natgillin/translations-raw huggingface dataset:
Break-through bleeding and spotting may occur during treatment.If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Če se vmesne krvavitve ali krvavkast izcedek pojavijo po določenem času zdravljenja ali se po prenehanju zdravljenja nadaljujejo, je treba raziskati vzrok zanje.
Irregular bleeding and/or spotting was reported in the CE 0.45 mg/BZA 20 mg group by 7% of women during the first 3 months of treatment and by 3% of women during months 10 to 12.
V skupini s kombinacijo 0,45 mg CE/20 mg BZA je o neredni krvavitvi in/ali krvavkastem izcedku poročalo 7 % žensk v prvih 3 mesecih zdravljenja in 3 % žensk med 10. in 12. mesecem.
• dimpling of the skin
• izcedek iz nožnice;
Adverse reactions that have been observed with bazedoxifene monotherapy
Neželeni učinki, ki so jih opazili pri monoterapiji z bazedoksifenom
Herbal preparations containing St John's wort (Hypericum perforatum) may induce the metabolism of oestrogens.
Zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), lahko inducirajo presnovo estrogenov.
Very common: may affect more than 1 in 10 people
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnic
• Enlargement of hepatic haemangiomas, a benign (non-cancerous) tumour of the liver
• povečanje jetrnih hemangiomov, benignega (nerakastega) tumorja jeter;
The metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, such as anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz).
Pri sočasni uporabi snovi, ki inducirajo delovanje encimov za presnovo zdravil, kot so antikonvulzivi (npr. fenobarbital, fenitoin, karbamazepin) in zdravila proti okužbam (npr. rifampicin, rifabutin, nevirapin, efavirenz), se presnova estrogenov lahko zveča.
Risk of venous thromboembolism
Tveganje za vensko trombembolijo
In clinical trials of up to 2 years duration, CE/BZA was associated with an increase from baseline in the concentration of serum triglycerides of approximately 16% at month 12 and 20% at month 24.
V kliničnih preskušanjih, ki so trajala do 2 leti, je bilo zdravljenje s CE/BZA povezano z zvečanjem koncentracije trigliceridov v serumu za okrog 16 % po 12 mesecih in 20 % po 24 mesecih glede na izhodiščno vrednost, zato je treba razmisliti o letnem spremljanju ravni trigliceridov v serumu.
Use in this population is therefore not recommended (see sections 4.4 and 5.2).
Uporaba pri tej populaciji zato ni priporočljiva (glejte poglavji 4.4 in 5.2).
Renal cell carcinomas were observed in an 18-month bone efficacy study in aged ovariectomised cynomolgus monkeys at exposure ratios of 0.05 to 16.3 times, and dose ratios, based on surface area (mg/m2), of approximately 0.2 to 24 times the clinical dose of 20 mg.
V 18-mesečni študiji učinka na kosti pri ostarelih opicah cinomolgus z ovariektomijo so pri 0,05- do 16,3-kratnemu razmerju izpostavljenosti in približno 0,2- do 24-kratnemu razmerju odmerkov glede na površino (mg/m2) v primerjavi s kliničnim odmerkom 20 mg opazili pojav karcinomov ledvičnih celic.
CE Oestrogen only
Samo estrogen CE
The Women's Health Initiative (WHI) trial found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only therapy.
V preskušanju Women's Health Initiative (WHI) niso ugotovili zvečanja tveganja za raka dojke pri ženskah, ki so jim opravili histerektomijo in so uporabljale samo estrogensko zdravljenje.
The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce uridine diphosphate glucuronosyltransferases (UGTs), such as rifampicin, phenobarbital, carbamazepine, and phenytoin, potentially leading to decreased systemic concentrations of bazedoxifene.
Presnovo bazedoksifena lahko zveča sočasna uporaba snovi, ki so znani induktorji uridin difosfatglukuronoziltransferaz (UGT), kot so rifampicin, fenobarbital, karbamazepin in fenitoin.
Women taking CE/BZAshould not take additionaloestrogens as this may increase the risk of endometrial hyperplasiaand endometrial carcinoma.
