FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose proportionality has been demonstrated from 25 to 60 micrograms per dose.
Maltese: Il-proporzjonalità tad-doża ntweriet minn 25 sa 60 mikrogramma għal kull doża.
English: anhydrous citric acid, cetylpyridinium chloride - anode electrode: layers of silver foil and electrically conductive adhesive tape - cathode electrode: layers of polyisobutylene/silver chloride/carbon black composite material,
Maltese: anhydrous citric acid, cetylpyridinium chloride - elettrodu anodiku: saffi ta' fojl tal-fidda u tejp adeżiv li jikkonduċi l-elettriku - elettrodu katodiku: saffi ta' materjal kompost ta' polyisobutylene/silver chloride/carbon black,
English: There are no clinical data on the effects of fentanyl on fertility.
Maltese: M'hemm ebda dejta klinika dwar l-effetti ta' fentanyl fuq il-fertilità.
English: 95% CIa, b Patient Global Assessment of Method of Pain Control -1st 24 hour (% of patients rating good or excellent) C-2000-007
Maltese: 95% CIa, b Valutazzjoni Globali tal-Pazjent tal-Metodu ta' Kontroll tal-Uġigħ - l
English: Serotoninergic medicinal products
Maltese: IL-PRODOTT MEDIĊINALI
English: IONSYS was also evaluated in four active-control trials (predominantly female (65%), Caucasian (85%), with a mean age of 55 years (range, 18-91 years), and primarily comprised of surgeries including lower abdominal and orthopedic bone procedures) using a standard intravenous patient controlled analgesia (PCA) morphine regimen as the comparator.
Maltese: IONSYS kien evalwat ukoll f'erba' provi b'kontroll attiv (fil-biċċa l-kbira nisa (65 %), Kawkasi (85 %), b'età medja ta' 55 sena (medda ta' 18-91 sena), u li prinċipalment kienu komposti minn operazzjonijiet li jinkludu proċeduri tal-għadam ortopediċi u tal-parti t'isfel tal-addome) permezz ta' reġim standard ta' morfina ġol-vina għal analġeżija skont il-bżonn tal-pazjent (PCA) bħala l komparatur.
English: • you are taking medicines for fungal infections (such as ketoconazole, itraconazole or
Maltese: • qed tieħu mediċini għal infezzjoni fungali (bħal ketoconazole, itraconazole jew fluconazole);
English: Tear at notch
Maltese: Uġigħ ta' ras
English: Hepatic disease may delay elimination.
Maltese: Mard epatiku jista' jdewwem l eliminazzjoni.
English: Cough
Maltese: Dawl
English: Fentanyl is metabolised primarily in the liver to norfentanyl by CYP3A4 isoform.
Maltese: Fentanyl huwa prinċipalment metabolizzat fil-fwied għal norfentanyl minn isoforma ta' CYP3A4.
English: The overall adverse reaction profile for morbidly obese patients (BMI > 40) does not suggest a meaningful difference in safety compared to patients with BMI ≤ 40.
Maltese: Pazjenti obeżi Il-profil globali tar-reazzjonijiet avversi għal pazjenti b'obeżità patoloġika (BMI > 40) ma jissuġġerixxix differenza sinifikanti fis-sigurtà meta mqabbel mal-pazjenti b'BMI ≤ 40.
English: To dispose of a used IONSYS system:
Maltese: Biex tarmi sistema IONSYS użata:
English: Low battery or defective system
Maltese: Batterija baxxa jew sistema difettuża
English: About 9% of the dose is recovered in the faeces, primarily as metabolites.
Maltese: Madwar 9 % tad-doża tiġi rkuprata mill-ippurgar, primarjament bħala metaboliti.
English: Fentanyl is metabolised into inactive metabolites in the liver.
Maltese: Mard epatiku Fentanyl huwa metabolizzat f'metaboliti inattivi fil-fwied.
English: Itraconazole, a potent CYP3A4 inhibitor, at 200 mg/day orally for 4 days had no significant effect on the pharmacokinetics of intravenous fentanyl.
Maltese: Itraconazole, inibitur qawwi ta' CYP3A4, f'200 mg/kuljum li jingħata mill-ħalq għal 4 ijiem ma kellu ebda effett sinifikanti fuq il-farmakokinetika ta' fentanyl mogħti ġol-vina.
