FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies with esketamine, there were no cases of interstitial cystitis, however a higher rate of lower urinary tract symptoms was observed (pollakiuria, dysuria, micturition urgency, nocturia, and cystitis) in esketamine-treated patients compared with placebo-treated patients.
Croatian: U kliničkim ispitivanjima esketamina nije opažen nijedan slučaj intersticijskog cistitisa, no zabilježena je viša stopa simptoma donjeg urinarnog trakta (polakizurije, dizurije, urgencija mokrenja, nokturije i cistitisa) u bolesnika liječenih esketaminom nego u onih koji su primali placebo.
English: The mean terminal half-life following administration as a nasal spray generally ranged from 7 to 12 hours.
Croatian: Srednja vrijednost terminalnog poluvijeka nakon primjene lijeka u obliku spreja za nos u načelu se kretala u rasponu od 7 do 12 sati.
English: The incidence of increased SBP (≥ 180 mmHg) was 3% and DBP (≥ 110 mmHg) was
Croatian: Incidencija povišenja SKT-a do vrijednosti ≥ 180 mmHg iznosila je 3%, dok je incidencija povišenja DKT-a do vrijednosti ≥ 110 mmHg iznosila 4%.
English: Spravato has not been studied in patients with severe hepatic impairment (Child-Pugh class C).
Croatian: Spravato se nije ispitivao u bolesnika teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
English: What Spravato is
Croatian: Što je Spravato
English: Every other week Weekly or every other week 7 (7.8%)
Croatian: Svaki drugi tjedan Svaki tjedan ili svaki drugi tjedan
English: The Cmax and AUC∞ of esketamine were 8% higher and 103% higher, respectively, in subjects with Child-Pugh class B (moderate) hepatic impairment, relative to healthy subjects.
Croatian: Cmax i AUC∞ esketamina bili su 8% odnosno 103% veći u ispitanika s oštećenjem jetrene funkcije Child-Pugh stadija B (umjereno) nego u zdravih ispitanika.
English: Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode (see section 5.1).
Croatian: Spravato je u kombinaciji sa selektivnim inhibitorima ponovne pohrane serotonina (SSRI) ili inhibitorima ponovne pohrane serotonina i noradrenalina (SNRI) indiciran za odrasle osobe s velikim depresivnim poremećajem rezistentnim na liječenje koje nisu odgovorile na najmanje dvije različite terapije antidepresivima tijekom trenutne umjerene do teške depresivne epizode (vidjeti dio 5.1).
English: The objective of this EM is to detail:
Croatian: Cilj je ovog edukacijskog materijala objasniti:
English: Spravato should not be administered if an increase in blood pressure or intracranial pressure poses a serious risk (see section 4.3).
Croatian: Spravato se ne smije primijeniti ako povišenje krvnog ili intrakranijalnog tlaka predstavlja ozbiljan rizik (vidjeti dio 4.3).
English: In elderly patients the initial Spravato dose is 28 mg esketamine (day 1, starting dose, see Table 2 above).
Croatian: U starijih bolesnika početna doza lijeka Spravato iznosi 28 mg (početna doza koja se primjenjuje 1. dana, vidjeti gornju Tablicu 2).
English: Concomitant use of Spravato with CNS depressants may increase the risk for sedation (see section 4.5).
Croatian: Istodobna primjena lijeka Spravato i depresora središnjeg živčanog sustava (SŽS) može povećati rizik od sedacije (vidjeti dio 4.5).
English: Confirm delivery and rest
Croatian: Potvrdite isporuku lijeka i napravite pauzu
English: Tell your doctor if you get any of the above while you are taking Spravato.
Croatian: Obavijestite svog liječnika ako primijetite bilo što od prethodno navedenoga dok uzimate Spravato.
English: Patients with clinically significant or unstable cardiovascular or respiratory conditions require additional precautions.
Croatian: U bolesnika s klinički značajnim ili nestabilnim kardiovaskularnim ili respiratornim stanjima potrebno je poduzeti dodatne mjere opreza.
English: In a study of abuse potential conducted in recreational polydrug users (n=41), single doses of esketamine nasal spray (84 mg and 112 mg) and the positive control drug intravenous ketamine (0.5 mg/kg infused over 40 minutes) produced significantly greater scores than placebo on subjective ratings of “drug liking” and on other measures of subjective drug effects.
