qanastek/EMEA-V3 huggingface dataset:
No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
Kliniškai reikšmingo kartu vartojam vaist poveikio raloksifeno koncentracijai plazmoje nenustatyta.
Concomitant use of vaginal oestrogen preparations was allowed in the clinical trial programme, if necessary to treat atrophic vaginal symptoms.
Vykdant klinikini tyrim program makšties gleivin s atrofijos simptomams gydyti buvo leista, jei b tina, vartoti estrogen preparatus makšt.
Compared to placebo there was no increased use in OPTRUMA treated patients.
OPTRUMA gydytos pacient s vartojo estrogen ne daugiau negu gavusios placebo.
In vitro, raloxifene did not interact with the binding of warfarin, phenytoin, or tamoxifen.
In vitro raloksifenas nekonkuruoja d l prisijungimo viet su varfarinu, fenitoinu ar tamoksifenu.
Raloxifene should not be co-administered with cholestyramine (or other anion exchange resins), which significantly reduces the absorption and enterohepatic cycling of raloxifene.
Raloksifeno negalima vartoti kartu su cholestiraminu (ar kitomis anijonus kei ian iomis dervomis), kurios ryškiai sumažina raloksifeno absorbcij ir enterohepatin cirkuliacij.
However, since the overall extent of absorption and the elimination rate of raloxifene are not affected, raloxifene can be concurrently administered with ampicillin.
Didžiausi raloksifeno koncentracij mažina kartu vartojamas ampicilinas, ta iau bendroji raloksifeno absorbcija ir eliminacijos greitis nepakinta, tod l j galima vartoti kartu su ampicilinu.
Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin (CBG), with corresponding increases in total hormone concentrations.
Raloksifenas vidutiniškai padidina hormonus prijungian i globulin – lytinius steroidinius hormonus prijungian io globulino (SHBG), tiroksin prijungian io globulino (TBG) ir kortikosteroidus prijungian io globulino (CBG) – koncentracij, d l to atitinkamai did ja bendroji hormon koncentracija.
These changes do not affect concentrations of free hormones.
Šie poky iai neveikia laisv j hormon koncentracijos.
OPTRUMA is only for use in postmenopausal women.
OPTRUMA skiriama tik moterims pomenopauziniu periodu.
OPTRUMA must not be taken by women of child bearing potential.
OPTRUMA negalima skirti vaisingo amžiaus moterims.
Raloxifene may cause foetal harm when administered to a pregnant woman.
N š iosios vartojamas raloksifenas gali pakenkti vaisiui.
If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus (see section 5.3).
5. 3 skyri).
Its clinical use, therefore, cannot be recommended in breast-feeding women.
Nežinoma, ar raloksifeno išsiskiria su motinos pienu, tod l k dik kr timi maitinan i moter šiuo vaistiniu preparatu gydyti nerekomenduojama.
OPTRUMA may affect the development of the baby.
OPTRUMA gali sutrikdyti k dikio raid.
4.7 Effects on ability to drive and use machines
4 4. 7 Poveikis geb jimui vairuoti ir valdyti mechanizmus
Raloxifene has no known influence on the ability to drive and use machines.
OPTRUMA geb jimo vairuoti ir valdyti mechanizmus neveikia.
In osteoporosis treatment and prevention studies involving over 13,000 postmenopausal women all adverse reactionswere recorded.
Osteoporoz s gydymo ir profilaktikos tyrim, kuriuose dalyvavo daugiau kaip 13 000 moter postmenopauz s periodu, buvo registruotos visos nepageidaujamos reakcijos neatsižvelgiant j priežast.
The duration of treatment in these studies ranged from 6 to 60 months.
Gydymo trukm svyravo nuo 6 iki 60 m nesi.
The majority of adverse reactions have not usually required cessation of therapy.
D l daugumos nepageidaujam reakcij gydymo nutraukti nereik jo.
In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7% of 581 OPTRUMA treated patients and 11.1% of 584 placebo-treated patients.
Profilaktikos klinikini tyrim metu gydym d l nepageidaujam reakcij reik jo nutraukti 10, 7% iš 581 OPTRUMA gydyt pacien i ir 11, 1% iš 584 placeb gavusi pacien i.
In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8% of 2,557 OPTRUMA treated patients and 11.1% of 2,576 placebo treated patients.
Gydymo klinikini tyrim metu gydym d l nepageidaujam reiškini reik jo nutraukti 12, 8% iš 2 557 OPTRUMA gydyt pacien i ir 11, 1% iš 2 576 placeb gavusi pacien i.
The adverse reactions associated with the use of raloxifene in osteoporosis clinical trials are summarised in the table below.
Nepageidaujamos reakcijos, susijusios su raloksifeno vartojimu osteoporoz s klinikini tyrim metu, apibendrintos žemiau esan ioje lentel je.
The following convention has been used for the classification of the adverse reactions: very common (1/ 10), common (1/ 100 to < 1/ 10), uncommon (1/ 1,000 to < 1/ 100), rare (1/ 10,000 to < 1/ 1,000) very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Nepageidaujam reakcij klasifikacijai naudotas šis susitarimas: labai dažni (1/ 10), dažni (nuo 1/ 100 iki < 1/ 10), nedažni (nuo 1/ 1 000 iki < 1/ 100), reti (nuo 1/ 10 000 iki < 1/ 1 000), labai reti (< 1/ 10 000), dažnis nežinomas (negali b ti vertintas pagal turimus duomenis).
Peripheral oedema
Kraujagysli sutrikimai Labai dažni: vazodilatacija (paraudimas su karš io poj iu) Nedažni: ven tromboembolija, skaitant gili j ven tromboz, plau i embolij ir tinklain s ven tromboz, paviršini ven tromboflebitas Skeleto, raumen ir jungiamojo audinio sutrikimai Dažni: koj m šlungis Bendrieji sutrikimai ir vartojimo vietos pažeidimai Labai dažni: gripo sindromas Dažni: periferin edema
Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in OPTRUMA patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3% OPTRUMA and 18.2% placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6% for OPTRUMA and 7.1% placebo).
