FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR and risk management plan summary for Budesonide/Formoterol Teva Pharma B.V. can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ ta' Budesonide/Formoterol Teva Pharma B.V. jinsab fuq is-sit talAġenzija:ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva Pharma B.V. 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li Budesonide/Formoterol Teva Pharma B.V. 160/4.5 mikrogrammi u 320/9 mikrogrammi wrew li għandhom profil ta' kwalità komparabbli u li huma ekwivalenti għall-qawwiet korrispondenti ta' Symbicort Turbohaler.
English: Budesonide/Formoterol Teva Pharma B.V. is a ‘hybrid medicine'.
Maltese: Budesonide/Formoterol Teva Pharma B.V. huwa ‘mediċina ibrida'.
English: The reference medicine for Budesonide/Formoterol Teva Pharma B.V. is Symbicort Turbohaler.
Maltese: Il-mediċina ta' referenza għal Budesonide/Formoterol Teva Pharma B.V. hija Symbicort Turbohaler.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Budesonide/Formoterol Teva Pharma B.V. is given using a different inhaler.
Maltese: Dan ifisser li huwa simili għall‘mediċina ta' referenza' li fiha l-istess sustanzi attivi, iżda Budesonide/Formoterol Teva Pharma B.V. jingħata bl-użu ta' inalatur differenti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva Pharma B.V. on 19 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Budesonide/Formoterol Teva Pharma B.V. valida fl-Unjoni Ewropea kollha fid-19 ta' Novembru 2014.
English: Budesonide/Formoterol Teva Pharma B.V. is a medicine that contains the active substances budesonide and formoterol.
Maltese: Budesonide/Formoterol Teva Pharma B.V. huwa mediċina li fiha s-sustanzi attivi budesonide u lformoterol.
English: This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva Pharma B.V.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Budesonide/Formoterol Teva Pharma B.V.
English: Budesonide/Formoterol Teva Pharma B.V.
Maltese: Kif jintuża Budesonide/Formoterol Teva Pharma B.V.?
English: budesonide / formoterol
Maltese: Sommarju tal-EPAR għall-pubbliku budesonide / formoterol
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Maltese: Dan jaħdem b'mod simili għall-ormoni tal-kortikosterojdi prodotti b'mod naturali, u jnaqqas l-attività tassistema immunitarja billi jeħel ma' riċetturi f'diversi tipi ta' ċelloli immuni.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Maltese: Dan jista' jintuża f'pazjenti li l-marda tagħhom ma tkunx qiegħda tiġi kkontrollata sew bilkura b'mediċina oħra tal-ażma msejħa kortikosterojdi u “agonisti tal-beta-2 li jaħdmu għal żmien qasir” li jittieħdu man-nifs, jew f'pazjenti li l-marda tagħhom qiegħda tiġi kkontrollata sew bil-kura bilkortikosterojdi u b'“agonisti tal-beta-2 li jaħdmu għal żmien twil” li jittieħdu man-nifs.
English: Why is Budesonide/Formoterol Teva Pharma B.V. approved?
Maltese: Għalxiex ġie approvat Budesonide/Formoterol Teva Pharma B.V.?
English: Budesonide/Formoterol Teva Pharma B.V. can be used for the regular treatment of asthma.
Maltese: Budesonide/Formoterol Teva Pharma B.V. jista' jintuża għal kura regolari tal-ażma.
English: A risk management plan has been developed to ensure that Budesonide/Formoterol Teva Pharma B.V. is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Budesonide/Formoterol Teva Pharma B.V. jintuża bl-aktar mod sigur possibbli.
English: The full EPAR for Prepandrix 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: Prepandrix contains a flu strain called ‘A/Indonesia/05/2005' (H5N1).
Maltese: Prepandrix fih ir-razza tal-influwenza msejħa ‘A/Indonesia/05/2005' (H5N1).
English: Prepandrix is a ‘prepandemic' vaccine.
Maltese: Prepandrix huwa vaċċin ‘prepandemiku'.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivared, adjuvanted)
Maltese: Vaċċin għall-Influwenza Prepandemika (H5N1) (virjon maqsum, mhux attivat, adġuvant)
English: At 21 days after the second injection, over 90% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Maltese: Wara 21 jum wara t-tieni injezzjoni, aktar minn 90% tan-nies li ngħataw il-vaċċin kellhom livelli ta' antikorpi li jistgħu jipproteġuhom kontra l-H5N1.
English: This is a summary of the European public assessment report (EPAR) for Prepandrix.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Prepandrix.
