FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with hyperbilirubinaemia had higher concentrations for total SN-38 (see section 5.2) and therefore the risk of neutropenia is increased.
Maltese: Pazjenti b'iperbilirubinemija kellhom konċentrazzjonijiet ogħla għal SN-38 totali (ara sezzjoni 5.2), u għalhekk ir-riskju ta' newtropenija jiżdied.
English: ONIVYDE pegylated liposomal contains sodium, if you are on a controlled sodium diet, see section 2.
Maltese: Jekk inti qiegħed fuq dieta kkontrollata ta' sodium, ara sezzjoni 2.
English: Patients with deficient glucuronidation of bilirubin, such as those with Gilbert's syndrome, may be at greater risk of myelosuppression when receiving therapy with ONIVYDE pegylated liposomal.
Maltese: Il-pazjenti bi glukuronidazzjoni defiċjenti ta' bilirubina, bħal dawk bis-sindromu ta' Gilbert, jistgħu jkunu f'riskju ikbar ta' majelosuppressjoni meta jirċievu t-terapija b'ONIVYDE lipożomali pegilat.
English: Direct measurement of irinotecan shows that 95% of irinotecan remains liposome-encapsulated during circulation.
Maltese: Il-kejl dirett ta' irinotecan lipożomali juri li 95% ta' irinotecan jibqa' inkapsulat fil-liposom waqt iċċirkolazzjoni.
English: Myelosuppression/neutropenia
Maltese: Majelosoppressjoni/newtropenija
English: In the clinical trial demonstrating effectiveness of ONIVYDE pegylated liposomal, higher plasma exposures of total irinotecan and SN-38 for patients in the ONIVYDE pegylated liposomal +5-FU/LV treatment arm were associated with longer OS and PFS as well as with higher ORR (objective response rate).
Maltese: Fil-prova klinika li turi l-effikaċja ta' ONIVYDE lipożomali pegilat, esponimenti ogħla ta' irinotecan u ta' SN-38 totali fil-plażma għal pazjenti fil-parti tal-istudju dwar il-kura b'ONIVYDE lipożomali pegilat+5-FU/LV, kienu assoċjati ma' OS u PFS itwal kif ukoll ma' ORR ogħla (rata ta' rispons oġġettiv).
English: stomatitis and pyrexia.
Maltese: - Żomm dan il-fuljett.
English: After you have been given ONIVYDE pegylated liposomal you will be given two other medicines, leucovorin and 5-fluorouracil.
Maltese: Wara li tkun ingħatajt ONIVYDE lipożomali pegilat se tingħata żewġ mediċini oħra, leucovorin u 5-fluorouracil.
English: ONIVYDE pegylated liposomal is a cancer medicine that contains the active substance irinotecan.
Maltese: ONIVYDE lipożomali pegilat huwa mediċina ta' kontra l-kanċer li fih is-sustanza attiva irinotecan.
English: Name and address of the manufacturer(s) responsible for batch release Les Laboratoires Servier Industrie
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Les Laboratoires Servier Industrie 905 Route de Saran
English: Tel: + 34 91 748 96 30
Maltese: Laboratorios Servier S.L. Tel: + 34 91 748 96 30
English: Grade 3 or higher and serious treatment emergent adverse reactions were more frequent in patients < 65 years (84.1% and 50.8%) compared to patients ≥ 65 years (68.5 % and 44.4%).
Maltese: Reazzjonijiet avversi ta' Grad 3 jew ogħla u dawk li żviluppaw mill-kura, kienu aktar frekwenti f'pazjenti li kellhom <65 sena (84.1% u 50.8%) meta mqabbla ma' pazjenti li kellhom ≥ 65 sena (68.5% u 44.4%).
English: Neutropenic fever/sepsis appeared more frequently in the ONIVYDE pegylated liposomal +5-FU/LV combination arm [in 4 patients (3.4%)] compared to 5-FU/LV control arm [in 1 patient (0.7%)].
Maltese: Id-deni newtropeniku/sepsis deher iktar spiss fil-parti tal-istudju dwar il-kombinazzjoni ONIVYDE lipożomali pegilat+5-FU/LV [f'4 pazjenti (3.4%)] meta mqabbel mal-parti tal-istudju dwar il-kontroll 5-FU/LV [f'pazjent 1 (0.7 %)].
