FrancophonIA/ELRC3.0 huggingface dataset:
English: If you stop taking Activelle
Slovenian: Če ste prenehali jemati zdravilo Activelle
English: b. Duration-dependency of the proliferative effect of unopposed oestrogens
Slovenian: b. Časovna odvisnost proliferativnega učinka estrogenov, ki niso modificirani z učinki progestogena
English: HOW TO USE ACTIVELLE
Slovenian: KAKO JEMATI ZDRAVILO ACTIVELLE
English: • Go for regular breast screening (mammography) and cervical smear tests.
Slovenian: • na redna presejalna slikanja dojk (mamografijo) in brise materničnega vratu.
English: • If you are bed-ridden for a longer period through surgery, injury or illness
Slovenian: • ste zaradi operacije, poškodbe ali bolezni za daljši čas priklenjeni na posteljo,
English: • Migraine or (severe) headache
Slovenian: • migrena ali (hud) glavobol,
English: It is intended for once daily administration to postmenopausal women with an intact uterus.
Slovenian: Zdravilo je namenjeno za uporabo enkrat dnevno pri ženskah v postmenopavzi, ki imajo neokrnjeno maternico.
English: • If any of your close family has had blood clots
Slovenian: • je imel krvne strdke kdo od vaših najbližjih sorodnikov,
English: • If you have a kidney or heart disorder
Slovenian: • če imate kakšno bolezen ledvic ali srca,
English: At doses higher than normally used in OC and HRT formulations masculinisation of female foetuses was observed.
Slovenian: Ob odmerkih, večjih od tistih, ki se ponavadi uporabljajo v pripravkih za peroralno kontracepcijo in HNZ, so opažali maskulinizacijo ženskih plodov.
English: LIST OF EXCIPIENTS Activelle contains lactose.
Slovenian: Zdravilo Activelle vsebuje laktozo.
English: An overdose of Activelle could make you feel sick or vomit.
Slovenian: Preveliko odmerjanje zdravila Activelle lahko povzroči slabost v želodcu ali bruhanje.
English: Denmark - Activelle low filmovertrukne tabletter
Slovenian: Danska - Activelle low filmovertrukne tabletter
English: It is unknown whether the findings apply to younger postmenopausal women or other HRT products.
Slovenian: Ni znano, ali to velja tudi za mlajše ženske po menopavzi oz. za druga zdravila za HNZ.
English: • A history of endometrial hyperplasia (see below)
Slovenian: • anamneza hiperplazije endometrija (glejte spodaj),
English: Activelle is a continuous combined HRT product containing 17β-estradiol and norethisterone acetate with the intent of avoiding the regular withdrawal bleeding associated with cyclic or sequential HRT.
Slovenian: Vsebujejo 17β-estradiol in noretisteronacetat z namenom, da bi preprečili redne odtegnitvene krvavitve, ki spremljajo ciklično ali sekvenčno HNZ.
English: • Liver disorders (e.g. liver adenoma)
Slovenian: • bolezni jeter (npr. adenom jeter),
English: Personal or strong family history of thromboembolism, or recurrent spontaneous abortion, should be investigated in order to exclude a thrombophilic predisposition.
Slovenian: Za izključitev trombofilnega nagnjenja je treba preveriti osebno ali potrjeno družinsko anamnezo trombembolij ali ponavljajočih se spontanih splavov.
English: From a clinical study there is some evidence for an increased risk of dementia among women older than 65 years, who started using another type of oestrogen/progestagen combination than the one in Activelle.
Slovenian: Izsledki ene klinične študije so nakazali večje tveganje za demenco pri ženskah, ki so začele po 65. letu uporabljati neko drugo estrogensko-progestagensko kombinacijo, ne zdravila Activelle.
English: It is a lower strength with a lower oestrogen/progestogen ratio than the currently approved Activelle, which contains 1 mg E2 and 0.5 mg NETA.
Slovenian: Zdravilo ima manjšo jakost in manjše razmerje estrogena/progestogena kot trenutno odobrena oblika zdravila Activelle, ki vsebuje 1 mg E2 in 0,5 mg NETA.
