FrancophonIA/ELRC3.0 huggingface dataset:
English: In conclusion, the CHMP considered that the Applicant provided limited information on the patient treatment (titration towards an efficient dose, multiple administrations, administration up to the highest dosage) which prevented an evaluation of efficacy and safety of Rapinyl in the clinical setting and characterisation of the full clinically relevant time effect profile of the drug.
Maltese: Fl-aħħar nett, is-CHMP ħass li l-applikant ipprovda informazzjoni limitata dwar it-trattament talpazjent (titrazzjoni lejn doża effiċjenti, iżjed minn għoti wieħed, għoti sa l-akbar doża) li impediet evalwazzjoni ta' l-effikaċja u s-sigurtà ta' Rapinyl fl-ambjent kliniku u karatterizzazzjoni tal-profil kliniku rilevanti sħiħ ta' l-effett tal-mediċina mal-ħin.
English: Respiratory depression, hypotension and profound sedation may occur.
Maltese: Jista' jkun hemm dipressjoni respiratorja, pressjoni baxxa u sedazzjoni profonda.
English: One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
Maltese: Kull pillola għal taħt l-ilsien fiha 50 mikrogramma fentanyl (bħala citrate) 100 mikrogramma fentanyl (bħala citrate)
English: • vomiting, diarrhoea, constipation, stomach ache, bloated feeling, indigestion, loss of appetite
Maltese: • remettar, dijarea, stitikezza, uġigħ fl-istonku, tħossok minfuħ, indiġestjoni, nuqqas t'aptit
English: • medicines used to treat o depression o allergies o anxiety and psychosis
Maltese: • mediċini użati biex jittrattaw o id-dipressjoni o l-allerġiji o l-ansjetà u l-psikosi
English: Based on the review of the data and on the Applicant responses to list of outstanding issues and to the remaining issues, the CHMP considered the benefit/risk ratio of Rapinyl to be positive and the application for Rapinyl sublingual tablet 50, 100, 200, 300, 400, 600 and 800 μg to be approvable, provided that the Applicant implements the amendments made to the text of the Product Information and fulfills the conditions to the Marketing Authorisation as described in Annex IV.
Maltese: Fuq il-bażi ta' leżami mill-ġdid ta' l-informazzjoni u fuq it-tweġibiet ta' l-applikant għal-lista ta' kwistjonijiet pendenti u għall-kwistjonijiet li fadal, is-CHMP ikkunsidra r-relazzjoni tal-benefiċċju/riskju ta' Rapinyl bħala waħda pożittiva u li l-applikazzjoni għal Rapinyl pillola għal taħt l-ilsien 50, 100, 200, 300, 400, 600 u 800 µg tista' tiġi approvata, bil-kundizzjoni li l-applikant jimplimenta l-emendi magħmula fit-test ta' lInformazzjoni dwar il-Prodott u jissodisfa l-kundizzjonijiet għall-Awtorizzazzjoni għat-Tqegħid talprodott fis-Suq kif deskritt fl-Anness
English: The Applicant implemented a revised a cautionary statement in section 4.4 of the SPC, recommending extra caution during the titration of patients with mouth wounds or mucositis.
Maltese: L-applikant aġġorna s-sezzjoni 4.4 ta' l-SPC bi twissija ta' kawtela, li fiha rrakkomanda iżjed kawtela waqt it-titrazzjoni ta' pazjenti li jkollhom feriti f'ħalqhom jew mukożite.
English: Pack size: Packs of 10 or 30 sublingual tablets.
Maltese: Pakketti ta' 10 jew 30 pillola għal taħt l-ilsien.
English: Rapinyl is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
Maltese: Rapinyl mhux rakkomandat biex jintuża f'pazjenti li rċevew impedituri ta' monoamine oxidase (MAO) fi żmien 14-il jum minħabba li tħarrix sever u imprevedibbli b'impedituri MAO ġie rapportat b'analġesiċi opjojdi.
English: What Rapinyl looks like and contents of the pack
Maltese: Id-Dehra ta' Rapinyl u l-kontenut tal-pakkett
English: Psychiatric disorders Common: Depression, anorexia, concentration impaired, euphoria
Maltese: Mhux komuni: Aġitazzjoni, depersonalizzazzjoni, vulnerabilità emozzjonali
English: The reasonably low intra-individual variation in fentanyl plasma concentrations was also noted, including variation related to fluid intake, mouth wounds, xerostomia (dry mouth) and mucositis.
