FrancophonIA/ELRC3.0 huggingface dataset:
English: Suicide attempt Suicidal ideation
Maltese: Manteniment tal-prova t'effikaċja
English: RXULTI 1 mg film-coated tablets
Maltese: RXULTI 1 mg pilloli miksija b'rita
English: In the primary analysis of time to impending relapse patients on brexpiprazole showed a significantly longer time to relapse compared with patients on placebo (p < 0.0001).
Maltese: Fl-analiżi primarja ta' żmien ta' rikaduta imminenti pazjenti fuq brexpiprazole wrew ħin sinjifikanti itwal għal rikaduta meta mqabbla ma' pazjenti fuq plaċebo (p < 0.0001).
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100):
English: Hyperglycaemia and diabetes mellitus
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM
English: PHARMACEUTICAL FORM
Maltese: PRODOTT MEDIĊINALI
English: • a history of seizures (fits) or epilepsy.
Maltese: • storja ta' aċċessjonijiet (tal-qamar) jew epilessija.
English: RXULTI 2 mg film-coated tablets EU/1/18/1294/005 (28 film-coated tablets)
Maltese: 2 mg pilloli miksija b'rita EU/1/18/1294/005 (28 pilloli miksija b'rita)
English: Strong CYP3A4 inhibitors
Maltese: Impedituri qawwija ta' CYP3A4
English: Appropriate care is advised when prescribing brexpiprazole for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medicinal products with anticholinergic activity, or being subject to dehydration.
Maltese: Attenzjoni xierqa hi rakkomandata meta brexpiprazole jiġi preskritt lil pazjenti li jesperjenzaw kundizzjonijiet li jistgħu jikkontribwixxu għal żieda fit-temperatura ċentrali tal-ġisem, eż. eżerċizzju intensiv, esponiment għal sħana qawwija, teħid ta' prodotti mediċinali fl-istess waqt ma' attività antikolinerġika, jew tkun suġġett għal deidrazzjoni.
English: RXULTI film-coated tablets contain lactose.
Maltese: Din il-mediċina tista' tikkaġuna żieda fil-piż sinjifikanti li tista' taffettwalek saħħtek.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u indirizz} <{tel}> <{faks}> <{posta elettronika}>
English: The active substance is fentanyl.
Maltese: Is-sustanza attiva hi fentanyl.
English: Name approval pending
Maltese: Isem Approvat Pendenti
English: 50μg 100μg 200μg 300μg 400μg 600μg 800μg
Maltese: 50µg 100µg 200µg 300µg 400µg 600µg 800µg
English: Fentanyl is metabolised by CYP3A4.
Maltese: Fentanyl jiġi metabolizzat b'CYP3A4.
English: Eye disorders Common: Vision abnormal
Maltese: Komuni: Vista abnormali
English: Silicified microcrystalline cellulose Croscarmellose sodium
Maltese: Silicified microcrystalline cellulose Croscarmellose sodium Magnesium stearate
English: ProStrakan Ltd, Galabank Business Park, Galashiels TD1 1QH UK
Maltese: ProStrakan Ltd, Galabank Business Park, Galashiels TD1 1QH Ir-Renju Unit
English: • muscle relaxants
Maltese: • rilassaturi tal-muskoli
English: (Invented) Name Strength
Maltese: Isem (Inventat) Qawwa
English: The other ingredients are mannitol (E421), silicified microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
Maltese: Is-sustanzi l-oħra huma mannitol (E421), silicified microcrystalline cellulose, croscarmellose sodium u magnesium stearate.
English: About 80-85% of fentanyl is bound by plasma proteins, mainly α1-glycoprotein and to a lesser extent albumin and lipoprotein.
Maltese: Madwar 80-85% ta' fentanyl jintrabat mal-proteini fil-plażma, prinċipalment ma' α1-glycoprotein u fi proporzjon ferm inqas ma' l-albumina u lipoproteina.
English: Rapinyl 50 micrograms Rapinyl 100 micrograms Rapinyl 200 micrograms Rapinyl 300 micrograms Rapinyl 400 micrograms Rapinyl 600 micrograms Rapinyl 800 micrograms
Maltese: Rapinyl 50 mikrogramma Rapinyl 100 mikrogramma Rapinyl 200 mikrogramma Rapinyl 300 mikrogramma Rapinyl 400 mikrogramma Rapinyl 600 mikrogramma Rapinyl 800 mikrogramma
English: Mean maximal plasma concentrations of fentanyl range from 0.2 to 1.3 ng/ml (after administration of 100 to 800 µg Rapinyl) and are reached within 22.5 to 240 minutes.
