FrancophonIA/ELRC3.0 huggingface dataset:
English: Reduced fetal body weight was noted also in the rat fertility study at dose 18 µg/kg/day and was accompanied with delayed ossification at dose 54 µg/kg/day.
Danish: Reduceret føtal legemsvægt blev ligeledes observeret i et fertilitetsstudie med rotter med doser på 18 μg/kg/dag og var ved doser på 54 μg/kg/dag ledsaget af forsinket ossifikation.
English: Evidence of paediatric efficacy was seen in a dose-controlled ICU study in a largely post-operative population aged 1 month to ≤ 17 years.
Danish: Evidens for virkning er set i et dosiskontrolleret studie på intensivafdelinger i en stor post-operativ population af børn i alderen 1 måned til ≤ 17 år.
English: The most abundant circulating dexmedetomidine metabolites are two isomeric Nglucuronides.
Danish: De mest udbredte cirkulerende metabolitter af dexmedetomidin er to isomere Nglukuronider.
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.
Danish: Omtrent 50 % af patienterne, der blev behandlet med dexmedetomidin, krævede ikke tillægsbehandling med midazolam under en gennemsnitlig behandlingsperiode på 20,3 timer (højst 24 timer).
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.
Danish: Patienter, der blev behandlet med dexmedetomidin, havde hyppigere hypotension og bradykardi, men mindre hyppigt takykardi end dem, som fik midazolam, og havde hyppigere takykardi men lignende hypotension som hos patienter, der blev behandlet med propofol.
English: Uncommon: Dyspnoea, apnoea
Danish: Dyspnø, apnø
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULES OR VIALS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Ampuller eller hætteglas
English: Dexdor is not recommended for patient controlled sedation.
Danish: Dexdor bør ikke anvendes til patientkontrolleret sedation.
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.
Danish: De størrste metabolitter i urinen er de to isomere N-glukuronider, som tilsammen udgør cirka 34 % af dosis og N-methyl 3-hydroxymethyl dexmedetomid O-glukuronid, som udgør 14,51 % af dosis.
English: Dexdor should not be used during pregnancy unless the clinical condition of the woman requires treatment with dexmedetomidine.
Danish: Dexdor bør ikke anvendes under graviditet med mindre kvindens kliniske tilstand gør behandling med dexmedetomidin nødvendig.
English: 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.
Danish: Delirium målt efter CAM-ICU-skalaen var reduceret i et studie sammenlignet med midazolam, og delirium-relaterede bivirkninger var lavere med dexmedetomidin sammelignet med propofol.
English: Induction of dexmedetomidine in vitro was observed on CYP1A2, CYP2B6, CYP2C8, CYP2C9 and CYP3A4, and induction in vivo cannot be excluded.
Danish: Induktion af dexmedetomidin in vitro er set med CYP1A2, CYP2B6, CYP2C8, CYP2C9 og CYP3A4, og induktion in vivo kan ikke udelukkes.
English: Dexmedetomidine reduces heart rate and blood pressure through central sympatholysis but at higher concentrations causes peripheral vasoconstriction leading to hypertension (see section 5.1).
Danish: Dexmedetomidin reducerer puls og blodtryk ved central sympatolyse, men højere koncentrationer forårsager perifer vasokonstriktion, som medfører hypertension til følge (se pkt.
English: When Dexdor is administered for conscious sedation, patients should be continuously monitored by persons not involved in the conduct of the diagnostic or surgical procedure.
Danish: Når Dexdor indgives til vågen sedation, skal patienterne overvåges kontinuerligt af personer, der ikke er involveret i udførelsen af den diagnostiske eller kirurgiske procedure.
English: Advanced heart block (grade 2 or 3) unless paced.
Danish: Udtalt hjerteblok (af 2. eller 3. grad), medmindre der behandles med pacemaker.
English: 200 micrograms/2 ml 400 micrograms/4 ml 1000 micrograms/10 ml
Danish: 200 mikrogram/2 ml 400 mikrogram/4 ml 1000 mikrogram/10 ml
English: Caution should be exercised when administering dexmedetomidine to elderly patients.
Danish: Der skal udvises forsigtighed når dexmedetomidin administreres til ældre patienter.
English: When Dexdor is used in an outpatient setting patients should normally be discharged into the care of a suitable third party.