Vazodilatacija (paraudimas su karš io poj iu) šiek tiek dažniau pasireišk OPTRUMA grup je lyginant su placebo grupe (klinikiniai osteoporoz s profilaktikos tyrimai, 2- 8 metai po menopauz s, 24, 3% vartojant OPTRUMA ir 18, 2% - placeb; klinikiniai osteoporoz s gydymo tyrimai, vidutinis amžius – 66 metai, 10, 6% vartojant OPTRUMA ir 7, 1% - placeb).
This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time.
Ši nepageidaujama reakcija dažniausiai pasireikšdavo per pirmuosius šešis gydymo m nesius ir retai prasid davo v liau.
In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8% in the raloxifene-treated patients and 4.7% in the placebo-treated patients.
Tyrimo RUTH, kuriame dalyvavo 10 101 moteris, kurios postmenopauz s periodu sirgo dokumentuota išemine širdies liga arba kurioms buvo padid jusi širdies vainikin s kraujotakos reiškini rizika, metu iš raloksifenu gydyt tiriam j kraujagysli išsipl timas (paraudimas su karš io poj iu) pasireišk 7, 8%, iš vartojusi placebo − 4, 7%.
Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8% or 3.22 cases per 1,000 patient years.
Vis placebu kontroliuot klinikini tyrim, kuriuose tirtas osteoporoz s gydymas raloksifenu, metu ven tromboembolijos, skaitant gili j ven tromboz, plau i embolij ir tinklain s ven tromboz, dažnumas buvo apie 0, 8%, arba 3, 22 atvej 1 000 pacien i met.
A relative risk of 1.60 (CI 0.95, 2.71) was observed in OPTRUMA treated patients compared to placebo.
OPTRUMA gydytoms pacient ms, lyginant su gavusiomis placebo, nustatyta reliatyvi 1, 60 (PI 0, 95, 2, 71) rizika.
The risk of a thromboembolic event was greatest in the first four months of therapy.
Didžiausia tromboembolijos rizika yra pirmuosius keturis gydymo m nesius.
Superficial vein thrombophlebitis occurred in a frequency of less than 1%.
Paviršini ven tromboflebitas pasireišk mažiau kaip 1%.
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.
Tyrimo RUTH metu raloksifenu gydyt grup je ven tromboembolijos reiškini dažnis buvo maždaug 2% arba 3, 88 atvejai 1 000 pacient met, placebo grup je − 1, 4% arba 2, 7 atvejai 1 000 pacient met.
The hazard ratio for all VTE events in the RUTH study was
Tyrimo RUTH metu vis tromboembolijos reiškini rizikos santykis (RS) buvo 1, 44 (1, 06 – 1, 95).
Superficial vein thrombophlebitis occurred in a frequency of 1% in the raloxifene group and 0.6% in the placebo group.
Raloksifenu gydyt grup je paviršini ven tromboflebito dažnis buvo 1%, placebo grup je − 0, 6%.
Another adverse reaction observed was leg cramps (5.5% for OPTRUMA, 1.9% for placebo in the prevention population and 9.2% for OPTRUMA, 6.0% for placebo in the treatment population).
5 Kita steb ta nepageidaujama reakcija buvo koj m šlungis (prevencin je grup je – 5, 5% vartojant OPTRUMA, 1, 9% - placeb, gydomojoje grup je – 9, 2% vartojant OPTRUMA, 6, 0% - placeb).
In the RUTH study, leg cramps were observed in 12.1% of raloxifene-treated patients and 8.3% of placebo-treated patients.
Tyrimo RUTH metu raloksifenu gydytoms moterims koj m šlungio dažnis buvo 12, 1%, vartojusioms placeb − 8, 3%.
Flu syndrome was reported by 16.2% of OPTRUMA treated patients and 14.0% of placebo treated patients.
Gripo sindromas pasitaik 16, 2% OPTRUMA gydyt ir 14, 0% placeb gavusi pacien i.
One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend.
Kitas pokytis – periferin edema – yra statistiškai nepatikimas (p > 0, 05), bet reikšmingai priklauso nuo vaisto doz s.
This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1% for OPTRUMA and 1.9% for placebo; and in the treatment population occurred at an incidence of 7.1% for OPTRUMA and 6.1% for placebo.
Prevencin je grup je periferin edema buvo 3, 1% OPTRUMA ir 1, 9% placeb vartojusi pacien i, o gydomojoje grup je – 7, 1% OPTRUMA ir 6, 1% placeb vartojusi pacien i.
Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo- controlled clinical trials of raloxifene in osteoporosis.
Placebu kontroliuotame tyrime, kuriame tirtas osteoporoz s gydymas raloksifenu, pasteb tas nedidelis (6 – 10%) trombocit kiekio sumaž jimas.
Rare cases of moderate increases in AST and/ or ALT have been reported where a causal relationship to raloxifene can not be excluded.
Aprašoma retai pasitaikanti vidutiniškai padid jusi AST ir (ar) ALT koncentracija; šios reakcijos priežastis gali b ti ir raloksifenas.
A similar frequency of increases was noted among placebo patients.
Panašiai šie rodikliai padid ja placeb gavusioms pacient ms.
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.
Tyrime RUTH, kuriame dalyvavo moterys, kurios postmenopauz s periodu sirgo dokumentuota išemine širdies liga arba kurioms buvo padid jusi širdies vainikin s kraujotakos reiškini rizika, papildoma nepageidaujama reakcija tulžies akmenlig pasireišk 3, 3% raloksifenu gydyt tiriam j, o vartojusi placeb − 2, 6%.
Cholecystectomy rates for raloxifene (2.3%) were not statistically significantly different from placebo (2.0%).
