FrancophonIA/ELRC3.0 huggingface dataset:
English: In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone (106 versus 55 patients, 2:1 randomisation) as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, a higher rate of death, including death due to infection, was observed for the necitumumab plus paclitaxel/carboplatin arm during the first 4 months (see also section 4.4), with a later trend towards improved survival after 4 months.
Maltese: Fi prova klinika ta' fażi 2 li investigat necitumumab flimkien ma' paclitaxel u carboplatin kontra paclitaxel u carboplatin waħidhom (106 kontra 55 patients, 2:1 b'mod arbitrarju) bħala terapija tal ewwel grad f'pazjenti b'NSCLC skwamuż metastatiku ta' Stadju IV, ġiet osservata rata ogħla ta'
English: ADRs reported in ≥ 1 % of necitumumab treated patients in SQUIRE
Maltese: Tabella 3. ADRs irrappurtati f'≥ 1 % tal-pazjenti ttrattati b'necitumumab fi SQUIRE
English: Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity.
Maltese: Immunoġeniċità Bħal ma jiġri bil-proteini terapewtiċi l-oħra kollha, hemm il-possibbiltà ta' immunoġeniċità.
English: The recommended dose of Portrazza is 800 mg (flat dose) administered as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle.
Maltese: Id-doża rrakkomandata ta' Portrazza hija 800 mg (doża fissa) mogħtija bħala infużjoni fil-vina fuq perjodu ta' 60 minuta fil-Jiem 1 u 8 ta' kull ċiklu ta' 3 ġimgħat.
English: Overall survival Number of events (n) Median - months (95 % CIa) Hazard ratio (95 % CI)b, c Two-sided log-rank p-valuec 1-year Overall survival rate (%)
Maltese: Sopravivenza totali Numru ta' avvenimenti (n) Medjan -xhur (95 % CIa) Proporzjon ta' periklu (95 %
English: It is administered as an intravenous infusion over approximately 60 minutes via an infusion pump.
Maltese: madwar 60 minuta permezz ta' pompa tal-infużjoni.
English: Thromboembolic events
Maltese: Avvenimenti tromboemboliċi fil-vini
English: In patients with detectable EGFR protein expression (indicated patient population), overall survival was statistically significantly improved in the Portrazza+GC Arm as compared to the GC Arm with an estimated reduction in risk of death of 21% (hazard ratio [HR] = 0.79 [0.69, 0.92]; p = 0.002) and a median OS of 11.7 months in the Portrazza+GC Arm and 10.0 months in the GC Arm. A statistically significant improvement in progression-free survival was also observed (HR = 0.84 [0.72, 0.97]; p = 0.018), with a median PFS of 5.7 months in the Portrazza+GC Arm and 5.5 months in the GC Arm.
Maltese: F'pazjenti b'espressjoni tal-proteina EGFR li setgħet titkejjel (popolazzjoni ta' pazjenti indikata), issopravivenza totali tjiebet b'mod sinifikanti u statistiku fil-Fergħa ta' Portrazza+GC meta mqabbla mal-fergħa ta' GC bi stima ta' tnaqqis ta' 21% fir-risku ta' mewt (proporzjon ta' periklu [HR hazard ratio] = 0.79 [0.69, 0.92]; p = 0.002) u OS b'medjan ta' 11.7 xhur fil-Fergħa ta' Portrazza+GC u 10.
English: • Following improvement to Grade ≤ 2, resume at reduced dose of
Maltese: • Wara titjib għal Grad ≤ 2, erġa' kompli bid-doża mnaqqsa ta'
English: Twelve of the fifteen patients died within 30 days of the last dose of necitumumab and had comorbid conditions including history of coronary artery disease (n=3), hypomagnesemia (n=4), chronic obstructive pulmonary disease (n=7), and hypertension (n=5).
Maltese: Tnax mill-ħmistax-il pazjent mietu fi żmien 30 jum mill-aħħar doża ta' necitumumab u kellhom kondizzjonijiet ta' komorbidità inkluż storja ta' mard tal-arterji koronarji (n=3), ipomanjesimja (n=4), mard kroniku ostruttiv tal-pulmuni (n=7), u pressjoni għolja (n=5).
