natgillin/translations-raw huggingface dataset:
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.
Sequential treatment consisted of first-line capecitabine (1250 mg/m2 twice daily for 14 days), second-line irinotecan (350 mg/m2 on day
Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 7 mg vandfri lactose.
Each film-coated tablet contains 7 mg anhydrous lactose.
Oversigt over indlægssedlen:
Encephalopathy:
DPD-mangel
Renal impairment
Hævelse af led, Knoglesmerter, Ansigtssmerter, Muskuloskeletal stivhed,
Joint swelling, Bone pain, Facial pain, Musculoskeletal stiffness, Muscular weakness
EU/1/12/763/013 30 filmovertrukne tabletter EU/1/12/763/014 60 filmovertrukne tabletter EU/1/12/763/015 120 filmovertrukne tabletter
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
EU/1/12/763/016 30 filmovertrukne tabletter EU/1/12/763/017 60 filmovertrukne tabletter EU/1/12/763/018 120 filmovertrukne tabletter
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
intravenøs 22 timer
intravenous 2 hr
9/l, eller antallet af blodplader falder til under 75 x 10
9/L or that the platelet count drops below
30 Filmovertrukne tabletter: EU/1/12/763/016 60 Filmovertrukne tabletter: EU/1/12/763/017 120 Filmovertrukne tabletter: EU/1/12/763/018
- 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
Fortsæt med samme dosis
Maintain dose level
Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 25 mg vandfri lactose.
Each film-coated tablet contains 25 mg anhydrous lactose.
Kolonkræft, kolorektalkræft og ventrikelkræft
Colon, colorectal and gastric cancer
30 Filmovertrukne tabletter: EU/1/12/763/010 60 Filmovertrukne tabletter: EU/1/12/763/011 120 Filmovertrukne tabletter: EU/1/12/763/012
- 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
EU/1/12/763/007 30 filmovertrukne tabletter EU/1/12/763/008 60 filmovertrukne tabletter EU/1/12/763/009 120 filmovertrukne tabletter
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
30 Filmovertrukne tabletter: EU/1/12/763/007 60 Filmovertrukne tabletter: EU/1/12/763/008 120 Filmovertrukne tabletter: EU/1/12/763/009
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
EU/1/12/763/010 30 filmovertrukne tabletter EU/1/12/763/011 60 filmovertrukne tabletter EU/1/12/763/012 120 filmovertrukne tabletter
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
Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 15 mg vandfri lactose.
Each film-coated tablet contains 15 mg anhydrous lactose.
EU/1/12/763/001 30 filmovertrukne tabletter EU/1/12/763/002 60 filmovertrukne tabletter EU/1/12/763/003 120 filmovertrukne tabletter
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
Gastrointestinal blødning, Konstipation, Øvre abdominale smerter,
Gastrointestinal haemorrhage, Constipation, Upper abdominal pain, Dyspepsia, Flatulence, Dry mouth
linjebehandling med capecitabin (1.000 mg/m to gange dagligt i 14 dage) plus oxaliplatin (130 mg/m på dag 1).
1), and third-line combination of capecitabine (1000 mg/m 2 twice daily for 14 days) with oxaliplatin
30 Filmovertrukne tabletter: EU/1/12/763/004 60 Filmovertrukne tabletter: EU/1/12/763/005 120 Filmovertrukne tabletter: EU/1/12/763/006
- 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
30 Filmovertrukne tabletter: EU/1/12/763/013 60 Filmovertrukne tabletter: EU/1/12/763/014 120 Filmovertrukne tabletter: EU/1/12/763/015
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
Perifere ødemer, Utilpashed, Brystsmerter
Pyrexia, Oedema peripheral, Malaise, Chest pain
EU/1/12/763/004 30 filmovertrukne tabletter EU/1/12/763/005 60 filmovertrukne tabletter EU/1/12/763/006 120 filmovertrukne tabletter
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
Hud og subkutane væv Alopeci, Neglesygdomme
Headache, Lethargy Dizziness, Paraesthesia, Dysgeusia
Nedre abdominale smerter,
Hepatic impairment.
Kvalme,
Diabetes,
30 Filmovertrukne tabletter: EU/1/12/763/001 60 Filmovertrukne tabletter: EU/1/12/763/002 120 Filmovertrukne tabletter: EU/1/12/763/003
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
Ældre (se pkt.
Elderly (see section 4.2):
De kan få brug for at læse den igen.
You may need to read it again.
Den potentielle risiko for mennesker kendes ikke.
The potential risk for humans is unknown.
• Efter anmodning fra EMEA
• At the request of the EMEA
• hvis De stadig kan blive gravid.
• if you could still become pregnant.
