FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Stoga se preporučuje oprez ako se ovaj lijek koristi u žena koje su podvrgnute histerektomiji zbog endometrioze, posebice ako je poznato da imaju rezidualnu endometriozu.
English: Women with an intact uterus with abnormal bleeding of unknown aetiology or women with an intact uterus who have previously been treated with unopposed oestrogens should be examined with special care in order to exclude hyperstimulation/malignancy of the endometrium before initiation of treatment with [invented name]
Croatian: Hiperplazija endometrija i rak Žene s intaktnom maternicom s abnormalnim krvarenjem nepoznate etiologije ili žene s intaktnom maternicom koje su prethodno liječene neoponiranim estrogenom potrebno je posebno pažljivo pregledati kako bi se isključila hiperstimulacija/malignitet endometrija prije početka liječenja s [zaštićeni naziv]
English: Cream [invented name] is used in women for the treatment of atrophic vulva disorders attributable to oestrogen deficiency and for Lichen sclerosus (long-term itchy skin signs) on external genitals.
Croatian: Krema [zaštićeni naziv] se koristi u žena za liječenje poremećaja atrofične stidnice koji se pripisuju nedostatku estrogena i za liječenje skleroznog lišaja (dugotrajni znakovi kože koja svrbi) na vanjskim genitalijama.
English: [invented name] (approximately 1 cm of cream) is thinly applied once daily with the fingers onto diseased skin areas of the external female genital area and then gently rubbed in.
Croatian: [zaštićeni naziv] (približno 1 cm kreme) u tankom se sloju primjenjuje jednom dnevno prstima na oboljela područja kože vanjskog područja ženskih genitalija i potom ga je potrebno lagano utrljati.
English: [invented name] is a cream for vaginal use which contains estradiol
Croatian: [zaštićeni naziv] je krema za vaginalnu primjenu koja sadrži estradiol
English: − You should only use [invented name] under medical supervision.
Croatian: [Zaštićeni naziv] se mora koristiti samo pod liječničkim nadzorom.
English: There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without existing CAD who received combined oestrogenprogestagen or oestrogen-only.
Croatian: Na temelju radnomiziranih kontroliranih ispitivanja ne postoji dokaz o zaštiti od infarkta miokarda u žena s postojećom BKA ili bez nje koje su primile kombinaciju estrogena i progesterona ili samo estrogen.
English: The changes to the relevant sections of the summary of product characteristics and package leaflet is the outcome of the referral procedure.
Croatian: Promjene u odgovarajućim dijelovima Sažetka opisa svojstava lijeka i Upute o lijeku ishod su postupka arbitraže.
English: The risk of haemorrhagic stroke is not increased during use of HRT.
Croatian: Rizik od hemoragijskog moždanog udara nije povećan tijekom uporabe HNT-a.
English: In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.
Croatian: U ispitivanju na milijun žena, 5 godina primjene HNT-a rezultirao je jednim dodanim slučajem na 2 500 korisnika.
English: [This section should have all of the following text]
Croatian: [Ovaj dio mora sadržavati cijeli sljedeći tekst]
English: Compare
Croatian: Usporedba
English: The following information applies, unless you have been prescribed [invented name] otherwise by your doctor.
Croatian: Osim ako Vam Vaš liječnik nije propisao [zaštićeni naziv] drukčije, vrijede sljedeće informacije.
English: The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogen-progestagen and possibly also oestrogen-only HRT, that is dependent on the duration of taking HRT.
Croatian: Ukupni dokazi ukazuju na povećani rizik od raka dojke u žena koje uzimaju kombinaciju estrogea i progestagena, a možda i HNT koji se sastoji samo od estrogena, što ovisi o trajanju uzimanja HNT-a.
English: The following adverse reactions have been associated with oral and/or transdermal oestrogen therapy (class effects):
Croatian: Sljedeće nuspojave povezane su s peroralnom i/ili transdermalnom terapijom estrogenima (učinak razreda):
English: [invented name] should not be used immediately prior to sexual intercourse or as a lubricant.
