FrancophonIA/ELRC3.0 huggingface dataset:
English: Maximum concentrations of sufentanil are achieved approximately 50 minutes after a single dose; this is shortened to approximately 20 minutes following repeat dosing.
Maltese: Il-konċentrazzjonijiet massimi ta' sufentanil intlaħqu madwar 50 minuta wara doża waħda; dan il-perjodu jitnaqqas għal madwar 20 minuta wara dożi ripetuti.
English: available in pack sizes of 1 and 10, 20 cartridges and multipacks containing 40 (2 packs of 20), 60 (3 packs of 20) and 100 (5 packs of 20) cartridges, equivalent to 40, 400, 800, 1,600, 2,400 and 4,000 sublingual tablets, respectively.
Maltese: (3 pakketti ta' 20) u 100 (5 pakketti ta' 20) stoċċ, ekwivalenti għal 40, 400, 800, 1,600, 2,400 u 4,000 pillola għal taħt l-ilsien, rispettivament.
English: See section “Method of administration”.
Maltese: Ara s-sezzjoni “Metodu ta' kif għandu jingħata”.
English: The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
Maltese: Il-pazjenti għandhom jiġu segwiti mill-qrib għal sinjali u sintomi ta' depressjoni respiratorja u sedazzjoni.
English: Clearance is not affected by race, sex, renal parameters, hepatic parameters, or concomitant CYP3A4 substrates.
Maltese: It-tneħħija mhijiex affettwata mir-razza, is-sess, il-parametri tal-kliewi, il-parametri tal-fwied, jew substrati konkomitanti ta' CYP3A4.
English: The duration of the concomitant use should be limited (see section 4.4).
Maltese: D-durata tal-użu konkomitanti għandhom ikunu limitati (ara sezzjoni 4.4).
English: Pharmacotherapeutic group: Opioid anaesthetics, ATC Code: N01AH03
Maltese: Anestetiċi tal-loppju, Kodiċi ATC:
English: Lot see page 1 Lot see reverse
Maltese: Lot ara paġna 1 Lot ara fuq wara
English: A population pharmacokinetic analysis of plasma sufentanil concentrations following usage of Zalviso in patients and healthy volunteers (N = 700), which included 75 patients with moderate and 7 patients with severe renal impairment, did not identify renal function as a significant covariate for clearance.
Maltese: Analiżi farmakokinetika tal-popolazzjoni ta' konċentrazzjonijiet ta' sufentanil fil-plażma wara l-użu ta' Zalviso f'pazjenti u voluntiera b'saħħithom (N = 700) li kienu jinkludu 75 pazjent b'indeboliment tal-kliewi moderat u 7 pazjenti b'indeboliment sever, il-funzjoni tal-kliewi ma ġietx identifikata bħala kovarjat sinjifikanti għat-tneħħija.
English: Pharmacokinetic data from intravenous sufentanil administration did not reveal age related differences.
Maltese: It-tagħrif farmakokinetiku mill-għoti ta' sufentanil ġol-vini ma wera l-ebda differenza relatata mal-età.
English: Sufentanil crosses the placenta.
Maltese: Sufentanil jgħaddi minn ġol-plaċenta.
English: The most serious adverse reaction of sufentanil is respiratory depression, potentially leading to apnoea and respiratory arrest (see section 4.4).
Maltese: Ir-reazzjoni avversa l-aktar serja ta' sufentanil hija d-depressjoni respiratorja, li tista' twassal għal apnea u arrest respiratorju (ara sezzjoni 4.4).
English: Sufentanil acts as a full agonist in µ-opioid receptors.
Maltese: Sufentanil jaġixxi bħala agonist sħiħ fir-riċetturi tal-µ-opjojdi.
