FrancophonIA/ELRC3.0 huggingface dataset:
English: Neutropenia/leukopenia was the most notable important haematological toxicity.
Maltese: In-newtropenija/lewkopenija kienet l-iktar tossiċità ematoloġika importanti b'mod notevoli.
English: Tél/Tel: +32 (0)2 529 43 11
Maltese: Tel: +32 (0)2 529 43 11
English: Servier Italia S.p.A. Tel: + 39 (06) 669081
Maltese: Tel: + 39 (06) 669081
English: Very common: Neutropenia, Leukopenia, Anaemia, Thrombocytopenia
Maltese: Komuni ħafna: Newtropenija, Lewkopenija, Anemija, Tromboċitopenija
English: Servier Polska Sp. z o.o.
Maltese: Servier Italia S.p.A.
English: The most common adverse reactions (incidence ≥ 20%) of ONIVYDE pegylated liposomal +5-FU/LV were: diarrhoea, nausea, vomiting, decreased appetite, neutropenia, fatigue, asthenia, anaemia,
Maltese: L-iktar reazzjonijiet avversi komuni (inċidenza ≥ 20%) ta' ONIVYDE lipożomali pegilat+5-FU/LV kienu: dijarea, dardir, rimettar, nuqqas ta' aptit, newtropenija, għeja, astenja, anemija, stomatite u deni.
English: Pre-medication
Maltese: TAL-PRODOTT MEDIĊINALI
English: Table 4: Efficacy results from NAPOLI-1 clinical study
Maltese: Tabella 4 Riżultati tal-effikaċja mill-istudju kliniku NAPOLI-1
English: Common: Hypoglycaemia, Hyponatraemia, Hypophosphataemia
Maltese: Ipogliċemija, Iponatremija, Ipofosfatemja
English: The following adverse reactions, considered to be possibly or probably related to the administration of ONIVYDE pegylated liposomal, were reported in 264 patients with metastatic adenocarcinoma of the pancreas, 147 of whom received ONIVYDE pegylated liposomal monotherapy (100 mg/m and 117 received ONIVYDE pegylated liposomal (70 mg/m2) in combination with 5-FU/LV.
Maltese: Ir-reazzjonijiet avversi li ġejjin, li huma kkunsidrati bħala possibbilment jew probabbilment relatati mal-għoti ta' ONIVYDE lipożomali pegilat, ġew irrappurtati f'264 pazjent b'adenokarċinoma metastatika tal-frixa, 147 minnhom irċivew il-monoterapija b'ONIVYDE lipożomali pegilat (100 mg/m2) u 117 irċivew ONIVYDE lipożomali pegilat (70 mg/m2) flimkien ma' 5-FU/LV.
English: In the clinical study, early diarrhoea onset occurred in 35 patients (29.9%) and cholinergic events occurred in 4 patients (3.4%) receiving ONIVYDE pegylated liposomal +5-FU/LV.
Maltese: Fl-istudju kliniku, il-bidu ta' dijarea bikrija seħħ f'35 pazjent (29,9%) u avvenimenti kolinerġiċi seħħew f'4 pazjenti (3.4%) li kienu qed jirċievu ONIVYDE lipożomali pegilat+5-FU/LV.
English: Common: Infusion related reaction, Oedema
Maltese: Komuni: Reazzjoni relatata mal-infużjoni, Edima
English: The pharmacokinetic parameters of total irinotecan and SN-38 analytes, following the administration of ONIVYDE pegylated liposomal 70 mg/m are presented in Table 5.
Maltese: Il-parametri farmakokinetiċi ta' irinotecan totali u l-analiti SN-38, wara l-għoti ta' ONIVYDE lipożomali pegilat 70 mg/m huma ppreżentati f'Tabella 5.
English: In safety pharmacology studies in dogs, ONIVYDE pegylated liposomal had no effect on cardiovascular, hemodynamic, electrocardiographic, or respiratory parameters at doses up to 18 mg/kg or 360 mg/m
Maltese: Fl-istudji farmakoloġiċi dwar is-sigurtà fil-klieb, ONIVYDE lipożomali pegilat ma kellu l-ebda effett fuq il-parametri kardjovaskulari, emodinamiċi, elettrokardjografiċi, jew respiratorji f'dożi sa 18 mg/kg jew 360 mg/m2.
