FrancophonIA/ELRC3.0 huggingface dataset:
English: Spontaneous reports from post-marketing experience.
Maltese: Rapporti spontanji minn esperjenza ta' wara t-tqegħid fis-suq.
English: Urticaria Erythema Onychoclasis
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Progression Free Survival Number of events (%) Median (95% CI), months
Maltese: Sopravivenza Mingħajr Progressjoni Numru ta' avvenimenti (%) Medjan (95% CI), xhur
English: Includes multiple adverse reaction terms.
Maltese: * Tinkludi ħafna termini ta' reazzjoni avversa.
English: The median age was 73 years (range, 65 to 90 years), 63% were male, and 91% were Caucasian.
Maltese: Il-medjan tal-età kien 73 sena (firxa, 65 sa 90 sena), 63% kienu rġiel, u 91% kienu Kawkasiċi.
English: Cases of invasive fungal infections, including cases of Aspergillosis, Cryptococcosis and Pneumocystis jiroveci infections have been reported following the use of ibrutinib.
Maltese: Każijiet ta' infezzjonijiet invażivi bil-fungu, inklużi każijiet ta' infezzjonijiet ta' Aspergillosis, Cryptococcosis u Pneumocystis jiroveci ġew irrappurtati wara l-użu ta' ibrutinib.
English: If a moderate CYP3A4 inhibitor (e.g., fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone and dronedarone) is indicated, reduce IMBRUVICA dose to 280 mg for the duration of the inhibitor use.
Maltese: (eż., fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone u dronedarone), naqqas id-doża ta' IMBRUVICA għal 280 mg matul iż-żmien ta' użu tal-impeditur.
English: IMBRUVICA should be held at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
Maltese: IMBRUVICA m'għandux jingħata għal mill-inqas 3 sa 7 ijiem qabel u wara kirurġija skont it-tip ta' kirurġija u r-riskju ta' fsada.
English: All patients had a baseline ECOG performance status of 0 (48%) or 1-2 (52%).
Maltese: Ilpazjenti kollha kellhom stat ta' eżekuzzjoni ta' ECOG ta' 0 (48%) jew 1-2 (52%) fil-linja bażi.
English: At baseline, 39.2% of patients had Rai Stage IV, 45.1% had bulky disease (≥5 cm), 35.3% had deletion 17p and 31.4% had deletion 11q.
Maltese: Fil-linja bażi, 39.2% tal-pazjenti kellhom Rai Stadju IV, 45.1% kellhom mard ta' massa kbira (≥ 5 ċm), 35.3% kellhom del17p u 31.4% kellhom del11q mill-kromosoma.
English: Chronic lymphocytic leukaemia (CLL)/Waldenström's macroglobulinaemia (WM) The recommended dose of IMBRUVICA is three capsules (420 mg) once a day.
Maltese: Lewkimja limfoċitika kronika (CLL)/makroglobulinemija ta' Waldenström (WM) Id-doża rrakkomandata ta' IMBRUVICA hija tliet kapsuli (420 mg) darba kuljum.
English: Table 2: ORR and DOR in patients with relapsed or refractory MCL (Study PCYC-1104-CA)
Maltese: Tabella 2: ORR u DOR f'pazjenti b'MCL rikaduta jew refrattarja (Studju PCYC-1104-CA) Total N = 111
English: • medicines called kinase inhibitors for treatment of other cancers - crizotinib or imatinib
Maltese: • mediċini msejħa impedituri ta' kinase għat-trattament ta' kanċers oħra - crizotinib jew imatinib
English: Tumor flare in the form of IgM increase occurred in 8.0% of subjects in the IMBRUVICA+rituximab arm and 46.7% of subjects in the placebo+rituximab arm.
Maltese: Tumuri li jmorru għall-agħar f'daqqa f'għamla ta' żieda fl-IgM seħħew fi 8.0% tal-individwi fil-grupp ta' IMBRUVICA+rituximab u 46.7% tal-individwi fil-grupp ta' plaċebo+rituximab.
