FrancophonIA/ELRC3.0 huggingface dataset:
English: Zebinix can also be used in adolescents and children above 6 years of age, in combination with existing therapies, to treat partial-onset seizures with or without secondary generalisation.
Maltese: jintuża wkoll f adoloxxenti u tfal li jkollhom aktar minn 6 snin, f kombinazzjoni ma terapiji eżistenti, għall-kura ta' aċċessjonijiet parzjali tal-bidu b' ġeneralizzazzjoni sekondarja jew mingħajrha.
English: This reduces the activity of the nerve cells in the brain, reducing the intensity and the number of seizures.
Maltese: Dan inaqqas l-attività taċ-ċelloli tan-nervituri fil-moħħ, b' hekk jitnaqqsu l-intensità u n-numru ta' aċċessjonijiet.
English: Severe skin reactions, including Stevens-Johnson syndrome, have also been reported with Zebinix.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zebinix.
English: Epilepsy is caused by excessive electrical activity in the brain.
Maltese: jiżdied ma mediċini antiepilettiċi eżistenti.
English: For electrical impulses to travel along nerves there needs to be a rapid movement of sodium into the nerve cells.
Maltese: L-epilessija tiġi kkawżata minn attività elettrika eċċessiva fil-moħħ. Sabiex l-impulsi elettriċi jivvjaġġaw tul in-nervituri jeħtieġ li jkun hemm moviment rapidu tas-sodju fiċ-ċelloli tan-nervituri.
English: How does Zebinix work?
Maltese: Kif jintuża Zebinix?
English: Zebinix contains the active substance eslicarbazepine acetate.
Maltese: Il-ġeneralizzazzjoni sekondarja sseħħ meta aktar tard lattività żejda tilħaq il-moħħ kollu.
English: For the full list of side effects and restrictions with Zebinix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b' Zebinix, ara l-fuljett ta' tagħrif.
English: Grades ≥3
Maltese: Gradi ≥3
English: • The active substance is aflibercept.
Maltese: • Is-sustanza attiva hija aflibercept.
English: 19.8 (16.4 to 23.2)
Maltese: 19.8 (16.4 sa 23.2)
English: EU/1/12/814/001 EU/1/12/814/002
Maltese: EU/1/12/814/001 EU/1/12/814/002 EU/1/12/814/003
English: • polyvinyl chloride (PVC) containing bis(2-ethylhexyl) phthalate (DEHP)
Maltese: • polyvinyl chloride (PVC) li jkun fih bis(2-ethylhexyl) phthalate (DEHP)
English: 3.9 (3.02 to 4.30)
Maltese: 3.9 (3.02 sa 4.30)
English: 11.1 (8.5 to 13.8)
Maltese: 11.1 (8.5 sa 13.8)
English: Date of first authorisation: 01 February 2013 Date of latest renewal: 21 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 01 Frar 2013 Data ta' l-aħħar tiġdid: 21 Settembru 2017
English: Proteinuria (1),(3)
Maltese: Protejnurja (1),(3)
English: Stratified log-rank test p-value Overall Response Rate (CR+PR) (95 % CI) (%)
Maltese: Stratified log-rank test p-value Rata tar-Rispons Ġenerali (CR+PR) (95% CI) (%)c
English: ‘Palmar-Plantar Erythrodysaesthesia syndrome')
Maltese: Plantar Erythrodysaesthesia syndrome')
English: 4.67 (4.21 to 5.36)
Maltese: 4.67 (4.21 sa 5.36)
English: • Gastrointestinal (GI) perforation
Maltese: • Perforazzjoni gastrointestinali (GI) • Formazzjoni ta' fistula
English: sanofi-aventis groupe 54, rue La Boétie 75008 Paris France
Maltese: sanofi-aventis groupe 54, rue La Boétie 75008 Paris Franza
English: 5.3 (4.50 to 5.55)
Maltese: 5.3 (4.50 sa 5.55)
English: Palmar-Plantar Erythrodysaesthesia syndrome
Maltese: Sindromu Palmar-Plantar Erythrodysaesthesia
English: 5.4 (4.53 to 5.68)