English: Each IONSYS system contains fentanyl hydrochloride equivalent to 9.7 mg of fentanyl and delivers 40 micrograms fentanyl per dose, to a maximum of 80 doses (3.2 mg/24 hours).
Maltese: Kull sistema IONSYS fiha fentanyl hydrochloride ekwivalenti għal 9.7 mg ta' fentanyl u tagħti 40 mikrogramma ta' fentanyl għal kull doża, sa massimu ta' 80 doża (3.2 mg/24 siegħa).
English: Also contains: glycol-modified polyethylene terephthalate, purified water, sodium hydroxide, polacrilin, polyvinyl alcohol, trisodium citrate dihydrate, anhydrous citric acid, cetylpyridinium chloride monohydrate, sodium chloride, silver foil, electrically conductive adhesive tape (ECAT), polyisobutylene/silver chloride/carbon black, polyisobutene, polyisobutylene, rosin ester, siliconised polyester.
Maltese: Fih ukoll: polyethylene terephthalate mmodifikat bi glycol, ilma purifikat, sodium hydroxide, polacrilin, alkoħol tal-polyvinyl, trisodium citrate dihydrate, anhydrous citric acid, cetylpyridinium chloride monohydrate, sodium chloride, fojl tal-fidda, tejp adeżiv li jikkonduċi l-elettriku (ECAT), polyisobutylene/silver chloride/carbon black, polyisobutene, polyisobutylene, rosin ester, polyester silikonizzat.
English: Fentanyl exhibits three compartment distribution pharmacokinetics.
Maltese: Fentanyl jesebixxi farmakokinetika ta' distribuzzjoni fi tliet kompartimenti.
English: • Beeping for 15 seconds
Maltese: madwar 15-il minuta.
English: Table 1: Placebo-controlled Trials (N=727) Patients Percent (n) of patients who withdrew due to inadequate analgesia Hours 3-24
Maltese: Tabella 1: Pazjenti fi Provi kkontrollati bi Plaċebo (N=727) Perċentwal (n) ta' pazjenti li rtiraw minħabba analġeżija
English: IONSYS delivers a nominal dose of 40 micrograms fentanyl over each 10-minute dosing period at steady state.
Maltese: IONSYS jagħti doża nominali ta' 40 mikrogramma ta' fentanyl fuq perjodu ta' dożaġġ ta' 10 minuti fi stat fiss.
English: The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Maltese: L-użu konkomitanti ta' agonisti/antagonisti tal-opjojdi (eż. buprenorphine, nalbuphine, pentazocine) mhux irrakkomandat.
English: The placebo-controlled trials included 791 patients that were predominantly female (72%), Caucasian (82%), with a mean age of 45-54 years (range, 18-90 years), and primarily comprised of surgeries including lower abdominal (including pelvic) and orthopedic bone procedures.
Maltese: Il-provi kkontrollati bi plaċebo kienu jinkludi 791 pazjent li fil-biċċa l-kbira tagħhom kienu nisa (72 %), Kawkasi (82 %), b'età medja bejn 45 u 54 sena (medda bejn 18 u 90 sena), u kienu prinċipalment komposti minn operazzjonijiet li jinkludu proċeduri talgħadam ortopediċi u tal-addome t'isfel (inkluż il-pelvi).
English: Patients who completed 24 hours of IONSYS treatment in the seven controlled studies used a wide range of the available 80 doses, with a mean of 29.0 doses/patient (range of 0-93 doses) with the majority of patients (56.5%) using between 11 to 50 doses.
Maltese: Il-pazjenti li lestew 24 siegħa ta' kura b'IONSYS fis-seba' studji kkontrollati użaw medda wiesgħa ta' 80 doża disponibbli, b'medja ta' 29.0 doża/pazjent (medda ta' 0-93 doża) bil-maġġoranza tal-pazjenti (56.5 %) li jużaw bejn 11 u 50 doża.
English: More than 90% of the administered dose of fentanyl is eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites.
Maltese: Aktar minn 90 % tad-doża mogħtija ta' fentanyl hija eliminata permezz ta' bijotrasformazzjoni għal metaboliti inattivi b'Ndealkilazzjoni u b'idroliżi.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal
English: • Blinking red light for 15 seconds
Maltese: • Ħoss għal 15-il sekonda
English: Confusional state Hallucination Nervousness
Maltese: Stat konfużjonali Alluċinazzjoni
English: Data on IONSYS in paediatrics is limited to information from a single clinical trial.
