FrancophonIA/ELRC3.0 huggingface dataset:
English: ZALTRAP will be given with other chemotherapy medicines including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Maltese: Jingħata ma' mediċini oħra msejħa "kimoterapija", inkluż ‘5 fluorouracil',
English: • Blocking of the veins by a blood clot (also called ‘venous thrombo-embolic events'): Common (may affect up to 1 in 10 people) - this may include a blood clot in the lungs or legs.
Maltese: • Imblukkar tal-vini minn embolu (imsejħa wkoll ‘avveniment venali trombo-embolitiku'): Komuni (jista' jaffettwa sa 1 minn kull 10 persuni) - dan jista' jinkludi embolu fil-pulmun jew fis-saqajn.
English: GI perforation including fatal GI perforation has been reported in patients treated with ZALTRAP.
Maltese: Perforazzjoni gastro-intestinali inkluż perforazzjoni gastro-intestinali fatali kienu rrappurtati f'pazjenti kkurati b'ZALTRAP.
English: Arterial thromboembolism (1) Venous thromboembolism (1)
Maltese: Tromboemboliżmu arterjali (1) Tromboemboliżmu venali (1)
English: One 4 ml vial of concentrate contains 100 mg aflibercept.
Maltese: Kunjett wieħed ta' 4 ml ta' konċentrat fih aflibercept 100 mg.
English: Treatment with ZALTRAP is associated with potential for compromised wound healing (wound dehiscence, anastomotic leakage).
Maltese: Il-kura b'ZALTRAP huwa assoċjat ma' riskju li jkun hemm fejqan mhux komplet tal-feriti (qsim talferita, tnixxija anastomotika).
English: These data are exploratory and the statistical interaction test was non-significant (lack of evidence for heterogeneity in treatment effect between the RAS wild-type and RAS mutant subgroups).
Maltese: interazzjoni ma kienx sinifikanti (nuqqas ta' evidenza ta' eteroġenjità fl-effett tat-trattament bejn is sottogruppi tal-RAS tipiku li ssib fin-natura u l-RAS mutanti).
English: Dehydration (1)
Maltese: Desidratazzjoni (1)
English: 6.7 (5.72 to 8.21)
Maltese: 72 sa 8.21)
English: Proteinuria should be monitored by urine dipstick analysis and/or urinary protein creatinine ratio (UPCR) for the development or worsening of proteinuria before each aflibercept administration.
Maltese: Il-protejnurja għandha tiġi mmonitorjata permezz ta' test b'dipstick fl-awrina u/jew analiżi talproporzjon tal-proteini u l-kreatinina fl-awrina (UPCR) għall-bidu jew l-aggravar tal-protejnurja qabel kull amministrazzjoni ta' aflibercept.
English: The concentration of the final ZALTRAP solution for intravenous infusion should be kept within the range of 0.6 mg/ml to 8 mg/ml of aflibercept.
Maltese: Il-konċentrazzjoni finali tas-soluzzjoni ZALTRAP għall-infużjoni ġol-vini għandha tinżamm fil-medda ta' 0.6 mg/ml għal 8 mgml ta'
English: In other studies, severe intracranial haemorrhage and pulmonary haemorrhage/haemoptysis including fatal events have occurred in patients receiving ZALTRAP (see section 4.4).
Maltese: Fi studji oħrajn, emorraġija intrakranjali severa u emorraġija pulmonari/emoptisi inkluż avvenimenti fatali seħħew f'pazjenti li kienu qed jirċievu ZALTRAP (ara sezzjoni 4.4).
English: Stratified on ECOG performance status (0 versus 1 versus 2) and prior bevacizumab (yes versus no).
Maltese: Stratified Cochran-Mantel-Haenszel test p-value a Stratifikat fuq l-ECOG performance status (0 kontra 1 kontra 2) u bevacizumab minn qabel (iva kontra le).
English: If recurrence, the treatment should be suspended until <2 grams per 24 hours and then the dose reduces to 2 mg/kg.
Maltese: Jekk ikun hemm rikorrenza, il-kura għandha tiġi mwaqqfa sakemm <2 grammi kull 24 siegħa u mbagħad id-doża titnaqqas sa 2 mg/kg.
English: There have been no formal studies with ZALTRAP in patients with renal impairment (see section 5.2).
Maltese: Ma saru l-ebda studji formali ta' ZALTRAP f'pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: Administration of aflibercept to mice bearing xenotransplant or allotransplant tumours inhibited the growth of various cancer types.
