FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Diluted solution After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended.
Maltese: Wara d-dilwazzjoni b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni, huwa rrakkomandat użu mmedjat.
English: o TYSABRI increases the risk of developing encephalitis, meningitis and acute retinal necrosis (ARN) caused by herpes simplex and varicella zoster viruses o Guidance on screening for ARN.
Maltese: (ARN, acute retinal necrosis) ikkawżati minn viruses ta' herpes simplex u varicella zoster o Gwida dwar l-iscreening għal ARN.
English: A condition called JCV GCN (JC
Maltese: Ittestjar għal antikorpi kontra JCV
English: 1) Oral prednisone 1.5 mg/kg/d x 2 wks with taper over 2 months
Maltese: 1) Prednisone orali 1.5 mg/kg/j × ġimagħtejn bi tnaqqis gradwali fuq perjodu ta' xahrejn 2) Methylprednisolone li jingħata ġol-vini (1 g/j għal 3 jew 5 ijiem) bi tnaqqis gradwali orali fuq perjodu ta' xahrejn
English: Contents of the pack and other information What TYSABRI contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih TYSABRI
English: It is unknown if patients switching from these therapies to TYSABRI have an increased risk of PML, therefore these patients should be monitored more frequently (i.e. similarly to patients switching from immunosuppressants to TYSABRI, see MRI screening for PML).
Maltese: Mhux magħruf jekk il-pazjenti li jaqilbu minn dawn it-terapiji għal TYSABRI ikollhomx riskju akbar ta' PML, u għalhekk dawn il-pazjenti għandhom jiġu mmonitorjati b'mod aktar frekwenti (i.e. bħall-pazjenti li jaqilbu minn immunosoppressanti għal TYSABRI), ara MRI screening għal PML).
English: TYSABRI is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups:
Maltese: TYSABRI huwa indikat bħala monoterapija li timmodifika l-marda f'adulti bi sklerożi multipla attiva ħafna li tirkada u tbatti għall-ġruppi ta' pazjenti li ġejjin:
English: The efficacy of TYSABRI when administered with EID has not been established, and therefore the benefit/risk balance of EID is unknown (see section 4.4).
Maltese: L-effikaċja ta' TYSABRI meta jingħata f'EID ma ġietx determinata, u għalhekk il-proporzjon ta' bejn il-benefiċċju u r-riskju ta' EID mhux magħruf (ara sezzjoni 4.4).
English: These medicines cannot be used with TYSABRI (see Using other medicines, below).
Maltese: Dawn il-mediċini ma jistgħux jintużaw ma' TYSABRI (ara Meta tuża mediċini oħra, taħt).
English: Patients should not be tested for anti-JCV antibodies within 2 weeks of PLEX due to removal of antibodies from the serum, or within 6 months of IVIg (i.e. 6 months = 5x half-life for immunoglobulins).
Maltese: Il-pazjenti m'għandhomx jiġu ttestjati għal antikorpi kontra JCV fi żmien ġimagħtejn minn PLEX minħabba t-tneħħija tal-antikorpi mis-serum, jew fi żmien 6 xhur minn IVIg (i.e. 6 xhur = 5x il-half-life għall-immunoglobulini).
English: Body weight was found to influence clearance in a less-thanproportional manner, such that a 43% change in body weight resulted in a 31% to 34% change in clearance.
Maltese: Instab li l-piż tal-ġisem influwenza ttneħħijja f'mod inqas minn proporzjonali, b'tali mod li tibdil ta' 43% fil-piż tal-ġisem wassal għall tibdil ta' 31% sa 34% fit-tneħħijja.
English: Within the limitations of these data, there were no new safety signals identified in this patient population.
Maltese: Fil-limitazzjonijiet ta' din id-data, ma kien hemm l-ebda sinjali ġodda ta' sigurtà identifikati f'din il-popolazzjoni ta' pazjenti.