English: In patients with baseline cytopenias, sustained hematologic improvement was: platelets 77.1% versus 42.9%; haemoglobin 84.3% versus 45.5% for ibrutinib and chlorambucil respectively.
Maltese: F'pazjenti b'ċitopeniji fil-linja bażi, titijib ematoloġiku li nżamm kien: plejtlits 77.1% versus 42.9%; emoglobina 84.
English: p-value associated with response rate was <0.0001.
Maltese: Valur p assoċjat mar-rata ta' rispons kien <0.0001.
English: Polyvinyl chloride (PVC) laminated with polychlorotrifluoroethylene (PCTFE)/aluminium blister of 14 film-coated tablets in a cardboard wallet.
Maltese: Folji magħmula minn polyvinyl chloride (PVC) laminat b'polychlorotrifluoroethylene (PCTFE)/aluminju ta' 14-il pillola miksija b'rita f'portafoll tal-kartun.
English: Rituximab was administered weekly at a dose of 375 mg/m2 for 4 consecutive weeks (weeks 1-4) followed by a second course of weekly rituximab for 4 consecutive weeks (weeks 17-20).
Maltese: Rituximab ingħata darba fil-ġimgħa bid-doża ta' 375 mg/m2 għal 4 ġimgħat konsekuttivi (ġimgħat 1-4) segwit minn tieni kors ta' rituximab fil-ġimgħa għal 4 ġimgħat konsekuttivi (ġimgħat 17-20).
English: The median age was 71 years (range, 40 to 87 years), 64% were male, and 96% were Caucasian.
Maltese: Il-medjan tal-età kien 71 sena (firxa, 40 sa 87 sena), 64% kienu rġiel, u 96% kienu Kawkasi.
English: INFORMATION IN BRAILLE Imbruvica 140 mg
Maltese: Imbruvica 140 mg
English: IRC evaluated.
Maltese: Ivvalutat permezz ta' IRC.
English: Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate.
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita ta' 560 mg fiha 112 mg ta' lactose monohydrate.
English: EU/1/14/945/008 (30 tablets)
Maltese: EU/1/14/945/008 (30 pillola)
English: Number of events (%) Median (95% CI), months
Maltese: Numru ta' avvenimenti (%) Medjan (95% CI), xhur
English: Very common Rash Common
Maltese: Komuni ħafna Raxx* Komuni
English: Janssen-Cilag B.V. Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Maltese: Tel: +31 76 711 1111 janssen@jacnl.jnj.com
English: Based on mean exposure (AUC) at the 560 mg/day clinical dose, AUC ratios were 2.6 and 21 at the NOAEL in male and female rats, and 0.4 and 1.8 at the NOAEL in male and female dogs, respectively.
Maltese: Abbażi tal-medja tal-esponiment (AUC) bid-doża klinika ta' 560 mg/kuljum, il-proporzjonijiet tal-AUC kienu 2.6 u 21 fin-NOAEL fil-firien irġiel u nisa, u 0.4 u 1.8 fin-NOAEL fil-klieb irġiel u nisa, rispettivament.
English: In rats, moderate pancreatic acinar cell atrophy (considered adverse) was observed at doses of ≥100 mg/kg in male rats (AUC exposure margin of 2.6-fold) and not observed in females at doses up to 300 mg/kg/day (AUC exposure margin of 21.3-fold).
Maltese: Fil-firien, kienet osservata atrofija moderata taċ-ċellula acinar tal-frixa (meqjusa bħala avversa) b'dożi ta' ≥ 100 mg/kg fil-firien irġiel (marġini ta' esponiment tal-AUC 2.6 drabi aktar) u ma kinitx osservata fin-nisa b'dożi sa 300 mg/kg/kuljum (marġini ta' esponiment tal-AUC ta' 21.3 drabi aktar).
English: Each carton contains (28 film-coated tablets) 2 wallets.
Maltese: Kull kartuna fiha (28 pillola miksija b'rita) 2 portafolli.