English: Renal impairment
Maltese: Reazzjoni anafilattika
English: In patients receiving ONIVYDE pegylated liposomal +5-FU/LV, the incidence of ≥ Grade 3 neutropenia was higher among Asian patients [18 of 33 (55%)] compared to Caucasians patients [13 of 73 (18%)].
Maltese: F'pazjenti li kienu qed jirċievu ONIVYDE lipożomali pegilat+5-FU/LV, l-inċidenza ta' newtropenija ta' ≥ Grad 3 kienet ogħla fost il-pazjenti Ażjatiċi [18 minn 33 (55 %)] meta mqabbla ma' pazjenti Kawkasi [13 minn 73 (18 %)].
English: In the clinical study Grade 3 or Grade 4 diarrhoea occurred in 15 out of 117 patients (12.8%) receiving ONIVYDE pegylated liposomal +5-FU/LV.
Maltese: Fl-istudju kliniku, seħħet dijarea ta' Grad 3 jew ta' Grad 4 fi 15 minn 117-il pazjent (12.8%) li rċivew ONIVYDE lipożomali pegilat+5-FU/LV.
English: Febrile neutropenia (body temperature > 38°C and neutrophil count ≤ 1,000 cells/mm³) should be urgently treated in the hospital with broad-spectrum intravenous antibiotics.
Maltese: Newtropenija bid-deni (temperatura tal-ġisem ta' > 38°C u għadd tan-newtrofili ta' ≤ 1000 ċelluli/mm³) għandha tiġi kkurata b'urġenza fl-isptar b'antibijotiċi bi spettru wiesa' ġol-vini.
English: ONIVYDE pegylated liposomal /5-FU adjustment (for patients homozygous for UGT1A1*28 without previous increase to 70 mg/m
Maltese: Aġġustament ta' ONIVYDE lipożomali pegilat/5-FU (għal pazjenti li huma omożigużi għal UGT1A1*28 mingħajr żieda preċedenti għal 70 mg/m
English: Very common: Pyrexia, Peripheral oedema, Mucosal inflammation, Fatigue, Asthenia
Maltese: Komuni ħafna: Deni, Edema periferali, Infjammazzjoni mukuża, Għeja, Astenja
English: Each pack contains one vial with 10 ml of concentrate.
Maltese: Kull pakkett fih kunjett wieħed b'10 mL ta' konċentrat.
English: Sepsis with neutropenic fever and consequent septic shock with fatal outcome has been observed in patients with metastatic pancreatic adenocarcinoma treated with ONIVYDE pegylated liposomal.
Maltese: 3. Sepsis b'deni newtropeniku u xokk settiku konsegwenti b'eżitu fatali ġew osservati f'pazjenti b'adenokarċinoma pankreatika metastatika kkurati b'ONIVYDE lipożomali pegilat.
English: ONIVYDE pegylated liposomal is a cytotoxic medicinal product.
Maltese: ONIVYDE lipożomali pegilat huwa prodott mediċinali ċitotossiku.
English: In the intent to treat (all randomised) population, the median age was 63 years (range 31-87 years), 57 % were males, and 61% were Caucasian and 33% were Asian.
Maltese: Fil-popolazzjoni bl-intenzjoni li tiġi kkurata (kollha magħżula b'mod każwali), l-età medjana kienet 63 sena (medda 31-87 sena), 57 % kienu rġiel, u 61 % kienu Kawkasi u 33 % kienu Ażjatiċi.
English: Underweight patients (body mass index < 18.5 kg/m
Maltese: Pazjenti b'piż inqas milli suppost (indiċi tal-massa tal-ġisem ta' < 18.5 kg/m
English: ONIVYDE pegylated liposomal /5-FU adjustment (for patients not homozygous for UGT1A1*28)
Maltese: Aġġustament ta' ONIVYDE lipożomali pegilat/5-FU (għal pazjenti mhux omożigużi għal UGT1A1*28)
English: Aseptic techniques must be followed during the preparation of the infusion.
Maltese: Għandhom jiġu segwiti tekniki asettiċi waqt il-preparazzjoni tal-infużjoni.
