natgillin/translations-raw huggingface dataset:
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.
Dup 3 ani de tratament, la 1, 9% din 211 femei tratate cu raloxifen 60 mg/ zi s- a observat prin TVU o cre tere cu cel pu in 5 mm a grosimii endometrului, în compara ie cu aceea i cre tere la 1, 8% din cele 219 femei care au primit placebo.
There were no differences between the raloxifene and placebo groups with respect to the incidence of reported uterine bleeding.
Nu au fost diferen e între grupurile cu raloxifen i placebo în privin a inciden ei sânger rilor uterine raportate.
Endometrial biopsies taken after six months therapy with OPTRUMA 60 mg daily demonstrated non- proliferative endometrium in all patients.
Biopsiile endometriale recoltate dup ase luni de tratament cu OPTRUMA 60 mg pe zi au eviden iat endometru neproliferativ la toate pacientele.
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.
Adi ional, într- un studiu cu de 2, 5 ori doza zilnic recomandat de OPTRUMA, nu au existat dovezi de proliferare endometrial i nu au existat cre teri ale volumului uterin.
In the osteoporosis treatment trial, endometrial thickness was evaluated annually in a subset of the study population (1,644 patients) for 4 years.
În studiul de tratament al osteoporozei, grosimea endometrului a fost evaluat anual la un subset al popula iei studiului (1644 paciente), timp de 4 ani.
Endometrial thickness measurements in OPTRUMA treated women were not different from baseline after 4 years of therapy.
Dimensiunile grosimii endometrului la femeile tratate cu OPTRUMA nu au diferit de nivelul ini ial dup 4 ani de tratament.
There was no difference between OPTRUMA and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Nu au existat diferen e între femeile tratate cu OPTRUMA i cu placebo în privin a frecven ei sânger rilor vaginale (mici sânger ri) sau scurgerilor vaginale.
Fewer OPTRUMA treated women than placebo treated women required surgical intervention for uterine prolapse.
Mai pu ine femei tratate cu OPTRUMA decât cu placebo au necesitat interven ie chirurgical pentru prolaps uterin.
Safety information following 3 years of raloxifene treatment suggests that raloxifene treatment does not increase pelvic floor relaxation and pelvic floor surgery.
Informa iile cu privire la siguran a administr rii dup 3 ani de tratament în 3 studii dublu orb, controlate placebo, cu raloxifen sugereaz c raloxifenul nu cre te relaxarea plan eului pelvin sau interven iile chirurgicale la nivelul plan eului pelvin.
After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
Dup 4 ani, raloxifenul nu a crescut riscul de cancer endometrial sau ovarian.
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.
La femeile în postmenopauz care au primit tratament cu raloxifen timp de 4 ani, polipii endometriali benigni au fost raporta i la 0, 9% din cazuri, fa de 0, 3% la femeile care au primit tratament placebo.
d) Effects on breast tissue
d) Efectele asupra esutului mamar
OPTRUMA does not stimulate breast tissue.
OPTRUMA nu stimuleaz esutul mamar.
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).
În cadrul tuturor studiilor controlate placebo, OPTRUMA nu a putut fi deosebit de placebo în privin a frecven ei i severit ii simptomelor mamare (absen a edemului, sensibiliz rii dureroase i a durerii mamare).
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).
În cursul celor 4 ani ai studiului clinic de tratament al osteoporozei (implicând 7705 paciente), în compara ie cu placebo, tratamentul cu OPTRUMA a redus riscul de cancer mamar total cu 62% (RR 0, 38; IÎ 0, 21, 0, 69), riscul de cancer mamar invaziv cu 71% (RR 0, 29, IÎ 0, 13, 0, 58) i riscul de cancer mamar invaziv pozitiv pentru receptorul de estrogen (RE) cu 79% (RR 0, 21, IÎ 0, 07, 0, 50).
OPTRUMA has no effect on the risk of ER negative breast cancers.
OPTRUMA nu a avut efect asupra cancerelor mamare cu RE negativ.
These observations support the conclusion that raloxifene has no intrinsic oestrogen agonist activity in breast tissue.