Maltese: Il-konċentrazzjonijiet massimi medji ta' fentanyl filplazma ivarjaw minn 0.2 sa 1.3 ng/ml (wara l-għoti ta' 100 sa 800 µg Rapinyl) u jintlaħqu bejn 22.5 sa 240 minuta wara.
English: The following adverse reactions associated with other medicinal products containing fentanyl have also been reported (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1000 to < 1/100; rare ≥ 1/10,000 to < 1/1000; very rare < 1/10,000; not known (cannot be estimated from available data)):
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu assoċjati ma' prodotti oħra ta' fentanyl li wkoll ġew rapportati (komuni ħafna ≥ 1/10; komuni ≥ 1/100 sa < 1/10; mhux komuni ≥ 1/1000 sa < 1/100; rari ≥ 1/10,000 sa < 1/1000; rari ħafna < 1/10,000; mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli)):
English: Like other opioids fentanyl showed mutagenic effects in vitro in mammalian cells.
Maltese: Bħal opjojdi oħra fentanyl wera effetti mutaġeniċi in vitro fiċ-ċelluli mammiferi.
English: The Applicant also provided data demonstrating that Rapinyl met the primary efficacy endpoint (Sum of Pain Intensity Difference from baseline to 30 minutes (SPID30)) and that the results were highly statistically significant (p=0.0004).
Maltese: L-applikant ipprovda wkoll informazzjoni li turi li Rapinyl laħaq l-endpoint primarju ta' leffikaċja (Total tad-Differenza fil-Qawwa ta' l-Uġigħ mil-linja bażi sa 30 minuta (SPID30)) u li rriżultati kienu statistikament sinifikanti ferm (p=0.0004).
English: Manufacturer:
Maltese: Komuni:
English: Maintenance therapy:
Maltese: Terapija ta' manteniment:
English: The CHMP acknowledged the data submitted, noting and assessing the data from the clinical studies EN3267-005 and EN3267-007.
Maltese: Is-CHMP irrikonoxxa l-informazzjoni ppreżentata, billi nnota u vvaluta l-informazzjoni mill-istudji kliniċi EN3267-005 u EN3267-007.
English: Upon repeated administration of opioids such as fentanyl, tolerance and physical and/or psychological dependence may develop.
Maltese: Ma' l-għoti ripetut ta' opjojdi bħal fentanyl, tista' tiżviluppa tolleranza u d-dipendenza fiżika u/jew psikoloġika.
English: The CHMP adopted a List of Questions (LoQ) to be addressed by the Applicant.
Maltese: Is-CHMP adotta Lista ta' Mistoqsijiet (LoQ) li kellhom jiġu indirizzati mill-Applikant.
English: A marketing authorization application was submitted by the Applicant ProStrakan Ltd through the Decentralised Procedure for Rapinyl, a sublingual tablet containing 50, 100, 200, 300, 400, 600 or 800 µg fentanyl, as citrate.
Maltese: L-applikant, ProStrakan Ltd, issottometta applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq permezz tal-Proċedura Deċentralizzata għal Rapinyl, pillola għal taħt l-ilsien li fiha 50, 100, 200, 300, 400, 600 jew 800 µg fentanyl, bħala ċitrat (citrate).
English: The CHMP considered the pharmacokinetic data in healthy volunteers vs. patients to be limited; however it agreed that the available data do not indicate alarming differences.
Maltese: Is-CHMP ikkunsidra li l-informazzjoni farmakokinetika minn voluntiera b'saħħithom vs. il-pazjenti hija limitata; madankollu huwa qabel li l-informazzjoni disponibbli ma tindikax differenzi allarmanti.
English: Secondary effects of fentanyl on central nervous system (CNS), respiratory and gastro-intestinal function are typical of opioid analgesics and are considered to be class effects.
Maltese: L-effetti sekondarji fuq is-sistema nervuża ċentrali (SNĊ), il-funzjoni respiratorja u gastro-intestinali huma tipiċi ta' opjojdi analġesiċi u huma kkonsidrati li huma effetti tal-kategorija.
English: Common: Asthenia, application site irritation
Maltese: Komuni: Astenja, irritazzjoni fis-sit ta' applikazzjoni Disturbi psikjatriċi
English: • Rare side effects (affects 1 to 10 users in 10,000): hiccups
Maltese: • Effetti sekondarji rari (jaffettwaw minn 1 sa 10 f'kull 10,000 utent): sulluzzu
English: Dose titration:
Maltese: Tittrazzjoni tad-doża:
English: Rapinyl tablets are contained in blisters, available in cartons of 10 or 30 tablets.
