FrancophonIA/ELRC3.0 huggingface dataset:
English: In pregnant rabbits, ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal malformations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased post-implantation loss.
Maltese: Fi fniek tqal, ibrutinib b'doża ta' 15-il mg/kg/jum jew aktar ġie assoċjat ma' formazzjonijiet difettużi fl-iskeletru (sternebrae magħqudin flimkien) u ibrutinib b'doża ta' 45 mg/kg/jum ġie assoċjat ma' żieda ta' telf tat-tqala wara l-impjantazzjoni.
English: A randomised, multicenter, open-label phase 3 study (PCYC-1115-CA) of IMBRUVICA versus chlorambucil was conducted in patients with treatment-naïve CLL who were 65 years of age or older.
Maltese: Sar studju arbitrarju, b'ħafna ċentri, ta' fażi 3 (PCYC-1115-CA) b'IMBRUVICA versus chlorambucil fejn kemm l-investigaturi kif ukoll il-pazjenti kienu jafu liema mediċina qed tintuża f'pazjenti b'CLL li ma kinitx ġiet ittrattata qabel li kellhom 65 sena jew aktar.
English: The safety and efficacy of IMBRUVICA in WM (IgM-excreting lymphoplasmacytic lymphoma) were evaluated in an open-label, multi-center, single-arm trial of 63 previously treated patients.
Maltese: Fost il-pazjenti li kienu ġew ittrattati qabel, in-numru medjan ta' trattamenti preċedenti kien ta' 2 (firxa, trattament 1 sa 6 trattamenti).
English: There are no data in patients with severe renal impairment or patients on dialysis (see section 4.2).
Maltese: Ma hemm lebda data f'pazjenti b'indeboliment qawwi tal-kliewi jew pazjenti fuq id-dijalisi (ara sezzjoni 4.2).
English: Median follow-up time on study=26.5 months.
Maltese: Żmien medjan ta' segwitu fl-istudju=26.5 xhur.
English: Hepatitis B virus (HBV) status should be established before initiating treatment with IMBRUVICA.
Maltese: L-istat tal-virus tal-epatite B (HBV - Hepatitis B virus) għandu jiġi stabbilit qabel jinbeda t-trattament b'IMBRUVICA.
English: • severe infections throughout the body (sepsis)
Maltese: • infezzjonijiet qawwija mal-ġisem kollu (sepsi)
English: • severe fungal infections
Maltese: • infezzjonijiet severi bil-fungu
English: HR (95% CI) Overall Response Rate CR
Maltese: HR (95% CI) Rata ta' Rispons Totali
English: Race There are insufficient data to evaluate the potential effect of race on ibrutinib pharmacokinetics.
Maltese: M'hemmx data suffiċjenti biex tivvaluta l-effett tar-razza li jista' jkun hemm fuq il-farmakokinetika ta' ibrutinib.
English: IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib.
Maltese: Kull pillola fiha 560 mg ta' ibrutinib.
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules).
Maltese: Għal pazjenti b'indeboliment ħafif tal-fwied (klassi A ta' Child-Pugh), id-doża rrakkomandata hija 280 mg kuljum (żewġ kapsuli).
English: If the benefit outweighs the risk and a strong or moderate CYP3A4 inducer must be used, monitor patient closely for lack of efficacy (see sections 4.3 and 4.4).
Maltese: Jekk il-benefiċċju jkun akbar mir-riskju u jkollu jintuża induttur qawwi jew moderat ta' CYP3A4, immonitorja l-pazjenti millqrib għal nuqqas ta' effikaċja (ara sezzjonijiet 4.3 u 4.4).
English: The safety and efficacy of IMBRUVICA in children and adolescents aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' IMBRUVICA fit-tfal u l-adolexxenti minn età ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: Mild CYP3A4 inhibitors
Maltese: Impedituri qawwija ta' CYP3A4
English: Grapefruit and Seville oranges should be avoided during IMBRUVICA treatment, as these contain moderate inhibitors of CYP3A4 (see section 4.2).
Maltese: Il-grejpfrut u l-laring ta' Sivilja għandhom jiġu evitati waqt trattament b'IMBRUVICA, minħabba li dawn fihom impedituri moderati ta' CYP3A4
English: UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561 lv@its.jnj.com
Maltese: +371 678 93561 lv@its.jnj.com
English: The treatment effect of ibrutinib in Study PCYC-1112-CA was consistent across high-risk patients with deletion 17p/TP53 mutation, deletion 11q, and/or unmutated IGHV.
