FrancophonIA/ELRC3.0 huggingface dataset:
English: The SPID for PecFent-treated episodes was also significantly different to placebo at 10 15, 45 and 60 minutes after administration.
Maltese: L-SPID għal episodji kkurati b'PecFent kien ukoll differenti b'mod sinifikanti għal plaċebo wara 10 15, 45 u 60 minuta wara l-għoti.
English: PecFent contains propylparahydroxybenzoate (E216).
Maltese: PecFent fih propylhydroxybenzoate (E216)
English: The primary endpoint was the comparison between the summed pain intensity difference at 30 minutes after dosing (SPID30), which was 6.57 in the PecFent-treated episodes compared to 4.45 for placebo (p<0.0001 ).
Maltese: Il-punt aħħari primarju kien il-paragun bejn it-total ta' differenza ta' intensità tal-uġigħ wara 30 minuta mid-dożaġġ (SPID30), li kien 6.57 fl-episodji kkurati b'PecFent meta mqabbel ma' 4.45
English: Pharmacokinetic parameters in adult subjects receiving PecFent and OTFC
Maltese: Parametri farmakokinetiċi f'persuni adulti li jkunu qed jirċievu PecFent u OTFC
English: 0.95 ml (950 micrograms fentanyl) - 2 spray bottle or
Maltese: 0.95 ml (950 micrograms fentanyl) - Flixkun b'2 sprejs jew
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 jkunu qed jirċievu terapija ta' manteniment bl-opjojdi huma dawk li jkunu qed jieħdu mill inqas 60 mg ta' morfina orali kuljum, mill-inqas 25 mikrogramma ta' fentanyl li jgħaddi minn ġolġilda kull siegħa, mill-inqas 30 mg ta' oxycodone kuljum, mill-inqas 8 mg ta' hydromorphone orali kuljum jew doża ekwianalġesika ta' opjojd ieħor għal ġimgħa jew aktar.
English: • The starting dose is 100 micrograms.
Maltese: • Id-doża tal-bidu hi ta' 100 mikrogramma.
English: Take off the white plastic protective cap from the nozzle (Figure 1).
Maltese: Neħħi l-għatu protettiv abjad tal-plastik minn fuq in-nozzle (Figura 1).
English: • you have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency) with opioid use
Maltese: • qatt żviluppajt insuffiċjenza adrenali jew nuqqas ta' ormoni tas-sess (defiċjenza ta' androgen)
English: Upper respiratory tract congestion
Maltese: fuq tal-apparat respiratorju
English: [2 spray bottle:] 1 bottle - 0.95 ml (2 sprays) per bottle
Maltese: [Flixkun b'2 sprejs:] 1 flixkun - 0.95 ml (2 sprejs) kull flixkun
English: Dose-proportionality was demonstrated for Cmax and AUC in the dose range 100 micrograms to 800 micrograms.
Maltese: Il-proporzjonalità mad-doża ntweriet għal Cmax u AUC fid-medda tad-doża ta' 100 mikrogramma sa 800 mikrogramma.
English: Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
Maltese: Pazjenti mingħajr terapija ta' manteniment b'opioid minħabba li hemm riskju miżjud ta' depressjoni respiratorja.
English: See section 4.
Maltese: Figura 4
English: EU/1/10/644/003 EU/1/10/644/004 EU/1/10/644/006
Maltese: EU/1/10/644/003 EU/1/10/644/004
English: You will hear a second ‘click' and there should now be a single large red bar in the counting window (Figure 3b).
Maltese: Ser tisma' t-tieni ‘klikk' u issa għandu jkun hemm bar waħda kbira ħamra fil counting window (Figura 3b).
English: Neutropenia
Maltese: Nervożità
English: In the randomised, placebo-controlled study (CP043) 9.4% of 459 PecFent-treated BTP episodes in 73 patients required use of any further (rescue) medicinal products within 60 minutes of dosing.
Maltese: Fl-istudju (CP043) li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, 9.4% ta' 459 episodji ta' BTP ikkurati b'PecFent fi 73 pazjent kienu jeħtieġu l-użu ta' xi prodotti mediċinali (ta' salvataġġ) addizzjonali fi żmien 60 minuta mid-dożaġġ.