Maltese: Amministrazzjoni ta' aflibercept lill-ġrieden li kellhom tumuri xenotransplant jew tumuri allotransplant waslet għall-inibizzjoni tal-iżvilupp ta' diversi tipi ta' kanċer.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of GI perforation (all grades) was 0.8 % for patients treated with ZALTRAP and 0.3 % for patients treated with placebo.
Maltese: III kkontrollati bil-plaċebo (popolazzjonijiet bil-kanċer tal-kolorektum, frixa, u tal-pulmun), l inċidenza ta'perforazzjoni gastro-intestinali (il-gradi kollha) kienet 0.8% għal pazjenti kkurati b'ZALTRAP u 0.3 % għal pazjenti kkurati bil-plaċebo.
English: Patients treated with ZALTRAP have an increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events.
Maltese: Pazjenti kkurati b'ZALTRAP għandhom riskju akbar ta' emorraġija, inklużi avvenimenti emorraġiċi serji u xi kultant fatali.
English: Approximately 10 % of patients (10.4 % and 9.8 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively) received prior oxaliplatin-based adjuvant chemotherapy and progressed on or within 6 months of completion of adjuvant chemotherapy.
Maltese: Madwar 10% tal-pazjenti (10.4 % u 9.8 % tal-pazjenti kkurati bil-korsijiet plaċebo/FOLFIRI u ZALTRAP/FOLFIRI, rispettivament) irċevew minn qabel kimoterapija awżiljarja bbażata fuq oxaliplatin u l-marda ppoggressat fuq jew fi żmien 6 xhur mit tmiem tal-kimoterapija awżiljarja.
English: Compromised wound healing (1)
Maltese: Fejqan kompromess tal-feriti (1)
English: • toothache
Maltese: Kunjett wieħed
English: Patients with prior bevacizumab excluding adjuvant only (n (%))
Maltese: Pazjenti bi bevacizumab minn qabel u awżiljarji esklużi biss (n (%))
English: ZALTRAP should be suspended when proteinuria ≥2 grams per 24 hours and resumed when proteinuria < 2 grams per 24 hours.
Maltese: ZALTRAP għandu jkun imwaqqaf meta jkun hemm protejnurja ≥ 2 grammi għal kull 24 siegħa u jerġa' jingħata meta proteinurja <2 grammi kull 24 siegħa.
English: Overall objective response rate by IRC
Maltese: c Ir-rata tar-rispons oġġettiv ġenerali mill-IRC
English: Grade 3-4 GI perforation events occurred in 0.8 % of patients treated with ZALTRAP and 0.2 % of patients treated with placebo (see section 4.4).
Maltese: Avvenimenti ta' perforazzjoni gastrointestinali tal-gradi 3-4 seħħew f'0.8% tal-pazjenti kkurati b'ZALTRAP u 0.2 % tal-pazjenti kkurati bil-plaċebo (ara sezzjoni 4.4).
English: VTE include deep venous thrombosis and pulmonary embolism.
Maltese: Avvenimenti tromboemboliċi fil-vini Avvenimenti tromboembolitiċi fil-vini (VTE) jinkludu trombożi tal-vini u emboliżmu pulmonari.
English: The efficacy and safety of ZALTRAP were evaluated in a randomised, double-blind, placebo-controlled study in patients with metastatic colorectal cancer who had previously been treated with an oxaliplatin-based treatment with or without prior bevacizumab.
Maltese: L-effikaċja u s-sigurtà ta' ZALTRAP kienu evalwati fi studju randomizzat, double-blind, u kkontrollat bi plaċebo f'pazjenti b'kanċer metastatiku tal-kolorektum li qabel ġew ikkurati bi trattament ibbażat fuq oxaliplatin bi jew mingħajr bevacizumab mogħti minn qabel.
English: Adverse reactions in Table 1 are defined as either any adverse clinical reaction or laboratory abnormality having ≥ 2 % greater incidence (all grades) in the aflibercept treatment group in comparison to the placebo treatment group in the MCRC study including those that do not meet this threshold but were consistent with the anti-VEGF class and were seen in any study with aflibercept.
Maltese: Ir-reazzjonijiet avversi fit-Tabella 1 huma definiti bħala jew kwalunkwe reazzjoni klinika avversa jew anormalità tal-laboratorju fejn hemm ≥ 2 % inċidenza akbar (gradi kollha) fil-grupp tal-kura b'aflibercept meta mqabbla mal-grupp ta' kura bil-plaċebo fl-istudju MCRC inklużi dawk li ma jilħqux dan il-livell, iżda kienu konsistenti mal-klassi anti-VEGF u kienu jidhru fi kwalunkwe studju b'aflibercept.
