FrancophonIA/ELRC3.0 huggingface dataset:
English: The displayed frequency categories use 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
Maltese: Il-kategoriji ta' frekwenza murija jużaw il-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Serotonergic medicinal products
Maltese: Prodotti mediċinali serotonerġiċi
English: Bradycardia, Cyanosis
Maltese: Bradikardija, Ċjanosi
English: hydroxyzine, or lorazepam) and medicines for mental conditions (anti-psychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
Maltese: hydroxyzine, jew lorazepam) u mediċini għal kondizzjonijiet mentali (antipsikotiċi, bħal aripiprazole, haloperidol, olanzapine, risperidone, jew phenothiazines).
English: Adults and Children:
Maltese: Adulti u Tfal:
English: nausea (35.7%), vomiting (23.2%), constipation (23.1%), somnolence (15.0%), dizziness (13.1%), and headache (11.8%).
Maltese: 7%), rimettar (23.2%), stitikezza (23.1%), ħedla tan-ngħas (15.0%), sturdament (13.1%), u uġigħ ta' ras (11.8%).
English: • Fits (seizures).
Maltese: • Attakki (aċċessjonijiet).
English: - see below for more information
Maltese: - ara taħt għal aktar informazzjoni
English: The patches are designed to deliver approximately 12, 25, 50, 75, and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day respectively.
Maltese: Il-gareż huma ddisinjati biex jagħtu madwar 12, 25, 50, 75, u100 mkg/siegħa fentanyl fiċ-ċirkulazzjoni sistemika, li jirrapreżentaw madwar 0.3, 0.6, 1.2, 1.8, u 2.4 mg kuljum rispettivament.
English: Gastrointestinal tract
Maltese: Passaġġ gastrointestinali
English: • Some antihistamines, especially ones that make you sleepy (such as chlorpheniramine, clemastine,
Maltese: • Xi antiistamini, speċjalment dawk li jraqqduk (bħal chlorpheniramine, clemastine,
English: Pharmacotherapeutic group: Analgesics, Opioids, phenylpiperidine derivatives, ATC code: N02AB03
Maltese: Analġesiċi, Opiojdi, derivati ta' phenylpiperidine, Kodiċi ATC:
English: Skin temperature elevation may enhance the absorption of transdermally-applied fentanyl (see section 4.4).
Maltese: Żieda fit-temperatura tal-ġilda tista' ttejjeb l-assorbiment ta' fentanyl applikat b'mod transdermali (ara sezzjoni 4.4).
English: DUROGESIC Dosage (mcg/h)
Maltese: Doża ta' DUROGESIC (mkg/siegħa)
English: • Medicines to treat tuberculosis (such as rifampicin).
Maltese: • Mediċini biex jitrattaw it-tuberkulożi (bħal rifampicin).
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: 0.4b tapentadol oral parenteral tramadol oral parenteral a The oral/IM potency for morphine is based on clinical experience in patients with chronic pain.
Maltese: 0.4b tapentadol orali parenterali tramadol orali parenterali a Il-qawwa tal-morfina mill-ħalq/IM hija bbażata fuq esperjenza klinika f'pazjenti b'uġigħ kroniku.
English: Keep all patches (used and unused) out of the sight and reach of children.
Maltese: Iftaħ il-ġnieb tal-qartas aktar, u itwi l-qartas miftuħ qisu ktieb.
English: Pharmacokinetic/Pharmacodynamic Relationships
Maltese: Relazzjonijiet Farmakokinetiċi/Farmakodinamiċi
English: The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic active substances such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with active substances which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
Maltese: (SSRIs - Selective Serotonin Re-uptake Inhibitors) u Inibituri tal-Assorbiment mill-Ġdid ta' Serotonin u Norepinephrine (SNRIs - Serotonin Norepinephrine Re-uptake Inhibitors), u ma' sustanzi attivi li jindebolixxu l-metaboliżmu tas-serotonin (inkluż Inibituri ta' Monoamine Oxidase [MAOIsMonoamine Oxidase Inhibitors]).
English: Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract.
Maltese: L-opiojdi jżidu s-sodizza u jnaqqsu l-kontrazzjonijiet propulsivi tal-muskolu lixx tal-passaġġ gastrointestinali.