Maltese: L-effett tat-trattament ta' ibrutinib fl-Istudju PCYC-1112-CA kien konsistenti għall-pazjenti kollha li kellhom riskju għoli b'del17p/mutazzjoni f'TP53, del11q, u/jew IGHVmingħajr mutazzjoni.
English: Progression-free survival (PFS) was assessed by IRC according to IWCLL criteria indicated a 77% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. With a median follow-up time on study of 31 months, the median PFS was not reached in the IMBRUVICA+obinutuzumab arm and was 19 months in the chlorambucil+obinutuzumab arm. Efficacy results for Study PCYC-1130-CA are shown in Table 5 and the Kaplan-Meier curve for PFS is shown in Figure 5.
Maltese: Sopravivenza mingħajr progressjoni (PFS - Progression-free survival) ġiet stmata permezz tal-IRC skont il-kriterji IWCLL indikat tnaqqis sinifikanti b'mod statistiku ta' 77% fir-riskju ta' mewt jew progressjoni fil-grupp ta' IMBRUVICA.
English: If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg (one capsule) for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Maltese: Jekk ilbenefiċċju jkun akbar mir-riskju u jkollu jintuża impeditur qawwi ta' CYP3A4, naqqas id-doża ta' IMBRUVICA għal 140 mg (kapsula waħda) matul iż-żmien ta' użu tal-impeditur jew waqqaf IMBRUVICAb'mod temporanju (għal 7 ijiem jew inqas).
English: Febrile neutropenia Leukocytosis Lymphocytosis
Maltese: Newtropenija bid-deni Lewkoċitosi Limfoċitosi
English: Leukostasis
Maltese: Pożoloġija
English: Figure 4: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1115-CA with 48 Months Follow-up
Maltese: Kaplan-Meier ta' PFS (Popolazzjoni ITT) fl-Istudju PCYC-1115-CA b'48 Xahar ta' Segwitu
English: The European Medicines Agency has waived the obligation to submit the results of studies with IMBRUVICA in all subsets of the paediatric population in MCL, CLL and lymphoplasmacytic lymphoma (LPL) (for information on paediatric use, see section 4.2).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b' IMBRUVICA f'kull sett tal-popolazzjoni pedjatrika f'MCL, CLL u limfoma limfoplasmaċitika (LPL) (għal informazzjoni dwar l-użu pedjatriku, ara sezzjoni 4.2).
English: In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the CYP3A4 inhibitor erythromycin increased Cmax by 3.4-fold and AUC by 3.0-fold.
Maltese: F'pazjenti b'tumuri malinni taċ-ċellula B li ħadu IMBRUVICA mal-ikel, l-għoti fl-istess waqt talimpeditur qawwi ta' CYP3A4 erythromycin żied is-Cmax bi 3.4 darbiet u l-AUC bi 3 darbiet.
English: The median time since diagnosis was 42 months, and median number of prior treatments was 3 (range: 1 to 5 treatments), including 35% with prior high-dose chemotherapy, 43% with prior bortezomib, 24% with prior lenalidomide, and 11% with prior autologous or allogeneic stem cell transplant.
Maltese: Il-medjan ta' żmien mid-dijanjosi kien 42 xahar, u lmedjan tan-numru ta' trattamenti li ttieħdu qabel kien 3 (firxa: trattament 1 sa 5), inkluż 35% li qabel ħadu kimoterapija b'doża għolja, 43% li qabel ħadu bortezomib, 24% li qabel ħadu lenalidomide, u 11% li qabel sarilhom trapjant awtologu jew alloġeniku taċ-ċelluli stem.
English: IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
Maltese: Kull pillola fiha 140 mg ta' ibrutinib.
English: In patients at high risk and where alternatives to IMBRUVICA are non-suitable, tightly controlled treatment with anticoagulants should be considered.
Maltese: F'pazjenti b'riskju għoli u fejn mhumiex adattati alternattivi għal IMBRUVICA, għandu jitqies trattament b'antikoagulanti kkontrollata b'mod strett.
