natgillin/translations-raw huggingface dataset:
Caution is advised when administering dexmedetomidine together with spinal or epidural anaesthesia due to possible increased risk of hypotension or bradycardia.
Pri uporabi deksmedetomidina skupaj s spinalno ali epiduralno anestezijo je potrebna previdnost zaradi možnega povečanega tveganja za pojav hipotenzije ali bradikardije.
Evidence of paediatric efficacy was seen in a dose-controlled ICU study in a largely post-operative population aged 1 month to ≤ 17 years.
opravljeni na oddelku za intenzivno nego, na večinoma postoperativni populaciji v starosti od 1 meseca do ≤ 17 let.
Induction of dexmedetomidine in vitro was observed on CYP1A2, CYP2B6, CYP2C8, CYP2C9 and CYP3A4, and induction in vivo cannot be excluded.
Opazili so indukcijo deksmedetomidina in vitro na CYP1A2, CYP2B6, CYP2C8, CYP2C9 in
- If you get any side effects, talk to your doctor.
- Če opazite kateri koli neželeni učinek, se posvetujete z zdravnikom.
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.
Pri podganah je subkutano dajanje največjega odmerka 200 µg/kg/dan povzročilo povečano pogostnost smrti zarodkov in plodov in zmanjšalo telesno maso plodov.
A single case of hypothermic bradycardia in a neonate has been reported in the literature.
V literaturi so poročali o enem samem primeru hipotermične bradikardije pri novorojenčku.
Manufacturer Orion Corporation Orion Pharma Orionintie 1
Izdelovalec Orion Corporation Orion Pharma Orionintie 1
2 ml glass ampoules 2, 5 or 10 ml glass vials
2 ml steklene ampule 2, 5 ali 10 ml steklene viale
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnih in ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
2 ml Type I glass ampoules
2 ml ampule iz stekla tipa I
Not known (frequency cannot be estimated from the available data) - increased need to pass urine
- premajhna učinkovitost zdravila Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
- The active substance is dexmedetomidine.
- Učinkovina je deksmedetomidin.
Advanced heart block (grade 2 or 3) unless paced.
Napredovali srčni blok (2. ali 3. stopnje), če bolnik nima srčnega spodbujevalnika.
Dexmedetomidine is very potent and the infusion rate is given per hour.
Deksmedetomidin je zelo močno zdravilo, zato je njegova hitrost infundiranja podana na uro.
Use of a loading dose of Dexdor in ICU sedation is not recommended and is associated with increased adverse reactions.
Uporaba udarnega odmerka zdravila Dexdor za sedacijo na oddelkih za intenzivno nego ni priporočljiva in je povezana s povečanjem neželenih učinkov.
Body weightadjusted plasma clearance in new-born infants (under 1 month) appeared lower (0.9 l/h/kg) than in the older groups due to immaturity.
zaradi nezrelosti nižji (0,9 l/h/kg) kot pri starejših skupinah.
The mean t1/2 for the subjects with mild, moderate or severe hepatic impairment was prolonged to 3.9, 5.4, and 7.4 hours, respectively.
Srednja vrednost t1/2 pri preiskovancih z blago jetrno okvaro je bila podaljšana na 3,9, pri tistih z zmerno jetrno okvaro na 5,4 in pri tistih s hudo jetrno okvaro na 7,4 ure.
Dexmedetomidine is metabolised in the liver and should be used with caution in patients with hepatic impairment.
Deksmedetomidin se presnovi v jetrih, zato ga je treba pri bolnikih z jetrno okvaro uporabljati previdno.
Also contains sodium chloride,water for injections.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi natrijev klorid, vodo za injekcije.
Dexdor is given as a loading infusion followed by maintenance infusion.
Zdravilo Dexdor se daje kot udarna infuzija, ki ji sledi vzdrževalna infuzija.
In the reproductive toxicity studies, dexmedetomidine had no effect on male or female fertility in the rat, and no teratogenic effects were observed in the rat or rabbit.