English: Attention deficit/hyperactivity disorder
Maltese: Dipressjoni Nuqqas ta' attenzjoni/disturbi ta' iperattività Ansjetà
English: There is a risk of clinically significant respiratory depression associated with the use of fentanyl.
Maltese: Hemm riskju ta' tnaqqis respiratorju klinikament sinifikanti assoċjat mal-użu ta' fentanyl.
English: • Insomnia
Maltese: Insomnja
English: The mean pain intensity scores (73 patients) for all PecFent-treated episodes (459 episodes) compared to those treated with placebo (200 episodes) were significantly lower at 5, 10, 15, 30, 45 and 60 minutes following administration (see Figure 1).
Maltese: episodji) meta mqabbla ma' dawk ikkurati bi plaċebo (200 episodju) kienu iktar baxxi b'mod sinifikanti wara 5, 10, 15, 30, 45 u 60 minuta wara l-għoti (ara Figura 1).
English: PecFent is available in two strengths: 100 micrograms/spray and 400 micrograms/spray.
Maltese: PecFent hu disponibbli f'żewġ qawwiet: 100 mikrogramma/sprej u 400 mikrogramma/sprej.
English: • Drug abuse
Maltese: • Abbuż mid-droga
English: • Do not drink alcohol while using PecFent.
Maltese: • Tixrobx alkoħol meta tkun qed tuża PecFent.
English: Common side effects (may affect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw minn 1 sa 10 persuni):
English: Following treatment of the acute rhinitic state with oxymetazoline, there were reductions in Cmax and exposure, and increases in Tmax that were statistically, and possibly clinically, significant.
Maltese: Wara l-kura ta' stat rinitiku akut b'oxymetazoline, kien hemm tnaqqis fis-Cmax u fl-espożizzjoni, u żidiet fit-Tmax li kienu statistikament, u possibbilment klinikament, sinifikanti.
English: Coadministration with medicinal products that induce 3A4 activity may reduce the efficacy of PecFent.
Maltese: L-għoti flimkien ma' prodotti mediċinali li jikkaġunaw żieda fl-attività ta' 3A4, jista' jnaqqas l-effikaċja ta' PecFent.
English: Excipients with known effect: Each spray contains 0.02 mg propylparahydroxybenzoate (E216).
Maltese: Kull sprej fih 0.02 mg ta' propyl parahydroxybenzoate (E216).
English: Pharyngolaryngeal pain Rhinalgia
Maltese: Uġigħ faringolarinġeali Rinalġja
English: Of the 355 patients treated in the open-label treatment phase, 90 % required no increase in dose.
Maltese: Mit-355 pazjent ikkurati fil-fażi ta' kura open-label, 90% ma kellhom bżonn l-ebda żieda fid-doża.
English: B. PecFent 200 µg dose
Maltese: PecFent 100 µg dose B. PecFent 200 µg dose C.
English: 1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate).
Maltese: 1 sprej (100 mikrolitri) fih 100 mikrogramma fentanyl (bħala citrate).
English: The patients entering the double-blind phase treated up to 10 episodes of BTP with either PecFent (7 episodes) or placebo (3 episodes) in a random order.
Maltese: Il-pazjenti li jkunu ser jibdew il-fażi double-blind kienu kkurati sa 10 episodji ta' BTP jew b'PecFent (7 episodji) jew bi plaċebo (3 episodji) f'ordni każwali.
English: Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
Maltese: koma), instabilità awtonomika (eż. takikardija, pressjoni tad-demm instabbli, ipertermija), abnormalitajiet newromuskolari (eż. iperrifleksija, nuqqas ta' koordinazzjoni, riġidità), u/jew sintomi gastrointestinali (eż. dardir, rimettar, dijarea).
English: 1 spray (100 microlitres) contains 400 micrograms fentanyl (as citrate).
Maltese: 1 sprej (100 mikrolitri) fih 400 mikrogramma fentanyl (bħala citrate).
English: It is contained in a clear glass bottle, fitted with a metering pump.
Maltese: Tinsab fi flixkun ta' ħġieġ ċar, mgħammar b'pompa metering.
