FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP agreed on a statement that the usual duration of treatment for most indications is in the range of 5-14 days but that the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.
Maltese: IlCHMP qabel fuq dikjarazzjoni li d-dewma normali tat-trattament għall-biċċa l-kbira tal-indikazzjonijiet huwa fil-medda ta' 5-14-il ġurnata iżda li t-tul tat-trattament għandu jkun iggwidat mis-severità talinfezzjoni, il-patoġenu(i) u l-progress kliniku u batterjoloġiku tal-pazjent.
English: For the drug product, the MAH presented and discussed the description and composition of the drug product, the pharmaceutical development, the manufacture, control of excipients, the control of drug products, the reference standard, the container closure system and the stability.
Maltese: Għall-prodott tal-mediċina, il-MAH ippreżenta u ddiskuta d-deskrizzjoni u l-kompożizzjoni tal-prodott tal-mediċina, l-iżvilupp farmaċewtiku, il-manifattura, il-kontroll tas-sustanzi mhux attivi, il-kontroll tal-prodotti tal-mediċina, listandard ta' referenza, is-sistema tal-għeluq tal-kontenitur u l-istabilità.
English: “Complicated intra-abdominal infections”
Maltese: “Infezzjonijiet ikkumplikati ġewwa l-addome”
English: Regarding adult and adolescent patients (> 12 years of age), the dosage depends on the severity, location of the infection and the indication.
Maltese: Fir-rigward tal-pazjenti adulti u adoloxxenti (> 12-il sena), id-dożaġġ jiddependi mis-severità, mill-post tal-infezzjoni u millindikazzjoni.
English: The CHMP adopted a harmonised wording for Section 4.6.
Maltese: Il-CHMP adotta formulazzjoni armonizzata għas-Sezzjoni 4.6.
English: Regarding CAP, the CHMP noted that the non-comparative studies submitted in the context of the initial MAA were performed involving patients with respiratory tract infections including lower respiratory tract infections and acute exacerbation of chronic bronchitis (AECB).
Maltese: Fir-rigward tal-CAP, il-CHMP innota li l-istudji non-komparattivi ppreżentati fil-kuntest tal-MAA inizjali saru bil-parteċipazzjoni ta' pazjenti li kellhom infezzjonijiet tal-apparat respiratorju, fosthom infezzjonijiet fil-parti ta' isfel tal-apparat respiratorju u taħrix akut ta' bronkite kronika (AECB).
English: Tazocin in the treatment of LRTIs.
Maltese: III għal Tazocin u l-ismijiet assoċjati (ara l-Anness I).
English: The CHMP adopted a harmonised wording for Section 4.4.
Maltese: Il-CHMP adotta formulazzjoni armonizzata għal Sezzjoni 4.4.
English: The CHMP revised the MAH proposal to bring it in line with the current guidelines and considered that the available evidence sufficiently supports the use of Tazocin 4.5 g every 8 hours for this indication.
Maltese: Il-CHMP irreveda l-proposta tal-MAH sabiex iġibha konformi mal-linji gwida preżenti u qies li l-evidenza disponibbli tappoġġja b'mod suffiċjenti l-użu ta' Tazocin 4.5 g kull 8 sigħat għal din l-indikazzjoni.
English: The CHMP noted the data submitted.
Maltese: Il-CHMP innota d-dejta ppreżentata.
English: The CHMP decided to remove the triple combination (intramuscular administration with lidocaine) from the scope of the procedure, in line with the notification.
Maltese: Il-CHMP iddeċieda li jneħħi lkombinazzjoni tripla (għoti ġol-muskoli ma' lidokaina) mill-ambitu tal-proċedura, bi qbil mannotifikazzjoni.
English: A harmonised wording was adopted for Section 5.2.
Maltese: Ġiet adottata formulazzjoni armonizzata għasSezzjoni 5
English: The CHMP adopted a harmonised wording for Section 4.3.
Maltese: Il-CHMP adotta formulazzjoni armonizzata għas-Sezzjoni 4.3.
English: Module 2 (QOS) was also updated in line with Module 3.
Maltese: Sar ukoll aġġornament talModulu 2 (QOS) bi qbil ma' Modulu 3.
English: Based on the numerous clinical studies, the pharmacokinetic properties of Tazocin and its antibacterial spectrum, the efficacy of the drug is established in this indication, but the CHMP also noted that uncomplicated UTI is a very common infection and according to international guidance documents, there are several recommended treatment options, generally not including Tazocin.