English: An improvement was observed in subgroups for OS and PFS including the pre-specified stratification factors [ECOG PS score (0-1 vs. 2) and geographic region (North America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia)]; in patients age 70 and over, the hazard ratio for overall survival was 1.03 (0.75, 1.42) (see Figure 2).
Maltese: Ġie osservat titjib fis-sottogruppi għal OS u PFS inkluż il-fatturi ta' stratifikazzjoni speċifikati minn qabel [punteġġ ta' PS ta' ECOG (0-1 vs. 2) u r-reġjun ġeografiku (l-Amerika ta' Fuq, l-Ewropa, u lAwstralja vs. l-Amerika t'Isfel, l-Afrika t'Isfel, u l-Indja vs. l-Asja tal-Lvant)]; f'pazjenti li kellhom 70 sena jew aktar, il-proporzjon ta' periklu għas-sopravivenza totali kien 1.03 (0.75, 1.42) (ara Figura 2).
English: The skin effects were consistent with the known class effects of EGFR inhibitors.
Maltese: L-effetti fil-ġilda kienu konsistenti mal-effetti magħrufa tal-klassi ta' inibituri ta' EGFR.
English: Permanently discontinue if symptoms do not resolve to Grade ≤ 2 after holding for 2 consecutive cycles (6 weeks)
Maltese: Waqqaf b'mod permanenti jekk is sintomi ma jgħaddux għal Grad ≤ 2 wara li twaqqfu għal 2 ċikli konsekuttivi (6 ġimgħat).
English: The most common adverse reactions were skin reactions, venous thromboembolic events and laboratory abnormalities (hypomagnesaemia and albumin-corrected hypocalcaemia).
Maltese: L-aktar reazzjonijiet avversi komuni kienu reazzjonijiet fil-ġilda, avvenimenti tromboemboliċi filvini, u anormalitajiet tal-laboratorju (ipomanjesimja u ipokalċimja kkoreġuta bl-albumina).
English: This medicine contains 76 mg sodium per dose.
Maltese: Din il-mediċina fiha 76 mg sodium f'kull doża.
English: Skin reactions were reported in approximately 78 % of patients and mainly presented as acneiform rash, dermatitis acneiform, dry skin, pruritus, skin fissures, paronychia and palmar-plantar erythrodysaesthesia syndrome.
Maltese: Reazzjonijiet fil-ġilda ġew irrappurtati f'madwar 78% tal-pazjenti u dehru l-aktar bħala raxx jixbah lakne, dermatite tixbah l-akne, ġilda xotta, prurite, qsim fil-ġilda, paronikja u sindrom ta'
English: Pre-emptive skin treatment including skin moisturiser, sun screen, topical steroid cream (1 % hydrocortisone) and an oral antibiotic (e.g. doxycycline) may be useful in the management of dermatologic reactions as clinically appropriate.
Maltese: Trattament ta' prevenzjoni għall-ġilda inkluż moisturiser għall-ġilda, krema li tipproteġi l-ġilda mix xemx, krema topika bi sterojd (1% hydrocortisone) u antibijotiku orali (eż. doxycycline) jistgħu jkunu ta' użu fl-immaniġġjar ta' reazzjonijiet dermatoloġiċi skont il-bżonn kliniku.
English: - Cardiorespiratory disorders
Maltese: - Disturbi kardjorespiratorji
English: Following improvement to Grade ≤ 2, resume at reduced dose of 400 mg.
Maltese: Wara titjib għal Grad ≤ 2, erġa' ibda bid-doża mnaqqsa ta' 400 mg.
English: Progressively decreasing serum magnesium levels occur frequently (81.3%) and may lead to severe Hypomagnesaemia (18.7%) (see also section 4.8).
Maltese: Livelli dejjem jonqsu ta' manjesju fis-serum iseħħu b'mod frekwenti (81.3%) u jistgħu jwasslu għal ipomanjesimja severa (18.7%) (ara wkoll sezzjoni 4.8).
English: It is available in packs of: - 1 vial of 50 mL
Maltese: Huwa disponibbli f'pakketti ta': - kunjett 1 ta' 50 mL
English: In addition, necitumumab induces EGFR internalization and degradation in vitro.
Maltese: Barra dan, necitumumab in vitro jikkaġuna internalizzazzjoni u degradazzjoni ta' EGFR.