Croatian: [zaštićeni naziv] ne smije se koristi neposredno prije spolnog odnosa ili kao lubrikant.
English: Additional cases per 1000 HRT user 5 years (95% CI)
Croatian: 1 000 korisnika HNT-a tijekom 5 godina (95% CI)
English: Estradiol is rapidly metabolised in the liver and intestinal tract to estrone and subsequently to estriol.
Croatian: Estradiol se ubrzano metabolizira u jetri i probavnom sustavu na estron i potom na estriol.
English: Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).
Croatian: Cetilni stearilni alkohol može uzrokovati lokalnu iritaciju kože (npr. kontaktni dermatitis).
English: Prolonged use of [invented name] over extensive areas may only proceed with special caution, after a thorough clinical evaluation of the risks and benefits, in cases of: - endometriosis.
Croatian: Produljena primjena [zaštićeni naziv] na širokom području može se nastaviti isključivo uz posebni oprez, nakon temeljite kliničke procjene rizika i koristi, u slučajevima:
English: Coronary artery disease (CAD)
Croatian: Bolest koronarnih arterija (BKA)
English: During prolonged use, vigilance is required for possible systemic effects.
Croatian: Tijekom produljene uporabe potreban je nadzor radi pojave mogućih sistemskih učinaka.
English: Therefore, prolonged treatment beyond 4 weeks is not recommended.
Croatian: Stoga se ne preporučuje produljeno liječenje dulje od 4 tjedna.
English: Oestrogens increase the number of superficial and intermediate cells and decrease the number of basal cells in vaginal smear.
Croatian: Estrogeni povećavaju broj površinskih stanica i stanica srednjeg sloja te smanjuju broj bazalnih stanica razmaza vaginalnog iscjetka.
English: Oral oestrogen only* Oral combined oestrogen-progestogen
Croatian: Samo oralni estrogen* Kombinacija oralnog estrogena i progestagena
English: less than 1 in 10,000 patients treated
Croatian: manje od 1 na 10 000 liječenih bolesnika
English: − if you are known to be allergic (hypersensitive) to oestradiol, prednisolone, cetyl stearyl alcohol or any of the other ingredients of [invented name]
Croatian: − ako znate da ste alergični (preosjetljivi) na estradiol, prednizolon, cetilni stearilni alkohol ili bilo koji drugi sastojak [zaštićeni naziv]
English: [Invented name] should not be used immediately prior to sexual intercourse or as a lubricant, in order to avoid possible undesirable effects in the partner.
Croatian: [Zaštićeni naziv] ne smije se koristiti neposredno prije spolnog odnosa ili kao lubrikant kako bi se izbjegle moguće nuspojave kod partnera.
English: - Pregnancy
Croatian: - trudnoća
English: Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis.
Croatian: Stimulacija neoponiranim estrogenom može uzrokovati premaligne ili maligne transformacije u rezidualnim žarištima endometrioze.
English: For the initial short-term external treatment of acute, mild, inflamed, burning and itching skin diseases of the external female genital area for which weak acting corticosteroids and estradiol are indicated, in postmenopausal patients.
Croatian: Za početno kratkotrajno liječenje akutnih, blagih, upaljenih, žarećih i svrbljivih bolesti kože u području vanjskih ženskih genitalija za koje su indicirani kortikosteroidi slabog djelovanja i estradiol kod bolesnica u postmenopauzi.
English: Transient, mild local irritation (e.g. pruritus, burning).
Croatian: Prolazna, blaga lokalna iritacija (npr. pruritus, žarenje).
English: It could be a sign that your endometrium has become thicker.
Croatian: To bi mogao biti znak zadebljanja Vašeg endometrija Rak dojke
English: - known hypersensitivity to oestradiol, prednisolone, cetyl stearyl alcohol or to any of the excipients of [invented name] .
