FrancophonIA/ELRC3.0 huggingface dataset:
English: Paroxetine - The strong CYP2D6 inhibitor paroxetine increased the systemic exposure of lasofoxifene by 35% which is not considered to be clinically meaningful.
Danish: Paroxetin - Den stærke CYP2D6-inhibitor paroxetin øger den systemiske eksponering for lasofoxifen med 35 %, hvilket ikke vurderes at være klinisk relevant.
English: All women in the study received calcium (600-1200 mg/day) and Vitamin D (400-800 IU/day).
Danish: Alle kvinder i studiet fik calcium (600-1200 mg dagligt) og vitamin D (400800 IU dagligt).
English: Patients with this medical history should have serum triglycerides monitored when taking lasofoxifene.
Danish: Hos patienter med dette i anamnesen bør niveauet af triglycerider i serum monitoreres under behandlingen med lasofoxifen.
English: You should talk to your doctor before starting to take FABLYN:
Danish: Tal med lægen, inden De begynder at tage FABLYN, hvis:
English: At steady state, the half-life of lasofoxifene in postmenopausal women is approximately 6 days, resulting in small fluctuations in concentrations over the 24-hour dosing interval.
Danish: Lasofoxifens halveringstid hos postmenopausale kvinder er ca. 6 dage ved steady state, hvilket giver små koncentrationsudsving over doseringsintervallet på 24 timer.
English: Blister packs of 7, 28 or 30 tablets and bottles of 90 tablets.
Danish: Blisterpakninger med 7, 28 eller 30 tabletter og beholdere med 90 tabletter.
English: FABLYN is only for use in postmenopausal women.
Danish: Fablyn må kun anvendes til postmenopausale kvinder.
English: FABLYN can be taken with or without food and drink.
Danish: Brug af FABLYN sammen med mad og drikke FABLYN kan tages med eller uden mad og drikke.
English: Lasofoxifene produces tissue and cell-specific effects in estrogen-responsive tissues.
Danish: Lasofoxifen har vævs- og cellespecifikke virkninger i østrogen-responsivt væv.
English: All women in the study received calcium (1,000 mg/day) and Vitamin D (400-800 IU/day).
Danish: Alle kvinder i studiet fik calcium (1000 mg dagligt) og vitamin D (400-800 IU dagligt).
English: Placebo-treated women had a 1.9% incidence in cystic change over 3 years, whereas the FABLYNtreated women had a 20.4% incidence.
Danish: Placebobehandlede kvinder havde en forekomst af cystiske forandringer på 1,9 % over 3 år, mens Fablyn-behandlede kvinder havde en forekomst på 20,4 %.
English: It is unlikely that FABLYN will cause vaginal bleeding.
Danish: Det er ikke normalt, at FABLYN giver blødning fra skeden.
English: There was no evidence of osteomalacia, marrow fibrosis, cellular toxicity, woven bone or other abnormalities affecting the quality of the bone following lasofoxifene treatment.
Danish: Der var ingen tegn på osteomalaci, knoglemarvsfibrose, cellulær toksicitet, woven bone eller andre abnormiteter, som kunne påvirke knoglekvaliteten efter lasofoxifen-behandling.
English: If you forget to take FABLYN
Danish: Hvis De har glemt at tage FABLYN
English: Treatment with FABLYN can be restarted as soon as you regain your mobility and in consultation with your doctor.
Danish: Behandlingen kan genoptages, så snart De kan bevæge Dem normalt igen og efter aftale med lægen.
English: • Excessive sweating
Danish: • Kraftig sveden
English: Lasofoxifene is highly protein bound, predominantly cleared by metabolism and is likely to undergo enterohepatic circulation (see section 5.2).
Danish: Lasofoxifen er i høj grad proteinbundet, elimineres hovedsageligt ved metabolisme og indgår sandsynligvis i den enterohepatiske cirkulation (se pkt.
English: Contains lactose See the package leaflet for further information.
Danish: Se indlægssedlen for yderligere information.
English: In clinical studies, lasofoxifene did not alter the metabolism of dextromethorphan (CYP2D6 substrate) and chlorzoxazone (CYP2E1 substrate) or the pharmacokinetics of warfarin (CYP2C9 substrate), methylprednisolone (CYP3A4 substrate) or digoxin (MDR1 P-glycoprotein substrate).
