FrancophonIA/ELRC3.0 huggingface dataset:
English: Ibrutinib was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse at oral doses up to 2000 mg/kg/day with an exposure margin of approximately 23 (males) to 37 (females) times the human AUC of ibrutinib at a dose of 560 mg daily.
Maltese: Ibrutinib ma kienx karċinoġeniku fi studju ta' 6 xhur fil-ġurdien transġeniku (Tg.rasH2) b'dożi orali sa 2,000 mg/kg/kuljum b'marġini ta' esponiment ta' madwar 23 (irġiel) sa 37 (nisa) drabi l-AUC ta' ibrutinib fil-bniedem bid-doża ta' 560 mg kuljum.
English: In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the strong CYP3A4 inhibitor voriconazole increased Cmax by 6.7-fold and AUC by 5.7-fold.
Maltese: F'pazjenti b'tumuri malinni taċ-ċellula B li ħadu IMBRUVICA mal-ikel, l-għoti fl-istess waqt tal-impeditur qawwi ta' CYP3A4 voriconazole żied is-Cmax b'6.7 darbiet u l-AUC b'5.7 darbiet.
English: IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Maltese: IMBRUVICA bħala sustanza waħedha huwa indikat għat-trattament ta' pazjenti adulti b'limfoma taċċellula mantle (MCL - mantle cell lymphoma) rikaduta jew refrattarja.
English: IMBRUVICA contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: IMBRUVICA fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, li tista' tgħid huwa essenzjalment ‘mingħajr sodium'.
English: Progression free survival (PFS) as assessed by IRC according to International Workshop on CLL (IWCLL) criteria indicated an 84% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1115-CA are shown in Table 4 and the Kaplan-Meier curves for PFS and OS are shown in Figures 2 and 3, respectively.
Maltese: Sopravivenza ħielsa mill-progressjoni (PFS - progression free survival) kif stmat mill-IRC skont ilkriterji tal-Workshop Internazzjonali dwar CLL (IWCLL - International Workshop on CLL) indikat tnaqqis sinifikanti b'mod statistiku ta' 84% fir-riskju ta' mewt jew progressjoni fil-fergħa ta' IMBRUVICA.
English: Tumour lysis syndrome
Maltese: Sindrome tal-lisi tat-tumur (Tumour Lysis Syndrome, TLS):
English: Moderate CYP3A4 inhibitors
Maltese: Impedituri moderati ta' CYP3A4
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Maltese: Għal pazjenti li jkollhom test pożittiv għal infezzjoni tal-HBV, hija rrakkomandata konsultazzjoni ma' tabib b'esperjenza fit-trattament tal-epatite B.
English: Table 10: ORR and DOR in patients with WM
Maltese: ORR u DOR f'pazjenti b'WM
English: Petechiae
Maltese: Stitikezza
English: Mildly decreased trabecular and cortical bone was seen in female rats administered ≥100 mg/kg/day (AUC exposure margin of 20.3-fold).
Maltese: Għadam trabekulari u tal-kortiċi bi tnaqqis ħafif deher fil-firien nisa mogħtija ≥ 100 mg/kg/kuljum (marġini ta' esponiment tal-AUC ta' 20.3 darba).
English: Includes events with fatal outcome.
Maltese: Jinkludu każijiet b'riżultat fatali.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
Maltese: PORTAFOLL GĦALL-PILLOLA TA' 420 MG (30 jum)
English: At baseline, 39% of patients had bulky disease (≥5 cm), 49% had high-risk score by Simplified MCL International Prognostic Index (MIPI), and 72% had advanced disease (extranodal and/or bone marrow involvement) at screening.
Maltese: Fil-linja bażi, 39% talpazjenti kellhom mard ta' massa kbira (≥ 5 ċm), 49% kellhom punteġġ ta' riskju għoli skont l-Indiċi ta' Pronjożi Internazzjonali Simplifikati għal MCL (MIPI - MCL International Prognostic Index), u 72% kellhom mard avvanzat ('il barra mill-għoqiedi u/jew b'involviment tal-mudullun tal-għadam) meta ġew eżaminati.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg tablets ibrutinib
Maltese: IMBRUVICA 280 mg pilloli ibrutinib
English: Co-administration of ketoconazole, a very strong CYP3A4 inhibitor, in 18 fasted healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by 29- and 24-fold, respectively.
Maltese: L-għoti flimkien ma' ketoconazole, impeditur qawwi ħafna ta' CYP3A4, fi 18-il individwu f'saħħithom u sajma, żied l-esponiment (Cmax u AUC) ta' ibrutinib b'29- u 24-darba aktar, rispettivament.
