FrancophonIA/ELRC3.0 huggingface dataset:
English: The symptoms responded to leg raising and anticholinergics such as atropine or glycopyrrolate.
Maltese: Is-sintomi rrispondew għall-elevazzjoni tar-riġlejn u anti kolinerġiċi bħal atropine jew glycopyrrolate.
English: Inhibition of CYP enzymes including CYP2B6 by dexmedetomidine has been studied in human liver microsome incubations.
Maltese: Inibizzjoni tal-enzimi CYP inkluż CYP2B6 minn dexmedetomidine kienet studjata f'inkubazzjonijiet ta' mikrosomi tal-fwied uman.
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).
Maltese: F'pazjenti mhux intubati għandha tiġi ssorveljata r-respirazzjoni minħabba r-riskju ta' depressjoni respiratorja u f'xi każijiet apnea (ara sezzjoni 4.8).
English: Acute cerebrovascular conditions.
Maltese: Kundizzjonijiet ċerebrovaskulari akuti.
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.
Maltese: Pressjoni baxxa u bradikardija kienu wkoll l-aktar reazzjonijiet avversi serji frekwenti relatati ma' dexmedetomidine li jseħħu f'1.7% u 0.9% tal-pazjenti randomised fit-Taqsima tal-Kura Intensiva (ICU) rispettivament.
English: The concentration of the final solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml.
Maltese: Il-konċentrazzjoni tas-soluzzjoni finali wara d-dilwazzjoni għandha tkun ta' 4 mikrogrammi/mL jew 8 mikrogrammi/mL.
English: Compatibility studies have shown potential for adsorption of dexmedetomidine to some types of natural rubber.
Maltese: Studji ta' kompatibilità wrew potenzjal għall-assorbiment ta' dexmedetomidine minn xi tipi ta' lastiku naturali.
English: Dexmedetomidine is a selective alpha-2 receptor agonist with a broad range of pharmacological properties.
Maltese: Dexmedetomidine huwa agonist selettiv tar-riċettur alpha-2 b'firxa wiesgħa ta' kwalitajiet farmakoloġiċi.
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
Maltese: 1 Ara s-sezzjoni dwar Deskrizzjoni ta' reazzjonijiet avversi magħżula 2 Reazzjoni avversa osservata wkoll fl-istudji tas-sedazzjoni proċedurali 3 Inċidenza “komuni” fl-istudji tas-sedazzjoni fl-ICU
English: PC: {number} SN: {number} NN: {number}
Maltese: - M'għandekx tmur id-dar mhux akkumpanjat.
English: Data in new-born infants (28 - 44 weeks gestation) is very limited and restricted to maintenance doses ≤ 0.2 mcg/kg/h.
Maltese: Id-dejta fit-trabi tat-twelid (28 - 44 ġimgħa ta' tqala) hija limitata ħafna u ristretta għal dożi ta' manteniment ta' ≤0.2 µg/kg/h.
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).
Maltese: L-istima medja tal-half-life terminali tal-eliminazzjoni (t1/2) hija madwar 1.9 sa 2.5 sigħat (l-inqas 1.35, l-aktar 3.68 siegħa) u l-istima medja tal-volum ta' distribuzzjoni fi stat fiss (Vss) hija madwar 1.16 sa 2.16 l/kg (90 sa 151 litru).
English: The adverse drug reaction (ADR) of hyperthermia is already highlighted in the Summary of Product Characteristics (SmPCs) therefore is subject to routine pharmacovigilance and routine risk minimisation, however the current warning in section 4.4 of the SmPC does not mention the lack of effect of cooling through other measures.
Maltese: Ir-reazzjoni avversa għall-mediċina (ADR) ta' ipertermija diġà hija msemmija fis-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) u għalhekk hija soġġetta għal farmakoviġilanza ta' rutina u minimizzazzjoni tar-riskju ta' rutina, madanakollu t-twissija attwali f'sezzjoni 4.4 tal-SmPC ma ssemmix in-nuqqas ta' effett tat-tkessiħ permezz ta' miżuri oħra.
English: Excipients
Maltese: Aġitazzjoni
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.
