natgillin/translations-raw huggingface dataset:
Both considered the endometrial safety of Activelle 0.5 mg/0.1 mg to be insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/CHMP/021/97 rev 1). 
Obe državi sta menili, da endometrijska varnost zdravila Activelle 0,5 mg/0,1 mg glede na smernice CHMP za hormonska nadomestna zdravila (EMEA/CHMP/021/97 rev 1) ni bila zadostno dokazana.
As for the KLIM/PD/11/USA trial, sample size may be considered too low to draw definite conclusion with regard to endometrial safety. 
Kot pri preskušanju KLIM/PD/11/USA, je tudi v tej študiji velikost vzorca premajhna, da bi lahko prišli do jasnih zaključkov glede endometrijske varnosti.
• Significant increase in blood pressure 
• pomembnega zvišanja krvnega tlaka,
Every woman is at risk of getting breast cancer whether or not she takes HRT. 
Rak na dojki ogroža vsako žensko, ne glede na to, ali uporablja HNZ ali ne.
In women with an intact uterus, the risk of endometrial hyperplasia and endometrial cancer increases with increasing duration of use of unopposed oestrogens. 
Pri ženskah z intaktno maternico se tveganje za hiperplazijo endometrija in raka na endometriju povečuje s trajanjem uporabe neoponiranih estrogenov.
• Medicines used for epilepsy (such as phenobarbital, phenytoin and carbamazepin) 
• zdravila proti epilepsiji (npr. fenobarbital, fenitoin in karbamazepin),
According to evidence from a large number of epidemiological studies and one randomised placebocontrolled trial, the Women's Health Initiative (WHI), the overall risk of breast cancer increases with increasing duration of HRT use in current or recent HRT users. 
Po ugotovitvah velikega števila epidemioloških študij in enega randomiziranega, s placebom kontroliranega preskušanja (WHI - Women's Health Initiative) se celotno tveganje za raka na dojki pri sedanjih in nedavnih uporabnicah HNZ povečuje s trajanjem HNZ.
Take one tablet once a day, at about the same time each day Take the tablet with a glass of water. 
Vzemite eno tableto enkrat na dan, vsak dan ob približno istem času.
Bulgaria - Noviana™ филмирани таблетки 
Bolgarija - Noviana™ филмирани таблетки
• Heartburn (dyspepsia) 
• zgaga (dispepsija)
Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively. 
V serumu so lahko zvišani še drugi beljakovinski nosilci, tj. vezalni globulin za kortikoide (CBG), kar povzroči zvišanje kortikosteroidov v obtoku, in vezalni globulin za spolne hormone (SHBG), kar povzroči zvišanje spolnih steroidov v obtoku.
It is well established that the use of unopposed oestrogens in women with an intact uterus is associated with a gradually increasing incidence of hyperplasia with duration of treatment. 
Dobro je znano, da je uporaba estrogenov, ki niso modificirani z učinki progestogena, pri ženskah z neokrnjeno maternico povezana s postopnim povečevanjem pojavnosti hiperplazije, ki je odvisna od trajanja zdravljenja.
The dose-dependency of the proliferative effect of unopposed oestrogens on the endometrium was sustained by data from the KLIM/PD/11/USA trial for E2 (0.5 mg and 1 mg) and from Pickar et al for conjugated equine oestrogens (CEE, 0.3 to 0.625 mg). 
Odvisnost od odmerka pri proliferativnem učinku estrogenov, ki niso modificirani z učinki progestogena, na endometrij je bil podprt s podatki iz preskušanja KLIM/PD/11/USA za E2 (0,5 mg in 1 mg) in podatki iz študije Pickar et al. za konjugirane konjske estrogene (CEE, 0,3 do 0,625 mg).
Norethisterone acetate: As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer. 
Noretisteronacetat: estrogeni spodbujajo rast endometrija, zato neoponirani estrogeni povečujejo tveganje za hiperplazijo endometrija in za raka na endometriju.
• If you have any vaginal bleeding, which has not been diagnosed by your doctor 
• imate krvavitve iz nožnice, katerih vzroka zdravnik še ni ugotovil,
• Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer 
• dejavniki tveganja za estrogensko odvisne tumorje, npr. dedna dispozicija za raka na dojki v 1.
If VTE develops after initiating therapy, the drug should be discontinued. 
Če se VTE pojavi po uvedbi zdravljenja, je treba uporabo zdravila prekiniti.
The calendar dial pack with 28 tablets consists of the following 3 parts: - The base made of coloured non-transparent polypropylene - The ring-shaped lid made of transparent polystyrene - The centre-dial made of coloured non-transparent polystyrene Not all pack sizes may be marketed. 
