natgillin/translations-raw huggingface dataset:
Ospemifene exhibits linear pharmacokinetics in the fed state within the dose range of 60 mg to 240 mg.
Ospemifen pokazuje linearnu farmakokinetiku kada se uzima na nakon jela u rasponu doze od 60 mg do 240 mg.
Other special populations
Ostale posebne populacije Spol
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.
Incidencija abnormalnih, ali klinički ne i značajnih nalaza pri palpaciji dojki ili mamografiji smanjila se u populaciji koja je primala 60 mg ospemifena tijekom jednogodišnjeg ispitivanja (ispitivanje 3) od 1,6% do 0,6% odnosno 11,8% do 8,1%.
The pharmacokinetics of ospemifene has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class score >9).
Farmakokinetika ospemifena nije ispitana u bolesnica s teškim oštećenjem jetre (Child-Pugh rezultat >9).
In two separate 12 week pivotal trials (trials 1 and 2), ospemifene was associated with a statistically significant mean decrease from baseline in the percentage of parabasal cells and vaginal pH and a statistically significant mean increase from baseline in the percentage of superficial cells, compared with placebo (P<0.001 for each parameter) at weeks 4 and 12.
U dva odvojena ključna ispitivanja u trajanju od 12 tjedana (ispitivanja 1 i 2), ospemifen je povezan sa statistički značajnim srednjim smanjenjem postotka parabazalnih stanica i vaginalnog pH u odnosu na početak ispitivanja, i statistički značajnim srednjim porastom postotka površinskih stanica u odnosu na početak ispitivanja, u usporedbi s placebo skupinom (P<0,001 za svaki parametar) u 4. i 12. tjednu.
Furthermore in vitro studies have shown that ospemifene is a weak inducer for CYP2B6 and CYP3A4.
Nadalje, u ispitivanjima in vitro pokazano je da ospemifen je slab induktor CYP2B6 i CYP3A4.
The clinical efficacy and safety of ospemifene was determined primarily from two multi-centre, placebo-controlled trials of 12 weeks duration (trials 1 and 2) and a third long-term safety trial of 52 weeks duration (trial 3) in post-menopausal patients with VVA.
Klinička djelotvornost i sigurnost ospemifena utvrđena je prvenstveno u dva multicentrična, placebom kontrolirana ispitivanja u trajanju od 12 tjedana (ispitivanje 1 i 2) i trećim ispitivanjem sigurnosti dugotrajne primjene u trajanju od 52 tjedna (ispitivanje 3), provedenima na bolesnicama u postmenopauzi s VVA-om.
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.
Tablete Senshio su ovalne, bikonveksne, bijele do gotovo bijele, filmom obložene tablete (oko 12 mm duge i 6,45 mm široke) s utisnutom oznakom „60“ na jednoj strani.
Therefore, co-administration of ospemifene with strong enzyme inducers like carbamazepine, phenytoin, St John's wort and rifabutin would be expected to decrease the exposure of ospemifene, which may decrease the clinical effect.
Stoga bi se pri istodobnoj primjeni ospemifena s jakim induktorima enzima poput karbamazepina, fenitoina, gospine trave i rifabutina očekivalo smanjenje izloženosti ospemifenu, što može smanjiti klinički učinak.
The reproductive effects observed are considered to be related to oestrogen receptor activity of ospemifene.
Za primijećene reproduktivne učinke smatra se da su povezani s aktivnošću ospemifena na estrogenskim receptorima.
Senshio contains lactose.
Senshio sadrži laktozu.
The long-term study (trial 3) was a 52-week, randomised, double-blind, placebo-controlled safety and efficacy study in 426 postmenopausal women with an intact uterus.
Ispitivanje dugotrajne primjene (ispitivanje 3) bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje sigurnosti i djelotvornosti u trajanju od 52 tjedna, a provedeno je na 426 žena u postmenopauzi s intaktnim uterusom.
No cases of endometrial hyperplasia were reported at either time point.
