FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who require a nasal corticosteroid or nasal decongestant on a dosing day should be advised not to administer these medicinal products within 1 hour before Spravato administration.
Croatian: Kortikosteroidi ili dekongestivi za nazalnu primjenu Bolesnike koji na dan primjene lijeka Spravato trebaju uzeti nazalni kortikosteroid ili nazalni dekongestiv treba uputiti da navedene lijekove ne primjenjuju unutar sat vremena prije primjene lijeka Spravato.
English: ● Patients for whom an increase in blood pressure or intracranial pressure poses a serious risk (see section 4.8): Patients with aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels).
Croatian: • Primjena u bolesnika kod kojih povišenje krvnog ili intrakranijalnog tlaka predstavlja ozbiljan rizik (vidjeti dio 4.8): bolesnici s aneurizmatskom bolešću krvnih žila (uključujući intrakranijalne krvne žile, prsnu ili trbušnu aortu te periferne arterije) bolesnici koji imaju intracerebralno krvarenje u anamnezi bolesnici koji su nedavno (unutar 6 tjedana) imali kardiovaskularni događaj, uključujući infarkt miokarda.
English: CARTON (for 1 and 6 nasal spray devices)
Croatian: KUTIJA (s 1 i 6 sprejeva za nos)
English: In individuals who were dependent on ketamine, withdrawal symptoms of cravings, anxiety, shaking, sweating and palpitations have been reported upon discontinuing ketamine.
Croatian: U osoba koje su bile ovisne o ketaminu su nakon prekida njegove primjene prijavljeni simptomi ustezanja koji uključuju žudnju, anksioznost, tresenje, znojenje i palpitacije.
English: Sodium hydroxide (for pH adjustment) Water for injections
Croatian: citratna kiselina hidrat dinatrijev edetat natrijev hidroksid (za podešavanje pH) voda za injekcije
English: Spravato contains the active substance esketamine.
Croatian: Spravato sadrži djelatnu tvar esketamin.
English: Oral AD + placebo nasal spray
Croatian: Oralni AD + placebo u spreju za nos
English: The mean esketamine Cmax and AUC∞ values produced by a 28-mg dose were 21% and 18% higher, respectively, in elderly subjects (age range 65 to 81 years) compared with younger adult subjects (age range 22 to 50 years).
Croatian: Srednje vrijednosti Cmax i AUC∞ esketamina nakon primjene doze od 28 mg bile su 21% odnosno 18% veće u starijih ispitanika (raspon dobi: 65 - 81 godina) nego u mlađih odraslih ispitanika (raspon dobi: 22 - 50 godina).
English: Pre-treatment of subjects with a history of allergic rhinitis and pre-exposed to grass pollen with oxymetazoline administered as a nasal spray (2 sprays of 0.05% solution administered at 1 hour prior to nasal administration of esketamine) had minor effects on the pharmacokinetics of esketamine.
Croatian: U ispitanika s alergijskim rinitisom u anamnezi koji su bili izloženi peludi trava prethodno liječenje oksimetazolinom u spreju za nos (2 potiska otopine od 0,05% primijenjena 1 sat prije nazalne primjene esketamina) u maloj je mjeri utjecalo na farmakokinetiku esketamina.
English: Device full
Croatian: Sprej je pun
English: If expired, get a new device.
Croatian: Ako je rok valjanosti istekao, uzmite drugi sprej.
English: Pre-treatment of healthy subjects with oral ticlopidine, an inhibitor of hepatic CYP2B6 activity, (250 mg twice daily for 9 days prior to and on the day of esketamine administration) had no effect on the Cmax of esketamine administered as a nasal spray.
Croatian: U zdravih ispitanika prethodno peroralno liječenje tiklopidinom, koji je inhibitor aktivnosti jetrenog enzima CYP2B6 (250 mg dvaput na dan tijekom 9 dana prije primjene esketamina i na dan njegove primjene), nije imalo učinka na Cmax esketamina primijenjenog u obliku spreja za nos.
English: The mean esketamine Cmax and AUC∞ values produced by an 84-mg dose were 67% and 38% higher in elderly subjects (age range 75 to 85 years) compared with younger adult subjects (age range 24 to 54 years).