English: A reduced starting dose of ONIVYDE pegylated liposomal (irinotecan) of 50 mg/m should be considered for patients known to be homozygous for the UGT1A1*28 allele (see sections 4.8 and 5.1).
Maltese: Għandha tiġi kkunsidrata doża tal-bidu mnaqqsa ta' ONIVYDE lipożomali pegilat (irinotecan) ta' 50 mg/m għal pazjenti magħrufa li huma omożigoti għall-allel UGT1A1*28 (ara sezzjonijiet 4.8 u 5.1).
English: In a pooled analysis from 353 patients, higher plasma SN-38 Cmax was associated with increased likelihood of experiencing neutropenia, and higher plasma total irinotecan Cmax was associated with increased likelihood of experiencing diarrhoea.
Maltese: F'analiżi miġbura minn 353 pazjent, Cmax ogħla ta' SN-38 fil-plażma kien assoċjat ma' probabbiltà akbar li pazjent ikollu newtropenija, u Cmax ogħla ta' irinotecan totali fil-plażma kien assoċjat ma' probabbiltà akbar li l-pazjent ikollu d-dijarea
English: There was insufficient data in patients with severe renal impairment (CLcr < 30 ml/min) to assess its effect on pharmacokinetics (see sections 4.2 and 4.4).
Maltese: Ma kienx hemm biżżejjed dejta f'pazjenti b'indeboliment sever tal-kliewi (CLcr < 30 mL/min) biex jiġi evalwat l-impatt tiegħu fuq il-farmakokinetika (ara sezzjonijiet 4.2 u 4.4).
English: Reduce ONIVYDE pegylated liposomal dose to 50 mg/m
Maltese: Naqqas id-doża ta' ONIVYDE lipożomali pegilat għal 50 mg/m
English: Grade 3 or higher neutropenia occurred more frequently in patients treated with ONIVYDE pegylated liposomal +5-FU/LV (27.4%) compared to patients treated with 5-FU/LV (1.5%).
Maltese: Newtropenija ta' Grad 3 jew ogħla seħħet b'mod iktar frekwenti f'pazjenti kkurati b'ONIVYDE lipożomali pegilat+5-FU/LV (27.4 %) meta mqabbla ma' pazjenti kkurati b'5-FU/LV (1.5 %).
English: Conversely, patients > 75 years (n=12) experienced more frequent serious adverse reactions, dose delay, dose reduction and discontinuation compared to patients ≤ 75 years (n=105) when treated with ONIVYDE pegylated liposomal +5-FU/LV in the pancreatic adenocarcinoma study.
Maltese: Bil-maqlub, pazjenti ta' > 75 sena (n=12) kellhom reazzjonijiet avversi serji, dewmien tad-doża, tnaqqis fid-doża u t-twaqqif tad-doża, b'mod aktar frekwenti meta mqabbla ma' pazjenti ta' ≤ 75 sena (n=105) meta kienu kkurati b'ONIVYDE lipożomali pegilat+ 5-FU/LV fi studju dwar adenokarċinoma pankreatika.
English: SN-38 is approximately 1,000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumour cell lines.
Maltese: SN-38 huwa bejn wieħed u ieħor 1,000 darba iktar qawwi minn irinotecan bħala inibitur ta' topoisomerase I ippurifikat minn razez ta' ċelluli tattumur tal-bniedem u ta' annimali gerriema.
English: Patients randomised to ONIVYDE pegylated liposomal +5-FU/LV received ONIVYDE pegylated liposomal at 70 mg/m as an intravenous infusion over 90 minutes, followed by
Maltese: Il-pazjenti li ntgħażlu b'mod każwali għal ONIVYDE lipożomali pegilat+5-FU/LV irċivew ONIVYDE lipożomali pegilat f'doża ta' 70 mg/m bħala infużjoni ġol-vini fuq perjodu ta' 90 minuta,
English: Clearance (CL)
Maltese: Tneħħija (CL)
English: infection) - telaprevir (a medicine used to treat a liver disease called hepatitis C) - nefazodone (a medicine used to treat depression, low mood) - gemfibrozil (medicine used to treat high fat levels in the blood)
Maltese: HIV) - telaprevir (mediċina użata biex tikkura marda tal-fwied imsejħa epitate Ċ) - nefazodone (mediċina użata biex tikkura d-depressjoni u burdati ta' dwejjaq) - gemfibrozil (mediċina użata biex tikkura livelli għoljin ta' xaħam fid-demm)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 43mg/10 ml
Maltese: INDIVIDWALI 43 mg/10 mL
English: Grade 3 or higher thrombocytopenia occurred in 2.6% of patients treated with ONIVYDE pegylated liposomal +5-FU/LV and 0% in patients treated with 5-FU/LV.