V študijah vpliva na sposobnost razmnoževanja deksmedetomidin ni vplival na plodnost podganjih samic in samcev, pri podganah in kuncih pa tudi niso opažali nobenih teratogenih učinkov.
Dexdor contains an active substance called dexmedetomidine which belongs to a medicine group called sedatives.
Zdravilo Dexdor vsebuje učinkovino deksmedetomidin iz skupine zdravil, ki jim pravimo sedativi.
- 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
- če imate katero od srčnih bolezni, - če sodite med starostnike, - če imate nevrološko bolezen (na primer poškodbo glave ali hrbtenjače oziroma možgansko kap), - če imate hude težave z jetri, - če ste imeli kdaj v preteklosti močno zvišano temperaturo po prejemu nekaterih zdravil, še posebej anestetikov.
5 x 2 ml ampoules 25 x 2 ml ampoules 5 x 2 ml vials 4 x 4 ml vials 4 x 10 ml vials
5 x 2 ml ampule 25 x 2 ml ampule 5 x 2 ml viale 4 x 4 ml viale 4 x 10 ml viale
Hospital intensive care Dexdor is administered to you by a doctor or nurse in hospital intensive care.
Zdravilo Dexdor vam bo dal zdravnik ali medicinska sestra na bolnišničnem oddelku za intenzivno nego.
Marketing Authorisation Holder Orion Corporation Orionintie 1
Imetnik dovoljenja za promet Orion Corporation Orionintie 1
Pack sizes 5 x 2 ml ampoules 25 x 2 ml ampoules 5 x 2 ml vials 4 x 4 ml vials 4 x 10 ml vials
Velikosti pakiranj 5 x 2 ml ampule 25 x 2 ml ampule 5 x 2 ml viale 4 x 4 ml viale 4 x 10 ml viale
Those patients who withdrew due to insufficient sedation were switched to either propofol or midazolam.
Bolnikom, ki so bili nezadostno sedirani, so odvzeli deksmedetomidin in jim dali propofol ali midazolam.
Data in new-born infants (28 - 44 weeks gestation) to children 17 years of age are limited.
- 44. teden gestacije) in otroke stare do 17 let, je malo.
The mean plasma clearance values of unbound dexmedetomidine for subjects with mild, moderate, and severe hepatic impairment were 59%, 51% and 32% of those observed in the normal healthy subjects, respectively.
Srednje vrednosti plazemskega očistka nevezanega deksmedetomidina pri preiskovancih z blago jetrno okvaro znašajo 59 %, pri tistih z zmerno jetrno okvaro 51 % in pri tistih s hudo jetrno okvaro 32 % vrednosti, ugotovljenih pri normalnih zdravih preiskovancih.
There is no experience in the use of Dexdor for more than 14 days.
Ni izkušenj z uporabo zdravila Dexdor, daljšo od 14 dni, zato morate vsako daljšo uporabo zdravila Dexdor vedno ponovno oceniti.
Users should therefore be ready to use an alternative sedative for acute control of agitation or during procedures, especially during the first few hours of treatment.
Uporabniki morajo biti zato pripravljeni, da bodo morali bolniku dati kakšen drug sedativ za akuten nadzor agitacije oziroma med posegi.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
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
V s placebom nadzorovanih preskušanjih pri populaciji postoperativnih bolnikov na oddelkih za intenzivno nego, ki so bili predhodno intubirani in sedirani z midazolamom ali propofolom, je med sedacijo v času do 24 ur zdravilo Dexdor bistveno zmanjšalo potrebo tako po rešilnem sedativu (midazolamu ali propofolu) kot po opioidih.
Hypotension and bradycardia were also the most frequent dexmedetomidine-related serious adverse reactions occurring in 1.7% and 0.9% of randomised Intensive Care Unit (ICU) patients respectively.
Najpogostejša resna neželena učinka, povezana z uporabo deksmedetomidina, sta bila tudi hipotenzija, ki se je pojavljala pri 1,7 % in bradikardija, ki se je pojavljala pri 0,9 % randomiziranih bolnikov na oddelkih za intenzivno nego.