English: The clinical relevance is not known, but the exposure to substrates of CYP2B6 (such as efavirenz and bupropion) and of co-regulated enzymes may be reduced upon co-administration with ibrutinib.
Maltese: Irrilevanza klinika mhijiex magħrufa, iżda l-esponiment għal sustrati ta' CYP2B6 (bħal efavirenz u bupropion) u ta' enzimi rregolati flimkien miegħu jista' jitnaqqas meta jsir għoti flimkien ma' ibrutinib.
English: Table 8: Subgroup analysis of PFS (Study PCYC-1112-CA)
Maltese: Tabella 8: Analiżi ta' PFS ta' sottogrupp (Studju PCYC-1112-CA) Proporzjon ta' Periklu
English: In an in vitro study, ibrutinib demonstrated inhibition of collagen-induced platelet aggregation.
Maltese: Fi studju in vitro, ibrutinib wera inibizzjoni tal-aggregazzjoni tal-plejtlets ikkaġunata mill-kollaġen.
English: Table 4: Efficacy results in Study PCYC-1115-CA Endpoint
Maltese: Tabella 4: Riżultati ta' effikaċja fl-Istudju PCYC-1115-CA Skop finali
English: The dihydrodiol metabolite is at most a weak inducer of CYP450 isoenzymes in vitro.
Maltese: Il-metabolit dihydrodiol huwa l-aktar l-aktar, indutturi dgħajjef tal-isoenzimi ta' CYP450 in vitro.
English: Chronic lymphocytic leukaemia (CLL)/Waldenström's macroglobulinaemia (WM) The recommended dose of IMBRUVICA is 420 mg once a day.
Maltese: Lewkimja limfoċitika kronika (CLL)/makroglobulinemija ta' Waldenström (WM) Id-doża rrakkomandata ta' IMBRUVICA hija 420 mg darba kuljum.
English: A high number of circulating lymphocytes (>400,000/mcL) may confer increased risk.
Maltese: Numru kbir ta' limfoċiti jiċċirkulaw (> 400,000/mcL) jistgħu jżidu r-riskju.
English: The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian.
Maltese: Il-medjan tal-età kien ta' 68 sena (firxa: 40 sa 84 sena), 77% kienu rġiel u 92% kienu Kawkasiċi.
English: At baseline, 52% had advanced clinical stage (Rai Stage III or IV), 32% of patients had bulky disease (≥5 cm), 44% with baseline anemia, 22% with baseline thrombocytopenia, 28% had a CrCL <60 mL/min, and the median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 4 (range, 0 to 12).
Maltese: III jew IV), 32% tal-pazjenti kellhom mard ta' massa kbira (≥5 ċm), 44% b'anemija fil-linja bażi, 22% bi tromboċitopenija fil-linja bażi, 28% kellhom CrCL <60 mL/min, u l-medjan tal-Punteġġ Assenjat ta' Mard Kumulattiv għall-Pazjenti Ġerjatriċi (CIRS-G - Cumulative Illness Rating Score for Geriatrics) kien 4 (firxa, 0 sa 12).
English: chest discomfort (symptoms of heart rhythm problems)
Maltese: qtugħ ta' nifs, skumdità fis-sider (sintomi ta' problemi tar-ritmu tal-qalb)
English: Caution should be exercised if co-administering ibrutinib with CYP3A4 substrates administered orally with narrow therapeutic range (such as dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus and tacrolimus).
Maltese: Għandu jkun hemm kawtela jekk ibrutinib jingħata flimkien ma'sustrati ta' CYP3A4 mgħotija mill-ħalq b'medda terapewtika stretta (bħal dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus u tacrolimus).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/945/001 (90 hard capsules) EU/1/14/945/002 (120 hard capsules)
Maltese: EU/1/14/945/001 (90 kapsula iebsa) EU/1/14/945/002 (120 kapsula iebsa)
English: At a median duration follow up of 16.4 months, the ORR by IRC for the 51 relapsed or refractory patients was 64.7% (95% CI: 50.1%; 77.6%), all PRs.