Croatian: Srednje vrijednosti Cmax i AUC∞ esketamina nakon primjene doze od 84 mg bile su 67% odnosno 38% veće u starijih ispitanika (raspon dobi: 75 - 85 godina) nego u mlađih odraslih ispitanika (raspon dobi: 24 - 54 godine).
English: ● increased blood pressure
Croatian: • povišen krvni tlak
English: The median time to relapse for a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray group was 273 days, whereas the median was not estimable for Spravato plus oral AD, as this group never reached 50% relapse rate.
Croatian: Medijan vremena do relapsa iznosio je 273 dana uz novouvedeni oralni antidepresiv (SNRI: duloksetin, venlafaksin s produljenim oslobađanjem; SSRI: escitalopram, sertralin) plus placebo u spreju za nos, dok se za Spravato plus oralni antidepresiv medijan nije mogao procijeniti, jer stopa relapsa u toj skupini nikada nije dosegnula 50%.
English: Esketamine was not mutagenic with or without metabolic activation in the Ames test. Genotoxic effects with esketamine were seen in a screening in vitro micronucleus test in the presence of metabolic activation.
Croatian: Esketamin nije bio mutagen u Amesovu testu, uz metaboličku aktivaciju ili bez nje.
English: For patients in stable remission, the relapse rate based on Kaplan-Meier estimates during the 12- and 24-weeks double-blind follow up period was 13% and 32% for Spravato and 37% and 46% for placebo nasal spray, respectively.
Croatian: Za bolesnike u stabilnoj remisiji stopa relapsa procijenjena Kaplan-Meierovom metodom tijekom 12-tjednog odnosno 24-tjednog dvostruko slijepog razdoblja praćenja iznosila je 13% odnosno 32% uz Spravato te 37% odnosno 46% uz placebo u spreju za nos.
English: Patients on dialysis were not studied.
Croatian: Lijek se nije ispitivao u bolesnika na dijalizi.
English: The terminal half-life of esketamine was not affected by clarithromycin pre-treatment.
Croatian: Prethodno liječenje klaritromicinom nije utjecalo na terminalni poluvijek esketamina.
English: Some patients using Spravato may experience nausea or vomiting.
Croatian: Spravato mogu se javiti mučnina ili povraćanje.
English: Your doctor will discuss with you whether to stop breast-feeding or stop using this medicine.
Croatian: Liječnik će s Vama razgovarati o tome trebate li prekinuti dojenje ili prestati primjenjivati ovaj lijek, uzimajući u obzir koristi dojenja za Vas i Vaše dijete i dobrobit liječenja za Vas.
English: In Study TRD3005, patients (≥ 65 years) initiated treatment with Spravato 28 mg plus a newly initiated daily oral AD or a newly initiated daily oral AD plus placebo nasal spray (day 1).
Croatian: U ispitivanju TRD3005, bolesnici (u dobi od ≥ 65 godina) liječenje su započeli lijekom Spravato u dozi od 28 mg plus novouvedenim oralnim antidepresivom koji se primjenjivao svaki dan ili novouvedenim oralnim antidepresivom koji se primjenjivao svaki dan plus placebom u spreju za nos (1. dan).
English: Pre-treatment of healthy subjects with nasal administration of mometasone furoate (200 mcg per day for 2 weeks with the last mometasone furoate dose administered at 1 hour prior to nasal administration of esketamine) had minor effects on the pharmacokinetics of esketamine.
Croatian: U zdravih je ispitanika prethodna nazalna primjena mometazonfuroata (200 μg na dan tijekom 2 tjedna, uz posljednju dozu primijenjenu 1 sat prije nazalne primjene esketamina) u maloj mjeri utjecala na farmakokinetiku esketamina.
English: Pre-treatment with oral clarithromycin, an inhibitor of hepatic CYP3A4 activity, (500 mg twice daily for 3 days prior to and on the day of esketamine administration) increase the mean Cmax and AUC∞ of nasally administered esketamine by approximately 11% and 4%, respectively.