Maltese: 5.4 (4.53 sa 5.68)
English: Diarrhoea (1) Stomatitis
Maltese: Dijarea (1) Stomatite
English: Proteinuria (see section 4.4)
Maltese: Protejnurja (ara sezzjoni 4.4)
English: <2D barcode carrying the unique identifier included.>
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: EU/1/12/814/001 1 vial (100 mg/4 ml) EU/1/12/814/002 3 vials (100 mg/4 ml) EU/1/12/814/003 1 vial (200 mg/8 ml)
Maltese: EU/1/12/814/001 kunjett wieħed (100 mg/4 ml) EU/1/12/814/002 3 kunjetti (100 mg/4 ml)
English: Sanofi-aventis Deutschland GmbH Industriepark Höchst D-65926 Frankfurt am Main Germany
Maltese: Sanofi-aventis Deutschland GmbH Industriepark Höchst D-65926 Frankfurt am Main
English: • Nephrotic syndrome or thrombotic microangiopathy (TMA)
Maltese: • Sindromu nefrotiku jew mikroanġjopatija trombotika (TMA)
English: Irinotecan dose should be reduced by 15-20 %.
Maltese: Id-doża ta' irinotecan għandha tkun imnaqqsa b'15-20%.
English: Aflibercept is expected to degrade to small peptides and individual amino acids.
Maltese: Aflibercept huwa mistenni li jiddegrada f'peptidi żgħar u amino acids individwali.
English: Neutropenic infection/sepsis (1)
Maltese: Infezzjoni newtropenika/sepsis (1)
English: Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main Germany
Maltese: Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main
English: Proteinuria
Maltese: Protejnurja
English: Vascular endothelial growth factor A and B (VEGF-A, VEGF-B), and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as potent mitogenic, chemotactic, and vascular permeability factors for endothelial cells.
Maltese: Il-vascular endothelial growth factor A u B (VEGF-A, VEGF-B), u l-placental growth factor (PlGF) huma membri tal-familja VEGF ta' fatturi anġjoġeniċi li jistgħu jaġixxu bħala fatturi potenti mitoġeniċi, kemotattiċi, u vaskulari b'permeabilità għal ċelluli endoteljali.
English: • Grade 4 venous thromboembolic events (including pulmonary embolism)
Maltese: • Episodji tromboembolitiċi fil-vini tal-grad 4 (inkluż emboliżmu pulmonari)
English: 6.7 (5.75 to 8.21)
Maltese: 6.7 (5.75 sa 8.21)
English: The hazard ratio (95 % CI) of progression free survival was 0.76 (0.63 to 0.91) for ECOG performance status 0 and 0.75 (0.61 to 0.92) for ECOG performance status 1.
Maltese: Il-hazard ratio (95 % CI) ta' progression free survival kien 0.76 (0.761 sa 0.91) għal ECOG performance status 0 u 0.75 (0.61-0.92) għall ECOG performance status 1.
English: 0.817 (0.714 to 0.935)
Maltese: 0.817 (0.714 sa 0.935)
English: 11.7 (9.96 to 13.77) 12.5 (10.78 to 15.47)
Maltese: 11.7 (9.96 sa 13.77) 12.5 (10.78 sa 15.
English: Neutropenic infection/sepsis (1) Urinary tract infection Nasopharyngitis
Maltese: Infezzjoni newtropenika/sepsis (1) Infezzjoni fl-apparat urinarju
English: The diagnosis of PRES is confirmed by brain Magnetic Resonance Imaging (MRI).
Maltese: Id-dijanjosi ta' PRES hija kkonfermata mill-Magnetic Resonance Imaging tal-moħħ (MRI).
English: The most frequent adverse reactions leading to permanent discontinuation in ≥ 1 % of patients treated with the ZALTRAP/FOLFIRI regimen were vascular disorders (3.8 %) including hypertension (2.3 %), infections (3.4 %), asthenia/fatigue (1.6 %, 2.1 %),diarrhoea (2.3 %), dehydration (1 %), stomatitis (1.1 %), neutropenia (1.1 %), proteinuria (1.5 %), and pulmonary embolism (1.1 %).
