FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Po uvajalni fazi so bolniki 4 tedne prejemali zdravilo Spravato enkrat na teden, od 8. tedna dalje pa so za določanje frekvence odmerjanja uporabili algoritem (na osnovi ocene MADRS): bolniki v remisiji (kar pomeni s skupno oceno MADRS ≤ 12) so zdravilo prejemali vsak drugi teden, če pa se je njihova skupna ocena MADRS zvišala na > 12, so jim za naslednje 4 tedne frekvenco odmerjanja povečali na enkrat tedensko, pri čemer je bil cilj pri bolniku vzdrževati najmanjšo frekvenco odmerjanja, ki omogoča ohranjanje odziva/remisije.
English: ● Switch hands to insert tip into the second nostril.
Slovenian: ● naj zamenja roki, da si bo lahko vstavil vrh pršilnika v drugo nosnico,
English: Food and liquid intake recommendations prior to administration Since some patients may experience nausea and vomiting after administration of Spravato, patients should be advised not to eat for at least 2 hours before administration and not to drink liquids at least 30 minutes prior to administration (see section 4.8).
Slovenian: Priporočila glede uživanja hrane in pijače pred odmerjanjem Pri nekaterih bolnikih po odmerjanju zdravila Spravato lahko pride do navzee in bruhanja, zato je treba bolnike opozoriti, naj najmanj 2 uri pred odmerjanjem ne uživajo hrane in najmanj 30 minut pred odmerjanjem ne pijejo nobene pijače (glejte poglavje 4.8).
English: At the end of 16 weeks of treatment period, patients in stable remission (n=176) or stable response (n=121) were randomised to continue with Spravato or stop Spravato and switch to placebo nasal spray.
Slovenian: Na koncu 16-tedenskega obdobja zdravljenja so bolnike, ki so bili v stabilni remisiji (n=176) ali stanju stabilnega odziva (n=121), randomizirali na nadaljnje zdravljenje z zdravilom Spravato ali na prekinitev zdravljenja z zdravilom Spravato in prehod na prejemanje placebo pršila za nos.
English: Spravato was evaluated in three Phase 3 short-term (4-week) randomised, double-blind, active-controlled studies in patients with TRD.
Slovenian: Zdravilo Spravato so ocenjevali v treh kratkoročnih (4-tedenskih) randomiziranih, dvojno slepih, aktivno kontroliranih študijah faze 3 pri bolnikih z na zdravljenje neodzivno depresijo.
English: ● Sleep apnoea with morbid obesity (BMI ≥35);
Slovenian: ● apneja v spanju v povezavi z bolezensko debelostjo (ITM ≥35);
English: ● Medicines that can increase your blood pressure, such as, thyroid hormones, asthma medications such as xanthine derivatives, medications for child birth bleeding (ergometrine) and heart medication such as vasopressin.
Slovenian: ● zdravila, ki lahko zvišajo krvni tlak, kot so ščitnični hormoni, zdravila za astmo, kot so derivati ksantina, zdravila, ki jih uporabljamo pri porodni krvavitvi (ergometrin) in zdravila za srce, kot je vazopresin,
English: Before first device only:
Slovenian: Samo pred uporabo prvega pršilnika:
English: Instruct the patient to: ● Recline head at about 45 degrees during administration to keep medicine inside the nose.
Slovenian: ● naj med odmerjanjem drži glavo pod kotom približno 45 stopinj, da se bo zdravilo zadržalo v nosu.
English: Table 6: Response and remission rates in 4-week clinical trials based on BOCF data
Slovenian: Preglednica 6: Stopnje odziva in remisije v 4-tedenskih kliničnih študijah na osnovi podatkov BOCF (metoda uporabe izhodiščne vrednosti za nadomeščanje manjkajočih vrednosti)
English: The mean clearance of esketamine administered by the intravenous route was approximately 89 L/hour.
Slovenian: Povprečni očistek intravensko apliciranega esketamina je bil približno 89 l/uro.
English: The selection of the newly initiated oral AD was determined by the investigator based on the patient's prior treatment history.
