FrancophonIA/ELRC3.0 huggingface dataset:
English: • Abrupt onset of abdominal pain and passage of bright red blood in the stool, with or without diarrhoea due to sudden blockage of an artery supplying the intestines (ischaemic colitis)
Croatian: • Iznenadni bolovi u trbuhu uz pojavu svijetlocrvene krvi u stolici, sa ili bez proljeva zbog naglog začepljena arterije u crijevima (ishemijski kolitis)
English: There is some evidence of increased risk of probable dementia in women who start using continuous oestrogen-only therapy after the age of 65.
Croatian: Postoje neki dokazi za povećani rizik od vjerojatne demencije u žena koje započnu uzimati kontinuiranu terapiju samim estrogenom nakon napunjenih 65 godina.
English: • Dry mouth
Croatian: • Suhoća usta
English: 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%.
Croatian: U dvogodišnjem ispitivanju kancerogenosti na štakorima opažena je povećana incidencija benignih tumora granulozna stanica jajnika u ženki štakora pri koncentracijama u hrani od 0,03% i 0,1%.
English: The pharmacokinetics of CE/BZA have not been evaluated in women over 75 years of age.
Croatian: Farmakokinetika KE/BZA nije ispitivana u žena starijih od 75 godina.
English: Black Iron oxide (E172) Propylene glycol (E1520) Hypromellose 2910 (6 mPa•s)
Croatian: Tinta za označavanje crni željezov oksid (E172) propilenglikol (E1520) hipromeloza 2910 (6 mPa•s)
English: SERMs (including bazedoxifene) and oestrogens individually increase the risk of VTE (see section 4.8).
Croatian: Selektivni modulatori estrogenskih receptora (uključujući bazedoksifen) i estrogeni svako zasebno povećavaju rizik od VTE (vidjeti dio 4.8).
English: Ovarian cancer is much rarer than breast cancer.
Croatian: Rak jajnika mnogo je rjeđi od raka dojke.
English: Breast cancer risk associated with the use of oestrogens alone is represented by several studies.
Croatian: Na rizik od raka dojke povezanog s primjenom samih estrogena ukazuje nekoliko ispitivanja.
English: DUAVIVE contains lactose, sucrose, maltitol liquid, glucose and sorbitol
Croatian: DUAVIVE sadrži laktozu, saharozu, tekući maltitol, glukozu i sorbitol
English: In a 1 year study, CE 0.45 mg/BZA 20 mg showed a significant difference from baseline in lumbar spine BMD (+1.52%) at month 12 compared to placebo.
Croatian: U jednogodišnjem ispitivanju s 0,45 mg KE/20 mg BZA pokazalo je značajnu razliku u odnosu na početne vrijednosti BMD-a lumbalne kralježnice (+1,52%) u 12. mjesecu u usporedbi s placebom.
English: Systemic exposure (AUC) of bazedoxifene in these groups was 2.6 and 6.6 times that observed in postmenopausal women administered 20 mg/day for 14 days.
Croatian: Sistemska izloženost bazedoksifenu (AUC) u tim je skupinama bila je 2,6 odnosno 6,6 puta veća od izloženosti u postmenopauzalnih žena koje su primale dozu od 20 mg dnevno tijekom 14 dana.
English: Deep vein thrombosis, thrombophlebitis superficial
Croatian: Duboka venska tromboza, površinski tromboflebiti
English: If a tablet is forgotten, it should be taken as soon as the patient remembers.
Croatian: Ako bolesnica zaboravi uzeti tabletu, mora ju uzeti čim se sjeti.
English: • Nausea (feeling sick)
Croatian: • Mučnina (osjećaj mučnine)
English: CE/BZA is contraindicated in these patients (see section 4.3).
Croatian: KE/BZA je kontraindiciran u tih bolesnica (vidjeti dio 4.3).
English: Body mass index (BMI)
Croatian: Indeks tjelesne mase (ITM)
English: Also contains: lactose, sucrose, polydextrose and maltitol liquid.
