natgillin/translations-raw huggingface dataset:
EVISTA was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
Uporaba zdravila EVISTA je bila povezana z zmanjšano resorpcijo kostnega tkiva in s srednjim pozitivnim premikom ravnotežja kalcija za 60 mg na dan, kar je bilo predvsem posledica zmanjšane izgube kalcija z urinom.
iv) Histomorphometry (bone quality).
iv) Histomorfometrija (kakovost kosti):
In a study comparing EVISTA with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
V raziskavi, v kateri so zdravilo EVISTA 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.
Clinical trials showed that a 60 mg daily dose of EVISTA significantly decreased total cholesterol (3 to 6%), and LDL cholesterol (4 to 10%).
8 skupnega holesterola (3 do 6%) in LDL holesterola (4 do 10%).
After 3 years therapy EVISTA decreased fibrinogen (6.71%).
Po 3 letih terapije z zdravilom EVISTA je znižana vrednost fibrinogena (6, 71%).
In the osteoporosis treatment study, significantly fewer EVISTA-treated patients required initiation of hypolipidaemic therapy compared to placebo.
V študiji zdravljenja osteoporoze je bila pri bolnicah, zdravljenih z zdravilom EVISTA, uvedba hipolipemične terapije potrebna pri značilno manjšem številu v primerjavi s placebom.
EVISTA therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Osemletno zdravljenje z zdravilom EVISTA pri bolnicah, vključenih v študijo zdravljenja osteoporoze, ni značilno vplivalo na tveganje za srčnožilne dogodke.
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).
Podobno v študiji RUTH raloksifen v primerjavi s placebom ni vplival na incidenco miokardnega infarkta, hospitalizacije akutnega koronarnega sindroma, kapi ali celokupno smrtnost, vključno s celokupno kardiovaskularno smrtnostjo (za povečanje tveganja smrtne kapi glejte poglavje 4. 4).
The relative risk of venous thromboembolic events observed during raloxifene treatment was 1.60 (CI 0.95, 2.71) when compared to placebo, and was 1.0 (CI 0.3, 6.2) when compared to oestrogen or
Relativno tveganje za venske tromboembolične zaplete, ki so jih ugotovili med zdravljenjem z raloksifenom, je bilo RR 1, 60 (CI 0, 95, 2, 71) v primerjavi s placebom, in RR 1, 0 (95% CI 0, 3– 6, 2) v primerjavi z estrogensko ali hormonsko nadomestno terapijo.
In clinical trials, EVISTA did not stimulate the postmenopausal uterine endometrium.
V kliničnih preskušanjih zdravilo EVISTA ni stimuliralo postmenopavzalnega materničnega endometrija.
Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Proučili so rezultate skoraj 3. 000 transvaginalnih ultrazvočnih preiskav pri 831 ženskah iz vseh skupin odmerjanja.
After 3 years of treatment, at least a 5 mm increase in endometrial thickness, assessed with transvaginal ultrasound, was observed in 1.9% of the 211 women treated with raloxifene 60 mg/ day compared to 1.8% of the 219 women who received placebo.
Pri 1, 9% od 211 žensk, ki so jih zdravili z raloksifenom v odmerku 60 mg na dan, so po 3 letih zdravljenja ugotovili najmanj 5- milimetrsko povečanje debeline endometrija, kar so ugotavljali s transvaginalnim ultrazvokom, v primerjavi z 1, 8% od 219 žensk, ki so prejemale placebo.
Endometrial biopsies taken after six months therapy with EVISTA 60 mg daily demonstrated non- proliferative endometrium in all patients.
Biopsija endometrija po šestih mesecih terapije z zdravilom EVISTA v odmerku 60 mg na dan je pri vseh bolnicah pokazala neproliferativni endometrij.
In addition, in a study with 2.5 x the recommended daily dose of EVISTA there was no evidence of endometrial proliferation and no increase in uterine volume.
Poleg tega v raziskavi z 2, 5- kratnim priporočenim dnevnim odmerkom zdravila EVISTA ni bilo nobenih znakov proliferacije endometrija in niso ugotovili povečanja prostornine maternice.
In the osteoporosis treatment trial, endometrial thickness was evaluated annually in a subset of the study population (1,644 patients) for 4 years.
V raziskavi zdravljenja osteoporoze so v obdobju vseh 4 let enkrat na leto ugotavljali debelino endometrija v podskupini opazovane populacije (1. 644 bolnic).
Endometrial thickness measurements in EVISTA treated women were not different from baseline after 4 years of therapy.