Croatian: U ispitivanju mogućnosti zlouporabe lijeka provedenom u rekreacijskih korisnika više droga (n=41), uz jednokratne doze esketamina u spreju za nos (84 mg i 112 mg) i intravenski primijenjenog ketamina (0,5 mg/kg u obliku 40-minutne infuzije), koji se koristio kao pozitivna kontrola, zabilježeni su značajno veći rezultati na ljestvici kojom su ispitanici subjektivno ocjenjivali „koliko im se lijek sviđa“, kao i prema drugim mjerilima subjektivnih učinaka lijeka u odnosu na placebo.
English: The following EM should be provided to patients:
Croatian: Bolesnicima treba dati sljedeće edukacijske materijale:
English: In Study TRD3001, the treatment effect for the Spravato 84 mg plus oral AD group compared with oral AD plus placebo was not statistically significant.
Croatian: U ispitivanju TRD3001 učinak liječenja lijekom Spravato u dozi od 84 mg plus oralnim antidepresivom nije bio statistički značajan u odnosu na oralni antidepresiv plus placebo.
English: Baseline demographic and disease characteristics for patient in TRD3002, TRD3001, and TRD3005 are presented in Table 4.
Croatian: Početne demografske značajke i značajke bolesti u bolesnika iz ispitivanja TRD3002, TRD3001 i TRD3005 prikazane su u Tablici 4.
English: The mean clearance of esketamine administered by the intravenous route was approximately 89 L/hour.
Croatian: Srednja vrijednost klirensa intravenski primijenjenog esketamina iznosila je približno 89 l/h.
English: 56 mg or 84 mg every 2 weeks or once weekly
Croatian: 56 mg ili 84 mg svaka 2 tjedna ili jedanput tjedno
English: Spravato should be used with caution in patients with the following conditions.
Croatian: Spravato treba primjenjivati uz oprez u bolesnika sa stanjima navedenima u nastavku.
English: ● Switch hands to insert tip into the second nostril.
Croatian: • prebaci sprej u drugu ruku i stavi vrh spreja u drugu nosnicu
English: EU/1/19/1410/001 (1 spray container) EU/1/19/1410/002 (2 spray containers) EU/1/19/1410/003 (3 spray containers) EU/1/19/1410/004 (6 spray containers)
Croatian: EU/1/19/1410/001 (1 sprej za nos) EU/1/19/1410/002 (2 spreja za nos) EU/1/19/1410/003 (3 spreja za nos) EU/1/19/1410/004 (6 sprejeva za nos)
English: • In patients with clinically significant or unstable cardiovascular or respiratory conditions, SPRAVATO should be administered in a clinical setting where equipment for cardiopulmonary resuscitation and staff trained in cardiopulmonary resuscitation are available;
Croatian: • u bolesnika s klinički značajnim ili nestabilnim kardiovaskularnim ili respiratornim stanjima SPRAVATO treba primjenjivati u kliničkim uvjetima u kojima su na raspolaganju oprema za kardiopulmonalnu reanimaciju i osoblje obučeno za taj postupak
English: For patients of Japanese ancestry, initial Spravato dose is 28 mg esketamine (day 1, starting dose, see Table 3).
Croatian: U bolesnika japanskog podrijetla početna doza lijeka Spravato iznosi 28 mg esketamina (početna doza koja se primjenjuje prvoga dana, vidjeti Tablicu 3).
English: Patients directly enrolled were administered Spravato (56 mg or 84 mg twice weekly) plus oral AD in a 4-week open label induction phase.
Croatian: Izravno uključeni bolesnici primali su Spravato (56 mg ili 84 mg dvaput tjedno) plus oralni antidepresiv tijekom 4-tjedne otvorene faze uvodnog liječenja.
English: Mean plasma esketamine Cmax and AUC∞ values produced by a single, 56-mg dose of esketamine were approximately 14% and 33% higher, respectively, in Chinese subjects compared to Caucasians.
Croatian: Srednje plazmatske vrijednosti Cmax i AUC∞ esketamina nakon primjene jedne doze od 56 mg bile su približno 14% odnosno 33% veće u Kineza nego u bijelaca.
English: The active substance is esketamine.
Croatian: Djelatna tvar je esketamin.
