FrancophonIA/ELRC3.0 huggingface dataset:
English: Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
Slovenian: Ritonavir in nelfinavir, ki sta sicer znana kot močna zaviralca, pri sočasni uporabi s steroidnimi hormoni delujeta ravno nasprotno, in sicer kot induktorja.
English: [invented name] should not be used in the following cases:
Slovenian: Zdravilo [izmišljeno ime] se ne sme uporabljati v primeru:
English: [invented name] belongs to a group of medicines called local Hormone Replacement Therapy (HRT).
Slovenian: Zdravilo [izmišljeno ime] spada v skupino zdravil, ki jih imenujemo zdravila za lokalno hormonsko nadomestno zdravljenje (HNZ).
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.
Slovenian: Povečano tveganje se pokaže po nekaj letih uporabe, vendar se v nekaj (največ petih) letih po koncu zdravljenja vrne na izhodiščno raven.
English: [Invented name] should not be used immediately prior to sexual intercourse or as a lubricant, in order to avoid possible undesirable effects in the partner.
Slovenian: Zdravilo [izmišljeno ime] se ne sme uporabljati tik pred spolnim odnosom ali namesto lubrikanta, da se prepreči možne neželene učinke pri partnerju.
English: Over 95% of estriol is excreted in the urine, mainly in the form of glucuronides.
Slovenian: Več kot 95 % estriola se izloči z urinom,
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).
Slovenian: Ni znano, ali bi daljše zdravljenje ali ponavljajoče se zdravljenje lahko povzročilo odebelitev maternične sluznice (hiperplazijo endometrija) in raka maternice (raka endometrija).
English: It is therefore less likely that the conditions mentioned below will get worse or come back during treatment with [invented name].
Slovenian: Zato je manj verjetno, da se bodo med zdravljenjem z zdravilom [izmišljeno ime] poslabšala ali ponovno pojavila naslednja stanja:
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
Slovenian: − če imate benigni ali maligni tumor, občutljiv za estrogene, kot so na primer fibroidi v maternici ali rak maternične sluznice, ali če obstaja sum, da ga imate;
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.
Slovenian: opazovalnih študijah so večinoma poročali o majhnem povečanju tveganja za diagnosticiranje raka dojke, ki je znatno manjše kot pri ženskah, ki uporabljajo estrogenskoprogestogenske kombinacije.
English: Part A. - 0.01% w/w estradiol containing medicinal products for topical use(as per Annex I)
Slovenian: Del A. - Zdravila za lokalno uporabo, ki vsebujejo 0,01 % m/m estradiola (navedena v Prilogi I)
English: Vigilance is required for possible systemic effects.
Slovenian: Potrebna je pozornost zaradi možnih sistemskih učinkov.
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.
Slovenian: Ženske, ki imajo hipertrigliceridemijo, je treba med nadomeščanjem estrogenov ali hormonskim nadomestnim zdravljenjem skrbno spremljati, saj so pri estrogenskem zdravljenju žensk s to motnjo poročali o redkih primerih velikega zvišanja trigliceridov v plazmi, ki je povzročilo pankreatitis.
English: Please talk to your doctor.
Slovenian: Posvetujte se z zdravnikom.
English: − if you have an untreated endometrial hyperplasia (i.e. thickening of the lining of the womb)
Slovenian: − če imate nezdravljeno hiperplazijo endometrija (tj. zadebeljeno maternično sluznico);
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.
Slovenian: Ne uporabljajte zdravila [izmišljeno ime], če uporabljate druga zdravila za HNZ, kot na primer estrogen v obliki tablet, obližev ali gela za zdravljenje vročinskih oblivov ali preprečevanje osteoporoze.
English: As an active substance, [invented name] contains 17ß-estradiol (0.005%).
Slovenian: Zdravilo [izmišljeno ime] vsebuje zdravilno učinkovino 17ß-estradiol (0,005 %).
English: At around ≥ 0.01% topically or systemically, estradiol widens the capillary vessels and promotes general blood perfusion.
Slovenian: V koncentraciji približno ≥ 0,01 % pri lokalni ali sistemski uporabi razširi kapilare in spodbuja splošno perfuzijo krvi.
