FrancophonIA/ELRC3.0 huggingface dataset:
English: If it is within 6 hours before your next dose, skip the missed dose and take the next dose at the usual time.
Croatian: Ako je preostalo manje od 6 sati do sljedeće doze, preskočite dozu koju ste propustili i uzmite sljedeću u uobičajeno vrijeme.
English: In repeated dose toxicity studies the liver appeared as a target organ for toxicity in the different species tested.
Croatian: U ispitivanjima toksičnosti ponovljenih doza, jetra se činila ciljnim organom toksičnosti u različitih ispitanih vrsta.
English: Concomitant administration of food decreased the rate of absorption, but not the extent of absorption.
Croatian: Istodobna primjena hrane smanjila je brzinu apsorpcije, ali ne i veličinu apsorpcije.
English: mBMI was derived as the product of serum albumin and Body Mass Index.
Croatian: mBMI je određen kao umnožak serumskog albumina i indeksa tjelesne mase.
English: These results support the administration of tafamidis with or without food.
Croatian: Ovi rezultati podupiru primjenu tafamidisa s hranom ili bez nje.
English: No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis meglumine.
Croatian: Nisu provedena ispitivanja interakcija kojima bi se procijenio učinak drugih lijekova na tafamidismeglumin.
English: Therequirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Pharmacokinetic parameters were similar after single and repeated administration of 20 mg dose, indicating a lack of induction or inhibition of tafamidis metabolism.
Croatian: Farmakokinetički parametri bili su slični nakon primjene jednokratne i ponovljene doze od 20 mg, što ukazuje na nedostatak indukcije ili inhibicije metabolizma tafamidisa.
English: The effects of tafamidis on cardiac disease progression have not yet been adequately characterised.
Croatian: Učinci tafamidisa na napredovanje srčane bolesti još nisu primjereno opisani.
English: • Push capsule through the exposed aluminium foil.
Croatian: • protisnite kapsulu kroz otkrivenu aluminijsku foliju.
English: Pfizer Europe MA EEIG (as MA Holder logo)
Croatian: Pfizer Europe MA EEIG (kao logotip nositelja odobrenja)
English: PVC/PA/Alu/PVC-Alu/PET/Paper perforated unit dose blisters.
Croatian: PVC/PA/Al/PVC-Al/PET/papir perforirani blister s jediničnim dozama.
English: This medicine has been authorised under ‘exceptional circumstances'.
Croatian: Ovaj lijek je odobren u “iznimnim okolnostima”.
English: Adverse reactions are listed below by MedDRA System Organ Class (SOC) and frequency categories using the standard convention: Very common (1/10), Common (1/100 to <1/10), and Uncommon (1/1,000 to <1/100).
Croatian: Niže navedene nuspojave prikazane su prema MedDRA klasifikaciji organskih sustava (SOC) i kategorijama učestalosti korištenjem ove standardne konvencije: vrlo često (1/10), često (1/100 i <1/10) i manje često (1/1000 i <1/100).
English: As Vyndaqel works by stabilizing the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilized, and your disease may progress.
Croatian: Budući da Vyndaqel djeluje tako da stabilizira TTR protein, ako prestanete uzimati Vyndaqel, taj protein više neće biti stabiliziran i može doći do napredovanja bolesti.
English: • The need to counsel patients on important risks associated with Vyndaqel therapy and appropriate precautions when using the medicine, particularly the avoidance of pregnancy and the need for effective contraception.
Croatian: • Bolesnike je potrebno upozoriti na važne rizike povezane s terapijom Vyndaqelom i odgovarajućim mjerama opreza kad se uzima ovaj lijek, osobito izbjegavanja trudnoće i potrebe za učinkovitom kontracepcijom.
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code N07XX08 Mechanism of action
Croatian: Farmakoterapijska skupina: drugi lijekovi za živčani sustav, ATK oznaka: N07XX08
English: The soft capsules should be swallowed whole, not crushed or cut, and taken with or without food.