English: Prepandrix must not be given to people who are hypersensitive (allergic) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Maltese: Prepandrix m'għandux jingħata lil persuni li huma ipersensittivi (allerġiċi) għal xi wieħed millkomponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli (baxxi ħafna) ta' traċċi fil-vaċċin, bħal bajd, proteina tat-tiġieġ, ovalbumin (proteina fl-abjad tal-bajd), formaldehyde, gentamicin sulphate (antibijotiku) u sodium deoxycholate.
English: The main study of Prepandrix included 675 healthy adults and compared the ability of Prepandrix, with or without the adjuvant, to trigger the production of antibodies (‘immunogenicity').
Maltese: L-istudju prinċipali ta' Prepandrix inkluda 675 adult b'saħħithom u qabbel il-kapaċità ta' Prepandrix, b'adġuvant jew mingħajru, li jqanqal il-produzzjoni ta' antikorpi (‘immunoġeniċiti').
English: The most common side effects with Prepandrix (seen in more than 1 patient in 10) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni bi Prepandrix (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, artralġija (uġigħ fil-ġogi), mijalġija (uġigħ fil-muskoli), reazzjonijiet fis-sit tal-injezzjoni (ebusija, nefħa, uġigħ u ħmura), deni u għeja (ħedla).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prepandrix on 14 May 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Prepandrix fl-14 ta' Mejju 2008.
English: There are some data with a vaccine containing a similar H5N1 strain that support the use of half-doses (0.25 ml) in children three to nine years of age.
Maltese: Hemm xi dejta fuq vaċċin li fih razza simili ta' H5N1 li ssostni l-użu ta' nofs dożi (0.25 ml) fi tfal ta' bejn it-tliet u d-disa' snin.
English: The participants received two injections of Prepandrix 21 days apart.
Maltese: Il-parteċipanti ngħataw żewġ injezzjonijiet ta' Prepandrix 21 jum 'il bogħod minn xulxin.
English: Prepandrix contains small amounts of haemagglutinins (proteins from the surface) of the H5N1 virus.
Maltese: Pandemrix fih ammonti żgħar ta' ħemaglutinins (proteini mill-wiċċ) ta' vajrus imsemmi H5N1.
English: What is Prepandrix?
Maltese: X'inhu Prepandrix?
English: Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.
Maltese: L-esperti tas-saħħa jinsabu mħassba bil-fatt li fil-futur l-influwenza pandemika tista' tiġi kkawżata mir-razza H5N1 tal-vajrus.
English: What is the risk associated with Prepandrix?
Maltese: X'inhu r-riskju assoċjat ma' Prepandrix?
English: The main study showed that Prepandrix containing the adjuvant produced an antibody response that met these criteria.
Maltese: L-istudju prinċipali wera li Prepandrix li fih l-istimulant, ipproduċa reazzjoni ta' antikorpi li laħqet dawn il-kriterji.
English: The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-livell ta' antikorpi kontra l-vajrus tal-influwenza fid-demm fi tliet mumenti differenti: qabel ma ngħata l-vaċċin, fil-jum tat-tieni injezzjoni (il-21 jum) u 21 jum wara (it-42 jum).
English: The emulsion contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Maltese: Il-vaċċin fih ‘stimulant' (kompost li fih iż-żejt) sabiex itejjeb ir-reazzjoni immunitarja.
English: Prepandrix is a vaccine for use in adults to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Maltese: Prepandrix huwa vaċċin li jintuża fl-adulti bħala protezzjoni kontra l-influwenza kkawżata mir-razza (tip) H5N1 tal-vajrus tal-influwenza A.
English: Why has Prepandrix been approved?
Maltese: Għaliex ġie approvat Prepandrix?
English: The CHMP decided that Prepandrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Prepandrix huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Other information about Prepandrix
Maltese: Tagħrif ieħor dwar Prepandrix
English: How has Prepandrix been studied?
Maltese: Kif ġie studjat Prepandrix?
English: For the full list of all side effects reported with Prepandrix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Prepandrix, ara l-fuljett ta' tagħrif.
English: Prepandrix is given by injection into the shoulder or thigh as two 0.5 ml doses, at least three weeks apart.
Maltese: Imbagħad is-sistema immunitarja tkun tista' tipproduċi antikorpi aktar malajr meta tkun esposta għall-vajrus mill-ġdid.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Maltese: Pandemija tal-influwenza sseħħ meta titfaċċa razza ġdida tal-vajrus tal-influwenza li tista' tinfirex faċilment minn persuna għal oħra minħabba li nnies ma jkollhomx immunità (protezzjoni) kontriha.
