FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 7: Dosing frequency used the majority of the time; maintenance phase (Study TRD3003)
Croatian: Tablica 7: Učestalost primjene koja se koristila većinu vremena; faza održavanja (ispitivanje TRD3003)
English: Table 6: Response and remission rates in 4-week clinical trials based on BOCF data
Croatian: Tablica 6: Stope odgovora i remisije u 4-tjednim kliničkim ispitivanjima na temelju prijenosa početno zabilježenih vrijednosti (BOCF)
English: Spravato can increase your blood pressure for about 1 to 2 hours after you use it so your blood pressure will be measured before you start using Spravato and after using it.
Croatian: Spravato može povisiti krvni tlak tijekom približno 1 - 2 sata nakon primjene i stoga će Vam se krvni tlak izmjeriti prije početka primjene lijeka Spravato i nakon uzimanja lijeka.
English: ● excessive sweating
Croatian: • pojačano znojenje
English: Dissociation was reported as severe in intensity at the incidence of less than 4% across studies.
Croatian: Incidencija teške disocijacije iznosila je manje od 4% u svim kliničkim ispitivanjima.
English: When the administration is intended for outpatients, it should only be reserved to an environment where the patient is appropriately followed-up.
Croatian: Kada je primjena lijeka namijenjena ambulantnim bolesnicima, mora se odvijati isključivo u uvjetima u kojima se provodi odgovarajuće praćenje bolesnika.
English: No dose adjustment is necessary in patients with mild (Child Pugh class A) or moderate (Child Pugh class B) hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem jetrene funkcije.
English: Patients with clinically significant or unstable cardiovascular or respiratory conditions
Croatian: Bolesnici s klinički značajnim ili nestabilnim kardiovaskularnim ili respiratornim stanjima
English: Animal studies with ketamine showed evidence of developmental neurotoxicity.
Croatian: U ispitivanjima ketamina na životinjama zabilježeni su dokazi razvojne neurotoksičnosti.
English: ● Stimulants such as those used for conditions such as narcolepsy or medicines for ADHD (for example, amphetamines, methylphenidate, modafanil, armodafinil)
Croatian: • stimulanse poput onih koji se koriste za liječenje stanja kao što je narkolepsija ili lijekove za ADHD (primjerice amfetamine, metilfenidat, modafinil, armodafinil)
English: Patients who were responders (455), continued receiving treatment with Spravato plus oral AD in a 12-week optimisation phase.
Croatian: Bolesnici s odgovorom (455) nastavili su primati Spravato plus oralni antidepresiv tijekom 12-tjedne faze optimizacije terapije.
English: No green dots Two sprays (28 mg) delivered
Croatian: Nijedna zelena točka Isporučena su dva potiska (28 mg)
English: Restoration of dopaminergic neurotransmission in brain regions involved in the reward and motivation, and decreased stimulation of brain regions involved in anhedonia, may contribute to the rapid response.
Croatian: Obnavljanje dopaminergičkog neuroprijenosa u dijelovima mozga odgovornima za osjećaj nagrade i motivacije te smanjena stimulacija dijelova mozga odgovornih za anhedoniju mogu pridonijeti brzom odgovoru na liječenje.
English: Study SUSTAIN-1 (TRD3003) was a long-term randomised, double-blind, parallel-group, active-controlled, multicenter, relapse prevention study.
Croatian: Ispitivanje SUSTAIN-1 (TRD3003) bilo je dugoročno, randomizirano, dvostruko slijepo, aktivnim lijekom kontrolirano, multicentrično ispitivanje s paralelnim skupinama, u kojem se lijek primjenjivao u prevenciji relapsa.
English: Animal studies showed that fertility and reproductive capacities were not adversely affected by esketamine.
Croatian: Ispitivanja na životinjama pokazala su da esketamin nema štetnih učinaka na plodnost i reproduktivnu sposobnost.
English: Data in animals have shown excretion of esketamine in milk.
Croatian: Podaci iz ispitivanja na životinjama pokazali su da se esketamin izlučuje u mlijeko.
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).
Croatian: Potrebno je pažljivo pratiti krvni tlak kod istodobne primjene lijeka Spravato i psihostimulansa (npr. amfetamina, metilfenidata, modafinila, armodafinila) ili drugih lijekova koji mogu povisiti krvni tlak (npr. derivata ksantina, ergometrina, hormona štitnjače, vazopresina ili MAO inhibitora kao što su tranilcipromin, selegilin i fenelzin).
