FrancophonIA/ELRC3.0 huggingface dataset:
English: This belongs to a group of medicines called anti-depressants and you have been given this medicine to treat your depression.
Slovenian: Sodi v skupino zdravil, ki jih imenujemo antidepresivi in to zdravilo prejemate za zdravljenje depresije.
English: Other related terms included derealisation (1.9%), depersonalisation (1.7%), illusions (1.5%), and distortion of time (1.2%).
Slovenian: Podobna stanja so med drugimi opisovali tudi z izrazi, kot so derealizacija (1,9%), depersonalizacija (1,7%), iluzije (1,5%) in izkrivljeno zaznavanje časa (1,2%).
English: ● pain when urinating or seeing blood in your urine - these could be signs of bladder problems.
Slovenian: ● bolečine pri uriniranju ali prisotnost krvi v urinu - to so lahko znaki težav s sečnim mehurjem.
English: ● panic attacks
Slovenian: ● napadi panike
English: Depression getting worse
Slovenian: Poslabšanje depresije
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).
Slovenian: V okviru posameznega organskega sistema so neželeni učinki razvrščeni po kategorijah pogostnosti v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: Sedation/somnolence
Slovenian: Sedacija/somnolenca
English: Pharmacotherapeutic group: Psychoanaleptics; Other antidepressants, ATC code: N06AX27.
Slovenian: Farmakoterapevtska skupina: psihoanaleptiki, drugi antidepresivi, oznaka ATC: N06AX27.
English: ● Presence or history of mania or bipolar disorder;
Slovenian: ● prisotnost ali anamneza manije ali bipolarne motnje;
English: The need for continued treatment should be reexamined periodically.
Slovenian: Občasno je treba ponovno oceniti potrebo po nadaljnjem zdravljenju.
English: Tell your doctor or go to the nearest hospital straight away if you have thoughts of harming or killing yourself at any time.
Slovenian: Takoj obvestite zdravnika ali pojdite v najbližjo bolnišnico, če vam kadar koli pride na misel oziroma razmišljate o tem, da bi se poškodovali ali da bi si vzeli življenje.
English: Patients on dialysis were not studied.
Slovenian: Bolnikov na dializnem zdravljenju niso proučevali.
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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Spravato pri zdravljenju velike depresivne motnje za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: TRD3005 (≥ 65 years)
Slovenian: TRD3005 (≥ 65 let)
English: What Spravato is and what it is used for
Slovenian: Kaj je zdravilo Spravato in za kaj ga uporabljamo
English: Effect of esketamine on other medicinal products
Slovenian: Vpliv esketamina na druga zdravila
English: ● had a serious head injury or serious problems affecting the brain, particularly where there is increased pressure in the brain
Slovenian: ● ste imeli kdaj resno poškodbo glave ali resne težave s prizadetostjo možganov, zlasti v povezavi z zvišanim tlakom v možganih
English: ● feeling very sleepy with low energy
Slovenian: ● občutek močne zaspanosti s pomanjkanjem energije
English: These effects did not increase over time and were reversible after discontinuing ketamine.
Slovenian: Ti učinki se sčasoma niso okrepili in so po prekinitvi uporabe ketamina izzveneli.
English: You might ask them to read this leaflet.
Slovenian: Lahko ga prosite, da prebere to Navodilo za uporabo.
English: If not, dispose of device and get a new one.
Slovenian: V nasprotnem primeru zavrzite pršilnik in vzemite novega.
English: Hepatotoxicity has been reported with chronic ketamine use, therefore, the potential for such an effect due to long-term use of Spravato cannot be excluded.
Slovenian: Pri kronični uporabi ketamina so poročali o hepatotoksičnem delovanju, zato ni mogoče izključiti možnosti takega delovanja pri dolgotrajni uporabi zdravila Spravato.
English: ● Repeat Step 4 to deliver second spray.
Slovenian: ● naj ponovi 4. korak, da si odmeri drugi vpih.
English: Both parameters were approximately 40% higher in Japanese subjects, relative to Caucasian subjects.
Slovenian: Pri Japoncih sta bila oba parametra za približno 40% višja kot pri belcih.
