FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you use Orgalutran
Croatian: Što morate znati prije nego počnete primjenjivati Orgalutran
English: The frequency of hypersensitivity reactions (very rare, < 1/10,000) has been deduced from post-marketing surveillance.
Croatian: Učestalost reakcija preosjetljivosti (vrlo rijetko, < 1/10 000) utvrđena je praćenjem nakon stavljanja lijeka u promet.
English: Other ingredients: acetic acid, mannitol, water for injections, sodium hydroxide and/or acetic acid as pH adjustment.
Croatian: Drugi sastojci: acetatna kiselina, manitol, voda za injekcije, natrijev hidroksid i/ili acetatna kiselina za podešavanje pH.
English: Once the needle has been correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.
Croatian: Kad je igla u pravilnom položaju, polako i ravnomjerno potiskujte naprijed klip štrcaljke kako bi pravilno injicirali otopinu, a da ne oštetite kožno tkivo.
English: These events have included anaphylaxis (including anaphylactic shock), angioedema and urticaria.
Croatian: Ovi su događaji uključivali anafilaksiju (uključujući anafilaktički šok), angioedem i urtikariju.
English: The efficacy and safety of Orgalutran has not been established in women weighing less than 50 kg or more than 90 kg.
Croatian: Učinkovitost i sigurnost primjene lijeka Orgalutran nisu ustanovljene u žena čija je tjelesna težina manja od 50 kg ili veća od 90 kg.
English: Clinical studies with subcutaneous administration of Orgalutran at single doses up to 12 mg did not show systemic adverse reactions.
Croatian: Klinička ispitivanja u kojima je Orgalutran primijenjen supkutano u pojedinačnim dozama do 12 mg nisu pokazala sustavne nuspojave.
English: Please refer to the Package Leaflet of the gonadotrophin-containing medicine prescribed for you.
Croatian: Molimo pročitajte uputu o lijeku za lijek koji Vam je liječnik propisao, a koji sadrži gonadotropine.
English: After a single subcutaneous administration of 0.25 mg, serum levels of ganirelix rise rapidly and reach peak levels (Cmax) of approximately 15 ng/mL within 1 to 2 hours (tmax).
Croatian: Nakon primjene jedne supkutane injekcije od 0,25 mg, serumske razine ganireliksa brzo rastu i dostižu vršne koncentracije (Cmax) od približno 15 ng/ml unutar 1 do 2 sata (tmax).
English: EU/1/00/130/001, 1 pre-filled syringe EU/1/00/130/002, 5 pre-filled syringes
Croatian: EU/1/00/130/001, 1 napunjena štrcaljka EU/1/00/130/002, 5 napunjenih štrcaljki
English: Ganirelix is also the main compound found in urine.
Croatian: Ganireliks je i glavni spoj koji se nalazi u mokraći.
English: )If a hypersensitivity reaction is suspected, Orgalutran should be discontinued and appropriate treatment administered.
Croatian: Ako se sumnja na reakciju preosjetljivosti, potrebno je prekinuti primjenu lijeka Orgalutran i primijeniti odgovarajuće liječenje.
English: EU/1/00/130/001 1 pre-filled syringe EU/1/00/130/002 5 pre-filled syringes
Croatian: EU/1/00/130/001 1 napunjena štrcaljka EU/1/00/130/002 5 napunjenih štrcaljki
English: Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue.
Croatian: - Preosjetljivost na gonadotropin-oslobađajući hormon (GnRH) ili bilo koji analog GnRH.
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, occasionally ovulation may occur too early causing a significant reduction in the chance of getting pregnant.
Croatian: U žena koje su uključene u postupke medicinski potpomognute oplodnje, uključujući oplodnju in vitro (IVF) i druge metode, ponekad se ovulacija može pojaviti prijevremeno, što uzrokuje značajno smanjenu šansu za začeće.
