FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were stratified for prior nephrectomy status within 3 geographic regions and were randomly assigned (1:1:1) to receive IFN-α alone (n = 207), temsirolimus alone (25 mg weekly; n = 209), or the combination of IFN-α and temsirolimus (n = 210).
Maltese: Il-pazjenti kienu stratifikati għall-istat tan-nefrektomija fil-passat fi 3 żoni ġeografiċi u kienu assenjati b'mod random (1:1:1) biex jirċievu (IFN-) waħdu (n = 207), temsirolimus waħdu (25 mg darba fil-ġimgħa; n = 209), jew il-kumbinazzjoni IFN- u temsirolimus (n = 210).
English: Adverse reactions that were reported in RCC and MCL patients in the phase 3 studies are listed below (Table 1), by system organ class, frequency and grade of severity (NCI-CTCAE).
Maltese: Ir-reazzjonijiet avversi li kienu rrappurtati f'pazjenti b'RCC u MCL fl-istudji ta' Fażi 3 huma elenkati hawn taħt (Tabella 1), skont is-sistema tal-klassifika tal-organi, il-frekwenza u l-grad ta' severità (NCI-CTCAE).
English: After first dilution of the concentrate with 1.8 ml of the supplied solvent, the concentrate-solvent mixture contains 35% volume ethanol (alcohol), i.e., up to 0.693 g per 25 mg dose of temsirolimus, equivalent to 17.6 ml beer or 7.3 ml wine per dose.
Maltese: Wara l-ewwel dilwizzjoni tal-konċentrat b'1.8 ml tas-solvent fornut, it-taħlita tal-konċentrat-solvent ikun fiha 35% ta' ethanol (alkoħol) skond il-volum; i.e., sa 0.693 g f'kull doża ta' 25 mg ta' temsirolimus, ekwivalenti għal 17.6 ml ta' birra jew 7.3 ml ta' nbid f'kull doża.
English: Patients administered the higher dose of 175 mg of temsirolimus for the initial treatment of MCL may receive up to 4.85 g of ethanol (equivalent to 123 ml beer or 51 ml wine per dose).
Maltese: Pazjenti li jingħataw id-doża ogħla ta' 175 mg ta' temsirolimus għall-kura inizjali ta' MCL, jistgħu jirċievu sa 4.85 g ta' ethanol (ekwivalenti għal 123 ml ta' birra jew 51 ml ta' nbid f'kull doża).
English: Agents such as protease inhibitors (nelfinavir, ritonavir), antifungals (e.g. itraconazole, ketoconazole, voriconazole), and nefazodone are strong CYP3A4 inhibitors and may increase blood concentrations of the active drug substances, temsirolimus and its metabolite, sirolimus.
Maltese: Mediċini bħal inibituri tal-protease (nelfinavir, ritonavir), antifungali (eż.itraconazole, ketoconazole, voriconazole), u nefazodone huma inibituri qawwija ta' CYP3A4 u jistgħu jżidu l-konċentrazzjonijiet fid-demm tas-sustanzi attivi tal-mediċina, temsirolimus u l-metabolit tiegħu, sirolimus.
English: Increased alanine aminotransferase a: One fatal case b: One pleural effusion fatal event occurred in the low-dose (175/25 mg) arm of the MCL study *Most NCI-CTC Grade 3 and above reactions observed in clinical trials of temsirolimus for MCL ** Most NCI-CTC all grades reactions observed in clinical trials of temsirolimus for MCL *** All NCI-CTC Grade 1 and 2 reactions observed in clinical trials of temsirolimus for MCL ****Interstitial lung disease is defined by a cluster of related Preferred Terms: interstitial lung disease (n = 6), pneumonitisa (n = 7), alveolitis (n = 1), alveolitis allergic (n = 1), pulmonary fibrosis (n = 1)
Maltese: ** Il-biċċa l-kbira tar-reazzjonijiet NCI-CTC tal-gradi kollha kienu osservati fil-provi kliniċi ta' temsirolimus għal MCL *** Ir-reazzjonijiet kollha NCI-CTC ta' Grad 1 u 2 kienu osservati fil-provi kliniċi ta' temsirolimus għal MCL ****Mard interstizjali tal-pulmuni huwa definit bħala ġabra ta' Termini Preferuti relatati: mard interstizjali tal-pulmuni (n = 6), pulmonite a (n = 7), alveolite (n = 1), alveolite allerġika (n = 1), fibrożi pulmonari (n = 1) u pulmonite esinofilika (n = 0).
