FrancophonIA/ELRC3.0 huggingface dataset:
English: Children > 1 month post-natal, predominantly post-operative, have been evaluated for treatment up to 24 hours in the ICU and demonstrated a similar safety profile as in adults.
Danish: Børn >1 måned postnatalt, fortrinsvis post-operativt, er blevet vurderet ved behandling i op til 24 timer på intensivafdeling og udviste samme sikkerhedsprofil som voksne.
English: Dexmedetomidine has analgesic and anaesthetic/analgesic-sparing effects.
Danish: Dexmedetomidin har analgetiske og anæstesi-/analgesi-besparende virkninger.
English: Expected effects are primarily cardiovascular and should be treated as clinically indicated (see section 4.4).
Danish: Forventede bivirkninger er primært kardiovaskulære og bør behandles som klinisk indiceret (se pkt.
English: Very high temperatures had been reported in a small number of the case reports, and that anti-pyretic agents or/external cooling were not effective.
Danish: I et mindre antal tilfælde blev meget høje temperaturer rapporteret, og her var antipyretiske midler eller ekstern afkøling ikke effektivt.
English: The concentrate is a clear, colourless solution, pH 4.5 - 7.0
Danish: Koncentratet er en klar, farveløs opløsning, pH 4,5-7,0.
English: 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.
Danish: Supplerende analgetika eller sedativa (f.eks. opioider midazolam, eller propofol) er anbefalet ved smertefulde procedurer eller hvis øget sedation er nødvendigt.
English: Total volume of infusion
Danish: Totalt infusionsvolumen
English: Dexdor has major impact on the ability to drive and use machines.
Danish: Dexdor har stor indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter enkelte og gentagne doser og genotoksicitet.
English: The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation.
Danish: Infusionshastighedens for vedligeholdelsesdosen skal tilpasses for at opnå det ønskede sedationsniveau.
English: This possibility should be considered if the patient develops agitation and hypertension shortly after stopping dexmedetomidine.
Danish: Denne risiko skal overvejes, hvis patienten udvikler agitation og hypertension kort efter seponering af dexmetdetomidin.
English: In the age groups 1 months to 6 years, body weight-adjusted plasma clearance appeared higher but decreased in older children.
Danish: I aldersgruppen 1 måned til 6 år er den vægtjusterede plasmaclearance højere, men faldt hos ældre børn.
English: All patients should have continuous cardiac monitoring during Dexdor infusion.
Danish: Alle patienter skal kontinuerligt kardielt monitoreres under Dexdorinfusion.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/718/001-002, EU/1/11/718/004, EU/1/11/718/006-007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/718/001-002, EU/1/11/718/004, EU/1/11/718/006-007
English: Depending on the procedure concomitant local anaesthesia or analgesia may be needed in order to achieve the desired clinical effect.
Danish: Afhængigt af proceduren kan samtidig lokalt virkende anæstetika eller sedativa nødvendig for at opnå ønsket klinisk effekt.
English: Several cases of dexmedetomidine overdose have been reported both in the clinical trial and the postmarketing data.
Danish: Der er rapporteret adskillige tilfælde af dexmedetomidinoverdosis, både i kliniske studier og efter markedsføring.
English: The time to recovery after the use of dexmedetomidine was reported to be approximately one hour.
Danish: Restitutionstiden efter brug af dexmedetomidin er rapporteret til at være ca. 1 time.
English: Patients could be successfully extubated without stopping the Dexdor infusion.
Danish: Patienterne kunne med held ekstuberes uden at stoppe infusionen med Dexdor.
English: Data in new-born infants (28 - 44 weeks gestation) to children 17 years of age are limited.
Danish: Data for nyfødte (gestationsalder 28-44 uger) til børn i alderen 17 år er begrænsede.
English: The time to recovery ranged from a short time after discontinuation of dexmedetomidine, to some days later.
Danish: Restitueringstiden varierede fra kort tid efter seponering af dexmedetomidin til nogle dage senere.
English: Elderly patients appear to have an increased risk for hypotension (see section 4.4) but the limited data available from procedural sedation do not suggest a clear dose dependency.