English: In clinical studies, luteal phase support was given according to study centres' practice or according to the clinical protocol.
Croatian: U kliničkim ispitivanjima podrška lutealnoj fazi davala se sukladno praksi pojedine klinike ili kliničkom protokolu.
English: Orgalutran is supplied in pre-filled syringes and should be injected slowly, just under the skin, preferably in the upper leg.
Croatian: Orgalutran se nalazi u napunjenoj štrcaljki i treba ga injicirati polako, pod kožu, najbolje u natkoljenicu.
English: Reproduction studies carried out with ganirelix at doses of 0.1 to 10 g/kg/day subcutaneously in the rat and 0.1 to 50 g/kg/day subcutaneously in the rabbit showed increased litter resorption in the highest dose groups.
Croatian: Ispitivanja utjecaja na reprodukciju provedena s ganireliksom primijenjenim supkutano štakorima u dozama od 0,1 do 10 µg/kg/dan te zečevima u dozama od 0,1 do 50 µg/kg/dan, pokazala su povećanu resorpciju zametaka u skupinama koje su primale najviše doze.
English: Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting on day 5 or day 6 of FSH administration or on day 5 or day 6 following the administration of corifollitropin alfa.
Croatian: Orgalutran (0,25 mg) treba primijeniti supkutanom injekcijom jedanput na dan, počevši od 5. ili 6. dana primjene FSH-a ili 5. ili 6. dana nakon primjene korifolitropina alfa.
English: The starting day of Orgalutran is depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol.
Croatian: Prvi dan primjene lijeka Orgalutran ovisi o odgovoru jajnika, tj. o broju i veličini folikula koji se razvijaju i/ili količini estradiola u cirkulaciji.
English: In case of a high ovarian response, either as a result of a high exposure to gonadotrophins in the early follicular phase or as a result of high ovarian responsiveness, premature LH rises may occur earlier than day 6 of stimulation.
Croatian: U slučaju jakog odgovora jajnika, bilo zbog velike izloženosti gonadotropinima u ranoj folikularnoj fazi, bilo zbog visoke osjetljivosti jajnika, prijevremeni porast LH-a može nastupiti prije 6. dana stimulacije.
English: In controlled studies of Orgalutran with FSH, using a long protocol of GnRH agonist as a reference, treatment with the Orgalutran regimen resulted in a faster follicular growth during the first days of stimulation but the final cohort of growing follicles was slightly smaller and produced on average less oestradiol.
Croatian: U kontroliranim ispitivanjima lijeka Orgalutran s FSH-om, uzimajući za usporedbu dugi protokol s agonistom GnRH-a, liječenje Orgalutran injekcijama dovelo je do bržeg rasta folikula prvih dana stimulacije, ali je konačan ukupni broj rastućih folikula bio nešto manji, s prosječno manjom količinom estradiola.
English: Other medicines and Orgalutran Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: Disposable pre-filled syringes (siliconised type I glass), containing 0.5 mL of sterile, ready for use, aqueous solution closed with a rubber piston that does not contain latex.
Croatian: Napunjena štrcaljka za jednokratnu primjenu (silikonizirano staklo tipa I) s 0,5 ml sterilne vodene otopine spremne za primjenu, zatvorena gumenim klipom koji ne sadrži lateks.
English: Orgalutran is used as part of the treatment for assisted reproduction techniques (ART) including in vitro fertilisation (IVF).
Croatian: Orgalutran se koristi u sklopu postupka medicinski potpomognute oplodnje, uključujući oplodnju in vitro (IVF).
English: After repeated dosing 0.25 mg/day steady-state levels of approximately 0.6 ng/mL were reached within 2 to 3 days.
Croatian: Nakon ponovljenog doziranja 0,25 mg/dan, razine u stanju dinamičke ravnoteže od približno 0,6 ng/ml postignute su unutar 2-3 dana.
English: Supplied in cartons containing 1 or 5 pre-filled syringes.
