FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections occurred at a higher frequency in patients receiving the ZALTRAP/FOLFIRI regimen (46.2 %, all grades; 12.3 %, grade 3-4) than in patients receiving the placebo/FOLFIRI regimen (32.7%, all grades; 6.9 %, grade 3-4), including urinary tract infection, nasopharyngitis, upper respiratory tract infection, pneumonia, catheter site infection, and tooth infection.
Maltese: (46.2 %, il-gradi kollha; 12.3 %, gradi 3-4) milli f'pazjenti li kienu qed jirċievu l-kors plaċebo/FOLFIRI (32.7%, il-gradi kollha; 6.9 %, gradi 3-4 ), inkluż infezzjoni fl-apparat urinarju, nażofarinġite, infezzjoni fl-apparat respiratorju, pnewmonja, infezzjoni fis-sit tal-kateter, u infezzjoni fis-snien.
English: Frequencies are based on all grades and defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1, 000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1, 000), rari ħafna (< 1/10, 000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Grade 3-4 events occurred in 11 patients (1.8 %) treated with the ZALTRAP/FOLFIRI regimen and 3 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
Maltese: Avvenimenti tal-gradi 3-4 seħħew fi 11-il pazjent (1.8 %) ikkurati bil-kors ZALTRAP/FOLFIRI u 3 pazjenti (0.5 %) ikkurati bil-kors plaċebo/FOLFIRI .
English: Mild to moderate hypersensitivity reactions to ZALTRAP (including flushing, rash, urticaria, and pruritus) (see section 4.4)
Maltese: Reazzjonijiet ta' sensittività eċċessiva għal ZALTRAP li jvarjaw minn ħfief għal moderati (inkluż fwawar, raxx, urtikarja, u ħakk) (Ara sezzjoni 4.4)
English: Increased AST (2) Increased ALT (2)
Maltese: Żieda fl-AST (2) Żieda fl-ALT (2)
English: Analysis for OS and PFS by ECOG PS was also performed.
Maltese: Saret analiżi għall-OS u PFS permezz ta' ECOG PS.
English: In a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy, 63 patients with mild hepatic impairment (total bilirubin > 1.0 x - 1.5 x ULN and any AST) and 5 patients with moderate hepatic impairment (total bilirubin > 1.5 x - 3 x ULN and any AST) were treated with ZALTRAP.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni b'dejta minn 1507 pazjenti b'diversi tipi ta' tumuri malinni avvanzati li kienu qed jirċievu ZALTRAP bil- jew mingħajr kimoterapija, 63 pazjent b'indeboliment ħafif tal-fwied (bilirubin totali > 1.0 x - 1.5 x ULN u kull tip ta' AST) u 5 pazjenti b'indeboliment moderat tal-fwied (bilirubin totali > 1.5 x - 3 x ULN u kull tip ta' AST) kienu kkurati b'ZALTRAP.
English: In the pivotal study of MCRC patients, positive responses in the ADA assay were observed at higher levels in patients treated with the placebo/FOLFIRI regimen [18/526 (3.4 %)] than with the ZALTRAP/FOLFIRI regimen [8/521 (1.5 %)].
Maltese: Fl-istudju prinċipali ta' pazjenti b'MCRC, riżultati pożittivi fl-assaġġ ADA kienu osservati f'livelli ogħla f'pazjenti kkurati bil-kors plaċebo/FOLFIRI [18/526 (3.4 %)] milli bil-kors ZALTRAP/FOLFIRI [8/521 (1.5 %)].
English: Hypersensitivity reactions
Maltese: Sensittività eċċessiva
English: Hypersensitivity (1)
Maltese: Sensittività eċċessiva (1)
English: Arterial thromboembolic events (ATE)
Maltese: Avvenimenti tromboembolitiċi arterjali (ATE)
English: One ml of concentrate contains 25 mg aflibercept.
Maltese: Millilitru wieħed ta' konċentrat fih 25 mg aflibercept.
English: Distribution The volume of distribution of free aflibercept at steady-state is approximately 8 litres.
