FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Croatian: Bolesnice s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze, nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom sukrazeizomaltaze ne bi trebale uzimati ovaj lijek.
English: A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56).
Croatian: Meta analiza 52 epidemiološke studije ukazala je na povećani rizik od nastanka raka jajnika u žena koje trenutno primaju hormonsko nadomjesno liječenje (HNL) u usporedbi sa ženama koje nikada nisu primale hormonsko nadomjesno liječenje (HNL) (RR 1,43, 95%-tni CI 1,31 - 1,56).
English: Pulmonary embolism
Croatian: Plućna embolija
English: Do not store above 25C.
Croatian: Ne čuvati na temperaturi iznad 25º C.
English: Very common: may affect more than 1 in 10 people • Abdominal pain (stomach ache)
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba • Bol u trbuhu (abdominalna bol)
English: • regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.
Croatian: • redovito pregledavate dojke kako biste uočili sve promjene kao što su jamice na koži, promjene na bradavicama ili kvržice koje možete vidjeti ili napipati.
English: For the treatment of postmenopausal symptoms, CE/BZA should only be initiated for symptoms that adversely affect quality of life.
Croatian: Za liječenje postmenopauzalnih simptoma, terapija KE/BZA-om se smije uvesti samo u slučaju simptoma koji štetno utječu na kvalitetu života.
English: In case of overdose it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Croatian: U slučaju predoziranja preporučuje se praćenje bolesnika kako bi se uočili eventualni znakovi ili simptomi nuspojava te je potrebno odmah započeti s odgovarajućim simptomatskim liječenjem.
English: CE are soluble in water and are well-absorbed from the gastrointestinal tract after release from the medicinal product formulation.
Croatian: KE topivi su u vodi i dobro se apsorbiraju u probavnom sustavu nakon oslobađanja iz formulacije lijeka.
English: Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death.
Croatian: Krvni ugrušci mogu biti ozbiljni, a ako jedan dođe u pluća može uzrokovati bol u prsištu, nedostatak zraka, kolaps pa čak i smrt.
English: The bazedoxifene component of this medicine has been reported to cause problems with eyesight such as blurred vision.
Croatian: Zabilježeno je da bazedoksifen komponenta ovog lijeka uzrokuje probleme s vidom kao što je zamućen vid.
English: In a pharmacokinetic study (n=24) BMI appeared to have little impact on systemic exposure to CE and BZA.
Croatian: U farmakokinetičkom ispitivanju (n=24) pokazalo se da je ITM imao malo utjecaja na sistemsku izloženost KE-u i BZA-i.
English: • go for regular breast screening and cervical smear tests, as recommended by your doctor.
Croatian: • odlazite na redovite preglede dojki i briseve sluznice grlića maternice, prema preporukama liječnika
English: • Worsening of porphyria, a rare blood disorder which is passed down in families (inherited).
Croatian: • Pogoršanje porfirije, rijetkog poremećaja krvi koji se nasljeđuje u obitelji.
English: Women should be told to contact their doctors immediately when they are aware of a potential thromboembolic symptom (e.g., painful swelling of a leg, sudden pain in the chest, dyspnoea).
Croatian: Bolesnicama se mora reći da se odmah jave liječniku čim postanu svjesne mogućih tromboembolijskih simptoma (npr. bolno oticanje noge, iznenadna bol u prsima, dispneja).
English: 28 modified-release tablets
Croatian: 28 tableta s prilagođenim oslobađanjem
English: - Untreated endometrial hyperplasia.
Croatian: Neliječena hiperplazija endometrija.
English: This change in BMD was similar to that shown with bazedoxifene 20 mg alone (+1.35%) and less than that seen with CE 0.45 mg/ medroxyprogesterone 1.5 mg (+2.58%) in the same study.
Croatian: Ta promjena u BMD-u bila je slična onoj sa samim bazedoksifenom 20 mg (+1,35%) i manja od one sa 0,45 mg KE/1,5 mg medroksiprogesterona (+2,58%) u tom istom ispitivanju.
English: Mean ± SD Steady-State Pharmacokinetic Parameters (n=24) Cmax (ng/mL)
Croatian: Srednja vrijednost ± SD farmakokinetičkih parametara u stanju dinamičke ravnoteže (n=24) Cmax (ng/ml)
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Croatian: Tijekom liječenja preporučuju se povremeni pregledi, a njihovu prirodu i učestalost treba prilagoditi svakoj ženi zasebno.
English: • Erythema multiforme: symptoms may include skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.
Croatian: • Multiformni eritem: simptomi mogu uključivati kožni osip s ružičastocrvenim mrljama posebice na dlanovima ili stopalima iz kojih mogu nastati mjehurići.
