FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Ringer-lactat, glucoseinjektionsvæske 50 mg/ml (5 %), natriumchloridinjektionsvæske 9 mg/ml (0,9 %), mannitol 200 mg/ml (20 %), thiopentalnatrium, etomidat, vecuroniumbromid, pancuroniumbromid, succinylcholin, atracuriumbesylat, mivacuriumchlorid, rocuroniumbromid, glycopyrrolatbromid, phenylephrinhydrochlorid, atropinsulfat, dopamin, noradrenalin, dobutamin, midazolam, morphinsulfat, fentanylcitrat og plasmasubstitutter.
English: New-born infants may be particularly sensitive to the bradycardic effects of Dexdor in the presence of hypothermia and in conditions of heart rate-dependent cardiac output.
Danish: Nyfødte kan være specielt følsomme overfor Dexdors bradykardiellee virkning ved eksisterende hypotermi og ved en tilstand hvor det kardielle slagvolumen er afhængig af pulsfrevensen.
English: Dexdor should not be given as a bolus dose and in the ICU a loading dose is not recommended.
Danish: Dexdor bør ikke gives som en bolusdosis og på intensivafdelingen er støddosis ikke anbefalet.
English: Dexmedetomidine lacks the anticonvulsant action of some other sedatives and so will not suppress underlying seizure activity.
Danish: Dexmedetomidin har ikke samme antikonvulsive virkning som andre sedativa og kan dermed ikke undertrykke underliggende krampeaktivitet.
English: Dexdor is intended for use in an intensive care setting, operating room and during diagnostic procedures.
Danish: Dexdor er beregnet til anvendelse på intensivafdelinger, operationsstuer og ved diagnostiske indgreb.
English: The solution should be shaken gently to mix well.
Danish: Infusionsvæsken skal rystes let for at blive blandet godt.
English: This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.
Danish: Ved fravær af andre kliniske tegn og symptomer er dette alene ikke at betragte som manglende virkning.
English: In the rat fertility study, dexmedetomidine had no effect on male or female fertility.
Danish: I fertilitetsstudier med rotter havde dexmedetomidin ingen virkning på han- eller hunrotters fertilitet.
English: Although dexmedetomidine is dosed to effect, it is advisable to use components with synthetic or coated natural rubber gaskets.
Danish: Selvom demedetomidin doseres til virkning, tilrådes det, at anvende komponenter med syntetiske pakninger eller overtrukne naturgummipakninger.
English: Preparation of solution
Danish: Tilberedning af opløsning
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
Danish: 1* Se punktet Beskrivelse af udvalgte bivirkninger2 Bivirkninger som også sås i studier med vågen sedation
English: For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
Danish: Til sedation af ikke-intuberede voksne patienter før og/eller under diagnostiske eller kirurgiske indgreb hvor sedation er nødvendig, det vil sige vågen sedation.
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
Danish: I placebokontrollerede studier fra en postoperativ intensiv afdeling med en population, der tidligere var intuberet og sederet med midazolam eller propofol, reducerede Dexdor signifikant behovet for både erstatningssedativa (midazolam og propofol) og opioider under sedering i op til 24 timer.
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.
Danish: Dexdor kan fortyndes med glucose 50 mg/ml (5 %), Ringerlactat, mannitol eller natriumchlorid 9 mg/ml (0,9 %) injektionsvæske for at opnå den ønskede koncentration på enten 4 mikrogram/ml eller 8 mikrogram/ml før administrationen.
English: Sedation of adult ICU (Intensive Care Unit) patients
Danish: Til sedation af voksne patienter på intensivafdeling:
English: The difference in means in dose of rescue midazolam was -1.8 mg (95% CI: -2.7 - -0.86) favouring dexmedetomidine.
Danish: Forskellen i mediandosis akut midazolam var -1,8 mg (95% CI:-2,7 - -0,86) til dexmedetomidins fordel.