English: Skin reactions were reported with necitumumab (see section 4.8).
Maltese: Reazzjonijiet fil-ġilda Ġew irrappurtati reazzjonijiet fil-ġilda b'necitumumab (ara sezzjoni 4.8).
English: These include low blood levels of magnesium, calcium, potassium or phosphate.
Maltese: diversi sustanzi bħall-magniżjum, il-kalċju, il-potassju u l-fosfat.
English: The most common serious adverse reactions (Grade ≥3) observed in necitumumab-treated patients are skin reactions (6.3 %) and venous thromboembolic events (4.3 %).
Maltese: L-aktar reazzjonijiet avversi komuni serji (Grad ≥3) osservati f'pazjenti ttrattati b'necitumumab huma reazzjonijiet fil-ġilda (6.3%) u avvenimenti tromboembloiċi fil-vini (4.3%).
English: Common Muscle spasms
Maltese: Spażmi fil muskoli
English: Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 6 % in the pemetrexed and cisplatin alone arm) and mainly present as stroke and myocardial infarction.
Maltese: Avvenimenti tromboemboliċi fl-arterji (ATEs) ġew irrappurtati f'madwar 4% tal-pazjenti ttrattati b'necitumumab flimkien ma' pemetrexed u cisplatin (versus 6% fil-fergħa ta' pemetrexed u cisplatin waħedhom) u jidhru l-aktar bħala puplesija u infart mijokardijaku.
English: Hypophosphataemiac
Maltese: Ipofosfatimjac
English: The recommended dose of Portrazza is 800 mg on days 1 and 8 of each 3-week cycle.
Maltese: Id-doża rrakkomandata ta' Portrazza hija 800 mg fil-jiem 1 u 8 ta' kull ċiklu ta' 3 ġimgħat.
English: Progression free survival Number of events (n) Median - months (95 % CI) Hazard ratio (95 % CI) b, c Two-sided log-rank p-value c a Abbreviations: CI = confidence interval b Hazard ratio is expressed as treatment/control and estimated from Cox model c Stratified by the randomization strata (ECOG PS [0-1 vs. 2], and geographic region [North
Maltese: Valur p log-rank bilateralic a Tqassir: CI = confidence interval b Il-proporzjon ta' periklu huwa rrapreżentat minn trattament/kontroll u stmat mill-mudell Cox c Stratifikat permezz tal-istrata ta' għażla b'mod arbitrarju (PS ta' ECOG ta' [0-1 vs. 2], u reġjun ġeografiku [l-Amerika ta' Fuq, l-Ewropa, u l-Awstralja vs. l-Amerika t'Isfel, l-Afrika t'Isfel, u l-Indja vs. l-Asja tal-Lvant])
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 February 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Frar 2016
English: GC Arm N=548
Maltese: N=548
English: The following convention has been used for classification of frequency:
Maltese: Il-konvenzjoni li ġejja kienet użata għallklassifikazzjoni tal-frekwenza:
English: Patients underwent radiographic assessment of disease status every six weeks, until radiographic documentation of progressive disease (PD).
Maltese: Il-pazjenti saritilhom valutazzjoni radjugrafika tal-istat tal-marda kull sitt ġimgħat, sakemm kien hemm dokumentazzjoni radjugrafika ta' progressjoni tal-marda (PD - progressive disease).
English: Skin reactions may occur in approximately 80 out of 100 patients who take Portrazza and are usually mild to moderate.
Maltese: Reazzjonjiet fil-ġilda x'aktarx iseħħu f'madwar 80 minn 100 pazjenti li jieħdu Portrazza u s-soltu jkunu minn ħfief sa moderati.
English: Contraceptive measures or abstinence are recommended (see section 4.6).
Maltese: Huma rrakkomandati miżuri ta' kontraċezzjoni jew astinenza (ara sezzjoni 4.6).
English: Store in a refrigator (2˚C - 8˚C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2˚C - 8˚C).
English: Portrazza 800 mg concentrate for solution for infusion necitumumab
Maltese: Portrazza 800 mg konċentrat għal soluzzjoni għall-infużjoni necitumumab
English: Premedication
Maltese: MEDIĊINALI
English: Clinically relevant toxicities with respect to the elderly and those patients with Eastern Cooperative Oncology Group (ECOG) performance status score 2 (ECOG PS2) were similar to the overall population in patients receiving necitumumab plus chemotherapy consisting of gemcitabine and cisplatin.