Croatian: Također sadrži: laktozu, saharozu, polidekstrozu i tekući maltitol.
English: • Growth of benign meningioma, a non-cancerous tumour of the membranes around the brain or spinal cord
Croatian: Rast benignog meningeoma, nekancerogenog tumora ovojnica mozga i leđne moždine
English: 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.
Croatian: Cjelokupni dokazi ukazuju na mogući povećani rizik od raka dojke u žena koje uzimaju terapiju samim estrogenom, ovisno o trajanju terapije.
English: Visual acuity reduced, blurred vision, photopsia, visual field defect, visual impairment, dry eye, eyelid oedema, blepharospasm, eye pain and eye swelling
Croatian: Smanjenje oštrine vida, zamućen vid, fotopsija, poremećaj vidnog polja, oštećenje vida, suhoća očiju, edem očnog kapka, blefarospazam, bol u oku i oticanje oka
English: Hypersensitivity Angioedema; anaphylactic/ana phylactoid reactions; urticaria
Croatian: Angioedem; anafilaktičke i anafilaktoidne reakcije; urtikarija
English: For women in their 50s who are not taking HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period.
Croatian: Kod žena u 50-im godinama koje ne uzimaju HNL, u prosjeku u 8 na 1000 slučajeva očekuje se moždani udar tijekom razdoblja od 5 godina.
English: In 6-month carcinogenicity studies in transgenic mice, there was an increased incidence of benign, ovarian granulosa-cell tumours in female mice given 150 or 500 mg/kg/day.
Croatian: 6-mjesečnim ispitivanjima kancerogenosti provedenima na transgeničnim miševima zabilježena je povećana incidencija benignih tumora granuloza stanica jajnika u ženki miševa kojima je primijenjena doza od 150 ili 500 mg/kg na dan.
English: CE 0.45 mg/BZA 20 mg demonstrated similar changes in mammographic breast density compared to placebo over 1 year of treatment.
Croatian: Liječenje s 0,45 mg KE/20 mg BZA je pokazalo slične promjene u mamografskoj gustoći tkiva dojki u usporedbi s placebom tijekom 1 godine liječenja.
English: Hirsutism; rash; pruritus; chloasma
Croatian: Hirzutizam; osip; pruritus; kloazma
English: Risk ratio
Croatian: Omjer rizika
English: Use of CE/BZA in this population is contraindicated (see sections 4.2, 4.3 and 4.4).
Croatian: Primjena KE/BZA u ovoj skupini je kontraindicirana (vidjeti dijelove 4.2, 4.3 i 4.4).
English: If more than one tablet has been forgotten, only the most recent tablet should be taken, the patient should not take double the usual dose to make up for missed tablets.
Croatian: Ako je bolesnica zaboravila uzeti više od jedne tablete, treba uzeti samo zadnju tabletu.
English: • Symptoms of pancreatitis which may include severe upper abdominal pain which may spread to your back, accompanied by abdominal swelling, fever, nausea and vomiting
Croatian: • Simptomi pankreatitisa koji mogu obuhvaćati jaku bol u trbuhu koja se može širiti u leđa, uz oticanje trbuha, vrućicu, mučninu i povraćanje
English: • Blood clot in the leg veins
Croatian: • Krvni ugrušak u venama nogu
English: Oestrogens may be poorly metabolised in women with impaired liver function.
Croatian: Estrogeni se slabije metaboliziraju u bolesnica s oštećenom funkcijom jetre.
English: Studies in rats with bazedoxifene have shown adverse effects on fertility (see section 5.3).
Croatian: U ispitivanjima provedenim na štakorima, bazedoksifen je pokazao neželjene učinke na plodnost (vidjeti dio 5.3).
English: Venous thromboembolic events (including, pulmonary embolism, retinal vein thrombosis, deep vein thrombosis and thrombophlebitis)
Croatian: Venska tromboembolija (uključujući plućnu emboliju, trombozu retinalne vene, duboku vensku trombozu i tromboflebitis)
English: Bazedoxifene undergoes little or no cytochrome P450 (CYP)-mediated metabolism.