English: Venous thrombosis, pulmonary embolism
Slovenian: Žilne bolezni venska tromboza, pljučna embolija
English: Ovarian cancer is rare.
Slovenian: Rak jajčnikov Rak jajčnikov se pojavi redko.
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.
Slovenian: Zdravnik bo presodil, kako dolgo morate uporabljati kremo in ali je potrebno nadaljnje zdravljenje z visokoodmerno kremo estradiola, ki ne vsebuje kortikosteroidov, ali s kremo, ki ne vsebuje zdravilnih učinkovin.
English: Intolerance to contact lenses
Slovenian: Očesne bolezni intoleranca za kontaktne leče
English: [Invented name] should not be used in patients who are treated with systemic Hormone Replacement Therapy (HRT).
Slovenian: Zdravilo [izmišljeno ime] se ne sme uporabljati pri bolnicah, ki se zdravijo s sistemskim hormonskim nadomestnih zdravljenjem (HNZ).
English: When applied vaginally, estradiol is absorbed from the vaginal epithelium and enters the bloodstream in concentrations which are transiently above the postmenopausal range.
Slovenian: Po vaginalni uporabi se estradiol absorbira iz epitelija nožnice in preide v krvni obtok v koncentracijah, ki so prehodno večje od tistih, ki so običajne po menopavzi.
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.
Slovenian: Bodite posebno previdni, kadar zdravilo [izmišljeno ime] uporabljate skupaj z izdelki iz lateksa (kot so npr. kondomi, diafragme), saj vsebuje pomožne snovi (druge sestavine, zlasti stearate), ki lahko zmanjšajo funkcionalnost teh izdelkov ter s tem njihovo zanesljivost.
English: Stop using [invented name] and see a doctor immediately
Slovenian: Prenehajte uporabljati zdravilo [izmišljeno ime] in takoj obiščite zdravnika:
English: It is uncertain whether long term (more than one year) or repeated use of local vaginally administered oestrogen products possess a similar risk.
Slovenian: Ni gotovo, ali je pri dolgotrajni (več kot enoletni) oziroma ponavljajoči se lokalni uporabi estrogenskih zdravil v nožnici tveganje podobno.
English: Part B. - 0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products
Slovenian: Del B. - Zdravila, ki vsebujejo 0,005 % m/m estradiola/0,4 % m/m prednizolona
English: Women with an intact uterus with abnormal bleeding of unknown aetiology or women with an intact uterus who have previously been treated with unopposed oestrogens should be examined with special care in order to exclude hyperstimulation/malignancy of the endometrium before initiation of treatment with [invented name]
Slovenian: Ženske z ohranjeno maternico, ki imajo etiološko nepojasnjeno nenormalno krvavitev, in ženske z ohranjeno maternico, ki so bile predhodno zdravljene z neoponiranimi estrogeni, je treba posebno skrbno pregledati, da se pred začetkom zdravljenja z zdravilom [izmišljeno ime] izključi morebitna hiperstimulacija ali malignom endometrija.
English: [invented name] should not be used in children or adolescents.
Slovenian: Zdravilo [izmišljeno ime] se ne sme uporabljati pri otrocih in mladostnikih.
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.
Slovenian: Pred začetkom uporabe zdravila obvestite zdravnika, če imate ali ste kdaj imeli karkoli od naštetega spodaj.
English: If you get breakthrough bleeding or spotting, you should stop using [invented name].
Slovenian: Če opazite vmesno krvavitev ali krvavkast izcedek, prenehajte uporabljati zdravilo [izmišljeno ime].
English: Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk.
Slovenian: Bolnice z znanimi trombofiličnimi stanji imajo večje tveganje za VTE, ki ga lahko HNZ še dodatno poveča.
English: If symptoms persist beyond 4 weeks, alternative therapies should be considered.
Slovenian: Če simptomi atrofije nožnice po štirih tednih ne izginejo, je treba razmisliti o drugih možnostih zdravljenja.
English: Section 4.7 Effects on ability to drive and use machines [The text below should be inserted in this section and the existing text should be deleted]
Slovenian: Poglavje 4.7 Vpliv na sposobnost vožnje in upravljanja strojev [Besedilo v nadaljevanju je treba vstaviti v to poglavje, obstoječe besedilo pa izbrisati.]
