FrancophonIA/ELRC3.0 huggingface dataset:
English: Dexmedetomidine was similar to midazolam (Ratio 1.07; 95% CI 0.971, 1.176) and propofol (Ratio 1.00; 95% CI 0.922, 1.075) on the time in target sedation range in a predominently medical population requiring prolonged light to moderate sedation (RASS 0 to -3) in the ICU for up to 14 days, reduced the duration of mechanical ventilation compared to midazolam and reduced the time to extubation compared to midazolam and propofol.
Croatian: Deksmedetomidin je pokazao slične rezultate kao i midazolam (omjer 1,07; 95% CI 0,971, 1,176) i propofol (omjer 1,00; 95% CI 0,922, 1,075) u ciljanom rasponu sedacije kod uglavnom nekirurških bolesnika kojima je bila potrebna produžena blaga do umjerena sedacija (RASS 0 do -3) u jedinicama intenzivnog liječenja sve do 14 dana, pri čemu je smanjeno trajanje mehaničke ventilacije u usporedbi s midazolamom i smanjeno vrijeme proteklo do ekstubacije u usporedbi s midazolamom i propofolom.
English: Manufacturer Orion Corporation Orion Pharma Orionintie 1
Croatian: Orion Corporation Orion Pharma Orionintie 1
English: Dexmedetomidine normally does not cause deep sedation and patients may be easily roused.
Croatian: Deksmedetomidin normalno ne uzrokuje duboku sedaciju te je bolesnike moguće lako razbuditi.
English: Dexmedetomidine is therefore not suitable in patients with severe cardiovascular instability.
Croatian: Deksmedetomidin stoga nije pogodan kod bolesnika s izrazito nestabilnim kardiovaskularnim sustavom.
English: Patients should be monitored continuously for early signs of hypotension, hypertension, bradycardia, respiratory depression, airway obstruction, apnoea, dyspnoea and/or oxygen desaturation (see section 4.8).
Croatian: Bolesnike je potrebno neprekidno nadzirati da bi se ustanovili rani znakovi hipotenzije, hipertenzije, bradikardije, respiratorne depresije, opstrukcije dišnih puteva, apneje, dispneje i/ili desaturacije kisikom (vidjeti dio 4.8).
English: The maintenance infusion of study drug could be titrated from 0.2 µg/kg/h to 1 µg/kg/h.
Croatian: Infuzija održavanja lijekom koji se ispituje mogla se titrirati od 0,2 µg/kg/h do 1 µg/kg/h.
English: Care should be taken if combining dexmedetomidine with other substances with sedative or cardiovascular actions as additive effects may occur.
Croatian: Oprez je nužan u slučaju kombiniranja deksmedetomidina s drugim tvarima sa sedativnim ili kardiovaskularnim djelovanjem jer može doći do aditivnih učinaka.
English: Care should be taken in severe hepatic impairment as excessive dosing may increase the risk of adverse reactions, over-sedation or prolonged effect as a result of reduced dexmedetomidine clearance.
Croatian: Oprez je nužan i kod teških poremećaja rada jetre jer davanje prevelikih doza može povećati rizik od štetnih nuspojava, prejake sedacije ili produženog trajanja njezinih učinaka, a sve zbog sporijeg klirensa deksmedetomidina.
English: The cardiovascular effects depend on the dose; with lower infusion rates the central effects dominate leading to decrease in heart rate and blood pressure.
Croatian: Kardiovaskularni učinci ovise o dozi, a pri manjim brzinama infundiranja dominiraju učinci na centralni živčani sustav koji vode do usporavanja srčane frekvencije i snižavanja krvnog tlaka.
English: In relatively healthy non-ICU subjects treated with dexmedetomidine, bradycardia has occasionally led to sinus arrest or pause.
Croatian: Kod relativno zdravih ispitanika koji nisu bili na intenzivnom liječenju, a davan im je deksmedetomidin, bradikardija je katkad dovela do zastoja sinusnog ritma ili sinusne stanke.