Croatian: Prethodno peroralno liječenje klaritromicinom, koji je inhibitor aktivnosti jetrenog enzima CYP3A4 (500 mg dvaput na dan tijekom 3 dana prije primjene esketamina i na dan njegove primjene), povećalo je srednje vrijednosti Cmax i AUC∞ nazalno primijenjenog esketamina za približno 11% odnosno 4%.
English: EU/1/19/1410/002 (2 spray containers) EU/1/19/1410/003 (3 spray containers)
Croatian: EU/1/19/1410/002 (2 spreja za nos) EU/1/19/1410/003 (3 spreja za nos)
English: Spravato 28 mg nasal spray, solution esketamine
Croatian: Spravato 28 mg sprej za nos, otopina esketamin
English: Dependence and tolerance have been reported with prolonged use of ketamine.
Croatian: Kod dugotrajne primjene ketamina prijavljene su ovisnost i tolerancija na lijek.
English: It is recommended to monitor for urinary tract and bladder symptoms during the course of treatment and refer to an appropriate healthcare provider when symptoms persist.
Croatian: Preporučuje se tijekom čitavog liječenja nadzirati bolesnike zbog mogućih simptoma urinarnog trakta i mokraćnog mjehura te ih u slučaju perzistentnih simptoma uputiti odgovarajućem zdravstvenom radniku.
English: Spravato 84 mg + oral AD
Croatian: Spravato 84 mg + oralni AD
English: Use of the same nostril for 2 consecutive sprays If administration in the same nostril occurs, a replacement device should not be used.
Croatian: Ako se oba potiska primijene u istu nosnicu, ne smije se upotrijebiti nadomjesni sprej.
English: Mean baseline score (SD)
Croatian: Srednja vrijednost početnog rezultata (SD)
English: Vascular disorders hypertension
Croatian: Krvožilni poremećaji hipertenzija
English: The mean absolute bioavailability of 84 mg esketamine administered as a nasal spray is approximately
Croatian: Srednja vrijednost apsolutne bioraspoloživosti esketamina u dozi od 84 mg primijenjenog u obliku spreja za nos iznosi približno 48%.
English: ● itchy nose
Croatian: • svrbež nosa
English: ● urgent need to pass urine
Croatian: • hitna potreba za mokrenjem
English: Renal and urinary disorders pollakiuria, dysuria, micturition urgency
Croatian: Poremećaji bubrega i mokraćnog sustava polakizurija, dizurija, hitna potreba za mokrenjem
English: Eye disorders vision blurred
Croatian: Poremećaji oka zamagljen vid
English: The pharmacokinetics of esketamine nasal spray was compared between healthy Asian subjects and Caucasian subjects.
Croatian: Farmakokinetika esketamina u spreju za nos uspoređivala se u zdravih ispitanika azijskog podrijetla i onih bijele rase.
English: Spravato 28 mg, 56 mg or 84 mg + oral AD
Croatian: Spravato 28 mg, 56 mg ili 84 mg + oralni AD
English: This device is intended for administration by the patient, under supervision of a healthcare professional.
Croatian: Ovaj sprej namijenjen je za bolesnikovu samostalnu primjenu pod nadzorom zdravstvenog radnika.
English: o The “Readiness for a patient to leave the healthcare setting” checklist for HCPs (attached to the HCP guide): the objective of this EM is to aid HCPs in evaluating when, following SPRAVATO administration, a patient is deemed stable and safely allowed to leave the clinic/facility where SPRAVATO has been administered.
Croatian: • prije i nakon primjene lijeka SPRAVATO treba pomno nadzirati bolesnikov krvni tlak zbog mogućeg rizika od srčanih štetnih događaja o Kontrolni popis za zdravstvene radnike kojim se ocjenjuje je li bolesnik spreman za odlazak iz zdravstvene ustanove (priložen Vodiču za zdravstvene radnike): Cilj je ovog edukacijskog materijala pomoći zdravstvenim radnicima da nakon primjene lijeka SPRAVATO ocijene kada je bolesnik stabilan i kada mu mogu sigurno dopustiti da ode iz klinike/zdravstvene ustanove u kojoj je SPRAVATO primijenjen.
English: The maintenance of antidepressant efficacy was demonstrated in a relapse prevention trial.
