FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore the CHMP was of the view that the submitted pharmacokinetic study report V-808 did not confirm the relevance of the bibliographic data submitted to demonstrate safety and efficacy of Loraxin.
Maltese: Għalhekk is-CHMP kien tal-fehma li r-rapport tal-istudju farmakokinetiku sottomess V-808 ma kienx jikkonferma r-rilevanza tad-dejta biblijografika sottomessa biex turi s-sigurtà u l-effikaċja ta' Loraxin.
English: The application for Loraxin is therefore based on publicly available bibliographic data as it is possible to replace results of the pre-clinical and clinical trials by detailed references to published scientific literature (information available in the public domain) if it can be demonstrated that the active substances of a medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognized efficacy and an acceptable level of safety.
Maltese: L-applikazzjoni għal Loraxin hija għalhekk ibbażata fuq dejta biblijografika disponibbli pubblikament peress li huwa possibbli li r-riżultati tal-provi pre-kliniċi u kliniċi jiġu sostitwiti b'referenzi dettaljati għal reċensjoni xjentifika ppubblikata (informazzjoni disponibbli fiddominju pubbliku) jekk jista' jintwera li s-sustanzi attivi ta' prodott mediċinali ilhom f'użu mediċinali stabbilit sew fil-Komunità għal mill-anqas għaxar snin, b'effikaċja rikonoxxuta u b'livell aċċettabbli ta' sigurtà.
English: Part II.1.d) of Annex I of Directive 2001/83/EC is states that “ the non-clinical and/or clinical overviews must explain the relevance of any data submitted which concern a product different from the product intended for marketing.
Maltese: Parti II.1.d) tal-Anness I tad-Direttiva 2001/83/KE tgħid li “r-rapporti mhux kliniċi u/jew kliniċi għandhom jispjegaw ir-rilevanza ta' kwalunkwe dejta sottomessa li tikkonċerna prodott differenti millprodott maħsub għat-tqegħid fis-suq.
English: In view of the above, the CHMP considered that the pharmaceutical, pharmacokinetic and clinical data/documentation referred to by the MAH was not considered sufficient to establish the relevance of the bibliographic data to Loraxin.
Maltese: Fid-dawl ta' dan ta' hawn fuq, is-CHMP ikkunsidra li d-dejta/dokumentazzjoni farmaċewtika, farmakokinetika u klinika msemmija mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ma kinitx ikkunsidrata biżżejjed biex tistabbilixxi r-rilevanza tad-dejta biblijografika għal Loraxin.
English: Overall summary of the scientific evaluation of Loraxin and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Loraxin u ismijiet assoċjati (ara Anness I)
English: Therefore the CHMP considered the provided clinical data to be very limited and not strong enough to address what a potential difference in exposure, compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted bibliography, could mean for efficacy and safety for each indication.
Maltese: Għalhekk is-CHMP ikkunsidra li d-dejta klinika pprovduta kienet limitata ħafna u ma kinitx b'saħħitha biżżejjed biex tindirizza s-sinifikat ta' differenza potenzjali flespożizzjoni, meta mqabbla mal-espożizzjoni miksuba wara l-għoti tal-prodott użat fl-istudji kliniċi pivotali deskritti fil-bibljografija sottomessa, fuq l-effikaċja u s-sigurtà għal kull indikazzjoni.
English: • The data referred to by the MAH is not considered sufficient to address what a potential difference in exposure, compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted bibliography, could mean for efficacy and safety for each indication.
Maltese: • Id-dejta msemmija mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq mhijiex ikkunsidrata biżżejjed biex tindirizza s-sinifikat ta' differenza potenzjali fl-espożizzjoni, meta mqabbla mal espożizzjoni miksuba wara l-għoti tal-prodott użat fl-istudji kliniċi pivotali deskritti fil-biblijografika sottomessa, fuq l-effikaċja u s-sigurtà għal kull indikazzjoni.
English: Denmark
Maltese: Finland
English: Based on the pharmacokinetic study results used to bridge Loraxin to the published literature, there is a potential for difference in exposure after Loraxin administration as compared to the product Clarityn, and the MAH has not adequately justified why this potential difference in exposure is unlikely to have a clinically significant difference in efficacy or safety.