Maltese: Abl-bażi tad-diversi studji kliniċi, tal-proprjetajiet farmakokinetiċi ta' Tazocin u talispettru antibatteriku tiegħu, din l-indikazzjoni taċċerta l-effikaċja tas-sustanza, iżda l-CHMP innota wkoll li l-UTI mingħajr kumplikazzjonijiet hija infezzjoni komuni ħafna u li skont id-dokumenti ta' gwida internazzjonali hemm diversi opzjonijiet ta' trattament rakkomandati li ġeneralment ma jinkludux Tacozin.
English: There is vast clinical experience in treating neutropenic adults as well as children > 2 years with fever suspected to be due to bacterial infections, often in combination with an aminoglycoside and the safety of piperacillin-tazobactam is well documented in immunocompetent patients.
Maltese: Hemm esperjenza klinika vasta fit-trattament ta' adulti newtropeniċi kif ukoll ta' tfal ta' iżjed minn sentejn b'deni li jkun issuspettat li ġej minn infezzjonijiet batteriċi, ħafna drabi f'kombinazzjoni mal-aminoglikoside, u s-sikurezza tal-piperaċillina-tażobaktam hija dokumentata sewwa f'pazjenti immunokompetenti.
English: The CHMP agreed to the revised proposal and adopted a harmonised wording for Section 5.1.
Maltese: Il-CHMP qabel mal-proposta riveduta u adotta formulazzjoni armonizzata għas-Sezzjoni 5
English: The CHMP considered that the justifications provided by the MAH for the proposed wording were acceptable and adopted a harmonised wording for Section 4.8.
Maltese: Il-CHMP qies li l-ġustifikazzjonijiet ipprovduti mill-MAH għallformulazzjoni proposta kienu aċċettabbli u adotta formulazzjoni armonizzata għas-Sezzjoni 4.8.
English: The MAH only provided in vitro data in support of this section and identified the pathogens against which clinical efficacy has been demonstrated in clinical trials.
Maltese: Il-MAH ipprovda biss dejta in vitro b'appoġġ għal din is-sezzjoni u identifika l-patoġeni li kontrihom intweriet effikaċja klinika fil-provi kliniċi.
English: Therefore, the CHMP considered the evidence sufficient to support the use of Tazocin in the treatment of HAP and VAP.
Maltese: Il-CHMP ikkonkluda li l-MAH ipprovda evidenza sodisfaċenti li turi l-effikaċja ta' Tazocin fit-trattament tal-LRTIs.
English: With regards to the method of administration, the CHMP recommended intravenous infusion over 30 minutes based on the relationship between efficacy and the time during which the free (unbound) drug concentration in blood exceeds the MIC of the organism (T > MIC).
Maltese: Rigward il-metodu ta' kif għandu jingħata, il-CHMP irrakkomanda l-infużjoni fil-vini fuq 30 minuta bbażata fuq ir-relazzjoni bejn l-effikaċja u l-ħin li matulu l-konċentrazzjoni libera (mhux imwaħħla) talmediċina fid-demm taqbeż il-MIC tal-organiżmu (T > MIC).
English: Although pharmacokinetic data suggest that piperacillin and tazobactam concentrations in both bone and synovial tissue are sufficient to treat the majority of infections caused by susceptible organisms, the available clinical documentation is considered too limited and insufficient to justify an indication in treatment of bone and joint infections.
Maltese: Għalkemm id-dejta farmakokinetika tissuġġerixxi li lkonċentrazzjonijiet tal-piperaċillina u tat-tażobaktam fit-tessut kemm tal-għadam u kemm tas-sinovja huma suffiċjenti sabiex jittrattaw il-biċċa l-kbira tal-infezzjonijiet ikkawżati minn organiżmi suxxettibbli, id-dokumentazzjoni klinika disponibbli hija kkunsidrata limitata wisq u insuffiċjenti biex tiġġustifika indikazzjoni fit-trattament ta' infezzjonijiet fl-għadam u fil-ġogi.
English: The CHMP included only the preclinical information relevant to prescribers and also the current state of knowledge about the reproductive toxicity of the product, in line with the text approved for recent EU procedures for generics of piperacillin-tazobactam and including a summary of published data about the reproductive toxicity testing of piperacillin and tazobactam.
