FrancophonIA/ELRC3.0 huggingface dataset:
English: Adjusting for body weight, clearance (L/h/kg) appears to be approximately 80% higher in children 2 to 5 years old and 25% higher in children 6 to 10 years old when compared to children 11 to 16 years old, who are expected to have a similar clearance as adults.
Maltese: Wara li jsir aġġustament għall-piż tal-ġisem, it-tneħħija (L/siegħa/kg) tidher li hija madwar 80% ogħla fi tfal li kellhom minn 2 sa 5 snin u 25% ogħla fi tfal li kellhom minn 6 sa 10 snin meta mqabbla ma' tfal li kellhom minn 11 sa 16-il sena, li huma mistennija li jkollhom tneħħija bħal dik tal-adulti.
English: Oral 24-hour morphine (mg/day)
Maltese: morfina mill-ħalq kuljum Morfina mill-ħalq f'24 siegħa (mg/kuljum)
English: Fatigue, Oedema peripheral, Asthenia, Malaise, Feeling cold
Maltese: Għeja, Edima periferali, Astenja, Telqa tal ġisem mingħajr sinjali ta' mard,
English: Applicati on site eczema
Maltese: Applika l-garża
English: This includes any possible side effects not listed in this leaflet.
Maltese: Ara sezzjoni għal-lista sħiħa ta' effetti sekondarji possibbli.
English: • Medicines used to treat HIV infection (such as ritonavir).
Maltese: • Mediċini użati biex jitrattaw infezzjoni bl-HIV (bħal ritonavir).
English: Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Maltese: Depressjoni respiratorja wara doża eċċessiva tista' ddum aktar mit-tul ta' żmien ta' azzjoni tal-antagonist tal-opiojd.
English: The safety profile in children and adolescents treated with DUROGESIC was similar to that observed in adults.
Maltese: Il-profil ta' sigurtà fi tfal u adolexxenti ttrattati b'DUROGESIC kien jixbah dak li deher fl-adulti.
English: In two paediatric studies, the required fentanyl transdermal patch dose was calculated conservatively: 30 mg to 44 mg oral morphine per day or its equivalent opioid dose was replaced by one DUROGESIC 12 mcg/h patch.
Maltese: F'żewġ studji pedjatriċi, id-doża meħtieġa tal-garża fentanyl li tipprovdi mediċina li tgħaddi minn ġol-ġilda ġiet ikkalkulata b'mod konservattiv: 30 mg sa 44 mg ta' morfina mill-ħalq kuljum jew iddoża ekwivalenti tagħha ta' opiojd ġew sostitwiti b'garża waħda ta' 12-il mkg/siegħa DUROGESIC.
English: This may result in increased serum concentrations (see section 5.2) and the patient should be monitored closely.
Maltese: Dan jista' jwassal għal żieda fil-konċentrazzjonijiet fisserum (ara sezzjoni 5.2) u l-pazjenti għandu jiġi mmonitorjat mill-qrib.
English: • Swollen hands, ankles or feet (peripheral oedema)
Maltese: • Idejn, għekiesi jew saqajn minfuħin (edima periferali)
English: To convert paediatric patients from oral or parenteral opioids to DUROGESIC, refer to Equianalgesic potency conversion (Table 1) and Recommended DUROGESIC dosage based upon daily oral morphine dose (Table 4).
Maltese: Biex taqleb pazjenti pedjatriċi minn opiojdi mill-ħalq jew parenterali għal DUROGESIC, irreferi għall-Konverzjoni tal-qawwiet ekwivalenti tal-analġesiċi (Tabella 1) u d-Doża rrakkomandata ta' DUROGESIC abbażi tad-doża ta' morfina mill-ħalq kuljum (Tabella 4).
English: Fentanyl then becomes available to the systemic circulation.
Maltese: Fentanyl imbagħad isir disponibbli għaċċirkulazzjoni sistemika.
English: To derive the DUROGESIC dosage corresponding to the calculated 24-hour, equianalgesic morphine dosage, use dosage-conversion Table 2 or 3 as follows: a. Table 2 is for adult patients who have a need for opioid rotation or who are less clinically stable (conversion ratio of oral morphine to transdermal fentanyl approximately equal to b. Table 3 is for adult patients who are on a stable, and well-tolerated, opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 100:1).
Maltese: Biex tikseb id-doża ta' DUROGESIC li taqbel mad-doża analġesika ekwivalenti ta' morfina kkalkulata għal 24 siegħa, uża t-Tabelli 2 jew 3 ta' konverżjoni tad-doża kif ġej: a.
