natgillin/translations-raw huggingface dataset:
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, selective estrogen receptor modulators, ATC code: G03XC05.
selektivni modulatorji estrogenskega receptorja, oznaka ATC: G03XC05.
Your doctor may recommend that you stop treatment at least 4 to 6 weeks prior to major surgery or during a long period of bed rest e.g. injury or illness.
da vsaj 4 do 6 tednov pred večjo operacijo ali med daljšo nepokretnostjo, npr. zaradi poškodbe ali bolezni, prenehate z zdravljenjem.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
This happens naturally after menopause (post-menopause).
Po menopavzi (pomenopavzno) se to zgodi naravno.
This difference is not considered clinically relevant and no dose adjustment is necessary in patients with renal impairment.
Ta razlika ne šteje kot klinično pomembna, zato odmerka pri bolnicah z ledvično okvaro ni treba prilagajati.
Breast cancer
Rak na dojki
Senshio tablets are oval biconvex, white to off-white, film-coated tablets (approximately 12 mm long by 6.45 mm wide) debossed with “60” on one side.
Zdravilo Senshio tablete so ovalne, bikonveksne, bele do belkaste, filmsko obložene tablete (dolge približno 12 mm in široke približno 6,45) z vtisnjeno oznako "60" na eni strani.
Relief
Olajšanje
These changes in pharmacokinetics of ospemifene by moderate hepatic impairment are not considered to be clinically significant in consideration of inherent pharmacokinetic variability of ospemifene.
Te spremembe v farmakokinetiki ospemifena zaradi blage jetrne okvare ne veljajo kot klinično pomembne glede na inherentno farmakokinetično variabilnost ospemifena.
7 film-coated tablets 28 film-coated tablets 84 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 7 filmsko obloženih tablet 28 filmsko obloženih tablet 84 filmsko obloženih tablet
This binding results in activation of some oestrogenic pathways (agonism) and blockade of other oestrogenic pathways (antagonism).
Z vezavo se aktivirajo nekatere estrogenske poti (agonizem) in blokirajo druge estrogenske poti
Ospemifene is primarily metabolised by the liver.
Ospemifen se primarno presnavlja v jetrih.
Across all placebo controlled clinical trials, there was no significant difference in breast related adverse events between ospemifene and placebo.
V vseh s placebom kontroliranih kliničnih preskušanjih ni bilo značilnih razlik med ospemifenom in placebom v neželenih dogodkih,
If you forget to take Senshio
Če ste pozabili vzeti zdravilo Senshio
Decreases in oestrogen levels that occur after the menopause lead to VVA, characterised by decreased maturation of vaginal epithelial cells, a progressive decrease in the vascularity of the vaginal tissues, and decreased lubrication.
Zmanjšanje ravni estrogena po menopavzi povzroči VVA, za kar je značilen upad dozorevanja epitelijskih celic nožnice, progresivno zmanjšanje vaskularnosti tkiva nožnice in manjše vlaženje.
Ospemifene should be discontinued at least 4 to 6 weeks prior to and during prolonged immobilisation (e.g., post-surgical recovery, prolonged bed rest).
6 tednov pred dolgotrajno imobilizacijo in med njo (npr. okrevanje po operaciji, dolgotrajno ležanje v postelji).
In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks.
V vseh primerih je treba vsaj enkrat na leto opraviti skrbno presojo tveganj in koristi ob upoštevanju drugih simptomov menopavze,
In a 2-year carcinogenicity study in rats, a clear increase in mostly benign thymic tumours was recorded at all ospemifene dose levels.
V 2-letni študiji kancerogenosti pri podganah so pri vseh ravneh odmerkov ospemifena opazili očitno povečanje večinoma benignih tumorjev timusa.
The reproductive effects observed are considered to be related to oestrogen receptor activity of ospemifene.
Velja, da so opaženi učinki na sposobnost razmnoževanja povezani z aktivnostjo estrogenskih receptorjev ospemifena.
In the adrenal gland, there was an increased incidence of adrenal subcapsular cell and adrenal cortical tumours in animals dosed at high dose.