Nije zabilježen niti jedan slučaj hiperplazije endometrija niti u jednoj vremenskoj točki ispitivanja.
There were no abnormal breast palpation findings in the placebo group at baseline or at study end.
Nije bilo abnormalnih nalaza palpacije dojki u skupini koja je primala placebo na početku ili na kraju ispitivanja.
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.
U ispitivanjima in vitro, ospemifen i 4-hidroksiospemifen nisu inhibirali P-glikoprotein (P-gp), protein rezistencije raka dojke (engl. breast cancer resistance protein, BCRP), polipeptidni prijenosnik organskih aniona (engl. organic anion transporter polypeptide, OATP)1B1, OATP1B3, OCT2, prijenosnik organskih aniona (engl. organic anion transporter, OAT)1, OAT3 niti pumpu za izbacivanje žučnih soli (engl. bile salt export pump, BSEP) u klinički relevantnim koncentracijama.
Inhibition of UGT1A3, UGT2B7, UGT1A1, or UGT1A8 may potentially affect the glucuronidation of ospemifene and/or 4-hydroxyospemifene.
Inhibicija enzima UGT1A3, UGT2B7, UGT1A1 ili UGT1A8 potencijalno može utjecati na glukuronidaciju ospemifena i/ili 4-hidroksiospemifena.
A trend was observed in both trials in the improvement of MBS from baseline to week 4 in favour of ospemifene compared to placebo, although the difference was not statistically significant.
U oba ispitivanja primijećen je trend poboljšanja simptoma koji najviše smeta od početka ispitivanja do 4. tjedna u korist ospemifena u usporedbi s placebom, iako razlika nije bila statistički značajna.
Obligation to conduct post-authorisation measures
• Obveza provođenja mjera nakon davanja odobrenja
In those trials, a total of 1,102 subjects received 60 mg of ospemifene and 787 subjects received placebo.
Tijekom tih ispitivanja ukupno je 1102 ispitanica primalo 60 mg ospemifena a 787 ispitanica je primalo placebo.
For subjects completing the trial 1 extension study (ospemifene, n=41; placebo, n= 18) and for subjects in the long-term 52-week safety study (trial 3: ospemifene, n=276; placebo, n=46), endometrial safety was assessed by endometrial biopsy at baseline and at 12 months.
U ispitanica koje su dovršile produžetak ispitivanja 1 (ospemifen, n=41; placebo, n=18) i u ispitanica koje su sudjelovale u ispitivanju sigurnosti dugotrajne primjene u trajanju od 52 tjedna (ispitivanje 3: ospemifen, n=276; placebo, n=46), sigurnost za endometrij procijenjena je na temelju biopsije endometrija učinjene na početku ispitivanja i nakon 12 mjeseci.
Senshio is not indicated during breast-feeding.
Senshio nije indiciran za primjenu tijekom dojenja.
7 film-coated tablets 28 film-coated tablets 84 film-coated tablets
OBLIK I SADRŽAJ 7 filmom obloženih tableta 28 filmom obloženih tableta 84 filmom obloženih tableta
Rifampicin, a strong CYP3A / CYP2C9 enzyme inducer, decreased the AUC of ospemifene by 58%.
Rifampicin, jaki induktor enzima CYP3A / CYP2C9, smanjio je AUC ospemifena za 58%.
CYP2C9 poor metabolisers
Slabi metabolizatori CYP2C9
In in vitro studies ospemifene is a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8 and CYP2D6.
U ispitivanjima in vitro ospemifen je slabi inhibitor CYP2B6, CYP2C9, CYP2C19, CYP2C8 i CYP2D6.
In healthy subjects, the absorption of ospemifene is not affected by co-administration of oral omeprazole, a medicinal product that increases gastric pH.
U zdravih ispitanica na apsorpciju ospemifena ne utječe istodobna primjena oralnog omeprazola, lijeka koji povisuje želučani pH.
Ospemifene is primarily metabolised by the liver.