Croatian: U ispitivanju primjene lijeka Spravato u prevenciji relapsa dokazana je održana djelotvornost antidepresiva.
English: Exposure in rabbits was in the region of human exposure based on AUC values.
Croatian: Prema vrijednostima AUC-a, izloženost u kunića bila je unutar raspona koji se postiže u ljudi.
English: Adverse reactions reported with esketamine are listed in the table below.
Croatian: U sljedećoj su tablici navedene nuspojave prijavljene kod primjene esketamina.
English: Cognitive and memory impairment have been reported with long-term ketamine use or drug abuse.
Croatian: Kod dugotrajne primjene ili zlouporabe ketamina prijavljeni su kognitivni poremećaji i poremećaji pamćenja.
English: Stable Remission
Croatian: Stabilna remisija
English: In study TRD3002, esketamine plus a newly initiated oral AD demonstrated clinically meaningful and statistical superiority compared to a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Table 5), and symptom reduction was observed as early as 24 hours post-dose.
Croatian: U ispitivanju TRD3002 kombinacija esketamina i novouvedenog oralnog antidepresiva pokazala je klinički važnu i statističku superiornost u odnosu na novouvedeni oralni antidepresiv (SNRI: duloksetin, venlafaksin s produljenim oslobađanjem; SSRI: escitalopram, sertralin) plus placebo u spreju za nos (Tablica 5), a ublažavanje simptoma opaženo je već 24 sata nakon primjene doze lijeka.
English: The terminal half-life of esketamine was not affected by ticlopidine pre-treatment.
Croatian: Prethodno liječenje tiklopidinom nije utjecalo na terminalni poluvijek esketamina.
English: Each nasal spray device delivers 28 mg esketamine as two sprays.
Croatian: Jedan sprej za nos isporučuje 28 mg esketamina u dva potiska.
English: Spravato (56 mg or 84 mg) + oral AD Oral AD + placebo nasal spray
Croatian: Spravato (56 mg ili 84 mg) + oralni AD Oralni AD + placebo u spreju za nos
English: ● Do not press the plunger.
Croatian: • ne pritišće klip
English: In these patients, Spravato should be administered in a setting where appropriate resuscitation equipment and healthcare professionals with training in cardiopulmonary resuscitation are available.
Croatian: Spravato treba primjenjivati u uvjetima u kojima su na raspolaganju odgovarajuća oprema za oživljavanje i zdravstveni radnici obučeni za kardiopulmonalnu reanimaciju.
English: Patients in TRD3001 and TRD3002 initiated treatment with Spravato 56 mg plus a newly initiated daily oral AD or a newly initiated daily oral AD plus placebo nasal spray on day 1.
Croatian: U ispitivanjima TRD3001 i TRD3002 bolesnici su 1. dana započeli liječenje lijekom Spravato u dozi od 56 mg plus novouvedenim oralnim antidepresivom koji se primjenjivao svaki dan ili novouvedenim oralnim antidepresivom koji se primjenjivao svaki dan plus placebom u spreju za nos.
English: If you are not sure, talk to your doctor before using Spravato - your doctor will decide whether or not you can use this medicine.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom prije nego primijenite Spravato.
English: 56 mg + oral AD Spravato
Croatian: 56 mg + oralni AD Spravato
English: Following oral administration of radiolabelled esketamine, approximately 86% and 2% of administered radioactivity was recovered in urine and faeces, respectively.
Croatian: Nakon peroralne primjene radioaktivno označenog esketamina, približno 86% primijenjene radioaktivnosti pronađeno je u mokraći, a približno 2% u fecesu.
English: Based on the reduction in MADRS total score from baseline, the proportion of patients in Studies TRD3001, TRD3002 and TRD3005 who demonstrated response to Spravato plus oral AD treatment was greater than for oral AD plus placebo nasal spray throughout the 4-week double-blind induction phase (Table 6).
Croatian: Udio bolesnika koji su u ispitivanjima TRD3001, TRD3002 i TRD3005 ostvarili odgovor na liječenje u vidu smanjenja ukupnog MADRS rezultata od početne vrijednosti bio je veći u skupinama koje su primale Spravato plus oralni antidepresiv nego u onima koje su primale oralni antidepresiv plus placebo u spreju za nos tijekom čitave 4-tjedne dvostruko slijepe faze uvodnog liječenja (Tablica 6).