• ANDRE BETINGELSER
• OTHER CONDITIONS
• Når der modtages ny information, som kan påvirke den gældende sikkerhedsspecifikation,
• When new information is received that may impact on the current Safety Specification,
Linearitet/non-linearitet:
Linearity/non-linearity:
Ligeledes skal en opdateret RMP indsendes
In addition, an updated RMP should be submitted
Børn og unge under 18 år:
Children and adolescents below 18 years of age:
Programmet skal have både elektroniske og printede skemaer, som har identisk indhold.
The programme shall have both electronic and printed form, which are identical in terms of content.
Programmet skal indeholde følgende primære budskaber:
The programme shall convey the following key messages:
Ældre kvinder (65 år eller derover):
Elderly women (65 years and older):
De må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
Do not take a double dose to make up for a forgotten tablet.
• Web-baseret
• Web-based
• Ændring af appetitten
• Change in appetite
Må ikke anvendes, hvis pakningen har været åbnet.
Do not use if box has been opened.
• På CD
• On CD
• Bivirkninger, hvor hyppigheden ikke er kendt: Hyppigheden kan ikke bestemmes ud fra de tilgængelige data
• Not known: frequency cannot be estimated from the available data
Deres læge kan anbefale, at De stopper behandlingen mindst 3 uger, inden De skal indlægges.
Your doctor may recommend that you stop treatment at least 3 weeks prior to this time.
• Referencer til myndigheders internationale guidelines, der er relevante for kontrol af uterus.
• References to authoritative international guidelines relevant for uterine surveillance.
De har eller har haft brystkræft.
• if you have or have had breast cancer.
Alle histologiske fund var benigne.
All histology findings were benign.
Navn og adresse på fremstilleren af det biologisk aktive stof Ikke relevant.
Name and address of the manufacturer of the biological active substance Not applicable
• BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Denne binding resulterer i aktivering af nogle østrogen-pathways og blokering af andre.
This binding results in the activation of some estrogenic pathways and a blockade of others.
Pharmacovigilancesystem
Pharmacovigilance system
Selvom alle disse tumorer anses for at være forårsaget af en gnaver-specifik hormonel mekanisme, er relevansen for mennesker ukendt.
Although all of these tumours are believed to be the result of rodent-specific hormonal mechanisms, their relevance for humans is currently unknown.
Voksne (postmenopausale kvinder):
Adult (postmenopausal women):
I tilfælde af overdosering skal der initieres generelt understøttende behandling afhængigt af patientens symptomer.
In the event of overdose, general supportive measures should be initiated based on the patient's signs and symptoms.
Det skal overholde myndighedernes internationale guidelines samt understøttes af udgivelser i medicinske tidsskrifter, der anvender peer review.
It must be in line with authoritative international guidelines and supported by evidence published in peer reviewed medical journals.
Disse ændringer vurderes ikke at være klinisk relevante.
These changes are not considered to be clinically meaningful.
Lasofoxifen er i høj grad bundet til proteiner i humant plasma (>99 %).
Lasofoxifene is highly bound to proteins in human plasma (>99%).
Den totale forekomst af vaginalblødning var lav (≤ 2,6 % i alle behandlingsgrupper).
The overall incidence of vaginal bleeding was low (≤ 2.6% in all treatment groups).
Denne stigning blev set efter 12 måneder, og steg ikke signifikant gennem de 3 år.
The increase was observed at 12 months, and did not significantly increase through 3 years.
Disse forskelle anses ikke for at være klinisk relevante.
These differences are not considered to be clinically meaningful.
Lignende resultater for vaginalt pH og MI sås i PEARL-studiet.
Similar results for vaginal pH and MI were observed in the PEARL study.
pharmacovigilance-plan eller risikominimeringsaktiviteter.
Pharmacovigilance Plan or risk minimisation activities
Programmaterialet skal være tilgængeligt som følger:
The programme materials shall be provided via the following means:
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).
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).
De fleste bivirkninger, der blev set i studierne, var milde og krævede generelt ikke seponering af behandlingen.
Most of the adverse reactions occurring during the studies were mild and generally did not require discontinuation of therapy.
Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Pfizer Manufacturing Deutschland GmbH
Name and address of the manufacturer responsible for batch release Pfizer Manufacturing Deutschland GmbH
• Diabetes (de typiske symptomer er øget tørst, hyppig vandladning)
• Diabetes (typical symptoms are excessive thirst, frequent urination)
En ud af 11 patienter fik hedeture, som hyppigst blev set i de første 6 måneder af behandlingen.
Hot flush occurred in about one in 11 patients and was most commonly reported during the first 6 months of treatment.
FABLYN kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, FABLYN can cause side effects, although not everybody gets them.
