FrancophonIA/ELRC3.0 huggingface dataset:
English: If any of the above conditions appears for the first time while taking Intrarosa, stop taking it at once and consult your doctor immediately.
Slovenian: Če se katero koli od navedenih stanj prvič pojavi pri jemanju zdravila Intrarosa, to zdravilo takoj prenehajte jemati in se nemudoma posvetujte z zdravnikom.
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only systemic HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Slovenian: Epidemiološki dokazi obširne metaanalize kažejo rahlo zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko HNZ, kar postane očitno po petih letih uporabe in se po prenehanju sčasoma zmanjšuje.
English: For women taking oestrogen-only therapy there is no increased risk of developing a heart disease.
Slovenian: Pri ženskah, ki jemljejo samo estrogensko zdravljenje, tveganje za nastanek srčne bolezni ni povečano.
English: It is used to relieve menopausal symptoms in the vagina such as dryness or irritation.
Slovenian: Uporablja se za lajšanje menopavznih simptomov v vagini, kot sta suhost ali draženje.
English: Warnings and precautions When to take special care with Intrarosa
Slovenian: Opozorila in previdnostni ukrepi Kdaj morate biti pri uporabi zdravila Intrarosa posebej pozorni
English: Other conditions observed with HRT
Slovenian: Druga stanja, ki so bila opažena pri HNZ
English: Other medicines and Intrarosa
Slovenian: Druga zdravila in zdravilo Intrarosa
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 z obstoječo hipertrigliceridemijo je treba med estrogenskim nadomestnim ali hormonskim nadomestnim zdravljenjem skrbno spremljati, saj so pri estrogenskem zdravljenju pri tej motnji poročali o redkih primerih velikega porasta plazemskih trigliceridov, kar je pripeljalo do pankreatitisa.
English: Wash it or throw it away after using for one week (two extra applicators are provided).
Slovenian: Aplikator umijte ali zavrzite po enem tednu uporabe (na voljo sta še dva aplikatorja za rezervo).
English: Two pessaries should not be used to make up for a forgotten dose.
Slovenian: Ne sme se uporabiti dveh globul, da bi se nadomestil zamujeni odmerek.
English: Due to melting of the hard fat base added to an expected increase in vaginal secretions due to treatment, vaginal discharge can occur although it does not require to stop the medication (see section 4.8).
Slovenian: Zaradi topljenja trde maščobne podlage, ki med zdravljenjem pričakovano poveča količino vaginalnih izcedkov, se lahko pojavi vaginalni izcedek, kar pa ne zahteva prekinitve zdravljenja (glejte poglavje 4.8).
English: • asthma;
Slovenian: • astmo;
English: Remove 1 applicator from the package.
Slovenian: Iz škatle odstranite en aplikator.
English: • a disease affecting the eardrum and hearing (otosclerosis);
Slovenian: • bolezen, ki prizadene bobnič in sluh (otoskleroza);
English: On the 389 evaluable end-of-study endometrial biopsies performed after 52 weeks of treatment with Intrarosa, no histological abnormalities were reported on the biopsies.
Slovenian: Varnost za endometrij: Pri 389 ocenljivih biopsijah endometrija ob koncu študije, opravljenih po 52 tednih zdravljenja z zdravilom Intrarosa, niso poročali o histoloških nepravilnosti bioptov.
English: There are no data on the use of Intrarosa in pregnant women.
Slovenian: Podatkov o uporabi zdravila Intrarosa pri nosečnicah ni.
English: The applicator should then be withdrawn and disassembled, and the two pieces of the applicator should be rinsed for 30 seconds under running water before wiping with paper towel and reassembled.
Slovenian: Aplikator je treba nato odstraniti in razstaviti ter oba kosa 30 sekund spirati pod tekočo vodo,
English: Intrarosa does not stimulate the endometrium as shown by atrophy of the lining of the womb in all women treated with Intrarosa for one year during the clinical trials.
Slovenian: Zdravilo Intrarosa ne spodbuja endometrija, na kar kaže atrofija maternične sluznice pri vseh ženskah, ki so se v kliničnih preskušanjih eno leto zdravile z njim.
English: • if you notice signs of a blood clot, such as: - painful swelling and redness of the legs; - sudden chest pain; - difficulty in breathing.
Slovenian: • če opazite znake krvnega strdka, kot so: - boleče otekanje in pordelost nog; - nenadna bolečina v prsnem košu;
English: Exogenous prasterone is metabolized in the same manner as endogenous prasterone.
Slovenian: Eksogeni prasteron se presnavlja na enak način kot endogeni prasteron.