Aceste observa ii sus in concluzia c raloxifenul nu are activitate agonist estrogenic intrinsec în esutul mamar.
e) Effects on cognitive function
e) Efectele asupra func iei cognitive
No adverse effects on cognitive function have been seen.
Nu au fost constatate reac ii adverse asupra func iei cognitive.
9 5.2 Pharmacokinetic properties
9 5. 2 Propriet i farmacocinetice
Absorption
Absorb ie
Raloxifene is absorbed rapidly after oral administration.
Raloxifenul este absorbit rapid dup administrarea oral.
Approximately 60% of an oral dose is absorbed.
Se absoarbe aproximativ 60% dintr- o doz oral.
Presystemic glucuronidation is extensive.
Glucuronidarea presistemic este intens.
Absolute bioavailability of raloxifene is 2%.
Biodisponibilitatea absolut a raloxifenului este 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.
Timpul de atingere a concentra iei i biodisponibilit ii plasmatice maxime este în func ie de metabolizarea sistemic i de ciclul entero- hepatic al raloxifenului i al metaboli ilor s i glucuronida i.
The volume of distribution is not dose dependent.
Volumul de distribu ie nu este dependent de doz.
Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4 '- glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′ -diglucuronide.
Raloxifenul sufer o metabolizare extensiv în glucuronoconjuga i la primul pasaj hepatic: raloxifen - 4 '- glucuronid, raloxifen- 6- glucuronid i raloxifen- 6, 4' - glucuronid.
No other metabolites have been detected.
Nu au fost detecta i al i metaboli i.
Raloxifene comprises less than 1% of the combined concentrations of raloxifene and the glucuronide metabolites.
Raloxifenul reprezint mai pu in de 1% din concentra iile combinate ale raloxifenului i metaboli ilor glucuronida i.
Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
Concentra iile raloxifenului sunt men inute prin reciclare enterohepatic, rezultând un timp de înjum t ire plasmatic de 27, 7 ore.
Results from single oral doses of raloxifene predict multiple dose pharmacokinetics.
Rezultatele ob inute cu doze orale unice de raloxifen anticipeaz farmacocinetica dozelor multiple.
Increasing doses of raloxifene result in slightly less than proportional increase in the area under the plasma time concentration curve (AUC).
Cre terea dozelor de raloxifen rezult în cre terea mai pu in decât propor ional a ariei de sub curba concentra iei plasmatice în func ie de timp (ASC).
Excretion
Excre ie
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.
Cea mai mare parte a unei doze de raloxifen i a metaboli ilor glucuronida i se excret în decurs de 5 zile i se reg se te în primul rând în fecale, mai pu in de 6% excretându- se în urin.
Special populations
Popula ii speciale
Renal insufficiency - Less than 6% of the total dose is eliminated in urine.
Insuficien a renal - Mai pu in de 6% din doza total se elimin prin urin.
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.
Într- un studiu de farmacocinetic popula ional, sc derea cu 47% a clearance- ului creatininei ajustat pentru masa non - lipidic a corpului a rezultat în sc derea cu 17% a clearance- ului raloxifenului i sc derea cu 15% a clearance- ului conjuga ilor raloxifenului.
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.
Insuficien a hepatic - Farmacocinetica unei doze unice de raloxifen la paciente cu ciroz i insuficien hepatic u oar (clasa Child- Pugh A) a fost comparat cu cea de la persoane s n toase.
Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Concentra iile plasmatice ale raloxifenului au fost de aproximativ 2, 5 ori mai mari decât la lotul de control i s- au corelat cu concentra iile bilirubinei.
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).
Într- un studiu de carcinogenitate la obolani, cu durata de 2 ani, la femelele tratate cu doz mare (279 mg/ kg i zi), s- a observat o cre tere a tumorilor ovariene cu origine în celulele granuloase/ tecale.
Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
Expunerea sistemic (ASC) la raloxifen în acest grup a fost de aproximativ 400 ori cea de la femeile în postmenopauz la care se administreaz doza de 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.
