natgillin/translations-raw huggingface dataset:
- 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.
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.
In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene Teva.
V redkih primerih se lahko med zdravljenjem z zdravilo Raloksifen Teva zvišajo koncentracije jetrnih encimov v krvi.
If you stop taking Raloxifene Teva
Če ste prenehali jemati zdravilo Raloksifen Teva
Uncommon: Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial vein thrombophlebitis, Arterial thromboembolic reactions a
Občasni: venski tromboembolični zapleti, vključno z globoko vensko trombozo, pljučnimi embolijami, trombozo mrežničnih ven, tromboflebitis povrhnjih ven, arterijske tromboembolične reakcijea
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).
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).
Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Raloksifen je indiciran za zdravljenje in preprečevanje osteoporoze pri ženskah po menopavzi.
Driving and using machines Raloxifene Teva has no or negligible effects on driving or using machines.
Zdravilo Raloksifen Teva nima učinkov ali ima zanemarljive učinke na vožnjo ali upravljanje s stroji.
iv) Histomorphometry (bone quality).
(BMD - bone mineral density).
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).
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).
There is no relevant use of Raloxifene in the paediatric population.
Raloksifen Teva ni primerna pri pediatrični populaciji.
No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
V teh raziskavah niso ugotovili nobenih klinično pomembnih učinkov sočasne uporabe naštetih zdravil na plazemske koncentracije raloksifena
The PSUR submission schedule for Raloxifene Teva should follow PSUR submission schedule for the reference medicinal product.
• 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.
th year alone, raloxifene reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
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).
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.
Če jemljete zdravila za srce, ki vsebujejo digitalis, ali antikoagulante za redčanje krvi, kakor je npr.
Must not be used in women with child bearing potential.
Zdravilo se ne sme uporabljati pri ženskah v rodni dobi.
• Gallstones.
• žolčni kamni
Raloxifene does not stimulate breast tissue.
d) Vplivi na tkivo dojk Raloksifen ne stimulira tkiva dojk.
Gastrointestinal disorders Very common: Gastrointestinal symptoms a such as nausea, vomiting, abdominal pain, dyspepsia
Zelo pogosti: gastrointestinalni simptomia, kot so navzea, bruhanje, bolečine v trebuhu, dispepsija
Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Aktivni venski tromboembolični zapleti (VTE) ali venski tromboembolični zapleti v anamnezi, vključno s trombozo globokih ven, pljučno embolijo in trombozo retinalnih ven.
Raloxifene Teva mimics some of the helpful effects of oestrogen after the menopause.
Po menopavzi zdravilo Raloxifen Teva posnema nekatere koristne učinke estrogena.
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.
V študiji RUTH se je periferni edem pojavljal pri 14,1 % bolnic zdravljenih z raloksifenom in 11,7 %
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.
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.
How to take Raloxifene Teva
Kako jemati zdravilo Raloksifen Teva
What you need to know before you take Raloxifene Teva
Kaj morate vedeti, preden boste vzeli zdravilo Raloksifen Teva Ne jemljite zdravila Raloksifen Teva
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.
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,
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.
Kot selektivni modulator estrogenskega receptorja (SERM) deluje raloksifen bodisi kot selektivni agonist ali kot antagonist na tkiva, ki se odzivajo na estrogen.
Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Ena filmsko obložena tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg proste baze raloksifena.
No cases of raloxifene overdose were reported during clinical trials.
V kliničnih študijah niso poročali o nobenem primeru prevelikega odmerjanja raloksifena.
Endometrial thickness measurements in raloxifene treated women were not different from baseline after 4 years of therapy.
ki so bile zdravljene z raloksifen, se po 4 letih terapije niso razlikovale od začetnih vrednosti.
Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene.
Vsaka tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg raloksifena.
What Raloxifene Teva looks like and contents of the pack
Izgled zdravila Raloksifen Teva in vsebina pakiranja
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.
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 %
In postmenopausal women with osteoporosis, raloxifene reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
raloksifen zmanjša incidenco zlomov vretenc, ohrani kostno maso in poveča mineralno kostno gostoto
6.5 Nature and contents of container Transparent PVC/PVdC - Aluminium blisters.
Prozorni neprepustni PVC/PVdC - aluminijasti pretisni omoti.
Raloxifene and oestrogen affect bone remodelling and calcium metabolism similarly.
iii) Kinetika kalcija: Raloksifen in estrogen imata podoben vpliv na prestrukturiranje kostnega tkiva in presnovo kalcija.
In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
Pri odraslih bolnicah, ki so vzele več kot 120 mg raloksifena naenkrat, so poročali o simptomih krčev in omotice.
Raloxifene Teva 60 mg film-coated tablets raloxifene hydrochloride
Raloksifen Teva 60 mg filmsko obložene tablete raloksifenijev klorid
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
• simptomi v prebavilih, kot so siljenje na bruhanje, bruhanje, bolečina v trebuhu in razdražen želodec
Raloxifene is only for use in postmenopausal women.