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti li wasslu għal twaqqif permanenti f'≥ 1% tal-pazjenti kkurati bil-kors ZALTRAP/FOLFIRI kienu disturbi vaskulari (3.8 %) inkluż pressjoni għolja (2.3 %), infezzjonijiet (3.4 %), astenja/għeja (1.6 %, 2.1 %), dijarea (2.3 %), desidratazzjoni (1 %), stomatite (1.1 %), newtropenija (1.1 %), protejnurja (1.5 %), u emboliżmu pulmonari (1.1 %).
English: ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) have been observed in patients treated with aflibercept (see section 4.8).
Maltese: ATE (inkluż attakk temporanju ta' iskemija, inċident ċerebrovaskulari, anġina pectoris, trombus intrakardijaku, infart mijokardijaku, emboliżmu arterjali, u kolite iskemika) ġew osservati f'pazjenti kkurati b'aflibercept (ara sezzjoni 4.8).
English: The use of granulocyte colony-stimulating factor (G-CSF) may be considered.
Maltese: L-użu ta' granulocyte colony-stimulating factor (G-CSF) jista' jiġi kkunsidrat.
English: versus 12.2 % Grades 3-4), increased AST (57.5 % versus 50.2 % all grades; 3.1 % versus 1.7% Grades 3-4), stomatitis (50.1 % versus 32.9 % all grades; 12.8 % versus 4.6 % Grades 3-4), fatigue (47.8 % versus 39.0 % all grades; 12.6 % versus 7.8 % Grade 3-4), thrombocytopenia (47.4 % versus 33.8 % all grades; 3.3 % versus 1.7 % Grades 3-4), increased ALT (47.3 % versus 37.1 % all grades; 2.7 % versus 2.2 % Grades 3-4), decreased appetite (31.9 % versus 23.8 % all grades; 3.4 % versus 1.8 % Grade 3-4), weight loss (31.9 % versus 14.4 % all grades; 2.6 % versus 0.8 % Grades 3-4), dysphonia (25.4 % versus 3.3 % all grades; 0.5 % versus 0 Grades 3-4), headache (22.3 % versus 8.8 % all grades; 1.6 % versus 0.3 % Grades 3-4), asthenia (18.3 % versus 13.2 % all grades; 5.1% versus 3.0 % Grades 3-4), Palmar- Plantar Erythrodysaesthesia syndrome (11.0 % versus 4.3 % all grades; 2.8 % versus 0.5 % Grades 3-4), and skin hyperpigmentation (8.2 % versus 2.8 % all grades; 0 versus 0 Grades 3-4).
Maltese: (il-gradi kollha) f'pazjenti kkurati bil-kors ZALTRAP/FOLFIRI kontra l-kors plaċebo/FOLFIRI (f'ordni ta' frekwenza li tonqos): lewkopenja (78.3 % kontra 72.4 % il-gradi kollha; 15.6 % kontra 12.2% Gradi 3-4), żieda fl-AST (57.5 % kontra 50.2 % il-gradi kollha; 3.1 % kontra 1.7 % Gradi 3-4), stomatite (50.1% kontra 32.9% il-gradi kollha; 12.8 % kontra 4.6% Gradi 3-4), għeja (47.8% kontra 39.0% il-gradi kollha; 12.6 % kontra 7.8% Gradi 3-4), tromboċitopenja (47.4% kontra 33.8% il-gradi kollha; 3.3% kontra 1.7 % Gradi 3-4), żieda fl-ALT (47.3% kontra 37.1 % il-gradi kollha; 2.7% kontra 2.2% Gradi 3-4), tnaqqis fl-aptit (31.9% kontra 23.8% il-gradi kollha; 3.4% kontra 1.8% Gradi 3-4),
English: 0.812 (0.634 to 1.042)
Maltese: 0.812 (0.634 sa 1.042)
English: Leucopenia (2) Neutropenia (1),(2) Thrombocytopenia (2)
Maltese: Lewkopenja (2) Newtropenja (1), (2) Tromboċitopenija (2)
English: Aflibercept binds to human VEGF-A (equilibrium dissociation constant KD of 0.5 pM for VEGF-A165 and 0.36 pM for VEGF-A121), to human PlGF (KD of 39 pM for PlGF-2), and to human VEGF-B (KD of 1.92 pM) to form a stable, inert complex which has no detectable biological activity.