English: The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to oestrogen-progestagen combined HRT (CEE + MPA) per 10,000 women years.
Slovenian: • med 18 in 20 (najboljša ocena = 19) za 10-letno uporabo V preskušanju WHI so ocenili, da bi bilo po 5,6-letnem spremljanju žensk v starosti od 50 do 79 let zaradi kombiniranega estrogensko-progestagenskega HNZ (KEE + MPA) dodatnih 8 primerov invazivnega raka na dojki na 10.000 žensk-let.
English: • If your blood pressure goes up while you're taking Activelle
Slovenian: • se vam med jemanjem zdravila Activelle zviša krvni tlak,
English: • Leiomyoma (uterine fibroids) or endometriosis
Slovenian: • leiomiomi (maternični miomi) ali endometrioza,
English: Gall bladder disease Gall bladder disease has been reported after treatment with oestrogen/progestagen.
Slovenian: Bolezen žolčnika Po zdravljenju z estrogeni/progestageni je opisana bolezen žolčnika.
English: • Excessive growth of the womb lining (endometrial hyperplasia)
Slovenian: • čezmerna rast maternične sluznice (hiperplazija endometrija)
English: Endometrial cancer:
Slovenian: Rak na endometriju
English: Long-term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies.
Slovenian: V nekaterih epidemioloških študijah je bila dolgotrajna (vsaj 5- do 10-letna) uporaba zdravil za HNZ, ki vsebujejo samo estrogen, pri histerektomiranih ženskah povezana z večjim tveganjem za raka na jajčniku.
English: 6.5 Nature and contents of container 1 x 28 tablets or 3 x 28 tablets in calendar dial packs.
Slovenian: Škatla z 1 x 28 tablet ali 3 x 28 tablet v koledarskem pakiranju.
English: • Hypertension
Slovenian: • hipertenzija,
English: • High blood pressure
Slovenian: • visok krvni tlak,
English: The WHI trial reported a risk estimate of 1.24 (95%CI 1.01 - 1.54) after 5.6 years of use of oestrogenprogestagen combined HRT (CEE + MPA) in all users compared with placebo.
Slovenian: V primerjavi s placebom je bilo ocenjeno tveganje po 5,6 leta kombiniranega estrogenskoprogesteronskega HNZ (KEE + MPA) v preskušanju WHI pri vseh uporabnicah 1,24 (95 % IZ 1,01
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Izpolni država članica]
English: There is only limited experience of treating women older than 65 years with Activelle.
Slovenian: Pri ženskah po 65. letu je z zdravilom Activelle le malo izkušenj.
English: Metabolism of 17β-estradiol, occurs mainly in the liver and gut but also in target organs, and involves the formation of less active or inactive metabolites, including estrone, catecholestrogens and several oestrogen sulphates and glucuronides.
Slovenian: Presnova vključuje nastanek manj aktivnih ali neaktivnih presnovkov, med njimi estrona, kateholestrogenov ter več estrogenskih sulfatov in glukuronidov.
English: • Weight gain caused by fluid retention
Slovenian: • povečanje telesne mase zaradi zastajanja tekočine
English: Based on several other studies of various doses of 1) unopposed oestrogens, 2) oestrogen-progestogen sequential combinations and 3) oestrogen-progestogen continuous combinations, the CHMP considered it reasonable and scientifically acceptable to extrapolate that this low dose continuous oestrogen-progestogen combination would result in a considerably lower rate of endometrial hyperplasia than seen with a combination containing twice the oestrogen dose.
Slovenian: Večina članov CHMP je bila mnenja, da je predlagatelj/imetnik dovoljenja za promet z zdravilom primerno utemeljil razlog, zakaj ni izvedel biopsijske endometrijske študije o natančnih odmerkih, kar pa ni bilo narejeno za zdravilo Activelle 0,5 mg/0,1 mg. Na osnovi nekaterih drugih študij z različnimi odmerki 1) estrogenov, ki niso modificirani z učinki progestogena, 2) sekvenčne kombinacije estrogena in progestogena ter 3) kontinuirane kombinacije estrogena in progestogena, je bil CHMP mnenja, da je smiselno in znanstveno sprejemljivo z ekstrapolacijo pokazati, da bo ta nizek odmerek kontinuirane kombinacije estrogena in progestogena povzročil nižjo stopnjo hiperplazije endometrija kot kombinacija, ki vsebuje dvakratni odmerek estrogena.