English: Polyvinyl chloride (PVC) bags and medical devices must not be used for the administration of preparations containing polysorbate 80, because polysorbate 80 leaches di-2-ethylhexylphthalate (DEHP) from PVC.
Maltese: Boroż magħmulin minn polyvinyl chloride (PVC) u tagħmir mediku ma jridux jintużaw għall-għoti ta' preparazzjonijiet li jkun fihom polysorbate 80, għax polysorbate 80 jerħi di-2-ethylhexylphthalate (DEHP) mill-polyvinyl chloride (PVC).
English: Very common Fatigue Oedema (including generalised oedema, facial oedema, peripheral oedema, scrotal oedema, genital oedema)
Maltese: Komuni ħafna Għeja Edima (li tinkludi edima ġeneralizzata, edima fil-wiċċ, edima periferali, edima fl-iskrotum, edima fl-organi ġenitali)
English: In the MCL clinical trial, hyperlipaemia was reported as an adverse event in 9.3% of patients.
Maltese: Filprova klinika MCL, l-iperlipemija kienet irrappurtata bħala avveniment avvers f'9.3% tal-pazjenti.
English: Store in a refrigerator (2°C - 8°C)
Maltese: Aħżen fi friġġ (2C-8C)
English: Rhabdomyolysis
Maltese: Il-Belġju
English: PFIZER ΕΛΛΑΣ A.E. Tηλ: +30 210 67 85 800
Maltese: Tηλ: +30 210 67 85 800
English: An increased rate of fatal events was observed in patients with moderate and severe hepatic impairment.
Maltese: Rata miżjuda ta' avvenimenti fatali ġiet osservata f'pazjenti b'indeboliment tal-kliewi moderat u sever.
English: Abbreviation: ANC = absolute neutrophil count.
Maltese: ANC = għadd assolut tan-newtrofili
English: Dry skin
Maltese: U LUŻU
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: MCL clinical trial is a controlled, randomised, open-label, multicentre, outpatient study comparing 2 different dosing regimens of temsirolimus with an investigator's choice of therapy in patients with relapsed and/or refractory MCL.
Maltese: Il-prova klinika MCL hi studju outpatient, ikkontrollat, randomised, open-label, multiċentriku, li qabbel 2 korsijiet differenti ta' dożaġġ ta' temsirolimus ma' terapija tal-għażla tal-investigatur f'pazjenti li rkadew u/jew li huma refrattarji għal MCL.
English: Torisel, when diluted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl) phthalate extraction (DEHP) from polyvinyl chloride (PVC).
Maltese: Meta dilwit, Torisel ikun fih polysorbate 80, li hu magħruf li jżid ir-rata ta' l-estrazzjoni ta' di-(2ethylhexyl)phthalate (DEHP) minn polyvinyl chloride (PVC).
English: In the MCL clinical trial, a Phase 3 clinical trial for MCL, 11% of patients reported hyperglycaemia as an adverse event.
Maltese: Fil-prova klinika MCL, prova klinika ta' Fażi 3 għal MCL, 11% tal-pazjenti rrappurtaw ipergliċemija bħala avveniment avvers.
English: After first dilution of the concentrate with 1.8 ml of solvent, the concentration of temsirolimus is 10 mg/ml (see section 4.2).
Maltese: Wara l-ewwel dilwizzjoni tal-konċentrat b'1.8 ml ta' solvent, il-konċentrazzjoni ta' temsirolimus tkun ta' 10 mg/ml (ara sezzjoni 4.2).