English: Median OS (95 % CI) (months)
Maltese: OS medjan (95 % CI) (xhur)
English: Table 1 - Adverse reactions reported in patients treated with the ZALTRAP/FOLFIRI regimen from the MCRC study
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati f'pazjenti kkurati bil-kors ZALTRAP/FOLFIRI millistudju MCRC
English: Diarrhoea and dehydration
Maltese: Dijarea u desidratazzjoni
English: Adverse reactions and laboratory abnormalities reported in patients treated with the ZALTRAP/FOLFIRI regimen compared to patients treated with the placebo/FOLFIRI regimen are listed in Table 1 according to MedDRA system organ class and frequency categories.
Maltese: Ir-reazzjonijiet avversi u anormalitajiet minn studji fil-laboratorju rrappurtati f'pazjenti kkurati bilkors ZALTRAP/FOLFIRI meta mqabbla ma' pazjenti kkurati bil-kors plaċebo/FOLFIRI huma mniżżlin fit-Tabella 1 skond is-sistema MedDRA tal-klassifika tal-organi u l-kategoriji ta' frekwenza.
English: * Aflibercept is produced in a Chinese hamster ovary (CHO) K-1 mammalian expression system by recombinant DNA technology.
Maltese: * Aflibercept huwa magħmul fl-ovarju tal-ħamster Ċiniż fis-sistema mammifera ta' espressjoni (CHO)
English: One ml of concentrate for solution for infusion contains 25 mg aflibercept*.
Maltese: U KWANTITATTIVA Millilitru wieħed tal-prodott ikkonċentrat għal soluzzjoni għall-infużjoni fih 25 mg aflibercept*.
English: In the pivotal study of MCRC patients, episodes of bleeding/haemorrhage (all grades) was reported in 37.8 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 19.0 % of patients treated with the placebo/FOLFIRI regimen.
Maltese: Fl-istudju prinċipali ta' pazjenti b'MCRC, ġew irrappurtati episodji ta' fsada/emorraġija (il-gradi kollha) f'37.8% tal-pazjenti kkurati bil-kors ZALTRAP/FOLFIRI meta mqabbla ma' 19.0% tal-pazjenti kkurati bil-kors plaċebo/FOLFIRI.
English: Grade 3-4 diarrhoea was reported in 19.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 7.8 % of patients treated with the placebo/FOLFIRI regimen.
Maltese: Dijarea tal-gradi 3-4 kienet irrappurtata f'19.3 % tal-pazjenti kkurati bil-kors ZALTRAP/FOLFIRI meta mqabbla ma' 7.8 % tal-pazjenti kkurati bil-kors plaċebo/FOLFIRI.
English: An increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events has been reported in patients treated with aflibercept (see section 4.8).
Maltese: Ġiet irrapportata żieda fir-riskju ta' emorraġija, inklużi avvenimenti emorraġiċi serji u xi kultant fatali f'pazjenti kkurati b'aflibercept (ara sezzjoni 4.8).
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C and for 8 hours at 25°C.
Maltese: L-istabbiltà kimikali u fiżikali waqt l-użu hija ta' 24 siegħa f'temperatura ta' 2°C sa 8°C u għal
English: Grade 3 GI fistula formation occurred in 2 patients treated with ZALTRAP (0.3 %) and in 1 placebo-treated patient (0.2 %).
Maltese: Formazzjoni ta' fistula gastro-intestinali tal-grad 3 saret f'2 pazjenti kkurati b'ZALTRAP (0.3 %) u f'pazjent wieħed kkurat bil-plaċebo (0.2 %).
English: Nephrotic syndrome (1) Thrombotic microangiopathy (1)
Maltese: Mikroanġjopatija trombotika (1)
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of VTE (all grades) was 7.1 % for patients treated with ZALTRAP and 7.1 % for patients treated with placebo.
Maltese: III kkontrollati bil-plaċebo (popolazzjonijiet bil-kanċer tal-kolorektum, frixa, u tal-pulmun), linċidenza ta' VTI (il-gradi kollha) kienet 7.1 % għal pazjenti kkurati b'ZALTRAP u 7.1 % għal pazjenti kkurati bil-plaċebo.
English: Tests may include blood and urine tests, x-ray or other scanning techniques and/or other tests.
Maltese: It-testijiet jistgħu jinkludu testijiet tad-demm u l-awrina, x-ray jew metodi oħra ta' skanjar u / jew testijiet oħra.
