FrancophonIA/ELRC3.0 huggingface dataset:
English: Both IELT and IPE scores continued to increase slightly more throughout the remainder of the double-blind phase.
Croatian: Rezultati IELT i IPE bodova su se nadalje blago povećavali sve do kraja dvostruko slijepe faze.
English: Specific interaction studies with lidocaine/prilocaine and anti-arrhythmic medicinal products class III (e.g. amiodarone) have not been performed, but caution is advised (see also section 4.4).
Croatian: Nisu provedena ciljana istraživanja interakcija s lidokainom/prilokainom i antiaritmicima skupine III (npr. amiodarion), ali oprez se preporučuje (vidjeti još i dio 4.4).
English: Any barrier contraceptives (e.g. male or female condom), which are made from polyurethane-based material cannot be guaranteed to protect against disease or pregnancy when you are also using Fortacin.
Croatian: Sva mehanička sredstva za kontracepciju (kao što su muški ili ženski prezervativi) izrađena od poliuretanskih materijala ne mogu jamčiti sigurnost od prenosivih bolesti ili trudnoće kad se koriste uz Fortacin.
English: A study in rats showed that Fortacin caused a reduction in sperm motility.
Croatian: Ispitivanja na štakorima pokazala su da je Fortacin izazvao smanjenje pokretljivosti spermija.
English: - if you or your sexual partner are allergic to lidocaine or prilocaine or any of the other ingredients of this medicine (listed in section 6); - if you or your sexual partner have a history of allergy or sensitivity to other local anaesthetics with a similar structure (known as amide-type local anaesthetics).
Croatian: - ako ste vi ili vaša seksualna partnerica alergični na lidokain ili prilokain ili neki drugi sastojak ovog lijeka (naveden u dijelu 6), - ako vi ili vaša seksualna partnerica imate povijest alergija ili osjetljivosti na druge lokalne anestetike slične strukture (poznati i kao lokalni anestetici amidnog tipa).
English: The PEP scores followed a similar pattern of improvement to the IELT and IPE scores.
Croatian: Rezultati PEP ocjena pratili su sličan obrazac poboljšanja kakav su imali i IELT i IPE bodovi.
English: These adverse reactions caused discontinuation of treatment in 0.2% and 0.5% of patients, respectively.
Croatian: Te su nuspojave uzrokovale prekid liječenja u 0,2 % pacijenata u prvom i 0,5 % u drugom slučaju.
English: Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive medicinal products.
Croatian: Teški neurološki simptomi (konvulzije, depresije središnjeg živčanog sustava) moraju se liječiti simptomatski potporom respiratornom sustavu i primjenom antikonvulzivnih lijekova.
English: The steady-state volume of distribution is 1.1 to 2.1 L/kg after intravenous administration.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže je 1,1 do 2,1 L/kg nakon intravenske primjene.
English: Prilocaine is also distributed in breast milk.
Croatian: Prilokain se također izlučuje u majčinu mlijeku.
English: What you need to know before you use Fortacin Do not use Fortacin
Croatian: Što morate znati prije nego počnete primjenjivati Fortacin
English: The effectiveness of the medicinal product has been demonstrated to persist on repeat use over time.
Croatian: Pokazalo se da se učinkovitost ovog lijeka ne smanjuje ponovljenom primjenom tijekom vremena.
English: The most frequent adverse reactions reported with the use of this medicinal product in female partners were vulvovaginal burning sensation (3.9%), and genital hypoaesthesia (1.0%).
Croatian: Najčešće nuspojave koje su prijavljene u vezi s primjenom ovog lijeka u ženskih partnerica bile su osjet pečenja u vulvovaginalnom području (3,9 %) i genitalna hipoestezija (1,0 %).
English: Patients with severe hepatic disease, because of their inability to metabolise local anaesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine and prilocaine (see section 4.2).
Croatian: Bolesnici s teškim oštećenjem jetre, zahvaljujući nesposobnosti da normalno metaboliziraju lokalne anestetike, u većoj su opasnosti od toksičnih koncentracija lidokaina i prilokaina u plazmi (vidjeti dio 4.2).