English: The mean steady-state volume of distribution of esketamine administered by the intravenous route is 709 L.
Croatian: Srednja vrijednost volumena distribucije intravenski primijenjenog esketamina u stanju dinamičke ravnoteže iznosi 709 l.
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.
Croatian: Prije propisivanja lijeka Spravato potrebno je pažljivo ocijeniti bolesnike s drugim kardiovaskularnim i cerebrovaskularnim stanjima kako bi se utvrdilo nadmašuju li moguće koristi liječenja lijekom Spravatom rizike povezane s njegovom primjenom.
English: On average, esketamine Cmax was 10% lower and AUC∞ was 17% higher in Korean subjects, relative to Caucasian subjects.
Croatian: Cmax esketamina bio je prosječno 10% manji, a njegov AUC∞ prosječno 17% veći u Korejaca nego u bijelaca.
English: Enrollment in TRD3003 was staggered over approximately 2 years.
Croatian: Bolesnici su se u ispitivanje TRD3003 uključivali postupno tijekom približno 2 godine.
English: Urinary tract symptoms
Croatian: Simptomi urinarnog trakta
English: ● Repeat Steps 2-5 if more than one device is required.
Croatian: • Ako bolesnik treba primijeniti više od jednog spreja, ponovite korake 2 - 5.
English: The selection of the newly initiated oral AD was determined by the investigator based on the patient's prior treatment history.
Croatian: Novouvedeni oralni antidepresiv birao je ispitivač na temelju terapija koje je bolesnik prethodno primao.
English: Device empty
Croatian: Sprej je prazan
English: ● feeling abnormal
Croatian: • neuobičajeno osjećanje
English: Blood pressure should be measured around 40 minutes post-dose and subsequently as clinically warranted until values decline.
Croatian: Krvni tlak treba izmjeriti približno 40 minuta nakon primjene doze, a zatim sukladno kliničkoj potrebi sve dok se njegove vrijednosti ne snize.
English: Spravato + Oral AD (N=90)
Croatian: Spravato + oralni AD (N=90)
English: A substantial increase in blood pressure could occur after any treatment session.
Croatian: Krvni se tlak može značajno povisiti nakon bilo kojeg terapijskog tretmana.
English: ● Hold device as shown with the thumb gently supporting the plunger.
Croatian: • drži sprej kako je prikazano na slici, tako da palcem nježno pridržava klip
English: ● ever had lung problems causing breathing difficulty (pulmonary insufficiency), including
Croatian: • ako ste ikada imali plućnih tegoba koje su uzrokovale otežano disanje (plućnu insuficijenciju),
English: No case of respiratory depression was observed in clinical trials with esketamine nasal spray (Spravato); rare cases of deep sedation have been reported.
Croatian: U kliničkim ispitivanjima esketamina u spreju za nos (Spravato) nije opažen nijedan slučaj respiratorne depresije; prijavljeni su rijetki slučajevi duboke sedacije.
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).
Croatian: Pri svakom terapijskom tretmanu praćenje bolesnika treba se odvijati pod nadzorom zdravstvenog radnika, koji na temelju kliničke prosudbe treba ocijeniti kada se bolesnik smatra stabilnim (vidjeti dio 4.7).
English: Confirm required number of devices.
Croatian: Provjerite imate li potreban broj sprejeva.
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.
Croatian: SPRAVATO je namijenjen za bolesnikovu samostalnu primjenu pod izravnim nadzorom zdravstvenog radnika i treba se izdavati zdravstvenim ustanovama u kojima će se primjenjivati, sukladno dogovoru u pojedinačnim državama članicama i u skladu s lokalnim propisima i/ili lokalnim zdravstvenim sustavom.
English: General disorders and administration site conditions feeling abnormal, feeling drunk, feeling of body temperature change
Croatian: Opći poremećaji i reakcije na mjestu primjene neuobičajeno osjećanje, osjećaj opijenosti, osjećaj promjene tjelesne temperature
English: Tell the medical staff right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures (fits) after using this medicine.
Croatian: Odmah recite medicinskom osoblju ako Vam se nakon primjene lijeka pojavi bol u prsnom košu, nedostatak zraka, iznenadna jaka glavobolja, promjene vida ili napadaji.
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.
Croatian: Povećanje vrijednosti Cmax i AUC-a bilo je manje nego proporcionalno dozi kod povećanja doze s 28 mg na 56 mg ili 84 mg, ali gotovo proporcionalno dozi kod povećanja doze s 56 mg na 84 mg.