Maltese: Il-pilloli Rapinyl jiġu f'kartuni ta' 10 pilloli jew 30 pillola.
English: Doses higher than 800 micrograms have not been evaluated in clinical studies.
Maltese: Dożi ogħla minn 800 mikrogramma ma ġewx evalwati fi studji kliniċi.
English: The volume of distribution of fentanyl at steady state is about 3-6 l/kg.
Maltese: Il-volum ta' distribuzzjoni ta' fentanyl fi stadju fiss hu ta' madwar 3-6 l/kg.
English: • a head injury, because Rapinyl may cover up the extent of the injury
Maltese: • ferita fir-ras peress li Rapinyl jista' jkopri l-firxa tal-ferita
English: HOW TO STORE RAPINYL
Maltese: Tieħux Rapinyl
English: Conclusion on LoQ
Maltese: Konklużjoni dwar il-LoQ
English: The CHMP considered that while the efficacy data showed statistically significant difference in favour of Rapinyl versus placebo on SPID 30, the CHMP considered that the primary endpoints should include the assessment of pain intensity difference by simple scale and to define responder.
Maltese: Is-CHMP ikkunsidra li filwaqt li l-informazzjoni dwar l-effikaċja wriet differenza statistika sinifikanti favur Rapinyl meta mqabbel mal-plaċebo fuq SPID 30, huwa ħass li l-endpoints primarji għandhom jinkludu l-valutazzjoni tad-differenza fil-qawwa ta' l-wġigħ permezz ta' skala sempliċi u li jiġi identifikat min iwieġeb.
English: • Certain types of antiviral medicines used to treat infections caused by viruses (called protease inhibitors, containing e.g. ritonavir).
Maltese: • Ċertu tipi ta' mediċini antivirali użati biex jittrattaw infezzjonijiet kontra l-vajrusis (imsejħa protease inhibitors, li fihom eż. ritonavir).
English: Total plasma clearance of fentanyl is about 0.5 l/h/kg.
Maltese: It-tneħħija totali fil-plażma ta' fentanyl hi ta' madwar 0.5 l/h/kg.
English: Active substances that inhibit CYP3A4 activity such as macrolide antibiotics (e.g. erythromycin), azole antifungal agents (e.g. ketoconazole, itraconazole) or certain protease inhibitors (e.g. ritonavir) may increase the bioavailability of fentanyl by decreasing its systemic clearance, potentially enhancing or prolonging opioid effects.
Maltese: Mediċini li jimpedixxu l-attività ta' CYP3A4 bħall-antibijotiċi makrolidi (eż. erythromycin), sustanzi ta' kontra l-moffa azole (eż. ketoconazole, itraconazole) jew ċertu impedituri tal-protease (eż. ritonavir) jistgħu jżidu l-bijodisponibilità ta' fentanyl billi jnaqqsu t-tneħħija sistemika, u b'hekk jistgħu jħarrxu jew idewmu l-effetti opjojdi.
English: Adverse reactions from clinical studies with Rapinyl in patients and volunteers, with a suspected relationship to treatment, are listed below by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10).
Maltese: Reazzjonijiet avversi minn studji kliniċi b'Rapinyl f'pazjenti u volontieri, b'relazzjoni suspettata għat-trattament, huma elenkati hawn isfel skond is-sistema tal-klassifika tal-organi u l-frekwenza (komuni ħafna ≥ 1/10; komuni ≥ 1/100 sa < 1/10).
English: An extrapolation of the PID at 10 and 15 minutes to responder rates has been provided by the Applicant.
Maltese: L-applikant ipprovda estrapolazzjoni tal-PID wara 10 u 15-il minuta għar-rati ta' dawk li rrispondew.
English: The Applicant referred to the provided analysis of Pain Intensity Difference (PID) for Rapinyl compared to placebo from the 10 minute time point in the EN3267-005 study.
Maltese: L-applikant irrefera għall-analiżi pprovduta dwar is-Differenza fl-Intensità ta' l-Uġigħ (PID) għal Rapinyl imqabbel ma' plaċebo mill-punt temporali ta' 10 minuti fl-istudju EN3267-005.