Într- un studiu de de carcinogenitate la oareci, cu durata 21 de luni, a existat o inciden crescut a tumorilor testiculare cu celule intersti iale i a adenoamelor i adenocarcinoamelor prostatice la masculii c rora li s- au administrat 41 sau 210 mg/ kg i a leiomioblastoamelor la masculii cu 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.
La oarecii femele, inciden a crescut a tumorilor ovariene la animalele c rora li s- au administrat 9 pân la 242 mg/ kg (de 0, 3 pân la 32 ori ASC de la om) a inclus tumori benigne i maligne cu origine în celulele granuloase/ tecale i tumori benigne de origine celular epitelial.
The female rodents in these studies were treated during their reproductive lives, when their ovaries were functional and highly responsive to hormonal stimulation.
Femelele de roz toare din aceste studii au fost tratate în cursul vie ii reproductive, atunci când ovarele lor erau func ionale i foarte responsive la stimularea hormonal.
10 Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
10 Spre deosebire de ovarele înalt responsive din acest model la roz toare, ovarul uman dup menopauz este relativ neresponsiv la stimularea hormonal reproductiv.
The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
Raloxifen nu a fost genotoxic în niciuna dintre bateriile extensive de sisteme de teste care au fost aplicate.
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.
La doze de 0, 1 pân la 10 mg/ kg i zi la femelele de obolan, raloxifenul a perturbat ciclurile estrale ale femelelor de obolan în cursul tratamentului, dar nu a întârziat acupl rile fertile dup terminarea tratamentului i numai marginal a redus num rul de pui dintr- o na tere, a crescut durata gesta iei i a modificat etapele de timp ale evenimentelor dezvolt rii neonatale.
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.
Atunci când a fost administrat în perioada de preimplantare, raloxifenul a întârziat i perturbat implantarea embrionului, rezultând o gesta ie prelungit i reducerea num rului de pui dintr- o na tere, dar dezvoltarea puilor pân la în rcare nu a fost afectat.
Teratology studies were conducted in rabbits and rats.
Studiile de teratogenitate s- au efectuat la iepuri i obolani.
In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/ kg) and hydrocephaly (≥ 10 mg/ kg) were seen.
La iepuri s- au constatat avorturi i o mic rat de defecte septale ventriculare (0, 1 mg/ kg) i hidrocefalie (10 mg/ kg).
In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/ kg).
La obolani au survenit retardarea dezvolt rii fetale, coaste ondulate i cavita ie renal (1 mg/ kg).
Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
Raloxifenul este un antiestrogenic potent în uterul de obolan i a împiedicat cre terea tumorilor mamare dependente de estrogeni la obolani i oareci.
Povidone Polysorbate 80 Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
Povidon Polisorbat 80 Lactoz anhidr Lactoz monohidrat Crospovidon Stearat de magneziu
Titanium dioxide (E 171) Polysorbate 80 Hypromellose Macrogol 400 Carnauba wax
Dioxid de titan (E 171) Polisorbat 80 Hipromeloz Macrogol 400 Cear carnauba
6.5 Nature and content of container
11 6. 5 Natura i con inutul ambalajului
OPTRUMA tablets are packed either in PVC/ PE/ PCTFE blisters or in high density polyethylene bottles.
OPTRUMA este ambalat în blistere din PVC/ PE/ PCTFE sau în flacoane din polietilen de înalt densitate.
Blister boxes contain 14, 28, or 84 tablets.
Cutiile cu blistere con in 14, 28 sau 84 comprimate.
Bottles contain 100 tablets.
Flacoanele con in 100 de comprimate.
11 Not all pack sizes may be marketed in all countries.
Este posibil ca nu toate m rimile de ambalaj s fie comercializate.
6.6 Special precautions for disposal
6. 6 Precau ii speciale pentru eliminarea reziduurilor
No special requirements.
F r cerin e speciale.
Eli Lilly Nederland B. V Grootslag 1-5 NL-3991 RA Houten The Netherlands
Eli Lilly Nederland BV Grootslag 1- 5 NL- 3991 RA Houten Olanda.