English: Activelle 0.5 mg/0.1 mg is a continuous combined hormone replacement therapy (HRT) product containing 0.5 mg estradiol (E2) and 0.1 mg norethisterone acetate (NETA).
Slovenian: Activelle 0,5 mg/0,1 mg je zdravilo, ki se uporablja za kontinuirano kombinirano hormonsko nadomestno zdravljenje (HNZ) in vsebuje 0,5 mg estradiola (E2) ter 0,1 mg noretisteron acetata (NETA).
English: Additional data on effects of continuous oestrogen -progestogen combined products on emdometrial hyperplasia.
Slovenian: Dodatni podatki o učinkih zdravil za kontinuirano zdravljenje s kombinacijo estrogena in progestogena na endometrijsko hiperplazijo.
English: • Painful swelling in your leg
Slovenian: • boleča oteklina na nogi,
English: Depression or depression aggravated
Slovenian: Psihiatrične motnje depresija ali poslabšanje depresije živčnost
English: Treatment with unopposed oestrogens for long periods of time also increases the risk of cancer of the lining of the womb (endometrial cancer).
Slovenian: Dolgotrajno zdravljenje samo z estrogeni lahko poveča tveganje za raka na maternični sluznici (raka na endometriju).
English: Pharmaceutical Form
Slovenian: FARMACEVTSKA OBLIKA
English: Excipient: Each film-coated tablet contains lactose monohydrate 37.5 mg. For a full list of excipients, see section 6.1.
Slovenian: Pomožna snov: ena filmsko obložena tableta vsebuje 37,5 mg laktoze monohidrata.
English: For oestrogen plus progestagen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with oestrogens alone.
Slovenian: Več epidemioloških študij je pri kombiniranem HNZ z estrogenom in progestagenom pokazalo večje celotno tveganje za raka na dojki kot pri uporabi estrogenov samih.
English: • Oestrogen-dependent neoplasms benign and malignant, e.g. endometrial cancer
Slovenian: • estrogensko odvisne benigne in maligne neoplazme, npr. rak na endometriju ,
English: However, some CHMP members considered that even if the observed hyperplasia incidence with the new dose E2 0.5 mg/NETA 0.1 mg should be lower than that observed with the E2 1mg/NETA 0.1mg combination, it is not unequivocally demonstrated that it will be in an acceptable range regarding the European guideline.
Slovenian: Kljub temu so bili nekateri člani CHMP mnenja, da ni mogoče nedvoumno dokazati, da bo opazovana pojavnost hiperplazije v sprejemljivem razponu glede na evropske smernice, kljub temu, da bi nov odmerek E2 0,5 mg/NETA 0,1 mg moral imeti manjši učinek na pojavnost hiperplazije kot tisti, ki so ga opazili pri kombinaciji E2 1 mg/NETA 0,1 mg.
English: Activelle 0.5 mg/0.1 mg is a continuous combined HRT that contains the half dose of estradiol (E2) and the fifth of the dose of norethisterone acetate (NETA) that in the known fixed combination Activelle (E2 1 mg/NETA 0.5 mg).
Slovenian: Zdravilo Activelle 0,5 mg/0,1 mg se uporablja za kontinuirano kombinirano HNZ, vsebuje pa polovico odmerka estradiola (E2) in petino odmerka noretisteron acetata (NETA) iz stare fiksne kombinacije zdravila Activelle (E2 1 mg/NETA 0,5 mg).
English: Lactose monohydrate Maize starch Hydroxypropylcellulose Talc
Slovenian: Jedro tablete: laktoza monohidrat koruzni škrob hidroksipropilceluloza smukec magnezijev stearat
English: The risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods (see section 4.8).