Maltese: Distribuzzjoni Il-volum ta' distribuzzjoni ta' aflibercept ħieles fl-istat fiss hija madwar 8 litri.
English: Linear clearance observed in the dose range of 2 to 9 mg/kg is likely due to non saturable biological mechanisms of elimination such as protein catabolism.
Maltese: It-tneħħija lineari osservata fid-doża ta' 2 sa 9 mg/kg hija x'aktarx minħabba l-mekkaniżmi bijoloġiċi mhux saturabbli ta' eliminazzjoni bħal kataboliżmu tal proteini.
English: In the pivotal study of MCRC patients, ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) were reported in 2.6 % of patients treated with the ZALTRAP/FOLFIRI regimen and 1.5 % of patients treated with the placebo/FOLFIRI regimen.
Maltese: Fl-istudju prinċipali ta' pazjenti b'MCRC, ATE (inkluż attakk temporanju ta' iskemija, inċident ċerebrovaskulari, anġina pectoris, trombus intrakardijaku, infart mijokardijaku, emboliżmu arterjali, u kolite iskemika) kienu rrappurtati f'2.6 % tal-pazjenti kkurati bil-kors ZALTRAP/FOLFIRI u f'1.5 % tal-pazjenti kkurati bil-kors plaċebo/FOLFIRI.
English: Dyspnoea Epistaxis
Maltese: Epistassi Disfonija
English: PFS (based on tumour assessment by the IRC): Significance threshold is set to 0.0001
Maltese: b PFS (ibbażat fuq valutazzjoni tat-tumur mill-IRC): il-limitu tas-sinifikanza huwa ssettjat għal 0.0001
English: • polyethylene lined PVC
Maltese: • PVC miksi bil-polyethylene
English: Arterial thromboembolism (1) Venous thromboembolism (1) Haemorrhage (1)
Maltese: Tromboemboliżmu arterjali (1) Tromboemboliżmu venali (1) Emorraġija (1)
English: A limited number of patients having moderate/severe renal impairment at baseline (N = 49) were treated with ZALTRAP.
Maltese: Numru limitat ta' pazjenti li jkollhom indeboliment renali moderat/qawwi fil-linja bażi (N = 49) kienu kkurati b'ZALTRAP.
English: ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
Maltese: ZALTRAP flimkien ma' kimoterapija b'irinotecan/5-fluorouracil/folinic acid (FOLFIRI) huwa indikat fl-adulti b'kanċer metastatiku tal-kolorektum (MCRC) li hu reżistenti għal jew kompla żviluppa wara kura li fiha oxaliplatin.
English: One vial of 4 ml contains 100 mg of aflibercept (25 mg / ml).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed ta' 4 ml fih 100 mg ta' aflibercept (25 mg/ml).
English: The incidence of diarrhoea, dizziness, asthenia, weight decrease, and dehydration was increased by ≥5% in elderly compared to younger patients.
Maltese: L-inċidenza ta' dijarea, sturdament, astenja, tnaqqis fil-piż, u desidratazzjoni żdiedet bi ≥ 5% fl-anzjani meta mqabbla ma' pazjenti iżgħar fl-età.
English: Demographics were well balanced between the treatment arms (age, race, ECOG performance status, and prior bevacizumab status).
Maltese: Id-demografija kienet ibbilanċjata tajjeb bejn il-gruppi ta' kura (età, razza, ECOG performance status, u l-istat ta' qabel ta' bevacizumab).
English: If you also have previously received or are receiving intravenous bisphosphonates dental treatment or dental surgery, (e.g. tooth extractions), should be avoided.
Maltese: Jekk qabel irċevejt ukoll jew qed tirċievi bisphosphonates minn ġol-vini, trattament dentali jew kirurġija dentali (eż. qligħ ta' snien), għandu jiġi evitat.
English: Of the 1,226 patients randomised in the study, the median age was 61 years, 58.6 % were male, 97.8 % had a baseline ECOG performance status (PS) of 0 or 1, and 2.2 % had a baseline ECOG performance status (PS) of 2.