English: Dexmedetomidine is relatively free from respiratory depressive effects when given as monotherapy to healthy subjects.
Croatian: Deksmedetomidin je relativno bez depresivnih učinaka na dišni sustav kad se daje kao monoterapija zdravim ispitanicima.
English: Studies from outside the ICU have confirmed that Dexdor can be administered safely to patients without endotracheal intubation provided adequate monitoring is in place.
Croatian: Ispitivanja na osobama koje nisu bile u jedinici intenzivnog liječenja potvrdile su kako se Dexdor može sigurno davati bolesnicima bez endotrahealne intubacije, pod uvjetom da ih se odgovarajuće nadzire.
English: Dexmedetomidine treated patients had more frequent hypotension and bradycardia but less tachycardia than those receiving midazolam and more frequent tachycardia but similar hypotension to propofoltreated patients.
Croatian: Bolesnici koji su primali deksmedetomidin češće su patili od hipotenzije i bradikardije, ali su rjeđe patili od tahikardije od onih koji su primali midazolam, a uz sličnu učestalost hipotenzije češće su patili od tahikardije nego oni koji su primali propofol.
English: Dexmedetomidine is excreted in human milk, however levels will be below the limit of detection by 24 hours following treatment discontinuation.
Croatian: Deksmedetomidin se izlučuje u majčinu mlijeku, ali nakon prekida primjene njegova razina pada ispod granice detekcije u roku od 24 sata.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for dexmedetomidine, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir izvješće o procjeni rizika Odbora za procjenu rizika u području farmakovigilancije (PRAC) u periodički ažuriranom izvješću o neškodljivosti (PSUR) za deksmedetomidin znanstveni zaključci Odbora za lijekove za primjenu kod ljudi (CHMP) jesu:
English: The minor metabolites dexmedetomidine carboxylic acid, 3-hydroxymethyl dexmedetomidine and its Oglucuronide individually comprised 1.11 to 7.66% of the dose.
Croatian: 3-hidroksimetil deksmedetomidin i njegov O-glukuronid pojedinačno su nosili 1,11 do 7,66% doze.
English: In the rat fertility study, dexmedetomidine had no effect on male or female fertility.
Croatian: U ispitivanju plodnosti štakora, deksmedetomidin nije utjecao na plodnost.mužjaka ni ženki.
English: Withdrawal syndrome, hyperthermia Uncommon: Drug ineffective, thirst
Croatian: Sindrom ustezanja, hipertermija Manje često: Nedjelotvornost lijeka, žeđ
English: Patients should be advised to refrain from driving or other hazardous tasks for a suitable period of time after receiving Dexdor for procedural sedation.
Croatian: Bolesnike je potrebno upozoriti da se suzdrže od upravljanja vozilom i drugih opasnih radnji još određeno vrijeme nakon svjesne sedacije lijekom Dexdor.
English: The difference in means in dose of rescue midazolam was -1.8 mg (95% CI: -2.7 - -0.86) favouring dexmedetomidine.
Croatian: Razlika u srednjim vrijednostima rescue doze midazolama iznosila je -1,8 mg (95% CI: -2,7 - -0,86) u korist deksmedetomidina.
English: Dexdor is administered to you by a doctor or a nurse prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
Croatian: Dexdor će vam dati liječnik ili medicinska sestra prije i/ili tijekom dijagnostičkih ili kirurških postupaka za koje je potrebna sedacija, tj. svjesna sedacija / sedacija u budnom stanju.
English: The major urinary metabolites are the two isomeric N-glucuronides, which together accounted for approximately 34% of the dose and N-methyl 3-hydroxymethyl dexmedetomidine O-glucuronide that accounted for 14.51% of the dose.
Croatian: N-glukuronida, koji zajedno nose približno 34% doze i N-metil 3-hidroksimetil deksmedetomidin O-glukuronid koji nosi 14,51% doze.
English: Therefore the PRAC recommends a more prominent warning that dexmedetomidine should not be used in malignant hyperthermia-sensitive patients.