Maltese: Il-CHMP inkluda biss it-tagħrif ta' qabel l-użu kliniku li huwa rilevanti għal min jikteb riċetta għall-mediċina u wkoll l-istat preżenti tal-għarfien dwar l-effett tossiku talprodott fuq is-sistema riproduttiva, bi qbil mat-test approvat għall-proċeduri riċenti tal-UE għallmediċini ġeneriċi tal-piperaċillina-tażobaktam u inkluda sommarju tad-dejta ppubblikata dwar littestjar tal-effett tossiku tal-piperaċillinċ u tat-tażobaktam fuq is-sistema riproduttiva.
English: Similarly, the clinical and pharmacokinetic data from comparative studies in adults and children, as well as wide clinical experience in children aged > 2 years, support the safety and efficacy in the treatment of intra-abdominal infections in paediatric patients.
Maltese: Bl-istess mod, id-dejta klinika u farmakokinetika li rriżultat minn studji komparattivi f'persuni adulti u tfal kif ukoll l-esperjenza klinika wiesgħa fi tfal ta' iżjed minn sentejn, jappoġġaw is-sikurezza u l-effikaċja fit-trattament ta' infezzjonijiet ġewwa l-addome f'pazjenti pedjatriċi.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Tazocin and associated names (see Annex I).
Maltese: • is-sommarju tal-karatteristiċi tal-prodott, it-tikketti u l-fuljett ta' tagħrif proposti mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq ġew ivvalutati fuq il-bażi tad-dokumentazzjoni ppreżentata u d-diskussjoni xjentifika fil-Kumitat il-CHMP irrakkomanda l-emenda tal-awtorizzazzjonijiet għat-tqegħid fis-suq li s-sommarju talkaratteristiċi tal-prodott, it-tikketti u l-fuljett ta' tagħrif tagħhom huma ppreżentati fl-Anness
English: The MAH proposed a wording in line with its Core Data Sheet.
Maltese: Il-MAH ippreżenta proposta ta' formulazzjoni li taqbel mal-Core Data Sheet tiegħu.
English: The CHMP agreed with the MAH proposal but enforced some additions, in particular by inserting a caution regarding use in patients without severe hypersensitivity reaction to non-penicillin β-lactams but who may have had non-severe reactions and by supplementing the warning on pseudomembranous colitis.
Maltese: Kif diġà ġie affermat, il-piperaċillina-tażobaktam għandha titħalla għal sitwazzjonijiet fejn tassew tkun meħtieġa sustanza bi spettru wiesa', jiġifieri mhux biex jiġu ttrattati infezzjonijiet li ma jkunx severi.
English: All member states use the same minimum inhibitory concentration (MIC) based on UK-breakpoints but due to national approvals and different approval times there were minor divergences in the presentation of the data and also the summary/listing of susceptible organism differed slightly.
Maltese: L-Istati Membri kollha jużaw l-istess konċentrazzjoni inibitorja minima (MIC) bbażata fuq breakpoints tar-Renju Unit iżda minħabba l-approvazzjonijiet nazzjonali u żżminijiet differenti tal-approvazzjoni, kien hemm diverġenzi żgħar fil-preżentazzjoni tad-dejta u anki ssommarju/lista ta' organiżmi suxxettibbli varjaw daqsxejn.
English: However, taking into account the view of the CHMP drafting group and despite the very limited data for this indication and acknowledging the difficulties of conducting retrospective analysis, the CHMP was of the opinion that piperacillin-tazobactam has broad-spectrum antibacterial activity and is therefore a suitable option for the treatment of bacteraemia.
Maltese: Madankollu, wara li kkunsidra l-opinjoni tal-grupp tal-CHMP responsabbli mit-tfassil u minkejja d-dejta limitata ħafna għal din l-indikazzjoni u filwaqt li rrikonoxxa d-diffikultajiet biex issir analiżi retrospettiva, il-CHMP kien tal-opinjoni li l-piperaċillina-tażobaktam għandha attività antibatterika ta' spettru wiesa' u għalhekk hija opzjoni adattata għat-trattament tal-batterimja.
English: The CHMP considered that the studies suggests that Tazocin is efficacious in the treatment of cSSTI and was of the opinion that the safety and efficacy of Tazocin in the treatment of skin and soft tissue infections is well justified by numerous clinical studies, treatment guidelines from scientific societies and experience from clinical practice.