English: 1 Stokenchurch Business Park Ibstone Road, HP14 3FE - UK Tel: +44 (0)870 351 8960 medicalinformationuk@grunenthal.com
Maltese: 3FE - UK Tel: +44 (0)870 351 8960 medicalinformationuk@grunenthal.com
English: As Zalviso may affect your breathing, your doctor or nurse will check your breathing during treatment; - have a head injury or brain tumour; - have problems with your heart and circulation, especially slow heart rate, irregular heart beats, low blood volume or low blood pressure; - have moderate to severe liver or severe kidney problems, as these organs have an effect on the way in which your body breaks down and eliminates the medicine; - have a history of medicine or alcoholabuse; - are regularly using a prescribed opioid medicine (e.g. codeine, fentanyl, hydromorphone,
Maltese: Minħabba li Zalviso jista' jaffettwa n-nifs tiegħek, it-tabib jew l-infermier tiegħek ser jeżamina n-nifs tiegħek matul it-trattament; - għandek korriment fir-ras jew tumur tal-moħħ; - għandek problemi b'qalbek u ċ-ċirkolazzjoni, b'mod speċjali qalb li tħabbat bil-mod, taħbit tal-qalb irregolari, volum tad-demm baxx jew pressjoni baxxa; - għandek problemi tal-fwied minn moderati sa severi jew problemi fil-kliewi severi, minħabba li dawn l-organi għandhom effett fuq il-mod kif ġismek ikisser u jelimina l-mediċina; - għandek storja ta' abbuż ta' mediċini jew alkoħol; - qed tagħmel użu regolari minn mediċina opjojdi preskritta (eż. kodeina, fentanyl,
English: Zalviso sublingual tablets contain the azo colouring agent sunset yellow FCF Aluminium Lake (E110), which may cause allergic reactions.
Maltese: Zalviso pilloli għal taħt l-ilsien fihom is-sustanza koloranti azo sunset yellow FCF Aluminium Lake (E110), li tista' tikkawża reazzjonijiet allerġiċi.
English: Involuntary muscle spasms
Maltese: Spażmi involontarji fil-muskoli Kontrazzjonijiet tal-muskoli*
English: In the micronucleus test in female rats, single intravenous doses of sufentanil as high as 80 µg/kg (approximately 2.5 times the upper human intravenous dose) produced no structural chromosome mutations.
Maltese: Fit-test tal-mikronukleu f'firien nisa, dożi waħdiena ġol-vini ta' sufentanil għoljin daqs 80 µg/kg (madwar 2.5 darbiet l-ogħla doża mogħtija gol-vini għall-bniedem) ma pproduċew l-ebda mutazzjonijiet strutturali fil-kromosomi.
English: In the placebo-controlled Phase 3 trials, approximately 20 % of enrolled patients were elderly (≥ 75 years of age) and approximately 30 % of enrolled patients were 65 to 75 years of age.
Maltese: Fi provi kliniċi kkontrollati bi plaċebo ta' Fażi 3, madwar 20% tal-pazjenti li pparteċipaw kienu anzjani (≥ 75 sena) u madwar 30% tal-pazjenti li pparteċipaw kellhom minn 65 sa 75 sena.
English: Patients were treated using the Zalviso dosing regimen of 15 micrograms sufentanil sublingually as needed with a minimum 20 minute lock-out interval over a period of 72 hours.
Maltese: Il-pazjenti kienu kkurati permezz tar-reġim tad-dożaġġ ta' Zalviso ta' 15-il mikrogramma sufentanil mogħti taħt l-ilsien kif meħtieġ b'intervall ta' imblokk minimu ta' 20 minuta fuq perjodu ta' 72 siegħa.
English: oxycodone); - have abnormally slow bowel movements; - have a disease of the gall bladder or pancreas.
Maltese: hydromorphone, oxycodone); - għandek moviment tal-musrana (ippurgar) bil-mod b'mod anormali; - għandek marda tal-marrara jew tal-frixa.
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: Fil-bnedmin il-qawwa hija 7 sa 10 darbiet aktar minn fentanyl u 500 sa 1,000 darba aktar mill-morfina (kull doża meħuda mill-ħalq).
English: After 48 hours more than half of the subjects in the Zalviso group had a relevant pain reduction (30 % responder rate) in these trials (visceral pain 60 %, nociceptive pain 54.9 %).
Maltese: Wara 48 siegħa aktar minn nofs l-individwi fil-grupp ta' Zalviso kellhom tnaqqis rilevanti fl-uġigħ (rata ta' rispons ta' 30%) f'dawn il-provi (uġigħ vixxerali 60%, uġigħ noċiċettiv
English: Multipack: 1600 sublingual tablets [40 (2 packs of 20) cartridges of 40 sublingual tablets each] Multipack: 2400 sublingual tablets [60 (3 packs of 20) cartridges of 40 sublingual tablets each] Multipack: 4000 sublingual tablets [100 (5 packs of 20) cartridges of 40 sublingual tablets each]
Maltese: Pakkett multiplu: 4000 pillola għal taħt l-ilsien [100 (5 pakketti ta' 20) stoċċ ta' 40 pillola għal taħt l-ilsien]
English: When Zalviso was administered every 20 minutes, steady state plasma concentrations were achieved after 13 doses.