Ospemifen se prvenstveno metabolizira u jetri.
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.
Pad razine estrogena koji se događa nakon menopauze dovodi do VVA, karakterizirane smanjenim sazrijevanjem stanica vaginalnog epitela, progresivnim smanjenjem vaskularnosti vaginalnih tkiva i smanjenom lubrikacijom.
Any of the following medicines, which may lead to a reduced effect of Senshio: Rifampicin and rifabutin commonly used to treat tuberculosis.
• bilo kojim od sljedećih lijekova, jer to može smanjiti učinak lijeka Senshio: o rifampicinom i rifabutinom koji se obično koriste za liječenje tuberkuloze o karbamazepinom i fenitoinom koji se koriste zaliječenje konvulzija/napadaja
Ospemifene is absorbed rapidly after oral administration, with a Tmax of approximately 3 - 4 hours post-dose in the fed state.
Ospemifen se brzo apsorbira nakon peroralne primjene, s Tmax od oko 3 do 4 sata nakon doze uzete nakon jela.
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.
Neklinički nalazi ukazuju da ospemifen i njegov glavni metabolit imaju na vaginu učinak nalik estrogenu, povećavajući maturaciju i transformaciju stanica vaginalnog epitela u stanice koje luče sluz.
Each film-coated tablet contains 60 mg ospemifene.
Jedna filmom obložena tableta sadrži 60 mg ospemifena.
Ospemifene has not been formally studied in women with a prior history of breast cancer.
Ospemifen nije formalno ispitan na ženama koje su imale rak dojke u anamnezi.
The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective estrogen receptor modulators (SERMs).
Rizik za pojavu VTE (tromboze dubokih vena i plućne embolije) povećan je tijekom primjene drugih selektivnih modulatora estrogenskih receptora (engl. selective oestrogen receptor modulator, SERM).
Active or past history of venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Aktivni venski tromboembolijski događaji (engl. venous thromboembolic event, VTE) ili takav događaj u anamnezi, uključujući duboku vensku trombozu, plućnu emboliju i trombozu retinalne vene.
In total, there were 317 subjects on ospemifene and 64 subjects on placebo who had a baseline as well as a week 52 biopsy.
Sveukupno je 317 ispitanica na ospemifenu i 64 ispitanica na placebu bilo podvrgnuto biopsiji na početku ispitivanja i u 52. tjednu.
If you forget to take Senshio
Ako ste zaboravili uzeti Senshio
The safety of using ospemifene concomitantly with oestrogens or other SERMS, such as tamoxifen, toremifene, bazedoxifene and raloxifene, has not been studied and its concurrent use is not recommended.
Sigurnost istodobne primjene ospemifena s estrogenima ili drugim selektivnim modulatorima estrogenskih receptora, poput tamoksifena, toremifena, bazedoksifena i raloksifena, nije ispitana te se istodobna primjena ne preporučuje.
Oval biconvex, white to off-white, film-coated tablets of dimensions 12 mm x 6.45 mm, debossed with “60” on one side.
Ovalne bikonveksne bijele do gotovo bijele filmom obložene tablete dimenzija 12 mm x 6,45 mm, s utisnutom oznakom „60“ na jednoj strani.
Relief
Olakšanje
Senshio is used to treat women with moderate to severe post-menopausal symptoms in and outside the vagina, such as itching, dryness, burning and pain during sex (dyspareunia) if local oestrogen therapy is not suitable.
Senshio se koristi za liječenje umjerenih do teških simptoma postmenopauze u i izvan vagine, poput svrbeža, suhoće rodnice, peckanja i boli prilikom snošaja (dispareunija) u žena u kojih lokalna terapija estrogena nije prikladna.
Ospemifene's biological actions are mediated through the binding of ospemifene and its major metabolite to oestrogen receptors.
Biološka djelovanja ospemifena posredovana su vezivanjem ospemifena i njegovog glavnog metabolita na estrogenske receptore.