English: Mean (95% CI)
Maltese: Medja (95% CI)
English: Cl (l/h/kg)
Maltese: N Cl (l/h/kg)
English: EU/1/11/718/001 EU/1/11/718/002 EU/1/11/718/004 EU/1/11/718/006 EU/1/11/718/007
Maltese: EU/1/11/718/001 EU/1/11/718/002 EU/1/11/718/004
English: Lifepharma (ZAM) Ltd Τηλ.
Maltese: Lifepharma (ZAM) Ltd
English: 200 micrograms/2 ml 400 micrograms/4 ml 1000 micrograms/10 ml
Maltese: 200 mikrogramma/2 mL 400 mikrogramma/4 mL 1,000 mikrogramma/10 mL
English: Dexmedetomidine is 94% bound to plasma proteins.
Maltese: Dexmedetomidine huwa 94% marbut mal-proteini fil-plażma.
English: Myocardial ischaemia or infarction, tachycardia
Maltese: Iskemija mijokardijaka jew infart, takikardija
English: 400 mcg/ 4 ml
Maltese: 400 µg/4 mL
English: Available data suggest that the formation of the oxidised metabolites is mediated by several CYP forms (CYP2A6, CYP1A2, CYP2E1, CYP2D6 and CYP2C19).
Maltese: Dejta disponibbli tissuġġerixxi li l-formazzjoni tal-metaboliti ossidati hija medjata minn diversi forom ta' CYP (CYP2A6, CYP1A2, CYP2E1, CYP2D6 u CYP2C19).
English: In healthy volunteers it exhibits a rapid distribution phase with a central estimate of the distribution half-life (t1/2α) of about 6 minutes.
Maltese: F'voluntiera f'saħħithom huwa juri fażi ta' distribuzzjoni rapida bi stima ċentrali tal-half-life ta' distribuzzjoni (t1/2α) ta' madwar 6 minuti.
English: Manufacturer Orion Corporation Orion Pharma Orionintie 1
Maltese: Manifattur Orion Corporation Orion Pharma Orionintie 1
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).
Maltese: It-tneħħija mill-plażma (Cl) għandha valur stmat medju ta' 0.46 sa 0.73 l/h/kg (35.7 sa 51.1 l/h).
English: Pharmacotherapeutic group: Psycholeptics, other hypnotics and sedatives, ATC code: N05CM18
Maltese: Psikolettiċi, ipnotiċi u sedattivi oħrajn, Kodiċi ATC: N05CM18
English: Alpha-2 agonists have rarely been associated with withdrawal reactions when stopped abruptly after prolonged use.
Maltese: L-agonisti alpha-2 rarament kienu assoċjati ma' reazzjonijiet ta' rtirar meta jitwaqqfu f'daqqa wara użu fit-tul.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċcipjenti, ara sezzjoni 6.1.
English: Lactated Ringers, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) solution for injection, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma-substitute.
Maltese: Lactated Ringers, soluzzjoni ta' 5% glucose, soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride, 200 mg/mL (20%) mannitol, thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, u sostitut tal-plażma.
English: 1000 mcg/ 10 ml
Maltese: 1,000 µg/10 mL
English: The concentrate is a clear, colourless solution, pH 4.5 - 7.0
Maltese: Il-konċentrat huwa soluzzjoni ċara, bla kulur, pH 4.5 - 7.0
English: The minor metabolites dexmedetomidine carboxylic acid, 3-hydroxymethyl dexmedetomidine and its Oglucuronide individually comprised 1.11 to 7.66% of the dose.
Maltese: Il-metaboliti minuri dexmedetomidine carboxylic acid, 3-hydroxymethyl dexmedetomidine u O-glucuronide tiegħu individwalment ammontaw għal 1.11 sa 7.66% tad-doża.
English: Approximately 28% of the urinary metabolites are unidentified minor metabolites.
Maltese: Madwar 28% tal-metaboliti fl-awrina huma metaboliti minuri mhux identifikati.
English: Under 1 month 1 to < 6 months 6 to < 12 months 12 to < 24 months 2 to < 6 years 6 to < 17 years
Maltese: Inqas minn xahar Xahar sa <6 xhur 6 sa <12-il xahar 12 sa <24 xahar Sentejn sa <6 snin 6 sa <17-il sena
English: - A loading infusion of 1.0 microgram/kg over 10 minutes.