Maltese: Meta Zalviso ngħata kull 20 minuta, il-konċentrazzjonijiet fil-plażma kisbu stat fiss wara 13-il doża.
English: The concomitant use of CNS depressants including barbiturates, neuroleptics or other opioids, halogen gases or other non-selective CNS depressants (e.g. alcohol) may enhance respiratory depression.
Maltese: L-użu fl-istess ħin ta' mediċini kontra d-depressjoni tas-CNS inkluż barbiturates, neuropleptics jew opjojdi oħra, gassijiet aloġeni jew mediċini kontra d-depressjoni tas-CNS oħra mhux selettivi (eż. l-alkoħol) jistgħu jżidu d-depressjoni respiratorja.
English: Other symptoms that may occur are loss of consciousness, coma, cardiovascular shock and muscle rigidity.
Maltese: Sintomi oħra li jistgħu jseħħu huma li tintilef minn sensik, koma, xokk kardjovaskulari u ebusija fil-muskoli.
English: Children and adolescents Zalviso should not be used in children and adolescents below 18 years.
Maltese: Tfal u adolexxenti Zalviso ma għandux jintuża minn tfal u adolexxenti taħt it-18-il sena.
English: Sufentanil as a µ-opioid receptor agonist may cause spasm of the sphincter of Oddi.
Maltese: Sufentanil huwa metabolizzat l-aktar fil-fwied u eliminat fl-awrina u l-ippurgar.
English: The concomitant use of opioids with sedating medicinal products such as benzodiazepines or related substances increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.
Maltese: L-użu konkomitanti ta' opjojdi ma' prodotti mediċinali ta' sedazzjoni bħal benzodiazepines jew sustanzi relatati jżid ir-riskju ta' sedazzjoni, depressjoni respiratorja, koma u mewt minħabba l-effett addittiv ta' depressjoni tas-CNS.
English: Marketing Authorisation Holder and Manufacturer Grünenthal GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Grünenthal GmbH
English: CARTRIDGE
Maltese: Treddigħ
English: Depending on individual sensitivity, the clinical picture is determined by the degree of respiratory depression.
Maltese: Skont is-sensittività tal-individwu, l-istampa klinika hija determinata mil-livell ta' depressjoni respiratorja.
English: Sufentanil as a µ-opioid receptor agonist may slow the gastrointestinal motility.
Maltese: Sufentanil bħala agonist tar-riċetturi tal-µ-opjojdi jista' jnaqqas il-motilità gastro-intestinali.
English: Zalviso is provided in a polycarbonate cartridge, each of which contains 40 sublingual tablets and is packed in a polyester film/LDPE/aluminium foil/LDPE sachet with an oxygen absorber.
Maltese: Zalviso huwa pprovdut fi skartoċċ tal-polikarbonat, kull wieħed fih 40 pillola għal taħt l-ilsien u ppakkjat f'film tal-poliester/LDPE/fojl tal-aluminjum/qartas tal-LDPE b'assorbitur tal-ossiġnu.
English: Zalviso was also considered to be easier to use by healthcare professionals (P = 0.017).
Maltese: Zalviso kien ikkunsidrat ukoll bħala aktar faċli biex jintuża mill-professjonisti fil-kura tas-saħħa (P = 0.017).
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1. - Depressjoni respiratorja sinifikanti.
English: Approximately 80 % of the intravenously administered dose of sufentanil is excreted within 24 hours.
Maltese: Madwar 80% tad-doża mogħtija ġol-vini ta' sufentanil tiġi eliminata fi żmien 24 siegħa.
English: Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Maltese: Zalviso huwa indikat għall-ġestjoni ta' uġigħ minn moderat sa sever wara operazzjonijiet f'pazjenti adulti.
English: Sufentanil may obscure the clinical course of patients with head injury.
Maltese: Sufentanil jista' joskura l-perkors kliniku ta' pazjenti b'korriment fir-ras.
English: No pharmacokinetic data exist for the Zalviso in paediatric patients.
Maltese: L-ebda tagħrif farmakokinetiku ma jeżisti għal Zalviso f'pazjenti pedjatriċi.
English: Respiratory depression caused by sufentanil can be reversed by opioid antagonists.
Maltese: Id-depressjoni respiratorja kkawżata minn sufentanil hija riversibbli permezz ta' antagonisti tal-opjojdi.
English: Their frequencies were established based on data from intravenous administration of sufentanil: common - muscle twitching; uncommon - hypersensitivity, apathy, nervousness, ataxia, dystonia, hyperreflexia, heart rate decreased and dry skin.
