FrancophonIA/ELRC3.0 huggingface dataset:
English: Through NMDA receptor antagonism, esketamine produces a transient increase in glutamate release leading to increases in α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPAR) stimulation and subsequently to increases in neurotrophic signalling which may contribute to the restoration of synaptic function in these brain regions involved with the regulation of mood and emotional behaviour.
Slovenian: Z antagonističnim delovanjem na receptorje NMDA esketamin povzroča prehodno povečano sproščanje glutamata, kar poveča stimulacijo receptorjev α-amino-3-hidroksi-5-metil-4-izoksazol propionske kisline (receptorjev AMPAR) in s tem povzroči nevrotrofično signaliziranje, ki lahko prispeva k obnovitvi sinaptične funkcije v predelih možganov, ki so vpleteni v uravnavanje razpoloženja in emocionalnega vedenja.
English: Do not use Spravato
Slovenian: Ne uporabljajte zdravila Spravato
English: Using Spravato with certain medicines may cause side effects.
Slovenian: Uporaba zdravila Spravato sočasno z nekaterimi drugimi zdravili lahko povzroča neželene učinke.
English: Before Spravato administration, patients should be instructed not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a vehicle or operating machinery, until the next day following a restful sleep (see section 4.4).
Slovenian: Pred apliciranjem zdravila Spravato je treba bolnikom naročiti, naj ne izvajajo potencialno nevarnih dejavnosti, pri katerih je potrebna popolna prisebnost in dobra motorična koordinacija, kot je upravljanje vozila ali strojev, do naslednjega dne, ko si odpočijejo in se naspijo (glejte poglavje 4.4).
English: Response was defined as ≥ 50% reduction in the MADRS total score from baseline of the induction phase.
Slovenian: Odziv je bil opredeljen kot ≥ 50-odstotno znižanje skupne ocene MADRS od izhodišča uvajalne faze.
English: Table 5: Primary efficacy results for change in MADRS total score for 4-week clinical trials (ANCOVA BOCF)
Slovenian: Preglednica 5: Rezultati primarnega cilja opazovanja za oceno učinkovitosti glede spremembe skupne ocene MADRS v 4-tedenskih kliničnih preskušanjih (model ANCOVA BOCF)
English: Published studies in animals (including primates) at doses resulting in light to moderate anaesthesia demonstrate that the use of anaesthetic agents during the period of rapid brain growth or synaptogenesis results in cell loss in the developing brain, that can be associated with prolonged cognitive deficiencies.
Slovenian: Po podatkih objavljenih študij na živalih (vključno s primati) uporaba anestetičnih sredstev v odmerkih, ki povzročajo blago do zmerno anestezijo, v obdobju hitre rasti možganov oziroma sinaptogeneze povzroča propadanje celic v razvijajočih se možganih, kar je lahko povezano z dolgotrajnimi kognitivnimi primanjkljaji.
English: ● change in sense of taste
Slovenian: ● sprememba v zaznavanju okusa
English: Do not prime or test before use.
Slovenian: Pršilnika ne smete sprožiti ali preizkušati pred dejansko uporabo.
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.
Slovenian: Če ste v dvomu, se posvetujte z zdravnikom, preden uporabite zdravilo Spravato - zdravnik bo odločil, ali smete uporabljati to zdravilo ali ne.
English: The maximum single esketamine nasal spray dose tested in healthy volunteers was 112 mg which showed no evidence of toxicity and/or adverse clinical outcomes.
Slovenian: Največji enkratni odmerek esketamina v pršilu za nos, ki so ga testirali pri zdravih prostovoljcih, je bil 112 mg in pri tem odmerku ni bilo nobenih znakov toksičnega delovanja in/ali neželenih kliničnih posledic.
English: Animal studies with ketamine showed evidence of developmental neurotoxicity.
Slovenian: V študijah na živalih s ketaminom se je pokazalo, da ta povzroča razvojno nevrotoksičnost.