Slovenian: Izbiro novo uvedenega peroralnega antidepresiva je opravil raziskovalec na osnovi bolnikove anamneze predhodnega zdravljenja.
English: The pharmacokinetic profile of esketamine is similar after a single dose and repeat dose administration with no accumulation in plasma when esketamine is administered twice a week.
Slovenian: Farmakokinetični profil esketamina je pri enkratnem odmerku podoben kot pri ponavljajočem odmerjanju, pri čemer pri odmerjanju esketamina dvakrat na teden ne prihaja do kopičenja učinkovine v plazmi.
English: In the flexible dose studies, TRD3002 and TRD3005, up titration of Spravato dose was based on clinical judgement and dose could be down titrated based on tolerability.
Slovenian: V študijah s prilagodljivim odmerjanjem (študijah TRD3002 in TRD3005) je zviševanje odmerka zdravila Spravato temeljilo na klinični presoji, odmerke pa je bilo mogoče tudi znižati na osnovi prenašanja odmerka.
English: Blood pressure should be closely monitored when Spravato is used concomitantly with psychostimulants (e.g., amphetamines, methylphenidate, modafanil, armodafinil) or other medicinal products that may increase blood pressure (e.g. xanthine derivatives, ergometrine, thyroid hormones, vasopressin, or MAOIs, such as, tranylcypromine, selegiline, phenelzine).
Slovenian: Krvni tlak je treba skrbno spremljati pri sočasni uporabi zdravila Spravato s psihostimulansi (kot so amfetamini, metilfenidat, modafanil, armodafinil) ali drugimi zdravili, ki lahko zvišajo krvni tlak (na primer z derivati ksantina, ergometrinom, ščitničnimi hormoni, vazopresinom in zaviralci monoamin oksidaze (zaviralci MAO), kot so tranilcipromin, selegilin in fenelzin).
English: Subsequent doses should be increased in increments of 28 mg up to 56 mg or 84 mg, based on efficacy and tolerability.
Slovenian: Nadaljnje odmerke je treba povečevati postopno, v korakih po 28 mg do odmerka 56 mg ali 84 mg na osnovi učinkovitosti in prenašanja.
English: These adverse reactions were reported as transient and self-limited and occurred on the day of dosing.
Slovenian: Poročali so, da so bili ti neželeni učinki prehodni in so izzveneli spontano, pojavljali pa so se na dan odmerjanja zdravila.
English: o The HCP guide, aiming at addressing the risks of Transient dissociative states and perception disorders, Drug abuse, Disturbances in consciousness, and Blood pressure increased, should incorporate adequate reference to patient's safety, and highlight that:
Slovenian: o Vodnik za zdravstvene delavce, ki mora obravnavati tveganja za prehodna disociativna stanja in motnje percepcije, zlorabo zdravila, motnje zavesti in zvišanje krvnega tlaka, mora vključevati ustrezne napotke za varnost bolnika in poudariti, da:
English: Other medicines and Spravato Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: ● Medicines for depression or Parkinson's disease known as monoamine oxidase inhibitors (MAOIs) (for example, tranylcypromine, selegiline, phenelzine).
Slovenian: ● zdravila za depresijo ali Parkinsonovo bolezen, ki jih imenujemo zaviralci monoaminooksidaze (zaviralce MAO) (na primer tranilcipromin, selegilin ali fenelzin).
English: In case one or two treatment sessions are missed, the next session should be scheduled when the next session was scheduled to occur based on current treatment frequency.
Slovenian: Če bolnik izpusti en ali dva pregleda pri zdravniku, se je treba za naslednji pregled dogovoriti na datum po razporedu glede na trenutno frekvenco odmerjanja.
English: A substantial increase in blood pressure could occur after any treatment session.
Slovenian: Do znatnega zvišanja krvnega tlaka lahko pride po kateremkoli obisku za prejem zdravila.
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.