English: The incidence for the 5-year period was 11%.
Maltese: L-inċidenza għall-perjodu ta' 5 snin kienet ta' 11%.
English: Gastrointestinal disorders
Maltese: Disturbi gastrointestinali Komuni ħafna Dijarea Rimettar
English: Table 3: Efficacy Results in patients with relapsed or refractory MCL (Study MCL3001) Endpoint
Maltese: Tabella 3: Riżultati ta' Effikaċja f'pazjenti b'MCL li rkadiet jew li hija refrattarja għattrattament (Studju MCL3001)
English: Ibrutinib has a pH dependent solubility, with lower solubility at higher pH.
Maltese: Ibrutinib għandu solubilità li tiddependi fuq il-pH, b'solubilità inqas f'pH ogħla.
English: Lowest Observed Effect Level (LOEL) (60 mg/kg/day) margins in the dog are 3.6-fold (males) and 2.3-fold (females).
Maltese: Il-marġini tal-Livell l-Aktar Baxx fejn jiġi Osservat Effett (LOEL - Lowest Observed Effect Level) (60 mg/kg/kuljum) fil-kelb huma 3.6 drabi (irġiel) u 2.3 drabi (nisa) aktar.
English: Adverse reactions in patients treated with ibrutinib for B-cell malignancies and post-marketing adverse reactions are listed below by system organ class and frequency grouping.
Maltese: Reazzjonijiet avversi f'pazjenti ttrattati b'ibrutinib għal tumuri malinni taċ-ċelluli B u reazzjonijiet avversi wara t-tqegħid fis-suq huma elenkati taħt permezz tal-klassi tas-sistemi u tal-organi u l-gruppi ta' frekwenza.
English: Of the 1200 patients treated with IMBRUVICA, 64% were 65 years of age or older.
Maltese: Mill-1,200 pazjent ttrattati b'IMBRUVICA, 64% kellhom 65 sena jew aktar.
English: Consequently the foetal NOAEL was 5 mg/kg/day (approximately 0.7 times the AUC of ibrutinib at a dose of 560 mg daily) (see section 4.6).
Maltese: Konsegwenza ta' dan in-NOAEL tal-fetu kien 5 mg/kg/jum (madwar 0.7 drabi aktar mill-AUC ta' ibrutinib b'doża ta' 560 mg kuljum) (ara sezzjoni 4.6).
English: As no clinical data are available on this interaction, it cannot be excluded that ibrutinib could inhibit intestinal P-gp and BCRP after a therapeutic dose.
Maltese: Minħabba li m'hemmx data klinika disponibbli dwar din linterazzjoni, ma jistax jiġi eskluż li ibrutinib jista' jinibixxi P-gp tal-intestini u BCRP wara doża terapewtika.
English: The safety and efficacy of IMBRUVICA in patients with relapsed or refractory MCL were evaluated in a single open-label, multi-center phase 2 study (PCYC-1104-CA) of 111 patients.
Maltese: Is-sigurtà u l-effikaċja ta' IMBRUVICA f'pazjenti b'MCL rikaduta jew refrattarja ġew stmati fi studju wieħed ta' fażi 2, b'ħafna ċentri, open-label (PCYC-1104-CA) ta' 111-il pazjent.
English: Number of prior lines
Maltese: Numru ta' linji qabel
English: Agents that may have their plasma concentrations altered by ibrutinib Ibrutinib is a P-gp and breast cancer resistance protein (BCRP) inhibitor in vitro.
Maltese: Sustanzi li jista' jkollhom il-konċentrazzjonijiet tagħhom fil-plażma mibdula minn ibrutinib In vitro ibrutinib huwa impeditur ta' P-gp u tal-proteina ta' reżistenza tal-kanċer tas-sider (BCRPbreast cancer resistance protein).
English: The treatment effect of ibrutinib in Study PCYC-1115-CA was consistent across high-risk patients with del17p/TP53 mutation, del11q, and/or unmutated IGHV.
Maltese: L-effett tat-trattament ta' ibrutinib fl-Istudju PCYC-1115-CA kien konsistenti għall-pazjenti kollha b'riskju għoli b'del17p/mutazzjoni TP53, del11q, u/jew IGHV mingħajr mutazzjoni.