Ženske, ki jemljejo CE/BZA, ne smejo jemati dodatnih estrogenov, saj to lahko zveča tveganje za hiperplazijo endometrija in karcinom endometrija.
Irregular bleeding and/or spotting was reported in the CE 0.45 mg/BZA 20 mg group by 8% of women during the first 3 months and by 4% of women during months 10 to 12.
V skupini s kombinacijo 0,45 mg CE/20 mg BZA je o neredni krvavitvi in/ali krvavkastem izcedku poročalo 8 % žensk v prvih 3 mesecih in 4 % žensk med 10. in 12. mesecem.
Any increased risk to users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestagen combinations.
Zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko zdravljenje, je bistveno manjše kot pri ženskah, ki uporabljajo kombinacije estrogena in progestogena.
The overall evidence suggests a possible increased risk of breast cancer in women taking oestrogen-only therapy that is dependent on the duration of therapy.
Zbrani dokazi kažejo na zvečano tveganje za raka dojke pri ženskah, ki uporabljajo samo estrogensko zdravljenje; to tveganje je odvisno od trajanja zdravljenja.
Exacerbation of porphyria; hypocalcaemia (in patients with disease that can predispose to severe hypocalcaemia)
Presnovne in prehranske motnje intoleranca za glukozo poslabšanje porfirije, hipokalciemija (pri bolnicah z boleznijo, ki povzroča dovzetnost za hudo hipokalciemijo)
Growth potentiation of benign meningioma; fibrocystic breast disease
zvečanje rasti benignih meningiomov, fibrocistična bolezen dojk povečanje hepatičnih hemangiomov
• Palpitations (awareness of your heart beat)
• palpitacije (razbijanje srca);
Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1,000 women with a uterus not using HRT.
Tveganje za raka endometrija pri ženskah, ki imajo maternico in ki ne uporabljajo HNZ, je približno 5 na 1.000 žensk.
• Blood clot in the leg veins
• krvni strdki v venah nog;
Black Iron oxide (E172) Propylene glycol (E1520) Hypromellose 2910 (6 mPa•s)
propilenglikol (E1520) hipromeloza 2910 (6 mPa•s)
The use of oestrogen-only therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Zdravljenje samo z estrogenom je povezano z do 1,5-kratnim zvečanjem relativnega tveganja za ishemično možgansko kap.
Use of oestrogen-only HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see section 4.4).
Uporaba samo estrogenskega HNZ je povezana z zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
- Known, suspected, or past history of breast cancer.
- Znan rak dojke, sum nanj ali rak dojke v anamnezi.
CLINICAL PARTICULARS
Klinični podatki
Oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Zdravljenje samo z estrogenom je povezano z do 1,5-kratnim zvečanjem tveganja za ishemično možgansko kap.
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišični krči
In a 2-year carcinogenicity study in rats, an increased incidence of benign, ovarian granulosa-cell tumours was observed in female rats at dietary concentrations of 0.03% and 0.1%.
V 2-letni študiji kancerogenosti na podganah so pri samicah, ki so s hrano prejemale koncentracije 0,03 % in 0,1 %, opazili zvečanje incidence benignih granulozocelularnih tumorjev na jajčnikih.
In women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period.
Pri ženskah, starih od 50 do 54 let, ki ne uporabljajo HNZ, bodo v 5-letnem obdobju diagnosticirali raka jajčnikov pri približno dveh ženskah od 2.000.
• Alopecia (hair loss)
• alopecija (izpadanje las oziroma dlak);
• if you become pregnant
• če zanosite;
Bazedoxifene Baseline-adjusted total estrone
bazedoksifen skupni estron, prilagojen glede na izhodiščno vrednost
• Blood clot in the lungs
• krvni strdki v pljučih;
Blood triglycerides increased
Preiskave zvečane vrednosti trigliceridov v krvi
• Symptoms of pancreatitis which may include severe upper abdominal pain which may spread to your back, accompanied by abdominal swelling, fever, nausea and vomiting
• simptomi vnetja trebušne slinavke, ki lahko vključujejo hude bolečine v zgornjem delu trebuha, ki se lahko širijo proti hrbtu, spremljajo pa jih otekanje trebuha, zvišana telesna temperatura, občutek slabosti s siljenjem na bruhanje in bruhanje;
Ovarian cancer
Rak jajčnikov
Adverse reactions reported with CE and/or bazedoxifene monotherapy
Neželeni učinki, o katerih so poročali pri monoterapiji s CE in/ali bazedoksifenom
For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period.