English: Each ml of ONIVYDE pegylated liposomal contains 0.144 mmol (3.31 mg) sodium.
Maltese: Kull mL ta' ONIVYDE lipożomali pegilat fih 0.144 mmol (3.31 mg) ta' sodium.
English: Rate Difference (95% CI) p-value
Maltese: Differenza fir-Rata (95 % CI)
English: The use of ONIVYDE pegylated liposomal should be avoided in patients with bilirubin > 2.0 mg/dl, or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) or > 5 times ULN if liver metastasis is present (see section 4.4).
Maltese: Lużu ta' ONIVYDE lipożomali pegilat għandu jiġi evitat f'pazjenti b'bilirubina > 2.0 mg/dl, jew b'aspartate aminotransferase (AST) u b'alanine aminotransferase (ALT) > 2.5 darbiet iżjed mil-limitu normali (ULN) jew > 5 darbiet tal-ULN jekk ikun hemm preżenti metastasi tal-fwied (ara sezzjoni 4.4).
English: Neutropenia/leukopenia
Maltese: Newtropenija/lewkopenija
English: Regular monitoring of complete blood counts should be conducted in patients with total bilirubin of 1.0-2.0 mg/dl.
Maltese: Monitoraġġ regolari tal-għadd tad-demm sħiħ għandu jitwettaq f'pazjenti b'bilirubina totali ta' 1.0-2.0 mg/dl.
English: Myelosuppression (neutropenia/leukopenia, thrombocytopenia and, anaemia) was more common in the ONIVYDE pegylated liposomal +5-FU/LV arm compared to the 5-FU/LV control arm.
Maltese: Il-majelosuppressjoni (newtropenija/lewkopenija, tromboċitopenija u anemija) kienet aktar komuni filparti tal-istudju dwar ONIVYDE lipożomali pegilat+5-FU/LV meta mqabbla mal-parti tal-istudju talkontroll 5-FU/LV.
English: A total of 417 patients were randomised to the ONIVYDE pegylated liposomal +5-FU/LV arm (N=117), ONIVYDE pegylated liposomal monotherapy arm (N=151) and 5-FU/LV arm (N=149).
Maltese: Total ta' 417-il pazjent intgħażlu b'mod każwali għall-parti tal-istudju dwar ONIVYDE lipożomali pegilat+5-FU/LV (N=117), għall-parti tal-istudju dwar monoterapija b'ONIVYDE lipożomali pegilat (N=151) u għall-parti tal-istudju dwar 5-FU/LV (N=149).
English: In vitro studies indicate that irinotecan, SN-38 and another metabolite aminopentane carboxylic acid (APC) do not inhibit cytochrome P-450 isozymes.
Maltese: L-istudji in vitro jindikaw li irinotecan, SN-38 u metabolit ieħor ta' aċidu aminopentane carboxylic (APC) ma jinibixxux l-isożimi ta' ċitokrom P-450.
English: No data are available.
Maltese: M'hemm l-ebda dejta disponibbli.
English: In clinical trials, ONIVYDE pegylated liposomal was administered at doses up to 210 mg/m to patients with various cancers.
Maltese: Fil-provi kliniċi, ONIVYDE lipożomali pegilat ngħata f'dożi sa 210 mg/m lil pazjenti b'diversi kanċers.
English: Irinotecan belongs to a group of cancer medicines called ‘topoisomerase inhibitors'.
Maltese: Irinotecan jappartjeni għal grupp ta' mediċini kontra l-kanċer imsejħa 'inibituri ta' topoisomerase'.
English: Table 2: Recommended dose modifications for ONIVYDE pegylated liposomal +5-FU/LV for Grade 3-4 toxicities in patients homozygous for UGT1A1*28
Maltese: Tabella 2: Modifikazzjonijiet rakkomandati tad-doża għal ONIVYDE lipożomali pegilat +5-FU/LV għal tossiċitajiet ta' Grad 3-4 f'pazjenti li huma omożigużi għal UGT1A1*28
English: Mean baseline albumin level was 3.6 g/dl, and baseline KPS was 90-100 in 55% of patients.
Maltese: Il-medja tal-livell ta' albumina fil-linja bażi kien 3.6 g/dl, u l-linja bażi tal-KPS kienet 90-100 f'55% talpazjenti.