Croatian: - poznata preosjetljivost na estradiol, prednizolon, cetilni stearilni alkohol ili neku od pomoćnih tvari [zaštićeni naziv].
English: Incidence per 1000 women placebo arm over 5 years
Croatian: Incidencija na 1 000 žena skupina koja prima placebo tijekom 5 godina
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.
Croatian: HNT je povezan s 1,3 do 3 puta povećanim relativnim rizikom od razvoja venske tromboembolije (VTE), tj. duboke venske tromboze ili plućne embolije.
English: At around ≥ 0.01% topically or systemically, estradiol widens the capillary vessels and promotes general blood perfusion.
Croatian: Pri koncentraciji od približno ≥ 0,01% topikalno ili sistemski primijenjen estradiol širi kapilare i potiče opću prokrvljenost.
English: If severe upper abdominal complaints, enlarged liver or signs of intra-adominal haemorrhage occur, a liver tumour should be considered in the differential diagnosis.
Croatian: Ako se pojave jaki bolovi u gornjem dijelu abdomena, povećana jetra te intraabdominalno krvarenje, potrebno je diferencijalnom dijagnozom razmotriti tumor jetre.
English: Depression, hair loss, joint pain, leg cramps, abnormal uterine bleeding, breast pain, breast tenderness, breast enlargement, breast discharge, weight increase or decrease, increased blood fats (triglycerides)
Croatian: Depresija, gubitak kose, bol u zglobovima, grčevi u nogama, abnormalno krvarenje iz maternice, bol u dojkama, osjetljivost dojki, uvećanje dojki, iscjedak iz dojki, porast ili pad tjelesne težine, povišene masnoće u krvi (trigliceridi)
English: frequency cannot be estimated from the available data Uncommon: temporarily mild local irritation (e.g. itching, burning) and slight discharge may occur.
Croatian: Manje često: mogu se pojaviti privremena blaga lokalna iritacija (npr. svrbež, žarenje) i blagi iscjedak.
English: [invented name] is a cream containing estradiol for vaginal use.
Croatian: [zaštićeni naziv] je krema koja sadrži estradiol za vaginalnu primjenu.
English: HRT is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Croatian: HNT je povezan s 1,3 do 3 puta većim rizikom od razvoja venske tromboembolije (VTE), tj. duboke venske tromboze ili plućne embolije.
English: Endometrial hyperplasia and carcinoma
Croatian: Hiperplazija endometrija i rak
English: For the initial short-term external treatment of acute, mild, inflamed, burning and itching skin diseases of the external female genital area for which weak acting corticosteroids and estradiol are indicated, in women beyond menopause.
Croatian: Za početno kratkotrajno liječenje akutnih, blagih, upaljenih, žarećih i svrbljivih bolesti kože u području vanjskih ženskih genitalija za koje su indicirani kortikosteroidi slabog djelovanja i estradiol kod bolesnica nakon menopauze.
English: Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk.
Croatian: Bolesnici s poznatim trombofilijskim stanjima pod povećanim su rizikom od VTE-a, a HNT
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.
Croatian: Kada se promatra žene u pedesetim godinama koje ne uzimaju HNT, u prosjeku, tijekom razdoblja od 5 godina, očekuje se da će 4 do 7 žena na njih 1 000 dobiti krvni ugrušak u venama.
English: Psychiatric disorders
Croatian: Psihijatrijski poremećaji Depresija
English: [Invented name] should not be used during breastfeeding.
Croatian: [zaštićeni naziv] ne smije se koristiti tijekom dojenja.
English: Unopposed oestrogen stimulation may lead to premalignant transformation in the residual foci of endometriosis.
Croatian: Stimulacija neoponiranim estrogenom može uzrokovati premaligne transformacije u zaostalim žarištima endometrioze.
English: Randomised controlled data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy.