Maltese: Mill-1226 pazjent randomizzat fl-istudju, l-età medjana kienet 61 sena, 58.6 % kienu rġiel, 97.8 % kellhom linja bażi tal-ECOG performance status (PS) ta' 0 jew 1, u 2.2 % kellhom linja bażi tal-ECOG performance status (PS) ta' 2.
English: There are no data available for patients with severe hepatic impairment (total bilirubin > 3 x ULN and any AST).
Maltese: M'hemmx dejta disponibbli għal pazjenti b'indeboliment epatiku sever (bilirubin totali >3 x ULN u kull tip ta' AST).
English: Treatment assignment was stratified by the ECOG performance status (0 versus 1 versus 2) and according to prior therapy with bevacizumab (yes or no).
Maltese: L-għażla tal-kura ttieħdet mil-ECOG performance status (0 kontra 1 kontra 2) u skont it-terapija ta' qabel bi bevacizumab (iva jew le).
English: In sexually mature female cynomolgus monkeys inhibition of ovarian function and follicular development was evidenced.
Maltese: Fix-xadini cynomolgus femminili li kienu sesswalment maturi, kien hemm evidenza ta' inibizzjoni tal-funzjoni ovarja u tal-iżvilupp follikulari.
English: Patients with thromboembolic events of Grade 3 or lower need to be closely monitored.
Maltese: Pazjenti b'avvenimenti tromboemboliċi ta' Grad 3 jew inqas jeħtieġu li jiġu mmonitorjati mill-qrib.
English: Compromised wound healing
Maltese: Fejqan kompromess tal-feriti
English: In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 69.2 % of patients treated with ZALTRAP/FOLFIRI and 56.5 % of patients treated with placebo/FOLFIRI.
Maltese: Fl-istudju prinċipali ta' pazjenti b'MCRC, dijarea (il-gradi kollha) ġiet osservata f'69.2% tal-pazjenti kkurati b'ZALTRAP/FOLFIRI u f'56.5 % tal-pazjenti kkurati bi plaċebo/FOLFIRI.
English: Severe diarrhoea
Maltese: Dijarea severa
English: Potential for compromised wound healing (wound dehiscence, anastomotic leakage) has been reported with aflibercept (see section 4.8).
Maltese: Il-potenzjal għal fejqan kompromess tal-feriti (qsim fil-ferita, tnixxija anastomotika) kienet irrappurtata b'aflibercept (ara sezzjoni 4.8).
English: Diluted solutions of ZALTRAP should be administered using infusion sets containing a 0.2 micron polyethersulfone filter.
Maltese: Soluzzjonijiet dilwiti ta' ZALTRAP għandhom jiġu amministrati bl-użu ta' settijiet ta' infużjoni li jkun fihom filtru ta' 0.2 micron magħmul mill-polyethersulfone.
English: • Dilute it to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution or 5 % glucose solution for infusion.
Maltese: 9 mg/ml (0.9 %) jew 5 % glucose soluzzjoni għall-infużjoni.
English: ZALTRAP must not be administered as an intravitreal injection (see sections 4.3 and 4.4).
Maltese: ZALTRAP m'għandux jingħata bħala injezzjoni intravitreali (ara sezzjonijiet 4.3 u 4.4).
English: Table 4 - Post-hoc analyses excluding adjuvant patients a,b
Maltese: Tabella 4 - Analiżi post-hoc li jeskludu pazjenti b'terapija awżiljarjaa, b Plaċebo/FOLFIRI (N = 550)
English: In the few patients with severe renal impairment, drug exposure was similar to that observed in patients with normal renal function.
Maltese: Fil-ftit pazjenti b'indeboliment renali sever, l-esponiment tal-mediċina kien simili għal dak osservat f'pazjenti b'funzjoni renali normali.
English: Pack size of 1 vial or 3 vials.
Maltese: Daqs tal-pakkett ta' kunjett 1 jew 3 kunjetti.
