natgillin/translations-raw huggingface dataset:
Med den ene hånd presses de to kammerudløsningsknapper ind samtidigt på siden kk
ed With one hand, squeeze the two chamber release
af hoveddelen, mens hoveddelen trækkes hele vejen ud af kammeret med den anden hånd. i ge Læ
ris Buttons at the same time on the side of the base while pulling the base all the way out of the chamber with the other hand.
le
ho ut ra n ge lo
er
Cleaning o
66 Rengøring Kammer og mundstykke – 1 gang om ugen
Chamber and mouthpiece – once a week tn uc od pr al in
g als til Hvordan
How ic
et Skil insulininhalatoren ad.
Take your insulin inhaler apart. ed
er Drej mundstykket til åben position.
Turn the mouthpiece to the open position.
ris to au e Fugt en ren blød klud og anvend en mild flydende er
71 Dampen a clean soft cloth and use mild liquid soap to wipe the outside and inside of the chamber and mouthpiece.
kammeret i opvaskemaskine.
Do NOT put the chamber in the dishwasher.
Skyl sæben grundigt ud af kammeret og læ
Thoroughly rinse the soap out of the chamber and mouthpiece with warm water.
Sørg for at der ikke er vanddråber tilbage og luk herefter mundstykket. e
Ensure that no water droplets remain, and then close the mouthpiece.
Sæt kammeret tilbage i hoveddelen. kk
Reattach the chamber to the base.
Yderligere information om hvordan De sætter kammeret tilbage i hoveddelen, finder De i punktet i
ed For instructions on how to attach the chamber to the base refer to the section “Put your insulin inhaler together”.
” Sådan samles insulininhalatoren ”. er
ris If the washed chamber is not dry prior to taking your next dose, use your spare chamber.
Hvis det vaskede kammer ikke er tørt, før De tager næste dosis, skal De bruge reservekammeret. t le
ho Base - once a week
Hoveddelen – 1 gang om ugen id m ge Læ
ut ra n ge lo
67 Hvordan Kom ikke hoveddelen i vand.
Do not put the base in water. tn
Gør ikke indersiden af insulinfrigivelsesenheden våd.
Do not get the inside of the IRU wet. uc
Brug ikke sæbe eller andre rengøringsmidler.
Do not use soap or any other cleanser. od
Fugt en ren, blød klud med vand.
Dampen a clean soft cloth with water. pr
g al Vær opmærksom på, at der ikke må komme vand ind i insulinfrigivelsesenheden, når De gør toppen
While cleaning the top of the base be careful not to get any water into the IRU.
På dette tidspunkt må
Do not take the IRU out at this time.
Det blå
Keep the blue handle al
t håndtag skal være lukket.
closed in
et Aftør kun TOPPEN og YDERSIDEN af
Wipe only the TOP and OUTSIDE surfaces of ic
er hoveddelen.
the Base.
Aftør ikke blisteråbningen.
Do not wipe the blister slot ed M
ris Hold toppen af hoveddelen op mod bunden af kammeret.
72 Put your insulin inhaler together Line the top of the base with the open end of the chamber.
Den blå prik i bunden af kammeret skal
The blue dot on the bottom of the chamber must be on the same side as the blue button.
Skub hoveddelen tilbage i kammeret. au e er ng læ e kk
Push the base back into the chamber to store.
Opbevar insulininhalatoren på et tørt sted ved stuetemperatur. i
ed ris ho Store your insulin inhaler in a dry place at room
UDSKIFTNING AF INSULINFRIGIVELSES - er
REPLACING YOUR INSULIN RELEASE
ENHEDEN Udskift insulinfrigivelsesenheden t le
ra UNIT (IRU) Change the IRU
hver 2. uge De skal udgå at tage EXUBERA i fugtige id
Every 2 weeks You should avoid taking EXUBERA in moist c onditions e.g. a bathroom following a steamy n ge lo shower as this will usually give you a lower insulin dose than you need (see package leaflet o
omgivelser f. eks. i et badeværelse efter et m
on the blisters for advice). tn
dampende bad, da dette sædvanligvis vil give Dem mindre insulin end De har behov for (se yderligere ge
In this case you uc
Hvis De ved et uheld udsætter Deres inhalator for Læ
must change the IRU prior to you next inhalation. od
Mens kammeret fjernes fra hoveddelen (se ” Skil insulininhalatoren ad ”), holdes hoveddelen i
How Take out the used IRU While the chamber is removed from the base pr
¼ omgang mod uret hen til aflåsningssymbolet.
(see “Take your insulin inhaler apart”), hold the base in your hand with the grey button facing al
g als Træk den brugte insulinfrigivelsesenhed op og ud
Turn the used IRU about a one-quarter turn counter clockwise towards the unlock symbol. in ic ed M
il af hoveddelen og smid denne væk.
73 Pull the used IRU up and out of the base and discard.
t et Smid den brugte insulinfrigivelsesenhed væk i henhold til de lokale krav eller tjek dette med
Dispose of the us ed IRU safely according to local requirements or check with your healthcare professional.
er sundhedspersonalet.
ed Put in a new IRU
ris to Indsæt en ny insulinfrigivelsesenhed au e er
ris Remove the IRU from its packaging.
Tag insulinfrigivelsesenheden ud af pakningen. ng
ho Hold the new IRU so the top is facing you.
De vil kunne se en læ
You will see a blue line on it.
insulinfrigivelsesenheden er placeret udfor er
While holding the IRU
aflåsningssymbolet på toppen af hoveddelen. t le
ut with one hand, turn the top counter-clockwise as far as it will go.
Skub forsigtigt insulinfrigivelsesenheden ind i hoveddelen.
ra Line up the blue line on the top of the IRU with the unlock symbol on the top of the base. n ge lo Push the IRU gently into the base.
Pres ikke denne ind, den skal nemt id
Do not force, it should easily drop into place.
kunne sættes på plads, (hvis den nye insulinfrigivelsesenhed ikke kan sættes på plads m
does not drop into place or fits tightly, remove tn
eller sidder stramt, fjern da denne og prøv igen). ge
and try again). uc
Drej toppen af insulinfrigivelsesenheden med uret, Læ
Turn the top of the IRU clockwise until the blue od
indtil den blå streg peger mod låsesymbolet på toppen af hoveddelen.
line points to the lock symbol on the top of the base.
Den nye insulinfrigivelsesenhed er nu låst på plads.
The new IRU is now locked in place. pr al in ic ed M
69
74
London, den 25. september 2008 Dok. ref.
Ref.
EMEA/ 548372/ 2008
EMEA/ 477488/ 2008
Den 9. september 2008 meddelte Pfizer Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at det ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for EXULETT til behandling af komplicerede hud - og bløddelsinfektioner hos voksne, når de vides eller formodes at være forårsaget af modtagelige grampositive bakterier.
On 9 September 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for EXULETT, for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
EXULETT skulle have været anvendt til behandling af voksne med komplicerede infektioner i huden og ‘ bløddelene ’ under huden. ‘ Kompliceret ’ betyder, at infektionen er vanskelig at behandle, fordi den har spredt sig til det dybereliggende væv under huden, fordi kirurgisk behandling kan blive nødvendig, eller for patienten har andre lidelser, som kan have indvirkning på behandlingsresponsen.
EXULETT was to be used to treat adults with complicated infections of the skin and the ‘ soft tissues’ below the skin. ‘ Complicated’ means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
EXULETT skulle udelukkende have været anvendt, når man vidste eller formodede, at infektionen var forårsaget af bakterietyper, der er klassificeret som ‘ grampositive ’, og som ville blive dræbt af lægemidlet.
EXULETT was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘ Gram-positive’ and that would be killed by the medicine.
Disse bakterier omfatter Staphylococcus aureus (herunder ‘ meticillin- resistente ’ former kendt som ‘ MRSA ’) og Streptococcus pyogenes.
These bacteria include Staphylococcus aureus (including ‘ methicillin-resistant’ forms known as ‘ MRSA’) and Streptococcus pyogenes.
Det aktive stof i EXULETT, dalbavancin, er et antibiotikum, som tilhører gruppen af ‘ glycopeptider ’.
The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘ glycopeptides’.
Det krævedes, at patienterne, som indgik i denne undersøgelse, havde komplicerede hud - og bløddelsinfektioner (såsom bylder eller sårinfektioner), der skyldtes grampositive bakterier.
The patients included in this study were required to have complicated skin and soft tissue infections (such as abscesses or wound infections) that were due to Gram-positive bacteria.
Når virksomheden har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. inden udvalget afgiver en udtalelse, stille eventuelle supplerende spørgsmål til virksomheden på dag 180.
Reproduction is authorised provided the source is acknowledged.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP' s liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at EXULETT ikke kunne godkendes til behandling af komplicerede hud - og bløddelsinfektioner hos voksne, når de vides eller formodes at være forårsaget af modtagelige grampositive bakterier.
Based on the review of the data and the company’ s response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that EXULETT could not have been approved for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
På tilbagetrækningstidspunktet var det derfor CHMP' s opfattelse, at fordelene ved EXULETT ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of EXULETT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
1 BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET DER SKAL IMPLEMENTERES AF MEDLEMSLANDENE
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
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.
Programmaterialet skal være tilgængeligt som følger: • Web- baseret • På CD • På papir
The programme materials shall be provided via the following means: • Web-based • On CD • Printed on paper
Programmet skal indeholde følgende primære budskaber: • FABLYN øger risikoen for venøs tromboemboli (VTE). • De anbefalede tiltag for at nedsætte risikoen for venøs tromboemboli baseret på produktresuméet, herunder kontraindikationen vedrørende patienter med aktiv eller tidligere tilfælde af VTE. • FABLYN medfører morfologiske forandringer, især cystisk atrofi i endometriet.
The programme shall convey the following key messages: • FABLYN increases risk of venous thromboembolism (VTE). • The approaches recommended for mitigation of risk of venous thromboembolism based on the SmPC, including contraindication of FABLYN in patients with active or past history of VTE. • FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.
Dette medfører en forøgelse af den gennemsnitlige endometrietykkelse. • På baggrund af kliniske studier er de morfologiske forandringer, forårsaget af FABLYN, godartede og kræver ikke yderligere undersøgelser, medmindre der opstår vaginalblødning. • Referencer til myndighedernes internationale guidelines, der er relevante for kontrol af uterus. • Behovet for at stoppe behandlingen med FABLYN og foretage undersøgelse, hvis der opstår uforudset uterusblødning.
It results in increased mean endometrial thickness. • Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs. • References to authoritative international guidelines relevant for uterine surveillance. • The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding occurs.
Det fås som trekantede, ferskenfarvede tabletter (500 mikrogram).
It is available as triangular, peach-coloured tablets (500 micrograms).
Tabletten kan tages på alle tidspunkter af dagen og uden hensyntagen til indtagelse af mad og drikke.
It can be taken at any time of day, with or without food or drink.
Fablyn bør anvendes med forsigtighed til kvinder med svær lever - eller nyresygdom.
Fablyn should be used with caution in women with severe liver or kidney problems.
Gradvist bliver knoglerne tynde og skøre, og sandsynligheden for brud (fraktur) øges.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Lasofoxifen virker som en østrogenreceptor “ agonist ” (et stof, som stimulerer østrogenreceptoren) i visse former for kropsvæv.
Lasofoxifene acts as an ‘ agonist ’ of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Lasofoxifen har samme effekt som østrogen i knoglerne.
The effects of Fablyn were first tested in experimental models before being studied in humans.
Virkningen blev hovedsageligt bedømt på antallet af kvinder, som fik et nyt brud på rygsøjlen, vurderet ud fra røntgenbilleder.
The main measure of effectiveness was the number of women who had a new fracture in the spine as seen on X-rays.
I løbet af fem år fik 6% af de kvinder, som fik Fablyn 500 mikrogram, et nyt rygsøjlebrud (155 ud af 2 748) sammenlignet med 9% af dem, der fik placebo (255 ud af 2 744).
Over five years, 6% of the women taking Fablyn 500 micrograms had a new spine fracture (155 out of 2,748), compared with 9% of those taking placebo (255 out of 2,744).
Den fuldstændige liste over indberettede bivirkninger ved Fablyn fremgår af indlægssedlen.
For the full list of all side effects reported with Fablyn, see the Package Leaflet.
Fablyn bør ikke anvendes af personer, der kan være overfølsomme (allergiske) over for lasofoxifen eller et eller flere af de øvrige indholdsstoffer.
Fablyn should not be used in people who may be hypersensitive (allergic) to lasofoxifene or any of the other ingredients.
Det må ikke anvendes til patienter, som har haft problemer med venøs tromboemboli, herunder dyb venøs trombose, lungeemboli (blodprop i lungerne) og retinal venetrombose (blodprop i øjets nethinde).
It must not be used in patients who have had problems with venous thromboembolism including deep vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Fablyn må kun anvendes til kvinder, der har været gennem overgangsalderen, og må derfor ikke anvendes til kvinder, som kan blive gravide, eller kvinder, som er gravide eller ammer.
Fablyn is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant, or women who are pregnant or breast-feeding.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Fablyn er større end risiciene ved behandling af osteoporose hos postmenopausale kvinder, som er i højrisikogruppen for brud.
The Committee for Medicinal Products for Human Use (CHMP) decided that Fablyn’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Fablyn.
The Committee recommended that Fablyn be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Fablyn?
Which measures are being taken to ensure the safe use of Fablyn?
Andre oplysninger om Fablyn:
Other information about Fablyn:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fablyn til Pfizer Limited den 24. februar 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Fablyn to Pfizer Limited on 24 February 2009.
Den fuldstændige EPAR for Fablyn findes her.
The full EPAR for Fablyn can be found here.
EU- nummer EU/ 1/ 08/ 500/ 001 EU/ 1/ 08/ 500/ 002 EU/ 1/ 08/ 500/ 003 EU/ 1/ 08/ 500/ 004
EU/ 1/ 08/ 500/ 001 EU/ 1/ 08/ 500/ 002 EU/ 1/ 08/ 500/ 003 EU/ 1/ 08/ 500/ 004
Særnavn FABLYN FABLYN FABLYN FABLYN
FABLYN FABLYN FABLYN FABLYN
Styrke 500 μg 500 μg 500 μg 500 μg
500 μ g 500 μ g 500 μ g 500 μ g
Lægemiddelform Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Emballage Blister (PV/ PVC/ alu) Blister (PV/ PVC/ alu) Blister (PV/ PVC/ alu) Beholder (HDPE)
Blister (PV/ PVC/ alu) Blister (PV/ PVC/ alu) Blister (PV/ PVC/ alu) Bottle (HDPE)
Paknings- størrelse 7 tabletter 28 tabletter 30 tabletter 90 tabletter
7 tablets 28 tablets 30 tablets 90 tablets
Hver filmovertrukken tablet indeholder 71, 34 mg lactose.
Each film-coated tablet contains 71.34 mg lactose.
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.
5. 1).
A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).
5. 1).
When determining the choice of FABLYN or other therapies, including estrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
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.
Postmenopausale kvinder behøver i gennemsnit 1500 mg calcium dagligt.
Postmenopausal women require an average of 1,500 mg/ day of elemental calcium.
Det anbefalede daglige indtag af vitamin D er 400- 800 IU.
The recommended intake of vitamin D is 400-800 IU daily.
5. 2).
Therefore safety and efficacy have not been studied (see section 5.2).
2 Ældre kvinder (65 år eller derover):
2 Elderly women (65 years and older):
5. 2).
No dose adjustment is necessary in elderly female patients (see section 5.2).
5. 2).
No dose adjustment is required in patients with mild to moderate hepatic insufficiency (see section 5.2).
Derfor skal der udvises forsigtighed ved behandling af disse patienter.
Safety and efficacy of lasofoxifene have not been evaluated in patients with hepatic insufficiency with liver function test > 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
5. 2).
No dose adjustment is necessary in patients with mild or moderate renal insufficiency (see section 5.2).
Derfor skal der udvises forsigtighed ved behandling af disse patienter.
Safety and efficacy of lasofoxifene have not been evaluated in patients with severe renal insufficiency; therefore, FABLYN should be used with caution in these patients.
5. 1).
Due to the chronic nature of the disease process, FABLYN is intended for long-term use (see section 5.1).
Graviditet og amning:
Pregnancy and lactation:
4. 6).
It must not be taken by women of child-bearing potential, pregnant women and lactating women (see section 4.6).
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.
4. 3 og 4. 8).
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).
Da immobilisering i sig selv øger risikoen for venøse tromboemboliske hændelser, bør Fablyn seponeres mindst 3 uger før og under langvarig immobilisering (f. eks. post- operativ hvile, forlænget sengeleje), og behandlingen bør først genoptages, når patienten er fuldt oppegående.
Because immobilization increases the risk for venous thromboembolic events independent of therapy, FABLYN should be discontinued at least 3 weeks prior to and during prolonged immobilization (e. g., post-surgical recovery, prolonged bed rest), and therapy should be resumed only after the patient is fully ambulatory.
5. 1).
FABLYN-treated and placebo-treated groups had similar incidences of endometrial hyperplasia and endometrial cancer (see section 5.1).
3 Lasofoxifen har været forbundet med benigne endometrielle påvirkninger.
3 Lasofoxifene has been associated with benign endometrial effects.
1, 5 mm.
These cystic findings contributed to an approximate 1.5 mm increase in mean endometrial thickness.
Som følge af disse benigne påvirkninger fik flere Fablyn- behandlede end placebo- behandlede patienter foretaget en diagnostisk undersøgelse af uterus under PEARL- studiet (se pkt.
As a consequence of these benign effects, more FABLYN-treated patients had a diagnostic uterine procedure compared to placebo-treated patients in the PEARL trial (see section 5.1).
Fablyn bør derfor ikke anvendes sammen med systemisk østrogenbehandling.
The concurrent use of FABLYN and systemic estrogen or hormone therapy has not been studied and therefore concomitant use of FABLYN with systemic estrogens is not recommended.
Alle uforklarede mammaforandringer, opstået under Fablyn- behandling, bør undersøges.
Any unexplained breast abnormality occurring during FABLYN therapy should be investigated.
5. 1).
FABLYN does not eliminate the risk of breast cancer (see section 5.1).
Begrænsede kliniske data tyder på, at lasofoxifen kan være forbundet med en stigning i triglyceridniveauet i serum hos patienter med tidligere oral østrogeninduceret hypertriglyceridæmi (> 5, 6 mmol/ l).
Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (> 5.6 mmol/ l), lasofoxifene may be associated with a marked increase in serum triglycerides.
5. 2).
Lasofoxifene is highly protein bound, predominantly cleared by metabolism and is likely to undergo enterohepatic circulation (see section 5.2).
Derfor bør der udvises forsigtighed ved brug af Fablyn til disse patienter.
Safety and efficacy of FABLYN have not been evaluated in patients with liver function test > 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
5. 2).
Safety and efficacy of FABLYN have not been evaluated in patients with severe renal insufficiency; therefore, FABLYN should be used with caution in these patients (see section 4.2 and section 5.2).
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp lactase deficiency) eller glucose/ galactose- malabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Derfor antages andre anionbytter- resiner og andre inhibitorer af disse CYP- isoformer ikke at forårsage klinisk relevante ændringer i Fablyn- eksponeringen, og dosisjustering er derfor ikke nødvendig.
Based on the absence of clinically relevant effects of cholestyramine (anion exchange resin), fluconazole (CYP2C9 inhibitor), ketoconazole (CYP3A4/ 5 inhibitor) and paroxetine (CYP2D6 inhibitor) on lasofoxifene pharmacokinetics, other anion exchange resins and other inhibitors of these CYP isoforms are unlikely to produce clinically meaningful alterations in FABLYN exposure and no dose adjustments are required.