English: • Reminder of the approved dosing; cross reference to EU SmPC
Maltese: • Tfakkira tad-dożaġġ approvat, kontroreferenza għall-SmPC (Sommarju tal-Karatteristiċi tal
English: Patients should be re-informed about the risk factors for PML, like duration of treatment, immunosuppressant use prior to receiving TYSABRI and the presence of antiJohn Cunningham virus (JCV) antibodies (see section 4.4.
Maltese: Il-kura rrappurtata f'dawn il-każijiet kienet tinkludi terapija antivirali, u f'xi każijiet, operazzjoni (ara sezzjoni 4.4).
English: Cases of JCV GCN have also been reported during postmarketing use of TYSABRI.
Maltese: TYSABRI, jew it-tul tal-esponiment għal TYSABRI.
English: • Treatment initiation and treatment continuation forms
Maltese: • Formoli ta' bidu tal-kura u ta' kontinwazzjoni tal-kura
English: • If you are allergic to natalizumab or any of the other ingredients of this medicine (listed in section 6).
Maltese: • Jekk inti allerġiku għal natalizumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: Testing for serum anti-JCV antibody prior to initiating TYSABRI therapy or in patients receiving the medicinal product with an unknown antibody status is recommended.
Maltese: Huwa rrakkomandat ittestjar għal antikorpi kontra JCV fis-serum qabel tinbeda t-terapija b'TYSABRI jew f'pazjenti li qed jirċievu l-prodott mediċinali li għandhom stat ta' antikorpi mhux magħruf.
English: Disease exacerbations or infusion related events may indicate the development of antibodies against natalizumab.
Maltese: Il-piż tal-ġisem u l-preżenza ta' antikorpi għal natalizumab biss instabu li jinfluwenzaw id-dispożizzjoni ta' natalizumab.
English: Therefore, following PLEX or IA, periodic clinical monitoring of patients, including MRI monitoring, may be useful for the early detection of IRIS.
Maltese: Għalhekk, wara PLEX jew IA, il-monitoraġġ kliniku perjodiku tal-pazjenti, inkluż monitoraġġ bl-MRI, jista' jkun utli għal identifikazzjoni minn kmieni ta' IRIS.
English: • Reminder of PML symptoms • When MRI imaging may be warranted
Maltese: • Meta l-immaġnar bl-MRI jista' jkun iġġustifikat
English: Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μg/ml to 29 μg/ml.
Maltese: konċentrazzjonijiet fi stat stabbli ta' natalizumab tul il-perijodu ta' dożaġġ varjat minn 23 μg/ml sa
English: Each ml of concentrate contains 20 mg of natalizumab.
Maltese: Kull ml ta' konċentrat fih 20 mg ta' natalizumab.
English: • A reminder regarding serious infections and the need to speak to their doctor if they have severe persistent infection
Maltese: • Tfakkira dwar infezzjonijiet serji u l-ħtieġa li jkellmu lit-tabib tagħhom jekk ikollhom infezzjoni severa persistenti
English: An accelerated elimination procedure as defined in the teriflunomide Summary of Product Characteristics is recommended or alternatively washout period should not be shorter than 3.5 months.
Maltese: eliminazzjoni mgħaġġla, kif definita fis-Sommarju tal-Karatteristiċi tal-Prodott ta' teriflunomide, hi rakkomandata, jew alternattivament, il-perjodu ta' tneħħija (washout period) m'għandux ikun ta' inqas minn 3.5 xhur.
English: IRIS is generally suspected when patients with PML exhibit signs of clinical worsening usually, but not always, accompanied by gadolinium enhancement of PML lesions with or without mass effect on brain MRI.
Maltese: Għandhom ikunu disponibbli riżorsi għall-immaniġġjar ta' reazzjonijiet ta' sensitività eċċessiva u aċċess għall-MRI.