Koledarsko pakiranje z 28 tabletami je sestavljeno iz naslednjih 3 delov: - podlage iz obarvanega, neprozornega polipropilena, - obročastega pokrovčka iz prozornega polistirena, - osrednje kazalne ploščice iz obarvanega, neprozornega polistirena.
Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels (by radio-immunoassay). 
Estrogeni zvišajo raven vezalnega globulina za tiroksin (TBG) in tako zvišajo količino celotnega ščitničnega hormona v obtoku, merjenega z beljakovinsko vezanim jodom (PBI), koncentracijo T4 (s kolono ali radioimunskim preskusom) ali koncentracijo T3 (z radioimunskim preskusom).
- the endometrial safety of Activelle 0.5mg estradiol/0.1mg NETA product is sufficiently supported from the submitted data. 
- je endometrijska varnost zdravila Activelle 0,5 mg estradiola/0,1 mg NETA zadostno podprta s predloženimi podatki,
• If you have cancer of the womb lining (endometrium), or if such an oestrogen dependent cancer is suspected 
• imate raka na maternični sluznici (endometriju) ali če obstaja sum na takšnega, od estrogenov odvisnega raka,
The MWS reported that, compared to never users, the use of various types of oestrogen-progestagen combined HRT was associated with a higher risk of breast cancer (RR = 2.00, 95%CI 1.88 - 2.12) than use of oestrogens alone (RR = 1.30, 95%CI 1.21 - 1.40) or use of tibolone (RR=1.45, 95%CI 
V primerjavi z ženskami, ki niso nikoli uporabljale HNZ, je MWS pokazala večje tveganje za raka na dojki pri uporabi različnih vrst kombiniranega estrogensko-progestagenskega HNZ (RT = 2,00, 95 % IZ: 1,88-2,12) kot pri uporabi estrogenov samih (RT = 1,30, 95 % IZ: 1,21-1,40) ali pri uporabi tibolona (RT = 1,45, 95 % IZ 1,25-1,68).
• Herbal products containing St John's Wort (Hypericum perforatum). 
• zeliščni pripravki, ki vsebujejo šentjanževko (Hypericum perforatum).
the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Activelle and associated names (see Annex I). 
je CHMP za zdravilo Activelle in z njim povezana imena (glejte Dodatek I) priporočil odobritev dovoljenja (dovoljenj) za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
Brown pigmented patches in the face, redness of the skin including inflammation on the hands or the legs (erythema multiforme), hump rose or a bruise-like rash. 
Rjavo obarvane lise po obrazu, pordelost kože z vnetjem dlani ali nog (multiformni eritem), vozličaste vnetne spremembe ali podplutbam podoben izpuščaj.
Between 0 and 3 (best estimate = 1.5) for 5 years' use 
• med 0 in 3 (najboljša ocena = 1,5) za 5-letno uporabo
All adverse reactions observed with a higher frequency in patients treated with Activelle compared to placebo and which on an overall judgement are possible related to treatment are presented below. 
Spodaj so navedeni vsi neželeni učinki, ki so se pri uporabnicah zdravila Activelle pojavljali pogosteje kot pri uporabnicah placeba in ki so po splošni presoji lahko povezani z zdravljenjem.
Excessive growth of the womb lining (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer) 
Čezmerna rast maternične sluznice (hiperplazija endometrija) in rak maternične sluznice (rak na endometriju)
Hungary - Noviana filmtabletta 
Madžarska - Noviana filmtabletta
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
In women with amenorrhea and not taking HRT or women transferring from another continuous combined HRT product, treatment with Activelle may be started on any convenient day. 
Ženske z amenorejo, ki ne uporabljajo HNZ, in tiste, ki preidejo z drugega kontinuiranega kombiniranega zdravila za HNZ, lahko začnejo jemati zdravilo Activelle kateri koli dan, ki jim ustreza.
11% of women at month 1, 15% of women at month 4 and 11 % of women at the end of the 6 month trial reported bleeding or spotting. 
Krvavitve ali krvavkast izcedek je 1. mesec navajalo 11 % žensk, 4. mesec 15 % in na koncu 6-mesečnega preskušanja 11 %.
Endometrial hyperplasia 
Hiperplazija endometrija
For other HRT products there are only limited data from trials examining the effects on the risk of cardiovascular disease. 