Croatian: Meke kapsule trebaju se progutati cijele i ne smiju se drobiti niti rezati, a mogu se uzeti s hranom ili bez nje.
English: The adverse reactions were generally mild or moderate in severity.
Croatian: Nuspojave su općenito bile blage ili umjerene težine.
English: The soft capsule should be swallowed whole, not crushed or cut.
Croatian: Meka se kapsula mora progutati cijela, ne smije se drobiti niti rezati.
English: However, the difference in clearance would not be clinically significant and would not result in clinically relevant different steady-state levels compared to younger subjects.
Croatian: Međutim, razlika u klirensu ne bi bila klinički značajna i ne bi rezultirala klinički značajno različitim razinama u stanju dinamičke ravnoteže u usporedbi s onima u mlađih ispitanika.
English: You should inform your doctor or pharmacist if you are taking any of the following:
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate neki od sljedećih lijekova:
English: As patients with moderate hepatic impairment have lower TTR levels than healthy subjects, dosage adjustment is not necessary as the stoichiometry of tafamidis with its target protein TTR would be sufficient for stabilization of the TTR tetramer.
Croatian: Kako bolesnici s umjerenim oštećenjem jetre imaju niže razine TTR od zdravih ispitanika, prilagodba doze nije potrebna jer bi stehiometrija tafamidisa s njegovim ciljnim proteinom TTR bila dovoljna za stabilizaciju TTR tetramera.
English: This route of biotransformation is plausible in humans, as approximately 59% of the total administered dose is recovered in faeces, and approximately 22% recovered in urine.
Croatian: Ovo je vjerojatno put biotransformacije u ljudi, jer se približno 59% ukupne primijenjene doze otkrije u stolici, a približno 22% u mokraći.
English: Tafamidis meglumine is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Тafamidis meglumin se ne preporučuje u trudnoći i u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Vyndaqel, can prevent TTR from breaking up and forming amyloid deposits.
Croatian: Vyndaqel može spriječiti raspadanje TTR-a i stvaranje depozita amiloida.
English: In clinical trials of healthy volunteers, the highest dose of tafamidis given was 480 mg in a single dose and 60 mg once daily for two weeks.
Croatian: U kliničkim ispitivanjima sa zdravim dobrovoljcima najviša primijenjena doza tafamidisa bila je 480 mg u jednokratnoj dozi i 60 mg jedanput na dan tijekom dva tjedna.
English: To remove capsule: tear off one individual blister, peel the paper at the curved arrow and push through the aluminium foil.
Croatian: Da biste izvadili kapsulu: odvojite jedan pojedinačni dio blistera, odlijepite papir kod zakrivljene strelice i protisnite kroz aluminijsku foliju.
English: The secondary endpoints demonstrated that tafamidis meglumine treatment resulted in less deterioration of neurologic function and improved nutritional status (mBMI) compared with placebo, as shown in the following table.
Croatian: Sekundarne mjere ishoda pokazale su da je terapija tafamidismegluminom rezultirala manjim propadanjem neurološke funkcije i poboljšanim stanjem uhranjenosti (mBMI) u usporedbi s placebom, kako je prikazano u sljedećoj tablici.
English: Vyndaqel is believed to have no or negligible influence on the ability to drive and use machines.
Croatian: Smatra se da Vyndaqel ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: In vitro data also indicated that tafamidis meglumine does not significantly inhibit cytochrome P450 enzymes CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6.
Croatian: In vitro podaci također su pokazali da tafamidismeglumin ne inhibira značajno enzime citokroma P450 CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP2D6.
English: • That patients should be advised to contact their doctor about adverse events and that physicians/pharmacists should report suspected adverse reactions to Vyndaqel since there is limited knowledge about the clinical safety due to the rare nature of transthyretin amyloidosis.