English: CE/BZA is only for use in postmenopausal women, and is contraindicated in women who are or may become pregnant (see section 4.3).
Croatian: KE/BZA je samo za primjenu u postmenopauzalnih žena i kontraindiciran je u žena koje mogu zatrudnjeti (vidjeti dio 4.3).
English: There is no relevant use of CE/BZA in the paediatric population.
Croatian: Nema relevantne primjene KE/BZA u pedijatrijskoj populaciji.
English: Safety and efficacy have not been evaluated further in women with hepatic insufficiency.
Croatian: Sigurnost i djelotvornost nisu dalje ispitivani u žena s insuficijencijom jetre.
English: • Changes in your interest in sex (increased or decreased libido)
Croatian: • Promjene u zainteresiranosti za spolni odnos (povećan ili smanjen libido)
English: If any of the above conditions appear for the first time while taking this medicine, stop taking it at once and consult your doctor immediately.
Croatian: Ako se bilo koje od gore navedenih stanja pojavi po prvi puta za vrijeme uzimanja ovog lijeka, smjesta prestanite uzimati lijek te se odmah obratite svom liječniku.
English: For women with a history of cholestatic jaundice associated with past oestrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, CE/BZA should be discontinued.
Croatian: U žena s anamnezom kolestatske žutice povezanom s prijašnjim uzimanjem estrogena ili s trudnoćom, treba biti oprezan i, u slučaju ponovne pojave, liječenje KE/BZA-om treba prekinuti.
English: Migraine; headache; dizziness; nervousness
Croatian: Migrena; glavobolja; omaglica; nervoza
English: • smoking
Croatian: • pušenje
English: Therapy should be discontinued in case a contraindication is discovered (e.g., venous thromboembolism, stroke, and pregnancy) and in the following situations:
Croatian: Liječenje treba prekinuti ako se otkrije kontraindikacija (npr. venska tromboembolija, moždani udar i trudnoća), kao i u sljedećim situacijama:
English: • Medicines for tuberculosis (such as rifampicin, rifabutin);
Croatian: • lijekove za tuberkulozu (kao što su rifampicin, rifabutin);
English: • a disease affecting the eardrum and hearing (otosclerosis)
Croatian: • bolest koja utječe na bubnjić uha i sluh (otoskleroza)
English: Women already on chronic anticoagulant treatment require careful consideration of the benefit risk of use of hormone therapy.
Croatian: U žena koje već primaju kroničnu terapiju antikoagulansima potrebna je pomna procjena koristi i rizika primjene hormonske terapije.
English: CE/BZA has not been studied in women over 75 years of age.
Croatian: KE/BZA nije ispitan u žena starijih od 75 godina.
English: Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Croatian: U nastavku su prikazani rezultati najvećeg randomiziranog placebom kontroliranog ispitivanja (WHI ispitivanje) i najvećeg epidemiološkog ispitivanja (Ispitivanje Milijun žena - MWS).
English: The data from the largest randomised trial are summarised below:
Croatian: U nastavku su sažeti rezultati najvećeg randomiziranog ispitivanja:
English: This medicine contains conjugated oestrogens and bazedoxifene and is used to treat women with a uterus (womb).
Croatian: Ovaj lijek sadrži konjugirane estrogene i bazedoksifen i koristi se za liječenje žena koje imaju maternicu.
English: DUAVIVE is a medicine that contains two active substances called conjugated oestrogens and bazedoxifene.
Croatian: DUAVIVE je lijek koji sadrži dvije djelatne tvari koje se nazivaju konjugirani estrogeni i bazedoksifen.
English: *WHI study in women with no uterus, which did not show an increase in risk of breast cancer
Croatian: *WHI ispitivanje u žena bez maternice nije pokazalo povećanje rizika od raka dojke
English: In women with no personal history of VTE but with a first-degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).
Croatian: Ženama koje u osobnoj anamnezi nemaju VTE, ali su u srodstvu prvog stupnja s osobom koja je imala trombozu u mlađoj dobi, mogu se ponuditi pretrage pomno uzimajući u obzir njihova ograničenja (pretragom se može otkriti samo dio trombofilijskih poremećaja).
English: The following side effects have been observed when either conjugated oestrogens and/or bazedoxifene (the active ingredients in this medicine) has been used alone and may occur also with this medicine:
Croatian: Sljedeće nuspojave zabilježene su kad su konjugirani estrogeni i/ili bazedoksifen (djelatni sastojci ovog lijeka) nisu uzimani u kombinaciji nego sami, a mogu se također javiti i s ovim lijekom:
English: Following administration of BZA alone, a linear increase in plasma concentrations for single doses from 0.5 mg up to 120 mg and multiple daily doses from 1 mg to 80 mg was observed.