Danish: I kliniske studier ændrede lasofoxifen ikke metaboliseringen af dextromethorphan (CYP2D6-substrat) og chlorzoxazon (CYP2E1-substrat) eller farmakokinetikken af warfarin (CYP2C9-substrat), methylprednisolon (CYP3A4-substrat) eller digoxin (MDR1 P-glycoproteinsubstrat).
English: Steady-state pharmacokinetics of lasofoxifene are consistent with expectations from its single-dose pharmacokinetics.
Danish: Lasofoxifens steady state-farmakokinetik stemmer overens med, hvad der kunne forventes ud fra enkeltdosis-farmakokinetikken.
English: • The approaches recommended for mitigation of risk of venous thromboembolism based on the
Danish: • De anbefalede tiltag for at nedsætte risikoen for venøs tromboemboli baseret på produktresuméet,
English: 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).
Danish: 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).
English: Elderly:
Danish: Ældre:
English: 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.
Danish: Kvinderne i dette studie var i gennemsnit 67 år (interval 59 til 80) og i gennemsnit var der gået 20 år siden menopausen.
English: Lasofoxifene and its metabolites are primarily excreted in feces, with a minor component of urinary excretion of active substance-related material.
Danish: Lasofoxifen og dets metabolitter udskilles primært i fæces med kun en mindre del af det lasofoxifen-relaterede materiale udskilt i urinen.
English: More FABLYN-treated patients (7.0%) had a diagnostic procedure compared to placebo-treated patients (2.7%).
Danish: Flere Fablyn-behandlede patienter (7,0 %) end placebobehandlede patienter (2,7 %) fik foretaget en diagnostisk procedure.
English: These side effects may occur with certain frequencies, which are defined as follows:
Danish: Disse bivirkninger kan forekomme som vist nedenfor:
English: • 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.
Danish: • Øvrige indholdsstoffer: vandfrit lactose; mikrokrystalliseret cellulose; croscarmellose natrium; silica; kolloid vandfri silica; magnesiumstearat; sunset yellow FCF (E110); hypromellose; lactosemonohydrat; titandioxid (E171)og triacetin.
English: • Tiredness, abnormal or excessive bleeding commonly from the nose
Danish: • Træthed, unormal eller kraftig blødning, som oftest fra næsen
English: The tablets are provided in blister packs containing 7, 28 or 30 tablets, and in bottle packs containing 90 tablets.
Danish: Tabletterne findes i blisterpakninger med 7, 28 eller 30 tabletter, og i beholder med 90 tabletter.
English: 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.
Danish: 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.
English: Lasofoxifene was studied, as a single 0.25 mg dose, in healthy subjects and subjects with mild or moderate hepatic impairment.
Danish: Lasofoxifen blev undersøgt som en enkeltdosis på 0,25 mg hos raske frivillige og frivillige med mild eller moderat leverinsufficiens.
English: 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.
Danish: 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).
English: Effects on breast:
Danish: Virkninger på brystvæv:
English: Ketoconazole - The strong CYP3A4/5 inhibitor ketoconazole increased the systemic exposure of lasofoxifene by 20% which is not considered to be clinically meaningful.
Danish: Ketoconazol - Den stærke CYP3A4/5-inhibitor ketoconazol øger den systemiske eksponering for lasofoxifen med 20 %, hvilket ikke vurderes at være klinisk relevant.
English: • if you currently have or previously had blood clots, for example in your veins, lungs or eyes
Danish: • hvis De har eller har haft blodpropper, f.eks. i blodåre, lunger eller øjne (blodprop i benene,
English: 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.
Danish: 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.
English: FABLYN does not eliminate the risk of breast cancer (see section 5.1).
Danish: Fablyn eliminerer ikke risikoen for mammacancer (se pkt.
English: • if you have any vaginal bleeding.
Danish: • hvis De har blødning fra skeden.
English: Three metabolites of lasofoxifene were detected in plasma: the direct glucuronide conjugate, the glucuronide of a hydroxylated metabolite, and the methylated catechol.
Danish: Der er fundet tre metabolitter af lasofoxifen i plasma: det direkte glucuronidkonjugat, glucuronid af en hydroxyleret metabolit og methyleret catechol.
