FrancophonIA/ELRC3.0 huggingface dataset:
English: Asthenia
Croatian: Apsorpcija
English: Antipsychotics, Anxiolytics and Hypnotics Triazolam Alprazolam Midazolam oral
Croatian: Antipsihotici, anksiolitici i hipnotici
English: Lactose monohydrate Povidone
Croatian: Sunitinib Dasatinib Lapatinib
English: AUC: ↑ 2.1-fold
Croatian: AUC: ↑ 2,1 puta
English: Contraindicated due to the risk of QT prolongation (see section 4.3).
Croatian: Kontraindicirana zbog rizika od produljenja QT intervala (vidjeti dio
English: AUC: ↑ have been observed
Croatian: AUC: ↑ 2 puta
English: Buprenorphine:
Croatian: Telitromicin:
English: ↑in plasma concentrations of docetaxel have been observed Potential ↑in plasma concentrations of busulfan
Croatian: Potencijalno ↑ plazmatskih koncentracija busulfana
English: Dronedarone
Croatian: Dabigatran
English: Lapatinib:
Croatian: Ombitasvir:
English: Overdose
Croatian: Dojenje
English: Take one capsule in the morning and one capsule at night.
Croatian: Uzmite jednu kapsulu ujutro i jednu kapsulu navečer.
English: EU/1/14/974/001 56 capsules EU/1/14/974/002 196 capsules EU/1/14/974/003 14 capsules
Croatian: EU/1/14/974/001 56 kapsula EU/1/14/974/002 196 kapsula EU/1/14/974/003 14 kapsula
English: The relevance of these findings for humans is not known.
Croatian: Nije poznat značaj tih nalaza za ljude.
English: Press down at 1 and at the same time pull at 2.
Croatian: Za primjenu kroz usta Pritisnite na 1 i istovremeno povucite za 2.
English: • Pain in arms, legs or back
Croatian: • Bol u rukama, nogama ili leđima
English: Take one capsule at the same time every day.
Croatian: Uzmite jednu kapsulu svaki dan u isto vrijeme.
English: It may be taken with or without food.
Croatian: Može se uzimati s hranom ili bez nje.
English: If you are pregnant, think that you may be pregnant or are planning to have a baby, tell your doctor who will discuss with you whether you can take this medicine during your pregnancy.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku koji će s Vama razgovarati o tome smijete li uzimati ovaj lijek tijekom trudnoće.
English: amiodarone or sotalol.
Croatian: amiodarona ili sotalola.
English: Characteristics in specific groups
Croatian: Značajke u posebnim skupinama
English: No significant differences were found in the efficacy and safety profiles of elderly patients and younger patients.
Croatian: Nisu pronađene značajne razlike u profilima djelotvornosti i sigurnosti u starijih i mlađih bolesnika.
English: Information for the patient:
Croatian: Informacije za bolesnika:
English: The patient alert card shall contain the following key elements:
Croatian: Kartica s upozorenjima za bolesnike će sadržavati sljedeće ključne elemente;
English: Information for healthcare professionals:
Croatian: Informacije za zdravstvene radnike:
English: If you cannot swallow the capsule whole, tell your doctor.
Croatian: Ako ne možete progutati cijelu kapsulu, obavijestite o tome svojeg liječnika.
English: Your doctor will determine if Cerdelga is suitable for you before you start taking it, using a simple laboratory test.
Croatian: Vaš liječnik će odrediti je li Cerdelga prikladna za Vas prije nego što ju počnete uzimati pomoću jednostavne laboratorijske pretrage.
English: The capsules may be taken with or without food.
Croatian: Kapsule se mogu uzimati s hranom ili bez nje.
English: Do not open, crush, dissolve, or chew the capsule before swallowing it.
Croatian: Nemojte otvarati, drobiti, otapati ili žvakati kapsulu prije gutanja.
English: Breast-feeding is not recommended during treatment with this medicine.
Croatian: Dojenje se ne preporučuje tijekom liječenja ovim lijekom.