Slovenian: Učinkovitost in varnost zdravila Spravato v pršilu za nos so raziskovali v petih kliničnih študijah faze 3 pri odraslih bolnikih (starih od 18 do 86 let), ki so imeli na zdravljenje neodzivno depresijo in so ustrezali kriterijem DSM-5 za hudo depresivno motnjo ter so bili neodzivni na zdravljenje z najmanj dvema peroralnima antidepresivoma z ustreznim odmerjanjem in dovolj dolgim trajanjem zdravljenja trenutno prisotne epizode hude depresije.
English: total score ≤ 12 in at least 3 of the last 4 weeks of the optimisation phase and stable response was defined as ≥ 50% reduction in the MADRS total score from baseline for the last 2 weeks of the optimisation phase, but not in stable remission.
Slovenian: Stabilna remisija je bila opredeljena kot skupna ocena MADRS ≤ 12 v najmanj 3 od zadnjih 4 tednov faze optimizacije, stanje stabilnega odziva pa je bilo opredeljeno kot ≥ 50-odstotno znižanje skupne ocene MADRS od izhodišča v obdobju zadnjih 2 tednov faze optimizacije, pri čemer bolnik ni v stabilni remisiji.
English: At each treatment session, patients should be monitored under the supervision of a healthcare professional to assess when the patient is considered stable based on clinical judgement (see section 4.7).
Slovenian: Pri vsakem pregledu mora biti bolnik pod nadzorom zdravstvenega delavca, ki na osnovi kliničnega stanja oceni, kdaj je bolnik stabilen (glejte poglavje 4.7).
English: Type-I glass vial with a chlorobutyl rubber stopper.
Slovenian: Viala iz stekla tipa I z zamaškom iz klorobutilne gume.
English: ● After the first 4 weeks, Spravato is usually used once a week
Slovenian: ● Po prvih 4 tednih običajno uporabljamo zdravilo Spravato enkrat na teden.
English: Instruct patient to blow nose before first device only.
Slovenian: Bolniku naročite, naj se usekne samo pred uporabo prvega pršilnika.
English: Excipients: Citric acid monohydrate, disodium edetate, sodium hydroxide, water for injections.
Slovenian: Pomožne snovi: citronska kislina monohidrat, dinatrijev edetat, natrijev hidroksid, voda za injekcije.
English: Spravato can cause transient increases in systolic and/or diastolic blood pressure which peak at approximately 40 minutes after administration of the medicinal product and last approximately 1-2 hours (see section 4.8).
Slovenian: Zdravilo Spravato lahko povzroči prehodno zvišanje sistoličnega in/ali diastoličnega krvnega tlaka, pri čemer do največjega zvišanja pride približno 40 minut po odmerjanju zdravila, traja pa približno 1-2 uri (glejte poglavje 4.8).
English: Enrollment in TRD3003 was staggered over approximately 2 years.
Slovenian: Vključevanje preiskovancev v študijo TRD3003 je potekalo približno 2 leti.
English: Dissociation symptoms typically resolved by 1.5 hours post-dose and the severity tended to reduce over time with repeated treatments.
Slovenian: Simptomi disociiranosti so praviloma izzveneli v 1,5 ure po odmerjanju, njihova izraženost pa je sčasoma z nadaljnjim prejemanjem kazala trend upadanja.
English: The mean steady-state volume of distribution of esketamine administered by the intravenous route is 709 L.
Slovenian: Pri intravenskem odmerjanju je povprečni volumen porazdelitve esketamina v stanju dinamičnega ravnovesja 709 l.
English: ● severe liver problems.
Slovenian: ● ste imeli hude težave z jetri.
English: Spravato is for nasal use only.
Slovenian: Zdravilo Spravato je samo za nazalno uporabo.
English: ● Nose rest should touch the skin between the nostrils.
Slovenian: ● naj prirobnico za nos prisloni na kožo med obema nosnicama.
English: ● If liquid drips out, dab nose with a tissue.
Slovenian: ● Če iz nosu polzi tekočina, jo nežno popivnajte z robčkom.
English: ● Hold device as shown with the thumb gently supporting the plunger.