English: ● Medicines used to treat nervous disorders or severe pain (for example, benzodiazepines, opioids), or medicines or beverages containing alcohol
Slovenian: ● zdravila, ki jih uporabljamo pri boleznih živčevja ali hudih bolečinah (na primer benzodiazepine, opioide) ali zdravila oziroma pijače, ki vsebujejo alkohol,
English: The main cytochrome P450 (CYP) enzymes responsible for esketamine N-demethylation are CYP2B6 and CYP3A4.
Slovenian: Od citokromov P450 (CYP) sta poglavitna encima, ki sta odgovorna za N-demetilacijo esketamina, CYP2B6 in CYP3A4.
English: Response and remission rates
Slovenian: Stopnje odziva in remisije
English: This medicine may cause a temporary increase in your blood pressure after taking a dose.
Slovenian: To zdravilo lahko povzroči začasno zvišanje krvnega tlaka po odmerjanju.
English: If any of the above apply to you (or you are not sure), talk to your doctor before using Spravato.
Slovenian: Če karkoli od navedenega velja za vas (ali če ste v dvomu), se posvetujte z zdravnikom, preden uporabite zdravilo Spravato.
English: The most commonly observed adverse reactions in treatment-resistant depression patients treated with Spravato were dizziness (30%), nausea (27%), dissociation (26%), headache (24%), somnolence (18%), vertigo (18%), dysgeusia (17%), hypoaesthesia (11%), and vomiting (10%).
Slovenian: Neželeni učinki, ki so jih najbolj pogosto opažali pri bolnikih, ki so imeli na zdravljenje neodzivno hudo depresijo in so prejemali zdravilo Spravato, so bili omotičnost (30%), navzea (27%), disociiranost (26%), glavobol (24%), somnolenca (18%), vrtoglavica (18%), disgevzija (17%), hipestezija (11%) in bruhanje (10%).
English: ● Insert tip straight into the first nostril.
Slovenian: ● naj vstavi vrh pršilnika naravnost v prvo nosnico,
English: Other populations at risk
Slovenian: Druge skupine bolnikov z večjim tveganjem
English: Overall a total of 705 patients were enrolled; 437 directly enrolled; 150 transferred from TRD3001, and 118 transferred from TRD3002.
Slovenian: Skupno so vključili 705 bolnikov: 437 so jih vključili neposredno, 150 so jih vključili iz študije TRD3001 in 118 iz študije TRD3002.
English: ● decreased feeling or sensitivity, including around the mouth area
Slovenian: ● zmanjšana občutljivost oziroma zaznavanje, tudi v predelu okrog ust
English: There are no or limited data on the use of esketamine in pregnant women.
Slovenian: Podatkov o uporabi esketamina pri nosečnicah ni oziroma so omejeni.
English: Noresketamine is subsequently metabolised via CYP-dependent pathways to other metabolites, some of which undergo glucuronidation.
Slovenian: Noresketamin se nato v procesih, ki so odvisni od encimov CYP, presnavlja v druge presnovke, med katerimi so nekateri podvrženi glukuronidaciji.
English: The potential for esketamine to have neurotoxic effects on developing foetuses cannot be excluded (see section 4.6).
Slovenian: Možnosti, da ima esketamin potencial za nevrotoksično delovanje na razvijajoči se plod, ni mogoče izključiti (glejte poglavje 4.6).
English: Close supervision and monitoring should continue until the patient recovers.
Slovenian: Bolnika je treba skrbno nadzorovati in spremljati, dokler ne okreva.
English: 2 green dots (0 mg delivered)
Slovenian: 2 zeleni piki (0 mg danega zdravila)
English: If blood pressure is elevated prior to Spravato administration a decision to delay Spravato therapy should take into account the balance of benefit and risk in individual patients.
Slovenian: Če je krvni tlak zvišan pred odmerjanjem zdravila Spravato, je treba pri odločanju za odlog odmerjanja zdravila Spravato upoštevati razmerje med koristmi in tveganji pri posameznem bolniku.
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts and should receive careful monitoring during treatment.
Slovenian: Znano je, da pri bolnikih, ki imajo v anamnezi s samomorom povezane dogodke ali izkazujejo visoko stopnjo samomorilnih ideacij že pred začetkom zdravljenja, obstaja povečano tveganje za samomorilne misli in poskuse samomora, zato je treba te bolnike med zdravljenjem skrbno spremljati.
