FrancophonIA/ELRC3.0 huggingface dataset:
English: After you have been given Dexdor you must not drive, operate machinery, or work in dangerous situations until the effects are completely gone.
Slovenian: Po prejemu zdravila Dexdor ne smete voziti, upravljati strojev ali delati v nevarnih okoliščinah, dokler učinki ne izginejo popolnoma.
English: In healthy volunteers it exhibits a rapid distribution phase with a central estimate of the distribution half-life (t1/2α) of about 6 minutes.
Slovenian: Pri zdravih prostovoljcih ima hitro porazdelitveno fazo s centralno ocenjenim razpolovnim časom (t1/2α) približno 6 minut.
English: Ampoules and vials are intended for single patient use only.
Slovenian: Ampule in viale so namenjene za uporabo pri samo enem bolniku.
English: - if you have some disorders of heart rhythm (heart block grade 2 or 3).
Slovenian: - če imate katero od motenj srčnega ritma (srčni blok 2. ali 3. stopnje),
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 September 2011
Slovenian: Datum prve odobritve: 16. september 2011
English: No major pharmacokinetic differences have been observed based on gender or age.
Slovenian: Doslej niso opazili nikakršnih večjih farmakokinetičnih razlik glede na spol ali starost.
English: The oxygen saturation should be monitored by pulse oximetry.
Slovenian: Nasičenost s kisikom je treba nadzorovati s pulzno oksimetrijo.
English: Elderly patients appear to have an increased risk for hypotension (see section 4.4) but the limited data available from procedural sedation do not suggest a clear dose dependency.
Slovenian: Zdi se, da imajo starejši bolniki povečano tveganje za hipotenzijo (glejte poglavje 4.4), vendar omejeni podatki, ki so na voljo pri proceduralni sedaciji, ne kažejo nedvoumne odvisnosti od odmerka.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, 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).
Slovenian: Neželeni učinki so razvrščeni v naslednje kategorije pogostnosti (najprej so podani najpogostejši) na podlagi naslednjega dogovora: 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).
English: The event was reported as mild in 1 and moderate in 3 cases.
Slovenian: V 1 primeru so poročali kot o blagem dogodku in v 3 primerih kot o zmernem dogodku.
English: After dose adjustment, a new steady state sedation level may not be reached for up to one hour.
Slovenian: Po prilagoditvi odmerka morda nove stopnje sedacije v ravnovesnem stanju ne boste dosegli prej kot v eni uri.
English: Plasma protein binding is constant over the concentration range of 0.85 to 85 ng/ml.
Slovenian: Njegova stopnja vezave na plazemske beljakovine je konstantna v razponu koncentracij od 0,85 do 85 ng/ml.
English: Depending on the procedure concomitant local anaesthesia or analgesia may be needed in order to achieve the desired clinical effect.
Slovenian: Odvisno od posega sta morda potrebni sočasna lokalna anestezija ali analgezija, da se doseže želeni klinični učinek.
English: After sedation/wake-up
Slovenian: Po sedaciji/zbujanju
English: No dose adjustment is normally required for elderly patients (see section 5.2).
Slovenian: Pri starejših bolnikih običajno ni potrebna nikakršna prilagoditev odmerka (glejte poglavje 5.2).
English: If not used immediately, in-use storage times and conditions prior to the use are the responsibility of the user and would not normally be longer than 24 hours at 2° to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, je za čas shranjevanja med uporabo in pogoje shranjevanja pred uporabo odgovoren sam uporabnik in običajno naj ne bi presegli 24 ur pri temperaturi med 2 °C in 8 °C, razen če je redčenje potekalo v nadzorovanih in validiranih aseptičnih pogojih.
English: These metabolites have negligible pharmacological activity.
Slovenian: Ti presnovki imajo zanemarljivo farmakološko delovanje.