English: The concentrate also contains: anhydrous ethanol, all-rac-α-tocopherol (E 307), propylene glycol and citric acid (E 330).
Maltese: Il-konċentrat fih ukoll: anhydrous ethanol, all-rac-a-tocopherol (E 307), propylene glycol, anhydrous citric acid (E 330).
English: Torisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1).
Maltese: Torisel hu indikat għall-kura ta' pazjenti adulti li għandhom rikaduta u/jew li huma refrattarji għal limfoma taċ-ċelluli mantle (MCL), (ara sezzjoni 5.1).
English: 1 vial of concentrate contains 474 mg of anhydrous ethanol 1.8 ml of the solvent provided contains 358 mg anhydrous ethanol For the full list of excipients, see section 6.1.
Maltese: 1.8 ml tas-solvent ipprovdut fih 358 mg ta' ethanol anidru.
English: 1.0 x 109/l
Maltese: 1.0 x 10
English: 1.0 x 109/l
Maltese: 1.0 x 10
English: After further dilution of the concentrate-solvent mixture with sodium chloride 9 mg/ml (0.9%) solution for injection, the solution may be stored for up to 6 hours below 25°C and protected from light.
Maltese: Wara dilwizzjoni addizzjonali tat-taħlita tal-konċentrat-solvent b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni, is-soluzzjoni tista' tinħażen sa 6 sigħat f'temperatura taħt 25C u tkun protetta mid-dawl.
English: c Based on Cochran-Mantel-Hansel test stratified by prior nephrectomy and region.
Maltese: Ibbażat fuq it-test Cochran-Mantel-Haenszel, stratifikat skond in-nefrektomija fil-passat u skond irreġjun.
English: RCC clinical trial 1 was a Phase 3, multi-centre, 3-arm, randomised, open-label study in previously untreated patients with advanced RCC and with 3 or more of 6 pre-selected prognostic risk factors (less than 1 year from time of initial RCC diagnosis to randomisation, Karnofsky performance status of 60 or 70, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dl, lactate dehydrogenase1.5 times the upper limit of normal, more than 1 metastatic organ site).
Maltese: Il-prova klinika RCC 1 kienet studju multiċentriku ta' Fażi 3, li kien fih 3 partijiet, randomised, openlabel li sar fuq pazjenti li ma kinux ikkurati fil-passat u li kellhom RCC avvanzata, u bi 3 jew iktar minn 6 fatturi ta' riskju pronjostiku magħżula minn qabel (inqas minn sena miż-żmien tad-dijanjosi inizjali ta' RCC sar-randomisation, stat tal-prestazzjoni ta' Karnofsky ta' 60 jew 70, emoglobina inqas minn mil-limitu t'isfel tan-normal, livell ta' kalċju kkoreġut ta' aktar minn 10 mg/dl, lactate dehydrogenase >1.5 darbiet tal-limitu ta' fuq tan-normal, aktar minn sit 1 ta' organu metastatiku).
English: Clear glass vial (type 1), with butyl rubber stopper and a plastic flip-top closure sealed with aluminum containing 2.2 ml of solvent
Maltese: Kunjett ta' ħġieġ ċar (ħġieġ ta' tip 1), b'tapp tal-lastku tal-butyl u għatu flip-top tal-plastik issiġillat bl-aluminju li fih 2.2 ml ta' solvent
English: Pre-specified interim analysis Median overall survival, Months (95% CI) Final analysis
Maltese: Analiżi interim pre-speċifika Medjan tassopravivenza totali Xhur (95% CI)
English: Therefore, when temsirolimus is co-administered with medicinal products which are P-gp substrates (e.g. digoxin, vincristine, colchicine, dabigatran, lenalidomide, and paclitaxel) close monitoring for adverse events related to the co-administered medicinal products should be observed.
Maltese: Għalhekk, meta temsirolimus jingħata flimkien ma' prodotti mediċinali li huma substrati ta' P-gp (eż. digoxin, vincristine, colchicine, dabigatran, lenalidomide, u paclitaxel), għandu jsir monitoraġġ mill-qrib għal avvenimenti avversi marbuta mal-prodotti mediċinali mogħtija flimkien.