Slovenian: Med dolgotrajno uporabo samih estrogenov se poveča tveganje za hiperplazijo endometrija in karcinom na njem (glejte poglavje 4.8).
English: • Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users (For further information, see sections 4.3 and 4.4)
Slovenian: • venska trombembolija (tj. globoka venska tromboza nog ali medenice in pljučna embolija) je bila pogostejša pri uporabnicah hormonskega nadomestnega zdravljenja kot pri neuporabnicah
English: • Breast pain or breast discomfort
Slovenian: • bolečine v dojkah ali nelagodje v dojkah
English: What Activelle contains
Slovenian: Kaj vsebuje zdravilo Activelle
English: Breast pain Breast discomfort
Slovenian: Bolezni prebavil bolečine v trebuhu navzeja napihnjenost trebuha dispepsija
English: Overdose may be manifested by nausea and vomiting.
Slovenian: Preveliko odmerjanje se lahko kaže z navzejo in bruhanjem.
English: It is estimated that in healthy women who use HRT for 5 years, the number of additional cases of VTE over a 5 year period will be between 2 and 6 (best estimate =4) per 1000 women aged 50-59 years and between 5 and 15 (best estimate =9) per 1000 women aged 60-69 years.
Slovenian: Ocenjeno število dodatnih primerov VTE pri zdravih ženskah, ki HNZ uporabljajo 5 let, je v 5-letnem obdobju med 2 in 6 (najboljša ocena = 4) na 1.000 žensk v starostni skupini od 50 do 59 let in med 5 in 15 (najboljša ocena = 9) na 1.000 žensk v starostni skupini od 60 do 69 let.
English: • Jaundice or deterioration in liver function
Slovenian: • zlatenice ali poslabšanja delovanja jeter,
English: It is estimated that for women who use conjugated oestrogens and MPA for 5 years, the number of additional cases will be between 0 and 3 (best estimate = 1) per 1000 users aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 users aged 60-69 years.
Slovenian: Ocenjeno število dodatnih primerov pri ženskah, ki uporabljajo konjugirane estrogene in MPA 5 let, je med 0 in 3 (najboljša ocena = 1) na 1.000 uporabnic v starostni skupini od 50 do 59 let in med 1 in 9 (najboljša ocena = 4) na 1.000 uporabnic v starostni skupini od 60 do 69 let.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolni država članica]
English: Detailed information on this medicinal product is available on the website of:{name of MS/Agency}[PIQ-QRD1]
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani {Ime države članice/Agencije}
English: The tablets are imprinted NOVO 291 on one side and the Novo Nordisk logo (an Apis bull) on the other side.
Slovenian: Filmsko obložene tablete so bele, okrogle, s premerom 6 mm. Tablete imajo na eni strani vtisnjen napis NOVO 291, na drugi strani pa logotip družbe Novo Nordisk (bika Apisa).
English: Hypromellose Triacetin Talc
Slovenian: Filmska obloga: hipromeloza triacetin smukec
English: In this leaflet:
Slovenian: Ob upoštevanju, da:
English: • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Slovenian: • Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: • Skin and subcutaneous tissue disorder: Seborrhoea, rash, angioneurotic oedema
Slovenian: • Bolezni kože in podkožja: diseboreja, izpuščaj, angionevrotični edem
English: The most frequently reported adverse reaction in the clinical trial with Activelle was vaginal bleeding.
Slovenian: V kliničnem preskušanju zdravila Activelle je bila krvavitev iz nožnice najpogosteje opisan neželeni učinek.
English: The addition of a progestagen reduces, but does not completely eliminate, the oestrogen-induced risk of endometrial hyperplasia in nonhysterectomised women.
Slovenian: Dodatek progestagena pri nehisterektomiranih ženskah zmanjša tveganje za hiperplazijo endometrija, ki je povezano z estrogenom, ga pa ne odpravi.
English: • Untreated endometrial hyperplasia
Slovenian: • nezdravljena hiperplazija endometrija,
English: Fluid retention, see also “General disorders and administration site conditions
Slovenian: Presnovne in prehranske motnje zastajanje tekočine; glejte tudi »Splošne težave in spremembe na mestu aplikacije«
English: Depending on the duration of treatment and oestrogen dose, the reported increase in endometrial cancer risk among unopposed oestrogen users varies from 2-to 12-fold greater compared with non-users.