Croatian: Bazedoksifen se malo ili nimalo metabolizira posredovanjem citokroma P450 (CYP).
English: Conjugated oestrogens
Croatian: Konjugirani estrogeni
English: In a 12-week study, CE 0.45 mg/BZA 20 mg significantly reduced the number and severity of hot flushes compared to placebo at weeks 4 and 12.
Croatian: U 12tjednom ispitivanju 0,45 mg KE/20 mg BZA značajno je smanjilo broj i jačinu valunga u usporedbi s placebom u 4. i 12. tjednu.
English: • yellowing of your skin or the whites of your eyes (jaundice).
Croatian: • žutilo kože ili bjeloočnica (žutica).
English: Other conditions
Croatian: Ostala stanja
English: If VTE develops after initiating therapy, or is suspected, CE/BZA should be discontinued immediately.
Croatian: Ako nastupi VTE nakon početka liječenja ili se na nju sumnja, uzimanje KE/BZA se mora odmah prekinuti.
English: Pancreatitis; ischaemic colitis; vomiting
Croatian: Pankreatitis; ishemijski kolitis; povraćanje
English: * Taken from baseline incidence rates in developed countries Overall risk ratio.
Croatian: * Preuzeto iz početnih stopa incidencije u razvijenim zemljama
English: For women who have been taking HRT for 5 years, there will be about 3 cases per 2,000 users (i.e. about 1 extra case).
Croatian: U žena koje primaju hormonsko nadomjesno liječenje (HNL) 5 godina bit će otprilike 3 slučaja na 2000 korisnica (tj. otprilike jedan dodatni slučaj).
English: Reproductive toxicity and impairment of fertility studies with CE/BZA have not been conducted.
Croatian: Ispitivanja reproduktivne toksičnosti i oštećenja plodnosti s KE/BZA nisu provedena.
English: Breast cancer risk
Croatian: Rizik od raka dojke
English: • Feeling irritable
Croatian: • Osjećaj razdražljivosti
English: • Blood clot in the lungs
Croatian: • Krvni ugrušak u plućima
English: Systemic exposure (AUC) to bazedoxifene in these groups was 35 and 69 times that in postmenopausal women administered 20 mg/day for 14 days.
Croatian: Sistemska izloženost bazedoksifenu (AUC) u tim je skupinama bila je 35 odnosno 69 puta veća od izloženosti u postmenopauzalnih žena koje su primale dozu od 20 mg dnevno tijekom 14 dana.
English: How to store DUAVIVE
Croatian: Kako čuvati DUAVIVE
English: The risk of having a stroke is about 1.5 times higher in HRT users than in non-users.
Croatian: Rizik od moždanog udara približno je 1,5 veći kod žena koje uzimaju HNL u usporedbi sa ženama koje ih ne uzimaju.
English: • a large increase in your blood pressure (symptoms may be headache, tiredness, dizziness)
Croatian: • Veliki porast krvnog tlaka (simptomi mogu biti glavobolja, umor, omaglica)
English: The effect of CE/BZA on the risk of dementia is unknown.
Croatian: Utjecaj KE/BZA na rizik od demencije nije poznat.
English: 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.
Croatian: Karcinomi bubrežnih stanica opaženi su u 18-mjesečnom ispitivanju djelotvornosti na kosti u starijih makaki majmunica koje su bile podvrgnute ovarijektomiji pri omjerima izloženosti od 0,05 do 16,3 puta i omjerima doza prema tjelesnoj površini (mg/m otprilike 0,2 do 24 puta većim nego kod primjene kliničke doze od 20 mg.