Maltese: Fil-medjan ta' tul ta' żmien ta' segwitu ta' 16.4 xhur, l-ORR ta' IRC għall-51 pazjent li rkadew jew li kienu refrattarji għattrattament kien 64.7% (95% CI: 50.1%; 77.6%), kollha kemm huma PRs. L-ORR inkluż PR b'limfoċitosi kien 70.6%.
English: The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian.
Maltese: Il-medjan tal-età kien 67 sena (firxa: 30 sa 88 sena), 68% kienu rġiel, u 90% kienu Kawkasiċi.
English: Ibrutinib caused malformations in rabbits at a dose of 15 mg/kg/day (approximately 2.0 times the exposure (AUC) in patients with MCL administered ibrutinib 560 mg daily and 2.8 times the exposure in patients with CLL or WM receiving ibrutinib dose 420 mg per day).
Maltese: Ibrutinib ikkawża formazzjonijiet difettużi fil-fniek b'doża ta' 15-il mg/kg/jum (madwar darbtejn aktar mill-esponiment (AUC) f'pazjenti b'MCL mogħtija ibrutinib 560 mg kuljum u 2.8 drabi aktar mill-esponiment f'pazjenti b'CLL jew WM li jkunu qed jirċievu doża ta' 420 mg kuljum ta' ibrutinib).
English: Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), debossed with “ibr” on one side and “420” on the other side.
Maltese: Pilloli oblung ħodor fl-isfar sa ħodor (twal 17.5 mm u wisgħin 7.4 mm), imnaqqxa b'“ibr” fuq naħa waħda u “420” fuq in-naħa l-oħra.
English: The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
Maltese: Il-medjan tal-età kien 69 sena (firxa, 36 sa 89 sena), 66% kienu rġiel, u 79% kienu Kawkasi.
English: The open-label, multi-center study (PCYC-1102-CA) included 51 patients with relapsed or refractory CLL, who received 420 mg once daily.
Maltese: L-istudju open-label, b'ħafna ċentri (PCYC-1102-CA) kien jinkludi 51 pazjent b'CLL rikaduta jew refrattarja, li rċivew 420 mg darba kuljum.
English: Table 6: Subgroup Analysis of PFS (Study PCYC-1130-CA) N Hazard Ratio
Maltese: Analiżi tas-Sottogrupp għal PFS (Studju PCYC-1130-CA) N Proporzjon ta' Periklu
English: A randomised, multi-center, open-label phase 3 study of IMBRUVICA versus ofatumumab (PCYC-1112-CA) was conducted in patients with relapsed or refractory CLL.
Maltese: Sar studju ta' fażi 3, arbitrarju, b'ħafna ċentri, open-label, ta' IMBRUVICA versus ofatumumab (PCYC-1112-CA) f'pazjenti b'CLL rikaduta jew refrattarja.
English: Uncommon Angioedema Panniculitis
Maltese: Mhux komuni Anġjoedima Pannikulite*
English: IMBRUVICA 140 mg hard capsules ibrutinib
Maltese: IMBRUVICA 140 mg kapsuli ibrutinib
English: No maximum tolerated dose was reached in the phase 1 study in which patients received up to 12.5 mg/kg/day (1,400 mg/day).
Maltese: Ma nlaħqet l-ebda doża massima ttollerata fl-istudju ta' fażi 1 fejn il-pazjenti rċivew sa 12.5 mg/kg/kuljum (1,400 mg/kuljum).
English: There is no specific antidote for IMBRUVICA.
Maltese: Ma hemm l-ebda antidotu speċifiku għal IMBRUVICA.
English: Table 9: Efficacy Results in patients with CLL (Study CLL3001)
Maltese: Riżultati ta' effikaċja f'pazjenti b'CLL (Studju CLL3001)
English: A large increase in the number of circulating lymphocytes (e.g., >400,000/mcL) has been observed in some patients.
Maltese: Żieda kbira fin-numru ta' limfoċiti li jiċċirkulaw (e.g., > 400,000/mcL) ġiet osservata f'xi pazjenti.
