FrancophonIA/ELRC3.0 huggingface dataset:
English: Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4).
Maltese: Bħala mediċina waħidha, Pazenir huwa indikat għat-trattament ta' kanċer metastatiku tas-sider f'pazjenti adulti fejn it-trattament inizjali jkun falla u li għalihom it-terapija standard li jkun fiha anthracycline ma tkunx indikata (ara sezzjoni 4.4).
English: There have been rare reports of reduced visual acuity due to cystoid macular oedema during treatment with human serum albumin-paclitaxel nanoparticles.
Maltese: Kien hemm rapporti rari ta' tnaqqis fiċ-ċarezza tal-vista minħabba edima makulari ċistojde matul it trattament b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel.
English: Common: Hyperbilirubinaemia
Maltese: Komuni: Newtropenija bid-deni
English: Paclitaxel and gemcitabine do not share a common metabolic pathway.
Maltese: Paclitaxel u gemcitabine ma jużawx l-istess passaġġ metaboliku.
English: Medical or healthcare professionals
Maltese: U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: • Dizziness
Maltese: • Tinfaraġ
English: For metastatic breast cancer patients and non-small cell lung cancer patients with moderate to severe hepatic impairment (total bilirubin > 1.5 to ≤ 5 x ULN and AST ≤ 10 x ULN), a 20% reduction in dose is recommended.
Maltese: Flimkien ma' dan, Pazenir mhuwiex rakkomandat f'pazjenti b'adenokarċinoma metastatika tal-frixa li jkollhom indeboliment moderat sa sever tal-fwied (bilirubina totali ta' > 1.5 x ULN u AST ta'≤ 10 x ULN) (ara sezzjoni 5.2).
English: Human serum albumin-paclitaxel nanoparticles (100mg/m2/week) + carboplatin (N=521)
Maltese: Nanopartiċelli ta' albumina tas serum uman-paclitaxel (125 mg/m2)/ gemcitabine (N=431)
English: A higher median cumulative dose of gemcitabine was delivered in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm (11400 mg/m2) when compared with the gemcitabine arm (9000 mg/m2).
Maltese: albumina tas-serum uman-paclitaxel/gemcitabine (11,400 mg/m2) meta mqabbel mal-parti talistudju b'gemcitabine (9000 mg/m2).
English: Pharmacokinetic/pharmacodynamic modelling using data from 125 patients with advanced solid tumours indicates that patients ≥ 65 years of age may be more susceptible to development of neutropenia within the first treatment cycle, although the plasma paclitaxel exposure is not affected by age.
Maltese: Mudell ta' farmakokinetika/farmakodinamika bl-użu ta' data minn 125 pazjent b'tumuri solidi avvanzati jindika li pazjenti ≥ 65 sena jafu jkunu iktar suxxettibbli għall-iżvilupp ta' newtropenija matul l-ewwel ċiklu ta' trattament.
English: Monitor patients closely for signs and symptoms of pneumonitis.
Maltese: Immonitorja millqrib il-pazjenti kollha għal sinjali u sintomi ta' pulmonite.
English: Rare: Extravasation
Maltese: 1: Sensittività eċċessiva
English: MedDRA = Medical Dictionary for Regulatory Activities: SMQ = Standardized MedDRA Query 1 Based on laboratory assessments: maximal degree of myelosuppression (treated population) 2 Peripheral neuropathy is evaluated using the SMQ neuropathy (broad scope) 3 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Maltese: 2 Newropatija periferali tiġi evalwata bl-użu ta' SMQ newropatija (skop wiesgħa) 3 Il-pnewmonite tiġi evalwata bl-użu ta' SMQ mard tal-interstizju tal-pulmuni (skop wiesgħa)
English: For patients with total bilirubin > 5 x ULN or AST > 10 x ULN, there are insufficient data to permit dosage recommendations regardless of indication (see sections 4.4 and 5.2).
Maltese: Għal pazjenti b'bilirubina totali ta' > 5 x ULN jew AST ta' > 10 x ULN, m'hemmx biżżejjed data biex tippermetti rakkomandazzjonijiet dwar id-dożaġġ irrispettivament mill-indikazzjoni (ara sezzjonijiet 4.4 u 5.2).