English: Concomitant use of Spravato with CNS depressants (e.g., benzodiazepines, opioids, alcohol) may increase sedation, which therefore should be closely monitored.
Slovenian: Sočasna uporaba zdravila Spravato z zaviralci osrednjega živčevja (kot so benzodiazepini, opioidi in alkohol) lahko okrepi učinek sedacije, ki jo je treba zato skrbno spremljati.
English: Uncommon (may affect up to 1 in 100 people) ● increased saliva
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 oseb) ● povečano izločanje sline
English: Administration of a comparable supratherapeutic dose of esketamine by the intranasal route is unlikely to be feasible.
Slovenian: Odmerjanje primerljivih supraterapevtskih odmerkov esketamina intranazalno po vsej verjetnosti ni praktično izvedljivo.
English: Treatment discontinuation with Spravato does not require tapering off; based on data from clinical trials the risk of withdrawal symptoms is low.
Slovenian: Pri prekinitvi zdravljenja z zdravilom Spravato postopno zmanjševanje odmerka ni potrebno, saj je po podatkih iz kliničnih študij tveganje za pojavljanje odtegnitvenih simptomov majhno.
English: What Spravato is and what it is used for What you need to know before you use Spravato How to use Spravato
Slovenian: Kaj je zdravilo Spravato in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Spravato Kako uporabljati zdravilo Spravato Možni neželeni učinki
English: Within each pack, each device is individually packaged in a sealed blister.
Slovenian: V vsakem pakiranju je vsak pršilnik posamezno pakiran v neprodušno zaprtem pretisnem omotu.
English: Patients who were responders (455), continued receiving treatment with Spravato plus oral AD in a 12-week optimisation phase.
Slovenian: Odzivni bolniki (455) so nadaljevali s prejemanjem zdravila Spravato v kombinaciji s peroralnim antidepresivom v 12-tedenski fazi optimizacije.
English: The time to reach maximum plasma concentration (tmax) is typically 20 to 40 minutes after the last nasal spray of a treatment session (see section 4.2).
Slovenian: Čas do dosežene najvišje koncentracije v plazmi (tmax) je praviloma od 20 do 40 minut po zadnjem vpihu posameznega prejema zdravila (glejte poglavje 4.2).
English: General disorders and administration site conditions feeling abnormal, feeling drunk, feeling of body temperature change
Slovenian: Splošne težave in spremembe na mestu aplikacije nenormalno počutje, občutek pijanosti, občutek spreminjanja telesne temperature
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).
Slovenian: Zaradi možnosti, da pride do sedacije, disociiranosti in zvišanja krvnega tlaka, mora zdravstveni delavec bolnika po odmerjanju opazovati, dokler ne presodi, da je bolnikovo klinično stanje stabilno in je bolnik pripravljen, da zapusti zdravstveno ustanovo (glejte poglavje 4.4).
English: ● Check that indicator shows no green dots.
Slovenian: ● Prepričajte se, da indikator ne kaže več nobene zelene pike.
English: After Cmax was reached following nasal administration, the decline in esketamine concentrations in plasma was rapid for the first few hours and then more gradual.
Slovenian: Pri nazalnem odmerjanju se po doseženi najvišji koncentraciji Cmax koncentracija esketamina v plazmi v prvih nekaj urah znižuje hitro, nato pa bolj postopoma.
English: During and after each use of this medicine, your doctor will check your condition and decide how long to monitor you.
Slovenian: Med vsakim odmerjanjem zdravila in po njem bo zdravnik preveril vaše stanje in presodil, kako dolgo vas je treba spremljati.
English: ● decreased feeling or sensitivity in the mouth
Slovenian: ● zmanjšana občutljivost oziroma zaznavanje v ustih
English: Gender and body weight
Slovenian: Spol in telesna masa
English: Animal studies have shown that ketamine, the racemic mixture of arketamine and esketamine, induces neurotoxicity in developing foetuses (see section 5.3).