Cholecistektomijos dažnis moterims, gydytoms raloksifenu (2, 3%) ar vartojusioms placebo (2%), statistikai reikšmingai nesiskyr.
OPTRUMA (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Gydymas OPTRUMA (n = 317) klinikini tyrim metu buvo lygintas su sud tine (n = 110) pakaitine hormon terapija (PHT) ir cikline (n = 205) PHT.
The incidence of breast symptoms and uterine bleeding in raloxifene treated women was significantly lower than in women treated with either form of HRT.
Raloksifenu gydytoms moterims kr ties simptom ir kraujavimas iš gimdos pasitaik gerokai re iau negu kuri nors PHT gavusioms pacient ms.
The adverse reactions reported in post-marketing experience are presented in the table below.
Nepageidaujamos reakcijos, pasteb tos vaistiniui preparatui esant rinkoje, išvardytios žemiau esan ioje lentel je.
Mild breast symptoms such as pain, enlargement and tenderness.
Kraujo ir limfin s sistemos sutrikimai Labai reti: trombocitopenija Virškinimo trakto sutrikimai Labai reti: virškinimo trakto sutrikimo simptomai tokie kaip pykinimas, v mimas, pilvo skausmas, dispepsija Bendrieji sutrikimai ir vartojimo vietos pažeidimai Reti: periferin edema Tyrimai Labai reti: padid j s kraujosp dis Nerv sistemos sutrikimai Labai reti: galvos skausmas, skaitant migrenin Odos ir poodinio audinio sutrikimai Labai reti: išb rimas Lytin s sistemos ir kr ties sutrikimai Labai reti: silpnas kr t skausmas, padid jimas ir jautrumas.
Vascular disorders Rare: venous thromboembolic reaction Very rare: arterial thromboembolic reaction
Kraujagysli sutrikimai Reti: ven tromboembolijos reakcija Labai reti: arterij tromboembolijos reakcija
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
Kai kuri klinikini tyrim metu ne didesne kaip 600 mg paros doze buvo gydoma 8 savaites, 120 mg paros doze − 3 metus.
No cases of raloxifene overdose were reported during clinical trials.
Klinikini tyrim metu pranešim api raloksifeno perdozavim negauta.
In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
6 Suaugusiems žmon ms, iš karto išg rusiems didesn negu 120 mg doz, buvo koj m šlungio ir galvos svaigimo atvej.
In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg.
Didžiausia mažesni negu 2 met vaik iš karto atsitiktinai išgerta doz yra 180 mg.
In children, symptoms of accidental overdoseincluded ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
Pasteb ti atsitiktinio perdozavimo simptomai vaikams yra ataksija, galvos svaigimas, v mimas, išb rimas, viduriavimas, tremoras, paraudimas ir šarmin s fosfataz s kiekio padid jimas.
The highest overdose has been approximately 1.5 grams.
Didžiausia iš karto išgerta doz yra 1, 5 g.
No fatalities associated with overdose have been reported.
Su perdozavimu susijusios mirties atvej nebuvo.
There is no specific antidote for raloxifene hydrochloride.
Specifinio raloksifeno hidrochlorido priešnuodžio n ra.
G03XC01
Farmakoterapin grup – selektyvusis estrogen receptori moduliatorius (SERM), ATC kodas – G03XC01.
As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
Selektyvus estrogen receptori moduliatorius (SERM), raloksifenas, veikia selektyviai agonistiškai ar antagonistiškai estrogenams jautrius audinius.
It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
Jis agonistiškai veikia kaulus ir iš dalies cholesterolio metabolizm (mažina bendrojo ir MTL- cholesterolio kiek), bet ne pogumbur ir gimdos bei kr ties audinius.
Raloxifene 'biological actions, like those of oestrogen, are mediated through high affinity binding to s oestrogen receptors and regulation of gene expression.
Raloksifenas, kaip ir estrogenai, yra labai giminingas estrogen receptoriams ir, prisijung s prie j, reguliuoja gen ekspresij.
This binding results in differential expression of multiple oestrogen-regulated genes in different tissues.
Šio prisijungimo rezultatas yra skirting audini vairi estrogen reguliuojam gen diferencin ekspresija.
Recent data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/ or gene-specific.
Paskutinieji duomenys rodo, kad estrogen receptorius gali reguliuoti gen ekspresij mažiausiai dviem skirtingais b dais: ligandui, audiniui ir (ar) genui specifiniu b du.
The decrease in oestrogen availability which occurs at menopause, leads to marked increases in bone resorption, bone loss and risk of fracture.
D l sumaž jusio estrogen kiekio menopauz s laikotarpiu ženkliai padid ja kaulo rezorbcija, sumaž ja kaulo mas ir padid ja l ži tikimyb.
Bone loss is particularly rapid for the first 10 years after menopause when the compensatory increase in bone formation is inadequate to keep up with resorptive losses.
Kaulo mas grei iausiai maž ja per pirmuosius 10 met po menopauz s, kai kompensacinis kaulo mas s did jimas neatitinka kaul rezorbcijos.
Other risk factors which may lead to the development of osteoporosis include early menopause; osteopenia (at least 1 SD below peak bone mass); thin body build; Caucasian or Asian ethnic origin; and a family history of osteoporosis.
Kiti rizikos faktoriai, d l kuri gali prasid ti osteoporoz, yra ankstyvoji menopauz, osteopenija (bent 1 SD mažiau didžiausios kaul mas s), asteniškas k no sud jimas, etnin kilm (baltieji ar azijie iai) ir šeimin osteoporoz s anamnez.
Replacement therapies generally reverse the excessive resorption of bone.
Pakaitin hormon terapija dažniausiai sumažina kaul rezorbcij.
In postmenopausal women with osteoporosis, OPTRUMA reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Osteoporoze sergan ioms moterims pomenopauziniu periodu OPTRUMA sumažina stuburo l ži tikimyb, saugo kaulo mas ir didina kaul mineral tank (BMD).