English: • Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis.
Slovenian: • Nezavirana stimulacija z estrogenom lahko povzroči predrakavo ali rakavo transformacijo v rezidualnih endometriotičnih žariščih.
English: Table 1: Primary Efficacy Analysis - Change from Baseline to Week 12 in the Most Bothersome Symptom Dyspareunia (ITT Population; LOCF)
Slovenian: Preglednica 1: Primarna analiza učinkovitosti - sprememba od izhodišča do 12. tedna pri najbolj motečem simptomu, disparevniji (populacija ITT; LOCF)
English: • If you have or have ever had a liver disease and your liver function tests have not returned to normal;
Slovenian: • Če imate ali ste kdaj imeli bolezen jeter in se preiskave delovanja vaših jeter niso normalizirale.
English: Intrarosa has not been studied in women with uncontrolled hypertension (blood pressure above 140/90 mmHg) and cardiovascular disease.
Slovenian: Pri ženskah z nenadzorovano hipertenzijo (krvni tlak nad 140/90 mmHg) in srčno-žilnimi boleznimi zdravila Intrarosa niso proučevali.
English: • For oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range, it is not recommended to add a progestagen.
Slovenian: • Pri estrogenskih zdravilih za vaginalno uporabo, pri katerih sistemska izpostavljenost estrogenu ostaja v normalnem pomenopavznem območju, dodajanje progestagenov ni priporočljivo.
English: Heart disease (heart attack) / Hypertension
Slovenian: Bolezen srca (miokardni infarkt)/hipertenzija
English: Prasterone administered in the vagina is an inactive precursor that enters the vaginal cells and is converted intracellularly into cell-specific small amounts of both oestrogens and androgens depending upon the level of enzymes expressed in each cell type.
Slovenian: Prasteron, dan v vagino, je neaktivni prekurzor, ki vstopi v celice vagine in se znotrajcelično pretvori v majhno količino tako estrogenov kot tudi androgenov, odvisno od ravni encimov, izraženih v vsaki vrsti celic.
English: − Wipe with a paper towel and reassemble.
Slovenian: potem pa obrisati s papirnato brisačo in sestaviti.
English: Testosterone
Slovenian: Testosterona
English: For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).
Slovenian: Pri ženskah v 50. letih, ki jemljejo HNZ, bo v petih letih 11 primerov na 1 000 uporabnic (tj. dodatni trije primeri).
English: How long to use After initial use, see your doctor at least every 6 months to check if you need to keep using Intrarosa.
Slovenian: Po začetni uporabi opravite pregled pri zdravniku vsakih šest mesecev, da preverite, ali morate zdravilo Intrarosa uporabljati še naprej.
English: Intrarosa is only used in adult women.
Slovenian: Zdravilo Intrarosa se uporablja samo pri odraslih ženskah.
English: The Cmax and AUC0-24 of the metabolites testosterone and estradiol were also slightly higher in women treated with the Intrarosa pessary compared to those receiving placebo but all remained within normal values of postmenopausal women (< 10 pg estradiol/mL; < 0.26 ng testosterone/mL) as measured by validated mass spectrometry-based assays for both the study samples and reference values.
Slovenian: Cmax in AUC0-24 presnovkov testosterona in estradiola sta bila nekoliko višja tudi pri ženskah, zdravljenih z globulami zdravila Intrarosa, v primerjavi s tistimi, ki so prejemale placebo, vendar so, merjeno z validiranimi testi na osnovi masne spektrometrije, tako pri študijskih vzorcih kot pri referenčnih vrednostih vsi ostali znotraj normalnih vrednosti pri ženskah po menopavzi (< 10 pg estradiola/ml, < 0,26 ng testosterona/ml).
English: Systemic metabolism has not been studied in this application.
Slovenian: Sistemska presnova pri tej uporabi ni bila proučevana.
English: 2 *WHI study in women with no uterus, which did not show an increase in risk of breast cancer 3 *Study in women with no uterus
Slovenian: 2 * Študija WHI pri ženskah brez maternice, ki ni pokazala povečanega tveganja za raka dojk
English: Prasterone
Slovenian: Prasterona
English: • If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism);
Slovenian: • Če imate ali ste kdaj imeli v veni krvni strdek (tromboza), na primer v nogah (globoka venska tromboza) ali pljučih (pljučna embolija).
English: • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);
Slovenian: • aktivna ali nedavna arterijska trombembolična bolezen (npr. angina pektoris, miokardni infarkt)
English: • various skin disorders: - discoloration of the skin especially of the face or neck known as “pregnancy patches” (chloasma); - painful reddish skin nodules (erythema nodosum); - rash with target-shaped reddening or sores (erythema multiforme).
