FrancophonIA/ELRC3.0 huggingface dataset:
English: Nonclinical studies provided no additional data of relevance to clinical safety beyond those already included in other sections of the SmPC.
Croatian: Neklinička ispitivanja nisu pružila dodatne podatke koji bi bili važni za kliničku sigurnost osim onih već uključenih u druge dijelove SmPC-a.
English: As in all postoperative patients, prophylactic measures need to be considered to prevent VTE following surgery.
Croatian: Kao kod svih postoperativnih bolesnika, potrebno je uzeti u obzir profilaktičke mjere za sprječavanje VTE-a nakon kirurškog zahvata.
English: For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life.
Croatian: Za liječenje simptoma postmenopauze, HNT je potrebno započeti samo za simptome koji negativno utječu na kvalitetu života.
English: In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
Croatian: U svim je slučajevima potrebno provesti pažljivu procjenu rizika i koristi barem na godišnjoj bazi, a HNT je potrebno nastaviti sve dok korist nadmašuje rizik.
English: 17β-Estradiol is a well-known substance.
Croatian: 17β-estradiol je dobro poznata tvar.
English: The occurrence of such an event is more likely in the first year of HRT than later.
Croatian: Pojava takvog događaja vjerojatnija je u prvoj godini HNT-a nego kasnije.
English: The applicator should be cleaned with warm water each time after use.
Croatian: Aplikator se mora oprati toplom vodom nakon svake primjene.
English: However, being a HRT product, the following need to be considered:
Croatian: Međutim, s obzirom na to da se radi o HNT lijeku, potrebno je razmotriti sljedeće:
English: Medical history and regular check-ups
Croatian: Medicinska anamneza i redoviti pregledi
English: HRT is therefore contraindicated in these patients (see section 4.3).
Croatian: HNT je stoga kontraindiciran u ovih bolesnika (vidjeti dio 4.3).
English: # Overal risk ratio.
Croatian: # Ukupni omjer rizika.
English: Section 4.6 Fertility, Pregnancy and lactation
Croatian: Dio 4.6 Plodnost, trudnoća i dojenje
English: - The level of risk is dependent on the duration of use (see section 4.4).
Croatian: - Razina rizika ovisi o trajanju uporabe (vidjeti dio 4.4).
English: Your doctor may decide to perform a physical examination.
Croatian: Vaš će liječnik možda odlučiti da Vas želi pregledati.
English: − if you have any unexplained vaginal bleedings
Croatian: − ako patite od neobjašnjivih vaginalnih krvarenja
English: - Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Croatian: Prikazani su rezultati najvećeg randomiziranog placebom kontroliranog ispitivanja (WHI ispitivanje) i najvećeg epidemiološkog ispitivanja (MWS).
English: [Invented name] is for use in postmenopausal women only.
Croatian: [Zaštićeni naziv] se koristi samo kod žena u postmenopauzi.
English: This medicine contains inactive ingredients (especially stearates) that may reduce the functionality of these products, thereby making them less reliable.
Croatian: Ovaj lijek sadrži neaktivne sastojke (posebice stearate) koji mogu smanjiti funkcionalnost tih proizvoda i time smanjiti njihovu pouzdanosti.
English: It is caused by a drop in the levels of oestrogen in your body.
Croatian: Uzrokuje ih pad razina estrogena u Vašem tijelu.
English: Like all medicines, [invented name] can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, [zaštićeni naziv] može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Heart disease (heart attack)
Croatian: Srčana bolest (srčani udar)
English: Investigations including appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Croatian: Pretrage koje uključuju odgovarajuće alate za snimanje, npr. mamografija, potrebno je provesti u skladu s trenutačno prihvaćenim praksama probira, izmijenjenim u skladu s kliničkim potrebama pojedinca.
English: Application beyond 4 weeks is not recommended, due to potential systemic exposure to estradiol during treatment.
Croatian: Primjena dulja od 4 tjedna ne preporučuje se zbog potencijalne sistemske izloženosti estradiolu tijekom liječenja.
English: Some studies including the WHI trial suggest that the long-term use of combined HRTs may confer a similar or slightly smaller risk (see Section 4.8).
Croatian: Neka ispitivanja uključujući WHI ispitivanje ukazuju na to da dugotrajna uporaba kombiniranog HNT-a može donijeti sličan ili nešto manji rizik (vidjeti dio 4.8).
English: Before you start (or restart) HRT, your doctor will ask about your own and your family's medical history.