Based on these risk factors, prevention of osteoporosis with OPTRUMA is indicated for women within ten years of menopause, with BMD of the spine between 1.0 and 2.5 SD below the mean value of a normal young population, taking into account their high lifetime risk for osteoporotic fractures.
Remiantis šiais rizikos faktoriais, osteoporoz s prevencijai OPTRUMA skiriama moterims, kurioms menopauz trunka ne ilgiau kaip 10 met, o stuburo BMD yra 1, 0- 2, 5 SD mažesnis negu vidutinis jaunos populiacijos rodiklis, d l didel s osteoporozini l ži tikimyb s.
Likewise, OPTRUMA is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/ or with vertebral fractures, irrespective of BMD.
Taip pat OPTRUMA skiriama osteoporoz s ar diagnozuotos osteoporoz s gydymui moterims, kuri stuburo BMD yra 2, 5 SD mažesnis negu vidutinis jaunos populiacijos rodiklis ir (ar) yra stuburo l ži, neatsižvelgiant BMD.
i) Incidence of fractures.
i) L ži dažnis.
Forty five women with osteoporosis or 15 women with
Tyrime dalyvavusioms 7 705 moterims (vidutinis amžius 66 metai), kurioms buvo osteoporoz arba osteoporoziniai l žiai pomenopauziniu periodu, 3 met gydymas OPTRUMA sumažino stuburo l ži dažn atitinkamai 47% (RS 0, 53; PI 0, 35, 0, 79; p < 0, 001) ir 31% (RS 0, 69; PI 0, 56, 0, 86; p < 0, 001).
7 osteoporosis with an existing fracture would need to be treated with OPTRUMA for 3 years to prevent one or more vertebral fractures.
45 osteoporoze sergan ias moteris ir 15 moter, kurioms jau yra osteoporozini l ži, reik t gydyti OPTRUMA 3 metus, kad b t išvengta vieno ar keli stuburo l ži.
OPTRUMA 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.
4 met gydymas OPTRUMA 46% (RS 0, 54, PI 0, 38, 0, 75) sumažino stuburo l ži dažn osteoporoze sergan ioms moterims ir 32% (RS 0, 68, PI 0, 56, 0, 83) – sergan ioms osteoporoze, kurioms jau yra osteoporozini l ži.
In the 4th year alone, OPTRUMA reduced the new vertebral fracture risk by 39% (RR 0.61, CI 0.43, 0.88).
Vien ketvirtaisiais gydymo metais OPTRUMA 39% (RS 0, 61,
An effect on non-vertebral fractures has not been demonstrated.
7 PI 0, 43, 0, 88) sumažino nauj stuburo slanksteli l ži rizik.
From the 4th to the 8th year, patients were permitted the concomitant use of bisphosphonates, calcitonin and fluorides and all patients in this study received calcium and vitamin D supplementation.
Nuo ketvirt j iki aštunt j gydymo met pacient ms buvo leista kartu vartoti bisfosfonatus, kalcitonin ir fluoridus ir visos šiame tyrime dalyvavusios pacient s vartojo kalcio ir vitamino D papild.
In the RUTH study overall clinical fractures were collected as a secondary endpoint.
Tyrimo RUTH metu antrin vertinamoji baigtis buvo vis klinikini l ži dažnis.
Optruma reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47 0.89).
0, 47 - 0, 89).
These results may have been confounded by baseline differences in BMD and vertebral fractures.
Šiuos rezultatus gali supainioti prieš pradedant gydyti buv s BMD ir stuburo l ži skirtumas.
There was no difference between treatment groups in the incidence of new nonvertebral fractures.
Nauj ne stuburo l ži dažnis abiejuose tiriamosiose grup se nesiskyr.
During the whole length of the study concomitant use of other bone-active medications was permitted.
Visu tyrimo laikotarpiu tiriamosioms buvo leista vartoti kit kaulus veikian i medikament.
ii) Bone Mineral Density (BMD):
ii) Kaul mineral tankis (BMD).
The efficacy of OPTRUMA once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
OPTRUMA efektyvumas pomenopauziniu periodu jaunesn ms kaip 60 met moterims, kurioms gimda buvo išimta arba neišimta ir kurios vartojo vaist vien kart per par, buvo nustatytas po 2 met gydymo.
The women were 2 to 8 years postmenopausal.
Šioms moterims po menopauz s buvo pra j 2- 8 metai.
Three trials included 1,764 postmenopausal women who were treated with OPTRUMA and calcium or calcium supplemented placebo.
Trijuose tyrimuose dalyvavusios 1 764 moterys, kurioms buvo pomenopauzinis periodas, buvo gydytos OPTRUMA ir kalciu arba placebu ir kalciu.
In one of these trials the women had previously undergone hysterectomy.
Viename ši tyrim dalyvavo moterys po histerektomijos.
OPTRUMA produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
OPTRUMA, lyginant su placebu, ženkliai padidino šlaunikaulio bei stuburo mineral tank ir bendr mineralini medžiag kiek organizme.
This increase was generally a 2% increase in BMD compared to placebo.
Lyginant su placebu, BMD padid jo 2%.
A similar increase in BMD was seen in the treatment population who received OPTRUMA for up to 7 years.
Panašiai BMD padid jo ir moterims, kurios OPTRUMA buvo gydytos net 7 metus.
In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was: for the spine 37% decreased and 63% increased; and for the total hip 29% decreased and 71% increased.
Atliekant prevencinius tyrimus, moterys, kurioms BMD gydant raloksifenu padid jo arba sumaž jo, pasiskirst taip: stuburo BMD sumaž jo 37% ir padid jo 67% moter; šlaunikaulio – sumaž jo 29%, o padid jo 71%.
