FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending on individual sensitivity, the clinical picture is determined by the degree of respiratory depression.
Maltese: istampa klinika tiġi ddeterminata mil-livell ta' depressjoni respiratorja, skont is-sensittività tal individwu.
English: Convulsions Coma
Maltese: Mhux komuni
English: Pharmacokinetic/Pharmacodynamic Relationship
Maltese: Relazzjoni farmakokinetika/farmakodinamika
English: Therefore, sufentanil should be used with caution in patients with biliary tract disease, including acute pancreatitis.
Maltese: Għalhekk, sufentanil għandha tintuża b'kawtela f'pazjenti b'mard fl-apparat biljari, inkluża pankreatite akuta.
English: The majority (>90%) of healthcare professionals found Dzuveo easy to use.
Maltese: Il-maġġoranza (>90%) tal professjonisti tal-kura tas-saħħa sabu Dzuveo faċli biex tużah.
English: Orthostatic hypertension Flushing
Maltese: Calcium hydrogen phosphate
English: low blood volume or low blood pressure; - Have moderate to severe liver problems or severe kidney problems, as these organs have an effect on the way in which your body breaks down and eliminates the medicine; have abnormally slow bowel movements; - Have a disease of the gall bladder or pancreas; - Have a history of medicine or alcohol abuse;
Maltese: - Problemi bil-koordinazzjoni tal-movimenti tal-muskoli, kontrazzjonijiet fil-muskoli, rogħda jew tregħid eċċessiv, eżaġerazzjoni tar-riflessi, sensazzjoni ta' ħruq, ħass ħażin, sensazzjoni mhux normali fil-ħilda (on of the skin (tingiż, ġismek iqum xewk xewk), tnemnim ġenerali, għeja,
English: Each pouch contains one applicator and one sufentanil 30 micrograms tablet.
Maltese: Kull borża fiha applikatur wieħed u pillola waħda sufentanil ta' 30 mikrogramma.
English: How to store Dzuveo
Maltese: Mediċini oħra u Dzuveo
English: Hypocalcaemia Hypoalbuminaemia Hypokalaemia Hyponatraemia
Maltese: Iperlipidimja Ipofosfatemija Ipovolemija
English: Concomitant use of sufentanil and sedative medicines such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death.
Maltese: L-użu fl-istess ħin ta' sufentanil u mediċini sedattivi bħal benzodiazepines jew mediċini oħrajn relatati jista' jirriżulta f'sedazzjoni, depressjoni respiratorja, koma u mewt.
English: Dzuveo 30 micrograms sublingual tablet sufentanil
Maltese: Pillola Dzuveo ta' 30 mikrogramma għal taħt l-ilsien sufentanil
English: Sufentanil may increase plasma serotonin level and its concomitant use with other serotoninergic agents may increase the risk of serotonin syndrome.
Maltese: Sufentanil jista' jżid il-livell ta' serotonin fil-plasma u l-użu konkomitanti tiegħu ma' sustanzi serotoninerġiċi oħrajn jista' jżid ir-riskju tas-sindrome ta' serotonin.
English: Bradycardia
Maltese: Ipostesija
English: abdominal, bunionectomy).
Maltese: -6.7) fil-pazjenti tal-bunionectomy (p=0.005) rispettivament.
English: Other symptoms that may occur are loss of consciousness, coma, cardiovascular shock and muscle rigidity.
Maltese: Sintomi oħra li jistgħu jseħħu huma t-telf tas-sensi, koma, xokk kardjovaskulari u ebusija fil-muskoli.
English: Low doses of intravenous sufentanil associated with likely vagal (cholinergic) activity cause mild bradycardia and mildly reduced systemic vascular resistance without significantly lowering blood pressure (see section 4.4).
Maltese: Dożi baxxi ta' sufentanil mogħtija ġol-vini assoċjati mal-probabbiltà ta' attività vagali (kolinerġika) jikkawżaw bradikardija ħafifa u reżistenza vaskulari sistematika ftit imnaqqsa mingħajr ma jbaxxu b'mod sinifikanti l-pressjoni tad-demm (ara sezzjoni 4.4).