Croatian: Prije početka (ili ponovnog početka) HNT-a, Vaš liječnik će Vas pitati o Vašoj osobnoj te obiteljskoj anamnezi.
English: If prolonged immobilisation is to follow elective surgery, temporarily stopping HRT 4 to 6 weeks earlier is recommended.
Croatian: Ako se nakon elektivnog kirurškog zahvata provodi produljena imobilizacija, preporučuje se privremeno zaustavljanje HNT-a 4 do 6 tjedana ranije.
English: [Invented name] , is for short-term (4 weeks) local treatment in the vagina and the absorption into the blood is lower.
Croatian: [Zaštićeni naziv] je namijenjen kratkotrajnom (4 tjedna) lokalnom liječenju vagine, a apsorpcija u krv je slabija.
English: If you notice any of the following when using HRT: - Migraine-like headaches which happen for the first time - Yellowing of your skin or the whites of your eyes (jaundice).
Croatian: Ako primijetite bilo što od sljedećega tijekom uporabe HNT-a: - glavobolje nalik migreni koje se događaju po prvi put - žutilo Vaše kože ili bjeloočnica Vaših očiju (žutica).
English: As a precaution, [invented name] may not be used in children or adolescents.
Croatian: Kao mjera opreza, [zaštićeni naziv] ne smije se koristiti kod djece ili adolescenata.
English: One filled applicator dose (= 2 g cream) is inserted before retiring to bed.
Croatian: Jedna doza napunjenog aplikatora (= 2 g kreme) umeće se prije odlaska u krevet.
English: The following values were determined after single-dose administration of 2 g [invented name], equivalent to 200 µg E2: AUCδ0-∞ = 887.5 pg/ml*h; AUCδ0-tz = 799.5 pg/ml*h; Cδmax = 86.2 pg/ml.
Croatian: što je jednako 200 µg E2: AUCδ0-∞ = 887,5 pg/ml*sat; AUCδ0-tz = 799,5 pg/ml*sat; Cδmax = 86,2 pg/ml.
English: Especially prolonged use (>4 weeks) is therefore not recommended.
Croatian: Posebice produljena uporaba (> 4 tjedna) stoga nije preporučena.
English: [In this section the use of the cream with the applicator is inserted.
Croatian: [U ovaj dio umetnuti su podaci o uporabi kreme s aplikatorom.
English: - It belongs to a group of hormones called oestrogens.
Croatian: - Pripada skupini hormona zvanih estrogeni.
English: It is used to relieve menopausal symptoms in the vagina such as dryness or irritation.
Croatian: Koristi se za olakšavanje simptoma menopauze u vagini kao što su suhoća ili iritacija.
English: Given that systemic exposure occurs during treatment with [Invented name], prolonged treatment beyond 4 week is not recommended.
Croatian: S obzirom na to da se sistemska izloženost događa tijekom liječenja s [zaštićeni naziv], ne preporučuje se produljeno liječenje dulje od 4 tjedna.
English: Take special care with [invented name] Tell your doctor if you have or have ever had any of the following problems before you start the treatment.
Croatian: Recite svom liječniku ako imate ili ste ikada imali ijedan od sljedećih problema prije početka liječenja.
English: Patients 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: Bolesnicima je potrebno reći da se moraju odmah obratiti svojim liječnicima ako postanu svjesni potencijalnih tromboembolijskih simptoma (npr. bolno oticanje nogu, iznenadna bol u prsištu, dispneja).
English: Oestrogens maintain vaginal pH around normal range (4.5) which enhances normal bacterial flora.
Croatian: Estrogeni održavaju pH vagine u normalnom rasponu (4,5) što poboljšava normalnu bakterijsku floru.
English: If unexpected bleeding should occur, treatment with [invented name] must be suspended until the cause of bleeding has been clarified (see section 4.4 on endometrial safety).
Croatian: U slučaju neočekivanog krvarenja, liječenje s [zaštićeni naziv] se mora prekinuti sve dok se ne razjasni uzrok krvarenja (vidjeti dio 4.4 o sigurnosti endometrija).
English: The biological effect of 17β-estradiol is carried out through a number of specific oestrogen receptors.
Croatian: Biološki učinak 17β-estradiola ostvaruje se preko brojnih specifičnih estrogenskih receptora.
English: The occurrence of such an event is more likely in the first year of using HT (see section 4.4).
Croatian: Pojava takvog događaja vjerojatnija je u prvoj godini uporabe HT-a (vidjeti dio 4.4).
English: Ovarian cancer is rare.