English: Figure 3: Kaplan-Meier curve of OS (ITT Population) in Study PCYC-1115-CA
Maltese: Kaplan-Meier ta' OS (Popolazzjoni ITT) fl-Istudju PCYC-1115-CA
English: The safety profile is based on pooled data from 1200 patients treated with IMBRUVICA in three phase 2 clinical studies and six randomised phase 3 studies and from post-marketing experience.
Maltese: Il-profil ta' sigurtà huwa bbażat fuq ġabra ta' data minn 1,200 pazjent ttrattati b'IMBRUVICA fi tliet studji kliniċi ta' fażi 2 u sitt studji arbitrarji ta' fażi 3 u minn esperjenza ta' wara t-tqegħid fis-suq.
English: The dose of ibrutinib should be reduced to 140 mg once daily or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Maltese: Id-doża ta' ibrutinib għandha titnaqqas għal 140 mg darba kuljum jew ma tingħatax sa 7 ijiem meta jintuża flimkien ma' impedituri qawwija ta' CYP3A4.
English: With a median follow-up time on study of 48 months in Study PCYC-1115-CA and its extension study, an 86% 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' 48 xahar waqt l-Istudju PCYC-1115-CA u l-istudju ta' estensjoni tiegħu, ġie osservat tnaqqis ta' 86% fir-risku ta' mewt jew progressjoni tal-marda skont l-istima talinvestigatur għall-pazjenti fil-grupp ta' IMBRUVICA.
English: • Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has come back or has not responded to treatment.
Maltese: • Limfoma taċ-ċellula mantle (MCL - Mantle Cell Lymphoma), tip ta' kanċer li jaffettwa lgħoqod tal-limfa, meta l-marda terġa' tiġi lura jew ma tkunx irrispondiet għat-trattament.
English: CI=confidence interval; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response; NR=not reached
Maltese: CI, confidence interval =intervall ta' kunfidenza; CR, complete response=rispons sħiħ;
English: Unmutated IGHV
Maltese: IMBRUVICA mal-ikel
English: At baseline, 58% of patients had at least one tumour ≥5 cm. Thirty-two percent of patients had deletion 17p (with 50% of patients having deletion 17p/TP53 mutation), 24% had 11q deletion, and 47% of patients had unmutated IGHV.
Maltese: Tnejn u tletin fil-mija tal-pazjenti kellhom del17p (b'50% tal-pazjenti li kellhom del17p/mutazzjoni TP53, 24% kellhom del11q mill-kromosoma u 47% tal-pazjenti kellhom IGHV mingħajr mutazzjoni.
English: The safety and efficacy of IMBRUVICA in patients with treatment naïve CLL/SLL were further evaluated in a randomized, multi-center, open-label, Phase 3 study (PCYC-1130-CA) of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab.
Maltese: Is-sigurtà u l-effikaċja ta' IMBRUVICA f'pazjenti b CLL/SLL li qatt ma kienu ħadu trattament qabel ġew ivvalutati aktar fi studju arbitrarju, b'ħafna ċentri, ta' Fażi 3 (PCYC-1130-CA) fejn kemm linvestigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża ta' IMBRUVICA flimkien ma' obinutuzumab versus chlorambucil flimkien ma' obinutuzumab.
English: atazanavir, or fosamprenavir
Maltese: Mekkaniżmu ta' azzjoni
English: Musculoskeletal pain
Maltese: Okkorrenza tat-tossiċità
English: Hypertension has occurred in patients treated with IMBRUVICA (see section 4.8).
Maltese: Arritmija kardijaka u Pressjoni għolja u sezzjoni 4.8).
English: Atrial fibrillation Uncommon Ventricular tachyarrhythmia
Maltese: Fibrillazzjoni tal-atriju Takiarritmija tal-ventrikulu
English: Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita ta' 280 mg fiha 56 mg ta' lactose monohydrate.
English: Co-administration of grapefruit juice, containing CYP3A4 inhibitors, in eight healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by approximately 4- and 2-fold, respectively.
Maltese: L-għoti flimkien mal-meraq tal-grejpfrut, li fih impedituri ta' CYP3A4, fi tmien individwi f'saħħithom, żied l-esponiment (Cmax u AUC) għal ibrutinib b'madwar 4 drabi u darbtejn aktar rispettivament.
English: Gender
Maltese: Iva
English: Table 5: Efficacy results in Study PCYC-1130-CA Endpoint
Maltese: Riżultati ta' effikaċja fl-Istudju PCYC-1130-CA
English: Upon initiation of treatment, a reversible increase in lymphocyte counts (i.e., ≥50% increase from baseline and an absolute count >5,000/mcL), often associated with reduction of lymphadenopathy, has been observed in about three fourths of patients with CLL treated with IMBRUVICA.