OPTRUMA and oestrogen affect bone remodelling and calcium metabolism similarly.
OPTRUMA bei estrogenai kaul atsinaujinim ir kalcio metabolizm veikia panašiai.
OPTRUMA 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.
OPTRUMA sumažina kaul rezorbcij, ir vidutinis teigiamas 60 mg per par kalcio balanso pokytis susidaro daugiausia d l sumaž jusio kalcio išsiskyrimo su šlapimu.
iv) Histomorphometry (bone quality).
iv) Histomorfometrija (kaulo kokyb).
In a study comparing OPTRUMA with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
OPTRUMA ir estrogen lyginam j tyrim metu nustatyta, kad abiem vaistais gydyt pacien i kaulai histologiškai buvo normal s, mineralizacijos sutrikim, pintos kaul strukt ros arba kaul iulp fibroz s nebuvo.
Raloxifene decreases resorption of bone; this effect on bone is manifested as reductions in the serum and urine levels of bone turnover markers, decreases in bone resorption based on radiocalcium kinetics studies, increases in BMD and decreases in the incidence of fractures.
Šis poveikis pasireiškia sumaž jusiais kaul apykaitos žymekliais serume ir šlapime, sumaž jusia kaul rezorbcija (nustatyta tiriant radioaktyvaus kalcio kinetik), padid jusiu BMD ir retesniais l žiais.
b) Effects on lipid metabolism and cardiovascular risk
b) Poveikis lipid metabolizmui ir širdies kraujagysli lig rizika
Clinical trials showed that a 60 mg daily dose of OPTRUMA significantly decreased total cholesterol (3 to 6%), and LDL cholesterol (4 to 10%).
Klinikini tyrim metu nustatyta, kad 60 mg OPTRUMA paros doz ženkliai mažina bendrojo cholesterolio (3- 6%) ir MTL cholesterolio (4- 10%) kiek.
Women with the highest baseline cholesterol levels had the greatest decreases.
Labiausiai sumaž jo cholesterolio kiekis toms moterims, kuri bazin cholesterolio koncentracija buvo didžiausia.
HDL cholesterol and triglyceride concentrations did not change significantly.
DTL cholesterolio ir triglicerid koncentracijos ryškiau nepasikei ia.
After 3 years therapy OPTRUMA decreased fibrinogen (6.71%).
Po 3 gydymo met OPTRUMA sumažino fibrinogeno kiek (6, 71%).
In the osteoporosis treatment study, significantly fewer OPTRUMA-treated patients required initiation of hypolipidaemic therapy compared to placebo.
Osteoporoz s gydymo klinikinio tyrimo metu žymiai mažesniam skai iui OPTRUMA vartojusi pacien i negu gavusi placebo teko prad ti lipid kiekio mažinimo gydym.
OPTRUMA therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Aštuoneri met gydymas OPTRUMA netur jo reikšmingos takos širdies ir kraujagysli sistemos reiškini rizikai pacient ms, dalyvavusioms osteoporoz s gydymo klinikiniame tyrime.
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).
4. 4 skyri).
8 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 hormonal replacement therapy.
Santykin ven tromboembolijos atvej rizika gydymo raloksifenu metu buvo 1, 60 (PI 0, 95, 2, 71) lyginant su placebo ir 1, 0 (PI 0, 3, 6, 2) lyginant su pakaitine estrogen arba hormon terapija.
The risk of a thromboembolic event was greatest in the first four months of therapy.
Didžiausia ven tromboembolijos atvej rizika buvo pirmaisiais keturiais gydymo m nesiais.
In clinical trials, OPTRUMA did not stimulate the postmenopausal uterine endometrium.
Klinikini tyrim metu nustatyta, kad OPTRUMA neskatina gimdos endometriumo proliferacijos.
Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
Lyginant su placebo, raloksifenas nebuvo susij s su tepiomis išskyromis, kraujavimu ar endometriumo
Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Buvo vertinta 831 skirtingas vaisto dozes vartojusi moter beveik 3000 ultragarsinio tyrimo per makšt duomen.
Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo.
Raloksifenu gydyt moter endometriumo sustor jimas buvo toks pat, kaip placeb gavusi moter.
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.
Po trej met gydymo bent 5 mm sustor j s endometriumas, matomas ultragarsinio tyrimo per makšt metu, buvo nustatytas 1, 9% iš 211 moter, vartojusi 60 mg raloksifeno per par, ir 1, 8% iš 219 moter, vartojusi placeb.
There were no differences between the raloxifene and placebo groups with respect to the incidence of reported uterine bleeding.
Kraujavimas iš gimdos raloksifen ir placeb vartojusi moter grup je nesiskyr.
Endometrial biopsies taken after six months therapy with OPTRUMA 60 mg daily demonstrated non- proliferative endometrium in all patients.
Visoms pacient ms po 6 m nesi gydymo OPTRUMA (60 mg per par) atlikta endometriumo biopsija ir nustatytas neproliferacinis endometriumas.
In addition, in a study with 2.5 x the recommended daily dose of OPTRUMA there was no evidence of endometrial proliferation and no increase in uterine volume.
Klinikinio tyrimo metu, kai buvo vartojamos 2, 5 kart didesn s negu rekomenduojamos paros doz s, endometriumo proliferacijos ir padid jusios gimdos mas s nenustatyta.
In the osteoporosis treatment trial, endometrial thickness was evaluated annually in a subset of the study population (1,644 patients) for 4 years.
Osteoporoz s gydymo klinikinio tyrimo, kuris truko 4 metus, metu 1644 pacient s endometriumo storis buvo vertinamas kasmet.
Endometrial thickness measurements in OPTRUMA treated women were not different from baseline after 4 years of therapy.
OPTRUMA gydyt moter endometriumo storis iš prieš gydym ir po 4 met nesiskyr.
There was no difference between OPTRUMA and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
OPTRUMA ir placebu gydyt moter kraujavimo, tepi ar kitoki išskyr iš makšties dažnumas buvo toks pat.