English: Before you have this medicine, tell your doctor or nurse if any of the following apply as Dexdor should be used cautiously:
Slovenian: Preden prejmete to zdravilo, povejte svojemu zdravniku ali medicinski sestri, če za vas velja karkoli od naštetega, ker bo treba v tem primeru zdravilo Dexdor uporabljati bolj previdno:
English: When used in an outpatient setting close monitoring should continue for at least one hour (or longer based on the patient condition), with medical supervision continued for at least one further hour to ensure the safety of the patient.
Slovenian: Če se zdravilo uporablja v ambulantah, je treba natančno spremljanje bolnika podaljšati za vsaj še eno uro (ali več, odvisno od bolnikovega stanja), pri čemer je bolnik pod zdravniškim nadzorom vsaj še eno dodatno uro, da se zagotovi varnost bolnika.
English: At high concentration hypertension may be more prominent than hypotension.
Slovenian: Pri visokih koncentracijah lahko postane hipertenzija bolj izrazita od hipotenzije.
English: Mean (95% CI)
Slovenian: Povprečne vrednosti (95% IZ)
English: Compatibility studies have shown potential for adsorption of dexmedetomidine to some types of natural rubber.
Slovenian: Študije kompatibilnosti so pokazale možnost adsorpcije deksmedetomidina na nekatere vrste naravne gume.
English: If you have been given more Dexdor than you should
Slovenian: Če ste prejeli večji odmerek zdravila Dexdor, kot bi smeli
English: Patients with neurological disorders
Slovenian: Bolniki z nevrološkimi boleznimi
English: Lifepharma (ZAM) Ltd Τηλ.
Slovenian: Lifepharma (ZAM) Ltd
English: Patients could be successfully extubated without stopping the Dexdor infusion.
Slovenian: Bolnike je bilo mogoče uspešno ekstubirati, ne da bi jim morali ustaviti infuzijo zdravila Dexdor.
English: The maximum dose of 1.4 micrograms/kg/h should not be exceeded.
Slovenian: Največjega odmerka 1,4 mikrogramov/kg/h ne smete preseči.
English: The concentrate is a clear, colourless solution.
Slovenian: Koncentrat je bistra in brezbarvna raztopina.
English: During procedural sedation a small bolus of another sedative may be used if a rapid increase in sedation level is required.
Slovenian: Med sedacijo pri ohranjeni zavesti se lahko uporabi majhen bolusni odmerek drugega sedativa, če je potrebno hitro povišanje stopnje sedacije.
English: If you are given too much Dexdor, your blood pressure may go up or down, your heartbeat may slow down, you may breathe more slowly and you may feel more drowsy.
Slovenian: Če prejmete preveč zdravila Dexdor, vam bo morda krvni tlak narasel ali padel, srčni utrip se vam lahko upočasni, morda boste počasneje dihali in morda se boste počutili bolj zaspano.
English: Children > 1 month post-natal, predominantly post-operative, have been evaluated for treatment up to 24 hours in the ICU and demonstrated a similar safety profile as in adults.
Slovenian: Pri otrocih > 1 mesec po rojstvu, predvsem pri postoperativnih, so ocenili zdravljenje do 24 ur na oddelkih za intenzivno nego in dokazali podoben varnostni profil kot pri odraslih.
English: Approximately 50% of patients treated with dexmedetomidine did not require rescue addition of midazolam during a median treatment period of 20.3 hours, not exceeding 24 hours.
Slovenian: Približno 50 % bolnikov, zdravljenih z deksmedetomidinom, ni potrebovalo dodatka rešilnega midazolama med medianim obdobjem zdravljenja 20,3 ure, ki ni preseglo 24 ur.
English: What Dexdor is and what it is used for What you need to know before you are given Dexdor How to use Dexdor
Slovenian: Kaj je zdravilo Dexdor in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Dexdor Kako uporabljati zdravilo Dexdor
English: It has a sympatholytic effect through decrease of the release of noradrenaline in sympathetic nerve endings.