In isolated cases bradycardia has progressed to periods of asystole in patients with pre-existing bradycardia.
V redkih primerih je pri bolnikih z obstoječo bradikardijo le-ta napredovala do daljše asistolije.
The concentrate is a clear, colourless solution, pH 4.5 - 7.0
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilen koncentrat) Koncentrat je bistra in brezbarvna raztopina s pH vrednostjo med 4,5 in 7,0.
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.
Proceduralna sedacija/sedacija pri ohranjeni zavesti Zdravilo Dexdor vam bo dal zdravnik ali medicinska sestra pred in/ali med diagnostičnimi ali kirurškimi posegi, ki zahtevajo sedacijo, t.i. proceduralno sedacijo/sedacijo pri ohranjeni zavesti.
SPECIAL STORAGE CONDITIONS Keep the ampoules/vials in the outer carton in order to protect from light.
Ampule/viale shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
- if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
Kaj morate vedeti, preden boste prejeli zdravilo Dexdor Zdravila Dexdor ne smete prejeti - če ste alergični na deksmedetomidin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Dexmedetomidine is eliminated by extensive metabolism in the liver.
Deksmedetomidin se izloča z obsežno presnovo v jetrih.
Dexmedetomidine is relatively free from respiratory depressive effects when given as monotherapy to healthy subjects.
Deksmedetomidin takorekoč ne povzroča depresije dihanja, če se uporablja kot monoterapija pri zdravih ljudeh.
Delirium measured by the CAM-ICU scale was reduced in a study compared to midazolam and delirium-related adverse events were lower on dexmedetomidine compared to propofol.
V študiji primerjave z midazolamom je bil delirij, ki so ga merili z lestvico CAM-ICU, manj pogost in tudi z delirijem povezani neželeni učinki pri prejemanju deksmedetomidina so bili manj pogosti kot pri propofolu.
Uncommon: Hallucination Cardiac disorders Very common: Bradycardia1,2 Common:
Zelo pogosti: bradikardija1,2 Pogosti:
- if you have recently had a stroke or other serious condition affecting blood supply to the brain.
- če imate zelo nizek krvni tlak, ki se ne izboljša z zdravljenjem, - če ste pred kratkim doživeli kap ali drugo resno stanje, ki vpliva na oskrbo možganov s krvjo.
In the rabbit study intravenous administration of the maximum dose, 96 µg/kg/day, produced exposures that are similar to those observed clinically.
V študiji pri kuncih so z intravenskim dajanjem največjega odmerka 96 µg/kg/dan dosegli stopnjo izpostavljenosti v okviru razpona kliničnih izpostavljenosti.
Sedation of adult ICU (Intensive Care Unit) patients The most frequently reported adverse reactions with dexmedetomidine in ICU setting are hypotension, hypertension and bradycardia, occurring in approximately 25%, 15% and 13% of patients respectively.
Najpogosteje poročani neželeni učinki pri uporabi deksmedetomidina na oddelkih za intenzivno nego so hipotenzija, ki se pojavlja pri približno 25 % bolnikov, hipertenzija, ki se pojavlja pri približno 15 % bolnikov in bradikardija, ki se pojavlja pri približno 13 % bolnikov.
Procedural sedation/awake sedation
Proceduralna sedacija/sedacija pri ohranjeni zavesti
The risk difference in proportion of subjects randomised to dexmedetomidine not requiring rescue midazolam was 43% (95% CI: 23 % - 57%) compared placebo.
Razlika v tveganju za delež bolnikov, randomiziranih v skupino z deksmedetomidinom, ki niso potrebovali rešilnega midazolama, je bila v primerjavi s skupino s placebom 43 % (95 % IZ: 23 % - 57 %).
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
- nizek ali visok krvni sladkor - slabost, bruhanje ali suha usta - nemir - visoka temperatura - simptomi po prenehanju jemanja zdravila
Care should be taken if combining dexmedetomidine with other substances with sedative or cardiovascular actions as additive effects may occur.
