FrancophonIA/ELRC3.0 huggingface dataset:
English: In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was:
Slovenian: V preskušanjih preventive osteoporoze so bili odstotki preiskovank, pri katerih so ugotovili povečanje ali zmanjšanje BMD med terapijo z raloksifenom,
English: Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in raloxifene patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3 % raloxifene and 18.2 % placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6 % for raloxifene and 7.1 % placebo).
Slovenian: V primerjavi z bolnicami, ki so prejemale placebo, je bila pogostnost pojavov vazodilatacije (vročinskih oblivov) zmerno povečana pri bolnicah, zdravljenih z raloksifenom (pri kliničnih preskušanjih za preventivo osteoporoze, trajanje menopavze 2 do 8 let - 24,3 % pri raloksifenu in 18,2 % pri placebu; pri kliničnih raziskavah za zdravljenje osteoporoze, povprečna starost 66 let - 10,6 % pri raloksifenu in 7,1 % pri placebu).
English: Tablet core: pregelatinized starch (maize), magnesium stearate, povidone (K30), colloidal anhydrous silica and microcrystalline cellulose, silicified.
Slovenian: Jedro tablete: predgelirani škrob (koruzni), magnezijev stearat, povidon (K30), brezvodni koloidni silicijev dioksid in mikrokristalna celuloza (silificirana).
English: In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7 % of 581 raloxifene treated patients and 11.1 % of 584 placebo-treated patients.
Slovenian: V populaciji, pri kateri so raloksifen uporabljali za preventivo, so zdravljenje zaradi katere koli od neželenih učinkov prekinili pri 10,7 % od 581 bolnic, zdravljenih z raloksifenom, in pri 11,1 % od 584 bolnic, ki so prejemale placebo.
English: In the RUTH study, raloxifene did not affect the incidence of stroke, compared to placebo.
Slovenian: V študiji RUTH raloksifen ni imel vpliva na pogostnost možganske kapi, v primerjavi s placebom.
English: There was no difference between raloxifene and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Slovenian: Tudi ni bilo razlike med ženskami, zdravljenimi z raloksifenom, in tistimi, ki so prejemale placebo, kar zadeva incidenco vaginalne krvavitve (krvavega izcedka) ali izcedka iz nožnice.
English: - If you have active uterine cancer, as there is insufficient experience of Raloxifene Teva use in women with this disease.
Slovenian: - Če imate aktivni rak maternice, saj pri ženskah s to boleznijo ni zadostnih izkušenj z uporabo zdravila Raloksifen Teva.
English: White to off-white, film coated, oval shaped tablets, embossed with the number “60” on one side and “N” on the other side of the tablet.
Slovenian: Filmsko obložene tablete so bele do belkaste, ovalne tablete z vtisnjeno številko 60 na eni strani in črko N na drugi strani tablete.
English: The majority of side effects seen with Raloxifene Teva have been mild.
Slovenian: Neželeni učinki, ki so jih opažali pri zdravilu Raloksifen Teva, so bili večinoma blagi.
English: INFORMATION IN BRAILLE Raloxifene Teva 60 mg
Slovenian: Raloksifen Teva 60 mg
English: Raloxifene has no effect on the pharmacokinetics of methylprednisolone given as a single dose.
Slovenian: Raloksifen ne vpliva na farmakokinetiko metilprednizolona, ki ga bolnici damo v enkratnem odmerku.
English: How to store Raloxifene Teva Contents of the pack and other information
Slovenian: Shranjevanje zdravila Raloksifen Teva Vsebina pakiranja in dodatne informacije
English: • Mild breast symptoms such as pain, enlargement and tenderness
Slovenian: • blagi simptomi dojk, kot so bolečina, povečanje in občutljivost
English: Uncommon: Fatal strokes
Slovenian: Občasni: možganske kapi s smrtnim izidom
English: - If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness.
Slovenian: Pred začetkom jemanja zdravila Raloksifen Teva se posvetujte z zdravnikom ali farmacevtom: - Če ste dalj časa nepokretni, denimo uporabljate invalidski voziček, ste bili sprejeti v bolnišnico ali ležite v postelji pri okrevanju po operaciji ali zaradi nepričakovane bolezni.
English: In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene Teva.
Slovenian: V redkih primerih se lahko med zdravljenjem z zdravilo Raloksifen Teva zvišajo koncentracije jetrnih encimov v krvi.