Fewer OPTRUMA treated women than placebo treated women required surgical intervention for uterine prolapse.
OPTRUMA gydytoms moterims re iau reik jo chirurgin s intervencijos d l gimdos prolapso.
Safety information following 3 years of raloxifene treatment suggests that raloxifene treatment does not increase pelvic floor relaxation and pelvic floor surgery.
3 met gydymo raloksifenu saugumo duomenys leidžia manyti, kad gydant raloksifenu nepadid ja dubens pagrindo relaksacijos ir dubens pagrindo chirurginio gydymo atvej.
After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
Po 4 met raloksifenas nepadidino endometriumo ar kiaušidži v žio rizikos.
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.
0, 9% moter, vartojusi raloksifen 4 metus pomenopauziniu periodu, aprašyta gerybini endometriumo polip lyginant su 0, 3% placeb vartojusi moter.
d) Effects on breast tissue
d) Poveikis kr ties audiniams
OPTRUMA does not stimulate breast tissue.
OPTRUMA nestimuliuoja kr ties audini.
Across all placebo-controlled trials, OPTRUMA was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
Vis placebu kontroliuojam tyrim metu kr ties simptom (tinimo, sustand jimo, kr ties skausmo) dažnis ir intensyvumas, vartojant OPTRUMA ir placeb, nesiskyr.
Over the 4 years of the osteoporosis treatment trial (involving 7705 patients), OPTRUMA 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).
4 metus trukusio osteoporoz s bandomojo gydymo metu (dalyvavo 7705 pacient s), gydymas OPTRUMA lyginant su placebo poveikiu 62% (RR 0, 38; CI 0, 21, 0, 69) sumažino vis kr ties v žio form rizik, 71% (RR 0, 29, CI 0, 13, 0, 58) sumažino invazinio kr ties v žio rizik ir 79% (RR 0, 21, CI 0, 07, 0, 50) sumažino invazinio estrogen receptoriui (ER) teigiamo kr ties v žio rizik.
OPTRUMA has no effect on the risk of ER negative breast cancers.
OPTRUMA neveikia rizikos susirgti ER neigiamu v žiu.
These observations support the conclusion that raloxifene has no intrinsic oestrogen agonist activity in breast tissue.
Šie steb jimai patvirtina išvad, kad raloksifenui neb dingas vidinis estrogen aktyvumas kr ties audiniuose.
No adverse effects on cognitive function have been seen.
Nepasteb ta, kad vaistas veikt pažinimo funkcij.
9 5.2 Pharmacokinetic properties
5. 2 Farmakokinetin s savyb s
Approximately 60% of an oral dose is absorbed.
Išgertas raloksifenas greitai absorbuojasi, maždaug 60% vaisto doz s.
Presystemic glucuronidation is extensive.
Daug vaisto gliukuroninama prieš jam patenkant sistemin kraujotak.
Absolute bioavailability of raloxifene is 2%.
Absoliutus raloksifeno biologinis sisavinimas yra 2%.
The time to reach average maximum plasma concentration and bioavailability are functions of systemic interconversion and enterohepatic cycling of raloxifene and its glucuronide metabolites.
Laikas, per kur pasiekiama didžiausia vaisto koncentracija kraujyje, ir biologinis sisavinimas priklauso nuo sistemini vaisto poky i ir enterohepatin s raloksifeno bei jo gliukuronint metabolit cirkuliacijos.
Raloxifene is distributed extensively in the body.
Raloksifenas pasiskirsto po vis organizm.
The volume of distribution is not dose dependent.
Pasiskirstymo t ris nuo doz s nepriklauso.
Raloxifene is strongly bound to plasma proteins (98-99%).
Raloksifenas yra stipriai susijung s su plazmos baltymais (98- 99%).
Metabolism
9 Metabolizmas
Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4 '- glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′ -diglucuronide.
Raloksifenas aktyviai metabolizuojamas pirmojo prasiskverbimo per kepenis metu iki gliukuronido konjugat: raloksifeno- 4 ’ - gliukuronido, raloksifeno- 6- gliukuronido ir raloksifeno- 6, 4 ’ - digliukuronido.
No other metabolites have been detected.
Kit metabolit nenustatyta.
Raloxifene comprises less than 1% of the combined concentrations of raloxifene and the glucuronide metabolites.
Raloksifenas sudaro mažiau kaip 1% bendrosios raloksifeno ir jo gliukuronid metabolit koncentracijos.
Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
Raloksifeno koncentracij palaiko enterohepatin cirkuliacija, jo pusin s eliminacijos periodas yra 27, 7 val.
Results from single oral doses of raloxifene predict multiple dose pharmacokinetics.
Pagal vienkartin s geriamosios vaisto doz s rezultatus sprendžiama apie daugkartini dozi farmakokinetik.
Increasing doses of raloxifene result in slightly less than proportional increase in the area under the plasma time concentration curve (AUC).
Didinant raloksifeno dozes, mažiau negu proporcingai did ja plotas po koncentracijos kreive (AUC).
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.
Didžiausia raloksifeno doz s ir jo gliukuronint metabolit dalis išsiskiria per 5 dienas su išmatomis ir mažiau kaip 6% - su šlapimu.
Special populations
Specialios pacien i grup s
Renal insufficiency - Less than 6% of the total dose is eliminated in urine.
Mažiau kaip 6% visos vaisto doz s išsiskiria su šlapimu.
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.
Populiacijos farmakokinetikos tyrim metu buvo nustatyta, kad, 47% sumaž jus kreatinino klirensui (koreguotas pagal ideal k no svor), 17% sumaž ja raloksifeno klirensas ir 15% - raloksifeno konjugat klirensas.
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.