English: Nasal spray, solution 1 bottle - 1.55 ml (8 sprays) per bottle 4 bottles - 1.55 ml (8 sprays) per bottle 12 bottles - 1.55 ml (8 sprays) per bottle
Maltese: U KONTENUT Sprej għall-imnieħer, soluzzjoni flixkun 1 - 1.55 ml (8 sprejs) f'kull flixkun 4 fliexken - 1.55 ml (8 sprejs) f'kull flixkun 12 fliexken - 1.55 ml (8 sprejs) f'kull flixkun
English: A double-blind, randomised, placebo-controlled crossover study has been conducted in which 114 patients who experienced on average 1 to 4 episodes of break through pain (BTP) per day while taking maintenance opioid therapy were entered into an initial open-label titration phase in order to identify an effective dose of PecFent (Study CP043).
Maltese: Sar studju double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bil-plaċebo, tat-tip crossover, li fih 114-il pazjent li kellhom bħala medja minn 1 sa 4 episodji ta' wġigħ temporanju li jseħħ għal għarrieda (BTP - break through pain) kuljum waqt li kienu qed jieħdu terapija ta' manteniment bl-opjojdi, ġew irreġistrati f'fażi inizjali ta' titrazzjoni open-label sabiex tiġi identifikata doża effettiva ta' PecFent (Studju CP043).
English: Of the patients entering the titration phase, only 7 (6.1 %) were unable to be titrated to an effective dose due to lack of efficacy and 6 (5.3 %) withdrew due to adverse events.
Maltese: Mill-pazjenti li daħlu fil-fażi ta' titrazzjoni, 7 (6.1%) biss ma kinux kapaċi jiġu ttitrati għal doża effettiva minħabba n-nuqqas ta' effikaċja, u 6 (5.3%) irtiraw mill-istudju minħabba avvenimenti avversi.
English: Dose-proportionality was demonstrated for Cmax and area under the curve (AUC) in the dose range 100 micrograms to 800 micrograms (see Figure 3).
Maltese: Il-proporzjonalità mad-doża ntweriet għas-Cmax u ż-żona taħt il-kurva (AUC) fil-medda tad-doża ta' 100 mikrogramma sa 800 mikrogramma (ara Figura 3).
English: PecFent 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: PecFent 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 tar-riflessi, riġidità fil-muskoli, nuqqas ta' koordinazzjoni u/jew sintomi gastrointestinali (eż. dardir, rimettar, dijarea).
English: • Information on the correct indication
Maltese: • Informazzjoni dwar l-indikazzjoni korretta
English: Epistaxis Rhinorrhoea Nasal discomfort
Maltese: Konġestjoni nażali Ipoestesija intranażali
English: Other medicines and PecFent
Maltese: Mediċini oħra u PecFent
English: Product strength (micrograms)
Maltese: (mikrogrammi)
English: 8 spray bottle:
Maltese: Flixkun bi 8 sprejs:
English: In the PecFent clinical trial programme, 104 (26.1%) of patients were over 60 years of age, 67 (16.8%) over 65 years and 15 (3.8%) over 75 years.
Maltese: (16.8%) kellhom iktar minn 65 sena u 15 (3.8%) iktar minn 75 sena.
English: PecFent 100 micrograms/spray nasal spray, solution Each ml of solution contains 1,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate)
Maltese: U KWANTITATTIVA PecFent 100 mikrogramma/sprej għall-imnieħer, soluzzjoni Kull ml ta' soluzzjoni fih 1,000 mikrogramma ta' fentanyl (bħala citrate) sprej 1 (100 mikrolitru) fih 100 mikrogramma ta' fentanyl (bħala citrate)
English: • The counter will stay on the number “8”.
Maltese: • Il-counter ser jibqa' fuq in-numru “8”.
English: Proteinuria Urinary hesitation
Maltese: Anurja Disurja Proteinurja
English: You may experience withdrawal symptoms similar to the possible side effects of PecFent when discontinuing PecFent.
Maltese: Jista' jkollok sintomi ta' meta tieqaf tieħu l-mediċina simili għall-effetti sekondarji possibbli ta' PecFent meta twaqqaf PecFent.
English: • retching, stomach pains, indigestion
Maltese: • dardir, uġigħ fl-istonku, indiġestjoni
English: Dysgeusia Dizziness Somnolence Headache
Maltese: Kif gћandek tuża PecFent
English: A new bottle of PecFent will show two red lines in the counting window in the white plastic top on the bottle (Figure 1 and Figure 3a).