Pri sočasni uporabi deksmedetomidina z drugimi učinkovinami, ki imajo sedativno ali srčno-žilno delovanje, je potrebna previdnost, ker se lahko pojavijo aditivni učinki.
Respiration should be monitored in non-intubated patients due to the risk of respiratory depression and in some case apnoea (see section 4.8).
Pri vseh bolnikih je treba med infundiranjem zdravila Dexdor izvajati neprekinjeno spremljanje delovanja srca, pri neintubiranih pa je treba spremljati tudi dihanje zaradi tveganja za nastanek depresije dihanja in v nekaterih primerih apneje (glejte poglavje 4.8).
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.
Mediana vrednost rešilnega odmerka midazolama je bila 1,5 mg (razpon: 0,5-7,0 mg) v skupini, ki je prejemala deksmedetomidinom v odmerku 1,0 μg/kg, 2,0 mg (razpon: 0,5-8,0 mg) v skupini, ki je prejemala 0,5 μg/kg deksmedetomidina, in 4,0 mg (razpon: 0,5-14,0 mg) v skupini s placebom.
Dexmedetomidine has analgesic and anaesthetic/analgesic-sparing effects.
Deksmedetomidin ima analgetično in anestetično delovanje oziroma zmanjša potrebno količino analgetika.
Hyperglycaemia, hypoglycaemia Uncommon: Metabolic acidosis, hypoalbuminaemia
presnovna acidoza, hipoalbuminemija
Dexdor must be administered only as a diluted intravenous infusion using a controlled infusion device.
Zdravilo Dexdor se sme uporabljati le v obliki razredčene intravenske infuzije s pomočjo pripomočka za nadzorovano infundiranje.
Maintenance of Procedural Sedation:
Vzdrževanje sedacije pri ohranjeni zavesti:
What Dexdor contains
Kaj vsebuje zdravilo Dexdor
Approximately 28% of the urinary metabolites are unidentified minor metabolites.
V urinu so izmerili manj kot 1 % nespremenjene učinkovine, približno 28 % presnovkov v urinu pa predstavljajo neopredeljeni, manj pomembni presnovki.
Caution should be exercised when administering dexmedetomidine to patients with pre-existing bradycardia.
Pri uporabi deksmedetomidina pri bolnikih z obstoječo bradikardijo je potrebna previdnost.
Study 2 randomised patients undergoing awake fibreoptic intubation under topical anaesthesia to receive a loading infusion of dexmedetomidine 1 µg/kg (n=55) or placebo (normal saline) (n=50) given over 10 minutes and followed by a fixed maintenance infusion of 0.7 µg/kg/h.
Študija 2: randomizirani bolniki, ki so bili podvrženi fiberoptični intubaciji pri ohranjeni zavesti pod lokalno anestezijo, so prejeli udarno infuzijo deksmedetomidina 1 μg/kg (n=55) ali infuzijo placeba (fiziološka raztopina) (n=50), ki je bila aplicirana v 10 minutah.
Additional analgesia or sedatives (e.g. opioids, midazolam, or propofol) are recommended in case of painful procedures or if increased depth of sedation is necessary.
Pri bolečih postopkih ali v primeru potrebe po globlji sedaciji se priporoča dodatna analgezija ali uporaba dodatnih sedativov (npr. opioidov, midazolama ali propofola).
The time to recovery ranged from a short time after discontinuation of dexmedetomidine, to some days later.
Do okrevanja je prišlo hitro po prekinitvi zdravljenja z deksmedetomidinom oziroma nekaj dni po njej, pri večini pa v 12 urah.
The most abundant circulating dexmedetomidine metabolites are two isomeric Nglucuronides.
Presnovka deksmedetomidina, ki sta v krvi navzoča v največjih količinah, sta dva izomerna N-glukuronida.
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.