Slovenian: • različne bolezni kože: - obarvanje kože, zlasti na obrazu ali vratu, imenovano „nosečniške lise“ (kloazma); - boleči rdeče obarvani kožni vozliči (nodozni eritem); - izpuščaj s pordelostjo v obliki tarče ali bolečino (multiformni eritem).
English: Intrarosa has not been studied in women with abnormal Pap smears (Atypical Squamous Cells of Undetermined Significance (ASCUS)) or worse.
Slovenian: Zdravilo Intrarosa ni bilo proučevano pri ženskah z nenormalnimi brisi PAP (atipične ploščate celice nedoločenega pomena (ASCUS-Atypical Squamous Cells of Undetermined Significance)) ali še resnejšim stanjem.
English: Systemic oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Slovenian: Sistemsko zdravljenje samo z estrogeni je povezano z do 1,5-kratnim povečanjem tveganja za ishemično kap.
English: Fertility Intrarosa is not indicated in fertile women.
Slovenian: Plodnost Zdravilo Intrarosa ni indicirano pri plodnih ženskah.
English: In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk.
Slovenian: V vseh primerih je treba vsaj na vsakih šest mesecev natančno oceniti koristi in tveganja ter zdravljenje z zdravilom Intrarosa nadaljevati, dokler so koristi večje od tveganj.
English: • fluid retention due to cardiac or kidney problems.
Slovenian: • zastajanje tekočine v telesu zaradi težav s srcem ali ledvicami.
English: Table 1 shows the mean change in severity score in MBS dyspareunia after 12 weeks with associated statistical testing for the difference vs. placebo for Trial 1 (ERC-231) and Trial 2 (ERC-238).
Slovenian: V preglednici 1 je prikazana povprečna sprememba stopnje resnosti pri MBS disparevniji po 12 tednih s pridruženim statističnim preskušanjem glede razlike v primerjavi s placebom za preskušanji 1 (ERC-231) in 2
English: • Intrarosa may weaken condoms, diaphragms and cervical caps made of latex.
Slovenian: • Zdravilo Intrarosa lahko poškoduje kondome, diafragme in cervikalne kapice iz lateksa.
English: However, if the next dose is due in less than 8 hours, the patient should skip the missed pessary.
Slovenian: Če pa naslednji odmerek sledi prej kot v 8 urah, naj bolnica zamujeno globulo preskoči.
English: Cases of ovarian and breast cancer have rarely been reported in women treated with 6.5 mg of prasterone for 52 weeks.
Slovenian: O primerih raka jajčnikov in dojk so pri ženskah, zdravljenih s 6,5 mg prasterona 52 tednov, poročali redko.
English: White to off-white, bullet-shaped pessary approximately 28 mm long and 9 mm in diameter at its widest end.
Slovenian: Bela do belkasta globula v obliki naboja, dolga približno 28 mm in s premerom 9 mm na najširšem delu.
English: • If VTE develops after initiating therapy, the drug should be discontinued.
Slovenian: • Če pride do VTE po začetku zdravljenja, je treba zdravilo ukiniti.
English: • Porphyria.
Slovenian: • porfirija
English: Read the instructions on how to use Intrarosa at the end of the leaflet carefully before using this medicine.
Slovenian: Pred uporabo zdravila skrbno preberite navodila za uporabo zdravila Intrarosa na koncu tega navodila.
English: The risk of getting stroke is about 1.5 times higher in HRT users than in non-users.
Slovenian: Tveganje za možgansko kap je pri uporabnicah HNZ približno 1,5-krat večje kot pri neuporabnicah.
English: • Untreated endometrial hyperplasia;
Slovenian: • nezdravljena hiperplazija endometrija
English: Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer.
Slovenian: Dokazi kažejo, da jemanje kombiniranega estrogensko-progestogenskega in morda tudi samo estrogenskega HNZ povečuje tveganje za raka dojk.
English: Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
Slovenian: Krvni strdki so lahko resni in če kateri od njih zaide v pljuča, lahko povzroči bolečine v prsnem košu,
English: Additional cases per 1000 HRT users
Slovenian: Dodatnih primerov na 1.000 uporabnic HNZ
English: There is some evidence of increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65.
Slovenian: Obstaja nekaj dokazov o večjem tveganju za demenco pri ženskah, ki začnejo uporabljati stalno kombinirano ali samo estrogensko HNZ po 65. letu starosti.
English: The most bothersome symptom (MBS) dyspareunia (co-primary endpoint) was assessed at baseline and 12 weeks with the severity scored as follows: None=0, Mild=1, Moderate=2, Severe=3.