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 (see section 4.4).
Croatian: U tih bolesnika Spravato treba primjenjivati u uvjetima u kojima su na raspolaganju odgovarajuća oprema za oživljavanje i zdravstveni radnici obučeni za kardiopulmonalnu reanimaciju (vidjeti dio 4.4).
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.
Croatian: • lijekove koji mogu povisiti krvni tlak kao što su hormoni štitnjače, lijekovi za liječenje astme poput derivata ksantina, lijekovi za liječenje krvarenja nakon poroda (ergometrin) i lijekovi za liječenje srčanih bolesti poput vazopresina
English: Assessment before treatment Prior to dosing with Spravato blood pressure should be assessed.
Croatian: Ocjena prije liječenja Prije primjene lijeka Spravato potrebno je ocijeniti krvni tlak.
English: Spravato has a major influence on the ability to drive and use machines.
Croatian: Spravato značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The potential for esketamine to have neurotoxic effects on developing foetuses cannot be excluded (see section 4.6).
Croatian: Ne mogu se isključiti mogući neurotoksični učinci esketamina na plod u razvoju (vidjeti dio 4.6).
English: For additional assistance or to share your feedback refer to the Package Leaflet for the contact information of the local representative of the Marketing Authorisation Holder.
Croatian: Ako Vam je potrebna dodatna pomoć ili želite dati povratne informacije, potražite kontaktne podatke lokalnog predstavnika nositelja odobrenja za stavljanje lijeka u promet u uputi o lijeku.
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.
Croatian: Stabilna se remisija definirala kao ukupan MADRS rezultat ≤ 12 tijekom najmanje 3 od posljednja 4 tjedna faze optimizacije liječenja, dok se stabilan odgovor definirao kao smanjenje ukupnog MADRS rezultata za ≥ 50% u odnosu na početnu vrijednost tijekom posljednja 2 tjedna faze optimizacije, ali bez postizanja stabilne remisije.
English: In clinical studies, Spravato has been reported to cause somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo and anxiety (see section 4.8).
Croatian: U kliničkim je ispitivanjima prijavljeno da Spravato uzrokuje somnolenciju, sedaciju, disocijativne simptome, poremećaje percepcije, omaglicu, vrtoglavicu i anksioznost (vidjeti dio 4.8).
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.
Croatian: U odnosu na ispitanike s normalnom bubrežnom funkcijom (klirens kreatinina [CLCR]: 88 - 140 ml/min), Cmax esketamina bio je prosječno 20 - 26% veći u ispitanika s blagim (CLCR: 58 - 77 mL/min), umjerenim (CLCR: 30 - 47 ml/min) ili teškim (CLCR: 5 - 28 ml/min, bez dijalize) oštećenjem bubrežne funkcije nakon primjene doze od 28 mg esketamina u spreju za nos.
English: If baseline blood pressure is elevated the risks of short-term increases in blood pressure and benefit of Spravato treatment should be considered (see section 4.4).
Croatian: Ako je početni krvni tlak povišen, treba razmotriti rizike kratkotrajnog povišenja krvnog tlaka i korist liječenja lijekom Spravato (vidjeti dio 4.4).
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.
Croatian: Poznato je da je rizik od suicidalnih misli ili pokušaja samoubojstva veći u bolesnika koji u anamnezi imaju suicidalne događaje ili u kojih su prije početka liječenja u značajnoj mjeri bile prisutne suicidalne ideje, pa te bolesnike treba pažljivo nadzirati tijekom liječenja.
English: LS mean change from baseline to end of week 4 (SE)
Croatian: Srednja vrijednost promjene (LS) od početka ispitivanja do kraja 4. tjedna (SE)
English: • The steps for SPRAVATO self-administration under direct HCP supervision;
Croatian: • koracima za samostalnu primjenu lijeka SPRAVATO pod izravnim nadzorom zdravstvenog radnika
English: ● ever had slow or fast heartbeats causing shortness of breath, palpitations or chest discomfort,
Croatian: • ako ste ikada imali spore ili brze otkucaje srca koji su uzrokovali nedostatak zraka, osjećaj lupanja srca ili nelagodu u prsnom košu, ošamućenost ili nesvjesticu
English: The need for continued treatment should be reexamined periodically.
Croatian: Potrebno je periodički preispitivati potrebu za nastavkom liječenja.