Meritve debeline endometrija pri ženskah, ki so bile zdravljene z zdravilom EVISTA, se po 4 letih terapije niso razlikovale od začetnih vrednosti.
There was no difference between EVISTA and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Tudi ni bilo razlike med ženskami, zdravljenimi z zdravilom EVISTA, in tistimi, ki so prejemale placebo, kar zadeva incidenco vaginalne krvavitve (krvavega izcedka) ali izcedka iz nožnice.
Fewer EVISTA treated women than placebo treated women required surgical intervention for uterine prolapse.
V skupini, zdravljeni z zdravilom EVISTA, je manj žensk potrebovalo kirurški poseg zaradi prolapsa maternice kot v skupini, ki je prejemala placebo.
In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
Pri ženskah po menopavzi, ki so se 4 leta zdravile z raloksifenom, so poročali o benignih polipih endometrija pri 0, 9% bolnic v primerjavi z 0, 3% bolnic, ki so prejemale placebo.
EVISTA does not stimulate breast tissue.
Zdravilo EVISTA ne stimulira tkiva dojk.
Across all placebo-controlled trials, EVISTA was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
V več kot 4 letih preskušanja zdravljenja osteoporoze, ki je vključevalo 7. 705 bolnic, je zdravljenje z zdravilom EVISTA v primerjavi s placebom zmanjšalo tveganje za vse vrste raka dojke za 62%
Over the 4 years of the osteoporosis treatment trial (involving 7705 patients), EVISTA 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).
9 (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).
EVISTA has no effect on the risk of ER negative breast cancers.
Zdravilo EVISTA ne vpliva na tveganje za ER negativne vrste raka dojke.
Approximately 60% of an oral dose is absorbed.
Absorbira se približno 60% peroralnega odmerka.
Absolute bioavailability of raloxifene is 2%.
Njegova absolutna biološka uporabnost je 2%.
Raloxifene is strongly bound to plasma proteins (98-99%).
Raloksifen se močno veže na plazemske beljakovine (98– 99%).
Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4'- glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′ -diglucuronide.
Raloksifen se že pri prvem prehodu skozi jetra v veliki meri presnovi v glukuronidne konjugate: raloksifen- 4 '- glukuronid, raloksifen- 6- glukuronid in raloksifen- 6, 4' - diglukuronid.
Raloxifene comprises less than 1% of the combined concentrations of raloxifene and the glucuronide metabolites.
Količina samega raloksifena je manjša od 1% celotnega seštevka koncentracij raloksifena in njegovih glukuronidnih presnovkov.
Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
Koncentracija raloksifena se vzdržuje z enterohepatično cirkulacijo, zato je njegov plazemski razpolovni čas 27, 7 ure.
The majority of a dose of raloxifene and glucuronide metabolites are excreted within 5 days and are found primarily in the faeces, with less than 6% excreted in urine.
Večji del odmerka raloksifena in njegovih glukuronidnih presnovkov se izloči v roku 5 dni in jih najdemo predvsem v blatu, manj kot 6% pa se jih izloči z urinom.
Renal insufficiency - Less than 6% of the total dose is eliminated in urine.
Ledvična insuficienca – Manj kot 6% celotnega odmerka se izloči z urinom.
In a population pharmacokinetic study, a 47% decrease in lean body mass adjusted creatinine clearance resulted in a 17% decrease in raloxifene clearance and a 15% decrease in the clearance of raloxifene conjugates.
V populacijski farmakokinetični raziskavi je 47% znižanje očistka kreatinina, prilagojenega telesni masi brez maščevja, povzročilo 17% znižanje očistka raloksifena in 15% znižanje očistka konjugatov raloksifena.
Hepatic insufficiency - The pharmacokinetics of a single dose of raloxifene in patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) have been compared to that in healthy individuals.
Jetrna insuficienca – Farmakokinetiko enkratnega odmerka raloksifena pri bolnicah s cirozo in blago jetrno okvaro (razred A po Child- Pughu) so primerjali s farmakokinetiko enega odmerka raloksifena pri zdravih preiskovankah.
Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Plazemske koncentracije raloksifena so bile približno 2, 5- krat višje kot plazemske koncentracije pri preiskovankah iz kontrolne skupine in so bile v korelaciji s koncentracijami bilirubina.
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).
10 V 2- letni raziskavi kancerogenosti zdravila na podganah so pri samicah, ki so prejemale visoke odmerke (279 mg/ kg/ dan), ugotovili povečanje pogostnosti pojava tumorjev ovarija, ki so izvirali iz granulozne ali tekalne plasti celic ovarijskih foliklov.
Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
Sistemska izpostavljenost raloksifenu (AUC) v tej skupini preiskovanih podgan je bila približno 400- krat večja od vrednosti za ženske po menopavzi, ki dobi odmerek 60 mg.
In a 21-month carcinogenicity study in mice, there was an increased incidence of testicular interstitial cell tumours and prostatic adenomas and adenocarcinomas in males given 41 or 210 mg/ kg, and prostatic leiomyoblastoma in males given 210 mg/ kg.
V 21- mesečni raziskavi kancerogenosti na miših so ugotavljali povečano incidenco tumorjev testisa, ki so izvirali iz intersticijskih celic, adenomov prostate in adenokarcinomov pri samcih, ki so prejemali odmerke 41 ali 210 mg/ kg, ter leiomioblastoma prostate pri samcih, ki so prejemali odmerke 210 mg/ kg.
In female mice, an increased incidence of ovarian tumours in animals given 9 to 242 mg/ kg (0.3 to 32 times the AUC in humans) included benign and malignant tumours of granulosa/ theca cell origin and benign tumours of epithelial cell origin.
Pri mišjih samicah je povečana incidenca ovarijskih tumorjev pri tistih živalih, ki so prejele 9 do 242 mg/ kg (0, 3 - do 32- kratne AUC za človeka), vključevala tako benigne kot maligne tumorje, ki so izvirali iz granulozne ali tekalne plasti celic ovarijskih foliklov, ter benigne tumorje epitelijskega izvora.
10 The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
Reproduktivni in razvojni učinki, ki so jih opažali pri živalih, so v skladu z znanim farmakološkim profilom raloksifena.
At doses of 0.1 to 10 mg/ kg/ day in female rats, raloxifene disrupted estrous cycles of female rats during treatment, but did not delay fertile matings after treatment termination and only marginally reduced litter size, increased gestation length, and altered the timing of events in neonatal development.
Povzročil je le mejno zmanjšanje števila mladičev in podaljšanje gestacije ter spremenil mejna razvojna obdobja v času neonatalnega razvoja.
In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/ kg) and hydrocephaly (≥ 10 mg/ kg) were seen.
Pri kuncih so opažali splave, majhno pogostnost defektov ventrikularnega septuma (≥ 0, 1 mg/ kg) in hidrocefalijo (≥ 10 mg/ kg).
In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/ kg).
Pri podganah so se pojavili zastoj razvoja ploda, valovita rebra in ledvične ciste (≥ 1 mg/ kg).
Povidone Polysorbate 80 Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
Jedro tablete: povidon polisorbat 80 brezvodna laktoza laktoza monohidrat krospovidon magnezijev stearat
Titanium dioxide (E 171) Polysorbate 80 Hypromellose Macrogol 400 Carnauba wax
Filmska obloga tablete: titanov dioksid (E171) polisorbat 80 hipromeloza makrogol 400 karnauba vosek
Shellac Propylene glycol Indigo carmine (E 132)
Črnilo: šelak propilenglikol indigotin (E132)
6.2 Incompatibilities
11 6. 2 Inkompatibilnosti
EVISTA tablets are packed either in PVC/ PE/ PCTFE blisters or in high density polyethylene bottles.
Tablete EVISTA so pakirane v pretisne omote PVC/ PE/ PCTFE ali v stekleničke iz polietilena visoke gostote.
Bottles contain 100 tablets.
Stekleničke vsebujejo po 100 tablet.
Daiichi Sankyo Europe GmbH Zielstattstrasse 48 D-81379 Munich Germany
Daiichi Sankyo Europe GmbH Zielstattstrasse 48 D- 81379 Muenchen Nemčija
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJ ZA PROMET
5 August 1998 Date of last renewal:
5. avgust 1998 Datum zadnjega podaljšanja dovoljenja za promet:
Lilly SA Avda de la Industria 30 28108 Alcobendas Madrid Spain
Lilly SA Avda de la Industria 30 28108 Alcobendas Madrid Španija
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
16 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
BLISTER BOX FILM COATED TABLETS:
ŠKATLA S PRETISNIM OMOTOM S FILMSKO OBLOŽENIMI TABLETAMI:
EU/ 1/ 98/ 073/ 001 14 film coated tablets EU/ 1/ 98/ 073/ 002 28 film coated tablets EU/ 1/ 98/ 073/ 003 84 film coated tablets
EU/ 1/ 98/ 073/ 001 14 filmsko obloženih tablet EU/ 1/ 98/ 073/ 002 28 filmsko obloženih tablet EU/ 1/ 98/ 073/ 003 84 filmsko obloženih tablet
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU PRETISNI OMOT (VSE VELIKOSTI PAKIRANJ PRETISNIH OMOTOV):
EVISTA 60 mg film coated tablets raloxifene hydrochloride
EVISTA 60 mg filmsko obložene tablete (raloksifenijev klorid)
Read all of this leaflet carefully before you start taking your medicine. • Keep this leaflet.
