FrancophonIA/ELRC3.0 huggingface dataset:
English: Part A. - 0.01% w/w estradiol containing medicinal products for topical use(as per Annex I)
Croatian: Dio A. - lijekovi koji sadrže 0,01% m/m estradiola za topikalnu uporabu (prema Prilogu I.)
English: Endometrial safety of long-term (more than one year) or repeated use of local vaginally administered oestrogen is uncertain.
Croatian: Sigurnost endometrija kod dugotrajne (više od godine dana) ili ponovljene uporabe lokalnog vaginalno primijenjenog estrogena nije jasno utvrđena.
English: [invented name] should be applied with an applicator.
Croatian: [zaštićeni naziv] se mora primijeniti aplikatorom.
English: In rare cases benign, and in even rarer cases malignant liver tumours leading to isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as those contained in [invented name].
Croatian: U rijetkim slučajevima benigni te u još rjeđim slučajevima maligni tumori jetre koji uzrokuju izolirane slučajeve po život opasnog intraabdominalnog krvarenja uočeni su nakon uporabe hormonskih tvari poput onih koje se nalaze u [zaštićeni naziv].
English: Estradiol is the most potent natural oestrogen to act intracellularly.
Croatian: Estradiol je najsnažniji prirodni estrogen koji djeluje unutar stanica.
English: The reported increase in endometrial cancer risk among systemic oestrogen-only users varies from 2- to 12-fold compared with non-users, depending on both duration of treatment and on oestrogen dose.
Croatian: Prijavljeni porast rizika od raka endometrija kod osoba koje uzimaju samo sistemski estrogen obično varira od 2 do 12 puta u usporedbi s onima koje ga ne koriste, ovisno o trajanju liječenja i o dozi estrogena.
English: In prolonged use (beyond 4 weeks), you should look out for possible systemic side effects (e.g. chest pain) and skin atrophy.
Croatian: Kod produljene uporabe (dulje od 4 tjedna) morate obratiti pozornost na moguće sistemske nuspojave (npr. bol u prsištu) i atrofiju kože.
English: Take special care with [invented name]
Croatian: Budite posebno oprezni s [zaštićeni naziv]
English: The steroid receptor complex is bound to the cells' DNA and induces synthesis of specific proteins.
Croatian: Kompleks receptora steroida vezan je na DNK stanica i inducira sintezu specifičnih proteina.
English: - you are unable to walk for a long time because of major surgery, injury or illness - you are seriously overweight (BMI >30 kg/m - you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots - if any of your close relatives has ever had a blood clot in the leg, lung or another organ - you have systemic lupus erythematosus (SLE) - you have cancer.
Croatian: - ne možete hodati dulje vrijeme zbog većeg kirurškog zahvata, ozljede ili bolesti - ozbiljno ste pretili (BMI >30 kg/m2) - imate problem sa zgrušavanjem krvi koji zahtijeva dugotrajno liječenje lijekom koji sprječava krvne ugruške - ako je netko od Vaših bližih rođaka ikada imao krvni ugrušak u nogama, plućima ili nekom drugom organu - imate sistemski lupus eritematozus (SLE) - imate rak.
English: Maturation of the vaginal epithelium is dependent upon oestrogens.
Croatian: Sazrijevanje vaginalnog epitela ovisi o estrogenima.
English: Generally recognised risk factors for VTE include use of oestrogens, older age, major surgery, prolonged immobilisation obesity (BMI>30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
Croatian: Opće prepoznati čimbenici rizika za VTE uključuju uporabu estrogena, stariju dob, veći kirurški zahvat, produljenu imobilizaciju, pretilost (BMI > 30 kg/m2), trudnoću/postpartalno razdoblje, sistemski lupus eritematozus (SLE) i rak.
English: Section 6.5 Nature and contents of container [The text below should be deleted from this section]
Croatian: Dio 6.5 Vrsta i sadržaj spremnika [Tekst u nastavku potrebno je izbrisati iz ovog dijela]
English: The use of HRT carries risks which need to be considered when deciding whether to start taking [invented name], or whether to carry on taking it.
Croatian: Uporaba HNT-a nosi rizik koji se mora razmotriti prilikom odlučivanja o početku uzimanja
English: […] and cutaneous use in the external genital area.
Croatian: […] i primjena na koži na području vanjskih genitalija.
English: A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Croatian: Blagi porast rizika od raka jajnika prijavljen je u žena koje uzimaju HNT tijekom najmanje 5 do 10 godina.
English: [invented name] works by replacing the oestrogen which is normally produced in the ovaries of women.
