FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Cimzia are provided with a physician information pack containing the following:
Maltese: Id-detentur tal-awtorizzażżjoni tat-tqegħid fis-suq (MAH) għandu jassigura li, qabel ma jitpoġġa fis-suq, it-tobba kollha li huma mistennija li jiktbu/ jużaw Cimzia jingħataw pakkett ta' tagħrif għat-tobba li fih dawn li ġejjin:
English: • The need to evaluate patients for both active and inactive tuberculosis prior to starting the treatment, including use of appropriate screening tests,
Maltese: • Il-bżonn li tevalwa l-pazjenti għat-tuberkulożi kemm attiv u inattiv, qabel ma tibda ttrattament, inkluż l-użu ta' testijiet ta' tiftix addattati,
English: 24 August 2011
Maltese: 24 ta' Awwissu 2011
English: The mutual recognition procedure (UK/V/0373/001/MR) started on 29 July 2010.
Maltese: Il-proċedura ta' rikonoxximent reċiproku (UK/V/0373/001/MR) bdiet fid-29 ta' Lulju 2010.
English: International non-proprietary name (inn): amoxicillin, clavulanic acid
Maltese: Denominazzjoni komuni internazzjonali (inn): amossiċillina, aċidu klavulaniku
English: The marketing authorisation holder, Dechra Ltd, submitted an application for Clavudale 50 mg via a mutual recognition procedure in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Spain and Sweden on the basis of the marketing authorisation granted by the United Kingdom.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Dechra Ltd, issottometta applikazzjoni għal Clavudale 50 mg permezz ta' proċedura ta' rikonoxximent reċiproku fl-Awstrija, fil-Belġju, firRepubblika Ċeka, fid-Danimarka, fil-Finlandja, fi Franza, fil-Ġermanja, fil-Greċja, fl-Ungerija, fl-Islanda, fl-Irlanda, fil-Lussemburgu, fil-Pajjiżi l-Baxxi, fin-Norveġja, fil-Polonja, fil-Portugall, fir-Repubblika Slovakka, fi Spanja u fl-Isvezja abbażi tal-awtorizzazzjoni għat-tqegħid fis-suq mgħotija mir-Renju Unit.
English: The Committee appointed Dr Karolina Törneke as rapporteur and Ms Helen Jukes as co-rapporteur.
Maltese: Il-Kumitat ħatar lil Dr Karolina Törneke bħala rapporteur u lis-Sinjorina Helen Jukes bħala korapporteur.
English: The application was submitted as a generic of the reference product, Synulox Palatable Tablets 50 mg marketed by Pfizer Ltd.
Maltese: L-applikazzjoni ġiet sottomessa bħala mediċina ġenerika tal-prodott ta' referenza, Synulox Palatable Tablets 50 mg mqiegħda fis-suq minn Pfizer Ltd.
English: Written explanations were provided by the marketing authorisation holder on 11 April 2011.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ressaq spjegazzjonijiet bil-miktub fil-11 ta' April 2011.
English: Clavudale 50 mg is intended for the treatment of pathogen-specific skin infections, infections of the oral cavity, urinary tract infections, respiratory disease and enteritis.
Maltese: Clavudale 50 mg pillola għall-qtates u għall-klieb u ismijiet assoċjati (Clavudale 50 mg) fiha lamossiċillina u l-aċidu klavulaniku. Clavudale 50 mg huwa maħsub għall-kura ta' infezzjonijiet tal-ġilda speċifiċi għal patoġeni, infezzjonijiet tal-kavità orali, infezzjonijiet fl-apparat urinarju, mard respiratorju u enterite.
English: The final opinion was converted into a Decision by the European Commission on 24 August 2011.
Maltese: L-opinjoni finali ġiet ikkonvertita f'Deċiżjoni mill-Kummissjoni Ewropea fl-24 ta' Awwissu 2011.
English: On 28 January 2011, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by two of the Concerned Member States, the Netherlands and Sweden, that the safety and efficacy of the product had not been sufficiently demonstrated.
Maltese: Fit-28 ta' Jannar 2011, ir-Renju Unit, bħala l-Istat Membru ta' Referenza, irrefera l-kwistjoni lillAġenzija Ewropea tal-Mediċini skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE, minħabba tħassib imqajjem minn tnejn mill-Istati Membri involuti, il-Pajjiżi l-Baxxi u l-Isvezja, li s-sigurtà u l-effikaċja tal-prodott ma kinux intwerew b'mod suffiċjenti.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Clavudale 50 mg tablet for cats and dogs and associated
Maltese: Abbażi tal-valutazzjoni tar-rapporteur tad-dejta attwalment disponibbli, is-CVMP qies li l-profil ta' benefiċċju/riskju ta' Clavudale 50 mg pillola għall-qtates u għall-klieb u ismijiet assoċjati huwa pożittiv, u għalhekk fis-6 ta' April 2011 adotta opinjoni li tirrakkomanda l-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Ref. EMEA/CHMP/384877/2008
Maltese: EMEA/CHMP/556344/2008
English: Risperdal and associated names is as an antipsychotic, indicated for the treatment of schizophrenia, manic episodes associated with bipolar disorders, persistent aggression in patients with moderate to severe Alzheimer's dementia and treatment of persistent aggression in conduct disorder in children.
Maltese: Risperdal u ismijiet assoċjati huwa antipsikotiku, indikat għat-trattament tal-iskizofrenija, episodji manijaċi assoċjati ma' disturbi bipolari, aggressjoni persistenti f'pazjenti b'dimenzja tal-Alzheimer moderata sa severa u trattament ta' aggressjoni persistenti f'disturbi fl-imġiba tat-tfal.
English: This medicinal product belongs to the list of products identified in 2007 for SPC harmonisation.
Maltese: Dan il-prodott mediċinali jappartjeni għal-lista ta' prodotti identifikati fl-2007 għall-armonizzazzjoni tal-SPC.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal and associated names International Non-Proprietary Name (INN): risperidone
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA RIFERIMENT SKONT L-ARTIKOLU 30 GĦAL Risperdal u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): risperidone
English: On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal and associated names.
Maltese: Fl-24 ta' Lulju 2007, il-Kummissjoni Ewropea ippreżentat lill-EMEA riferment skont l-Artikolu 30 tad-Direttiva 2001/83/KE, kif emendata, sabiex jiġu armonizzati s-Sommarji tal-Karatteristiċi talProdott (SPC), it-Tikketta u l-Fuljett ta' Tagħrif awtorizzati fuq livell nazzjonali, tal-prodott mediċinali Risperdal u ismijiet assoċjati.
English: It is available as film coated tablets, oro-dispersible tablets (rapidly disintegrating) and oral solution.
Maltese: Jiġi bħala pilloli miksijin b'rita, pilloli li jinħallu fil-ħalq (li jiddisintegraw malajr) u bħala soluzzjoni orali.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal and associated names approved across EU Member States, with respect to the indications, the posology and method of administration, the contra-indications, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Maltese: Il-bażi għar-riferiment kien li kien hemm diverġenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) ta' Risperdal u ismijiet assoċjati approvati madwar l-Istati Membri tal-UE, fir-rigward talindikazzjonijiet, il-pożoloġija u l-metodu ta' għoti, il-kontraindikazzjonijiet, it-twissijiet speċjali u lprekawzjonijiet għall-użu u l-interazzjoni ma' prodotti mediċinali oħrajn u ma' forom ta' interazzjoni oħrajn.
English: During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Maltese: Matul il-laqgħa tiegħu ta' Lulju 2008, is-CHMP, fid-dawl tad-dejta ġenerali ppreżentata u taddiskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-proposta għall-armonizzazzjoni tal-SPC, Tikketta u Fuljett ta' Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
English: The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal and associated names.
Maltese: Is-CHMP ta opinjoni pożittiva fl-24 ta' Lulju 2008 u rrakkomanda l-armonizzazzjoni tal-SPC, itTikketta u l-Fuljett ta' Tagħrif għal Risperdal u l-ismijiet assoċjati.
English: MedDRA Preferred Term % % % % % %
Maltese: Terminu Ippreferut MedDRA % % % % % %
English: Best Overall Response Rate (CR/PR)
Maltese: Rata ta' Rispons Globali (CR/PR)
English: Rash***
Maltese: Raxx***
English: 5 Including increased alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin.
Maltese: Inkluż żjieda f'alanine aminotransferase [ALT], aspartate aminotransferase [AST] u bilirubin.
English: Tablet coat: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.