English: Immunosuppressive effects and vaccines
Maltese: Effetti immunosoppressivi u tilqim
English: Grade 3 or Grade 4 (< 1,000 cells/mm3) or
Maltese: Grade 4 (< 1,000 ċellula/mm jew deni newtropeniku
English: One ml of concentrate contains 0.144 mmol (3.31 mg) sodium.
Maltese: Millilitru wieħed ta' konċentrat fih 0.144 mmol (3.31 mg) ta' sodium.
English: Neutropenic fever/neutropenic sepsis was reported in 6% of Asian patients compared to 1% of Caucasians patients.
Maltese: Deni newtropeniku/sepsis newtropeniku ġew irrappurati f'6 % tal-pazjenti Ażjatiċi meta mqabbla ma' 1 % tal-pazjenti Kawkasi.
English: Table 1: Recommended dose modifications for ONIVYDE pegylated liposomal +5-FU/LV for Grade 3-4 toxicities for patients not homozygous for UGT1A1*28
Maltese: Tabella 1: Modifikazzjonijiet rakkomandati tad-doża għal ONIVYDE lipożomali pegilat+5-FU/LV għal tossiċitajiet ta' Grad 3-4 għal pazjenti mhumiex omożigużi għal UGT1A1*28
English: Adverse reaction frequency**
Maltese: Frekwenza tar-reazzjoni avversa**
English: CA Papaellinas Ltd. Τηλ: + 357 22 741 741
Maltese: Τηλ: + 357 22 741 741
English: Patients randomised to 5-FU/LV received leucovorin 200 mg/m intravenously over 30 minutes, followed by 5-FU 2,000 mg/m intravenously over 24 hours, administered on Days 1, 8, 15 and 22 of a 6 week cycle.
Maltese: Il-pazjenti li ntgħażlu b'mod każwali għal 5-FU/LV rċevew leucovorin 200 mg/m ġol-vini fuq perjodu ta' 30 minuta, segwit minn 5-FU 2,000 mg/m ġol-vini fuq perjodu ta' 24 siegħa mogħti fil-ġranet 1, 8, 15 u 22 ta' ċiklu ta' 6 ġimgħat.
English: Laboratorios Servier S.L.
Maltese: Servier Laboratories (Ireland) Ltd.
English: ONIVYDE pegylated liposomal is not recommended for use in patients with severe renal impairment (CLcr < 30 ml/min).
Maltese: ONIVYDE lipożomali pegilat mhuwiex rakkomandat għall-użu f'pazjenti b'indeboliment sever tal-kliewi (CLcr < 30 mL/min).
English: Patients receiving concomitant non-liposomal irinotecan and ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased SN-38 exposure by 109%.
Maltese: Pazjenti li jkunu qed jirċievu irinotecan mhux lipożomali u ketoconazole, inibitur ta' CYP3A4 u UGT1A1, żiedu l-esponiment ta' SN-38 b'109%.
English: In a population pharmacokinetic analysis, patients with baseline total bilirubin concentrations of 1-2 mg/dl (n=19) had average steady state concentrations for total SN-38 that were increased by 37% (0.98 [95%CI: 0.94-1.02] and 1.29 [95%CI: 1.11-1.5] ng/ml, respectively) compared to patients with baseline bilirubin concentrations of < 1 mg/dl (n=329); however, there was no effect of elevated ALT/AST concentrations on total SN-38 concentrations.
Maltese: F'analiżi faramkokinetika tal-popolazzjoni, il-pazjenti b'konċentrazzjonijiet tal-bilirubina totali fil-linja bażi ta' -2 mg/dl (n=19) kellhom konċentrazzjonijiet medji fl-istat fiss għal SN 38 SN-38 totali li żdiedu b'37 % (0.98 [95 %CI: 0.94-1.02] u 1.29 [95 %CI: 1.11-1.5] ng/mL, rispettivament) meta mqabbla ma' pazjenti b'konċentrazzjonijiet ta' bilirubina fil-linja bażi ta' < 1 mg/dl (n=329); madankollu, ma kienx hemm l-ebda effett ta' konċentrazzjonijiet għoljin ta' ALT/AST fuq il-konċentrazzjonijiet ta' SN-38 totali.
English: Individuals who are 7/7 homozygous for the UGT1A1*28 allele are at increased risk for neutropenia from non-liposomal irinotecan.