English: 150 mg/m2.
Maltese: 150 mg/m 2 (ara sezzjoni 5.1).
English: Temsirolimus distribution is dose-dependent with mean (10th, 90th percentiles) maximal specific binding in blood cells of 1.4 mg (0.47 to 2.5 mg).
Maltese: Iddistribuzzjoni ta' temsirolimus tiddependi mid-doża, bil-medja (l-10 u d-90 percentiles) tat-twaħħil speċifiku massimu fiċ-ċelluli tad-demm ta' 1.4 mg (0.47 sa 2.5 mg).
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: The most serious reactions observed with temsirolimus in clinical trials are hypersensitivity/infusion reactions (including some life-threatening and rare fatal reactions), hyperglycaemia/glucose intolerance, infections, interstitial lung disease (pneumonitis), hyperlipaemia, intracranial haemorrhage, renal failure, intestinal perforation, wound healing complication, thrombocytopenia, neutropenia (including febrile neutropenia), pulmonary embolism.
Maltese: L-aktar reazzjonijiet serji osservati b'temsirolimus fil-provi kliniċi huma reazzjonijiet ta' sensittività eċċessiva/għall-infużjoni (li jinkludu xi reazzjonijiet li huma ta' periklu għall-ħajja u reazzjonijiet fatali rari), ipergliċemija/intolleranza għal glucose, infezzjonijiet, mard interstizjali tal-pulmuni (pnewmonite), iperlipemija, emorraġija fil-kranju, insuffiċjenza renali, perforazzjoni intestinali, kumplikazzjoniet fil-fejqan tal-feriti, tromboċitopenija, newtropenija (inkluża newtropenija bid-deni), emboliżmu pulmonari.
English: Very common Dyspnoeaa Epistaxis **
Maltese: Komuni ħafna Dispneja Epistassi **
English: Temsirolimus was found to be ineffective in paediatric patients with neuroblastoma, rhabdomyosarcoma, and high-grade glioma (n = 52).
Maltese: Instab li temsirolimus ma kienx effettiv f'pazjenti pedjatriċi li kellhom newroblastoma, rabdomijosarkoma, u glijoma ta' grad għoli (n = 52).
English: Inhibition of mTOR activity results in a G1 growth delay at nanomolar concentrations and growth arrest at micromolar concentrations in treated tumour cells resulting from selective disruption of translation of cell cycle regulatory proteins, such as D-type cyclins, c-myc, and ornithine decarboxylase.
Maltese: L-inibizzjoni tal-attività ta' mTOR tirriżulta f'dewmien tat-tkabbir G1 f'konċentrazzjonijiet nanomolari u waqfien fit-tkabbir f'konċentrazzjonijiet mikromolari fiċ-ċelluli tat-tumur li jkunu kkurati, li jirriżulta mill-interruzzjoni selettiva tal-bdil tal-proteini regulatorji taċ-ċiklu taċ-ċelluli, bħal cyclins ta' tip D, c-myc, u ornithine decarboxylase.
English: Adverse reactions that were reported in post-marketing experience are listed below (Table 2).
Maltese: Ir-reazzjonijiet avversi li kienu rrappurtati fl-esperjenza ta' wara t-tqegħid fis-suq huma elenkati hawn taħt (Tabella 2).
English: c Compared with inv choice based on log-rank test. d Compared with inv choice alone based on Fisher's exact test.
Maltese: Meta mqabbel mal-għażla tal-investigatur waħidha bbażat fuq il-Fisher's exact test.
English: Temsirolimus also was associated with statistically significant advantages over investigator's choice in the secondary endpoint of ORR.
Maltese: Temsirolimus kien assoċjat ukoll ma' vantaġġi statistikament sinifikanti fuq l-għażla tal-investigatur fl-endpoint sekondarju tar-rata tar-rispons totali (ORR).