English: You may find it helpful to talk to a relative or a close friend if you are depressed and ask them if they think your depression is getting worse or if they are worried about your behaviour.
Slovenian: Če ste depresivni, vam morda lahko pomaga, če se pogovorite s sorodnikom ali dobrim prijateljem in ga vprašate, ali se mu zdi, da je pri vas prišlo do poslabšanja depresije, oziroma je zaskrbljen zaradi vašega vedenja.
English: ● ever had a condition called bipolar disorder, or symptoms of mania (where you become very over-active or over excited)
Slovenian: ● ste imeli kdaj bolezen, ki jo imenujemo bipolarna motnja, ali simptome manije (pri kateri postanete prekomerno aktivni ali pretirano vznemirjeni in vzneseni)
English: ● Rest in a comfortable position (preferably, semi-reclined) for 5 minutes after each device.
Slovenian: ● naj počiva v udobnem položaju (če se le da v polsedečem) 5 minut po uporabi vsakega pršilnika.
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.
Slovenian: Bolnike (in njihove skrbnike) je treba opozoriti, naj bodo pozorni na kakršnokoli klinično poslabšanje, samomorilno vedenje ali samomorilne misli in neobičajne spremembe vedenja ter naj se ob pojavu teh simptomov, takoj posvetujejo z zdravnikom.
English: The degree to which esketamine is bound to plasma proteins is not dependent on hepatic or renal function.
Slovenian: Obseg vezave esketamina na beljakovine v plazmi ni odvisen od jetrne ali ledvične funkcije.
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.
Slovenian: Povprečni končni razpolovni čas izločanja esketamina iz plazme je bil pri Azijcih od 7,1 do 8,9 ur, pri belcih pa 6,8 ur.
English: Remission was defined as a MADRS total score ≤ 12.
Slovenian: Remisija je bila opredeljena kot skupna ocena MADRS ≤ 12.
English: What you need to know before you use Spravato
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Spravato
English: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 oseb)
English: ● Patients with uncontrolled brady- or tachyarrhythmias that lead to haemodynamic instability;
Slovenian: ● bolniki z neobvladano bradiaritmijo ali tahiaritmijo, ki povzroča hemodinamsko nestabilnost;
English: ● ever had problems with drug abuse - prescribed medicines or illegal drugs - or a problem with alcohol
Slovenian: ● ste imeli kdaj težave z zlorabo substanc - zdravil na zdravniški recept ali prepovedanih drog ali težave z alkoholom
English: It is unknown whether esketamine is excreted in human milk.
Slovenian: Ni znano, ali se esketamin izloča v materino mleko.
English: Dose adjustments should be made based on efficacy and tolerability to the previous dose.
Slovenian: Odmerek je mogoče prilagajati na osnovi učinkovitosti in prenašanja predhodnega odmerka.
English: This risk persists until significant remission occurs, therefore, patients should be closely monitored.
Slovenian: To tveganje je prisotno, dokler ne pride do pomembnega izboljšanja oziroma remisije, zato je bolnike treba skrbno spremljati.
English: • Monitoring of blood pressure before and after SPRAVATO dosing;
Slovenian: • spremljanja krvnega tlaka pred odmerjanjem zdravila SPRAVATO in po njem;
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.
Slovenian: Relaps je bil opredeljen kot skupna ocena MADRS ≥ 22 v obdobju dveh zaporednih tednov ali hospitalizacija zaradi poslabšanja depresije ali katerikoli drug klinično pomemben dogodek, ki pomeni relaps.
English: The following EM should be provided to HCPs (and acknowledgement of receipt recorded):
Slovenian: Zdravstveni delavci morajo prejeti naslednja izobraževalna gradiva (in zabeležiti potrditev prejema gradiva):
English: Treatment-resistant depression - Short-term studies
Slovenian: Na zdravljenje neodzivna depresija - kratkoročne študije
English: ● change in perception of time
Slovenian: ● spremenjeno zaznavanje časa
English: The terminal half-life of esketamine was similar in the elderly and younger adult subjects (see section 4.2).
Slovenian: Končni razpolovni čas esketamina je bil pri starejših in mlajših odraslih osebah podoben (glejte poglavje 4.2).
English: If you use too much Spravato, you are more likely to get side effects (see “Possible side effects”).