Danish: Ældre patienter kan have en højere risiko for hypotension (se pkt 4.4) men begrænset data fra brug ved vågne sedation viser ingen klar sammenhæng med dosis.
English: Pharmacotherapeutic group: Psycholeptics, other hypnotics and sedatives, ATC code: N05CM18
Danish: Farmakoterapeutisk klassifikation: psykoleptika, andre hypnotika og sedativa, ATC-kode: N05CM18
English: Taking into account the PRAC Assessment Report on the PSUR(s) for dexmedetomidine, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC´s vurderingsrapport om PSUR´en/PSUR´erne for dexmedetomidin er CHMP nået frem til følgende videnskabelige konklusioner:
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.
Danish: Begrundelse for ændringen af betingelserne i markedsføringstilladelsen På baggrund af de videnskabelige konklusioner for dexmedetomidin er CHMP af den opfattelse, at fordelings / risikobalancen for lægemidlet (e), der indeholder dexmedetomidin, er uændret, med forbehold af de foreslåede ændringer af produktinformationen CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-tilladelserne bør ændres.
English: Available data suggest that the formation of the oxidised metabolites is mediated by several CYP forms (CYP2A6, CYP1A2, CYP2E1, CYP2D6 and CYP2C19).
Danish: Tilgængelige data tyder på, at dannelsen af de oxiderede metabolitter er medieret ved adskillige CYP-former (CYP2A6, CYP1A2, CYP2E1, CYP2D6 og CYP2C19).
English: Patients failing to achieve an adequate level of sedation with the maximum dose of dexmedetomidine should be switched to an alternative sedative agent.
Danish: Patienter, som ikke opnår et adækvat sedationsniveau med den maksimale dosis af dexmedetomidin, bør skifte til et alternativt sedativum.
English: Dexmedetomidine is excreted in human milk, however levels will be below the limit of detection by 24 hours following treatment discontinuation.
Danish: Dexmedetomidin udskilles i human mælk, dog er niveauet under detektionsgrænsen 24 timer efter afsluttet behandling.
English: Bradycardia does not normally require treatment, but has commonly responded to anti-cholinergic medicine or dose reduction where needed.
Danish: Bradykardi er normalt ikke behandlingskrævende, men har almindeligvis responderet på antikolinerg behandling eller dosisreduktion, hvor det var påkrævet.
English: Dexmedetomidine is very potent and the infusion rate is given per hour.
Danish: Dexmedetomidin er meget kraftigt virkende og infusionshastigheden er angivet pr. time.
English: Compatibility studies have shown potential for adsorption of dexmedetomidine to some types of natural rubber.
Danish: Kompatibilitetsstudier har vist et potentiale for adsorption af dexmedetomidin til nogle typer af naturgummi.
English: Dexmedetomidine is therefore not suitable in patients with severe cardiovascular instability.
Danish: Dexmedetomidin er derfor ikke egnet til patienter med alvorlig kardiovaskulær ustabilitet.
English: Lifepharma (ZAM) Ltd Τηλ.
Danish: Lifepharma (ZAM) Ltd
English: The safety and efficacy of dexmedetomidine for sedation of non-intubated patients prior to and/or during surgical and diagnostic procedures was evaluated in two randomised, double-blind, placebocontrolled multicentre clinical trials.
Danish: Sikkerheden og effekten af dexmedetomidin til sedation af ikke-intuberede patienter før og/eller under kirurgiske og diagnostiske indgreb blev evalueret i to randomiserede, dobbeltblindede, placebokontrollerede, kliniske multicenterstudier.
English: For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 micrograms/kg given over 10 minutes may be suitable.
Danish: Ved mindre invasive procedurer såsom ved øjenkirurgi kan en stødinfusion på 0,5 mikrogram/kg over 10 minutter være passende.
English: Hypotension does not normally require specific treatment but, where needed, users should be ready to intervene with dose reduction, fluids and/or vasoconstrictors .
Danish: Hypotension er normalt ikke behandlingskrævende, men om nødvendigt skal brugerne være klar til at intervenere med dosisreduktion, væsker og/eller vasokonstriktorer.
English: For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).