Slovenian: Najbolj neprijeten simptom (MBS), disparevnija (soprimarni cilj študije), je bila v izhodišču in po 12 tednih ocenjena po lestvici resnosti: Brez = 0, blaga = 1, zmerna = 2, huda = 3.
English: • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency);
Slovenian: • Če imate motnjo strjevanja krvi (npr. pomanjkanje beljakovine C, beljakovine S ali antitrombina).
English: The following risks apply to HRT medicines which circulate in the blood.
Slovenian: Pri zdravilih za HNZ, ki vstopajo v kri, so prisotna naslednja tveganja.
English: These may be signs of a liver disease;
Slovenian: To so lahko znaki bolezni jeter; • če zanosite;
English: • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery);
Slovenian: Obvestite svojega zdravnika, če kar koli od naštetega velja za vas: • zaradi večje operacije, poškodbe ali bolezni ne morete dolgo časa hoditi (če boste potrebovali operacijo, glejte tudi poglavje 3):
English: Since Intrarosa acts locally in the vagina, no dosage adjustment is needed for postmenopausal women having renal or hepatic impairment or any other systemic anomaly or disease.
Slovenian: Ker zdravilo Intrarosa deluje lokalno v vagini, prilagajanje odmerka pri ženskah po menopavzi, ki imajo okvaro ledvic ali jeter ali katero koli drugo sistemsko anomalijo ali bolezen, ni potrebno.
English: Common (≥ 1/100 to < 1/10)
Slovenian: Organski sistem pogosti (≥ 1/100 do < 1/10)
English: The risk ratio is not constant but will increase with increasing duration on use Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
Slovenian: Opomba: Ker se pojavnost raka dojk razlikuje po državah EU, se bo sorazmerno spreminjalo tudi število dodatnih primerov raka dojk.
English: Keep it in a clean place.
Slovenian: Aplikator hranite na čistem mestu.
English: Intrarosa has no influence in the ability to drive and use machines.
Slovenian: Zdravilo Intrarosa nima vpliva na sposobnost vožnje in upravljanja strojev.
English: Uncommon (≥ 1/1,000 to < 1/100)
Slovenian: občasni (≥ 1/1 000 do
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 se bo v vaših venah pojavil krvni strdek, se povečuje z leti in če za vas velja kaj od naštetega.
English: Table 3: Cmax and AUC0-24 of Prasterone, Testosterone, and Estradiol on Day 7 Following Daily Administration of Placebo or Intrarosa (mean ± S.D.)
Slovenian: Preglednica 3: Cmax in AUC0-24 prasterona, testosterona in estradiola na 7. dan vsakodnevnega dajanja placeba ali zdravila Intrarosa (povprečje ± SD)
English: There is no consensus about the possible role of varicose veins in VTE.
Slovenian: O morebitni vlogi krčnih žil pri VTE ni soglasja.
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: Čezmerno tveganje se pokaže po nekaj letih uporabe, vendar se v nekaj (največ pet) letih po prenehanju zdravljenja vrne na izhodišče.
English: The applicator should be activated (by pulling back the plunger) before use.
Slovenian: Pri vstavljanju z aplikatorjem je treba upoštevati naslednje korake: aplikator je treba pred uporabo aktivirati (s potegom bata nazaj).
English: • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia);
Slovenian: • rast materničnega sluznice zunaj maternice (endometrioza) ali čezmerna rast maternične sluznice v anamnezi (endometrijska hiperplazija);
English: At baseline, women had ≤ 5.0% superficial cells in the vaginal smear, a vaginal pH ˃ 5.0 and they had identified dyspareunia (moderate to severe) as their most bothersome symptom (MBS) of VVA.
Slovenian: V izhodišču so ženske imele ≤ 5,0 % površinskih celic v vaginalnem brisu in vaginalni pH > 5,0 ter so kot svoj najbolj neprijeten simptom(MBS- most bothersome symptom) VVA navedle disparevnijo (zmerno do hudo).
English: Oral oestrogen-only*3
Slovenian: Samo peroralni estrogen*3
English: Use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see section 4.4).
Slovenian: Uporaba samo estrogena ali kombiniranega estrogensko-progestagenskega HNZ je bila povezana z rahlo povečanim tveganjem za nastanek raka jajčnikov (glejte poglavje 4.4).
English: Posology The recommended dose is 6.5 mg prasterone (one pessary) administered once daily, at bedtime.
Slovenian: Odmerjanje Priporočeni odmerek je 6,5 mg prasterona (ena globula) enkrat na dan, pred spanjem.