Croatian: Stoga Odbor za procjenu rizika u području farmakovigilancije preporučuje dodavanje istaknutijeg upozorenja da se deksmedetomidin ne smije koristiti kod pacijenata osjetljivih na malignu hipertermiju.
English: During procedural sedation a small bolus of another sedative may be used if a rapid increase in sedation level is required.
Croatian: Ako je tijekom svjesne sedacije potrebno brzo povećanje razine sedacije, moguće je upotrijebiti mali bolus nekog drugog sedativa.
English: The following medicines may enhance the effect of Dexdor: - medicines that help you sleep or cause sedation (e.g. midazolam, propofol) - strong pain medicines (e.g. opioids such as morphine, codeine) - anaesthetic medicines (e.g. sevoflurane, isoflurane)
Croatian: - lijekovi koji pomažu usnivanju ili izazivaju sedaciju (npr. midazolam i propofol) - jaki lijekovi protiv bolova (npr. opioidi poput morfina i kodeina) - anestetici (npr. sevofluran i izofluran)
English: Vascular disorders: Very common: Hypotension1,2, hypertension1,2
Croatian: Hipotenzija1,2*, hipertenzija1,2*
English: How to use Dexdor
Croatian: Kako primjenjivati Dexdor
English: No pharmacokinetic interactions between dexmedetomidine and isoflurane, propofol, alfentanil and midazolam have been demonstrated.
Croatian: Nisu se pokazale nikakve farmakokinetičke interakcije deksmedetomidina s izofluranom, propofolom, alfentanilom ni midazolamom.
English: ANNEX II
Croatian: DODATAK IV
English: In the rat, subcutaneous administration at the maximum dose, 200 µg/kg/day, caused an increase in embryofetal death and reduced the fetal body weight.
Croatian: 200 µg/kg/dnevno, dovelo do povećanja embriofetalne smrtnosti i smanjenja fetalne tjelesne mase.
English: Depending on the procedure concomitant local anaesthesia or analgesia may be needed in order to achieve the desired clinical effect.
Croatian: Da bi se postigao željeni klinički učinak, ovisno o postupku može biti potrebna i istodobna lokalna anestezija ili analgezija.
English: The most abundant circulating dexmedetomidine metabolites are two isomeric Nglucuronides.
Croatian: Dva najzastupljenija metabolita deksmedetomidina u optoku su dva izomerna N-glukuronida.
English: Dexdor can be diluted in glucose 50 mg/ml (5%), Ringers, mannitol or sodium chloride 9 mg/ml (0.9%) solution for injection to achieve the required concentration of either 4 micrograms/ml or 8 micrograms/ml prior to administration.
Croatian: Dexdor se može razrijediti otopinom glukoze koncentracije 50 mg/ml (5%), Ringerovom otopinom, otopinom manitola ili natrijevog klorida koncentracije 9 mg/ml (0,9%) za injekcije kako bi se prije primjene postigla potrebna koncentracija od 4 mikrograma/ml ili 8 mikrograma/ml.
English: For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 micrograms/kg given over 10 minutes may be suitable.
Croatian: Za manje invazivne postupke kao što je oftalmološka kirurgija može biti prikladna infuzija udarne doze od 0,5
English: Adverse reactions Metabolism and nutrition disorders Common:
Croatian: Poremećaji metabolizma i prehrane Često:
English: A single case of hypothermic bradycardia in a neonate has been reported in the literature.
Croatian: Iz literature je poznat samo jedan slučaj hipotermne bradikardije novorođenčeta.
English: 1 See section on Description of selected adverse reactions 2 Adverse reaction observed also in procedural sedation studies 3 Incidence ‘common' in ICU sedation studies
Croatian: Opis odabranih nuspojava 2 Nuspojava je zabilježena i u ispitivanjima svjesne sedacije 3 Incidencija je "česta" u ispitivanjima svjesne sedacije
English: 2 ml Type I glass ampoules
Croatian: I volumena 2 ml bočice od stakla tipa
English: The mean midazolam rescue dose was 1.1 mg in the dexmedetomidine group, and 2.8 mg in the placebo group.