English: In the pivotal study of MCRC patients, neutropenia (all grades) has been reported in 67.8 % of patients treated with ZALTRAP/FOLFIRI and 56.3 % of patients treated with placebo/FOLFIRI.
Maltese: Fl-istudju prinċipali ta' pazjenti b'MCRC, newtropenja (il-gradi kollha) kienet irrappurtata f'67.8% tal-pazjenti kkurati b'ZALTRAP/FOLFIRI u f'56.3 % tal-pazjenti kkurati bi plaċebo/FOLFIRI.
English: A population pharmacokinetic analysis was conducted with data from 1,507 patients with various types of advanced malignancies receiving ZALTRAP with or without chemotherapy.
Maltese: Analiżi farmakokinetika tal-popolazzjoni saret fuq dejta miġbura minn 1507 pazjenti b'diversi tipi ta'tumuri malinni avvanzati li kienu qed jirċievu ZALTRAP bil- jew mingħajr kimoterapija.
English: Seventeen (17) patients treated with ZALTRAP (1.6 %) and two (2) placebo-treated patients (0.2 %) were also positive in the neutralising antibody assay.
Maltese: (1.6 %) u żewġ (2) pazjenti kkurati bi plaċebo (0.2%) kienu wkoll pożittivi fl-assaġġ tan newtralizzazzjoni tal-antikorpi.
English: Positive results in the neutralising antibody assay in the MCRC pivotal study were also higher in patients treated with the placebo/FOLFIRI regimen [2/526 (0.38 % )] than with the ZALTRAP/FOLFIRI regimen [1/521 (0.19 %)].
Maltese: [2/526 (0.38%)] milli bil-kors ZALTRAP/FOLFIRI [1/521 (0.19 %)].
English: Figure 1 - Overall survival (months) - Kaplan-Meier curves by treatment group - ITT population
Maltese: Kaplan-Meier skont il-grupp tal-kura - popolazzjoni ITT
English: Hypertension (1) Haemorrhage (1)
Maltese: Sindromu nefrotiku (1)
English: In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in 0.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 0.5 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Maltese: Fl-istudju prinċipali ta' pazjenti b'MCRC, reazzjonijiet severi ta' sensittività eċċessiva kienu rrappurtati f'0.3 % tal-pazjenti kkurati bil-kors ZALTRAP/FOLFIRI u f'0.5 % tal-pazjenti kkurati bilkors plaċebo/FOLFIRI (ara sezzjoni 4.4).
English: VTE including deep vein thrombosis (DVT) and pulmonary embolism (infrequently fatal) have been reported in patients treated with aflibercept (see section 4.8).
Maltese: Avvenimenti venużi avvenimenti tromboemboliċi (VTE) VTE inkluż trombożi tal-vini (DVT) u emboliżmu pulmonari (kultant fatali) kienu rrappurtati f'pazjenti kkurati b'aflibercept (ara sezzjoni 4.8).
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of nephrotic syndrome was 0.5 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Maltese: (popolazzjonijiet bil-kanċer tal-kolorektum, frixa, u tal-pulmun), l-inċidenza ta' sindromu nefrotiku kienet ta' 0.5 % għal pazjenti kkurati b'ZALTRAP u 0.1 % għal pazjenti kkurati bil-plaċebo (ara sezzjoni 4.4).
English: Invasive dental procedures should, if possible, be avoided in patients treated with Zaltrap and who have previously received or are receiving intravenous bisphosphonates (see section 4.8).
Maltese: Jekk ikun possibbli, proċeduri invasivi dentali għandhom jiġu evitati f'pazjenti li rċevew qabel jew li qed jirċievu bisphosphonates mogħtija minn ġol-vini (ara sezzjoni 4.8).
English: Additional adverse reactions and laboratory abnormalities reported with a ≥5 % difference (all grades) in patients treated with the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen
Maltese: Reazzjonijiet avversi oħra u anormalitajiet tal-laboratorju rrappurtati b'differenza ta' ≥ 5% (il-gradi kollha) f'pazjenti kkurati bil-kors ZALTRAP/FOLFIRI kontra l-kors plaċebo/FOLFIRI
English: There is no relevant use of ZALTRAP in the paediatric population for the indication of metastatic colorectal cancer.
Maltese: M'hemmx użu rilevanti ta' ZALTRAP fil-popolazzjoni pedjatrika fl-indikazzjoni ta' kanċer metastatiku tal-kolorektum.