English: Cerdelga has not been tested in children and adolescents under 18 years of age.
Croatian: Cerdelga nije ispitana u djece i adolescenata mlađih od 18 godina.
English: The size of the capsule is ‘size 2' (dimensions 18.0 x 6.4 mm).
Croatian: Kapsula je „veličine 2“ (dimenzija 18,0 x 6,4 mm).
English: Continue taking Cerdelga every day for as long as your doctor tells you.
Croatian: Nastavite uzimati lijek Cerdelga svaki dan sve dok Vam to kaže Vaš liječnik.
English: While pressing your thumb and finger together at one end of the sleeve (1) gently pull the blister/wallet out to open the sleeve (2).
Croatian: Dok istovremeno pritišćete palcem i prstom na jednom kraju košuljice (1) lagano izvucite blister/ovitak da biste otvorili košuljicu (2).
English: The capsules should be swallowed whole, preferably with water, and should not be crushed, dissolved, or opened.
Croatian: Kapsule treba progutati cijele, najbolje s vodom i ne smiju se drobiti, otapati niti otvarati.
English: In the event of acute overdose, the patient should be carefully observed and given symptomatic treatment and supportive care.
Croatian: U slučaju akutnog predoziranja, bolesnika treba pomno motriti i dati mu simptomatsku terapiju i potpornu njegu.
English: What Cerdelga is and what it is used for
Croatian: Što je Cerdelga i za što se koristi
English: Eliglustat is moderately bound to human plasma proteins (76 to 83%) and is mainly distributed in plasma.
Croatian: Eliglustat se umjereno veže za ljudske proteine plazme (76% do 83%) i uglavnom se distribuira u plazmi.
English: As a result the amount of this medicine in the blood can differ between patients which could affect how a patient would respond.
Croatian: Zbog toga se količina ovog lijeka u krvi može razlikovati između bolesnika što može imati utjecaj na bolesnikov odgovor.
English: Standard Deviation
Croatian: Standardna devijacija
English: As a precautionary measure, it is recommended to avoid the use of Cerdelga during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Cerdelga tijekom trudnoće.
English: Your doctor will determine which medicines you can use based on how fast your body breaks down eliglustat.
Croatian: Vaš liječnik će odrediti koje lijekove možete koristiti ovisno o brzini kojom Vaše tijelo razgrađuje eliglustat.
English: Do not stop taking Cerdelga without talking to your doctor.
Croatian: Nemojte prestati uzimati lijek Cerdelga bez razgovora s Vašim liječnikom.
English: Contents of the pack and other information What Cerdelga contains
Croatian: Sadržaj pakiranja i druge informacije Što Cerdelga sadrži
English: o Always consult the doctor who prescribed eliglustat before you start using other medicines.
Croatian: o Uvijek se savjetujte s liječnikom koji Vam je propisao eliglustat prije nego što počnete uzimati druge lijekove.
English: Cerdelga must not be used with certain type of medicines.
Croatian: Cerdelga se ne smije uzimati s određenim vrstama lijekova.
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Croatian: (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000)]).
English: Medicines that must not be taken in combination with each other and Cerdelga
Croatian: Lijekovi koji se ne smiju uzimati u kombinaciji jedni s drugima i lijekom Cerdelga
English: Reports from the subregistry are to be submitted with each PSUR.
Croatian: Izvješća iz pod registra se moraju podnositi sa svakim PSUR-om.
English: Date of first authorisation: 19 January 2015 Date of latest renewal:
Croatian: Datum prvog odobrenja: 19. siječnja 2015.
English: - If you are allergic to eliglustat or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na eliglustat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: For these patients, monitoring for further improvement or an alternative treatment modality should be considered.
Croatian: Za te je bolesnike potrebno razmotriti praćenje daljnjeg poboljšanja ili alternativni način liječenja.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cerdelga therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se donijeti odluka da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Cerdelga uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: People differ in the speed that their body breaks down this medicine.