Maltese: Ġiet innotata wkoll ilvarjazzjoni raġonevolment baxxa fil-konċentrazzjonijiet ta' fentanyl fil-plażma ta' l-istess individwu, fosthom varjazzjoni relatata mat-teħid tal-fluwidi, feriti fil-ħalq, kserostomija (ħalq xott) u mukożite.
English: The Applicant confirmed that the tablets used in the Endo Phase III studies, EN3267-005 and EN3267-007, are qualitatively and quantitatively identical to the tablets currently under review in Europe and that the manufacturing process is the same using fentanyl citrate from the same supplier, with identical specifications.
Maltese: III ta' Endo, EN3267-005 u EN3267-007, huma kwalitattivament u kwantitattivament identiċi għall-pilloli li attwalment qegħdin jiġu eżaminati fl-Ewropa u li l-proċess tal-produzzjoni huwa l-istess billi juża fentanyl ċitrat mill-istess fornitur, bi speċifikazzjonijiet identiċi.
English: Strength (micrograms) of supplemental (second) sublingual tablet to be taken 15-30 minutes after first tablet, if required
Maltese: Qawwa (mikrogrammi) (tat-tieni) pillola suppliemntali li trid tittieħed 15-30 minuta wara l-ewwel pillola, jekk meħtieġ
English: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: [Ara Anness I - Biex jitlesta fil-pajjiż partikolari] {Isem u indirizz} <{tel}> <{faks}> <{posta elettronika}>
English: The Applicant also defended the 800ug dose and discussed the safety of Rapinyl when superimposed on a continuous fentanyl or non-fentanyl opioid pain therapy and considered that the transmucosal delivery of fentanyl produces consistent results, independent of the type of baseline therapy.
Maltese: L-applikant iddefenda wkoll id-doża ta' 800ug u ddiskuta s-sigurtà ta' Rapinyl meta jingħata fuq terapija analġeżika kontinwa abbażi ta' fentanyl jew ta' oppjojdi ieħor u qies li t-twassil ta' fentanyl minn ġolmukuża jipproduċi riżultati konsistenti, indipendentement mit-tip ta' terapija bażi.
English: • extreme drowsiness
Maltese: Disturbi vaskulari
English: The efficacy data show that Rapinyl is statistically different from placebo in the treatment of BTP and these results seem clinically relevant.
Maltese: L-informazzjoni dwar l-effikaċja turi li Rapinyl huwa statistikament differenti mill-plaċebo fittrattament tal-BTP u dawn ir-riżultati jidhru klinikament rilevanti.
English: Switching from other fentanyl containing products to Rapinyl must not occur at a 1:1 ratio because of different absorption profiles.
Maltese: It-taqlib minn prodotti oħra li fihom fentanyl għal Rapinyl m'għandux iseħħ fuq proporzjon ta' 1:1 minħabba l-profili ta' assorbiment differenti.
English: • Certain types of antibiotic medicines used to treat infections (called macrolides, containing e.g. erythromycin ).
Maltese: • Ċertu tipi ta' mediċini antibijotiċi użati biex jittrattaw infezzjonijiet (imsejħa makrolidi, li jkun fihom eż. erythromycin).
English: Animal studies have shown reduced fertility and increased mortality in rat foetuses.
Maltese: Studji fuq l-annimali wrew fertilità mnaqqsa u żieda fl-imwiet tal-feti fil-firien.
English: Therefore, although the CHMP considers that Rapinyl could be used for the treatment of breakthrough pain in cancer patients the combined available pharmacokinetic, pharmacological and clinical data were considered insufficient and the CHMP requested the Applicant to provide clinical demonstration of the efficacy and safety of Rapinyl at the proposed dosages, including the highest one.
Maltese: Għaldaqstant, għalkemm is-CHMP iqis li Rapinyl jista' jintuża għat-trattament ta' wġigħ qawwi f'pazjenti morda bil-kanċer, l-informazzjoni farmakokinetika, farmakoloġika u klinika disponibbli ma kinitx meqjusa bħala suffiċjenti u s-CHMP talab lill-Applikant sabiex jipprovdi dimostrazzjoni klinika ta' l-effikaċja u s-sigurtà ta' Rapinyl biddożi proposti, inkluża l-akbar waħda.
English: Fentanyl is approximately 100-fold more potent than morphine as an analgesic.
Maltese: Fentanyl huwa madwar 100 darba aktar qawwi mill-morfina bħala analġesiku.
English: A statistically significant decrease in pain intensity was achieved and clinically important decreases in pain occurred more rapidly in patients treated with Rapinyl compared to placebo.