Zdravilo Dexdor smejo uporabljati le zdravstveni delavci, ki so izurjeni za zdravljenje bolnikov na intenzivni negi ali za anesteziološko obravnavo bolnika v operacijski sobi.
Pharmacotherapeutic group: Psycholeptics, other hypnotics and sedatives, ATC code: N05CM18
Farmakoterapevtska skupina: Psiholeptiki, drugi hipnotiki in sedativi, oznaka ATC: N05CM18 Deksmedetomidin je selektiven agonist receptorjev alfa-2 s širokim razponom farmakoloških lastnosti.
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).
3,68 ure), srednji ocenjeni porazdelitveni volumen v ravnovesnem stanju (Vss) pa je približno 1,16 do 2,16 l/kg (90 do 151 litrov).
Study 1 randomised patients undergoing elective surgeries/procedures under monitored anaesthesia care and local/regional anaesthesia to receive a loading infusion of dexmedetomidine either 1 µg/kg (n=129) or 0.5 µg/kg (n=134), or placebo (normal saline; n=63) given over 10 minutes and followed by a maintenance infusion started at 0.6 µg/kg/h.
Študija 1: randomizirani bolniki, na katerih so opravili elektivne operacije/posege pod nadzirano anestezijsko oskrbo in lokalno/regionalno anestezijo, so prejeli udarno infuzijo deksmedetomidina, bodisi v odmerku 1 μg/kg (n=129) bodisi v odmerku 0,5 μg/kg (n=134),
The cardiovascular effects depend on the dose; with lower infusion rates the central effects dominate leading to decrease in heart rate and blood pressure.
Srčno-žilni učinki so odvisni od odmerka - pri manjših hitrostih infundiranja prevladujejo centralni učinki, kar vodi do zmanjšanja srčne frekvence in krvnega tlaka, pri večjih odmerkih pa prevlada učinek periferne vazokonstrikcije, kar vodi do povečanja sistemske žilne upornosti in krvnega tlaka, medtem ko je bradikardni učinek dodatno poudarjen.
Inhibition of CYP enzymes including CYP2B6 by dexmedetomidine has been studied in human liver microsome incubations.
Pri inkubaciji mikrosomov v človeških jetrih so preučili inhibicijo encimov CYP, vključno s CYP2B6,
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.
V primerjavi tako s propofolom kot z midazolamom so bolnike tudi lažje zbudili in so bili ti bolj kooperativni ter so lažje povedali, ali imajo bolečine ali ne. Bolniki, zdravljeni z deksmedetomidinom, so imeli pogosteje hipotenzijo in bradikardijo, vendar manj tahikardije od tistih, ki so prejemali midazolam, ter pogosteje tahikardijo in podobno pogosto hipotenzijo kot bolniki, zdravljeni s propofolom.
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.
Ocenjeni farmakokinetični parametri so: t1/2 približno 1,5 ure, Vss približno 93 litrov in Cl približno 43 l/h.
Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care.
Zdravilo Dexdor smejo uporabljati le zdravstveni delavci, ki so izurjeni za zdravljenje bolnikov na intenzivni negi.
Patients should be advised to refrain from driving or other hazardous tasks and where possible to avoid the use of other agents that may sedate (e.g, benzodiazepines, opioids, alcohol) for a suitable period of time based on observed effects of dexmedetomidine, the procedure, concomitant medications, the age and the condition of the patient.
Če je mogoče, naj se za določeno časovno obdobje, odvisno od opaženih učinkov deksmedetomidina, opravljenega posega, sočasnega zdravljenja, starosti in stanja bolnika, izognejo uporabi drugih sredstev, ki lahko povzročajo sedativne učinke (npr. benzodiazepinov, opioidov, alkohola).
Resuscitation was required in isolated cases of severe overdose resulting in cardiac arrest.
V redkih primerih hudega prevelikega odmerjanja, ki so vodili do zastoja srca, je bilo potrebno oživljanje.
Very common (affects more than 1 user in 10) - slow heart rate - low or high blood pressure - change in breathing pattern or stopping breathing.