Slovenian: ● naj drži pršilnik tako, da s palcem nežno podpira bat, kot je prikazano,
English: 56 mg pack = 2 nasal spray devices 84 mg pack = 3 nasal spray devices
Slovenian: 56-miligramsko pakiranje = 2 nosna pršilnika 84-miligramsko pakiranje = 3 nosni pršilniki
English: If expired, get a new device.
Slovenian: Če je rok uporabnosti potekel, vzemite nov pršilnik.
English: The decision to prescribe Spravato should be determined by a psychiatrist.
Slovenian: Odločitev o tem, ali je bolniku primerno predpisati zdravilo Spravato ali ne, mora sprejeti psihiater.
English: The mean absolute bioavailability of 84 mg esketamine administered as a nasal spray is approximately
Slovenian: Povprečna absolutna biološka razpoložljivost 84-miligramskega odmerka esketamina, apliciranega s pršilom za nos, je približno 48%.
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.
Slovenian: V študiji potenciala za zlorabo, ki so jo izvajali pri uporabnikih več rekreacijskih drog (n=41), sta enkraten odmerek esketamina v pršilu za nos (84 mg oziroma 112 mg) in pozitivna kontrolna substanca (intravenski ketamin v odmerku 0,5 mg/kg s 40-minutno infuzijo) v primerjavi s placebom pridobila statistično značilno višje ocene pri subjektivnem vrednotenju "všečnosti droge" (angl. drug liking) in pri drugih merilih subjektivnega doživljanja učinkov droge.
English: The AUC∞ was 13 to 36% higher in the subjects with mild to severe renal impairment.
Slovenian: AUC∞ je bila pri osebah z blago do hudo okvaro ledvic za 13 do 36% večja.
English: The dosing frequency used the majority of the time during the maintenance phase is shown in Table 7.
Slovenian: V preglednici 7 so navedene frekvence odmerjanja, ki so jih uporabljali večino časa v vzdrževalni fazi.
English: Both administration and post-administration observation of Spravato should be carried out in an appropriate clinical setting.
Slovenian: Tako odmerjanje zdravila kot opazovanje po odmerjanju zdravila Spravato je treba izvajati v ustreznem kliničnem okolju.
English: In elderly patients the initial Spravato dose is 28 mg esketamine (day 1, starting dose, see Table 2 above).
Slovenian: Pri starejših bolnikih je začetni odmerek zdravila Spravato 28 mg esketamina (na 1. dan, začetni odmerek, glejte preglednico 2 zgoraj).
English: The objective of this EM is to detail:
Slovenian: Namen tega izobraževalnega gradiva je predstaviti:
English: Study TRD3005 (N=137)
Slovenian: Študija TRD3005 (N=137)
English: Concomitant use of Spravato with CNS depressants may increase the risk for sedation (see section 4.5).
Slovenian: Sočasna uporaba zdravila Spravato z zaviralci osrednjega živčevja lahko poveča tveganje za sedacijo (glejte poglavje 4.5).
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 oseb)
English: Dissociation
Slovenian: Disociiranost
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.
Slovenian: o Vodnik za bolnika, ki mora obravnavati tveganja za prehodna disociativna stanja in motnje percepcije, zlorabo zdravila, motnje zavesti in zvišanje krvnega tlaka.
English: Study TRD3001 (N=342)
Slovenian: Študija TRD3001 (N=342)
English: 84 mg = 3 devices
Slovenian: 84 mg = 3 pršilniki
English: When the administration is intended for outpatients, it should only be reserved to an environment where the patient is appropriately followed-up.
Slovenian: Kadar je predvideno apliciranje zdravila ambulantnemu bolniku, mora le-to potekati v okolju, ki omogoča ustrezno spremljanje bolnika.
English: This medicine is a clear, colourless solution, provided in a single-use nasal spray device.
Slovenian: To zdravilo je bistra brezbarvna raztopina, ki je na voljo v nosnem pršilniku za enkratno uporabo.
English: In all short-term studies, the primary efficacy endpoint was change in MADRS total score from baseline to day 28.
Slovenian: V vseh kratkoročnih študijah je bil primarni cilj opazovanja za oceno učinkovitost sprememba skupne ocene MADRS (na lestvici MontgomeryAsperg Depression Rating Scale) od izhodišča do 28. dne.