Na primer pri ženskah, starih od 50 do 54 let, ki ne uporabljajo HNZ, bodo v obdobju 5 let pri približno 2 ženskah izmed 2.000 odkrili raka jajčnikov.
• you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing.
• če opazite znake krvnega strdka, kot so boleče otekanje in rdečica nog, nenadna bolečina v prsnem košu ali težko dihanje.
After opening the blister pouch, use within 60 days.
Uporabite v 60 dneh po odprtju zaščitnega ovoja s pretisnim omotom.
- Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels (by radio-immunoassay).
- Estrogeni zvečajo koncentracijo globulina, ki veže ščitnične hormone (TBG - thyroid binding globulin), in tako zvišajo raven celotne količine ščitničnih hormonov v krvnem obtoku, merjenih z jodom, vezanim na beljakovine (PBI - protein-bound iodine), ravnjo
Very rare: may affect up to 1 in 10,000 people
Zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnic
Rare: may affect up to 1 in 1,000 people
Redki: pojavijo se lahko pri največ 1 od 1.000 bolnic
The effect of CE/BZA on the risk of dementia is unknown.
Vpliv CE/BZA na tveganje za demenco ni znan.
The additive effect of all sources of sorbitol from other concomitantly administered medicinal products and dietary sources should be taken into account.
Upoštevati je treba aditivni učinek sočasnega jemanja zdravil, ki vsebujejo sorbitol, in sorbitola, ki ga vnesemo s hrano.
Bazedoxifene undergoes little or no cytochrome P450 (CYP)-mediated metabolism.
K presnovi bazedoksifena le malo ali nič prispeva presnova, ki jo uravnava citokrom P450 (CYP).
Glucuronidation is the major metabolic pathway.
Glavna presnovna pot je glukuronidacija.
How to take DUAVIVE
Kako jemati zdravilo DUAVIVE
In one study, amenorrhea was reported in 97% of the women who received CE 0.45 mg/BZA 20 mg during months 10 to 12.
V eni študiji so o amenoreji poročali pri 97 % žensk, ki so prejemale kombinacijo 0,45 mg CE/20 mg BZA, med 10. in 12. mesecem zdravljenja.
Intolerance to contact lenses
Očesne bolezni neprenašanje kontaktnih leč
MINIMUM PARTICULARS TO APPEAR ON BLISTERS AND STRIPS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU IN DVOJNEM TRAKU
In rabbit studies with BZA, abortion and an increased incidence of heart (ventricular septal defect) and skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) anomalies in the fetuses were present at maternally toxic dosages of  0.5 mg/kg/day (1.5 times the human exposure).
V študijah BZA na kuncih so se pri odmerkih  0,5 mg/kg/dan (izpostavljenost, 1,5-krat večja od tiste pri človeku), ki so bili toksični za mater, pojavljali splav, pri plodovih pa zvečana incidenca anomalij srca (defekt prekatnega pretina) in skeleta (zapoznelo zakostenevanje skeleta, deformirane ali napačno razvrščene kosti, predvsem hrbtenice in lobanje).
Oestrogens may be poorly metabolised in women with impaired liver function.
Pri ženskah z okvarjenim delovanjem jeter se estrogeni lahko slabo presnavljajo.
- Known, past or suspected oestrogen-dependent malignant tumours (e.g., endometrial cancer).
- Znani, od estrogenov odvisni maligni tumorji (npr. rak endometrija), sum nanje ali od estrogenov odvisni maligni tumorji v anamnezi.
In another study, amenorrhea was reported in 96% of the women who received CE 0.45 mg/BZA 20 mg during months 10 to 12.
V drugi študiji so o amenoreji poročali pri 96 % žensk, ki so prejemale kombinacijo 0,45 mg CE/20 mg BZA, med 10. in 12. mesecem zdravljenja.