English: Nasally administered Spravato or placebo; oral AD = a newly initiated AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline)
Croatian: Spravato ili placebo primijenjeni u nos; oralni AD = novouvedeni antidepresiv (SNRI: duloksetin, venlafaksin s produljenim oslobađanjem; SSRI: escitalopram, sertralin)
English: Do not use Spravato if you are breast-feeding.
Croatian: Nemojte uzimati Spravato ako dojite.
English: 2 nasal spray devices 3 nasal spray devices
Croatian: 2 spreja za nos 3 spreja za nos
English: Only initiate treatment with Spravato in patients with clinically significant or unstable cardiovascular or respiratory conditions if the benefit outweighs the risk.
Croatian: U bolesnika s klinički značajnim ili nestabilnim kardiovaskularnim ili respiratornim stanjima liječenje lijekom Spravato smije se uvesti samo ako korist nadmašuje rizik.
English: 84 mg + oral AD Oral AD + placebo nasal spray
Croatian: 84 mg + oralni AD Oralni AD + placebo u spreju za nos
English: ● severe liver problems.
Croatian: • ako imate teških jetrenih tegoba
English: Spravato contains esketamine and may be subject to abuse and diversion.
Croatian: Budući da Spravato sadrži esketamin, može biti podložan zlouporabi i prosljeđivanju lijeka drugim osobama u nedopuštene svrhe.
English: Remission rate
Croatian: Stopa remisije
English: About
Croatian: Približno
English: Nose rest
Croatian: Sprej za nos
English: Do not use Spravato if any of the above apply to you.
Croatian: Ako se bilo što od navedenoga odnosi na Vas, nemojte primijeniti Spravato.
English: Sex, n (%)
Croatian: Broj specifičnih antidepresiva, n (%)
English: ● spinning sensation (“vertigo”)
Croatian: • osjećaj vrtnje (vrtoglavica)
English: ● Hand device to patient.
Croatian: • Dajte sprej bolesniku.
English: Spravato 56 mg or 84 mg + oral AD
Croatian: Spravato 56 mg ili 84 mg + oralni AD
English: 28 mg, 56 mg or 84 mg once weekly, all dose changes should be in 28 mg increments
Croatian: 28 mg, 56 mg ili 84 mg jedanput tjedno; svaku promjenu doze treba provoditi u koracima od 28 mg
English: 28 mg, 56 mg or 84 mg every 2 weeks or once weekly, all dose changes should be in 28 mg increments
Croatian: 28 mg, 56 mg ili 84 mg svaka 2 tjedna ili jedanput tjedno; svaku promjenu doze treba provoditi u koracima od 28 mg
English: Prior oral antidepressants with nonresponse (i.e., failed antidepressants) Number of specific antidepressants, n (%)
Croatian: Prethodni oralni antidepresivi na koje bolesnik nije odgovorio (tj. neuspješno liječenje antidepresivima)
English: A treatment session consists of nasal administration of Spravato and a post-administration observation period.
Croatian: Terapijski tretman sastoji se od primjene lijeka Spravato u nos i razdoblja promatranja nakon primjene.
English: Patients in stable remission who continued treatment with Spravato plus oral AD experienced a statistically significantly longer time to relapse of depressive symptoms than did patients on a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Figure 1).
Croatian: Kod bolesnika u stabilnoj remisiji koji su nastavili liječenje lijekom Spravato i oralnim antidepresivom zabilježeno je statistički značajno dulje vrijeme do relapsa simptoma depresije nego u onih koji su primali novouvedeni oralni antidepresiv (SNRI: duloksetin, venlafaksin s produljenim oslobađanjem; SSRI: escitalopram, sertralin) plus placebo u spreju za nos (Slika 1).
English: The device dispenses two sprays.
Croatian: Sprejem se mogu primijeniti dva potiska.
English: Ketamine, the racemic mixture of arketamine and esketamine, is a medicinal product that has been reported to be abused.