Croatian: Srednja vrijednost rescue doze midazolama iznosila je 1,1 mg u skupini koja je primala deksmedetomidin, a 2,8 mg u skupini koja je primala placebo.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Orion Corporation
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: The pharmacokinetics of dexmedetomidine has been assessed following short term IV administration in healthy volunteers and long term infusion in ICU population.
Croatian: Farmakokinetička svojstva deksmedetomidina ocjenjivana su prilikom kratkotrajnog i.v. davanja kod zdravih dobrovoljaca te prilikom dugotrajne infuzije kod bolesnika u jedinicama intenzivnog liječenja.
English: Induction of dexmedetomidine in vitro was observed on CYP1A2, CYP2B6, CYP2C8, CYP2C9 and CYP3A4, and induction in vivo cannot be excluded.
Croatian: Indukcija deksmedetomidinom in vitro opažena je kod CYP1A2, CYP2B6, CYP2C8, CYP2C9 i
English: The risk difference in proportion of subjects randomised to dexmedetomidine not requiring rescue midazolam was 43% (95% CI: 23 % - 57%) compared placebo.
Croatian: Razlika rizika u udjelu ispitanika koji su slučajnim odabirom stavljeni u skupinu koja je primala deksmedetomidin, a da im nije bio potreban rescue midazolam, iznosila je 43% (95% CI: 23% - 57%) u usporedbi s skupinom koja je primala placebo.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Croatian: Znanstveni zaključci i osnove za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: Some patients receiving Dexdor have been observed to be arousable and alert when stimulated.
Croatian: Kod nekih je bolesnika koji primaju Dexdor zabilježeno da ih se stimulacijom može dovesti u budno stanje.
English: Dexdor is given as a loading infusion followed by maintenance infusion.
Croatian: Dexdor se primjenjuje kao infuzija početne udarne doze nakon koje slijedi infuzija održavanja.
English: Dexmedetomidine has analgesic and anaesthetic/analgesic-sparing effects.
Croatian: Deksmedetomidin ima analgetički učinak, a omogućuje i upotrebu manjih količina anestetika/analgetika.
English: The PRAC endorsed this revision.
Croatian: Odbor za procjenu rizika u području farmakovigilancije odobrio je te izmjene.
English: Advanced heart block (grade 2 or 3) unless paced.
Croatian: Uznapredovali srčani blok (stupanj 2 ili 3) ako bolesnik nema elektrostimulator srca.
English: In placebo controlled trials in a post-operative ICU population previously intubated and sedated with midazolam or propofol, Dexdor significantly reduced the requirement for both rescue sedative
Croatian: Sedacija odraslih bolesnika u jedinici za intenzivno liječenje (JIL) U placebom kontroliranim ispitivanjima na bolesnicima koji se nakon operacije nalaze u jedinici intenzivnog liječenja, a koji su ranije bili intubirani i sedirani midazolamom ili propofolom, Dexdor je značajno smanjio potrebe i za dodatnim sedativima (midazolam ili propofol) i za opioidima za vrijeme sedacije sve do 24 sata.
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for dexmedetomidine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing dexmedetomidine is unchanged subject to the proposed changes to the product information The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Croatian: Na temelju znanstvenih zaključaka za deksmedetomidin Odbor za lijekove za primjenu kod ljudi mišljenja je da je odnos koristi/rizika medicinskog proizvoda koji sadrži deksmedetomidin nepromijenjen prema predloženim izmjenama u informacijama o proizvodu.
English: For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
Croatian: Za sedaciju neintubiranih odraslih bolesnika prije i/ili tijekom dijagnostičkih ili kirurških postupaka za koje je potrebna sedacija, tj. svjesna sedacija / sedacija u budnom stanju (engl. procedural/awake sedation).
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Croatian: Odbor za lijekove za primjenu kod ljudi složio se sa znanstvenim zaključcima Odbora za procjenu rizika u području farmakovigilancije.
English: For storage conditions after dilution of the medicinal product, see section 6.3
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: SPECIAL STORAGE CONDITIONS Keep the ampoules/vials in the outer carton in order to protect from light.