Croatian: Ljudi se razlikuju po brzini kojom njihovo tijelo razgrađuje ovaj lijek.
English: Please tell your doctor or pharmacist if you are using, or have recently used, or might use, any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The majority of extension phase discontinuations were due to transition to commercial product from year 3 onwards.
Croatian: Većina prekida liječenja u fazi produžetka dogodila se zbog prelaska na komercijalni lijek u 3. godini i nadalje.
English: • cilostazol - used to treat cramp-like pain in your legs when you walk caused by insufficient blood supply in your legs
Croatian: • cilostazol - primjenjuje se za liječenje bolova nalik grčevima u Vašim nogama kada hodate što je uzrokovano nedovoljnom opskrbom Vaših nogu krvlju
English: Gender, body weight, age, and race
Croatian: Spol, tjelesna težina, dob i rasa
English: After intravenous administration, the volume of distribution was 816 L, suggesting wide distribution to tissues in humans.
Croatian: Nakon intravenske primjene, volumen distribucije bio je 816 l, što upućuje na široku distribuciju u tkiva kod ljudi.
English: Eliglustat was not mutagenic in a standard battery of genotoxicity tests and did not show any carcinogenic potential in standard lifetime bioassays in mice and rats.
Croatian: Eliglustat nije bio mutagen u standardnoj bateriji testova genotoksičnosti i nije pokazivao kancerogeni potencijal u standardnim cjeloživotnim bio-testovima na miševima i štakorima.
English: • have had a heart attack or heart failure.
Croatian: • ste imali srčani udar ili zatajenje srca
English: The MAH shall complete, within the stated timeframe, the below measure:
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere:
English: Five Cerdelga-treated patients (26%) achieved a reduction of at least 2 points in the BMB score.
Croatian: Pet bolesnika liječenih lijekom Cerdelga (26%) postiglo je smanjenje od najmanje 2 boda u rezultatu BMB-a..
English: This may cause mild increases in the PR, QRS, and QTc intervals.
Croatian: To može uzrokovati blago produljenje PR, QRS i QTc intervala.
English: PETG/COC.PETG/PCTFE-aluminium blister Each blister wallets contains 14 hard capsules.
Croatian: PETG/COC.PETG/PCTFE-aluminijski blister Jedan blister ovitak sadrži 14 tvrdih kapsula.
English: Based on the population pharmacokinetic analysis, gender, body weight, age, and race had limited or no impact on the pharmacokinetics of eliglustat.
Croatian: Temeljem populacijske farmakokinetičke analize, spol, tjelesna težina, dob i rasa imali su ograničen ili nikakav učinak na farmakokinetiku eliglustata.
English: Consumption of grapefruit or its juice should be avoided (see section 4.5).
Croatian: Treba izbjegavati konzumiranje grejpa ili njegovog soka (vidjeti dio 4.5).
English: ‘Other medicines and Cerdelga.'
Croatian: „Drugi lijekovi i Cerdelga.“
English: Nineteen patients completed 4 years of treatment.
Croatian: Devetnaest bolesnika dovršilo je 4 godine liječenja.
English: How to pull the blister/wallet from the sleeve
Croatian: Kako izvući blister/ovitak iz košuljice
English: Consumption of grapefruit or its juice should be avoided.
Croatian: Treba izbjegavati konzumiranje grejpa ili njegovog soka.
English: There are many medicines in these categories and depending on how your body breaks down Cerdelga the effects may differ from person to person.
Croatian: Mnogi se lijekovi nalaze u tim kategorijama, a ovisno o tome kako Vaše tijelo razgrađuje lijek Cerdelga učinak se može razlikovati od osobe do osobe.
English: Each pack contains 14, 56 or 196 hard capsules.
Croatian: Jedno pakiranje sadrži 14, 56 ili 196 tvrdih kapsula.
English: Eighteen patients completed 8 years of treatment.
Croatian: Osamnaest bolesnika dovršilo je 8 godina liječenja.