Raloksifen je namenjen le za zdravljenje žensk po menopavzi.
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.
1.000 bolniških let v skupini raloksifena in 1,4 % ali 2,70 primerih na 1.000 bolnic-let v skupini placeba.
- 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).
- 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).
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.
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.
It is not known whether raloxifene is excreted in human milk.
Ni znano, ali se raloksifen izloča v materino mleko, zato njegove klinične uporabe pri doječih materah ne priporočamo.
Raloxifene must not be taken by women of child bearing potential.
Raloksifena ne smejo jemati ženske v rodni dobi.
In clinical trials, raloxifene did not stimulate the postmenopausal uterine endometrium.
c) Vplivi na endometrij in medenično dno V kliničnih preskušanjih raloksifen ni stimuliral postmenopavzalnega materničnega endometrija.
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.
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 %
However, there was an increase in death due to stroke in women assigned to raloxifene.
Vendar je bilo pri ženskah, ki so dobivale raloksifen, več smrti zaradi možganske kapi.
So any vaginal bleeding while you take Raloxifene Teva is unexpected.
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.
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.
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,
NAME OF THE MEDICINAL PRODUCT Raloxifene Teva 60 mg film-coated tablets raloxifene hydrochloride
Navodilo za uporabo Raloksifen Teva 60 mg filmsko obložene tablete raloksifenijev klorid
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.
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).
NAME OF THE MEDICINAL PRODUCT Raloxifene Teva 60 mg film-coated tablets
Raloksifen Teva 60 mg filmsko obložene tablete
Fewer raloxifene treated women than placebo treated women required surgical intervention for uterine prolapse.
V skupini, zdravljeni z raloksifenom, je manj žensk potrebovalo kirurški poseg zaradi prolapsa maternice kot v skupini, ki je prejemala placebo.
Slightly decreased (6-10 %) platelet counts have been reported during raloxifene treatment in placebo-controlled clinical trials of raloxifene in osteoporosis.
Med zdravljenjem z raloksifenom v s placebom nadzorovanih kliničnih študijah raloksifena pri osteoporozi so opažali tudi rahlo znižanje
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Vascular disorders
Občasni: trombocitopenijaa
Raloxifene Teva reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
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.
Musculoskeletal and connective tissue disorders Common: Leg cramps
Bolezni mišično-skeletnega sistema in vezivnega tkiva
In the RUTH study, leg cramps were observed in 12.1 % of raloxifene-treated patients and 8.3 % of placebo-treated patients.
12,1 % bolnic zdravljenih z raloksifenom in 8,3 % bolnic, ki so jemale placebo.
Pregelatinized starch (maize) Magnesium stearate Povidone (K30)
Jedro tablete: predgelirani škrob (koruzni) magnezijev stearat povidon (K30) brezvodni koloidni silicijev dioksid mikrokristalna celuloza (silificirana)
How Raloxifene Teva works
Kako deluje zdravilo Raloksifen Teva
Skin and subcutaneous tissue disorders Common: Rash a
tkivo in/ali gen. a) Vplivi na okostje
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).
možganske kapi ali celokupno smrtnost, vključno s celokupno kardiovaskularno smrtnostjo (za povečanje tveganja smrtne kapi glejte poglavje 4.4).
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).
V 2-letni raziskavi kancerogenosti zdravila na podganah so pri samicah, ki so prejemale visoke odmerke
The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.
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.
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
Zelo pogosti: sindrom gripe Pogosti: periferni edem
Term(s) included based on postmarketing experience.
Zelo pogosti: zvišan krvni tlaka a Neželeni učinki so vključeni na podlagi izkušenj v obdobju trženja.
A relative risk of 1.60 (CI 0.95, 2.71) was observed in raloxifene treated patients compared to placebo.
Pri bolnicah, zdravljenih z raloksifenom, je bilo v primerjavi s tistimi, ki so prejemale placebo, ugotovljeno relativno tveganje 1,60
This overview was last updated in 10-2019.
Pregled je bil nazadnje posodobljen 10-2019.
The recommended dose is one tablet once a day taken with food and at the same time each day.
Priporočeni odmerek je ena tableta enkrat na dan, zaužita s hrano vsak dan ob istem času.
Further information on Senshio can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/senshio .
Nadaljnje informacije o zdravilu Senshio so na voljo na spletni strani agencije: www.ema.europa.eu/medicines/human/EPAR/senshio .
Senshio is available as tablets (60 mg).
Zdravilo Senshio je na voljo v obliki tablet (60 mg).
Senshio received a marketing authorisation valid throughout the EU on 15 January 2015.
Za zdravilo Senshio je bilo 15. januarja 2015 izdano dovoljenje za promet, veljavno po vsej EU.
Since Senshio is given by mouth the Agency considered that this medicine is a valuable alternative for women for whom local treatment is unsuitable.