Danish: Til sedation af voksne patienter på intensivafdeling, der har behov for et sedationsniveau, der ikke er dybere end opvågning ved verbal stimulering (svarende til Richmond Agitation-Sedation Scale (RASS) 0 til -3).
English: Ampoules and vials are intended for single patient use only.
Danish: Ampuller og hætteglas er kun beregnet til anvendelse hos en enkelt patient.
English: Dexmedetomidine half life in children (1 months to 17 years) appears similar to that seen in adults, but in new-born infants (under 1 month) it appears higher.
Danish: Dexmedetomidins halveringstid synes at være den samme hos børn (1 måned til 17 år) som hos voksne, men højere hos nyfødte (under 1 måned).
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Studier med dyr har vist reproduktionstoksicitet (se pkt.
English: Cardio-vascular effects and precautions
Danish: Kardiovaskulære virkninger og forsigtighedsregler
English: Therefore the PRAC recommends a more prominent warning that dexmedetomidine should not be used in malignant hyperthermia-sensitive patients.
Danish: Derfor anbefaler PRAC en mere fremtrædende advarsel om at dexmedetomidin ikke bør anvendes til malign hypertermi-sensitive patienter.
English: Dexmedetomidine is a selective alpha-2 receptor agonist with a broad range of pharmacological properties.
Danish: Dexmedetomidin er en selektiv alpha-2-receptoragonist med et bredt område af farmakologiske egenskaber.
English: Dexdor should be used immediately after dilution.
Danish: Dexdor skal anvendes umiddelbart efter fortynding.
English: A decision must be made whether to discontinue breastfeeding or to discontinue dexmedetomidine therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Danish: Der skal træffes en afgørelse om enten at ophøre med amning eller ophøre behandling med dexmedetomidin under hensyntagen til barnets fordel af amning og kvindens fordel af behandlingen.
English: The pharmacokinetics of dexmedetomidine in subjects with severe renal impairment (creatinine clearance <30 ml/min) is not altered relative to healthy subjects.
Danish: Dexmedetomidins farmakokinetik hos personer med alvorligt nedsat nyrefunktion (kreatininclearance <30 ml/min) er uændret i relation til raske personer.
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
Danish: - hvis du har en unormalt langsom puls (enten på grund af sygdom eller et højt niveau af fysisk kondition) - hvis du har et lavt blodtryk - hvis du har et lavt blodvolumen, for eksempel efter blødning - hvis du har visse hjertesygdomme - hvis du er ældre - hvis du har neurologiske forstyrrelser (for eksempel beskadigelse af hovedet eller rygmarven eller slagtilfælde) - hvis du har alvorlige leverproblemer - hvis du på noget tidspunkt har udviklet alvorlig feber efter nogle lægemidler, især narkosemidler
English: There are three types of initial metabolic reactions; direct N-glucuronidation, direct N-methylation and cytochrome P450 catalysed oxidation.
Danish: Der findes tre typer af initial metaboliske reaktioner, direkte N-glukuronidering, direkte N-methylering og cytochrom P450 katalyseret oxidation.
English: Dexmedetomidine is therefore not suitable in patients who will not tolerate this profile of effects, for example those requiring continuous deep sedation.
Danish: Dexmedetomidin egner sig derfor ikke til patienter der ikke tåler denne effekt profil, f.eks. hvis dyb vedvarende sedation er krævet.
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.
Danish: Studier gennemført udenfor intensivafdelingen bekræfter, at Dexdor kan administreres sikkert til patienter uden endotracheal intubation forudsat at tilstrækkelig monitorering er tilgængelig.
English: Dexmedetomidine may induce hyperthermia that may be resistant to traditional cooling methods.
Danish: Dexmedetomidin kan inducere hypertermi, som kan være resistent mod traditionelle afkølingsmetoder.
English: Dexdor contains an active substance called dexmedetomidine which belongs to a medicine group called sedatives.
Danish: Dexdor indeholder en aktiv substans, der kaldes dexmedetomidin og som tilhører en gruppe medicin, der kaldes sedativa.
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.
Danish: Hos rotten medførte subkutan administration af den maksimale dosis på 200 μg/kg/dag en stigning i embryoføtal død og reducerede den føtale legemsvægt.