English: Triangular, peach-coloured, film-coated tablets debossed with “Pfizer” on one side and “OPR 05” on the other side.
Danish: Trekantede, ferskenfarvede filmovertrukne tabletter præget med “Pfizer” på den ene side og “OPR 05” på den anden side.
English: FABLYN has no effect on the risk of ER negative breast cancer or ER negative invasive breast cancers.
Danish: Fablyn påvirker ikke risikoen for østrogenreceptor-negativ mammacancer eller østrogenreceptor-negativ invasiv mammacancer.
English: • Swelling of hands, arms, feet or legs, limb pain
Danish: • Hævede hænder, arme, fødder eller ben, bensmerter
English: New radiographic vertebral fracture in patients with ≥ 1 baseline fracture
Danish: Nye radiografisk verificerede rygsøjlefrakturer hos patienter med ≥ 1 baseline-fraktur
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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.
Danish: Fablyn filmovertrukne tabletter findes i PVC-blisterpakninger med aluminumsfolie eller i HDPEbeholdere med børnesikret polypropylenlåg, der er beklædt med polyethylen/aluminumsfolie.
English: It results in increased mean endometrial thickness.
Danish: Dette medfører en forøgelse af den gennemsnitlige endometrietykkelse.
English: No data are available on its concomitant use with agents used in the treatment of early or advanced breast cancer.
Danish: Der findes ingen oplysninger om samtidig brug af Fablyn og midler mod tidlig eller fremskreden mammacancer.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: 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)).
Danish: 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)).
English: 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.
Danish: Der er ikke observeret nogen klinisk betydende ændringer i lasofoxifens farmakokinetik i aldersgruppen 40 til 80 år i en farmakokinetisk populationsanalyse.
English: The duration of treatment in postmenopausal women was 60 months, 2,852 were randomized to FABLYN and 2,852 were randomized to placebo.
Danish: I alt 2852 personer blev randomiseret til Fablyn og 2852 til placebo.
English: No dose adjustment is necessary in elderly female patients (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos ældre kvindelige patienter (se pkt.
English: • 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)
Danish: • 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)
English: 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.
Danish: Fablyns virkning på knoglevæv viser sig ved reduktion af serumog urinindholdet af knogleomsætningsmarkører, forøgelse af knoglemineraldensiteten (BMD) samt nedsat forekomst af frakturer.
English: * Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial thickness findings.
Danish: * Endometriehypertrofi er en MedDRA-term, som betegner endometrietykkelse påvist ved ultralyd.
English: 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.
Danish: 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.
English: 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).
Danish: Risk-benefit bør vurderes for patienter med risiko for venøse tromboemboliske hændelser af enhver ætiologi (se pkt.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The apparent volume of distribution (V/F) of lasofoxifene in postmenopausal women is approximately 1,350 l.
Danish: Lasofoxifens fordelingsvolumen hos postmenopausale kvinder er ca. 1350 l.
English: • Infection in the ear, eye, respiratory tract or skin, diarrhea, blood in stools
Danish: • Betændelse i øret, øjet, halsen eller huden, diarré, blod i afføringen
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: 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.
Danish: 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.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 24 February 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Percentage of patients with new fracture n=778
Danish: Procentdel af patienter med nye frakturer n=778
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 90 film-coated tablets
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 90 filmovertrukne tabletter
English: Table 1: Adverse reactions observed in placebo-controlled osteoporosis treatment clinical trials in more FABLYN-treated women than in placebo-treated women
Danish: Tabel 1: Bivirkninger set i placebokontrollerede osteoporose-studier med en højere hyppighed hos Fablyn-behandlede end hos placebobehandlede kvinder
English: Endocrine disorders
Danish: Det endokrine system
English: 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.
Danish: 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.
English: Do not take FABLYN if you are pregnant or breast-feeding as it might be excreted in mother's milk.
Danish: Hvis De er gravid eller ammer, må De ikke tage FABLYN, da det kan udskilles i modermælken.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: FABLYN has not been studied in women with a prior history of breast cancer.
Danish: Fablyn er ikke undersøgt hos kvinder med mammacancer i anamnesen.
English: 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.
Danish: 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.