Maltese: Malli jinbeda t-trattament, ġiet osservata żieda riversibbli fl-għadd tal-limfoċiti (i.e., żieda ta' ≥ 50% mil-linja bażi u għadd assolut ta' > 5,000/mcL), ta' spiss assoċjata ma' tnaqqis ta' limfadenopatija, f'madwar tliet kwarti tal-pazjenti b'CLL ttrattati b'IMBRUVICA.
English: IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg of ibrutinib.
Maltese: Kull pillola fiha 420 mg ta' ibrutinib.
English: In pregnant rats, ibrutinib at a dose of 80 mg/kg/day was associated with increased post-implantation loss and increased visceral (heart and major vessels) malformations and skeletal variations with an exposure margin 14 times the AUC found in patients at a daily dose of 560 mg. At a dose of ≥40 mg/kg/day, ibrutinib was associated with decreased foetal weights (AUC ratio of ≥5.6 as compared to daily dose of 560 mg in patients).
Maltese: Fil-firien tqal, ibrutinib b'doża ta' 80 mg/kg/kuljum kien assoċjat ma' żieda fit-telf tat-tqala wara limpjantazzjoni u żieda fil-formazzjonijiet difettużi tal-vixxri (qalb u kanali tad-demm prinċipali) u varjazzjonijiet skeletriċi b'marġini ta' esponiment 14-il darba aktar mill-AUC f'pazjenti b'doża kuljum ta' 560 mg.
English: The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Maltese: Id-doża ta' ibrutinib għandha titnaqqas għal 280 mg darba kuljum meta jintuża flimkien ma' impedituri moderati ta' CYP3A4.
English: At baseline, 53% of patients had bulky disease (≥5 cm), 21% had high-risk score by Simplified MIPI, 60% had extranodal disease and 54% had bone marrow involvement at screening.
Maltese: Fil-linja bażi, 53% tal-pazjenti kellhom mard ta' massa kbira (≥ 5 ċm), 21% kellhom punteġġ ta' riskju għoli skont l-MIPI Simplifikati, 60% kellhom mard 'il barra mill-għoqiedi u 54% kellhom involviment tal-mudullun tal-għadam meta ġew eżaminati.
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
Maltese: Għal pazjenti b'indeboliment ħafif tal-fwied (klassi A ta' Child-Pugh), id-doża rrakkomandata hija 280 mg kuljum.
English: Best Overall Response (%) CR
Maltese: L-Aħjar Rispons Totali (%) CR
English: The dose of ibrutinib should be reduced to 140 mg once daily (one capsule) or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Maltese: Id-doża ta' ibrutinib għandha titnaqqas għal 140 mg darba kuljum (kapsula waħda) jew ma tingħatax sa 7 ijiem meta jintuża flimkien ma' impedituri qawwija ta' CYP3A4.
English: Population pharmacokinetics indicated that age does not significantly influence ibrutinib clearance from the circulation.
Maltese: Farmakokinetika ta' popolazzjoni indikat li l-età ma tinfluwenzax it-tneħħija ta' ibrutinib miċċirkulazzjoni b'mod sinifikanti.
English: In MCL, CLL and WM, IMBRUVICA works by blocking Bruton's tyrosine kinase, a protein in the body that helps these cancer cells grow and survive.
Maltese: Billi jimblokka din il-proteina, IMBRUVICA jgħin biex joqtol u jnaqqas in-numru ta' ċelluli tal-kanċer.
English: If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Maltese: Jekk ilbenefiċċju jkun akbar mir-riskju u jkollu jintuża impeditur qawwi ta' CYP3A4, naqqas id-doża ta' IMBRUVICA għal 140 mg matul iż-żmien ta' użu tal-impeditur jew waqqaf IMBRUVICAb'mod temporanju (għal 7 ijiem jew inqas).
English: Patients (n=269) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or chlorambucil at a starting dose of 0.5 mg/kg on days 1 and 15 of each 28-day cycle for a maximum of 12 cycles, with an allowance for intrapatient dose increases up to 0.8 mg/kg based on tolerability.