Ker se zdravilo Senshio jemlje peroralno, je agencija menila, da je to zdravilo dragocena alternativa za ženske, za katere lokalno zdravljenje ni primerno.
What measures are being taken to ensure the safe and effective use of Senshio?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Senshio?
Women also received non-hormonal vaginal lubricant for use as needed.
Ženske so prejele tudi nehormonski vaginalni lubrikant, ki so ga uporabljale po potrebi.
Oestrogen hormones help to maintain the health of tissue in and around the vagina.
Estrogenski hormoni pomagajo ohranjati zdravje tkiva v vagini in okoli nje.
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.
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.
The European Medicines Agency decided that Senshio's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Senshio večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
As for all medicines, data on the use of Senshio are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Senshio stalno spremljajo.
An overview of Senshio and why it is authorised in the EU
Pregled zdravila Senshio in zakaj je odobreno v EU
Side effects reported with Senshio are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Senshio, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Senshio have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Senshio upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The main measure of effectiveness was related to the change in symptoms such as pain associated with sexual activity and vaginal dryness, using a validated questionnaire.
Glavno merilo učinkovitosti je bilo povezano s spremembo simptomov, kot sta bolečina med spolno aktivnostjo in suhost vagine, kar so ugotavljali s pomočjo potrjenega vprašalnika.
Other information about Senshio
Druge informacije o zdravilu Senshio
As the levels of oestrogen hormones fall during the menopause, the vaginal lining may become thin and dry.
Ker ravni estrogena med menopavzo upadejo, se vaginalna sluznica lahko stanjša in izsuši.
For more information about using Senshio, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Senshio glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
It is used in women who cannot use oestrogen therapy applied in the vagina.
Uporablja se pri ženskah, ki ne morejo uporabljati estrogenskega zdravila, ki se daje v vagino.
This means that it acts in the same way as oestrogen in some tissues in the body such as the vagina and so helps to reduce symptoms of vulvovaginal atrophy.
To pomeni, da v nekaterih tkivih v telesu, kot je vagina, deluje enako kot estrogen in tako pripomore k zmanjšanju simptomov atrofije vulve in vagine.
The studies also showed that Senshio was effective in restoring the vaginal environment including its acidity and thickness of the lining.
Študiji sta pokazali tudi, da je zdravilo Senshio učinkovito obnovilo vaginalno okolje, tudi njegovo kislost in debelino sluznice.
What benefits of Senshio have been shown in studies?
Kakšne koristi zdravila Senshio so se pokazale v študijah?
What are the risks associated with Senshio?
Kakšna tveganja so povezana z zdravilom Senshio?
The Agency considered that the safety profile of Senshio, which was studied for up to 15 months, was in line with medicines working in a similar way (SERMs), but noted, however, that long-term use of SERMs might be associated with risks such as endometrial hyperplasia, stroke and venous thromboembolism and requested further studies to investigate these risks with Senshio.
Agencija je menila, da je varnostni profil zdravila Senshio, ki so ga preučevali do 15 mesecev, skladen z zdravili, ki delujejo na podoben način (selektivni modulatorji estrogenskih receptorjev), vendar je opozorila, da je lahko dolgotrajna uporaba selektivnih modulatorjev estrogenskih receptorjev povezana s tveganji za hiperplazijo endometrija, možgansko kap in vensko trombembolijo, ter zahtevala, naj se izvedejo nadaljnje študije, da bi preučili ta tveganja pri uporabi zdravila Senshio.
The company that markets Senshio is carrying out a study to further investigate long-term potential risks such as endometrial hyperplasia, stroke and venous thromboembolism.
Podjetje, ki trži zdravilo Senshio, izvaja študijo, da bi nadalje preučilo morebitna dolgoročna tveganja, kot so hiperplazija endometrija, možganska kap in venska trombembolija.
What is Senshio and what is it used for?
Kaj je zdravilo Senshio in za kaj se uporablja?
Senshio must also not be used in women who have breast cancer or another cancer that is sex-hormone dependent such as endometrial cancer (cancer of the womb).
Zdravila Senshio prav tako ne smejo uporabljati ženske z rakom dojke ali drugimi vrstami raka, ki so odvisne od spolnih hormonov, kot je rak endometrija (rak maternice).
The Agency noted that the degree of improvement with Senshio was comparable to that with oestrogen treatments that are applied to the vagina.
Agencija je opozorila, da je bila stopnja izboljšanja, ugotovljena pri zdravilu Senshio, primerljiva s stopnjo izboljšanja pri estrogenskih zdravilih, ki se dajejo v vagino.
In addition, it must not be used in patients with unexplained vaginal bleeding or patients with endometrial hyperplasia (abnormal thickening of the lining of the womb).
Ne smejo ga uporabljati niti bolnice z nepojasnjenimi krvavitvami iz vagine ali bolnice s hiperplazijo endometrija (nenormalno zadebelitvijo maternične sluznice).