English: A group of symptoms caused by a serious infection of the brain including:
Maltese: Sintomi ta' infezzjonijiet serji li jinkludu:
English: • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Maltese: • Pazjenti bi sklerozi multipla severa li tirkada u tbatti u li qed tiżviluppa malajr definiti b'żewġ episodji jew aktar ta' rkadar li jikkawżaw diżabilità f'sena, u b'leżjoni waħda jew aktar li tidher aħjar b'Gadolinium f'MRI tal-moħħ jew bi żjieda sinnifikanti fil-kwantità ta' leżjonijiet T2 meta mqabbel ma' MRI reċenti ta' qabel.
English: Current pharmacokinetic/pharmacodynamic statistical modelling and simulation indicate that the risk of MS disease activity for patients switching to longer dosing intervals may be higher for patients with body weight >80kg or those with dosing intervals ≥7 weeks.
Maltese: Mudellar u simulazzjoni kurrenti ta' statistika farmakokinetika/farmakodinamika jindikaw li r-riskju ta' attività tal-marda MS
English: Consistent with efficacy results observed for patients switching from beta interferon or glatiramer acetate to TYSABRI, for patients switching from fingolimod (n=147) to TYSABRI, a significant decrease in annualised relapse rate (ARR) was observed, which remained stable over 2 years, and mean EDSS scores remained similar from baseline to Year 2.
Maltese: Ir-riskju ta' sensittività eċċessiva kienet l-akbar b'infużjonijiet tal-bidu u f'pazjenti li huma esposti mill-ġdid għal TYSABRI wara espożizzjoni qasira fil-bidu (wieħed jew tnejn infużjonijiet) u perjodu estiż (tlett xhur jew aktar) mingħajr kura.
English: After 2 years of treatment, patients should be reinformed about the risks of TYSABRI, especially the increased risk of Progressive Multifocal Leukoencephalopathy (PML), and should be instructed together with their caregivers on early signs and symptoms of PML.
Maltese: Wara sentejn ta' kura, il-pazjenti għandhom jiġu infurmati mill-ġdid dwar ir-riskji ta' TYSABRI, speċjalment dwar iżżjieda fir-riskju ta' Lewkoenċefalopatija Multifokali Progressiva (PML), u flimkien mal-persuni li jieħdu ħsiebhom għandhom jiġu mgħarrfa dwar is-sinjali u s-sintomi bikrija ta' PML.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Tqala Studji fuq l-annimali wrew effet tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Biogen Pharma d.o.o.
Maltese: Genesis Pharma SA
English: Irrespective of the presence or absence of PML risk factors, heightened clinical vigilance for PML should be maintained in all patients treated with TYSABRI and for 6 months following discontinuation of therapy.
Maltese: Irrispettivament mill-preżenza jew in-nuqqas ta' fatturi ta' riskju ta' PML, għandha tinżamm viġilanza klinika ogħla mis-soltu għal PML fil-pazjenti kollha kkurati b'TYSABRI u għal 6 xhur wara li titwaqqaf it-terapija.
English: Currently available evidence suggests that the risk of PML is low at an index equal to or below 0.9 and increases substantially above 1.5 for patients who have been on treatment with TYSABRI for longer than 2 years.
Maltese: Evidenza attwalment disponibbli tissuġġerixxi li r-riskju ta' PML hu baxx f'indiċi daqs jew inqas minn 0.9, u jiżdied b'mod sostanzjali f'indiċi ta' aktar minn 1.5 għal pazjenti li kienu fuq kura b'TYSABRI għal aktar minn sentejn.
English: Nausea
Maltese: jiżdied.
English: However, it has recently been suggested that corticosteroids may be useful to treat IRIS, particularly in patients with severe to life-threatening IRIS (Tan et al., 2009, Clifford et al., 2010).
Maltese: 2009, Clifford et al., 2010).