Croatian: • Bolesnicima treba savjetovati da posjete liječnika u vezi s nuspojavama i da liječnici/ljekarnici trebaju prijaviti sumnju na nuspojave Vyndaqela budući da je poznavanje kliničke sigurnosti ograničeno zbog rijetke učestalosti transtiretinske amiloidoze.
English: Within the planned post-authorisation sub-study of the THAOS registry the MAH shall evaluate in non-V30M patients the effects of Vyndaqel on disease progression and its long term safety as detailed in a CHMP agreed protocol, and shall provide yearly updates on the collected data within the annual re-assessment.
Croatian: Unutar planiranog podispitivanja registra THAOS nakon odobrenja za stavljanje lijeka u promet, nositelj odobrenja procijenit će u ne-V30M bolesnika učinke Vyndaqela na napredovanje bolesti i njegovu dugoročnu sigurnost kako je opisano u planu ispitivanja dogovorenom s CHMP-om i svake će godine osigurati nadopune prikupljenih podataka unutar godišnje procjene.
English: The overall clinical data reflect exposure of 127 TTR amyloid polyneuropathy patients to 20 mg of tafamidis meglumine administered daily for an average of 538 days (ranging from 15 to 994 days).
Croatian: Sveukupni klinički podaci odražavaju izloženost 127 bolesnika s TTR amiloidnom polineuropatijom tafamidismegluminom u dozi od 20 mg na dan koji se primjenjivao u prosjeku 538 dana (u rasponu od 15 do 994 dana).
English: After oral administration of the soft capsule, the maximum plasma concentration (Cmax) is achieved at a median time (tmax) of 2 hours after dosing in the fasted state.
Croatian: Nakon oralne primjene meke kapsule, najviša koncentracija u plazmi (Cmax) postiže se nakon medijana vremena (tmax) od 2 sata nakon primjene doze natašte.
English: Do not use this medicine after the expiry date which is stated on the blister card and on the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji.
English: • If you are able to become pregnant, you must use birth control during treatment and for one month after stopping treatment.
Croatian: • Ako možete zatrudnjeti, morate koristiti kontracepciju za vrijeme liječenja i tijekom jednog mjeseca nakon prestanka liječenja.
English: TTR amyloid polyneuropathy is caused by a protein called TTR that does not work properly.
Croatian: TTR amiloidnu polineuropatiju uzrokuje protein koji se zove TTR i koji ne funkcionira ispravno.
English: As there are no data available regarding the use of tafamidis meglumine post-liver transplantation, tafamidis meglumine should be discontinued in patients who undergo liver transplantation.
Croatian: Kako nema dostupnih podataka o primjeni tafamidismeglumina nakon transplantacije jetre, primjenu tafamidismeglumina treba prekinuti u bolesnika koji se podvrgnu transplantaciji jetre.
English: Based on repeated measures analysis of variance with change from baseline as the dependent variable, an unstructured covariance matrix, treatment, month and treatment-by-month as fixed effects, and subject as a random effect in the model.
Croatian: Na temelju ponovljenih mjerenja u analizi varijance s promjenom u odnosu na početnu vrijednost kao ovisnom varijablom, nestrukturiranom matricom kovarijance, terapijom, mjesecom i terapijom po mjesecu kao fiksnim učincima te ispitanikom kao slučajnim učinkom u modelu.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tafamidis in milk.
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazali su da se tafamidis izlučuje u mlijeko liječenih žena.
English: The reported treatment-related adverse events were mild to moderate and included: headache, somnolence, myalgia, insomnia, hordeolum, photosensitivity reaction, and presyncope.
Croatian: Prijavljene nuspojave povezane s terapijom bile su blage do umjerene te su uključivale: glavobolju, somnolenciju, mijalgiju, nesanicu, ječmenac (hordeolum), reakciju fotoosjetljivosti i presinkopu.
English: These intermediates then misassemble into soluble oligomers, profilaments, filaments, and amyloid fibrils.
Croatian: Ti se međuspojevi potom krivo spajaju u topljive oligomere, profilamente, filamente i amiloidne fibrile.
