FrancophonIA/ELRC3.0 huggingface dataset:
English: The following information is intended for healthcare professionals only:
Croatian: Informacije u nastavku namijenjene su isključivo zdravstvenim radnicima:
English: ● if you are allergic to esketamine, a similar medicine called ketamine used for anaesthesia, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na esketamin, njemu sličan lijek koji se zove ketamin, a koristi se za anesteziju, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: What Spravato is and what it is used for What you need to know before you use Spravato How to use Spravato
Croatian: Što je Spravato i za što se koristi Što morate znati prije nego počnete primjenjivati Spravato Kako primjenjivati Spravato
English: ● difficulty with your attention, judgment and thinking (see also “Driving and using machines” and “Possible side effects”).
Croatian: • poteškoće s pažnjom, sposobnošću prosuđivanja i razmišljanja (pogledajte i dijelove „Upravljanje vozilima i strojevima“ i „Moguće nuspojave“).
English: 2 green dots (0 mg delivered)
Croatian: 2 zelene točke (isporučeno 0 mg)
English: Within the designated system organ classes, adverse reactions are listed under headings of frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: Unutar pojedinačnih organskih sustava nuspojave su navedene po sljedećim kategorijama učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The safety and efficacy of Spravato in paediatric patients aged 17 years and younger have not been established.
Croatian: Sigurnost i djelotvornost lijeka Spravato u pedijatrijskih bolesnika u dobi od ≤ 17 godina nisu ustanovljene.
English: There is no relevant use of Spravato in children less than 7 years of age in the indication for treatment-resistant depression.
Croatian: Nema relevantne primjene lijeka Spravato u djece mlađe od 7 godina za indikaciju depresije rezistentne na liječenje.
English: ● Spravato is usually used twice a week for the first 4 weeks
Croatian: • Spravato se obično primjenjuje dvaput tjedno tijekom prva 4 tjedna.
English: If your blood pressure is high before using this medicine, your doctor will decide whether to start the medicine or wait until your blood pressure is lower.
Croatian: Ako Vam je krvni tlak visok prije primjene ovog lijeka, liječnik će odlučiti treba li započeti liječenje ovim lijekom ili pričekati dok se krvni tlak ne snizi.
English: ● After this, Spravato is usually used either once a week or once every 2 weeks.
Croatian: • Nakon toga, Spravato se obično primjenjuje ili jedanput tjedno ili jedanput svaka 2 tjedna.
English: Within each pack, each device is individually packaged in a sealed blister.
Croatian: Unutar jednog pakiranja svaki je sprej pojedinačno zapakiran u zatvoreni blister.
English: Other CYP enzymes, including CYP2C19 and CYP2C9, contribute to a much smaller extent.
Croatian: Drugi CYP enzimi, uključujući CYP2C19 i CYP2C9, u puno manjoj mjeri pridonose tom procesu.
English: If not, dispose of device and get a new one.
Croatian: Ako ih ne prikazuje, bacite sprej i uzmite novi.
English: ● ever had problems with drug abuse - prescribed medicines or illegal drugs - or a problem with alcohol
Croatian: • ako ste ikada imali problema sa zlouporabom propisanih lijekova ili ilegalnih droga ili problema s alkoholom
English: ● panic attacks
Croatian: • napadaji panike
English: It is given, together with another antidepressant, if you have tried at least 2 other antidepressant medicines but they have not helped.
Croatian: Ovaj se lijek primjenjuje zajedno s još jednim antidepresivom ako ste već uzimali najmanje 2 druga lijeka protiv depresije, ali Vam oni nisu pomogli.
English: ● Rest in a comfortable position (preferably, semi-reclined) for 5 minutes after each device.
Croatian: • ostane u udobnom položaju (po mogućnosti poluležećem) 5 minuta nakon primjene svakog spreja
English: ● change in perception of time
Croatian: • promjena predodžbe o vremenu
English: ● decreased feeling or sensitivity, including around the mouth area
Croatian: • smanjen osjet ili osjetljivost, uključujući na području oko usta
English: Missed treatment session(s)
Croatian: Propušteni terapijski tretman(i)
English: Both parameters were approximately 40% higher in Japanese subjects, relative to Caucasian subjects.
Croatian: Vrijednosti obaju parametara bile su približno 40% veće u Japanaca nego u bijelaca.
English: Pregnancy Do not use Spravato if you are pregnant.