English: Co-administration of fentanyl with a serotonergic medicinal products, 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: L-għoti ta' fentanyl flimkien ma' prodotti mediċinali serotonerġiċi, bħal Inibitur Selettiv talAssorbiment mill-Ġdid ta' Serotonin r (SSRI) jew Inibitur tal-Assorbiment mill-Ġdid ta' Serotonin u Norepinephrine (SNRI) jew Inibitur ta' Monoamine Oxidase (MAOI), jista' jżid ir-riskju ta' sindrom tas-serotonin, kundizzjoni li tista' tkun ta' periklu għall-ħajja.
English: Cases of serotonin syndrome have been reported when fentanyl was administered concomitantly with highly serotonergic drugs (see sections 4.4. and 4.5).
Maltese: Każijiet ta' sindrom tas-serotonin ġew irrappurtati meta fentanyl ingħata flimkien ma' mediċini serotonerġiċi ħafna (ara sezzjonijiet 4.4. u 4.5).
English: The adverse reactions reported with the use of DUROGESIC from these clinical studies, including the above-mentioned adverse reactions, and from post-marketing experiences are listed below in Table 5.
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-użu ta' DUROGESIC minn dawn l-istudji kliniċi, inkluż ir reazzjonijiet avversi msemmija hawn fuq, u minn esperjenza ta' wara t-tqegħid fis-suq huma elenkati taħt f'Tabella 5.
English: The serum fentanyl concentrations attained are proportional to the DUROGESIC patch size.
Maltese: Il-konċentrazzjonijiet miksuba ta' fentanyl fis-serum huma fi proporzjon mad-daqs tal-garża DUROGESIC.
English: • The patches are waterproof
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression.
Maltese: Il-manifestazzjonijiet ta' doża eċċessiva ta' fentanyl huma estensjoni tal-azzjonijiet farmakoloġiċi tiegħu, fejn l-aktar effett serju huwa depressjoni respiratorja.
English: The potential for serious or life-threatening hypoventilation exists regardless of the dose of DUROGESIC transdermal system administered.
Maltese: Il-possibbiltà ta' ipoventilazzjoni serja jew ta' periklu għall-ħajja teżisti irrispettivament mid-doża tas-sistema transdermali ta' DUROGESIC mogħtija.
English: • Do not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the patch
Maltese: • Tużax sapun jew kwalunkwe sustanzi li jnaddfu l-ġilda, kremi, moisturisers, żjut jew terra qabel tapplika l-garża
English: Step 3: Peel and press
Maltese: Pass 3: Qaxxar u agħfas
English: Starting dosages of 25 mcg/h and higher were used by the remaining 179 subjects, 174 (97.2%) of whom had been on opioid doses of at least 45 mg of oral morphine equivalents per day.
Maltese: Dożi tal-bidu ta' 25 mkg/siegħa u aktar intużaw għall-bqija tal-179 individwu l-ieħor, li minnhom 174 (97.2%) kellhom dożi ta' opiojdi ekwivalenti għal mill-inqas 45 mg morfina mill-ħalq kuljum.
English: Avoid touching the adhesive side of the patch.
Maltese: Evita li tmiss in-naħa tal-garża minn fejn teħel.
English: An increase in skin temperature through the application of a heating pad on low setting over the DUROGESIC system during the first 10 hours of a single application increased the mean fentanyl AUC value by 2.2-fold and the mean concentration at the end of heat application by 61%.
Maltese: Żieda fit-temperatura tal-ġilda permezz ta' applikazzjoni ta' kuxxinett sħun fuq qawwa baxxa fuq is-sistema DUROGESIC matul l-ewwel 10 sigħat ta' applikazzjoni waħda żiedet il-medja tal-valur tal-AUC ta' fentanyl b'2.2 drabi u l-medja tal-konċentrazzjoni fit-tmiem tal-applikazzjoni tas-sħana b'61%.
English: The pharmacokinetics of transdermal fentanyl do not change with repeated application.
Maltese: Il-farmakokinetika ta' fentanyl minn ġol-ġilda ma tinbidilx b'applikazzjoni ripetuta.
English: Even though impairment of renal function is not expected to affect fentanyl elimination to a clinically relevant extent, caution is advised because fentanyl pharmacokinetics has not been evaluated in this patient population (see section 5.2).