Slovenian: Študije na živalih so pokazale, da je ketamin, ki je racemat arketamina in esketamina, nevrotoksičen za plod v razvoju (glejte poglavje 5.3).
English: The dose recommendations for Spravato are shown in Table 1 and Table 2 (adults ≥65 years).
Slovenian: Priporočila za odmerjanje zdravila Spravato so prikazana v preglednici 1 in preglednici 2 (za odrasle, ki so stari ≥ 65 let).
English: • The influence of SPRAVATO on the patient's ability to drive or operate machinery
Slovenian: • vpliva zdravila SPRAVATO na bolnikovo sposobnost vožnje in upravljanja strojev.
English: The maintenance of antidepressant efficacy was demonstrated in a relapse prevention trial.
Slovenian: Ohranjanje antidepresivnega učinka so dokazali v preskušanju preprečevanja relapsa.
English: Ketamine, the racemic mixture of arketamine and esketamine, is a medicinal product that has been reported to be abused.
Slovenian: Ketamin, ki je racemat arketamina in esketamina, je zdravilo, pri katerem so poročali o zlorabah.
English: Instructions for Use SPRAVATO (esketamine) Nasal Spray Device
Slovenian: Navodila za uporabo SPRAVATO (esketamin) Nosni pršilnik
English: • The steps for SPRAVATO self-administration under direct HCP supervision;
Slovenian: • korakov pri samoapliciranju zdravila SPRAVATO pod neposrednim nadzorom zdravstvenega delavca;
English: Blood pressure should be measured around 40 minutes post-dose and subsequently as clinically warranted until values decline.
Slovenian: Krvni tlak je treba bolniku izmeriti približno 40 minut po odmerjanju in kasneje še tolikokrat, kot je klinično upravičeno, dokler se vrednosti ne znižajo.
English: In patients whose blood pressure prior to dose administration is judged to be elevated (as a general guide: >140/90 mmHg for patients <65 years of age and >150/90 mmHg for patients ≥65 years of age), it is appropriate to adjust lifestyle and/or pharmacologic therapies to reduce blood pressure before starting treatment with Spravato.
Slovenian: Pri bolnikih, pri katerih je pred apliciranjem odmerka krvni tlak ocenjen kot zvišan (po splošnih smernicah: >140/90 mmHg pri bolnikih, ki so stari <65 let, in >150/90 mmHg pri bolnikih, ki so stari ≥65 let), je smiselno prilagoditi način življenja in/ali farmakološko zdravljenje za znižanje krvnega tlaka pred začetkom zdravljenja z zdravilom Spravato.
English: During the maintenance phase, Spravato dosing should be individualised to the lowest frequency to maintain remission/response.
Slovenian: V vzdrževalni fazi je odmerjanje zdravila Spravato treba prilagoditi posamezniku, tako da je pogostnost prejemanja najmanjša, s katero je pri njem mogoče vzdrževati remisijo oziroma odziv.
English: or see, feel, or hear things that are not there (hallucinations)
Slovenian: ● bolnik vidi, čuti, sliši ali okuša nekaj, kar v resnici ni prisotno (halucinacije)
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.
Slovenian: Potencial za zlorabo, nepravilno uporabo in preprodajo zdravila Spravato je minimalen, ker odmerjanje zdravila poteka pod neposrednim nadzorom zdravstvenega delavca.
English: ● sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation), difficulties in breathing (respiratory depression).
Slovenian: ● zaspanost (sedacijo), izgubo zavesti, omotičnost, vrtoglavico, tesnobo ali občutek odmaknjenosti od samega sebe, svojih misli, občutkov, prostora in časa (disociiranost), oteženo dihanje (depresijo dihanja).
English: The recovered radioactivity consisted primarily of esketamine metabolites.
Slovenian: Prestreženo radioaktivnost so večinoma predstavljali presnovki esketamina.
English: In long-term clinical trials, the effect of esketamine nasal spray on cognitive functioning was evaluated over time and performance remained stable.
Slovenian: V dolgoročnih kliničnih preskušanjih so vrednotili časovni potek vpliva, ki ga ima esketamin v pršilu za nos na kognitivne funkcije, in ocenili, da je izvedbena sposobnost preiskovancev ostala stabilna.