English: Blood and lymphatic system disorders1
Maltese: Disturbi tad-demm u tas-sistema limfatika1
English: The recommended dose of Pazenir is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
Maltese: Id-doża rakkomandata ta' Pazenir hi ta' 260 mg/m2 li tingħata fil-vina fuq perjodu ta' 30 minuta kull
English: Hepatobiliary disordesrs
Maltese: Dispersjoni rikostitwita
English: Based on population pharmacokinetic analysis, the total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni, il-volum totali tad-distribuzzjoni hu ta' madwar 1,741 L; il-volum kbir ta' distribuzzjoni jindika distribuzzjoni extravaskulari estensiva u/jew irbit ta' paclitaxel mat-tessut.
English: Gastrointestinal disorders Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.
Maltese: Kien hemm dardir f'29% tal-pazjenti u dijarea f'25% tal-pazjenti.
English: • Severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Maltese: • Infjammazzjoni severa/joħorġu leżjonijiet tal-ġilda u tal-membrani mukużi (sindrome ta'
English: Hypersensitivity to the active substance or to any of the excipients listed in section Breast-feeding (see section 4.6).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1. Treddigħ (ara sezzjoni 4.6).
English: Fir st
Maltese: FEJN MA
English: The effectiveness and safety of human serum albumin-paclitaxel nanoparticles in patients with central nervous system (CNS) metastases has not been established.
Maltese: L-effettività u s-sigurtà ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel f'pazjenti b'metastasi fis-sistema nervuża ċentrali (CNS - central nervous system) ma kinux stabbiliti.
English: • Pain in the muscles
Maltese: • Uġigħ fil-muskoli
English: Common: Sepsis, pneumonia, oral candidiasis
Maltese: Komuni: Sepsis, pnewmonja, kandidijasi tal-ħalq
English: Table 6: Adverse reactions reported with human serum albumin-paclitaxel nanoparticlesmonotherapy at any dose in clinical studies
Maltese: Tabella 6: Reazzjonijiet avversi rrappurtati b'monoterapija ta' nanopartiċelli ta' albumina tas serum uman-paclitaxel fi kwalunkwe doża fi studji kliniċi
English: When reconstituted, Pazenir concentrate contains 4.2 mg of sodium per ml.
Maltese: Meta rikostitwit, konċentrat ta' Pazenir ikun fih 4.2 mg ta' sodium f'kull ml.
English: *Survival [95% CI] (weeks) > 1st-line therapy
Maltese: *Sopravivenza [CI ta' 95%] (ġimgħat) > Terapija tal-ewwel għażla
English: Table 6 lists adverse reactions associated with the administration of human serum albumin-paclitaxel nanoparticles to patients from studies in which human serum albumin-paclitaxel nanoparticles has been administered as monotherapy at any dose in any indication (N = 789).
Maltese: Tabella 6 telenka reazzjonijiet avversi assoċjati mal-għoti ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel lil pazjenti minn studji li fihom ingħataw biss nanopartiċelli ta' albumina tas-serum uman-paclitaxel bħala monoterapija fi kwalunkwe doża fi kwalunkwe indikazzjoni (N = 789).
English: p-value
Maltese: a valur-Pb
English: This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.
Maltese: Din l-istabbiltà tirriżulta fl-inibizzjoni tar-riorganizzazzjoni dinamika normali tax-xibka tal-mikrotubuli li hi essenzjali għal interphase vitali u l-funzjonijiet ċellulari mitotiċi.
English: Grade 4 cutaneous toxicity, diarrhoea, or mucositis
Maltese: Tossiċità tal-ġilda, dijarea, jew mukożite ta' Grad 4
English: Reduce subsequent dose only if criteria in Table 4 are met.
Maltese: Naqqas id-doża sussegwenti biss jekk il-kriterji f'Tabella 4 jiġu ssodisfati.