-Alle kliniske frakturer
-All clinical fractures
Indenfor hver organklasse og hyppighed er bivirkningerne ikke opstillet efter hvor alvorlige de er, men i alfabetisk rækkefølge.
In each system organ class and frequency, adverse reactions are not presented in order of decreasing seriousness but in alphabetical order.
Denne medicin kræver ingen særlige forholdsregler vedrørende opbevaringen.
This medicine does not require any special storage conditions.
Der findes ikke tilstrækkelige data vedrørende brugen af lasofoxifen til gravide.
There are no adequate data from the use of lasofoxifene in pregnant women.
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.
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.
Virkninger på lipidmetabolisme og kardiovaskulær risiko:
Effects on lipid metabolism and cardiovascular risk:
Der skal suppleres med calcium og/eller vitamin D, hvis det daglige indtag ikke er tilstrækkeligt.
Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.
Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen.
Read all of this leaflet carefully before you start taking this medicine.
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
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
Fremstiller er: Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Tyskland.
The Manufacturer is Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Germany.
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)).
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)).
Lasofoxifens egenskaber blev evalueret hos 758 patienter i konventionelle kliniske farmakologistudier.
The disposition of lasofoxifene was evaluated in 758 subjects in conventional clinical pharmacology studies.
Fablyn Placebo Relativ risikoreduk tion (95% CI) vs. placebo
FABLYN Placebo Relative risk reduction (95% CI) vs. placebo
• hvis De er gravid eller ammer.
• if you are pregnant or breast-feeding.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Desuden bør kvinder i behandling med Fablyn vejledes om jævnligt at bevæge sig under længerevarende rejser.
In addition, women taking FABLYN should be advised to move about periodically during prolonged travel.
Programmet skal inkludere produktresuméets fulde tekst.
The programme shall include the full text of the SmPC.
A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Resultater fra 1-års-studie med asiatiske patienter
Results from one-year trial in Asian subjects
Tabel 2: Forekomsten af frakturer hos postmenopausale kvinder gennem 5 år
Table 2: Fracture incidence in postmenopausal women over 5 years
Dette skal undersøges af Deres læge, inden De begynder at tage
This must be investigated by your doctor before starting treatment.
Uforklaret uterin blødning.
Unexplained uterine bleeding.
• Inden for 60 dage efter, en vigtig milepæl er nået i forbindelse med pharmacovigilance eller risikominimering.
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
INFORMATION I BRAILLE-SKRIFT FABLYN
INFORMATION IN BRAILLE FABLYN
Overordnet set svarer de observerede virkninger på reproduktion og udvikling hos dyr til de virkninger, der er set med stoffer i SERM-klassen.
Overall, the reproductive and developmental effects observed in animals are consistent with the SERM class of compounds.
Dette program bør fokusere på fortolkning af endometriebiopsier fra kvinder i behandling med FABLYN.
This programme should focus on interpretation of endometrial biopsy of women treated with FABLYN.
Indtagelse af et måltid med højt fedtindhold ændrer ikke den orale biotilgængelighed af lasofoxifen.
Ingestion of a high fat meal does not change the oral bioavailability of lasofoxifene.
Lasofoxifen bindes til både albumin og α1-acid glycoprotein, men påvirker ikke bindingen af hverken warfarin eller propranolol.
Lasofoxifene binds to both albumin and α1-acid glycoprotein; however, it does not affect the binding of either warfarin or propranolol.
Filmovertrukken tablet.
Film-coated tablet.
Vigtig information om nogle af de øvrige indholdsstoffer i FABLYN FABLYN indeholder lactose.
Important information about some of the ingredients of FABLYN FABLYN contains lactose.
Muskelsitren sås hos 1 ud af 9 patienter.
Muscle spasms occurred in about one in 9 patients .
• hvis De er overfølsom (allergisk) over for lasofoxifen eller et af de øvrige indholdsstoffer.
• if you are allergic (hypersensitive) to lasofoxifene or any of the other ingredients of FABLYN.
• Behovet for at stoppe behandlingen med FABLYN og foretage undersøgelser, hvis der opstår uforudset uterusblødning.
• The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding occurs.
Hvis De sidder for lang tid i den samme stilling, kan Deres blodcirkulation forværres, og det øger risikoen for blodpropper.
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.
Behandlingen nedsatte også knogleomsætningsmarkører.
It also reduced markers of bone turnover.
Der findes ingen specifik antidot til Fablyn.
There is no specific antidote for FABLYN.
Virkninger på endometriet:
Effects on the endometrium:
Rygsøjlefrakturer er den mest almindelige type fraktur som følge af osteoporose hos postmenopausale kvinder.
Vertebral fractures are the most common type of osteoporotic fracture in postmenopausal women.