Maltese: Abbażi tar-riżultati tal-istudju farmakokinetiku użati biex jorbtu lil Loraxin mar-reċensjoni ppubblikata, hemm potenzjal għal differenza fl-espożizzjoni wara l-għoti ta' Loraxin meta mqabbla mal-prodott Clarityn, u d-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ma ġġustifikax b'mod adegwat għaliex din id-differenza potenzjali fl-espożizzjoni mhijiex probabbli li jkollha differenza klinikament sinifikanti fuq l-effikaċja jew is-sigurtà.
English: Therefore, a scientifically valid approach such as the demonstration of comparable kinetics may be necessary to bridge Loraxin to a similar product.
Maltese: Għalhekk, jista' jkun hemm bżonn ta' approċċ xjentifikament validu bħatturija ta' kinetiċi komparabbli biex jorbot lil Loraxin ma' prodott simili.
English: Loratadine is a second-generation long-acting, non-sedating antihistamine with no significant antimuscarinic activity.
Maltese: Loratadine huwa antistamin li jaġixxi fit-tul u mhux sedattiv tat-tieni ġenerazzjoni mingħajr ebda attività antimuskarinika sinifikanti.
English: As a result, procedural and legal considerations are outside the remit of the CHMP, and therefore the re-examination of the referral procedure under Article 29(4) of Directive 2001/83/EC focussed only on the scientific points addressed in the grounds for reexamination.
Maltese: Bħala riżultat, kunsiderazzjonijiet proċedurali u legali huma barra mill-kompetenza tasCHMP, u għalhekk l-eżami mill-ġdid tal-proċedura ta' riferiment skont l-Artikolu 29(4) tadDirettiva 2001/83/KE iffoka biss fuq il-punti xjentifiċi indirizzati fir-raġunijiet għall-eżami mill-ġdid.
English: The experts reports submitted during the referral procedure suggest that that there could be a slightly lower exposure to loratadine, based on the results of the supportive pharmacokinetic study provided by the MAH.
Maltese: Ir-rapporti tal-esperti sottomessi matul il-proċedura ta' riferiment jissuġġerixxu li jista' jkun hemm espożizzjoni kemxejn anqas baxxa għal loratadine, abbażi tar-riżultati tal-istudju farmakokinetiku ta' appoġġ ipprovdut mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Based on the published literature and the pharmacokinetic study results used to bridge Loraxin to the published literature, the relevance of the literature data submitted which concern a product different from the product intended for marketing was not addressed satisfactorily.
Maltese: Abbażi tar-reċensjoni ppubblikata u r-riżultati tal-istudju farmakokinetiku użati biex jorbtu lil Loraxin mar-reċensjoni ppubblikata, ir-rilevanza tad-dejta tar-reċensjoni sottomessa li tikkonċerna prodott differenti mill-prodott maħsub għal tqegħid fis-suq ma ġietx indirizzata b'mod sodisfaċenti.
English: Overall, the CHMP was still of the view that due to its limitations, the study could not confirm the relevance of the bibliographic data submitted to demonstrate safety and efficacy of Loraxin.
Maltese: B'mod ġenerali, is-CHMP kien għadu tal-fehma li minħabba l-limitazzjonijiet tiegħu, l-istudju ma setax jikkonferma r-rilevanza tad-dejta biblijografika sottomessa biex turi s-sigurtà u l-effikaċja ta' Loraxin.
English: System organ class (SOC)
Maltese: Sistema tal-klassifika tal-organi (SOC)
English: Secondary endpoints
Maltese: Punt finali sekondarji
English: * primary analysis
Maltese: * analiżi primarja
English: Manufacturer Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
Maltese: Manifattur Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, L-Irlanda
English: Name and address of the manufacturer of the biological active substance Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
Maltese: Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
English: 25-75 percentile (months)
Maltese: 25-75 perċentil (xhur)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1344/001 100 mg/4 ml vial EU/1/18/1344/002 400 mg/16 ml vial
Maltese: EU/1/18/1344/001 100 mg/4 ml kunjett EU/1/18/1344/002 400 mg/16 ml kunjett
English: 1 Kaplan-Meier estimates
Maltese: Stimi Kaplan-Meier
English: XELOX or XELOX + bevacizumab
Maltese: XELOX jew XELOX + bevacizumab
English: a Interferon alfa-2a 9 MIU 3x/week b Bevacizumab 10 mg/kg q 2 wk
Maltese: Interferon alfa-2a 9 MIU 3x/ġimgħa Bevacizumab 10 mg/kg q 2 wk
English: Sucrose, succinic acid, disodium edetate, polysorbate 80, sodium hydroxide, water for injections.