5 August 1998 Date of last renewal:
5 August 1998 Data ultimei reînnoiri a autoriza iei:
5 August 2003
28 Iulie 2003
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DE IN TORUL( II) AUTORIZA IEI DE FABRICA IE RESPONSABIL( I) PENTRU ELIBERAREA SERIEI
Name and address of the manufacturers responsible for batch release
Numele i adresa produc torului( ilor) responsabil( i) pentru eliberarea seriei
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• CONDI II SAU RESTRIC II CU PRIVIRE LA SIGURAN A I EFICACITATEA UTILIZ RII MEDICAMENTULUI
The Marketing Authorisation Holder will provide the PSUR at 3-yearly intervals.
De in torul autoriza iei de punere pe pia va depune RPAS la intervale de 3 ani.
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
16 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I AMBALAJUL PRIMAR
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Fiecare comprimat filmat con ine 60 mg clorhidrat de raloxifen, echivalent cu 56 mg raloxifen
Also includes lactose
Con ine lactoz.
See leaflet for further information
A se vedea prospectul pentru mai multe informa ii
For oral use
Oral
Marketing Authorisation Holder:
De in torul Autoriza iei de punere pe pia:
Batch {number}
Lot {num r}
Medicinal product subject to medical prescription.
Medicament eliberat pe baz de prescrip ie medical.
Optruma
INFORMA II ÎN BRAILLE Optruma
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
18 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR
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/ 074/ 001 14 comprimate filmate EU/ 1/ 98/ 074/ 002 28 comprimate filmate EU/ 1/ 98/ 074/ 003 84 comprimate filmate
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS):
20 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE BLISTER SAU PE FOLIE TERMOSUDAT
NAME OF THE MARKETING AUTHORISATION HOLDER
NUMELE DE IN TORULUI AUTORIZA IEI DE PUNERE PE PIA
Lot {number}
Lot {num r}
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
OPTRUMA 60 mg comprimate filmate (clorhidrat de raloxifen)
Read all of this leaflet carefully before you start taking your medicine. • Keep this leaflet.
Citi i cu aten ie i în întregime acest prospect înainte de a începe s lua i acest medicament. • P stra i acest prospect.
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.
S- ar putea s fie necesar s - l reciti i. • Dac ave i orice întreb ri suplimentare, adresa i- v medicului dumneavoastr sau farmacistului. • Acest medicament a fost prescris pentru dumneavoastr.
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.
Le poate face r u, chiar dac au acelea i simptome cu ale dumneavoastr. • Dac vreuna dintre reac iile adverse devine grav sau dac observa i orice reac ie advers nemen ionat în acest prospect, v rug m s - i spune i medicului dumneavoastr sau farmacistului.
What OPTRUMA is and what it is used for 2.
Ce este OPTRUMA i pentru ce se utilizeaz 2.
Before you take OPTRUMA 3.
Înainte s lua i OPTRUMA 3.
How to take OPTRUMA 4.
Cum s lua i OPTRUMA 4.
Possible side effects 5.
Reac ii adverse posibile 5.
How to store OPTRUMA 6.
Cum se p streaz OPTRUMA 6.
Further information
Informa ii suplimentare
WHAT OPTRUMA IS AND WHAT IT IS USED FOR
CE ESTE OPTRUMA I PENTRU CE SE UTILIZEAZ
OPTRUMA belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
OPTRUMA apar ine unui grup de medicamente nehormonale denumit modulatori selectivi ai receptorului de estrogen (MSRE).
When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down.
Atunci când femeile ajung la menopauz, nivelul estrogenului, hormonul sexual feminin, scade.
OPTRUMA mimics some of the helpful effects of oestrogen after the menopause.
Dup menopauz, OPTRUMA imit unele din efectele utile ale estrogenului.
OPTRUMA is used to treat and prevent osteoporosis in postmenopausal women.
OPTRUMA este utilizat pentru tratarea i prevenirea osteoporozei la femeile în postmenopauz.