English: Nail disorder Ecchymosis*** Petechiae***
Maltese: Disturb fid-dwiefer Ekkimożi*** Tbenġil***
English: In 23 healthy subjects the concentration of desipramine, a CYP2D6 substrate, was unaffected when 25 mg of temsirolimus was co-administered.
Maltese: Fi 23 individwu b'saħħithom il-konċentrazzjoni ta' desipramine, substrat ta' CYP2D6, ma kinitx affettwata meta ġie ko-amministrat 25 mg ta' temsirolimus.
English: The use of temsirolimus was associated with increases in serum triglycerides and cholesterol.
Maltese: L-użu ta' temsirolimus kien assoċjat ma' żidiet fit-triglycerides u l-kolesterol fis-serum.
English: Overall survival Months (95% CI)
Maltese: Proporzjon talperiklu (95% CI)
English: • Inject the withdrawn volume rapidly into 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to ensure adequate mixing.
Maltese: • Injetta l-volum li jkun inġibed malajr ġo 250 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni biex ikun żgurat taħlit adegwat.
English: Rhinitis
Maltese: Rinite
English: Clear glass vial (type 1), with butyl rubber stopper and a plastic flip-top closure sealed with aluminum containing 1.2 ml of concentrate
Maltese: Kunjett ta' ħġieġ ċar (ħġieġ ta' tip 1), b'tapp tal-lastku tal-butyl u għatu flip-top tal-plastik issiġillat bl-aluminju li fih 1.2 ml ta' konċentrat
English: a Based on log-rank test stratified by prior nephrectomy and region.
Maltese: Ibbażata fuq it-test log-rank, stratifikat skond in-nefrektomija fil-passat u skond ir-reġjun.
English: Median PFS of the temsirolimus 175/75 mg group (4.8 months) was prolonged by 2.9 months compared to the investigator's choice group (1.9 months).
Maltese: Il-medjan tal-PFS tal-grupp li ngħata temsirolimus 175/75 mg (4.8 xhur) kien imtawwal b'2.9 xhur meta mqabbel mal-grupp li ngħata l-għażla tal-investigatur (1.9 xhur).
English: However, in vitro studies in human liver microsomes followed by physiologically-based pharmacokinetic modelling indicate that the blood concentrations achieved after a 175 mg dose of temsirolimus most likely leads to relevant inhibition of CYP3A4/5 (see section 5.2).
Maltese: Madankollu, fi studji in vitro f'mikrosomi tal-fwied uman segwiti minn immudellar farmakokinetiku bbażat fuq il-fiżjoloġija jindikaw li l-konċentrazzjonijiet tad-demm miksuba wara doża ta' 175 mg ta' temsirolimus, jistgħu possibbilment iwasslu għal inibizzjoni relevanti ta' CYP3A4/5 (ara sezzjoni 5.2).
English: In Part 1, 14 patients aged from 1 to 17 years with advanced recurrent/refractory solid tumours received temsirolimus at doses ranging from 10 mg/m2 to
Maltese: F'Parti 1, 14-il pazjent li kellhom minn sena sa 17-il sena u li kellhom tumuri solidi avvanzati rikorrenti/refrattarji, irċivew temsirolimus f'dożi li jvarjaw minn 10 mg/m2 sa 150 mg/m2.
English: Following administration of a single 25 mg intravenous dose of temsirolimus in patients with cancer, mean Cmax in whole blood was 585 ng/ml (coefficient of variation [CV] = 14%), and mean AUC in blood was 1627 ng•h/ml (CV = 26%).
Maltese: Wara l-għoti ta' doża waħda ta' 25 mg ġol-vini ta' temsirolimus f'pazjenti bil-kanċer, il-medja tas-Cmax fid-demm sħiħ kienet ta' 585 ng/ml (koeffiċjent tal-varjazzjoni, CV = 14%), u lmedja ta' l-AUC fid-demm kienet ta' 1627 ng•h/ml (CV = 26%).