Croatian: Nakon primjene same BZA, zabilježeno je linearno povećanje koncentracije u plazmi za jednokratnu dozu od 0,5 mg do 120 mg i za višestruke dnevne doze od 1 mg do 80 mg.
English: It is not known whether bazedoxifene is excreted in human milk.
Croatian: Nije poznato izlučuje li se bazedoksifen u majčino mlijeko.
English: Patients with known thrombophilic states have an increased risk of VTE and hormone therapy may add to this risk.
Croatian: Bolesnice s dijagnosticiranim trombofilijskim stanjima imaju povećan rizik od VTE, a hormonska terapija može pridonijeti tom riziku.
English: There is no consensus about the possible role of varicose veins in VTE.
Croatian: Nema usklađenog mišljenja o mogućoj ulozi varikoznih vena na razvoj VTE.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“ ili „EXP“.
English: There were no significant pharmacokinetic interactions between bazedoxifene and the following medicinal products: ibuprofen, atorvastatin and azithromycin or an antacid containing aluminium and magnesium hydroxide.
Croatian: Nije bilo značajnih farmakokinetičkih interakcija između bazedoksifena i lijekova koji sadrže ibuprofen, atorvastatin i azitromicin, ili antacida koji sadrže aluminijev i magnezijev hidroksid.
English: Of the total number of women in phase 3 clinical trials who received CE/BZA 20 mg, 2.4% (n=77) were aged ≥65 years.
Croatian: Od ukupnog broja ispitanica u kliničkim ispitivanjima faze 3. koje su primile KE/BZA 20 mg , 2,4% (n=77) bile su u dobi ≥65 godina.
English: Clinically, an increased metabolism of oestrogens may lead to decreased effect and changes in the uterine bleeding profile.
Croatian: Klinički, pojačani metabolizam estrogena može dovesti do smanjenog učinka i promjena u profilu krvarenja iz maternice.
English: • Cervical erosion found on medical examination
Croatian: • Erozija grlića maternice utvrđena liječničkim pregledom
English: Women taking CE/BZA should not be taking progestins, additional oestrogens or selective oestrogen receptor modulators (SERMs).
Croatian: Žene koje uzimaju KE/BZA ne smiju uzimati progestine, dodatne estrogene ili selektivne modulatore estrogenskih receptora (SERM).
English: - Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully monitored when being treated with CE/BZA.
Croatian: Estrogeni mogu izazvati zadržavanje tekućine pa se stoga bolesnice sa srčanom ili bubrežnom disfunkcijom mora pomno nadzirati tijekom terapije KE/BZA-om.
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Croatian: Smanjuje se vezanje T3 na smolu, što održava povišen TBG.
English: In clinical trials with bazedoxifene monotherapy, somnolence was reported as an adverse reaction, and patients should be advised on the potential effect on driving and using machines.
Croatian: U kliničkim ispitivanjima s bazedoksifenom kao monoterapijom zabilježena je somnolencija kao nuspojava pa je bolesnike potrebno savjetovati o potencijalnom utjecaju na upravljanje vozilima i rad sa strojevima.
English: The extra risk depends on how long you take HRT.
Croatian: Povećani rizik ovisi o dužini uzimanja HNL.
English: Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see section 4.8).
Croatian: Neke druge studije, uključujući studiju WHI ukazuju na to da uporaba kombiniranog hormonskog nadomjesnog liječenja (HNL) može biti povezana sa sličnim ili blago nižim rizikom (vidjeti dio 4.8).
English: Since you are more likely to get a blood clot in your veins as you get older and if any of the following applies to you, inform your doctor promptly:
Croatian: Budući da je veća vjerojatnost da će krvni ugrušak u venama nastati u starijoj životnoj dobi, odmah obavijestite liječnika ako se nešto od navedenog odnosi na Vas:
English: 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.
Croatian: Ako se probojno krvarenje ili točkasto krvarenje pojavi nakon stanovitog razdoblja liječenja ili se nastavi nakon što je liječenje prekinuto, mora se ispitati razlog tome, pričemu može biti potrebna biopsija endometrija kako bi se isključile zloćudne bolesti endometrija.
English: Stop taking DUAVIVE and see a doctor immediately
Croatian: Prestanite uzimati lijek DUAVIVE te se odmah obratite liječniku
English: In addition, women taking CE/BZA should be advised to move about periodically during travel involving prolonged immobilisation.