Maltese: Id-differenza fir-riskju fi proporzjon ta' individwi magħżula b'mod randomised għall-grupp ta' dexmedetomidine 1 μg/kg u għall-grupp ta' dexmedetomidine 0.5 μg/kg li ma kinux jeħtieġu midazolam għas-sopravivenza kienet ta' 48% (95% CI: 37%57%) u 40% (95% CI: 28% - 48%), rispettivament imqabbla mal-plaċebo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 September 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Settembru 2011
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.
Maltese: Dexdor jista' jiġi dilwit f'soluzzjoni ta' 50 mg/mL (5%) glucose, Ringers, mannitol jew soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride biex tinkiseb il-konċentrazzjoni meħtieġa ta' 4 mikrogrammi/mL jew 8 mikrogrammi/mL qabel l-għoti.
English: Please refer to section 4.2.
Maltese: Prodott, sezzjoni 4.2).
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).
Maltese: sedazzjoni mhux aktar fond minn tqanqil b'rispons għal stimulazzjoni verbali (li jikkorrispondi għall-Iskala ta' Aġitazzjoni-Sedazzjoni Richmond (RASS) 0 sa -3).
English: No pharmacokinetic interactions between dexmedetomidine and isoflurane, propofol, alfentanil and midazolam have been demonstrated.
Maltese: Ma ntwerew l-ebda interazzjonijiet farmakokinetiċi bejn dexmedetomidine u isoflurane, propofol, alfentanil u midazolam.
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.
Maltese: Il-valuri medji ta' tneħħija mill-plażma ta' dexmedetomidine mhux marbut għall-individwi b'indeboliment epatiku ħafif, moderat, u sever kienu ta' 59%, 51% u 32% ta' dawk osservati f'individwi normali f'saħħithom, rispettivament.
English: Dexdor contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free'.
Maltese: Dexdor fih anqas minn 1 mmol sodium (23 mg) għal kull mL, jiġifieri essenzjalment ‘ħieles mis-sodium'.
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.
Maltese: Evidenza ta' effikaċja pedjatrika kienet osservata fi studju fl-ICU b'doża kontrollata f'popolazzjoni fil-biċċa l-kbira wara operazzjoni b'età minn xahar sa ≤17-il sena.
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.
Maltese: Iċ-ċitokromju P-450 jikkatalizza l-formazzjoni ta' żewġ metaboliti minuri fiċċirkolazzjoni, 3-hydroxymethyl dexmedetomidine magħmul permezz ta' hydroxylation tal-grupp 3-methyl ta' dexmedetomidine u H-3 magħmul permezz ta' ossidazzjoni fiċ-ċirku imidazole.
English: The available data is summarised in the following table;
Maltese: Id-dejta disponibbli hija miġbura fil-qosor fit-tabella li ġejja;
English: These effects were associated with clear maternal toxicity.
Maltese: Dawn l-effetti kienu assoċjati ma' tossiċità materna ċara.
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.
Maltese: Intensiva huma pressjoni baxxa, pressjoni għolja u bradikardija, li jseħħu f'madwar 25%, 15% u 13%
English: Each 1 ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
Maltese: U KWANTITATTIVA Kull 1 ml ta' konċentrat fih dexmedetomidine hydrochloride ekwivalenti għal 100 mikrogramma dexmedetomidine.
English: How to use Dexdor
Maltese: Dexdor.
English: Polyuria
Maltese: Hrvatska
English: Following IV administration of radiolabeled dexmedetomidine an average 95% of radioactivity was recovered in the urine and 4% in the faeces after nine days.
Maltese: Wara għoti IV ta' dexmedetomidine radjutikkettat medja ta' 95% tar-radjuattività kienet irkuprata flawrina u 4% fl-ippurgar wara disat ijiem.
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).
Maltese: Il-pazjenti għandhom jiġu ssorveljati kontinwament għal sinjali bikrija ta' pressjoni baxxa, pressjoni għolja, bradikardija, dipressjoni respiratorja, imblukkar tal-passaġġ tal-arja, apnea, qtugħ ta' nifs u/jew desaturazzjoni ta' ossiġnu (ara sezzjoni 4.8).
English: Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
Maltese: Kull mL ta' konċentrat fih dexmedetomidine hydrochloride ekwivalenti għal 100 mikrogramma dexmedetomidine.