Vienkartin s raloksifeno doz s farmakokinetika pacient ms, kurioms buvo diagnozuota kepen ciroz ir nesunkus kepen nepakankamumas (Child- Pugh A klas), buvo lyginta su farmakokinetika sveik moter organizme.
Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Raloksifeno koncentracija plazmoje buvo beveik 2, 5 kart didesn negu kontrolin s grup s moter ir koreliavo su bilirubino koncentracija.
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).
Žiurki dvej met kancerogeninio poveikio tyrimo metu pasteb ta, kad žiurki patel ms, vartojusioms dideles vaisto dozes (279 mg/ kg per par), padažn jo kiaušidži granulosa/ theca l steli kilm s navik.
Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
Šios grup s sistemin raloksifeno ekspozicija (AUC) buvo beveik 400 kart didesn negu moter, vartojusi 60 mg dozes.
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.
Peli 21 m nesio kancerogeninio poveikio tyrimo metu dažniau pasitaik s klidži intersticini l steli navik ir prostatos adenom patinams, gavusiems 41mg/ kg ar 210 mg/ kg, ir prostatos lejomioblastom patinams, gavusiems 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.
Peli patel ms, gavusioms 9- 242 mg/ kg (AUC 0, 3- 32 kartus didesnis negu žmon ms), nustatyta daugiau gerybini ir piktybini granulosa/ theca l steli kilm s navik ir gerybini epitelini l steli kilm s navik.
The female rodents in these studies were treated during their reproductive lives, when their ovaries were functional and highly responsive to hormonal stimulation.
Ši tyrim metu buvo gydytos vaisingos graužik patel s, kai j kiaušid s funkcionavo ir jautriai reagavo hormon stimuliacij.
In contrast to the highly responsive ovaries in this rodent model, the human ovary after menopause is relatively unresponsive to reproductive hormonal stimulation.
Skirtingai nuo ši jautriai hormon stimuliacij reaguojan i graužik kiaušidži, moter kiaušid s po menopauz s hormon stimuliacij beveik nereaguoja.
10 Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
Raloksifeno genotoksinio poveikio nenustatyta jokiais naudotos test sistemos tyrimais.
The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
Vaisto poveikis gyv n reprodukcijai ir raidai atitinka žinomas farmakologines raloksifeno savybes.
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.
Raloksifenas, kurio buvo duodama 0, 1- 10 mg/ kg per par žiurki patel ms, nutrauk estrogen cikl, bet, nutraukus gydym, vaisingumas iš karto atsinaujino, nedaug sumaž jo jaunikli dydis, pailg jo gestacijos trukm ir pakito naujagimi raidos laikas.
When given during the preimplantation period, raloxifene delayed and disrupted embryo implantation resulting in prolonged gestation and reduced litter size but development of offspring to weaning was not affected.
Raloksifenas, duodamas priešimplantaciniu periodu, l tina ar nutraukia embriono implantacij, d l to pailg ja gestacija, sumaž ja jaunikli dydis, bet palikuoni raida nepakinta.
Teratology studies were conducted in rabbits and rats.
Teratologinis vaisto poveikis tirtas bandym su triušiais ir žiurk mis metu.
In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/ kg).
Triušiams vyko daugiau abort, atsirado nedaug skilveli pertvaros defekt (≥ 0, 1 mg/ kg) ir hidrocefalija (≥ 10 mg/ kg), žiurk ms pasteb ta atsilikusi vaisiaus raida, banguoti šonkauliai ir ertmi inkstuose (≥ 1 mg/ kg).
Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
Raloksifenas stipriai antiestrogeniškai veikia žiurki gimd ir trukdo augti nuo estrogen priklausomiems žiurki ir peli kr ties navikams.
Povidone Polysorbate 80 Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
Tablet s šerdis Povidonas Polisorbatas 80 Bevanden laktoz Laktoz s monohidratas Krospovidonas Magnio stearatas
Titanium dioxide (E 171) Polysorbate 80 Hypromellose Macrogol 400 Carnauba wax
Tablet s dangalas Titano dioksidas (E 171) Polisorbatas 80 Hipromelioz Makrogolis 400 Karnaubo vaškas
Not applicable.
Duomenys neb tini.
Store in the original package.
Laikyti gamintojo pakuot je.
6.5 Nature and content of container
6. 5 Pakuot ir jos turinys
OPTRUMA tablets are packed either in PVC/ PE/ PCTFE blisters or in high density polyethylene bottles.
OPTRUMA tablet s supakuotos polivinilchlorido (PVC), polietileno (PE) ir polichlortrifluoretileno (PCTFE) lizdines plokšteles arba didelio tankio polietileno buteliukus.
Blister boxes contain 14, 28, or 84 tablets.
D žut s lizdin se plokštel se yra 14, 28 arba 84 tablet s, buteliuke − 100 table i.
11 Not all pack sizes may be marketed in all countries.
Gali b ti tiekiamos ne vis dydži pakuot s.
6.6 Special precautions for disposal
6. 6 Special s reikalavimai atliekoms tvarkyti
No special requirements.
Speciali reikalavim n ra.
Eli Lilly Nederland B. V Grootslag 1-5 NL-3991 RA Houten The Netherlands
Eli Lilly Nederland B. V Grootslag 1- 5 NL- 3991 RA Houten, Olandija (Nyderlandai)
5 August 1998 Date of last renewal:
Rinkodaros teis s atnaujinimo data:
5 August 2003
2003 m. rugpj io 5 d.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
GAMYBOS LICENCIJOS TUR TOJAS, ATSAKINGAS UŽ SERIJ IŠLEIDIM
Name and address of the manufacturers responsible for batch release
Gamintojo, atsakingo už serij išleidim, pavadinimas ir adresas
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Su pakuote pateikiamame lapelyje nurodomas gamintojo, atsakingo už konkre ios serijos išleidim, pavadinimas ir adresas.