Danish: Når Dexdor anvendes ambulatorisk skal patienter normalt udskrives til pleje hos en passende tredjepart.
English: The hypotensive effects of dexmedetomidine may be of greater significance in those patients with preexisting hypotension (especially if not responsive to vasopressors), hypovolaemia, chronic hypotension or reduced functional reserve such as patients with severe ventricular dysfunction and the elderly and special care is warranted in these cases (see section 4.3).
Danish: Dexmedetomidins hypotensive virkning kan være mere udtalt hos patienter med eksisterende hypotension (især de, som ikke responderer på vasopressorer), hypovolæmi, kronisk hypotension eller reduceret funktionsreserve, såsom patienter med alvorlig ventrikulær dysfunktion samt hos ældre, og særlig forsigtighed er i disse tilfælde påkrævet (se pkt.
English: Cytochrome P-450 catalyses the formation of two minor circulating metabolites, 3-hydroxymethyl dexmedetomidine produced by hydroxylation at the 3-methyl group of dexmedetomidine and H-3 produced by oxidation in the imidazole ring.
Danish: Cytochrom P-450 katalyserer dannelsen af to mindre cirkulerende metabolitter, 3-hydroxymethyl dexmedetomidin produceret ved hydroxylering ved 3-methylgruppen af dexmedetomidin og H-3 produceret ved oxidation i imidazolringen.
English: Dexmedetomidine is relatively free from respiratory depressive effects when given as monotherapy to healthy subjects.
Danish: Dexmedetomidin er relativt fri for respirationsdeprimerende virkninger, når det bliver givet som monoterapi til raske personer.
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.
Danish: Hos patienter med nedsat perifer autonom aktivitet (f.eks. på grund af rygmarvsskade) kan der forekomme mere udtalte hæmodynamiske ændringer efter initiering af dexmedetomidin og skal derfor behandles med forsigtighed.
English: 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.
Danish: Patienter skal rådes til ikke at køre bil eller udføre risikofyldt arbejde og hvis muligt undgå at bruge andre sedative midler (f.eks. benzodiazepiner, opioider, alkohol) i en passende tidsperiode som baseres på de observerede effekter af dexmedetomidin, typen af indgreb, hvilken anden medicin patienten får, samt alder og patientens tilstand.
English: The minor metabolites dexmedetomidine carboxylic acid, 3-hydroxymethyl dexmedetomidine and its Oglucuronide individually comprised 1.11 to 7.66% of the dose.
Danish: De mindre metabolitter dexmedetomidincarboxylsyre, 3-hydroxymethyl dexmedetomidin og dens O-glukuronid udgør hver for sig 1,11 % til 7,66 % af dosis.
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.
Danish: Lokal vasokonstriktion ved højere koncentrationer kan være af større signifikans hos patienter med iskæmisk hjertesygdom eller alvorlig cerebrovaskulær sygdom.
English: Care should be taken if combining dexmedetomidine with other substances with sedative or cardiovascular actions as additive effects may occur.
Danish: Der skal udvises forsigtighed, hvis dexmedetomidin kombineres med andre stoffer med sederende eller kardiovaskulære virkninger, da der kan forekomme additive virkninger.
English: If you are using medicines which lower your blood pressure and heart rate, co-administration with Dexdor may enhance this effect.
Danish: Hvis du tager medicin, som nedsætter dit blodtryk og din puls, kan samtidig anvendelse af Dexdor forstærke denne virkning.
English: Keep the ampoules or vials in the outer carton in order to protect from light.
Danish: Opbevar ampullerne eller hætteglassene i den ydre karton for at beskytte mod lys.
English: Dexdor contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free'.
Danish: Dexdor indeholder mindre end 1 mmol natrium (23 mg) pr. ml, det vil sige det er i det væsentlige 'natriumfrit'.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Danish: Opbevaring Kemisk og fysisk stabilitet efter åbning er dokumenteret i 24 timer ved 25 °C.
English: Dexmedetomidine is 94% bound to plasma proteins.
Danish: Dexmedetomidin har en plasmaproteinbinding på 94 %.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVEDNDT LÆGEMIDDEL SAMT AFFALD HERAF
English: - The other ingredients are sodium chloride and water for injections.
