FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are mannitol, sodium starch glycolate type A, sodium hydrogen carbonate, sodium carbonate anhydrous, citric acid anhydrous, magnesium stearate.
Maltese: Is-sustanzi l-oħra huma mannitol, sodium starch glycolate tip A, sodium hydrogen carbonate, sodium carbonate anhydrous, citric acid anhydrous, magnesium stearate.
English: Absorption:
Maltese: Assorbmient:
English: Secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Maltese: L-effetti farmakoloġiċi sekondarji huma depressjoni respiratorja, bradikardja, ipotermja, stitikezza, mijosi, dipendenza fiżika u ewforja.
English: Bradyarrhythmias
Maltese: Bradiarritmija
English: The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Maltese: Il-proteina ta' twaħħil maġġuri hija alpha-1-acid glycoprotein, iżda albumin u lipoproteini t-tnejn jikkontribwixxu xi ftit.
English: Bend 3.
Maltese: OĦRAJN 1.
English: All opioid µ-receptor agonists, including fentanyl, produce dose dependent respiratory depression.
Maltese: L-antagonisti tar-riċettur µ tal-opioids kollha, inkluż fentanyl, jipproduċu depressjoni respiratorja dipendenti mid-doża.
English: Agents that affect CYP3A4 activity
Maltese: Indutturi ta' CYP3A4
English: Effentora with food, drink and alcohol
Maltese: Effentora ma' ikel, xorb u alkoħol
English: • inflammation of the oesophagus, paralysis of the gut, gall bladder disorder
Maltese: • infjammazzjoni fl-esofagu, paraliżi tal-musrana, disturb fil-marrara
English: Titration in patients not switching from other fentanyl containing products The initial dose of Effentora should be 100 micrograms, titrating upwards as necessary through the range of available tablets strengths (100, 200, 400, 600, 800 micrograms).
Maltese: Titrazzjoni f'pazjenti li mhux ha jaqilbu minn prodotti oħra li fihom fentanyl Id-doża tal-bidu ta' Effentora għandha tkun 100 mikrogramma, b'titrazzjoni 'l fuq skond il-bżonn fil firxa ta' qawwa tal-pilloli disponibbli (100, 200, 400, 600, 800 mikrogramma).
English: amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression.
Maltese: amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, meraq tal-grejpfrut, u verapamil) jista' jwassal għal żjieda fil-konċentrazzjonijiet ta' fentanyl fil-plażma, u potenzjalment jikkawżaw reazzjonijiet avversi tal-mediċina serji inkluż depressjoni respiratorja fatali.
English: Photopsia
Maltese: Fotopsija
English: In the pivotal clinical study (study 1), the primary endpoint was the average sum of differences in pain intensity scores from dosing to 60 minutes, inclusive (SPID60), which was statistically significant compared to placebo (p<0.0001).
Maltese: Fl-istudji kliniku pivitali (studju 1), l-mira primarja kienet l-medja ta' l-għadd tad-differenza fil punteġġi ta' l-intensità ta' l-uġigħ mill-iddożar sa 60 minuta, inkluża (SPID60), li kienet statistikament sinnifikanti meta mqabbla mal-plaċebo (p<0.0001).
English: Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Maltese: Pazjenti li qed jirċievu terapija ta' manteniment b'opioid huma dawk li qed jieħdu ta' l-inqas 60 mg ta' morphine orali kuljum, ta' l-inqas 25 mikrogramma ta' fentanyl transdermali kull siegħa, ta' l-inqas 30 mg ta' oxycodone kuljum, ta' l-inqas 8 mg ta' hydromorphone orali kuljum jew doża ekwianalġeżika ta' opioid ieħor għal ġimgħa jew aktar.