Maltese: Aflibercept jeħel ma' VEGF-A tal-bniedem (equilibrium dissociation constant KD ta' 0.5pM għal VEGF-A165 u 0.36 pM għal VEGF-A121), ma' PlGF tal-bniedem (KD ta' 39 pM għal PlGF-2), u ma' VEGF-B tal-bniedem (KD ta' 1.92 pM) biex jifforma molekula kumplessa stabbli u inerti li ma għandiex attività bijoloġika traċċabbli.
English: Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Water for injections
Maltese: Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide u/jew hydrochloric acid (għal aġġustament tal-pH)
English: Aflibercept, also known as VEGF TRAP in the scientific literature, is a recombinant fusion protein consisting of VEGF-binding portions from the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of the human IgG1.
Maltese: Aflibercept, magħruf ukoll bħala TRAP VEGF fil-letteratura xjentifika, huwa recombinant fusion protein li tikkonsisti f'partijiet li jorbtu VEGF mill-partijiet extraċellulari tar-riċetturi umani VEGF 1 u 2 magħquda mal-parti Fc tal-IgG1 uman.
English: 0.645 (0.498 to 0.835)
Maltese: 0.645 (0.498 sa 0.835)
English: Of the 611 patients treated with the ZALTRAP/FOLFIRI regimen in the pivotal study of MCRC patients, 172 (28.2 %) were aged ≥ 65 and < 75 and 33 (5.4 %) were age ≥ 75.
Maltese: Mis-611-il pazjent kkurati bil-kors ZALTRAP/FOLFIRI fl-istudju prinċipali ta' pazjenti b'MCRC, 172 (28.2 %) kienu ta' età ≥65 u < 75 u 33 (5.4%) kienu ta' età ≥75.
English: 0.661 (0.512 to 0.852)
Maltese: 0.661 (0.512 sa 0.852)
English: Number of events, n (%) Median PFS (95 % CI) (months)
Maltese: Numru ta' avvenimenti, n (%) Median PFS Medjan (95% CI) (xhur)
English: Exploratory biomarker analyses were undertaken in the VELOUR trial including analyses of RAS mutational status in 482 of 1,226 patients (n = 240 aflibercept; 242 placebo).
Maltese: RAS f'482 minn 1226 pazjent (n = 240 aflibercept; 242 placebo).
English: 0.862 (0.676 to 1.100)
Maltese: 0.862 (0.676 sa 1.100)
English: 11.7 (9.66 to 13.27) 13.8 (11.01 to 15.87)
Maltese: 11.7 (9.66 sa 13.27) 13.8 (11.01 sa 15.
English: 6.90 (6.51 to 7.20)
Maltese: 6.90 (6.51 sa 7.20)
English: ZALTRAP may affect male and female fertility.
Maltese: ZALTRAP jista' jaffettwa l-fertilità maskili u femminili.
English: 0.797 (0.679 to 0.936)
Maltese: 0.797 (0.679 sa 0.936)
English: VEGF-A acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.
Maltese: VEGF A taġixxi permezz ta' żewġ riċetturi ta' tyrosine kinases, VEGFR-1 u VEGFR-2, preżenti fuq il-wiċċ taċ-ċelluli endoteljali.
English: 6.9 (6.24 to 7.20)
Maltese: 6.9 (6.24 sa 7.20)
English: 200 mg / 8 ml 1 vial
Maltese: 200 mg/8 ml
English: • Severe haemorrhage
Maltese: • Emorraġija severa
English: 0.766 (0.645 to 0.908)
Maltese: 0.766 (0.645 sa 0.908)
English: / L (see section 4.2).