O drugih zdravilih za HNZ je le malo podatkov iz raziskav, ki so proučevale tveganje za srčnožilne bolezni.
endometriosis (presence of womb lining tissue outside the womb) or have had endometrial hyperplasia (excessive growth of the womb lining) 
endometriozo (prisotnost tkiva maternične sluznice zunaj maternice) ali hiperplazijo endometrija (čezmerno rast maternične sluznice),
Belgium - Activelle minor comprimés pelliculés 
Belgija - Activelle minor comprimés pelliculés
France - Activelle 0,5 mg/0,1 mg comprimé pelliculé Germany - Noviana 
Francija - Activelle 0,5 mg/0,1 mg comprimé pelliculé Nemčija - Noviana
HRT may increase the risk of blood clots 2-3 times in the veins, especially in the first year of treatment. 
Krvni strdki ogrožajo vsako žensko, ne glede na to, ali uporablja HNZ ali ne. HNZ lahko poveča tveganje za krvne strdke v venah za 2- do 3-krat, zlasti v prvem letu uporabe.
Activelle is a continuous combined hormone replacement therapy intended for use in women with an intact uterus. 
Zdravilo Activelle je namenjeno za stalno kombinirano hormonsko nadomestno zdravljenje žensk z intaktno maternico.
Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting. 
Pozabljen odmerek poveča verjetnost vmesne krvavitve in krvavkastega izcedka.
• Pain in arms or legs 
• bolečine v rokah ali nogah
Herbal preparations containing St John's Wort (Hypericum perforatum) may induce the metabolism of oestrogens and progestagens. 
Zeliščni pripravki, ki vsebujejo šentjanževko (Hypericum perforatum), lahko inducirajo presnovo estrogenov in progestagenov.
There is no evidence of beneficial effects on the risks of cardiovascular disease with HRT in the menopause. 
Ni dokazov, da bi HNZ v menopavzi ugodno vplivalo na tveganje za srčnožilne bolezni.
Member State Marketing Authorisation Holder 
Država članica Imetnik dovoljenja za promet z zdravilom
In women with an intact womb, the risk of excessive growth of the womb lining (endometrial hyperplasia) is increased. 
Pri ženskah z ohranjeno maternico se poveča tveganje za čezmerno rast maternične sluznice (hiperplazijo endometrija).
• Eye disorders: Visual disturbances 
• Očesne bolezni: motnje vida
There are some evidence from clinical studies that use of oestrogen-only products for more than 5 years increases the risk of ovarian cancer among women who have had their womb removed. 
Nekateri izsledki kliničnih študij kažejo, da več kot 5-letna uporaba zdravil, ki vsebujejo zgolj estrogen, povečuje tveganje za raka na jajčniku pri ženskah z odstranjeno maternico.
Between 5 and 7 (best estimate = 6) for 5 years' use 
• med 5 in 7 (najboljša ocena = 6) za 5-letno uporabo
o About 16 cases of invasive breast cancer would be diagnosed in 5 years. 
• bi pri 1.000 ženskah v skupini s placebom v 5 letih diagnosticirali okrog 16 primerov invazivnega raka na dojki.
- The endometrial safety data was extrapolated from another combination containing 1.0 mg estradiol and 0.1mg norethisterone acetate (NETA). 
- Podatki o endometrijski varnosti so bili ekstrapolirani iz druge terapevtske kombinacije, ki je vsebovala 1,0 mg estradiola in 0,1 mg noretisteron acetata (NETA).
-The endometrial safety of the combination of oestrogen and progestogen for the new ratio of 0.5mg/0.1mg cannot be extrapolated from the already licensed dose of Activelle, which contains 1mg estradiol and 0.5mg NETA. 
- Endometrijske varnosti kombinacije estrogena in progestogena v novem razmerju 0,5 mg/0,1 mg ni mogoče ekstrapolirati iz že obstoječega in odobrenega odmerka zdravila Activelle, ki vsebuje 1 mg estradiola in 0,5 mg NETA.
The applicant/MAH was asked to demonstrate the endometrial safety of Activelle 0.5mg/0.1mg for the following reasons: 
Predlagatelja/imetnika dovoljenja za promet z zdravilom so pozvali, naj dokaže endometrijsko varnost zdravila Activelle 0,5 mg/0,1 mg zaradi naslednjih razlogov:
Talk to your doctor if your symptoms are not better after three months of treatment. 
Če se vam simptomi po treh mesecih zdravljenja ne izboljšajo, se morate pogovoriti z zdravnikom.
• A history of, or risk factors for, thromboembolic disorders (see below) 
• anamneza trombemboličnih motenj ali dejavniki tveganja zanje (glejte spodaj),
• Hepatobilitary disorders: Gallbladder disease, cholelithiasis, cholelithiasis aggravated, cholelithiasis re-occurrence 
• Bolezni jeter, žolčnika in žolčevodov: bolezen žolčnika, holelitiaza, poslabšanje holelitiaze, ponoven pojav holelitiaze
Noviana film-coated tablets 
Noviana filmcoated tablets
This study focused on prevention of osteoporosis but endometrial safety of unopposed E2 0.5 mg or 1 mg during 2 years was also assessed. 