Maltese: L-individwi li huma 7/7 omożigoti għall-allel UGT1A1*28 huma f'riskju akbar għal newtropenija minn irinotecan mhux lipożomali.
English: The cumulative biliary and urinary excretion of irinotecan and its metabolites (SN-38 and SN-38 glucuronide) over a period of 48 hours following administration of non-liposomal irinotecan in two patients ranged from approximately 25% (100 mg/m2) to 50%
Maltese: L-eliminazzjoni kumulattiva biljari u mill-awrina ta' irinotecan u l-metaboliti tiegħu (SN-38 u SN-38 glucuronide) fuq perjodu ta' 48 siegħa wara l-għoti ta' irinotecan mhux lipożomali f'żewġ pazjenti varjat bejn wieħed u ieħor minn 25 % (100 mg/m sa 50 % (300 mg/m
English: • Aseptic techniques must be followed during the preparation of the infusion.
Maltese: • Għandhom jiġu segwiti tekniki asettiċi waqt il-preparazzjoni tal-infużjoni.
English: Excipients:
Maltese: Komuni:
English: Interactions with strong CYP3A4 inducers
Maltese: Indutturi qawwija ta' CYP3A4
English: It is especially important that you tell your doctor if you are also taking the following medicines, since they increase the availability of irinotecan in your body: - ketoconazole, itraconazole or voriconazole (medicines used to treat fungal infections) - clarithromycin (an antibiotic medicine used to treat bacterial infections) - indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, atazanavir (medicines against HIV
Maltese: Huwa importanti b'mod speċjali li tgħid lit-tabib tiegħek jekk tkun qed tieħu wkoll il-mediċini li ġejjin, peress li dawn iżidu d-disponibbiltà ta' irinotecan f'ġismek: - ketoconazole, itraconazole or voriconazole (mediċini użati biex jikkuraw infezzjonijiet fungali) - clarithromycin (mediċina antibijotika użata biex tikkura l-infezzjonijiet batteriċi) - indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, atazanavir (mediċini kontra infezzjoni bl
English: The recommended dose and regimen of ONIVYDE pegylated liposomal is 70 mg/m intravenously over 90 minutes, followed by LV 400 mg/m intravenously over 30 minutes, followed by 5-FU 2,400 mg/m intravenously over 46 hours, administered every 2 weeks.
Maltese: Id-doża rakkomandata u l-kors ta' ONIVYDE lipożomali pegilat huma 70 mg/m ġol-vini fuq perjodu ta' 90 minuta, segwiti minn LV 400 mg/m ġol-vini fuq perjodu ta' 30 minuta, segwiti minn 5-FU 2,400 mg/m ġol-vini fuq perjodu ta' 46 siegħa, mogħtija kull ġimagħtejn.
English: Acute renal failure was reported in 6 of 117 patients (5.1%) in the ONIVYDE pegylated liposomal +5-FU/LV arm, 10 of 147 (6.8%) in the ONIVYDE pegylated liposomal monotherapy arm and 6 of 134 patients (4.5%) in the 5-FU/LV arm.
Maltese: Ġiet irrappurata insuffiċjenza akuta tal-kliewi f'6 minn 117-il pazjent (5.1%) fil-parti tal-istudju dwar ONIVYDE lipożomali pegilat+5-FU/LV, 10 minn 147 (6.8%) fil-parti tal-istudju dwar il-monoterapija b'ONIVYDE lipożomali pegilat u 6 minn 134 pazjent (4.5%) fil-parti tal-istudju dwar 5-FU/LV.
English: LV 400 mg/m intravenously over 30 minutes, followed by 5-FU 2,400 mg/m intravenously over 46 hours, administered every 2 weeks.
Maltese: segwit minn LV 400 mg/m ġol-vini fuq perjodu ta' 30 minuta, segwit minn 5-FU 2,400 mg/m ġolvini fuq perjodu ta' 46 siegħa, mogħtija kull ġimagħtejn.
English: Fisher's exact test
Maltese: It-test eżatt ta' Fisher
English: Myelosuppression
Maltese: Majelosoppressjoni
English: In case of cholinergic symptoms atropine should be administered.
Maltese: F'każ ta' sintomi kolinerġiċi, għandha tingħata atropine.
English: Early onset diarrhoea, typically appearing ≤ 24 hours after dose administration, can occur and is usually transient.