Maltese: Il-CHMP ħass li l-istudji jissuġġerixxu li Tazocin huwa effikaċi fit-trattament tas-cSSTI u kien tal-opinjoni li s-sikurezza u l-effikaċja ta' Tazocin fit-trattament talinfezzjonijiet tal-ġilda u tat-tessuti rotob hija ġustifikata sewwa b'diversi studji kliniċi, b'linji gwida dwar it-trattament minn soċjetajiet xjentifiċi u bl-esperjenza mill-prattika klinika.
English: Tazobactam is a penicillanic acid sulfone derivative with β-lactamase inhibitory properties similar to those of sulbactam although it is regarded as more potent.
Maltese: It-tażobaktam huwa derivattiv solforiku talaċidu peniċillaniku bi proprjetajiet inibitorji ta' betalattamasi li huma simili ta' dawk ta' sulbactam, għalkemm dan huwa kkunsidrat iżjed b'saħħtu.
English: Tazocin was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the product.
Maltese: Tazocin ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SPC), minħabba d-deċiżjonijiet nazzjonali diverġenti mill-Istati Membri rigward l-awtorizzazzjoni talprodott.
English: “Tazocin may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection”
Maltese: “Tazocin jista' jintuża fil-ġestjoni ta' pazjenti newtropeniċi b'deni li jkun issuspettat li ġej minn infezzjoni batterika”
English: The CHMP noted that the supporting evidence is mainly derived from studies in febrile neutropenia and that only about a quarter of patients across different trials had “bacteraemia”.
Maltese: Il-CHMP innota li levidenza ta' sostenn hija derivata prinċipalment minn studji dwar in-newtropenija bid-deni u li madwar kwart biss tal-pazjenti fil-provi differenti kellhom “batterimja”.
English: a MedDRA preferred term (Version 16).
Maltese: a Terminu ppreferut MedDRA (Verżjoni 16).
English: Manufacturer Lilly S.A., Avda de la Industria, 30, Alcobendas, Madrid, 28108, Spain
Maltese: Lilly S.A., Avda de la Industria, 30, Alcobendas, Madrid, 28108, Spanja
English: The protein is known as epidermal growth factor receptor (EGFR).
Maltese: epidermal growth factor receptor).
English: The drip lasts about 60 minutes.
Maltese: madwar 60 minuta.
English: Abbreviations: C = cisplatin; G = gemcitabine.
Maltese: Tqassir: C = cisplatin; G = gemcitabine.
English: a Grade per NCI-CTCAE, Version 3.0
Maltese: a Grad skont NCI-CTCAE, Verżjoni 3.0
English: Portrazza contains sodium
Maltese: Portrazza fih sodium
English: Mannitol (E421) Polysorbate 80 (E433) Water for injections
Maltese: Mannitol (E421) Polysorbate 80 (E433) Ilma għall-injezzjonijiet
English: Kaplan Meier plot of overall survival (ITT population)
Maltese: Plott Kaplan Meier ta' sopravivenza totali (popolazzjoni ITT)
English: Name and address of the manufacturer(s) of the biological active substance(s) ImClone Systems LLC
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i) ImClone Systems LLC
English: Hypersensitivity/infusion-related reactions (IRRs) were reported with necitumumab.
Maltese: Reazzjonijiet ta' sensittività eċċessiva/marbuta mal-infużjoni (IRRs - infusion-related reactions) ġew irrappurtati b'necitumumab.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of 50 mL contains 800 mg necitumumab (16 mg/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed ta' 50 mL fih 800 mg necitumumab (16 mg/mL).
English: Median age was 62 (32-86), 83 % of patients were men; 83.5 % were Caucasian; and 91 % were smokers.
Maltese: Il-medjan tal-età kien ta' 62 (32-86), 83% tal-pazjenti kienu rġiel; 83.5% kienu Kawkasiċi; u 91% kienu jpejpu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1084/001
Maltese: EU/1/15/1084/001
English: The overall survival hazard ratio [HR] was 0.83 [0.55, 1.52].
Maltese: Il-proporzjon ta' periklu- (hazard ratio) [HR] tassopravivenza totali kienet ta' 0.83 [0.55, 1.52].
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda Manifattur
English: - The other ingredients are sodium citrate dihydrate (E331), citric acid anhydrous (E330), sodium chloride (see section 2 “Portrazza contains sodium”), glycine (E640), mannitol (E421), polysorbate 80 (E433) and water for injections.