Maltese: Flixkun ġdid ta' PecFent ser juri żewġ linji ħomor fil-counting window fit-top abjad tal-plastik fuq il-flixkun (Figura 1 u Figura 3a).
English: No data on the pharmacokinetics of PecFent in elderly patients are available.
Maltese: M'hemmx dejta disponibbli dwar il-farmakokinetika ta' PecFent.
English: • Do not store PecFent above 25°C.
Maltese: • Taħżinx PecFent f'temperatura 'l fuq minn 25°C.
English: D. PecFent 800 µg dose
Maltese: PecFent 400 µg dose D. PecFent 800 µg dose E.
English: Amount
Maltese: Figura
English: PecFent 100 micrograms/spray nasal spray, solution PecFent 400 micrograms/spray nasal spray, solution
Maltese: PecFent 100 mikrogramma/sprej għall-imnieħer, soluzzjoni PecFent 400 mikrogramma/sprej għall-imnieħer, soluzzjoni
English: Hyperalgesia
Maltese: Artralġja
English: • seeing or hearing things that are not really there (hallucinations/delirium), feeling confused
Maltese: • tara jew tisma' affarijiet li mhumiex hemm fil-verità (alluċinazzjonijiet/delirju), tħossok konfuż
English: • PecFent 400 micrograms/spray nasal spray, solution Each ml of solution contains 4,000 micrograms fentanyl (as citrate).
Maltese: • PecFent 400 mikrogramma/sprej soluzzjoni ta' sprej nażali Kull ml ta' soluzzjoni fih 4,000 mikrogramma fentanyl (bħala citrate).
English: Other nasally administered treatments should be avoided within 15 minutes of dosing with PecFent.
Maltese: Kuri oħrajn mogħtija minn ġol-imnieħer għandhom jiġu evitati fi żmien 15-il minuta mid-dożaġġ b'PecFent.
English: In a double-blind, randomized comparator-controlled study (Study 044) of similar design to Study 043 conducted in opioid-tolerant patients with breakthrough cancer pain on stable doses of regularly scheduled opioids, PecFent was shown to be superior to immediate-release morphine sulfate (IRMS).
Maltese: Fi studju double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat b'komparatur (Studju 044), li kien imfassal bħal Studju 043 li twettaq fuq pazjenti tolleranti għall-opjojdi li kellhom uġigħ temporanju tal-kanċer li jseħħ għal għarrieda, li kienu fuq dożi stabbli ta' opjojdi skedati regolarment, intwera li PecFent kien superjuri għal morphine sulfate li jintreħa b'mod immedjat (IRMS).
English: Pruritus
Maltese: Urtikarja
English: • memory loss
Maltese: • telf ta' memorja
English: • Patients must wait at least 4 hours before treating another episode of BTP with PecFent.
Maltese: • Il-pazjent irid jistenna mill-inqas 4 sigħat qabel ma jikkura episodju ieħor ta' BTP b'PecFent.
English: Other side effects (frequency not known (frequency cannot be estimated from the available data))
Maltese: Effetti sekondarji oħra (frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli))
English: • protein in the urine
Maltese: • Proteina fl-awrina
English: In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 mcg/kg/day, s.c.) and is consistent with the sedative effects of fentanyl in animal studies.
Maltese: Fi studju dwar il-fertilità u l-iżvilupp embrijoniku bikri li sar fuq il-firien, kien osservat effett medjat mill-irġiel f'dożi għoljin (300 mcg/kg/jum, s.c.) u dan hu konsistenti mal-effetti sedattivi ta' fentanyl fi studji li saru fuq l-annimali.
English: Check that there is a green bar or a number showing in the counting window (Figure 4): this confirms that the PecFent bottle has been primed (see ‘Preparing the PecFent bottle for use' above).