Slovenian: Če uporabite preveč zdravila Spravato, bo z večjo verjetnostjo prišlo do neželenih učinkov (glejte poglavje “Možni neželeni učinki”).
English: Treatment-resistant depression - Long-term studies
Slovenian: Na zdravljenje neodzivna depresija - dolgoročne študije
English: Data in animals have shown excretion of esketamine in milk.
Slovenian: Podatki pri živalih kažejo na izločanje esketamina v mleko.
English: You will use the Spravato nasal spray yourself - under the supervision of your doctor or other healthcare professional in a healthcare setting, such as, the doctor's office or clinic.
Slovenian: Zdravilo Spravato pršilo za nos boste uporabljali sami - pod nadzorom zdravnika ali drugega zdravstvenega delavca v zdravstveni ustanovi, kot je zdravnikova ordinacija ali ambulanta.
English: Instruct the patient to:
Slovenian: Bolniku naročite:
English: If you stop using Spravato
Slovenian: Če ste prenehali uporabljati zdravilo Spravato
English: ● Check indicator again to confirm device is empty.
Slovenian: ● Ponovno preglejte indikator in se prepričajte, da je pršilnik prazen.
English: ● History of brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure.
Slovenian: ● anamneza možganske poškodbe, hipertenzivne encefalopatije, intratekalnega zdravljenja z vzpostavljenimi ventrikularnimi spoji (ventricular shunts) ali katerokoli drugo stanje, ki je povezano z zvišanim intrakranialnim tlakom.
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.
Slovenian: Neželeni učinki, ki obsegajo sedacijo (9,1%) in somnolenco (18,0%), so bili večinoma blagi do zmerni, pojavili so se na dan odmerjanja in spontano izzveneli istega dne.
English: Relapse-prevention study
Slovenian: Študija preprečevanja relapsa
English: The guide for patients also aims at increasing awareness about:
Slovenian: • Vodnik za bolnika je namenjen tudi izboljšanju poznavanja:
English: It is important to make sure you come in for your scheduled appointments, so that this medicine is effective for you.
Slovenian: Pomembno je, da zagotovo pridete na vsak obisk za prejem zdravila po razporedu, da bo zdravilo pri vas lahko učinkovito.
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.
Slovenian: Odločiti se je treba, ali je bolje prekiniti z dojenjem ali prekiniti zdravljenje z zdravilom Spravato oziroma se mu odpovedati, in pri tem upoštevati koristi dojenja za otroka in koristi zdravljenja za žensko.
English: ● Haemodynamically significant valvular heart disease or heart failure (NYHA Class III-IV).
Slovenian: ● hemodinamsko pomembna bolezen srčnih zaklopk ali srčno popuščanje (stopnje III-IV po klasifikaciji NYHA).
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.
Slovenian: V primerih sedacije niso opažali simptomov dihalne stiske, hemodinamski parametri (ki vključujejo vitalne znake in saturacijo krvi s kisikom) pa so ostali v okviru normalnih vrednosti.
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.
Slovenian: Pred predpisovanjem zdravila Spravato je treba pri vsakem bolniku oceniti tveganje za zlorabo ali nepravilno uporabo, bolnike, ki prejemajo esketamin, pa je treba v času zdravljenja spremljati glede razvoja vedenjskih vzorcev oziroma stanj, ki pomenijo zlorabo ali nepravilno uporabo, vključno z vedenjem, ki je usmerjeno v iskanje droge.
English: If you see a green dot, have patient spray again into the second nostril.
Slovenian: Če vidite zeleno piko, naročite bolniku, naj si ponovno odmeri vpih v drugo nosnico.
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.
Slovenian: Zaradi predvidenega povečanja izpostavljenosti zdravilu in pomanjkanja kliničnih izkušenj uporaba zdravila Spravato ni priporočena pri bolnikih z okvaro jeter Child-Pugh razreda C (huda okvara).
English: How much to use
Slovenian: Koliko zdravila je treba uporabiti
English: Sedative effects typically resolved by 1.5 hours post-dose.
Slovenian: Sedativni učinki so praviloma izzveneli v 1,5 ure po odmerjanju.
English: Your doctor will decide whether you should use this medicine.