English: Total volume of infusion
Maltese: Volum totali ta' infużjoni
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)
Maltese: - Pressjoni baxxa (55% fil-grupp ta' dexmedetomidine kontra 30% fil-grupp tal-plaċebo li jkunu qed jirċievu midazolam u fentanyl ta' sopravivenza)
English: Dexdor 100 micrograms/ml concentrate for solution for infusion Dexmedetomidine
Maltese: Dexdor 100 mikrogramma/mL konċentrat għal soluzzjoni għall-infużjoni dexmedetomidine
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Iddejta attwalment disponibbli hija deskritta f'sezzjonijiet 4.8, 5.1 u 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
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.
Maltese: Studju 2 għażel il-pazjenti b'mod randomised li jkunu għaddejjin minn intubazzjoni fibra ottika taħt anestesija topika biex jirċievu infużjoni għolja tal-bidu ta' dexmedetomidine ta' 1 µg/kg (n=55) jew plaċebo (soluzzjoni bil-melħ normali; n=50) li tingħata fuq 10 minuti u tkun segwita minn infużjoni ta' manteniment fissa ta' 0.7 µg/kg/siegħa.
English: Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
Maltese: Kull kunjett ta' 10 mL fih 1,000 mikrogramma ta' dexmedetomidine.
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.
Maltese: Dexmedetomidine jintrabat kemm mal-albumina kif ukoll mal-glikoproteina Alpha-1-acid tas-serum tal-bniedem bl-albumina tas serum bħala l-proteina prinċipali li magħha jintrabat dexmedetomidine fil-plażma.
English: The event was reported as mild in 1 and moderate in 3 cases.
Maltese: L-avveniment kien irrappurtat bħala ħafif f'każ wieħed u moderat fi 3 każijiet.
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.
Maltese: (Proporzjon 1.00; 95% CI 0.922, 1.075) fil-ħin tal-firxa ta' sedazzjoni fil-mira f'popolazzjoni medika predominanti li kienet teħtieġ sedazzjoni ħafifa għal moderata fit-tul (RASS 0 sa -3) fl-ICU għal perjodu ta' mhux aktar minn 14-il ġurnata, naqqas it-tul ta' ventilazzjoni mekkanika meta mqabbel ma' midazolam u naqqas il-ħin biex titneħħa l-intubazzjoni meta mqabbel ma' midazolam u propofol.
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.
Maltese: Il-ħin medjan għall-ewwel doża ta' sopravivenza kien ta' 114-il minuta fil-grupp ta' dexmedetomidine 1.0 µg/kg, 40 minuta fil-grupp ta' dexmedetomidine 0.5 µg/kg, u 20 minuta fil-grupp tal-plaċebo.
English: Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).
Maltese: Kull kunjett ta' 10 mL fih 1,000 mikrogramma ta' dexmedetomidine (bħala hydrochloride).
English: Sodium chloride Water for injections
Maltese: Fih ukoll sodium chloride, ilma għall-injezzjonijiet.
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)
Maltese: Id-differenza fil-medji tad-doża ta' midazolam għassopravivenza fil-grupp ta' dexmedetomidine 1 μg/kg u fil-grupp ta' dexmedetomidine 0.5 μg/kg imqabbla mal-plaċebo kienet ta' -3.1 mg (95% CI: -3.8 - -2.5) u -2.7 mg (95% CI:3.3 - -2.1), rispettivament jiffavorixxu lil dexmedetomidine.
English: Hrvatska Malta România Orion Oyj
Maltese: Orion Oyj
English: Hospital intensive care Dexdor is administered to you by a doctor or nurse in hospital intensive care.
Maltese: Kura intensiva fl-isptar Dexdor jingħatalek minn tabib jew infermier f'taqsima ta' kura intensiva fi sptar.
English: Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride).
Maltese: Kull ampulla ta' 2 mL fiha 200 mikrogramma ta' dexmedetomidine (bħala hydrochloride).
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.
Maltese: Il-farmakokinetika ta' dexmedetomidine hija lineari fil-firxa ta' dożaġġ minn 0.2 sa 1.4 µg/kg/h u ma jakkumulax waqt kura li ddum sa 14-il ġurnata.
English: For storage conditions after dilution of the medicinal product, see section 6.3
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Dexmedetomidine has analgesic and anaesthetic/analgesic-sparing effects.