Croatian: [Zaštićeni naziv] djeluje nadomještanjem estrogena koji se normalno stvara u jajnicima žena.
English: The existing relevant text need to be modified accordingly]
Croatian: Postojeći odgovarajući tekst potrebno je promijeniti u skladu s time]
English: - Diabetes mellitus with or without vascular involvement
Croatian: - dijabetes mellitus uz ili bez zahvaćenosti krvnih žila
English: There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65.
Croatian: Postoje određeni dokazi o većem riziku od gubitka pamćenja u žena koje počinju primjenjivati HNT nakon 65. godine života.
English: If unexpected genital bleeding occurs, treatment should be discontinued, the reason should be investigated which may include vaginal ultrasound investigation and endometrial biopsy to exclude endometrial hyperplasia or malignancy.
Croatian: Ako se pojavi neočekivano krvarenje iz genitalija, liječenje se mora prekinuti, a razlog istražiti, što može uključivati i pretrage vaginalnim ultrazvukom i biopsiju endometrija kako bi se isključila hiperplazija endometrija ili malignitet.
English: HRT, especially oestrogen-progestagen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Croatian: HNT, posebice kombinirana terapija estrogena i progestagena, povećava gustoću mamografskih slika što može negativno utjecati na radiološko otkrivanje raka dojke.
English: Similarly to other steroid hormones, estradiol acts directly on genetic information (DNA) via specific receptors.
Croatian: Slično kao i ostali steroidni hormoni, estradiol djeluje izravno na genetičke informacije (DNK) putem specifičnih receptora.
English: If symptoms of vaginal atrophy persist beyond 4 weeks, alternative therapies should be considered.
Croatian: Ako se simptomi vaginalne atrofije nastave nakon 4 tjedna, moraju se uzeti u obzir alternativne terapije.
English: If you get breakthrough bleeding or spotting, it's usually nothing to worry about, but you should make an appointment to see your doctor.
Croatian: Ako iskusite probojno ili točkasto krvarenje, to je obično pojava zbog koje se ne morate brinuti, ali morate dogovoriti pregled kako biste posjetili liječnika.
English: Insert the contents of 1 filled applicator (= 2 g cream) before bedtime.
Croatian: Umetnite sadržaj jednog napunjenog aplikatora (= 2 g kreme) prije odlaska u krevet.
English: The risk of getting stroke is about 1.5 times higher in HRT users than in non-users.
Croatian: Rizik od moždanog udara je otprilike 1,5 puta veći u korisnica HNT-a nego u onih koje ga ne koriste.
English: Take special care when using [invented name] together with latex products (e.g. condoms, diaphragms), as it contains excipients (other ingredients, particularly stearates) which can reduce the functionality of such products, thereby making them less reliable.
Croatian: Budite posebno oprezni prilikom uporabe [zaštićeni naziv] zajedno s proizvodima od lateksa (npr. s kondomima, dijafragmama) jer sadrži pomoćne tvari (druge sastojke, posebice stearate) koji mogu smanjiti funkcionalnost takvih proizvoda pa ih stoga čine manje pouzdanim.
English: − when using [invented name] at the same time as latex products (e.g. condoms, diaphragms).
Croatian: − ako koristite [zaštićeni naziv] u isto vrijeme kada i proizvode od lateksa (npr. kondome, dijafragme).
English: The number of extra cases of stroke due to use of HRT will increase with age.
Croatian: Broj dodatnih slučajeva moždanog udara zbog uporabe HNT-a porast će s dobi.
English: As well as its typical hormonal effects during the reproductive period, higher concentrations of estradiol also exert characteristic effects on the skin.
Croatian: Kao i njegovi tipični hormonski učinci tijekom reproduktivnog razdoblja, više koncentracije estradiola također imaju karakteristične učinke na kožu.
English: As well as its typical hormonal effects during the reproductive period, estradiol also exerts characteristic effects on the skin.
Croatian: Kao i njegovi tipični hormonski učinci tijekom reproduktivnog razdoblja, estradiol također iskazuje karakteristične učinke na kožu.
English: Any existing section should be deleted.]
Croatian: Bilo koji postojeći tekst potrebno je izbrisati.]
English: Chloasma/melasma, hirsutism, pruritus, rash
Croatian: Kloazma/melazma, hirzutizam, pruritus, osip
English: - It is exactly the same as the estradiol produced by the ovaries of women.
Croatian: - Identičan je estradiolu koji nastaje u jajnicima žena.
English: The risk of coronary artery disease is slightly increased in users of combined oestrogenprogestogen HRT over the age of 60 (see section 4.4).