Ta študija se je osredotočala na preprečevanje osteoporoze, ocenjevala pa je tudi endometrijsko varnost 0,5 mg ali 1 mg E2, ki ni modificiran z učinki progestogena.
• Other ingredients are: Lactose monohydrate, maize starch, hydroxypropylcellulose, magnesium stearate, hypromellose, triacetin and talc. 
Pomožne snovi so laktoza, koruzni škrob, hidroksipropilceluloza, magnezijev stearat, hipromeloza, triacetin in smukec.
Do not take Activelle 
Ne jemljite zdravila Activelle
estradiol/norethisterone acetate 
estradiol, noretisteronacetat
Take a tablet every day without stopping[PIQ-QRD2]. 
Tablete jemljite vsak dan, brez prekinitev.
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. 
Bolnico je treba natančno nadzirati, če ima katero od naslednjih stanj, če je kakšno tako stanje imela v preteklosti oz. se ji je poslabšalo med nosečnostjo ali predhodnim hormonskim zdravljenjem.
Iceland - Activelle® low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Ireland - Activelle low 0.5mg/0.1mg film-coated tablets Italy - Activelle® 0,5 mg/0,1 mg compresse film-rivestite Latvia - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Lithuania - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Luxembourg - Activelle minor comprimés pelliculés The Netherlands - Activelle filmomhulde tabletten Norway - Noviana 0,5 mg/0,1 mg tablett filmdrasjert Portugal - 0,5mg Estradiol + 0.1 mg Acetato de Noretisterona Comprimidos revestidos por película Romania - Noviana comprimate filmate 
Islandija - Activelle® low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Irska - Activelle low 0.5mg/0.1mg film-coated tablets Italija - Activelle® 0,5 mg/0,1 mg compresse film-rivestite Latvija - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Litva - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Luksemburg - Activelle minor comprimés pelliculés Nizozemska - Activelle filmomhulde tabletten
• If you have diabetes or gallstone disease 
• če imate sladkorno bolezen ali žolčne kamne,
Patients with any of the following rare hereditary diseases should not take this medicine: galactose intolerance, lactase deficiency or glucose-galactose malabsorption. 
Bolnice z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
In the WHI study, the continuous combined conjugated equine oestrogen and medroxyprogesterone acetate (CEE + MPA) product used was associated with breast cancers that were slightly larger in size and more frequently had local lymph node metastases compared to placebo. 
V študiji WHI so bili raki na dojki pri uporabnicah stalne kombinacije konjugiranega ekvinega estrogena in medroksiprogesteronacetata (KEE + MPA) nekoliko večji kot pri uporabnicah placeba in so imeli pogosteje metastaze v lokalnih bezgavkah.
Driving and using machines Activelle does not affect the use of any machines or the ability to drive safely. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Activelle ne vpliva na sposobnost upravljanja vozil in strojev.
- the risk of hyperplasia in Activelle 0.5 mg estradiol/0.1 mg NETA is lower than for the 1 mg estradiol/0.1 mg NETA product, containing one half of the dose as compared with the commercially available HRT product. 
- je tveganje za pojav hiperplazije pri uporabi zdravila Activelle 0,5 mg estradiola/0,1 mg NETA manjše kot pri zdravilu z 1 mg estradiola/0,1 mg NETA, ki vsebuje eno polovico odmerka v primerjavi s komercialnim zdravilom za HNZ,
One large randomised clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischaemic stroke in healthy women during treatment with continuous combined conjugated oestrogens and MPA. 
Eno veliko randomizirano klinično preskušanje (preskušanje WHI) je pri zdravih ženskah kot vzporedni izid ugotovilo večje tveganje za ishemično možgansko kap med zdravljenjem s stalno kombinacijo konjugiranih estrogenov in MPA.
You should therefore always tell your doctor about any close relative suffering from serious illness, and you should also tell your doctor about any changes, you might find in your breasts. 
Prav tako morate zdravniku povedati za vse spremembe, ki si jih morda odkrijete na dojkah.
Vulvovaginal mycotic infection, see also “Reproductive system and breast disorders 
Infekcijske in parazitske bolezni vulvovaginalna glivična okužba; glejte tudi »Motnje reprodukcije in dojk«
• New onset of migraine-type headache 
• novonastalega glavobola migrenskega tipa.
• Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura 
• bolezni kože in podkožja: kloazma, multiformni eritem, nodozni eritem, žilna purpura,
WHAT ACTIVELLE IS AND WHAT IT IS USED FOR Activelle belongs to a group of hormone replacement therapy (HRT) medicines, called continuous combined HRT which are taken every day without interruptions. 
Activelle spada v skupino zdravil za hormonsko nadomestno zdravljenje (HNZ), ki ga imenujemo stalno kombinirano HNZ; pri takšnem zdravljenju jemljete zdravilo vsak dan, brez prekinitev.
Pruritus or urticaria 
• srbenje ali koprivnica
Stop taking Activelle 
Nehajte jemati zdravilo Activelle
• Unexplained migraine-type headaches, with or without disturbed vision. 
• nepojasnjeni migrenski glavoboli, z motnjami vida ali brez njih, čim prej pojdite k zdravniku.
If you stop taking Activelle 
Če ste prenehali jemati zdravilo Activelle
b. Duration-dependency of the proliferative effect of unopposed oestrogens 
b. Časovna odvisnost proliferativnega učinka estrogenov, ki niso modificirani z učinki progestogena
HOW TO USE ACTIVELLE 
KAKO JEMATI ZDRAVILO ACTIVELLE
• Go for regular breast screening (mammography) and cervical smear tests. 
• na redna presejalna slikanja dojk (mamografijo) in brise materničnega vratu.
• If you are bed-ridden for a longer period through surgery, injury or illness 
• ste zaradi operacije, poškodbe ali bolezni za daljši čas priklenjeni na posteljo,
• Migraine or (severe) headache 
• migrena ali (hud) glavobol,
It is intended for once daily administration to postmenopausal women with an intact uterus. 
Zdravilo je namenjeno za uporabo enkrat dnevno pri ženskah v postmenopavzi, ki imajo neokrnjeno maternico.
• If any of your close family has had blood clots 
• je imel krvne strdke kdo od vaših najbližjih sorodnikov,
• If you have a kidney or heart disorder 
• če imate kakšno bolezen ledvic ali srca,
At doses higher than normally used in OC and HRT formulations masculinisation of female foetuses was observed. 
Ob odmerkih, večjih od tistih, ki se ponavadi uporabljajo v pripravkih za peroralno kontracepcijo in HNZ, so opažali maskulinizacijo ženskih plodov.
LIST OF EXCIPIENTS Activelle contains lactose. 
Zdravilo Activelle vsebuje laktozo.
An overdose of Activelle could make you feel sick or vomit. 
Preveliko odmerjanje zdravila Activelle lahko povzroči slabost v želodcu ali bruhanje.
Denmark - Activelle low filmovertrukne tabletter 
Danska - Activelle low filmovertrukne tabletter
It is unknown whether the findings apply to younger postmenopausal women or other HRT products. 
Ni znano, ali to velja tudi za mlajše ženske po menopavzi oz. za druga zdravila za HNZ.
• A history of endometrial hyperplasia (see below) 
• anamneza hiperplazije endometrija (glejte spodaj),
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. 
Vsebujejo 17β-estradiol in noretisteronacetat z namenom, da bi preprečili redne odtegnitvene krvavitve, ki spremljajo ciklično ali sekvenčno HNZ.
• Liver disorders (e.g. liver adenoma) 
• bolezni jeter (npr. adenom jeter),
Personal or strong family history of thromboembolism, or recurrent spontaneous abortion, should be investigated in order to exclude a thrombophilic predisposition. 
Za izključitev trombofilnega nagnjenja je treba preveriti osebno ali potrjeno družinsko anamnezo trombembolij ali ponavljajočih se spontanih splavov.
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. 
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.
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. 
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.
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. 
• 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.
• If your blood pressure goes up while you're taking Activelle 
• se vam med jemanjem zdravila Activelle zviša krvni tlak,
• Leiomyoma (uterine fibroids) or endometriosis 
• leiomiomi (maternični miomi) ali endometrioza,
Gall bladder disease Gall bladder disease has been reported after treatment with oestrogen/progestagen. 
Bolezen žolčnika Po zdravljenju z estrogeni/progestageni je opisana bolezen žolčnika.
• Excessive growth of the womb lining (endometrial hyperplasia) 
• čezmerna rast maternične sluznice (hiperplazija endometrija)
Endometrial cancer: 
Rak na endometriju
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. 
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.
6.5 Nature and contents of container 1 x 28 tablets or 3 x 28 tablets in calendar dial packs. 
Škatla z 1 x 28 tablet ali 3 x 28 tablet v koledarskem pakiranju.
• Hypertension 
• hipertenzija,
• High blood pressure 
• visok krvni tlak,