English: Ear and labyrinth disorders vertigo hyperacusis, tinnitus
Croatian: Poremećaji uha i labirinta vrtoglavica hiperakuzija, tinitus
English: The potential for abuse, misuse and diversion of Spravato is minimised due to the administration taking place under the direct supervision of a healthcare professional.
Croatian: Mogućnost zlouporabe, namjerne pogrešne uporabe i prosljeđivanje lijeka Spravato drugim osobama u nedopuštene svrhe minimizira se zahvaljujući primjeni pod izravnim nadzorom zdravstvenog radnika.
English: Of the patients randomised to Spravato, 60% received 84 mg and 40% received 56 mg dose.
Croatian: Među bolesnicima randomiziranima za liječenje lijekom Spravato njih 60% primalo je dozu od 84 mg, a njih 40% dozu od 56 mg.
English: Nasal administration of 84 mg esketamine twice a week for 2 weeks did not affect the mean plasma AUC of oral bupropion (single 150 mg dose), a substrate of hepatic CYP2B6.
Croatian: Nazalna primjena 84 mg esketamina dvaput tjedno tijekom 2 tjedna nije utjecala na srednju vrijednost plazmatskog AUC-a oralnog bupropiona (jedna doza od 150 mg), koji je supstrat jetrenog enzima CYP2B6.
English: Administration of a comparable supratherapeutic dose of esketamine by the intranasal route is unlikely to be feasible.
Croatian: Nije vjerojatno da se nazalnim putem može primijeniti usporediva supraterapijska doza esketamina.
English: Prepare device
Croatian: Pripremite sprej
English: Cases of interstitial cystitis have been reported with daily and long-term ketamine use at high doses.
Croatian: Kod svakodnevne i dugoročne primjene visokih doza ketamina prijavljeni su slučajevi intersticijskog cistitisa.
English: ● eyes, ears, or sense of touch are deceived or tricked in some way (something is not what it seems to be)
Croatian: • zavarana osjetila vida, sluha ili dodira (stvari nisu onakve kakvima se čine)
English: 28 mg = 1 device
Croatian: 28 mg = 1 sprej
English: Table 2: Recommended dosing for Spravato in adults ≥65 years Induction phase
Croatian: Tablica 2: Preporučeno doziranje lijeka Spravato u odraslih u dobi od ≥ 65 godina Faza uvodnog liječenja
English: The Cmax and AUC∞ of esketamine produced by a 28-mg doses were similar between subjects with Child-Pugh class A (mild) hepatic impairment and healthy subjects.
Croatian: Cmax i AUC∞ esketamina nakon primjene doze od 28 mg bili su slični u ispitanika s oštećenjem jetrene funkcije Child-Pugh stadija A (blago) i zdravih ispitanika.
English: After the induction phase, patients received Spravato weekly for 4 weeks and starting from week 8, an algorithm (based on the MADRS) was used to determine the dosing frequency; patients in remission (i.e., MADRS total score was ≤ 12) were dosed every other week, however, if the MADRS total score increased to > 12, then the frequency was increased to weekly dosing for the next 4 weeks; with the objective of maintaining the patient on the lowest dosing frequency to maintain response/remission.
Croatian: Bolesnici u remisiji (tj. oni s ukupnim MADRS rezultatom ≤ 12) lijek su primali svaki drugi tjedan, no ako se ukupni MADRS rezultat povećao na > 12, učestalost primjene povećala se na jedanput tjedno tijekom sljedeća 4 tjedna; pritom je cilj bio da se održi najmanja učestalost primjene potrebna za održavanje odgovora/remisije.
English: Because of the possibility of sedation, dissociation and elevated blood pressure, patients must be monitored by a healthcare professional until the patient is considered clinically stable and ready to leave the healthcare setting (see section 4.4).
Croatian: Zdravstveni radnik treba nadzirati bolesnike zbog moguće sedacije, disocijacije i povišenja krvnog tlaka sve dok ne ocijeni da je bolesnik klinički stabilan i spreman za odlazak iz zdravstvene ustanove (vidjeti dio 4.4).
English: Gastrointestinal disorders nausea, vomiting dry mouth, hypoaesthesia oral salivary hypersecretion
Croatian: Poremećaji probavnog sustava mučnina, povraćanje suha usta, hipoestezija usne šupljine hipersekrecija sline
English: Table 1: Recommended dosing for Spravato in adults <65 years Induction phase
Croatian: Tablica 1: Preporučeno doziranje lijeka Spravato u odraslih u dobi od < 65 godina Faza uvodnog liječenja
English: It is important to make sure you come in for your scheduled appointments, so that this medicine is effective for you.