Maltese: Il-pazjenti (n = 269) ntagħżlu b'mod arbitrarju 1:1 biex jew jirċievu IMBRUVICA 420 mg kuljum sakemm ikun hemm progressjoni talmarda jew tossiċità mhux aċċettabbli, jew chlorambucil bid-doża tal-bidu ta' 0.5 mg/kg fil-jiem 1 u 15 ta' kull ċiklu ta' 28 jum għal massimu ta' 12-il ċiklu, bil-permess għal żidiet fid-doża sa 0.8 mg/kg flistess pazjenti abbażi tat-tollerabbiltà.
English: IMBRUVICA 420 mg film-coated tablets
Maltese: IMBRUVICA 420 mg pilloli miksija b'rita
English: Tumour response was assessed according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.
Maltese: Ir-rispons għat-tumur ġie stmat skont il-kriterji riveduti tal-Grupp ta' Ħidma Internazzjonali (IWG - International Working Group) għal limfoma mhux ta' Hodgkin (NHL - non-Hodgkin's lymphoma).
English: Juvenile toxicity studies have not been conducted.
Maltese: Ma sarux studji ta' tossiċità fiż-żgħażagħ.
English: The corresponding increase in unbound ibrutinib exposure (AUCunbound, last) is estimated to be 4.1-, 9.8-, and 13-fold in subjects with mild, moderate, and severe hepatic impairment, respectively (see section 4.2).
Maltese: Iż-żieda korrispondenti fl-esponiment għal ibrutinib mhux marbut (AUC mhux marbut, l-aħħar) hija stmata li tkun 4.1, 9.8, u 13-il darba aktar f'individwi b'indeboliment tal-fwied ħafif, moderat u qawwi, rispettivament (ara sezzjoni 4.2).
English: IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib.
Maltese: Kull pillola fiha 280 mg ta' ibrutinib.
English: Patients (n=150) were randomized 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with rituximab until disease progression or unacceptable toxicity.
Maltese: Il-pazjenti (n=150) intagħżlu b'mod arbitrarju 1:1 biex jew jirċievu IMBRUVICA 420 mg kuljum jew plaċebo flimkien ma' rituximab sakemm ikun hemm progressjoni tal-marda jew tossiċità mhux aċċettabbli.
English: Analysis of OS demonstrated a 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA arm. Efficacy results for Study PCYC-1112-CA are shown in Table 7.
Maltese: Analiżi ta' OS uriet tnaqqis sinifikanti b'mod statistiku ta' 57% fir-riskju ta' mewt għal pazjenti fil-fergħa ta' IMBRUVICA.
English: The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Maltese: Id-doża ta' ibrutinib għandha titnaqqas għal 280 mg darba kuljum (żewġ kapsuli) meta jintuża flimkien ma' impedituri moderati ta' CYP3A4.
English: The median time since diagnosis was 43 months, and median number of prior treatments was 2 (range: 1 to 9 treatments), including 51% with prior high-dose chemotherapy, 18% with prior bortezomib, 5% with prior lenalidomide, and 24% with prior stem cell transplant.
Maltese: Il-medjan taż-żmien mid-dijanjosi kien ta' 43 xahar, u n-numru medjan ta' trattamenti preċedenti kien ta' 2 (firxa: minn trattament 1 sa 9 trattamenti), inkluż 51% li qabel kienu ħadu kimoterapija b'doża qawwija, 18% li qabel kienu ħadu bortezomib, 5% li qabel kienu ħadu lenalidomide, u 24% li qabel sarilhom trapjant taċ-ċelluli stem.
English: Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA arm.
Maltese: IRC skont ilkriterji IWCLL kienet tindika tnaqqis sinifikanti b'mod statistiku ta' 78% fir-riskju ta' mewt jew progressjoni għal pazjenti fil-fergħa ta' IMBRUVICA.
English: Each carton contains one bottle of either 90 or 120 hard capsules.
Maltese: Kull kartuna fiha flixkun wieħed ta' 90 jew ta' 120 kapsula iebsa.
English: Co-administration of strong or moderate CYP3A4 inhibitors with IMBRUVICA may lead to increased ibrutinib exposure and consequently a higher risk for toxicity.
Maltese: L-għoti ta' impedituri qawwija jew moderati ta' CYP3A4 flimkien ma' IMBRUVICA jista' jwassal għal żieda fl-esponiment għal ibrutinib u konsegwenza ta' dan riskju akbar ta' tossiċità.