Danish: - Øvrige indholdsstoffer: natriumchlorid og vand til injektionsvæsker.
English: Caution is advised when administering dexmedetomidine together with spinal or epidural anaesthesia due to possible increased risk of hypotension or bradycardia.
Danish: Forsigtighed tilrådes, når dexmedetomidin gives sammen med spinal eller epidural anæstesi på grund af en mulig øget risiko for hypotension eller bradykardi.
English: 2, 5 or 10 ml Type I glass vials (with filling volumes of 2, 4 and 10 ml), grey bromobutyl rubber closure with fluoropolymer coating
Danish: 2, 5 eller 10 ml hætteglas af glastype I (med nominelle volumina på 2, 4 og 10 ml), lukket med en grå bromobutylgummiprop med fluoropolymer overtræk.
English: In the rabbit study intravenous administration of the maximum dose, 96 µg/kg/day, produced exposures that are similar to those observed clinically.
Danish: I studier med kaniner medførte intravenøs administration af 96 μg/kg/dag eksponeringer, som er tilsvarende de, der sås klinisk.
English: Metabolite H-1, N-methyl 3-hydroxymethyl dexmedetomidine O-glucuronide, is also a major circulating product of dexmedetomidine biotransformation.
Danish: Metabolit H-1, N-methyl 3-hydroxymethyl dexmedtomidin O-glucuronid, er ligeledes et betydende cirkulerende produkt af dexmedetomidins biotransformation.
English: - The maintenance infusion is generally initiated at 0.6-0.7 microgram/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 microgram/kg/hour.
Danish: Vedligeholdelsesinfusionen er generelt initieret med 0,6-0,7 mikrogram/kg/time og titreret til ønsket klinisk effekt med doser liggende mellem 0,2 til 1 mikrogram/kg/time.
English: 1000 mcg/ 10 ml
Danish: 1000 mikrog/10 ml
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.
Danish: Der skal udvises forsigtighed ved alvorligt nedsat leverfunktion, da ekstremt høje doser kan øge risikoen for bivirkninger, oversedering eller forlænget virkning som følge af nedsat dexmedetomidin clearance.
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.
Danish: Patienter i god fysisk form og med lav hvilepuls, kan være særlig følsomme for alpha-2-receptor-agonisters virkning på bradykardi, og der er rapporteret tilfælde af forbigående sinusarrest.
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).
Danish: Den gennemsnitlige estimerede terminale eliminationshalveringstid (t½) er cirka 9 til 2,5 timer (min. 1,35, max. 3,68 timer) og genemsnitligt estimeret steady state -distributionsvolumen (Vss) er cirka 1,16 til 2,16 l/kg (90 til 151 liter).
English: In double blind comparator controlled ICU studies the incidence of cortisol suppression in patients treated with dexmedetomidine (n=778) was 0.5% compared with 0% in patients treated with either midazolam (n=338) or propofol (n=275).
Danish: I dobbelt blindede komparator-kontrollerede ICU studier var der hos patienter i behandling med dexmedetomidin (n-778) en forekomst af cortisolsuppression på 0,5 % sammenlignet med 0 % hos patienter i behandling med enten midazolam (n=338) eller propofol (n=275).
English: Dexdor contains less than 1 mmol sodium (23 mg) per ml.
Danish: Dexdor indeholder mindre end 1 mmol natrium (23 mg) per ml.
English: The maintenance infusion of study drug could be titrated from 0.2 µg/kg/h to 1 µg/kg/h.
Danish: Vedligeholdelsesinfusionen af studiemedicinen kunne titreres fra 0,2 mikrog/kg/time til 1 mikrog/kg/time.
English: Dexdor should not be used as a general anaesthetic induction agent for intubation or to provide sedation during muscle relaxant use.
Danish: Dexdor må ikke anvendes som et generelt anæstetisk induktionsmiddel til intubation eller til at fremkalde sedation under anvendelse af muskelrelaksantia.
English: Hypertension has been associated with the use of a loading dose and this reaction can be reduced by avoiding such a loading dose or reducing the infusion rate or size of the loading dose.
Danish: Hypertension er sat i forbindelse med anvendelse af bolusdosis og denne reaktion kan reduceres ved at undgå bolusdosis eller ved at reducere infusionshastigheden eller størrelsen af bolusdosis.