English: Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Maltese: Tabella 11: Riżultati ta' effikaċja fl-Istudju PCYC-1127-CA
English: Patients between 65 and 70 years of age were required to have at least one comorbidity that precluded the use of frontline chemo-immunotherapy with fludarabine, cyclophosphamide, and rituximab.
Maltese: Pazjenti li kellhom bejn 65 u 70 sena kien jeħtieġ li jkollhom mill-inqas komorbidità waħda li tipprekludi l-użu tal-aktar kimoimmunoterapija importanti bi fludarabine, cyclophosphamide, u rituximab.
English: Ibrutinib has a pH dependent solubility, with lower solubility at higher pH. A lower Cmax was observed in fasted healthy subjects administered a single 560 mg dose of ibrutinib after taking omeprazole at 40 mg once daily for 5 days (see section 5.2).
Maltese: Ġiet osservata Cmax aktar baxxa f'individwi f'saħħithom sajma li ngħataw doża waħda ta' 560 mg ibrutinib wara li ħadu omeprazole bid-doża ta' 40 mg darba kuljum għal 5 ijiem (ara sezzjoni 5.2).
English: Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita ta' 140 mg fiha 28 mg ta' lactose monohydrate.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg tablets ibrutinib
Maltese: IMBRUVICA 140 mg pilloli ibrutinib
English: IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
Maltese: IMBRUVICA bħala sustanza waħedha huwa indikat għat-trattament ta' pazjenti adulti b'makroglobulinemija ta' Waldenström (WM - Waldenström's macroglobulinaemia) li rċivew millinqas terapija waħda oħra qabel, jew bħala trattament tal-ewwel preferenza għall-pazjenti li mhumiex adattati għal kimo-immunoterapija.
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily (one capsule).
Maltese: Għal pazjenti b'indeboliment moderat tal-fwied (klassi B ta' Child-Pugh), id-doża rrakkomandata hija 140 mg kuljum (kapsula waħda).
English: The overall response to IMBRUVICA was independent of prior treatment including bortezomib and lenalidomide or underlying risk/prognostic factors, bulky disease, gender or age.
Maltese: Ir-rispons totali għal IMBRUVICA kien indipendenti minn trattament li ttieħed qabel inkluż bortezomib u lenalidomide jew fatturi ta' riskju diġà eżistenti/fatturi pronostiċi, mard ta' massa kbira, sess jew età.
English: Atrial fibrillation, atrial flutter and cases of ventricular tachyarrhythmia have been reported in patients treated with IMBRUVICA.
Maltese: Fibrillazzjoni tal-atriju, tferfir tal-atriju u każijiet ta' takiarritmija tal-ventrikulu kienu rrappurtati f'pazjenti ttrattati b'IMBRUVICA.
English: EXPIRY DATE
Maltese: Skop finali
English: Treatment-emergent grade 3 or 4 cytopenias (neutropenia, thrombocytopenia and anaemia) were reported in patients treated with IMBRUVICA.
Maltese: Ċitopeniji ta' grad 3 jew 4 li jfiġġu minħabba t-trattament (newtropenija, tromboċitopenija u anemija) kienu rrappurtati f'pazjenti ttrattati b'IMBRUVICA.
English: With a median follow-up time on study of 65 months in Study PCYC-1112-CA, an 85% reduction in the risk of death or progression by investigator assessment was observed for patients in the IMBRUVICA arm.
Maltese: Bi żmien medjan ta' segwitu ta' 65 xahar waqt l-Istudju PCYC-1112-CA, ġie osservat tnaqqis ta' 85% fir-riskju ta' mewt jew progressjoni permezz ta' stima tal-investigatur għall-pazjenti fil-grupp ta' IMBRUVICA.
English: Cases of atrial fibrillation and atrial flutter have been reported particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation.
Maltese: Każijiet ta' fibrillazzjoni tal-atriju u tferfir tal-atriju kienu rrappurtati b'mod partikulari f'pazjenti b'fatturi kardijaċi ta' riskju, pressjoni għolja, infezzjonijiet akuti, u storja preċedenti ta' fibrillazzjoni tal-atriju.
English: Patients (n=229) were randomized 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity or chlorambucil at a dose of 0.5 mg/kg on Days 1 and 15 of each 28-day cycle for 6 cycles.
Maltese: Il-pazjenti (n=229) ntagħżlu b'mod arbitrarju 1:1 biex jew jirċievu IMBRUVICA 420 mg kuljum sa progressjoni tal-marda jew tossiċità mhux aċċettabbli jew chlorambucil bid-doża ta' 0.5 mg/kg fil-Jiem 1 u 15 ta' kull ċiklu ta' 28 jum għal 6 ċikli.