English: If you stop taking Raloxifene Teva
Slovenian: Če ste prenehali jemati zdravilo Raloksifen Teva
English: Uncommon: Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial vein thrombophlebitis, Arterial thromboembolic reactions a
Slovenian: Občasni: venski tromboembolični zapleti, vključno z globoko vensko trombozo, pljučnimi embolijami, trombozo mrežničnih ven, tromboflebitis povrhnjih ven, arterijske tromboembolične reakcijea
English: Another adverse reaction observed was leg cramps (5.5 % for raloxifene, 1.9 % for placebo in the prevention population and 9.2 % for raloxifene, 6.0 % for placebo in the treatment population).
Slovenian: Naslednji opaženi neželeni učinek so bili krči v nogah (5,5 % pri raloksifenu in 1,9 % pri placebu v skupini, v kateri so raloksifen uporabljali za preventivo, ter 9,2 % pri raloksifenu in 6,0 % pri placebu v skupini, v kateri so raloksifen uporabljali za zdravljenje).
English: Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Slovenian: Raloksifen je indiciran za zdravljenje in preprečevanje osteoporoze pri ženskah po menopavzi.
English: Driving and using machines Raloxifene Teva has no or negligible effects on driving or using machines.
Slovenian: Zdravilo Raloksifen Teva nima učinkov ali ima zanemarljive učinke na vožnjo ali upravljanje s stroji.
English: iv) Histomorphometry (bone quality).
Slovenian: (BMD - bone mineral density).
English: Over the 4 years of the osteoporosis treatment trial (involving 7705 patients), raloxifene treatment compared to placebo reduced the risk of total breast cancer by 62 % (RR 0.38; CI 0.21, 0.69), the risk of invasive breast cancer by 71 % (RR 0.29, CI 0.13, 0.58) and the risk of invasive oestrogen receptor (ER) positive breast cancer by 79 % (RR 0.21, CI 0.07, 0.50).
Slovenian: V več kot 4 letih preskušanja zdravljenja osteoporoze (vključenih 7.705 bolnic) je zdravljenje z raloksifenom v primerjavi s placebom zmanjšalo tveganje za vse vrste raka dojke za 62 % (RR 0,38 pri 95 % CI 0,21-0,69), tveganje za invazivni rak dojke za 71 % (RR 0,29 pri 95 % CI 0,13-0,58) ter tveganje za invazivni rak dojke, pozitiven za estrogenske receptorje (ER), za 79 % (RR 0,21 pri 95 % CI 0,07-0,50).
English: There is no relevant use of Raloxifene in the paediatric population.
Slovenian: Raloksifen Teva ni primerna pri pediatrični populaciji.
English: No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
Slovenian: V teh raziskavah niso ugotovili nobenih klinično pomembnih učinkov sočasne uporabe naštetih zdravil na plazemske koncentracije raloksifena
English: The PSUR submission schedule for Raloxifene Teva should follow PSUR submission schedule for the reference medicinal product.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) PSURi za zdravilo Raloksifen Teva morajo biti predloženi v skladu s časovnim razporedom za predložitev PSURov za referenčno zdravilo.
English: th year alone, raloxifene reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Slovenian: Samo v četrtem letu zdravljenja je prejemanje raloksifena znižalo tveganje za nov zlom vretenca za 39 % (RR 0,61 pri 95 % CI 0,43-0,88).
English: If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.
Slovenian: Če jemljete zdravila za srce, ki vsebujejo digitalis, ali antikoagulante za redčanje krvi, kakor je npr.
English: Must not be used in women with child bearing potential.
Slovenian: Zdravilo se ne sme uporabljati pri ženskah v rodni dobi.
English: • Gallstones.
Slovenian: • žolčni kamni
English: Raloxifene does not stimulate breast tissue.
Slovenian: d) Vplivi na tkivo dojk Raloksifen ne stimulira tkiva dojk.
English: Gastrointestinal disorders Very common: Gastrointestinal symptoms a such as nausea, vomiting, abdominal pain, dyspepsia
Slovenian: Zelo pogosti: gastrointestinalni simptomia, kot so navzea, bruhanje, bolečine v trebuhu, dispepsija
English: Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Slovenian: Aktivni venski tromboembolični zapleti (VTE) ali venski tromboembolični zapleti v anamnezi, vključno s trombozo globokih ven, pljučno embolijo in trombozo retinalnih ven.
English: Raloxifene Teva mimics some of the helpful effects of oestrogen after the menopause.
Slovenian: Po menopavzi zdravilo Raloxifen Teva posnema nekatere koristne učinke estrogena.
English: In the RUTH study, peripheral oedema occurred in 14.1 % of the raloxifene-treated patients and 11.7 % of the placebo-treated patients, which was statistically significant.