English: Common: Myoclonus, insomnia, taste disorders Uncommon: Abnormal gait/coordination, vertigo, amnesia, speech disorders, tremor
Maltese: Komuni: Majoklonus, nuqqas ta' rqad, disturbi fit-togħma Mhux komuni: Pass/koordinazzjoni mhux normalit, vertiġoni, amnesija, disturbi fit-taħdit, rogħda
English: Fentanyl is metabolised primarily via CYP3A4 to a number of pharmacologically inactive metabolites, including norfentanyl.
Maltese: Fentanyl huwa metabolizzat prinċipalment permezz ta' CYP3A4 f'għadd ta' metaboliti farmakoloġikament mhux attivi, li jinkludu norfentanyl.
English: Common: Gastro-intestinal occlusion, dysphagia, mouth ulcers/stomatitis, tongue disorder Uncommon: Enlarged abdomen, flatulence, thirst Rare: Hiccups
Maltese: Komuni: okklużjoni gastro-intestinali, disfaġja, ulċeri tal-ħalq/stomatite, disturbi fl-ilsien Mhux komuni: Addome minfuħ, gass, għatx
English: Therefore the efficacy/safety profile of Rapinyl could be established.
Maltese: Għaldaqstant, l-effikaċja/profil tas-sigurtà ta' Rapinyl ma setgħux jiġu stabbiliti.
English: The analgesic effects of fentanyl are related to the blood level of the active substance; in opioid-naïve patients, minimum effective analgesic serum concentrations of fentanyl range from 0.3-1.2 ng/ml, while blood levels of 10-20 ng/ml produce surgical anaesthesia and profound respiratory depression.
Maltese: 3-1.2 ng/ml, filwaqt li l-livelli tad-demm ta' 10-20 ng/ml jipproduċu anestesija kirurġika u dipressjoni respiratorja profonda.
English: • Uncommon side effects (affects 1 to 10 users in 1,000): feeling restless, feeling detached, moodswings, trembling, difficulty speaking, being forgetful, loss of coordination, vertigo, slow or fast heartbeat, high blood pressure, difficulty breathing, slow or shallow breathing, asthma, bloating, wind, thirst, difficulty going to the toilet, change in frequency of going to the toilet, feeling unwell
Maltese: • Effetti sekondarji mhux komuni (jaffettwaw minn 1 sa 10 f'1,000 utent): tħossok li m'għandekx kwiet, tħossok mwarrab, bidliet fil-burdata, rogħda, diffiċli titħadded, tinsa, nuqqas ta' koordinazzjoni, vertiġini, qalb tħabbat bil-mod jew bil-qawwi, pressjoni għolja tad-demm, diffiċli tieħu nifs, nifs bil-mod u fil-baxx, ażma, nefħa, gass, għatx, tħossha diffiċli tmur fit-tojlit, bidla fid-drabi li tmur fit-tojlit, ma tħossokx f'sikktek
English: Do not use Rapinyl after the expiry date which is stated on the carton after EXP.
Maltese: Tużax Rapinyl wara d-data ta' skadenza li tidher fuq il-kartuna wara EXP.
English: Concomitant use of other CNS depressants, such as other morphine derivatives (analgesics and antitussives), general anaesthetics, skeletal muscle relaxants, sedative antidepressants, sedative H1 antihistamines, barbiturates, anxiolytics (ie benzodiazepines), hypnotics, antipsychotics, clonidine and related substances may produce increased CNS depressant effects.
Maltese: H1, barbiturati, anksjolitiċi (ie. benzodiazepines), ipnotiċi, antipsikotiċi, clonidine u sustanzi relatati jistgħu jżidu l-effetti sedattivi tas-SNĊ.
English: The CHMP was of the opinion that the Applicant should provide an analysis of the percentage of 30% and 50% responders at 10 and 15 minutes in order to better evaluate the clinically relevant time-effect profile.
Maltese: Is-CHMP kien ta' lopinjoni li l-applikant għandu jipprovdi analiżi tal-perċentwali ta' dawk li rrispondew 30% u 50% wara 10 u 15-il minuta sabiex ikun ivvalutat aħjar il-profil kliniku sinifikanti ta' l-effett mal-ħin.
English: The Applicant provided data from a study investigating the pharmacokinetics of Rapinyl in 8 opioid tolerant cancer patients, which demonstrated that the pharmacokinetic parameters in patients were not different from those in healthy volunteers, with a similar pharmacokinetic variability.