Slovenian: Ima simpatikolitično delovanje, saj zmanjšuje sproščanje noradrenalina iz simpatičnih živčnih končičev.
English: The pharmacokinetic distribution half -life of Dexdor has been estimated to be around 6 min, which can be taken into consideration, together with the effects of other administered medications, when assessing the appropriate time needed for titration to desired clinical effect of Dexdor.
Slovenian: Ocenjeno je, da je razpolovna doba porazdelitve zdravila Dexdor približno 6 min, kar lahko skupaj z učinki drugih uporabljenih zdravil upoštevamo pri oceni ustreznega časa titracije zdravila Dexdor, potrebnega za dosego želenega kliničnega učinka.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Vascular disorders: Very common: Hypotension1,2, hypertension1,2
Slovenian: Žilne bolezni: Zelo pogosti: hipotenzija1,2, hipertenzija1,2
English: Data on the effects of Dexdor in patients with heart rate <60 are very limited and particular care should be taken with such patients.
Slovenian: Podatki o učinkih zdravila Dexdor na bolnike s srčno frekvenco <60 so zelo omejeni, zato je pri njih potrebna posebna previdnost.
English: Dexdor has been shown to be compatible when administered with the following intravenous fluids and medicinal products:
Slovenian: Izkazalo se je, da je zdravilo Dexdor združljivo z naslednjimi intravenskimi tekočinami in zdravili:
English: Alpha-2 agonists have rarely been associated with withdrawal reactions when stopped abruptly after prolonged use.
Slovenian: Ukinitev agonistov alfa-2 je redko povezana z odtegnitvenimi reakcijami, če jih nenadoma ukinemo po daljši uporabi.
English: Very high temperatures had been reported in a small number of the case reports, and that anti-pyretic agents or/external cooling were not effective.
Slovenian: Pri majhnem številu poročil o primerih so poročali o zelo visokih temperaturah, pri čemer antipiretiki ali hlajenje niso bili učinkoviti.
English: In cases of overdose with clinical symptoms, dexmedetomidine infusion should be reduced or stopped.
Slovenian: V primerih prevelikega odmerjanja s kliničnimi simptomi je treba infuzijo deksmedetomidina zmanjšati ali ustaviti.
English: Dexmedetomidine half life in children (1 months to 17 years) appears similar to that seen in adults, but in new-born infants (under 1 month) it appears higher.
Slovenian: Razpolovni čas deksmedetomidina pri otrocih (1 mesec do 17 let) je podoben, kot so ga ugotovili pri odraslih, vendar je bil pri novorjenčkih (mlajših od 1 meseca) višji.
English: Dexdor should not be used during pregnancy unless the clinical condition of the woman requires treatment with dexmedetomidine.
Slovenian: Dexdor se med nosečnostjo ne sme uporabljati, razen če klinično stanje ženske zahteva zdravljenje z deksmedetomidinom.
English: Total volume of infusion
Slovenian: Volumen topila Celotni volumen infuzije
English: Dexmedetomidine is 94% bound to plasma proteins.
Slovenian: Deksmedetomidin je 94 % vezan na plazemske beljakovine.
English: The reported highest infusion rates of dexmedetomidine in these cases have reached up to 60 µg/kg/h for 36 minutes and 30 µg/kg/h for 15 minutes in a 20-month-old child and in an adult, respectively.
Slovenian: Poročane največje hitrosti infundiranja deksmedetomidina v teh primerih so dosegle do 60 µg/kg/h v času 36 minut pri 20-mesečnem otroku in 30 µg/kg/h v času
English: Several cases of dexmedetomidine overdose have been reported both in the clinical trial and the postmarketing data.
Slovenian: Poročali so o več primerih prevelikega odmerjanja deksmedetomidina, tako v kliničnih preskušanjih kot v okviru postmarketinških izkušenj.