Croatian: Osim toga, žene koje uzimaju KE/BZA treba savjetovati da je tijekom putovanja koje je povezano s produljenom imobilizacijom potrebno povremeno se kretati.
English: DUAVIVE is used in postmenopausal women who still have their uterus (womb) and have not had a natural period in the last 12 months.
Croatian: DUAVIVE se primjenjuje u postmenopauzalnih žena koje još imaju maternicu i nisu imale prirodnu menstruaciju zadnjih 12 mjeseci.
English: Growth potentiation of benign meningioma; fibrocystic breast disease
Croatian: Potenciranje rasta benignog meningeoma; fibrocistična bolest dojki
English: Urticaria, rash, pruritus
Croatian: Utrikarija, osip, pruritus
English: The pharmacokinetics of a 20 mg single dose of BZA were evaluated in a study in 26 healthy postmenopausal women.
Croatian: Farmakokinetika jednokratne doze BZA od 20 mg ispitivana je u 26 zdravih postmenopauzalnih žena.
English: The active ingredients of CE are primarily the sulphate esters of estrone, equilin sulphates and 17α/β- estradiol.
Croatian: Djelatne tvari KE prvenstveno su sulfatni esteri estrona, ekvilin-sulfati i 17α/β- estradiol.
English: Lactose, sucrose and glucose
Croatian: Laktoza, saharoza i glukoza
English: CE components, 17β-estradiol, estrone, and estriol are excreted in the urine, along with glucuronide and sulfate conjugates.
Croatian: Komponente KE, 17β-estradiol, estron i estriol izlučuju se urinom, zajedno s glukuronidom i suflatnim konjugatima.
English: Glucose intolerance;
Croatian: Netolerancija glukoze
English: Relief of oestrogen-deficiency symptoms and bleeding patterns
Croatian: Ublažavanje simptoma nedostatka estrogena i obrasci krvarenja
English: Should a stroke occur or be suspected, CE/BZA should be discontinued immediately (see section 4.3).
Croatian: Ako nastupi moždani udar ili se na njega sumnja, uzimanje KE/BZA se mora odmah prekinuti (vidjeti dio 4.3).
English: • Changes in breast tissue
Croatian: • Promjene u tkivu dojke
English: Changes in weight (increase or decrease)
Croatian: Promjene u tjelesnoj težini (povećanje ili smanjenje)
English: Bazedoxifene belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs).
Croatian: Bazedoksifen pripada skupini nehormonskih lijekova koji se nazivaju selektivni modulatori estrogenskih receptora (SERM).
English: • Signs of a blood clot in the eye (retinal vein), such as one sided visual disturbance including loss of vision, pain and swelling of the eye especially if sudden.
Croatian: • Znakovi krvnog ugruška u oku (retinalnoj veni), poput smetnji vida na jedno oko, uključujući gubitak vida, bol i oticanje oka, posebice ako je iznenadno.
English: - Women with pre-existing hypertriglyceridaemia should be followed closely during treatment with oestrogens, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
Croatian: - Žene s prethodno dijagnosticiranom hipertrigliceridemijom mora se pomno pratiti tijekom liječenja estrogenima, jer su uz estrogensku terapiju u tom stanju zabilježeni rijetki slučajevi velikog povećanja razine triglicerida u plazmi, što je dovelo do pankreatitisa.
English: CE/BZA pairs CE with the selective oestrogen receptor modulator (SERM), BZA, which is defined as a tissue selective oestrogen complex (TSEC).
Croatian: KE/BZA je kombinacija KE sa selektivnim modulatorima estrogenskih receptora (SERM), BZA-om, koji se definira kao tkivno selektivni estrogenski kompleks (TSEC).
English: This medicinal product contains lactose, sucrose, glucose (in polydextrose and maltitol liquid) and sorbitol (in polydextrose).
Croatian: Ovaj lijek sadrži laktozu, saharozu, glukozu (u polidekstrozi i tekućem maltitolu) i sorbitol (u polidekstrozi).
English: When you take DUAVIVE do not take additional oestrogens as this may increase the risk of endometrial hyperplasia.
Croatian: Kada uzimate DUAVIVE nemojte uzimati dodatne estrogene, jer to može povećati rizik od hiperplazije endometrija.
English: Among these, 1,585 women were treated with CE 0.45 mg/BZA 20 mg and 1,241 received placebo.
Croatian: Među njima, 1585 žena dobivalo je 0,45 mg KE/20 mg BZA, a 1241 žena dobivala je placebo.
English: This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use oestrogen therapy will increase with age (see section 4.4).
Croatian: Ovaj relativni rizik ne ovisi o dobi ili trajanju primjene, ali kako je početni rizik uvelike ovisan o dobi, ukupni rizik od moždanog udara u žena koje primaju estrogensku terapiju povećat će se s dobi (vidjeti dio 4.4).
