisk iskæmisk hændelse hos Fablyn-behandlede patienter.
In the same study at 5 years, there was no increase in the risk of stroke including hemorrhagic, ischemic, embolic stroke, stroke type unspecified and transient ischemic attacks in FABLYN-treated patients.
Fablyn eliminerer ikke risikoen for mammacancer (se pkt.
FABLYN does not eliminate the risk of breast cancer (see section 5.1).
• hvis De har blødning fra skeden.
• if you have any vaginal bleeding.
Der er fundet tre metabolitter af lasofoxifen i plasma: det direkte glucuronidkonjugat, glucuronid af en hydroxyleret metabolit og methyleret catechol.
Three metabolites of lasofoxifene were detected in plasma: the direct glucuronide conjugate, the glucuronide of a hydroxylated metabolite, and the methylated catechol.
Trekantede, ferskenfarvede filmovertrukne tabletter præget med “Pfizer” på den ene side og “OPR 05” på den anden side.
Triangular, peach-coloured, film-coated tablets debossed with “Pfizer” on one side and “OPR 05” on the other side.
Fablyn påvirker ikke risikoen for østrogenreceptor-negativ mammacancer eller østrogenreceptor-negativ invasiv mammacancer.
FABLYN has no effect on the risk of ER negative breast cancer or ER negative invasive breast cancers.
• Hævede hænder, arme, fødder eller ben, bensmerter
• Swelling of hands, arms, feet or legs, limb pain
Nye radiografisk verificerede rygsøjlefrakturer hos patienter med ≥ 1 baseline-fraktur
New radiographic vertebral fracture in patients with ≥ 1 baseline fracture
I osteoporose-studierne resulterede Fablyn-behandling i en konstant, statistisk signifikant hæmning af knogleresorption og knogledannelse, afspejlet i ændringer i serum- og urinindholdet af knogleomsætningsmarkører (f.eks. C-telopeptid og knogledannelsesmarkører: osteocalcin, procollagen type 1 N-terminal propeptid og knoglespecifik alkalisk fosfatase).
In the osteoporosis treatment trials, FABLYN therapy resulted in consistent, statistically significant suppression of bone resorption and bone formation, as reflected by changes in serum and urine markers of bone turnover (e.g., C-telopeptide and markers of bone formation: osteocalcin, procollagen type 1 N-terminal propeptide, and bone-specific alkaline phosphatase).
I et 3-års substudie under PEARL-studiet (n=760) forøgede Fablyn signifikant BMD (sammenlignet med placebo) i lænderygsøjle (3,3 %), total hofte (3,0 %), lårbenshals (3,3 %), trochanter major (3,6 %), intertrochantær-område (2,6 %), Wards trekant (5,9 %) og underarm (1,8 %) efter 3 år.
In a 3-year substudy of the PEARL study (n=760), FABLYN significantly increased BMD (compared to placebo) at lumbar spine (3.3%), total hip (3.0%), femoral neck (3.3%), greater trochanter (3.6%), intertrochanteric area (2.6%), Ward's triangle (5.9%) and forearm (1.8%) at 3 years.
Fablyn filmovertrukne tabletter findes i PVC-blisterpakninger med aluminumsfolie eller i HDPEbeholdere med børnesikret polypropylenlåg, der er beklædt med polyethylen/aluminumsfolie.
FABLYN film-coated tablets are supplied in PVC blisters with aluminum foil backing or HDPE bottles with polyethylene/aluminum foil lined polypropylene child-resistant closures.
Dette medfører en forøgelse af den gennemsnitlige endometrietykkelse.
It results in increased mean endometrial thickness.
Der findes ingen oplysninger om samtidig brug af Fablyn og midler mod tidlig eller fremskreden mammacancer.
No data are available on its concomitant use with agents used in the treatment of early or advanced breast cancer.
Plasmaindholdet af lasofoxifen var omtrent det samme hos raske frivillige som hos frivillige med mild leverinsufficiens (Child-Pugh Class A) og moderat øget (38 %) hos frivillige med moderat leverinsufficiens (Child-Pugh Class B) sammenlignet med raske frivillige.
Plasma lasofoxifene exposure was approximately the same in healthy subjects as in subjects with mild hepatic impairment (Child-Pugh Class A) and was modestly increased (38%) in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to healthy subjects.