English: IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets ibrutinib
Maltese: IMBRUVICA 140 mg pilloli miksija b'rita IMBRUVICA 280 mg pilloli miksija b'rita IMBRUVICA 420 mg pilloli miksija b'rita IMBRUVICA 560 mg pilloli miksija b'rita ibrutinib
English: Tumour lysis syndrome has been reported with IMBRUVICA therapy.
Maltese: Sindrome tal-lisi tat-tumur ġie rapportat b'terapija ta' IMBRUVICA.
English: Other medicines and IMBRUVICA
Maltese: Mediċini oħra u IMBRUVICA
English: Ibrutinib has minimal renal clearance; urinary excretion of metabolites is <10% of the dose.
Maltese: Ibrutinib għandu tneħħija minima mill-kliewi; it-tneħħija tal-metaboliti mal-awrina hija ta' < 10% taddoża.
English: Consequently the foetal NOAEL was 10 mg/kg/day (approximately 1.3 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 10 mg/kg/kuljum (madwar 1.3 drabi aktar mill-AUC ta' ibrutinib b'doża ta' 560 mg kuljum) (ara sezzjoni 4.6).
English: Lymphocytosis
Maltese: Il-Belġju
English: Each bottle contains either 90 or 120 capsules.
Maltese: Kull flixkun fih 90 jew 120 kapsula.
English: Each carton contains (30 film-coated tablets) 3 wallets.
Maltese: Kull kartuna fiha (30 pillola miksija b'rita) 3 portafolli.
English: Consider alternative agents with less CYP3A4 induction.
Maltese: Ikkunsidra sustanzi alternattivi b'inqas induzzjoni ta' CYP3A4.
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily.
Maltese: Għal pazjenti b'indeboliment moderat tal-fwied (klassi B ta' Child-Pugh), id-doża rrakkomandata hija 140 mg kuljum.
English: The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian.
Maltese: Il-medjan tal-età kien 63 sena (firxa: 44 sa 86 sena), 76% kienu rġiel, u 95% kienu Kawkasi.
English: Dose adjustments Moderate and strong CYP3A4 inhibitors increase the exposure of ibrutinib (see sections 4.4 and 4.5).
Maltese: Aġġustamenti fid-doża Impedituri moderati u qawwijin ta' CYP3A4 iżidu l-esponiment għal ibrutinib (ara sezzjonijiet 4.4 u
English: IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets
Maltese: IMBRUVICA 140 mg pilloli miksija b'rita IMBRUVICA 280 mg pilloli miksija b'rita IMBRUVICA 420 mg pilloli miksija b'rita IMBRUVICA 560 mg pilloli miksija b'rita
English: The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian.
Maltese: Ilmedjan tal-età kien ta' 64 sena (firxa, minn 31 sa 86 sena), 66% kienu rġiel, u 91% kienu Kawkasiċi.
English: Use of preparations containing St. John's Wort is contraindicated in patients treated with IMBRUVICA.
Maltese: John's Wort huwa kontraindikat f'pazjenti ttrattati b'IMBRUVICA.
English: PFS Median (95% CI), months
Maltese: PFS Medjan (95% CI), xhur
English: Manufacturer Janssen-Cilag SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina, Italy
Maltese: Borgo S. Michele, 04100 Latina, L-Italja
English: Based on in vitro data, ibrutinib is a weak CYP2B6 inducer and may have the potential to affect the expression of other enzymes and transporters regulated via the constitutive androstane receptor (CAR), e.g. CYP2C9, CYP2C19, UGT1A1 and MRP2.
Maltese: Abbażi ta' data in vitro, ibrutinib huwa induttur dgħajjef ta' CYP2B6 u jista' jkollu l-potenzjal li jaffettwa l-espressjoni ta' enzimi u trasportaturi oħra rregolati permezz tar-riċettur kostituttiv ta' androstane (CAR - constitutive androstane receptor), eż. CYP2C9, CYP2C19, UGT1A1 u MRP2.