5-årsresultater fra stort, multinationalt frakturstudie (PEARL)
5-year results from large, multinational fracture trial (PEARL)
Postmenopausale kvinder behøver i gennemsnit 1500 mg calcium dagligt.
Postmenopausal women require an average of 1,500 mg/day of elemental calcium.
Warfarin - Lasofoxifen havde ingen virkning på farmakokinetikken af R- og S-warfarin.
Warfarin - Lasofoxifene had no effect on the pharmacokinetics of R- and S- warfarin.
Farmakoterapeutisk klassifikation: Selektiv østrogenreceptormodulator (SERM), ATC-kode: {not yet assigned}
Pharmacotherapeutic group: Selective Estrogen Receptor Modulator (SERM), ATC code: {not yet assigned}
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Eberth
NAME OF THE MARKETING AUTHORISATION HOLDER Eberth
Indehaveren af markedsføringstilladelsen skal også give adgang til uddannelsesprogrammer for patologer.
The MAH shall also provide access to educational programme for pathologists.
-Non-vertebrale frakturer
-Non-vertebral fractures
Denne analyse inkluderede 2049 postmenopausale kvinder, bestående af 85,5 % kaukasiske, 8,6 % latin-amerikanske, 3,4 % asiatiske og 1,9 % afro-amerikanske kvinder.
This analysis included 2,049 postmenopausal women consisting of 85.5% Caucasian, 8.6% Hispanic, 3.4% Asian, and 1.9% African American.
Nogle asymptomatiske patienter kan muligvis opleve hedeture efter start af behandling.
In some asymptomatic patients, hot flushes may occur upon beginning therapy.
Hjælpestoffer: Hver filmovertrukken tablet indeholder 71,34 mg lactose.
Excipient: Each film-coated tablet contains 71.34 mg lactose.
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.
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.
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.
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.
Denne reduktion blev set gennem det første år og blev fastholdt gennem 5 år.
This decrease was observed through the first year and was maintained through 5 years.
Alle tilfælde af uforklaret vaginalblødning skal undersøges, hvis det er klinisk indiceret.
Any unexplained vaginal bleeding should be investigated as clinically indicated.
• 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.
• if you are taking FABLYN, you should walk around or exercise your legs and feet at regular intervals when traveling long distances.
I dette studie øgede Fablyn signifikant rygsøjle- og hofte-BMD (total hofte og alle subkomponenter af hoften) med 2 til 4 %.
In this study, FABLYN significantly increased spine and hip (total hip and all subcomponents of the hip) BMD by 2 to 4%.
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.
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.
Virkninger på vulvovaginal atrofi (VVA):
Effects on vulvar and vaginal atrophy (VVA):
YDERLIGERE OPLYSNINGER
Further information
Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer før og under markedsføringen af lægemidlet.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Lasofoxifen har været forbundet med benigne endometrielle påvirkninger.
Lasofoxifene has been associated with benign endometrial effects.
Mindre end 2 % af den administrerede dosis blev genfundet i urinen som uomdannet lasofoxifen.
Less than 2% of the administered dose was recovered in the urine as unchanged lasofoxifene.
Da Fablyn udelukkende er indiceret til brug hos postmenopausale kvinder, er der ikke foretaget nogen vurdering af effekten af køn på lasofoxifens farmakokinetik.
Since FABLYN is indicated for use only in postmenopausal women, no assessment of the effect of gender on lasofoxifene pharmacokinetics has been made.
Farmakokinetiske data fra mere end 2000 postmenopausale kvinder, inklusive patienter i udvalgte osteoporose-studier, har dannet grundlag for en populationsfarmakokinetisk analyse.
Pharmacokinetic data from over 2,000 postmenopausal women including patients in selected osteoporosis clinical trials contributed to a population pharmacokinetic analysis.
• På papir
• Printed on paper
Der sås også andre venøse tromboemboliske hændelser.
Other venous thromboembolic events could also occur.
• FABLYN øger risikoen for venøs tromboemboli (VTE).
• FABLYN increases risk of venous thromboembolism (VTE).
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Forseglet pakning.
OTHER SPECIAL WARNING(S), IF NECESSARY Sealed pack.
Lasofoxifen var ikke genotoksisk i nogen af de omfattende tests, som blev benyttet.
Lasofoxifene was not genotoxic in any of the battery of tests applied.
Det er derfor usandsynligt, at Fablyn ændrer farmakokinetikken af lægemidler, der metaboliseres via disse CYPisoformer eller transporteres af MDR1 P-glycoprotein.
Therefore FABLYN is unlikely to alter the pharmacokinetics of medicinal products that are cleared by metabolism via these CYP isoforms, or are transported by MDR1 P-glycoprotein.
Den anbefalede dosis er en tablet på 500 µg dagligt.
The recommended dose is one 500 microgram tablet daily.