English: Effentora 100 micrograms buccal tablets Effentora 200 micrograms buccal tablets Effentora 400 micrograms buccal tablets Effentora 600 micrograms buccal tablets Effentora 800 micrograms buccal tablets
Maltese: Effentora 100 mikrogramma pilloli għall-ħalq Effentora 200 mikrogramma pilloli għall-ħalq Effentora 400 mikrogramma pilloli għall-ħalq Effentora 600 mikrogramma pilloli għall-ħalq Effentora 800 mikrogramma pilloli għall-ħalq
English: The concomitant use of Effentora with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors (e.g.,
Maltese: (e.ż., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, u nelfinavir) jew inibituri moderati ta' CYP3A4
English: • If you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.
Maltese: • Jekk m'intix qed tuża b'mod regolari mediċina opoid (eż codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) preskritta kuljum fuq skeda regolari, għal ta' l-inqas ġimgħa, għall-kontroll tal-uġigħ persistenti tiegħek.
English: • Educational material for the healthcare professionals
Maltese: • Materjal edukattiv għal pazjenti
English: Tolerance, physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl (see section 4.4).
Maltese: Tolleranza, dipendenza fiżika u/jew psikoloġika jistgħu jiżviluppaw wara għoti ripetut ta' opioids bħal fentanyl (ara sezzjoni 4.4).
English: Chronic obstructive pulmonary disease
Maltese: Mard pulmonari ostruttiv kroniku
English: • drug abuse
Maltese: • abbuż mid-droga
English: Co-administration of fentanyl with other central nervous system depressants, including other opioids, sedatives or hypnotics, (including benzodiazepines), general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol can produce additive depressant effects which may result in a fatal outcome (see section 4.4).
Maltese: L-għoti fl-istess ħin ta' fentanyl ma' depressanti tas-sistema nervuża ċentrali oħra, inkluż opioids oħra, sedattivi jew ipnotiċi, (inkluż benzodiazepines), anestetiċi ġenerali, phenothiazines, kalmanti, rilassanti tal-muskoli skeltrali, antistamini sedattivi u alkoħol, jista' jipproduċi effetti depressanti miżjuda li jistgħu jwasslu għal riżultat fatali (ara sezzjoni 4.4).
English: Effentora 200, 400, 600 and 800 micrograms buccal tablets contain 20 mg sodium per tablet.
Maltese: Effentora 200, 400, 600 u 800 mikrogramma pilloli għall-ħalq fihom 20 mg sodium f'kull pillola.
English: Anaphylaxis and hypersensitivity have been reported in association with the use of oral transmucosal fentanyl products (see Section 4.8).
Maltese: Anafilassi u ensittività eċċessiva ġew irrappurtati f'assoċjazzjoni mal-użu ta' prodotti orali transmukożali li fihom fentanyl (ara sezzjoni 4.8).
English: Pruritus Hyperhidrosis Rash
Maltese: Iperidrosi Raxx
English: Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
Maltese: Deher titjib statistikament sinnifikanti fid-differenza fl-intensità tal-uġigħ b'Effentora kontra plaċebo minn wara 10 minuti fi Studju 1 u minn wara 15-il minuta (l-aktar punt ta' ħin bikri mkejjel) fi Studju
English: Two double-blind, randomized, placebo-controlled crossover studies have been conducted involving a total of 248 patients with BTP and cancer who experienced on average 1 to 4 episodes of BTP per day while taking maintenance opioid therapy.
Maltese: Twettqgħu żewġ studji crossover, double-blind, randomised, ikkontrollati bil-plaċebo li nvolvew 248 pazjent b'BTP u kanċer li kellhom esperjenza ta' medja ta' episodju wieħed sa 4 episodji ta' BTP kuljum waqt li qed jieħdu terapija ta' manteniment b'opioid.
English: Patients with xerostomia
Maltese: Pazjenti bi xerostomia
English: Fentanyl is metabolised in the liver and in the intestinal mucosa to norfentanyl by CYP3A4 isoform.
Maltese: Fentanyl huwa metabolizzat fil-fwied u fil-mukuża tal-musrana għal norfentanyl permezz ta' isoforma ta' CYP3A4.