English: In the flexible dose study TRD3002, at day 28, 67% of the patients randomised to Spravato were on 84 mg.
Croatian: U ispitivanju s primjenom fleksibilne doze TRD3002, 28. dana je 67% bolesnika randomiziranih za liječenje lijekom Spravato primalo dozu od 84 mg.
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:
Croatian: o Vodič za zdravstvene radnike, koji je namijenjen pružanju informacija o rizicima od prolaznih disocijativnih stanja i poremećaja percepcije te zlouporabe lijeka, poremećaja svijesti i povišenja krvnog tlaka, treba sadržavati odgovarajuće informacije o sigurnosti bolesnika, uz naglasak na to da:
English: 56 mg = 2 devices
Croatian: 56 mg = 2 spreja
English: Respiratory depression may occur at high doses following rapid intravenous injection of esketamine or ketamine when used for anaesthesia.
Croatian: Nakon primjene brze intravenske injekcije visokih doza esketamina ili ketamina za anesteziju može nastupiti respiratorna depresija.
English: 84 mg = 3 devices
Croatian: 84 mg = 3 spreja
English: Esketamine is rapidly absorbed by the nasal mucosa following nasal administration and can be measured in plasma within 7 minutes following a 28 mg dose.
Croatian: Nakon nazalne primjene esketamin se brzo apsorbira kroz nosnu sluznicu te se u plazmi može izmjeriti unutar 7 minuta nakon primjene doze od 28 mg.
English: Hepatic enzyme inhibitors
Croatian: Inhibitori jetrenih enzima
English: ● sleep apnoea and are extremely overweight
Croatian: • ako imate apneju u snu i izuzetno prekomjernu tjelesnu težinu
English: Prior to prescribing Spravato, each patient's risk for abuse or misuse should be assessed and patients receiving esketamine should be monitored for the development of behaviours or conditions of abuse or misuse, including drug seeking behaviour, while on therapy.
Croatian: Kod svakog bolesnika treba prije propisivanja lijeka Spravato ocijeniti rizik od zlouporabe ili namjerne pogrešne uporabe lijeka, a bolesnike koji primaju esketamin treba pratiti tijekom liječenja zbog mogućeg razvoja takvih stanja ili ponašanja, uključujući kompulzivno traženje lijeka (engl. drug-seeking).
English: • The influence of SPRAVATO on the patient's ability to drive or operate machinery
Croatian: • utjecaju lijeka SPRAVATO na bolesnikovu sposobnost upravljanja vozilima ili rada sa strojevima
English: Nervous system disorders dizziness, headache, dysgeusia, somnolence, hypoaesthesia mental impairment, tremor, lethargy, dysarthria, paraesthesia, sedation
Croatian: Poremećaji živčanog sustava omaglica, glavobolja, disgeuzija, somnolencija, hipoestezija mentalni poremećaji, tremor, letargija, dizartrija, parestezija, sedacija
English: Stable response
Croatian: Stabilan odgovor
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).
Croatian: Spravato može uzrokovati prolazna povišenja sistoličkog i/ili dijastoličkog krvnog tlaka, koja dosežu vršnu vrijednost približno 40 minuta nakon primjene lijeka i traju približno 1 - 2 sata (vidjeti dio 4.8).
English: Spravato was evaluated in three Phase 3 short-term (4-week) randomised, double-blind, active-controlled studies in patients with TRD.
Croatian: Spravato se ocjenjivao u trima kratkoročnim (4 tjedna), randomiziranim, dvostruko slijepim, aktivnim lijekom kontroliranim ispitivanjima faze 3 provedenima u bolesnika s depresijom rezistentnom na liječenje.
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.
Croatian: Farmakokinetika jedne doze od 56 mg esketamina primijenjenog u obliku spreja za nos bila je slična u ispitanika s alergijskim rinitisom koji su bili izloženi peludi trava i zdravih ispitanika.
English: Both administration and post-administration observation of Spravato should be carried out in an appropriate clinical setting.
Croatian: I primjena lijeka Spravato i promatranje nakon primjene trebaju se provoditi u odgovarajućem kliničkom okruženju.
English: Study TRD3005 (N=137)
Croatian: Ispitivanje TRD3005 (N=137)
English: ● ever had a condition called psychosis - where you believe in things that are not true (delusions)
Croatian: • ako ste ikada imali stanje koje se zove psihoza - kod kojega osoba vjeruje u stvari koje nisu istinite (deluzije) ili vidi, osjeća ili čuje stvari kojih nema (halucinacije)
English: However, intravenously-administered esketamine was devoid of genotoxic properties in an in vivo bone marrow micronucleus test in rats and an in vivo Comet assay in rat liver cells.