Maltese: Sucrose, succinic acid, disodium edetate, polysorbate 80, sodium hydroxide, ilma għall-injezzjonijiet.
English: Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01X C07
Maltese: Kategorija farmakoterapewtika: ustanzi antineoplastiċi u immunomodulanti, sustanzi antineoplastiċi, sustanzi antineoplastiċi oħra, antikorpi monoklonali, Kodiċi ATC: L01X C07
English: Investigator assessment*
Maltese: Valutazzjoni tal-investigatur*
English: Table 11 Efficacy results for trial E4599
Maltese: Tabella 11 Riżultati tal-effikaċja għall-prova E4599
English: IRF assessment
Maltese: Valutazzjoni IRF
English: Metastatic disease progression was inhibited and microvascular permeability was reduced.
Maltese: Progressjoni metastatika tal-marda metastatika kienet imwaqqfa u l-permeabilità mikrovaskulari mnaqqsa.
English: (See section 4.2 for information on paediatric use).
Maltese: (Ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/ml to 16.5 mg/ml.
Maltese: Il-konċentrazzjoni tas-soluzzjoni finali ta' bevacizumab għandha tinżamm fil-firxa ta' 1.4 mg/ ml sa 16.5 mg/ ml.
English: The 649 randomised patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%, no CNS metastases and adequate organ function.
Maltese: Is-649 pazjent randomised (641 ikkurati) kellhom Karnofsky Performance Status (KPSKarnofsky Performance Status) ta' ≥ 70%, l-ebda metastasi fis-CNS u funzjoni tal-organi adegwata.
English: FOLFOX-4 or XELOX + placebo (n=701)
Maltese: FOLFOX-4 jew XELOX + plaċebo (n=701)
English: Overall response rate (invest.
Maltese: Rata ta' rispons totali (valutazzjoni invest.
English: Table 6 Treatment regimens in trial NO16966 (mCRC)
Maltese: Tabella 6 Korsijiet tal-kura fi prova NO16966 (mCRC)
English: Gastrointestinal perforation b,d
Maltese: Perforazzjoni gastrointestinali b,d
English: Zirabev 25 mg/ml sterile concentrate bevacizumab
Maltese: Zirabev 25 mg/ml konċentrat sterili bevacizumab
English: Overall response rate Rate (%)
Maltese: Rata ta' rispons totali Rata (%)
English: Table 4 Efficacy results for trial AVF2107g
Maltese: Tabella 4 Riżultati tal-effikaċja għall-prova AVF2107g
English: Marketing Authorisation Holder Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Il-Belġju
English: Table 12 Efficacy results for trial BO17704
Maltese: Tabella 12 Riżultati tal-effikaċja għall-prova BO17704
English: Efficacy results for trials AVF0780g and AVF2192g AVF0780g
Maltese: Riżultati dwar effikaċja għall-provi AVF0780g u AVF2192g
English: The recommended dose is 5 mg, 7.5 mg, 10 mg or 15 mg per kilogram of your body weight.
Maltese: Id-doża rakkomandata hija 5 mg, 7.5 mg, 10 mg jew 15 mg għal kull kilogramma tal-piż tiegħek.
English: GI-vaginal fistulae in study GOG-0240
Maltese: Fistuli gastrointestinali vaġinali fi studju GOG-0240
English: Median PFS (on treatment)**
Maltese: PFS medjan (fuq il-kura)**
English: Table 8 Efficacy results for trial E3200
Maltese: Tabella 8 Riżultati tal-effikaċja għall-prova E3200
English: Bevacizumab vs. No Bevacizumab
Maltese: Plaċebo jew bevacizumab
English: Arm 2 IFL + bevacizumaba
Maltese: Kategorija 2 IFL + bevacizumab
English: Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 bevacizumab + FOLFOX-4 and 244 bevacizumab monotherapy).