Maltese: - Is-sustanzi l-oħra huma sodium citrate dihydrate (E331), citric acid anhydrous (E330), sodium chloride (ara sezzjoni 2 “Portrazza fih sodium”), glycine (E640), mannitol (E421), polysorbate 80 (E433) u ilma għall-injezzjonijiet.
English: Abbreviations: C = cisplatin; G = gemcitabine; ITT = intent-to-treat.
Maltese: Tqassir: C = cisplatin; G = gemcitabine ;
English: Abbreviations: GC = gemcitabine and cisplatin alone; Portrazza+GC = necitumumab plus gemcitabine and cisplatin; MedDRA = Medical Dictionary for Regulatory Activities.
Maltese: Tqassir: GC = gemcitabine u cisplatin waħedhom; Portrazza+GC = necitumumab flimkien ma' gemcitabine u cisplatin; MedDRA = Dizzjunarju Mediku għal Attivitajiet Regulatorji
English: The ECOG PS was 0 for 31.5 %, 1 for 59.7 %, and 2 for 9 % of patients; over 50 % had metastatic disease at more than 2 sites.
Maltese: Il-PS ta ECOG kien 0 għal 31.5%, 1 għal 59.7 %, u 2 għal 9% tal-pazjenti; aktar minn 50% kellhom mard metastatiku f'aktar minn 2 postijiet.
English: What Portrazza contains - The active substance is necitumumab.
Maltese: X'fih Portrazza - Is-sustanza attiva hi necitumumab.
English: Excipients: sodium citrate dihydrate, citric acid anhydrous, sodium chloride, glycine, mannitol, polysorbate 80 and water for injections.
Maltese: Eċċipjenti: sodium citrate dihydrate, citric acid anhydrous, sodium chloride, glycine, mannitol,
English: Severe ATEs were reported in 3 % of patients.
Maltese: ATEs severi kienu rrappurtati fi 3% tal-pazjenti.
English: • Immediately and permanently discontinue treatment with necitumumab.
Maltese: • Waqqaf it-trattament b'necitumumab immedjatament u b'mod permanenti.
English: Forest plot for subgroup analysis of overall survival (ITT population)
Maltese: Plott forest għal analiżi ta' sottogrupp għal sopravivenza totali (Popolazzjoni ITT)
English: Mean total systemic clearance (CLtot) at steady state following 800 mg on Day 1 and Day 8 of a 21-day cycle was 0.014 l/hr (CV 39 %).
Maltese: (CLtot - total systemic clearance) fl-istat fiss wara 800 mg f'Jum 1 u Jum 8 minn ċiklu ta' 21 jum kienet 0.014 L/siegħa (CV 39%).
English: Of the ITT population, 982 patients (89.8%) were evaluable for an EGFR protein expression analysis by immunohistochemistry (IHC) using Dako PharmDx Kit.
Maltese: Mill-popolazzjoni ITT, 982 pazjent (89.8%) setgħu jiġu vvalutati għal analiżi ta' espressjoni talproteina EGFR permezz ta' immunoistokimika (IHC - immunohistochemistry) bl-użu tal-Kit Dako
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC22
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: Any grade
Maltese: Kwalunkwe grad
English: Other medicines and Portrazza
Maltese: Mediċini oħra u Portrazza
English: See also section 2 under “Warnings and precautions”.
Maltese: Ara wkoll sezzjoni 2 taħt “Twissijiet u prekawzjonijiet”.
English: The incidence of fatal VTEs was similar between arms (0.2%).
Maltese: L-inċidenza ta' VTEs fatali kienet simili bejn il-fergħat (0.2%).
English: Use of post-study systemic therapy was similar in the 2 arms (47.3 % in the Portrazza+GC arm and 44.7 % in the GC arm).
Maltese: L-użu ta' terapija sistemika wara l-istudju kien simili fiż-2 fergħat (47.3% fil-fergħa ta' Portrazza+GC u 44.7 % fil-fergħa GC).
English: No drug-drug interactions were observed between Portrazza and gemcitabine/cisplatin.
Maltese: Ma ġew osservati l-ebda interazzjonijiet ta' mediċina m'oħra bejn Portrazza u gemcitabine/cisplatin.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 800 mg/50 mL
Maltese: INDIVIDWALI 800 mg/50 mL
English: Cardiorespiratory arrest or sudden death was reported in 2.8% (15/538) of patients treated with necitumumab in combination with gemcitabine and cisplatin compared to 0.6% (3/541) of patients treated with chemotherapy alone.