Croatian: Randomizirani kontrolirani podaci ne ukazuju na povećani rizik od BKA kod žena koje su podvrgnute histerektomiji uporabom samostalne estrogenske terapije.
English: [The text below should be inserted by replacing the existing text in the relevant paragraph]
Croatian: [Tekst u nastavku potrebno je umetnuti zamjenom postojećeg teksta u odgovarajućem odlomku]
English: The use of oestrogen-only and oestrogen + progestogen therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Croatian: Uporaba terapije samim estrogenom i terapije estrogenom i progestagenom povezana je s povećanjem relativnog rizika od ishemijskog moždanog udara do 1,5 puta.
English: For women aged 50 to 79 who are taking oestrogenprogestagen HRT over 5 years, there will be 13 to 20 cases in 1000 users (i.e. an extra 4 to 6 cases).
Croatian: do 79 koje uzimaju estrogen-progestagen HNT tijekom 5 godina, zabilježit će se 13 do 20 slučajeva na 1 000 korisnika (tj. dodatnih 4 do 6 slučajeva).
English: US WHI studies - additional risk of breast cancer after 5 years' use Age range (years)
Croatian: WHI ispitivanja u SAD-u - dodatni rizik od raka dojke nakon petogodišnje uporabe Dobni raspon (godine)
English: − if you have an untreated endometrial hyperplasia (i.e. thickening of the lining of the womb)
Croatian: − ako imate neliječenu hiperplaziju endometrija (tj. zadebljanje sluznice maternice)
English: Vigilance is required for possible systemic effects.
Croatian: Potreban je nadzor radi pojave mogućih sistemskih učinaka.
English: WHI studies combined - Additional risk of ischaemic stroke* over 5 years' use
Croatian: Kombinirana WHI ispitivanja - dodatni rizik od ishemijskog moždanog udara* tijekom uporabe u trajanju od 5 godina
English: [invented name] is a cream for vaginal use.
Croatian: [Zaštićeni naziv] je krema za vaginalnu primjenu.
English: If you use too much [invented name] on one occasion, side effects such as nausea may occur.
Croatian: Ako primijenite previše [zaštićeni naziv] odjednom, mogu se pojaviti nuspojave poput mučnine.
English: Vaginitis including infection of the genitals caused by a fungus, changes in sexual drive, mood disturbances, dizziness, headache, migraine, anxiety, intolerance to contact lenses, blood clots in a vein (thrombosis), nausea, bloating, abdominal pain, hirsutism, pruritus, rash, oedema
Croatian: Manje često Vaginitis, uključujući infekciju genitalija uzrokovanu gljivicama, promjene u seksualnoj želji, promjene raspoloženja, omaglica, glavobolja, migrena, tjeskoba, nepodnošljivost kontaktnih leća, krvni ugrušci u veni (tromboza), mučnina, nadutost, bol u trbuhu, hirzutizam (pojačana dlakavost muškog tipa), svrbež, osip, edem
English: Evidence suggests that taking combined oestrogen-progestagen and possibly also oestrogenonly HRT increases the risk of breast cancer.
Croatian: Dokazi ukazuju na to da uzimanje kombinacije estrogena i progestagena te moguće i HNT-a s čistim estrogenom povećava rizik od raka dojke.
English: Section 4.8 Undesirable effects [The text below should be inserted in this section.
Croatian: Dio 4.8 Nuspojave [Tekst u nastavku potrebno je umetnuti u ovaj dio.
English: Slight discharge
Croatian: Direktive 2001/83/EZ.
English: Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
Croatian: broj dodatnih slučajeva raka dojke također će se mijenjati razmjerno tome.
English: CEE oestrogen-only CEE+MPA oestrogen & progestogen
Croatian: CEE+MPA estrogen i progestagen $
English: [The wording of the indication should be deleted and the text below should be inserted in its place]
Croatian: [Tekst navoda indikacije potrebno je izbrisati, a tekst u nastavku umetnuti na njegovo mjesto]
English: For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).