English: 1 ≥106.3 and ≤ 108.3 CFU of live Bordetella bronchiseptica bacteria strain B-C2 per dose
Maltese: 1≥ 106.3 u ≤ 108.3 PJK (CPU) ta' batterja ħajja Bordatella bronchiseptica strejn B-C2 kull doża
English: Route of Administration
Maltese: Mod ta' Amministrazzjoni
English: Vial (type I glass) in carton box
Maltese: Kunjett (ħġieġ tip I) f'kaxxa tal-kartun
English: Vial (type I glass) in plastic box
Maltese: Kunjett (ħġieġ tip I) f'kaxxa tal-plastik
English: Pack size l t o r
Maltese: Il-pakkett li jmiss mal-prodott
English: Immediate Packaging
Maltese: Daqs talpakkett t x
English: Overall survival (final analysis)***
Maltese: Sopravivenza globali (analiżi finali)***
English: Interferon alfa-2a 9 MIU 3x/week.
Maltese: Interferon alfa-2a 9 MIU 3x/ġimgħa.
English: System organ class (SOC)
Maltese: Klassi tas-sistemi u talorgani (SOC - System organ class)
English: 2009;45:228Y247).
Maltese: Eur J Cancer. 2009;45:228Y247).
English: 25-75 percentile (months)
Maltese: 25-75 perċentali (xhur)
English: Secondary endpoints
Maltese: Punti finali sekondarji
English: Blinded independent review (protocol-defined primary analysis).
Maltese: ^ Analiżi indipendenti u blinded (analiżi primarja definita mill-protokoll).
English: Pulmonary embolism,
Maltese: Emboliżmu pulmonari,
English: 0.65 (p < 0.0001) 95% CI (0.56; 0.76)
Maltese: 0.65 (p < 0.0001) CI ta' 95% (0.56; 0.76)
English: (12.0 vs. 15.0 months;
Maltese: (12.0 vs. 15.
English: The incidence varied between 10% (4/40) and 20%
Maltese: L-inċidenza varjat bejn 10% (4/40) u 20% (3/15).
English: Subject to a p-value boundary of 0.0116.
Maltese: Suġġett għal-limitu ta' valur p ta' 0.0116.
English: Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.
Maltese: Analiżi finali tas-sopravivenza globali mwettqa meta 46.7% tal-pazjenti kienu mietu b'data meta waqqfet tinġabar id-dejta ta' 31 ta' Marzu 2013.
English: 0.80 (p = 0.003) 95% CI (0.69; 0.93)
Maltese: 0.80 (p = 0.003) CI ta' 95% (0.69; 0.93)
English: MVASI may impair female fertility.
Maltese: MVASI jista' jnaqqas il-fertilità femminili.
English: Name and address of the manufacturer of the biological active substance Amgen Inc
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Amgen Inc
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 ta' Jannar 2018
English: MVASI is a biosimilar medicinal product.
Maltese: MVASI huwa prodott mediċinali bijoloġiku simili.
English: Investigator assessed PFS analysis with data cut-off date of 30 November 2010.
Maltese: Analiżi ta' PFS evalwata mill-investigatur b'data meta waqqfet tinġabar id-dejta ta' 30 ta' Novembru
English: 5-Fluorouracil
Maltese: Oxaliplatin Leucovorin 5-Fluorouracil
English: Intestinal perforation, Ileus,
Maltese: Perforazzjoni talmusrana, Ileus,
English: Placebo + IFNa
Maltese: Plaċebo + IFNa
English: Arm 1
Maltese: Grupp 1
English: Metastatic disease progression was inhibited and microvascular permeability was reduced.
Maltese: Progressjoni metastatika tal-marda kienet imwaqqfa u l-permeabilità mikrovaskulari mnaqqsa.
English: ML18147 Fluoropyrimidine/irinotecan or Fluoropyrimidine/oxaliplatin based chemotherapy
Maltese: ML18147 Kimoterapija bbażata fuq fluoropyrimidine/irinotecan jew fluoropyrimidine/oxaliplatin
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 (KPS) ta' ≥ 70%, l-ebda metastasi fis-CNS u funzjoni tal-organi adegwata.
English: • abnormal urine test (protein in the urine),
Maltese: • test tal-awrina mhux normali (proteina fl-awrina),
English: Bevacizumab may impair female fertility (see sections 4.6 and 4.8).
Maltese: Bevacizumab jista' jtellef il-fertilità femminili (ara sezzjonijiet 4.6 u 4.8).