English: For more information, see ‘Blood clots in a vein (thrombosis)'
Slovenian: Za več informacij glejte razdelek „Krvni strdki v veni (tromboza)“
English: • yellowing of your skin or the whites of your eyes (jaundice).
Slovenian: • rumeno obarvanje kože ali beločnic (zlatenica).
English: In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk following discussions with their doctor.
Slovenian: V vseh primerih je treba vsaj na vsakih šest mesecev natančno oceniti koristi in tveganja ter zdravljenje z zdravilom Intrarosa po pogovoru z zdravnikom nadaljevati, dokler so koristi večje od tveganj.
English: If a dose is forgotten, it should be taken as soon as the patient remembers.
Slovenian: Če bolnica pozabi uporabiti odmerek, naj ga uporabi takoj, ko se na to spomni.
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 povedati, naj se v primeru, da začutijo potencialen tromemboličen simptom (npr. boleče otekanje noge, nenadno bolečino v prsnem košu, dispnejo), takoj obrnejo na zdravnika.
English: Ovarian cancer is rare - much rarer than breast cancer.
Slovenian: Rak jajčnikov je redek, bistveno redkejši od raka dojk.
English: • you have systemic lupus erythematosus (SLE);
Slovenian: • imate sistemski eritematozni lupus;
English: However Intrarosa is for local treatment in the vagina and the absorption into the blood is very low.
Slovenian: Vendar pa se zdravilo Intrarosa uporablja za lokalno zdravljenje v vagini in se ga v kri absorbira zelo malo.
English: Intrarosa does not affect your ability to drive and use machines.
Slovenian: Zdravilo Intrarosa ne vpliva na sposobnost vožnje in upravljanja strojev.
English: • a liver disorder, such as a benign liver tumour;
Slovenian: • bolezen jeter, npr. benigen tumor jeter;
English: In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when exogenous oestrogens are administered for prolonged periods.
Slovenian: Pri ženskah z intaktno maternico se tveganje za hiperplazijo in rak endometrija pri dolgotrajnem dajanju eksogenih estrogenov poveča.
English: • Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk.
Slovenian: • Pri bolnicah z znanimi trombofilnimi stanji obstaja večje tveganje za VTE, ki ga lahko poveča uporaba HNZ.
English: • Empty your bladder and wash your hands before handling the pessary and applicator.
Slovenian: • Pred prijemanjem globule in aplikatorja izpraznite mehur in si umijte roke.
English: - The active substance is prasterone.
Slovenian: - Učinkovina je prasteron.
English: What you need to know before you use Intrarosa
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Intrarosa
English: The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogenprogestagen and possibly also oestrogen-only systemic HRT, that is dependent on the duration of taking HRT.
Slovenian: Splošni dokazi kažejo povečano tveganje za raka dojk pri ženskah, ki jemljejo kombinirano estrogensko-progestagensko in morda celo samo estrogensko sistemsko HNZ, ki je odvisno od trajanja
English: Stop taking Intrarosa and see a doctor immediately
Slovenian: Zdravilo Intrarosa prenehajte jemati in nemudoma obiščite zdravnika
English: Million Women study- Estimated additional risk of breast cancer after 5 years' use
Slovenian: Študija Million Women - Ocenjeno dodatno tveganje za raka dojk po 5 letih uporabe
English: • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
Slovenian: • akutna bolezen jeter ali bolezen jeter v anamnezi, dokler se izvidi preiskav delovanja jeter ne normalizirajo
English: Non-interventional PASS - Drug Utilisation Study (DUS) to describe the baseline characteristics, utilisation patterns of EU postmenopausal women initiating treatment with Intrarosa and to assess whether EU prescribers abide by the contraindications stated in the EU SmPC.
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet - študija o uporabi zdravil (DUS) za opis osnovnih značilnosti in vzorcev predpisovanja pri ženskah v EU po menopavzi, ki začenjajo zdravljenje z zdravilom Intrarosa, in za oceno,
English: Intrarosa can be inserted in the vagina with the finger or with an applicator provided within the identified pack.
Slovenian: Zdravilo Intrarosa se lahko vstavi v vagino s prstom ali z aplikatorjem, ki je v škatli.
English: Intrarosa has not been studied in women with endometrial hyperplasia.
Slovenian: Zdravila Intrarosa pri ženskah s hiperplazijo endometrija niso proučevali.
English: For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users.
Slovenian: Pri ženskah, starih od 50 do 54 let, je 5-letna uporaba HNZ povzročila približno en dodaten primer na 2.000 uporabnic.