English: Always use [invented name] exactly according to the instructions given in this leaflet.
Slovenian: Pri uporabi zdravila [izmišljeno ime] natančno upoštevajte napotke v tem navodilu.
English: If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Slovenian: Če se kadar koli med zdravljenjem pojavi krvavitev ali krvavkast izcedek, je treba poiskati vzrok s preiskavami, ki lahko vključujejo tudi biopsijo endometrija za izključitev malignih sprememb endometrija.
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.
Slovenian: Zdravnik bo presodil, kako dolgo naj traja zdravljenje in ali je potrebno nadaljnje zdravljenje z visokoodmerno kremo estradiola, ki ne vsebuje kortikosteroidov, ali s kremo brez zdravilnih učinkovin.
English: Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer.
Slovenian: Dolgotrajna uporaba (vsaj 5 do 10 let) zdravil za HNZ, ki vsebujejo samo estrogen, je bila povezana z rahlo povečanim tveganjem za raka jajčnikov.
English: Endometrial hyperplasia and carcinoma
Slovenian: Hiperplazija in karcinom endometrija
English: Cream [invented name] is used in women for the treatment of atrophic vulva disorders attributable to oestrogen deficiency and for Lichen sclerosus (long-term itchy skin signs) on external genitals.
Slovenian: Krema [izmišljeno ime] se uporablja pri ženskah za zdravljenje atrofičnih sprememb nožnice, ki so posledica pomanjkanja estrogena, ter za lichen sclerosus (dolgotrajne srbeče spremembe na koži) na zunanjih spolovilih.
English: In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.
Slovenian: V študiji Million Women Study je bilo petletno HNZ povezano z enim dodatnim primerom na 2.500 žensk, ki so uporabljale HNZ.
English: [invented name] should be applied with an applicator.
Slovenian: Zdravilo [izmišljeno ime] je treba dajati z aplikatorjem.
English: Additional cases per 1000 HRT user 5 years (95% CI)
Slovenian: Dodatni primeri na 1.000 uporabnic HNZ v 5 letih (95odstotni IZ)
English: − if you are known to be allergic (hypersensitive) to oestradiol, prednisolone, cetyl stearyl alcohol or any of the other ingredients of [invented name]
Slovenian: − če veste, da ste alergični na (preobčutljivi za) estradiol, prednizolon, cetil in stearilalkohol ali katero koli drugo sestavino zdravila [izmišljeno ime];
English: Vigilance is required for possible systemic side effects and skin atrophy.
Slovenian: Potrebna je pozornost zaradi možnih sistemskih neželenih učinkov in atrofije kože.
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.
Slovenian: - če ne morete hoditi dalj časa, ker ste imeli večji kirurški poseg, poškodbo ali bolezen; - če imate izrazito preveliko telesno maso (ITM > 30 kg/m - če imate katero koli motnjo strjevanja krvi, ki zahteva dolgotrajno zdravljenje z zdravilom, ki se uporablja za preprečevanje krvnih strdkov; - če je kdo od vaših bližnjih sorodnikov kdaj imel krvni strdek v nogi, pljučih ali drugem organu;
English: No studies have been performed on the dermal absorption of oestradiol within the external female genital area from [invented name].
Slovenian: Študije o dermalni absorpciji estradiola iz zdravila [izmišljeno ime] na predelu zunanjih ženskih spolovil niso bile izvedene.
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.
Slovenian: Pri ženskah, ki so jim odstranili maternico in uporabljajo samo estrogensko zdravljenje, se tveganje za pojav bolezni srca ne poveča.
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]
Slovenian: Poglavje 4.4 Posebna opozorila in previdnostni ukrepi [Celotno obstoječe besedilo v tem poglavju je treba izbrisati in ga nadomestiti s spodnjim besedilom.]
English: If pregnancy occurs during medication with [invented name], treatment should be withdrawn immediately.
Slovenian: Če ženska med uporabo zdravila [izmišljeno ime] zanosi, je treba zdravljenje takoj prekiniti.
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.
Slovenian: Če se pojavijo nepričakovane genitalne krvavitve, je treba prekiniti zdravljenje in raziskati vzrok s preiskavami, ki lahko vključujejo vaginalni ultrazvok in biopsijo endometrija, da se izključijo hiperplazija endometrija in maligne spremembe.