English: Eczema, Dermatitis allergic, Skin disorder,
Maltese: Ekżema, Dermatite allerġika, Disturb fil-ġilda, Dermatite, Dermatite talkuntatt
English: Somnolence, Dizziness, Headache
Maltese: Insomnja, Depressjoni, Ansjetà, Stat ta'
English: DUROGESIC and associated names (see Annex I) 12 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 25 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 50 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 75 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 100 micrograms/hour transdermal patch
Maltese: DUROGESIC u ismijiet assoċjati (ara Anness I) 12-il mikrogramma/siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda DUROGESIC u ismijiet assoċjati (ara Anness I) 25 mikrogramma/siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda DUROGESIC u ismijiet assoċjati (ara Anness I) 50 mikrogramma/siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda DUROGESIC u ismijiet assoċjati (ara Anness I) 75 mikrogramma/siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda DUROGESIC u ismijiet assoċjati (ara Anness I) 100 mikrogramma/siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: Step 2: Open the sachet
Maltese: Pass 2: Iftaħ il-qartas
English: The concomitant use of other central nervous system depressants, (including opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquilizers, sedating antihistamines, and alcoholic beverages) and skeletal muscle relaxants, may produce additive depressant effects; hypoventilation, hypotension, profound sedation, coma or death may occur.
Maltese: Il-prodotti mediċinali li jaħdmu b'mod ċentrali u l-alkoħol L-użu flimkien ma' depressanti oħra tas-sistema nervuża ċentrali, (inkluż opiojdi, sedattivi, ipnotiċi, anestetiċi ġenerali, phenothiazines, kalmanti, antiistamini li jraqqdu, u xorb alkoħoliku) u rilassanti tal-muskoli skeletriċi, jistgħu jipproduċu effetti depressanti addittivi; jistgħu jseħħu ipoventilazzjoni, ipotensjoni, sedazzjoni profonda, koma jew mewt.
English: Side effects and DUROGESIC
Maltese: Effetti sekondarji u DUROGESIC
English: CYP3A4 Inducers
Maltese: Indutturi ta' CYP3A4
English: • Medicines to help you calm down (tranquillisers, such as alprazolam, clonazepam, diazepam,
Maltese: • Mediċini biex jgħinuk tikkalma (kalmanti, bħal alprazolam, clonazepam, diazepam,
English: Apnoea, Hypoven tilation
Maltese: Apnea, Ipoventil azzjoni
English: There are no clinical data on the effects of fentanyl on fertility.
Maltese: Ma hemm l-ebda dejta klinika dwar l-effetti ta' fentanyl fuq il-fertilità.
English: Hyperhidrosis, Pruritus, Rash, Erythema
Maltese: Iperidrosi, Prurite, Raxx, Eritema
English: • Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
Maltese: • Xi mediċini użati biex jittrattaw l-epilessija (bħal carbamazepine, phenobarbital, jew phenytoin).
English: DUROGESIC may be worn continuously for 72 hours.
Maltese: DUROGESIC jista' jintlibes kontinwament għal 72 siegħa.
English: Opioid-naïve patients
Maltese: Opioid preċedenti
English: DUROGESIC with antidepressants
Maltese: DUROGESIC ma' antidepressanti
English: Fentanyl is rapidly distributed to various tissues and organs, as indicated by the large volume of distribution (3 to 10 L/kg after intravenous dosing in patients).
Maltese: Fentanyl jiġi ddistribwit malajr f'diversi tessuti u organi, kif indikat mill-volum ta' distribuzzjoni kbir (3 sa 10 L/kg wara għoti ta' doża mill-vini lill-pazjenti).
English: Examples of active substance that may decrease fentanyl plasma concentrations include: carbamazepine, phenobarbital, phenytoin and rifampicin (this list is not exhaustive).
Maltese: Eżempji ta' sustanzi attivi li jistgħu jnaqqsu l-konċentrazzjonijiet ta' fentanyl fil-plasma jinkludu: carbamazepine, phenobarbital, phenytoin u rifampicin (din il-lista ma tinkludix kollox).
English: • in adults who need continuous pain treatment
Maltese: • f'adulti li jeħtieġu trattament kontinwu għall-uġigħ
English: • Areas that you move a lot (joints), skin that is irritated or with cuts.
Maltese: • Postijiet li jiċċaqalqu ħafna (ġogi), ġilda li hija irritata jew maqsuma.