English: IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.
Maltese: IMBRUVICA flimkien ma' rituximab huwa indikat għattrattament ta' pazjenti adulti b'WM.
English: Ibrutinib did not show meaningful inhibition of platelet aggregation using other agonists of platelet aggregation.
Maltese: Ibrutinib ma weriex inibizzjoni sinifikanti ta' aggregazzjoni tal-plejtlets bl-użu ta' agonisti oħra talaggregazzjoni tal-plejtlets.
English: IMBRUVICA 280 mg film-coated tablets Macrogol
Maltese: IMBRUVICA 280 mg pilloli miksija b'rita Macrogol
English: Severe cardiac disease Patients with severe cardiovascular disease were excluded from IMBRUVICA clinical studies.
Maltese: Minn żmien għal żmien immonitorja l-pazjenti kollha b'mod kliniku għal arritmija kardijaka.
English: Bulky disease <5 cm ≥5 cm
Maltese: Mard ta' massa kbira <5 ċm ≥5 ċm
English: The Kaplan-Meier curve for PFS is shown in Figure 6.
Maltese: Il-kurva Kaplan-Meier għal PFS qed tintwera f'Figura 6.
English: • medicines called statins to treat high cholesterol - rosuvastatin
Maltese: • mediċini msejħa statins biex jittrattaw livell għoli ta' kolesterol - rosuvastatin
English: Ventricular tachyarrhythmia
Maltese: FULJETT TA' TAGĦRIF
English: Rituximab was administered at a dose of 375 mg/m2 in the first cycle,
Maltese: Rituximab ingħata bid-doża ta' 375 mg/m2 fl-ewwel ċiklu f'Jum 1, u 500 mg/m2 fiċ-Ċikli
English: Discontinuation and dose reduction due to adverse reactions Of the 1200 patients treated with IMBRUVICA for B-cell malignancies, 5% discontinued treatment primarily due to adverse reactions.
Maltese: Mill-1,200 pazjent ttrattati b'IMBRUVICA għal tumuri malinni taċ-ċelluli-B, 5% waqqfu t-trattament primarjament minħabba reazzjonijiet avversi.
English: The safety and efficacy of IMBRUVICA in patients previously treated for CLL were further evaluated in a randomised, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with BR versus placebo+BR (Study CLL3001).
Maltese: Is-sigurtà u l-effikaċja ta' IMBRUVICA f'pazjenti li kienu ttrattati għal CLL qabel ġew ivvalutati aktar fi studju arbitrarju, b'ħafna ċentri ta' fażi 3 fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża ta' IMBRUVICA flimkien ma' BR versus plaċebo + BR (Studju CLL3001).
English: Response Rate (CR, VGPR, PR) Median duration of response, months (range)
Maltese: Rata ta' rispons (CR, VGPR, PR)
English: Simulations using fasted conditions suggested that the strong CYP3A4 inhibitor clarithromycin may increase the AUC of ibrutinib by a factor of 14.
Maltese: Simulazzjonijiet li kienu qed jużaw kundizzjonijiet ta' sawm issuġġerew li l-impeditur qawwi ta' CYP3A4 clarithromycin jista' jżid l-AUC ta' ibrutinib b'fattur ta' 14.
English: White opaque, hard capsule of 22 mm in length, marked with “ibr 140 mg” in black ink.
Maltese: Kapsula iebsa, bajda, opaka, twila 22 mm, immarkata b'“ibr 140 mg” b'linka sewda.
English: The safety and efficacy of IMBRUVICA in WM were further evaluated in patients with treatmentnaïve or previously treated WM in a randomized, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with rituximab versus placebo in combination with rituximab (PCYC-1127-CA).
Maltese: Is-sigurtà u l-effikaċja ta' IMBRUVICA f'WM ġew ivvalutati aktar f'pazjenti li qatt ma jkunu ħadu trattament qabel jew b'WM li kient ġiet ittrattata qabel fi studju arbitrarju, b'ħafna ċentri, ta' fażi 3 fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża ta' IMBRUVICA flimkien ma' rituximab versus plaċebo flimkien ma' rituximab (PCYC-1127-CA).
English: EU/1/14/945/012 - 28 tablets (2 wallet packs of 14) EU/1/14/945/006 - 30 tablets (3 wallet packs of 10)
Maltese: EU/1/14/945/012 (28 pillola) EU/1/14/945/006 (30 pillola)
English: It is not recommended to administer IMBRUVICA to patients with severe hepatic impairment (Child-Pugh class C).