English: DUAVIVE 0.45 mg/20 mg modified-release tablets
Croatian: DUAVIVE 0,45 mg/20 mg tablete s prilagođenim oslobađanjem
English: Hypromellose 2910 (6 mPa•s) (E464) Titanium dioxide (E171) Macrogol (400)
Croatian: Ovojnica u boji hipromeloza 2910 (6 mPa•s) (E464) titanijev dioksid (E171) makrogol (400) crveni željezov oksid (E172)
English: The use of oestrogen-only therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Croatian: Terapija samim estrogenom povezana je s do 1,5 puta većim relativnim rizikom od ishemijskog moždanog udara.
English: 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.
Croatian: Nakon višekratnih doza 0,45 mg KE/20 mg BZA, srednje vrijednosti farmakokinetičkih parametara u stanju ravnoteže za KE i bazedoksifen (početna vrijednost prilagođena za ukupni estron) sažete su u nastavku.
English: Risk of ischaemic stroke
Croatian: Rizik od ishemijskog moždanog udara
English: • Enlargement of hepatic haemangiomas, a benign (non-cancerous) tumour of the liver
Croatian: • Povećanje hemangioma jetre, benignog (dobroćudnog) tumora jetre
English: When single doses of CE 0.625 mg/BZA 20 mg were administered with a high-fat meal, bazedoxifene Cmax was unaffected, but Area Under Curve (AUC) increased by approximately 25%.
Croatian: Kada su se jednokratne doze 0,625 mg KE/20 mg BZA davale uz obrok koji je sadržavao visok postotak masnoća, Cmax bazedoksifena se nije mijenjao, ali se površina ispod krivulje (engl.
English: The recommended dose is 0.45 mg conjugated oestrogens (CE) and 20 mg bazedoxifene (BZA) taken as a single oral tablet, once daily.
Croatian: Preporučena doza je 0,45 mg konjugiranih estrogena (KE) i 20 mg bazedoksifena (BZA) odnosno jedna tableta za peroralnu primjenu jedanput na dan.
English: For women in their 50s who are taking HRT, there will be 11 cases in 1,000 users, over 5 years (i.e., 3 extra cases).
Croatian: Kod žena u 50-im godinama koje uzimaju HNL, očekuju se 11 slučajeva na 1000 korisnica tijekom 5 godina (tj. 3 dodatna slučaja).
English: Retinal vein thrombosis
Croatian: Retinalna venska tromboza
English: • Dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids)
Croatian: • Suhoća očiju, bol u očima, smanjena vidna oštrina, oštećenje vida, blefarospazam (neuobičajeno, nevoljno žmirkanje ili grč vjeđa)
English: The distribution of CE and bazedoxifene after administration of CE/BZA has not been studied.
Croatian: Distribucija KE i bazedoksifena nakon primjene KE/BZA nije ispitivana.
English: Ovarian cancer is rare-much rarer than breast cancer.
Croatian: Rak jajnika rijetko se pojavljuje - mnogo je rjeđi od raka dojke.
English: Additional cases per 1,000 never-users of HRT over a 5 year period*
Croatian: Dodatni slučajevi na 1000 novih korisnica HNL tijekom 5 godina*
English: If so, you should see your doctor more often for check-ups:
Croatian: Ako jeste, trebate češće odlaziti liječniku na preglede: fibroidi unutar maternice
English: For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2,000 users.
Croatian: U žena u dobi od 50 do 54 godine koje primaju hormonsko nadomjesno liječenje (HNL) 5 godina to rezultira otprilike jednim dodatnim slučajem na 2000 korisnica.
English: 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.
Croatian: Ako je identificiran trombofilijski poremećaj uz trombozu u članova obitelji ili je poremećaj težak (npr. deficijencija antitrombina, proteina
English: • Increases in your triglyceride levels (fatty substances in the blood)
Croatian: • Povećanje razine triglicerida (masnoća u krvi)
English: Uncommon: may affect 1 in 100 people • Gall bladder disease (e.g. gallstones, inflammation of the gall bladder (cholecystitis))
Croatian: Manje česte: mogu se javiti u do 1 na 100 osoba • Bolest žučnog mjehura (npr. žučni kamenci, upala žučnog mjehura (kolecistitis))
English: 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.