English: The mean terminal half-life following administration as a nasal spray generally ranged from 7 to 12 hours.
Slovenian: Povprečni končni razpolovni čas po odmerjanju s pršilom za nos je večinoma znašal od 7 do 12 ur.
English: One device contains 2 sprays (1 spray for each nostril)
Slovenian: En pršilnik vsebuje 2 vpiha (1 vpih v vsako nosnico)
English: Instruct the patient to: ● Sniff gently after spraying to keep medicine inside nose.
Slovenian: Bolniku naročite: ● naj po vpihu nežno vdihava skozi nos, da se bo zdravilo zadržalo v nosu.
English: It is given, together with another antidepressant, if you have tried at least 2 other antidepressant medicines but they have not helped.
Slovenian: Zdravilo prejema bolnik poleg drugega antidepresiva, če so ga že prej poskušali zdraviti z dvema ali več drugimi antidepresivi, ki pa mu niso pomagali.
English: ● nasal dryness including dry crusts in the nose
Slovenian: ● suhost nosne sluznice, vključno s pojavljanjem krast v nosu
English: Study SUSTAIN-1 (TRD3003) was a long-term randomised, double-blind, parallel-group, active-controlled, multicenter, relapse prevention study.
Slovenian: Študija SUSTAIN-1 (TRD3003) je bila dolgoročna, randomizirana, dvojno slepa, aktivno nadzorovana, multicentrična študija preprečevanja relapsa z vzporednimi skupinami.
English: Esketamine is extensively metabolised in the liver.
Slovenian: Esketamin se obsežno presnavlja v jetrih.
English: If more than 2 treatment sessions have been missed, per clinical judgment, adjustment of the dose or frequency of Spravato may be clinically appropriate.
Slovenian: Če bolnik izpusti več kot 2 pregleda, se bolniku po klinični presoji prilagodi velikost odmerka ali pogostnost odmerjanja zdravila Spravato.
English: Spravato has a major influence on the ability to drive and use machines.
Slovenian: Zdravilo Spravato ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
English: ● if you have ever had certain conditions such as: an aneurysm (a weak spot in a blood vessel wall where it widens or bulges out) bleeding in the brain
Slovenian: ● če ste imeli kadarkoli katero od naslednjih bolezni: anevrizma (oslabljen del žilne stene, kjer je žila razširjena oziroma se izboči), krvavitev v možganih.
English: • Due to the potential risk of cardiac adverse events, the patient's blood pressure should be carefully monitored before and after SPRAVATO intake.
Slovenian: • je zaradi možnega tveganja za razvoj srčnih neželenih dogodkov treba pred uporabo zdravila SPRAVATO in po njem skrbno spremljati bolnikov krvni tlak.
English: Neuropsychiatric and motor impairments
Slovenian: Nevropsihiatrične in motorične motnje
English: Animal studies showed that fertility and reproductive capacities were not adversely affected by esketamine.
Slovenian: Študije na živalih so pokazale, da esketamin nima neugodnega vpliva na plodnost in sposobnost razmnoževanja.
English: The MAH shall ensure that in each MS where SPRAVATO is marketed a CAP is implemented to prevent/minimise the important identified risk of Drug abuse.
Slovenian: Imetnik DzP mora zagotoviti, da v vsaki državi članici, kjer je zdravilo SPRAVATO na trgu, vzpostavi program nadzorovanega dostopa za preprečevanje oziroma zmanjševanje pomembnega ugotovljenega tveganja glede zlorabe zdravila.
English: ● If you have any further questions, ask your doctor or pharmacist.
Slovenian: ● Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: ● pain when passing urine
Slovenian: ● bolečine pri uriniranju
English: These patients should be carefully assessed before prescribing Spravato and treatment initiated only if the benefit outweighs the risk:
Slovenian: Pri teh bolnikih je potreben skrben pregled, preden jim zdravnik predpiše zdravilo Spravato, z zdravljenjem pa sme pri njih začeti samo, če koristi presegajo tveganja:
English: Clinical symptoms are described as convulsions, cardiac arrhythmias, and respiratory arrest.