Maltese: Indeboliment tal-kliewi Anke jekk indeboliment tal-funzjoni tal-kliewi mhux mistenni li jaffettwa l-eliminazzjoni ta' fentanyl sa grad rilevanti b'mod kliniku, hija rrakkomandata attenzjoni minħabba li l-farmakokinetika ta' fentanyl ma ġietx ivvalutata f'din il-popolazzjoni ta' pazjenti (ara sezzjoni 5.2).
English: Dose titration and maintenance therapy The DUROGESIC patch should be replaced every 72 hours.
Maltese: Titrazzjoni tad-doża u terapija ta' manteniment Il-garża DUROGESIC għandha tinbidel kull 72 siegħa.
English: Fentanyl induced mutagenic effects in mammalian cells in vitro, comparable to other opioid analgesics.
Maltese: Fentanyl induċa effetti mutaġeniċi f'ċelluli tal-mammali in vitro, kumparabbli ma' dawk ta' analġesiċi oħra tal-opiojdi.
English: • Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine,
Maltese: • Xi mediċini użati biex jittrattaw id-depressjoni msejħa SSRIs jew SNRIs (bħal citalopram,
English: STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA
English: Severe and unpredictable interactions with MAOIs, involving the potentiation of opiate effects or the potentiation of serotoninergic effects, have been reported.
Maltese: Ġew irrappurtati interazzjonijiet severi u imprevedibbli ma' MAOIs, li jinvolvu effetti talopijati li jitqawwew jew effetti serotonerġiċi li jitqawwew.
English: (Uncommon, this may affect up to 1 in 100 people.)
Maltese: (Mhux komuni, din tista' taffettwa sa persuna waħda minn kull 100.)
English: Do not sunbathe, have long hot baths or saunas or use hot whirlpool spa baths.
Maltese: gvieret tal-elettriku, hot-water bottles, sodod bl-ilma msaħħan, lampi tas-sħana jew biex tismar.
English: However, as the influence of renal impairment on the pharmacokinetics of fentanyl has not been evaluated, caution is advised (see sections 4.2 and 4.4).
Maltese: Madanakollu, minħabba li l-influwenzata' indeboliment tal-kliewi fuq il-farmakokinetika ta' fentanyl ma ġietx stmata, hija rrakomandata l kawtela (ara sezzjonijiet 4.2 u 4.4).
English: There is a high inter-subject variability in fentanyl pharmacokinetics, in the relationships between fentanyl concentrations, therapeutic and adverse effects, and in opioid tolerance.
Maltese: Hemm differenzi kbar bejn indivdiwu u ieħor fil-farmakokinetika ta' fentanyl, fir-relazzjoni bejn il konċentrazzjonijiet, l-effetti terapewtiċi u l-effetti avversi ta' fentanyl, u fit-tolleranza għall-opiojdi.
English: Fentanyl can be abused in a manner similar to other opioid agonists.
Maltese: Fentanyl jista' jiġi abbużat b'mod simili għal dak ta' agonisti oħra tal-opiojdi.
English: The average bioavailability of fentanyl after application of the transdermal patch is 92%.
Maltese: Il-bijodisponibiltà medja ta' fentanyl wara l-applikazzjoni tal-garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda hija ta' 92%.
English: These findings have been taken into consideration in determining the dosing recommendations for paediatric patients (see sections 4.2 and 4.4).
Maltese: Dawn is sejbiet tqiesu għad-determinazzjoni tar-rakkomandazzjonijiet tad-dożi għal pazjenti pedjatriċi (ara sezzjonijiet 4.2 u 4.4).
English: • Itchy skin rash (eczema), allergic reaction or other skin disorders where the patch is placed
Maltese: • Raxx bil-ħakk fil-ġilda (ekżema), reazzjoni allerġika jew disturbi oħra fil-ġilda fejn titqiegħed il-garża
English: Opioid-naïve and not opioid-tolerant states
Maltese: Pazjenti tolleranti għall-opiojdi
English: • There is enough medicine in each patch to last 3 days (72 hours).
Maltese: • Fil-gareż hemm mediċina biżżejjed biex isservi 3 ijiem (72 siegħa).
English: The extent of interaction with strong CYP3A4 inhibitors is expected to be greater than with weak or moderate CYP3A4 inhibitors.
Maltese: interazzjoni ma' inibituri qawwija ta' CYP3A4 hija mistennija li tkun akbar milli ma' inibituri dgħajfa jew moderati ta' CYP3A4.