Croatian: Ako prestanete primjenjivati Spravato Važno je da se pobrinete da dolazite na zakazane termine primjene kako bi ovaj lijek bio učinkovit.
English: Dispose of used device(s) in accordance with local requirements.
Croatian: Upotrijebljeni(e) sprej(eve) potrebno je zbrinuti sukladno nacionalnim propisima.
English: In clinical trials, increases in systolic and diastolic blood pressure (SBP and DBP) over time were about 7 to 9 mmHg in SBP and 4 to 6 mmHg in DBP at 40 minutes post-dose and 2 to 5 mmHg in SBP and 1 to 3 mmHg in DBP at 1.5 hours post-dose in patients receiving Spravato plus oral antidepressants (see section 4.4).
Croatian: U kliničkim ispitivanjima u bolesnika koji su primali Spravato plus oralne antidepresive povišenja sistoličkog i dijastoličkog krvnog tlaka (SKT i DKT) tijekom vremena iznosila su približno 7 - 9 mmHg za SKT i 4 - 6 mmHg za DKT 40 minuta nakon primjene doze, odnosno 2 - 5 mmHg za SKT i 1 - 3 mmHg za DKT 1,5 sati nakon primjene doze (vidjeti dio 4.4).
English: ● ever had an overactive thyroid that is not properly treated (hyperthyroidism)
Croatian: • ako ste ikada imali prekomjerno aktivnu štitnjaču koja nije liječena na odgovarajući način
English: Weeks 5-8: 56 mg or 84 mg once weekly
Croatian: 5. - 8. tjedan: 56 mg ili 84 mg jedanput tjedno
English: Figure 1: Time to relapse in patients in stable remission in study TRD3003 (full analysis set)
Croatian: Slika 1: Vrijeme do relapsa u bolesnika u stabilnoj remisiji u ispitivanju TRD3003 (potpuni skup podataka za analizu)
English: ● Presence or history of mania or bipolar disorder;
Croatian: • manija ili bipolarni poremećaj, prisutni trenutno ili u anamnezi
English: The frequency of markedly abnormal blood pressure elevations of SBP (≥40 mmHg increase) ranged from 8% (<65 years) to 17% (≥65 years) and DBP (≥25 mmHg increase) ranged from 13% (<65 years) to 14% (≥65 years) in patients receiving esketamine plus oral antidepressant.
Croatian: Učestalost izraženih povišenja krvnog tlaka u bolesnika koji su primali esketamin plus oralni antidepresiv kretala se u rasponu od 8% (< 65 godina) do 17% (≥ 65 godina) za SKT (povišenje za ≥ 40 mmHg) te u rasponu od 13% (< 65 godina) do 14% (≥ 65 godina) za DKT (povišenje za ≥ 25 mmHg).
English: In all short-term studies, the primary efficacy endpoint was change in MADRS total score from baseline to day 28.
Croatian: U svim je kratkoročnim ispitivanjima primarna mjera ishoda za djelotvornost bila promjena ukupnog rezultata na Montgomery-Åsbergovoj ljestvici za ocjenu depresije (engl.
English: ● fast heartbeat
Croatian: • brzi otkucaji srca
English: In an embryo foetal developmental toxicity study with nasally administered ketamine in rats, the offspring was not adversely affected in the presence of maternal toxicity at doses resulting in exposure up to 6-fold higher than human exposure, based on AUC values.
Croatian: U ispitivanju toksičnih učinaka nazalno primijenjenog ketamina na embriofetalni razvoj štakora, toksičnost za majku pri dozama kojima se postiže izloženost do 6 puta veća od one u ljudi (na temelju vrijednosti AUC-a) nije štetno utjecala na mladunčad.
English: Figure 2: Time to relapse in patients in stable response in study TRD3003 (full analysis set)
Croatian: Slika 2: Vrijeme do relapsa u bolesnika sa stabilnim odgovorom u ispitivanju TRD3003 (potpuni skup podataka za analizu)
English: Changes in blood pressure
Croatian: Promjene krvnog tlaka
English: The nasal spray device is a single-use device that delivers a total of 28 mg of esketamine, in two sprays (one spray per nostril).