Croatian: Trudnoća Nemojte uzimati Spravato ako ste trudni.
English: ● problems with thinking
Croatian: • poteškoće s razmišljanjem
English: What you need to know before you use Spravato
Croatian: Što morate znati prije nego počnete primjenjivati Spravato
English: 3 or more Newly initiated oral antidepressant medication initiated at randomisation, n (%) SNRI SSRI Withdrawn from study (for any reason), n/N (%)
Croatian: 3 ili više Novi oralni antidepresiv uveden pri randomizaciji, n (%) SNRI SSRI Povlačenje iz ispitivanja (iz bilo kojeg razloga), n/N (%)
English: Your doctor will decide whether you should use this medicine.
Croatian: Vaš će liječnik odlučiti smijete li primjenjivati ovaj lijek.
English: ● had a serious head injury or serious problems affecting the brain, particularly where there is increased pressure in the brain
Croatian: • ako ste imali ozbiljnu ozljedu glave ili ozbiljne tegobe koje su zahvaćale mozak, osobito ako su bile praćene povišenim tlakom u mozgu
English: Pharmacotherapeutic group: Psychoanaleptics; Other antidepressants, ATC code: N06AX27.
Croatian: Farmakoterapijska skupina: Psihoanaleptici, ostali antidepresivi, ATK oznaka: N06AX27.
English: ● nasal dryness including dry crusts in the nose
Croatian: • suh nos, uključujući suhe kraste u nosu
English: Spravato can make you feel sleepy, dizzy, and have other side effects that can temporarily affect your ability to drive vehicles or use machines and do activities that need you to be completely alert.
Croatian: Spravato može uzrokovati pospanost, omaglicu i druge nuspojave koje mogu privremeno utjecati na Vašu sposobnost upravljanja vozilima i strojevima, kao i poduzimanja aktivnosti koje zahtijevaju potpunu pozornost.
English: You might ask them to read this leaflet.
Croatian: Možete ih zamoliti i da pročitaju ovu uputu o lijeku.
English: Prepare patient
Croatian: Pripremite bolesnika
English: The terminal half-life of esketamine was similar in the elderly and younger adult subjects (see section 4.2).
Croatian: Terminalni poluvijek esketamina bio je sličan u starijih i mlađih odraslih ispitanika (vidjeti dio 4.2).
English: The primary outcome measure to assess the prevention of depressive relapse was measured as time to relapse.
Croatian: Primarna mjera ishoda za ocjenu prevencije relapsa depresije bilo je vrijeme do relapsa.
English: Relapse was defined as a MADRS total score ≥ 22 for 2 consecutive weeks or hospitalisation for worsening depression or any other clinically relevant event indicative of relapse.
Croatian: Relaps se definirao kao ukupan MADRS rezultat ≥ 22 tijekom 2 uzastopna tjedna, hospitalizacija zbog pogoršanja depresije ili bilo koji drugi klinički važan događaj koji ukazuje na relaps.
English: The maintenance phase was of variable duration and continued until the individual patient had a relapse of depressive symptoms or discontinued for any other reason, or the study ended because the required number of relapse events occurred.
Croatian: Faza održavanja bila je varijabilnog trajanja i nastavila se sve dok pojedini bolesnik nije doživio relaps simptoma depresije ili prekinuo liječenje zbog nekog drugog razloga, odnosno dok ispitivanje nije završilo zato što je dosegnut potreban broj relapsa.
English: The main cytochrome P450 (CYP) enzymes responsible for esketamine N-demethylation are CYP2B6 and CYP3A4.
Croatian: Glavni enzimi citokroma P450 (CYP) odgovorni za N-demetilaciju esketamina su CYP2B6 i CYP3A4.
English: ● Check that indicator shows 2 green dots.
Croatian: • Provjerite prikazuje li indikator 2 zelene točke.
English: Treatment-resistant depression - Short-term studies
Croatian: Depresija rezistentna na liječenje - kratkoročna ispitivanja
English: ● ever had a condition called bipolar disorder, or symptoms of mania (where you become very over-active or over excited)
Croatian: • ako ste ikada imali stanje koje se zove bipolarni poremećaj ili simptome manije (kod kojih osoba postane izrazito prekomjerno aktivna ili prekomjerno uzbuđena)
English: Elderly (65 years of age and older)
Croatian: Starije osobe (u dobi od 65 ili više godina)
English: Adverse reactions of sedation (9.1%) and somnolence (18.0%) were primarily mild or moderate in severity, occurred on the day of dosing and resolved spontaneously the same day.