Croatian: Rizik od bolesti koronarnih arterija blago je povećan u korisnica kombiniranog HNT-a na bazi estrogena i progestagena starijih od 60 godina (vidjeti dio 4.4).
English: Therapy with [invented name] should only be administered together with clinical monitoring.
Croatian: Terapija [zaštićeni naziv] mora se primjenjivati isključivo pod kliničkim nadzorom.
English: * No differentiation was made between ischaemic and haemorrhagic stroke
Croatian: * Nema razlike između ishemijskog i hemoragijskog moždanog udara
English: If pregnancy occurs during medication with [invented name], treatment should be withdrawn immediately.
Croatian: Ako se tijekom liječenja s [zaštićeni naziv] dogodi trudnoća, liječenje se mora odmah prekinuti.
English: According to the current, standard classification system for topical corticosteroids, i.e. weak (I), moderately potent (II), potent (III) and very potent (IV), prednisolone - closely related to natural hydrocortisone (= cortisol) - belongs to the first group.
Croatian: na slabe (I), umjereno jake (II), jake (III) i vrlo jake (IV), prednizolon - blisko srodan prirodnom hidrokortizonu (= kortizol) - pripada prvoj skupini.
English: Clinically, an increased metabolism of oestrogens may lead to decreased effect and changes in the uterine bleeding profile.
Croatian: Klinički, povećani metabolizam estrogena može uzrokovati smanjeni učinak i promjene u profilu krvarenja maternice.
English: In another study, mean estradiol serum concentrations at baseline and at day 31 (i.e. about 36 h after administration of study medication on day 29) were 6.4 pg/ml and 15.1 pg/ml, respectively, in the [invented name] group and 4.4 pg/ml and 6.2 pg/ml, respectively, in the placebo group.
Croatian: U drugom ispitivanju prosječne serumske koncentracije estradiola na početku te 31. dan (tj. otprilike 36 sati nakon primjene ispitivanog lijeka 29. dan) bile su 6,4 pg/ml,, odnosno 15,1 pg/ml u skupini koja je primala [zaštićeni naziv] te 4,4
English: When applied vaginally, estradiol is absorbed from the vaginal epithelium and enters the bloodstream in concentrations which are transiently above the postmenopausal range.
Croatian: Kad se primjenjuje vaginalno, estradiol se apsorbira iz epitela vagine i ulazi u krvotok u koncentracijama koje su prolazno veće od raspona karakterističnog za razdoblje poslije menopauze.
English: Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women.
Croatian: Liječenje vaginalne atrofije zbog nedostatka estrogena u žena u postmenopauzi.
English: For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease.
Croatian: Za žene kojima je odstranjena maternica i koje uzimaju terapiju samim estrogenom ne postoji povećani rizik od razvijanja srčane bolesti.
English: The doctor will decide on the duration of treatment, and whether further treatment is needed with a corticosteroid-free, high-dose oestradiol cream or a cream with no active substances.
Croatian: Liječnik će odrediti trajanje liječenja i je li potrebno daljnje liječenje kremom estradiola visoke doze bez kortikosteroida ili kremom bez djelatnih tvari.
English: There is no consensus about the possible role of varicose veins in VTE.
Croatian: Nema dogovora oko moguće uloge varikoznih vena u VTE-u.
English: No studies have been performed on the dermal absorption of oestradiol within the external female genital area from [invented name].
Croatian: Nisu provedena ispitivanja o dermalnoj apsorpciji estradiola iz [zaštićeni naziv] unutar vanjskog područja ženskih genitalija.
English: Taking oestrogen-only HRT tablets for a long time can increase the risk of developing cancer of the womb lining (the endometrium).
Croatian: Uzimanje HNT tableta sa samim estrogenom tijekom dugo vremena može povećati rizik od razvoja raka sluznice maternice (endometrija).
English: − if you have an benign or malignant tumour which is sensitive to oestrogens, such as fibroids inside your womb or uterine or cancer of the womb lining, or if you are suspected of having one
Croatian: − ako imate benigni ili maligni tumor koji je osjetljiv na estrogene, poput fibroida unutar maternice ili raka sluznice maternice ili ako se sumnja da imate nešto od navedenog
English: It is unknown whether prolonged treatment or repeated treatment courses will cause thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb (endometrial cancer).
Croatian: Nije poznato da li će produljeno liječenje ili ponovljeni ciklusi liječenja uzrokovati zadebljanje sluznice maternice (hiperplazija endometrija) i rak maternice (rak endometrija).
English: Herbal preparations containing St John's Wort (Hypericum Perforatum) may induce the metabolism of oestrogens.
Croatian: Biljni pripravci koji sadrže gospinu travu (Hypericum Perforatum) mogu inducirati metabolizam estrogena.