Maltese: Dexmedetomidine għandu effetti analġeżiċi u anastetiċi/tnaqqis fl-użu tal-analġeżiċi.
English: In clinical studies, cases of sinus arrest reversed spontaneously or responded to treatment with atropine and glycopyrrolate.
Maltese: Fi studji kliniċi, każijiet ta' arrest tas-sinus reġgħu lura għan-normal spontanjament jew irrispondew għall-kura b'atropine u glycopyrrolate.
English: Vascular disorders: Very common: Hypotension1,2, hypertension1,2
Maltese: Pressjoni baxxa1,2, pressjoni għolja1,2 Disturbi respiratorji, toraċiċi u medjastinali
English: The risk difference in proportion of subjects randomised to dexmedetomidine not requiring rescue midazolam was 43% (95% CI: 23 % - 57%) compared placebo.
Maltese: Id-differenza fir-riskju fi proporzjon ta' individwi magħżula b'mod każwali għal dexmedetomidine li ma kinux jeħtieġu midazolam kienet ta' 43% (95% CI: 23% - 57%)
English: Dexmedetomidine exhibits a two-compartment disposition model.
Maltese: Dexmedetomidine juri mudell ta' dispożizzjoni ta' żewġ kompartimenti.
English: Dexdor is intended for use in an intensive care setting, operating room and during diagnostic procedures.
Maltese: Dexdor huwa maħsub għall-użu f'ambjent ta' kura intensiva, kamra tal-operazzjoni u matul proċeduri dijanjostiċi.
English: The pharmacokinetics of dexmedetomidine in subjects with severe renal impairment (creatinine clearance <30 ml/min) is not altered relative to healthy subjects.
Maltese: Il-farmakokinetika ta' dexmedetomidine f'individwi b'indeboliment renali sever (tneħħija talkrejatinina <30 mL/min) ma tinbidilx meta mqabbla ma' individwi f'saħħithom.
English: Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Maltese: Kull ampulla ta' 2 mL fiha 200 mikrogramma ta' dexmedetomidine.
English: Dexdor has been shown to be compatible when administered with the following intravenous fluids and medicinal products:
Maltese: Dexdor intwera li huwa kompatibbli meta jingħata mal-fluwidi li jistgħu jingħataw fil-vini u malprodotti mediċinali li ġejjin:
English: Plasma protein binding is constant over the concentration range of 0.85 to 85 ng/ml.
Maltese: It-twaħħil mal-proteini filplażma huwa kostanti fuq firxa ta' konċentrazzjoni ta' 0.85 sa 85 ng/mL.
English: No major pharmacokinetic differences have been observed based on gender or age.
Maltese: Ma kinux osservati differenzi farmakokinetiċi maġġuri bbażati fuq is-sess jew l-età.
English: After dilution Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Maltese: Stabbilità kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'25°C.
English: Dexdor contains an active substance called dexmedetomidine which belongs to a medicine group called sedatives.
Maltese: Dexdor fih sustanza attiva msejħa dexmedetomidine li tagħmel parti minn grupp ta' mediċini li jissejħu sedattivi.
English: Shelf life
Maltese: JEW KUNJETTI
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.
Maltese: Studju 1 għażel il-pazjenti b'mod randomised li jkunu għaddejjin minn kirurġiji/proċeduri mhux meħtieġa b'urġenza taħt kura ta' anestesija ssorveljata u anestesija lokali/reġjonali biex jirċievu infużjoni għolja tal-bidu ta' dexmedetomidine ta' 1 µg/kg (n=129) jew 0.5 µg/kg
English: Hyperglycaemia, hypoglycaemia Uncommon: Metabolic acidosis, hypoalbuminaemia
Maltese: Aċidożi metabolika, ipoalbuminemija Disturbi psikjatriċi
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
Maltese: Kunjetti ta' 2, 5 jew 10 mL tal-ħġieġ Tip I (b'volumi li jistgħu jimtlew ta' 2, 4 u 10 mL), għata ta' lewn griż ta' lastiku bromobutyl b'kisja ta' fluoropolymer
English: After sedation/wake-up
Maltese: Wara sedazzjoni/qawmien
English: Less than 1% of unchanged parent drug was recovered in the urine.
Maltese: Inqas minn 1% tal-mediċina oriġinali mhux mibdula kienet irkuprata fl-awrina.