Maltese: Inkiseb tnaqqis statistiku sinifikanti fl-intensità ta' l-uġigħ u kien hemm tnaqqis kliniku importanti aktar malajr fil-pazjenti ttrattati b'Rapinyl meta mqabbel mal-plaċebo.
English: The Applicant considered the rate and extent of absorption to be similar for Rapinyl and Actiq and that the similarity in the PK profiles during the first 30-minute rapid absorption phase is established.
Maltese: L-applikant ikkunsidra r-rata u l-livell ta' assorbiment bħala simili għal Rapinyl u Actiq u li x-xebh fil-profili farmakokinetiċi matul l-ewwel fażi ta' 30 minuta ta' assorbiment rapidu hija stabbilita.
English: Within 72 hours of intravenous fentanyl administration around 75% of the dose is excreted into the urine, mostly as metabolites, with less than 10% as unchanged drug.
Maltese: Fi żmien 72 siegħa mit-teħid ġol-vina ta' fentanyl madwar 75% tad-doża tiġi eliminata fl-awrina, prinċipalment bħala metaboliti, b'inqas minn 10% bħala l-mediċina mhux mibdula.
English: Uncommon: Bradycardia, tachycardia, hypertension Very rare: Arrhythmias
Maltese: Mhux komuni: Bradikardja, takikardja, pressjoni għolja Rari ħafna: Arritmiji
English: The Applicant also discussed the difference between the volunteers (opioid-naïve) and the target patient population (chronic opioid users), noting that the pattern of related events was consistent with available literature on the safety profile of fentanyl products and the absence of dose-related trends in the incidence of adverse events.
Maltese: L-applikant iddiskuta wkoll id-differenza bejn il-voluntiera (qatt ma ħadu oppjojdi qabel) u l-popolazzjoni tal-pazjenti fil-mira (utenti kroniċi ta' l-oppjojdi), fejn innota li l-mudell ta' l-episodji relatati kien konsistenti mal-letteratura disponibbli dwar il-profil tassigurtà tal-prodotti li fihom fentanyl u n-nuqqas ta' xejriet relatati mad-doża fl-inċidenza ta' episodji avversi.
English: The Applicant discussed the previously provided SAE dataset up to the 18th January 2008 safety cut off and considered that the new safety data supplemented the bridging strategy and was in line with a further review of SAE data up to the 15th May-08.
Maltese: L-applikant iddiskuta d-dataset ipprovdut qabel ta' SAE sal-qtugħ il-linja tas-sigurtà tat-18 ta' Jannar 2008 u ħass li l-informazzjoni ġdida dwar is-sigurtà ssuplimentat l-istrateġija ta' bridging u kienet konformi ma' eżami mill-ġdid ieħor ta' l-informazzjoni dwar is-SAE sal-15 ta' Mejju 2008.
English: Rapinyl and associated names (see Annex I) 50 microgram sublingual tablets [See Annex I - To be completed nationally]
Maltese: Rapinyl u ismijiet assoċjati (ara Anness I) 50 mikrogramma pilloli għal taħt l-ilsien [Ara Anness I - biex jimtela mill-pajjiż partikolari]
English: In conclusion, the Applicant believes that the demonstration of a statistically significant improvement in PID at 10 and 15 minutes in EN3267005 is the appropriate, clinically relevant measure of the early effectiveness of Rapinyl, and that an improvement in PID is directly reflected in an increase in responder rate.
Maltese: Fl-aħħar nett, l-applikant jemmen li l-wiri ta' titjib statistiku sinifikanti fil-PID wara 10 u 15-il minuta fl-istudju EN3267-005 huwa l-kejl adatt, klinikament rilevanti ta' l-effikaċja bikrija ta' Rapinyl, u li titjib fil-PID huwa direttament rifless fir-rata ta' dawk li rrispondew.
English: Spain
Maltese: L-Ispanja
English: The Applicant considered that Rapinyl can be successfully titrated and repeatedly administered effectively and safely to treat patients with multiple episodes of breakthrough pain.
Maltese: L-applikant ikkunsidra li Rapinyl jista' jiġi titrat b'suċċess u jingħata ripetutament b'mod effikaċi u mingħajr periklu biex jiġu ttrattati pazjenti b'episodji multipli ta' wġigħ episodiku qawwi.
English: Rapinyl 800 microgram sublingual tablets
Maltese: Rapinyl 800 mikrogramma pilloli għal taħt l-ilsien
English: 800 micrograms fentanyl (as citrate)
Maltese: 800 mikrogramma fentanyl (bħala citrate)
English: Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract leading to a prolongation in gastrointestinal transit time, which may be responsible for the constipating effect of fentanyl.