English: [Invented name] should not be used in patients who are treated with systemic Hormone Replacement Therapy (HRT).
Croatian: [Zaštićeni naziv] ne smije se koristiti u bolesnika koji se liječe sistemskom hormonskom nadomjesnom terapijom (HNT).
English: Similarly to other steroid hormones, estradiol acts directly on genetic information (DNA) via specific receptors following systemic administration.
Croatian: Slično kao i ostali steroidni hormoni, estradiol djeluje izravno na genetičke informacije (DNK) putem specifičnih receptora nakon sistemske primjene.
English: In addition, due to the content of the corticosteroid prednisolone in [invented name] , skin atrophy might occur with prolonged use, further increasing systemic exposure to oestradiol.
Croatian: Pored toga, zbog sadržaja kortikosteroida prednizolona u [zaštićeni naziv], atrofija kože može se javiti kod produljene uporabe, što dodatno povisuje sistemsku izloženost estradiolu.
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 HRT will increase with age, see section 4.4.
Croatian: Ovaj relativni rizik ne ovisi o dobi ili trajanju uporabe, ali budući da početni rizik uvelike ovisi o dobi, ukupni se rizik od moždanog udara kod žena koje koriste HNT povećava s dobi,
English: [The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Croatian: [Postojeće informacije o lijeku bit će izmijenjene (umetanje, zamjena ili brisanje teksta prema potrebi) kako bi se uskladile s dogovorenim tekstom kako je navedeno u nastavku]
English: Treatment should not exceed 4 weeks.
Croatian: Liječenje ne smije trajati dulje od 4
English: - An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestogen therapy for more than 5 years.
Croatian: - Do 2 puta veći rizik od dijagnoze raka dojke zabilježen je u žena koje uzimaju kombiniranu terapiju estrogenom i progestagenom duže od 5 godina.
English: The endometrial safety of prolonged treatment and repeated treatment courses is unknown.
Croatian: Nije poznata sigurnost endometrija tijekom produljenog liječenja i tijekom ponovljenih ciklusa liječenja.
English: Section 4.4 Special warnings and precautions for use [All current text in this section should be deleted and replaced by the text below]
Croatian: Dio 4.4 Posebna upozorenja i mjere opreza pri uporabi [Sav trenutni tekst u ovom dijelu potrebno je izbrisati i zamijeniti tekstom u nastavku]
English: As an active substance, [invented name] contains 17ß-estradiol (0.005%).
Croatian: [Zaštićeni naziv] sadrži djelatnu tvar 17ß-estradiol (0,005 %).
English: Over 95% of estriol is excreted in the urine, mainly in the form of glucuronides.
Croatian: Više od 95% estriola izlučuje se urinom,
English: Therefore, for safety reasons, you should use [invented name] no longer than 4 weeks.
Croatian: Stoga se zbog sigurnosnih razloga [zaštićeni naziv] ne smije koristiti dulje od 4 tjedna.
English: Observational studies have mostly reported a small increase in risk of having breast cancer diagnosed that is substantially lower than found in users of oestrogenprogestagen combinations.
Croatian: Opservacijska ispitivanja uglavnom su ukazala na mali porast rizika od dijagnosticiranog raka dojke koji je znatno niži od rizika u korisnika kombinacija estrogena i progestagena.
English: Other adverse reactions have been reported in association with oestrogen/progestogen treatment.
Croatian: Prijavljene su i druge nuspojave u vezi s liječenjem estrogenom/progestagenom.
English: The woman should be advised to contact her doctor in case bleeding or spotting occurs during treatment with [invented name].
Croatian: Žene je potrebno savjetovati da se u slučaju krvarenja ili točkastog krvarenja tijekom liječenja s [zaštićeni naziv] obrate svom liječniku.
English: Part B. - 0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products
Croatian: Dio B. - lijekovi koji sadrže 0,005 % m/m estradiola / 0,4 % m/m prednizolona
English: Using [invented name] together with latex products (e.g. condoms, diaphragms) can reduce the functionality of such products thereby making them less reliable as [invented name] contains excipients (other ingredients, particularly stearates).
Croatian: Uporaba [zaštićeni naziv] s proizvodima od lateksa (npr. kondomi, dijafragme) može smanjiti funkcionalnost takvih proizvoda i tako ih načiniti manje pouzdanim jer [zaštićeni naziv] sadrži pomoćne tvari (ostale sastojke, posebice stearate).
English: [This section should have all of the following text only]
Croatian: [Ovaj dio mora sadržavati samo cijeli sljedeći tekst]
English: Do not use [invented name] immediately before sexual intercourse or as a lubricant, to prevent possible side effects in your partner.
