FrancophonIA/ELRC3.0 huggingface dataset:
English: Before you start (or restart) HRT, your doctor will ask about your own and your family's medical history.
Slovenian: Pred začetkom uporabe (ali ponovne uporabe) HNZ bo zdravnik preveril vašo osebno in družinsko zdravstveno zgodovino.
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Slovenian: Med zdravljenjem se priporočajo redni zdravstveni pregledi, katerih pogostnost in narava morata biti prilagojena vsaki ženski posebej.
English: The existing relevant text need to be modified accordingly]
Slovenian: Obstoječe besedilo je treba ustrezno spremeniti.]
English: This may relieve discomfort in the vagina.
Slovenian: To lahko ublaži neprijeten občutek v nožnici.
English: Conditions which need supervision
Slovenian: Stanja, pri katerih je potreben nadzor:
English: […] and cutaneous use in the external genital area.
Slovenian: […] in dermalna uporaba na zunanjih spolovilih.
English: Inform your doctor if any of these situations applies to you:
Slovenian: Obvestite zdravnika, če za vas velja karkoli od naslednjega:
English: - It is exactly the same as the estradiol produced by the ovaries of women.
Slovenian: - Je popolnoma enak kot estradiol, ki ga proizvajajo jajčniki pri ženskah.
English: Do not use a double dose of [invented name] to make up for a forgotten single dose.
Slovenian: Ne uporabite dvojnega odmerka zdravila [izmišljeno ime], če ste pozabili uporabiti prejšnji enkratni odmerek.
English: Route of administration: cream for vaginal use
Slovenian: Pot uporabe: krema za vaginalno uporabo
English: The results of most epidemiological studies to date relevant to inadvertent foetal exposure to oestrogens indicate no teratogenic or foetotoxic effect.
Slovenian: Izsledki večine doslej opravljenih epidemioloških študij, povezani z naključno izpostavljenostjo ploda estrogenom, ne kažejo teratogenih ali fetotoksičnih učinkov.
English: The changes to the relevant sections of the summary of product characteristics and package leaflet is the outcome of the referral procedure.
Slovenian: Spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
English: Talk to a doctor or pharmacist.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom.
English: Very rare (< 1/10,000),
Slovenian: Zelo redki (< 1/10.000)
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Slovenian: Vezava T3 na smolo je zmanjšana, kar odraža zvišanje TBG.
English: Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.
Slovenian: Klinični pregled (vključno s pregledom medenice in dojk) mora temeljiti na teh podatkih ter kontraindikacijah in opozorilih o uporabi.
English: The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.
Slovenian: Zdravilna učinkovina, sintetični 17β-estradiol, je kemično in biološko identična endogenemu človeškemu estradiolu.
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).
Slovenian: Bolnicam je treba naročiti, naj se takoj posvetujejo z zdravnikom, če opazijo možne simptome trombembolije (npr. boleče otekanje noge, nenadna bolečina v prsnem košu, dispneja).
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.
Slovenian: To relativno tveganje ni odvisno od starosti ali trajanja uporabe, ker pa je izhodiščno tveganje zelo odvisno od starosti, se celotno tveganje za možgansko kap pri ženskah, ki uporabljajo HNZ, s starostjo poveča (glejte poglavje 4.4).
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1antitrypsin, ceruloplasmin).
Slovenian: Zvišajo se lahko tudi druge beljakovine v plazmi (angiotenzinogen/substrat renina, alfa-1-antitripsin, ceruloplazmin).
English: − if you have ever developed malignant tumours which are sensitive to oestrogens
Slovenian: − če so se pri vas kadar koli pojavili maligni tumorji, ki so občutljivi za estrogene;
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]
Slovenian: [Obstoječe informacije o zdravilu je treba spremeniti (vstaviti, zamenjati ali izbrisati besedilo, kot je primerno), tako da bodo odražale odobreno besedilo, ki je navedeno spodaj.]
English: There is no evidence that HRT will prevent a heart attack.
Slovenian: Dokazov, da bi HNZ preprečilo srčno kap, ni.
English: Go for regular breast screening as recommended by your doctor.
Slovenian: Hodite na redna presejalna slikanja dojk v skladu s priporočili zdravnika.
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.
Slovenian: Če opazite vmesno krvavitev ali krvavkast izcedek, to običajno ni razlog za skrb, vendar pa se kljub temu naročite na obisk pri zdravniku.