Croatian: Čuvati ampule/bočice u vanjskom pakiranju radi zaštite od svjetlosti.
English: Dexdor must be administered only as a diluted intravenous infusion using a controlled infusion device.
Croatian: Način primjene Dexdor se mora primjenjivati samo kao razrijeđena intravenska infuzija putem uređaja za kontroliranu infuziju.
English: The median (range) midazolam rescue dose was 1.5 (0.5-7.0) mg in the dexmedetomidine1.0 µg/kg group, 2.0 (0.5-8.0) mg in the dexmedetomidine 0.5 µg/kg group, and 4.0 (0.5-14.0) mg in the placebo group.
Croatian: Medijan (raspon) rescue doze midazolama bio je 1,5 (0,5 - 7,0) mg u skupini koja je primala deksmedetomidin od 1,0 µg/kg, 2,0 (0,5 - 8,0) mg u skupini koja je primala deksmedetomidin od 0,5 µg/kg i 4,0 (0,5 - 14,0) mg u skupini koja je primala placebo.
English: 44 weeks gestation) is very limited and restricted to low doses (≤ 0.2 mcg/kg/h) (see sections 5.2 and
Croatian: Podaci za novorođenčad (28 - 44 tjedna gestacije) vrlo su ograničeni i odnose se samo na male doze (≤0,2 μg/kg/h) (vidjeti dijelove 5.2 i 4.4).
English: Dexdor should not be given as a bolus dose and in the ICU a loading dose is not recommended.
Croatian: Dexdor se ne smije primjenjivati u bolusnoj dozi, a u jedinici za intenzivno liječenje ne preporučuje se primjena udarne doze.
English: Dexdor contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free'.
Croatian: Dexdor sadrži manje od 1 mmol natrija (23 mg) po ml, tj. zanemarive količine natrija.
English: In isolated cases bradycardia has progressed to periods of asystole in patients with pre-existing bradycardia.
Croatian: U izoliranim se slučajevima, kod bolesnika s već postojećom bradikardijom, ona razvila u razdoblja asistole.
English: Plasma pharmacokinetics of dexmedetomidine is similar in the ICU population following infusion >24 h. The estimated pharmacokinetic parameters are: t1/2 approximately 1.5 hours, Vss approximately 93 litres and Cl approximately 43 l/h.
Croatian: Procijenjeni farmakokinetički parametri iznose: t1/2 približno 1,5 sat, Vss približno 93 litara, a Cl približno 43 l/h.
English: Transient hypertension has been observed primarily during the loading dose in association with the peripheral vasoconstrictive effects of dexmedetomidine and a loading dose is not recommended in
Croatian: Prolazna je hipertenzija zabilježena prvenstveno tijekom davanja udarne doze, vezano za periferne vazokonstrikcijske učinke deksmedetomidina pa se davanje udarne doze ne preporučuje za sedaciju bolesnika u jedinici za intenzivno liječenje.
English: Dexdor contains an active substance called dexmedetomidine which belongs to a medicine group called sedatives.
Croatian: Sadržaj pakiranja i druge informacije Što je Dexdor i za što se koristi Dexdor sadrži djelatnu tvar deksmedetomidin koja pripada skupini lijekova pod nazivom sedativi.
English: Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care.
Croatian: Dexdor smiju primjenjivati samo zdravstveni radnici stručni u postupanju s bolesnicima kojima je potrebno intenzivno liječenje.
English: No dose adjustment is required for patients with renal impairment.
Croatian: Prilagođavanje doze nije potrebno kod bolesnika s oštećenjem funkcije bubrega.
English: Dexdor should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Dexdor treba prije primjene vizualno provjeriti na prisutnost čestica i promjenu boje.