Additional cases per 1,000 never-users of HRT over a 5 year period*
Dodatni primeri na 1.000 žensk, ki niso nikoli uporabljale HNZ v obdobju 5 let*
If pregnancy occurs during treatment with CE/BZA, it should be withdrawn immediately.
Če ženska med zdravljenjem s CE/BZA zanosi, je treba uporabo zdravila takoj prekiniti.
You may experience breast tenderness, dizziness, abdominal pain, drowsiness/fatigue or experience a short period of vaginal bleeding.
Morda boste imeli občutljive dojke, lahko se pojavijo omotica, bolečine v trebuhu, dremavost/utrujenost ali kratkotrajne krvavitve iz nožnice.
If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe' (e.g., antithrombin, protein S, or protein C deficiencies or a combination of defects) hormone therapy is contraindicated.
Če se odkrije trombofilično okvaro, ki sovpada s trombozo pri družinskih članih, ali če je okvara »huda« (npr.
Modified-release tablet.
tableta s prirejenim sproščanjem
In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.The reported increase in endometrial cancer risk among oestrogen-onlyusers varies from 2-to 12-fold greater compared with non-users, depending on duration of treatment and oestrogendose.After stopping treatment,risk may remain elevated for at least 10 years.
Zvečano tveganje za raka endometrija, o katerem so poročali pri ženskah, ki so uporabljale samo estrogen, je od 2- do 12-krat večje kot pri neuporabnicah, odvisno pa je od trajanja zdravljenja in odmerka estrogena.
• Breast pain, breast tenderness, swollen breasts
• bolečine v dojkah, občutljivost dojk, otekle dojke;
Hypromellose 2910 (3 mPa•s) (E464) Sucrose monopalmitate Ascorbic acid
Aktivna obloga iz bazedoksifena saharoza hipromeloza 2910 (3 mPa•s) (E464) saharoza monopalmitat askorbinska kislina
Do not take DUAVIVE
Ne jemljite zdravila DUAVIVE
In studies conducted in rabbits, bazedoxifene alone has shown reproductive toxicity (see section 5.3).
Študije na kuncih so pri samostojni uporabi bazedoksifena pokazale škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
• Migraine
• migrena;
Randomised controlled data found no increased risk of coronary artery disease in hysterectomised women using oestrogen-only therapy.
Randomizirani nadzorovani podatki niso pokazali zvečanega tveganja bolezni koronarnih arterij pri ženskah z odstranjeno maternico, ki se zdravijo samo z estrogeni.
If VTE develops after initiating therapy, or is suspected, CE/BZA should be discontinued immediately.
Če se po uvedbi zdravljenja pojavi VTE ali sum nanjo, je treba zdravljenje s CE/BZA nemudoma prekiniti.
Polydextrose (E1200) (contains glycerol and glucose) Maltitol liquid
Prozorna obloga hidroksietilceluloza povidon (E1201) polidekstroza (E1200) (vsebuje glicerol in glukozo) tekoči maltitol poloksamer 188
• Thrush (vaginal yeast infection)
• kandidoza (glivična okužba nožnice);
There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without existing CAD who received oestrogen-only therapy.
Iz randomiziranih nadzorovanih kliničnih preskušanj pri ženskah z obstoječo KAB ali brez nje, ki so uporabljale zdravljenje samo z estrogenom, ni dokazov o zaščiti pred miokardnim infarktom.
Treatment of rats with BZA at maternally toxic dosages  1 mg/kg/day ( 0.4 times the human dose based on body surface area) resulted in reduced numbers of live foetuses and/or reductions in foetal body weights.
( 0,4-kratni odmerek kot pri človeku glede na telesno površino), ki so bili toksični za mater, je povzročilo zmanjšanje števila živih plodov in/ali zmanjšanje telesne mase plodov.
Oestrogen dose proportionality was assessed in two studies of CE. Dose-proportional increases in both AUC and Cmax were observed across the dose range from 0.3 mg to 0.625 mg of CE for total (conjugated plus unconjugated) equilin, total estrone adjusted for baseline, and unconjugated estrone adjusted for baseline.