Croatian: Sprej za nos je pomagalo za jednokratnu uporabu kojim se isporučuje ukupno 28 mg esketamina u dva potiska (po jedan potisak u svaku nosnicu).
English: ● Hyperthyroidism that has not been sufficiently treated;
Croatian: • nedostatno liječena hipertireoza
English: Nasal administration of 84 mg esketamine twice a week for 2 weeks reduced the mean plasma AUC∞ of oral midazolam (single 6 mg dose), a substrate of hepatic CYP3A4, by approximately 16%.
Croatian: Nazalna primjena 84 mg esketamina dvaput tjedno tijekom 2 tjedna smanjila je srednju vrijednost plazmatskog AUC∞ oralnog midazolama (jedna doza od 6 mg), koji je supstrat jetrenog enzima CYP3A4, za približno 16%.
English: This medicine is a clear, colourless solution, provided in a single-use nasal spray device.
Croatian: Ovaj je lijek bistra, bezbojna otopina koja dolazi u spreju za nos za jednokratnu uporabu.
English: • All patients must be monitored accordingly after SPRAVATO administration until considered clinically stable to leave the healthcare setting;
Croatian: • svi bolesnici moraju biti pod odgovarajućim nadzorom nakon primjene lijeka SPRAVATO, sve dok se ne ocijeni da su klinički stabilni i spremni za odlazak iz zdravstvene ustanove
English: After depressive symptoms improve, treatment is recommended for at least 6 months.
Croatian: Preporučuje se liječenje nastaviti još najmanje 6 mjeseci nakon poboljšanja simptoma depresije.
English: Talk to your doctor before using Spravato if you have:
Croatian: Obratite se svom liječniku prije nego primijenite Spravato:
English: CARTON (for 2 and 3 nasal spray devices)
Croatian: KUTIJA (s 2 i 3 spreja za nos)
English: One device contains 2 sprays (1 spray for each nostril)
Croatian: Jedan sprej za nos primjenjuje se u 2 potiska (po 1 potisak u svaku nosnicu)
English: o The guide for patients, aiming at addressing the risks of transient dissociative states and perception disorders, drug abuse, disturbances in consciousness and blood pressure increased.
Croatian: o Vodič za bolesnike, koji je namijenjen pružanju informacija o rizicima od prolaznih disocijativnih stanja i poremećaja percepcije te zlouporabe lijeka, poremećaja svijesti i povišenja krvnog tlaka.
English: or see, feel, or hear things that are not there (hallucinations)
Croatian: • halucinacije (vidite, osjećate, čujete ili možete namirisati stvari kojih nema)
English: How to store Spravato
Croatian: Kako primjenjivati Spravato
English: ● Presence or history of psychosis;
Croatian: • psihoza, prisutna trenutno ili u anamnezi
English: Oral AD + Placebo Nasal Spray (N=59)
Croatian: Oralni AD + placebo u spreju za nos (N=59)
English: Spravato is for nasal use only.
Croatian: Spravato je namijenjen samo za nazalnu primjenu.
English: Blood pressure should be monitored after dose administration.
Croatian: Potrebno je pratiti krvni tlak nakon primjene doze.
English: ● headache
Croatian: • glavobolja
English: After dosing with Spravato, blood pressure should be reassessed at approximately 40 minutes and subsequently as clinically warranted (see section 4.4).
Croatian: Krvni tlak treba ponovno ocijeniti približno 40 minuta nakon primjene lijeka Spravato, a zatim sukladno kliničkoj potrebi (vidjeti dio 4.4).
English: No dose adjustment is necessary in patients with mild to severe renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije.
English: Table 4: Baseline demographic characteristics for TRD3002, TRD3001, and TRD3005 (full analysis sets)
Croatian: Tablica 4: Početne demografske značajke u ispitivanjima TRD3002, TRD3001 i TRD3005 (potpuni skup podataka za analizu) Ispitivanje TRD3002 (N=223)
English: In patients with clinically significant or unstable cardiovascular or respiratory conditions, SPRAVATO should be administered in a setting where appropriate resuscitation equipment and healthcare professionals with training in cardiopulmonary resuscitation are available.
Croatian: U bolesnika s klinički značajnim ili nestabilnim kardiovaskularnim ili respiratornim stanjima SPRAVATO treba primjenjivati u uvjetima u kojima su na raspolaganju odgovarajuća oprema za oživljavanje i zdravstveni radnici obučeni za kardiopulmonalnu reanimaciju.