English: The free fraction of ibrutinib also increased with degree of impairment, with 3.0, 3.8 and 4.8% in subjects with mild, moderate and severe liver impairment, respectively, compared to 3.3% in plasma from matched healthy controls within this study.
Maltese: Il-porzjon ħieles ta' ibrutinib żdied ukoll malgrad ta' indeboliment, bi 3.0, 3.8 u 4.8% f'individwi b'indeboliment ħafif, moderat u qawwi, rispettivament, meta mqabbel ma' 3.3% fil-plażma minn kontrolli mqabbla f'saħħithom f'dan listudju.
English: Progression-free survival (PFS) was assessed by IRC according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.
Maltese: Is-sopravivenza ħielsa mill-progressjoni (PFS Progession-free survival) ġiet ivvalutata mill-IRC skont il-kriterji revisti tal-Grupp Internazzjonali ta' Ħidma (IWG International Working Group) dwar limfoma mhux ta' Hodgkin (NHL, non-Hodgkin's lymphoma).
English: Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001
Maltese: Kaplan-Meier ta' PFS (Popolazzjoni ITT) fl-Istudju MCL3001
English: At baseline, 56% of patients had at least one tumour ≥5 cm, 26% had del11q.
Maltese: Fil-linja bażi, 56% tal-pazjenti kellhom mill-inqas tumur wieħed ≥ 5 ċm, 26% kellhom del11q mill-kromosoma.
English: The median investigator-assessed PFS2 (time from randomisation until PFS event after first subsequent anti-neoplastic therapy) according to IWCLL criteria was 65.4 months [95% CI (51.61, not estimable)] in the IMBRUVICA arm and 38.5 months [95% CI (19.98, 47.24)] in the ofatumumab arm, respectively; HR=0.54 [95% CI (0.41, 0.71)].
Maltese: Il-medjan ta' PFS2 stamat mill-investigatur (żmien mill-għażla arbitrarja sal-avveniment ta' PFS wara l-ewwel terapija antineoplastika sussegwenti) skont il-kriterji ta' IWCLL kien ta' 65.4 xhur [95% CI (51.61, ma setgħux jiġu stmati)] fil-grupp ta' IMBRUVICA u 38.5 xhur [95% CI (19.98, 47.
English: Preparations containing St. John's Wort are contraindicated during treatment with IMBRUVICA, as efficacy may be reduced.
Maltese: John's Wort huma kontraindikati waqt trattament b'IMBRUVICA, minħabba li tista' tonqos l-effikaċja.
English: At baseline, the median serum IgM value was 3.2 g/dL (range, 0.6 to 8.3 g/dL), 63% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L) and MYD88 L265P mutations were present in 77% of patients, absent in 13% of patients, and 9% of patients were not evaluable for mutation status.
Maltese: ≤11 g/dL jew 6.8 mmol/L) u kien hemm preżenti mutazzjonijiet MYD88 L265P f'77% tal-pazjenti, assenti fi 13% tal-pazjenti, u 9% tal-pazjenti ma setgħux jiġu evalwati għall-istat ta' mutazzjoni.
English: After confirmed disease progression, patients on chlorambucil were able to crossover to ibrutinib.
Maltese: Wara konferma ta' progressjoni tal-marda, il-pazjenti fuq chlorambucil setgħu jaqilbu fuq ibrutinib.
English: • medicines called antibiotics to treat bacterial infections - clarithromycin, telithromycin,
Maltese: • mediċini msejħa antibijotiċi biex jittrattaw infezzjonijiet bil-batterji - clarithromycin,
English: The primary endpoint in this study was investigator-assessed overall response rate (ORR).
Maltese: Il-punt finali primarju f'dan l-istudju kien ir-rata ta' rispons totali (ORR - overall response rate) stmata mill-investigatur.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
Maltese: IMBRUVICA 560 mg pilloli ibrutinib
English: NE=not estimable; HR=hazard ratio; CI=confidence interval; ORR=overall response rate; PFS=progression-free survival IRC evaluated.