Gennem 5 års follow-up fik 37 Fablyn-behandlede kvinder (1,3 % eller 2,90 pr. 1000 patientår) VTE sammenlignet med 18 placebobehandlede kvinder (0,6 % eller 1,41 pr. 1000 patientår) og hazard ratio var 2,06 (95 % CI: 1,17; 3,61).
Through 5 years of follow-up, 37 FABLYN-treated women (1.3%, or 2.90 per 1,000 patients years) had a VTE compared to 18 placebo-treated women (0.6%, or 1.41 per 1,000 patients years) and the hazard ratio was 2.06 (95% CI: 1.17, 3.61).
I en undergruppe af studiepopulationen, designet til at undersøge endometriehistologi (1080 patienter) ved en TVU efter 3 år, blev der fundet histologisk benigne endometriepolypper hos 20 af 366 (5,5 %) Fablynbehandlede kvinder og hos 12 af 360 (3,3 %) placebobehandlede kvinder.
In a subset of the study population designed to look at endometrial histology (1,080 patients) with a TVU at 3 years, histologically benign endometrial polyps were reported in 20 of 366 (5.5%) FABLYN-treated women and 12 of 360 (3.3%) placebo-treated women.
Signifikant færre Fablyn-behandlede kvinder fik moderate eller alvorlige rygsøjlefrakturer (bestemt ved Genant-skala) sammenlignet med placebobehandlede kvinder (5,2 % placebobehandlede kvinder versus 3,3 % Fablyn-behandlede kvinder; p = 0,0006).
Significantly fewer women treated with FABLYN experienced moderate or severe vertebral fractures (as determined by the Genant scale) compared to women treated with placebo (5.2% placebo-treated women versus 3.3% FABLYN-treated women; p = 0.0006).
Clearance af lasofoxifen kan være øget hos patienter i kronisk behandling med inducere af CYP3A4 og UGT-enzymer (f.eks. phenytoin, carbamazepin, barbiturater og perikum), hvilket vil resultere i lavere steady state-koncentrationer og potentielt nedsat effekt.
Lasofoxifene clearance may be increased in patients chronically treated with inducers of CYP3A4 and UGTs (eg, phenytoin, carbamazepine, barbiturates and St John's Wort) resulting in reduced steadystate concentrations and may result in reduced efficacy.
Sammenlignet med placebo nedsatte Fablyn-behandling risikoen for invasiv mammacancer med 85 % (placebo: 20 (0,7 %), Fablyn: 3 (0,1 %); HR 0,15 (CI 0,04; 0,50)), risikoen for alle typer af mammacancer med 79 % (placebo: 24 (0,9 %), Fablyn: 5 (0,2 %); HR 0,21 (CI 0,08; 0,55)), risikoen for østrogenreceptor-positiv invasiv mammacancer med 83 % (placebo: 18 (0,7 %), Fablyn: 3 (0,1 %); HR 0,17 (CI 0,05; 0,57)) og risikoen for østrogenreceptor-positiv mammacancer med 81 % (placebo: 21 (0,8 %), Fablyn: 4 (0,1 %); HR 0,19 (CI 0,07; 0,56)).
Over the 5 years of the PEARL study (involving 8,556 patients), FABLYN treatment compared to placebo reduced the risk of invasive breast cancer by 85% (placebo: 20 (0.7%), FABLYN: 3 (0.1%); HR 0.15 (CI 0.04, 0.50)), the risk of all breast cancer by 79% (placebo: 24 (0.9%), FABLYN: 5 (0.2%); HR 0.21 (CI 0.08, 0.55)), the risk of estrogen receptor (ER) positive invasive breast cancer by 83% (placebo: 18 (0.7%), FABLYN: 3 (0.1%); HR 0.17 (CI 0.05, 0.57)) and the risk of estrogen receptor (ER) positive breast cancer by 81% (placebo: 21 (0.8%), FABLYN: 4 (0.1%); HR 0.19 (CI 0.07, 0.56)).
Der er ikke observeret nogen klinisk betydende ændringer i lasofoxifens farmakokinetik i aldersgruppen 40 til 80 år i en farmakokinetisk populationsanalyse.
No clinically meaningful differences in lasofoxifene pharmacokinetic were observed over the age range of 40 to 80 years of age based on the results of a population pharmacokinetic analysis.
I alt 2852 personer blev randomiseret til Fablyn og 2852 til placebo.