English: The safety of DUROGESIC was evaluated in 1565 adult and 289 paediatric subjects who participated in 11 clinical studies (1 double-blind, placebo-controlled; 7 open-label, active-controlled; 3 open-label, uncontrolled) used for the management of chronic malignant or non-malignant pain.
Maltese: Is-sigurtà ta' DUROGESIC ġiet evalwata f'1,565 adult u 289 individwu pedjatriku li pparteċipaw fi 11-il studju kliniku (studju wieħed ikkontrollat bi plaċebo, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża; 7 studji fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema mediċina qed tintuża, ikkontrollati b'mod attiv; 3 studji fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema mediċina qed tintuża, mhux ikkontrollati) użat għall-imaniġġjar ta' uġigħ kroniku malinn jew mhux malinn.
English: The simulations suggest that the steady-state AUC of patients with Child-Pugh Grade B liver disease (Child-Pugh Score = 8) would be approximately 1.36 times larger compared with that of patients with normal liver function (Grade A; Child-Pugh Score = 5.5).
Maltese: Is simulazzjonijiet jissuġġerixxu li l-AUC fl-istat fiss tal-pazjenti b'mard tal-fwied ta' Grad B ta' ChildPugh (Punteġġ ta' Child-Pugh = 8) tkun madwar 1.36 aktar meta mqabbla ma' dik ta' pazjenti b'funzjoni normali tal-fwied (Grad A;
English: DUROGESIC contains a medicine called fentanyl.
Maltese: DUROGESIC fih mediċina msejħa fentanyl.
English: • Some antibiotics used to treat infection (such as erythromycin or clarithromycin).
Maltese: • Xi antibijotiċi użati biex jittrattaw infezzjoni (bħal erythromycin jew clarithromycin).
English: Discontinuation of DUROGESIC
Maltese: DUROGESIC
English: Table 1: Conversion Table - Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Equianalgesic 24-hour Oral Morphine Dose (mg/day Prior Opioid x Factor = Equianalgesic 24-hour Oral Morphine Dose) Prior Opioid
Maltese: Tabella 1: Tabella ta' Konverżjoni - Fatturi ta' Multiplikazzjoni biex Tikkonverti d-Doża ta' Kuljum ta' Opiojdi Preċedenti għad-Doża Analġesika Ekwivalenti ta' Morfina mill-Ħalq f'24
English: • Stomach pain or indigestion
Maltese: • Uġigħ fl-istonku jew indigestjoni
English: This was determined in a human keratinocyte cell assay and in clinical studies in which 92% of the dose delivered from the system was accounted for as unchanged fentanyl that appeared in the systemic circulation.
Maltese: Dan ġie ddeterminat minn assaġġ taċċelluli keratinoċiti tal-bniedem u minn studji kliniċi li fihom 92% tad-doża merħija mis-sistema nstabet bħala fentanyl mhux mibdul li deher fiċ-ċirkulazzjoni sistemika.
English: Cases of serious respiratory depression after coadministration of CYP3A4 inhibitors with transdermal fentanyl have been reported, including a fatal case after coadministration with a moderate CYP3A4 inhibitor.
Maltese: Kienu rrappurtati każijiet ta' depressjoni respiratorja serja wara għoti ta' inibituri ta' CYP3A4 flimkien ma' fentanyl minn ġol-ġilda, inkluż każ fatali wara għoti flimkien ma' inibitur moderat ta' CYP3A4.
English: Among the remaining 5 subjects with a starting dosage of at least 25 mcg/h whose prior opioid doses were <45 mg of oral morphine equivalents per day, 1 (0.6%) had previously been receiving <30 mg of oral morphine equivalents per day and 4 (2.2%) had been receiving 30 to 44 mg of oral morphine equivalents per day (see section 4.8).
Maltese: Fost il5 individwi li kien għad fadal b'doża tal-bidu ta' mill-inqas 25 mkg/siegħa li d-dożi preċedenti talopiojdi tagħhom kienu ekwivalenti għal <45 mg morfina mill-ħalq kuljum, persuna 1 (0.6%) kienet qed tirċievi l-ekwivalenti ta' <30 mg morfina mill-ħalq kuljum qabel u 4 (2.2%) kienu qed jirċievu l ekwivalenti ta' 30 sa 44 mg morfina mill-ħalq kuljum (ara sezzjoni 4.8).