English: - dimpling of the skin - changes in the nipple - any lumps you can see or feel
Slovenian: - udrta koža; - spremembe bradavice; - kakršne koli bule, ki jih lahko vidite ali zatipate.
English: Ovarian cancer is much rarer than breast cancer.
Slovenian: Rak jajčnikov se pojavlja veliko redkeje kot rak dojke.
English: [Invented name] , is for short-term (4 weeks) local treatment in the vagina and the absorption into the blood is lower.
Slovenian: Zdravilo [izmišljeno ime] je namenjeno za kratkotrajno (štiritedensko) lokalno zdravljenje v nožnici, absorpcija v kri pa je manjša.
English: It is not known how these risks apply to locally administered treatments such as [invented name] .
Slovenian: V kolikšni meri se ta tveganja nanašajo na zdravila za lokalno zdravljenje, kot je zdravilo [izmišljeno ime], ni znano.
English: Estradiol is the most potent natural oestrogen to act intracellularly.
Slovenian: Estradiol je najmočnejši naravni estrogen, ki deluje znotraj celic.
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.
Slovenian: V skladu z veljavnim standardnim sistemom razvrščanja kortikosteroidov za lokalno zdravljenje, po katerem se ti delijo na šibke (I), zmerno močne (II), močne (III) in zelo močne (IV), prednizolon, ki je zelo soroden naravnemu hidrokortizonu (kortizolu), spada v prvo skupino.
English: For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used.
Slovenian: Zdravljenje postmenopavzalnih simptomov je treba začeti in nadaljevati z najmanjšim učinkovitim odmerkom čim krajši čas (glejte tudi poglavje 4.4).
English: 17β-Estradiol is a well-known substance.
Slovenian: 17β-estradiol je dobro znana učinkovina.
English: HRT and cancer
Slovenian: HNZ in rak
English: Any existing section should be deleted.]
Slovenian: Morebitno obstoječe poglavje je treba izbrisati.]
English: A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Slovenian: O rahlo povečanem tveganju za raka jajčnikov so poročali pri ženskah, ki so uporabljale HNZ najmanj 5 do 10 let.
English: Therapy with [invented name] should only be administered together with clinical monitoring.
Slovenian: Zdravljenje z zdravilom [izmišljeno ime] se lahko uporablja samo skupaj s kliničnim spremljanjem.
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.
Slovenian: Zato je treba pred ponovitvijo štiritedenskega zdravljenja z zdravilom [izmišljeno ime] ponovno oceniti zdravljenje in pri tem nameniti posebno pozornost morebitnim simptomom hiperplazije ali karcinoma endometrija.
English: In addition, estradiol also has rapid, non-genomic effects (signal transduction).
Slovenian: Poleg tega ima estradiol tudi hitre negenomske učinke (prenos signalov).
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.
Slovenian: Če se odkrije trombofilična motnja, ki je povezana s trombozo pri družinskih članih, ali motnja, ki je „huda“ (npr. pomanjkanje antitrombina, proteina S ali proteina C ali kombinacija motenj), je HNZ kontraindicirano.
English: Therefore, for safety reasons the maximum duration of treatment is limited to 4 weeks.
Slovenian: Zato je zaradi varnosti najdaljši čas zdravljenja omejen na štiri tedne.
English: Insert the contents of 1 filled applicator (= 2 g cream) before bedtime.
Slovenian: Vsebino 1 napolnjenega aplikatorja (= 2 g kreme) vstavite pred spanjem.
English: For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life.
Slovenian: Hormonsko nadomestno zdravljenje postmenopavzalnih simptomov se lahko uvede samo za simptome, ki negativno vplivajo na kakovost življenja.
English: During the first week of treatment, [invented name] should be applied every other day - i.e. at 48-hourly intervals - and twice a week thereafter (maintenance dose).
Slovenian: Prvi teden zdravljenja je zdravilo [izmišljeno ime] treba dajati vsak drugi dan, kar pomeni v 48-urnih presledkih, kasneje pa dvakrat na teden (vzdrževalni odmerek).
English: − if you have skin diseases in the external genital area caused by bacterial, fungal or viral infections
Slovenian: − če imate bolezni kože na zunanjih spolovilih, ki so posledica bakterijskih, glivičnih ali virusnih okužb.