Maltese: Il-frekwenzi tagħhom kienu stabbiliti fuq il-bażi tat-tagħrif mill-għoti ġol-vini ta' sufentanil: komuni - kontrazzjonijiet muskolari; mhux komuni - sensittività eċċessiva, apatija, tħossok nervuż, atassja, distonja, iperrifleksija, tnaqqis fit-taħbit tal-qalb u ġilda xotta.
English: This route of administration results in higher absolute bioavailability by avoiding intestinal and first-pass liver 3A4 enzyme metabolism.
Maltese: Dan il-mod kif jingħata jirriżulta f'bijodisponibbiltà assoluta akbar billi jevita l-metaboliżmu tal-enzimi 3A4 intestinali u tal-fwied first-pass.
English: Patients who were treated with Zalviso between 48 and 72 hours in the three controlled trials used a wide range of the available 216 doses, with a mean of 49 doses/patient (range of 8-153 doses) with the majority of patients (69.7 %) using between 24 to 72 doses.
Maltese: Pazjenti li kienu trattati b'Zalviso bejn 48 u 72 siegħa fit-tliet provi bil-kontrolli użaw firxa wiesgħa mill-216-il doża disponibbli, b'medja ta' 49 doża/pazjent (firxa ta' 8-153 doża) bil-maġġoranza ta' pazjenti (69.7%) jużaw bejn 24 sa 72 doża.
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 mogħti 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: Analgesic plasma concentrations of sufentanil may provoke nausea and vomiting by irritation of the chemoreceptor trigger zone.
Maltese: Il-konċentrazzjonijiet fil-plażma analġeżiċi ta' sufentanil jistgħu jikkawżaw nawsja u rimettar permezz tal-irritazzjoni taż-żona li tiskatta l-kemoriċetturi.
English: After prolonged use of other substances with µ-opioid receptor activity, symptoms of withdrawal were observed after abrupt interruption of the treatment.
Maltese: Wara użu fit-tul ta' sustanzi oħra li għandhom attività ta' riċetturi tal-µ-opjojd, kienu osservati sintomi ta' rtirar wara interruzzjoni f'daqqa tal-kura.
English: Based on the population pharmacokinetic analysis for Zalviso in patients and healthy volunteers (N = 700), which included 13 patients with moderate and 6 patients with severe hepatic impairment, hepatic function was not identified as a significant covariate for clearance.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni għal Zalviso f'pazjenti u voluntiera b'saħħithom (N = 700) li kienu jinkludu 13-il pazjent b'indeboliment moderat tal-fwied u 6 pazjenti b'indeboliment sever, il-funzjoni tal-fwied ma ġietx identifikata bħala kovarjat sinifikanti għat-tneħħija.
English: The maximum amount of sublingual sufentanil that can be delivered via the Zalviso administration device over an hour is 45 micrograms (3 doses).
Maltese: L-ammont massimu ta' sufentanil għal taħt l-ilsien li jista' jingħata permezz tal-apparat tal-għoti Zalviso fuq perjodu ta' siegħa huwa ta' 45 mikrogrammi (3 dożi).
English: Zalviso sublingual tablets are available in pack sizes of 1, 10 and 20 cartridges and in multipacks containing 40 (2 packs of 20), 60 (3 packs of 20) and 100 (5 packs of 20) cartridges, equivalent to 40, 400, 800, 1,600, 2,400 and 4,000 sublingual tablets, respectively.
Maltese: Zalviso huwa disponibbli fid-daqsijiet tal-pakkett ta' 1 u 10, 20 stoċċ u pakketti multipli li fihom 40 (2 pakketti ta' 20), 60
English: Dry mouth
Maltese: Żamma tal-awrina
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Eċċipjent(i) b'effett magħruf
English: Clinical trials have shown that sufentanil administered intravenously causes less respiratory depression when compared with equianalgesic doses of fentanyl.
Maltese: Provi kliniċi wrew li sufentanil mogħti ġol-vini jikkawża anqas depressjoni respiratorja meta mqabbel mad-dożi ekwianalġeżiċi ta' fentanyl.
English: An opiate antagonist (e.g. naloxone) should be administered in the event of respiratory depression.
Maltese: Għandu jingħata antagonist tal-opjati (eż. naloxene) fil-każ ta' depressjoni respiratorja.
English: High doses of intravenously administered sufentanil are known to cause muscle rigidity, probably as a result of an effect on the substantia nigra and the striate nucleus.