English: Fever/external heat application
Maltese: Deni/applikazzjoni esterna ta' sħana
English: The minimum effective fentanyl concentration depends on the pain intensity and the previous use of opioid therapy.
Maltese: Il-konċentrazzjoni minima effettiva ta' fentanyl tiddependi fuq l-intensità tal-uġigħ u l-użu preċedenti ta' terapija tal-opiojdi.
English: • Medicines used to treat fungal infection (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
Maltese: • Mediċini użati biex jitrattaw infezzjoni bil-fungu (bħal itraconazole, ketoconazole, fluconazole,
English: The tendency of tolerance development varies widely among individuals.
Maltese: It-tendenza għall-iżvilupp ta' tolleranza tvarja ħafna fost l-individwi.
English: The incidence of respiratory depression increases as the DUROGESIC dose is increased (see section 4.9).
Maltese: L-inċidenza ta' depressjoni respiratorja tiżdied meta d-doża ta' DUROGESIC tiżdied (ara sezzjoni 4.9).
English: Examples of active substances that may increase fentanyl concentrations include: amiodarone, cimetidine, clarithromycin, diltiazem, erythromycin, fluconazole, itraconazole, ketoconazole, nefazodone, ritonavir, verapamil and voriconazole (this list is not exhaustive).
Maltese: clarithromycin, diltiazem, erythromycin, fluconazole, itraconazole, ketoconazole, nefazodone,
English: • You are elderly - you may be more sensitive to the effects of this medicine.
Maltese: • Int anzjan/anzjana - jista' jkun li inti tkun aktar sensittiv/a għall-effetti ta' din il-mediċina.
English: In a rat study fentanyl did not influence male fertility.
Maltese: Fi studju fil-firien fentanyl ma influwenzax il-fertilità tal-firien irġiel.
English: Confusional state, Hallucination
Maltese: konfużjoni, Alluċinazzjoni
English: • Spinning sensation (vertigo)
Maltese: • Sensazzjoni li kollox qed idur bik (vertigo)
English: It is recommended that DUROGESIC is used in patients who have demonstrated opioid tolerance (see section 4.2).
Maltese: Huwa rrakkomandat li DUROGESIC jintuża f'pazjenti li urew tolleranza għall-opiojdi (ara sezzjoni 4.2).
English: 1a parenteral buprenorphine sublingual parenteral codeine oral parenteral
Maltese: 1a parenterali buprenorphine taħt l-ilsien parenterali codeine orali parenterali
English: All patients should be advised to avoid exposing the DUROGESIC application site to direct external heat sources such as heating pads, electric blankets, heated water beds, heat or tanning lamps, sunbathing, hot water bottles, prolonged hot baths, saunas and hot whirlpool spa baths.
Maltese: Il-pazjenti kollha għandhom jiġu avżati biex jevitaw li jesponu l-post tal-applikazzjoni ta' DUROGESIC għal sorsi ta' sħana esterna diretta bħal kuxxinetti tas-sħana, gvieret tal-elettriku, sodod bl-ilma sħun, lampi tas-sħana jew biex tismar, tixxemmex, hot water bottles, banjijiet sħan fit-tul, sawni u pixxini msaħħna bl-ilma li jiċċirkula fi spa.
English: • Slow heart beat (bradycardia) or low blood pressure
Maltese: • Taħbit tal-qalb bil-mod (bradikardija) jew pressjoni baxxa
English: • Muscle tremors or spasms
Maltese: • Tħossok stordut
English: The concomitant use of DUROGESIC with cytochrome P450 3A4 (CYP3A4) inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression.
Maltese: L-użu ta' DUROGESIC flimkien ma' inibituri taċ-ċitokrom P450 3A4 (CYP3A4) jista' jwassal għal żieda fil-konċentrazzjonijiet ta' fentanyl fil-plażma, li jista' jżid jew itawwal kemm l-effetti terapewtiċi kif ukoll l-effetti avversi, u jista' jikkawża depressjoni respiratorja serja.
English: • Medicines for relaxing your muscles (such as cyclobenzaprine or diazepam).
Maltese: • Mediċini biex jirrilassawlek il-muskoli (bħal cyclobenzaprine, jew diazepam).
English: The concomitant use of CYP3A4 inhibitors and DUROGESIC is not recommended, unless the patient is closely monitored (see section 4.4).