English: − You should only use [invented name] under medical supervision.
Slovenian: − Zdravilo [izmišljeno ime] lahko uporabljate samo pod zdravniškim nadzorom.
English: Risk of coronary artery disease
Slovenian: Tveganje za bolezen koronarnih arterij
English: Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed.
Slovenian: Estrogeni lahko povzročijo zastajanje tekočine, zato je treba bolnice z nepravilnim delovanjem srca ali ledvic skrbno spremljati.
English: Section 4.8 Undesirable effects [The text below should be inserted in this section.
Slovenian: Poglavje 4.8 Neželeni učinki [Besedilo v nadaljevanju je treba vstaviti v to poglavje.
English: Like all medicines, [invented name] can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo [izmišljeno ime] neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
English: Effect of HRT on heart and circulation
Slovenian: Vpliv HNZ na srce in ožilje
English: One filled applicator dose (= 2 g cream) is inserted before retiring to bed.
Slovenian: Odmerek v enem napolnjenem aplikatorju (= 2 g kreme) se vstavi pred spanjem.
English: Section 5.2 Pharmacokinetic properties [The text below should be inserted in this section.
Slovenian: Poglavje 5.2 Farmakokinetične lastnosti [Besedilo v nadaljevanju je treba vstaviti v to poglavje.
English: Oestrogens increase the number of superficial and intermediate cells and decrease the number of basal cells in vaginal smear.
Slovenian: Estrogeni povečajo število površinskih in intermediarnih celic ter zmanjšajo število bazalnih celic v nožničnem brisu.
English: In prolonged use (beyond 4 weeks), you should look out for possible systemic side effects (e.g. chest pain) and skin atrophy.
Slovenian: Pri daljši uporabi (več kot štiri tedne) morate biti pozorni na morebitne sistemske neželene učinke (npr. bolečine v prsnem košu) in atrofijo kože.
English: Interactions of [invented name] with other medicinal products were not investigated.
Slovenian: Medsebojno delovanje zdravila [izmišljeno ime] z drugimi zdravili ni bilo raziskano.
English: Endometrial safety of long-term (more than one year) or repeated use of local vaginally administered oestrogen is uncertain.
Slovenian: Varnost endometrija pri dolgotrajni (več kot enoletni) ali ponavljajoči se lokalni vaginalni uporabi estrogena je negotova.
English: Therefore, for safety reasons, you should use [invented name] no longer than 4 weeks.
Slovenian: Zato zaradi varnosti zdravila [izmišljeno ime] ne smete uporabljati več kot štiri tedne.
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.
Slovenian: V drugi študiji so bile povprečne koncentracije estradiola v serumu v skupini z zdravilom [izmišljeno ime] 6,4 pg/ml ob izhodišču in 15,1 pg/ml na 31. dan (tj. 36 ur po uporabi preiskovanega zdravila na 29. dan), v skupini s placebom pa 4,4 pg/ml oziroma 6,2 pg/ml.
English: - Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestogen combinations.
Slovenian: - Vsako povečano tveganje pri uporabnicah samo estrogenskega zdravljenja je bistveno manjše od tveganja, ki ga opažajo pri uporabnicah estrogensko-progestogenskega zdravljenja.
English: HRT, especially oestrogen-progestagen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Slovenian: HNZ, zlasti kombinirano estrogensko-progestogensko zdravljenje, povečuje gostoto na mamografskih posnetkih, kar lahko negativno vpliva na radiološko odkrivanje raka dojke.
English: Before initiating or reinstituting hormone therapy, a complete personal and family medical history should be obtained.
Slovenian: Zdravstveni pregled/spremljanje Pred uvedbo ali ponovno uvedbo hormonskega zdravljenja je treba pridobiti popolno osebno in družinsko anamnezo.
English: [invented name] may only be used with special caution, after a thorough clinical evaluation of the risks and benefits, in the following cases:
Slovenian: Zdravilo [izmišljeno ime] se lahko uporablja samo ob posebni previdnosti po temeljitem kliničnem vrednotenju razmerja med tveganji in koristmi v primeru:
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse> .
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z <zdravnikom> <ali> <,> <farmacevtom> <ali medicinsko sestro>.
English: [Invented name] should not be used for more than 4 weeks.