English: Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Maltese: Paclitaxel hu sustanza kontra l-mikrotubuli li tgħin fil-bini ta' mikrotubuli minn dimers tat-tubulin u tistabbilizza l-mikrotubuli billi tfixkel id-dipolimerizzazzjoni.
English: Randomised comparative study
Maltese: Studju każwali komparattiv
English: Stability of the reconstituted dispersion in the infusion bag Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2°C-8°C, protett minn dawl qawwi, segwit minn perjodu ta' 4 sigħat f'temperatura ta' 15°C-25°C.
English: Pharmacokinetic interactions between Pazenir and gemcitabine have not been evaluated in humans.
Maltese: Interazzjonijiet farmakokinetiċi bejn Pazenir u gemcitabine ma ġewx evalwati fil-bnedmin.
English: Resume Pazenir at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Maltese: Erġa' kompli b'Pazenir b'doża mnaqqsa meta n-newropatija periferali titjieb għal Grad 0 jew 1 (ara sezzjoni 4.2).
English: 2 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Maltese: 2 Il-pnewmonite tiġi evalwata bl-użu ta' SMQ mard interstizjali tal-pulmuni (ambitu wiesgħa)
English: Delay of next cycle due to persistent neutropenia2 (Nadir
Maltese: Komuni ħafna: Newropatija periferali2
English: Day 15: If Day 8 doses were given without modification:
Maltese: Jekk id-dożi ta' Ġurnata 8 kienu ġew imnaqqsa:
English: For patients with mild hepatic impairment (total bilirubin > 1 to ≤ 1.5 x ULN and aspartate aminotransferase [AST] ≤ 10 x ULN), no dose adjustments are required, regardless of indication.
Maltese: Pazjenti b'indeboliment tal-fwied Għal pazjenti b'indeboliment ħafif tal-fwied (bilirubina totali ta' > 1 sa ≤ 1.5 x ULN u aspartate aminotransferase [AST] ta' ≤ 10 x ULN), l-ebda aġġustamenti fid-doża mhuma meħtieġa,
English: Efficacy Parameter
Maltese: Parametru ta' Effikaċja
English: Common: Febrile neutropenia Rare: Pancytopenia
Maltese: Mhux komuni: Panċitopenija
English: From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be filled into an infusion bag immediately.
Maltese: Minn perspettiva mikrobijoloġika, sakemm il-metodu talftuħ/rikostituzzjoni/dilwizzjoni ma jipprekludix ir-riskji ta' kontaminazzjoni bil-mikrobi, il-prodott għandu jimtela f'borża tal-infużjoni immedjatament.
English: Very common: Alopecia, rash Common: Pruritus, dry skin, nail disorder, flushing
Maltese: Komuni ħafna: Alopeċja, raxx Komuni: Ħakk, ġilda xotta, disturbi fid-dwiefer, fwawar
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed before treatment is considered (see section 4.4).
Maltese: Pazjenti b'adenokarċinoma tal-frixa li jkollhom 75 sena u iktar għandhom jiġu evalwati bir-reqqa qabel jiġi kkunsidrat it-trattament (ara sezzjoni 4.4).
English: • Abdominal pain
Maltese: • Reazzjoni allerġika
English: Table 7: Adverse reactions reported with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine (N=421)
Maltese: Reazzjonijiet avversi rrappurtati b'nanopartiċelli ta' albumina tas-serum uman paclitaxel flimkien ma' gemcitabine (N=421)
English: Common: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, weight decreased
Maltese: Komuni: Żieda f'alanine aminotransferase, żieda f'aspartate aminotransferase, żieda ta' alkaline phosphatase fid-demm, tnaqqis fil-piż MedDRA = Medical Dictionary for Regulatory Activities:
English: Uncommon: Dysuria, pollakiuria, haematuria, nocturia, polyuria, urinary incontinence
Maltese: Komuni ħafna: Dijarea, rimettar, dardir, stitikezza
English: From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be used immediately.
Maltese: Minn perspettiva mikrobijoloġika, sakemm il-metodu tal-ftuħ/rikostituzzjoni/dilwizzjoni ma jipprekludix ir-riskji ta' kontaminazzjoni bil-mikrobi, il-prodott għandu jintuża immedjatament.