English: It must be administered only as a diluted intravenous infusion using a controlled infusion device
Danish: Det må kun administreres som intravenøs infusion efter fortynding og under anvendelse af et kontrolleret infusionsudstyr.
English: The risk difference in proportion of subjects randomised to dexmedetomidine not requiring rescue midazolam was 43% (95% CI: 23 % - 57%) compared placebo.
Danish: Risikofordelingen i forholdet mellem forsøgspersoner randomiseret til dexmedetomidin, der ikke krævede akut midazolam, var 43% (95% CI: 23% - 57%) sammenlignet med placebo.
English: 2 ml Type I glass ampoules
Danish: 2 ml ampuller af glastype I.
English: Also contains sodium chloride,water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også natriumchlorid, vand til injektionsvæsker.
English: Myocardial ischaemia or infarction, tachycardia
Danish: Myokardieiskæmi eller myokardieinfarkt, takykardi
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.
Danish: Dette kan sammen med effekten af anden administreret medicin tages med i betragtningen ved vurdering af den nødvendige tid for titrering til den ønskede kliniske effekt af Dexdor.
English: A single case of hypothermic bradycardia in a neonate has been reported in the literature.
Danish: Der er i litteraturen rapporteret et enkelt tilfælde af hypotermisk bradykardi hos en nyfødt.
English: Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care.
Danish: Dexdor må kun administreres af sundhedspersonale, der er kvalificeret til at behandle patienter, der kræver intensiv pleje.
English: 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.
Danish: • Studie 1: Bestod af randomiserede patienter, der gennemgik elektive operationer/indgreb under overvåget anæstesi og lokal/regional anæstesi som modtog en stødinfusin dexmedetomidin, enten 1 mikrog/kg (n = 129) eller 0,5 mikrog/kg (n = 134) eller placebo (normalt saltvand, n = 63) givet over 10 minutter og efterfulgt af en vedligeholdelsesinfusion på initialt 0,6 mikrog/ kg/time.
English: 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.
Danish: • Studie 2 randomiserede patienter, der gennemgik vågen fiberoptisk intubation under topikal anæstesi og som modtog en stødinfusion dexmedetomidin 1 mikrog/kg (n = 55) eller placebo (normal saltvand) (n = 50) givet over 10 minutter og efterfulgt af en fast vedligeholdelsesinfusion på 0,7 mikrog/kg/time.
English: Very common (affects more than 1 user in 10) - slow heart rate - low or high blood pressure - change in breathing pattern or stopping breathing.
Danish: Meget almindelige bivirkninger (forekommer hos flere end l ud af 10 behandlede) - langsom puls - lavt eller højt blodtryk - ændring i vejrtrækningsmønster eller vejrtrækningsstop
English: Maintenance of Procedural Sedation:
Danish: Vedligeholdelse af vågen sedation:
English: A lower starting infusion rate should be considered for frail patients.
Danish: Til svækkede patienter kan en lavere initial infusionshastighed overvejes.
English: Resuscitation was required in isolated cases of severe overdose resulting in cardiac arrest.
Danish: I enkeltstående tilfælde af alvorlig overdosering, som medførte hjertestop, var genoplivning nødvendig.
English: 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
Danish: Pakningsstørrelser 5 x 2 ml ampuller 25 x 2 ml ampuller 5 x 2 ml hætteglas 4 x 4 ml hætteglas 4 x 10 ml hætteglas
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.
Danish: Ved lavere infusionshastigheder dominerer de centrale virkninger og medfører nedsat pulsfrekvens og blodtryk.
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.
Danish: Median (interval) akut midazolam dosis var 1,5 (0,5-7,0) mg i dexmedetomidin 1.0 mikrog/kg gruppen, 2,0 (0,5-8,0) mg i 0,5 mikrog/kg dexmedetomidin gruppen og 4,0 (0,514,0) mg i placebogruppen.