Pred začetkom jemanja natančno preberete navodilo! • Navodilo shranite.
Do not pass it on to others.
Morda ga boste želeli ponovno prebrati. • Če imate dodatna vprašanja se posvetujte z zdravnikom ali s farmacevtom. • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
What EVISTA is and what it is used for 2.
Kaj je zdravilo EVISTA in za kaj ga uporabljamo 2.
Before you take EVISTA 3.
Kaj morate vedeti, preden boste vzeli zdravilo EVISTA 3.
How to take EVISTA 4.
Kako jemati zdravilo EVISTA 4.
How to store EVISTA 6.
Shranjevanje zdravila EVISTA 6.
WHAT EVISTA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO EVISTA IN ZA KAJ GA UPORABLJAMO
EVISTA belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
EVISTA sodi v skupino nehormonskih zdravil, imenovano selektivni modulatorji estrogenskega receptorja.
EVISTA mimics some of the helpful effects of oestrogen after the menopause.
Po menopavzi zdravilo EVISTA posnema nekatere koristne učinke estrogena.
EVISTA is used to treat and prevent osteoporosis in postmenopausal women.
Zdravilo EVISTA se uporablja za zdravljenje in preprečevanje osteoporoze pri ženskah po menopavzi.
EVISTA reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Pri ženskah s postmenopavzalno osteoporozo zdravilo EVISTA zmanjša tveganje za zlome vretenc.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause.
Še posebej pogosta je pri ženskah po menopavzi.
BEFORE YOU TAKE EVISTA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO EVISTA
Do not take EVISTA:
Ne jemljite zdravila EVISTA
• If you are allergic (hypersensitive) to raloxifene or any of the ingredients of EVISTA. • If there is still a possibility that you can get pregnant, EVISTA 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). • If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice). • If you have any unexplained vaginal bleeding.
• Če ste alergični na (preobčutljivi za) raloksifen ali katerokoli sestavino zdravila EVISTA. • Če je še vedno možnost, da lahko zanosite, saj zdravilo EVISTA lahko poškoduje vašega nerojenega otroka. • Če vas trenutno zdravijo zaradi krvnih strdkov ali so vas v preteklosti zdravili zaradi teh motenj (tromboza globokih ven, pljučna embolija ali tromboza retinalnih ven). • Če imate bolezen jeter (jetrne bolezni so na primer ciroza, blaga okvara jeter ali holestatska zlatenica). • Če imate kakršnokoli nerazložljivo krvavitev iz nožnice.
This must be investigated by your doctor. • If you have active uterine cancer, as there is insufficient experience of EVISTA use in women with this disease. • If you have severe kidney problems.
V tem primeru vas mora pregledati vaš zdravnik. • Če imate aktivni rak maternice, saj pri ženskah s to boleznijo ni zadostnih izkušenj z uporabo zdravila EVISTA. • Če imate hude težave z ledvicami.
23 Take special care with EVISTA
23 V nadaljevanju navajamo nekaj možnih razlogov, zaradi katerih zdravljenje s tem zdravilom ne bi bilo primerno za vas.
If any of them apply to you, talk to your doctor before you take the medicine.
Če katerikoli od njih velja za vas, se morate pogovoriti s svojim zdravnikom, še preden začnete jemati zdravilo.
• 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. • If you are receiving oral oestrogen therapy. • If you are suffering from breast cancer, as there is insufficient experience of EVISTA use in women with this disease. • If you have had a cerebrovascular accident (e. g. stroke), or if your doctor has told you that you are at high risk of having one.
• 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. • Če prejemate peroralno estrogensko terapijo. • Če imate raka dojke, ker ni zadosti izkušenj z uporabo zdravila EVISTA pri ženskah s to boleznijo. • Če ste že imeli cerebrovaskularni dogodek (npr. kap) ali če vam je vaš zdravnik povedal, da imate visoko tveganje za tak dogodek.
You should have this investigated by your doctor.
Malo verjetno je, da bi zdravilo EVISTA povzročilo krvavitev iz nožnice, zato je vsaka krvavitev iz nožnice v času jemanja zdravila EVISTA nepričakovana in morate prositi svojega zdravnika, naj vas pregleda.