Maltese: Dejta dwar IONSYS fil-pedjatrija hija limitata għal informazzjoni minn prova klinika waħda.
English: Systemic absorption of fentanyl increases as a function of time independent of the frequency of dosing, with the initial dose being approximately 16 micrograms.
Maltese: L-assorbiment sistemiku ta' fentanyl jiżdied bħala funzjoni li hija indipendenti mill-ħin tal-frekwenza tad-dożaġġ, bid-doża inizjali tkun madwar 16-il mikrogramma.
English: However elderly patients should be observed closely for adverse effects of fentanyl (see sections 4.4 and 4.8).
Maltese: Madankollu, il-pazjenti anzjani għandhom jiġu osservati mill-qrib għal effetti avversi ta' fentanyl (ara sezzjonijiet 4.4 u 4.8).
English: As illustrated in Table 1 below, IONSYS (fentanyl hydrochloride) was superior to placebo in all studies.
Maltese: Kif indikat fit-Tabella 1 hawn taħt, IONSYS (fentanyl hydrochloride) kien superjuri għal plaċebo fl-istudji kollha.
English: Dry mouth Dyspepsia Flatulence Ileus
Maltese: Fentanyl Użu minn fuq il-ġilda
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Maltese: Fentanyl, sustanza attiva b'rata ta' eliminazzjoni għolja, jiġi metabolizzat malajr u b'mod estensiv, laktar minn CYP3A4.
English: IONSYS is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Maltese: IONSYS huwa indikat għall-ġestjoni ta' uġigħ akut ta' natura moderata sa severa wara operazzjoni f'pazjenti adulti.
English: Some medicines can affect the way IONSYS works, or make it more likely that you will have side effects.
Maltese: IONSYS, jew jagħmluha aktar probabbli li jkollok effetti sekondarji.
English: The concomitant use of other central nervous system depressants including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages, may produce additive depressant effects.
Maltese: L-użu konkomitanti ta' dipressanti oħrajn tas-sistema nervuża ċentrali inklużi opjojdi oħrajn, sedattivi jew ipnotiċi, anestetiċi ġenerali, phenothiazines, aġenti sedattivi, rilassanti tal-muskoli skeletriċi, antistamini sedattivi, u xorb alkoħoliku, jistgħu jikkaġunaw effetti dipressanti addittivi.
English: Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
Maltese: Madwar 75 % ta' fentanyl jitneħħa mal-awrina, fil-biċċa l-kbira bħala metaboliti, b'anqas minn 10 % bħala sustanza attiva kif inhi.
English: When IONSYS is applied without activating the electrical current, the average absorption rate of fentanyl over 24 hours was 2.3 micrograms fentanyl/hour, indicating minimal passive delivery.
Maltese: Meta IONSYS jiġi applikat mingħajr ma jiġi attivat il-kurrent elettriku, ir-rata medja ta' assorbiment ta' fentanyl fuq 24 siegħa kienet 2.3 mikrogrammi ta' fentanyl/fis-siegħa, li tindika għoti passiv minimu.
English: 3.7%)a, b
Maltese: NUMRU(I)
English: Fentanyl induced mutagenic effects in mammalian cells in vitro, comparable to other opioid analgesics.
Maltese: Fentanyl induċa effetti mutaġeniċi f'ċelloli tal-mammiferi in vitro, paragunabbli għal analġeżiċi tal-opjojdi oħrajn.
English: • nervousness
Maltese: Nervi
English: The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression (see section 5.2).
Maltese: Il-manifestazzjonijiet ta' doża eċċessiva ta' fentanyl huma estensjoni tal-azzjonijiet farmakoloġiċi tiegħu, l-aktar effett serju jkun dipressjoni respiratorja (ara sezzjoni 5.2).
English: Severe respiratory depression or cystic fibrosis.
Maltese: Dipressjoni respiratorja severa jew fibrożi ċistika. 4.4
English: Each IONSYS system is designed to deliver up to 80 10-minute doses of fentanyl over a period of 24 hours.
Maltese: Kull sistema IONSYS hija ddisinjata biex tagħti sa 80 doża ta' 10 minuti ta' fentanyl fuq perjodu ta' 24 siegħa.
English: Special precautions for disposal should be followed (see section 6.6).