Slovenian: V študiji RUTH se je periferni edem pojavljal pri 14,1 % bolnic zdravljenih z raloksifenom in 11,7 %
English: In a study comparing raloxifene with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Slovenian: iv) Histomorfometrija (kakovost kosti): V raziskavi, v kateri so raloksifen primerjali z estrogenom, so ugotavljali, da je pri obeh zdravilih kostno tkivo zdravljenih bolnic histološko normalno in da ni nobenih znakov defektov v mineralizaciji kosti, kostnega spleta ali fibroze kostnega mozga.
English: How to take Raloxifene Teva
Slovenian: Kako jemati zdravilo Raloksifen Teva
English: What you need to know before you take Raloxifene Teva
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Raloksifen Teva Ne jemljite zdravila Raloksifen Teva
English: In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.
Slovenian: V študiji pri ženskah po menopavzi z dokumentirano koronarno srčno boleznijo ali z večjim tveganjem za koronarne dogodke raloksifen v primerjavi s placebom ni vplival na incidenco miokardnega infarkta,
English: ATC code: G03XC01 Mechanism of action and Pharmacodynamic effect As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
Slovenian: Kot selektivni modulator estrogenskega receptorja (SERM) deluje raloksifen bodisi kot selektivni agonist ali kot antagonist na tkiva, ki se odzivajo na estrogen.
English: Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Slovenian: Ena filmsko obložena tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg proste baze raloksifena.
English: No cases of raloxifene overdose were reported during clinical trials.
Slovenian: V kliničnih študijah niso poročali o nobenem primeru prevelikega odmerjanja raloksifena.
English: Endometrial thickness measurements in raloxifene treated women were not different from baseline after 4 years of therapy.
Slovenian: ki so bile zdravljene z raloksifen, se po 4 letih terapije niso razlikovale od začetnih vrednosti.
English: Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene.
Slovenian: Vsaka tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg raloksifena.
English: What Raloxifene Teva looks like and contents of the pack
Slovenian: Izgled zdravila Raloksifen Teva in vsebina pakiranja
English: In a study of 7,705 postmenopausal women with a mean age of 66 years and with osteoporosis or osteoporosis with an existing fracture, raloxifene treatment for 3 years reduced the incidence of vertebral fractures by 47 % (RR 0.53, CI 0.35, 0.79; p < 0.001) and 31 % (RR 0.69, CI 0.56, 0.86; p < 0.001) respectively.
Slovenian: i) Incidenca zlomov: V raziskavi pri 7.705 ženskah po menopavzi s srednjo starostjo 66 let in z osteoporozo je 3-letno zdravljenje z raloksifenom zmanjšalo incidenco zlomov vretenc za 47 % (relativno tveganje (RR) 0,53 pri 95 % intervalu zaupanja (CI) 0,35-0,79; p < 0,001), pri ženskah z osteoporozo in obstoječim zlomom pa je bila incidenca zlomov vretenc zmanjšana za 31 % (RR 0,69 pri 95 %
English: In postmenopausal women with osteoporosis, raloxifene reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Slovenian: raloksifen zmanjša incidenco zlomov vretenc, ohrani kostno maso in poveča mineralno kostno gostoto
English: 6.5 Nature and contents of container Transparent PVC/PVdC - Aluminium blisters.
Slovenian: Prozorni neprepustni PVC/PVdC - aluminijasti pretisni omoti.
English: Raloxifene and oestrogen affect bone remodelling and calcium metabolism similarly.
Slovenian: iii) Kinetika kalcija: Raloksifen in estrogen imata podoben vpliv na prestrukturiranje kostnega tkiva in presnovo kalcija.
English: In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
Slovenian: Pri odraslih bolnicah, ki so vzele več kot 120 mg raloksifena naenkrat, so poročali o simptomih krčev in omotice.
English: Raloxifene Teva 60 mg film-coated tablets raloxifene hydrochloride
Slovenian: Raloksifen Teva 60 mg filmsko obložene tablete raloksifenijev klorid
English: • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
Slovenian: • simptomi v prebavilih, kot so siljenje na bruhanje, bruhanje, bolečina v trebuhu in razdražen želodec
English: Raloxifene is only for use in postmenopausal women.
Slovenian: Raloksifen je namenjen le za zdravljenje žensk po menopavzi.
English: In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0 % or 3.88 cases per 1000 patient-years in the raloxifene group and 1.4 % or 2.70 cases per 1000 patient-years in the placebo group.
Slovenian: 1.000 bolniških let v skupini raloksifena in 1,4 % ali 2,70 primerih na 1.000 bolnic-let v skupini placeba.