English: Patients already intubated and sedated may switch to dexmedetomidine with an initial infusion rate of 0.7 micrograms/kg/h which may then be adjusted stepwise within the dose range 0.2 to 1.4 micrograms/kg/h in order to achieve the desired level of sedation, depending on the patient's response.
Danish: Patienter, der i forvejen er intuberede og sederede kan skifte til dexmedetomidin med en initial infusionshastighed på 0,7 mikrogram/kg/t, som herefter trinvist kan tilpasses indenfor dosisområdet 0,2 - 1,4 mikrogram/kg/t med henblik på at opnå det ønskede sedationsniveau afhængig af patientens respons.
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.
Danish: Der er meget begrænsede data vedrørende virkning for patienter med en puls på <60, og der skal især udvises forsigtighed hos disse patienter.
English: 400 mcg/ 4 ml
Danish: 400 mikrog/4 ml
English: Most dexmedetomidine patients required no additional sedative treatment.
Danish: De fleste patienter, som blev behandlet med dexmedetomidin, havde ikke behov for yderligere behandling med sedativa.
English: Dexmedetomidine treatment should be discontinued in the event of a sustained unexplained fever and is not recommended for use in malignant hyperthermia-sensitive patients.
Danish: Behandling med dexmedetomidinskal seponeres i tilfælde af en vedvarende uforklarlig feber og behandling anbefales ikke til malign hypertermi-sensitive patienter.
English: With higher doses, peripheral vasoconstricting effects prevail leading to an increase in systemic vascular resistance and blood pressure, while the bradycardic effect is further emphasised.
Danish: Med højere doser er forsnævring af blodkar en fremherskende virkning, som medfører en stigning i den vaskulære modstand og blodtryk, mens bradykardi er endnu mere udtalt.
English: The mean percentage of unbound dexmedetomidine in plasma ranged from 8.5% in healthy subjects to 17.9% in subjects with severe hepatic impairment.
Danish: Den gennemsnitlige procentdel af ikke bundet dexmedetomidin i plasma er 8,5 % hos raske personer til 17,9 % hos personer med alvorligt nedsat leverfunktion.
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.
Danish: Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 behandlede) - nedsat hjertefunktion - opsvulmet mave - tørst - en tilstand, hvor der er for meget syre i kroppen - lav koncentration af æggehvidestoffer i blodet - åndenød - hallucinationer - medicinen har en utilstrækkelig virkning.
English: Dexdor is given as a loading infusion followed by maintenance infusion.
Danish: Dexdor gives som en stødinfusion efterfulgt af en vedligeholdelsesinfusion.
English: The concentration of the final solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml.
Danish: Koncentrationen af den færdige infusionsvæske efter fortynding bør være enten 4 mikrogram/ml eller 8 mikrogram/ml.
English: Some patients receiving Dexdor have been observed to be arousable and alert when stimulated.
Danish: Hos nogle patienter, i behandling med Dexdor, er det observeret at disse er lette at vække og kvikke ved stimulering.
English: 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.
Danish: De gennemsnitlige plasmaclearance værdier for ikke bundet dexmedetomidin hos personer med let, moderat eller alvorligt nedsat leverfunktion var henholdsvis 59 %, 51 % og 32 % af de værdier, som blev observeret hos raske personer.
English: After dilution Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Danish: Efter fortynding: Kemisk og fysisk stabilitet efter åbning er dokumenteret i 24 timer ved 25 °C.
English: Dexmedetomidine is metabolised in the liver and should be used with caution in patients with hepatic impairment.
Danish: Dexmedetomidin metaboliseres i leveren og skal anvendes med forsigtighed hos patienter med nedsat leverfunktion.
English: However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine, a reduction in dosage of dexmedetomidine or the concomitant anaesthetic, sedative, hypnotic or opioid may be required.
Danish: På grund af risiko for farmakodynamiske interaktioner ved samtidig administration af dexmedetomidin kan det dog være påkrævet at reducere dosis af enten dexmedetomidin eller det samtidige anæstetikum, sedativum, hypnotikum eller opioid.
English: This medicine does not require any special temperature storage conditions.
Danish: Der er ingen særlige krav vedrørende opbevaringstemperatur for dette lægemiddel.