English: Your doctor may change your dose if needed and will monitor your heart and blood pressure during the treatment.
Slovenian: Če bo potrebno, vam bo zdravnik lahko spremenil odmerek in bo med zdravljenjem tudi spremljal delovanje vašega srca in krvni tlak.
English: Expected effects are primarily cardiovascular and should be treated as clinically indicated (see section 4.4).
Slovenian: Med pričakovane učinke sodijo predvsem srčno-žilni, ki jih je treba zdraviti v skladu s kliničnimi indikacijami (glejte poglavje 4.4).
English: Local vasoconstriction at higher concentration may be of greater significance in patients with ischaemic heart disease or severe cerebrovascular disease who should be monitored closely.
Slovenian: Lokalna vazokonstrikcija pri višjih koncentracijah je lahko bolj signifikantna pri bolnikih z ishemično srčno boleznijo ali hudo cerebrovaskularno boleznijo, ki jih morate zato skrbno nadzorovati.
English: Dexdor has major impact on the ability to drive and use machines.
Slovenian: Zdravilo Dexdor pomembno vpliva na sposobnost upravljanja vozil in strojev.
English: Dexmedetomidine is therefore not suitable in patients who will not tolerate this profile of effects, for example those requiring continuous deep sedation.
Slovenian: Deksmedetomidin torej ni primeren za bolnike, ki bodo slabo prenašali tak profil učinkov, na primer za tiste, ki potrebujejo neprekinjeno globoko sedacijo.
English: Ask your doctor for advice before having this medicine
Slovenian: Posvetujte se z zdravnikom, preden vzamete to zdravilo.
English: 44 weeks gestation) is very limited and restricted to low doses (≤ 0.2 mcg/kg/h) (see sections 5.2 and
Slovenian: - 44. teden gestacije) je zelo malo in so omejeni na nizke odmerke (≤ 0.2 µg/kg/h) (glejte poglavji 5.2 in 4.4).
English: Other medicines and Dexdor
Slovenian: Druga zdravila in zdravilo Dexdor
English: The possibility of enhanced hypotensive and bradycardic effects should be considered in patients receiving other medicinal products causing these effects, for example beta blockers, although additional effects in an interaction study with esmolol were modest.
Slovenian: Možnost za okrepljeno hipotenzivno in bradikardno delovanje je torej treba upoštevati pri bolnikih, ki prejemajo druga zdravila s tovrstnimi učinki, na primer blokatorje beta, čeprav so bili v študiji medsebojnega delovanja z esmololom dodatni učinki majhni.
English: For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 micrograms/kg given over 10 minutes may be suitable.
Slovenian: Za manj invazivne postopke, kot so oftalmološki kirurški posegi, je lahko primerna tudi udarna infuzija 0,5 mikrogramov/kg, aplicirana v 10 minutah.
English: In vitro study suggests that interaction potential in vivo exists between dexmedetomidine and substrates with dominant CYP2B6 metabolism.
Slovenian: Študija in vitro kaže, da obstaja interakcijski potencial in vivo med deksmedetomidinom in substrati z dominantnim metabolizmom s CYP2B6.
English: Following IV administration of radiolabeled dexmedetomidine an average 95% of radioactivity was recovered in the urine and 4% in the faeces after nine days.
Slovenian: Po intravenski uporabi radioaktivno označenega deksmedetomidina so po devetih dneh izmerili povprečno 95 % radioaktivnosti v urinu in 4 % v blatu.
English: A reduced maintenance dose may be considered (see sections 4.4 and 5.2).
Slovenian: Po potrebi uporabite zmanjšan vzdrževalni odmerek (glejte poglavji 4.4 in 5.2).