The recommended dose is one tablet taken orally at the same time each day.
Preporučena doza je jedna tableta uzeta kroz usta uvijek u isto doba svaki dan.
Senshio contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Senshio sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
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 izloženost (AUC) pri primijenjenim dozama bila je 0,3, 1,0 i 1,2 puta veća od AUC-a u žena u postmenopauzi koje su primale 60 mg/dan.
Venous thromboembolic events (VTEs)
Venski tromboembolijski događaji (VTE)
Both CYP2C9 and CYP3A4 are involved in the metabolism of ospemifene.
I CYP2C9 i CYP3A4 uključeni su u metabolizam ospemifena.
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 promjene u farmakokinetici ospemifena uzrokovane umjerenim oštećenjem jetre ne smatraju se klinički značajnim uzimajući u obzir farmakokinetičku varijabilnost ospemifena.
These changes result in clinical signs which include vaginal dryness, redness, petechiae, pallor, and friability in the mucosa.
Ove promjene imaju za posljedicu pojavu kliničkih znakova koji uključuju suhoću vagine, crvenilo, petehije, bljedilo i fragilnost sluznice.
Following a single oral administration of 60 mg ospemifene in the fed state, 17.9%, 10.0% and 1.4% of the administered dose was excreted in faeces as ospemifene, 4hydroxyospemifene and 4'-hydroxyospemifene, respectively.
Nakon jednokratne peroralne primjene 60 mg ospemifena nakon jela, 17,9% primijenjene doze izlučuje se fecesom u obliku ospemifena, 10,0% u obliku 4-hidroksiospemifena, odnosno 1,4% u obliku 4'-hidroksiospemifena.
The risk of VTE associated with ospemifene cannot be excluded.
Rizik za pojavu VTE-a povezanog s ospemifenom ne može se isključiti.
In the liver, an increase in hepatocellular tumours were recorded at all ospemifene dose levels.
U jetri je zabilježen porast hepatocelularnih tumora pri svim razinama doze ospemifena.
Systemic exposure (AUC) at these doses was 2.1-, 4.0- and 4.7-times the AUC in postmenopausal woman administered 60 mg/day.
Sistemska izloženost (AUC) pri tim dozama bila je 2,1, 4,0 i 4,7 puta veća od AUC-a u žena u postmenopauzi koje su primale 60 mg/dan.
Endometrial safety in women was assessed at baseline and 12 weeks in the two 12-week phase III studies (trials 1 and 2: ospemifene, n=302; placebo, n= 301).
Sigurnost za endometrij u žena procjenjivana je na početku i u 12. tjednu u dva ispitivanja faze III u trajanju od 12 tjedana (ispitivanja 1 i 2: ospemifen, n=302; placebo, n=301).
Dyspareunia 60 mg OSP Placebo p-value 60 mg OSP Placebo p-value
Dispareunija 60 mg OSP Placebo p-vrijednost 60 mg OSP Placebo p-vrijednost
In vitro, ospemifene and 4-hydroxyospemifene did not inhibit or induce the activity of CYP450 enzymes at clinically relevant concentrations.
In vitro, ospemifen i 4-hidroksiospemifen nisu inhibirali ili inducirali aktivnost enzima CYP450 u klinički relevantnim koncentracijama.
In a 2-year carcinogenicity study in female mice, ospemifene caused treatment related increases in neoplastic findings in the adrenal gland and ovary.
U dvogodišnjem ispitivanju kancerogenosti na ženkama miša, ospemifen je uzrokovao porast neoplastičkih nalaza u nadbubrežnoj žlijezdi i jajniku povezanih s liječenjem.
In the adrenal gland, there was an increased incidence of adrenal subcapsular cell and adrenal cortical tumours in animals dosed at high dose.
U nadbubrežnoj žlijezdi incidencija tumora adrenalnih subkapsularnih stanica i adrenalnih kortikalnih tumora bila je povećana u životinja koje su primale visoke doze.