The duration of treatment in postmenopausal women was 60 months, 2,852 were randomized to FABLYN and 2,852 were randomized to placebo.
Dosisjustering er ikke nødvendig hos ældre kvindelige patienter (se pkt.
No dose adjustment is necessary in elderly female patients (see section 5.2).
• Brændende fornemmelse, svimmelhed, følelsesløshed, hukommelsestab, nedsat eller delvis nedsat bevægelighed af lemmerne, hovedpine, uro i benene (en uimodståelig trang til at bevæge benene for at stoppe en ubehagelig eller mærkelig fornemmelse i benet)
• Burning sensation, dizziness, numbness, memory impairment, impaired or partial loss of movement of a limb, headache, restless legs syndrome (an irresistible urge to move legs to stop an uncomfortable or odd sensations)
Fablyns virkning på knoglevæv viser sig ved reduktion af serumog urinindholdet af knogleomsætningsmarkører, forøgelse af knoglemineraldensiteten (BMD) samt nedsat forekomst af frakturer.
The effects of FABLYN on bone are manifested as reductions in the serum and urine levels of bone turnover markers, increases in bone mineral density (BMD), and decreases in incidence of fractures.
* Endometriehypertrofi er en MedDRA-term, som betegner endometrietykkelse påvist ved ultralyd.
* Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial thickness findings.
Hos kvinder med en uterus ved baseline blev der fundet histologisk benigne endometriepolypper hos 34 af 2302 (1,5 %) Fablyn-behandlede kvinder versus 18 af 2309 (0,8 %) placebobehandlede kvinder.
In all women with a uterus at baseline, histologically benign endometrial polyps were reported in 34 of 2,302 (1.5%) FABLYN-treated women versus 18 of 2,309 (0.8%) placebo-treated women.
Risk-benefit bør vurderes for patienter med risiko for venøse tromboemboliske hændelser af enhver ætiologi (se pkt.
The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology (see sections 4.3 and 4.8).
Der er identificeret fem metaboliske pathways for lasofoxifen: direkte glucuronidation; direkte sulfonering; hydroxylering af phenyltetralin-delen (med efterfølgende konjugerende metabolisme af catechol-intermediaterne ved metylering og glucuronidation); oxidering af pyrrolidinringen; og phenylhydroxylering.
Five metabolic pathways of lasofoxifene have been identified: direct glucuronidation; direct sulfation; hydroxylation at the phenyl tetraline moiety (with subsequent conjugative metabolism of the catechol intermediates by methylation and glucuronidation); oxidation at the pyrrolidine ring; and phenyl hydroxylation.
I den tilsvarende 2-års undersøgelse på mus (≥2 mg/kg/dag; mindre end den systemiske eksponering efter en human dosis på 0,5 mg/dag baseret på plasma-AUC) sås en øget forekomst af adrenokorticale adenomer og carcinomer, interstitielle celletumorer i testes, benigne og maligne ovarietumorer og benigne uterine glandulære polypper.
In the corresponding 2-year study in mice (≥2 mg/kg/day; less than systemic exposure following a human dose of 0.5 mg/day based on plasma AUC), there was an increased incidence of adrenal cortical adenoma and carcinoma, interstitial cell tumors of the testis, benign and malignant ovarian tumors and benign uterine glandular polyps.
Lasofoxifens fordelingsvolumen hos postmenopausale kvinder er ca. 1350 l.
The apparent volume of distribution (V/F) of lasofoxifene in postmenopausal women is approximately 1,350 l.
• Betændelse i øret, øjet, halsen eller huden, diarré, blod i afføringen
• Infection in the ear, eye, respiratory tract or skin, diarrhea, blood in stools
• BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE
Lasofoxifen kan være forbundet med benigne endometrielle virkninger: cystiske endometrieforandringer set ved ultralydsundersøgelser og histologisk påvist benign cystisk atrofi (en variant af atrofisk endometrium), der medfører en forøgelse af den gennemsnitlige endometrietykkelse på ca. 1,5 mm.