English: After coadministration of weak, moderate or strong CYP3A4 inhibitors with short term intravenous fentanyl administration, decreases in fentanyl clearance were generally ≤25%,
Maltese: Wara għoti ta' inibituri dgħajfa, moderati jew qawwijin ta' CYP3A4 flimkien ma' fentanyl minn ġol-vini għal perjodu qasir, tnaqqis fit-tneħħija ta' fentanyl ġeneralment kien ≤25%, madankollu b'ritonavir (inibitur qawwi ta'
English: They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients (see also Section 4.4).
Maltese: Huma għandhom affinità kbira għar-riċetturi tal-opiojdi b'attività intrinsika relattivament baxxa u għalhekk jantagonizzaw b'mod parzjali l-effett analġesiku ta' fentanyl u jistgħu jikkaġunaw sintomi ta' waqfien ta' mediċina li tivvizzja f'pazjenti dipendenti fuq l-opiojdi (ara wkoll Sezzjoni 4.4).
English: Drinking alcohol may make these effects worse.
Maltese: Ix-xorb tal-alkoħol jista' jagħmel dawn l-effetti agħar.
English: Children aged 16 years and above Follow adult dosage.
Maltese: Segwi d-dożi tal-adulti.
English: If concomitant use of DUROGESIC with a CYP3A4 inhibitor cannot be avoided, close monitoring for signs or symptoms of increased or prolonged therapeutic effects and adverse effects of fentanyl (in particular respiratory depression) is warranted, and the DUROGESIC dosage must be reduced or interrupted as deemed necessary (see section 4.5).
Maltese: Jekk l-użu ta' DUROGESIC flimkien ma' inibitur ta' CYP3A4 ma jkunx jista' jiġi evitat, huwa meħtieġ monitoraġġ mill-qrib għal sinjali u sintomi ta' żieda jew dewmien fl-effetti terapewtiċi u fl-effetti avversi ta' fentanyl (b'mod partikolari depressjoni respiratorja), u d-doża ta' DUROGESIC għandha titnaqqas jew titwaqqaf b'mod temporanju skont ilħtieġa (ara sezzjoni 4.5).
English: Caution should be exercised when treating patients with myasthenia gravis.
Maltese: Għandha tintuża l-kawtela meta wieħed jittratta pazjenti b'myasthenia gravis.
English: DUROGESIC may interact with these medicines and you may experience changes to mental status such as feeling agitated, seeing, feeling, hearing, or smelling things that are not there (hallucinations) and other effects such as changing blood pressure, fast heart beat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomitting and diarrhoea.
Maltese: DUROGESIC jista' jkollu interazzjoni ma' dawn il-mediċini u inti jista' jkollok bidliet fl-istat mentali bħal tħossok aġitat, tara, tħoss, tisma' jew ixxomm affarijiet li ma jkunux hemm (alluċinazzjonijiet) u effetti oħra bħal pressjoni li tinbidel, taħbit mgħaġġel tal-qalb, temperatura għolja tal-ġisem, riflessi reattivi ż-żejjed, nuqqas ta' koordinazzjoni, ebusija fil-muskoli, dardir, rimettar, u dijarea.
English: • Constricted pupils (miosis)
Maltese: • Pupilla ċkejkna minħabba kontrazzjoni tal-muskolu (mijosi)
English: Caution is advised upon concomitant use of CYP3A4 inducers and DUROGESIC.
Maltese: Hija rrakkomandata attenzjoni bl-użu ta' indutturi ta' CYP3A4 flimkien ma' DUROGESIC.
English: Applicati on site dermatiti s,
Maltese: Dermatit e fil-post talapplikazz joni,
English: Concomitant use of mixed opioid agonists/antagonists The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section 4.5).
Maltese: L-użu konkomitanti ta' buprenorphine, nalbuphine jew pentazocine mhuwiex irrakkomandat (ara wkoll sezzjoni 4.5).
English: • DUROGESIC may make you unusually drowsy, and make your breathing more slow or shallow.
Maltese: • DUROGESIC jista' jqabbdek ħedla ta' ngħas mhux tas-soltu, u jagħmel it-teħid tan-nifs tiegħek aktar bil-mod u qasir.
English: Caution is advised when DUROGESIC is co-administered with medicinal products that affect the serotonergic neurotransmitter systems.
Maltese: Hija rrakkomandata attenzjoni meta DUROGESIC jingħata flimkien ma' prodotti mediċinali li jaffettwaw is-sistemi serotonerġiċi ta' trasmissjoni newroloġika.