English: Dexdor should not be used during pregnancy or breast-feeding unless clearly necessary.
Danish: Dexdor bør ikke anvendes under graviditet eller amning, medmindre det er klart nødvendigt.
English: Specific studies have confirmed enhanced effects with isoflurane, propofol, alfentanil, and midazolam.
Danish: Specifikke studier har bekræftet øgede virkninger med isofluran, propofol, alfentanil og midazolam.
English: General precautions
Danish: Generelle forsigtighedsregler
English: SPECIAL STORAGE CONDITIONS Keep the ampoules/vials in the outer carton in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar ampullerne/hætteglassene i den ydre karton for at beskytte mod lys.
English: In isolated cases bradycardia has progressed to periods of asystole in patients with pre-existing bradycardia.
Danish: I enkeltstående tilfælde er bradykardi progredieret til perioder med asystoli hos patienter med eksisterende bradykardi.
English: Dexmedetomidine is eliminated by extensive metabolism in the liver.
Danish: Dexmedetomidin elimineres ved ekstensiv metabolisering i leveren.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: - Medicines to help you sleep, cause sedation or strong painkillers may not be appropriate for some time after you have been given Dexdor.
Danish: - Medicin, der hjælper dig med at sove, virker bedøvende og stærke smertestillende midler, kan være uhensigtsmæssige i nogen tid efter du har fået Dexdor.
English: The adverse reactions listed in Table 1 have been accumulated from pooled data of clinical trials in intensive care.
Danish: De bivirkninger, der er anført i tabel 1, er akkumuleret fra samlede data fra kliniske studier på intensivafdelinger.
English: In vitro study suggests that interaction potential in vivo exists between dexmedetomidine and substrates with dominant CYP2B6 metabolism.
Danish: In vitro-studier tyder på, at der er et interaktionspotentiale in vivo mellem dexmedetomidin og substrater med dominant CYP2B6-metabolisme.
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.
Danish: Patienter skal rådes til at afstå fra at køre bil eller udføre risikofyldte opgaver i en passende tidsperiode efter at have fået Dexdor til vågen sedation.
English: Experience of dexmedetomidine in severe neurological disorders such as head injury and after neurosurgery is limited and it should be used with caution here, especially if deep sedation is required.
Danish: Der er begrænset erfaring med dexmedetomidin ved alvorlige neurologiske forstyrrelser, såsom hovedskader og efter neurokirurgi, og skal her anvendes med forsigtighed, især hvis dyb sedation er påkrævet.
English: Adverse reactions Metabolism and nutrition disorders Common:
Danish: Bivirkninger Metabolisme og ernæring Almindelig:
English: It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care settings or awake sedation during different diagnostic or surgical procedures.
Danish: Det anvendes til at fremkalde en let bedøvelse (en tilstand af ro, døsighed eller søvn) af voksne på en intensivafdeling på et sygehus eller vågen bedøvelse ved forskellige diagnostiske eller kirugiske indgreb.
English: Clinically significant hypotension or bradycardia should be treated as described in section 4.4.
Danish: Klinisk signifikant hypotension eller bradykardi skal behandles som beskrevet i pkt.
English: No dose adjustment is required for patients with renal impairment.
Danish: Der kræves ingen dosisjustering hos patienter med nedsat nyrefunktion.
English: The symptoms responded to leg raising and anticholinergics such as atropine or glycopyrrolate.
Danish: Symptomerne responderede på elevation af underekstremiteter og antikolinergika såsom atropin eller glycopyrrolat.
English: No pharmacokinetic interactions between dexmedetomidine and isoflurane, propofol, alfentanil and midazolam have been demonstrated.
Danish: Der er ikke påvist farmakokinetiske interaktioner mellem dexmedetomidin og isofluran, propofol, alfentanil og midazolam.
English: Dexmedetomidine normally does not cause deep sedation and patients may be easily roused.
Danish: Dexmedetomidin medfører normalt ikke dyb sedation og patienter kan let vækkes.
English: Subjects with varying degrees of hepatic impairment (Child-Pugh Class A, B, or C) had decreased hepatic clearance of dexmedetomidine and prolonged plasma elimination t1/2.