English: Eighty-six of the 91 patients completing the 18 month treatment period subsequently enrolled in an open label extension study, where they all received once daily 20 mg tafamidis meglumine for an additional 12 months.
Croatian: Potom je 86 od 91 bolesnika koji su završili terapiju u trajanju od 18 mjeseci bilo uključeno u produžetak ispitivanja otvorenog tipa u kojem su svi primali 20 mg tafamidismeglumina jedanput na dan tijekom dodatnih 12 mjeseci.
English: • Urinary tract infection (symptoms may include: pain or a burning sensation when you urinate or a frequent need to urinate)
Croatian: • infekcija mokraćnog sustava (simptomi mogu uključivati: bol i žarenje pri mokrenju ili učestala potreba za mokrenjem)
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2011
Croatian: Datum prvog odobrenja: 16. studenoga 2011.
English: Tafamidis meglumine has not been studied in patients with severe hepatic impairment and caution is recommended (see section 5.2).
Croatian: Tafamidismeglumin nije ispitan u bolesnika s teškim oštećenjem jetre pa se preporučuje oprez (vidjeti dio 5.2).
English: Vyndaqel is available in two pack sizes of PVC/PA/Alu/PVC-Alu/PET/Paper perforated unit dose blisters: a pack of 30 x 1 soft capsules and a multipack of 90 soft capsules comprising of 3 cartons, each containing 30 x 1 soft capsules.
Croatian: Vyndaqel je dostupan u dvije veličine pakiranja s PVC/PA/Al/PVCAl/PET/papir perforiranim blisterima s jediničnim dozama: pakiranje od 30x1 mekih kapsula i višestruko pakiranje od 90 mekih kapsula koje se sastoji od 3 kutije, od kojih svaka sadrži 30x1 mekih kapsula.
English: The pre-specified Efficacy Evaluable analysis used observed data for those patients who completed the 18 month treatment per protocol.
Croatian: U unaprijed određenoj analizi procijenjene djelotvornosti koristili su se podaci iz promatranja onih bolesnika koji su dovršili liječenje u trajanju od 18 mjeseci prema planu ispitivanja.
English: This medicine is used to treat adult patients with this disease whose nerves have been affected (people with symptomatic polyneuropathy) to delay further progression.
Croatian: Ovaj se lijek primjenjuje u liječenju odraslih bolesnika kojima je ova bolest zahvatila živce (osobe sa simptomatskom polineuropatijom) kako bi se odgodilo napredovanje bolesti.
English: Children and adolescents do not have the symptoms of TTR amyloid polyneuropathy.
Croatian: Djeca i adolescenti nemaju simptome TTR amiloidne polineuropatije.
English: In the open-label extension study, the rate of change in the NIS-LL during the 12 months of treatment was similar to that observed in those patients randomised and treated with tafamidis in the previous double blind 18 month period.
Croatian: U produžetku ispitivanja otvorenog tipa, stopa promjene u NIS-LL tijekom 12 mjeseci terapije bila je slična onoj opaženoj u bolesnika koji su bili randomizirani i liječeni tafamidisom u prethodnom dvostruko slijepom 18-mjesečnom razdoblju.
English: There are no data on the use of Vyndaqel in pregnant women.
Croatian: Nema podataka o upotrebi Vyndaqela u trudnih žena.
English: Tafamidis binds non-cooperatively to the two thyroxine binding sites on the native tetrameric form of transthyretin preventing dissociation into monomers.
Croatian: Tafamidis se veže na nekooperativni način na dva mjesta za vezanje tiroksina na nativnom tetramernom obliku transtiretina i tako sprječava njegovo razdvajanje u monomere.
English: The folded monomers undergo partial denaturation to produce alternatively folded monomeric amyloidogenic intermediates.
Croatian: Presavijeni monomeri djelomično se denaturiraju, čime nastaju drugačije presavijeni monomerni amiloidogeni međuspojevi.