Maltese: Tmin mija u disgħa u għoxrin pazjent kienu randomised (292 FOLFOX-4, 293 bevacizumab + FOLFOX-4 u 244 b'monoterapija b'bevacizumab).
English: 5 mg/kg intravenous 30-90 min
Maltese: 5 mg/kg ġol-vini 3090 min
English: Thromboembolism (arterial)
Maltese: Tromboemboliżmu (arterjali)
English: The overall mean age was 59.4 years; 56.6% of patients had an ECOG performance status of 0, 43% had a value of 1 and 0.4% had a value of 2.
Maltese: L-età medja totali kienet ta' 59.4 sena; 56.6% tal-pazjenti kellhom performance status ECOG ta' 0, 43% kellhom valur ta' 1 u 0.4% kellhom valur ta' 2. 15.
English: FOLFOX-4 or XELOX + bevacizumab (n=699)
Maltese: FOLFOX-4 jew XELOX + bevacizumab (n=699)
English: 7.5 mg/kg intravenous 30-90 min
Maltese: 7.5 mg/kg ġol-vini 3090 min
English: Gastrointestinal disorder, Stomatitis, Proctalgia
Maltese: Disturb gastrointestinali , Stomatite, Proktalġja
English: Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Maltese: Effetti sekondarji severi ta' frekwenza mhux magħrufa (frekwenza ma tistax tiġi stmatamid-dejta disponibbli), jinkludu:
English: Pulmonary hypertension c,
Maltese: Pressjoni pulmonari għolja c,
English: FOLFOX-4 or FOLFOX-4 + bevacizumab
Maltese: FOLFOX-4 jew FOLFOX-4 + bevacizumab
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Stabbilità kimika u fiżika waqt l-użu ntweriet għal 48 siegħa f'2°C sa 30°C f'soluzzjoni għallinjezzjoni ta' 9 mg/ ml (0.9%) sodium chloride .
English: Proteinuria ranged in severity from clinically asymptomatic, transient, trace proteinuria to nephrotic syndrome, with the great majority as Grade 1 proteinuria (NCI-CTCAE v.3).
Maltese: Proteina fl-awrina varjat fis-severità minn klinikament bla sintomi, temporanja, traċċa ta' proteina fl-awrina għal sindrome nefrotika, bil-maġġoranza tkun proteina fl-awrina ta' Grad 1 (NCI-CTCAE v.3).
English: Best overall response - Primary analysis
Maltese: Sopravivenza globali - Analiżi primarja
English: Non-small cell lung cancer (NSCLC)
Maltese: Kanċer tal-pulmun taċ-ċelluli mhux żgħar (NSCLC - Non-small cell lung cancer)
English: The active substance is bevacizumab.
Maltese: Is-sustanza attiva hi bevacizumab.
English: *Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm
Maltese: * Analiżi tas-sopravivenza totali fit-twaqqif kliniku fil-31 ta' Jannar 2007 ** Analiżi primarja fit-twaqqif kliniku fil-31 ta' Jannar 2006
English: Efficacy results for study ML18147 (ITT population)
Maltese: Tabella 9 Riżultati tal-effikaċja għal studju ML18147 (popolazzjoni ITT)
English: Zirabev contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
Maltese: Zirabev fih is-sustanza attiva bevacizumab, li hija antikorp monoklonali umanizzat (tip ta' proteina li normalment tiġi magħmula mis-sistema immuni biex tgħin tiddefendi lill-ġisem minn infezzjoni u kanċer).
English: At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72).
Maltese: Fiż-żmien tal-analiżi primarja finali, il-punt finali primarju tal-EFS minn analiżi ċentrali indipendenti ma weriex differenza statistikament sinifikanti bejn iż-żewġ gruppi ta' trattament, b'HR ta' 0.93 (Ci ta' 95%: 0.61, 1.41; valur p = 0.72).