English: Platelet count (cells/mm3)
Maltese: Għadd ta' Plejtlits (ċelluli/mm3)
English: Withhold dose until improves to
Maltese: Sopravivenza mingħajr Progressjoni
English: Very common: Dehydration, decreased appetite, hypokalaemia
Maltese: Komuni: Deidratazzjoni, nuqqas t'aptit, ipokalimja
English: However, a subsequent analysis in 981 patients receiving human serum albumin-paclitaxel nanoparticles monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years.
Maltese: 15% kellhom ≥ 65 sena u 2% kellhom ≥ 75 sena, uriet inċidenza ogħla ta' ħruġ ta' demm mill imnieħer, dijarea, deidratazzjoni, għejja u edima periferali f'pazjeni ta' ≥ 65 sena.
English: • medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic), and including medicines for treating fungal infections (e.g. ketoconazole)
Maltese: • mediċini għat-trattament ta' infezzjonijiet (i.e. antibijotiċi bħal erythromycin, rifampicin, eċċ.;
English: Dose adjustments during treatment of pancreatic adenocarcinoma
Maltese: Aġġustamenti fid-doża matul it-trattament ta' adenokarċinoma tal-frixa
English: Table 2: Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma Cycle Day
Maltese: Tabella 2: Modifikazzjonijiet tad-doża għal newtropenija u/jew tromboċitopenija fil-bidu ta' ċiklu jew matul ċiklu għal pazjenti b'adenokarċinoma tal-frixa
English: There was no statistically significant difference in progression-free survival (by blinded radiologist assessment) and overall survival between the two treatment arms.
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti fis-sopravivenza ħielsa mill-progressjoni (permezz ta' evalwazzjoni blinded minn radjologu) u s-sopravivenza globali bejn iż-żewġ partijiet tal-istudju dwar it-trattament.
English: Uncommon: Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, loose stools, oesophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal haemorrhage
Maltese: Mhux komuni: Problemi biex tibla', gass, glossodinja (uġigħ fl-ilsien), ħalq xott, uġigħ tal-ħanek, purgar maħlul, esofaġite, uġigħ fin-naħa t'isfel taż-żaqq, ulċeri fil-ħalq, uġigħ fil-ħalq, emorraġija mir-rektum
English: Uncommon: Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism
Maltese: Komuni: Pulmonite interstizjali3, qtugħ ta' nifs, tinfaraġ, uġigħ fil-farinġi u l-larinġi, sogħla, rinite, tnixxija żejda mill-imnieħer Mhux komuni: Sogħla bil-katarru, qtugħ ta' nifs bl-istrapazz, konġestjoni tas-sinus, tnaqqis fil-ħsejjes tan-nifs, ħruġ ta' likwidu mill-plewra, rinite allerġika, tinħanaq, konġestjoni nażali, nixfa nażali, tħarħir, emboli pulmonari, tromboemboliżmu pulmonari
English: The effect of hepatic impairment on population pharmacokinetics of human serum albumin-paclitaxel nanoparticles was studied in patients with advanced solid tumours.
Maltese: L-effett tal-indeboliment tal-fwied fuq il-farmakokinetika tal-popolazzjoni ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel ġie studjat f'pazjenti b'tumuri solidi avvanzati.
English: Batch:
Maltese: Komuni:
English: The uncommon side effects may affect up to 1 in 100 people:
Maltese: L-effetti sekondarji mhux komuni jistgħu jaffettwaw sa persuna waħda minn kull 100:
English: Breast cancer (human serum albumin-paclitaxel nanoparticles administered as monotherapy)
Maltese: Kanċer tas-sider (nanopartiċelli ta' albumina tas-serum uman-paclitaxel mogħtija bħala monoterapija)
English: Patients should not be retreated with subsequent cycles of Pazenir until neutrophils recover to >1500 cells/mm3 and platelets recover to >100,000 cells/mm3 (see section 4.2).