English: Gastroesophageal reflux disease
Maltese: Marda tar-rifluss gastroesofaġali
English: NOTE: Avoid direct mucosal contact with the SDA tip.
Maltese: NOTA: Evita l-kuntatt diretta tal-ponta tal-SDA mal-mukoża.
English: Sufentanil should be administered with caution to patients with moderate to severe hepatic or severe renal impairment (see section 4.4).
Maltese: Sufentanil għandha tingħata b'kawtela f'pazjenti b'indeboliment moderat sa sever tal-fwied jew talkliewi (ara sezzjoni 4.4).
English: Sufentanil as a μ-opioid receptor agonist may slow the gastrointestinal motility.
Maltese: Bħala agonist tar-riċetturi tal-μ-opjojdi, sufentanil tista' tnaqqas il-motilità gastrointestinali.
English: Sufentanil acts as a full agonist in μ-opioid receptors.
Maltese: Sufentanil taġixxi bħala agonista sħiħ fir-riċetturi tal-µ-opjojdi.
English: Gastrointestinal disorders Nausea Vomiting
Maltese: Disturbi gastrointestinali
English: The efficacy of Dzuveo was evaluated in two double-blind, placebo-controlled trials involving 221 patients with moderate-to-severe acute postoperative pain (pain intensity of ≥ 4 on a 0-10 scale) after abdominal (studied up to 48-hours) or orthopedic (bunionectomy) surgery (studied up to 12 hours).
Maltese: L-effikaċja ta' Dzuveo ġiet evalwata f'żewġ provi double-blind u kkontrollati bi plaċebo li kienu jinvolvu 221 pazjent b'uġigħ akut moderat sa sever ta' wara operazzjoni (intensità ta' uġigħ ta' ≥ 4
English: Dzuveo should only be prescribed and administered by healthcare professionals who are experienced in the management of opioid therapy; particularly opioid adverse reactions, such as respiratory depression (see section 4.4).
Maltese: Dzuveo għandu jingħata b'riċetta biss minn professjonisti tal-kura tas-saħħa li għandhom esperjenza fil-ġestjoni ta' terapija opjojda; b'mod partikolari fir-reazzjonijiet avversi għall-opjojdi, bħal depressjoni respiratorja (ara sezzjoni 4.4).
English: Sufentanil overdose is manifested by an exaggeration of its pharmacological effects.
Maltese: Doża eċċessiva ta' sufentanil hija evidenzjata minn esaġerazzjoni tal-effetti farmakoloġiċi tiegħu.
English: Sufentanil has potential for abuse.
Maltese: itraconazole, ritonavir) ma jistgħux jiġu esklużi.
English: Oxygen saturation decreased Body temperature increased
Maltese: Tnaqqis fissaturazzjoni tal ossiġnu Żieda fit temperatura talġisem
English: Steady-state clearance is 129.3 L/hr.
Maltese: It-tneħħija fi stat fiss hija 129.3
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: AH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl- RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Abdominal discomfort Abdominal distension Abdominal Pain upper Epigastric discomfort Gastritis
Maltese: Aġitazzjoni Apatija Disturb tal-konverżjoni Diżorjentament Burdata ewforika Alluċinazzjoni
English: Hepatobilary disorders
Maltese: Emboliżmu pulmonari
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu skeletriċi u tat-tessuti konnettivi
English: The incidence and degree of bradycardia and hypotension with sufentanil may be greater in patients on chronic calcium channel and/or beta blocker therapy.
Maltese: Interazzjoni ma' imblokkaturi tal-kanal tal-kalċju u/jew tar-riċetturi beta L-inċidenza u l-grad ta' bradikardija u pressjoni baxxa b'sufentanil jistgħu jkunu ogħla f'pazjenti fuq terapija ta' imblokkaturi tal-kanal tal-kalċju kronika u/jew tar-riċetturi beta.
English: Hypoxia
Maltese: Anemija
English: Pregnancy
Maltese: Konvulżjonijiet
English: Sufentanil may produce bradycardia.
Maltese: Sufentanil għandha l-potenzjal għall-abbuż.
English: Children and adolescents Dzuveo should not be used in children and adolescents below 18 years.
Maltese: Dzuveo ma għandux jintuża minn tfal u adolexxenti taħt it-18-il sena.