Maltese: Kisja tal-pillola: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.
English: Erlotinib and statins
Maltese: Erlotinib u statins
English: Primary endpoint:
Maltese: Mira primarja:
English: Independent Review **
Maltese: Valutazzjoni Indipendenti **
English: Tarceva is indicated for adults.
Maltese: Tarceva huwa indikat għall-adulti.
English: Erlotinib and Carboplatin/Paclitaxel
Maltese: Erlotinib u Carboplatin/Paclitaxel
English: Baseline ECOG performance status (PS) = 0 Baseline ECOG performance status (PS) = 1 Baseline ECOG performance status (PS) = 2 Metastatic disease at baseline
Maltese: Linja bażi ta' ECOG performance status (PS)= 0 Linja bażi ta' ECOG performance status (PS) = 1 Linja bażi ta' ECOG performance status (PS) = 2 Marda metastatika f'linja bażi
English: -Palmar plantar erythrodysaesthesia syndrome
Maltese: -Sindrome ta' eritrodisasteżija palmariplantari
English: A study in normal healthy volunteers provided an estimate of the absolute bioavailability of 59%.
Maltese: Studju f'volontiera normali u f'saħħithom ipprovda estimu tal-bijodisponibiltà assoluta ta' 59%.
English: Including fatalities (see section 4.4).
Maltese: Inkluż imwiet (ara sezzjoni 4.4).
English: Gastrointestinal disorders Diarrhoea**
Maltese: Disturbi Gastro-intestinali Dijarea**
English: Erlotinib is a substrate for the P-glycoprotein active substance transporter.
Maltese: Erlotinib huwa substrat tat-trasportatur tas-sustanza attiva ta' P-glycoprotein.
English: (Voir/siehe Belgique/Belgien)
Maltese: Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)
English: Erlotinib and Capecitabine
Maltese: Erlotinib u Capecitabine
English: Cut-off date: April 2012
Maltese: April 2012
English: Erlotinib and Gemcitabine
Maltese: Erlotinib u Gemcitabine
English: Figure 1: Kaplan-Meier curve for investigator assessed PFS in trial ML20650 (EURTAC) (April 2012 cut-off)
Maltese: Kaplan-Meier għal PFS evalwata mill-investigatur fil-prova ML20650 (EURTAC) (waqfien April 2012)
English: Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%.
Maltese: It-tipjip ta' sigaretti ntwera li jnaqqas l-espożizzjoni għal erlotinib b'50-60%.
English: Cut-off date: Jan 2011
Maltese: Jannar 2011
English: The degree of reduction is likely to be clinically significant (see sections 4.2, 4.5, 5.1 and 5.2).
Maltese: Lammont ta' tnaqqis huwa probabbli li jkun klinikament sinifikanti (ara sezzjonijiet 4.2, 4.5, 5.1 u 5.2).
English: NCI-CTC Grade
Maltese: Grad ta' NCI-CTC
English: There are three main metabolic pathways identified: 1) O-demethylation of either side chain or both, followed by oxidation to the carboxylic acids; 2) oxidation of the acetylene moiety followed by hydrolysis to the aryl carboxylic acid; and 3) aromatic hydroxylation of the phenyl-acetylene moiety.
Maltese: 1) O-demethylation ta' waħda mill-katini tal-ġnub jew tat-tnejn, u wara ossidazzjoni għal carboxylic acids; 2) ossidazzjoni tal-parti acetylene u wara idroliżi għal aryl carboxylic acid; u 3) hydroxylation aromatika tal-parti phenyl-acetylene.
English: OS*** (months)
Maltese: OS*** (xhur)
English: • The active substance of Tarceva is erlotinib.
Maltese: • Is-sustanza attiva ta' Tarceva hija erlotinib.
English: Erlotinib binds to serum albumin and alpha-1 acid glycoprotein (AAG).
Maltese: Erlotinib jeħel ma' l-albumina tasserum u ma' alpha-1 acid glycoprotein (AAG).
English: Updated Analysis (62% OS maturity) (n=173)
Maltese: Analiżi Aġġornata (maturità ta' OS ta' 62%) (n=173)
English: See sections 4.2, 4.4, 4.5, and
Maltese: Ara sezzjonijiet 4.2, 4.4, 4.5 u
English: Tablet core: lactose monohydrate, cellulose microcrystalline, sodium starch glycolate type A, sodium laurilsulfate, magnesium stearate (see also section 2 for lactose monohydrate).