Maltese: L-applikant ipprovda informazzjoni minn studju li investiga l-farmakokinetika ta' Rapinyl fi 8 pazjenti morda bil-kanċer tolleranti għall-oppjojdi, li wera li l-parametri farmakokinetiċi fil-pazjenti ma kinux differenti minn dawk f'voluntiera b'saħħithom, b'varjabilità farmakokinetika simili.
English: o Final results of studies EN3267-005 and 3267-007, including detailed exposure of patients and full safety analysis.
Maltese: o ir-riżultati finali ta' l-istudji EN3267-005 u 3267-007, fosthom l-esponiment dettaljat talpazjenti u analiżi sħiħa dwar is-sigurtà.
English: o Analysis of the 30% and 50% responder rates at 10 and 15 minutes for the study EN-3267
Maltese: o analiżi tar-rati ta' dawk li rrispondew 30% u 50% wara 10 u 15-il minuta għall-istudju EN
English: Mutagenicity testing in bacteria and in rodents yielded negative results.
Maltese: Testijiet mutaġeniċi f'batterja u f'annimali gerriema taw riżultati negattivi.
English: While no analysis of 30% and 50% responders at 10 and 15 minutes was conducted in the interim analysis, this analysis was requested from the sponsor in the final clinical study report.
Maltese: Filwaqt li ma saret l-ebda analiżi ta' dawk li rrispondew 30% u 50% wara 10 u 15-il minuta fl-analiżi provviżorja, din l-analiżi ntalbet mill-isponsor fir-rapport finali ta' l-istudju kliniku.
English: Respiratory, thoracic and mediastinal disorders Common: Respiratory depression, rhinitis, pharyngitis
Maltese: Komuni: Dipressjoni respiratorja, rinite, farinġite
English: • Medicines called monoamine-oxidase (MAO) inhibitors, which are used for severe depression and Parkinson's disease.
Maltese: • Mediċini li jissejħu impedituri tal-monoamine-oxidase (MAO), li jintużaw għal dipressjoni severa u l-marda ta' Parkinson.
English: • Common side effects (affects 1 to 10 users in 100): feeling confused, feeling anxious or nervous, hallucinations, abnormal thinking, muscle twitching, difficulty sleeping, strange dreams, tongue or taste problems, flushing, mouth ulcers/blisters, blockage of the gut, difficulty swallowing, being accident-prone
Maltese: • Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 f'100 utent): tħossok konfuż, tħossok anzjuż/a jew nervuż/a, alluċinazzjonijiet, ħsibijiet mhux normali, muskolu jinġibed, diffikultà biex torqod, ħolm stamb, problemi bl-ilsien jew bit-togħma, fwawar, ulċeri tal-ħalq/infafet, l-imsaren jimblokkaw, diffiċli tibla', tkun suxxetibbli għal aċċidenti
English: • Certain types of antifungal medicines containing e.g. ketoconazole or itraconazole (used to treat fungal infections).
Maltese: • Ċertu tipi ta' mediċini kontra l-moffa li fihom eż. ketoconazole jew itraconazole (użati biex jittrattaw infezzjonijiet tal-moffa).
English: After Rapinyl administration, the main elimination half-life of fentanyl is about 7 hours (range 3-12.5 hours) and the terminal half-life is about 20 hours (range 11.5-25 hours).
Maltese: Wara l-għoti ta' Rapinyl, il-half-life ta' l-eliminazzjoni medja hi ta' madwar 7 sigħat (medda ta' 3-12.5 sigħat) u l-half life terminali hi ta' madwar 20 siegħa (medda 11.5-25 siegħa).
English: Grapefruit juice is also known to inhibit CYP3A4.
Maltese: Il-meraq tal-grejpfrut huwa magħruf li jimpedixxi CYP3A4.
English: Elderly, cachectic or generally impaired patients may have a lower fentanyl clearance, which could cause a longer terminal half-life for the compound (see sections 4.2 and 4.4).
Maltese: Pazjenti anzjani, kaċetiċi jew indeboliti b'mod ġenerali jista' jkollhom rata ta' tneħħija ta' fentanyl aktar baxxa, li jista' jwassal għal half-life terminali itwal għall-kompost (ara sezzjonijiet 4.2 u 4.4).
English: About 9% of the dose is recovered in the faeces, primarily as metabolites.
Maltese: Madwar 9% tad-doża ġiet rkuprata mill-ippurgar, prinċipalment bħala metaboliti.
English: The pharmacokinetics of Rapinyl have been shown to be dose proportional over the dose range of 100 to 800 µg.