Croatian: Za žene koje uzimaju HNT tijekom 5 godina bit će prisutno 2 do 3 slučaja na 1 000 korisnika (tj. do 1 dodatni slučaj).
English: Combined oestrogen-progestagen and oestrogen-only therapy are associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Croatian: Kombinirana terapija estrogenom i progestagenom i terapija čistim estrogenom povezane su s povećanjem rizika od ishemijskog moždanog udara do 1,5 puta.
English: Risk ratio and 95% CI Additional cases per 1000 HRT user 5 years (95% CI)
Croatian: Omjer rizika i 95% CI Dodatni slučajevi na 1 000 korisnika
English: Section 4.2 Posology and method of administration [The text below should be inserted by replacing the existing text of this section]
Croatian: Dio 4.2 Doziranje i način primjene [Tekst u nastavku potrebno je umetnuti zamjenom postojećeg teksta ovog dijela]
English: For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. 3 extra cases).
Croatian: Za žene u pedesetim koje uzimaju HNT bit će 11 slučajeva na 1 000 korisnica tijekom razdoblja od 5 godina (tj. 3 dodatna slučaja).
English: [All current text in this section should be deleted and replaced by the text below]
Croatian: [Sav trenutačni tekst u ovom dijelu potrebno je izbrisati i zamijeniti tekstom u nastavku]
English: Uncommon > 1/1000 to <1/100 (> 0.1% and
Croatian: > 1/1 000 do <1/100 (> 0,1% i
English: However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT increase with age.
Croatian: Međutim, početni rizik od moždanog udara uvelike ovisi o dobi, a ukupni se rizik od moždanog udara u žena koje koriste HNT
English: During treatment with [invented name], after each application there is a transient increase in plasma estradiol levels above the physiological range of postmenopausal women.
Croatian: Tijekom liječenja s [zaštićeni naziv], nakon svake primjene postoji prolazni porast u plazmatskim razinama estradiola iznad fiziološkog raspona u žena u postmenopauzi.
English: How to use [invented name]
Croatian: Kako primijeniti [zaštićeni naziv]
English: Nausea, bloating, abdominal pain
Croatian: Mučnina, nadutost, bol u abdomenu
English: During treatment with [invented name], after each application there is an increase in plasma oestradiol levels above the physiological range of postmenopausal women.
Croatian: Tijekom liječenja s [zaštićeni naziv], nakon svake primjene postoji porast u plazmatskim razinama estradiola iznad fiziološkog raspona u žena u postmenopauzi.
English: The following categories are used to express the frequency of side effects: Very common: more than 1 in 10 patients treated Common:
Croatian: Sljedeće se kategorije koriste za izražavanje učestalosti nuspojava: Vrlo često:
English: The WHI trial found no increase in risk of breast cancer in hysterectomised women using oestrogen-only HRT.
Croatian: WHI ispitivanje nije otkrilo povećani rizik od raka dojke u žena s histerektomijom koje koriste HNT koji se sastoji samo od estrogena.
English: The relationship between pre-existing hypertriglyceridaemia and low dose local vaginal oestrogen therapy is unknown.
Croatian: Odnos između postojeće hipertrigliceridemije i niske doze lokalne vaginalne estrogenske terapije nije poznat.
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.
Croatian: Kada se promatra žene u pedesetim godinama koje ne uzimaju HNT, u prosjeku se očekuje se da će 8 žena na njih 1 000 doživjeti moždani udar tijekom razdoblja od 5 godina.
English: 1 to 10 patients treated out of 100
Croatian: 1 do 10 liječenih bolesnika od njih 100
English: [The text below should be deleted]
Croatian: [Tekst u nastavku potrebno je izbrisati]
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sexhormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Croatian: corticoid binding globulin, CBG), globulin koji veže spolne hormone (engl. sex-hormone binding protein, SHBG), što uzrokuje povećanu razinu kortikosteroida odnosno spolnih steroida u cirkulaciji.