English: What Dexdor is and what it is used for What you need to know before you are given Dexdor How to use Dexdor
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Dexdor Sådan bliver du behandlet med Dexdor Bivirkninger
English: 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
Danish: 5 x 2 ml ampuller 25 x 2 ml ampuller 5 x 2 ml hætteglas 4 x 4 ml hætteglas 4 x 10 ml hætteglas
English: If you have been given more Dexdor than you should
Danish: Hvis du har fået for meget Dexdor
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.
Danish: Dexmedetomidin svarede til midazolam (forhold 1,07, 95 % Cl 0,971, 1.176) og propofol (forhold 1,00, 95 % Cl 0,922, 1.075) på det tidspunkt, hvor målet var at sedere en overvejende medicinsk population, som kræver forlænget, let til moderat sedering (RASS 0 til -3) på en intesivafdeling i op til 14 dage.
English: 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.
Danish: Hypotension, hypertension og bradykardi er de hyppigst rapporterede bivirkninger af dexmedetomidin på en intensivafdeling med en forekomst på henholdsvis ca. 25 %, 15 % og 13 % af patienterne.
English: - Hypotension (55 % in dexmedetomidine-group vs. 30 % in placebo-group receiving rescue midazolam and fentanyl) - Respiratory depression ( 38 % in dexmedetomidine-group vs. 35 % in placebo-group receiving rescue midazolam and fentanyl) - Bradycardia (14 % in dexmedetomidine-group vs. 4 % in placebo-group receiving rescue midazolam and fentanyl)
Danish: De hyppigst rapporterede bivirkninger af dexmedetomidin ved vågen sedation er listet herunder (studieprotokollerne fra fase III studier havde prædefinerede grænser for, hvornår ændringer i blodtryk, respirationsfrekvens samt hjertefrekvens skulle rapporteres som bivirkninger) - Hypotension (55 % i dexmedetomidin-gruppen vs. 30 % i placebo-gruppen som fik akut midazolam og fentanyl) - Respiratorisk depression (38 % i dexmedetomidin-gruppen vs. 35 % i placebo-gruppen som fik akut midazolam og fentanyl) - Bradykardi (14 % i dexmedetomidin-gruppen vs. 4 % i placebo-gruppen som fik akut midazolam og fentanyl)
English: Dexdor must be administered only as a diluted intravenous infusion using a controlled infusion device.
Danish: Dexdor må kun administreres som intravenøs infusion efter fortynding og under anvendelse af et kontrolleret infusionsudstyr.
English: Dexdor is diluted and it is given to you as an infusion (drip) into your veins.
Danish: Dexdor fortyndes, og du får det som infusion (drop) i en blodåre.
English: - The active substance is dexmedetomidine.
Danish: Dexdor indeholder - Aktive stof: dexmedetomidin.
English: Use of a loading dose of Dexdor in ICU sedation is not recommended and is associated with increased adverse reactions.
Danish: Det frarådes at administrere en bolusdosis af Dexdor ved sedation på intensivafdelingen, og det er associeret med øgede bivirkninger.
English: A reduced maintenance dose may be considered (see sections 4.4 and 5.2).
Danish: En dosisreduktion bør overvejes, se pkt 4.2.
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.
Danish: Dexdor må kun administreres af sundhedspersonale, som har erfaring med anæstetisk behandling af patienter på operationsstuen eller ved diagnostiske indgreb.
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.
Danish: Dexdor må kun administreres af sundhedspersonale, der er kvalificeret til at behandle patienter, der kræver intensiv pleje eller ved anæstetisk behandling af patienter på operationsstuen.
English: To maintain a Ramsay Sedation Scale ≥2 53% of the patients receiving dexmedetomidine did not require midazoloam rescue vs. 14% of patients receiving placebo.
Danish: For 53% af patienterne, der fik dexmedetomidin, var akut midazoloam ikke nødvendigt for at opretholde en Ramsay Sedation Scale ≥2 mod 14% af patienterne, der fik placebo.
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.