Croatian: Povećanje proporcionalno dozi u AUC i Cmax zapaženo je u cjelokupnom rasponu doza od 0,3 mg do 0,625 mg KE za ukupni (konjugirani plus nekonjugirani) ekvilin, ukupni estron prilagođen za početnu vrijednost te nekonjugirani estron prilagođen za početnu vrijednost.
English: The metabolic disposition of CE and BZA, after administration of CE/BZA, has not been studied.
Croatian: Metabolička dispozicija KE i BZA nakon primjene KE/BZA nije ispitivana.
English: Speak to your doctor for advice.
Croatian: Porazgovarajte sa svojim liječnikom o tome.
English: 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.
Croatian: Nepravilno krvarenje i/ili točkasto krvarenje prijavljeno je u skupini koja je primala 0,45 mg KE/20 mg BZA u 8% žena tijekom prva 3 mjeseca i u 4% žena tijekom 10 do 12 mjeseci liječenja.
English: If you are allergic to conjugated estrogens, bazedoxifene or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na konjugirane estrogene, bazedoksifen ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako imate, sumnjate da imate ili ste imali rak dojke.
English: - 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
Croatian: Ako imate neko od sljedećih stanja, liječnik Vas mora pomnije pratiti: problemi s bubrezima postojeća visoka razina masnoća u krvi (triglicerida) problemi s jetrom astma napadaji (epilepsija) migrena - sistemski eritemski lupus (SEL- rijetka bolest imunološkog sustava koja može zahvatiti mnoge tjelesne organe) zadržavanje tekućine
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Croatian: Ostali vezni proteini mogu biti povišeni u serumu, npr. globulin koji veže kortikoide (CBG) i globulin koji veže spolne hormone (engl.
English: CE/BZA is contraindicated during breast-feeding (see section 4.3).
Croatian: KE/BZA je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: You may experience breast tenderness, dizziness, abdominal pain, drowsiness/fatigue or experience a short period of vaginal bleeding.
Croatian: Mogu Vam se javiti osjetljivost u dojkama, omaglica, bol u trbuhu, omamljenost/umor ili kratkotrajno vaginalno krvarenje.
English: If any of these conditions apply to you, talk to your doctor before you take this medicine.
Croatian: Ako se bilo koje od gore navedenih stanja odnosi na Vas, porazgovarajte sa svojim liječnikom prije nego uzmete ovaj lijek.
English: CE/BZA has a minor influence on the ability to drive and use machines.
Croatian: KE/BZA malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Any increased risk to users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestagen combinations.
Croatian: Povećani rizik za bolesnice koje primaju terapiju samim estrogenima je znatno niži od rizika za bolesnice koje primaju kombiniranu terapiju estrogen-progestagen.
English: The addition of bazedoxifene in CE/BZAreduces the risk of endometrial hyperplasia,which may be a precursor of endometrial carcinoma.
Croatian: Dodatak bazedoksifena u KE/BZAsmanjuje rizik od hiperplazije endometrija što može biti prekursor rakaendometrija.
English: The risk of ovarian cancer varies with age.
Croatian: Rizik od nastanka raka jajnika ovisi o dobi.
English: Microcrystalline cellulose Hydroxypropylcellulose Hypromellose 2910 (6 mPa•s) (E464) Hypromellose 2910 (15 mPa•s) (E464) Macrogol (400)
Croatian: Inertno punilo ovojnice saharoza celuloza, mikrokristalična hidroksipropilceluloza hipromeloza 2910 (6 mPa•s) (E464) hipromeloza 2910 (15 mPa•s) (E464) makrogol (400)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije nego počnete uzimati ovaj lijek.
English: Oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Croatian: Terapija samim estrogenom povezana je s do 1,5 puta većim rizikom od ishemijskog moždanog udara.
English: Exacerbation of asthma
Croatian: Pogoršanje astme
English: The Women's Health Initiative (WHI) trial found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only therapy.