Maltese: Bidu tas-Sedazzjoni Proċedurali: - Infużjoni għolja tal-bidu ta' 1.0 mikrogramma/kg fuq 10 minuti.
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.
Maltese: L-għoti ta' dexmedetomidine flimkien ma' anestetiċi, sedattivi, ipnotiċi, u opjojdi probabbilment iqawwi l-effetti, inkluż effetti sedattivi, anestetiċi u kardjorespiratorji.
English: Adverse reactions Metabolism and nutrition disorders Common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni:
English: There are three types of initial metabolic reactions; direct N-glucuronidation, direct N-methylation and cytochrome P450 catalysed oxidation.
Maltese: N-glucuronidation diretta, N-methylation diretta u ossidazzjoni katalizzata miċ-ċitokromju P450.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Maltese: (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/718/001-002, EU/1/11/718/004, EU/1/11/718/006-007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/718/001-002, EU/1/11/718/004, EU/1/11/718/006-007
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
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.
Maltese: Matul il-perjodu ta' rappurtar attwali 16 ta' Marzu 2017 - 15 ta' Marzu 2018, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Orion pharma, wettaq reviżjoni kumulattiva tar-rapporti kollha tar-reazzjoni avversa ta' ipertermija.
English: Induction of dexmedetomidine in vitro was observed on CYP1A2, CYP2B6, CYP2C8, CYP2C9 and CYP3A4, and induction in vivo cannot be excluded.
Maltese: In vitro kien osservat induzzjoni ta' dexmedetomidine fuq CYP1A2, CYP2B6, CYP2C8, CYP2C9 u
English: Specific studies have confirmed enhanced effects with isoflurane, propofol, alfentanil, and midazolam.
Maltese: Studji speċifiċi kkonfermaw effetti msaħħa b'isoflurane, propofol, alfentanil, u midazolam.
English: Cardio-vascular effects and precautions
Maltese: Effetti kardjovaskulari u prekawzjonijiet
English: In vitro study suggests that interaction potential in vivo exists between dexmedetomidine and substrates with dominant CYP2B6 metabolism.
Maltese: Studju in vitro jissuġġerixxi li jeżisti l-potenzjal ta' interazzjoni in vivo bejn dexmedetomidine u sottostrati b'metaboliżmu ta' CYP2B6 dominanti.
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.
Maltese: Il-medja ta' t1/2 għall-individwi b'indeboliment epatiku ħafif, moderat jew sever twalet għal 3.9, 5.4, u 7.4 sigħat, rispettivament.
English: Dexdor contains less than 1 mmol sodium (23 mg) per ml.
Maltese: Dexdor fih anqas minn 1 mmol sodium (23 mg) għal kull mL.
English: The reported highest infusion rates of dexmedetomidine in these cases have reached up to 60 µg/kg/h for 36 minutes and 30 µg/kg/h for 15 minutes in a 20-month-old child and in an adult, respectively.
Maltese: L-ogħla rati ta' infużjoni ta' dexmedetomidine rrappurtati f'dawn il-każijiet laħqu sa 60 µg/kg/h għal 36 minuta u 30 µg/kg/h għal 15-il minuta f'tarbija b'età ta' 20 xahar u f'persuna adulta, rispettivament.
English: Sedation of adult ICU (Intensive Care Unit) patients
Maltese: Sedazzjoni tal-pazjenti adulti fl-ICU (Taqsima tal-Kura Intensiva)
English: Dexdor should not be used with medicines that cause temporary paralysis.
Maltese: Dexdor m'għandux jintuża ma' mediċini li jikkawżaw paralisi temporanja.
English: The PRAC endorsed this revision.
Maltese: Il-PRAC approva din ir-reviżjoni.
English: The median (range) midazolam rescue dose was 1.5 (0.5-7.0) mg in the dexmedetomidine1.0 µg/kg group, 2.0 (0.5-8.0) mg in the dexmedetomidine 0.5 µg/kg group, and 4.0 (0.5-14.0) mg in the placebo group.
Maltese: Id-doża medjana (medda) ta' midazolam għas-sopravivenza kienet ta' 1.5 (0.5-7.0) mg fil-grupp ta' dexmedetomidine 1.0 µg/kg, 2.0 (0.5-8.0) mg fil-grupp ta' dexmedetomidine 0.5 µg/kg, u 4.0 (0.5-14.0) mg fil-grupp tal-plaċebo.
English: Some patients receiving Dexdor have been observed to be arousable and alert when stimulated.