Danish: En læge eller sygeplejerske giver dig Dexdor inden og/eller under et diagnostisk eller kirurgisk indgreb, det vil sige vågen bedøvelse.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 September 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Marketing Authorisation Holder Orion Corporation Orionintie 1
Danish: Indehaver af markedsføringstilladelse Orion Corporation
English: Uncommon: Atrioventricular block first degree, cardiac output decreased
Danish: Atrioventrikulært blok af 1. grad, nedsat minutvolumen
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).
Danish: På grund af risiko for respirationsdepression og i nogle tilfælde apnø skal respirationen overvåges hos ikke-intuberede patienter (se pkt.
English: In case the required concentration is 8 micrograms/ml:
Danish: Såfremt den ønskede koncentration er 8 mikrogram/ml:
English: Alpha-2 agonists have rarely been associated with withdrawal reactions when stopped abruptly after prolonged use.
Danish: Ved brat seponering efter langvarig behandling har alpha-2-agonister sjældent været sat i forbindelse med abstinensreaktioner.
English: In case the required concentration is 4 micrograms/ml:
Danish: Såfremt den ønskede koncentration er 4 mikrogram/ml:
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)
Danish: De følgende typer af medicin kan forstærke virkningen af Dexdor: - medicin, som hjælper dig med at falde i søvn eller medfører en let bedøvelse (f. eks. midazolam,
English: Manufacturer Orion Corporation Orion Pharma Orionintie 1
Danish: Fremstiller Orion Corporation Orionintie 1
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.
Danish: De estimerede farmakokinetiske parametre er: t½ cirka 1,5 timer, Vss cirka 93 liter og Cl cirka 43 l/time.
English: Hospital intensive care Dexdor is administered to you by a doctor or nurse in hospital intensive care.
Danish: Intensivafdeling på hospital Din læge eller sygeplejerske på intensivafdelingen på et sygehus giver dig Dexdor.
English: The pharmacokinetics of dexmedetomidine is linear in the dosing range from 0.2 to 1.4 µg/kg/h and it does not accumulate in treatments lasting up to 14 days.
Danish: Dexmedetomidins farmakokinetik er lineær i dosisområdet fra 0,2 til 1,4
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Dexdor 100 micrograms/ml sterile concentrate dexmedetomidine
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Dexdor 100 mikrog/ml, sterilt koncentrat dexmedetomidin i.v.
English: - if you have recently had a stroke or other serious condition affecting blood supply to the brain.
Danish: - hvis du har forstyrrelser i hjerterytmen (hjerteblok af 2. eller 3. grad) - hvis du har meget lavt blodtryk, som ikke reagerer på behandling - hvis du for nylig har haft et slagtilfælde eller andre alvorlige tilstande, som påvirker blodforsyningen til hjernen.
English: Hyperglycaemia, hypoglycaemia Uncommon: Metabolic acidosis, hypoalbuminaemia
Danish: Hyperglykæmi, hypoglykæmi
English: Vascular disorders: Very common: Hypotension1,2, hypertension1,2
Danish: Hypotension1,2*, hypertension1,2* Luftveje, thorax og mediastinum Meget almindelig:
English: 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)
Danish: Forskellen i median akutdosis midazolam i dexmedetomidin 1 mikrog/kg og dexmedetomidin 0,5 mikrog/kg gruppen sammenlignet med placebo var henholdsvis -3,1 mg (95% CI: -3,8 -2,5) og -2,7 mg (95% CI: - 3,3 - -2,1), til dexmedetomidins fordel.
English: Dose reduction or discontinuation should be considered in a patient developing signs of myocardial or cerebral ischaemia.
Danish: Hvis patienten udvikler tegn på myokardieiskæmi eller cerebral iskæmi, skal dosisreduktion eller seponering overvejes.
English: Propofol or midazolam may be administered if needed until clinical effects of dexmedetomidine are established.
Danish: Indtil der er klinisk virkning af dexmedetomidin, kan der administreres propofol eller midazolam, hvis det er nødvendigt.