Croatian: Ispitivanje koje je provela Women's Health Initiative (WHI) nije pokazalo povećanje rizika od raka dojke u ženâ koje su uzimale terapiju samim estrogenom a ranije su podvrgnute histerektomiji.
English: 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.
Croatian: Na primjer, u žena u dobi od 50 do 54 godina koje ne primaju hormonsko nadomjesno liječenje (HNL), u otprilike dvije od 2000 žena bit će dijagnosticiran rak jajnika u razdoblju od 5 godina.
English: 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.
Croatian: U žena u dobi od 50 do 54 godine koje ne primaju hormonsko nadomjesno liječenje (HNL), otprilike dvjema ženama od 2000 bit će dijagnosticiran rak jajnika u razdoblju od 5 godina.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA MEĐUPAKIRANJU
English: DUAVIVE and cancer
Croatian: DUAVIVE i rak
English: 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.
Croatian: U jednom ispitivanju, amenoreja je zabilježena u 97% žena liječenih s 0,45 mg KE/20 mg BZA tijekom 10 do 12 mjeseci liječenja.
English: Use in this population is contraindicated (see sections 4.3, 4.4 and 5.2).
Croatian: Primjena u ovoj skupini je kontraindicirana (vidjeti dijelove 4.3, 4.4 i 5.2).
English: US WHI Oestrogen only (ET) arm - additional risk of breast cancer after 5 years use
Croatian: WHI ispitivanje u SAD - skupina koja je primala samo estrogen (ET) - dodatni rizik od raka dojke nakon 5 godina primjene
English: Women taking CE/BZAshould not take additionaloestrogens as this may increase the risk of endometrial hyperplasiaand endometrial carcinoma.
Croatian: Žene koje uzimaju KE/BZAne smiju uzimati dodatne estrogene jer to može povećati rizik od hiperplazije endometrija i rakaendometrija.
English: The DUAVIVE 0.45 mg/20 mg modified-release tablet is a pink, oval-shaped, tablet marked on one side with “0.45/20”.
Croatian: Tableta s prilagođenim oslobađanjem DUAVIVE od 0,45 mg/20 mg je ružičasta, ovalna tableta s „0,45/20” otisnutim na jednoj strani.
English: The active substances are conjugated oestrogens and bazedoxifene.
Croatian: Djelatne tvari su konjugirani estrogeni i bazedoksifen.
English: • Migraine
Croatian: • Migrena
English: Adverse reactions that have been observed with bazedoxifene monotherapy
Croatian: Nuspojave opažene kod monoterapije bazedoksifenom
English: Do not take DUAVIVE
Croatian: Nemojte uzimati DUAVIVE
English: Risk of venous thromboembolism
Croatian: Rizik od venske tromboembolije
English: DUAVIVE 0.45 mg/20 mg modified-release tablets conjugated oestrogens/bazedoxifene
Croatian: DUAVIVE 0,45 mg/20 mg tablete s prilagođenim oslobađanjem konjugirani estrogeni/bazedoksifen
English: Use in this population is not recommended (see sections 4.2 and 5.2).
Croatian: Primjena u ovoj skupini se ne preporučuje (vidjeti dijelove 4.2 i 5.2).
English: • increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
Croatian: • povećani rizik od dobivanja raka osjetljivog na estrogen (primjerice ako su Vam majka, sestra ili baka imale rak dojke) visoki krvni tlak poremećaji jetre kao što je benigni tumor jetre šećerna bolest žučni kamenci migrena ili jaka glavobolja
English: 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.
Croatian: Nepravilno krvarenje i/ili točkasto krvarenje je prijavljeno u 7% žena u skupini koja je primala 0,45 mg KE/20 mg BZA tijekom prva 3 mjeseca liječenja, a u 3% žena tijekom 10 do 12 mjeseci liječenja.
English: 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.
Croatian: U drugom ispitivanju, amenoreja je zabilježena u 96% žena liječenih s 0,45 mg KE/20 mg BZA tijekom 10 do 12 mjeseci liječenja.