English: Other medicines and Effentora
Maltese: Mediċini oħra u Effentora
English: Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, rare (≥1/10,000 to
Maltese: Ir-reazzjonijiet avversi huma mniżżla isfel bħala terminu ppreferut MedDRA skond is-sistema tal-klassifika tal-organi u l-frekwenza (frekwenzi huma definiti bħala: komuni ħafna ≥1/10, komuni ≥1/100 sa <1/10, mhux komuni ≥ 1/1,000 sa <
English: • Do not drink alcohol while using Effentora.
Maltese: • Tixrobx alkoħol waqt li qed tuża Effentora.
English: The buccal tablets are flat-faced, round bevelled-edge tablet, embossed one side with a “C” and on the other side with “1” for Effentora 100 micrograms, with “2” for Effentora 200 micrograms, with “4” for Effentora 400 micrograms, with “6” for Effentora 600 micrograms, with “8” for Effentora 800 micrograms.
Maltese: Il-pilloli għall-ħalq huma pillola b'wiċċ ċatt, tondi u b'xifer imtajjar, immarati fuq naħa waħda b'“C” u fuq in-naħa l-oħra b'“1” għal Effentora 100 mikrogramma, b'“2” għal Effentora 200 mikrogramma, b'“4” għal Effentora 400 mikrogramma, b'“6” għal Effentora 600 mikrogramma, b'“8” għal Effentora
English: • Some muscle relaxants - such as baclofen, diazepam (see also section “Warnings and precautions”.
Maltese: • Xi rilassanti tal-muskoli bħal baclofen, diazepam (ara wkoll is-sezzjoni “Twissijiet u prekawzjonijiet”.
English: Fentanyl concentrations obtained in serum were higher than in plasma: Serum AUC and Cmax were approximately 20% and 30% higher than plasma AUC and Cmax, respectively.
Maltese: AUC u Cmax fis-serum kienu madwar 20% u 30% ogħla mill-AUC u Cmax tal-plażma, rispettivament.
English: Hypogonadism Adrenal insufficiency, androgen deficiency
Maltese: defiċjenza tal androġeni
English: Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Effentora is given concurrently with agents that affect CYP3A4 activity.
Maltese: P450 3A4 (CYP3A4), għalhekk jistgħu jseħħu interazzjonijiet potenzjali meta Effentora jingħata flimkien ma' sustanzi li jaffettwaw l-attività ta' CYP3A4.
English: • Risk of interactions with other medications
Maltese: • Riskju ta' interazzjonijiet ma' mediċini oħrajn
English: In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
Maltese: Fi studji farkokinetiċi li qabblu il-biodisponibiltà assoluta u relattiva ta' Effentora u ta' fentanyl citrate orali minn ġol-mukuża (OTFC), ir-rata u l-kwantità ta' assorbiment ta' fentanyl f'Effentora wrew esponiment li kien bejn 30% sa 50% akbar minn dak għal fentanyl citrate orali minn ġol-mukuża.
English: Hypersensitivit y*
Maltese: Tintilef minn sensik*
English: In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p<0.0001).
Maltese: Fit-tieni studju pivitali (studju 2), l-mira primarja kienet SPID30, li kienet ukoll statistikament sinnifikanti meta mqabbla mal-plaċebo (p<0.
English: • Certain type of strong pain killers, calledpartial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine (medicines for treatment of pain).
Maltese: • Ċerti tipi ta' mediċini kontra l-uġigħ li jissejħu agonisti/antagonisti parzjali, eż. buprenorphine, nalbuphine u pentazocine (mediċini għal kura tal-uġigħ).
English: • For titration to 600 micrograms and 800 micrograms, tablets of 200 micrograms should be used.
Maltese: • Għal titrazzjoni sa 600 mikrogramma u 800 mikrogramma, għandhom jintużaw pilloli ta'
English: Effentora contains sodium
Maltese: Effentora fih is-sodium
English: • feeling anxious or confused, depression, insomnia
Maltese: • tħossok anzjuż jew konfuż, depressjoni, insomnja
English: Patients should be closely monitored for signs and symptoms of respiratory depression and sedation (see section 4.5).