Croatian: Međutim, intravenski primijenjen esketamin nije imao genotoksičnih svojstava u mikronukleusnom testu na koštanoj srži štakora in vivo, kao ni u kometnom testu na jetrenim stanicama štakora in vivo.
English: Response and remission rates
Croatian: Stope odgovora i remisije
English: Your blood pressure will be checked before and after using this medicine.
Croatian: Krvni tlak izmjerit će se prije i nakon primjene lijeka.
English: Excipients: Citric acid monohydrate, disodium edetate, sodium hydroxide, water for injections.
Croatian: Pomoćne tvari: citratna kiselina hidrat, dinatrijev edetat, natrijev hidroksid, voda za injekcije.
English: Spravato + Oral AD (N=62)
Croatian: Spravato + oralni AD (N=62)
English: Study TRD3001 (N=342)
Croatian: Ispitivanje TRD3001 (N=342)
English: Close monitoring is required for sedation and respiratory depression.
Croatian: Bolesnike treba pomno nadzirati zbog mogućeg razvoja sedacije i respiratorne depresije.
English: Skin and subcutaneous tissue disorders hyperhidrosis
Croatian: Poremećaji kože i potkožnog tkiva hiperhidroza
English: Each nasal spray device is individually packaged in a sealed blister.
Croatian: Svaki je sprej za nos pojedinačno zapakiran u zatvoren blister.
English: Patients must, therefore, be monitored by a HCP during and after each treatment session including an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting.
Croatian: Stoga zdravstveni radnik mora nadzirati bolesnike tijekom i nakon svakog terapijskog tretmana, što uključuje ocjenu bolesnika kako bi se utvrdilo je li on klinički stabilan i spreman za odlazak iz zdravstvene ustanove.
English: • Requirements for HCP supervision and post-dose observation, until the HCP confirms the patient is clinically stable and is allowed to leave the clinic/facility where SPRAVATO has been administered;
Croatian: • potrebi za nadzorom zdravstvenog radnika i promatranjem nakon primjene, sve dok zdravstveni radnik ne potvrdi da je bolesnik klinički stabilan i da može otići iz klinike/zdravstvene ustanove u kojoj je SPRAVATO primijenjen
English: In an embryo foetal developmental toxicity study with nasally administered ketamine in rabbits, skeletal malformations were observed and foetal body weight was reduced at maternally toxic doses.
Croatian: U ispitivanju toksičnih učinaka nazalno primijenjenog ketamina na embriofetalni razvoj kunića opažene su malformacije skeleta i smanjena tjelesna težina ploda kod primjene doza toksičnih za majku.
English: In study TRD3005, at day 28, 64% of the patients randomised to Spravato were on 84 mg, 25% on 56 mg, and 10% on 28 mg.
Croatian: U ispitivanju TRD3005, 28. dana je 64% bolesnika randomiziranih za liječenje lijekom Spravato primalo dozu od 84 mg, njih 25% primalo je dozu od 56 mg, a njih 10% dozu od 28 mg.
English: 56 mg pack = 2 nasal spray devices 84 mg pack = 3 nasal spray devices
Croatian: Pakiranje od 56 mg = 2 spreja za nos Pakiranje od 84 mg = 3 spreja za nos
English: Table 3: Recommended Dosing for Spravato in Adults of Japanese Ancestry Induction phase
Croatian: Tablica 3: Preporučeno doziranje lijeka Spravato u odraslih bolesnika japanskog podrijetla Faza uvodnog liječenja
English: Spravato is contraindicated in patients for whom an increase in blood pressure or intracranial pressure poses a serious risk (see section 4.3).
Croatian: Spravato je kontraindiciran u bolesnika kod kojih povišenje krvnog ili intrakranijalnog tlaka predstavlja ozbiljan rizik (vidjeti dio 4.3).
English: Spravato is intended to be self-administered by the patient under the direct supervision of a healthcare professional.
Croatian: Spravato je namijenjen za bolesnikovu samostalnu primjenu pod izravnim nadzorom zdravstvenog radnika.
English: There is no clinical experience with esketamine administered as a nasal spray in patients on dialysis.
Croatian: Nema kliničkog iskustva s primjenom esketamina u spreju za nos u bolesnika na dijalizi.