English: Gastrointestinal perforation
Maltese: Perforazzjoni gastro-intestinali
English: Skin hyperpigmentation
Maltese: Iperpigmentazzjoni tal-ġilda
English: Median PFS (95 % CI) (months)
Maltese: PFS Medjan (95% CI) (xhur)
English: In the pivotal MCRC study, 28.2 % of patients were aged ≥ 65 and < 75 and 5.4 % of patients were aged ≥ 75.
Maltese: Anzjani Fl-istudju prinċipali MCRC, 28.2 % tal-pazjenti kellhom bejn ≥ 65 u < 75 sena u 5.4 % tal-pazjenti kellhom ≥ 75 sena.
English: Elderly patients ≥65 years had an increased risk of diarrhoea, dizziness, asthenia, weight loss and dehydration.
Maltese: Pazjenti anzjani ≥ 65 sena kellhom riskju ogħla ta' dijarea, sturdament, astenja, telf ta' piż u desidratazzjoni.
English: Excessive activation of these receptors by VEGF-A can result in pathological neovascularisation and excessive vascular permeability.
Maltese: L-attivazzjoni eċċessiva ta' dawn ir-riċetturi minn VEGF-A tista' tirriżulta f'neovaskularizzazzjoni patoloġika u permeabilità vaskulari eċċessiva.
English: Aflibercept administration should be suspended for ≥ 2 grams of proteinuria/24 hours and restarted when proteinuria is <2 grams/24 hours.
Maltese: L-amministrazzjoni ta' aflibercept għandha tkun imwaqqfa meta jkun hemm ≥ 2 grammi ta' protejnurja/24 siegħa u terġa' tinbeda meta l-protejnurja tkun <2 grams/24 siegħa.
English: Population pharmacokinetics analysis and inter study comparisons did not reveal any pharmacokinetic drug-drug interaction between aflibercept and the FOLFIRI regimen.
Maltese: Analiżi farmakokinetika tal-popolazzjoni u paraguni bejn studji ma żvelawx xi interazzjoni farmakokinetika bejn aflibercept u r-reġim FOLFIRI.
English: Febrile neutropenia
Maltese: Disturbi Vaskulari
English: In full-thickness excisional and incisional skin wound models, aflibercept administration reduced fibrous response, neovascularisation, epidermal hyperplasia/re-epithelialisation, and tensile strength.
Maltese: Fil-mudelli ta' feriti fil-fond tal-ġilda kemm dawk ta' qtugħ kif ukoll ta' inċiżjoni, l-amministrazzjoni ta' aflibercept waslet għal tnaqqis fir-rata tal-għeluq tal-ġerħa, neovaskularizzazzjoni, epidermal hyperplasia/reepithelialisation, u s-saħħa tensili.
English: For additional toxicities related to irinotecan, 5-FU, or folinic acid, refer to the current respective summary of product characteristics.
Maltese: Għal tossiċitajiet addizzjonali relatati ma' irinotecan, 5-FU, jew folinic acid, irreferi għas-sommarju kurrenti tal-karatteristiċi tal-prodott rispettiv.
English: Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Maltese: Reazzjonijiet severi ta' sensittività eċċessiva (li jinkludu bronkospażmu, qtugħ ta' nifs, anġjoedema, u anafilassi) (ara sezzjonijiet 4.3 u 4.4)
English: Corresponding data in patients with RAS mutant type tumours showed a HR for OS of 0.9 (0.7-1.2) with median 12.6 and 11.2 months for aflibercept and placebo, respectively.
Maltese: HR għal OS ta' 0.9 (0.7-1.2) b'medjan ta' 12.6 u 11.2 ta' xahar għal aflibercept u plaċebo, rispettivament.
English: ZALTRAP must not be administered as an intravitreal injection (see section 4.3).
Maltese: ZALTRAP m'għandux jingħata bħala injezzjoni intravitreali (ara sezzjoni 4.3).
English: GI perforation (1)
Maltese: Fistula (1)
English: Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15 % of the total molecular mass, resulting in a total molecular weight of 115 kDa.