Maltese: Il-pazjenti m'għandhomx ikunu ttrattati mill-ġdid b'ċikli oħra ta' Pazenir sakemm innewtrofili jirkupraw għal > 1,500 ċellula/mm3 u l-plejtlits jirkupraw għal > 100,000 ċellula/mm3 (ara sezzjoni 4.2).
English: Human serum albumin-paclitaxel nanoparticles were administered to patients (N=521) as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle without any steroid premedication and without granulocyte colony stimulating factor prophylaxis.
Maltese: 30 minuta b'doża ta' 100 mg/m2 f'Jiem 1, 8 u 15 ta' kull ċiklu ta' 21 jum mingħajr l-ebda premedikazzjoni ta' sterojdi u mingħajr profilassi bil-fattur li jistimula l-kolonji tal-granuloċiti.
English: For Grade 2 or 3 cutaneous toxicity, Grade 3 diarrhoea, or Grade 3 mucositis, interrupt treatment until the toxicity improves to ≤ Grade 1, then restart treatment according to the guidelines in Table 5.
Maltese: Għal tossiċità tal-ġilda ta' Grad 2 jew 3, dijarea ta' Grad 3, jew mukożite ta' Grad 3, waqqaf it trattament sakemm it-tossiċità titjieb għal ≤ Grad 1, imbagħad ibda t-trattament mill-ġdid skont il-linji gwida f'Tabella 5.
English: Of the 421 patients with pancreatic adenocarcinoma in the randomized study who received human serum albumin-paclitaxel nanoparticles in combination with gemcitabine, 41% were 65 years and older and 10% were 75 years and older.
Maltese: Mill-421 pazjent b'adenokarċinoma tal-frixa fl-istudju li fih il-parteċipanti ntgħażlu b'mod każwali, li rċivew nanopartiċelli ta' albumina tas-serum uman-paclitaxel flimkien ma' gemcitabine, 41% kellhom 65 sena u iktar u 10% kellhom 75 sena u iktar.
English: • Coughing up blood
Maltese: • Tertir ta' bard
English: This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as human serum albuminpaclitaxel nanoparticles 260 mg/m2 given as a 30 minute infusion without premedication (N = 229).
Maltese: Din il-prova klinikab'ħafna ċentri saret f'pazjenti b'kanċer metastatiku tas-sider, li kienu ttrattati kull 3 ġimgħat b'paclitaxel waħdu, bħala paclitaxel ibbażat fuq is-solvent 175 mg/m2 mogħti bħala infużjoni ta' 3 sigħat bi premedikazzjoni biex tiġi evitata s-sensittività eċċessiva (N = 225), jew bħala nanopartiċelli ta' albumina tas-serum uman-paclitaxel 260 mg/m2 mogħtija bħala infużjoni ta'
English: The non-inferiority criterion was met for both PFS and OS with the upper bound of the 95% confidence interval for the associated hazard ratios being less than 1.176 (Table 13).
Maltese: għal proporzjonijiet ta' periklu assoċjati li kien inqas minn 1.176 (Tabella 13).
English: MedDRA = Medical Dictionary for Regulatory Activities; SMQ = Standardized MedDRA Query (a grouping of several MedDRA preferred terms to capture a medical concept).
Maltese: SMQ = Standardized MedDRA Query (Stħarriġ standardizzat tal-MedDRA - ġabra ta' diversi termini ppreferuti talMedDRA biex jinkiseb kunċett mediku).
English: Table 8: Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial Human serum albuminpaclitaxel nanoparticles (125 mg/m2)/ Gemcitabine
Maltese: Nanopartiċelli ta' albumina tas-serum uman-paclitaxel (125 mg/m2)/ Gemcitabine
English: Patients who have baseline neutrophil counts <1500 cells/mm
Maltese: Pazjenti li jkollhom għadd tan-newtrofili fil-linja bażi ta' < 1,500 ċellula/mm3.
English: Following human serum albumin-paclitaxel nanoparticles administration to patients with solid tumours, paclitaxel is evenly distributed into blood cells and plasma and is highly bound to plasma proteins (94%).