English: Efficacy results for study ML18147 (ITT population)
Maltese: Riżultati tal-effikaċja għal studju ML18147 (popolazzjoni ITT)
English: (p-value5,8 = 0.0126)
Maltese: (valur p5,8 = 0.0126)
English: 95% CI for one sample binomial using Pearson-Clopper method.
Maltese: CI ta' 95% għal binomjali ta' kampjum wieħed bl-użu tal-metodu Pearson-Clopper.
English: Wound healing complicationsa,b, Palmar-plantar erythrodysaesthesia syndrome
Maltese: Komplikazzjonijiet fil-fejqan tal-feritia,b, Sindrome ta' eritrodisasteżija palmari-plantari
English: FOLFOX-4 or XELOX + placebo (n = 701)
Maltese: FOLFOX-4 jew XELOX + plaċebo (n = 701)
English: Trehalose dihydrate, sodium phosphate, polysorbate 20, water for injections.
Maltese: TA' EĊĊIPJENTI Trehalose dihydrate, sodium phosphate, polysorbate 20, ilma għall-injezzjonijiet.
English: IRC assessment
Maltese: Valutazzjoni IRC
English: The majority of patients had serous adenocarcinoma histologic type (85% in CPP and CPB15, 86% in CPB15+).
Maltese: Ilmaġġoranza tal-pazjenti kellhom tip istoloġiku ta' adenokarċinoma seruża (85% f'CPP u CPB15, 86% f'CPB15+).
English: Arm 2
Maltese: Grupp 2
English: Pulmonary haemorrhage/ Haemoptysisa,b, Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Maltese: Emorraġija pulmonari/ Emoptisia,b, Emboliżmu pulmonari, Epistassi, Qtugħ ta' nifs, Ipoxja
English: Permanently discontinue MVASI 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 MVASI b'mod permanenti f'pazjenti b'fistula trakeoesofagali (TE - tracheoesophageal) jew kull fistula ta' grad 4 [US National Cancer Institute-Common Terminology Criteria għall-Avvenimenti Avversi (NCI-CTCAE v.3)].
English: • Study E2100 (paclitaxel) Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516)
Maltese: Żieda medjana f'PFS 5.6 xhur, HR 0.421 (p < 0.0001, CI ta' 95% 0.343; 0.516)
English: (p-value = 0.8910)
Maltese: (valur p = 0.8910)
English: Based on a substudy from NSABP C-08 with 295 patients.
Maltese: Ibbażat fuq sottostudju minn NSABP C-08 b'295 pazjent.
English: The majority of patients in both arms had an ECOG Performance Status (PS) of 0 (CT: 56.4% vs. CT + BV: 61.2%).
Maltese: Il-maġġoranza tal-pazjenti fiż-żewġ gruppi kellhom Stat ta' Ħila (PS - Performance Status) ta' ECOG ta' 0 (CT: 56.4% kontra CT + BV: 61.2%).
English: • CT + BV arm (chemotherapy plus bevacizumab):
Maltese: • Grupp CT + BV (kimoterapija flimkien ma' bevacizumab):
English: Non-small cell lung cancer (NSCLC)
Maltese: Kanċer fil-pulmun taċ-ċelluli mhux żgħar (NSCLC - non-small cell lung cancer)
English: Palmar-plantar erythrodysaesthesi a syndrome
Maltese: Sindrome ta' eritrodisasteżija palmari-plantari
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 ta' 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: Stabilità kimika u fiżika ta' 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: Ovarian failure/fertility (see sections 4.4 and 4.6)
Maltese: Insuffiċjenza tal-ovarji/fertilità (ara sezzjonijiet 4.4 u 4.6)
English: FOLFOX-4 or XELOX + bevacizumab (n = 699)
Maltese: FOLFOX-4 jew XELOX + bevacizumab (n = 699)
English: Efficacy results for trial E4599
Maltese: Riżultati tal-effikaċja għall-prova E4599
English: Overall survival6
Maltese: Sopravivenza globali6
English: The rate of infusion was based on tolerability, with an initial infusion duration of 90 minutes.