English: Results of study 304 indicate that skeletal improvements are maintained or continue to improve during at least 8 years of treatment with Cerdelga.
Croatian: Rezultati ispitivanja 304 upućuju da je poboljšanje kostiju održano ili se nastavilo poboljšavati tijekom najmanje 8 godina liječenja lijekom Cerdelga.
English: Cerdelga contains lactose
Croatian: Cerdelga sadrži laktozu
English: Patients who are URMs may not achieve adequate concentrations to achieve a therapeutic effect.
Croatian: Bolesnici koji su UBM-i možda neće postići adekvatne koncentracije za postizanje terapijskog učinka.
English: The safety and efficacy of Cerdelga in children and adolescents under the age of 18 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka Cerdelga u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: • Obligation to conduct post-authorisation measure
Croatian: • Obaveza provođenja mjera nakon davanja odobrenja
English: Food does not have a clinically relevant effect on eliglustat pharmacokinetics.
Croatian: Hrana nema klinički značajan učinak na farmakokinetiku eliglustata.
English: At 2 and 24 hours post-dose, 0.034 % and 0.013 % of labelled dose was detected in foetal tissue, respectively.
Croatian: Kod 2. i 24. sata nakon doziranja, 0,034% odnosno 0,013% obilježene doze otkriveno je u fetalnom tkivu.
English: There are no known effects on fertility at normal doses.
Croatian: Nema poznatih učinaka na plodnost pri uzimanju normalnih doza.
English: * The incidence of the adverse reaction was the same or higher with placebo than with Cerdelga in the placebo-controlled pivotal study.
Croatian: * Incidencija nuspojave bila je ista ili viša s placebom nego s lijekom Cerdelga u pivotalnom placebom kontroliranom ispitivanju.
English: Effects of eliglustat in toxicology studies were reversible and exhibited no evidence of delayed or recurring toxicity.
Croatian: Učinci eliglustata u toksikološkim ispitivanjima bili su reverzibilni i nisu ukazali na odgođenu ili ponavljajuću toksičnost.
English: Based on the aggregate data from all doses tested in this study, Cerdelga met the criteria set in this study to be declared non-inferior to Cerezyme (imiglucerase) in maintaining patient stability.
Croatian: Temeljem ukupnih podataka svih doza testiranih u ovom ispitivanju, Cerdelga je zadovoljila kriterije neinferiornosti postavljene u ovom ispitivanju u odnosu na Cerezyme (imigluceraza) u održavanju stabilnosti bolesnika.
English: The one URM who received 84 mg twice daily did not have an adequate response.
Croatian: Jedan UBM koji je primio 84 mg dva puta dnevno nije imao adekvatan odgovor.
English: During the open-label long term treatment period with Cerdelga (extension phase), all patients with complete data who continued to receive Cerdelga showed further improvements throughout the extension phase.
Croatian: U otvorenom razdoblju dugoročnog liječenja lijekom Cerdelga (faza produžetka ispitivanja), svi bolesnici s potpunim podacima koji su nastavili primati lijek Cerdelga pokazali su daljnja poboljšanja tijekom faze produžetka ispitivanja.
English: What Cerdelga looks like and contents of the pack
Croatian: Kako Cerdelga izgleda i sadržaj pakiranja
English: Median time to reach maximum plasma concentrations occurs between 1.5 to 6 hours after dosing, with low oral bioavailability (<5%) due to significant first-pass metabolism.
Croatian: Apsorpcija Medijan vremena za postizanje maksimalnih koncentracija u plazmi pojavljuje se 1,5 do 6 sati nakon doziranja s niskom oralnom bioraspoloživošću (< 5%) zbog značajnog metabolizma prvog prolaza.
English: For patients with stable disease who switch from enzyme replacement therapy to eliglustat, monitoring for disease progression (e.g. after 6 months with regular monitoring thereafter) should be performed for all disease domains to evaluate disease stability.