Maltese: L-opjojdi jżidu t-ton u jnaqqsu l-kontrazzjonijiet propulsivi tal-muskolu mieles tal-passaġġ gastro-intestinali li jwassal għal dewmin fil-ħin ta' transizzjoni gastro-intestinali, li jista' jkun responsabbli għall-effett stitiku ta' fentanyl.
English: Rapinyl 400 microgram sublingual tablets
Maltese: Rapinyl 400 mikrogramma pilloli għal taħt l-ilsien
English: 200 micrograms fentanyl (as citrate)
Maltese: 200 mikrogramma fentanyl (bħala citrate)
English: Pharmacotherapeutic group: Phenylpiperidine derivatives, ATC code: N02ABO3
Maltese: Is-CHMP qabel li l-karatteristiċi farmakodinamiċi u l-effikaċja ta' fentanyl huma stabbiliti sewwa u nnota l-mudell ta' wġigħ fil-BTP.
English: Renal and urinary disorders Uncommon: Urinary retention, change in urinary frequency Very rare: bladder spasm, oliguria
Maltese: Mhux komuni: Żamma awrinarja, bidla fil-frekwenza meta tgħaddi awrina Rari ħafna: spażmu fil-bużżieqa awrinarja, oligurja
English: Rapinyl may add to the effect of medicines that make you feel sleepy, including:
Maltese: Rapinyl jista' jżid l-effett ta' mediċini li jagħmluk bi ngħas, li jinkludu:
English: Rapinyl sublingual tablets are packaged in OPA/PVC/aluminium/aluminium blisters contained in a cardboard outer carton.
Maltese: Il-pilloli għal taħt l-ilsien ta' Rapinyl huma ppakkjati f'folji ta' OPA/PVC/aluminju/aluminju li jinsabu f'kartuna fuq barra tal-kardbord.
English: Rapinyl 300 microgram sublingual tablets
Maltese: Rapinyl 300 mikrogramma pilloli għal taħt l-ilsien
English: The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Maltese: L-użu fl-istess ħin ta' agonisti/antagonisti parzjali ta' opjojdi (eż. buprenorphine, nalbuphine, pentazocine) mhux rakkomandat.
English: • other strong pain-relieving medicines (opioid-type medicines e.g. for pain and cough)
Maltese: • mediċini qawwija oħra li jaġixxu kontra l-uġigħ (mediċini tat-tip opjojdi eż. għal uġigħ u sogħla)
English: Sublingual tablet
Maltese: TAL-PRODOTT MEDIĊINALI
English: Particular caution should be exercised during dose titration with Rapinyl in patients with chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression (e.g. myasthenia gravis) because of the risk of further respiratory depression, which could lead to respiratory failure.
Maltese: Attenzjoni partikolari għandha tiġi eżerċitata waqt tittrazzjoni tad-doża f'pazjenti li għandhom mard pulmonari ostruttiv kroniku jew kundizzjonijiet mediċi li jippredisponuhom għal dipressjoni respiratorja (eż. majastenja gravis) minħabba r-riskju akbar ta' dipressjoni respiratorja, li jista' jwassal għal falliment respiratorju.
English: Rapinyl 600 µg sublingual tablets
Maltese: Rapinyl 600 mikrogramma pilloli għal taħt l-ilsien
English: Blisters
Maltese: Tiblax
English: Use in patients with renal and hepatic impairment Patients with kidney or liver dysfunction should be carefully observed for signs of fentanyl toxicity during the Rapinyl titration phase (see section 4.4).
Maltese: Użu f'pazjenti b'indeboliment fil-kliewi u fil-fwied Pazjenti li għandhom funzjoni indebolita tal-kliewi jew tal-fwied għandhom jiġu osservati b'attenzjoni għal sinjali ta' tossiċità minn fentanyl waqt il-fażi ta' tittrazzjoni ta' Rapinyl (ara sezzjoni 4.4).
English: From the efficacy and safety data provided, Rapinyl seems to be comparable to other fentanyl containing products (Actiq and Effentora) for the treatment of BTP in cancer patients.
Maltese: Mill-informazzjoni pprovduta dwar is-sigurtà u l-effikaċja, Rapinyl jidher li huwa komparabbli ma' prodotti oħra li fihom fentanyl (Actiq u Effentora) għat-trattament tal-BTP f'pazjenti morda bilkanċer.