English: Pre-treatment with oral rifampicin, a potent inducer of the activity of multiple hepatic CYP enzymes such as CYP3A4 and CYP2B6, (600 mg daily for 5 days prior to esketamine administration) decreased the mean Cmax and AUC∞ values of esketamine administered as a nasal spray by approximately 17% and 28%, respectively.
Croatian: Prethodno peroralno liječenje rifampicinom, snažnim induktorom aktivnosti većeg broja jetrenih CYP enzima poput CYP3A4 i CYP2B6, (600 mg na dan tijekom 5 dana prije primjene esketamina) smanjilo je srednje vrijednosti Cmax i AUC∞ esketamina primijenjenog u obliku spreja za nos za približno 17% odnosno 28%.
English: For patients in stable response, the relapse rate based on Kaplan-Meier estimates during the 12- and 24-weeks double-blind follow up period was 21% and 21% for Spravato and 47% and 56% for placebo nasal spray, respectively.
Croatian: Za bolesnike sa stabilnim odgovorom stopa relapsa procijenjena Kaplan-Meierovom metodom tijekom 12-tjednog odnosno 24-tjednog dvostruko slijepog razdoblja praćenja iznosila je 21% i 21% uz Spravato te 47% i 56% uz placebo u spreju za nos.
English: Read these Instructions for Use in full before training and supervising patient.
Croatian: Prije provođenja obuke i nadziranja bolesnika pročitajte cijele Upute za uporabu.
English: Oral AD + Placebo Nasal Spray (N=86)
Croatian: Oralni AD + placebo u spreju za nos (N=86)
English: Treatment discontinuation with Spravato does not require tapering off; based on data from clinical trials the risk of withdrawal symptoms is low.
Croatian: Prema podacima iz kliničkih ispitivanja, rizik od simptoma ustezanja je malen.
English: The filled and stoppered vial is assembled into a manually-activated nasal spray device.
Croatian: Napunjena bočica s čepom uložena je u sprej za nos koji se ručno aktivira.
English: Urinary tract and bladder symptoms have been reported with Spravato use (see section 4.8).
Croatian: Kod primjene lijeka Spravato prijavljeni su simptomi urinarnog trakta i mokraćnog mjehura (vidjeti dio 4.8).
English: Response was defined as ≥ 50% reduction in the MADRS total score from baseline of the induction phase.
Croatian: Odgovor se definirao kao smanjenje ukupnog MADRS rezultata za ≥ 50% u odnosu na početnu vrijednost.
English: Following intravenous administration of radiolabelled esketamine, approximately 78% and 2% of administered radioactivity was recovered in urine and faeces, respectively.
Croatian: Nakon intravenske primjene radioaktivno označenog esketamina, približno 78% primijenjene radioaktivnosti pronađeno je u mokraći, a približno 2% u fecesu.
English: Life-threatening symptoms are expected based on experience with ketamine given at 25-fold the usual anaesthetic dose.
Croatian: Na temelju iskustva s primjenom ketamina u dozi 25 puta većoj od uobičajene anestetičke doze očekuju se simptomi opasni po život.
English: EU/1/19/1410/001 (1 spray container) EU/1/19/1410/004 (6 spray containers)
Croatian: EU/1/19/1410/001 (1 sprej za nos) EU/1/19/1410/004 (6 sprejeva za nos)
English: Hepatic enzyme inducers
Croatian: Induktori jetrenih enzima
English: ● high blood pressure
Croatian: • visok krvni tlak
English: The efficacy and safety of Spravato nasal spray was investigated in five Phase 3 clinical studies in adult patients (18 to 86 years) with treatment-resistant depression (TRD) who met DSM-5 criteria for major depressive disorder and were non-responders to at least two oral antidepressants (ADs) treatments, of adequate dosage and duration, in the current major depressive episode.
Croatian: Djelotvornost i sigurnost Spravato spreja za nos ispitivale su se u pet kliničkih ispitivanja faze 3 provedenih u odraslih bolesnika (u dobi od 18 do 86 godina) s depresijom rezistentnom na liječenje koji su zadovoljavali kriterije za veliki depresivni poremećaj prema 5. izdanju Dijagnostičkog i statističkog priručnika za psihičke poremećaje (engl.