Maltese: Il-farmakokinetiċi ta' Rapinyl intwerew li huma proporzjonali għad-doża fuq il-firxa ta' dożi ta' bejn 100 sa 800 µg.
English: The Applicant has characterised the pharmacokinetic profile of Rapinyl by demonstrating rapid delivery, predictable PK over the proposed dose range and also showing that Rapinyl achieves similar plasma concentrations and pharmacokinetic profiles as Actiq at both low and high doses.
Maltese: L-applikant ikkaratterizza l-profil farmakokinetiku ta' Rapinyl billi wera twassil rapidu, PK prevedibbli fuq ilvarjetà ta' dożaġġi proposta u billi wera wkoll li Rapinyl jikseb konċentrazzjonijiet fil-plażma u profili farmakokinetiċi simili għal Actiq kemm b'dożi baxxi kif ukoll għolja.
English: It comes in a range of different strengths and shapes.
Maltese: Hi tiġi f'għadd ta' qawwiet u forom differenti.
English: Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets
Maltese: Rapinyl 100 mikrogramma pilloli għal taħt l-ilsien Rapinyl 200 mikrogramma pilloli għal taħt l-ilsien Rapinyl 300 mikrogramma pilloli għal taħt l-ilsien Rapinyl 400 mikrogramma pilloli għal taħt l-ilsien Rapinyl 600 mikrogramma pilloli għal taħt l-ilsien Rapinyl 800 mikrogramma pilloli għal taħt l-ilsien
English: Symptoms of overdose include:
Maltese: Sintomi ta' doża eċċessiva jinkludu:
English: The Applicant concluded that Rapinyl is safe and well tolerated in patients, with an appropriate safety-profile of Rapinyl for this indication.
Maltese: L-applikant ikkonkluda li Rapinyl huwa sigur u ttollerat sewwa fil-pazjenti, bi profil tas-sigurtà xieraq ta' Rapinyl għal din l-indikazzjoni.
English: In addition, the sponsor provided a number of independent overwhelmingly positive benefit/risk judgements from experts in palliative care.
Maltese: Barra minn hekk, l-isponsor ipprovda numru ta' opinjonijiet indipendenti pożittivi ħafna dwar il-benefiċċju/riskju minn esperti fil-kura palljattiva.
English: Common side effects (affects 1 to 10 users in 100) include:
Maltese: Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 f'100 utent) jinkludu:
English: Carton Label
Maltese: Tikketta tal-Kartuna
English: In the absence of the data, the Applicant provided data demonstrating a direct correlation between 33% responder analysis and PID, and used the current available pain data and the PID values to estimate the responder rates between active and placebo treatment at earlier time points.
Maltese: Fl-assenza ta' l-informazzjoni, l-applikant ipprovda informazzjoni li turi korrelazzjoni diretta bejn l-analiżi ta' 33% ta' dawk li rrispondew u l-PID, u uża l-informazzjoni attwalment disponibbli dwar l-uġigħ u l-valuri PID biex jikkalkula r-rati ta' dawk li wieġbu bejn it-trattament attiv u plaċebo f'punti temporali aktar kmieni.
English: Fentanyl is a highly lipophilic drug absorbed very rapidly through the oral mucosa and more slowly through the gastrointestinal tract.
Maltese: Fentanyl huwa mediċina lipofilika hafna li jiġi assorbit malajr mill-mukosa tal-ħalq u aktar bil-mod permezz tal-passaġġ gastro-intestinali.
English: One patient had a successful suicide attempt but while suicidal ideation is known to be more common in patients with cancer than in the general population, neither suicide nor suicidal ideation has been reported as an adverse event associated with Actiq nor with Fentora/Effentora and based on the similar pharmacokinetic profile of Rapinyl and Actiq, the Applicant believes that this was a sporadic case, consistent with the investigator's assessment as being unrelated.
Maltese: Pazjent wieħed kellu attentat ta' suwiċidju li rnexxa iżda filwaqt li l-ħsibijiet dwar suwiċidju huma magħrufa li huma iżjed komuni filpazjenti morda bil-kanċer milli fil-popolazzjoni ġenerali, la s-suwiċidju u lanqas il-ħsibijiet dwar suwiċidju ma ġew irrappurtati bħala episodji avversi assoċjati ma' Actiq jew ma' Fentora/Effentora u fuq il-bażi tal-profil farmakokinetiku simili ta' Rapinyl u Actiq, l-applikant jemmen li dan kien każ sporadiku, konsistenti mal-valutazzjoni ta' l-investigatur bħala li mhuwiex relatat.