Maltese: Għandhom jiġu segwiti prekawzjonijiet speċjali għar-rimi (ara sezzjoni 6.6).
English: A single IONSYS system provided a sufficient number of doses for 99% of the studied patients over 24 hours.
Maltese: Sistema IONSYS waħda pprovdiet numru suffiċjenti ta' dożi għal 99 % tal-pazjenti studjati fuq 24 siegħa.
English: IONSYS is composed of an electronic controller and a drug unit with two hydrogels.
Maltese: IONSYS huwa magħmul minn kontrollur elettroniku u unità tal-mediċina b'żewġ hydrogels.
English: IONSYS 40 micrograms, with approximately 10% (174/1763) of exposures being in patients ≥ 75
Maltese: Il-pazjenti anzjani (≥65 sena) kienu 28 % (499/1763) mill-espożizzjoni tal-prova klinika kkontrollata totali għal IONSYS 40 mikrogramma, b'madwar 10 % (174/1763) tal-espożizzjonijiet ikunu f'pazjenti ≥75 sena.
English: Bottom housing assembly: - bottom housing unit: glycol-modified polyethylene terephthalate - anode hydrogel: polacrilin, purified water, sodium hydroxide, polyvinyl alcohol - cathode hydrogel: purified water, sodium chloride, sodium citrate, polyvinyl alcohol,
Maltese: - unità ta' lqugħ t'isfel: polyethylene terephthalate mmodifikat bi glycol - hydrogel anodiku: polacrilin, ilma ppurifikat, sodium hydroxide, alkoħol tal-polyvinyl - hydrogel katodiku: ilma ppurifikat, sodium chloride, sodium citrate, alkoħol tal-polyvinyl,
English: Fentanyl is excreted into human milk.
Maltese: Fentanyl huwa eliminat mill-ћalib tas-sider tal-bniedem.
English: Do not use the system 2.
Maltese: Neħħi s-sistema mill-pazjent 2.
English: The concomitant use of potent CYP3A4 inhibitors (e.g., as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) with IONSYS may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic effect and adverse reactions, and may cause serious respiratory depression.
Maltese: CYP3A4 (eż. amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, meraq tal grejpfrut, u verapamil) ma' IONSYS jista' jirriżulta f'żieda fil-konċentrazzjonijiet fil-plażma ta' fentanyl, li jistgħu jżidu jew itawlu kemm l-effett terapewtiku kif ukoll ir-reazzjonijiet avversi, u jistgħu jikkawżaw dipressjoni respiratorja serja.
English: The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Maltese: Il-proteina tal-irbit ewlenija hija l-glikoproteina alpha-1-acid,
English: 1 system delivers 40 micrograms fentanyl per dose, to a maximum of 80 doses (3.2 mg/24 hours).
Maltese: 40 mikrogramma ta' fentanyl għal kull doża, sa massimu ta' 80 doża (3.2 mg/24 siegħa).
English: Musculoskeletal and connective tissue
Maltese: Disturbi muskolu skeletriċi u tat-tessuti konnettivi
English: IONSYS should be removed before a magnetic resonance imaging (MRI) procedure, cardioversion, defibrillation, X-ray, CT scan or diathermy is undertaken.
Maltese: IONSYS għandu jitneħħa qabel issir proċedura ta' immaġni tar-reżonanza manjetika (MRI), kardjoverżjoni, defibrillazzjoni, X-ray, CT scan jew dijatermija.
English: silver foil, and electrically conductive adhesive tape - skin adhesive: polybutene, polyisobutylene, and rosin ester - protective liner: polyester film coated on one side with silicone.
Maltese: fojl tal-fidda, u tejp adeżiv li jikkonduċi l-elettriku - adeżiv tal-ġilda: polyisobutene, polyisobutylene, u rosin ester - inforra protettiva: miksi b'rita tal-polyester fuq naħa minnhom bis-silikon.
English: Mutagenicity testing in bacteria and in rodents yielded negative results.
Maltese: L-ittestjar tal-mutaġeniċità fil-batterja u r-rodituri rriżulta f'riżultati negattivi.
English: Studies in rats have revealed reduced fertility and enhanced embryo mortality (see section 5.3).
Maltese: L-istudji fil-firien żvelaw tnaqqis fil-fertilità u żieda fil-mortalità tal-embrijuni (ara sezzjoni 5.3).