Maltese: Prodott, sezzjoni 4.2).
English: 100 mg / 4 ml 1 vial
Maltese: 100 mg/4 ml
English: One vial of 8 ml contains 200 mg of aflibercept (25 mg / ml).
Maltese: Kunjett wieħed ta' 8 ml fih 200 mg ta' aflibercept (25 mg/ml).
English: Placebo/FOLFIRI (N = 614)
Maltese: Plaċebo/FOLFIRI (N = 614)
English: • DEHP free PVC containing trioctyl-trimellitate (TOTM)
Maltese: • PVC ħieles minn DEHP li fih triocty-trimellitate (TOTM)
English: • Arterial thromboembolic events (ATE)
Maltese: • Avvenimenti tromboemboliċi fl-arterji (ATE)
English: ZALTRAP 25 mg / ml sterile concentrate aflibercept
Maltese: ZALTRAP 25 mg/ml konċentrat sterili
English: Patients with a dipstick of ≥ 2+ for protein or a UPCR > 1 or a protein/creatinine ratio (PCR)> 100 mg/mmol should undergo a 24-hour urine collection.
Maltese: Pazjenti b' dipstick ta' ≥ 2+ għall-proteini jew UPCR> 1 jew proporzjon ta' proteina/kreatinina (PCR) >100 mg/mmol għandhom jiġbru l-urina matul 24 siegħa.
English: Thrombotic and embolic events
Maltese: Avvenimenti trombotiċi u embolitiċi
English: Infection (1)
Maltese: Infezzjoni (1)
English: 12.4 (11.17 to 13.54) 13.9 (12.72 to 15.64)
Maltese: 12.4 (11.17 sa 13.54) 13.9 (12.72 sa 15.
English: 0.777 (0.655 to 0.921)
Maltese: 0.777 (0.655 sa 0.921)
English: It will be given with other medicines called ‘chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Maltese: ZALTRAP se jingħata ma' mediċini kimoterapewtiċi oħra inkluż '5-fluorouracil', ‘folinic acid', u
English: As determined per IVRS
Maltese: Kif determinat skont IVRS
English: Proteinuria (1),(3) Increased serum creatinine
Maltese: Protejnurja (1),(3) Żieda fil-krejatinina fis-serum
English: Overall across all clinical oncology studies, similar incidence of low titre anti-drug antibody (ADA) responses (post baseline) in the ADA assay were observed in both patients treated with placebo and ZALTRAP (3.3 % and 3.8 %, respectively).
Maltese: reazzjonijiet b'antikorpi kontra l-mediċina (ADA) (wara l-linja bażi) fl-assaġġ ADA fiż-żewġ pazjenti kkurati bi plaċebo u b'ZALTRAP (3.3% u 3.8%, rispettivament).
English: Febrile neutropenia Thrombocytopenia (2)
Maltese: Newtropenija bid-deni Tromboċitopenija (2)
English: Ejection fraction decreased Nervous system disorders Very common
Maltese: Tnaqqis fil-frazzjoni li tiġi mitfugħa Disbturbi fis-sistema nervuża Komuni ħafna
English: This population included; 549 patients with mild renal impairment (CL CR between 50-80 ml/min), 96 patients with moderate renal impairment (CL CR between 30-50 ml/min), and 5 patients with severe renal impairment (CL CR < 30 ml/min).
Maltese: 549 pazjent b'indeboliment renali ħafif (CLCR bejn 50-80 ml/min), 96 pazjenti b'indeboliment renali moderat (CLCR bejn 30-50 ml/min), u 5 pazjenti b'indeboliment sever tal-kliewi (CLCR < 30 ml/minuta).
English: Oxaliplatin-based regimens were administered in combination with bevacizumab in 373 patients (30.4 %).
Maltese: bevacizumab lill-373 pazjent (30.4 %).
English: Irinotecan dose should be reduced by 15-20 % in subsequent cycles.
Maltese: Id-doża ta' irinotecan għandha tkun imnaqqsa b'15-20% fiċċikli sussegwenti.