Croatian: Dostupan u kutijama s 1 ili 5 napunjenih štrcaljki.
English: Other reported adverse reactions are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS (see also section 4.4), ectopic pregnancy and spontaneous abortion.
Croatian: Druge prijavljene nuspojave povezane su s kontroliranom hiperstimulacijom jajnika u sklopu postupka medicinski potpomognute oplodnje, osobito bol u zdjelici, abdominalna distenzija, OHSS (vidjeti i dio 4.4), ektopična trudnoća i spontani pobačaj.
English: GnRH regulates the release of gonadotrophins (luteinising hormone (LH) and follicle stimulating hormone (FSH)).
Croatian: GnRH regulira otpuštanje gonadotropina (luteinizirajućeg hormona (LH) i folikulostimulirajućeg hormona (FSH)).
English: Since infertile women undergoing assisted reproduction, and particularly in vitro fertilisation (IVF), often have tubal abnormalities the incidence of ectopic pregnancies might be increased.
Croatian: Budući da neplodne žene u postupku potpomognute oplodnje, a osobito izvantjelesne oplodnje (in vitro fertilizacije, IVF), često imaju nepravilnosti jajovoda, može biti povećana incidencija ektopičnih trudnoća.
English: Mannitol;
Croatian: Manitol
English: LH is needed to release the mature egg cells from the follicles and ovaries (i.e. ovulation).
Croatian: LH je potreban za otpuštanje zrelih jajnih stanica iz folikula i jajnika (tj. ovulaciju).
English: Following administration of multiple doses of 0.25 mg Orgalutran to female volunteers serum LH, FSH and E2 concentrations were maximally decreased by 74 %, 32 % and 25 % at 4, 16 and 16 hours after injection, respectively.
Croatian: Nakon primjene višestrukih doza lijeka Orgalutran od 0,25 mg zdravim ženama, serumske koncentracije LH-a smanjene su za najviše 74% 4 sata nakon injekcije, koncentracije FSH-a za najviše 32% 16 sati nakon injekcije, a koncentracije E2 za najviše 25% 16 sati nakon injekcije.
English: Orgalutran is used for
Croatian: Orgalutran se koristi
English: During or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may develop.
Croatian: Tijekom ili nakon hormonske stimulacije jajnika može nastupiti sindrom hiperstimulacije jajnika.
English: Medicinal product subject to restricted medical prescription (see annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and an increased incidence of multiple gestations.
Croatian: Smatra se da su razlog tome razlike u osobinama roditelja (npr. dob majke, osobine sperme) kao i veća incidencija višeplodnih trudnoća.
English: Controlled ovarian hyperstimulation with FSH or corifollitropin alfa may start at day 2 or 3 of menses.
Croatian: Kontrolirana hiperstimulacija jajnika s FSH ili korifolitropinom alfa može započeti 2. ili 3. dana menstruacijskog ciklusa.
English: The patient or her partner may perform the injections of Orgalutran themselves, provided that they are adequately instructed and have access to expert advice.
Croatian: Orgalutran može injicirati i sama bolesnica ili njezin partner ako su na odgovarajući način obučeni te im je dostupna stručna pomoć.
English: The needle cover contains dry natural rubber/latex which comes into contact with the needle and may cause allergic reactions (see section 6.5).
Croatian: Poklopac igle sadrži suhu prirodnu gumu/lateks, koji dolazi u doticaj s iglom te može uzrokovati alergijske reakcije (vidjeti dio 6.5).
English: Children and adolescents There is no relevant use of Orgalutran in children or adolescents.
Croatian: Nema relevantne primjene lijeka Orgalutran u djece ili adolescenata.
English: Pregnancy or breast-feeding.
Croatian: - Trudnoća ili dojenje.
English: Do not use this syringe and dispose of it properly.
Croatian: Nemojte koristiti tu štrcaljku, odložite je u otpad na primjeren način.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po injekciji, tj. zanemarive količine natrija.