Croatian: Sedacija (9,1%) i somnolencija (18,0%) uglavnom su bile blage ili umjerene težine, javljale su se na dan primjene lijeka i spontano su se povlačile istoga dana.
English: ● decreased feeling or sensitivity in the mouth
Croatian: • smanjen osjet ili osjetljivost u ustima
English: Esketamine is extensively metabolised in the liver.
Croatian: Esketamin se opsežno metabolizira u jetri.
English: Table 5: Primary efficacy results for change in MADRS total score for 4-week clinical trials (ANCOVA BOCF)
Croatian: Tablica 5: Primarni rezultati za djelotvornost u vidu promjene ukupnog MADRS rezultata u 4-tjednim kliničkim ispitivanjima (ANCOVA, BOCF)
English: Remission was defined as a MADRS total score ≤ 12.
Croatian: Remisija se definirala kao ukupan MADRS rezultat ≤ 12.
English: Esketamine exposure increases with dose from 28 mg to 84 mg.
Croatian: Izloženost esketaminu povećava se s povećanjem doze od 28 mg do 84 mg.
English: Allergic rhinitis
Croatian: Alergijski rinitis
English: The recovered radioactivity consisted primarily of esketamine metabolites.
Croatian: Pronađenu radioaktivnost činili su prvenstveno metaboliti esketamina.
English: The mean terminal half-life of esketamine in the plasma of Asian subjects ranged from 7.1 to 8.9 hours and was 6.8 hours in Caucasian subjects.
Croatian: Srednja vrijednost terminalnog poluvijeka esketamina u plazmi ispitanika azijskog podrijetla kretala se u rasponu od 7,1 do 8,9 sati, dok je kod bijelaca iznosila 6,8 sati.
English: What Spravato contains
Croatian: Što Spravato sadrži
English: Clinical symptoms are described as convulsions, cardiac arrhythmias, and respiratory arrest.
Croatian: Klinički simptomi opisani su kao konvulzije, srčane aritmije i zastoj disanja.
English: The degree to which esketamine is bound to plasma proteins is not dependent on hepatic or renal function.
Croatian: Stupanj vezivanja esketamina za proteine u plazmi ne ovisi o jetrenoj ni bubrežnoj funkciji.
English: In the cases of sedation, no symptoms of respiratory distress were observed, and haemodynamic parameters (including vital signs and oxygen saturation) remained within normal ranges.
Croatian: U slučajevima sedacije nisu opaženi simptomi respiratornog distresa, a hemodinamički parametri (uključujući vitalne znakove i zasićenost kisikom) ostali su unutar normalnog raspona.
English: These adverse reactions were reported as transient and self-limited and occurred on the day of dosing.
Croatian: Te su nuspojave prijavljene kao prolazne i samoograničavajuće, a javljale su se na dan primjene lijeka.
English: LS mean difference (95% CI)†
Croatian: Srednja vrijednost razlike (LS) (95% CI)
English: ● Haemodynamically significant valvular heart disease or heart failure (NYHA Class III-IV).
Croatian: • hemodinamički značajnu bolest srčanih zalistaka ili zatajenje srca (NYHA stupnja III - IV)
English: Treatment-resistant depression - Long-term studies
Croatian: Depresija rezistentna na liječenje - dugoročna ispitivanja
English: The following EM should be provided to HCPs (and acknowledgement of receipt recorded):
Croatian: Zdravstvenim radnicima treba dati sljedeće edukacijske materijale (i zabilježiti potvrdu o njihovu primitku):
English: However, the maximum dose of 84 mg should be used with caution in patients with moderate hepatic impairment.
Croatian: Međutim, maksimalnu dozu od 84 mg treba primjenjivati uz oprez u bolesnika s umjerenim oštećenjem jetrene funkcije.
English: ● ever had problems with the blood supply to your brain (such as a stroke)
Croatian: • ako ste ikada imali problema s dotokom krvi u mozak (poput moždanog udara)
English: ● Significant pulmonary insufficiency, including COPD;
Croatian: • značajnu plućnu insuficijenciju, uključujući KOPB
English: Indicator
Croatian: Indikator
English: Instruct the patient to:
Croatian: Recite bolesniku da:
English: ● change in sense of taste
Croatian: • promjena osjeta okusa
English: During and after each use of this medicine, your doctor will check your condition and decide how long to monitor you.