Croatian: Rak jajnika je rijedak.
English: If VTE develops after initiating therapy, the drug should be discontinued.
Croatian: Ako se VTE razvije nakon početka terapije, potrebno je prekinuti uporabu lijeka.
English: In addition, estradiol also has rapid, non-genomic effects (signal transduction).
Croatian: Pored toga, estradiol ima brze, negenomične učinke (prijenos signala).
English: Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
Croatian: Ritonavir i nelfinavir, iako su poznati kao snažni inhibitori, nasuprot tome iskazuju inducirajuća svojstva kada se koriste istodobno sa steroidnim hormonima.
English: It is therefore less likely that the conditions mentioned below will get worse or come back during treatment with [invented name].
Croatian: Stoga je manje vjerojatno da će se navedena stanja pogoršati ili vratiti tijekom liječenja s [zaštićeni naziv].
English: Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.
Croatian: Fizikalni pregled (uključujući pregled zdjelice i dojki) mora se voditi u skladu s ovime te u skladu s kontraindikacijama i upozorenjima za uporabu.
English: Estradiol conversion to estriol is irreversible.
Croatian: Konverzija estradiola u estriol je ireverzibilna.
English: − You should not use [invented name] immediately before sexual intercourse or as a lubricant.
Croatian: Uvijek primijenite [zaštićeni naziv] točno u skladu s uputama danim u ovoj Uputi o lijeku.
English: Go for regular breast screening as recommended by your doctor.
Croatian: Idite na redovite preglede probira za svoje dojke u skladu s preporukama Vašeg liječnika.
English: Very rare (<1/10,000),
Croatian: Vrlo rijetko (< 1/10 000),
English: Very rare (< 1/10,000),
Croatian: Vrlo rijetko (<1/10 000),
English: Hypersensitivity skin reaction (allergic contact eczema)
Croatian: Kožna reakcija preosjetljivosti (alergijski kontaktni ekcem)
English: Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
Croatian: Krvni ugrušci mogu biti ozbiljni i ako jedan od njih dospije u pluća i može uzrokovati bol u prsištu, nedostatak zraka, nesvjesticu ili čak smrt.
English: *Study in women with no uterus
Croatian: *Ispitivanja u žena bez maternice
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Croatian: Smanjuje se vezanje T3 na smolu, što odražava povišeni TBG.
English: $ When the analysis was restricte to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: after 5 years the risk was higher than non-users
Croatian: Kad je analiza bila ograničena na žene koje nisu koristile HNT prije ispitivanja, povišeni rizik nije uočen tijekom prvih 5 godina liječenja: nakon 5 godina rizik je bio viši nego kod onih koji nisu koristili HNT
English: Thus, prednisolone is particularly suitable for the treatment of inflammatory dermatoses in problem areas, as it has weak anti-inflammatory, antiallergic and antipruritic properties.
Croatian: Stoga je prednizolon posebice prikladan za liječenje upalnih dermatoza u problematičnim područjima jer ima slaba protuupalna, antialergijska i antipruritička svojstva.
English: The results of most epidemiological studies to date relevant to inadvertent foetal exposure to oestrogens indicate no teratogenic or foetotoxic effect.
Croatian: Rezultati većine dosadašnjih epidemioloških ispitivanja povezanih s nenamjernim izlaganjem fetusa estrogenima ne ukazuje na teratogeni ili fetotoksični učinak.
English: [invented name] should not be applied intravaginally or on other parts of the internal genital area.
Croatian: [Zaštićeni naziv] ne smije se primjenjivati intravaginalno ili na druge dijelove internih genitalnih područja.
English: [invented name] may only be used with special caution, after a thorough clinical evaluation of the risks and benefits, in the following cases:
Croatian: [zaštićeni naziv] može se koristiti samo uz poseban oprez, nakon temeljite kliničke procjene rizika i koristi, u sljedećim slučajevima:
English: Route of administration: cream for vaginal use
Croatian: Put primjene: krema za vaginalnu uporabu
English: It is not known how these risks apply to locally administered treatments such as [invented name] .
Croatian: Nije poznato u kojoj mjeri se ti rizici odnose na lokalno primijenjena liječenja poput [zaštićeni naziv].
English: If any of the above conditions appear for the first time while using [invented name] , stop using it at once and consult your doctor immediately.
Croatian: Ako se bilo koje od prethodno spomenutih stanja pojavi po prvi put dok uzimate [zaštićeni naziv], odmah ga prestanite primjenjivati i obratite se odmah svom liječniku.