Slovenian: Zdravnik bo odločil, ali smete uporabljati to zdravilo ali ne.
English: Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of Spravato.
Slovenian: Pri osebah z anamnezo zlorabe drog ali zdravil ali odvisnosti od zdravil lahko obstaja povečano tveganje za zlorabo ali nepravilno uporabo zdravila Spravato.
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.
Slovenian: Vzdrževalna faza je trajala različno dolgo, in sicer dokler pri posamezniku ni prišlo do ponovitve simptomov depresije ali do prekinitve zdravljenja iz katerega koli drugega razloga oziroma dokler niso študije zaključili, ker se je dopolnilo zahtevano število dogodkov, ki pomenijo relaps.
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.
Slovenian: Zdravilo Spravato lahko zviša krvni tlak za približno 1 do 2 uri po tem, ko ga uporabite, zato vam bodo izmerili krvni tlak pred začetkom uporabe in po uporabi zdravila Spravato.
English: Exposure in rabbits was in the region of human exposure based on AUC values.
Slovenian: Pri kuncih je bila izpostavljenost zdravilu v območju izpostavljenosti pri ljudeh na osnovi vrednosti AUC.
English: • The procedure for SPRAVATO intranasal administration, including preparation (fasting for 2 hours, no drinking for 30 minutes) and patient's monitoring;
Slovenian: • postopek intranazalne uporabe zdravila SPRAVATO, vključno s pripravo (prenehanje uživanja hrane 2 uri pred uporabo in pitja pijač 30 minut pred uporabo) in spremljanjem bolnika.
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).
Slovenian: Pred prihodom zdravila SPRAVATO na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom (imetnik DzP) s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnih gradiv in programa nadzorovanega dostopa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi drugimi vidiki programa.
English: Patient sprays once into each nostril
Slovenian: Bolnik sproži po en vpih v vsako nosnico
English: Spravato is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Spravato ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: ● ever had an overactive thyroid that is not properly treated (hyperthyroidism)
Slovenian: ● ste imeli kdaj prekomerno delovanje ščitnice, ki ni bilo ustrezno urejeno (hipertiroidizem)
English: ● feeling extremely happy (“euphoria”)
Slovenian: ● občutek izjemne veselosti in dobrega počutja (“evforija”)
English: Spravato is available in pack sizes containing 1, 2, 3, or 6 nasal spray devices.
Slovenian: Zdravilo Spravato je na voljo v pakiranjih, ki vsebujejo 1, 2, 3 ali 6 nosnih pršilnikov.
English: Spravato contains esketamine and may be subject to abuse and diversion.
Slovenian: Zdravilo Spravato vsebuje esketamin in bi bil lahko predmet zlorabe in preprodaje.
English: Pack sizes of 1, 2, 3, or 6 nasal spray devices.
Slovenian: Velikosti pakiranj: 1, 2, 3 ali 6 nosnih pršilnikov.
English: ● ever had problems with the blood supply to your brain (such as a stroke)
Slovenian: ● ste imeli kdaj težave z oskrbo možganov s krvjo (kot je možganska kap)
English: Esketamine is not a substrate of transporters P-glycoprotein (P-gp; multidrug resistance protein 1), breast cancer resistance protein (BCRP), or organic anion transporter (OATP) 1B1, or OATP1B3.
Slovenian: Esketamin ni substrat prenašalcev P-glikoproteina (P-gp; protein multiple rezistence proti zdravilom 1 ali protein MDR1), proteina pri odpornosti pri raku dojke (BCRP - breast cancer resistance protein), ali prenašalcev organskih anionov (OATP - organic anion transporter) OATP 1B1 ali OATP1B3.
English: Effect of other medicinal products on esketamine
Slovenian: Vpliv drugih zdravil na esketamin
English: Exposure numbers were influenced by the study stopping at a pre-determined number of relapses based on the interim analysis.
Slovenian: Na številke, ki opisujejo izpostavljenost zdravilu, je vplivala prekinitev študije ob vnaprej določenem številu relapsov na osnovi vmesne analize.
English: ● Hypersensitivity to the active substance, ketamine, or to any of the excipients listed in section 6.1
Slovenian: ● Preobčutljivost na učinkovino, ketamin ali ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Your doctor will discuss with you whether to stop breast-feeding or stop using this medicine.
