FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reaction observed with prasterone 6.5 mg pessaries obtained from clinical studies is tabulated below.
Slovenian: Preglednica z neželenimi učinki Neželeni učinki, opaženi pri zdravljenju z globulami 6,5 mg prasterona, ki so bili pridobljeni iz kliničnih študij, so prikazani v preglednici spodaj.
English: The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
Slovenian: Uporaba samo estrogenskega HNZ je bila povezana z rahlo povečanim tveganjem za raka jajčnikov.
English: Pregnancy Intrarosa is not indicated in pre-menopausal women of child-bearing age, including pregnancy.
Slovenian: Zdravilo Intrarosa ni indicirano za zdravljenje predmenopavznih žensk v rodni dobi, vključno nosečnic.
English: The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited.
Slovenian: Izkušnje pri zdravljenju žensk s prezgodnjo menopavzo (zaradi odpovedi jajčnikov ali operacije) so omejene.
English: It is available in blister packs of 28 pessaries with 6 applicators.
Slovenian: Na voljo je v škatli s pretisnim omotom z 28 globulami in šestimi aplikatorji.
English: Coronary artery disease (CAD)/ Hypertension
Slovenian: Bolezen koronarnih arterij (BKA)/hipertenzija
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: Sistemsko HNZ je povezano z 1,3-3-krat večjim tveganjem nastanka venske trombembolije (VTE), tj. globoke venske tromboze ali pljučne embolije.
English: Do not use two pessaries to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: However, if the next dose is due in less than 8 hours, skip the missed pessary.
Slovenian: Če pa naslednji odmerek sledi prej kot po osmih urah, zamujeno globulo preskočite.
English: Prasterone was not mutagenic or clastogenic in a standard battery of in vitro and in vivo studies.
Slovenian: Prasteron v standardni bateriji študij in vitro in in vivo ni bil mutagen ali klastogen.
English: Intrarosa is a white to off-white, bullet-shaped pessary approximately 28 mm long and 9 mm in diameter at its widest end.
Slovenian: Zdravilo Intrarosa je bela do belkasta globula v obliki naboja, dolga približno 28 mm in s premerom 9 mm v najširšem delu.
English: Estradiol
Slovenian: Estradiola
English: In clinical trials, no deep vein thrombosis has been observed with intravaginal prasterone while one case of pulmonary embolism which corresponds to an incidence lower with Intrarosa than in the placebo group.
Slovenian: V kliničnih preskušanjih z intravaginalnim prasteronom niso opazili nobenega primera globoke venske tromboze, opažen pa je bil en primer pljučne embolije, kar ustreza nižji pojavnosti pri zdravilu
English: Table 2: Percentage of Patients with Improvement, Relief or Substantial Improvement of MBS Dyspareunia after 12 Weeks on Intrarosa vs.
Slovenian: Preglednica 2: Odstotek bolnic z izboljšanjem, olajšanjem ali bistvenim izboljšanjem MBS disparevnije po 12 tednih zdravljenja z zdravilom Intrarosa v primerjavi s placebom (ITT; LOCF).
English: How much to use Use one pessary once a day, at bedtime.
Slovenian: Uporabljajte eno globulo enkrat na dan, pred spanjem.
English: What Intrarosa looks like and contents of the pack
Slovenian: Izgled zdravila Intrarosa in vsebina pakiranja
English: • Gently slide the pessary end of the applicator into your vagina as far as it will comfortably go.
Slovenian: • Počasi potisnite aplikator z globulo v vagino tako daleč, kolikor gre.
English: Prasterone is metabolised into estrogenic compounds.
Slovenian: Prasteron se presnovi v estrogenske spojine.
English: • Previous or current venous thromboembolism (deep vein thrombosis, pulmonary embolism);
Slovenian: • pretekla ali sedanja venska tromboza (globoka venska tromboza, pljučna embolija)
English: Ovarian cancer is much rarer than breast cancer.
Slovenian: Rak jajčnikov Rak jajčnikov je bistveno redkejši od raka dojk.
English: The risk of haemorrhagic stroke is not increased during use of HRT.
Slovenian: Tveganje za hemoragično možgansko kap pri uporabi HNZ ni povečano.
English: − with a common frequency (may affect up to 1 in 10 people): abnormal Pap smear (mostly
Slovenian: - pogostih (ki se lahko pojavijo pri največ 1 od 10 bolnic): nenormalni bris PAP (večinoma ASCUS ali
English: • If you have excessive thickening of the womb lining (endometrial hyperplasia ) that is not being treated;
Slovenian: • Če imate čezmerno zadebeljeno maternično sluznico (hiperplazija endometrija) in tega ne zdravite.
English: Risk ratio & 95%CI#
Slovenian: Razmerje tveganj in 95% IZ#
English: The following risks have been associated with systemic HRT and apply to a lesser extent for oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range.
Slovenian: S sistemskim hormonskim nadomestnim zdravljenjem (HNZ) so povezana naslednja tveganja, ki v manjši meri veljajo za estrogenska zdravila za vaginalno uporabo, pri kateri ostaja sistemska izpostavljenost estrogenom v normalnem pomenopavznem območju.
English: US WHI studies - additional risk of breast cancer after 5 years' use
Slovenian: Študije US WHI - dodatno tveganje za raka dojke po 5 letih uporabe
English: What Intrarosa is used for
Slovenian: Za kaj se zdravilo Intrarosa uporablja
English: The pessary should be inserted in the vagina as far as it can comfortably go without force.
Slovenian: Vaginalno globulo je treba v vagino vstaviti tako daleč, kolikor gre brez sile.
English: Age range (years)
Slovenian: Starostni razpon (let)
English: Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Slovenian: Čezmerna zadebelitev maternične sluznice (hiperplazija endometrija) in rak maternične sluznice
English: Compare
Slovenian: Primerjajte
English: • Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4);
Slovenian: • znane trombofilne bolezni (npr. pomanjkanje beljakovine C, beljakovine S ali antitrombina, glejte poglavje 4.4.)
English: Table 2 shows the percentage of subjects who reported a change from baseline in their MBS dyspareunia at week 12.
Slovenian: V preglednici 2 je prikazan odstotek oseb, ki so v 12. tednu poročale o spremembi MBS disparevnije glede na izhodiščno vrednost.
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 nastanek raka maternične sluznice (endometrija).
English: Intrarosa is used to treat postmenopausal women having moderate to severe symptoms of vulvar and vaginal atrophy.
Slovenian: Zdravilo Intrarosa se uporablja pri ženskah po menopavzi z zmernimi do hudimi simptomi atrofije vulve in vagine.
English: Pessary 28 pessaries and 6 applicators.
Slovenian: vaginalne globule 28 vaginalnih globul in šest aplikatorjev.
English: • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”);
Slovenian: • povečano tveganje za nastanek krvnih strdkov (glejte razdelek „Krvni strdki v veni
English: Age range (years) Incidence per 1000 women in placebo arm over 5 years
Slovenian: Starost (v letih) Incidenca na 1.000 žensk v skupini, ki je jemala placebo, v 5 letih
English: • Leave your index (pointer) finger free to press the applicator plunger after the applicator is inserted into your vagina.
Slovenian: • Kazalec pustite prost, da potisnete bat aplikatorja, potem ko ste aplikator vstavili v vagino.
English: • Undiagnosed genital bleeding;
Slovenian: • nepojasnjena genitalna krvavitev
English: What Intrarosa is and what it is used for
Slovenian: Kaj je zdravilo Intrarosa in za kaj ga uporabljamo
English: It is not required to stop Intrarosa if vaginal discharge occurs (see section 4.4).
Slovenian: Če se pojavi vaginalni izcedek, zdravljenja z zdravilom Intrarosa ni treba prekiniti (glejte poglavje 4.4).
English: 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.
Slovenian: npr. kortikoide vezoči globulin (CBG- corticoid binding globulin) ali spolne hormone vežoči globulin (SHBG- sex-hormone-binding globulin), kar vodi v zvišanje kortikosteroidov oz. spolnih steroidov v obtoku.
English: Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
Slovenian: Zdravilo Intrarosa je indicirano za zdravljenje atrofije vulve in vagine pri ženskah po menopavzi, ki imajo zmerne do hude simptome.
English: • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina;
Slovenian: • Če imate ali ste nedavno imeli bolezen, ki so jo povzročili krvni strdki v arterijah, npr.
English: None of these conditions has been observed with Intrarosa during the clinical trials.
Slovenian: Pri zdravilu Intrarosa med kliničnimi preskušanji ni bilo ugotovljeno nobeno od teh stanj.
English: Elderly No dose adjustment is considered necessary in elderly women.
Slovenian: Pri starejših bolnicah odmerka ni treba prilagajati.
English: Risk ratio and 95%CI
Slovenian: Razmerje tveganj in 95-% IZ
English: Concomitant use with systemic hormone replacement therapy (oestrogen-only or oestrogenprogestagen combination or androgen treatment) or vaginal oestrogens has not been investigated and is therefore not recommended.
Slovenian: Hkratne uporabe s sistemskim hormonskim nadomestnim zdravljenjem (samo z estrogenom ali kombinacijo estrogena in progestagena ali androgena) ali vaginalnimi estrogeni niso proučevali, zato se je ne priporoča.
English: WHI studies combined - Additional risk of ischaemic stroke*4 over 5 years' use
Slovenian: Študije WHI skupaj - dodatno tveganje za ishemično kap*4 več kot 5 let uporabe
English: Efficacy data were obtained from two US and Canadian randomised, double-blind, placebo-controlled, multicentre, pivotal phase III trials (ERC-231/Trial 1 and ERC-238/Trial 2) performed in postmenopausal women aged 40 to 80 years (mean age = 58.6 years in Trial 1 and 59.5 years in Trial 2) with vulvar and vaginal atrophy (VVA ).
Slovenian: 238/preskušanje 2) pri ženskah po menopavzi, starih od 40 do 80 let (povprečna starost = 58,6 let v preskušanju 1 in 59,5 leta v preskušanju 2), z atrofijo vulve in vagine (VVA- vulvar and vaginal atrophy).
English: Each pessary contains 6.5 mg of prasterone.
Slovenian: Ena globula vsebuje 6,5 mg prasterona.
English: • Insert one prasterone pessary in your vagina once a day at bedtime with an applicator or your finger.
Slovenian: • V vagino enkrat na dan pred spanjem z aplikatorjem ali prstom vstavite eno globulo s prasteronom.
English: The applicator should be inserted into the vagina as far as it can comfortably go without force.
Slovenian: Aplikator vstavite tako daleč v vagino, kolikor gre brez sile.
English: • you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots;
Slovenian: • imate izrazito čezmerno telesno maso (ITM > 30 kg/m2); • imate težave s strjevanjem krvi, ki jih je treba dolgo časa zdraviti z zdravilom za preprečevanje nastanka krvnih strdkov;
English: How to use Insert the pessary into the vagina with your finger or with an applicator provided in the pack.
Slovenian: Način uporabe vaginalna uporaba Zdravilo Intrarosa se lahko vstavi v vagino s prstom ali z aplikatorjem, ki je v pakiranju.
English: This is due to melting of the hard fat used as vehicle, added to the expected increase in vaginal secretions due to treatment.
Slovenian: ki služi kot vehikel, ob pričakovanem povečanju količine vaginalnih izločkov zaradi zdravljenja.
English: Intrarosa has not been studied in women with history of thromboembolic diseases, uncontrolled hypertension or heart disease.
Slovenian: Učinek HNZ na srce in obtočila Zdravila Intrarosa niso proučevali pri ženskah z anamnezo trombemboličnih bolezni, nenadzorovane hipertenzije ali bolezni srca.
English: It should be taken into account that these conditions may recur or be aggravated during treatment with Intrarosa, in particular: - Leiomyoma (uterine fibroids) or endometriosis - Risk factors for thromboembolic disorders (see below) - Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer - Hypertension - Liver disorders (e.g. liver adenoma) - Diabetes mellitus with or without vascular involvement - Cholelithiasis - Migraine or (severe) headache - Systemic lupus erythematosus.
Slovenian: - dejavniki tveganja za od estrogena odvisne tumorje, npr. dedovanje v prvem kolenu pri raku dojk, - hipertenzija, - bolezni jeter (npr. adenom jeter), - sladkorna bolezen s prizadetostjo ožilja ali brez nje, - holelitiaza, - migrena ali (hud) glavobol, - sistemski eritematozni lupus, - hiperplazija endometrija v anamnezi (glejte spodaj), - epilepsija, - astma, - otoskleroza.
English: • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestagen therapy for more than 5 years.
Slovenian: • Pri ženskah, ki so se zdravile z estrogensko-progestagenskim zdravljenjem več kot 5 let, so poročali o 2-krat povečanem tveganju za diagnozo raka dojk.
English: Intrarosa is for use in postmenopausal women only.
Slovenian: Zdravilo Intrarosa je namenjeno za uporabo samo pri ženskah po menopavzi.
English: Cases of breast and ovarian cancer have been reported in women treated with 6.5 mg of prasterone for 52 weeks (see section 4.4).
Slovenian: Pri ženskah, ki so bile 52 tednov zdravljene s 6,5 mg prasterona, so poročali o primerih raka dojk in jajčnikov (glejte poglavje 4.4).
English: No case of coronary artery disease has been reported during clinical trials.
Slovenian: Med kliničnim preskušanjem niso poročali o nobenem primeru bolezni koronarnih arterij.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Intrarosa in all subsets of the paediatric population.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom
English: One case of breast cancer at week 52 has been reported on 1196 women who have been exposed with the 6.5 mg dose which is below the incidence rate observed in the normal population of the same age.
Slovenian: 1 196 ženskah, ki so bile izpostavljene 6,5-miligramskemu odmerku, so po 52 tednih poročali o enem primeru raka dojk, kar je pod stopnjo pojavnosti, opazovano pri normalni populaciji iste starosti.
English: Figure 1: Serum Concentrations of Prasterone (A), Testosterone (B), and Estradiol (C) Measured Over a 24h Period on Day 7 Following Daily Administration of Placebo or Intrarosa (mean ± S.D.)
Slovenian: Slika 1: Serumske koncentracije prasterona (A), testosterona (B) in estradiola (C), merjene v 24
English: Additional cases per 1000 HRT users over 5 years
Slovenian: Dodatnih primerov na 1.000 uporabnic HNZ v 5 letih
English: • Known or suspected oestrogen-dependent malignant tumours (e.g endometrial cancer);
Slovenian: • znani od estrogena odvisni maligni tumorji (npr. rak endometrija) ali sum nanje
English: Do not take Intrarosa if any of the following applies to you.
Slovenian: če za vas velja kar koli od naslednjega.
English: WHI Studies - Additional risk of VTE over 5 years' use
Slovenian: Študije WHI - dodatno tveganje za VTE po 5 letih uporabe
English: • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining
Slovenian: • Če imate raka, ki je občutljiv na estrogene, npr. raka maternične sluznice (endometrija), ali če obstaja sum, da bi ga lahko imeli.
English: • blood clots in the veins of the legs or lungs (venous thromboembolism);
Slovenian: • rak jajčnikov; • krvni strdki v venah nog ali pljučih (venska trombembolija)
English: The most frequently observed adverse reaction was vaginal discharge.
Slovenian: Povzetek varnostnega profila Najpogosteje opaženi neželeni učinek je bil vaginalni izcedek.
English: Additional cases per 1000 HRT users over 5 years (95%CI)
Slovenian: Dodatnih primerov na 1.000 uporabnic HNZ v 5 letih (95-% IZ)
English: Incidence per 1000 women in placebo arm over 5 years
Slovenian: Incidenca na 1.000 žensk v skupini, ki je jemala placebo, v 5 letih
English: The use of Intraorsa in combination with hormone replacement therapy (oestrogen-only or oestrogenprogestagen combination or androgen treatment) or vaginal oestrogens is not recommended.
Slovenian: Uporaba zdravila Intrarosa v kombinaciji s hormonskim nadomestnim zdravljenjem (samo z estrogenom ali kombinacijo estrogena in progestagena ali androgena) ali vaginalnimi estrogeni ni priporočljiva.
English: The following diseases are reported more often in women using HRT medicines which circulate in the blood compared to women not using HRT.
Slovenian: Pri ženskah, ki jemljejo zdravila za HNZ, ki vstopajo v kri, so v primerjavi z ženskami, ki ne uporabljajo HNZ, pogosteje poročali o naslednjih boleznih: Ta tveganja so manjša pri estrogenskih zdravilih, ki se dajejo v vagino.
English: In a study conducted in postmenopausal women, administration of the Intrarosa pessary once daily for 7 days resulted in a mean prasterone Cmax and area under the curve from 0 to 24 hours (AUC0-24) at day 7 of 4.4 ng/mL and 56.2 ng h/mL, respectively, which were significantly higher than those in the group treated with placebo (Table 3; Figure 1).
Slovenian: V študiji, opravljeni pri ženskah po menopavzi, je uporaba globul zdravila Intrarosa enkrat na dan 7 dni privedla do povprečnega Cmax in površine pod krivuljo od 0 do 24 ur (AUC0-24) 4,4 ng/ml in
English: For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Slovenian: Na primer pri ženskah, starih od 50 do 54 let, bodo v 5-letnem obdobju diagnosticirali raka jajčnikov pri približno dveh ženskah od 2.000.
English: Speak to your doctor for advice.
Slovenian: Posvetujte se z zdravnikom.
English: Breast-feeding Intrarosa is not indicated during breast-feeding.
Slovenian: Dojenje Zdravilo Intrarosa ni indicirano med dojenjem.
English: Intrarosa contains the active substance prasterone.
Slovenian: Zdravilo Intrarosa vsebuje učinkovino prasteron.
English: Ischaemic stroke
Slovenian: Ishemična kap
English: Patients with renal and/or hepatic impairment
Slovenian: Bolnice z okvaro ledvic in/ali jeter
English: Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
Slovenian: Pojav krvnega strdka v veni bi v petletnem obdobju v povprečju pričakovali pri 4 do 7 ženskah od 1.000 v 50. letih, ki ne jemljejo HNZ.
English: Cases of abnormal Pap smears either Atypical Squamous Cells of Undetermined Significance (ASCUS) or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported with a common frequency in women treated with Intrarosa for 52 weeks (see section 4.4).
Slovenian: Pri ženskah, ki so bile 52 tednov zdravljene z zdravilom Intrarosa, so poročali o primerih nenormalnih brisov PAP, bodisi z atipičnimi ploščatimi celicami nedoločenega pomena (ASCUS) ali s ploščatocelično intraepitelijsko lezijo nizke stopnje (LSIL) (glejte poglavje 4.4).
English: If vaginal discharge occurs, it is not required to stop Intrarosa.
Slovenian: Če se pojavi izcedek iz vagine, zdravljenja z zdravilom Intrarosa ni treba prekiniti.
English: No cases of arterial thromboembolic disease have been reported during clinical trials.
Slovenian: Med kliničnim preskušanjem niso poročali o nobenem primeru arterijske trombembolične bolezni.
English: In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Slovenian: Pri ženskah, starih od 50 do 54 let, bodo v 5-letnem obdobju diagnosticirali raka jajčnikov pri približno dveh ženskah od 2.000.
English: Additional cases per 1000 never-users of HRT over a 5 year period*1
Slovenian: Dodatnih primerov na 1.000 žensk, ki nikoli niso uporabljale HNZ, v obdobju petih let *1
English: The occurrence of such an event is more likely in the first year of using HT (see section 4.4).
Slovenian: Pojav takega dogodka je verjetnejši v prvem letu HNZ
English: The following side effects have been reported with HRT containing estrogens but not with Intrarosa during clinical trials:
Slovenian: Pri HNZ, ki vsebuje estrogene, ne pa tudi pri zdravilu Intrarosa v času trajanja kliničnih preskušanj, so poročali o naslednjih neželenih učinkih:
English: • gallstones;
Slovenian: • žolčni kamni;
English: Speak to your doctor if you think this dose is too strong or not strong enough.
Slovenian: Če menite, da je odmerek premočen ali ni dovolj močen, se pogovorite z zdravnikom.
English: Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period.
Slovenian: Možgansko kap bi v petletnem obdobju pričakovali v povprečju pri 8 ženskah od 1.000 v 50. letih, ki ne jemljejo HNZ.
English: • Tear off one wrapped pessary from the 7-pessary strip.
Slovenian: • S traka s sedmimi globulami odtrgajte ovito globulo.
English: • 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).
Slovenian: • Estrogeni povečujejo tiroksin-vezoči globulin (TBG- thyroid binding globulin), kar vodi v porast celokupnega ščitničnega hormona, merjeno z na beljakovine vezanim jodom (PBI),
English: This is likely due to melting of the hard fat added to an expected increase in vaginal secretions due to treatment.
Slovenian: Do tega pride zaradi topljenja trde masti, ki med zdravljenjem pričakovano poveča količino vaginalnih izločkov.
English: Prasterone corrects the symptoms and signs of vulvar and vaginal atrophy by replacing the oestrogens which are normally produced before menopause by the ovaries of women.
Slovenian: Prasteron z nadomeščanjem estrogenov, ki jih pri ženskah pred menopavzo normalno tvorijo jajčniki,
English: If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe' (e.g, antithrombin, protein S, or protein C deficiencies or a combination of defects) HRT is contraindicated.
Slovenian: „huda“ (npr. pomanjkanje antitrombina, beljakovine S ali beljakovine C ali kombinacija okvar), je HNZ kontraindiciran.
English: • breast cancer;
Slovenian: • rak dojke;
English: If you become pregnant, stop taking Intrarosa and contact your doctor.
Slovenian: Intrarosa prenehajte jemati in se posvetujte z zdravnikom.
English: However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age (see section 4.8).
Slovenian: Ker pa je izhodiščno tveganje za kap zelo odvisno od starosti, se bo splošno tveganje za kap pri ženskah, ki uporabljajo
English: One case of pulmonary embolism has been reported in the 6.5 mg group and one in the placebo group during clinical trials.
Slovenian: 6,5-miligramski odmerek, o enem pa pri bolnicah, ki so jemale placebo.
English: Cervical/ uterine polyps Breast mass (benign)
Slovenian: Polipi na materničnem vratu/maternici Tvorba v dojki (benigna)
English: Intrarosa has not been studied in women with current or previous arterial thromboembolic disease.
Slovenian: Zdravilo Intrarosa pri ženskah s trenutno ali preteklo arterijsko trombembolično boleznijo ni bilo proučevano.
English: How to store Intrarosa
Slovenian: Kako uporabljati zdravilo Intrarosa
English: • Press the applicator plunger with your index (pointer) finger to release the pessary.
Slovenian: • S kazalcem pritisnite na bat aplikatorja, da sprostite globulo.
English: Intrarosa 6,5 mg pessary prasterone
Slovenian: Intrarosa 6,5 mg vaginalne globule prasteron