Maltese: Cooperative Oncology Group) kienu simili għal dawk tal-popolazzjoni globali f'pazjenti li kienu qed jirċievu necitumumab flimkien ma' kimoterapija li kienet tikkonsisti f'gemcitabine u cisplatin.
English: Venous thromboembolic events (VTEs) were reported in approximately 8 % of patients and mainly present as pulmonary embolism and deep vein thrombosis.
Maltese: Avvenimenti tromboemboliċi fil-vini (VTEs) ġew irrappurtati f'madwar 8% tal-pazjenti u jidhru l aktar bħala emboliżmu fil-pulmuni u trombożi fil-vini fil-fond.
English: Vascular disorders Common Venous thromboembolic events
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula Avvenimenti tromboemboliċi
English: Common Hypersensitivity reactions/infusionrelated reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva/marbuta mal-infużjoni
English: Following the dose regimen of 800 mg necitumumab on day 1 and day 8 of a 21 day schedule, the geometric mean of necitumumab Cmin was 98.5 μg/mL (Coefficient of Variation 80 %) in serum from patients with squamous NSCLC after five cycles of treatment in combination with gemcitabine and cisplatin.
Maltese: Wara l-kors terapewtiku ta' għoti ta' dożi ta' 800 mg necitumumab f'jum 1 u jum 8 minn skeda ta' 21 jum, il-medja ġeometrika tas-Cmin ta' necitumumab kienet 98.5 μg/mL (Koeffiċjent ta' Varjazzjoni 80%) f'serum minn pazjenti b'NSCLC skwamuż wara ħames ċikli ta' trattament flimkien ma' gemcitabine u cisplatin.
English: It is recommended that the prepared dosing solution be used immediately in order to minimize the risk of microbial contamination.
Maltese: Huwa rrakkomandat li s-soluzzjoni ppreparata biex tingħata d-doża tintuża immedjatament sabiex jitnaqqas ir-riskju ta' kontaminazzjoni bil-mikrobi.
English: Only use sodium chloride 9 mg/mL (0.9 %) solution for injection as a diluent.
Maltese: Uża biss soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%) bħala dilwent.
English: The pharmacokinetics of gemcitabine/cisplatin were not affected when co-administered with necitumumab and the pharmacokinetics of necitumumab were not affected when co-administered with gemcitabine/cisplatin.
Maltese: Il-farmakokinetika ta' gemcitabine/cisplatin ma kinitx affetwata meta ngħataw flimkien ma' necitumumab u l-farmakokinetika ta' necitumumab ma kinitx affettwata meta ngħata flimkien ma' gemcitabine/cisplatin.
English: Severe skin rections were reported in approximately 6 % of patients while 1.7 % of patients discontinued due to skin reactions.
Maltese: Reazzjonijiet severi fil-ġilda ġew irrappurtati f'madwar 6% tal-pazjenti filwaqt li 1.7% tal-pazjenti waqqfu t-trattament minħabba reazzjonijiet fil ġilda.
English: Necitumumab exhibits concentration-dependent clearance.
Maltese: c Ibbażati fuq valutazzjonijiet tal-laboratorju.
English: Cardiorespiratory disorders
Maltese: Disturbi kardjorespiratorji
English: Portrazza is given in combination with the medicines gemcitabine and cisplatin for up to 6 cycles and then it is given on its own.
Maltese: Portrazza jingħata flimkien mal-mediċini gemcitabine u cisplatin sa 6 ċikli imbagħad jingħata waħdu.
English: In patients with no detectable EGFR protein expression, no improvement in overall survival (hazard ratio [HR] = 1.52 [0.74, 3.12]) or progression free survival (hazard ratio [HR] = 1.33 [0.65, 2.70] was observed.
Maltese: jew fissopravivenza mingħajr progressjoni (proporzjon ta' periklu [HR] = 1.33 [0.65, 2.70].
English: Common Dysuria
Maltese: Disfaġja
English: To administer using pre-filled intravenous infusion containers Aseptically remove 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection from the prefilled 250 mL container and transfer 50 mL of necitumumab medicine into the container to bring the final volume in the container back to 250 mL.