Slovenian: Zdravilo [izmišljeno ime] se ne sme uporabljati več kot štiri tedne.
English: Hypersensitivity skin reaction (allergic contact eczema)
Slovenian: Preobčutljivostna kožna reakcija (alergijski kontaktni ekcem)
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.
Slovenian: Pri ženskah, starejših od 60 let, ki uporabljajo estrogensko-progestogensko HNZ, obstaja nekoliko večja verjetnost za pojav bolezni srca kot pri ženskah, ki ne uporabljajo HNZ.
English: As well as its typical hormonal effects during the reproductive period, higher concentrations of estradiol also exert characteristic effects on the skin.
Slovenian: Poleg značilnih hormonskih učinkov v obdobju reprodukcije imajo večje koncentracije estradiola tudi značilne učinke na kožo.
English: [invented name] is used:
Slovenian: Zdravilo [izmišljeno ime] se uporablja:
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.
Slovenian: Če se karkoli od naštetega pri vas prvič pojavi med uporabo zdravila [izmišljeno ime], ga takoj prenehajte uporabljati in se nemudoma posvetujte z zdravnikom.
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).
Slovenian: Farmakokinetični profil zdravila [izmišljeno ime] kaže, da med zdravljenjem pride do sistemske absorpcije estradiola v koncentracijah, ki so prehodno večje od koncentracij v obdobju po menopavzi (glejte poglavje 5.2).
English: Nonclinical studies provided no additional data of relevance to clinical safety beyond those already included in other sections of the SmPC.
Slovenian: Predklinične študije niso zagotovile nobenih drugih podatkov v zvezi s klinično varnostjo, razen tistih, ki so že vključeni v druga poglavja povzetka glavnih značilnosti zdravila.
English: [invented name] is unlikely to have any effect on alertness or coordination.
Slovenian: Verjetnost, da bi zdravilo [izmišljeno ime] imelo vpliv na budnost ali koordinacijo, je majhna.
English: Estradiol conversion to estriol is irreversible.
Slovenian: Pretvorba estradiola v estriol je ireverzibilna.
English: For more information, see ‘Blood clots in a vein (thrombosis)'.
Slovenian: Za več informacij glejte „Krvni strdki v veni (tromboza)“.
English: Risk ratio and 95% CI
Slovenian: Razmerje tveganja in 95-odstotni IZ
English: Compare
Slovenian: Primerjava
English: There is no consensus about the possible role of varicose veins in VTE.
Slovenian: Mnenja o morebitni vlogi varikoznih ven pri VTE so deljena.
English: Treatment should not exceed 4 weeks.
Slovenian: Zdravljenje ne sme trajati več kot štiri tedne.
English: The steroid receptor complex is bound to the cells' DNA and induces synthesis of specific proteins.
Slovenian: Kompleks steroida in receptorja se veže na celično DNK in sproži sintezo specifičnih beljakovin.
English: Thus, estradiol affects transcription (RNA synthesis) and therefore stimulates the synthesis of specific proteins.
Slovenian: Estradiol tako vpliva na transkripcijo (sintezo RNK) in s tem spodbuja sintezo specifičnih beljakovin.
English: Similarly to other steroid hormones, estradiol acts directly on genetic information (DNA) via specific receptors.
Slovenian: Estradiol podobno kot drugi steroidni hormoni po sistemski uporabi deluje neposredno na genske informacije (DNK) prek specifičnih receptorjev.
English: How long should you go on using [invented name]?
Slovenian: Koliko časa lahko uporabljate zdravilo [izmišljeno ime]?
English: If VTE develops after initiating therapy, the drug should be discontinued.
Slovenian: Če se po uvedbi zdravljenja pojavi VTE, je treba uporabo zdravila prekiniti.
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.
Slovenian: Med splošno znanimi dejavniki tveganja za VTE so uporaba estrogenov, višja starost, večji kirurški poseg, daljša imobilizacija, debelost (ITM > 30 kg/m2), nosečnost/poporodno obdobje, sistemski eritematozni lupus in rak.
English: For signs of a blood clot, see “Stop taking [invented name] and see a doctor immediately”.
Slovenian: Za znake krvnega strdka glejte „Prenehajte uporabljati zdravilo [izmišljeno ime] in takoj obiščite zdravnika“.