English: Paediatric population
Maltese: Tolleranza lokali
English: A population pharmacokinetic analysis of plasma sufentanil concentrations following usage of Dzuveo did not identify renal function as a significant covariate for clearance.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni għal Dzuveo, il-funzjoni tal-fwied ma ġietx identifikata bħala kovarjat sinifikanti għat-tneħħija.
English: Back Pain
Maltese: FEJN MA
English: - Medicines used to treat high blood pressure or angina (chest pain) known as calcium channel or beta blockers e.g. diltiazem and nifedipine.
Maltese: - Mediċini li jintużaw għall-kura tal-pressjoni għolja tad-demm jew tal-anġina (uġigħ fis-sider) magħrufin bħala imblokkaturi tal-kanal tal-kalċju jew tar-riċetturi beta eż. diltiazem u nifedipine.
English: Tremor Ataxia Dystonia Hyperreflexia Tremor Burning sensation Presyncope Paraesthesia Hypoaesthesia Lethargy Memory impairment Migraine
Maltese: Pressjoni għolja ortostatika Fwawar Pressjoni baxxa dijastolika Pressjoni baxxa ortostatika
English: Over 24 hours, the mean number of Dzuveo doses administered was 7.0 (210 micrograms/day).
Maltese: In-numru medju ta' dożi ta' Dzuveo mogħtija fuq 24 siegħa, kien 7.0
English: Procedural nausea Postoperative ileus Procedural vomiting Gastrointestinal stoma complication Procedural pain
Maltese: Kumplikazzjoni talistoma gastrointestinali
English: Analgesic plasma concentrations of sufentanil may provoke nausea and vomiting by irritation of the chemoreceptor trigger zone.
Maltese: Il-konċentrazzjonijiet ta' sufentanil fil-plażma analġeżiċi jistgħu jikkawżaw nawsja u rimettar permezz tal-irritazzjoni taż-żona li tiskatta l-kemoriċetturi.
English: If sufentanil is administered to the mother during this time, an antidote for the child should be readily available.
Maltese: Jekk sufentanil tingħata lill-omm waqt dan iż-żmien, għandu jkun hemm disponibbli antidotu għat-tarbija.
English: Very rare <1/10,000 Not known Cannot be estimated from the available data.
Maltese: Rari ħafna Mhux magħruf Ma tistax tittieħed stima mid-data disponibbli.
English: Intracranial pressure
Maltese: Pressjoni intrakranjali
English: Effect of BMI on dosing
Maltese: L-effetti tal-BMI fuq id-dożar
English: - Allergic reactions, itching of the skin.
Maltese: - Reazzjonijiet allerġiċi, ħakk fil-ġilda.
English: Blue-coloured flat-faced tablet with round edges and a diameter of 3 mm.
Maltese: fluwidu fil-pulmun, tħarħir.
English: - Any medicines which might make you sleepy (have a sedative effect), such as sleeping pills, medicines to treat anxiety (e.g. benzodiazipines), tranquillisers or other opioid medicines, as they can increase the risk of severe breathing problems, coma and may be life-threatening.
Maltese: - Kull mediċina li tista' tħeddlek (għandha effett sedattiv) bħal pilloli tal-irqad, mediċini li jikkuraw l-ansjetà (eż. benzodjazepini), kalmanti jew mediċini opjojdi oħra, għaliex dawn jistgħu jżidu r-riskju ta' problemi serji bin-nifs, koma u jistgħu jkunu ta' periklu għal ħajtek.
English: Dzuveo passes into breast milk and can cause side effects in the breast-fed child. Breastfeeding is not recommended while you are taking Dzuveo.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Mean absolute bioavailability after a single sublingual administration of the sufentanil tablet relative to a one-minute intravenous sufentanil infusion of the same dose was 53%.
Maltese: Il-bijodisponibbiltà assoluta medja wara l-għoti ta' darba taħt l-ilsien ta' pillola sufentanil imqabbla ma' infużjoni ta' minuta bl-istess doża ta' sufentanil kienet ta' 53%.
English: Repeat antagonist administration may be required as the duration of respiratory depression may last longer than the duration of the effect of the antagonist (see section 4.9).