English: - If there is still a possibility that you can get pregnant, Raloxifene Teva could harm your unborn child. - If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
Slovenian: - Če vas trenutno zdravijo zaradi krvnih strdkov ali so vas v preteklosti zdravili zaradi teh motenj (tromboza globokih ven, pljučna embolija ali tromboza mrežničnih ven).
English: Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) produced plasma concentrations of raloxifene which were approximately 2.5 times the controls.
Slovenian: Ko so bolnicam s cirozo in blago jetrno okvaro (razred A po Child Pughu) dali en odmerek raloksifena, so izmerili plazemske koncentracije raloksifena, ki so bile približno 2,5 krat višje od tistih, ki so jih ugotovili pri preiskovankah iz kontrolne skupine.
English: It is not known whether raloxifene is excreted in human milk.
Slovenian: Ni znano, ali se raloksifen izloča v materino mleko, zato njegove klinične uporabe pri doječih materah ne priporočamo.
English: Raloxifene must not be taken by women of child bearing potential.
Slovenian: Raloksifena ne smejo jemati ženske v rodni dobi.
English: In clinical trials, raloxifene did not stimulate the postmenopausal uterine endometrium.
Slovenian: c) Vplivi na endometrij in medenično dno V kliničnih preskušanjih raloksifen ni stimuliral postmenopavzalnega materničnega endometrija.
English: In a study (RUTH) of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an additional adverse reaction of cholelithiasis occurred in 3.3 % of patients treated with raloxifene and 2.6 % of patients treated with placebo.
Slovenian: V študiji (RUTH) postmenopavzalnih žensk z dokazano koronarno srčno boleznijo ali s povečanim tveganjem za koronarne dogodke se je pojavil dodatni neželeni učinek, holelitiaza pri 3,3 %
English: However, there was an increase in death due to stroke in women assigned to raloxifene.
Slovenian: Vendar je bilo pri ženskah, ki so dobivale raloksifen, več smrti zaradi možganske kapi.
English: So any vaginal bleeding while you take Raloxifene Teva is unexpected.
Slovenian: Malo verjetno je, da bi zdravilo Raloksifen Teva povzročilo krvavitev iz nožnice, zato je vsaka krvavitev iz nožnice v času jemanja zdravila Raloksifen Teva nepričakovana in morate prositi svojega zdravnika, naj vas pregleda.
English: In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8 % of 2,557 raloxifene treated patients and 11.1 % of 2,576 placebo treated patients.
Slovenian: V populaciji, pri kateri so raloksifen uporabljali za zdravljenje, so zdravljenje zaradi katerega koli od kliničnih neželenih dogodkov prekinili pri 12,8 % od 2.557 bolnic,
English: NAME OF THE MEDICINAL PRODUCT Raloxifene Teva 60 mg film-coated tablets raloxifene hydrochloride
Slovenian: Navodilo za uporabo Raloksifen Teva 60 mg filmsko obložene tablete raloksifenijev klorid
English: Raloxifene treatment for 4 years reduced the incidence of vertebral fractures by 46 % (RR 0.54, CI 0.38, 0.75) and 32 % (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
Slovenian: 46 % (RR 0,54 pri 95 % CI 0,38-0,75), pri bolnicah z osteoporozo in obstoječim zlomom pa je incidenca zmanjšana za 32 % (RR 0,68 pri 95 % CI 0,56-0,83).
English: NAME OF THE MEDICINAL PRODUCT Raloxifene Teva 60 mg film-coated tablets
Slovenian: Raloksifen Teva 60 mg filmsko obložene tablete
English: Fewer raloxifene treated women than placebo treated women required surgical intervention for uterine prolapse.
Slovenian: V skupini, zdravljeni z raloksifenom, je manj žensk potrebovalo kirurški poseg zaradi prolapsa maternice kot v skupini, ki je prejemala placebo.
English: Slightly decreased (6-10 %) platelet counts have been reported during raloxifene treatment in placebo-controlled clinical trials of raloxifene in osteoporosis.
Slovenian: Med zdravljenjem z raloksifenom v s placebom nadzorovanih kliničnih študijah raloksifena pri osteoporozi so opažali tudi rahlo znižanje
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Tel.: +36 1 288 64 00
Slovenian: Teva Gyógyszergyár Zrt., Tel.: +36 1 288 64 00
English: Vascular disorders
Slovenian: Občasni: trombocitopenijaa
English: Raloxifene Teva reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Slovenian: Zdravilo Raloksifen Teva se uporablja za zdravljenje in preprečevanje osteoporoze pri ženskah po menopavzi.Pri ženskah s postmenopavzalno osteoporozo zdravilo Raloksifen Teva zmanjša tveganje za zlome vretenc.