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• S LYGOS IR APRIBOJIMAI, SKIRTI SAUGIAM IR VEIKSMINGAM VAISTINIO PREPARATO VARTOJIMUI UŽTIKRINTI
The Marketing Authorisation Holder will provide the PSUR at 3-yearly intervals.
Rinkodaros teis s tur tojas periodiškai atnaujinamus saugumo protokolus pateiks 3 met intervalais.
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
16 INFORMACIJA ANT IŠORIN S IR VIDIN S PAKUOT S
BOTTLE LABEL, BOTTLE CARTON:
BUTELIO ETIKET, BUTELIO D ŽUT
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
OPTRUMA 60 mg pl vele dengtos tablet s Raloksifeno hidrochloridas
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
VEIKLIOJI (- IOS) MEDŽIAGA (- OS) IR JOS (-) KIEKIS (- IAI) Kiekvienoje OPTRUMA tablet je yra 60 mg raloksifeno hidrochlorido, atitinkan io 56 mg raloksifeno.
Also includes lactose
Tablet se yra laktoz s
See leaflet for further information
Daugiau informacijos rasite pakuot s lapelyje
100 film coated tablets
100 pl vele dengt table i
METHOD AND ROUTE(S) OF ADMINISTRATION
VARTOJIMO METODAS IR B DAS
For oral use
Vartoti per burn.
OTHER SPECIAL WARNING(S), IF NECESSARY
KITAS (- I) SPECIALUS (- S) SP JIMAS (- AI) (JEI REIKIA)
Eli Lilly Nederland B. V Grootslag 1-5 NL-3991 RA Houten The Netherlands
Eli Lilly Nederland B. V Grootslag 1- 5 NL- 3991 RA Houten Olandija (Nyderlandai)
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
18 INFORMACIJA ANT IŠORIN S PAKUOT S
BLISTER BOX FILM COATED TABLETS:
D ŽUT, KURIOJE YRA PL VELE DENGTOS TABLET S LIZDIN SE PLOKŠTEL SE
STATEMENT OF ACTIVE SUBSTANCE(S)
VEIKLIOJI (- IOS) MEDŽIAGA (- OS) IR JOS (-) KIEKIS (- IAI)
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Kiekvienoje OPTRUMA tablet je yra 60 mg raloksifeno hidrochlorido, atitinkan io 56 mg raloksifeno.
See leaflet for further information
Daugiau informacijos rasite informaciniame lapelyje
14 film coated tablets 28 film coated tablets 84 film coated tablets
14 pl vele dengt table i 28 pl vele dengtos tablet s 84 pl vele dengtos tablet s
EU/ 1/ 98/ 074/ 001 14 film coated tablets EU/ 1/ 98/ 074/ 002 28 film coated tablets EU/ 1/ 98/ 074/ 003 84 film coated tablets
EU/ 1/ 98/ 073/ 001 14 pl vele dengt table i EU/ 1/ 98/ 073/ 002 28 pl vele dengtos tablet s EU/ 1/ 98/ 073/ 003 84 pl vele dengtos tablet s
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS):
20 MINIMALI INFORMACIJA ANT LIZDINI PLOKŠTELI ARBA DVISLUOKSNI JUOSTELI LIZDIN PLOKŠTEL (VISOS LIZDINI PLOKŠTELI PAKUOT S)
NAME OF THE MARKETING AUTHORISATION HOLDER
RINKODAROS TEIS S TUR TOJO PAVADINIMAS
22 PACKAGE LEAFLET:
22 PAKUOT S LAPELIS:
Read all of this leaflet carefully before you start taking your medicine. • Keep this leaflet.
Atidžiai perskaitykite vis š lapel, prieš prad dami vartoti vaist,.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
- Jeigu kilt daugiau klausim, kreipkit s gydytoj arba vaistinink.
Do not pass it on to others.
- Šis vaistas skirtas Jums, tod l kitiems žmon ms jo duoti negalima.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Jeigu pasireišk sunkus šalutinis poveikis arba pasteb jote šiame lapelyje nenurodyt šalutin
What OPTRUMA is and what it is used for 2.
Kas yra OPTRUMA ir kam jis vartojamas 2.
Before you take OPTRUMA 3.
Kas žinotina prieš vartojant OPTRUMA 3.
How to take OPTRUMA 4.
Kaip vartoti OPTRUMA 4.
How to store OPTRUMA 6.
Kaip laikyti OPTRUMA 6.
WHAT OPTRUMA IS AND WHAT IT IS USED FOR
KAS YRA OPTRUMA IR KAM JIS VARTOJAMAS
OPTRUMA belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
OPTRUMA priklauso nehormonini vaist, vadinam selektyviais estrogen receptori moduliatoriais (SERM), grupei.
When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down.
Moteriai, kuriai prasideda menopauz, labai sumaž ja moteriškojo lytinio hormono estrogeno.
OPTRUMA mimics some of the helpful effects of oestrogen after the menopause.
OPTRUMA pakartoja kai kuriuos naudingus estrogeno poveikius.
OPTRUMA is used to treat and prevent osteoporosis in postmenopausal women.
OPTRUMA vartojama po menopauz s osteoporoz s gydymui ir profilaktikai.
OPTRUMA reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Vaistas mažina moter po menopauz s stuburo slanksteli l ži rizik.
A reduction in the risk of hip fractures has not been shown.
Nenustatyta, kad jis mažint šlaunikaulio l ži rizik.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause.
Ši liga ypa dažna moterims po menopauz s.
Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.
Nors iš pradži osteoporoz gali netur ti joki simptom, ji padidina kaul l ži tikimyb, ypa stuburo, šlaunikauli, riešo kaul bei sukelia nugaros skausm, gio sumaž jim ir stuburo iškrypim.
BEFORE YOU TAKE OPTRUMA
KAS ŽINOTINA PRIEŠ VARTOJANT OPTRUMA
Do not take OPTRUMA:
OPTRUMA vartoti negalima: