natgillin/translations-raw huggingface dataset:
Final study report by Q4 2021
Končno poročilo o študiji do četrtega četrtletja leta 2021.
The applicator should be kept in a clean place until next use.
Aplikator je treba do naslednje uporabe hraniti na čistem mestu.
During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Med zdravljenjem so priporočeni redni kontrolni pregledi, katerih pogostost in narava naj bo prilagojena posameznici.
- The only other ingredient is the hard fat (adeps solidus).
- Edina druga sestavina je trda mast (adeps solidus).
If prolonged immobilisation is to follow elective surgery temporarily stopping HRT 4 to 6 weeks earlier is recommended.
Če bo elektivni operaciji sledila dolgotrajna imobilizacija, je štiri do šest tednov pred tem priporočljivo začasno prekiniti HNZ.
The relative risk does not change with age or time since menopause.
Relativno tveganje ni odvisno od starosti ali časa od menopavze.
Risk of coronary artery disease
Tveganje za koronarno arterijsko bolezen
• probable memory loss if HRT is started over the age of 65.
• verjetna izguba spomina, če se HNZ začne po 65. letu.
Pharmacotherapeutic group: Other sex hormones and modulators of the genital system, ATC code: G03XX01.
Farmakoterapevtska skupina: Drugi spolni hormoni in zdravila za uravnavanje delovanja spolovil, oznaka ATC: G03XX01.
It is uncertain whether a risk exists with Intrarosa used for long term (more than one year) treatments.
Ni znano, ali tveganje obstaja pri uporabi zdravila Intrarosa za dolgotrajno zdravljenje (dlje kot eno leto).
• Carefully remove the pessary from the plastic wrap.
• Globulo previdno vzemite iz plastičnega ovoja.
It is inserted into your vagina, so the hormone is released where it is needed.
Vstavite ga v vagino, tako da se hormon sprošča, kjer je potrebno.
A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.311.56).
Pri metaanalizi 52 epidemioloških študij so poročali o povečanem tveganju za raka jajčnikov pri ženskah, ki trenutno uporabljajo HNZ, v primerjavi z ženskami, ki niso nikoli uporabljale HNZ (RT 1,43; 95-% IZ 1,31-1,56).
• if any of your close relatives has ever had a blood clot in the leg, lung or another organ;
• če je kateri od vaših bližnjih sorodnikov kdaj imel krvni strdek v nogah, pljučih ali drugem organu;
Standing position
Stoječ položaj
A. Using the applicator
A. Uporaba aplikatorja
• To wash the applicator:
• Čiščenje aplikatorja:
- Probable dementia over the age of 65 (see section 4.4).
- Verjetna demenca po 65. letu starosti (glejte poglavje 4.4).
• Remove the applicator.
• Odstranite aplikator.
• If you have any unexplained vaginal bleeding;
• Če imate kakršno koli nepojasnjeno krvavitev iz vagine.
If you get bleeding or spotting, it's usually nothing to worry about, but you should make an appointment to see your doctor.
Če bi se pri vas pojavila krvavitev ali krvav izcedek, to običajno ni nič zaskrbljujočega, vendar se dogovorite za pregled pri zdravniku.
• If you are allergic (hypersensitive) to prasterone or any of the other ingredients of Intrarosa (listed in section 6 Further information).
• Če ste alergični (preobčutljivi) na prasteron ali katero koli sestavino zdravila Intrarosa (navedeno v poglavju 6: Nadaljnje informacije).
• epilepsy;
• epilepsija;
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If you notice any of the following when taking HRT:
Če med jemanjem HNZ opazite kar koli od naslednjega:
Once you have started on Intrarosa you should see your doctor for regular check-ups (at least every 6 months).
Ko začnete jemati zdravilo Intrarosa, morate pri zdravniku redno opravljati kontrolne preglede (vsaj vsakih 6 mesecev).
However, it returns to normal within a few years (at most 5) after stopping treatment.
Pokaže se v nekaj letih, vendar se v nekaj letih (največ petih) po prenehanju zdravljenja vrne na normalno.
You may need to stop taking Intrarosa about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein).
Zdravilo Intrarosa boste približno štiri do šest tednov pred operacijo morda morali prenehati jemati, da zmanjšate nevarnost nastanka krvnega strdka (glejte poglavje 2 - krvni strdki v veni).
However, Intrarosa has been shown to have very low absorption into the blood, therefore the addition of a progestagen is not necessary.
Vendar se je pokazalo, da se zdravilo Intrarosa zelo slabo absorbira v kri, zato dodajanje progestagena ni potrebno.
At these check-ups, discuss with your doctor the benefits and risks of continuing with Intrarosa.
Pri teh pregledih se z zdravnikom pogovorite o koristih in tveganjih nadaljevanja zdravljenja z zdravilom Intrarosa.
Do not use this medicine after the expiry date which is stated on the carton and blisters after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnih omotih poleg oznake „EXP“.
4 *no differentiation was made between ischaemic and haemorrhagic stroke.
4*ni bilo razlikovanja med ishemično in hemoragično kapjo.
• This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age, see section 4.4.
• To relativno tveganje ni odvisno od starosti ali trajanja uporabe, ker pa je od starosti močno odvisno izhodiščno tveganje, se bo skupno tveganje za kap pri ženskah, ki uporabljajo HNZ, s starostjo povečevalo, glejte poglavje 4.4.
Pull back on the plunger until it stops to activate the applicator.
Povlecite bat, dokler se ne ustavi, da aktivirate aplikator.
HRT is therefore contraindicated in these patients (see section 4.3).
HNZ je zato pri teh bolnicah odsvetovano (glejte poglavje 4.3).
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness);
• velik porast krvnega tlaka (simptomi so lahko glavobol, utrujenost, omotica);
• If you have a rare blood problem called “porphyria” which is passed down in families (inherited);
• Če imate redko bolezen krvi, imenovano „porfirija“, ki se prenaša v družinah (z dedovanjem).
If you are going to have surgery, tell the surgeon that you are taking Intrarosa.
Če boste potrebovali operacijo, kirurgu povejte, da jemljete zdravilo Intrarosa.
T3 resin uptake is decreased, reflecting the elevated TBG.
Privzem T3 s smolami je zmanjšan, kar odraža zvišani TBG.
Carcinogenic and reproductive and development toxicity studies were not performed.
Študij karcinogenosti ter vpliva na sposobnost razmnoževanja in razvojne toksičnosti niso izvedli.
Hard fat (adeps solidus).
Trda mast (adeps solidus)
For more information about these side effects, see section 2.
Za več informacij o neželenih učinkih glejte poglavje 2.
If you forget to use a pessary, insert one as soon as you remember.
Če ste pozabili uporabiti globulo, jo vstavite takoj, ko se na to spomnite.
If you forget to use Intrarosa
Če ste pozabili uporabiti zdravilo Intrarosa
• fibroids inside your womb;
• fibroide v maternici;
As in all postoperative patients, prophylactic measures need be considered to prevent VTE following surgery.
Tako kot pri vseh bolnikih po operaciji, so po operaciji potrebni profilaktični ukrepi za preprečevanje VTE.
What you need to know before you use Intrarosa 3.
Kaj morate vedeti, preden boste uporabili zdravilo Intrarosa 3.
Blister composed of an outer layer of PVC and an inner layer of LDPE.
Pretisni omot, sestavljen iz zunanje plasti PVC in notranje plasti LDPE.
The flat end of the pessary should be placed into the open end of the activated applicator.
Ploščati konec globule je treba postaviti v odprti konec aktiviranega aplikatorja.
• Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed.
• Estrogeni lahko povzročijo zadrževanje tekočine, zato je treba bolnice s srčno ali ledvično disfunkcijo natančno opazovati.
It is less likely that the conditions mentioned below will get worse or come back during treatment with Intrarosa, but you should see your doctor if you are concerned.
Manj verjetno je, da se bodo spodaj navedene bolezni med zdravljenjem z zdravilom Intrarosa poslabšale ali ponovile, vendar se posvetujte z zdravnikom, če ste zaskrbljeni glede tega.
Treatment should not be restarted until the woman is completely mobilised.
dokler ni ženska popolnoma mobilizirana.
• The risk of coronary artery disease is slightly increased in users of combined oestrogen-progestagen HRT over the age of 60 (see section 4.4).
• Tveganje za koronarno arterijsko bolezen je nekoliko povečano pri uporabnicah kombiniranega estrogensko-progestagenskega HNZ, starejših od 60 let (glejte poglavje 4.4).
Placebo (N=9)
Placeba (N = 9)
Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, ceruloplasmin).
Zvišajo se lahko druge plazemske beljakovine (substrat angiotenzinogen/renin, antitripsin alfa-1, ceruloplazmin).
In the event of overdose, vaginal douching is recommended.
V primeru prevelikega odmerka se priporoča izpiranje vagine.
The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in non-users, especially during the first year of taking it.
Tveganje za krvne strdke v venah je pri uporabnicah HNZ približno 1,3- do 3-krat večje kot pri neuporabnicah, še posebej v prvem letu jemanja.
• Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestagen combinations.
• Vsako povečano tveganje za uporabnice samo estrogenskega zdravljenja je bistveno manjše kot pri uporabnicah kombinacije estrogena in progestagena.
• increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer);
• povečano tveganje za nastanek od estrogena odvisnega raka (npr. če imate mater, sestro ali babico, ki ima raka dojk);
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik
Lying position
Ležeč položaj
Each applicator should be discarded after one week of usage (two extra applicators are provided).
Po enem tednu uporabe je treba aplikator zavreči (na voljo sta dva dodatna aplikatorja).
Therapy should be discontinued in case a contraindication is discovered and in the following situation: - Jaundice or deterioration in liver function - Significant increase in blood pressure - New onset of migraine-type headache - Pregnancy.
Zdravljenje je treba prekiniti v primeru odkritja kontraindikacije in v naslednjih primerih: - zlatenica ali poslabšanje delovanja jeter, - pomembno zvišanje krvnega tlaka, - nov pojav glavobola migrenske vrste,
Therefore caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis since intravaginal prasterone has not been studied in women with endometriosis.
Zato je pri uporabi tega zdravila pri ženskah, pri katerih je bila zaradi endometrioze opravljena histerektomija, potrebna posebna previdnost, zlasti če je znano, da so imele rezidualno endometriozo, saj intravaginalni prasteron pri ženskah z endometriozo ni bil raziskan.
The side effect the most frequently reported in the clinical studies was vaginal discharge.
Neželeni učinek, o katerem so v kliničnih študijah najpogosteje poročali, je bil vaginalni izcedek.
• Slowly pull the plastic tabs on the pessary away from each other while keeping the pessary still between your fingers.
• S potegom počasi razmaknite oba plastična jezička na globuli, pri čemer globulo še vedno držite med prsti.
If you are not sure about any of the points below, talk to your doctor before taking Intrarosa,
Če o kateri koli od spodaj navedenih točk niste prepričani, se pogovorite z zdravnikom, preden vzamete zdravilo Intrarosa.
Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Intrarosa.
Če ste kdaj imeli katero od naslednjih težav, o tem pred začetkom zdravljenja povejte svojemu zdravniku, saj se lahko te težave med zdravljenjem z zdravilom Intrarosa ponovijo ali poslabšajo.
The applicator must be activated before use.
Aplikator morate pred uporabo aktivirati.
How to store Intrarosa 6.
Shranjevanje zdravila Intrarosa 6.
• Place the flat end of the pessary into the open end of the activated applicator as shown.
• Ploščati konec globule postavite v odprti konec aktiviranega aplikatorja, kot je prikazano.
For signs of a blood clot, see “Stop taking Intrarosa and see a doctor immediately”.
Glede znakov krvnih strdkov glejte razdelek „Zdravilo Intrarosa prenehajte jemati in nemudoma obiščite zdravnika“.
• Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
• Splošno prepoznani dejavniki tveganja za VTE vključujejo uporabo estrogenov, višjo starost, večjo operacijo, dolgotrajno imobilizacijo, debelost (ITM > 30 kg/m2), nosečnost/poporodno obdobje, sistemski eritematozni lupus in raka.
• Women already on chronic anticoagulant treatment require careful consideration of the benefitrisk of use of HRT.
• Pri ženskah, ki se kronično zdravijo z antikoagulantnimi zdravili, je treba skrbno razmisliti o koristih in tveganjih uporabe HNZ.