English: Compromised wound healing Aflibercept impaired wound healing in animal models (see section 5.3).
Maltese: Fejqan kompromess tal-feriti Aflibercept tellef il-fejqan tal-feriti fil-mudelli ta' annimali (ara sezzjoni 5.3).
English: For contraindications related to FOLFIRI components (irinotecan, 5-FU, and folinic acid), refer to the current respective summary of product characteristics.
Maltese: Għal kontraindikazzjonijiet relatati mal-komponenti ta' FOLFIRI (irinotecan, 5-FU, u folinic acid), irreferi għas-sommarju kurrenti tal-karatteristiċi tal-prodott rispettiv.
English: • The other ingredients are: sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide and/or hydrochloric acid and water for injections.
Maltese: • Is-sustanzi l-oħra huma: sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide u/jew hydrochloric acid u ilma għall-injezzjonijiet.
English: 6.9 (6.37 to 7.20)
Maltese: 6.9 (6.37 sa 7.20)
English: Also contains sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide and/or hydrochloric acid and water for injections.
Maltese: Fih ukoll sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide u/jew hydrochloric acid u ilma għall-injezzjoni.
English: The FOLFIRI regimen to be used is irinotecan 180 mg/m intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400 mg / m² intravenous bolus, followed by 5-FU 2400 mg / m² continuous intravenous infusion over 46 hours.
Maltese: minuta u folinic acid (dl racemic) 400 mg/m² infużjoni ġol-vina fuq perijodu ta' sagħtejn fl-istess ħin fl-ewwel jum billi tintuża linja Y, segwit minn 5-fluorouracil (5-FU) 400 mg/m² bolus ġol-vina, segwit minn 5-FU 2400 mg/m² infużjoni kontinwa intravenali fuq perijodu ta' 46 siegħa.
English: ZALTRAP should be discontinued for (see section 4.4):
Maltese: ZALTRAP għandu jitwaqqaf jekk ikun hemm (ara sezzjoni 4.4):
English: 0.788 (0.671 to 0.925)
Maltese: 0.788 (0.671 sa 0.925)
English: FOLFIRI Dose modification when used in combination with ZALTRAP Severe stomatitis and Palmar-Plantar Erythrodysaesthesia syndrome
Maltese: Stomatite severa u s-sindromu PalmarPlantar erythrodysaesthesia
English: Severe proteinuria, nephrotic syndrome, and thrombotic microangiopathy (TMA) have been observed in patients treated with aflibercept (see section 4.8).
Maltese: Protejnurja severa, sindromu nefrotiku, u mikroanġjopatija trombotika (TMA) ġew osservati f'pazjenti kkurati b'aflibercept (ara sezzjoni 4.8).
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX44
Maltese: Aġenti antineoplastiċi, aġenti antineoplastiċ1i oħra, Kodiċi ATC:
English: In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase, and hyperbilirubinaemia occurred in ≥ 20 % of patients.
Maltese: Fl-istudju prinċipali MCRC, kien hemm anemija dardir, rimettar, stitikezza, alopeċja, żieda fl-alkaline phosphatase, u iperbilirubinimija f'≥20 % tal-pazjenti.
English: The most common adverse reactions (all grades, ≥ 20 % 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 leucopenia, diarrhoea, neutropenia, proteinuria, increased aspartate aminotransferase (AST), stomatitis, fatigue, thrombocytopenia, increased alanine aminotransferase (ALT), hypertension, weight loss, decreased appetite, epistaxis, abdominal pain, dysphonia, increased serum creatinine, and headache (see Table 1).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni (il-gradi kollha, ≥ 20 % inċidenza) irrappurtaw inċidenza millinqas 2 % akbar għall-kors ZALTRAP/FOLFIRI meta mqabbel mal-kors plaċebo/FOLFIRI; dawn kienu, f'ordni fejn l-iktar frekwenti jiġi l-ewwel, lewkopenja, dijarea, newtropenija, protejnurja, żieda fl-aspartate aminotransferase (AST), stomatite, għeja, tromboċitopenja, żieda fl-alanine aminotransferase (ALT), pressjoni għolja, telf fil-piż, tnaqqis fl-aptit, epistassi, uġigħ addominali,
English: Leucopenia (2) Neutropenia (2)
Maltese: Lewkopenja (2) Newtropenja (2)
English: Respiratory, thoracic and mediastinal disorders Very common
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna
English: Thrombocytopenia has been reported in patients treated with the ZALTRAP/FOLFIRI regimen.