Maltese: B'mod asettiku neħħi 50 mL ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%) mill-kontenitur mimli għal-lest ta' 250 mL u ttrasferixxi 50 mL tal-prodott mediċinali necitumumab għal ġol-kontenitur biex iġġib il-volum finali ġol-kontenitur lura għal 250 mL.
English: The following table provides the frequency and severity of ADRs based on results from SQUIRE, a global, multicenter, two-arm, randomized Phase 3 study in adult patients with squamous NSCLC randomised to treatment with necitumumab in combination with gemcitabine/cisplatin or gemcitabine/cisplatin.
Maltese: studju globali, ta' Fażi 3 b'ħafna ċentri, b'żewġ fergħat fejn pazjenti adulti b'NSCLC skwamuż intgħażlu b'mod arbitrarju għal trattament b'necitumumab flimkien ma' gemcitabine/cisplatin jew b'gemcitabine/cisplatin.
English: Electrolyte abnormalities
Maltese: Anormalitajiet fl-elettroliti
English: o The need to carefully consider use of necitumumab in patients with a history of thromboembolic events or pre-existing risk factors for thromboembolic events o Information on relative risk of VTE or ATE in patients with a history of VTE or ATE o Advice that necitumumab should not be administered to patients with multiple risk factors for thromboembolic events unless the benefits outweigh the risks to the patient o The need to consider thromboprophylaxis after careful assessment of a patient's risk factors o Discontinuation of necitumumab in patients who experience a VTE or ATE should be considered after a thorough benefit risk assessment for the individual patient.
Maltese: o Deskrizzjoni tad-disturbi kardjorespiratorji inklużi r-rati tal-inċidenza mill-provi kliniċi o Informazzjoni li ż-żjieda fir-riskju ta' arrest kardjopulmonarju jew mewt għal għarrieda f'pazjenti b'passat mediku ta' mard fl-arterji koronarji, insuffiċjenza konġestiva tal-qalb jew arritmiji mhijiex magħrufa meta mqabbla ma' pazjenti li ma jbatux ukoll minn dawn il-kundizzjonijiet serji.
English: Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Maltese: Pazjenti b'passat mediku ta' sensittività eċċessiva severa jew ta' periklu għall-ħajja għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (ara sezzjoni 4.4).
English: • For subsequent infusions, please see premedication section.
Maltese: • Għal infużjonijiet sussegwenti, jekk jogħġbok ara s-sezzjoni dwar premedikazzjoni.
English: Patients should be carefully monitored for serum electrolytes, including serum magnesium, potassium, and calcium, prior to each necitumumab administration and after completion of necitumumab treatment, until within normal limits.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għall-elettroliti fisserum, inkluż il-manjesju, il-potassju, u l-kalċju fis-serum qabel kull għoti ta' necitumumab u wara t tmiem tat-trattament b'necitumumab, sakemm jiġu fil-limiti normali.
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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni ta' rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Pyrexia
Maltese: PharmDx.
English: Severe ATEs were reported in approximately 3 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm).
Maltese: ATEs severi ġew irrappurtati f'madwar 3 % tal-pazjenti ttrattati b'necitumumab flimkien ma' pemetrexed u cisplatin (versus 4 %
English: Patients were randomised to receive first-line Portrazza at 800 mg plus chemotherapy consisting of gemcitabine at 1,250 mg/m2 and cisplatin at 75 mg/m2 (Portrazza+GC Arm), or gemcitabine-cisplatin chemotherapy alone (GC Arm).
Maltese: kimoterapija li kienet tikkonsisti f'gemcitabine b'doża ta' 1,250 mg/m2 u cisplatin b'doża ta'
English: Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients and mainly present as stroke and myocardial infarction.
Maltese: Avvenimenti tromboemboliċi fl-arterji (ATEs) ġew irrappurtati f'madwar 4% tal-pazjenti u jidhru l aktar bħala puplesija u infart mijokardijaku.
English: Handling instructions Portrazza 800 mg concentrate for solution for infusion necitumumab
Maltese: Informazzjoni għall-utent Portrazza 800 mg konċentrat għal soluzzjoni għall-infużjoni necitumumab
English: Each 50 mL vial contains 800 mg of necitumumab.