An oestrogen-mediated increase in the number of superficial and intermediate cells and decrease in the number of parabasal cells in the vaginal mucosa is noted.
Pojavi se estrogensko posredovano povečanje števila površinskih in vmesnih celic ter zmanjšanje števila parabazalnih celic v vaginalni sluznici.
Follow the above instructions of Step 2, and then insert the pessary into the vagina with your finger as far as it can comfortably go. Do not use force.
Sledite navodilom 2. koraka in nato globulo vstavite v vagino s prstom, kolikor daleč udobno gre.
Physical (including pelvic and breast) examination should be guided by this and by the contraindications and special warnings and precautions for use according to the decision of their doctor.
Telesni pregled (vključno s pregledom medenice in dojk) naj se ravna po tem ter po kontraindikacijah in posebnih opozorilih in previdnostnih ukrepih skladno z odločitvijo zdravnika.
• If you have a vaginal infection you will need a course of antibiotics before taking Intrarosa.
• Če imate vaginalno okužbo, boste pred jemanjem zdravila Intrarosa potrebovali antibiotično zdravljenje.
Use of Intrarosa with condoms, diaphragms or cervical caps made of latex must be avoided since the rubber may be damaged by the preparation.
Treba se je izogibati uporabi zdravila Intrarosa s kondomi, diafragmami ali cervikalnimi kapicami, ker lahko pripravek poškoduje gumo.
The beneficial effects on the symptoms and signs of vulvar and vaginal atrophy are exerted through activation of the vaginal oestrogen and androgen receptors.
Koristni učinki na simptome in znake atrofije vulve in vagine so posredovani prek aktivacije vaginalnih estrogenskih in androgenskih receptorjev.
For the treatment of postmenopausal symptoms, Intrarosa should only be initiated for symptoms that adversely affect quality of life.
Za zdravljenje pomenopavznih simptomov se naj zdravilo Intrarosa uvede šele, ko simptomi negativno vplivajo na kakovost življenja.
• If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
• Če bi se kadar koli med zdravljenjem pojavila krvavitev ali krvavi izcedek, je treba odkriti vzrok, kar lahko vključuje biopsijo endometrija za izključitev raka na endometriju.
What Intrarosa is and what it is used for 2.
Kaj je zdravilo Intrarosa in za kaj ga uporabljamo 2.
Intrarosa contains the active ingredient prasterone, i.e. dehydroepiandrosterone (DHEA), which is biochemically and biologically identical to the endogenous human DHEA, a precursor steroid which is inactive by itself and it is converted into oestrogens and androgens.
Zdravilo Intrarosa vsebuje učinkovino prasteron, tj. dehidroepiandrosteron (DHEA), ki je biokemično in biološko identičen endogenemu humanemu DHEA, steroidnemu prekurzorju, ki je sam po sebi neaktiven in se pretvori v estrogene in androgene.
If pregnancy occurs during treatment with Intrarosa, the treatment should be withdrawn immediately.
Če pride med zdravljenjem z zdravilom Intrarosa do nosečnosti, je treba zdravljenje takoj prekiniti.
• migraine or severe headaches;
• migrena ali hudi glavoboli;
• In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).
• Pri ženskah brez VTE v osebni anamnezi vendar s sorodnikom v prvem kolenu z anamnezo tromboze v otroštvu se lahko po skrbnem svetovanju (s presejanjem se ugotovi le določen del trombofilnih okvar) glede njegovih omejitev ponudi presejanje.
28 pessaries are packed in a carton with 6 applicators.
28 globul je pakiranih v škatli s šestimi aplikatorji.
• Hypersensitivity to the active substance or to the excipient listed in section 6.1;
• preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
After 12 weeks of daily treatment with a prasterone 6.5 mg pessary (n=81 in Trial 1 and n=325 in Trial 2), the change from baseline, in comparison with placebo treatment (n=77 in Trial 1 and n=157 in Trial 2), demonstrated significant improvements of the 3 co-primary endpoints compared to placebo in both studies, namely increase of the percentage of superficial cells (p<0.0001), decrease of the percentage of parabasal cells (p<0.0001), and decrease in the vaginal pH (p<0.0001).