English: The other ingredients are: lactose monohydrate, sucrose, sucrose monopalmitate, polydextrose (E1200, containing glucose and sorbitol) and maltitol liquid (see section 2), microcrystalline cellulose, powdered cellulose, hydroxypropylcellulose, hydroxyethylcellulose, magnesium stearate, ascorbic acid, hypromellose (E464), povidone (E1201), poloxamer 188, calcium phosphate, titanium dioxide (E171), macrogol (400), red iron oxide (E172), black iron oxide (E172) and propylene glycol (E1520).
Croatian: Ostali sastojci su: laktoza hidrat, saharoza, saharozamonopalmitat, polidekstroza (E1200, sadrži glukozu i sorbitol) i tekući maltitol (pogledajte dio 2.), mikrokristalična celuloza, celuloza u prahu, hidroksipropilceluloza, hidroksietilceluloza, magnezijev stearat, askorbatna kiselina, hipromeloza (E464), povidon (E1201), poloksamer 188, kalcijev fosfat, titanijev dioksid (E171), makrogol (400), crveni željezov oksid (E172), crni željezov oksid (E172) i propilenglikol (E1520).
English: Incidence per 1,000 women in placebo arm over 5 years
Croatian: Incidencija na 1000 žena u placebo skupini tijekom 5 godina
English: However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use hormone therapy will increase with age (see section 4.8).
Croatian: Međutim, budući da je osnovni rizik od moždanog udara jako ovisan o dobi, ukupni rizik u žena koje primaju hormonsku terapiju povećat će se s dobi (vidjeti dio 4.8).
English: Oestrogen-only and bazedoxifene monotherapy increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking these medicines.
Croatian: Monoterapija samo estrogenom i bazedoksifenom povećava rizik od krvnog ugruška u venama (poznato kao duboka venska tromboza, DVT), posebice tijekom prve godine uzimanja lijeka.
English: In studies conducted in rabbits, bazedoxifene alone has shown reproductive toxicity (see section 5.3).
Croatian: U ispitivanjima provedenim na kunićima, primjena bazedoksifena samog pokazala je reproduktivnu toksičnost (vidjeti dio 5.3).
English: • a high level of fat in your blood (triglycerides)
Croatian: • visoka razina masnoća u krvi (triglicerida)
English: The table below lists the adverse reactions observed with CE/BZA (n = 3,168) in placebo-controlled clinical trials.
Croatian: U tablici niže prikazane su sve nuspojave zapažene u bolesnica liječenih KE/BZA-om (n=3168) u placebom kontroliranim kliničkim ispitivanjima.
English: Risk ratio & 95% CI
Croatian: Omjer rizika i 95%-tni CI
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Effects on bone mineral density (BMD)
Croatian: Učinak na mineralnu gustoću kostiju (engl. bone mineral density, BMD)
English: The disposition of a single 20 mg dose of bazedoxifene was compared in women with hepatic impairment (Child-Pugh Class A [n=6], B [n=6], and C [n=6]) and subjects with normal hepatic function (n=18).
Croatian: Primjena jednokratne doze od 20 mg bazedoksifena uspoređena je u žena s oštećenjem funkcije jetre (Child-Pugh klasa A [n=6], B [n=6] i C [n=6]) i ispitanica s normalnom funkcijom jetre (n=18).
English: *study in women with no uterus
Croatian: *Ispitivanje u žena bez maternice
English: - 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.
Croatian: - Bolesnice s terminalnim zatajenjem bubrega treba pomno nadzirati s obzirom da se očekuje povećanje razine cirkulirajućih komponenti estrogena iz KE/BZA.
English: Do not take this medicine if you are breast-feeding.
Croatian: Ne uzimajte ovaj lijek ako dojite.
English: The distribution of exogenous oestrogens is similar to that of endogenous oestrogens.
Croatian: Distribucija egzogenog estrogena slična je onoj kod endogenog estrogena.
English: Female rats were administered daily dosages of 0.3 to 30 mg/kg (0.15 to 14.6 times the human dose based on body surface area, mg /m2 [20 mg/kg dosage in humans is 12.3 mg/m2]) prior to and during mating with untreated males.
Croatian: Ženkama štakora primijenjene su dnevne doze od 0,3 do 30 mg/kg (izloženost 0,15 do 14,6 puta veća od one u ljudi prema tjelesnoj površini, mg /m2 [20 mg/kg doza u ljudi je 12,3 mg/m2]) prije i tijekom parenja s mužjacima koji nisu primali lijek.