Maltese: paclitaxel jiġi distribwit b'mod konsistenti ġoċ-ċelluli tad-demm u l-plażma u jeħel ħafna mal-proteini tal-plażma (94%).
English: Pharmacokinetic/pharmacodynamic modeling indicates that there is no correlation between hepatic function (as indicated by the baseline albumin or total bilirubin level) and neutropenia after adjusting for human serum albumin-paclitaxel nanoparticles exposure.
Maltese: Immudellar farmakokinetiku/farmakodinamiku jindika li m'hemm l-ebda korrelazzjoni bejn ilfunzjoni tal-fwied (kif indikat mil-livell ta' albumina fil-linja bażi jew ta' bilirubina totali) u newtropenija wara li tiġi aġġustata għall-esponiment ta' nanopartiċelli ta' albumina tas-serum uman paclitaxel.
English: After ruling out infectious etiology and upon making a diagnosis of pneumonitis, permanently discontinue treatment with Pazenir and gemcitabine and promptly initiate appropriate treatment and supportive measures (see section 4.2).
Maltese: Wara li teskludi etjoloġija infettiva u wara li tagħmel dijanjosi ta' pulmonite, waqqaf it-trattament b'Pazenir u gemcitabine b'mod permanenti u ibda mill-ewwel trattament u miżuri ta' appoġġ xierqa (ara sezzjoni 4.2).
English: Very common: Pain in extremity, arthralgia, myalgia Common: Muscular weakness, bone pain
Maltese: Komuni ħafna: Uġigħ fl-estremitajiet, artralġja, mijalġja Komuni: Dgħufija fil-muskoli, uġigħ fl-għadam
English: Of the 514 patients with non-small cell lung cancer in the randomized study who received human serum albumin-paclitaxel nanoparticles in combination with carboplatin, 31% were 65 years or older and 3.5% were 75 years or older.
Maltese: Mill-514-il pazjent b'kanċer tal-pulmun ta' ċelluli mhux żgħar fi studju li fih il-parteċipanti ntgħażlu b'mod każwali li rċivew nanopartiċelli ta' albumina tas-serum uman-paclitaxel flimkien ma' carboplatin, 31% kellhom 65 sena jew aktar u 3.5% kellhom 75 sena jew aktar.
English: Data from 106 patients accrued in two single-arm open-label studies and from 454 patients treated in a randomised Phase III comparative study are available to support the use of human serum albumin-paclitaxel nanoparticles in metastatic breast cancer.
Maltese: Data minn 106 pazjent li nġabret minn żewġ studji ta' fergħa waħda open-label u minn 454 pazjent mhux magħżula li kienu ttrattati fi studju komparattiv ta' Fażi
English: Very common: Neutropenia1, thrombocytopenia1, anaemia1, leukopenia1 Common: Febrile neutropenia, lymphopenia Uncommon: Pancytopenia
Maltese: Komuni ħafna: Newropatija periferali1, tibdil fis-sens tat-togħma, uġigħ ta' ras, sturdament
English: The reconstituted dispersion in the intravenous drip may be stored for up to 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Maltese: Madankollu, l-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2°C-8°C, protett minn dawl qawwi, segwit minn perjodu ta' 4 sigħat f'temperatura ta' 15°C-25°C.
English: The primary efficacy endpoint was overall response rate defined as the percentage of patients who achieved an objective confirmed complete response or partial response based on an independent, central, blinded radiological review using RECIST (Version 1.0).
Maltese: II-punt aħħari primarja tal-effikaċja kien ir-rata tar-rispons globali, definit bħala l-perċentwali ta' pazjenti li kisbu rispons sħiħ oġġettiv ikkonfermat jew rispons parzjali bbażat fuq evalwazzjoni radjuloġika indipendenti, ċentrali, blinded, bl-użu ta' RECIST (Verżjoni 1.0).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: There have been reports of tumour lysis syndrome during treatment with human serum albuminpaclitaxel nanoparticles.
Maltese: Kien hemm rapporti tas-sindrome tal-lisi tat-tumur waqt trattament b'nanopartiċelli ta' albumina tasserum uman-paclitaxel.