V razponu odmerkov od 0,3 mg do 0,625 mg CE so opazili od odmerka odvisno zvečanje vrednosti AUC in Cmax pri skupnem (konjugiranem in nekonjugiranem) ekvilinu, skupnem estronu, prilagojenem glede na izhodiščno vrednost, in nekonjugiranem estronu, prilagojenem glede na izhodiščno vrednost.
Reproductive toxicity and impairment of fertility studies with CE/BZA have not been conducted.
Študije vpliva na razmnoževanje in okvare plodnosti s kombinacijo CE/BZA niso bile izvedene.
• Signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain or difficulty in breathing.
• znaki krvnega strdka, kot so boleče otekanje ali rdečica nog, nenadna bolečina v prsnem košu ali težko dihanje;
• a high level of fat in your blood (triglycerides)
• zvišane ravni maščob (trigliceridov) v krvi;
• changes in the nipple
• spremembe na bradavicah;
However, it returns to normal within a few years (at most 5) after stopping treatment.
Dodatno tveganje postane očitno po nekaj letih uporabe, vendar se vrne na izhodiščno vrednost v nekaj (največ petih) letih po prekinitvi zdravljenja.
Adverse reactions that have been observed with CE monotherapy
Neželeni učinki, ki so jih opazili pri monoterapiji s CE
(see sections 4.6 and 5.3).
in 5.3).
A single 20 mg dose of BZA was administered to these subjects.
Tem preiskovankam so dali enkratni 20 mg odmerek BZA.
Randomised controlled data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy.
V podatkih iz randomiziranih nadzorovanih študij niso ugotovili zvečanega tveganja za KAB pri ženskah s histerektomijo, ki so uporabljale zdravljenje samo z estrogenom.
Following multiple doses of CE 0.45 mg/BZA 20 mg, the mean steady state pharmacokinetic parameters for CE and bazedoxifene (baseline adjusted for total estrone) are summarised below.
Povprečni farmakokinetični parametri CE in bazedoksifena v stanju dinamičnega ravnovesja po večkratnih odmerkih 0,45 mg CE/20 mg BZA (izhodiščne vrednosti so bile prilagojene glede na skupni estron) so povzeti v preglednici spodaj.
Dry mouth
Bolezni prebavil suha usta
Should a VTE event occur or be suspected, CE/BZA should be discontinued immediately.
Če se pojavi VTE ali sum na njo, je treba zdravljenje s CE/BZA nemudoma prekiniti.
The effect of CE/BZA on the risk of breast cancer is unknown.
Vpliv CE/BZA na tveganje za raka dojke ni znan.
Common: may affect 1 in 10 people
Pogosti: pojavijo se lahko pri 1 od 10 bolnic
The metabolic disposition of CE and BZA, after administration of CE/BZA, has not been studied.
Presnove CE in BZA po uporabi kombinacije CE/BZA niso raziskovali.
Each tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Ena tableta vsebuje 0,45 mg konjugiranih estrogenov in bazedoksifenacetat v količini, ki ustreza 20 mg bazedoksifena.
Use in this population is not recommended (see sections 4.2 and 5.2).
Uporaba pri tej skupini bolnic ni priporočljiva (glejte poglavji 4.2 in 5.2).
• Muscle spasms (including leg cramps)
• mišični krči (vključno s krči v nogah);
Each modified-release tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Ena tableta s prirejenim sproščanjem vsebuje 0,45 mg konjugiranih estrogenov in bazedoksifenacetat v količini, ki ustreza 20 mg bazedoksifena.
Oral oestrogen-only*
Samo peroralni estrogen*
The pharmacokinetics of CE/BZA have not been evaluated in patients with renal impairment.
Farmakokinetike CE/BZA pri bolnicah z okvaro ledvic niso raziskovali.
• Hot flushes
• vročinski oblivi;
Colour coating
Okvara jeter
• getting older
• staranje;
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora poslabšanje astme
The effect of DUAVIVE on the risk of ovarian cancer is unknown.
Učinek zdravila DUAVIVE na tveganje za raka jajčnikov ni znan.