Maltese: Qalba tal-pillola: lactose monohydrate, cellulose microcrystalline, sodium starch glycolate type A, sodium laurilsulfate, magnesium stearate (ara wkoll sezzjoni 2 għal lactose monohydrate).
English: Gastrointestinal perforation
Maltese: Disturbi Gastrointestinali
English: -Stevens-Johnson syndrome/Toxic epidermal necrolysis7
Maltese: Johnson/Nekrolis i epidermali tossika
English: The efficacy and safety of Tarceva as maintenance after first-line chemotherapy for NSCLC was investigated in a randomised, double-blind, placebo-controlled trial (BO18192, SATURN).
Maltese: L-effikaċja u s-sigurtà ta' Tarceva bħala manteniment wara kimoterapija preferita għal NSCLC kienu investigati fi prova randomised, double-blind u kkontrollata bil-plaċebo (BO18192, SATURN).
English: There have been rare reports of hypokalaemia and renal failure (including fatalities).
Maltese: Kien hemm rapporti rari ta' ipokalimja u insuffiċjenza renali (inkluż mwiet).
English: Cut-off date: Aug 2010
Maltese: Data tal-aħħar tiġdid: 02 ta' Lulju 2010
English: The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Maltese: Il-kategorija tal-frekwenza korrispondenti għal kull reazzjoni avversa tal-mediċina hija bbażata fuq il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: Pharmacotherapeutic group: antineoplastic agent protein kinase inhibitor, ATC code: L01XE03
Maltese: Kategorija farmakoterapewtika: sustanza antineoplastika, inibitur ta' protein kinase, Kodiċi ATC:
English: The objective response rate by RECIST in the Tarceva group was 8.9% (95% CI, 6.4 to 12.0).
Maltese: Ir-rata ta' rispons oġġettiv minn RECIST fil-grupp ta' Tarceva kienet ta' 8.9% (95% CI, 6.4 sa 12.0).
English: Table 2: Summary of ADRs per frequency category: Body System Very common
Maltese: Tabella 2: Sommarju ta' ADRs skont il-kategorija ta' frekwenza:
English: Δ
Maltese: HR
English: Erlotinib and other CYP substrates
Maltese: Erlotinib u substrati oħra ta' CYP
English: -Epistaxis
Maltese: -Epistassi
English: PFS (median in months), Investigator assessed p<0.0001
Maltese: Evalwata mill-Investigatur p<0.0001
English: The most frequent ADRs seen in patients treated with Tarceva in studies BO18192 and BO25460 were rash (BO18192: all grades 49.2%, grade 3: 6.0%; BO25460: all grades 39.4%, grade 3: 5.0%) and diarrhoea (BO18192: all grades 20.3%, grade 3: 1.8%; BO25460: all grades 24.2%, grade 3: 2.5%).
Maltese: L-aktar ADRs frekwenti osservati f'pazjenti ttrattati b'Tarceva fl-istudji BO18192 u BO25460 kienu raxx (BO18192: il-gradi kollha 49.2%, grad 3: 6.0%; BO25460: il-gradi kollha 39.4%, grad 3: 5.0%) u dijarea (BO18192: il-gradi kollha 20.
English: Tarceva contains the active substance erlotinib.
Maltese: Tarceva fih is-sustanza attiva erlotinib.
English: In a randomised double-blind study (BR.21; Tarceva administered as second line therapy), rash (75%) and diarrhoea (54%) were the most commonly reported adverse drug reactions (ADRs).
Maltese: Fi studju randomised u double-blind (BR.21; Tarceva mogħti bħala terapija tat-tieni preferenza), raxx (75%) u dijarea (54%) kienu l-aktar reazzjonijiet avversi tal-mediċina (ADRs) komuni li ġew irrapportati.