English: Vulvovaginal discomfort or burning sensation caused discontinuation of treatment in 0.3% of subjects.
Croatian: Vulvovaginalna nelagoda ili osjet pečenja uzrokovao je prekid liječenja kod 0,3 % ispitanika.
English: Fortacin is not approved for use by women.
Croatian: Fortacin nije odobren za primjenu u žena.
English: 85.2% of subjects in the Fortacin group achieved a mean IELT of > 1 minute over the course of 3 months of treatment with it, whereas 46.4% of the placebo subjects had a mean IELT of > 1 minute.
Croatian: 85,2 % ispitanika u skupini liječenoj lijekom Fortacin postiglo je srednju vrijednost IELT od > 1 minute tijekom 3 mjeseca liječenja, dok je 46,4 % onih ispitanika koji su bili u placebo skupini imalo srednji IELT > 1 minute.
English: As this medicine is applied to the surface of the head of the penis the risk of overdose is low.
Croatian: Budući da se ovaj lijek primjenjuje na površinu glavića penisa, rizik od predoziranja je malen.
English: Plasma levels of these metabolites detected after administration of Fortacin in clinical trials were low in both male and female subjects, even after doses of it many times in excess of the clinical dose were applied.
Croatian: Razine tih metabolita u plazmi utvrđenih nakon primjene lijeka Fortacin pri kliničkim ispitivanjima bile su niske i u muških i u ženskih ispitanika, čak i kada su primjenjivane doze višestruko veće od kliničke doze.
English: Patients on anti-arrhythmic medicinal products class III (e.g. amiodarone) should be treated with caution.
Croatian: Pacijenti koji primaju antiaritmike skupine III (kao što je amiodaron) trebaju biti liječeni uz oprez.
English: • Dapsone - used to treat skin conditions such as leprosy and dermatitis and also to prevent malaria and pneumonia in high-risk patients
Croatian: • Dapson - koristi se za liječenje kožnih bolesti poput gube i dermatitisa, a također i da bi spriječio malariju i upale pluća u visokorizičnih bolesnika
English: • vaginal thrush (Candida) infection
Croatian: • vaginalna gljivična infekcija (Candida)
English: Aluminium spray container with metering valve.
Croatian: Aluminijski spremnik spreja s odmjernim ventilom.
English: Methaemoglobinaemia may be accentuated in patients already taking medicinal products known to induce the condition, e.g. sulphonamides, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenobarbital, phenytoin, primaquine and quinine (see section 4.4).
Croatian: Methemoglobinemija može biti naglašena u pacijenata koji već uzimaju lijekove za koje je poznato da pospješuju to stanje, odnosno sulfonamide, acetanilid, anilinska bojila, benzokain, klorokin, dapson, metoklopramid, naftalen, nitrate i nitrite, nitrofurantoin, nitroglicerin, nitroprusid, pamakin, paraaminosalicilatnu kiselinu, fenobarbital, fenitoin, primakin i kinin (vidjeti dio 4.4).
English: If contact with the eye occurs, immediately rinse the eye with water or sodium chloride solution and protect it until sensation returns.
Croatian: Dospije li lijek u kontakt s očima, odmah isperite oči vodom ili otopinom natrijeva klorida i zaštitite ih do povratka osjeta.
English: No teratogenic effects were observed in studies of embryonic/foetal development in rats and rabbits receiving doses during organogenesis.
Croatian: Nisu primijećeni teratogeni učinci u studijama razvoja embrija/fetusa u štakora i kunića koji su primali doze tijekom organogeneze.
English: • Chloroquine, pamaquine, primaquine, quinine - used to treat malaria
Croatian: • Klorokin, pamakin, primakin, kinin - koriste se za liječenje malarije
English: • difficulty or pain passing urine
Croatian: • teškoće ili bol prilikom mokrenja
English: In a study of pregnant rats receiving a combination of lidocaine and prilocaine during organogenesis, no effects on embryonic/foetal development were observed.
Croatian: U studiji provedenoj na skotnim štakoricama koje su primale kombinaciju lidokaina i prilokaina u razdoblju organogeneze nisu uočeni nikakvi učinci na embrionalni/fetalni razvoj.
English: - The active substances are lidocaine and prilocaine.