Slovenian: Z zdravnikom se boste pogovorili, ali bi bilo bolje prenehati z dojenjem ali z uporabo tega zdravila.
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).
Slovenian: Na koncu odprte uvajalne faze je bilo 52% bolnikov v remisiji (s skupno oceno MADRS ≤ 12), 66% bolnikov pa je bilo odzivnih (z ≥ 50-odstotnim izboljšanjem skupne ocene MADRS).
English: It is a non-selective, non-competitive, antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.
Slovenian: Esketamin je neselektiven in nekompetitiven antagonist receptorjev N-metil-D-aspartata (receptorjev NMDA), ki so ionotropni glutamatni receptorji.
English: Close monitoring is required for sedation and respiratory depression.
Slovenian: Bolnike je treba skrbno spremljati glede sedacije in depresije dihanja.
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.
Slovenian: Zaradi uporabe zdravila Spravato lahko postanete zaspani, omotični in imate druge neželene učinke, ki lahko začasno zmanjšajo vašo sposobnost vožnje in upravljanja strojev ter izvajanje dejavnosti, pri katerih morate biti popolnoma prisebni.
English: The primary outcome measure to assess the prevention of depressive relapse was measured as time to relapse.
Slovenian: Primarno merilo izida za oceno uspešnosti preprečevanja ponovitve depresije je bil čas do relapsa.
English: ● frequent need to pass urine
Slovenian: ● pogosta potreba po uriniranju
English: It is recommended to maintain the dose the patient receives at the end of the induction phase in the maintenance phase.
Slovenian: Priporočeno je, da bolnik v vzdrževalni fazi zdravljenja začne prejemati enak odmerek, kot ga je prejemal na koncu uvajalne faze.
English: If blood pressure remains elevated for a prolonged period of time, assistance should promptly be sought from practitioners experienced in blood pressure management.
Slovenian: Če krvni tlak ostane zvišan dalj časa, je treba nemudoma zaprositi za pomoč zdravnika z izkušnjami pri nadzorovanju krvnega tlaka.
English: Elderly patients treated with Spravato may have a greater risk of falling once mobilised, therefore, these patients should be carefully monitored.
Slovenian: Pri starejših bolnikih, ki prejemajo zdravilo Spravato, obstaja večja nevarnost padca, ko se po odmerjanju začno premikati, zato je treba te bolnike res pozorno spremljati.
English: Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes.
Slovenian: Med zdravljenjem je potreben skrben nadzor bolnikov, posebno tistih s povečanim tveganjem in zlasti v začetnem obdobju zdravljenja ter pri spremembah odmerka.
English: 3 or more Newly initiated oral antidepressant medication initiated at randomisation, n (%) SNRI SSRI Withdrawn from study (for any reason), n/N (%)
Slovenian: 3 ali več novo uveden peroralni antidepresiv (uveden ob randomizaciji), n (%) SNRI SSRI izstop iz študije (iz kateregakoli razloga), n/N
English: If you are able to become pregnant you must use contraception during treatment.
Slovenian: Če ste v rodni dobi in bi lahko zanosili, morate med zdravljenjem uporabljati kontracepcijo.
English: Spravato is used in adults to reduce the symptoms of depression, such as, feeling sad, anxious, or worthless, sleeping difficulties, change in appetite, loss of interest in favourite activities, feeling of being slowed down.
Slovenian: Zdravilo Spravato uporabljamo pri odraslih za zmanjševanje simptomov depresije, kot so občutek žalosti, tesnoba ali občutek ničvrednosti, težave s spanjem, sprememba apetita, izguba zanimanja za najljubše dejavnosti in občutek upočasnjenosti.
English: Esketamine does not inhibit these transporters or multi-drug and toxin extrusion 1 (MATE1) and MATE2-K, or organic cation transporter 2 (OCT2), OAT1, or OAT3.
Slovenian: Esketamin ne zavira niti navedenih prenašalcev niti prenašalcev za ekstruzijo več zdravil in toksinov 1 (MATE1) in MATE2-K oziroma prenašalcev organskih kationov 2 (OCT2), OAT1 ali OAT3.