If necessary, because of impaired tolerance, ospemifene should be stopped as long as treatment with fluconazole lasts.
Ako je potrebno zbog neodgovarajuće podnošljivosti, primjenu ospemifena potrebno je prekinuti sve dok traje liječenje flukonazolom.
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.
Na farmakokinetiku ospemifena samo blago utječe blago do umjereno oštećenje jetre (Child-Pugh rezultat 5-9) u usporedbi sa zdravim podudarnim osobama iz kontrolne skupine.
No dose adjustment is necessary in elderly patients.
U starijih bolesnica prilagodba doze nije potrebna.
In the mammary gland, they have a predominantly oestrogen antagonist effect.
Njihov učinak na mliječnu žlijezdu je prevladavajuće estrogen-antagonistički.
In CYP2C9 poor metabolizers, co-administration of CYP3A4 inhibitors may increase systemic concentration of ospemifene to a larger extent.
Kod slabih metabolizatora CYP2C9 istodobna primjena inhibitora CYP3A4 može povećati sistemsku koncentraciju ospemifena u većoj mjeri.
Uncommon side effects (may affect up to 1 in 100 people): - Thickening of the womb lining (endometrium) as seen on ultrasound scan (endometrial hypertrophy).
Manje česte nuspojave (mogu se javiti u do 1 od 100 osoba): - zadebljanje sluznice maternice (endometrija) vidljivo ultrazvučnim pregledom (hipertrofija endometrija) - alergijska reakcija.
The most bothersome symptom (MBS) was assessed at baseline, 4 and 12 weeks with the severity scored as follows: None=0, Mild=1, Moderate=2, Severe=3.
Simptom koji najviše smeta procijenjen je na početku ispitivanja i u 4. i 12. tjednu, a težina simptoma je bodovana kako slijedi: bez simptoma=0, blagi=1, umjereni=2, teški=3.
Film coating: Hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin (E 1518), polyethylene glycol (E 1521).
Film-ovojnica: hipromeloza (E 464), laktoza hidrat, titanijev dioksid (E 171), triacetin (E 1518), polietilenglikol (E 1521).
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.
Nakon peroralne primjene [3-H]-ospemifena natašte, približno 75% doze izlučuje se fecesom, odnosno 7% urinom.
In the ovary, there was an increase in sex-cord stromal tumours, tubulostromal tumours, granulosa cell tumours and luteomas in all treatment groups.
U jajniku incidencija tumora specijalizirane strome jajnika, tubulostromalnih tumora, tumora granuloza stanica i luteoma bila je povećana u svim skupinama.
In the uterus ospemifene and its major metabolite have weak partial agonist/antagonist effects.
Učinci ospemifena i njegovog glavnog metabolita na uterus su slabi djelomično agonistički, djelomično antagonistički.
No clinically important pharmacokinetic differences between subjects with severe renal impairment and healthy subjects were observed.
Nisu primijećene bitne razlike u farmakokinetici između ispitanica s teškim oštećenjem bubrega i zdravih ispitanica.
If you stop using Senshio
Ako prestanete uzimati Senshio
Ospemifene and its major metabolite, 4-hydroxyospemifene, are metabolised by multiple metabolic pathways, the main enzymes involved are UGT1A3, UGT2B7, UGT1A1 and UGT1A8, and CYP2C9,
Ospemifen i njegov glavni metabolit 4-hidroksiospemifen metaboliziraju se putem višestrukih metaboličkih putova, a glavni enzimi koji sudjeluju su UGT1A3, UGT2B7, UGT1A1 i UGT1A8 te CYP2C9, CYP3A4 i CYP2C19.
No dose adjustment is necessary for patients with mild, moderate or severe renal impairment (see section 5.2).
U bolesnica s blagim, umjerenim ili teškim oštećenjem bubrega prilagodba doze nije potrebna (vidjeti dio 5.2).
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.