Croatian: Tijekom i nakon svake primjene ovog lijeka liječnik će provjeriti Vaše stanje i odlučiti koliko dugo će Vas nadzirati.
English: If you are able to become pregnant you must use contraception during treatment.
Croatian: Ako ste žena reproduktivne dobi, morate koristiti kontracepciju tijekom liječenja.
English: You will use this medicine under the supervision of your doctor in the doctor's office or clinic.
Croatian: Ovaj ćete lijek primjenjivati pod nadzorom liječnika u liječničkoj ordinaciji ili klinici.
English: Due to expected increase in exposure and lack of clinical experience, Spravato is not recommended in patients with Child-Pugh class C (severe) hepatic impairment.
Croatian: S obzirom na očekivano povećanje izloženosti lijeku i nedostatak kliničkog iskustva, primjena lijeka Spravato ne preporučuje se u bolesnika s oštećenjem jetrene funkcije Child-Pugh stadija C (teško).
English: Effect of other medicinal products on esketamine
Croatian: Učinak drugih lijekova na esketamin
English: Instruct patient to blow nose before first device only.
Croatian: Recite bolesniku da ispuše nos samo prije primjene prvog spreja.
English: Elderly patients treated with Spravato may have a greater risk of falling once mobilised, therefore, these patients should be carefully monitored.
Croatian: Stariji bolesnici liječeni lijekom Spravato mogu biti izloženi većem riziku od pada nakon što se ponovno počnu kretati i stoga te bolesnike treba pažljivo nadzirati.
English: Do not use Spravato
Croatian: Nemojte primjenjivati Spravato
English: The primary metabolic pathway of esketamine in human liver microsomes is N-demethylation to form noresketamine.
Croatian: Primarni metabolički put esketamina u ljudskim jetrenim mikrosomima je N-demetilacija kojom nastaje noresketamin.
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%).
Croatian: Najčešće opažene nuspojave u bolesnika s depresijom rezistentnom na liječenje koji su primali Spravato bile su omaglica (30%), mučnina (27%), disocijacija (26%), glavobolja (24%), somnolencija (18%), vrtoglavica (18%), disgeuzija (17%), hipoestezija (11%) i povraćanje (10%).
English: These patients should be carefully assessed before prescribing Spravato and treatment initiated only if the benefit outweighs the risk:
Croatian: Te bolesnike treba pažljivo ocijeniti prije propisivanja lijeka Spravato, a liječenje započeti samo ako korist nadmašuje rizik:
English: At the end of the open label induction phase, 52% of patients were in remission (MADRS total score ≤ 12) and 66% of patients were responders (≥ 50% improvement in MADRS total score).
Croatian: Na kraju otvorene faze uvodnog liječenja 52% bolesnika bilo je u remisiji (ukupan MADRS rezultat ≤ 12), dok je njih 66% odgovorilo na liječenje (poboljšanje ukupnog MADRS rezultata za ≥ 50%).
English: Management of Spravato overdose should consist of treating clinical symptoms and relevant monitoring.
Croatian: Liječenje predoziranja lijekom Spravato treba uključivati liječenje kliničkih simptoma i odgovarajuće praćenje.
English: Noresketamine is subsequently metabolised via CYP-dependent pathways to other metabolites, some of which undergo glucuronidation.
Croatian: Noresketamin se potom putevima ovisnima o CYP enzimima metabolizira u druge metabolite, od kojih neki prolaze glukuronidaciju.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Spravato in the treatment of major depressive disorder in one or more subsets of the paediatric population (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Spravato u jednoj ili više podskupina pedijatrijske populacije za liječenje velikog depresivnog poremećaja (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The dose recommendations for Spravato are shown in Table 1 and Table 2 (adults ≥65 years).
Croatian: Preporučene doze lijeka Spravato navedene su u Tablici 1 i Tablici 2 (odrasli u dobi od ≥ 65 godina).
English: Neuropsychiatric and motor impairments
Croatian: Neuropsihijatrijski i motorički poremećaji
English: During and after each use of this medicine, your doctor will check you and decide how long to monitor you.
Croatian: Tijekom i nakon svake primjene ovog lijeka liječnik će Vas pregledati i odlučiti koliko će Vas dugo nadzirati.
English: Do not use this medicine after the expiry date which is stated on the carton and the label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici.
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).