Slovenian: Opisano tveganje za raka na endometriju je med uporabnicami neoponiranih estrogenov v primerjavi z neuporabnicami od 2- do 12-krat večje, odvisno od trajanja zdravljenja in odmerka estrogena.
English: It is unknown whether the increased risk also extends to other HRT products.
Slovenian: Ni znano, ali večje tveganje spremlja tudi druga zdravila za HNZ.
English: There is no evidence from randomised controlled trials of cardiovascular benefit with continuous combined conjugated oestrogens and medroxyprogesterone acetate (MPA).
Slovenian: Randomizirana kontrolirana preskušanja stalne kombinacije konjugiranih estrogenov in medroksiprogesteronacetata (MPA) niso pokazala srčnožilnih koristi.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DISPENSER LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: You are also more likely to get a blood clot:
Slovenian: Verjetnost za pojav krvnega strdka je večja tudi, če:
English: Your doctor may ask you about any vaginal bleeding with Activelle at your regular check-ups.
Slovenian: Zdravnik vas bo na rednih pregledih verjetno povprašal po morebitnih krvavitvah iz nožnice med jemanjem tega zdravila.
English: The CHMP noted that the applicant had provided the following arguments to support the endometrial safety of Activelle 0.5 mg/0.1 mg:
Slovenian: CHMP je ugotovil, da je predlagatelj v podporo endometrijski varnosti zdravila Activelle 0,5 mg/0,1 mg priskrbel naslednje argumente:
English: Other conditions
Slovenian: DRUGI PODATKI
English: • If you have a liver disorder such as liver adenoma (a benign tumour)
Slovenian: • če imate kakšno bolezen jeter, npr. adenom (benigen tumor) na jetrih,
English: For non-users it is estimated that the number of cases of VTE that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 8 per 1000 women aged between 60-69 years.
Slovenian: Ocenjeno število primerov VTE, ki se v 5-letnem obdobju pojavijo pri neuporabnicah, je okrog 3 na 1.000 žensk v starostni skupini od 50 do 59 let in 8 na 1.000 žensk v starostni skupini od 60 do 69 let.
English: There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65.
Slovenian: Nekatere ugotovitve preskušanja WHI nakazujejo večje tveganje za verjetno demenco pri ženskah, ki začnejo stalno kombinacijo KEE in
English: • Feeling sick
Slovenian: • občutek slabosti
English: White, round, biconvex tablets with a diameter of 6 mm.
Slovenian: Bele, okrogle, bikonveksne tablete s premerom 6 mm. Tablete imajo na eni strani vtisnjen napis »NOVO 291« in na drugi bika Apisa.
English: Check with your doctor or pharmacist if you are unsure.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
English: INFORMATION IN BRAILLE Activelle 0.5 mg/0.1 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Activelle 0,5 mg/0,1 mg
English: Data suggest a dose-response relationship between unopposed-CEE and risk of hyperplasia.
Slovenian: Podatki kažejo od odmerka odvisno razmerje med konjugiranimi konjskimi estrogeni, ki niso modificirani z učinki progestogena, in tveganjem za pojav hiperplazije.
English: Ovarian cancer
Slovenian: Rak na jajčniku
English: • Undiagnosed genital bleeding
Slovenian: • diagnostično nepojasnjena krvavitev iz spolovil,
English: Hypersensitivity, see also “Skin and subcutaneous tissue disorders
Slovenian: Bolezni imunskega sistema preobčutljivost; glejte tudi »Bolezni kože in podkožja«
English: • Nervous system disorders: Dizziness
Slovenian: • Bolezni živčevja: omotica
English: • Gastrointestinal disorders: Dyspepsia, vomiting
Slovenian: • Bolezni prebavil: dispepsija, bruhanje
English: For oestrogen-only HRT, estimates of relative risk (RR) from a reanalysis of original data from 51 epidemiological studies (in which >80% of HRT use was oestrogen-only HRT) and from the epidemiological Million Women Study (MWS) are similar at 1.35 (95%CI 1.21 - 1.49) and 1.30 (95%CI 1.21 - 1.40), respectively.