Maltese: L-użu ta' inibituri ta' CYP3A4 flimkien ma' DUROGESIC mhuwiex irrakkomandat, ħlief jekk il-pazjent ikun immonitorjat mill-qrib (ara sezzjoni 4.4).
English: Additional restrictions apply to opioid-naïve patients with renal impairment (see section 4.2).
Maltese: Restrizzjonijiet oħra japplikaw għal pazjenti b'indeboliment tal-kliewi li qatt ma jkunu ħadu opiojdi qabel (ara sezzjoni 4.2).
English: These subjects received at least one dose of DUROGESIC and provided safety data (see section 5.1).
Maltese: Dawn l-individwi rċivew mill-inqas doża waħda ta' DUROGESIC u pprovdew dejta ta' sigurtà (ara sezzjoni 5.1).
English: To prevent overdose it is recommended that opioid-naïve patients receive low doses of immediate-release opioids (eg, morphine, hydromorphone, oxycodone, tramadol, and codeine) that are to be titrated until an analgesic dosage equivalent to DUROGESIC with a release rate of 12 mcg/h or 25 mcg/h is attained.
Maltese: Biex tiġi evitata doża eċċessiva huwa rrakkomandat li pazjenti li qatt ma jkunu ħadu opiojdi qabel jirċievu dożi żgħar ta' opiojdi li jintreħew b'mod immedjat (eż, morphine, hydromorphone, oxycodone, tramadol, u codeine) li għandhom jiġu mkejla kontinwament u aġġustati sakemm tinkiseb doża analġesika ekwivalenti għal DUROGESIC b'rata li terħi 12-il mkg/siegħa jew 25 mkg/siegħa.
English: • Some medicines used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine).You should not take DUROGESIC
Maltese: • Xi mediċini użati biex jittrattaw id-depressjoni jew il-marda ta' Parkinson imsejħa MAOIs (bħal isocarboxazid, phenelzine, selegiline, jew tranylcypromine).
English: In a study in cancer patients treated with transdermal fentanyl, plasma protein binding was on average 95% (range 77-100%).
Maltese: madwar 95% (firxa 77-100%).
English: • Medicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
Maltese: • Mediċini biex jgħinuk torqod (bħal temazepam, zaleplon, jew zolpidem).
English: A pharmacokinetic model has suggested that serum fentanyl concentrations may increase by 14% (range 0-26%) if a new patch is applied after 24 hours rather than the recommended 72-hour application.
Maltese: Mudell farmakokinetiku ssuġġerixxa li l-konċentrazzjonijiet ta' fentanyl fis-serum jistgħu jiżdiedu b'14% (firxa 0-26%) jekk tiġi applikata garża wara 24 siegħa u mhux wara 72 siegħa kif irrakkomandat.
English: Some studies in rats have revealed reduced fertility and enhanced embryo mortality at maternally toxic doses (see section 5.3).
Maltese: Xi studji fil-firien urew tnaqqis fil-fertilità u aktar imwiet tal-embriju b'dożi tossiċi għall-omm (ara sezzjoni 5.3).
English: Generally, a patient should wait for 2 days after stopping treatment with a CYP3A4 inhibitor before applying the first DUROGESIC patch.
Maltese: Ġeneralment, il-pazjent għandu jistenna jumejn wara li jwaqqaf it-trattament b'inibitur ta' CYP3A4 qabel japplika l-ewwel garża ta' DUROGESIC.
English: - Don't use hot whirlpool spa baths
Maltese: - Tużax pixxini msaħħna bl-ilma li jiċċirkula fi spa
English: The influence of renal impairment on the pharmacokinetics of fentanyl is expected to be limited because urinary excretion of unchanged fentanyl is less than 10% and there are no known active metabolites eliminated by the kidney.
Maltese: L-influwenza ta' indeboliment tal-kliewi fuq il-farmakokinetika ta' fentanyl hija mistennija li tkun limitata minħabba li t-tneħħija ta' fentanyl mhux mibdul fl-awrina hija inqas minn 10% u ma hemm l ebda metaboliti attivi magħrufa li li jiġu eliminati mill-kliewi.
English: however with ritonavir (a strong CYP3A4 inhibitor), fentanyl clearance decreased on average 67%.
Maltese: CYP3A4), it-tneħħija ta' fentanyl naqset b'madwar 67%.