English: Minimum effective analgesic serum concentrations of fentanyl in opioid-naïve patients treated for acute post-operative pain range from 0.2 to 1.2 ng/ml; undesirable effects increase in frequency at serum levels above 2 ng/ml.
Maltese: Il-konċentrazzjonijiet analġeżiċi effikaċi minimi fis-serum ta' fentanyl f'pazjenti li qatt ma ġew ikkurati qabel b'opjojdi għal medda ta' uġigħ akut wara operazzjoni minn 0.2 sa 1.2 ng/ml; l-effetti mhux mixtieqa jiżdiedu fil-frekwenza fil-livelli fis-serum 'il fuq minn 2 ng/ml.
English: IONSYS with food, drink and alcohol
Maltese: IONSYS mal-ikel, ix-xorb u l-alkoħol
English: Assembly of IONSYS
Maltese: APPARAT IONSYS
English: Studies with female rats revealed reduced fertility and enhanced embryo mortality.
Maltese: Studji bil-firien nisa żvelaw tnaqqis fil-fertilità u żieda fil-mortalità tal-embriju.
English: The primary efficacy endpoint was the patient global assessment of method of pain control at 24 hours used to test equivalence between IONSYS and intravenous PCA morphine using a pre-specified ± 10% equivalence boundary with a 2-sided 95% confidence interval.
Maltese: Il-punt ta' tmiem tal-effikaċja primarja kienet valutazzjoni globali tal-pazjent talmetodu ta' kontroll tal-uġigħ f'24 siegħa użat biex tiġi ttestjata l-ekwivalenza bejn IONSYS u lmorfina PCA mogħtija ġol-vina permezz ta' konfini ta' ekwivalenza ta' ±10 % speċifikat minn qabel b'intervall ta' kunfidenza ta' 95 % fuq żewġ naħat.
English: The other ingredients are: bottom housing unit: glycol-modified polyethylene terephthalate anode hydrogel: polacrilin, purified water, sodium hydroxide, polyvinyl alcohol cathode hydrogel: purified water, sodium chloride, sodium citrate, polyvinyl alcohol, anhydrous citric acid, cetylpyridinium chloride anode electrode: layers of silver foil and electrically conductive adhesive tape cathode electrode: layers of polyisobutylene/silver chloride/carbon black composite material, silver foil, and electrically conductive adhesive tape skin adhesive: polybutene, polyisobutylene, and rosin ester protective liner: polyester film coated on one side with silicone.
Maltese: Is-sustanzi l-oħra huma: unità ta' lqugħ t'isfel: polyethylene terephthalate mmodifikat bi glycol hydrogel anodiku: polacrilin, ilma purifikat, sodium hydroxide, polacrilin, alkoħol tal-polyvinyl hydrogel katodiku: ilma purifikat, sodium chloride, sodium citrate, alkoħol tal-polyvinyl, anhydrous citric acid, cetylpyridinium chloride elettrodu anodiku: saffi tal-fojl tal-fidda u tejp adeżiv li jikkonduċi l-elettriku elettrodu katodiku: saffi ta' materjal kompost ta' polyisobutylene/silver chloride/carbon black, fojl tal fidda, u tejp adeżiv li jikkonduċi l-elettriku adeżiv tal-ġilda: polybutene, polyisobutylene u rosin ester inforra protettiva: film tal-polyester miksi fuq naħa minnhom bis-silikon.
English: See also instructions in SmPC Section 6.6.
Maltese: Ara wkoll l-istruzzjonijiet fis-Sezzjoni 6.6 tal-SmPC.
English: Unlike morphine, no active fentanyl metabolites are eliminated by the kidney.
Maltese: B'differenza millmorfina, l-ebda metabolit attiv ta' fentanyl ma jiġi eliminat mill-kliewi.
English: Elderly patients should be observed carefully for adverse effects of fentanyl during IONSYS administration (see sections 4.2 and 4.8).
Maltese: Il-pazjenti anzjani għandhom jiġu osservati b'attenzjoni għal effetti avversi ta' fentanyl matul l-għoti ta' IONSYS (ara sezzjonijiet 4.2 u 4.8).
English: See package leaflet for disposal information.
Maltese: Sorsi oħra ta' informazzjoni
English: Troubleshooting
Maltese: Ipoksja
English: Each IONSYS is designed to deliver up to 80 10-minute doses of fentanyl over a period of 24 hours.