EVISTA does not treat postmenopausal symptoms, such as hot flushes.
Zdravilo EVISTA ne zdravi postmenopavzalnih simptomov, kakor so navali vročine.
EVISTA lowers total cholesterol and LDL ("bad") cholesterol.
Zdravilo EVISTA znižuje vrednost celokupnega holesterola in LDL ('slabega') holesterola.
However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking EVISTA.
Če ste v preteklosti že jemali estrogene in ob tem imeli močno povišane vrednosti trigliceridov, se pred jemanjem zdravila EVISTA pogovorite s svojim zdravnikom.
Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.
Obvestite svojega zdravnika, če jemljete holestiramin, ki se uporablja predvsem kot zdravilo za zniževanje koncentracij lipidov v krvi.
Pregnancy and breast-feeding EVISTA is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Nosečnost in dojenje Zdravilo EVISTA je namenjeno le ženskam po menopavzi in je ne smejo jemati ženske, ki bi še lahko zanosile.
Evista could harm your unborn child.
Zdravilo EVISTA lahko poškoduje vašega nerojenega otroka.
Do not take EVISTA if you are breast-feeding as it might be excreted in mother's milk.
Ne jemljite zdravila EVISTA, če dojite, saj lahko zdravilo prehaja v materino mleko.
Driving and using machines EVISTA has no known effects on driving or using machines.
Zdravilo EVISTA nima znanih učinkov na vožnjo ali upravljanje s stroji.
Important information about some ingredients of EVISTA If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product.
Če vam je vaš zdravnik povedal, da imate netoleranco za laktozo, ki je vrsta sladkorja, obvestite zdravnika, preden začnete jemati ta medicinski proizvod.
HOW TO TAKE EVISTA
KAKO JEMATI ZDRAVILO EVISTA
Always take this product exactly as your doctor has told you.
Pri jemanju tega zdravila natančno upoštevajte zdravnikova navodila.
24 The tablets are for oral use.
24 Tablete so namenjene peroralni uporabi.
Your doctor will tell you how long you should continue to take EVISTA.
Vaš zdravnik vam bo povedal, kako dolgo naj bi jemali zdravilo EVISTA.
If you stop taking EVISTA You should talk to your doctor first.
Če ste prenehali jemati zdravilo EVISTA Predhodno se posvetujte s svojim zdravnikom.
If you have the impression that the effect of this product is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek tega zdravila premočan ali prešibak, se posvetujte s svojim zdravnikom ali farmacevtom.
If you forget to take EVISTA Take a tablet as soon as you remember and then continue as before.
Če ste pozabili vzeti zdravilo EVISTA Vzemite eno tableto takoj, ko se spomnite, in potem nadaljujte enako kot prej.
If you take more EVISTA than you should Tell your doctor or pharmacist.
Če ste vzeli večji odmerek zdravila EVISTA, kot bi smeli Povejte svojemu zdravniku ali farmacevtu.
Like all medicines, EVISTA can cause side effects although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo EVISTA neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The majority of side effects seen with EVISTA have been mild.
Neželeni učinki, ki so jih opažali pri zdravilu EVISTA, so bili večinoma blagi.
The most common side effects (affects more than 1 user in 10) are: • Hot flushes (vasodilatation) • Flu syndrome
Najpogostejši neželeni učinki (prizadanejo več kot 1 uporabnika od 10) so: • Navali vročine (vazodilatacija) • Sindrom gripe
Common side effects (affects 1 to 10 users in 100) are: • Leg cramps • Swelling of hands, feet and legs (peripheral oedema) • Gallstones
Pogosti neželeni učinki (prizadanejo 1 do 10 uporabnikov od 100) so: • Krči v nogah • Otekanje dlani, stopal in nog (periferni edem) • Žolčni kamni
Uncommon side effects (affects 1 to 10 users in 1000) are: • Increased risk of blood clots in the legs (deep vein thrombosis) • Increased risk of blood clots in the lungs (pulmonary embolism) • Increased risk of blood clots in the eyes (retinal vein thrombosis) • Skin around the vein is red and painful (superficial vein thrombophlebitis)
Občasni neželeni učinki (prizadanejo 1 do 10 uporabnikov od 1. 000) so: • Povečano tveganje krvnih strdkov v nogah (globoka venska tromboza) • Povečano tveganje krvnih strdkov v pljučih (pljučna embolija) • Povečano tveganje krvnih strdkov v očeh (tromboza retinalnih ven) • Koža okrog ven je rdeča in boleča (tromboflebitis povrhnjih ven)