Croatian: Za bolesnike sa stabilnom bolešću koji su prebačeni sa enzimske nadomjesne terapije na eliglustat potrebno je provoditi praćenje zbog progresije bolesti (npr. nakon 6 mjeseci uz redovito praćenje nakon toga) za sve apekte bolesti da bi se mogla ocijeniti stabilnost bolesti.
English: There were no clinically meaningful differences between groups for any of the four individual disease parameters (see Table 4).
Croatian: Nije bilo klinički značajnih razlika između skupina za bilo koji od četiri pojedinačna parametra bolesti
English: Please speak to your doctor regarding these medicines before you start taking Cerdelga.
Croatian: Razgovarajte sa svojim liječnikom o tim lijekovima prije nego što počnete uzimati lijek Cerdelga.
English: Cerdelga showed sustained improvements in organ volume and haematological parameters over the 8 year treatment period (see Table 3).
Croatian: Cerdelga je pokazala kontinuirano poboljšanje u volumenu organa i hematološkim parametrima tijekom osmogodišnjeg razdoblja liječenja (vidjeti Tablicu 3).
English: If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Croatian: Ako se doza propusti, propisanu dozu treba uzeti u sljedeće vrijeme prema uobičajenom rasporedu;
English: The most frequently reported adverse reaction with Cerdelga is dyspepsia, in approximately 6% of the clinical trial patients.
Croatian: Najčešće prijavljivana nuspojava na lijek Cerdelga je dispepsija, kod približno 6% bolesnika iz kliničkih ispitivanja.
English: If you take more Cerdelga than you should
Croatian: Ako uzmete više lijeka Cerdelga nego što ste trebali
English: As a result glucosylceramide builds up in your spleen, liver and bones.
Croatian: Zbog toga se glukozilceramid nakuplja u Vašoj slezeni, jetri i kostima.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: o Eliglustat should not be used concomitantly with medicines that may have an impact on liver enzymes that play a role in the metabolism of eliglustat.
Croatian: o Eliglustat se ne smije koristiti istodobno s lijekovima koji mogu utjecati na jetrene enzime koji imaju ulogu u metabolizmu eliglustata.
English: After intravenous administration, eliglustat total body clearance was 86 L/h.
Croatian: Nakon intravenske primjene, ukupni tjelesni klirens eliglustata bio je 86 l/h.
English: • Acid reflux disease (gastrooesophageal reflux disease)
Croatian: • Bolest vraćanja kiseline (gastroezofagealna refluksna bolest)
English: No dosing recommendation for URMs can be given.
Croatian: Ne može se dati preporuka doze za UBM-e.
English: a Cerezyme/Cerdelga - Originally Randomized to Cerezyme b Cerdelga - Originally Randomized to Cerdelga
Croatian: a Cerezyme/Cerdelga - početno randomizirani na lijek Cerezyme b Cerdelga - početno randomizirani na lijek Cerdelga
English: In mature male rats, no effects on sperm parameters were observed at systemically non-toxic doses.
Croatian: U odraslih mužjaka štakora nisu zabilježeni učinci na parametre sperme u sistemski netoksičnim dozama.
English: Cerdelga has no or negligible influence on the ability to drive and use machines.
Croatian: Cerdelga ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: At the time of the highest plasma concentration (59-fold higher than normal therapeutic conditions), the subject experienced dizziness marked by disequilibrium, hypotension, bradycardia, nausea, and vomiting.
Croatian: U vrijeme najviše koncentracije u plazmi (59 puta više od normalnih terapijskih uvjeta), ispitanik je imao omaglicu karakteriziranu poremećajem ravnoteže, hipotenzijom, bradikardijom, mučninom i povraćanjem.
English: You may experience dizziness marked by loss of balance, slow heart rate, nausea, vomiting and lightheadedness.
Croatian: Možete osjećati omaglicu praćenu gubitkom ravnoteže, usporene srčane otkucaje, mučninu, povraćanje i ošamućenost.
English: The active substance in this medicine has been shown to pass in trace amounts into breast milk in animals.