Maltese: Dijarea li tibda kmieni, li tipikament tidher ≤24 siegħa wara l-għoti tad-doża, tista' sseħħ u normalment din tkun temporanja.
English: Other medicines and ONIVYDE pegylated liposomal
Maltese: Mediċini oħra u ONIVYDE lipożomali pegilat
English: Strong CYP3A4 inhibitors and UGT1A1 inhibitors
Maltese: Inibituri qawwija ta' CYP3A4 u inibituri ta' UGT1A1
English: ONIVYDE pegylated liposomal is a liposomal formulation of irinotecan with different pharmacokinetic properties compared to non-liposomal irinotecan.
Maltese: ONIVYDE lipożomali pegilat huwa formulazzjoni lipożomali ta' irinotecan b'karatteristiċi farmakokinetiċi differenti meta mqabbel ma' irinotecan mhux lipożomali.
English: The metabolic conversion of irinotecan to the active metabolite SN-38 is mediated by carboxylesterase enzymes.
Maltese: Il-konverżjoni metabolika ta' irinotecan għall-metabolit attiv SN-38 hija medjata mill-enżimi carboxylesterase.
English: Acute infusion reactions were reported in 8 of 117 patients (6.8%) in the ONIVYDE pegylated liposomal +5-FU/LV arm, 3 of 147 patients (2.0%) in the ONIVYDE pegylated liposomal monotherapy arm, and 8 of 134 patients (6.0%) in the 5-FU/LV arm.
Maltese: Ġew irrappurati reazzjonijiet għall-infużjoni akuti fi 8 minn 117-il pazjent (6.8%) fil-parti tal-istudju dwar ONIVYDE lipożomali pegilat+5-FU/LV, 3 minn 147 (2.0%) fil-parti tal-istudju dwar talmonoterapija b'ONIVYDE lipożomali pegilat, u 8 minn 134 pazjent (6.0%) fil-parti tal-istudju dwar 5-FU/LV.
English: Preparation of the solution and administration
Maltese: Preparazzjoni tas-soluzzjoni u l-amministriazzjoni
English: Optimise antiemetic therapy Reduce ONIVYDE pegylated liposomal dose to 50 mg/m
Maltese: Ottimizza t-terapija antiemetika Naqqas id-doża ta' ONIVYDE lipożomali pegilat għal 50 mg/m
English: In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, patients with a prior Whipple procedure had a higher risk of serious infections following treatment with ONIVYDE pegylated liposomal +5-FU/LV [9 of 29 (30%)] compared to 11 of 88 (12.5%) patients with no prior Whipple procedure.
Maltese: ONIVYDE lipożomali pegilat+5-FU/LV, il-pazjenti li kellhom proċedura Whipple minn qabel kellhom riskju ogħla għal infezzjonijiet serji wara l-kura b'ONIVYDE lipożomali pegilat+5-FU/LV [9 minn 29 (30 %)] meta mqabbla ma' 11 minn 88 (12.5 %) tal-pazjenti mingħajr proċedura minn qabel ta' Whipple.
English: ONIVYDE pegylated liposomal geomean (95% CI)
Maltese: Parametri PK Unità ONIVYDE lipożomali pegilat ġeomedju (95% CI)
English: ONIVYDE pegylated liposomal treatment should be delayed until diarrhoea resolves to ≤ Grade 1 (2-3 stools/day more than pre-treatment frequency).
Maltese: M'għandux jinbeda ċiklu ġdid ta' terapija sakemm id-dijarea tirrisolvi għal ≤ Grad 1 (2-3 darbiet ta' ppurgar/kuljum aktar mill-frekwenza ta' qabel il-kura).
English: s r.o.
Maltese: U L-UŻU C
English: In the population pharmacokinetic analysis in patients with ONIVYDE pegylated liposomal using the results of a subset with UGT1A1*28 genotypic testing, in which the analysis adjusted for the lower dose administered to patients homozygous for the UGT1A1*28 allele, patients homozygous (N=14) and non-homozygous (N=244) for this allele had total SN-38 average steady-state concentrations of 1.06 and 0.95 ng/ml, respectively.