Maltese: Tromboċitopenija ta' Grad 3 jew ogħla seħħet fi 2.6 % tal-pazjenti kkurati b'ONIVYDE lipożomali pegilat+5-FU/LV u 0 % f'pazjenti kkurati b'5-FU/LV.
English: The no-observed-adverse-effect level (NOAEL) in rats and dogs following 90 min intravenous infusion of ONIVYDE pegylated liposomal once every 3 weeks for 18 weeks was 155 mg/m
Maltese: Il-livell tal-ebda effett avers osservat (NOAEL) fil-firien u fil-klieb wara 90 minuta ta' infużjoni ġol-vini ta' ONIVYDE lipożomali pegilat darba kull 3 ġimgħat għal 18-il ġimgħa kien 155 mg/m
English: Camptothecins act as specific inhibitors of the enzyme DNA topoisomerase I. Irinotecan and its active metabolite SN-38 bind reversibly to the topoisomerase I-DNA complex and induce single-strand DNA lesions which block the DNA replication fork and are responsible for the cytotoxicity.
Maltese: Irinotecan u l-metabolit attiv tiegħu SN-38 jintrabtu b'mod riversibbli mal-kumpless tad-DNA topoisomerase I u jinduċu leżjonijiet tad-DNA bi strand waħda li jimblukkaw il-furketta ta' replikazzjoni tad-DNA u huma responsabbli għaċ-ċitotossiċità.
English: ONIVYDE pegylated liposomal, leucovorin and 5-fluorouracil should be administered sequentially.
Maltese: ONIVYDE lipożomali pegilat, leucovorin u 5-fluorouracil għandhom jingħataw b'mod sekwenzjali.
English: • ONIVYDE pegylated liposomal should be administered before leucovorin followed by 5-fluorouracil.
Maltese: • ONIVYDE lipożomali pegilat għandu jingħata qabel leucovorin segwit minn 5-fluorouracil.
English: Key eligibility criteria for patients with metastatic adenocarcinoma of the pancreas in the NAPOLI-1 clinical study were Karnofsky Performance Status (KPS) ≥ 70, normal bilirubin level, transaminase levels ≤ 2.5 times the ULN or ≤ 5 times the ULN for patients with liver metastases and albumin ≥ 3.0 g/dl.
Maltese: Il-kriterji ewlenin ta' eliġibilità għall-pazjenti b'adenokarċinoma metastatika tal-frixa fl-istudju kliniku NAPOLI-1 kienu L-Istatut tal- Prestazzjoni ta' Karnofsky (KPS) ≥ 70, livell ta' bilirubina normali,
English: History of severe hypersensitivity to irinotecan or to any of the excipients listed in section 6.1.
Maltese: Passat ta' sensittività eċċessiva severa għal irinotecan jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Disease characteristics included 68% of patients with liver metastases and 31% with lung metastases; 12% of patients had no prior lines of metastatic therapy, 56 % of patients had 1 prior line of metastatic therapy, 32% of patients had 2 or more prior lines of metastatic therapy.
Maltese: Il-karatteristiċi tal-marda kienu jinkludu 68% tal-pazjenti b'metastasi fil-fwied u 31% b'metastasi fil-pulmun; 12% tal-pazjenti ma kellhomx linji ta' terapija metastatika minn qabel, 56% tal-pazjenti kellhom linja 1 ta' terapija metastatika minn qabel, 32% tal-pazjenti kellhom 2 linji jew iżjed ta' terapija metastatika minn qabel.