Croatian: - Djelatne tvari su lidokain i prilokain.
English: Adverse drug reactions in female partners
Croatian: Nuspojave u ženskih partnerica
English: Prilocaine in high doses may cause an increase in the methaemoglobin level particularly in conjunction with methaemoglobin-inducing agents (e.g. sulphonamides).
Croatian: Prilokain u visokim dozama može uzrokovati povećanje razine methemoglobina i to posebno zajedno s tvarima koje izazivaju methemoglobinemiju (npr. sulfonamidi).
English: In an in vitro study of rats Fortacin has shown a reduction in sperm motility when 22.5 mg lidocaine and 7.5 mg prilocaine (i.e. the amount in 1 human dose) was in direct contact with rat sperm.
Croatian: Jedna in vitro studija lijeka Fortacin na štakorima pokazala je smanjenje pokretljivosti spermija kad je 22,5 mg lidokaina i 7,5 mg prilokaina (tj. količina u 1 ljudskoj dozi) došlo u izravan kontakt sa spermom štakora.
English: The recommended dose of Fortacin is 3 sprays (3 sprays = 1 dose) on the head of the penis before sexual intercourse.
Croatian: Preporučena doza lijeka Fortacin je 3 potiska (3 potiska = 1 doza) na glavić penisa prije spolnog odnosa.
English: Do not use this medicine after the expiry date which is stated on the spray container label and the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici spremnika spreja i kutiji iza oznake „Rok valjanosti“.
English: Lidocaine was not genotoxic and the carcinogenic potential of lidocaine has not been studied.
Croatian: Lidokain nije bio genotoksičan, a njegov karcinogeni potencijal nije ispitan.
English: Wait 5 minutes then wipe off any excess spray prior to having sexual intercourse.
Croatian: Pričekajte 5 minuta, a zatim potpuno obrišite višak tekućine prije spolnog odnosa.
English: In carcinogenicity studies of o-toluidine in rats, mice and hamsters, tumours were observed in several organs.
Croatian: U studijama karcinogenosti o-toluidina u štakora, miševa i hrčaka uočeni su tumori na nekoliko organa.
English: Fortacin may also come into contact with other mucous membranes such as your, or your partner's, mouth, nose and throat, causing them to feel slightly numb for a short while.
Croatian: Fortacin također može doći u doticaj s drugim sluznicama kao što su usta, nos ili grlo vas ili vaše partnerice, što će dovesti do osjeta blage utrnulosti na kraće vrijeme.
English: Via Matteo Civitali 1
Croatian: Recordati Industria Chimica e Farmaceutica S.p.A. Via Matteo Civitali 1
English: Fortacin is a colourless to light yellow cutaneous spray, solution in an aluminium spray container with metering valve.
Croatian: Fortacin bezbojan je do svijetlo žuti sprej za kožu, otopina u aluminijskom spremniku spreja, s odmjernim ventilom.
English: Embryotoxicity was observed in rabbits at doses toxic to the mother.
Croatian: Embriotoksičnost je u kunića primijećena pri dozama koje su bile toksične za majku.
English: Lidocaine is reported to be 66% bound by plasma proteins, including alpha-1-acid glycoprotein.
Croatian: Zabilježeno je da je 66 % lidokaina vezano na proteine plazme, uključujući alfa-1 kiseli glikoprotein.
English: Lidocaine and prilocaine are excreted in human milk, but at therapeutic doses of Fortacin no effects on the breastfed newborns/infants are anticipated due to active substance transfer from the male patient to his female partner.
Croatian: Dojenje Lidokain i prilokain izlučuju se majčino mlijeko, ali u terapijskim dozama lijeka Fortacin ne očekuje se učinak na dojenu novorođenčad/dojenčad s obzirom na prijenos djelatne tvari od muškog pacijenta na njegovu partnericu.
English: Men satisfying the International Society for Sexual Medicine (ISSM) criteria for premature ejaculation (PE) who had a baseline IELT ≤ 1 minutes in at least 2 of the first 3 sexual encounters during screening were eligible to enrol.