English: For the treatment of atrophic disorders of the vagina and vulva, which are due to a lack of oestrogen, e.g. atrophic vaginitis, coital problems, vaginal stenosis (narrowing), vulvar atrophy with burning and itching
Croatian: atrofijski vaginitis, problemi sa snošajem, vaginalna stenoza (suženje), atrofija vulve sa žarenjem i svrbežom
English: HRT and cancer
Croatian: HNT i rak
English: Do not use [invented name]
Croatian: Nemojte primjenjivati [zaštićeni naziv] ako
English: Arthralgias, leg cramps
Croatian: Artralgije, grčevi u nogama
English: Risk estimates have been drawn from systemic exposure (HRT) and it is not known how these apply to local treatment.
Croatian: Procjene rizika temelje se na sistemskoj izloženosti (HNT) te nije poznato na koji način se odnose na lokalno liječenje.
English: [The text below should be all deleted from this section]
Croatian: [Tekst u nastavku potrebno je sav izbrisati iz ovog dijela]
English: - Migraine or (severe) headache
Croatian: - Povišeni krvni tlak - Migrene ili jake glavobolje
English: Transient, mild skin irritation (e.g. burning, erythema).
Croatian: Prolazna, blaga iritacija kože (npr. žarenje, eritem).
English: 1 to 10 patients treated out of 1,000
Croatian: 1 do 10 liječenih bolesnika od njih 1 000
English: see section 4.4) - Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) - Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal - Known hypersensitivity to the active substances or to any of the excipients - Porphyria.
Croatian: - poznati trombofilijski poremećaji (npr. nedostatak proteina C, proteina S ili antitrombina, vidjeti dio 4.4) - aktivna ili nedavna arterijska tromboembolijska bolest (npr. angina, infarkt miokarda) - akutna bolest jetre ili anamneza bolesti jetre sve dok se testovi funkcije jetre ne vrate u normalu
English: [The currently existing text should be deleted from this section and be replaced by the text below.]
Croatian: [Postojeći tekst potrebno je izbrisati iz ovog dijela i zamijeniti tekstom u nastavku.]
English: Effect of HRT on heart and circulation
Croatian: Učinak HNT-a na srce i cirkulaciju Krvni ugrušci u veni (tromboza)
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 radio-immunoassay) or T3 levels (by radio-immunoassay).
Croatian: (mjereno jodom vezanim na proteine (engl. protein-bound iodine, PBI)), razine T4 (putem kolone ili radioimunotesta) ili razine T3 (putem radioimunotesta).
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Croatian: Izmjene odgovarajućih dijelova Sažetka opisa svojstava lijeka i Upute o lijeku
English: [The text below should be deleted from this section]
Croatian: [Tekst u nastavku potrebno je izbrisati iz ovog dijela]
English: Long-term use of oestrogen-only and combined oestrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.
Croatian: Dugotrajna uporaba samog estrogena i kombiniranog HNT-a na bazi estrogena i progestagena povezana je s blago povišenim rizikom od raka jajnika.
English: Possible side effects
Croatian: 4. MOGUĆE NUSPOJAVE
English: Million Women Study - Estimated additional risk of breast cancer after 5 years' use Age range (years) Additional cases per 1000 users of HRT over 5 year period*
Croatian: Ispitivanje na milijun žena - procijenjeni dodatni rizik od raka dojke nakon petogodišnje uporabe Dobni raspon (godine)
English: Combined oestrogen-progestogen
Croatian: Samo estrogenski HNT Kombinacija estrogena i progestagena
English: A relationship between ischaemic stroke and low dose local vaginal oestrogen therapy is uncertain.
Croatian: Odnos između ishemijskog moždanog udara i niske doze lokalne vaginalne estrogenske terapije nije jasno utvrđen.