English: N=353 refers to all the subjects included in the population PK analysis Values are obtained from published data [Schaaf LJ et al. Clin Cancer Res. 2006 Jun 15;12:3782-91]
Maltese: Il-valuri huma stmati mill-anliżi PK tal-popolazzjoni N=353 jirreferi għall-individwi kollha inklużi fl-analiżi PK tal-popolazzjoni Il-valuri nkisbu minn dejta ppubblikata [Schaaf LJ et al. Clin Cancer Res. 2006 Jun 15;12:3782-91]
English: Hazard Ratio (95% CI) p-value
Maltese: Numru ta' mwiet, n (%) OS Medjan (xhur) (95 % CI) Proporzjon tal-Periklu (95 % CI) valur-p
English: ONIVYDE pegylated liposomal should not be administered with strong CYP3A4-enzyme inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John's wort unless there are no therapeutic alternatives.
Maltese: ONIVYDE lipożomali pegilat m'għandux jingħata ma' indutturi qawwija tal-enzima CYP3A4 bħal antikonvulsanti (phenytoin, phenobarbital jew carbamazepine), rifampin, rifabutin u St.
English: Servier Pharma d. o. o. Tel: + 386 (0)1 563 48 11
Maltese: Tel: + 386 (0)1 563 48 11
English: Cardiac disorders
Maltese: Disturbi gastro-intestinali
English: Dilute with 5% glucose solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection to prepare a solution of the appropriate dose of ONIVYDE pegylated liposomal diluted to a final volume of 500 ml.
Maltese: Iddilwixxi b'soluzzjoni għall-injezzjoni ta' 5% ta' glucose jew soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) ta' sodium chloride, biex tipprepara soluzzjoni adattata tad-doża ta' ONIVYDE lipożomali pegilat dilwit sal-volum finali ta' 500 mL.
English: Hypersensitivity reactions, including acute infusion reaction may occur.
Maltese: Reazzjonijiet ta' sensittività eċċessiva, inkluża reazzjoni għall-infużjoni akuta jistgħu jseħħu.
English: (anaemia) - Low level of blood platelets (thrombocytopenia) - Diarrhoea (loose or watery and frequent stools) - Nausea and vomiting - Pain in the stomach or in the gut area - Sore mouth - Loss of weight - Loss of appetite - Loss of body fluid (dehydration) - Low level of salts (electrolytes) in the body (e.g. of potassium, magnesium) - Unusual hair loss - Tiredness - Dizziness - Swelling and fluid retention in the soft tissues (peripheral oedema)
Maltese: Komuni ħafna (jaffettwaw iktar minn persuna 1 minn kull 10) - Livelli baxxi ta' ċelluli bojod tad-demm (newtropenija u lewkopenija), Livell baxx ta' ċelluli tad-demm ħomor (anemija) - Livell baxx ta' plejtlits fid-demm (tromboċitopenija) - Dijarea (ippurgar frekwenti artab jew maħlul) - Dardir u rimettar - Uġigħ fl-istonku jew fiż-żona tal-imsaren - Feriti fil-ħalq - Telf ta' piż - Nuqqas ta' aptit - Telf ta' fluwidu tal-ġisem (deidratazzjoni) - Livell baxx ta' melħ (elettroliti) fil-ġisem (eż tal-potassium, magnesium) - Telf ta' xagħar mhux normali - Għeja - Sturdament - Nefħa u żamma tal-fluwidu fit-tessuti rotob (edema periferali)
English: Patients with a history of a Whipple procedure have a higher risk of serious infections following ONIVYDE pegylated liposomal in combination with 5-FU and leucovorin (see section 4.8).
Maltese: Il-pazjenti b'passat tal-proċedura ta' Whipple għandhom riskju ogħla ta' infezzjonijiet serji wara li jieħdu ONIVYDE lipożomali pegilat flimkien ma' 5-FU u leucovorin (ara sezzjoni 4.8).
English: Adverse reaction frequency** Infections and infestations Common: Septic shock, Sepsis, Pneumonia, Febrile neutropenia, Gastroenteritis, Oral candidiasis Uncommon: Biliary sepsis
Maltese: Xokk settiku, Sepsis, Pulmonite, Newtropenija bid-deni, Gastroenterite, Kandidjasi orali
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: ANNESS II A MANIFATTUR(I) RESPONSABBLI
English: ONIVYDE pegylated liposomal contains sodium
Maltese: ONIVYDE lipożomali pegilat fih is-sodium
English: Patients should be monitored for signs of infections.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali ta' infezzjonijiet.