English: Common (affects 1 to 10 users in 100) - chest pain or heart attack - fast heart rate - low or high blood sugar - nausea, vomiting or dry mouth - restlessness - high temperature - symptoms after stopping the medicine
Croatian: - bolovi u prsištu ili srčani udar - visoka srčana frekvencija - nizak ili visok šećer u krvi - mučnina, povraćanje ili suha usta
English: Dexdor should be administered only by health care professionals skilled in the anaesthetic management of patients in the operating room or during diagnostic procedures.
Croatian: Dexdor smiju primjenjivati samo zdravstveni djelatnici educirani za anesteziju bolesnika u operacijskoj dvorani ili tijekom dijagnostičkih postupaka.
English: Also contains sodium chloride,water for injections.
Croatian: POPIS POMOĆNIH TVARI Također sadrži natrijev klorid i vodu za injekcije.
English: Maintenance of Procedural Sedation:
Croatian: Održavanje svjesne sedacije:
English: - if you have an abnormally slow heart rate (either due to illness or high levels of physical fitness) - if you have low blood pressure - if you have low blood volume, for example after bleeding - if you have certain heart disorders - if you are elderly - if you have a neurological disorder (for instance head or spinal cord injury or stroke) - if you have severe liver problems - if you have ever developed a serious fever after some medicines, especially anaesthetics
Croatian: - ako vam je srčana frekvencija neuobičajeno niska (bilo zbog bolesti ili vrlo dobre tjelesne kondicije) - ako patite od niskoga krvnoga tlaka - ako patite od malena volumena krvi, primjerice nakon krvarenja
English: Uncommon (affects 1 to 10 users in 1,000) - reduced heart function - swelling of the stomach - thirst - a condition where there is too much acid in the body - low albumin level in blood - shortness of breath - hallucinations - the medicine is not effective enough.
Croatian: - stanje u kojemu se u tijelu nalazi previše kiseline - niska razina albumina u krvi - nedostatak zraka - halucinacije - nedovoljna djelotvornost lijeka.
English: A lower starting infusion rate should be considered for frail patients.
Croatian: Kod slabih bolesnika treba razmotriti nižu početnu brzinu infundiranja.
English: 6.5 Nature and contents of container
Croatian: 6.5 Vrsta i sadržaj spremnika ampule od stakla tipa
English: Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care or in the anaesthetic management of patients in the operating room.
Croatian: Dexdor smiju primjenjivati samo zdravstveni radnici stručni u postupanju s bolesnicima kojima je potrebno intenzivno liječenje ili u davanju anestezije bolesnicima u operacijskoj dvorani.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, odjeljak 4.2).
English: Use of a loading dose of Dexdor in ICU sedation is not recommended and is associated with increased adverse reactions.
Croatian: Primjena udarne početne doze lijeka Dexdor za sedaciju bolesnika u jedinici za intenzivno liječenje ne preporučuje se jer se povezuje s povećanjem nuspojava.
English: Data in new-born infants (28 - 44 weeks gestation) is very limited and restricted to maintenance doses ≤ 0.2 mcg/kg/h.
Croatian: Podaci za novorođenčad (28 - 44 tjedna gestacije) vrlo su ograničeni i odnose se samo na doze održavanja
English: The mean estimate of the terminal elimination half-life (t1/2) is approximately 1.9 to 2.5 h (min 1.35, max 3.68 h) and the mean estimate of the steady-state volume of distribution (Vss) is approximately 1.16 to 2.16 l/kg (90 to 151 litres).
Croatian: 3,68 h) a srednja procijenjena vrijednost distribucijskog volumena u stanju dinamičke ravnoteže (Vss) je približno 1,16 do 2,16 l/kg (90 do 151 litre).
English: Volume of diluent
Croatian: Volumen otopine za razrjeđivanje
English: - The active substance is dexmedetomidine.
Croatian: Što Dexdor sadrži - Djelatna tvar je deksmedetomidin.
English: Respiration should be monitored in non-intubated patients due to the risk of respiratory depression and in some case apnoea (see section 4.8).
Croatian: Kod neintubiranih bolesnika treba provoditi praćenje disanja zbog rizika od respiratorne depresije i, u nekim slučajevima,
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Dexdor Lijek čuvajte izvan pogleda i dohvata djece.