English: Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).
Maltese: Kull kunjett ta' 4 mL fih 400 mikrogramma ta' dexmedetomidine (bħala hydrochloride).
English: The sedative effects are mediated through decreased firing of locus coeruleus, the predominant noradrenergic nucleus, situated in the brainstem.
Maltese: tnaqqis fir-reħa tal-locus coeruleus, in-nukleu noradrinerġiku predominanti, li jinsab fis-sinsla talmoħħ.
English: However, the majority were within 12 hours.
Maltese: 10 minuti tista' tkun adattata.
English: Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).
Maltese: Kull kunjett ta' 2 mL fih 200 mikrogramma ta' dexmedetomidine (bħala hydrochloride).
English: Maintenance of Procedural Sedation:
Maltese: Manteniment tas-Sedazzjoni Proċedurali:
English: Orion Pharma AB Tel: + 46 8 623 6440
Maltese: Tel: + 46 8 623 6440
English: Expected effects are primarily cardiovascular and should be treated as clinically indicated (see section 4.4).
Maltese: L-effetti mistennija huma primarjament kardjovaskulari u għandhom jiġu kkurati kif klinikament indikat (ara sezzjoni 4.4).
English: 44 weeks gestation) is very limited and restricted to low doses (≤ 0.2 mcg/kg/h) (see sections 5.2 and
Maltese: (≤0.2 μg/kg/h) (ara sezzjonijiet 5.2 u 4.4).
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.
Maltese: Biex tinżamm Skala ta' Sedazzjoni Ramsay ≥2, 53% tal-pazjenti li kienu qed jirċievu dexmedetomidine ma kinux jeħtieġu midazoloam għas-sopravivenza kontra 14% tal-pazjenti li kienu qed jirċievu plaċebo.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet dwar dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: In the rabbit study intravenous administration of the maximum dose, 96 µg/kg/day, produced exposures that are similar to those observed clinically.
Maltese: Fl-istudju fuq il-fniek, l-għoti fil-vini tad-doża massima, 96 µg/kg/kuljum, wassal għal esponimenti li huma simili għal dawk osservati klinikament.
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)
Maltese: - mediċini qawwija kontra l-uġigħ (eż. opjojdi bħal morfina, codeine)
English: Dexdor 100 micrograms/ml concentrate for solution for infusion
Maltese: Dexdor 100 mikrogramma/mL konċentrat għal soluzzjoni għall-infużjoni
English: In approximately 50% of cases, positive dechallenges were reported.
Maltese: F'madwar 50% tal-każijiet, ġew irrappurtati dechallenges pożittivi.
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.
Maltese: Il-farmakokinetika fil-plażma ta' dexmedetomidine hija simili fil popolazzjoni tal-ICU wara infużjoni ta' >24 h.
English: The most common adverse reactions reported in conjunction with overdose include bradycardia, hypotension, hypertension, oversedation, respiratory depression and cardiac arrest.
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati f'konnessjoni ma' doża eċċessiva f'dawn il-każijiet kienu jinkludu, bradikardija, pressjoni baxxa, pressjoni għolja, sedazzjoni eċċessiva, tnaqqis respiratorju u arrest kardijaku.
English: General precautions
Maltese: Prekawzjonijiet ġenerali
English: Bradycardia does not normally require treatment, but has commonly responded to anti-cholinergic medicine or dose reduction where needed.
Maltese: Il-bradikardija normalment m'għandhiex bżonn kura, iżda rrispondiet b'mod komuni għal mediċini anti-kolinerġiċi jew għal tnaqqis fid-doża fejn meħtieġ.
English: The mean midazolam rescue dose was 1.1 mg in the dexmedetomidine group, and 2.8 mg in the placebo group.
Maltese: Id-doża medja ta' midazolam għas-sopravivenza kienet ta' 1.1 mg fil grupp ta' dexmedetomidine, u 2.8 mg fil-grupp tal-plaċebo.
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.
Maltese: - L-infużjoni ta' manteniment normalment tinbeda b'0.6-0.7 mikrogramma/kg/siegħa u tkun ittitrata sabiex jinkiseb l-effett kliniku mixtieq b'dożi li jvarjaw minn 0.2 għal 1 mikrogramma/kg/siegħa.