Danish: Personer med varierende grader af nedsat leverfunktion (Child-Pug Klasse A, B eller C) har en nedsat hepatisk clearance af dexmedetomidin og en forlænget plasmaelimination t½.
English: Dexmedetomidine binds to both human serum albumin and Alpha-1-acid glycoprotein with serum albumin as the major binding protein of dexmedetomidine in plasma.
Danish: Dexmedetomidin binder sig både til human serumalbumin og alpha 1-syre glycoprotein med serumalbumin som det vigtigste bindingsprotein for dexemedetomidin i plasma.
English: Dexmedetomidine may reduce cerebral blood flow and intracranial pressure and this should be considered when selecting therapy.
Danish: Dexmedetomidin kan nedsætte den cerebrale blodgenemstrømning og intrakranielt tryk, og dette skal tages i betragtning ved valg af behandling.
English: In clinical studies, cases of sinus arrest reversed spontaneously or responded to treatment with atropine and glycopyrrolate.
Danish: I kliniske studier ophævedes tilfælde af sinusarrest spontant eller responderede på behandling med atropin og glycopyrrolat.
English: Dexmedetomidine exhibits a two-compartment disposition model.
Danish: Dexmedetomidin udviser en to-kompartment dispositionsmodel.
English: 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.
Danish: Den vægtjusterede plasmaclearance hos nyfødte (under 1 måned) var lavere (0,9 l/t/kg) end hos de ældre grupper som følge af umodenhed.
English: The sedative effects are mediated through decreased firing of locus coeruleus, the predominant noradrenergic nucleus, situated in the brainstem.
Danish: Den sederende virkning er medieret ved en reduceret tænding af locus coeruleus, den dominerende noradrenerge nukleus, som sidder i hjernestammen.
English: Please see below in tabulated form the volumes needed to prepare the infusion.
Danish: I tabellen nedenfor ses hvilke volumina, der er nødvendige for tilberedning af infusionen.
English: Treatment of hypertension has generally not been necessary but decreasing the continuous infusion rate may be advisable.
Danish: Hypertension er normalt ikke behandlingskrævende, men det kan være tilrådeligt at reducere den kontinuerlige infusionshastighed.
English: Dexdor should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Dexdor skal inspiceres visuelt for partikler og misfarvning før administration.
English: Dexdor should not be used with medicines that cause temporary paralysis.
Danish: Dexdor må ikke anvendes sammen med medicin, der medfører forbigående lammelse.
English: Dexdor has been shown to be compatible when administered with the following intravenous fluids and medicinal products:
Danish: Dexdor har vist kompatibilitet ved administrationen sammen med følgende intravenøse væsker og lægemidler:
English: Plasma clearance (Cl) has a mean estimated value of 0.46 to 0.73 l/h/kg (35.7 to 51.1 l/h).
Danish: Plasmaclearance (Cl) har en gennemsnitlig estimeret værdi på 0,46 til 0,73 l/time/kg (35,7 til 51,1 l/time).
English: During the current reporting period 16 March 2017 - 15 Mar 2018, the market authorisation holder, Orion pharma undertook a cumulative review of all reports of the adverse reaction of hyperthermia Their review identified 172 reports, 91 of which were serious and 81 of which were non-serious.
Danish: I løbet af den nuværende rapporteringsperiode 16. marts 2017 - 15. marts 2018, foretog indehaveren af markedsføringstilladelsen - Orion Pharma en kumulativ gennemgang af alle bivirkningsrapporter omhandlende hypertermi.
English: - if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Dexdor - hvis du er allergisk over for dexmedetomidin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: 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.
Danish: Den gennemsnitlige t½ hos personer med let, moderat eller alvorligt nedsat leverfunktion var forlænget med henholdsvis 3,9; 5,4 og 7,4 timer.
English: The possibility of enhanced hypotensive and bradycardic effects should be considered in patients receiving other medicinal products causing these effects, for example beta blockers, although additional effects in an interaction study with esmolol were modest.
Danish: Risikoen for øget hypotensiv virkning og bradykardi skal overvejes hos patienter, der får andre lægemidler, der medfører disse virkninger som f.eks. betablokkere, selv om additive virkninger i interaktionsstudier med esmolol var beskedne.