English: These may be signs of a liver disease - A large rise in your blood pressure (symptoms may be headache, tiredness, dizziness) - Any of the conditions mentioned in the ‘Do not use [invented name] ' section
Slovenian: - zelo povišan krvni tlak (simptomi so lahko glavobol, utrujenost in omotica); - katero koli stanje, navedeno v poglavju „Ne uporabljajte zdravila [izmišljeno ime]“;
English: Other conditions
Slovenian: Druga stanja
English: The risk of haemorrhagic stroke is not increased during use of HRT.
Slovenian: Tveganje za hemoragično možgansko kap se med HNZ ne poveča.
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).
Slovenian: začasno prekiniti, dokler vzrok za krvavitev ni pojasnjen (glejte poglavje 4.4 o varnosti endometrija).
English: Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).
Slovenian: Cetil in stearilalkohol lahko povzroči lokalno draženje kože (npr. kontaktni dermatitis).
English: Changes in libido, mood disturbances
Slovenian: Duševne motnje depresija spremembe libida, motnje razpoloženja
English: However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT increase with age.
Slovenian: Ker pa je izhodiščno tveganje za možgansko kap močno odvisno od starosti, se celotno tveganje za možgansko kap pri uporabnicah HNZ s starostjo povečuje.
English: The following information applies, unless you have been prescribed [invented name] otherwise by your doctor.
Slovenian: Navodila za odmerjanje ter način in trajanje uporabe Naslednje informacije morate upoštevati, razen če vam je zdravnik zdravilo [izmišljeno ime] predpisal drugače.
English: Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women.
Slovenian: Zdravljenje atrofije nožnice zaradi pomanjkanja estrogena pri ženskah po menopavzi.
English: Oestrogens stimulate epithelial cell proliferation in the genital area and urinary tract, as well as increasing collagen synthesis in the skin.
Slovenian: Estrogeni spodbujajo proliferacijo epitelijskih celic v predelu spolovil in sečil ter povečajo sintezo kolagena v koži.
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.
Slovenian: Pri ženskah, ki uporabljajo sistemsko zdravljenje samo z estrogeni, so poročali o 2- do 12-krat večjem tveganju za raka endometrija v primerjavi z ženskami, ki ne uporabljajo HNZ, odvisno od trajanja zdravljenja in odmerka estrogena.
English: Post-marketing experience The following undesirable effects related to [invented name] have been reported:
Slovenian: Pri uporabi zdravila [izmišljeno ime] so poročali o naslednjih neželenih učinkih:
English: Estradiol is rapidly metabolised in the liver and intestinal tract to estrone and subsequently to estriol.
Slovenian: Estradiol se hitro presnavlja v jetrih in črevesju, kjer se pretvori v estron ter nato v estriol.
English: Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis.
Slovenian: Stimulacija z neoponiranimi estrogeni lahko povzroči predmaligno ali maligno spremembo rezidualnih žarišč endometrioze.
English: If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
Slovenian: Bolnico je treba skrbno nadzirati, če je katero koli stanje, navedeno v nadaljevanju, trenutno prisotno ali pa se je pojavilo v preteklosti in/ali se je poslabšalo med nosečnostjo ali predhodnim hormonskim zdravljenjem.
English: Its use beyond 4 weeks is not recommended.
Slovenian: Uporaba, daljša od štirih tednov, ni priporočljiva.
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.
Slovenian: Pri ženskah, ki so jim odstranili maternico in ki uporabljajo samo estrogensko HNZ v obdobju petih let, se tveganje za raka dojke samo rahlo poveča ali pa se sploh ne.
English: [invented name] (approximately 1 cm of cream) is thinly applied once daily with the fingers onto diseased skin areas of the external female genital area and then gently rubbed in.
Slovenian: Zdravilo [izmišljeno ime] (približno 1 cm kreme) je treba enkrat na dan s prsti na tanko nanesti na prizadete predele kože na zunanjih ženskih spolovilih in ga nato nežno vtreti v kožo.
English: The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogen-progestagen and possibly also oestrogen-only HRT, that is dependent on the duration of taking HRT.