English: The CHMP reviewed the death narratives and agreed with the Applicant conclusions.
Maltese: Is-CHMP eżamina mill-ġdid id-deskrizzjonijiet ta' l-imwiet u qabel mal-konklużjonijiet ta' l-applikant.
English: In this situation, endotracheal intubation, assisted ventilation and administration of opioid antagonists as well as muscle relaxants may be requested.
Maltese: F'din is-sitwazzjoni, intubazzjoni endotrakeali, ventilazzjoni assistita u l-għoti ta' antagonisti opjojdi kif ukoll rilassaturi muskolari jistgħu jiġu mitluba.
English: Opioid-naïve patients because of the risk of life-threatening respiratory depression.
Maltese: Kundizzjonijiet ta' dipressjoni respiratorja severa jew impediment sever fil-pulmuni.
English: 600 micrograms fentanyl (as citrate)
Maltese: 600 mikrogramma fentanyl (bħala citrate)
English: 300 micrograms fentanyl (as citrate)
Maltese: 300 mikrogramma fentanyl (bħala citrate)
English: Before Rapinyl therapy is initiated, it is important that the patient's long-acting opioid treatment used to control their persistent pain has been stabilised.
Maltese: Qabel it-terapija b'Rapinyl tiġi mibdija, huwa importanti li t-trattament opjojdi fit-tul tal-pazjent li tingħata sabiex jiġi kontrollat l-uġigħ persistenti ikun ġie stabilizzat.
English: Common: Vomiting, abdominal pain, diarrhoea, constipation, stomach discomfort, dyspepsia, dry mouth
Maltese: Komuni: Remettar, uġigħ addominali, dijarea, stitikezza, stonku mdardar, dispepsja, ħalq xott Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda
English: In conclusion, the CHMP requested additional data supporting the efficacy and safety of Rapinyl (independently of Actiq) in the treatment of BTP and adopted a List of Outstanding Issues.
Maltese: Fl-aħħarnett, is-CHMP talab iżjed informazzjoni li ssostni l-effikaċja u s-sigurtà ta' Rapinyl (indipendentement minn Actiq) fit-trattament tal-BTP u adotta Lista ta' Kwistjonijiet Pendenti (LoI).
English: 400 micrograms fentanyl (as citrate)
Maltese: 400 mikrogramma fentanyl (bħala citrate)
English: Patients (n=23) treated with Rapinyl only experienced dizziness, nausea and vomiting.
Maltese: Pazjenti (n=23) trattati b'Rapinyl biss ħassew ngħas, tqalligħ u remettar.
English: Taking the medicine
Maltese: U KWANTITATTIVA
English: • breathing problems or suffer from myasthenia gravis (a condition characterised by muscle weakness)
Maltese: • problemi bit-teħid tan-nifs jew tbati minn majastenja gravis (kundizzjoni li hi karatterizzata minn debolezza muskolari)
English: However, although the interim data support the proposed dose range for Rapinyl, the CHMP requested additional clinical data clearly demonstrating the efficacy/safety of Rapinyl.
Maltese: Madankollu, għalkemm linformazzjoni provviżorja ssostni l-medda ta' dożaġġi proposta għal Rapinyl, is-CHMP talab informazzjoni klinika addizzjonali li turi b'mod ċar l-effikaċja/sigurtà ta' Rapinyl.
English: Rapinyl 200 µg sublingual tablets
Maltese: Rapinyl 200 mikrogramma pilloli għal taħt l-ilsien
English: Rapinyl 800 µg sublingual tablets
Maltese: Rapinyl 800 µg pilloli għal taħt l-ilsien
English: Rapinyl 300 µg sublingual tablets
Maltese: Rapinyl 300 µg pilloli għal taħt l-ilsien
English: Very common: Dizziness, somnolence, headache Common: Vasovagal reaction, hypoaesthesia, paraesthesia, hyperacusis
Maltese: Komuni ħafna: Sturdament, ħedla, uġigħ ta' ras Komuni: Reazzjoni vażovagali, ipoestesja, paraestesja, iperakusi
English: BATCH NUMBER Lot: XXXX
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: In conclusion, the CHMP noted that no new data was provided by the Applicant during the procedure but disagreed with the Applicant point of view that further clinical efficacy and safety data are not needed, indeed the justification relies entirely on a bridging strategy that assumes that the bioavailability obtained with Rapinyl is twice higher than that obtained with Actiq at the same molar dose.