Maltese: Waqfien kardjorespiratorju jew mewt zoptu ġew irrappurtati fi 2.8% (15/538) ta' pazjenti ttrattati b'necitumumab flimkien ma' gemcitabine u cisplatin meta mqabbel ma' 0.6% (3/541) ta' pazjenti ttrattati bil-kimoterapija waħedha.
English: Based on the results of the population pharmacokinetic analysis, hepatic status (as assessed by alanine aminotransferase, aspartate transaminase and total bilirubin) had no significant effect on the pharmacokinetics of necitumumab.
Maltese: Abbażi tar-riżultati tal-analiżi farmakokinetika ta' popolazzjoni, l-istat epatiku (kif stmat permezz ta' alanine aminotransferase, aspartate transaminase u bilirubin totali) ma kellu l-ebda effett sinifikanti fuq il-farmakokinetika ta' necitumumab.
English: Common Arterial thromboembolic events
Maltese: Avvenimenti tromboemboliċi fl-arterji
English: Based on population pharmacokinetic approach (PopPK), the mean volume of distribution at steady state (Vss) for necitumumab was 6.97 L (CV
Maltese: Abbażi tal-mezz ta' farmakokinetika talpopolazzjoni (PopPK - population pharmacokinetics), il-medja tal-volum ta' distribuzzjoni fl-istat fiss (Vss - volume of distribution at steady state) għal necitumumab kienet 6.97 L (CV 31%).
English: Venous thromboembolic events (VTE) and arterial thromboembolic events (ATE), including fatal cases, were observed with necitumumab in combination with gemcitabine and cisplatin (see also section 4.8).
Maltese: Avvenimenti tromboemboliċi fil-vini (VTE - venous thromboembolic events) u avvenimenti tromboemboliċi fl-arterji (ATE - arterial thromboembolic events), li jinkludu każijiet fatali, ġew osservati b'necitumumab flimkien ma' gemcitabine u cisplatin (ara wkoll sezzjoni 4.8).
English: The large majority of patients (95.2% of evaluable patients; n = 935) had tumor samples expressing EGFR protein; 4.8% (n = 47) were not detectable for EGFR protein expression.
Maltese: n = 935) kellhom kampjuni tat-tumur li kien jesprimi l-proteina EGFR; 4.8% (n = 47) ma nstabitx fihom ilpreżenza ta' espressjoni ta' EGFR.
English: Name and address of the manufacturer(s) responsible for batch release Lilly, S.A.
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Lilly, S.A.
English: The incidence of fatal ATEs was 0.6% in the experimental arm versus 0.2% in the control arm (see also section 4.4).
Maltese: Linċidenza ta' ATEs fatali kienet 0.6% fil-fergħa tal-esperiment versus 0.2% fil-fergħa ta' kontroll (ara wkoll sezzjoni 4.4).
English: 50 mL solution in a vial (Type I glass) with a chlorobutyl elastomer stopper, an aluminium seal and a polypropylene cap.
Maltese: 50 mL ta' soluzzjoni f'kunjett (ħġieġ tat-Tip I) b'tapp tal-elastomer chlorobutyl, siġill tal-aluminju u għatu tal-polypropylene.
English: The materials will address the risks concerning arterial / venous thromboembolic events and cardiorespiratory disorders.
Maltese: Il-materjali se jindirizzaw ir-riskji li għandhom x'jaqsmu ma' avvenimenti tromboemboliċi arterjali / venużi u disturbi kardjorespiratorji.
English: SQUIRE, a global, multicenter, two-arm, randomized study of Portrazza, was conducted in 1,093 patients with stage IV (American Joint Committee on Cancer Version 7) squamous NSCLC, including patients with ECOG PS2, who had received no prior anticancer therapy for metastatic disease.
Maltese: SQUIRE, studju globali, b'ħafna ċentri, b'żewġ fergħat, ta' Portrazza, sar f'1,093 pazjent li ntgħażlu b'mod arbitrarju li kellhom NSCLC skwamuż ta' stadju IV (Kumitat Konġunt Amerikan dwar ilKanċer [American Joint Committee on Cancer] Verżjoni 7), inkluż pazjenti b'PS2 ta'ECOG, li ma kienu rċivew l-ebda terapija kontra l-kanċer għal mard metastatiku qabel.