English: In particular, if you experience unexpected genital bleeding you must discontinue treatment with [invented name] and consult a doctor
Croatian: Posebice, ako iskusite neočekivano genitalno krvarenje morate odmah prekinuti liječenje s [zaštićeni naziv] i obratiti se liječniku
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Croatian: Tijekom liječenja preporučuju se periodički pregledi čija je učestalost i priroda prilagođena svakoj ženi.
English: If symptoms persist beyond 4 weeks, alternative therapies should be considered.
Croatian: Ako simptomi ustraju dulje od 4 tjedna, moraju se uzeti u obzir alternativne terapije.
English: During prolonged use, you should look out for possible systemic effects (affecting the whole body).
Croatian: Tijekom produljene uporabe morate pratiti moguće sistemske učinke (koje zahvaćaju cijelo tijelo).
English: In medical terms this is known as ‘vaginal atrophy'.
Croatian: medicinskom smislu ti su simptomi poznati kao „atrofija vagine”.
English: * WHI study in women with no uterus, which did not show an increase in risk of breast cancer.
Croatian: * WHI ispitivanje u žena koje nemaju maternicu, a koje nije pokazalo porast rizika od raka dojke.
English: Interactions of [invented name] with other medicinal products were not investigated.
Croatian: Interakcije [zaštićeni naziv] s drugim lijekovima nisu ispitivane.
English: If you become pregnant, stop using [invented name] and contact your doctor.
Croatian: Ako zatrudnite, prestanite koristiti [zaštićeni naziv] i obratite se svom liječniku.
English: Dizziness, headache, migraine, anxiety
Croatian: Omaglica, glavobolja, migrena, anksioznost
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Informacije o lijeku mogu naknadno ažurirati nadležna tijela države članice u dogovoru s referentnom državom članicom, prema potrebi, te u skladu s postupcima zadanim u poglavlju 4. Naslova III.
English: Section 4.9 Overdose
Croatian: Dio 4.9 Predoziranje
English: It is uncertain whether long term (more than one year) or repeated use of local vaginally administered oestrogen products possess a similar risk.
Croatian: Nije sigurno da li dugotrajna (više od godine dana) ili ponovljena uporaba lokalno vaginalno primijenjenih lijekova s estrogenom predstavlja sličan rizik.
English: Risk ratio and 95% CI
Croatian: Omjer rizika i 95% CI
English: As its active substance, [invented name] contains 17ß-estradiol, a natural sex hormone, at a concentration of 0.01%.
Croatian: Kao djelatnu tvar, [zaštićeni naziv] sadrži 17ß-estradiol, prirodni spolni hormon, u koncentraciji od 0,01%.
English: - Leiomyoma (uterine fibroids) or endometriosis
Croatian: - lejomiom (fibroid maternice) ili endometrioza
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenih u Dodatku V*.
English: The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in nonusers, especially during the first year of taking it.
Croatian: Rizik od krvnih ugrušaka u venama je otprilike 1,3 do 3 puta veći u korisnica HNT-a nego u onih koje ne koriste HNT, posebice tijekom prve godine uzimanja.
English: For more information, see ‘Blood clots in a vein (thrombosis)'.
Croatian: Za više informacija pogledajte „Krvni ugrušci u veni (tromboza)”.
English: In the first week of treatment, [invented name] should be applied on every other day, i.e. at 48-hourly intervals, and twice weekly thereafter (maintenance dose).
Croatian: U prvom tjednu liječenja [zaštićeni naziv] mora se primjenjivati svaki drugi dan, tj. u 48-satnim intervalima i dva puta tjedno nakon toga (doza održavanja).
English: (≥1/1,000 to <1/100)
Croatian: (≥ 1/1 000 do < 1/100)
English: The pharmacokinetic profile of [Invented name] shows that there is systemic absorption of estradiol during treatment, in concentrations which are transiently above the postmenopausal levels (see Section 5.2).
Croatian: Farmakokinetički profil [zaštićeni naziv] pokazuje da postoji sistemska apsorpcija estradiola tijekom liječenja u koncentracijama koje su privremeno više od razina u postmenopauzi (vidjeti Dio 5.2.).
English: − if you have skin diseases in the external genital area caused by bacterial, fungal or viral infections
Croatian: − ako imate bolesti kože na području vanjskih genitalija uzrokovane bakterijskim gljivičnim ili virusnim infekcijama
English: Therefore, before a 4-week treatment course with [invented name] is repeated, treatment should be reviewed, with special consideration given to any symptoms of endometrial hyperplasia or carcinoma.