Croatian: Prijavljena je zlouporaba ketamina, lijeka koji je racemična smjesa arketamina i esketamina.
English: Difference (Spravato + oral AD minus Oral AD + placebo nasal spray) in least-squares mean change from baseline Treatment group that was statistically significantly superior to Oral AD + placebo nasal spray Median unbiased estimate (i.e., weighted combination of the LS means of the difference from Oral AD + placebo nasal spray), and 95% flexible confidence interval
Croatian: Medijan nepristrane procjene (tj. ponderirana kombinacija srednjih vrijednosti razlike (LS) u odnosu na oralni AD + placebo u spreju za nos) i fleksibilni interval pouzdanosti od 95%
English: In all three studies, a greater proportion of patients treated with Spravato plus oral AD were in remission at the end of the 4-week double-blind induction phase than for oral AD plus placebo nasal spray (Table 6).
Croatian: U svim je trima ispitivanjima na kraju 4-tjedne dvostruko slijepe faze uvodnog liječenje udio bolesnika u remisiji bio veći među onima liječenima lijekom Spravato plus oralnim antidepresivom nego među onima koji su primali oralni antidepresiv plus placebo u spreju za nos (Tablica 6).
English: Spravato 56 mg + oral AD
Croatian: Spravato 56 mg + oralni AD
English: Nasal spray, solution.
Croatian: Sprej za nos, otopina.
English: Spravato 28 mg nasal spray, solution
Croatian: Spravato 28 mg sprej za nos, otopina
English: In study TRD3005, a clinically meaningful but not statistically significant treatment effect in change in MADRS total scores from baseline at the end of the 4-week induction phase was observed favouring Spravato plus newly initiated oral AD compared with a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Table 5).
Croatian: U ispitivanju TRD3005 opažen je klinički važan, ali ne i statistički značajan učinak liječenja na promjenu ukupnog MADRS rezultata od početka ispitivanja do kraja 4-tjedne faze uvodnog liječenja, koji je bio u korist lijeka Spravato u kombinaciji s novouvedenim oralnim antidepresivom u odnosu na novouvedeni oralni antidepresiv (SNRI: duloksetin, venlafaksin s produljenim oslobađanjem; SSRI: escitalopram, sertralin) plus placebo u spreju za nos (Tablica 5).
English: The median time to relapse for a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray group (88 days) was shorter compared to Spravato plus oral AD group (635 days).
Croatian: Medijan vremena do relapsa bio je kraći (88 dana) u skupini koja je primala novouvedeni oralni antidepresiv (SNRI: duloksetin, venlafaksin s produljenim oslobađanjem; SSRI: escitalopram, sertralin) plus placebo u spreju za nos nego u onoj liječenoj lijekom Spravato i oralnim antidepresivom (635 dana).
English: MIN REST
Croatian: MIN PAUZE
English: In study TRD3001, a clinically meaningful treatment effect in change in MADRS total scores from baseline at the end of the 4-week induction phase was observed favouring Spravato plus newly initiated oral AD compared with a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Table 5).
Croatian: U ispitivanju TRD3001 opažen je klinički važan učinak liječenja na promjenu ukupnog MADRS rezultata od početka ispitivanja do kraja 4-tjedne faze uvodnog liječenja, koji je bio u korist lijeka Spravato u kombinaciji s novouvedenim oralnim antidepresivom u odnosu na novouvedeni oralni antidepresiv (SNRI: duloksetin, venlafaksin s produljenim oslobađanjem; SSRI: escitalopram, sertralin) plus placebo u spreju za nos (Tablica 5).
English: Each nasal spray device contains esketamine hydrochloride corresponding to 28 mg esketamine.
Croatian: Jedan sprej za nos sadrži 28 mg esketamina u obliku esketaminklorida.
English: ● feeling irritable
Croatian: • razdražljivost
English: This is because Spravato has not been studied for treatment-resistant depression in this age group.
Croatian: Ovaj lijek ne smije se davati djeci i adolescentima mlađima od 18 godina, jer se Spravato nije ispitivao za liječenje depresije rezistentne na liječenje u toj dobnoj skupini.
English: What Spravato is used for
Croatian: Za što se Spravato koristi