Slovenian: epidemiološke študije MWS (Million Women Study), sta podobni: 1,35 (95 % IZ: 1,21-1,49) oz. 1,30 (95 % IZ: 1,21-1,40).
English: • For women not using HRT, about 32 in every 1000 are expected to have breast cancer diagnosed between the ages of 50 and 64 years.
Slovenian: • je pričakovano število primerov diagnosticiranega raka na dojki v starostni skupini od 50 do 64 let med neuporabnicami HNZ okrog 32 na 1.000 žensk.
English: If you are experiencing any of the following conditions below, stop taking Activelle, and contact your doctor immediately:
Slovenian: Nehajte jemati zdravilo Activelle in se nemudoma posvetujte z zdravnikom, če:
English: • Myocardial infarction and stroke
Slovenian: • miokardni infarkt in možganska kap,
English: MANUFACTURER Novo Nordisk A/S
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Novo Nordisk A/S
English: There may be a slightly higher risk of having a stroke if you are taking HRT.
Slovenian: Če uporabljate HNZ, morda obstaja malenkost večje tveganje za možgansko kap.
English: If you have (or have had) any of the following conditions, tell your doctor.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Activelle Če imate (ali ste kdaj imeli) kaj od naslednjega, morate to povedati svojemu zdravniku.
English: Until a thorough evaluation of thrombophilic factors has been made or anticoagulant treatment initiated, use of HRT in such patients should be viewed as contraindicated.
Slovenian: Pri takšnih bolnicah je HNZ kontraindicirano, dokler niso trombofilni dejavniki temeljito ocenjeni oz. dokler ni uvedeno antikoagulantno zdravljenje.
English: • Cholelithiasis
Slovenian: • holelitiaza,
English: a. Dose-dependency of the proliferative effect of unopposed oestrogens
Slovenian: a. Odvisnost proliferativnega učinka estrogenov, ki niso modificirani z učinki progestogena, od odmerka
English: estradiol/norethisterone acetate Oral use
Slovenian: estradiol, noretisteronacetat Za peroralno uporabo.
English: • Gall bladder disease
Slovenian: • bolezen žolčnika,
English: Breast cancer:
Slovenian: Rak na dojki
English: • The active substances are estradiol and norethisterone acetate.
Slovenian: Zdravilni učinkovini sta estradiol in noretisteronacetat.
English: • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
Slovenian: • znani estrogensko odvisni maligni tumorji (npr. rak na endometriju) ali sum nanje,
English: Coronary artery disease (CAD)
Slovenian: Bolezen koronarnih arterij
English: For women who do not use HRT, it is estimated that the number of cases of stroke that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years.
Slovenian: Ocenjeno število primerov možganske kapi, ki se v 5letnem obdobju pojavijo pri neuporabnicah HNZ, je okrog 3 na 1.000 žensk v starostni skupini od 50 do 59 let in 11 na 1.000 žensk v starostni skupini od 60 do 69 let.
English: Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: Activelle in povezana imena (Glejte Dodatek I) 0,5 mg/0,1 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica]
English: • Fungal infection of the genitals or vaginal inflammation
Slovenian: • glivične okužbe spolovil ali vnetje nožnice
English: Novo Nordisk Farma B.V. Flemingweg 18
Slovenian: Novo Nordisk Farma B.V.
English: The following adverse reactions have been reported in the literature in association with oestrogen/progestagen treatment:
Slovenian: V povezavi z estrogensko-progestagenskim zdravljenjem so v literaturi opisani naslednji neželeni učinki:
English: Each tablet contains 0.5 mg estradiol (as hemihydrate) and 0.1 mg norethisterone acetate.
Slovenian: Ena tableta vsebuje 0,5 mg estradiola (v obliki hemihidrata) in 0,1 mg noretisteronacetata.
English: Bleeding with Activelle
Slovenian: Krvavitve med uporabo zdravila Activelle