English: Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate.
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita ta' 420 mg fiha 84 mg ta' lactose monohydrate.
English: Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
Maltese: Il-kurva Kaplan-Meier ta' PFS (Popolazzjoni ITT) fl-Istudju PCYC-1112- CA
English: Based on in vitro data, ibrutinib is a weak reversible inhibitor towards CYP3A4 at the intestinal level and may therefore increase the exposure to CYP3A4 substrates sensitive to gut CYP3A metabolism.
Maltese: Abbażi ta' data in vitro, ibrutinib huwa inibitur riversibbli dgħajjef ta' CYP3A4 fil-livell tal-musrana u għalhekk jista' jżid l-esponiment għal sustrati ta' CYP3A4 sensittivi għall-metaboliżmu ta' CYP3A fl-istonku u l-imsaren.
English: The median duration of treatment for MCL was 11 months (range, 0 to 87 months) with 31% and 17% of patients receiving treatment for more than 2 years and 4 years, respectively.
Maltese: Il-medjan tat-tul ta' żmien ta' trattament għal MCL kien 11-il xahar (firxa, 0 sa 87 xahar) b'31% u 17% tal-pazjenti li rċivew trattament għal aktar minn sentejn u 4 snin, rispettivament.
English: • mouth sores
Maltese: • uġigħ ta' ras
English: No effects on fertility or reproductive capacities were observed in male or female rats up to the maximum dose tested, 100 mg/kg/day (HED 16 mg/kg/day).
Maltese: Ma kienu osservati l-ebda effetti fuq il-fertilità jew il-kapaċitajiet riproduttivi f'firien irġiel jew nisa sal-ogħla doża ttestjata, 100 mg/kg/jum (HED16 mg/kg/jum).
English: Cases of cerebrovascular accident, transient ischaemic attack and ischaemic stroke including fatalities have been reported with the use of ibrutinib, with and without concomitant atrial fibrillation and/or hypertension.
Maltese: Ġew irrappurtati każijiet ta' aċċident ċerebrovaskulari, attakk iskemiku temporanju u puplesija iskemika inkluż fatalitajiet bl-użu ta' ibrutinib, ma' jew mingħajr fibrillazzjoni atrijali konkomitanti u/jew ipertensjoni.
English: The investigator-assessed ORR in the IMBRUVICA arm was 87.7% versus 22.4% in the ofatumumab arm. At the time of final analysis, 133 (67.9%) of the 196 subjects originally randomized to the ofatumumab treatment arm had crossed over to ibrutinib treatment.
Maltese: L-ORR stmat mill-investigatur fil-grupp ta' IMBRUVICA kien 87.7% versus 22.4% fil-fergħa ta' ofatumumab.
English: EU/1/14/945/010 (30 tablets)
Maltese: EU/1/14/945/010 - 30 pillola (3 pakketti portafolli ta' 10)
English: IMBRUVICA 280 mg film-coated tablets
Maltese: IMBRUVICA 280 mg pilloli miksija b'rita
English: The primary endpoint in this study was ORR per investigator assessment.
Maltese: Id-data ta' effikaċja ġiet valutata aktar minn Kumitat ta' Reviżjoni
English: Figure 2: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1115-CA
Maltese: Kaplan-Meier għal PFS (Popolazzjoni ITT) fl-Istudju PCYC-1115-CA
English: What IMBRUVICA is
Maltese: X'fih IMBRUVICA
English: Ibrutinib was found to induce gastrointestinal effects (soft faeces/diarrhoea and/or inflammation) and lymphoid depletion in rats and dogs with a No Observed Adverse Effect Level (NOAEL) of 30 mg/kg/day in both species.
Maltese: Ibrutinib instab li jinduċi effetti gastrointestinali (ippurgar artab/dijarea/u/jew infjammazzjoni) u tnaqqis fillimfojd fil-firien u l-klieb b'Livell ta' L-Ebda Effett Avvers
English: IMBRUVICA must not be taken with grapefruit juice or Seville oranges (see section 4.5).
Maltese: Pressjoni għolja seħħet f'pazjenti ttrattati b'IMBRUVICA (ara sezzjoni 4.8).
English: This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.
Maltese: Din il-limfoċitosi osservata hija effett farmakodinamku u m'għandhiex tiġi meqjusa bħala mard progressiv fin-nuqqas ta' sejbiet kliniċi oħra.