Maltese: Kull kunjett ta' 50 mL fih 800 mg ta' necitumumab.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: Il-punti ewlenin tal-materjal edukattiv għall-ispeċjalista:
English: Portrazza and gemcitabine were administered on days 1 and 8 of each 3-week treatment cycle, and cisplatin was administered on day 1 of each 3-week treatment cycle.
Maltese: Portrazza u gemcitabine ingħataw fil-jiem 1 u 8 ta' kull ċiklu ta' trattament ta' 3 ġimgħat, u cisplatin ingħata f'jum 1 ta' kull ċiklu ta' trattament ta' 3 ġimgħat.
English: b The table reflects the frequency of ADRs during the chemotherapy phase of study treatment in which Portrazza+GC was directly compared with GC.
Maltese: b It-tabella tirrifletti l-frekwenza ta' ADRs waqt il-fażi tal-kimoterapija tat-trattament tal-istudju fejn Portrazza+GC tqabbel direttament ma' GC.
English: Excipient with known effect Each 50 mL vial contains approximately 76 mg sodium.
Maltese: Kull kunjett ta' 50 mL fih madwar 76 mg sodium.
English: If not used immediately, the prepared necitumumab dosing solution must be stored at 2°C to 8°C for a duration not to exceed 24 hours, or may be held at 9°C to 25°C for up to 4 hours.
Maltese: Jekk ma tintużax immedjatament, is-soluzzjoni ta' necitumumab ppreparata biex tingħata d-doża għandha tinħażen f'temperatura ta' 2°C sa 8°C għal tul ta' ħin li ma jaqbiżx 24 siegħa, jew tista' tinżamm f'temperatura ta' 9°C sa 25°C sa 4 sigħat.
English: Hypomagnesaemiac
Maltese: Ipokalimjac
English: o Instruction for healthcare professionals to read the materials in conjunction with the SmPC.
Maltese: o Istruzzjoni għall-professjonisti fil-kura tas-saħħa li jaqraw il-materjali flimkien malSmPC
English: Necitumumab is a recombinant human IgG1 monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 1 (EGFR) and blocks the ligand binding site, blocking activation by all known ligands and inhibiting relevant biological consequences in vitro.
Maltese: IgG1 uman rikombinat li jintrabat b'affinità u speċifiċità kbira mar-riċettur 1 tal-fattur ta' tkabbir tal-epidermide tal-bniedem (EGFR - epidermal growth factor receptor) u jimblokka s-sit fejn jintrabat il-ligand, b'hekk jimblokka l-attivazzjoni mill-ligands kollha magħrufa u jinibixxi l-konsegwenzi bijoloġiċi rilevanti in vitro.
English: Administration of necitumumab should be carefully considered in those patients with a history of thromboembolic events (such as pulmonary embolism, deep vein thrombosis, myocardial infarction, stroke) or preexisting risk factors for thromboembolic events (such as advanced age, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with acquired or inherited thrombophilic disorders).
Maltese: puplesija) jew fatturi ta' riskju li jeżistu diġà għal avvenimenti tromboemboliċi (bħal età avvanzata, pazjenti b'perjodi twal ta' immobilizzazzjoni, pazjenti ipovolimiċi b'mod sever, pazjenti b'disturbi trombofiliċi akkwiżiti jew li jintirtu).
English: - Blood levels of magnesium, calcium, potassium and phosphate During treatment, your doctor will check your blood periodically for levels of several substances such as magnesium, calcium, potassium and phosphate.
Maltese: - Livelli ta' magniżjum, kalċju, potassju u fosfat fid-demm Waqt it-trattament, it-tabib tiegħek se jiċċekkja b'mod perjodiku għal-livelli fid-demm ta'
English: A similar observation was made in a clinical trial investigating necitumumab in combination with pemetrexed and cisplatin versus pemetrexed and cisplatin alone as the first-line therapy in patients with advanced non-squamous NSCLC.
Maltese: Kien hemm osservazzjoni simili fi prova klinika li investigat necitumumab flimkien ma' pemetrexed u cisplatin kontra pemetrexed u cisplatin waħidhom bħala terapija tal-ewwel grad f'pazjenti b'NSCLC mhux skwamuż avvanzat.
English: c Based on laboratory assessments.
Maltese: DATA TA' REVIŻJONI TAT-TEST