Maltese: Bħala konklużjoni, is-CHMP innota li ma ngħatat ebda informazzjoni ġdida mill-applikant waqt ilproċedura iżda ma qabilx mal-pożizzjoni ta' l-applikant li ma kinitx meħtieġa iżjed informazzjoni dwar l-effikaċja u s-sigurtà klinika, fil-fatt il-ġustifikazzjoni tibbaża kompletament fuq strateġija ta' bridging li tassumi li l-bijodisponibilità miksuba b'Rapinyl hija darbtejn ogħla minn dik miksuba b'Actiq blistess doża molari.
English: Common: Hallucinations, confusion, anxiety, nervousness, abnormal thinking, abnormal dreams Uncommon: Agitation, depersonalisation, emotional lability
Maltese: Komuni: Alluċinazzjonijiet, konfużjoni, ansjetà, nervożità, ħsibijiet mhux normali, ħolm mhux normali
English: The dose strength for the supplemental sublingual tablet should be increased from 100 to 200 micrograms at doses of 400 micrograms and higher.
Maltese: Il-qawwa tad-doża għandha tiżdied minn 100 sa 200 mikrogramma f'dożi ta' 400 mikrogramma u ogħla.
English: Safety data from EN3267-005 and EN3267-007 have also been provided based on an interim cut of the safety database in January 2008, comprising only serious adverse events (SAEs).
Maltese: Kienet ipprovduta wkoll informazzjoni dwar is-sigurtà minn EN3267-005 u EN3267-007 li kienet ibbażata fuq qtugħ provviżorju tad-dejtabejż dwar is-sigurtà f'Jannar 2008, li kienet tinkludi biss episodji avversi gravi (SAEs).
English: The Applicant was able to provide in the response to the LoOI the interim analyses from 2 ongoing Phase III safety and efficacy clinical studies (EN3267-005 and EN3267-007), performed in the US by Endo.
Maltese: III li għaddejjin dwar is-sigurtà u l-effikaċja (EN3267-005 u EN3267-007), imwettqa fl-Istati Uniti minn Endo. L-informazzjoni sottomessa tibni fuq tagħrif kliniku minn 221 voluntier u 41 pazjent.
English: Patients can be considered opioid tolerant if they take at least 60 mg oral morphine per day, 25 micrograms transdermal fentanyl per hour, or an equianalgesic dose of another opioid for a week or longer.
Maltese: Il-pazjenti għandhom ikunu kkonsidrati li huma tolleranti jekk jieħdu ta' lanqas 60 mg ta' morfina orali kuljum, 25 mikrogramm fentanyl minn ġol-ġilda kull siegħa, jew doża analġeżika ekwivalenti oħra ta' opjojdi għal ġimgħa jew aktar.
English: 50 microgram sublingual tablet is a white pentagon-shaped tablet 100 microgram sublingual tablet is a white round tablet 200 microgram sublingual tablet is a white oval-shaped tablet 300 microgram sublingual tablet is a white triangle-shaped tablet 400 microgram sublingual tablet is a white diamond-shaped tablet 600 microgram sublingual tablet is a white “D”-shaped tablet 800 microgram sublingual tablet is a white capsule-shaped tablet
Maltese: Il-pillola ta' 400 mikrogramma hi pillola bajda f'forma ta' djamant Il-pillola ta' 600 mikrogramma hi pillola bajda f'forma ta' D Il-pillola ta' 800 mikrogramm hi pillola bajda f'forma ta' kapsula
English: Actiq.
Maltese: Tel.
English: The Applicant provided further reassurances on the use of Rapinyl in patiens with mucositis, based on publications and guidelines, concluding that patients with mild/moderate mucositis can use oral medication, while transmucosal forms of fentanyl are not suitable for use in patients with severe mucositis where other routes of analgesia administration are preferable.
Maltese: L-applikant ipprovda iżjed assigurazzjonijiet dwar l-użu ta' Rapinyl f'pazjenti li jkollhom mukożite, ibbażati fuq pubblikazzjonijiet u linji gwida, li kkonkludew li pazjenti li jkollhom mukożite ħafifa/moderata jistgħu jużaw medikazzjoni orali, filwaqt li forom transmukożali ta' fentanyl mhumiex adatti biex jintużaw f'pazjenti li jkollhom mukożite akuta fejn huwa preferibbli li jintużaw metodi oħra għall-għoti ta' l-analġeżiċi.
English: Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Maltese: It-treġija ta' uġigħ li jisfonda f'pazjenti adulti li jużaw terapija opjojdi għal uġigħ minn kanċer kroniku.