Maltese: Mhuwiex irrakkomanadat li IMBRUVICA jingħata lill-pazjenti b'indeboliment tal-fwied qawwi (klassi C ta' Child-Pugh).
English: EU/1/14/945/011 - 28 tablets (2 wallet packs of 14) EU/1/14/945/005 - 30 tablets (3 wallet packs of 10)
Maltese: EU/1/14/945/011 (28 pillola) EU/1/14/945/005 (30 pillola)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
Maltese: PORTAFOLL GĦALL-PILLOLA TA' 420 MG (28 jum)
English: Agents that may increase ibrutinib plasma concentrations Concomitant use of IMBRUVICA and medicinal products that strongly or moderately inhibit CYP3A4 can increase ibrutinib exposure and strong CYP3A4 inhibitors should be avoided.
Maltese: L-użu ta' IMBRUVICA flimkien ma' prodotti mediċinali li jimpedixxu CYP3A4 b'mod qawwi jew b'mod moderat jista' jżid l-esponiment għal ibrutinib u impedituri qawwija ta' CYP3A4 għandu jiġi evitat.
English: Progression free survival (PFS) as assessed by IRC indicated an 80% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1127CA are shown in Table 11 and the Kaplan-Meier curve for PFS is shown in Figure 8.
Maltese: Sopravivenza mingħajr progressjoni (PFS, Progression Free Survival) skont kif stmata mill-IRC indikat tnaqqis sinifikanti b'mod statistiku ta' 80% fir-risku ta' mewt jew progressjoni fil-grupp ta' IMBRUVICA.
English: Day 1, and 500 mg/m2 Cycles 2 through 6, Day 1.
Maltese: 2 sa 6, f'Jum 1.
English: How to take IMBRUVICA
Maltese: X'inhu IMBRUVICA
English: In patients with preexisting atrial fibrillation requiring anticoagulant therapy, alternative treatment options to IMBRUVICA should be considered.
Maltese: F'pazjenti li diġà għandhom fibrillazzjoni tal-atriju li teħtieġ terapija b'antikoagulant, għandhom jitqiesu għażliet ta' trattament alternattiv għal IMBRUVICA.
English: Table 7: Efficacy results in patients with CLL (Study PCYC-1112-CA) Endpoint
Maltese: Riżultati ta' effikaċja f'pazjenti b'CLL (Studju PCYC-1112-CA) Punt finali
English: The updated Kaplan-Meier curve for PFS is shown in Figure 4.
Maltese: Il-kurva Kaplan-Meier għal PFS aġġornata qed tintwera f'Figura 4.
English: Administration of ibrutinib in fasted condition resulted in approximately 60% of exposure (AUClast) as compared to either 30 minutes before, 30 minutes after (fed condition) or 2 hours after a high fat breakfast.
Maltese: esponiment (AUClast) meta mqabbla ma' 30 minuta qabel, jew 30 minuta wara (kundizzjoni ta' stat mitmugħ) jew sagħtejn wara kollazzjon b'livell għoli ta' xaħam.
English: IMBRUVICA 560 mg film-coated tablets Macrogol
Maltese: IMBRUVICA 560 mg pilloli miksija b'rita Macrogol
English: • skin rash
Maltese: Stadju Rai
English: Onychoclasis
Maltese: Limfoċitosi
English: When administering IMBRUVICA in combination with anti-CD20 therapies, it is recommended to administer IMBRUVICA prior to rituximab or obinutuzumab when given on the same day.
Maltese: Meta tagħti IMBRUVICA flimkien ma' terapiji kontra CD20, huwa rrakkomandat li tagħti IMBRUVICA qabel rituximab jew obinutuzumab meta jingħataw fl-istess jum.
English: PFS hazard ratios for treatment-naïve patients, previously treated patients, and patients with or without MYD88 L265P mutations were consistent with the PFS hazard ratio for the ITT population.
Maltese: Il-proporzjonijiet ta' periklu ta' PFS għal pazjenti li qatt ma kienu ħadu trattament qabel, pazjenti li kienu ttrattati qabel u pazjenti b'mutazzjonijiet MYD88 L265P jew mingħajrhom kienu konsistenti mal-proporzjon ta' periklu ta' PFS għall-popolazzjoni ITT.
English: Shellac
Maltese: Nawsja
English: The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.
Maltese: Id-doża rrakkomandata ta' IMBRUVICA hija erba' kapsuli (560 mg) darba kuljum.