English: 56 mg = 2 devices
Slovenian: 56 mg = 2 pršilnika
English: Patients with clinically significant or unstable cardiovascular or respiratory conditions
Slovenian: Bolniki s klinično pomembno ali nestabilno obliko katere od kardiovaskularnih ali respiratornih bolezni
English: Studies TRANSFORM-1 (TRD3001) and TRANSFORM-2 (TRD3002) were conducted in adults (18 to < 65 years) and Study TRANSFORM-3 (TRD3005) was conducted in adults ≥ 65 years of age.
Slovenian: Študiji TRANSFORM-1 (TRD3001) in TRANSFORM-2 (TRD3002) so izvajali pri odraslih bolnikih (starih od 18 do < 65 let).
English: There is no specific antidote for esketamine overdose.
Slovenian: Za preveliko odmerjanje esketamina ni specifičnega antidota.
English: Your blood pressure will be checked before and after using this medicine.
Slovenian: Krvni tlak vam bodo izmerili pred uporabo in po uporabi zdravila.
English: Weeks 5-8: 56 mg or 84 mg once weekly
Slovenian: Tedni 5-8: 56 mg ali 84 mg enkrat na teden
English: You should avoid eating for 2 hours before treatment and not drinking liquids for 30 minutes before using this medicine.
Slovenian: Najmanj 2 uri pred odmerjanjem tega zdravila ne smete jesti in najmanj 30 minut pred odmerjanjem ne smete piti.
English: How to use Spravato
Slovenian: Kako uporabljati zdravilo Spravato
English: Examples of conditions which should be considered include, but are not limited to:
Slovenian: Primeri bolezni, pri katerih je to lahko potrebno, so med drugim lahko:
English: Spravato is contraindicated in patients for whom an increase in blood pressure or intracranial pressure poses a serious risk (see section 4.3).
Slovenian: Uporaba zdravila Spravato je kontraindicirana pri bolnikih, za katere zvišanje krvnega ali intrakranialnega tlaka pomeni resno tveganje (glejte poglavje 4.3).
English: Relative to the subjects with normal renal function (creatinine clearance [CLCR], 88 to 140 mL/min), the Cmax of esketamine was on average 20 to 26% higher in subjects with mild (CLCR, 58 to 77 mL/min), moderate (CLCR, 30 to 47 mL/min), or severe (CLCR, 5 to 28 mL/min, not on dialysis) renal impairment following administration of a 28-mg dose of esketamine nasal spray.
Slovenian: V primerjavi z vrednostmi pri osebah z normalno ledvično funkcijo (z očistkom kreatinina [CLCR] od 88 do 140 ml/min) je bila po odmerjanju 28-miligramskega odmerka esketamina v pršilu za nos Cmax esketamina v povprečju za 20 do 26% višja pri osebah z blago (CLCR: od 58 do 77 ml/min), zmerno (CLCR: od 30 do 47 ml/min) oziroma hudo okvaro ledvic (CLCR: od 5 do 28 ml/min, brez dializnega zdravljenja).
English: Table 3: Recommended Dosing for Spravato in Adults of Japanese Ancestry Induction phase
Slovenian: Preglednica 3: Priporočeno odmerjanje zdravila Spravato pri odraslih japonskega porekla Uvajalna faza
English: The potential for overdose of Spravato by the patient is minimised due to the product's design and the administration taking place under the supervision of a healthcare professional (see section 4.2).
Slovenian: Možnosti za preveliko odmerjanje zdravila Spravato so minimalne zaradi oblike zdravila in odmerjanja, ki ga je treba izvajati pod nadzorom zdravstvenega delavca (glejte poglavje 4.2).
English: During and after each use of this medicine, your doctor will check you and decide how long to monitor you.
Slovenian: Med odmerjanjem tega zdravila in po njem vas bo vsakokrat nadzoroval zdravnik, ki bo tudi presodil, kako dolgo vas je treba spremljati.
English: ● muscle tremors
Slovenian: ● mišični tremor (tresenje)
English: Esketamine is the S-enantiomer of racemic ketamine.