English: Co-administration of dexmedetomidine with anaesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of effects, including sedative, anaesthetic and cardiorespiratory effects.
Danish: Samtidig administration af dexmedetomidin og anæstetika, sedativa, hypnotika og opioider medfører sandsynligvis en øget virkning, herunder sedative, anæstetiske og kardiorespiratoriske virkninger.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mcg/ 2 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 200 mikrog/2 ml
English: In relatively healthy non-ICU subjects treated with dexmedetomidine, bradycardia has occasionally led to sinus arrest or pause.
Danish: Hos forholdsvis raske patienter, ikke indlagt på intensivafdeling, behandlet med dexmedetomidin, har bradykardi lejlighedsvist medført bradykardi med sinusarrest eller pause.
English: 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.
Danish: I studier af reproduktionstoksicitet havde dexmedetomidin ingen virkning på fertiliteten hos han- eller hunrotten, og der blev ikke set nogen teratogen virkning hos rotten eller kaninen.
English: The most common adverse reactions reported in conjunction with overdose include bradycardia, hypotension, hypertension, oversedation, respiratory depression and cardiac arrest.
Danish: De hyppigste bivirkninger, der er rapporteret i forbindelse med overdosis, omfatter bradykardi, hypotension, hypertension, oversedation, respirationsdepression og hjertestop.
English: The pharmacokinetics of dexmedetomidine has been assessed following short term IV administration in healthy volunteers and long term infusion in ICU population.
Danish: Dexmedetomidins farmakokinetik er blevet vurderet efter en kortids i.v.-administration til raske frivillige og langtidsinfusioner til patienter på intensivafdelinger.
English: 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.
Danish: Hypotension og bradykardi var ligeledes de hyppigste dexmedetomidin-relaterede alvorlige bivirkninger og forekom hos henholdsvis 1,7 % og 0,9 % af patienterne på randomiserede intensivafdelinger.
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).
Danish: Patienter skal kontinuerligt monitoreres for tidlige tegn på hypotension, hypertension, bradykardi, respirationsdepression, luftvejsobstruktion, apnø, dyspnø, og/eller iltafmætning (se pkt.
English: Inhibition of CYP enzymes including CYP2B6 by dexmedetomidine has been studied in human liver microsome incubations.
Danish: Dexmedetomidins hæmning af CYP-enzymer herunder CYP2B6 er blevet undersøgt i inkubationer med humane levermikrosomer.
English: Dexmedetomidine plasma protein binding is decreased in subjects with hepatic impairment compared with healthy subjects.
Danish: Dexmedetomidins plasmaproteinbinding er nedsat hos personer med nedsat leverfunktion sammenlignet med raske personer.
English: 2 ml glass ampoules 2, 5 or 10 ml glass vials
Danish: 2 ml glasampuller 2, 5 eller 10 ml hætteglas
English: Caution should be exercised when administering dexmedetomidine to patients with pre-existing bradycardia.
Danish: Der skal udvises forsigtighed ved administration af dexmedetomidin til patienter med eksisterende bradykardi.
English: What you need to know before you are given Dexdor
Danish: Det skal du vide, før du får Dexdor
English: After sedation/wake-up
Danish: Efter bedøvelse/ved opvågning
English: Data in new-born infants (28 - 44 weeks gestation) is very limited and restricted to maintenance doses ≤ 0.2 mcg/kg/h.
Danish: Data fra nyfødte (gestationsalder 28-44 uger) er meget begrænsede og er begrænset til vedligeholdelsesdoser < 0,2 mikrogram/kg/t.
English: The mean midazolam rescue dose was 1.1 mg in the dexmedetomidine group, and 2.8 mg in the placebo group.
Danish: Den gennemsnitlige midazolam-akutdosis var 1,1 mg i dexmedetomidin-gruppen og 2,8 mg i placebogruppen.
English: Elderly patients over 65 years of age may be more prone to hypotension with the administration of dexmedetomidine, including a loading dose, for procedures.
Danish: Ældre patienter over 65 år kan have en øget risiko for hypotension ved behandling med dexmedetomidin også når det administreres som en støddosis ved operation.
English: The oxygen saturation should be monitored by pulse oximetry.
Danish: Iltafmætningen skal monitoreres med pulsoximetri.