Croatian: Nemojte koristiti [zaštićeni naziv] neposredno prije spolnog odnosa ili kao lubrikant kako bi se spriječile moguće nuspojave kod Vašeg partnera.
English: Pregnancy and the breast-feeding
Croatian: Trudnoća i dojenje
English: There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65.
Croatian: Iz WHI ispitivanja proizlaze određeni dokazi o povećanom riziku vjerojatne demencije u žena koje počinju koristiti kontinuiranu kombinirani ili čisti estrogenski HNT u dobi iznad 65 godina.
English: Speak to your doctor for advice.
Croatian: Posavjetujte se sa svojim liječnikom.
English: Oestrogens stimulate epithelial cell proliferation in the genital area and urinary tract, as well as increasing collagen synthesis in the skin.
Croatian: Estrogen stimulira proliferaciju stanica epitela u području genitalija i urinarnog trakta te povećava sintezu kolagena u koži.
English: Intolerance to contact lenses
Croatian: Nepodnošenje kontaktnih leća
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) HRT is contraindicated.
Croatian: Ako je otkriven trombofilijski nedostatak koji se kod članova obitelji segregira s trombozom ili ako je nedostatak „težak” (npr. nedostaci antitrombina, proteina
English: Therefore, for safety reasons, the maximum duration of treatment is limited to 4 weeks.
Croatian: Stoga je, iz sigurnosnih razloga, maksimalno trajanje liječenja ograničeno na 4 tjedna.
English: In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.
Croatian: U žena s intaktnom maternicom, rizik od hiperplazije endometrija i raka povećan je kad se estrogeni primjenjuju samostalno tijekom produljenih razdoblja.
English: - Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestogen combinations.
Croatian: - Bilo koji povećani rizik u korisnika samostalne terapije estrogenom znatno je niži nego onaj uočen u korisnika koji uzimaju kombinaciju estrogena i progestagena.
English: See sction 4.2 and
Croatian: Vidjeti dijelove 4.2 i 4.4.
English: [invented name] is thinly applied (a string of ointment about 1 cm long) to affected skin areas of the external female genital area once daily with the fingers and then gently rubbed in. [invented name] should not be applied intravaginally or on other parts of the internal genital area.
Croatian: [zaštićeni naziv] primjenjuje se u tankom sloju (red masti dug otprilike 1 cm) na zahvaćena područja kože vanjskog područja ženskih genitalija jednom dnevno prstima i potom se lagano utrljava. [zaštićeni naziv] ne smije se primjenjivati intravaginalno ili na druge dijelove unutrašnjosti genitalija.
English: Therefore, for safety reasons the maximum duration of treatment is limited to 4 weeks.
Croatian: Stoga je zbog sigurnosnih razloga maksimalno trajanje liječenja ograničeno na 4 tjedna.
English: Its use beyond 4 weeks is not recommended.
Croatian: Uporaba lijeka dulje od 4 tjedna ne preporučuje se.
English: Undesirable effects - such as gastrointestinal complaints, nausea, etc - may occur after accidental or intentional administration of large amounts of [invented name].
Croatian: Nuspojave - poput gastrointestinalnih smetnji, mučnine, itd.. - mogu se javiti nakon slučajne ili namjerne primjene velikih količina [zaštićeni naziv]. Liječenje je simptomatsko.
English: For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.
Croatian: Za žene koje su se podvrgnule uklanjanju maternice i koje koriste HNT s čistim estrogenom tijekom 5 godina, povećanje rizika od raka dojke je bilo malo ili ga nije bilo.
English: Do not use [invented name] when you use other HRT products such as estrogen tablets, patches or gel for treatment of hot flushes or prevention of osteoporosis
Croatian: Nemojte koristiti [zaštićeni naziv] ako koristite druge HNT lijekove poput tableta estrogena, flastera ili gelova za liječenje navala vrućine ili sprječavanje osteoporoze
English: Vigilance is required for possible systemic side effects and skin atrophy.
Croatian: Nadzor je potreban za moguće sistemske nuspojave i atrofiju kože.
English: Your doctor will decide how long you should use the cream, and whether further treatment is needed with a corticosteroid-free but high-dose oestradiol cream, or a cream containing no active substances.
Croatian: Vaš će liječnik odrediti koliko kreme morate koristiti i je li potrebno daljnje liječenje kremom estradiola velike doze bez kortikosteroida ili kremom bez djelatnih tvari.
English: Common ≥ 1/100 to < 1/10 (≥ 1% and
Croatian: ≥ 1/100 do < 1/10 (≥ 1% i