English: The effect of Tarceva on overall survival was similar in patients with a baseline performance status (ECOG) of 2-3 (HR = 0.77, 95% CI 0.6-1.0) or 0-1 (HR = 0.73, 95% CI 0.6-0.9), male (HR = 0.76, 95% CI 0.6-0.9) or female patients (HR = 0.80, 95% CI 0.6-1.1), patients < 65 years of age (HR = 0.75, 95% CI 0.6-0.9) or older patients (HR = 0.79, 95% CI 0.6-1.0), patients with one prior regimen (HR = 0.76, 95% CI 0.6-1.0) or more than one prior regimen (HR = 0.75, 95% CI 0.6-1.0), Caucasian (HR = 0.79, 95% CI 0.6-1.0) or Asian patients (HR = 0.61, 95% CI 0.4-1.0), patients with adenocarcinoma (HR = 0.71, 95% CI 0.6-0.9) or squamous cell carcinoma (HR = 0.67, 95% CI 0.5-0.9), but not in patients with other histologies (HR 1.04, 95% CI 0.7-1.5), patients with stage IV disease at diagnosis (HR = 0.92, 95% CI 0.7-1.2) or < stage IV disease at diagnosis (HR = 0.65, 95% CI 0.5-0.8).
Maltese: (HR = 0.80, 95% CI 0.6-1.1), pazjenti b'eta' < 65 sena (HR = 0.75, 95% CI 0.6-0.9) jew pazjenti ixjaħ (HR = 0.79, 95% CI 0.6-1.0), pazjenti li ħadu kors wieħed minn qabel (HR = 0.76, 95% CI 0.6-1.0) jew ħadu aktar minn kors wieħed minn qabel (HR = 0.75, 95% CI 0.6-1.0), Kawkasi (HR = 0.79, 95% CI 0.6-1.0) jew pazjenti Asjatiċi (HR = 0.61, 95% CI 0.4-1.0), pazjenti b'adenokarċinoma (HR = 0.71, 95% CI 0.6-0.9) jew karċinoma taċ-ċellula skwamuża (HR = 0.67, 95% CI 0.5-0.9), iżda mhux f'pazjenti b'istoloġiji oħra (HR 1.04, 95% CI 0.7-1.5), pazjenti b'marda fi stadju IV fil-ħin taddijanjosi (HR = 0.92, 95% CI 0.7-1.2) jew b' marda < stadju IV fil-ħin tad-dijanjosi (HR = 0.65, 95% CI 0.5-0.8).
English: -Gastrointestinal perforations7
Maltese: -Perforazzjonijiet gastro-intestinali7
English: Reported diagnoses in patients suspected of having ILD-like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome (ARDS), alveolitis, and lung infiltration.
Maltese: Dijanjosi rrappurtati f'pazjenti ssuspettati li għandhom episodji jixbħu lil ILD jinkudu pulmonite, pulmonite tar-radjazzjoni, pulmonite talipersensittività, pulmonite tal-interstizju, mard tal-interstizju tal-pulmun, bronkolité obliterattiva, fibrosi pulmonari, Sindrome ta' Diffikultà Respiratorja Akuta (ARDS), alveolite u nfiltrazzjoni filpulmun.
English: The first 330 patients were centrally assessed (response rate 6.2%); 401 patients were investigatorassessed (response rate 11.2%).
Maltese: L-ewwel 330 pazjent kienu evalwati ċentralment (rata ta' rispons 6.2%); 401 pazjent kienu evalwati minn investigatur (rata ta' rispons 11.2%).
English: Pre-planned Interim Analysis (35% OS maturity) (n=153)
Maltese: Interim ippjanata minn qabel (maturità ta' OS ta' 35%) (n=153)
English: Erlotinib tested negative in conventional genotoxicity studies.
Maltese: Erlotinib ta' riżultat negattiv fi studji konvenzjonali ta' ġenotossiċità.
English: • Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome)
Maltese: • Infafet jew tqaxxir sever tal-ġilda (jissuġġerixxu s-sindrome Stevens-Johnson)
English: In two other double-blind, randomised, placebo-controlled Phase III studies BO18192 (SATURN) and BO25460 (IUNO); Tarceva was administered as maintenance after first-line chemotherapy.
Maltese: III double-blind, randomised u kkontrollati bil-plaċebo, BO18192 (SATURN) u BO25460 (IUNO); Tarceva ngħata bħala manteniment wara kimoterapija tal-ewwel għażla.
English: The adjusted hazard ratio (HR) for death in the Tarceva group relative to the placebo group was 0.73 (95% CI, 0.60 to 0.87) (p = 0.001).