Maltese: NE = mhux stmat (not estimable); HR = proporzjon ta' periklu (hazard ratio); ORR = rata ta' rispons globali;
English: CI=confidence interval; HR=hazard ratio; CR=complete response; PR=partial response.
Maltese: HR, hazard ratio = proporzjon ta' periklu; CR, complete response = rispons sħih; PR, partial response = rispons parzjali.
English: The study enrolled patients who were 65 years of age or older or <65 years of age with coexisting medical conditions, reduced renal function as measured by creatinine clearance <70 mL/min, or presence of del17p/TP53 mutation.
Maltese: L-istudju rreġistra fih pazjenti li kellhom età ta' 65 sena jew aktar jew età ta' <65 sena b'kondizzjonijiet mediċi fl-istess waqt, tnaqqis fil-funzjoni tal-kliewi mkejla bi tneħħija tal-kreatinina <70 mL/min, jew il-preżenza ta' del17p/ mutazzjoni ta' TP53.
English: IMBRUVICA 140 mg film-coated tablets and IMBRUVICA 420 mg film-coated tablets Macrogol
Maltese: IMBRUVICA 140 mg pilloli miksija b'rita u IMBRUVICA 420 mg pilloli miksija b'rita Macrogol
English: Very common Neutropenia Thrombocytopenia
Maltese: Komuni ħafna Newtropenija Tromboċitopenija
English: Effect on QT/QTc interval and cardiac electrophysiology The effect of ibrutinib on the QTc interval was evaluated in 20 healthy male and female subjects in a randomised, double-blind thorough QT study with placebo and positive controls.
Maltese: Effett fuq l-intervall QT/QTc u elettrofiżjoloġija kardijaka L-effett ta' ibrutinib fuq l-intervall QTc ġie vvalutat f'20 individwu raġel u mara f'saħħithom fi studju arbitrarju, bir-reqqa ta' QT bi plaċebo u kontrolli pożittivi fejn la l-investgaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża.
English: CI=confidence interval; CR=complete response; HR=hazard ratio; MR=minor response; NE=not estimable; PR=partial response; R=Rituximab; TTnT=time to next treatment; VGPR=very good partial response IRC evaluated.
Maltese: MR, minor response=rispons żgħir; NE, not estimable=ma jistax jiġi stmat; PR, partial response = rispons parzjali; R=Rituximab;
English: IMBRUVICA as a single agent or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).
Maltese: IMBRUVICA bħala sustanza waħedha jew flimkien ma' obinutuzumab huwa indikat għat-trattament ta' pazjenti adulti b'lewkimja limfoċitika kronika (CLL - chronic lymphocytic leukaemia) li qatt ma kienet ġiet ittrattata qabel (ara sezzjoni 5.1).
English: Efficacy results for Study MCL3001 are shown in Table 3 and the Kaplan-Meier curve for PFS in Figure 1.
Maltese: Ir-riżultati tal-effikaċja għall-Istudju MCL3001 qed jintwerew f'Tabella 3 u fil-kurva Kaplan-Meier għal PFS f'Figura 1.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
Maltese: IMBRUVICA 420 mg pilloli ibrutinib
English: Study PCYC-1127-CA had a separate monotherapy arm of 31 patients with previously treated WM who failed prior rituximab-containing therapy and received single agent IMBRUVICA.
Maltese: L-Istudju PCYC-1127-CA kellu grupp separat ta' monoterapija ta' 31 pazjent b'WM li kienet ġiet ittrattata qabel li ma kinitx ħadmet fuqhom terapija li kien fiha rituximab u rċivew IMBRUVICA waħdu.
English: Patients (n=391) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or ofatumumab for up to 12 doses (300/2,000 mg).
Maltese: Il-pazjenti (n = 391) ntagħżlu kif inzerta 1:1 biex jew jirċievu IMBRUVICA 420 mg kuljum sakemm ikun hemm progressjoni tal-marda jew tossiċità mhux aċċettabbli, jew ofatumumab sa 12-il doża (300/2,000 mg).