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni f'pazjenti b'ONIVYDE lipożomali pegilat bl-użu ta' riżultati ta' sottosett b'ittestjar ġenotopiku UGT1A1*28, fejn l-analiżi aġġustata għad-doża aktar baxxa mogħtija lill-pazjenti omożigoti għall-allel UGT1A1*28, il-pazjenti omożigoti (N=14) u mhux omożigoti (N=244) għal dan l-allel, kellhom medja ta' total ta' konċentrazzjonijiet ta' SN-38 flistat fiss ta' 1.06 u 0.95 ng/mL, rispettivament.
English: Based on the drug interaction of non-liposomal irinotecan and ketoconazole, co-administration of ONIVYDE pegylated liposomal with other inhibitors of UGT1A1 (e.g. atazanavir, gemfibrozil, indinavir) may also increase systemic exposure of ONIVYDE pegylated liposomal.
Maltese: Skont l-interazzjoni tal-mediċina ta' irinotecan mhux lipożomali u ketoconazole, l-għoti ta' ONIVYDE lipożomali pegilat flimkien ma' inibituri oħrajn ta' UGT1A1 (eż atazanavir, gemfibrozil, indinavir) jista' jżid ukoll l-esponiment sistemiku ta' ONIVYDE lipożomali pegilat.
English: The plasma protein binding of non-liposomal irinotecan is moderate (30% to 68%), and SN-38 is highly bound to human plasma proteins (approximately 95%).
Maltese: It-twaħħil ta' irinotecan mhux lipożomali mal-proteini fil-plażma huwa moderat (30% sa 68%), u SN-38 jeħel ħafna mal-proteini fil-plażma talbniedem (madwar 95 %).
English: Under these conditions, there was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas.
Maltese: Taħt dawn il-kundizzjonijiet, kien hemm tendenza lineari sinifikanti bid-doża għall-inċidenza ta' polipi stromali endometrijali tal-qarn uterin (uterine horn endometrial stromal polyps) u sarkomi stromali endometrijali kombinati.
English: Marketing Authorisation Holder Les Laboratoires Servier 50, rue Carnot
Maltese: 50, rue Carnot
English: Nervous system disorders Very common: Dizziness Common: Cholinergic syndrome, Dysgeusia
Maltese: Disturbi fis-sistema nervuża Komuni ħafna: Sturdament Komuni: Sindromu Kolinerġiku, Tibdil fis-sens tat-togħma
English: Grade 3 or higher anaemia occurred in 10.3% of patients treated with ONIVYDE pegylated liposomal +5-FU/LV and in 6.7% of patients treated with 5-FU/LV.
Maltese: Anemija ta' Grad 3 jew ogħla seħħet f'10.3 % tal-pazjenti kkurati b'ONIVYDE lipożomali pegilat+5-FU/LV u f'6.7 % tal-pazjenti kkurati b'5-FU/LV.
English: MPEG-2000-DSPE Sucrose octasulphate HEPES buffer
Maltese: It-tielet okkorrenza Waqqaf il-kura
English: Overall survival is illustrated in Figure 1.
Maltese: Issopravivenza globali qed tintwera f'Figura 1.
English: Compared to Caucasians, Asian patients were observed with a lower incidence of diarrhoea [14 (19.2%) out of 73 Caucasians had a ≥ Grade 3 diarrhoea, and 1 out of 33 (3.3%) Asians had a ≥ Grade 3 diarrhoea], but a higher incidence and higher severity of neutropenia.
Maltese: Meta mqabbla ma' pazjenti Kawkasi, pazjenti Ażjatiċi ġew osservati b'inċidenza aktar baxxa ta' dijarea [14 (19.2%) minn 73 Kawkażu kellhom dijarea ta' ≥ Grad 3, u 1 minn 33 (3.3%) Ażjatiku kellu dijarea ta' ≥ Grad 3], iżda inċidenza ogħla u severità ogħla ta' newtropenija.
English: ONIVYDE pegylated liposomal is used in combination with other cancer medicines, called 5-fluorouracil and leucovorin.
Maltese: ONIVYDE lipożomali pegilat jintuża flimkien ma' mediċini oħrajn, imsejħa 5-fluorouracil u leucovorin.
English: Servier Pharma, d. o. o. Tel: + 385 (0)1 3016 222
Maltese: Tel: + 385 (0)1 3016 222
English: The most common serious adverse reactions (≥ 2%) of ONIVYDE pegylated liposomal therapy were diarrhoea, vomiting, febrile neutropenia, nausea, pyrexia, sepsis, dehydration, septic shock, pneumonia, acute renal failure, and thrombocytopenia.