English: Similar comparative studies with corifollitropin alfa using either a GnRH antagonist or long agonist protocol have not been performed.
Croatian: Nisu provedena slična ispitivanja usporedbe korifolitropina alfa i protokola s antagonistom GnRH-a odnosno dugog protokola s agonistom GnRH-a.
English: OUTER CARTON TEXT Orgalutran 1/ 5 pre-filled syringes
Croatian: TEKST NA VANJSKOM PAKIRANJU Orgalutran 1/ 5 napunjenih štrcaljki
English: There was a tendency towards an increased incidence of LH and progesterone rises in women with a higher body weight (> 80 kg), but no effect on clinical outcome was observed.
Croatian: U žena s većom tjelesnom težinom (> 80 kg) opažena je tendencija prema povećanoj incidenciji porasta LH-a i progesterona, ali nije opažen učinak na klinički ishod.
English: Any blood drawn into the syringe means the needle tip has penetrated a blood vessel.
Croatian: Ako u štrcaljku uvučete malo krvi, to znači da je vrh igle probio krvnu žilu.
English: Uncommon: may affect up to 1 in 100 women Headache
Croatian: Manje često: mogu se javiti u do 1 na 100 žena - glavobolja - mučnina - malaksalost
English: This slightly higher incidence is thought to be related to characteristics of the patients undergoing fertility treatment (e.g. age of the woman, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproduction techniques.
Croatian: Smatra se da je to malo povećanje povezano s osobinama bolesnika koji se liječe od neplodnosti (npr. dob žene, osobine sperme) kao i s većim brojem višeplodnih trudnoća nakon primjene tehnika potpomognute oplodnje.
English: Orgalutran contains the active substance ganirelix and belongs to a group of medicines called “antigonadotrophin-releasing hormones” which act against the actions of the natural gonadotrophin releasing hormone (GnRH).
Croatian: Orgalutran sadrži djelatnu tvar ganireliks i pripada skupini lijekova koji se zovu "antagonisti gonadotropin-oslobađajućeg hormona", a koji sprječavaju djelovanje prirodnog gonadotropin-oslobađajućeg hormona (GnRH).
English: Solution for injection, 1 pre-filled syringe containing 0.5 mL Solution for injection, 5 pre-filled syringes each containing 0.5 mL
Croatian: Otopina za injekciju, 1 napunjena štrcaljka s 0,5 ml Otopina za injekciju, 5 napunjenih štrcaljki s 0,5 ml
English: Driving and using machines The effects of Orgalutran on ability to drive and use machines have not been studied.
Croatian: Upravljanje vozilima i strojevima Nisu ispitivani učinci lijeka Orgalutran na sposobnost upravljanja vozilima i strojevima.
English: The use of Orgalutran is contraindicated during pregnancy and breast-feeding (see section 4.3).
Croatian: Primjena lijeka Orgalutran tijekom trudnoće i dojenja je kontraindicirana (vidjeti dio 4.3).
English: Orgalutran contains sodium Orgalutran contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Croatian: Orgalutran sadrži natrij Orgalutran sadrži manje od 1 mmol natrija (23 mg) po injekciji, tj. zanemarive količine natrija.
English: Preparing the injection site
Croatian: Priprema mjesta injekcije
English: In clinical studies investigating more than 1,000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.
Croatian: U kliničkim ispitivanjima provedenima na više od 1000 novorođenčadi dokazano je da je incidencija kongenitalnih malformacija u djece rođene nakon kontrolirane stimulacije jajnika u kojoj se koristio Orgalutran usporediva s onom nakon kontrolirane stimulacije jajnika u kojoj se koristio agonist GnRH-a.
English: Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during the ovarian stimulation.
Croatian: Ganireliks se koristi za prevenciju prijevremenog naglog porasta razine LH-a, do kojeg bi inače moglo doći u tih žena tijekom stimulacije jajnika.