English: 200 micrograms/2 ml 400 micrograms/4 ml 1000 micrograms/10 ml
Slovenian: 200 mikrogramov/2 ml 400 mikrogramov/4 ml 1000 mikrogramov/10 ml
English: Danmark Orion Pharma A/S Tlf: +45 8614 00 00
Slovenian: Orion Pharma A/S Tlf: + 45 8614 00 00
English: This possibility should be considered if the patient develops agitation and hypertension shortly after stopping dexmedetomidine.
Slovenian: To možnost je treba upoštevati, če se pojavita agitacija in hipertenzija kmalu po prenehanju dajanja deksmedetomidina.
English: Hypotension does not normally require specific treatment but, where needed, users should be ready to intervene with dose reduction, fluids and/or vasoconstrictors .
Slovenian: Pri hipotenziji običajno ni potrebno specifično zdravljenje, vendar naj bodo uporabniki pripravljeni, da po potrebi ukrepajo z zmanjšanjem odmerka, vnosa tekočin in/ali uporabe vazokonstriktorjev.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Slovenian: Kemična in fizikalna stabilnost zdravila med uporabo je bila dokazana za 24 ur pri temperaturi 25 °C.
English: Dexdor should not be used with medicines that cause temporary paralysis.
Slovenian: Zdravila Dexdor ne smemo uporabljati skupaj z zdravili, ki povzročajo začasno paralizo.
English: The amount of Dexdor depends on your age, size, general condition of health, the level of sedation needed and how you respond to the medicine.
Slovenian: Količina zdravila Dexdor, ki jo bo uporabil, bo odvisna od vaše starosti, velikosti, splošnega zdravstvenega stanja, potrebne stopnje sedacije in tega,
English: In approximately 50% of cases, positive dechallenges were reported.
Slovenian: V približno 50 % primerov so poročali o izboljšanju po prenehanju jemanja zdravila.
English: What Dexdor is and what it is used for
Slovenian: Kaj je zdravilo Dexdor in za kaj ga uporabljamo
English: Treatment of hypertension has generally not been necessary but decreasing the continuous infusion rate may be advisable.
Slovenian: Zdravljenje hipertenzije običajno ni potrebno, je pa lahko priporočljivo zmanjšanje hitrosti kontinuirane infuzije.
English: General precautions
Slovenian: Splošni previdnostni ukrepi
English: The safety and efficacy of dexmedetomidine for sedation of non-intubated patients prior to and/or during surgical and diagnostic procedures was evaluated in two randomised, double-blind, placebocontrolled multicentre clinical trials.
Slovenian: Varnost in učinkovitost deksmedetomidina za sedacijo neintubiranih bolnikov pred in/ali med kirurškimi in diagnostičnimi postopki so ocenjevali v dveh randomiziranih, dvojno slepih, s placebom kontroliranih multicentričnih kliničnih preskušanjih.
English: Specific studies have confirmed enhanced effects with isoflurane, propofol, alfentanil, and midazolam.
Slovenian: Specifične študije so okrepljene učinke potrdile pri izofluranu, propofolu, alfentanilu in midazolamu.
English: The risk of insufficient sedation was increased in patients who were difficult to sedate with standard care immediately prior to switching.
Slovenian: Tveganje nezadostne sedacije je bilo povečano pri bolnikih, ki so jih težko sedirali s standardno nego/obravnavo neposredno preden so začeli uporabljati drug sedativ.
English: Dexmedetomidine is therefore not suitable in patients with severe cardiovascular instability.
Slovenian: Dexmedetomidin zato ni primeren za bolnike, ki imajo hudo nestabilnost srčno-žilnega sistema.
English: The adverse drug reaction (ADR) of hyperthermia is already highlighted in the Summary of Product Characteristics (SmPCs) therefore is subject to routine pharmacovigilance and routine risk minimisation, however the current warning in section 4.4 of the SmPC does not mention the lack of effect of cooling through other measures.