English: Tables 1, 2, and 3 should only be used to convert from other opioids to DUROGESIC and not from DUROGESIC to other therapies to avoid overestimating the new analgesic dose and potentially causing overdose.
Maltese: Tabelli 1, 2, u 3 għandhom jintużaw biss biex jikkonvertu minn opiojdi oħra għal DUROGESIC u mhux minn DUROGESIC għal terapiji oħra biex jiġi evitat li wieħed jikkalkula doża akbar talanalġesiku l-ġdid bil-possibbiltà li tingħata doża eċċessiva.
English: Muscle spasms
Maltese: Spażmi fil muskoli
English: It is recommended that DUROGESIC be used in patients who have demonstrated opioid tolerance.
Maltese: Huwa rrakkomandat li DUROGESIC jintuża f'pazjenti li wrew tolleranza għall-opiojdi.
English: • Gently tear or cut off the edge of the sachet completely (if you use scissors, cut close to the sealed edge of the sachet to avoid damaging the patch)
Maltese: • Qatta jew aqta' bil-mod it-tarf tal-qartas kompletament (jekk tuża mqass, aqta' qrib it-tarf issigillat tal-qartas biex tevita li tagħmel ħsara lill-garża)
English: A carcinogenicity study (daily subcutaneous injections of fentanyl hydrochloride for two years in Sprague Dawley rats) did not induce any findings indicative of oncogenic potential.
Maltese: Studju dwar il-kapaċità li jikkawża kanċer (injezzjonijiet ta' fentanyl hydrochloride taħt il-ġilda kuljum għal sentejn f'firien Sprague Dawley) ma kkaġunaw l-ebda sejbiet li jindikaw possibbiltà onkoġenika.
English: Following DUROGESIC application, the skin under the system absorbs fentanyl, and a depot of fentanyl concentrates in the upper skin layers.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: DUROGESIC may have more severe adverse effects in patients with chronic obstructive or other pulmonary disease.
Maltese: DUROGESIC jista' jkollu aktar effetti avversi severi f'pazjenti b'mard kroniku ostruttiv tal-pulmun jew mard tal-pulmun ieħor.
English: • Feeling sleepy (somnolence)
Maltese: • Ikollok qtugħ ta' nifs (dispnea)
English: Dosage titration should normally be performed in 12 mcg/h or 25 mcg/h increments, although the supplementary analgesic requirements (oral morphine 45/90 mg/day ≈ DUROGESIC 12/25 mcg/h) and pain status of the patient should be taken into account.
Maltese: Laġġustament tad-doża s-soltu għandu jsir b'żidiet ta' 12 mkg/siegħa jew 25 mkg/siegħa, għalkemm għandhom jitqiesu wkoll il-ħtiġijiet ta' analġesiċi supplimentari (morfina mill-ħalq 45/90 mg/jum ≈ DUROGESIC 12/25 mkg/siegħa) u l-istat ta' uġigħ tal-pazjent.
English: Table 3: Recommended starting dosage of DUROGESIC based upon daily oral morphine dosage (for patients on stable and well tolerated opioid therapy: conversion ratio of oral morphine to transdermal fentanyl is approximately equal to 100:1)
Maltese: Tabella 3: Id-doża rrakkomandata biex jinbeda biha DUROGESIC abbażi tad-doża ta' morfina mill ħalq kuljum (għall-pazjenti fuq terapija stabbli u ttollerata tajjeb bl-opiojdi: il-konverżjoni tal-proporzjon ta' morfina mill-ħalq ma' fentanyl mogħti minn ġol-ġilda hija ekwivalenti għal madwar 100:1)
English: DUROGESIC is for transdermal use.
Maltese: DUROGESIC qiegħed għal użu transdermali.
English: There have been very rare reports of newborn infants experiencing neonatal withdrawal syndrome when mothers chronically used DUROGESIC during pregnancy (see section 4.6).
Maltese: Kien hemm rapporti rari ħafna ta' trabi tat-twelid li kellhom is-sindrom ta' twaqqif ta' mediċina li tivvizzja fit-trabi tat-twelid meta l-ommijiet użaw DUROGESIC b'mod kroniku waqt it-tqala (ara sezzjoni 4.6).
English: Patients can then switch to DUROGESIC.