Croatian: Pokazalo se da djelatna tvar u ovom lijeku u tragovima prelazi u majčino mlijeko u životinja.
English: Pack sizes of 14 hard capsules in 1 blister wallet, 56 hard capsules in 4 blister wallets of 14 capsules each or 196 hard capsules in 14 blister wallets of 14 capsules each
Croatian: Veličina pakiranja od 14 tvrdih kapsula u 1 blister ovitku, 56 tvrdih kapsula u 4 blister ovitka sa 14 kapsula u svakom ili 196 tvrdih kapsula u 14 blister ovitaka sa 14 kapsula u svakom.
English: Nonclinical studies demonstrated a wide distribution of eliglustat to tissues, including bone marrow.
Croatian: Neklinička ispitivanja pokazala su široku distribuciju eliglustata u tkiva, uključujući koštanu srž.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak obzirom na reproduktivnu toksičnost (vidjeti dio 5.3).
English: If you are a poor metaboliser:
Croatian: Ako ste spori metabolizator:
English: Use of eliglustat in patients with pre-existing cardiac conditions has not been studied during clinical trials.
Croatian: Primjena eliglustata u bolesnika s već postojećim srčanim bolestima nije ispitivana u kliničkim ispitivanjima.
English: Do not use this medicine after the expiry date which is stated on the carton, sleeve and blister after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, košuljici i blisteru iza oznake „EXP“.
English: In turn this helps your affected organs to work better.
Croatian: To pomaže boljem radu zahvaćenih organa.
English: Electrocardiographic evaluation
Croatian: Elektrokardiografska procjena
English: A lactation study in the rat showed that 0.23% of labelled dose was transferred to pups during 24 hours post-dose, indicating milk excretion of eliglustat and/or its related materials.
Croatian: Ispitivanje laktacije u štakora pokazalo je da se 0,23% obilježene doze prenijelo na mladunčad tijekom 24 sata nakon doziranja, upućujući na izlučivanje eliglustata i/ili s njime povezanih tvari u mlijeko.
English: Grapefruit products contain one or more components that inhibit CYP3A and can increase plasma concentrations of eliglustat.
Croatian: Proizvodi od grejpa sadržavaju jednu ili više komponenata koje inhibiraju CYP3A i mogu povisiti koncentracije eliglustata u plazmi.
English: The build-up prevents these organs from working properly.
Croatian: To nakupljanje sprječava pravilan rad tih organa.
English: The highest eliglustat plasma concentration observed to date occurred in a Phase 1 single-dose dose escalation study in healthy subjects, in a subject taking a dose equivalent to approximately 21 times the recommended dose for GD1 patients.
Croatian: Najviša koncentracija eliglustata u plazmi opažena do danas pojavila se u ispitivanju faze 1 povećanja jednokratne doze u zdravih ispitanika, u jednog ispitanika koji je uzimao dozu ekvivalentnu približno 21 puta većoj od preporučene doze za bolesnike s GD1.
English: Gaucher disease type 1 is a rare, inherited condition in which a substance called glucosylceramide is not effectively broken down by your body.
Croatian: Gaucherova bolest tipa 1 je rijetko, nasljedno stanje kod kojeg se tvar koja se zove glukozilceramid ne razgrađuje učinkovito u Vašem tijelu.
English: • have an irregular, or abnormal heart beat, inluding a heart condition called long QT syndrome.
Croatian: • imate nepravilne ili abnormalne otkucaje srca, uključujući srčano stanje koje se zove sindrom produljenog QT intervala
English: 14 hard capsules 56 hard capsules 196 hard capsules
Croatian: 14 tvrdih kapsula 56 tvrdih kapsula 196 tvrdih kapsula
English: No clinically significant QTc prolonging effect of eliglustat was observed for single doses up to 675 mg.
Croatian: Nije zabilježen klinički značajan učinak produljenja QTc intervala za jednokratne doze eliglustata do 675 mg.