Maltese: Aflibercept huwa magħmul permezz ta' teknoloġija tadDNA rikombinanti użata fis-sistema ta' espressjoni mammifera (CHO) K-1 fl-ovarju tal-ħamster Ċiniż. Aflibercept hu glikoproteina dimerika b'piż molekulari tal-proteini ta' 97 kilodaltons (kDa) u fih glikosilazzjoni, li tikkostitwixxi 15% aktar tal-massa molekulari totali, u dan jirriżulta f'piż molekulari totali ta' 115 kDa.
English: Concentrate for solution for infusion (sterile concentrate).
Maltese: ZALTRAP huwa konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili).
English: Invasive dental procedures are also an identified risk factor.
Maltese: Proċeduri invasivi dentali huma wkoll fatturi ta' riskju identifikati.
English: Oropharyngeal pain Rhinorrhoea
Maltese: Popolazzjoni pedjatrika
English: Among the 1,226 randomised patients, 89.4 % and 90.2 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively, received prior oxaliplatin-based combination chemotherapy in the metastatic/advanced setting.
Maltese: Fost il-1226 pazjenti randomizzati, 89.4 % u 90.2 % tal-pazjenti kkurati bil-korsijiet plaċebo/FOLFIRI u ZALTRAP/FOLFIRI,
English: • The recommended dose is 4 mg for each kilogram of your body weight.
Maltese: • Id-doża rakkomandata hi ta' 4 mg għal kull kilogramma tal-piż tal-ġisem tiegħek.
English: Elderly (≥ 65 years of age) may be more likely to experience adverse reactions.
Maltese: Anzjani (≥ 65 sena) għandhom aktar ċans li jkollhom reazzjonijiet avversi.
English: Grade 3-4 neutropenic infection/sepsis occurred in 1.5 % of patients treated with the ZALTRAP/FOLFIRI regimen and 1.2 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Maltese: Infezzjoni/sepsis newtropenika tal-gradi 3-4 seħħet f'1.5 % tal-pazjenti kkurati bilkors ZALTRAP/FOLFIRI u f'1.2 % tal-pazjenti kkurati bil-kors plaċebo/FOLFIRI (ara sezzjoni 4.4).
English: Arterial thromboembolic events
Maltese: Avvenimenti trombotiċi u embolitiċi Avvenimenti tromboembolitiċi arterjali
English: ZALTRAP should be discontinued in patients with life-threatening (Grade 4) thromboembolic events (including pulmonary embolism) (see section 4.2).
Maltese: ZALTRAP għandu jitwaqqaf f'pazjenti li jkollhom avvenimenti tromboemboliċi (inkluż emboliżmu pulmonari) li huma ta' riskju għall-ħajja (Grad 4) (ara sezzjoni 4.2).
English: Aflibercept should be discontinued in patients with compromised wound healing requiring medical intervention (see section 4.2).
Maltese: Aflibercept għandu jitwaqqaf f'pazjenti b'fejqan kompromess tal-feriti u li jkollhom bżonn intervent mediku (ara sezzjoni 4.2).
English: OS in ITT population excluding patients who progressed during or within 6 months of adjuvant therapy demonstrated an HR (95 % CI) of 0.78 (0.68 to 0.90) [median OS (95 % CI) with Placebo/FOLFIRI 11.9 months (10.88 to 13.01) and with ZALTRAP/FOLFIRI 13.8 months (12.68 to 15.44)]
Maltese: Kif determinat skont IVRS b OS fil-popolazzjonijiet ITT waqt li jeskludu pazjenti likellhom aktar żvilup tal-marda tagħhom waqt jew fi żmien 6 xhur ta' terapija HR (95% CI) ta' 0.78 (0.68 sa 0.90) [OS medjan (95% CI) bi Plaċebo/FOLFIRI 11.9 xbur (10.
English: Dehydration (all grades) has been observed in 9.0 % of patients treated with ZALTRAP/FOLFIRI and 3.0 % of patients treated with placebo/FOLFIRI.