English: Results from once-daily dosing with tafamidis meglumine 15, 30, or 60 mg for 14 days demonstrated dose-dependent increases in Cmax and AUC between doses of 15 mg and 30 mg and less than dose proportional between 30 and 60 mg, indicating saturation of absorption process beyond 30 mg.
Croatian: Rezultati primjene tafamidismeglumina jedanput na dan u dozi od 15, 30 ili 60 mg tijekom 14 dana pokazali su povećanje Cmax i AUC ovisno o dozi, između doza od 15 mg i 30 mg a manje od proporcionalnog dozi između 30 i 60 mg, što je ukazivalo na zasićenje apsorpcijskog procesa kod doze iznad 30 mg.
English: The apparent steady state volume of distribution is 25.7 liters.
Croatian: Prividni volumen raspodjele u stanju dinamičke ravnoteže je 25,7 litara.
English: Although data are limited, (one open label study in 21 patients), taking into account the mechanism of action of tafamidis and the results on TTR stabilisation, tafamidis meglumine is expected to be beneficial in patients with stage 1 TTR amyloid polyneuropathy due to mutations other than V30M.
Croatian: Iako su podaci ograničeni (jedno ispitivanje otvorenog tipa u 21 bolesnika), uzimajući u obzir mehanizam djelovanja tafamidisa i rezultate TTR stabilizacije, očekuje se korist od tafamidismeglumina u bolesnika s prvim stadijem TTR amiloidne polineuropatije zbog mutacija, osim mutacije V30M.
English: Decreased foetal weights in males were associated with delayed sexual maturation (preputial separation) and impaired performance in a water-maze test for learning and memory.
Croatian: Smanjenje fetalne tjelesne težine u mužjaka bilo je povezano sa zakašnjelim spolnim sazrijevanjem (separacija prepucija) i smanjenom uspješnošću na testu „water-maze“ za ispitivanje funkcije učenja i pamćenja.
English: Pharmacokinetic data indicated decreased systemic exposure (approximately 40%) and increased total clearance (0.52 l/h vs. 0.31l/h) of tafamidis in patients with moderate hepatic impairment (Child-Pugh Score of 7-9 inclusive) compared to healthy subjects due to a higher unbound fraction of tafamidis.
Croatian: Farmakokinetički podaci pokazali su smanjenu sistemsku izloženost (približno 40%) i povećan ukupni klirens (0,52 l/h nasuprot 0,31 l/h) tafamidisa u bolesnika s umjerenim oštećenjem jetre (Child-Pugh rezultat od 7 do uključujući 9) u usporedbi sa zdravim ispitanicima zbog više nevezane frakcije tafamidisa.
English: Пфайзер Люксембург САРЛ, Клон България Тел.
Croatian: Пфайзер Люксембург САРЛ, Клон България
English: Vyndaqel N=64 P-value
Croatian: Vyndaqel N=64
English: Based on population PK results, subjects older than 60 years old had an average 19% lower estimate of clearance at steady-state compared to subjects less than 60 years old.
Croatian: Na temelju rezultata populacijske farmakokinetike, ispitanici stariji od 60 godina imali su prosječno 19% niži približni klirens u stanju dinamičke ravnoteže od ispitanika mlađih od 60 godina.
English: The European Medicines Agency has waived the obligation to submit the results of studies with tafamidis meglumine in all subsets of paediatric population in familial amyloid polyneuropathy (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja tafamidismeglumina u svim podskupinama pedijatrijske populacije u indikaciji obiteljske amiloidne polineuropatije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Urinary tract infection Vaginal infection
Croatian: Infekcije i infestacije infekcije mokraćnog sustava vaginalna infekcija
English: Tafamidis has not specifically been evaluated in patients with renal impairment, but a dosage adjustment in patients with renal impairment is considered not necessary.
Croatian: Tafamidis se nije posebno procjenjivao u bolesnika s oštećenjem bubrega, ali smatra se da nije potrebno prilagođavati doze u bolesnika s oštećenjem bubrega.