English: In this trial arterial thromboembolic reactions were observed in 11% (11/100) of patients compared to 5.8% (6/104) in the chemotherapy control group.
Maltese: F'din il-prova reazzjonijiet tromboemboliċi arterjali kienu osservati fi 11% (11/100) tal-pazjenti meta mqabbla ma' 5.8% (6/104) fil-grupp ta' kontroll b'kimoterapija.
English: The adverse reactions listed in this section fall into the following frequency categories: 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); not known (cannot be estimated from the available data).
Maltese: 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); mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Cerebrovascular accident,
Maltese: Emorraġija firrektum,
English: New cases of ovarian failure were reported in 2.6% patients in the mFOLFOX-6 group compared to 39% in the mFOLFOX-6 + bevacizumab group.
Maltese: Każijiet ġodda ta' insuffiċjenza talovarji kienu rrappurtati f'2.6% tal-pazjenti fil-gruppta' mFOLFOX-6 meta mqabbel ma' 39% filgrupp ta' mFOLFOX-6 + bevacizumab.
English: Pulmonary haemorrhage/haemoptysis
Maltese: Emorraġija/emoptiżi pulmonari
English: A total of 116 patients were randomised to receive bevacizumab 3 mg/kg every 2 weeks (n=39), 10 mg/kg every 2 weeks; (n=37), or placebo (n=40).
Maltese: Total ta' 116-il pazjent kienu randomised biex jirċievu bevacizumab 3 mg/kg kull ġimagħtejn (n=39), 10 mg/kg kull ġimagħtejn; (n=37), jew plaċebo (n=40).
English: In randomised clinical trials, age > 65 years was associated with an increased risk of developing arterial thromboembolic reactions, including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs).
Maltese: Fil-provi kliniċi randomised, età ta' > 65 sena kienet assoċjata ma' żjieda fir-riskju ta' żvilupp ta' reazzjonijiet tromboemboliċi arterjali, inkluż aċċidenti ċerebrovaskulari (CVAs), attakki iskemiċi temporanji (TIAs) u infarti mijokardijaċi (MIs).
English: The secondary endpoint of Overall Survival (OS) was not mature.
Maltese: Il-punt finali sekondarju ta' Sopravivenza Globali (OS - Overall Survival) ma kienx matur.
English: Zirabev is a biosimilar medicinal product.
Maltese: Zirabev huwa prodott mediċinali bijosimili.
English: • In a retrospective single institution series, 12 consecutive (2005 to 2008) children with relapsed or progressive high-grade glioma (3 with WHO Grade IV, 9 with Grade III) were treated with bevacizumab (10 mg/kg) and irinotecan (125 mg/m²) every 2 weeks.
Maltese: • F'serje retrospettiva b'istituzzjoni waħda, 12-il tifel u tifla konsekuttivi (2005 sa 2008) bi glijoma ta' grad għoli li rkadat jew progressiva (3 b'WHO Grad IV, 9 bi Grad III) kienu kkurati b'bevacizumab (10 mg/kg) u irinotecan (125 mg/m²) kull ġimagħtejn.
English: Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of patients treated with bevacizumab.
Maltese: Proteina fl-awrina ta' Grad 4 (sindrome nefrotiku) kienet osservata f'sa 1.4% tal-pazjenti ttrattati b' bevacizumab.
English: Fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy
Maltese: Kimoterapija bbażata fuq fluoropyrimidine/irinotecan jew fluoropyrimidine/oxaliplati
English: Pulmonary haemorrhage/ Haemoptysis b,d
Maltese: Emorraġija filpulmun/Emoptiżi b,d
English: The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p=0.1789), duration of objective response (6.7 vs 9.1 months) or time to symptom progression (HR = 1.172; p=0.5076).
Maltese: Iż-żjieda ta' erlotinib ma' bevacizumab ma wasslitx għal titjib f'OS (HR = 1.764; p=0.1789), tul tar-rispons oġġettiv (6.7 vs 9.1 xhur) jew ħin sal-progressjoni tas-sintomi (HR = 1.172; p=0.5076).
English: In terms of safety, there was a higher overall incidence of Grade 3-5 AEs in study E3200 relative to study ML18147.