English: Because of the half-life of ganirelix, the time between two Orgalutran injections as well as the time between the last Orgalutran injection and the hCG injection should not exceed 30 hours, as otherwise a premature LH surge may occur.
Croatian: Zbog poluvijeka ganireliksa razdoblje između dvije injekcije lijeka Orgalutran kao i razdoblje između posljednje injekcije lijeka Orgalutran i injekcije hCG-a ne smije premašiti 30 sati.
English: In addition, side effects are reported which are known to occur with controlled ovarian hyperstimulation treatment (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the womb) and miscarriage (see the patientinformation leaflet of the FSH-containing preparation you are treated with)).
Croatian: Osim toga, prijavljene su i nuspojave za koje se zna da se javljaju pri kontroliranoj hiperstimulaciji jajnika (na primjer bol u trbuhu, sindrom hiperstimulacije jajnika (OHSS), izvanmaternična trudnoća (kada se zametak razvija izvan maternice) i spontani pobačaj (pročitajte i uputu o lijeku za lijek koji uzimate, a koji sadrži FSH)).
English: Injection site
Croatian: Mjesto injekcije
English: Inspect the syringe before use.
Croatian: Prije primjene pregledajte otopinu.
English: When injecting Orgalutran in the afternoon the last Orgalutran injection should be given in the afternoon prior to the day of triggering ovulation.
Croatian: Kada se Orgalutran injicira poslijepodne, posljednju injekciju ovog lijeka treba dati poslijepodne, dan prije izazivanja ovulacije.
English: If you stop using Orgalutran
Croatian: Ako prestanete primjenjivati Orgalutran
English: Cases have been reported, as early as with the first dose, among patients administered Orgalutran.
Croatian: Prijavljeni su slučajevi već kod primjene prve doze u bolesnica koje su primile Orgalutran.
English: The incidence of congenital malformations after assisted reproduction techniques using Orgalutran is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.
Croatian: Broj urođenih malformacija u djece rođene nakon postupaka potpomognute oplodnje u kojima se koristio Orgalutran ne razlikuje se od onoga nakon postupaka potpomognute oplodnje u kojima su se koristili drugi analozi GnRH-a.
English: Ovarian hyperstimulation syndrome (OHSS)
Croatian: Sindrom hiperstimulacije jajnika
English: If you forget to use Orgalutran
Croatian: Ako ste zaboravili primijeniti Orgalutran
English: Final maturation of the egg cells in the follicles can be induced by administering human chorionic gonadotrophin (hCG).
Croatian: Konačno sazrijevanje jajnih stanica u folikulima može se potaknuti primjenom ljudskog korionskog gonadotropina (hCG).
English: The active substance ganirelix (INN) is a synthetic decapeptide with high antagonistic activity to the naturally occurring gonadotrophin releasing hormone (GnRH).
Croatian: Djelatna tvar ganireliks (INN) je sintetski dekapeptid s jakim antagonističkim djelovanjem na prirodni gonadotropinoslobađajući hormon (engl. gonadotrophin releasing hormone, GnRH).
English: The solution is ready for use and intended for subcutaneous administration.
Croatian: Otopina je pripremljena za uporabu i namijenjena za primjenu pod kožu.
English: What Orgalutran looks like and contents of the pack Orgalutran is a clear and colourless aqueous solution for injection.
Croatian: Orgalutran je bistra i bezbojna vodena otopina za injekciju.
English: The incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions.
Croatian: Incidencija urođenih malformacija nakon postupka potpomognute oplodnje može biti malo veća nego nakon spontanog začeća.
English: Ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin may start at day 2 or 3 of your period.
Croatian: Stimulacija jajnika folikulostimulirajućim hormonom (FSH) ili korifolitropinom može započeti 2. ili 3. dana menstruacijskog ciklusa.