Maltese: Iċċekkja li jkun hemm bar ħadra jew numru fil-counting window (Figura 4): dan jikkonferma li l-flixkun ta' PecFent ikun ġie ipprajmjat (ara ‘Kif tipprepara l-flixkun ta' PecFent għall-użu'
English: Package leaflet: Information for the user PecFent 100 micrograms/spray nasal spray, solution - two-spray bottle
Maltese: Informazzjoni għall-utent PecFent 100 mikrogramma/sprej għall-imnieħer, soluzzjoni (sprej nażali), flixkun b'2 sprejs
English: The concomitant use of PecFent with strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors (e.g. 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: (eż. amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, meraq tal-grejpfrut, u verapamil), jista' jirriżulta f'żieda filkonċentrazzjonijiet ta' fentanyl fil-plażma, li potenzjalment tista' tikkawża reazzjonijiet avversi serji tal-mediċina, li jinkludu tnaqqis respiratorju fatali.
English: After first use: 60 days
Maltese: Data tal-ewwel awtorizzazzjoni: 31 ta' Awwissu 2010
English: Severe respiratory depression or severe obstructive lung conditions.
Maltese: Tnaqqis respiratorju sever jew kundizzjonijiet ostruttivi severi fil-pulmun.
English: Concomitant use of nasally administered oxymetazoline has been shown to decrease the absorption of PecFent (see section 5.2).
Maltese: Intwera li l-użu fl-istess ħin ta' oxymetazoline mogħti mill-imnieħer inaqqas l-assorbiment ta' PecFent (ara sezzjoni 5.2).
English: 1 bottle - 1.55 ml (8 sprays) per bottle 4 bottles - 1.55 ml (8 sprays) per bottle 12 bottles 1.55 ml (8 sprays) per bottle
Maltese: [Flixkun bi 8 sprejs:] flixkun 1 - 1.55 ml (8 sprejs) f'kull flixkun4 fliexken - 1.55 ml (8 sprejs) f'kull flixkun 12 fliexken - 1.55 ml (8 sprejs) f'kull flixkun
English: Vertigo
Maltese: Deidrazzjoni
English: • You should not start breast-feeding within 5 days after the last dose of PecFent.
Maltese: • M'għandekx tibda t-treddigħ qabel 5 ijiem wara l-aħħar doża ta' PecFent.
English: Nasal congestion Intranasal hypoaesthesia Throat irritiation Postnasal drip Nasal dryness
Maltese: • It-tagħmir kollu mhux użat jew kontenituri vojta għandhom jiġu rritornati lura sistematikament skont ir-regolamenti lokali
English: o other pain killers called partial agonist/antagonist like buprenorphine, nalbuphine, pentazocine.
Maltese: o mediċini oħrajn kontra l-uġigħ imsejħa agonist/antagonist parzjali bħal buprenorphine,
English: • The counter will stay on the number “2”.
Maltese: • Il-counter ser jibqa' fuq in-numru “2”.
English: Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when PecFent is given concurrently with medicinal products that affect CYP3A4 activity.
Maltese: 3A4 (CYP3A4), għalhekk interazzjonijiet potenzjali jistgħu jseħħu meta PecFent jingħata fl-istess ħin ma' prodotti mediċinali li jaffettwaw l-attività ta' CYP3A4.
English: Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl.
Maltese: It-tolleranza u d-dipendenza fiżika u/jew psikoloġika jistgħu jiżviluppaw wara l-għoti ripetut ta' opjojdi bħal fentanyl.
English: fentanyl, oxycodone or hydromorphone) to control your constant background pain.
Maltese: oxycodone jew hydromorphone) biex tikkontrolla l-uġigħ fl-isfond kostanti tiegħek.
English: Coadministration of fentanyl with a serotoninergic medicinal product, 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: Teħid mill-Ġdid tas-Serotonin (SSRI) jew Inibitur tat-Teħid mill-Ġdid tas-Serotonin Norepinephrine (SNRI) jew Inibitur tal-Monoamine Oxidase (MAOI), jista' jżid ir-riskju tas-sindrome tas-serotonin, li hija kundizzjoni li tista' tkun ta' periklu għall-ħajja.
English: Face oedema Peripheral oedema Gait disturbance Pyrexia
Maltese: Disturb fil-mukuża nażali Sogħla
English: • PecFent 100 micrograms/spray nasal spray, solution Each ml of solution contains 1,000 micrograms fentanyl (as citrate).
Maltese: • PecFent 100 mikrogramma/sprej soluzzjoni ta' sprej nażali Kull ml ta' soluzzjoni fih 1,000 mikrogramma fentanyl (bħala citrate).