Maltese: L-iktar reazzjonijiet avversi serji komuni (≥ 2%) tat-terapija b'ONIVYDE lipożomali pegilat kienu dijarea, rimettar, newtropenija bid-deni, dardir, deni, sepsis, deidratazzjoni, xokk settiku, pulmonite, insuffiċjenza akuta tal-kliewi, u tromboċitopenija.
English: Table 3: Adverse reactions reported with ONIVYDE pegylated liposomal therapy in the NAPOLI-1 clinical study
Maltese: Tabella 3: Reazzjonijiet avversi rrappurtati bit-terapija b'ONIVYDE lipożomali pegilat flistudju kliniku NAPOLI-1 Sistema tal-Klassifika talOrgani MedDRA*
English: Compared to Caucasian patients, Asian patients have an increased risk of severe and febrile neutropenia following treatment with ONIVYDE pegylated liposomal +5-FU/LV (see sections 4.8 and 5.2).
Maltese: Meta mqabbla ma' pazjenti Kawkasi, il-pazjenti Ażjatiċi għandhom riskju akbar li jkollhom newtropenija severa u bid-deni wara l-kura b'ONIVYDE lipożomali pegilat+5-FU/LV (ara sezzjonijiet 4.8 u 5.2).
English: Co-administration of ONIVYDE pegylated liposomal +5-FU/LV does not alter the pharmacokinetics of ONIVYDE pegylated liposomal based on the population pharmacokinetic analysis.
Maltese: L-għoti flimkien ta' ONIVYDE lipożomali pegilat+5-FU/LV ma jibdilx il-farmakokinetika ta' ONIVYDE lipożomali pegilat skont l-analiżi faramkokinetika tal-popolazzjoni.
English: The safety and efficacy of ONIVYDE pegylated liposomal were investigated in a multinational, randomised, open label, controlled clinical trial (NAPOLI-1) that tested two treatment regimens for patients with metastatic pancreatic adenocarcinoma who had documented disease progression after gemcitabine or gemcitabine-containing therapy.
Maltese: Is-sigurtà u l-effikaċja ta' ONIVYDE lipożomali pegilat kienu investigati fi prova klinika (NAPOLI-1) multinazzjonali, li fiha l-parteċipanti ntgħażlu b'mod każwali, open-label, ikkontrollata, li ttestjat żewġ korsijiet ta' kura għal pazjenti b'adenokarċinoma tal-frixa metastatika li kellhom progressjoni tal-marda dokumentata wara terapija b'gemcitabine jew terapija li kien fiha gemcitabine.
English: The median time to nadir for ≥ Grade 3 neutropenia is 23 (range 8-104) days post first dose of treatment with ONIVYDE pegylated liposomal.
Maltese: Ilħin medjan għan-nadir għal newtropenija ta' ≥ Grad 3 huwa ta' 23 (medda 8-104) ġurnata wara lewwel doża ta' kura b'ONIVYDE lipożomali pegilat.
English: Diarrhoea can occur early (onset in ≤ 24 hours after starting ONIVYDE pegylated liposomal) or late (> 24 hours) (see section 4.8).
Maltese: Id-dijarea tista' sseħħ kmieni (li tibda f'≤ 24 siegħa wara li jinbeda ONIVYDE lipożomali pegilat) jew tard (> 24 siegħa) (ara sezzjoni 4.8).
English: ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
Maltese: ONIVYDE lipożomali pegilat 4.3 mg/mL konċentrat għal soluzzjoni għall-infużjoni Irinotecan
English: Reduce ONIVYDE pegylated liposomal dose to 43 mg/m
Maltese: Naqqas id-doża ta' ONIVYDE lipożomali pegilat għal 43 mg/m
English: Diarrhoea and related adverse reactions
Maltese: Dijarea u reazzjonijiet avversi relatati
English: Therefore, co-administration of ONIVYDE pegylated liposomal with other inhibitors of CYP3A4 (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) may increase systemic exposure of ONIVYDE pegylated liposomal.
Maltese: (eż. meraq tal-grejpfrut, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) jista' jżid l-esponiment sistemiku ta' ONIVYDE lipożomali pegilat.