Maltese: F'termini ta' sigurtà, kien hemm inċidenza globali ogħla ta' AEs ta' Grad 3-5 fl-istudju E3200 meta mqabbel mal-istudju ML18147.
English: Congestive heart failure (CHF) (see section 4.8)
Maltese: Insuffiċjenza tal-qalb konġestiva (CHF - Congestive heart failure) (ara sezzjoni 4.8)
English: Uncommon (≥ 0.1% to < 1%) reports of fistulae that involve areas of the body other than the gastrointestinal tract (e.g. bronchopleural and biliary fistulae) were observed across various indications.
Maltese: Rapporti mhux komuni (≥ 0.1% sa < 1%) ta' fistuli li jinvolvu partijiet oħra tal-ġisem minbarra lapparat gastrointestinali (eż. fistuli bronkoplewrali u biljari) kienu osservati tul diversi indikazzjonijiet.
English: Permanently discontinue Zirabev in patients with tracheoesophageal (TE) fistula or any Grade 4 fistula [US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v.3)].
Maltese: Waqqaf Zirabev b'mod permanenti f'pazjenti b'fistula trakeoesofagali (TE - tracheoesophageal) jew kull fistula ta' Grad 4 [Kriterji tat-Terminoloġija Komuni għall-Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kanċer tal-Istati Uniti (NCI-CTCAE - National Cancer Institute-Common Terminology Criteria for Adverse Events v.3)].
English: Primary endpoint
Maltese: Mira primarja
English: Sepsis, Abscess b,d
Maltese: Sepsis, Axxess b,d
English: No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of co-administered interferon alpha 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
Maltese: Ma kienet osservata l-ebda interazzjoni ta' rilevanza klinika ta' bevacizumab fuq ilfarmakokinetika ta' interferon alpha 2a, erlotinib (u l-metabolit attiv tiegħu OSI-420), jew ilkimoterapiji irinotecan (u l-metabolit attiv tiegħu SN38), capecitabine, oxaliplatin (kif determinat minn kejl ta' platinum ħieles u totali), u cisplatin mogħtija fl-istess waqt.
English: The 131 patients in the bevacizumab + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the trial, exhibited at 6, 12 and 18 months PFS event free rates of 73, 52 and 21% respectively, as compared to 61, 43 and 17% in the total population of patients receiving bevacizumab + IFN alfa-2a.
Maltese: 2a li naqqsu u żammew id-doża ta' IFN alfa-2a f'6 jew 3 MIU waqt il-prova, wrew rati ta' PFSmingħajr avvenimenti wara 6, 12 u 18-il xaharta' 73, 52 u 21% rispettivament, meta mqabbel ma' 61, 43 u 17% fil-popolazzjoni totali ta' pazjenti li kienu qed jirċievu bevacizumab + IFN alfa-2a.
English: Sepsis, Cellulitis, Abscess a,b
Maltese: Sepsis, Ċellulite, Axxess a,b
English: Information on foetal malformations observed in the post marketing setting are provided in section 4.6 Fertility, Pregnancy and Lactation and 4.8 Undesirable Effects.
Maltese: Informazzjoni dwar malformazzjonijiet tal-fetu osservati fl-ambjent ta' wara t-tqegħid fis-suq hija pprovduta f'sezzjoni 4.6 Fertilità, Tqala u Treddigħ u 4.8 Effetti Mhux mixtieqa.
English: • abnormal urine test (protein in the urine),
Maltese: • test tal-awrina mhux normali (proteina fl-awrina)
English: Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg q 3 weeks
Maltese: Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg q 3 ġimgħat
English: There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving bevacizumab monotherapy compared to patients receiving bevacizumab in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).
Maltese: Ma kien hemm la differenzi statistikament sinifikanti u lanqas ta' rilevanza klinika fit tneħħija ta' bevacizumab f'pazjenti li kienu qed jirċievu monoterapija ta' bevacizumab metamqabbel ma' pazjenti li kienu qed jirċievu bevacizumab flimkien ma' interferon alfa-2a, erlotinib jew kimoterapiji (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin jew cisplatin/gemcitabine).