English: Grade 3-4 ATE occurred in 1.7 % of patients treated with ZALTRAP and 1.0 % of patients treated with placebo (see section
Maltese: ATE tal-grad 3-4 seħħet f'1.7% tal-pazjenti kkurati b'ZALTRAP u 1.0 % tal-pazjenti kkurati bi plaċebo (ara sezzjoni 4.4).
English: Aflibercept acts as a soluble decoy receptor that binds to VEGF-A, with higher affinity than its native receptors, as well as the related ligands PlGF and VEGF-B. By acting as a ligand trap, aflibercept prevents binding of endogenous ligands to their cognate receptors and thereby blocks receptor mediated signaling.
Maltese: Aflibercept jaġixxi bħala riċettur solubbli li jeħel ma' VEGF-A, b'affinità ogħla mir-riċetturi proprji tiegħu, kif ukoll il-ligandi relatati PlGF u VEGF-B. Aflibercept jaħdem bħala nassa tal-ligandi u ma jħallix il-ligandi endoġeniċi jorbtu mar-riċetturi qarib tagħhom u b'hekk jimblokka s-sinjalazzjoni mmedjata mir-riċetturi.
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: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini D.
English: • 4 ml of concentrate in a 5 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Maltese: • 4 ml ta' konċentrat f'kunjett tal-ħġieġ ċar borosilicate (tip I) u ta' 5 ml issiġillat b'tapp flanġ ma'
English: Grade 3-4 VTE occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen and in 6.3 % of patients treated with the placebo/FOLFIRI regimen.
Maltese: VTE tal-gradi 3-4 seħħew f'7.9 % tal-pazjenti kkurati bil-kors ZALTRAP/FOLFIRI u f'6.3 % tal-pazjenti kkurati bil kors plaċebo/FOLFIRI.
English: If recurrence after irinotecan and 5-FU dose reductions, reduction of ZALTRAP dose to 2 mg/kg could be considered.
Maltese: Jekk ikun hemm rikorrenza wara li d-dożi ta' irinotecan u 5FU jkunu mnaqqsa, wieħed jista'jikkunsidra t-tnaqqis taddoża ta' ZALTRAP sa 2 mg/kg.
English: PlGF and VEGF-B bind only to VEGFR-1, which is also present on the surface of leucocytes.
Maltese: PlGF u VEGF B jorbtu biss ma' VEGFR-1, li hija wkoll preżenti fuq il-wiċċ tal-lewkoċiti.
English: Osteonecrosis of the Jaw (ONJ) Renal and urinary disorders
Maltese: Osteonekrożi tax-xedaq (ONX)
English: There are very limited data available for patients with severe renal impairment treated with aflibercept.
Maltese: Hemm dejta limitata disponibbli għall-pazjenti b'indeboliment sever tal-kliewi u li ġew kkurati b'aflibercept.
English: No dose adjustment is required for aflibercept (see sections 4.2, 4.8 and 5.2).
Maltese: L-ebda aġġustament tad-doża mhi meħtieġa għal aflibercept (ara sezzjonijiet 4.2, 4.8 u
English: Aflibercept administration resulted in a delay in wound healing in rabbits.
Maltese: L-amministrazzjoni ta' aflibercept waslet għal dewmien fil-fejqan tal-feriti fil-fniek.
English: Aflibercept treatment should be discontinued in patients who develop fistula (see section 4.2).
Maltese: It trattament b'aflibercept għandu jitwaqqaf f'pazjenti li jkollhom perforazzjoni gastro-intestinali (ara sezzjoni 4.2).
English: Batch
Maltese: Piż
English: Aflibercept should not be administered to patients with severe haemorrhage (see section 4.2).
Maltese: Aflibercept m'għandux jingħata lil pazjenti b'emorraġija severa (ara sezzjoni 4.2).
English: Grade 3-4 dehydration was reported in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.3 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Maltese: Desidratazzjoni tal-gradi 3-4 kienet irrappurtata f'4.3% tal-pazjenti kkurati bil-kors ZALTRAP/FOLFIRI meta mqabbla ma' 1.3 % tal-pazjenti kkurati bil-kors plaċebo/FOLFIRI kors (ara sezzjoni 4.4).
English: Due to hyperosmolality (1000 mOsmol / kg) of the ZALTRAP concentrate, undiluted ZALTRAP concentrate must not be administered as an intravenous push or bolus.