Maltese: Dożi għoljin ta' sufentanil mogħti ġol-vini huma magħrufin li jikkawżaw ebusija fil-muskoli, probabbilment bħala riżultat ta' effett fuq is-sustantia nigra u n-nukleu striate.
English: Zalviso contains the colouring agent sunset yellow FCF Aluminium Lake (E110), which may cause allergic reactions.
Maltese: Zalviso fih sunset yellow FCF Aluminium Lake (E110) Zalviso fih is-sustanza koloranti azo sunset yellow FCF Aluminium Lake (E110), li tista' tikkawża reazzjonijiet allerġiċi.
English: Sufentanil overdose is manifested by an exaggeration of its pharmacological effects.
Maltese: Doża eċċessiva ta' sufentanil hija evidenzjata minn eżaġerazzjoni tal-effetti farmakoloġiċi tagħha.
English: Each sublingual tablet contains 15 micrograms sufentanil (as citrate).
Maltese: Kull pillola għal taħt l-ilsien fiha 15-il mikrogramma sufentanil (bħala ċitrat).
English: Hypersensitivity* Anaphylactic shock
Maltese: Sensittività eċċessiva*
English: However if your doctor prescribes Zalviso together with sedating medicines the duration of concomitant treatment should be limited by your doctor.
Maltese: Madankollu, jekk it-tabib tiegħek jippreskrivi Zalviso flimkien ma' mediċini ta' sedazzjoni, d-durata tal-kura konkomitanti għandha tiġi limitata mit-tabib tiegħek.
English: As demonstrated in the active-controlled trial, the average time between Zalviso doses was approximately double as long as compared to intravenous morphine patient-controlled analgesia (approximately 80 minutes compared to approximately 45 minutes) over the first 48 hours.
Maltese: Kif muri fil-prova kkontrollata attivament, il-ħin medju bejn id-dożi ta' Zalviso kien madwar id-doppju meta mqabbel mal-analġeżija bil-morfina kkontrollata mill-pazjent (madwar 80 minuta mqabbel ma' madwar 45 minuta) matul l-ewwel 48 siegħa.
English: When patients titrated themselves to analgesic effect with Zalviso, plasma sufentanil concentrations averaged 60-100 pg/ml over two days of use, with no effect based on age or body mass index (BMI), or mild to moderate renal or liver impairment.
Maltese: Meta l-pazjenti għamlu d-dożaġġ huma stess biex jiksbu l-effett analġeżiku b'Zalviso, il-konċentrazzjonijiet fil-plażma ta' sufentanil kienu ta' medja ta' 60-100 pg/ml fuq perjodu ta' jumejn ta' użu, bl-ebda effett ibbażat fuq l-età jew l-indiċi tal-massa tal-ġisem (BMI), jew indeboliment tal-kliewi jew tal-fwied minn ħafif sa moderat.
English: Sufentanil caused embryolethality in rats and rabbits who were treated for 10-30 days during pregnancy with 2.5 times the maximum human dose by intravenous administration.
Maltese: Sufentanil ikkaġuna letalità embrijonika lil firien u fniek li kienu ttestjati għal 10-30 jum waqt it-tqala b'2.5 darbiet id-doża massima għall-bniedem permezz ta' għoti ġol-vina.
English: SACHET
Maltese: STOĊĊ
English: Drug Withdrawal Syndrome
Maltese: Sindrome ta' Rtirar tal-Mediċina
English: Since this decrease related to age is smaller than the observed inter-subject variability of 30-40 % in exposure parameters for sufentanil, this effect is not considered to be of clinical relevance, particularly given that Zalviso is only used on an ‘as-needed' basis.
Maltese: Minħabba li dan it-tnaqqis relatat mal-età huwa iżgħar mill-varjabbiltà osservata bejn l-individwi ta' 30-40% fil-parametri ta' esponiment għal sufentanil, dan l-effett ma tqisx bħala klinikament rilevanti, b'mod partikolari minħabba li Zalviso jintuża biss skont il-ħtieġa.
English: After removing from the sachet, the cartridge should be placed into the Zalviso administration device immediately.
Maltese: Dan ma jeskludix l-użu ta' kontromiżuri aktar diretti.
English: Endpoints & statistics
Maltese: Punti finali & statistika
English: Transporter inhibitors (lopinavir/ritonavir)
Maltese: Inibituri tat-trasportaturi (lopinavir/ritonavir)
English: Table 1 Summary of outcome events
Maltese: Tabella 1 Sommarju tal-avvenimenti finali
English: - The active substance is selexipag.