Croatian: Uključivanje je bilo dopušteno onim muškarcima koji su zadovoljavali kriterije Međunarodnog udruženja za seksualnu medicinu (ISSM) za preuranjenu ejakulaciju (PE) koji su imali početnu vrijednost IELT ≤ 1 minute u najmanje 2 od prva 3 spolna odnosa tijekom probira.
English: Fortacin may reduce the possibility of pregnancy, but is not a reliable contraceptive.
Croatian: Fortacin može smanjiti vjerojatnost začeća, ali nije pouzdan kontraceptiv.
English: • Benzocaine - a local anaesthetic used to treat pain and itching
Croatian: • Benzokain - lokalni anestetik koji liječi bol i svrbež
English: The active substances lidocaine and prilocaine block the transmission of nerve impulses in the glans penis, reducing the sensitivity of the glans penis.
Croatian: Djelatne tvari, likodain i prilokain, blokiraju prijenos živčanih impulsa u glaviću penisa smanjujući tako njegovu osjetljivost.
English: The plasma levels of lidocaine and prilocaine in male and female subjects were below the level associated with toxicity (5,000 ng/ml).
Croatian: Apsorpcija Razine lidokaina i prilokaina u plazmi u muških i ženskih ispitanika bile su ispod razine koja se povezuje s toksičnosti (5000 ng/ml).
English: • medicines for high blood pressure and to regulate your heart rhythm (so-called beta blockers)
Croatian: • lijekove protiv visokog krvnog tlaka i za regulaciju srčanog ritma (takozvani beta blokatori) • lijekove koji vam smanjuju želučanu kiselinu (cimetidin).
English: In Fortacin-treated subjects, IELT and IPE scores increased at the first measured timepoint.
Croatian: U ispitanika liječenih lijekom Fortacin, IELT i IPE rezultati povećali su se pri prvom mjerenju.
English: • Para-aminosalicylic acid (PAS) - used to treat tuberculosis
Croatian: • Para-aminosalicilatna kiselina (PAS) - koristi se za liječenje tuberkuloze.
English: Prilocaine is rapidly metabolised in both the liver, by cytochrome P450, and in the kidneys by amidases.
Croatian: Prilokain se brzo metabolizira i u jetri, putem citokroma P450, kao i u bubrezima putem amidaza.
English: Prilocaine is reported to be 55% bound to plasma proteins, including alpha-1-acid glycoprotein.
Croatian: Zabilježeno je da je 55% prilokaina vezano na proteine plazme, uključujući alfa-1 kiseli glikoprotein.
English: The prilocaine metabolite o-toluidine has genotoxic potential in vitro.
Croatian: Metabolit prilokaina o toluidin ima genotoksični potencijal in vitro.
English: The metabolism of lidocaine and prilocaine results in the formation of 2,6-xylidine and o-toluidine, respectively, amongst other metabolites.
Croatian: Metabolizam lidokaina i prilokaina dovodi do stvaranja 2,6-ksilidina, odnosno o-toluidina, među ostalim metabolitima.
English: As a precautionary measure, it is preferable to avoid the use of Fortacin during pregnancy unless effective male barrier contraceptive measures are taken in order to avoid potential foetal exposure.
Croatian: Kao mjeru opreza preporučuje se izbjegavati primjenu lijeka Fortacin za vrijeme trudnoće, osim ako se ne upotrijebi mehanička metoda muške kontracepcije kako bi se spriječilo potencijalno izlaganje ploda.
English: Caution is advised in case of severe hepatic impairment (see section 4.4).
Croatian: U slučaju teškog oštećenja jetre preporučuje se oprez (vidjeti dio 4.4).
English: Clinical trials have shown Fortacin to increase the intra-vaginal ejaculatory latency time (IELT), increase control over ejaculation and reduce the feelings of distress in patients with premature ejaculation as measured by the Index of Premature Ejaculation (IPE).
Croatian: Klinička su ispitivanja pokazala da Fortacin povećava trajanje vremena intravaginalne latencije ejakulacije (engl. intra-vaginal ejaculatory latency time - IELT), povećava kontrolu nad ejakulacijom i smanjuje osjećaj tjeskobe u pacijenata s preuranjenom ejakulacijom mjereno indeksom preuranjenje ejakulacije (engl.