Maltese: (1000 mOsmol /kg) tal-konċentrat ZALTRAP, konċentrat ZALTRAP li ma jkunx dilwit m'għandux jingħata bħala bolus ġol-vina.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of fistula (all grades) was 1.1 % for patients treated with ZALTRAP and 0.2 % for patients treated with placebo.
Maltese: kkontrollati bi plaċebo (popolazzjonijiet bil-kanċer tal-kolorektum, tal-pankreas u tal-pulmun), l inċidenza ta' fistula (gradi kollha) kienet ta' 1.1% għal pazjenti kkurati b'ZALTRAP u 0.2 % għalpazjenti kkurati bi plaċebo.
English: Overall efficacy results for the ZALTRAP/FOLFIRI regimen versus the placebo/FOLFIRI regimen are summarised in Figure 1 and Table 2.
Maltese: Ir-riżultati ġenerali tal-effikaċja tal-kors ZALTRAP/FOLFIRI kontra l-kors plaċebo/FOLFIRI huma mfissra fil-qosor fil-Figura 1 u t-Tabella 2.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of ATE (all grades) was 2.3 % for patients treated with ZALTRAP and 1.7 % for patients treated with placebo.
Maltese: III kkontrollati bil-plaċebo (popolazzjonijiet bil-kanċer tal-kolorektum, frixa, u tal-pulmun), l-inċidenza ta'ATE (gradi kollha) kienet ta' 2.3% għal pazjenti kkurati b'ZALTRAP u 1.7 % għal pazjenti kkurati bil-plaċebo.
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħrufa (il-frekwenza ma tistax tiġi stmata mid-data disponibbli):
English: No metabolism studies have been conducted with aflibercept since it is a protein.
Maltese: Ma sarux studji tal-metaboliżmu b'aflibercept peress li huwa proteina.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie 75008 Paris
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq sanofi-aventis groupe 54, rue La
English: At the recommended dose regimen of 4 mg/kg every two weeks, concentration of free aflibercept were near steady-state levels by the second cycle of treatment with essentially no accumulation (accumulation ratio of 1.2 at steady-state compared to the first administration).
Maltese: Fid-doża rakkomandata ta' 4 mg/kg kull ġimagħtejn, il-konċentrazzjoni ta' aflibercept ħieles kienet qrib il-livelli tal-istat fiss mat-tieni ċiklu ta' kura u ma kien hemm ebda akkumulazzjoni (proporzjon ta' akkumulazzjoni ta' 1.2 fl-istat fiss meta mqabbel mal-ewwel amministrazzjoni).
English: The most common reported form of bleeding was minor (grade 1-2) epistaxis occurring in 27.7 % of patients treated with the ZALTRAP/FOLFIRI regimen.
Maltese: L-aktar forma komuni ta' fsada rrappurtata kienet minuri (gradi 1-2) b'epistassi sseħħ f'27.7 % tal-pazjenti kkurati bil-kors ZALTRAP/FOLFIRI.
English: Dehydration (1) Decreased appetite Weight loss
Maltese: Desidratazzjoni (1) Nuqqas ta' aptit
English: The most common reported grades 3-4 reactions ( ≥5 % incidence) reported at least 2 % greater incidence for the ZALTRAP/FOLFIRI regimen as compared to the placebo/FOLFIRI regimen in order of decreasing frequency, were neutropenia, diarrhoea, hypertension, leucopenia, stomatitis, fatigue, proteinuria, and asthenia (see Table 1).
Maltese: L-aktar reazzjonijiet komuni rrappurtati tal-gradi 3-4 (≥ 5% inċidenza) urew inċidenza mill-inqas 2 % akbar għall-kors ZALTRAP/FOLFIRI meta mqabbel mal-kors plaċebo/FOLFIRI; dawn kienu, f'ordni fejn l-iktar frekwenti jiġi l-ewwel, newtropenja, dijarea, pressjoni għolja, lewkopenja, stomatite, għeja,
English: • 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Maltese: • 8 ml ta' konċentrat f'kunjett tal-ħġieġ ċar borosilicate (tip I) u ta' 5 ml issiġillat b'tapp flanġ ma'
English: In the pivotal study of MCRC patients, GI perforation (all grades) was reported in 3 of 611 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
Maltese: Fl-istudju prinċipali ta' pazjenti b'MCRC, il-perforazzjoni gastro-intestinali (ilgradi kollha) kienet irrappurtata fi 3 minn 611-il pazjent (0.5 %) ikkurati bil-kors ZALTRAP / FOLFIRI u 3 minn 605 pazjenti (0.5 %) ikkurati bil-kors plaċebo/FOLFIRI.