English: In patients with this disease, TTR breaks up and may form fibres called amyloid.
Croatian: U bolesnika s ovom bolešću, TTR se raspada i tako može stvoriti niti koje se zovu amiloid.
English: Other medicines and Vyndaqel
Croatian: Drugi lijekovi i Vyndaqel
English: Vyndaqel contains sorbitol
Croatian: Vyndaqel sadrži sorbitol
English: What Vyndaqel looks like and contents of the pack
Croatian: Kako Vyndaqel izgleda i sadržaj pakiranja
English: Other outcome measures included composite scores of large nerve fiber (nerve conduction, vibration threshold and heart rate response to deep breathing - HRDB) and small nerve fiber function (heat pain and cooling threshold and HRDB) and nutritional assessments utilizing the modified body mass index (mBMI - BMI multiplied by serum albumin in g/L).
Croatian: Druge mjere ishoda uključivale su kompozitni broj bodova za funkciju velikih živčanih vlakana (živčana provodljivost, prag za osjet vibracije i odgovor frekvencije srca na duboko disanje - HRDB) i malih živčanih vlakana (prag bola na toplinu i prag osjeta hladnoće te HRDB) te procjene stanja uhranjenosti pomoću modificiranog indeksa tjelesne mase (mBMI - BMI pomnožen s vrijednošću serumskog albumina izraženog u g/l).
English: Based on preclinical data, it is suggested that tafamidis is metabolised by glucuronidation and excreted via the bile.
Croatian: Na temelju nekliničkih podataka, smatra se da se tafamidis metabolizira glukuronidacijom i izlučuje putem žuči.
English: 4 CLINICAL PARTICULARS 4.1 Therapeutic indication
Croatian: 4.1 Terapijske indikacije
English: The pivotal study of tafamidis meglumine was an 18-month, multicenter, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of once-daily 20 mg tafamidis meglumine in 128 patients with TTR amyloid polyneuropathy with the V30M mutation and primarily stage 1 disease (do not routinely require assistance with ambulation).
Croatian: Ključno ispitivanje tafamidismeglumina bilo je multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u trajanju od 18 mjeseci kojim se procijenila sigurnost i djelotvornost tafamidismeglumina u dozi od 20 mg jedanput na dan u 128 bolesnika s TTR amiloidnom polineuropatijom i V30M mutacijom koji su bili u prvom stadiju bolesti (ne trebaju rutinski pomoć pri hodanju).
English: If you vomit after taking this medicine and can identify the intact Vyndaqel capsule, then an additional dose of Vyndaqel should be taken in the same day; if you cannot identify the Vyndaqel capsule, then no additional dose of Vyndaqel is necessary, and you can resume taking Vyndaqel the next day as usual.
Croatian: Ako povraćate nakon uzimanja ovog lijeka i možete pronaći cjelovitu kapsulu Vyndaqela u povraćenom sadržaju, onda se treba uzeti dodatna doza lijeka Vyndaqel istog dana; ako ne možete pronaći kapsulu Vyndaqel, onda nije potrebna dodatna doza Vyndaqela i možete nastaviti uzimati Vyndaqel od sljedećeg dana prema uobičajenom rasporedu.
English: The recommended dose of tafamidis meglumine is 20 mg orally once daily.
Croatian: Preporučena doza tafamidismeglumina je 20 mg peroralno jedanput na dan.
English: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Croatian: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija
English: Vyndaqel versus Placebo: NIS-LL and TQOL at Month 18 (Study Fx-005) Placebo
Croatian: Vyndaqel nasuprot placebu: NIS-LL i TQOL nakon 18 mjeseci (Ispitivanje Fx-005) Placebo
English: Fertility No impairment of fertility has been observed in nonclinical studies (see section 5.3).
Croatian: U nekliničkim ispitivanjima nije opaženo oštećenje plodnosti (vidjeti dio 5.3).