OPTRUMA reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
OPTRUMA reduce riscul de fracturi vertebrale la femeile cu osteoporoz în postmenopauz.
A reduction in the risk of hip fractures has not been shown.
Nu s- a demonstrat o reducere a riscului de fracturi de old.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause.
Osteoporoza este o boal care face ca oasele dumneavoastr s devin sub iri i fragile - aceast boal este frecvent la femei mai ales dup menopauz.
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.
Cu toate c la început poate s nu aib simptome, osteoporoza v predispune la fracturi ale oaselor, în special ale coloanei vertebrale, oldurilor i ale încheieturilor mâinii i poate s produc dureri de spate, sc dere în în l ime i încovoierea spatelui.
BEFORE YOU TAKE OPTRUMA
ÎNAINTE S LUA I OPTRUMA
Do not take OPTRUMA:
Nu lua i OPTRUMA:
• If you are allergic (hypersensitive) to raloxifene or any of the ingredients of OPTRUMA. • If there is still a possibility that you can get pregnant, OPTRUMA 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.
• Dac sunte i alergic (hipersensibil) la raloxifen sau la oricare dintre componentele OPTRUMA. • Dac exist înc posibilitatea s ramâne i gravid, OPTRUMA poate d una copilului dumneavoastr nen scut. • Dac sunte i sau a i fost tratat pentru cheaguri de sânge (tromboz venoas profund, embolie pulmonar sau tromboz venoas retinian). • Dac ave i o boal de ficat (exemplele de boli de ficat includ ciroza, insuficien a hepatic u oar sau icterul colestatic). • Dac ave i orice fel de sângerare vaginal neexplicat.
This must be investigated by your doctor. • If you have active uterine cancer, as there is insufficient experience of OPTRUMA use in women with this disease. • If you have severe kidney problems.
Aceasta trebuie investigat de c tre medicul dumneavoastr. • Dac ave i cancer uterin activ, pentru c nu exist suficiente date cu privire la utilizarea OPTRUMA la femeile cu aceast boal. • Dac ave i insuficien renal sever.
23 Take special care with OPTRUMA
23 Ave i grij deosebit cu OPTRUMA
The following are reasons why this product may not be suitable for you.
Cele ce urmeaz sunt motive pentru care acest produs ar putea s nu fie potrivit pentru dumneavoastr.
If any of them apply to you, talk to your doctor before you take the medicine.
Dac oricare din cele ce urmeaz vi se aplic, discuta i cu medicul dumneavoastr înainte de a lua medicamentul.
• 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 OPTRUMA 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.
Exemplele de imobilizare includ s fi i în scaun cu rotile, s fie nevoie s s fi i internat într- un spital sau s sta i în pat pe parcursul recuper rii dup o opera ie sau o boal nea teptat. • Dac vi se administreaz terapie oral estrogenic. • Dac suferi i de cancer de sân, deoarece nu exist suficient experien cu utilizarea OPTRUMA la femeile cu aceast boal. • Dac a i avut un accident cerebrovascular (de exemplu accident vascular cerebral), sau dac doctorul dumneavoastr v- a spus c ave i risc crescut de a avea unul.
It is unlikely that OPTRUMA will cause vaginal bleeding.
Este pu in probabil ca OPTRUMA s determine sângerare vaginal.
So any vaginal bleeding while you take OPTRUMA is unexpected.
Ca urmare, orice sângerare vaginal ce apare atunci când lua i OPTRUMA este nea teptat.
You should have this investigated by your doctor.
Trebuie s s v adresa i medicului dumneavoastr pentru a investiga acest eveniment.
OPTRUMA does not treat postmenopausal symptoms, such as hot flushes.
OPTRUMA nu trateaz simptomele postmenopauzei, cum ar fi bufeurile.
OPTRUMA lowers total cholesterol and LDL ("bad") cholesterol.
OPTRUMA scade colesterolul total i LDL- colesterolul (colesterolul „ r u ”).
In general, it does not change triglycerides or HDL ("good") cholesterol.
În general, ea nu modific trigliceridele sau HDL- colesterolul (colesterolul „ bun ”).