V nadledvični žlezi je bila večja pogostnost tumorjev subkapsularnih celic nadledvične žleze in adrenokortikalnih tumorjev pri živalih, ki so dobivale velike odmerke.
Furthermore in vitro studies have shown that ospemifene is a weak inducer for CYP2B6 and CYP3A4.
Študije in vitro so nadalje pokazale, da je ospemifen šibak induktor CYP2B6 in CYP3A4.
Senshio contains lactose.
Zdravilo Senshio vsebuje laktozo.
This medicine is only intended for use in postmenopausal women.
To zdravilo je namenjeno samo ženskam po menopavzi.
What Senshio is and what it is used for
Kaj je zdravilo Senshio in za kaj ga uporabljamo
Package leaflet: Information for the patient Senshio 60 mg film-coated tablets ospemifene This medicine is subject to additional monitoring.
Navodilo za uporabo Senshio 60 mg filmsko obložene tablete ospemifen Za to zdravilo se izvaja dodatno spremljanje varnosti.
On the basis of the scientific conclusions for ospemifene the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ospemifene is unchanged subject to the proposed changes to the product information
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za ospemifen odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) ospemifen, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Following oral administration of [3-H]-ospemifene in the fasted state, approximately 75% and 7% of the dose was excreted in faeces and urine respectively.
Po peroralni uporabi [3-H]-ospemifena na tešče so 75% odmerka izolirali iz blata in 7% odmerka iz urina.
What Senshio looks like and contents of the pack
Izgled zdravila Senshio in vsebina pakiranja
Taking into account the PRAC Assessment Report on the PSUR(s) for ospemifene, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za ospemifen je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Each film-coated tablet contains 1.82 mg lactose as monohydrate.
Pomožna(e) snov(i) z znanim učinkom Ena filmsko obložena tableta vsebuje 1,82 mg laktoze v obliki monohidrata.
Treatment should be resumed only after the patient is mobilised.
Zdravljenje smemo znova uvesti šele, ko je bolnica že povsem pokretna.
Non-interventional post-authorisation safety study (PASS): An observational retrospective cohort study of ospemifene to assess the incidence of venous thromboembolism and other safety concerns as agreed in the risk management plan, in VVA patients treated with ospemifene compared to 1) patients newly prescribed SERMs for oestrogen-deficiency conditions or breast cancer prevention, and 2) the incidence in untreated VVA patients.
(PASS): opazovalna retrospektivna kohortna študija ospemifena za ocenitev incidence venske trombembolije in drugih skrbi glede varnosti, kot je bilo dogovorjeno v načrtu za obvladovanje tveganja, pri bolnicah z atrofijo vulve in vagine, ki so se zdravile z ospemifenom, v primerjavi z 1) bolnicami, ki jim je bil selektivni modulatorji receptorjev estrogenov zaradi pomanjkanja estrogena ali preprečevanja raka na dojki predpisan prvič in 2) incidenco nezdravljenih bolnic z atrofijo vulve in vagine.
Senshio contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Zdravilo Senshio vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
Therefore, co-administration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.
Sočasni uporabi zdravila ospemifena z močnimi/zmernimi zaviralci CYP3A4 se je treba izogniti pri bolnicah, za katere je znano ali pri katerih obstaja sum, da imajo slabo presnovo s CYP2C9 na podlagi genotipizacije ali predhodne anamneze/izkušenj z drugimi substrati CYP2C9.
There were four co-primary endpoints for which change from baseline was assessed: percentage parabasal cells and superficial cells in the vaginal smear, vaginal pH, and MBS of VVA (dryness or dyspareunia).
Sprememba od izhodišča je bila ocenjena še za štiri sočasno opazovane dogodke: odstotek parabazalnih celic in površinskih celic v nožničnega brisa, nožnični pH ter MBS za VVA (suhost ali disparevnija).
In in vitro studies ospemifene is a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8 and CYP2D6.
V študijah in vitro je ospemifen šibak zaviralec CYP2B6, CYP2C9, CYP2C19, CYP2C8 in CYP2D6.
Ospemifene has not been formally studied in women with a prior history of breast cancer.
Ospemifena niso uradno preučili pri ženskah z rakom dojke v anamnezi.
Aciclovir used to treat cold sores and genital herpes.
o Aciklovir, ki se uporablja za zdravljenje herpes na ustnicah in genitalnega herpesa.
What you need to know before you take Senshio Do not take Senshio
Kaj morate vedeti, preden boste vzeli zdravilo Senshio Kako jemati zdravilo Senshio
Ospemifene was not teratogenic in rats or rabbits.
Ospemifen pri podganah ali kuncih ni bil teratogen.
Ospemifene is absorbed rapidly after oral administration, with a Tmax of approximately 3 - 4 hours post-dose in the fed state.
Ospemifen se po peroralnem dajanju s hrano hitro absorbira s Tmax približno 3-4 ure po odmerku.
No dose adjustment is necessary for patients with mild, moderate or severe renal impairment (see section 5.2).
Pri bolnicah z blago, zmerno ali hudo ledvično okvaro odmerka ni treba prilagajati (glejte tudi poglavje 5.2).
Suspected or active sex-hormone dependent malignancy (e.g. endometrial cancer).
Aktivna malignost, odvisna od spolnih hormonov (npr. rak endometrija) ali sum nanjo.
These results suggest that co-administration of ospemifene with any medicinal product that inhibits both CYP3A4 and CYP2C9 activity (e.g. fluconazole) would be expected to increase the exposure of ospemifene in a similar way.
Ti rezultati kažejo, da je pričakovati, da bo sočasna uporaba ospemifena s katerim koli zdravilom, ki zavira aktivnost CYP3A4 in CYP2C9 (npr. flukonazol),
If necessary, because of impaired tolerance, ospemifene should be stopped as long as treatment with fluconazole lasts.
Če je to potrebno zaradi slabšega prenašanja, je treba uporabo ospemifena ustaviti, dokler traja zdravljenje s flukonazolom.
Active or past history of venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Aktivna venska trombembolična bolezen ali venski trombembolični dogodki (VTE, venous thromboembolic events) v anamnezi, vključno z globoko vensko trombozo, pljučno embolijo in trombozo mrežnične vene.
The fate of remaining fraction is unknown but can probably be explained by formation of glucuronide metabolites.
Ni znano, kaj se zgodi s preostalim deležem, vendar verjetno nastajajo presnovki glukuronida.
Oxaliplatin, an anti-cancer medicine for advanced (metastatic) cancer of the large bowel (colon) or back passage (rectum).
o Oksaliplatin, zdravilo proti raku za napredovalega (metastatskega) raka debelega črevesa
Uncommon side effects (may affect up to 1 in 100 people): - Thickening of the womb lining (endometrium) as seen on ultrasound scan (endometrial hypertrophy).
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnic): - odebelitev maternične sluznice (endometrija), ugotovljena pri pregledu z ultrazvokom
Senshio is only for use in postmenopausal women and should not be used in women of child-bearing potential.
Zdravilo Senshio se uporablja le pri ženskah po menopavzi in se ne sme uporabljati za ženske v rodni dobi.
Ospemifene's biological actions are mediated through the binding of ospemifene and its major metabolite to oestrogen receptors.
Pri biološkem delovanju ospemifena sodeluje vezava ospemifena in njegovega glavnega presnovka na estrogenske receptorje.
Systemic exposure (AUC) at the administered doses was 0.3-, 1.0- and 1.2-times the AUC in postmenopausal woman administered 60 mg/day.
Sistemska izpostavljenost (AUC) pri uporabljenih odmerkih je bila 0,3-, 1,0- in 1,2-krat tolikšna kot AUC pri ženskah po menopavzi, ki so prejemale
Film coating: Hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin (E 1518), polyethylene glycol (E 1521).
Filmska obloga: hipromeloza (E 464), laktoza monohidrat, titanov dioksid (E 171), triacetin (E 1518), polietilenglikol (E 1521).
In the liver, an increase in hepatocellular tumours were recorded at all ospemifene dose levels.
V jetrih so pri vseh ravneh odmerka ospemifena zabeležili povečanje hepatocelularnih tumorjev.
In case of impaired tolerance of ospemifene, the latter should be stopped as long as treatment with fluconazole lasts.
V primeru slabega prenašanja ospemifena je treba uporabo ustaviti, dokler traja zdravljenje s flukonazolom.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Zdravilo Senshio vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
Fluconazole, a moderate CYP3A / moderate CYP2C9 / strong CYP2C19 inhibitor, increased the AUC of ospemifene by 2.7-fold.
Flukonazol, zmeren zaviralec CYP3A/zmeren zaviralec CYP2C9/močan zaviralec CYP2C19, je AUC ospemifena povečal za 2,7-krat.
The pharmacokinetics of ospemifene has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class score >9).
Farmakokinetike ospemifena niso ovrednotili pri bolnicah s hudo jetrno okvaro (razred po
In CYP2C9 poor metabolizers, co-administration of CYP3A4 inhibitors may increase systemic concentration of ospemifene to a larger extent.
CYP2C9 lahko sočasno dajanje zaviralcev CYP3A4 v večjem obsegu poveča sistemsko koncentracijo ospemifena.
In a 2-year carcinogenicity study in female mice, ospemifene caused treatment related increases in neoplastic findings in the adrenal gland and ovary.
V 2-letni študiji kancerogenosti pri mišjih samicah je ospemifen povzročil z zdravljenjem povezano povečanje novotvorb na nadledvični žlezi in jajčnikih.
Pharmacokinetics in subpopulations
240 mg. Farmakokinetika v podpopulacijah
- If any vaginal bleeding occurs while taking Senshio or soon after you have stopped taking it, you should speak to your doctor.
- Če se med jemanjem zdravila Senshio ali kmalu po tem, ko ste ga prenehali jemati, pojavi kakršna koli krvavitev iz nožnice, se posvetujte z zdravnikom.
Ketoconazole, a strong CYP3A4 inhibitor and moderate P-glycoprotein inhibitor, increased the AUC of ospemifene by 1.4-fold.
Ketokonazol, ki je močan zaviralec CYP3A4 in zmeren zaviralec P-glikoproteina, je AUC ospemifena povečal za 1,4-krat.
Do not take two tablets in one day to make up for a forgotten tablet.
Če ste pozabili vzeti tableto, vzemite izpuščeno tableto (s hrano) takoj, ko se spomnite, še isti dan. Ne vzemite dveh tablet v enem dnevu, če ste pozabili vzeti prejšnjo tableto.
In the ovary, there was an increase in sex-cord stromal tumours, tubulostromal tumours, granulosa cell tumours and luteomas in all treatment groups.
Na jajčnikih so v vseh skupinah, ki so dobivale zdravilo, opazili povečanje gonadnih stromalnih tumorjev, tubulostromalnih tumorjev, tumorjev granuloznih celic in luteomov.
Ospemifene exhibits linear pharmacokinetics in the fed state within the dose range of 60 mg to 240 mg.
Linearnost/nelinearnost Ospemifen kaže ob zaužitju s hrano linearno farmakokinetiko znotraj razpona odmerkov od 60 mg do
Ospemifene has been administered to subjects in single doses for up to 800 mg day and repeat doses up to 240 mg/day for 7 days and up to 200 mg/day for 12 weeks.
240 mg/dan 7 dni in do 200 mg/dan 12 tednov.
Senshio contains the active substance ospemifene.
Zdravilo Senshio vsebuje učinkovino ospemifen.
Nonclinical findings show that ospemifene and its major metabolite have an oestrogen like effect in the vagina increasing the cellular maturation and mucification of the vaginal epithelium.
Predklinični izsledki kažejo, da ospemifen in njegov glavni presnovek učinkujeta podobno kot estrogen in v nožnici povečata dozorevanje celic in nastajanje sluzi v epiteliju nožnice.
Trial 2 Dryness
Preskušanje 2 Suhost
Senshio has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Senshio nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
In bone, ospemifene has agonist-like activity.
V kosteh ima ospemifen aktivnost, podobno agonistični.
Ospemifene and 4-hydroxyospemifene accounted for approximately 20% and 14% of the total radioactivity in serum, respectively.
20% oz. 14% skupne radioaktivnosti v serumu.
BN
SN NN
- The other ingredients are: Tablet core: Colloidal silicon dioxide (E 551), magnesium stearate (E 578), mannitol (E 421), microcrystalline cellulose (E 460), povidone (E 1201), pregelatinised starch (maize), sodium starch glycolate (type A).
- Druge sestavine zdravila so: Jedro tablete: koloidni silicijev dioksid (E 551), magnezijev stearat (E 578), manitol (E 421), mikrokristalna celuloza (E 460), povidon (E 1201), predgelirani škrob
If you take more tablets than you should, tell your doctor or pharmacist.
Če ste vzeli večji odmerek zdravila Senshio, kot bi smeli Če ste vzeli več tablet kot bi smeli, to povejte zdravniku ali farmacevtu.
In in vitro studies, ospemifene and 4-hydroxyospemifene did not inhibit P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporter polypeptide (OATP)1B1, OATP1B3, OCT2, organic anion transporter (OAT)1, OAT3, or bile salt export pump (BSEP) transporters at clinically relevant concentrations.
(BCRP, breast cancer resistance protein), polipeptida organskega prenašalca anionov (OATP)1B1, OATP1B3, OCT2, organskega prenašalca anionov (OAT)1, OAT3 ali izlivnih črpalk žolčnih soli (BSEP, bile salt export pump) v klinično pomembnih koncentracijah.
The pharmacokinetics of medicinal products that are mainly metabolised by UGT1A3 and UGT1A9 could be affected when administered concomitantly with ospemifene and co-administration should be made with caution.
Sočasno jemanje ospemifena in zdravil, ki se v glavnem presnavljajo prek UGT1A3 in UGT1A9, lahko vpliva na farmakokinetiko teh zdravil, zato je pri sočasnem jemanju potrebna previdnost.
How to take Senshio
Kako jemati zdravilo Senshio
The incidence of endometrial hyperplasia was 0.3% (1 case out of 317 biopsies) after 1 year of treatment with an upper 95% confidence limit of 1.74% (see section 5.1).
1 letu zdravljenja z zgornjo 95-odstotno mejo zaupanja 1,74% (glejte poglavje 5.1).
Any of the following medicines, as their concentrations may be increased while taking Senshio: Metformin used to treat Type II diabetes.
Senshio povečajo: o Metformin, ki se uporablja za zdravljenje sladkorne bolezni tipa II.
Hypromellose (E 464) Lactose monohydrate Titanium dioxide (E 171) Triacetin (E 1518) Macrogols (E 1521)
laktoza monohidrat titanov dioksid (E 171) triacetin (E 1518)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Zdravilo Senshio vsebuje laktozo Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
Common side effects (may affect up to 1 in 10 people): - An infection of the genitals caused by a fungus (thrush) - Hot flushes - Muscle cramps - Vaginal or genital discharge - Rash
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnic): - glivična okužba spolovil (gobice) - vročinski oblivi - mišični krči - izcedek iz nožnice ali spolovil - izpuščaj
Trial 1 Dryness
Preskušanje 1 Suhost
Ospemifene and its major metabolite, 4-hydroxyospemifene, inhibited organic cation transporter (OCT)1 in vitro at clinically relevant concentrations.
Ospemifen in njegov glavni presnovek, 4-hidroksiospemifen, sta in vitro zavrla prenašalec organskih kationov (OCT, organic cation transporter)1 v klinično pomembnih koncentracijah.
In total, there were 317 subjects on ospemifene and 64 subjects on placebo who had a baseline as well as a week 52 biopsy.
Skupaj je bila biopsija ob izhodišču in v 52. tednu opravljena pri 317 osebah, ki so dobivale ospemifen in pri 64 osebah, ki so dobivale placebo.
The incidence of abnormal, but not clinically significant, findings on breast palpation and mammography decreased in the ospemifene 60 mg population during the 1-year study (trial 3) from 1.6% to 0.6% and from 11.8% to 8.1% respectively.
Incidenca nenormalnih, a klinično nepomembnih izsledkov pri palpaciji dojk in na mamografiji se je v 1-letni študiji pri populaciji z ospemifenom 60 mg zmanjšala (preskušanje 3) z
It is recommended that ospemifene should be taken with food at the same time each day.
Jemanje ospemifena se priporoča skupaj s hrano in vsaj dan ob istem času.
Symptoms of an allergic reaction may include rash, itchy skin, raised patches on your skin (urticaria), swelling of the tongue and throat that may cause difficulty in breathing or swallowing.
izbočene predele kože (koprivnica), otekanje jezika in žrela, ki lahko oteži dihanje ali požiranje.
Senshio 60 mg film-coated tablets
IME ZDRAVILA Senshio 60 mg filmsko obložene tablete
In vitro, ospemifene and 4-hydroxyospemifene inhibited glucuronidation mainly via UGT1A3 and UGT1A9 at clinically relevant concentrations.
Ospemifen in 4-hidroksiospemifen sta in vitro zavrla glukoronidacijo v glavnem prek UGT1A3 in UGT1A9 v klinično pomembnih koncentracijah.
Senshio 60 mg film-coated tablets ospemifene
IME ZDRAVILA Senshio 60 mg filmsko obložene tablete ospemifen
The pharmacokinetics of ospemifene is only mildly affected by mild and moderate hepatic impairment (Child Pugh scores 5-9) when compared to healthy matched controls.
V primerjavi s kontrolno skupino zdravih oseb so ugotovili, da na farmakokinetiko ospemifena le malo vpliva blaga ali zmerna okvara jeter (razred po Child-Pughu 5-9).
Effects of ospemifene on other medicinal products
Učinki ospemifena na druga zdravila
Talk to your doctor or pharmacist before taking Senshio if any of the following apply to you.
Če kar koli od navedenega velja za vas, se pred začetkom jemanja zdravila Senshio posvetujte z zdravnikom ali farmacevtom.
Colloidal silicon dioxide (E 551) Magnesium stearate (E 578) Mannitol (E 421) Microcrystalline cellulose (E 460) Povidone (E 1201) Pregelatinised starch (maize) Sodium starch glycolate (type A)
Jedro tablete: koloidni silicijev dioksid (E 551) magnezijev stearat (E 578) manitol (E 421) mikrokristalna celuloza (E 460) povidon (E 1201)
5.0% superficial cells in the vaginal smear, a vaginal pH >5.0 and were required to have at least one moderate or severe VVA symptom, where patients had to choose the symptom that was the most bothersome (MBS).
Študijska populacija je bila sestavljena iz pretežno zdravih žensk po menopavzi, starih med 41 in 80 leti (povprečna starost = 59 let), ki so imele ob izhodišču ≤ 5,0% površinskih celic v brisu nožnice, pH nožnice > 5,0 in ki so imele vsaj en zmeren ali hud simptom VVA, pri čemer so bolnice izbrale simptom, ki je bil najbolj moteč (MBS, most bothersome symptom).
Therefore, caution is recommended when co-administering ospemifene with fluconazole.
Zato se pri sočasni uporabi ospemifena s flukonazolom priporoča previdnost.
Tell your doctor immediately if you become pregnant while taking Senshio; treatment should be stopped immediately.
Če med jemanjem zdravila Senshio zanosite, o tem takoj obvestite zdravnika; takoj prenehajte z zdravljenjem.
The major metabolite, 4-hydroxyospemifene, was seen to undergo formation rate-limited elimination (with t1/2 similar to the parent compound) in a human mass balance study.
V študiji utežnega razmerja pri ljudeh so opazili, da je glavni presnovek, 4-hidroksiospemifen, predmet izločanja, omejenega s hitrostjo nastajanja (s podobnim t1/2 kot izhodišča spojina).
Senshio is for use only in postmenopausal women.
Zdravilo Senshio se uporablja samo pri ženskah po menopavzi.