• seizures (epilepsy)
• epileptični napadi;
- Active or past history of venous thromboembolism (e.g., deep venous thrombosis,
- Aktivna venska trombembolija ali venska trombembolija v anamnezi (npr. globoka venska tromboza, pljučna embolija in tromboza mrežnične vene).
This may be accompanied by bone pain and abdominal pain.
Pomanjkanje kalcija lahko spremljajo bolečine v trebuhu in kosteh.
Hepatic impairment The pharmacokinetics of CE/BZA have not been evaluated in women with hepatic impairment.
Okvara jeter Farmakokinetike kombinacije CE/BZA pri bolnicah z okvaro jeter niso raziskovali.
Bazedoxifene elicited male rat-specific nephropathies (corticomedullar nephrocalcinosis and enhanced spontaneous chronic progressive nephropathy) and associated adenomas and carcinomas at exposure ratios of 0.05 to 4 times, and dose ratios, based on surface area (mg/m2), of approximately
Bazedoksifen je pri 0,05- do 4-kratnemu razmerju izpostavljenosti in približno 0,6- do 22-kratnemu razmerju odmerkov glede na površino (mg/m2) v primerjavi s kliničnim odmerkom 20 mg pri samcih podgan izzval za podgane značilne nefropatije (kortikomedularno nefrokalcinozo in okrepljeno spontano kronično progresivno nefropatijo) ter s tem povezane adenome in karcinome.
• Drowsiness
• dremavost;
The effect of DUAVIVE on the risk of breast cancer is unknown.
Učinek zdravila DUAVIVE na tveganje za raka dojke ni znan.
• Increase in hair growth
• intenzivnejša rast las oz. dlak;
• A heart attack - symptoms will usually include pain, including chest pain spreading to the jaw, neck and upper arm. You may feel sweaty, breathless, fatigued, nauseous and faint in addition to the pain
• srčna kap - simptomi navadno vključujejo bolečino, kot je bolečina v prsnem košu, ki se širi proti čeljusti in nadlahti.
Uncommon: may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri največ 1 od 100 bolnic
- Patients with terminal renal insufficiency should be closely monitored, since it is expected that the level of circulating oestrogens components of CE/BZA will be increased.
- Pričakovati je, da bo raven estrogenskih komponent CE/BZA v obtoku zvišana, zato je treba bolnice s končnim stadijem ledvične insuficience pozorno spremljati.
stroke).
• srbenje.
• Vomiting
• bruhanje;
The effect of CE/BZA on the risk of ovarian cancer is unknown.
Učinek CE/BZA na tveganje za raka jajčnikov ni znan.
Abdominal pain Constipation; diarrhoea; nausea
Bolezni prebavil navzea pankreatitis, ishemični kolitis, bruhanje
The effect of DUAVIVE on the risk of stroke is unknown.
Učinek zdravila DUAVIVE na tveganje za možgansko kap ni znan.
Oestrous cycles and fertility were adversely affected in all bazedoxifene-treated female groups.
V vseh skupinah samic, ki so prejemale bazedoksifen, so opazili neželene učinke na estrusne cikle in plodnost.
A.
Po
How to store DUAVIVE
Shranjevanje zdravila DUAVIVE
- kidney problems - pre-existing high level of fat in your blood (triglycerides) - liver problems - asthma - seizures (epilepsy) - migraine - systemic lupus erythematosus (SLE - a rare disease of the immune system that affects many organs of the body) - fluid retention
- leiomiomi (maternični miomi) ali endometrioza; - dejavniki tveganja za trombembolične motnje (glejte spodaj); - dejavniki tveganja za nastanek od estrogenov odvisnih tumorjev, npr. dedno nagnjenje za raka dojke v 1. kolenu; - hipertenzija; - bolezni jeter (npr. adenom jeter); - sladkorna bolezen s prizadetostjo žilja ali brez nje; - holelitiaza; - migrena ali (hud) glavobol; - sistemski eritematozni lupus; - hiperplazija endometrija v anamnezi (glejte spodaj); - epilepsija; - astma; - otoskleroza.