English: This different pattern of follicular growth requires that FSH dose adjustments are based on the number and size of growing follicles, rather than on the amount of circulating oestradiol.
Croatian: Različiti uzorci rasta folikula nalažu da se doza FSH-a prilagodi na temelju broja i veličine rastućih folikula, radije nego na temelju količine estradiola u cirkulaciji.
English: The active substance is ganirelix (0.25 mg in 0.5 mL solution).
Croatian: Djelatna tvar je ganireliks (0,25 mg u 0,5 ml otopine).
English: Therefore, when injecting Orgalutran in the morning, treatment with Orgalutran should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation.
Croatian: Stoga, kada se Orgalutran injicira ujutro, liječenje ovim lijekom treba nastaviti cijelo vrijeme liječenja gonadotropinom, uključujući i dan kada se izaziva ovulacija.
English: In clinical studies Orgalutran was used with recombinant human follicle stimulating hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant.
Croatian: U kliničkim ispitivanjima Orgalutran se primjenjivao uz rekombinantni humani folikulostimulirajući hormon (FSH) ili korifolitropin alfa, kontinuirani stimulator folikula.
English: In clinical studies Orgalutran was used with recombinant follicle stimulating hormone (FSH) or corifollitropin alfa, a follicle stimulant with a long duration of action.
Croatian: U kliničkim ispitivanjima Orgalutran se primjenjivao uz rekombinantni folikulostimulirajući hormon (FSH) ili uz korifolitropin alfa, stimulator folikula dugog trajanja djelovanja.
English: Worsening of a pre-existing rash (eczema) has been reported in one subject after the first Orgalutran dose.
Croatian: • koprivnjača (urtikarija) - pogoršanje postojećeg osipa kože (ekcema) prijavljeno je u jedne ispitanice nakon prve doze lijeka Orgalutran
English: The pH (a measurement of the acidity) may have been adjusted with sodium hydroxide and acetic acid.
Croatian: Vrijednost pH (mjera kiselosti) može biti podešena natrijevim hidroksidom i acetatnom kiselinom.
English: Orgalutran is used to prevent the premature LH surge that might cause such a premature release of egg cells.
Croatian: Orgalutran se koristi za sprječavanje prijevremenog naglog porasta razine LH-a, koji bi mogao uzrokovati prijevremeno oslobađanje jajnih stanica.
English: Hypersensitivity reactions (including rash, facial swelling, dyspnoea, anaphylaxis (including anaphylactic shock), angioedema and urticaria) Worsening of a pre-existing eczema
Croatian: Poremećaji imunološkog sustava vrlo rijetko reakcije preosjetljivosti (uključujući osip, oticanje lica, dispneju, anafilaksiju (uključujući anafilaktički šok), angioedem i urtikariju) pogoršanje postojećeg ekcema
English: Very Common Local skin reaction at the site of injection (predominantly redness, with or without swelling)
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često lokalna reakcija na koži na mjestu injekcije (pretežno crvenilo sa ili bez otekline)
English: The needle cover contains dry natural rubber/latex which comes into contact with the needle and may cause allergic reactions.
Croatian: Poklopac igle sadrži suhu prirodnu gumu/lateks, koji dolazi u doticaj s iglom te može uzrokovati alergijske reakcije.
English: Orgalutran is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
Croatian: Orgalutran je indiciran za prevenciju prijevremenog naglog porasta razine luteinizirajućeg hormona (LH) u žena koje se podvrgavaju kontroliranoj hiperstimulaciji jajnika u sklopu postupaka potpomognute oplodnje.
English: Checking the correct needle position
Croatian: Provjerite je li igla ispravno postavljena
English: There is no experience on the use of Orgalutran in subjects with hepatic impairment, as they were excluded from clinical studies.
Croatian: Nema iskustva s primjenom lijeka Orgalutran u osoba s oštećenjem funkcije bubrega jer su bile izuzete iz kliničkih ispitivanja.