Po 12 tednih vsakodnevnega zdravljenja s prasteronom 6,5 mg v globulah (n = 81 v preskušanju 1 in n = 325 v preskušanju 2), pri čemer je sprememba glede na izhodišče v primerjavi s placebom (n = 77 v preskušanju 1 in n = 157 v preskušanju 2) v obeh študijah pokazala bistveno izboljšanje treh soprimarnih ciljev študije, tj. povečanja odstotka površinskih celic (p < 0,0001), zmanjšanja odstotka parabazalnih celic (p < 0,0001) in zmanjšanja vaginalnega pH (p < 0,0001).
Contents of the pack and other information What Intrarosa contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Intrarosa
• If you have or have ever had breast cancer, or if you are suspected of having it;
• Če imate ali ste kadar koli imeli raka dojk ali če obstaja sum, da bi ga lahko imeli.
Women with vaginal infection should be treated with appropriate antimicrobial therapy before starting Intrarosa.
Ženske z vaginalno okužbo je treba pred uvedbo zdravila Intrarosa zdraviti z ustreznim antibiotičnim zdravljenjem.
Intrarosa is thus different from the oestrogens preparations since it delivers also androgen metabolites.
Zdravilo Intrarosa se tako razlikuje od estrogenskih pripravkov, saj zagotavlja tudi androgene presnovke.
Trial 1 Trial 2
Preskušanje 1 Preskušanje 2
There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65.
Obstaja nekaj dokazov o večjem tveganju za izgubo spomina pri ženskah, ki začnejo uporabljati HNZ po 65. letu starosti.
“Substantial improvement” was restricted to patients who had moderate or severe MBS at baseline and changed from severe to mild or severe or moderate to none.
je bilo omejeno na bolnice, ki so imele na začetku zmerno ali hudo MBS in so prešle od hude do blage ali od hude ali zmerne do nič.
The number of extra cases of stroke due to use of HRT will increase with age.
Število dodatnih primerov možganske kapi zaradi uporabe HNZ se povečuje s starostjo.
• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE);
• bolezen imunskega sistema, ki prizadene številne telesne organe (sistemski eritematozni lupus);
- Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura.
- Bolezni kože in podkožja: kloazma, multiformni eritem, nodozni eritem, žilna purpura.
Abnormal Pap smear
Nenormalen bris PAP
Date of first authorisation: 08 january 2018
Datum prve odobritve: 08.
If any of the above conditions appears for the first time while taking Intrarosa, stop taking it at once and consult your doctor immediately.
Če se katero koli od navedenih stanj prvič pojavi pri jemanju zdravila Intrarosa, to zdravilo takoj prenehajte jemati in se nemudoma posvetujte z zdravnikom.
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.
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.
For women taking oestrogen-only therapy there is no increased risk of developing a heart disease.
Pri ženskah, ki jemljejo samo estrogensko zdravljenje, tveganje za nastanek srčne bolezni ni povečano.
It is used to relieve menopausal symptoms in the vagina such as dryness or irritation.
Uporablja se za lajšanje menopavznih simptomov v vagini, kot sta suhost ali draženje.
Warnings and precautions When to take special care with Intrarosa
Opozorila in previdnostni ukrepi Kdaj morate biti pri uporabi zdravila Intrarosa posebej pozorni
Other conditions observed with HRT
Druga stanja, ki so bila opažena pri HNZ
Other medicines and Intrarosa
Druga zdravila in zdravilo Intrarosa
• 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.
• 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.
Wash it or throw it away after using for one week (two extra applicators are provided).
Aplikator umijte ali zavrzite po enem tednu uporabe (na voljo sta še dva aplikatorja za rezervo).
Two pessaries should not be used to make up for a forgotten dose.
Ne sme se uporabiti dveh globul, da bi se nadomestil zamujeni odmerek.
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).
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).
• asthma;
• astmo;
Remove 1 applicator from the package.
Iz škatle odstranite en aplikator.
• a disease affecting the eardrum and hearing (otosclerosis);
• bolezen, ki prizadene bobnič in sluh (otoskleroza);
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.
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.
There are no data on the use of Intrarosa in pregnant women.
Podatkov o uporabi zdravila Intrarosa pri nosečnicah ni.