Slovenian: Esketamin je S-enantiomer racemata ketamina.
English: CARTON (for 2 and 3 nasal spray devices)
Slovenian: ŠKATLA (za 2 oziroma 3 nosne pršilnike)
English: No case of respiratory depression was observed in clinical trials with esketamine nasal spray (Spravato); rare cases of deep sedation have been reported.
Slovenian: V kliničnih študijah z esketaminom v pršilu za nos (zdravilom Spravato) niso opazili nobenega primera depresije dihanja, poročali pa so o redkih primerih globoke sedacije.
English: Some patients using Spravato may experience nausea or vomiting.
Slovenian: Pri nekaterih bolnikih, ki uporabljajo zdravilo Spravato, lahko pride do občutka slabosti (navzee) ali bruhanja.
English: After dosing with Spravato, blood pressure should be reassessed at approximately 40 minutes and subsequently as clinically warranted (see section 4.4).
Slovenian: Po odmerjanju zdravila Spravato je treba bolniku ponovno izmeriti krvni tlak po približno 40 minutah in nato še kasneje, če je to klinično potrebno (glejte poglavje 4.4).
English: The pharmacokinetics of a single, 56-mg dose of esketamine administered as a nasal spray was similar in subjects with allergic rhinitis who were exposed to grass pollen compared to healthy subjects.
Slovenian: Farmakokinetika enkratnega 56-miligramskega odmerka esketamina z odmerjanjem v pršilu za nos je bila pri osebah, ki so imele alergijski rinitis in so bile izpostavljene pelodu trav, podobna kot pri zdravih osebah.
English: After an initial 16 weeks of treatment with Spravato plus oral AD, the median duration of exposure to Spravato in the maintenance phase was 4.2 months (range: 1 day to 21.2 months) in Spravato -treated patients (stable remission and stable response).
Slovenian: V skupini bolnikov, ki so prejemali zdravilo Spravato, je bila po prvih 16 tednih zdravljenja z zdravilom Spravato v kombinaciji s peroralnim antidepresivom mediana trajanja izpostavljenosti zdravilu Spravato v vzdrževalni fazi 4,2 meseca (od 1 dneva do 21,2 meseca) (stabilna remisija ali stabilni odziv).
English: If you become pregnant while being treated with Spravato, talk to your doctor straight away - to decide whether to stop treatment and to learn about other options for treatment.
Slovenian: Če zanosite v času, ko uporabljate zdravilo Spravato, takoj obvestite zdravnika, da se bo lahko odločil, ali je potrebno prekiniti zdravljenje, in da vas seznani še z drugimi možnostmi zdravljenja.
English: SPRAVATO is intended to be self-administered by the patient under direct Healthcare Professional (HCP) supervision, and should be dispensed to the healthcare settings where administration takes place, as agreed at the MS level, based on local legal requirements and/or local healthcare systems.
Slovenian: Zdravilo je treba izdati zdravstveni ustanovi, v kateri bo potekalo apliciranje, kot bo dogovorjeno na ravni posamezne države članice glede na lokalne pravne zahteve in/ali lokalne zdravstvene sisteme .
English: The increase in Cmax and AUC values was less than dose-proportional between 28 mg and 56 mg or 84 mg, but it was nearly dose proportional between 56 mg and 84 mg.
Slovenian: Zvišanje Cmax in povečanje AUC sta v okviru odmerkov 28 mg in 56 mg oziroma 84 mg manj kot sorazmerna velikosti odmerka, sta pa skoraj sorazmerna velikosti odmerka v okviru odmerkov 56 mg in 84 mg.
English: Before prescribing Spravato, patients with other cardiovascular and cerebrovascular conditions should be carefully assessed to determine whether the potential benefits of Spravato outweigh its risks.
Slovenian: Bolnike, ki imajo katero od drugih kardiovaskularnih ali cerebrovaskularnih bolezni, je treba pred predpisovanjem zdravila Spravato skrbno pregledati in ugotoviti, ali možne koristi zdravljenja z zdravilom Spravato presegajo tveganja.