Maltese: Il-hazard ratio (HR) aġġustat għall-imwiet fil-grupp b' Tarceva relattiv għall-grupp ta' plaċebo kien ta' 0.73 (95% CI, 0.60 sa 0.87) (p = 0.001).
English: -Interstitial lung disease (ILD)3
Maltese: -Marda tal interstizju tal pulmun (ILD)3
English: -Alopecia -Dry skin1
Maltese: -Alopecja -Ġilda xotta 1
English: The primary endpoint was investigator assessed PFS.
Maltese: Il-punt finali primarju kien PFS evalwata mill-investigatur.
English: Including fatalities.
Maltese: Inkluż imwiet.
English: INFORMATION IN BRAILLE tarceva 25 mg
Maltese: tarceva 25 mg
English: CR=complete response; PR=partial response * A 58% reduction in the risk of disease progression or death was observed ** Overall concordance rate between investigator and IRC assessment was 70% *** A high crossover was observed with 82% of the patients in the chemotherapy arm receiving subsequent therapy with an EGFR tyrosine kinase inhibitor and all but 2 of those patients had subsequent Tarceva.
Maltese: CR = rispons komplut; PR = rispons parzjali * Kien osservat tnaqqis ta' 58% fir-riskju ta' progressjoni tal-marda jew mewt ** Ir-rata globali ta' qbil bejn valutazzjoni tal-investigatur u tal-IRC kienet ta' 70% *** Kien osservat crossover għoli bi 82% tal-pazjenti fil-grupp ta' kimoterapija jirċievu terapija sussegwenti b'inibitur ta' EGFR tyrosine kinase u kollha minbarra 2 minn dawn il-pazjenti komplew biex ħadu Tarceva.
English: The secondary endpoint of PFS showed no difference between Tarceva and placebo in maintenance treatment (HR=0.94, 95 % CI, 0.80 to 1.11; p=0.48).
Maltese: Il-punt finali sekondarju ta' PFS ma wera l-ebda differenza bejn Tarceva u plaċebo bħala trattament ta' manteniment (HR=0.94, CI ta' 95 %, 0.80 sa 1.11; p=0.48).
English: In a double-blind, randomised phase III study (MO22162, CURRENTS) comparing two doses of Tarceva (300 mg versus 150 mg) in current smokers (mean of 38 pack years) with locally advanced or metastatic NSCLC in the second-line setting after failure on chemotherapy, the 300 mg dose of Tarceva demonstrated no PFS benefit over the recommended dose (7.00 vs 6.86 weeks, respectively).
Maltese: III double-blind u randomised (MO22162, CURRENTS) li jqabbel żewġ dożi ta' Tarceva (300 mg kontra 150 mg) f'pazjenti li jpejpu (medja ta' 38 pakkett fis-sena) b'NSCLC avanzat lokalment jew metastatiku fl-ambjent tat-tieni għażla wara falliment tal-kimoterapija, id-doża ta' 300 mg ta' Tarceva ma wriet l-ebda benefiċċju ta' PFS fuq id-doża rakkomandata (7.00 vs 6.86 ġimgħat, rispettivament).
English: Concomitant administration of Tarceva with 300 mg ranitidine, an H2-receptor antagonist, decreased erlotinib exposure [AUC] and maximum concentrations [Cmax] by 33% and 54%, respectively.
Maltese: L-għoti ta' Tarceva flimkien ma' 300 mg ranitidine, antagonist tar-riċettur H2, jnaqqas l-espożizzjoni għal erlotinib [AUC] u l-konċentrazzjonijiet massimi [Cmax] bi 33% u 54%, rispettivament.
English: Dermatitis acneiform -Skin fissures
Maltese: Dermatite acneiform -Qsim fil-ġilda
English: Infections and infestations Infection*
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni*
English: The primary active metabolites were present in tumour at concentrations averaging 160 ng/g tissue, which corresponded to an overall average of 113% (range 88-130%) of the observed steady state peak plasma concentrations.
Maltese: Il-metaboliti attivi prinċipali kienu preżenti fit-tumur f'konċentrazzjonijiet fit-tessut b'medja ta' 160 ng/g, li tikkorrespondi għal medja totali ta' 113% (firxa 88-130%) ta' l-għola konċentrazzjonijiet fil-plażma osservati fi stat stabbli.
English: INFORMATION IN BRAILLE tarceva 150 mg
Maltese: tarceva 150 mg