Na farmakokinetiku lijekova koji se uglavnom metaboliziraju preko enzima UGT1A3 i UGT1A9 može se utjecati kada se daju istodobno s ospemifenom te je pri istodobnoj primjeni potreban oprez.
How to take Senshio
Kako uzimati Senshio
Senshio has no known or very little influence on the ability to drive and use machines.
Upravljanje vozilima i strojevima Senshio nema poznatih učinaka na sposobnost upravljanja vozilima ili strojevima, ili su oni vrlo mali.
Table 1 shows the mean change in severity score in MBS after 12 weeks with the associated statistical testing for the difference vs. placebo for trials 1 and 2.
Tablica 1 prikazuje srednju promjenu rezultata bodovanja težine simptoma koji najviše smeta bolesnicama nakon 12 tjedana, s pripadajućim statističkim testiranjem razlike u usporedbi s placebom u ispitivanju 1 i 2.
Ketoconazole, a strong CYP3A4 inhibitor and moderate P-glycoprotein inhibitor, increased the AUC of ospemifene by 1.4-fold.
Ketokonazol, snažni inhibitor CYP3A4 i umjereni inhibitor P-glikoproteina, povećao je AUC ospemifena 1,4 puta.
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).
Procjenjivane su promjene četiri koprimarnih mjera ishoda u odnosu na početak ispitivanja: postotak parabazalnih i površinskih stanica u vaginalnom razmazu, vaginalni pH i simptom VVA koji najviše smeta (suhoća ili dispareunija).
What you need to know before you take Senshio Do not take Senshio
Što morate znati prije nego počnete uzimati Senshio
Fluconazole, a moderate CYP3A / moderate CYP2C9 / strong CYP2C19 inhibitor, increased the AUC of ospemifene by 2.7-fold.
Flukonazol, umjereni CYP3A / umjereni CYP2C9 / jaki CYP2C19 inhibitor, povećao je AUC ospemifena 2,7 puta.
Senshio is only for use in postmenopausal women and should not be used in women of child-bearing potential.
Senshio je namijenjen samo za primjenu u žena u postmenopauzi i ne smije se koristiti u žena reproduktivne dobi.
- 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).
Drugi sastojci su: Jezgra tablete: koloidni silicijev dioksid (E 551), magnezijev stearat (E 578), manitol (E 421), mikrokristalična celuloza (E 460), povidon (E 1201), prethodno geliran škrob (kukuruzni), natrijev škroboglikolat (vrsta A).
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.
Stoga je istodobnu primjenu ospemifena sa snažnim/umjerenim inhibitorima CYP3A4 potrebno izbjegavati u bolesnika za koje se, na temelju genotipizacije ili ranijih podataka u anamnezi/iskustava s drugim supstratima CYP2C9, zna ili sumnja da su slabi metabolizatori CYP2C9.
If pregnancy occurs during treatment with ospemifene, ospemifene should be withdrawn immediately.
Ako tijekom liječenja ospemifenom žena zatrudni, liječenje se smjesta mora prekinuti.
St John's wort, a herbal medicine sometimes used to treat depression.
(antikonvulzivnim lijekovima) o gospinom travom, biljnim lijekom koji se ponekad koristi za liječenje depresije o orlistatom koji se ponekad koristi za liječenje pretilosti.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Senshio sadrži laktozu Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the AUC of ospemifene by 1.4-fold.
Istodobna primjena ketokonazola, snažnog inhibitora CYP3A4, povećao je AUC ospemifena 1,4 puta.
In case of impaired tolerance of ospemifene, the latter should be stopped as long as treatment with fluconazole lasts.
U slučaju neodgovarajuće podnošljivosti ospemifena, primjenu ospemifena potrebno je prekinuti dok traje liječenje flukonazolom.
Senshio contains the active substance ospemifene.
Senshio sadrži djelatnu tvar ospemifen.
Fri.
Peroralno.
Therefore, caution is recommended when co-administering ospemifene with fluconazole.
Stoga se preporučuje oprez pri istodobnoj primjeni ospemifena s flukonazolom.