Croatian: Prije primjene lijeka Spravato bolesnicima treba reći da ne poduzimaju potencijalno opasne aktivnosti koje zahtijevaju potpunu mentalnu budnost i motoričku koordinaciju, poput upravljanja vozilima ili rada sa strojevima, sve do sljedećega dana nakon što se dobro naspavaju (vidjeti dio 4.4).
English: One spray delivered
Croatian: Isporučen je jedan potisak
English: ● Nose rest should touch the skin between the nostrils.
Croatian: • graničnik za nos treba dodirivati kožu između nosnica
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
Croatian: • ako ste ikada imali određena stanja kao što su: aneurizma (slaba točka u stijenci krvne žile u kojoj dolazi do proširenja ili ispupčenja) krvarenje u mozgu
English: If you see a green dot, have patient spray again into the second nostril.
Croatian: Ako vidite zelenu točku, recite bolesniku da ponovno primijeni lijek u drugu nosnicu.
English: There is no specific antidote for esketamine overdose.
Croatian: Nema specifičnog antidota za predoziranje esketaminom.
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.
Croatian: Ako žena zatrudni tijekom liječenja lijekom Spravato, liječenje treba prekinuti, a bolesnicu upoznati s mogućim rizicima za plod i kliničkim/terapijskim mogućnostima što je prije moguće.
English: ● Insert tip straight into the first nostril.
Croatian: • stavi vrh spreja ravno u prvu nosnicu
English: ● History of brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure.
Croatian: • ozljeda mozga, hipertenzivna encefalopatija, intratekalna terapija uz ventrikularni šant ili bilo koje drugo stanje povezano s povišenim intrakranijalnim tlakom u anamnezi
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).
Croatian: Vrijeme do postizanja maksimalne plazmatske koncentracije lijeka (tmax) obično iznosi 20 - 40 minuta nakon posljednjeg potiska primijenjenog u pojedinom terapijskom tretmanu (vidjeti dio 4.2).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Spravato therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje / suzdržati se od liječenja lijekom Spravato, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
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.
Croatian: Nakon što je nazalno primijenjen esketamin dosegnuo Cmax, njegova je plazmatska koncentracija tijekom prvih nekoliko sati opadala brzo, a zatim postupnije.
English: Prior to the launch of SPRAVATO in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials (EM) and the controlled access programme (CAP), including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Croatian: Prije stavljanja lijeka SPRAVATO na tržište nositelj odobrenja za stavljanje lijeka u promet mora u svakoj državi članici s nacionalnim nadležnim tijelom dogovoriti sadržaj i oblik edukacijskih materijala i programa kontroliranog pristupa lijeku, uključujući komunikacijske medije, način distribucije i sve druge aspekte programa.
English: ● Take device from patient.
Croatian: • Uzmite sprej od bolesnika.
English: Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Croatian: Bolesnike (i njihove njegovatelje) treba upozoriti da pripaze na bilo kakvo kliničko pogoršanje, suicidalno ponašanje ili misli te neuobičajene promjene ponašanja i uputiti ih da u slučaju pojave tih simptoma odmah potraže liječničku pomoć.
English: A similar risk with esketamine cannot be excluded.
Croatian: Ne može se isključiti sličan rizik kod primjene esketamina.
English: This medicine may cause a temporary increase in your blood pressure after taking a dose.
Croatian: Ovaj lijek može privremeno povisiti krvni tlak nakon uzimanja doze.
English: Animal studies have shown that ketamine, the racemic mixture of arketamine and esketamine, induces neurotoxicity in developing foetuses (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da ketamin (racemična smjesa arketamina i esketamina) uzrokuje neurotoksičnost kod ploda u razvoju (vidjeti dio 5.3).
English: During the maintenance phase, Spravato dosing should be individualised to the lowest frequency to maintain remission/response.
Croatian: Tijekom faze održavanja doziranje lijeka Spravato treba individualno prilagoditi do najmanje učestalosti primjene koja je potrebna za održavanje remisije/odgovora.
English: Spravato is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Primjena lijeka Spravato ne preporučuje se u trudnica ni žena reproduktivne dobi koje ne koriste kontracepciju.
English: ● Peel blister and remove device.
Croatian: • Otvorite blister i izvadite sprej.
English: Spravato is available in pack sizes containing 1, 2, 3, or 6 nasal spray devices.
Croatian: Spravato je dostupan u pakiranjima koja sadrže 1, 2, 3 ili 6 sprejeva za nos.
English: Other medicines and Spravato Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.