English: In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, 5 of 8 underweight patients experienced a Grade 3 or 4 adverse reactions, mostly myelosuppression, while 7 of the 8 patients required dose modification such as dose delay, dose reduction or dose discontinuation.
Maltese: Fl-istudju kliniku li evalwa ONIVYDE lipożomali pegilat+5-FU/LV, 5 mit-8 pazjenti b'piż inqas milli suppost, kellhom reazzjonijiet avversi ta' Grad 3 jew 4, l-aktar majelosoppressjoni, filwaqt li 7 mit-8 pazjenti kienu jeħtieġu tibdil fid-doża bħal dewmien tad-doża, tnaqqis fid-doża jew twaqqif tad-doża.
English: Diarrhoea is a very common adverse reaction leading to colitis, ileus, gastroenteritis, fatigue, dehydration, weight loss, renal toxicities, hyponatraemia, and hypokalaemia.
Maltese: Id-dijarea hija reazzjoni avversa komuni ħafna li twassal għal kolite, ileus, gastroenterite, għeja, deidratazzjoni, telf fil-piż, tossiċitajiet renali, iponatremija, u ipokalemija.
English: The rates of adverse reactions leading to permanent treatment discontinuation were 11% for the ONIVYDE pegylated liposomal +5-FU/LV arm and 12% for the monotherapy arm.
Maltese: Ir-rati tar-reazzjonijiet avversi li wasslu għall-waqfien permanenti tal-kura kienu 11% għall-parti talistudju dwar ONIVYDE lipożomali pegilat+5-FU/LV u 12% għall-parti tal-istudju dwar ilmonoterapija.
English: No interaction of ONIVYDE pegylated liposomal (irinotecan) with other medicinal products is known.
Maltese: Ma hija magħrufa l-ebda interazzjoni ta' ONIVYDE lipożomali pegilat (irinotecan) ma' prodotti mediċinali oħrajn.
English: The volume of distribution of ONIVYDE pegylated liposomal 70 mg/m was 2.6 l/m 2, which suggests that
Maltese: Il-volum tad distribuzzjoni ta' ONIVYDE lipożomali pegilat 70 mg/m kien ta' 2.6 L/m 2, li jissuġġerixxi li ħafna minn ONIVYDE lipożomali pegilat huwa limitat għall-fluwidu vaskulari.
English: In clinical studies of non-liposomal irinotecan administered on a weekly dosage schedule, patients with modestly elevated baseline serum total bilirubin levels (1.0 to 2.0 mg/dl) had a significantly greater likelihood of experiencing first cycle Grade 3 or Grade 4 neutropenia than those with bilirubin levels that were less than 1.0 mg/dl.
Maltese: Fi studji kliniċi dwar irinotecan mhux lipożomali mogħti fuq skeda ta' dożaġġ kull ġimgħa, pazjenti b'livelli ta' bilirubina totali fis-serum modestament għoljin fil-linja bażi (1.0 sa 2.0 mg/dl) kellhom probabbiltà akbar b'mod sinifikanti li jkollhom newtropenija fl-ewwel ċiklu ta' Grad 3 jew Grad 4 milli dawk b'livelli ta' bilirubina li kienu inqas minn 1.0 mg/dl.
English: Following recovery to Grade 1 diarrhoea, resume ONIVYDE pegylated liposomal at a reduced dose (see section 4.2).
Maltese: Wara lirkupru għal dijarea ta' Grad 1, kompli ONIVYDE lipożomali pegilat b'doża mnaqqsa (ara sezzjoni 4.2).
English: The plasma pharmacokinetics of total irinotecan and total SN-38 were evaluated in patients with cancer who received ONIVYDE pegylated liposomal, as a single agent or as part of combination chemotherapy, at doses between 50 and 155 mg/m2.
Maltese: Il-farmakokintetika tal-plażma ta' irinotecan totali u l-SN-38 totali ġew evalwati f'pazjenti b'kanċer li rċivew ONIVYDE lipożomali pegilat, waħdu jew bħala parti minn kimoterapija kombinata, f'dożi bejn 50 u 155 mg/m2.