English: Each 1 ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
Danish: Hver 1 ml koncentrat indeholder dexmedetomidinehydrochlorid svarende til 100 mikrogram dexmedetomidin.
English: 44 weeks gestation) is very limited and restricted to low doses (≤ 0.2 mcg/kg/h) (see sections 5.2 and
Danish: Data for nyfødte (gestationsalder 28-44 uger) er meget begrænsede og begrænset til lave doser (≤ 0,2 mikrogram/kg/t) (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml koncentrat indeholder dexmedetomidinehydrochlorid svarende til 100 mikrogram dexmedetomidin.
English: Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
Danish: Hver milliliter koncentrat indeholder dexmedetomidinhydrochlorid svarende til 100 mikrogram dexmedetomidin.
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
Danish: Der er i forbindelse med dexmedetomidins perifere vasokonstriktive virkninger observeret forbigående hypertension, især under bolusdosis, og derfor frarådes bolusdosis ved sedation på intensivafdeling.
English: How to use Dexdor
Danish: Sådan bliver du behandlet med Dexdor
English: Orion pharma noted that case reports of overdose are frequently associated with ADRs of bradycardia, hypotension, over sedation, cardiac arrest, respiratory depression and hypertension so proposed to reinforce the existing warnings in section 4.9 of the SmPC and to include the adverse reaction of hypertension, and to redefine somnolence as respiratory depression.
Danish: Orion pharma bemærkede, at tilfælde af overdosering ofte er forbundet med bivirkninger som bradykardi, hypotension, oversedation, hjertestop, respirationsdepression og hypertension.
English: Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
Danish: Hvert 10 ml hætteglas indeholder 1.000 mikrogram dexmedetomidin.
English: Tabulated list of adverse reactions
Danish: Bivirkningsliste opstillet i tabelform
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Orion Corporation
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Procedural/awake sedation
Danish: Vågen sedation
English: Withdrawal syndrome, hyperthermia Uncommon: Drug ineffective, thirst
Danish: Uvirksomt lægemiddel, tørst
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
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 behandlede) - brystsmerter eller hjertetilfælde - hurtig hjertefrekvens - lavt eller højt blodsukker
English: and -2.7 mg (95% CI: -3.3 - -2.1), respectively favouring dexmedetomidine.The median time to first rescue dose was 114 minutes in the dexmedetomidine 1.0 µg/kg group, 40 minutes in the dexmedetomidine 0.5 µg/kg group, and 20 minutes in the placebo group.
Danish: Median tid til første akutdosis var 114 minutter i dexmedetomidin 1,0 mikrog/kg gruppen, 40 minutter i dexmedetomidin 0,5 mikrog/kg gruppen og 20 minutter i placebogruppen.
English: Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Danish: Hver 2 ml ampul indeholder 200 mikrogram dexmedetomidin.
English: Alertness/Sedation Scale ≤4) without need for rescue midazolam was 54% of the patients receiving dexmedetomidine 1 µg/kg and 40% of the patients receiving dexmedetomidine 0.5 µg/kg compared to 3% of patients receiving the placebo.The risk difference in proportion of subjects randomised to dexmedetomidine 1 μg/kg group and dexmedetomidine 0.5 μg/kg group not requiring rescue midazolam was 48% (95% CI: 37 % - 57%) and 40% (95% CI: 28 % - 48%), respectively compared placebo.
Danish: Risikofordelingen i forholdet mellem forsøgspersoner, der randomiseredes til dexmedetomidin 1 mikrog/kg gruppen og dexmedetomidin 0,5 mikrog/kg gruppen, og som ikke krævede akut midazolam, var hhv. 48% (95% CI: 37% - 57%) og 40% (95% CI: 28%48%), sammenlignet med placebo.
English: Hrvatska Malta România Orion Oyj
Danish: Orion Oyj
English: Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).
Danish: Hvert 10 ml hætteglas indeholder 1.000 mikrogram dexmedetomidin (som hydrochlorid).
English: Polyuria
Danish: Hrvatska
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Dexdor Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.