Maltese: L-għoti ripetut ta' antagonisti jista' jkun meħtieġ minħabba li d-depressjoni respiratorja tista' ddum iżjed mill-effett tal-antagonist (ara sezzjoni 4.9).
English: Magnesium stearate
Maltese: Edema pulmonari
English: Management of sufentanil overdose should be focused on treating symptoms of μ-opioid receptor agonism, including administration of oxygen.
Maltese: Wara kura fit-tul sufentanil tista' tikkawża sintomi ta' astinenza fit-tarbija tat-twelid.
English: - Diarrhoea, burping or belching, inflammation of stomach lining or gastritis, bloating, acid reflux,
Maltese: - Infjammazzjoni tal-pulmuni, ħmura u infjammazzjoni tal-għajnejn, infjammazzjoni tal-gerżuma.
English: Pusher
Maltese: Dzuveo.
English: Some insoluble excipients of the tablet may remain in the mouth after dissolution is complete; this is normal and does not indicate lack of absorption of sufentanil from the tablet.
Maltese: Xi eċċipjenti tal-pillola li ma jinħallux jistgħu jibqgħu fil-ħalq wara li tkun inħallet kollha; dan huwa normali u ma jindikax nuqqas ta' assorbiment ta' sufentanil mill-pillola.
English: Dzuveo is provided in a disposable single-dose applicator, to be administered by a healthcare provider as needed by the individual patient, but no more than once every hour, resulting in a maximum dose of 720 micrograms /day.
Maltese: Dzuveo jiġi f'applikatur ta' doża waħda li jintuża darba biss, u jingħata minn professjonist tal-kura tas- saħħa skont il-bżonn tal-pazjent individwali, iżda mhux aktar spiss minn darba f'siegħa, li jirriżulta f'doża massima ta' 720 mikrogramma kuljum.
English: When considering the use of sufentanil in a patient taking a CNS depressant, the duration of use of the CNS depressant and the patient's response should be assessed, including the degree of tolerance that has developed to CNS depression.
Maltese: Meta jiġi kkunsidrat l-użu ta' sufentanil f'pazjent li jkun qed jieħu depressant CNS, għandu jiġi vvalutat kemm ilu jittieħed id-depressant CNS u r-rispons tal-pazjent, inkluż il-grad ta' tolleranza li żviluppa għad-depressjoni tas-CNS.
English: This route of administration results in higher absolute bioavailability than oral (swallowed) administration by avoiding intestinal and first-pass liver 3A4 enzyme metabolism.
Maltese: Dan il-mod kif jingħata jirriżulta f'bijodisponibbiltà assoluta akbar mill-għoti b'mod orali (tinbela') billi jevita l-metaboliżmu tal-enzimi 3A4 intestinali u tal-fwied first-pass.
English: Hypnotic activity can be demonstrated by EEG alterations.
Maltese: L-attività ipnotika tista' tintwera permezz ta' bidliet fl-EEG.
English: Prior to the launch of Dzuveo in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Maltese: Qabel ma jintroduċu Dzuveo f'kull Stat Membru , id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH) għandu jaqbel fuq il-kontenut u l-format tal-materjali edukattivi, inkluż il-mezzi ta'
English: Do Not Use if Pouch Seal is Broken
Maltese: Stikka li timbotta Lokk
English: In humans the potency is 7 to 10-fold higher than fentanyl and 500 to 1,000-fold higher than morphine (per oral).
Maltese: 500 sa 1,000 darba aktar mill-morfina (kull doża meħuda mill-ħalq).
English: Miosis
Maltese: Mijosi
English: Sufentanil may obscure the clinical course of patients with head injury.
Maltese: Sufentanil tista' toskura l-perkors kliniku ta' pazjenti b'korriment fir-ras.
English: Headache Dizziness Somnolence Sedation
Maltese: Uġigħ mhux kardijaku fis-sider Skumdità fis-sider
English: The full EPAR and risk management plan summary for Mirvaso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Mirvaso is a medicine that contains the active substance brimonidine tartrate.
Maltese: Mirvaso huwa mediċina li fiha s-sustanza attiva brimonidine tartrate.
English: This is a summary of the European public assessment report (EPAR) for Mirvaso.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Mirvaso .