English: Co-administration of temsirolimus 5 mg with ketoconazole, a potent CYP3A4 inhibitor, had no significant effect on temsirolimus Cmax or AUC; however, sirolimus AUC increased 3.1-fold, and AUCsum (temsirolimus + sirolimus) increased 2.3-fold compared to temsirolimus alone.
Maltese: L-għoti flimkien ta' temsirolimus 5 mg ma' ketoconazole, inibitur qawwi ta' CYP3A4 , ma kellu lebda effett sinifikanti fuq is-Cmax jew l-AUC ta' temsirolimus; madankollu, l-AUC ta' sirolimus żdied bi 3.1 darbiet, u l-AUCsum (temsirolimus + sirolimus) żdied bi 2.3 darbiet meta mqabbel ma' temsirolimus waħdu.
English: In RCC clinical trial 1, temsirolimus 25 mg was associated with a statistically significant advantage over IFN-α in the primary endpoint of OS at the 2nd pre-specified interim analysis (n = 446 events,
Maltese: Fil-prova klinika RCC 1, temsirolimus 25 mg kien assoċjat ma' vantaġġ statistikament sinifikanti fuq IFN- fir-riżultat aħħari primarju ta' OS fit-2
English: The adverse reactions (all grades) experienced by at least 20% of the patients in RCC and MCL registration studies include anaemia, nausea, rash (including rash, pruritic rash, maculopapular rash, pustular rash), decreased appetite, oedema asthenia, fatigue, thrombocytopenia, diarrhoea, pyrexia, epistaxis, mucosal inflammation, stomatitis, vomiting, hyperglycaemia, hypercholesterolemia, dysgeusia, pruritus, cough, infection, pneumonia, dyspnoea.
Maltese: Ir-reazzjonijiet avversi (il-gradi kollha) esperjenzati tal-anqas minn 20% tal-pazjenti fl-istudji ta' reġistrazzjoni dwar RCC u MCL jinkludu anemija, nawseja, raxx (li jinkludi raxx, raxx pruritiku, raxx makulopapulari bl-infafet, raxx bil-ponot), tnaqqis fl-aptit, edema, astenja, għeja, tromboċitopenija, dijarea, deni, epistassi, infjammazzjoni fil-mukuża, stomatite, rimettar, ipergliċemija, iperkolesterolemija, disgewżja, ħakk, sogħla, infezzjoni, pnewmonja, dispneja.
English: Uncommon Pulmonary embolism a
Maltese: Effużjoni plewrali a,b
English: The Torisel concentrate must first be diluted with 1.8 ml of the supplied solvent to achieve a concentration of 10 mg/ml before administration in sodium chloride 9 mg/ml (0.9%) solution for injection (see dilution instructions at the end of the package leaflet).
Maltese: Il-konċentrat Torisel 30 mg irid l-ewwel ikun dilwit b'1.8 ml tas-solvent fornut biex tinkiseb konċentrazzjoni ta' 10 mg/ml qabel l-għoti f'soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%) (ara l-istruzzjonijiet dwar id-dilwizzjoni fit-tmiem tal-fuljett ta' tagħrif).
English: Very common Rash (including rash, pruritic rash, maculo-papular rash, rash, generalised rash, macular rash, papular rash) Pruritus (including pruritus generalised)
Maltese: Komuni ħafna Raxx (li jinkludi raxx, rakk bil-ħakk, raxx makulopapulari, raxx ġeneralizzat, maxx makulari, raxx papulari)
English: Median overall survival, Months (95% CI) Median progression-free survival by independent assessment
Maltese: Medjan talProgressjoniSopravivenza Ħielsa minn evalwazzjoni indipendenti Xhur (95% CI) Medjan talProgressjoniSopravivenza Ħielsa minn evalwazzjoni mill-investigatur Xhur (95% CI) Rata tar-rispons globali minn evalwazzjoni indipendenti % (95% CI)
English: The effect may also be more pronounced at a 25 mg dose.
Maltese: L-effett jista' jkun ukoll aktar prominenti f'doża ta' 25 mg.