Maltese: Desidratazzjoni (il-gradi kollha) ġiet osservata f'9.0 % tal-pazjenti kkurati b'ZALTRAP/FOLFIRI u f'3.0 % talpazjenti kkurati bi plaċebo/FOLFIRI.
English: In the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 9 of 611 patients (1.5 %) treated with the ZALTRAP/FOLFIRI
Maltese: Fl-istudju prinċipali ta' pazjenti b'MCRC, il-fistuli (anali, enterovesikulari, enterokutaneji, kolovaġinali, siti intestinali) kienu rrappurtati f'9 minn 611-il pazjent (1.5%) ikkurati bil-kors ZALTRAP/FOLFIRI reġimen u 3 minn 605 pazjenti (0.5 %) ikkurati bil-kors plaċebo/FOLFIRI.
English: A risk to the breast-fed child cannot be excluded.
Maltese: Ir-riskju għat-tarbija li qed tiġi mredda' ma jistax jiġi eskluż.
English: • Compromised wound healing requiring medical intervention
Maltese: • Fejqan kompromess tal-feriti li jeħtieġ intervent mediku
English: Grade 3-4 GI perforation events occurred in all 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and in 2 patients (0.3 %) treated with the placebo/FOLFIRI regimen.
Maltese: Avvenimenti ta' perforazzjoni gastro-intestinali tal-gradi 3-4 seħħew fit-3 pazjenti kollha (0.5%) ikkurati bil-kors ZALTRAP/FOLFIRI u f'2 pazjenti (0.3 %) ikkurati bil-kors plaċebo/FOLFIRI.
English: Male and female fertility are likely to be compromised during treatment with aflibercept based on studies in monkeys (see section 5.3).
Maltese: Il-fertilità maskili u femminili x'aktarx tkun kompromessa waqt il-kura b'aflibercept bbażat fuq studji fix-xadini (ara sezzjoni 5.3).
English: • Posterior reversible encephalopathy syndrome (PRES) (also known as reversible posterior leukoencephalopathy syndrome (RPLS))
Maltese: • Sindromu ta' enċefalopatija posterjuri u riversibbli (PRES) (magħruf ukoll bħala sindromu ta'
English: Patients with prior bevacizumab (n (%))
Maltese: Pazjenti mingħajr bevacizumab minn qabel (n (%))
English: Metabolism and nutrition disorders Very common
Maltese: Disturbi fil-metaboliżmu u fin-nutrizzjoni
English: Most findings were considered to be related to the pharmacological activity of aflibercept.
Maltese: Ħafna mir-riżultati kienu meqjusa bħala relatati mal-attività farmakoloġika ta' aflibercept.
English: Weekly/every two weeks intravenous administration of aflibercept to cynomolgus monkeys for up to 6 months resulted in changes in the bone (effects on growth plate and the axial and appendicular skeleton), nasal cavity, kidney, ovary, and adrenal gland.
Maltese: 6 xhur kien hemm tibdiliet fl-għadam (effetti fuq l-iżvilupp u l-iskeletru assjali u appendikulari), filkavita nażali, fil-kliewi, fl-ovarji, u fil-glandola adrenali.
English: These effects were fully reversible within 8-18 weeks after the last injection.
Maltese: Dawn l-effetti kienu riversibbli kompletament fi żmien 8-18-il ġimgħa wara l-aħħar injezzjoni.
English: Patients should be monitored for signs and symptoms of cardiac failure and ejection fraction decreased.
Maltese: Il-pazjenti għandhom ikunu osservati għal sinjali u sintomi ta' insuffiċjenza kardijaka u tnaqqis fil-frazzjoni tad-demm li tiġi mitfugħa.
English: Filters made of polyvinylidene fluoride (PVDF) or nylon must not be used.
Maltese: Filtri magħmula mill-polyvinylidene fluoride (PVDF) jew nylon m'għandhomx jintużaw.