English: This summary was last updated in 02-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 02-2014.
English: Why is Mirvaso approved?
Maltese: Għaliex ġie approvat Mirvaso?
English: Other information about Mirvaso
Maltese: Informazzjoni oħra dwar Mirvaso
English: The main measure of effectiveness was the percentage of patients who achieved a marked reduction of facial redness at different time points (3, 6, 9 and 12 hours) on days 1, 15 and 29 after the start of the treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-perċentwal ta' pazjenti li kisbu tnaqqis ċar filħmura tal-wiċċ f'punti tal-ħin differenti (3, 6, 9 u 12-il siegħa) fil-jiem 1, 15 u 29 wara l-bidu tal-kura.
English: Mirvaso has been evaluated in two main studies involving a total of 553 patients with moderate or severe facial redness caused by rosacea.
Maltese: Mirvaso ġie evalwat f'żewġ studji prinċipali li fihom ħadu sehem total ta' 553 pazjent bi ħmura moderata jew severa tal-wiċċ ikkawżata mir-rosaċea.
English: The most common side effects with Mirvaso (which may affect more than 1 in 100 people), which are usually mild to moderate in severity, are erythema (redness), pruritus (itching), flushing and a burning sensation of the skin.
Maltese: L-effetti sekondarji l-aktar komuni b'Mirvaso (li jistgħu jaffettwaw aktar minn 1 minn kull 100), li ġeneralment huma ħfief sa moderati, huma eritema (ħmura), prurite (ħakk), fwawar u sensazzjoni ta' ħruq fil-ġilda.
English: On day 29, 31.5% (40 out of 127) patients had reduction of facial redness 3 hours after application with Mirvaso compared with a response of 10.9% (14 out of 128) for placebo.
Maltese: F'Jum 29, 31.5% (40 minn 127) tal-pazjenti kellhom tnaqqis fil-ħmura tal-wiċċ 3 sigħat wara l-applikazzjoni ta' Mirvaso meta mqabbel ma' rispons ta' 10.9% (14 minn 128) għall-plaċebo.
English: What are the risks associated with Mirvaso?
Maltese: X'inhuma r-riskji assoċjati ma' Mirvaso?
English: • In the second study, on day 1 the percentage or patients who had reduction of facial redness 3 hours after application was 19.6% (29 out of 148 patients) for Mirvaso compared with 0 % (none out of 145 patients) for placebo.
Maltese: • Fit-tieni studju, f'jum 1 il-perċentwal ta' pazjenti li kellhom tnaqqis fil-ħmura tal-wiċċ 3 sigħat wara l-applikazzjoni kien ta' 19.6% (29 minn 148 pazjent) għal Mirvaso meta mqabbel ma' 0 % (l-ebda wieħed minn 145 pazjent) għall-plaċebo.
English: Mirvaso should not be used in children or adolescents aged from 2 to 18 years.
Maltese: Mirvaso m'għandux jintuża fi tfal jew adolexxenti minn sentejn sa 18-il sena.
English: • In the first study, on day 1 the percentage or patients who had reduction of facial redness 3 hours after application was 16.3% (21 out of 129) for Mirvaso compared with 3.1% (4 out of 131) for placebo.
Maltese: • Fl-ewwel studju, f'jum 1 il-perċentwal ta' pazjenti li kellhom tnaqqis fil-ħmura tal-wiċċ 3 sigħat wara l-applikazzjoni kien ta' 16.3% (21 minn 129) għal Mirvaso meta mqabbel ma' 3.1% (4 minn 131) għall-plaċebo.
English: The active substance in Mirvaso, brimonidine tartrate, works by attaching to receptors called alpha2adrenergic receptors on the cells of blood vessels of the skin and activating them.
Maltese: Is-sustanza attiva f'Mirvaso, il-brimonidine tartrate, taħdem billi teħel mar-riċetturi msejħa riċetturi alpha2-adrenerġiċi fuq iċ-ċelloli tal-vini tal-ġilda u tattivahom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mirvaso on 21 February 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Mirvaso fil-21 ta' Frar 2014.
English: Mirvaso is available as a gel (3 mg/g) and can only be obtained with a prescription.