English: Information about drug interactions with ONIVYDE pegylated liposomal is referenced from the published scientific literature for nonliposomal irinotecan.
Maltese: L-informazzjoni dwar interazzjonijiet ta' mediċina ma' ONIVYDE lipożomali pegilat hija rreferenzjata mil-letteratura xjentifika ppubblikata għal irinotecan mhux lipożomali.
English: Dosage adjustments
Maltese: Sopravivenza Globali
English: Servier Laboratories (Ireland) Ltd. Tel: + 353 (0)1 663 8110
Maltese: Tel: + 353 (0)1 663 8110
English: Optimise antiemetic therapy Reduce ONIVYDE pegylated liposomal dose to 43 mg/m
Maltese: Ottimizza t-terapija antiemetika Naqqas id-doża ta' ONIVYDE lipożomali pegilat għal 43 mg/m It-tielet okkorrenza Waqqaf il-kura
English: It blocks an enzyme called topoisomerase I, which is involved in the division of cell DNA.
Maltese: Dan jimblokka enzima msejħa topoisomerase I, li hija involuta fid-diviżjoni tad-DNA taċ-ċelluli.
English: Early onset diarrhoea may be accompanied by cholinergic symptoms such as rhinitis, increased salivation, flushing, diaphoresis, bradycardia, miosis and hyperperistalsis.
Maltese: Dijarea li tibda kmieni tista' tkun akkumpanjata minn sintomi kolinerġiċi bħal rinite, salivazzjoni miżjuda, fwawar, dijaforesi, bradikardija, mijożi u iperperistalsi.
English: Patients should be made aware of the risk of delayed diarrhoea which can be debilitating and, on rare occasions, life threatening since persistent loose or watery stools can result in dehydration, electrolyte imbalance, colitis, gastrointestinal (GI) ulceration, infection or sepsis.
Maltese: Il-pazjenti għandhom ikunu konxji tar-riskju ta' dijarea li ddum ma sseħħ li tista' tkun debilitanti u, f'okkażjonijiet rari, ta' periklu għall-ħajja, peress li ppurgar persistenti artab jew maħlul jista' jirriżulta f'deidratazzjoni, żbilanċ fl-elettroliti, kolite, ulċerazzjoni gastrointestinali (GI), infezzjoni jew sepsis.
English: For Grade 1 and 2 toxicities there are no dose modifications recommended.
Maltese: Għat-tossiċitajiet ta' Grad 1 u 2 m'hemm l-ebda modifikazzjoni fid-doża rakkomandata.
English: In a population pharmacokinetic analysis, mild-to-moderate renal impairment had no effect on the exposure of total SN-38 after adjusting for BSA.
Maltese: F'analiżi faramkokinetika tal-popolazzjoni, indeboliment minn ħafif sa moderat tal-kliewi ma kellu l-ebda effett fuq l-esponiment tal-SN-38 totali wara l-aġġustament għall-BSA.
English: Caution should be exercised in patients with hepatic impairment (bilirubin > 2 times upper limit of normal [ULN]; transaminases > 5 times ULN).
Maltese: Għandu jkun hemm kawtela f'pazjenti b'indeboliment tal-fwied (bilirubina > darbtejn ogħla mil-limitu ta' fuq tan-normal [ULN]; transaminases > 5 darbiet ULN).
English: Non-liposomal irinotecan was shown to cause atrophy of male and female reproductive organs after multiple daily irinotecan doses in animals (see section 5.3).
Maltese: Irinotecan mhux lipożomali ntwera li jikkawża atrofija tal-organi riproduttivi tal-irġiel u tan-nisa wara dożi multipli ta' irinotecan li ngħataw kuljum fl-annimali (ara sezzjoni 5.3).
English: Avoid eating grapefruits and drinking grapefruit juice while you are receiving ONIVYDE pegylated liposomal as it may increase the availability of the active substance of ONIVYDE pegylated liposomal in your body.
Maltese: Evita li tiekol grejpfruts u li tixrob meraq tal-grejpfrut waqt li tkun qed tirċievi ONIVYDE lipożomali pegilat peress li dan jista' jżid id-disponibbiltà tas-sustanza attiva ta' ONIVYDE lipożomali pegilat f'ġismek.