Lasofoxifene may be associated with benign endometrial effects: endometrial cystic change viewed on ultrasound and histological benign cystic atrophy (a variant of atrophic endometrium), contributing to approximately 1.5 mm increase in mean endometrial thickness.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 24 February 2009
Procentdel af patienter med nye frakturer n=778
Percentage of patients with new fracture n=778
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 90 filmovertrukne tabletter
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 90 film-coated tablets
Tabel 1: Bivirkninger set i placebokontrollerede osteoporose-studier med en højere hyppighed hos Fablyn-behandlede end hos placebobehandlede kvinder
Table 1: Adverse reactions observed in placebo-controlled osteoporosis treatment clinical trials in more FABLYN-treated women than in placebo-treated women
Det endokrine system
Endocrine disorders
Ifølge klinisk praksis (og retningslinjer for postmenopausale kvinder), vil disse benigne fund dog ikke berettige til yderligere undersøgelser hos kvinder uden vaginalblødning, da risikoen ved en diagnostisk undersøgelse af uterus overstiger fordelene.
However, in clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding (in accordance with guidelines for postmenopausal women), as the risks of diagnostic uterine procedures in asymptomatic women outweigh any benefits.
Hvis De er gravid eller ammer, må De ikke tage FABLYN, da det kan udskilles i modermælken.
Do not take FABLYN if you are pregnant or breast-feeding as it might be excreted in mother's milk.
Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Fablyn er ikke undersøgt hos kvinder med mammacancer i anamnesen.
FABLYN has not been studied in women with a prior history of breast cancer.
I 2-års carcinogenicitets-undersøgelser på rotter (≥1 mg/kg/dag; 7 gange den systemiske eksponering efter en human dosis på 0,5 mg/dag, baseret på plasma-AUC) sås en øget forekomst af renale tubulære adenomer og carcinomer hos hanner og granulosacelletumorer i ovarierne hos hunner.
In two-year carcinogenicity studies conducted in rats (≥1 mg/kg/day; 7 times systemic exposure following a human dose of 0.5 mg/day based on plasma AUC) an increased incidence of renal tubular adenoma and carcinoma in males and granulosa cell tumours of the ovary in females was noted.
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.
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.
Almindelige bivirkninger relateret til Fablyn var muskeltrækninger, hedeture og vaginalt udflåd.
Common adverse reactions considered to be related to FABLYN therapy were muscle spasms, hot flush and vaginal discharge.
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).
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).
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/08/500/001
MARKETING AUTHORISATION NUMBER EU/1/08/500/001
For at vurdere knoglekvaliteten, blev der efter 2 års behandling taget knoglebiopsier fra 71 postmenopausale kvinder.
To assess bone quality, bone biopsies were obtained from 71 postmenopausal women enrolled in BMD trials after 2 years of treatment.
• Nedsat puls i fødderne, blå mærker
• Decreased pulse in feet, bruising
Venøse Tromboemboliske hændelser (VTE): Den alvorligste bivirkning relateret til Fablyn var VTE (dyb venetrombose, lungeemboli og retinal venetrombose).
Venous Thromboembolic Events: The most serious adverse reaction related to FABLYN was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis).
Aktuelle eller tidligere venøse tromboemboliske hændelser, herunder dyb venetrombose, lungeemboli og retinal venetrombose.
Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
De har en alvorlig leversygdom.
• if you have severe liver disease.
• Mundtørhed, luftafgang fra tarmen (meget luft i maven eller tarmen), mavepine
• Dry mouth, flatulence (excessive amount of air or gases in the stomach or the intestine),
Det vides ikke, om lasofoxifen udskilles i modermælken.
It is not known whether lasofoxifene is excreted in human milk.
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.
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.
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.
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.
Brug ikke FABLYN efter den udløbsdato, der står på Udløbsdatoen (Exp) er den sidste dag i den nævnte måned..
The expiry date refers to the last day of that month.
FABLYN er en trekantet, ferskenfarvet, filmovertrukken tablet mærket med “Pfizer” på den ene side og “OPR 05” på den anden side.
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.
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).
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).
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).
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).
• Unormal eller uregelmæssig hjertebanken, hurtig puls
• Abnormal or irregular beating of the heart, increased heart rate
Efter oral administration af en opløsning af 14C-mærket lasofoxifen i mennesker genfandtes ca. 72 % af den radioaktive dosis efter 24
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).
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
I kliniske studier er der set en øget risiko for venøse tromboemboliske hændelser (dyb venetrombose og lungeemboli) hos Fablyn-behandlede kvinder sammenlignet med placebo.
In clinical trials, FABLYN-treated women had an increased risk of venous thromboembolic events (deep vein thrombosis and pulmonary embolism) compared to placebo.
Knoglehistomorfometri
Bone histomorphometry