English: Of the 289 subjects enrolled in these 3 studies, 110 initiated DUROGESIC treatment with a dosage of 12 mcg/h.
Maltese: Mill-289 individwu irreġistrati f'dawn it-3 studji, 110 bdew it-trattament b'DUROGESIC b'dożaġġ ta' 12-il mkg/siegħa.
English: Serotonin syndrome may include mental-status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (eg, hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhoea).
Maltese: anormalitajiet newromuskolari (eż, riflessjonijiet eċċessivi, nuqqas ta' koordinazzjoni, riġidità), u/jew sintomi gastrointestinali (eż, nawsja, rimettar, dijarea).
English: • Loss of appetite
Maltese: • Telf t'aptit
English: Opioid withdrawal symptoms (such as nausea, vomiting, diarrhoea, anxiety, and shivering) are possible in some patients after conversion from their previous opioid analgesic to DUROGESIC or if therapy is stopped suddenly (see section 4.2).
Maltese: Sintomi ta' twaqqif tal-opiojdi (bħal nawsja, rimettar, dijarea, ansjetà u rogħda) huma possibbli f'xi pazjenti wara bidla mill-analġesiku preċedenti tagħhom għal DUROGESIC jew jekk it-terapija titwaqqaf f'daqqa (ara sezzjoni 4.2).
English: • DUROGESIC can have life-threatening side effects in people who are not already regulary using prescribed opioid medicines.
Maltese: • DUROGESIC jista' jkollu effetti sekondarji ta' periklu għall-ħajja f'persuni li jkunux diġà qed jużaw mediċini opiojdi ordnati b'riċetta b'mod regolari.
English: • Medicines used to treat an irregular heart beat (such as amiodarone, diltiazem, or verapamil).
Maltese: • Mediċini użati biex jitrattaw taħbit tal-qalb mhux regolari (bħal amiodarone, diltiazem, jew verapamil).
English: • Loss of memory
Maltese: • Telf tal-memorja
English: Table 5: Adverse reactions in adult and paediatric patients System/organ class
Maltese: Reazzjonijiet avversi f'pazjenti adulti u pazjenti pedjatriċi
English: Renal impairment
Maltese: Burdata ewforika
English: Based on pooled safety data from these 3 clinical studies in paediatric subjects, the most commonly reported (i.e. ≥10% incidence) adverse reactions were vomiting (33.9%), nausea (23.5%), headache
Maltese: Abbażi ta' ġabra ta' dejta ta' sigurtà minn dawn it-3 studji kliniċi f'individwi pedjatriċi, l-aktar reazzjonijiet avversi rrappurtati b'mod komuni (i.e. inċidenza ≥10%) kienu rimettar (33.9%), nawsja (23.5%), uġigħ ta' ras (16.3%), stitikezza (13.5%), dijarea (12.8%), u ħakk (12.8%).
English: Fentanyl is an opioid analgesic, interacting predominantly with the µ opioid receptor.
Maltese: Fentanyl huwa analġesiku opiojd, b'interazzjoni prinċipali mar-riċettur opiojd µ.
English: Chronic pulmonary disease
Maltese: Mard kroniku tal-pulmun
English: Of these 110 subjects, 23 (20.9%) had previously been receiving <30 mg of oral morphine equivalents per day, 66 (60.0%) had been receiving 30 to 44 mg of oral morphine equivalents per day, and 12 (10.9%) had been receiving at least 45 mg of oral morphine equivalents per day (data not available for 9 [8.2%] subjects).
Maltese: 44 mg morfina mill-ħalq kuljum, u 12 (10.9%) kienu qed jirċievu l-ekwivalenti ta' mill-inqas 45 mg morfina mill-ħalq kuljum (dejta mhux disponibbli għal 9 [8.2%] individwi).
English: Pharmacodynamic-related interactions
Maltese: Interazzjonijiet marbuta mal-farmakodinamika
English: Fentanyl concentrations were measured in more than 250 children aged 2 to 17 years who were applied fentanyl patches in the dose range of 12.5 to 300 mcg/h.
Maltese: Il-konċentrazzjonijiet ta' fentanyl tkejlu f'aktar minn 250 tifel u tifla b'etajiet minn 2 sa 17-il sena li fuqhom ġew applikati gareż ta' fentanyl b'firxa ta' dożi minn 12.5 sa 300 mkg/siegħa.