Maltese: Kull IONSYS huwa ddisinjat biex jagħti sa 80 doża ta' 10 minuti ta' fentanyl fuq perjodu ta' 24 siegħa.
English: Additional analyses suggest that the surgical procedure type did not influence the trends in efficacy endpoints and the efficacy of IONSYS was similar across the range of body mass indices studied (< 25 to > 40 kg/m2
Maltese: Analiżijiet addizzjonali jissuġġerixxu li t-tip ta' proċedura kirurġika ma kinitx tinfluwenza x xejriet fil-punti ta' tmiem tal-effikaċja u l-effikaċja ta' IONSYS kienet simili fil-medda kollha tal indiċijiet tal-massa tal-ġisem studjati (Indiċi tal-Massa tal-Ġisem < 25 sa ≥ 40 kg/m2).
English: Fentanyl can be abused in a manner similar to other opioid agonists.
Maltese: Fentanyl jista' jiġi abbużat b'mod simili għal agonisti opjojdi oħrajn.
English: Transdermal system
Maltese: Tużax is-sistema
English: Published literature has indicated that the CYP3A4*22 and CYP3A5*3 single nucleotide polymorphisms influence fentanyl to norfentanyl metabolism with the potential for increased fentanyl exposure in patients with these genetic polymorphs.
Maltese: CYP3A5*3 jinfluwenzaw il-metaboliżmu minn fentanyl għal norfentanyl bil-potenzjal ta' żieda fl espożizzjoni ta' fentanyl f'pazjenti b'dawn il-polimorfi ġenetiċi.
English: None of the four demographic factors studied [weight (lean/obese), age, race, or gender] had a significant effect on active substance exposure (AUC) following use of IONSYS.
Maltese: L-ebda wieħed mill-erba' fatturi demografiċi studjati [piż (magħlub/obeż), età, razza, jew sess] ma kellu effett sinifikanti fuq l-espożizzjoni għas-sustanza attiva (AUC) wara l-użu ta' IONSYS.
English: Pharmacokinetic /pharmacodynamic relationship
Maltese: Relazzjoni farmakokinetika/farmakodinamika
English: • Educational material (including prescriber checklist) for the healthcare professionals
Maltese: • Materjal edukattiv (inkluż il-lista ta' kontroll għat-tobba li jippreskrivu l-mediċina) għallprofessjonisti fil-kura tas-saħħa
English: Paediatric population
Maltese: Emigranja Parestesija
English: For disposal instructions, see section 6.6.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Fentanyl has a well-known abuse potential.
Maltese: Fentanyl għandu potenzjal ta' abbuż magħruf sew.
English: Hypertonia Myalgia
Maltese: toraċiċi u medjastinali
English: You will hear IONSYS beep once each time you start a dose.
Maltese: IONSYS biex tibda doża ta' mediċina.
English: The safety and efficacy of IONSYS in children and adolescents younger than 18 years of age has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' IONSYS fit-tfal u adolexxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: The safety of IONSYS has not been established in patients with American Society of Anesthesiologists (ASA) physical status classification IV (i.e. patients with a severe systemic disease that is a constant threat to life).
Maltese: Is-sigurtà ta' IONSYS ma ġietx stabbilita f'pazjenti bl-istatus fiżiku tas-Soċjetà Amerikana talAnestesjoloġisti (American Society of Anesthesiologists - ASA) klassifikazzjoni IV (jiġifieri pazjenti b'mard sistemiku sever li huwa ta' periklu kostanti għall-ħajja).
English: • blue skin colour (lips and finger tips)
Maltese: • ġilda blu (xufftejn u ponot tas-swaba')
English: Co-administration of fentanyl with a serotoninergic agent, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Maltese: Prodotti mediċinali serotonerġiċi L-għoti flimkien ta' fentanyl ma' aġent serotonerġiku, bħal Inibitur Selettiv tal-Assorbiment mill-Ġdid ta' Serotonin (SSRI) jew Inibitur Selettiv tal-Assorbiment mill-Ġdid ta' Norepinephrine (SNRI) jew Inibitur ta' Monomaine Oxidase (MAOI), jista' jżid ir-riskju ta' sindrome ta' serotonin, kundizzjoni potenzjalment fatali.
English: Very Common Common
Maltese: Ħsibijiet mhux normali