Maltese: Mediċini oħra u DUROGESIC
English: DUROGESIC contains {name the excipient(s)
Maltese: DUROGESIC fih {isem tal-eċċipjent(i) [Biex timtela mill-pajjiż partikolari]
English: To guard against accidental ingestion by children, use caution when choosing the application site for DUROGESIC (see sections 4.2 and 6.6) and monitor adhesion of the patch closely.
Maltese: Biex tħares lit-tfal milli aċċidentalment jibilgħu il-garża, uża attenzjoni meta tagħżel il-post talapplikazzjoni għal DUROGESIC (ara sezzjonijiet 4.2 u 6.6) u mmonitorja t-twaħħil tal-garża b'attenzjoni.
English: * the assigned frequency (uncommon) is based on analyses of incidence including only adult and paediatric clinical study subjects with non-cancer pain.
Maltese: * il-frekwenza assenjata (mhux komuni) hija bbażata fuq analiżi ta' inċidenza li kienet tinkludi biss individwi adulti u pedjatriċi minn studji kliniċi b'uġigħ mhux tal-kanċer.
English: Data in subjects with cirrhosis and simulated data in subjects with different grades of impaired liver function treated with transdermal fentanyl suggest that fentanyl concentrations may be increased, and fentanyl clearance may be decreased compared to subjects with normal liver function.
Maltese: Indeboliment tal-fwied Minħabba li fentanyl jiġi mmetabolizzat f'metaboliti mhux attivi fil-fwied, indeboliment tal-fwied jista' jdewwem l-eliminazzjoni tiegħu.
English: DUROGESIC should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arms.
Maltese: DUROGESIC għandu jiġi applikat fuq ġilda mhux irritata u li ma kinitx esposta għal radjazzjoni fuq superfiċje ċatt tat-torso jew il-parti ta' fuq tad-driegħ.
English: • Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Maltese: • Xi mediċini użati biex jitrattaw anġina (uġigħ fis-sider) jew pressjoni għolja (bħal nicardipine).
English: If serotonin syndrome is suspected, treatment with DUROGESIC should be discontinued.
Maltese: Jekk ikun issuspettat sindrom ta' serotonin, it-trattament b'DUROGESIC għandu jitwaqqaf.
English: Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment.
Maltese: Pazjenti bi storja preċedenti ta' dipendenza fuq mediċina/abbuż tal-alkoħol jkunu f'riskju akbar li jiżviluppaw dipendenza u abbuż fi trattament bl-opiojdi.
English: Hypotension
Maltese: Ipotensjoni
English: Fentanyl may produce bradycardia and should therefore be administered with caution to patients with bradyarrhythmias.
Maltese: Fentanyl jista' jipproduċi bradikardija u għalhekk għandu jingħata b'attenzjoni lill-pazjenti li jkollhom bradiarritmiji.
English: • Feeling dizzy
Maltese: • Ħalq xott
English: Hypoaesthesia, Convulsion (including clonic convulsions and grand mal convulsion), Amnesia, Depressed level of consciousness, Loss of consciousness
Maltese: Konvulżjoni (li tinkludi konvulżjonijiet kloniċi u konvulżjoni grand mal), Amnesija, Livell depress ta' koxjenza, Telf missensi
English: Some studies with female rats revealed reduced fertility and enhanced embryo mortality.
Maltese: Xi studji b'firien nisa urew tnaqqis fil-fertilità u żieda fil-mortalità tal-embriju.
English: For management of respiratory depression, immediate countermeasures include removing the DUROGESIC patch and physically or verbally stimulating the patient.
Maltese: Għall-immaniġġjar ta' depressjoni respiratorja, kontramiżuri immedjati jinkludu tneħħi l-garża DUROGESIC u b'mod fiżiku u verbali tistimula l-pazjent.
English: • Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
Maltese: • Nuqqas ta' sensittività jew ħass, speċjalment fil-ġilda (ipoestesija)
English: • Muscle twitching
Maltese: • Diffikultà biex torqod
English: The potential for serious or life-threatening hypoventilation exists even if the lowest dose of DUROGESIC is used in initiating therapy in opioid-naïve patients (see sections 4.4 and
Maltese: Teżisti l-possibbiltà ta' ipoventilazzjoni serja jew ta' periklu għallħajja anke jekk tintuża l-inqas doża ta' DUROGESIC biex tinbeda terapija f'pazjenti li qatt ma jkunu ħadu opiojdi qabel (ara sezzjonijiet 4.4 u 4.9).
English: Do not use DUROGESIC after the expiry date which is stated on the carton and sachet.
Maltese: Tużax DUROGESIC wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-qartas.