Slovenian: Na splošno dokazi kažejo na povečano tveganje za raka dojke pri ženskah, ki uporabljajo kombinirano estrogensko-progestogensko HNZ in morda tudi samo estrogensko HNZ, pri čemer je tveganje odvisno od trajanja HNZ.
English: Clinically, an increased metabolism of oestrogens may lead to decreased effect and changes in the uterine bleeding profile.
Slovenian: Klinično lahko pospešena presnova estrogenov zmanjša učinek in povzroči spremembe v materničnih krvavitvah.
English: - Pregnancy
Slovenian: - nosečnost.
English: [invented name] works by replacing the oestrogen which is normally produced in the ovaries of women.
Slovenian: Zdravilo [izmišljeno ime] deluje tako, da nadomesti estrogen, ki sicer nastaja v ženskih jajčnikih.
English: [invented name] is a cream for vaginal use which contains estradiol
Slovenian: Zdravilo [izmišljeno ime] je krema za vaginalno uporabo, ki vsebuje estradiol.
English: Coronary artery disease (CAD)
Slovenian: Bolezen koronarnih arterij (BKA)
English: For the initial short-term external treatment of acute, mild, inflamed, burning and itching skin diseases of the external female genital area for which weak acting corticosteroids and estradiol are indicated, in postmenopausal patients.
Slovenian: Za začetno kratkotrajno zunanje zdravljenje akutnih, blagih, vnetnih, pekočih in srbečih kožnih bolezni ženskih zunanjih spolovil, za katere so indicirani šibki kortikosteroidi in estradiol, pri bolnicah po menopavzi.
English: [Invented name] should not be used during breastfeeding.
Slovenian: Zdravilo [izmišljeno ime] se ne sme uporabljati med dojenjem.
English: HRT is associated with a 1.3-3 fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Slovenian: HNZ je povezano z 1,3- do 3-krat večjim relativnim tveganjem za pojav venske trombembolije (VTE), tj. globoke venske tromboze ali pljučne embolije.
English: Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Slovenian: Čezmerno zadebeljena maternična sluznica (hiperplazija endometrija) in rak maternične sluznice (rak endometrija)
English: [invented name] is a cream containing estradiol for vaginal use.
Slovenian: Zdravilo [izmišljeno ime] je krema, ki vsebuje estradiol, za vaginalno uporabo.
English: For the initial short-term external treatment of acute, mild, inflamed, burning and itching skin diseases of the external female genital area for which weak acting corticosteroids and estradiol are indicated, in women beyond menopause.
Slovenian: Za začetno kratkotrajno zunanje zdravljenje akutnih, blagih, vnetnih, pekočih in srbečih kožnih bolezni ženskih zunanjih spolovil, za katere se uporabljajo šibki kortikosteroidi in estradiol, pri ženskah po menopavzi.
English: Taking oestrogen-only HRT tablets for a long time can increase the risk of developing cancer of the womb lining (the endometrium).
Slovenian: Dolgotrajno jemanje tablet za HNZ, ki vsebujejo samo estrogen, lahko poveča tveganje za razvoj raka maternične sluznice (endometrija).
English: [invented name] should not be applied intravaginally or on other parts of the internal genital area.
Slovenian: Zdravilo [izmišljeno ime] se ne sme nanašati v nožnico ali na druge predele notranjih spolovil.
English: Section 6.5 Nature and contents of container [The text below should be deleted from this section]
Slovenian: Poglavje 6.5 Vrsta ovojnine in vsebina [Besedilo v nadaljevanju je treba izbrisati iz tega poglavja.]
English: If you stop using [invented name]
Slovenian: Če ste prenehali uporabljati zdravilo [izmišljeno ime]
English: Herbal preparations containing St John's Wort (Hypericum Perforatum) may induce the metabolism of oestrogens.
Slovenian: Pripravki rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), lahko inducirajo presnovo estrogenov.
English: HRT is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Slovenian: HNZ je povezano z 1,3- do 3-krat večjim tveganjem za pojav venske trombembolije (VTE), tj. globoke venske tromboze ali pljučne embolije.
English: US WHI studies - additional risk of breast cancer after 5 years' use Age range (years)
Slovenian: Študije US WHI - dodatno tveganje za raka dojke po petletni uporabi Razpon starosti (leta)