English: Based on a whole blood mean Cmax concentration of 2.6 μM for temsirolimus in MCL patients receiving the 175 mg dose there is a potential for interactions with concomitantly administered medicinal products that are substrates of CYP3A4/5 in patients treated with the 175 mg dose of temsirolimus (see section 4.5).
Maltese: Ibbażat fuq konċentrazzjoni medja tas-Cmax fid-demm sħiħ ta' 2.6 μM għal temsirolimus f'pazjenti b'MCL li kienu qed jirċievu d-doża ta' 175 mg, hemm il-potenzjal għal interazzjonijiet ma' prodotti mediċinali li jingħataw fl-istess ħin li huma substrati ta' CYP3A4/5 f'pazjenti kkurati bid-doża ta' 175 mg ta' temsirolimus (ara sezzjoni 4.5).
English: Temsirolimus was not genotoxic in a battery of in vitro (bacterial reverse mutation in Salmonella typhimurium and Escherichia coli, forward mutation in mouse lymphoma cells, and chromosome aberrations in Chinese hamster ovary cells) and in vivo (mouse micronucleus) assays.
Maltese: Temsirolimus ma kienx ġenotossiku f'sensiela ta' assaġġi in vitro (mutazzjoni reverse batterjali f'Salmonella typhimurium u Escherichia coli, mutazzjoni forward fiċ-ċelluli tal-limfoma tal-ġrieden, u aberrazzjonijiet tal-kromosoma fiċ-ċelluli ta' l-ovarju tal-ħamster Ċiniż, u in vivo (mikronukleu talġrieden).
English: PVC bags and medical devices must not be used for the administration of preparations containing polysorbate 80, because polysorbate 80 leaches DEHP from PVC.
Maltese: Boroż tal-PVC u tagħmir mediku ma jridux jintużaw għall-għoti ta' preparazzjonijiet li jkun fihom polysorbate 80, għax polysorbate 80 jerħi DEHP mill-PVC.
English: For patients with severe hepatic impairment, a reduction of the temsirolimus dose to 10 mg is recommended to provide temsirolimus plus sirolimus exposures in blood (mean AUCsum approximately 6510 ng·h/ml; n=7), which approximate to those following the 25 mg dose (mean AUCsum approximately 6580 ng·h/ml; n=6) in patients with normal liver function (see sections 4.2 and 4.4).
Maltese: Għal pazjenti b'indeboliment sever tal-fwied, hu rakkomandat tnaqqis tad-doża ta' temsirolimus għal 10 mg biex tipprovdi espożizzjonijiet ta' temsirolimus flimkien ma' sirolimus fid-demm (medja talAUCsum madwar 6510 ng·h/ml; n=7), li joqorbu dawk li jkun hemm wara doża ta' 25 mg (medja talAUCsum madwar 6580 ng·h/ml; n=6) f'pazjenti b'funzjoni normali tal-fwied (ara sezzjonijiet 4.2 u
English: Mucosal inflammation Pyrexia
Maltese: Popolazzjoni pedjatrika
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to or even lower than clinical exposure levels and with possible relevance to clinical use, were as follows: pancreatic islet cell vacuolation (rat), testicular tubular degeneration (mouse, rat and monkey), lymphoid atrophy (mouse, rat and monkey), mixed cell inflammation of the colon/caecum (monkey), and pulmonary phospholipidosis (rat).
Maltese: Reazzjonijiet avversi li ma kinux osservati fi studji kliniċi, iżda li kienu osservati fl-annimali f'livelli ta' espożizzjoni simili għal, jew anki iktar baxxi mil-livelli ta' espożizzjoni klinika, u b'rilevanza possibbli għall-użu kliniku, kienu kif ġej: vakwolazzjoni taċ-ċelluli islet pankreatiċi (firien), deġenerazzjoni tubulari testikulari (fil-ġrieden, fil-firien u fix-xadini), atrofija limfojde (fil-ġrieden, fil-firien u fix-xadini), infjammazzjoni taċ-ċelluli mħallta tal-kolon/cecum (fix-xadini), u fosfolipidosi pulmonari (fil-firien).