Maltese: Il-pazjenti għandhom jiġu ssorveljati mill-qrib għal sinjali u sintomi ta' depressjoni respiratorja u sedazzjoni (ara sezzjoni 4.5).
English: Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl.
Maltese: Tolleranza u dipendenza fiżika u/jew psikoloġika jistgħu jiżviluppaw wara għoti ripetut ta' opioids bħal fentanyl.
English: • What is EFFENTORA for?
Maltese: • Għalxiex jintuża EFFENTORA?
English: Therefore it is not possible to definitively separate the effects of Effentora alone.
Maltese: Għalhekk mhux possibli li jiġu separati b'mod definittiv l-effetti ta' Effentora waħdu.
English: In clinical studies patients older than 65 years tended to titrate to a lower effective dose than younger patients.
Maltese: Fi studji kliniċi pazjenti 'l fuq minn 65 sena kellhom tendenza li jittitraw għal doża effettiva aktar baxxa minn pażjenti iżgħar.
English: The total plasma clearance of fentanyl following intravenous administration is approximately 42 L/h.
Maltese: It-tneħħija totali mill plażma ta' fentanyl wara għoti ġol-vini hija madwar 42 L/h.
English: • loss of consciousness, stop in breathing, convulsion (fits)
Maltese: • telf ta' koxjenza, waqfien tan-nifs, konvulżjoni (aċċessjonijiet)
English: The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Maltese: L-użu fl-istess waqt ta' agonisti/antagonisti parzjali ta' opioid (e.ż. buprenorphine, nalbuphine, pentazocine) mhux irrakkomandat.
English: Following oromucosal administration of Effentora, fentanyl is readily absorbed with an absolute bioavailability of 65%.
Maltese: Wara għoti oromukużali ta' Effentora, fentanyl huwa assorbit malajr b'biodisponibiltà assoluta ta'
English: Musculoskel etal and connective tissue disorders
Maltese: Disturbi muskolu skeletriċi u tat tessuti konnettivi
English: Date of first authorisation: 04 April 2008 Date of latest renewal: 20 February 2013
Maltese: Data tal-ewwel awtorizzazzjoni: 04 ta' April 2008
English: • Medicines called monoamine-oxidase (MAO) inhibitors (used for severe depression) or have done so in the past 2 weeks.
Maltese: • Mediċini msejjħa inibituri ta' monoamine-oxidase (MAO) (użati għal depressjoni severa) jew ħadt dawn fl-aħħar ġimagħtejn.
English: Hyperalgesia
Maltese: Iperalġeżja
English: As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl.
Maltese: Bħal bl-opioids kollha, hemm riskju ta' depressjoni respiratorja ta' sinifikanza klinika assoċjata ma' lużu ta' fentanyl.
English: • Severe respiratory depression or severe obstructive lung conditions.
Maltese: • Depressjoni respiratorja severa jew kondizzjonijiet severi ta' ostruzzjoni tal-pulmun.
English: You may experience withdrawal symptoms similar to the possible side effects of Effentora when discontinuing Effentora.
Maltese: Jista' jkollok sintomi tas-sindrome ta' rtirar li jkunu simili għall-effetti sekondarji possibbli ta' Effentora meta twaqqaf Effentora.
English: Cmax and AUC0-8 were 1% and 25% higher in patients with mucositis compared to those without mucositis, respectively.
Maltese: Cmax u AUC0-8 kienu 1% u 25% ogħla rispettivament, f'pazjenti b'mukożite meta mqabbel ma' dawk mingħajr mukożite.
English: Hepatic or renal impairment
Maltese: Anafilassi u ensittività eċċessiva
English: Dyspnoea Pharyngolaryngeal pain
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Buccal tablet.
Maltese: Għoti tal-pillola
English: Pharmacokinetic Parameters* in Adult Subjects Receiving Effentora
Maltese: Parametri Farmakokinetiċi* f'Individwi Adulti li Rċevew Effentora
English: Batch
Maltese: Mejt
English: Effentora may interact with these medicines and you may experience mental status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature above 38°C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g nausea, vomiting, diarrhoea).