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: It-tul ta' żmien ta' tnaqqis respiratorju wara doża eċċessiva jista' jkun itwal mill effetti tal-azzjoni tal-antagonist tal-opjojdi (eż. il-half life ta' naloxone tvarja minn 30 sa 81 minuta) u l-għoti ripetut jista' jkun meħtieġ.
English: The safety and efficacy of PecFent in children and adolescents aged below 18 years have not yet been established.
Maltese: Is-sigurtà u effikaċja ta' PecFent fit-tfal u adolexxenti li jkollhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: The metabolic pathways following nasal administration of PecFent have not been characterised in clinical studies.
Maltese: Il-passaġġi metaboliċi wara l-għoti nażali ta' PecFent ma kinux ikkaratterizzati fl-istudji kliniċi.
English: • muscle convulsions or trembling
Maltese: • tħossok stordut
English: Speech disorder Sedation
Maltese: Indeboliment talmemorja
English: • Do not drink grapefruit juice while using PecFent.
Maltese: • Tixrobx meraq tal-grejpfrut waqt li tkun qed tuża PecFent.
English: PecFent utilises the PecSys nasal drug delivery system to modulate the delivery and absorption of fentanyl.
Maltese: PecFent juża s-sistema ta' forniment nażali tal-mediċina PecSys biex jimmodula l-forniment u l assorbiment ta' fentanyl.
English: Relative bioavailability of fentanyl from the PecFent treatment compared to the 200 microgram OTFC was approximately
Maltese: Il-bijodisponibilità relattiva ta' fentanyl mill-kura b'PecFent meta mqabbla mal-OTFC ta' 200 mikrogramma kienet ta' madwar 120%.
English: Titration in patients switching between immediate-release fentanyl containing products Substantial differences may exist in the pharmacokinetic profile of immediate-release fentanyl medicinal products, which result in clinically important differences in the rate and extent of absorption of fentanyl.
Maltese: Jista' jkun hemm differenzi sostanzjali fil-profil farmakokinetiku ta' prodotti mediċinali b'fentanyl li jerħu b'mod immedjat, li jirriżultaw f'differenzi klinikament importanti fir-rata u l-grad ta' assorbiment ta' fentanyl.
English: In patients with chronic obstructive pulmonary diseases, fentanyl may cause more serious adverse reactions.
Maltese: F'pazjenti b'mard pulmonari ostruttiv kroniku, fentanyl jista' jikkawża reazzjonijiet avversi aktar serji.
English: PecFent 400 micrograms/spray nasal spray, solution Each ml of solution contains 4,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 400 micrograms fentanyl (as citrate)
Maltese: Kull ml ta' soluzzjoni fih 4,000 mikrogramma ta' fentanyl (bħala citrate) Sprej 1 (100 mikrolitru) fih 400 mikrogramma ta' fentanyl (bħala citrate)
English: In a long-term, open-label, safety study (Study 045), 355 patients entered the 16-week treatment phase, during which 42,227 episodes of breakthrough cancer pain (BTP) were treated with PecFent.
Maltese: Fi studju fit-tul, open-label, dwar is-sigurtà (Studju 045), 355 pazjent ipparteċipaw fil-fażi ta' kura ta' 16-il ġimgħa, li matulha 42,227 episodju ta' wġigħ temporanju tal-kanċer li seħħ għal għarrieda (BTP)
English: PecFent 100 micrograms/spray nasal spray Fentanyl
Maltese: PecFent 100 mikrogramma/sprej għall-imnieħer, soluzzjoni
English: PecFent 400 micrograms/spray nasal spray Fentanyl
Maltese: PecFent 400 mikrogramma/sprej għall-imnieħer, soluzzjoni
English: If switching to PecFent from another fentanyl product for BTP, independent dose titration with PecFent is required as the bioavailability between products differs significantly.
Maltese: Jekk wieħed jaqleb għal PecFent minn prodott ieħor li fih fentanyl għal BTP, hemm bżonn ta' titrazzjoni indipendenti mid-doża b'PecFent għax il-bijodisponibilità bejn il-prodotti tvarja b'mod sinifikanti.
English: Dose readjustment
Maltese: Bijotrasformazzjoni