Maltese: Xi pazjenti li rċevew Dexdor kienu osservati li setgħu jitqajmu u jkunu konxji meta jiġu stimulati.
English: Dexmedetomidine is eliminated by extensive metabolism in the liver.
Maltese: Dexmedetomidine huwa eliminat permezz ta' metaboliżmu estensiv fil-fwied.
English: 5 x 2 ml ampoules 25 x 2 ml ampoules 5 x 2 ml vials 4 x 4 ml vials 4 x 10 ml vials
Maltese: 5 ampulli x 2 mL 25 ampulla x 2 mL 5 kunjetti x 2 mL 4 kunjetti x 4 mL 4 kunjetti x 10 mL
English: - The active substance is dexmedetomidine.
Maltese: X'fih Dexdor - Is-sustanza attiva hija dexmedetomidine.
English: Orion pharma noted that case reports of overdose are frequently associated with ADRs of bradycardia, hypotension, over sedation, cardiac arrest, respiratory depression and hypertension so proposed to reinforce the existing warnings in section 4.9 of the SmPC and to include the adverse reaction of hypertension, and to redefine somnolence as respiratory depression.
Maltese: Orion pharma nnutat li r-rapporti tal-każijiet ta' doża eċċessiva ħafna drabi huma assoċjati ma' ADRs ta' bradikardija, pressjoni baxxa, sedazzjoni eċċessiva, arrest kardijaku, tnaqqis respiratorju u pressjoni għolja, u għalhekk ipproponiet it-tisħiħ tat-twissijiet eżistenti f'sezzjoni 4.9 tal-SmPC u li tiġi inkluża r-reazzjoni avversa tal-pressjoni għolja, u li l-ħedla tan-ngħas terġa' tiġi definita bħala tnaqqis respiratorju.
English: The safety and efficacy of Dexdor in children aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Dexdor fit-tfal ta' età minn 0 sa 18-il sena għadhom ma ġewx stabbiliti.
English: These metabolites have negligible pharmacological activity.
Maltese: Dawn il-metaboliti għandhom attività farmakoloġika negliġibbli.
English: Metabolite H-1, N-methyl 3-hydroxymethyl dexmedetomidine O-glucuronide, is also a major circulating product of dexmedetomidine biotransformation.
Maltese: Il-metabolit H-1, N-methyl 3-hydroxymethyl dexmedetomidine O-glucuronide wkoll huwa prodott ewlieni fiċ-ċirkolazzjoni tal-bijotrasformazzjoni ta' dexmedetomidine.
English: The adverse reactions listed in Table 1 have been accumulated from pooled data of clinical trials in intensive care.
Maltese: Ir-reazzjonijiet avversi elenkati f'Tabella 1 kienu akkumulati minn dejta miġbura minn provi kliniċi f'kura intensiva.
English: Respiratory, thoracic and mediastinal disorders Very common: Respiratory depression2,3
Maltese: Depressjoni respiratorja2,3
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.
Maltese: Individwi bi gradi varji ta' indeboliment epatiku (Child-Pugh Klassi A, B, jew Ċ) kellhom tneħħija epatika mnaqqsa ta' dexmedetomidine u titwil ta' t1/2 ta' eliminazzjoni mill-plażma.
English: Data in new-born infants (28 - 44 weeks gestation) to children 17 years of age are limited.
Maltese: Dejta minn trabi tat-twelid (28 - 44 ġimgħa ta' tqala) u tfal b'età sa 17-il sena hija limitata.
English: The difference in means in dose of rescue midazolam was -1.8 mg (95% CI: -2.7 - -0.86) favouring dexmedetomidine.
Maltese: Id-differenza fil-medji tad-doża ta' midazolam għas-sopravivenza kienet ta' -1.8 mg (95% CI: -2.7 - -0.86) tiffavorixxi lil dexmedetomidine.
English: Pack sizes 5 x 2 ml ampoules 25 x 2 ml ampoules 5 x 2 ml vials 4 x 4 ml vials 4 x 10 ml vials
Maltese: Daqsijiet tal-pakkett 5 ampulli x 2 mL 25 ampulla x 2 mL 5 kunjett x 2 mL 4 kunjetti x 4 mL 4 kunjetti x 10 mL
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).
Maltese: Fi studji double blind ikkontrollati b'komparatur fl-ICU, l-inċidenza ta' soppressjoni ta' cortisol f'pazjenti kkurati b'dexmedetomidine (n=778) kienet ta' 0.5% meta mqabbla ma' 0% f'pazjenti kkurati b'midazolam (n=338) jew propofol (n=275).