- nizek ali visok krvni tlak - sprememba v dihalnem vzorcu ali prenehanje dihanja
Dexdor is diluted and it is given to you as an infusion (drip) into your veins.
Zdravilo Dexdor je razredčeno in ga boste prejeli v obliki (kapalne) infuzije v veno.
Polyuria
poliurija
Dexdor should be administered only by health care professionals skilled in the anaesthetic management of patients in the operating room or during diagnostic procedures.
Zdravilo Dexdor smejo aplicirati samo zdravstveni delavci, izurjeni za anesteziološko obravnavo bolnikov med operativnimi ali diagnostičnimi posegi.
Containers
Vsebniki
Caution should be exercised when administering dexmedetomidine to elderly patients.
Pri dajanju deksmedetomidina starejšim bolnikom je potrebna previdnost.
How to store Dexdor
Shranjevanje zdravila Dexdor
Dexmedetomidine exhibits a two-compartment disposition model.
Model porazdelitve deksmedetomidina je dvoprostorni.
Adverse reactions Metabolism and nutrition disorders Common:
Presnovne in prehranske motnje Pogosti:
Dexdor should not be given as a bolus dose and in the ICU a loading dose is not recommended.
Zdravila Dexdor se ne sme uporabljati v bolusnem odmerku, na oddelkih za intenzivno nego pa ni priporočljiv udarni odmerek.
Dexmedetomidine plasma protein binding is decreased in subjects with hepatic impairment compared with healthy subjects.
V primerjavi z zdravimi preiskovanci je stopnja vezave deksmedetomidina na plazemske beljakovine zmanjšana pri preiskovancih z jetrno okvaro.
Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
En ml koncentrata vsebuje deksmedetomidinijev klorid v količini, ki ustreza 100 mikrogramom deksmedetomidina.
In case the required concentration is 4 micrograms/ml:
V primeru, da je potrebna koncentracija 4 mikrograme/ml:
In case the required concentration is 8 micrograms/ml:
V primeru, da je potrebna koncentracija 8 mikrogramov/ml:
Sedation of adult ICU (Intensive Care Unit) patients
Sedacija na oddelkih za intenzivno nego pri odraslih bolnikih:
A lower starting infusion rate should be considered for frail patients.
Pri oslabelih bolnikih po potrebi uporabite manjšo začetno hitrost infundiranja.
Dexdor should be inspected visually for particulate matter and discoloration prior to administration.
Zdravilo Dexdor je treba pred uporabo vizualno pregledati, da ugotovite morebitne delce in obarvanje.
ICU sedation.
- Navodilo shranite.
Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
Ena 10 ml viala vsebuje 1000 mikrogramov deksmedetomidina.
Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Ena 4 ml viala vsebuje 400 mikrogramov deksmedetomidina.
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
Predvsem pri uporabi udarnega odmerka v povezavi s perifernimi vazokonstriktornimi učinki deksmedetomidina so opazili prehodno hipertenzijo, zato uporaba udarnega odmerka za sedacijo na oddelkih za intenzivno nego ni priporočljiva.
The difference in means in dose of rescue midazolam in dexmedetomidine 1 μg/kg and dexmedetomidine 0.5 μg/kg group compared to placebo was -3.1 mg (95% CI: -3.8 - -2.5)
Razlika v povprečnem odmerku rešilnega midazolama med skupino, ki je prejemala deksmedetomidin v odmerku 1 μg/kg, in skupino, ki je prejemala placebo, je bila -3,1 mg (95 % IZ: -3,8 - -2,5) v prid skupini z deksmedetomidinom.
No dose adjustment is required for patients with renal impairment.
Ledvična okvara Pri bolnikih z ledvično okvaro običajno ni potrebna nikakršna prilagoditev odmerka.
Withdrawal syndrome, hyperthermia Uncommon: Drug ineffective, thirst
odtegnitveni sindrom, hipertermija
Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).
Ena 10 ml viala vsebuje 1000 mikrogramov deksmedetomidina (v obliki klorida).