Maltese: Effentora jista' jinteraġixxi ma' dawn il-mediċini u jista' jkollok bidliet fl-istat mentali (eż. aġitazzjoni, alluċinazzjonijiet, koma), u effetti oħra bħal temperatura tal-ġisem ogħla minn 38°C, żieda fir-rata tat-taħbita tal-qalb, pressjoni tad-demm instabbli, u esaġerazzjoni tarriflessi, riġidità fil-muskoli, nuqqas ta' koordinazzjoni u/jew sintomi gastrointestinali (eż. dardir, rimettar, dijarea).
English: Further findings at maternally toxic doses in F1 pups were delayed physical development, sensory functions, reflexes and behaviour.
Maltese: Aktar sejbiet b'dożi tossiċi għall omm fil-ġriewi F1 kienu żvilupp fiżiku, funzjonijiet sensorjali, riflessi u imġieba ttardjati.
English: The risk of respiratory depression is less in patients receiving chronic opioid therapy as these patients will develop tolerance to respiratory depressant effects.
Maltese: Ir-riskju ta' depressjoni respiratorja hija inqas f'pazjenti li qed jirċievu terapija kronika b'opioid peress li dawn il-pazjenti ser jiżviluppaw tolleranza għall-effetti ta' depressjoni respiratorja.
English: The safety and efficacy of Effentora in children aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Effentora fit-tfal minn età ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: • You have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency) with opioid use (see section 4 under “Serious side effects”).
Maltese: • Xi darba żviluppajt insuffiċjenza adrenali jew nuqqas ta' ormoni tas-sess (defiċjenza ta' androġen) bl-użu ta' opjojdi (ara sezzjoni 4 taħt “Effetti sekondarji serji”).
English: Malaise Sluggishness Chest discomfort Feeling abnormal Feeling jittery Thirst
Maltese: Korriment, avvelenament u komplikazzjonij iet ta' xi proċedura
English: Using benzodiazepines can increase the chances of getting serious side effects including death
Maltese: benzodiazepines jista' jżid il-possibbiltà li jkollok effetti sekondarji serji inkluż mewt
English: The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
Maltese: • Tuża antidipressanti jew antipsikotiċi (inibituri selettivi tat-teħid mill-ġdid ta' serotonin [SSRIsselective serotonin reuptake inhibitors], inibituri tat-teħid mill-ġdid ta' serotonin norepinephrine [SNRIs - serotonin norepinephrine reuptake inhibitors], inibituri ta' monoamine oxidase (MAO);
English: Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes.
Maltese: li tissejjaħ insuffiċjenza adrenali; kundizzjoni li fiha l-glandoli adrenali ma jipproduċux ormoni biżżejjed.
English: Convulsion
Maltese: Disartrija
English: • disturbance in thinking, movements disturbance
Maltese: • disturbi fil-ħsieb, disturbi fil-movimenti
English: Agents that can increase CNS depressant effects
Maltese: Sustanzi li jistgħu jżidu l-effetti depressanti fuq is-CNS
English: During titration, multiple tablets may be used: up to four 100 micrograms or up to four 200 micrograms tablets may be used to treat a single episode of BTP during dose titration according to the following schedule:
Maltese: Waqt titrazzjoni, pilloli multipli jistgħu jintużaw: sa erba' pilloli ta' 100 mikrogramma jew sa erba' pilloli ta' 200 mikrogramma jistgħu jintużaw għall-kura ta' episodju wieħed ta' BTP waqt titrazzjoni tad-doża skond il-programm li ġej:
English: The maintenance dose of Effentora should be increased when a patient requires more than one tablet per BTP episode for several consecutive BTP episodes.
Maltese: Id-doża ta' manteniment ta' Effentora għandha tiżdied meta pazjent ikollu bżonn aktar minn pillola waħda kull episodju ta' BTP għall diversi episodji konsekuttivi ta' BTP.