Maltese: - Is-sustanza attiva hi selexipag.
English: Date of first authorisation: 12 May 2016
Maltese: 12 ta' Mejju 2016
English: Uptravi 200 microgram
Maltese: Uptravi 200 mikrogramma
English: 17.9% of patients were ≥ 65 and 1.1% ≥ 75 years of age.
Maltese: 17.9% tal-pazjenti kellhom età ta' ≥ 65 u 1.1% ≥ 75 sena.
English: HR (99% CI) p-value
Maltese: HR (CI ta' 99%) valur p
English: • Severe arrhythmias.
Maltese: • Arritmiji severi.
English: Approximately 1%, 46%, 53%, and 1% of patients were in WHO FC I, II, III and IV, respectively, at baseline.
Maltese: Madwar 1%, 46%, 53%, u 1% tal-pazjenti kienu f'WHO FC I, II, III u IV, rispettivament, fil-linja bażi.
English: If you forget to take Uptravi.....................................16 If you stop taking Uptravi.........................................17 Titration diary...........................................................18
Maltese: Djarju tattitrazzjoni..................................................18
English: There are 2 phases of treatment with Uptravi:
Maltese: Hemm 2 fażijiet ta' trattament b'Uptravi:
English: Maintenance Selexipag Placebo Selexipag Placebo
Maltese: Manteniment Selexipag Plaċebo Selexipag Plaċebo
English: The exposure to selexipag was up to 4.2 years.
Maltese: L-esponiment għal selexipag kien sa 4.2 snin.
English: Figure 1 Kaplan-Meier estimates of the first morbidity-mortality event
Maltese: Stimi Kaplan-Meier tal-ewwel avveniment ta' morbidità-mortalità
English: Placebo (N=582)
Maltese: (N=582)
English: Paediatric population (< 18 years)
Maltese: Popolazzjoni pedjatrika (< 18-il sena)
English: Death up to EOT + 7 daysd n (%)
Maltese: Mewt sa EOT + 7 ijiemd n (%)
English: Inhibitors and inducers of CYP3A4
Maltese: Inibituri u indutturi ta' CYP3A4
English: When you move to your maintenance dose.............14
Maltese: Meta taqleb għad-doża ta' manteniment tiegħek ......14
English: Inhibitors of UGT1A3 and UGT2B7
Maltese: Inibituri ta' UGT1A3 u UGT2B7
English: Relative risk reduction (99% CI)
Maltese: Tnaqqis relattiv tarriskju (CI ta' 99%)
English: Pulmonary haemodynamics
Maltese: Emodinamiċi pulmonari
English: Inducers of CYP2C8
Maltese: Indutturi ta' CYP2C8
English: • Decompensated cardiac failure if not under close medical supervision.
Maltese: • Insuffiċjenza dekompensata tal-qalb jekk mhux taħt superviżjoni medika stretta.
English: The volume of distribution of selexipag at steady state is 11.7 L.
Maltese: Il-volum ta' distribuzzjoni ta' selexipag fi stat fiss huwa ta' 11.7 L.
English: Mannitol (E421), maize starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate.
Maltese: Mannitol (E421), maize starch, hydroxypropyl cellulose sostitut b'mod baxx, hydroxypropyl cellulose, magnesium stearate
English: Polyamide / aluminium / HDPE / PE with an embedded desiccant agent / HDPE blister sealed with an aluminium foil.
Maltese: Polyamide / aluminju / HDPE / PE b'desikkant integrat / folja tal-HDPE issiġillata b'fojl tal-aluminju.
English: = intravenous; PAH = pulmonary arterial hypertension; s.c. = subcutaneous.
Maltese: PAH = pressjoni għolja fl-arterja tal-pulmun; s.c. = taħt il-ġilda.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC27
Maltese: Sustanzi antitrombotiċi, inibituri tal-aggregazzjoni tal-plejtlits minbarra heparin, Kodiċi ATC: B01AC27 Mekkaniżmu ta' azzjoni
English: Median 6MWD at baseline was 376 m (range: 90-482 m) and 369 m (range: 50-515 m) in selexipag patients and placebo patients, respectively.
Maltese: 6MWD medjana fil-linja bażi kienet 376 m (firxa: 90-482 m) u 369 m (firxa: 50-515 m) f'pazjenti fuq selexipag u pazjenti fuq plaċebo, rispettivament.
English: Treatment comparison: selexipag vs placebo
Maltese: Paragun tat-trattament: selexipag kontra plaċebo