English: Each hard capsule contains 140 mg of ibrutinib.
Maltese: Kull kapsula iebsa fiha 140 mg ta' ibrutinib.
English: Patients treated for MCL in clinical studies received IMBRUVICA at 560 mg once daily and patients treated for CLL or WM in clinical studies received IMBRUVICA at 420 mg once daily.
Maltese: Pazjenti ttrattati għal MCL fi studji kliniċi rċivew IMBRUVICA b'doża ta' 560 mg darba kuljum u pazjenti ttrattati għal CLL jew WM fi studji kliniċi irċivew IMBRUVICA b'doża ta' 420 mg darba kuljum.
English: EU/1/14/945/009 - 28 tablets (2 wallet packs of 14) EU/1/14/945/010 - 30 tablets (3 wallet packs of 10)
Maltese: EU/1/14/945/009 (28 pillola) EU/1/14/945/010 (30 pillola)
English: EU/1/14/945/007 - 28 tablets (2 wallet packs of 14) EU/1/14/945/008 - 30 tablets (3 wallet packs of 10)
Maltese: EU/1/14/945/007 (28pillola) EU/1/14/945/008 (30 pillola)
English: Median (95% CI), months
Maltese: Medjan (95% CI), xhur
English: Patients were randomised 1:1 to receive either IMBRUVICA orally at 560 mg once daily for 21 days or temsirolimus intravenously at 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21-day cycle.
Maltese: Ilpazjenti ntgħażlu b'mod arbitrarju 1:1 biex jew jirċievu IMBRUVICA mill-ħalq bid-doża ta' 560 mg darba kuljum għal 21 jum jew temsirolimus mill-vini bid-doża ta' 175 mg fil-Jiem 1, 8, 15 tal-ewwel ċiklu segwiti minn 75 mg fil-Jiem 1, 8, 15 ta' kull miċ-ċiklu sussegwenti ta' 21 jum.
English: Efficacy results were also assessed by an IRC demonstrating an ORR of 83%, with a 11% VGPR rate and a 51% PR rate.
Maltese: Ir-riżultati ta' effikaċja ġew ivvalutati wkoll minn IRC fejn intwera ORR ta' 83%, b'rata ta' VGPR ta' 11% u rata ta' PR ta' 51%.
English: Co-administration of rifampicin, a strong CYP3A4 inducer, in 18 fasted healthy subjects, decreased exposure (Cmax and AUC) of ibrutinib by 92 and 90%, respectively.
Maltese: L-għoti flimkien ma' rifampicin, induttur qawwi ta' CYP3A4, fi 18-il individwu f'saħħithom u sajma, naqqas l-esponiment (Cmax u AUC) għal ibrutinib bi 92 u 90%, rispettivament.
English: The updated Kaplan-Meier curve for PFS is shown in Figure 7.
Maltese: Il-kurva Kaplan-Meier aġġornata ta' PFS qed tintwera f'Figura 7.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 October 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Ottubru 2014
English: Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Maltese: Kaplan-Meier ta' PFS (Popolzzjoni ITT Population) fl-Istudju PCYC-1130CA
English: Viral reactivation
Maltese: Riattivazzjoni tal-virus
English: When taking IMBRUVICA, tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare but serious brain infection which can be fatal (Progressive Multifocal Leukoencephalopathy or PML).
Maltese: Meta tieħu IMBRUVICA, għid lit-tabib minnufih jekk tinduna jew xi ħadd jinduna fuqek li jkollok: telf ta' memorja, problema biex taħseb, diffikultà biex timxi jew telf tal-vista - dawn jistgħu jkunu minħabba infezzjoni rari ħafna imma serja tal-moħħ li tista' tkun fatali (Lewkoenċefalopatija Multifokali Progressiva jew PML (Progressive Multifocal Leukoencephalopathy)).
English: The CR rate according to IWCLL criteria was 16.2% in the IMBRUVICA arm versus 3.0% in the chlorambucil arm. At the time of long-term follow-up, a total of 73 subjects (54.9%) originally randomized to the chlorambucil arm subsequently received ibrutinib as cross-over treatment.
Maltese: Ir-rata ta' CR skont il-kriterji IWCLL kienet 16.2% fil-grupp ta' IMBRUVICA versus 3.0% fil-grupp ta' chlorambucil.
English: It belongs to a class of medicines called protein kinase inhibitors.
Maltese: Huwa jagħmel parti minn klassi ta' mediċini msejħa impedituri tal-proteina kinase.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali urew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).