Maltese: Ir-rata ta' infużjoni kienet ibbażata fuq it-tollerabilità, b'tul ta' infużjoni fil-bidu ta' 90 minuta.
English: Approximate 95% CI for difference of two rates using Hauck-Anderson method.
Maltese: CI ta' madwar 95% għad-differenza ta' żewġ rati bl-użu tal-metodu Hauck-Anderson. test log-rank (stratifikat).
English: Bevacizumab 10 mg/kg q 2 wk.
Maltese: Bevacizumab 10 mg/kg q ġimagħtejn.
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: Gastrointestin al perforationa,b, Gastrointestin al ulcerc, Rectal haemorrhage
Maltese: Perforazzjoni gastrointestinalia,b, Ulċera gastrointestinaliċ, Emorraġija mirrektum
English: Most patients were FIGO stage III (both 68%) followed by FIGO stage IV (13% and 14%), FIGO stage II (10% and 11%) and FIGO stage I (9% and 7%).
Maltese: Il-biċċa l-kbira tal-pazjenti kienu FIGO stadju III (it-tnejn 68%) segwit minn FIGO stadju IV (13% u 14%), FIGO stadju II (10% u 11%) u FIGO stadju I (9% u 7%).
English: 400 mg/m2 IV bolus, 600 mg/m2 IV 22 h
Maltese: 85 mg/m2 IV 2 h 200 mg/m2 IV 2 h 400 mg/m2 IV bolus, 600 mg/m2 IV 22 h
English: 100 mg/4 mL
Maltese: INDIVIDWALI 100 mg/4 mL
English: Bevacizumab vs. No bevacizumab
Maltese: Plaċebo jew bevacizumab
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: Il-131 pazjent fil-grupp ta' bevacizumab + IFN alfa-2a li naqqsu u żammew id-doża ta' IFN alfa-2a f'6 jew 3 MIU waqt il-prova, wrew rati ta' PFS mingħajr avvenimenti wara 6, 12 u 18-il xahar ta' 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: 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 magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC07.
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi u immunomodulaturi, sustanzi antineoplastiċi, sustanzi antineoplastiċi oħra, antikorpi monoklonali, Kodiċi ATC:
English: Treatment regimens in trial NO16966 (mCRC)
Maltese: Korsijiet ta' kura fi prova NO16966 (mCRC) Kura
English: Arm 2 IFL + bevacizumaba
Maltese: Kategorija 2 IFL + bevacizumaba
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: Fi provi kliniċi randomised, età > 65 sena kienet assoċjata ma' żieda fir-riskju ta' żvilupp ta' reazzjonijiet tromboemboliċi arterjali, inkluż aċcidenti ċerebrovaskulari (CVAs - cerebrovascular accidents), attakki iskemiċi temporanji (TIAs - transient ischaemic attacks) u infarti mijokardiċi (Mis - myocardial infarctions).
English: The analysis of the primary endpoint showed no difference between the bevacizumab + placebo arm and the bevacizumab + erlotinib arm (median PFS 8.5 versus 9.9 months).
Maltese: L-analiżi tal-punt finali primarju ma wriet l-ebda differenza bejn il-grupp b'bevacizumab + plaċebo u l-grupp b'bevacizumab + erlotinib (PFS medjana 8.5 kontra 9.9 xhur).
English: Congestive heart failure (CHF)
Maltese: Insuffiċjenza tal-qalb konġestiva (CHF - Congestive heart failure)
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 f'11% (11/100) talpazjenti meta mqabbla ma' 5.8% (6/104) fil-grupp ta' kontroll b'kimoterapija.
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 malistudju ML18147.
English: XELOX or
Maltese: XELOX jew
English: Erlotinib N = 77#
Maltese: N = 77#
English: Efficacy results for trials AVF0780g and AVF2192g
Maltese: Riżultati dwar l-effikaċja għall-provi AVF0780g u AVF2192g AVF0780g