Slovenian: Klinične simptome so opisali kot konvulzije, motnje srčnega ritma in zastoj dihanja.
English: The filled and stoppered vial is assembled into a manually-activated nasal spray device.
Slovenian: Napolnjena in zaprta viala je povezana z nosnim pršilnikom, ki se aktivira ročno.
English: For the intravenous and oral routes of administration, < 1% of the dose was excreted in the urine as unchanged drug.
Slovenian: Tako pri intravenskem kot pri peroralnem odmerjanju se je < 1% danega odmerka izločil z urinom kot nespremenjena učinkovina.
English: Management of Spravato overdose should consist of treating clinical symptoms and relevant monitoring.
Slovenian: Zdravljenje v primeru prevelikega odmerjanja zdravila Spravato naj vključuje obvladovanje kliničnih simptomov in ustrezno spremljanje bolnika.
English: If a woman becomes pregnant while being treated with Spravato, treatment should be discontinued, and the patient should be counselled about the potential risk to the foetus and clinical/therapeutic options as soon as possible.
Slovenian: Če ženska zanosi v času zdravljenja z zdravilom Spravato, je treba zdravljenje prekiniti in bolnico opozoriti na možno tveganje za plod ter ji čimprej predstaviti klinične oziroma terapevtske možnosti.
English: Table 7: Dosing frequency used the majority of the time; maintenance phase (Study TRD3003)
Slovenian: Preglednica 7: Frekvenca odmerjanja, ki so jo uporabljali večino časa v vzdrževalni fazi (študija TRD3003)
English: Esketamine exposure increases with dose from 28 mg to 84 mg.
Slovenian: Izpostavljenost esketaminu se v okviru od 28 mg do 84 mg povečuje z velikostjo odmerka.
English: ● Do not press the plunger.
Slovenian: ● naj ne pritiska bata.
English: SPRAVATO may induce transient sedation, dissociative and perception disorders and/or hypertension.
Slovenian: Zdravilo SPRAVATO lahko povzroči prehodno sedacijo, disociativne motnje in motnje percepcije in/ali hipertenzijo.
English: ● itchy nose
Slovenian: ● srbeč nos
English: Psychiatric disorders dissociation euphoric mood, agitation, anxiety, illusion, irritability, panic attack, time perception altered, hallucination including visual hallucination, derealisation
Slovenian: Psihiatrične motnje disociiranost evforično razpoloženje, agitacija, tesnoba, iluzije, razdražljivost, napad panike, spremenjeno zaznavanje časa, halucinacije, kar vključuje vidne halucinacije, derealizacija
English: • All patients must be monitored accordingly after SPRAVATO administration until considered clinically stable to leave the healthcare setting;
Slovenian: • je treba vse bolnike po uporabi zdravila SPRAVATO ustrezno spremljati, dokler njihovo stanje ni ocenjeno kot klinično stabilno, da lahko zapustijo zdravstveno ustanovo;
English: ● difficulty speaking
Slovenian: ● oteženo govorjenje
English: The primary metabolic pathway of esketamine in human liver microsomes is N-demethylation to form noresketamine.
Slovenian: Primarni proces pri presnavljanju esketamina v humanih jetrnih mikrosomih je N-demetilacija, pri kateri nastaja noresketamin.
English: Drug abuse, dependence, withdrawal
Slovenian: Zloraba, odvisnost in odtegnitev zdravila
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.
Slovenian: V študiji embriofetalne razvojne toksičnosti z nazalnim odmerjanjem ketamina podganam pri mladičih ni prišlo do neželenih učinkov ob prisotni toksičnosti za samico pri odmerjanju, ki je pomenilo do 6-krat večjo izpostavljenost kot pri ljudeh na osnovi vrednosti AUC.
English: Of the patients randomised to Spravato, 60% received 84 mg and 40% received 56 mg dose.
Slovenian: Med bolniki, ki so prejemali zdravilo Spravato, jih je 60% prejemalo odmerek 84 mg, 40% pa je prejemalo odmerek 56 mg.