Maltese: Mirvaso jiġi bħala ġell (3 mg/g) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Mirvaso must not be used in children below 2 years of age or in patients receiving other medicines such as monoamine oxidase (MAO) inhibitors or certain antidepressants.
Maltese: Mirvaso m'għandux jintuża fit-tfal ta' taħt is-sentejn jew f'pazjenti li jkunu qegħdin jirċievu mediċini oħra bħall-inibituri tal-monoamine oxidase (MAO) jew ċerti antidepressanti.
English: On day 29, 25.4% (36 out of 142) of patients had reduction of facial redness 3 hours after application with Mirvaso compared with a response of 9.2 % (13 out of 142) for placebo.
Maltese: 4% (36 minn 142) tal-pazjenti kellhom tnaqqis fil-ħmura tal-wiċċ 3 sigħat wara l-applikazzjoni ta' Mirvaso meta mqabbel ma' rispons ta' 9.2% (13 minn 142) għall-plaċebo.
English: Regarding safety, the CHMP acknowledged that the safety profile is acceptable since most of the adverse events reported occur locally (on the skin) and are similar to those commonly observed with other rosacea medicines applied to the skin.
Maltese: Rigward is-sigurtà, is-CHMP irrikonoxxa li l-profil tas-sigurtà huwa aċċettabbli billi ħafna mill-avvenimenti avversi rrappurtati jseħħu lokalment (fuq il-ġilda) u huma simili għal dawk normalment osservati b'mediċini oħra għar-rosaċea li jiġu applikati fuq il-ġilda.
English: It is used to treat the facial erythema (redness of the skin of the face) in adults with rosacea, a long-term skin condition that often causes flushing and redness.
Maltese: Jintuża għall-kura ta' eritema filwiċċ (ħmura fil-ġilda tal-wiċċ) f'persuni adulti b'rosaċea, kundizzjoni fuq perjodu fit-tul tal-ġilda li sikwit tikkawża fwawar u ħmura.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Mirvaso's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Mirvaso huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The CHMP concluded that Mirvaso improves the facial redness in patients with rosacea.
Maltese: Is-CHMP ikkonkluda li Mirvaso jtejjeb il-ħmura tal-wiċċ f'pazjenti b'rosaċea.
English: A risk management plan has been developed to ensure that Mirvaso is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Mirvaso jintuża bl-aktar mod sigur possibbli.
English: Further information on Dexdor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This overview was last updated in 08-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'08-2018.
English: Dexdor received a marketing authorisation valid throughout the EU on 16 September 2011.
Maltese: Dexdor irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-16 ta' Settembru 2011.
English: The active substance in Dexdor, dexmedetomidine, is a selective alpha-2 receptor agonist.
Maltese: Is-sustanza attiva f'Dexdor, id-dexmedetomidine, hija agonista tar-riċettur alfa-2 selettiva.
English: Other information about Dexdor
Maltese: Informazzjoni oħra dwar Dexdor
English: Sedation in intensive care
Maltese: Sedazzjoni fil-kura intensiva
English: Dexdor contains the active substance dexmedetomidine.
Maltese: Dexdor fih is-sustanza attiva dexmedetomidine.
English: Patients in the Dexdor group received either 0.5 or 1 microgram/kg bodyweight.
Maltese: Il-pazjenti fil-grupp ta' Dexdor irċivew jew 0.5 jew mikrogramma 1/kg tal-piż tal-ġisem.
English: • in hospital intensive care units to bring about a light level of sedation in which the patient can still respond to verbal stimulation (corresponding to a score of between 0 and -3 on the Richmond Agitation-Sedation Scale);
Maltese: • f'unitajiet ta' kura intensiva fl-isptar biex jagħti livell ħafif ta' sedazzjoni li fih il-pazjent xorta jkun jista' jirrispondi għal stimulazzjoni verbali (li jikkorrispondi għal punteġġ ta' bejn 0 u -3 fuq l-Iskala ta' Aġitazzjoni-Sedazzjoni ta' Richmond);
English: Dexdor is an additional alternative medicine for achieving lighter levels of sedation in suitable patients.
Maltese: Dexdor huwa mediċina alternattiva addizzjonali għall-kisba ta' livelli eħfef ta' sedazzjoni f'pazjenti xierqa.