English: There is no relevant use of Fortacin in the paediatric population for the indication of treatment of primary premature ejaculation in adult men.
Croatian: Nema relevantne primjene lijeka Fortacin u pedijatrijskoj populaciji za indikaciju liječenja primarne preuranjene ejakulacije u odraslih muškaraca.
English: Effect on fertility
Croatian: Utjecaj na plodnost
English: Lidocaine can cross the blood brain barrier and the placenta and is distributed in breast milk.
Croatian: Lidokain može proći krvno-moždanu i placentarnu barijeru i izlučuje se u majčinu mlijeku.
English: Systemic exposure to lidocaine and prilocaine and their metabolites (respectively 2,6-xylidine and o-toluidine), is low following application to the glans penis in male patients and application to the cervix/vagina fornices in female subjects, at doses higher than recommended.
Croatian: Sustavna izloženost lidokainu i prilokainu i njihovim metabolitima (odnosno 2,6-ksilidinu i o-toluidinu) niska je nakon nanošenja lijeka na glavić penisa u muških ispitanika i nanošenja na cerviks/fornikse vagine ženskih ispitanica, pri dozama većima od preporučenih.
English: Fortacin sprayed onto mucous membranes of the patient or their partner, such as the mouth, nose and throat, or transferred onto female genitalia or anal lining, could be absorbed and temporary local numbness/anaesthesia is likely to result.
Croatian: Kad je Fortacin nanesen na sluznice pacijenta ili partnerice, kao što su usta, nos i grlo, ili prenesen na genitalije žene ili analno područje, može biti apsorbiran i vjerojatna posljedica je privremena lokalna otupljenost/anestezija.
English: • There is also a risk of a disorder reducing the amount of oxygen in the blood
Croatian: • Postoji također i rizik od smanjenja količine kisika u krvi (methemoglobinemija).
English: Patients or their partner with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to medicinal product-induced methaemoglobinaemia (see section 4.5).
Croatian: Pacijenti ili njihove partnerice s deficijencijom glukoza-6-fosfat dehidrogenaze ili urođenom ili idiopatskom methemoglobinemijom podložniji su methemoglobinemiji izazvanoj lijekovima (vidjeti dio 4.5).
English: The postnatal survival time of the offspring of rats treated during pregnancy and lactation with a dose toxic to the mother was shown to be reduced.
Croatian: Postnatalno vrijeme preživljavanja pokazalo se skraćenim u okota štakorica koje su tretirane tijekom trudnoće i laktacije dozama koje su toksične za majku.
English: In a carcinogenicity study of rats exposed to 2,6-xylidine in utero, postnatally and throughout their lifetime, tumours in the nasal cavity, subcutaneous tumours and liver tumours were observed.
Croatian: U studiji kancerogenosti na štakorima izloženim2,6-ksilidinu in utero, postnatalno i tijekom života, primijećeni su tumori u nosnoj šupljini, potkožni tumori i tumori jetre.
English: Due to the risk of partner transfer, patients hoping to achieve conception should either avoid using Fortacin, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible 5 minutes after applying the spray but prior to intercourse (see section 4.6).
Croatian: Uslijed rizika od prijenosa na partnericu, pacijenti koji nastoje postići oplodnju bi trebali izbjegavati primjenu lijeka Fortacin, ili, ako je on nužan za postizanje penetracije, trebaju oprati glavić penisa što je temeljitije moguće 5 minuta nakon nanošenja spreja, ali prije snošaja (vidjeti dio 4.6).
English: EXP Discard 12 weeks after first use.
Croatian: Rok valjanosti Baciti 12 tjedana nakon prve uporabe.
English: Although the systemic availability of prilocaine by cutaneous absorption of Fortacin is low, caution should be exercised in patients with anaemia, congenital or acquired methaemoglobinaemia or patients on concomitant therapy known to produce such conditions.
Croatian: Unatoč niskoj sistemskoj raspoloživosti prilokaina putem kožne apsorpcije lijeka Fortacin, potreban je oprez u pacijenata s anemijom, urođenom ili stečenom methemoglobinemijom te u pacijenata koji istodobno primaju terapiju za koju je poznato da može potaknuti takva stanja.