English: ZALTRAP 25 mg / ml concentration for solution for infusion aflibercept
Maltese: ZALTRAP 25 mg/ml konċentrat għal soluzzjoni għall-infużjoni aflibercept
English: In patients with RAS wild type tumours the HR (95 % CI) for OS was 0.7 (0.5-1.0) with a median OS of 16.0 months for patients treated with aflibercept, and 11.7 months for the patients treated with placebo.
Maltese: RAS tipiċi li ssib fin-natura, l-HR (95% CI) għal OS kien ta' 0.7 (0.5-1.0) b'OS medjan ta' 16.0 xhur għall-pazjenti kkurati b'aflibercept, u 11.7 xhur għall-pazjenti kkurati bi plaċebo.
English: Grade 3-4 haemorrhage including GI haemorrhage, haematuria, and post-procedural haemorrhage was reported in 2.9 % of patients receiving the ZALTRAP/FOLFIRI regimen compared with 1.7 % of patients receiving the placebo/FOLFIRI regimen.
Maltese: Emorraġija tal-Gradi 3-4 inkluż emorraġija gastro-intestinali, ematurja, u emorraġija wara l-proċedura kienet irrappurtata f'2.9% tal-pazjenti li kienu qed jieħdu l-kors ZALTRAP/FOLFIRI meta mqabbla ma' 1.7 % tal-pazjenti li rċevew il-kors plaċebo/FOLFIRI.
English: • urinary tract infection
Maltese: • infezzjoni fl-apparat urinarju
English: Ophthalmic / intravitreal use due to hyperosmotic properties of ZALTRAP (see section 4.4).
Maltese: Użu fl-għajnejn jew intravitreali minħabba n-natura iperosmolari ta' ZALTRAP (ara sezzjoni 4.4).
English: One 8 ml vial of concentrate contains 200 mg aflibercept.
Maltese: Kunjett wieħed ta' 8 ml ta' konċentrat fih aflibercept 200 mg.
English: However, results from a repeat dose toxicity study suggest there is a potential for aflibercept to impair reproductive function and fertility.
Maltese: Madankollu, studju dwar it-tossiċità b'dożi ripetuti wrew li aflibercept jista' itellef il-funzjoni riproduttiva u lfertilità.
English: Rectal haemorrhage Fistula (1) Aphthous stomatitis Haemorrhoids Proctalgia Toothache
Maltese: Kundizzjonijiet ta' astenja Nota: Reazzjonijiet avversi huma rrappurtati permezz tal-verżjoni MedDRA MEDDRA13.1 u ggradati permezz tal-NCI
English: This population pharmacokinetic analysis revealed no clinically meaningful differences in clearance or systemic exposure (AUC) of free aflibercept in patients with moderate and mild renal impairment at the 4 mg/kg dose of ZALTRAP as compared to the overall population studied.
Maltese: Din l-analiżi farmakokinetika tal-popolazzjoni ma wriet l-ebda differenza klinikament sinifikanti fit-tneħħija jew l-esponiment sistemiku (AUC) ta' aflibercept ħieles f'pazjenti b'indeboliment renali moderat u ħafif bid-doża ta' ZALTRAP 4 mg/kg meta mqabbla mal popolazzjoni ġenerali studjati.
English: • you have ever had any allergies - serious allergic reactions can happen during treatment with ZALTRAP (see section 4).
Maltese: • jekk qatt kellek xi allerġiji - reazzjonijiet allerġiċi serji jistgħu jiġru waqt il-kura b'ZALTRAP (ara sezzjoni 4).
English: 5-FU bolus should be reduced and the infusion dose reduced by 20 %.
Maltese: 5% u volum ta' distribuzzjoni ogħla ta' 20.
English: If you are a woman that could become pregnant you should use effective contraception (see “Contraception” section below for details on male and female contraception).
Maltese: Jekk inti mara li tista' toħroġ tqila għandek tuża kontraċezzjoni effettiva (ara t-taqsima Kontraċezzjoni hawn taħt għal dettalji dwar kontraċezzjoni maskili u femminili).