English: Musculoskeletal and connective tissue disorders Common: Leg cramps
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: In the RUTH study, leg cramps were observed in 12.1 % of raloxifene-treated patients and 8.3 % of placebo-treated patients.
Slovenian: 12,1 % bolnic zdravljenih z raloksifenom in 8,3 % bolnic, ki so jemale placebo.
English: Pregelatinized starch (maize) Magnesium stearate Povidone (K30)
Slovenian: Jedro tablete: predgelirani škrob (koruzni) magnezijev stearat povidon (K30) brezvodni koloidni silicijev dioksid mikrokristalna celuloza (silificirana)
English: How Raloxifene Teva works
Slovenian: Kako deluje zdravilo Raloksifen Teva
English: Skin and subcutaneous tissue disorders Common: Rash a
Slovenian: tkivo in/ali gen. a) Vplivi na okostje
English: Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
Slovenian: možganske kapi ali celokupno smrtnost, vključno s celokupno kardiovaskularno smrtnostjo (za povečanje tveganja smrtne kapi glejte poglavje 4.4).
English: In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/theca cell origin was observed in high-dose females (279 mg/kg/day).
Slovenian: V 2-letni raziskavi kancerogenosti zdravila na podganah so pri samicah, ki so prejemale visoke odmerke
English: The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.
Slovenian: Pri bolnicah, pri katerih obstaja tveganje za pojav venskih tromboemboličnih zapletov kakršne koli etiologije, je treba upoštevati razmerje med koristnostjo jemanja zdravila in tveganjem, ki ga jemanje zdravila povzroča.
English: Reproductive system and breast disorders Common: Mild breast symptoms a such as pain, enlargement and tenderness General disorders and administration site conditions Very common: Flu syndrome Common: Peripheral oedema Investigations
Slovenian: Zelo pogosti: sindrom gripe Pogosti: periferni edem
English: Term(s) included based on postmarketing experience.
Slovenian: Zelo pogosti: zvišan krvni tlaka a Neželeni učinki so vključeni na podlagi izkušenj v obdobju trženja.
English: A relative risk of 1.60 (CI 0.95, 2.71) was observed in raloxifene treated patients compared to placebo.
Slovenian: Pri bolnicah, zdravljenih z raloksifenom, je bilo v primerjavi s tistimi, ki so prejemale placebo, ugotovljeno relativno tveganje 1,60
English: This overview was last updated in 10-2019.
Slovenian: Pregled je bil nazadnje posodobljen 10-2019.
English: The recommended dose is one tablet once a day taken with food and at the same time each day.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan, zaužita s hrano vsak dan ob istem času.
English: Senshio (ospemifene)
Slovenian: Senshio (ospemifen)
English: Further information on Senshio can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/senshio .
Slovenian: Nadaljnje informacije o zdravilu Senshio so na voljo na spletni strani agencije: www.ema.europa.eu/medicines/human/EPAR/senshio .
English: Senshio is available as tablets (60 mg).
Slovenian: Zdravilo Senshio je na voljo v obliki tablet (60 mg).
English: Senshio received a marketing authorisation valid throughout the EU on 15 January 2015.
Slovenian: Za zdravilo Senshio je bilo 15. januarja 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: Since Senshio is given by mouth the Agency considered that this medicine is a valuable alternative for women for whom local treatment is unsuitable.
Slovenian: Ker se zdravilo Senshio jemlje peroralno, je agencija menila, da je to zdravilo dragocena alternativa za ženske, za katere lokalno zdravljenje ni primerno.
English: What measures are being taken to ensure the safe and effective use of Senshio?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Senshio?
English: Women also received non-hormonal vaginal lubricant for use as needed.
Slovenian: Ženske so prejele tudi nehormonski vaginalni lubrikant, ki so ga uporabljale po potrebi.
English: Oestrogen hormones help to maintain the health of tissue in and around the vagina.
Slovenian: Estrogenski hormoni pomagajo ohranjati zdravje tkiva v vagini in okoli nje.
English: However, ospemifene does not work in the same way in other tissues such as the breast and womb, where such activity could cause hyperplasia (growth) of tissues which could lead to cancer.
Slovenian: Vendar pa ospemifen ne deluje enako v drugih tkivih, kot so dojke in maternica, kjer bi takšna aktivnost lahko povzročila hiperplazijo (rast) tkiv, kar bi lahko privedlo do raka.