Slovenian: Neželeni učinek zdravila (ADR) hipertermija je že poudarjena v Povzetku glavnih značilnosti zdravila (SmPC) zato je predmet rutinske farmakovigilance in rutinskega zmanjševanja tveganja, vendar trenutno opozorilo v poglavju 4.4 Povzetka glavnih značilnosti zdravila ne omenja neučinkovitosti hlajenja z drugimi ukrepi.
English: Plasma clearance (Cl) has a mean estimated value of 0.46 to 0.73 l/h/kg (35.7 to 51.1 l/h).
Slovenian: Srednja ocenjena vrednost plazemskega očistka (Cl) je 0,46 do 0,73 l/h/kg (35,7 do 51,1 l/h).
English: Patients with high physical fitness and slow resting heart rate may be particularly sensitive to bradycardic effects of alpha-2 receptor agonists and cases of transient sinus arrest have been reported.
Slovenian: Bolniki z visoko stopnjo treniranosti, ki imajo nizko srčno frekvenco v mirovanju, so lahko še posebej občutljivi za bradikardne učinke agonistov receptorjev alfa-2 in poročali so že o primerih prehodnega sinusnega zastoja.
English: A decision must be made whether to discontinue breastfeeding or to discontinue dexmedetomidine therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z deksmedetomidinom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Bradycardia does not normally require treatment, but has commonly responded to anti-cholinergic medicine or dose reduction where needed.
Slovenian: Bradikardije običajno ni treba zdraviti, se je pa pogosto odzvala na uporabo antiholinergičnega zdravila ali na zmanjšanje odmerka, kadar je bilo to potrebno.
English: Respiratory, thoracic and mediastinal disorders Very common: Respiratory depression2,3
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti: depresija dihanja2,3
English: It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care settings or awake sedation during different diagnostic or surgical procedures.
Slovenian: Uporabljamo jih za doseganje sedacije (stanja umirjenosti, zaspanosti ali spanja) pri odraslih bolnikih na bolnišničnih oddelkih za intenzivno nego ali za doseganje sedacije pri ohranjeni zavesti med različnimi diagnostičnimi ali kirurškimi posegi.
English: The observed exposure levels in the rat are below the clinical exposure range.
Slovenian: Stopnje izpostavljenosti, ki so jih opazili pri podganah, so bile pod razponom klinične izpostavljenosti.
English: Lactated Ringers, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) solution for injection, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma-substitute.
Slovenian: Ringerjev laktat, 5 % raztopina glukoze, natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje, manitol 200 mg/ml (20 %), natrijev tiopental, etomidat, vekuronijev bromid, pankuronijev bromid, sukcinilholin, atrakurijev besilat, mivakurijev klorid, rokuronijev bromid, glikopirolatni bromid, fenilefrinijev klorid, atropinijev sulfat, dopamin, noradrenalin, dobutamin, midazolam, morfinijev sulfat, fentanil citrat in nadomestek plazme.
English: - Medicines to help you sleep, cause sedation or strong painkillers may not be appropriate for some time after you have been given Dexdor.
Slovenian: - Zdravila, ki vam pomagajo spati, povzročajo sedacijo ali lajšajo močne bolečine, za vas morda ne bodo primerna še nekaj časa po prejemu zdravila Dexdor.
English: In clinical studies, cases of sinus arrest reversed spontaneously or responded to treatment with atropine and glycopyrrolate.
Slovenian: V kliničnih študijah je v nekaterih primerih sinusni zastoj spontano minil ali pa se je odzval na zdravljenje z atropinom in glikopirolatom.
English: Patients with impaired peripheral autonomic activity (e.g. due to spinal cord injury) may have more pronounced haemodynamic changes after starting dexmedetomidine and so should be treated with care.
Slovenian: Bolniki z zmanjšano aktivnostjo perifernega avtonomnega sistema (npr. po poškodbah hrbtenjače) imajo lahko bolj izrazite hemodinamske spremembe po začetku infundiranja deksmedetomidina in jih je torej treba zdraviti bolj previdno.