Croatian: Stoga je prije ponavljanja 4-tjednog ciklusa liječenja s [zaštićeni naziv] potrebno razmotriti liječenje, s posebnim osvrtom na simptome hiperplazije endometrija ili raka.
English: − if you suffer or have suffered from endometriosis and have undergone hysterectomy (removal of the womb)
Croatian: − ako patite ili ste patili od endometrioze te ste se podvrgnuli histerektomiji (uklanjanje maternice)
English: However, the metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Croatian: Međutim, metabolizam estrogena može biti povećan istodobnom uporabom tvari za koje se zna da induciraju enzime koji metaboliziraju lijek, posebice citokrom P450 enzime, kao što su antikonvulzivi (npr. fenobarbital, fenitoin, karbamazepin) i antiinfektive (npr. rifampicin, rifabutin, nevirapin, efavirenc).
English: The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.
Croatian: Djelatna tvar, sintetski 17β-estradiol, kemijski je i biološki identičan endogenom humanom estradiolu.
English: The maximum duration of treatment is 4 weeks.
Croatian: Maksimalno trajanje liječenja je 4 tjedna.
English: This may relieve discomfort in the vagina.
Croatian: To može olakšati nelagodu u rodnici.
English: Women with pre-existing hypertriglyceridaemia should be followed closely during oestrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
Croatian: Žene s postojećom hipertrigliceridemijom potrebno je pomno nadzirati tijekom estrogenske zamjenske ili hormonske zamjenske terapije s obzirom na rijetke slučajeve velikog povećanja plazmatskih razina triglicerida koji uzrokuju pankreatitis prijavljene u ovom stanju kod terapije estrogenom.
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1antitrypsin, ceruloplasmin).
Croatian: Moguć je i porast razina drugih proteina u plazmi (angiotenzinogen/supstrat renina, alfa-1-antitripsin, ceruloplazmin).
English: Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed.
Croatian: Estrogeni mogu uzrokovati retenciju tekućine i stoga je potrebno pomno nadzirati bolesnike s disfunkcijom srca ili bubrega.
English: In women with no personal history of VTE but with 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: U žena koje nemaju osobnu anamnezu VTE-a ali imaju rođake u prvom koljenu s anamnezom tromboze u mladoj dobi, može se ponuditi probir nakon pažljivog savjetovanja u vezi s njegovim ograničenjima (probirom je identificiran samo dio trombofilijskih nedostataka).
English: [invented name] belongs to a group of medicines called local Hormone Replacement Therapy (HRT).
Croatian: [Zaštićeni naziv] pripada skupini lijekova zvanih lokalna hormonska nadomjesna terapija
English: The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment.
Croatian: Preveliki rizik postaje očit u roku od nekoliko godina primjene ali se vraća na početnu vrijednost u roku od nekoliko (najviše pet) godina nakon prekida liječenja.
English: Additional cases per 1000 users over 5 years
Croatian: 1 000 korisnika tijekom 5 godina
English: Stop using [invented name] and see a doctor immediately
Croatian: Prestanite primjenjivati [zaštićeni naziv] i odmah posjetite liječnika
English: Venous thrombosis, pulmonary embolism
Croatian: Venska tromboza, plućna embolija
English: Additional cases per 1000 users
Croatian: 1 000 korisnika
English: Thus, estradiol affects transcription (RNA synthesis) and therefore stimulates the synthesis of specific proteins.
Croatian: Stoga, estradiol utječe na transkripciju (sintezu RNK) i tako stimulira sintezu specifičnih proteina.
English: Women already on chronic anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
Croatian: Žene koje se već liječe kroničnom terapijom antikoagulansima zahtijevaju pozorno razmatranje omjera koristi i rizika kod uporabe HNT-a.
English: For signs of a blood clot, see “Stop taking [invented name] and see a doctor immediately”.
Croatian: Za znakove krvnog ugruška pogledajte „Prestanite primjenjivati [zaštićeni naziv] i odmah posjetite liječnika”.
English: Women over the age of 60 years who use oestrogen-progestagen HRT are slightly more likely to develop heart disease than those not taking any HRT.
Croatian: Za žene starije od 60 godina koje koriste estrogen-progestagen HNT nešto je vjerojatnije da će razviti bolest srca nego one koje ne uzimaju HNT.
English: [invented name] should not be used in children or adolescents.
Croatian: [zaštićeni naziv] ne smije se koristiti kod djece ili adolescenata.