English: See sction 4.2 and
Slovenian: Glejte poglavji 4.2 in 4.4.
English: During prolonged use, vigilance is required for possible systemic effects.
Slovenian: Med daljšo uporabo je potrebna pozornost zaradi možnih sistemskih učinkov.
English: As its active substance, [invented name] contains 17ß-estradiol, a natural sex hormone, at a concentration of 0.01%.
Slovenian: Zdravilo [izmišljeno ime] vsebuje zdravilno učinkovino 17ß-estradiol, ki je naravni spolni hormon, v koncentraciji 0,01 %.
English: Additional cases per 1000 users
Slovenian: Razmerje tveganja Dodatni primeri na 1.000 uporabnic
English: The occurrence of such an event is more likely in the first year of using HT (see section 4.4).
Slovenian: Pojav teh dogodkov je verjetnejši v prvem letu hormonskega zdravljenja (glejte poglavje 4.4).
English: Prolonged use of [invented name] over extensive areas may only proceed with special caution, after a thorough clinical evaluation of the risks and benefits, in cases of: - endometriosis.
Slovenian: Zdravilo [izmišljeno ime] se lahko dalj časa na večjih področjih uporablja samo ob posebni previdnosti po temeljitem kliničnem vrednotenju razmerja med tveganji in koristmi v primeru: - endometrioze.
English: The woman should be advised to contact her doctor in case bleeding or spotting occurs during treatment with [invented name].
Slovenian: Ženski je treba naročiti, naj se v primeru krvavitve ali krvavkastega izcedka med zdravljenjem z zdravilom [izmišljeno ime] posvetuje z zdravnikom.
English: − if you have any unexplained vaginal bleedings
Slovenian: - če imate kakršne koli nepojasnjene krvavitve iz nožnice;
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).
Slovenian: Tveganje za bolezen koronarnih arterij je rahlo povečano pri ženskah, starejših od 60 let, ki uporabljajo kombinirano estrogensko-progestogensko HNZ (glejte poglavje 4.4).
English: However, it returns to normal within a few years (at most 5) after stopping treatment.
Slovenian: Vendar pa se nekaj let (največ pet let) po prekinitvi zdravljenja zmanjša nazaj na običajno raven.
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).
Slovenian: Ženskam, ki v osebni anamnezi nimajo VTE, imajo pa sorodnika v prvem kolenu, ki ima v anamnezi trombozo v zgodnji starosti, se lahko predlaga presejalni pregled, potem ko se jih natančno seznani z njegovimi omejitvami (presejalni pregled odkrije le določen delež trombofiličnih motenj).
English: 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.
Slovenian: Verjetnost, da bi se pri vas pojavil krvni strdek v venah, se povečuje s starostjo, večja pa je tudi, če za vas velja karkoli od naštetega v nadaljevanju.
English: If severe upper abdominal complaints, enlarged liver or signs of intra-adominal haemorrhage occur, a liver tumour should be considered in the differential diagnosis.
Slovenian: Če se pojavijo hude težave v zgornjem delu trebuha, povečana jetra ali znaki intraabdominalne krvavitve, je treba pri diferencialni diagnozi upoštevati tudi možnost tumorja jeter.
English: It is used to relieve menopausal symptoms in the vagina such as dryness or irritation.
Slovenian: Uporablja se za lajšanje menopavzalnih simptomov v nožnici, kot sta suhost in draženje.
English: As well as its typical hormonal effects during the reproductive period, estradiol also exerts characteristic effects on the skin.
Slovenian: Poleg značilnih hormonskih učinkov v obdobju reprodukcije ima tudi značilne učinke na kožo.
English: Blood clots in a vein (thrombosis)
Slovenian: Krvni strdki v veni (tromboza)
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sexhormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Slovenian: Zvišane so lahko še druge vezavne beljakovine v serumu, tj. vezavni globulin za kortikoide (CBG - corticoid binding globulin) in vezavni globulin za spolne hormone (SHBG - sex-hormone-binding globulin), kar povzroči zvišanje kortikosteroidov oziroma spolnih steroidov v obtoku.
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.
Slovenian: Nekateri izsledki preskušanja WHI kažejo na povečano tveganje za morebitno demenco pri ženskah, ki začnejo uporabljati kontinuirano kombinirano ali samo estrogensko HNZ po 65. letu starosti.