English: Fortacin is only indicated for application to the glans penis.
Croatian: Fortacin je indiciran samo za primjenu na glaviću penisa.
English: • Sodium nitroprusside, isosorbide dinitrate - used to treat high blood pressure and heart failure
Croatian: • Natrijev nitroprusid, izosorbiddinitrat - koriste se za liječenje povišenog krvnog tlaka i zatajenja srca
English: The effectiveness of Fortacin in treating PE was assessed by measuring IELT and the co primary endpoints of ejaculatory control, sexual satisfaction, and distress using the IPE.
Croatian: Učinkovitost lijeka Fortacin u liječenju PE procijenjena je mjerenjem IELT-a i ko-primarnih mjera ishoda kontrole ejakulacije, spolnog zadovoljstva i tjeskobe korištenjem indeksa IPE.
English: • Glyceryl trinitrate (GTN, nitroglycerin), isosorbide mononitrate, erythrityl tetranitrate, pentaerythritol tetranitrate and other nitrate and nitrite medicines - used to treat angina (chest pain caused by the heart)
Croatian: • Gliceriltrinitrat (GTN, nitroglicerin), izosorbid mononitrat, eritritiltetranitrat, pentaeritritoltetranitrat i drugi nitrati i nitriti - koriste se za liječenje angine (bol u prsnom košu uzrokovana srcem)
English: If you or your sexual partner get any side effects, talk to your doctor or pharmacist.
Croatian: Ako vi ili vaša seksualna partnerica primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: • Phenobarbital, phenytoin - used to treat epilepsy
Croatian: • Fenobarbital, fenitoin - koriste se za liječenje epilepsije
English: The following side effects have been reported with Fortacin in female partners:
Croatian: Sljedeće nuspojave opažene su kod primjene lijeka Fortacin u ženskih partnerica:
English: Prilocaine was not genotoxic and the carcinogenic potential of prilocaine has not been studied.
Croatian: Prilokain Prilokain nije bio genotoksičan, a njegov karcinogeni potencijal nije ispitan.
English: Cutaneous spray, solution Colourless to light yellow solution
Croatian: Sprej za kožu, otopina Bezbojna do svijetlo žuta otopina
English: The positive changes in IELT and IPE domain scores were maintained during the open-label treatment phase.
Croatian: Pozitivne promjene IELT pokazatelja, kao i rezultata IPE, održane su tijekom otvorene faze liječenja.
English: Clinical studies have not been performed in patients with impaired renal function, however due to its method of administration and very low systemic absorption, no dosage adjustment is required.
Croatian: Nisu provedena klinička ispitivanja u pacijenata s oštećenom funkcijom bubrega, ali zbog načina primjene i vrlo niske sistemske apsorpcije, nije potrebno prilagoditi dozu.
English: The following side effects have been reported with Fortacin in male patients:
Croatian: Sljedeće nuspojave opažene su kod primijene lijeka Fortacin u muških bolesnika:
English: During the 3 months of the double-blind treatment phase, the geometric mean IELT increased from 0.58 to 3.17 minutes in the Fortacin group and from 0.56 to 0.94 minutes in the placebo group.
Croatian: 0,58 na 3,17 minuta u skupini koja je koristila Fortacin te s 0,56 na 0,94 minute u placebo skupini.
English: Clinical studies have not been performed in patients with impaired hepatic function, however due to its method of administration and very low systemic absorption, no dosage adjustment is required.
Croatian: Nisu provedena klinička ispitivanja u pacijenata s oštećenom funkcijom jetre, ali zbog načina primjene i vrlo niske sistemske apsorpcije, nije potrebno prilagoditi dozu.
English: There are no adequate data from the use of lidocaine and prilocaine on fertility in humans.
Croatian: Ne postoje odgovarajući podaci o utjecaju primjene lidokaina i prilokaina na plodnost u ljudi.
English: Lidocaine is excreted in the urine mainly as metabolites, with only a small proportion excreted unchanged.
Croatian: Lidokain se izlučuje uglavnom putem urina u obliku metabolita, dok se jedan mali dio izlučuje nepromijenjen.