Maltese: It-tromboċitopenja ġiet irrapportata f'pazjenti ikkurati bil-kors ZALTRAP/FOLFIRI.
English: Other subgroup analyses for overall survival and progression free survival according to age (< 65; ≥ 65), gender, presence of liver metastasis only, history of prior hypertension, and number of organs involved, showed a treatment effect favouring the ZALTRAP/FOLFIRI regimen over the placebo/FOLFIRI regimen.
Maltese: Analiżi oħra ta' sottogruppi għal OS u progression free survival skont l-età (<65; ≥65), sess, preżenza ta' metastasi fil-fwied biss, storja ta' pressjoni għolja, u n-numru ta' organi involuti, wera l-effett talkura li jiffavorixxi l-kors ZALTRAP/FOLFIRI fuq il-kors plaċebo/FOLFIRI.
English: A total of 1,226 patients were randomised (1:1) to receive either ZALTRAP (N = 612; 4 mg/kg as a 1 hour intravenous infusion on day 1) or placebo (N = 614), in combination with 5-fluouracil plus irinotecan [FOLFIRI: irinotecan 180 mg/m intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-FU 400 mg/m² intravenous bolus, followed by 5-FU 2,400 mg /m² continuous intravenous infusion over 46-hours].
Maltese: Kien hemm total ta' 1226 pazjent li ġew randomizzati (1:1) biex jirċievu jew ZALTRAP (N = 612; 4 mg/kg bħala infużjoni fil-vina fuq siegħa fl-ewwel jum) jew il-plaċebo (N = 614), flimkien ma' 5-fluouracil u irinotecan [FOLFIRI: irinotecan 180 mg/m infużjoni ġol-vina fuq 90 minuta u folinic acid (dl raċemat) 400 mg/m² infużjoni ġol-vina fuq sagħtejn fl-istess ħin fl-ewwel jum permeazz ta' linja Y, segwit minn 5-FU 400 mg/m²
English: This information supplements the sections 3 and 5 for the user.
Maltese: Din l-informazzjoni tissupplimenta s-sezzjonijiet 3 u 5 għall-utent.
English: Your doctor will temporarily stop the treatment before and after surgery.
Maltese: It-tabib tiegħek se jwaqqaf temporanjament it-trattament qabel u wara l kirurġija.
English: It is recommended that aflibercept not be initiated for at least 4 weeks following major surgery and not until the surgical wound is fully healed.
Maltese: Huwa rakkomandat li aflibercept ma jinbediex għal mill-inqas 4 ġimgħat wara kirurġija maġġuri u mhux qabel mal-feriti kirurġiċi jkunu kompletament imfejqa.
English: In sub-group analysis of overall survival, a benefit consistent with the overall population was observed in patients < 65 years old and ≥ 65 years old who received the ZALTRAP/FOLFIRI regimen.
Maltese: Fl-analiżi tas-sottogrupp ta' sopravivenza ġenerali, ġie osservat benefiċċju konsistenti mal popolazzjoni globali f'pazjenti < 65 sena u ≥ 65 sena li rċevew il-kors ZALTRAP/FOLFIRI. .
English: 0.758 (0.661 to 0.869)
Maltese: 0.758 (0.661 sa 0.869)
English: Other signs include feeling confused, problems with sight, walking, coordination or balance, problems in saying words or slurring of speech.
Maltese: Sinjali oħra jinkludu tħossok konfuż, problemi tal-vista, mixi, koordinazzjoni jew tal bilanċ, problemi fid-diskors jew fit-taħdit.