English: Differences in exposure with Effentora were observed in a clinical study with patients with grade 1 mucositis.
Maltese: Differenzi fl-esponiment b'Effentora kienu osservati fi studju kliniku b'pazjenti b'mukożite ta' grad 1.
English: • at the site of tablet application: pain, ulcer, irritation, bleeding, numbness, loss of sensation,
Maltese: • tħossok imdardar, rimettar • fil-post ta' l-applikazzjoni tal-pillola: uġigħ, ulċera, irritazzjoni, fsada, tnemnim, telf ta'
English: Do not give this medicine to children and adolescents below18 years of age.
Maltese: Tagħtix din il-mediċina lil tfal u adolexxenti ta' età inqas minn 18-il sena.
English: Oral pustule
Maltese: Infafet orali
English: Mouth ulceration Oral hypoaesthesia Oral discomfort Oral mucosal discolouration Oral soft tissue disorder Glossodynia Tongue blistering Gingival pain Tongue ulceration Tongue disorder Oesophagitis Chapped lips Tooth disorder
Maltese: Doża eċċessiva (teħid bi żball) f'persuna li qatt ma tkun ħadet opjojdi qabel Għall-kura ta' doża eċċessiva (teħid bi żball) f'persuna li qatt ma tkun ħadet opioids qabel, għandu jinkiseb aċċess ġol-vini u naloxone jew antagonisti tal-opioids oħra għandhom jiġu ntużati kif indikat klinikament.
English: Each tablet of Effentora 100 micrograms contains 10 mg of sodium.
Maltese: Kull pillola ta' Effentora 100 mikrogramma fiha 10 mg ta' sodium.
English: The symptoms of fentanyl overdose are expected to be similar in nature to those of intravenous fentanyl and other opioids, and are an extension of its pharmacological actions, with the most serious significant effects being altered mental status, loss of consciousness, hypotension, respiratory depression, respiratory distress, and respiratory failure, which have resulted in death.
Maltese: Is-sintomi ta' doża eċċessiva ta' fentanyl huma mistennija li jkunu ta' natura simili bħal dawk ta' fentanyl ġol-vini u ta' opioids oħra, u huma estensjoni ta' l-azzjonijiet farmakoloġiċi tiegħu, b'bidla fl istat mentali, telf ta' koxjenza, pressjoni baxxa, depressjoni respiratorja, diffikultà respiratorja, u insuffiċjenza respiratorja li wasslu għall-mewt, bħala l-aktar effetti sinnifikanti serji.
English: Dizziness Headache
Maltese: Stitikezza Stomatite
English: Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
Maltese: Effentora huwa ndikat għall-kura ta' uġigħ li jinħass (BTP) f'adulti bil-kanċer li diġà qed jirċievu terapija ta' manteniment b'opioid għall-uġigħ kroniku tal-kanċer.
English: In animal studies, male fertility was impaired (See Section 5.3).
Maltese: Fi studji fuq l-annimali, il-fertilità ġiet indebolita (ara sezzjoni 5.3).
English: Effentora 100 micrograms buccal tablets contain 10 mg sodium per tablet.
Maltese: Effentora 100 mikrogramma pilloli għall-ħalq fihom 10 mg sodium f'kull pillola.
English: BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Maltese: BTP huwa aggravament transitorju ta' uġigħ li jseħħ fuq sfond ta' uġigħ persistenti li altrimenti jkun ikkontrollat.
English: OTFC data was dose adjusted (800 mcg to 400 mcg)
Maltese: Ħin wara l-Għotja tad-Doża (sigħat) Tagħrif OTFC sar aġġustat (800 mcg sa 400 mcg)
English: The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist's action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary.
Maltese: Id-dewmien tad-depressjoni respiratorja wara doża eċċessiva jista' jkun itwal mill-effetti ta' l-azzjoni ta' l-antagonist tal-opioids (e.ż., il-half-life ta' naloxone tvarja minn 30 sa 81 minuta) u jista' jkun hemm bżonn ta' għotja ripetuta.