FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to launch of Alunbrig in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Alunbrig f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH, Marketing Authorisation Holder) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi media tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: No dose adjustment of Alunbrig is required for patients with mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥ 30 mL/min).
Maltese: Mhu meħtieġ l-ebda aġġustament fid-doża għal pazjenti b'indeboliment renali ħafif jew moderat (rata ta' filtrazzjoni glomerulari stmata (eGFR, estimated glomerular filtration rate) ≥ 30 mL/min).
English: Dose reduction for elevation of lipase and amylase occurred in 1.8% and 0.9% of patients, respectively at the 180 mg regimen (see sections 4.2 and 4.4).
Maltese: It-tnaqqis tad-doża għall-elevazzjoni fil-livelli ta' lipażi u amilażi seħħ f'1.8% u 0.9% tal-pazjenti, rispettivament fuq il-kors ta' 180 mg (ara sezzjonijiet 4.2 u 4.4).
English: • Alunbrig 180 mg: 30 film-coated tablets
Maltese: • Alunbrig 180 mg: 30 pillola miksija b'rita
English: Given that brigatinib exhibits high solubility and high permeability, inhibition of P-gp and BCRP is not expected to result in a clinically meaningful change in the systemic exposure of brigatinib.
Maltese: Peress li brigatinib juri solubbiltà għolja u permeabilità għolja, l-inibizzjoni ta' Pgp u BCRP mhux mistennija li tirriżulta f'bidla klinikament sinifikanti fl esponiment sistemiku ta' brigatinib.
English: • Alunbrig 30 mg: 60 or 120 film-coated tablets
Maltese: • Alunbrig 30 mg: 60 jew 120 pillola miksija b'rita
English: The median duration of peripheral neuropathy adverse reactions was 4.5 months, with a maximum duration of 28.7 months.
Maltese: It-tul medju tar-reazzjonijiet avversi tan-newropatija periferali kien ta' 4.5 xhur, b'tul massimu ta' 28.7 xhur.
English: • rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections
Maltese: • rifabutin, rifampicin: mediċini għall-kura tat-tuberkulożi jew ċerti infezzjonijiet oħra
English: Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Maltese: L-evalwazzjoni ta' NSCLC pożittiv għal ALK għandha titwettaq minn laboratorji li juru profiċjenza fit-teknoloġija speċifika li tiġi utilizzata.
English: In ALTA, peripheral neuropathy adverse reactions were reported in 27.3% of patients treated at the 180 mg regimen.
Maltese: F'ALTA, ir-reazzjonijiet avversi tan-newropatija periferali kienu rrappurtati fi 27.3% tal-pazjenti ttrattati fuq il-kors ta' 180 mg.
English: • digoxin: a medicine to treat heart problems
Maltese: • digoxin: mediċini għall-kura ta' problemi tal-qalb
English: In healthy subjects, coadministration of multiple 600 mg daily doses of rifampicin, a strong CYP3A inducer, with a single 180 mg brigatinib dose decreased brigatinib Cmax by 60%, AUC0-INF by 80% (5-fold), and AUC0-120 by 80% (5-fold), relative to a 180 mg brigatinib dose administered alone.
Maltese: F'individwi b'saħħithom, l-għoti flimkien ta' dożi multipli ta' 600 mg ta' rifampicinli jingħataw kuljum, induttur qawwi ta' CYP3A, b'doża waħda ta' 180 mg ta' brigatinib naqqas is-Cmax ta' brigatinib b'60%, AUC0INF b'80% (5 darbiet aktar), u AUC0-120 b'80% (5 darbiet aktar), b'mod relattiv għal doża ta' 180 mg ta' brigatinib li tingħata waħedha.
English: Bradycardia has occurred in patients treated with Alunbrig (see section 4.8).
Maltese: Il-bradikardija seħħet f'pazjenti ttrattati b'Alunbrig (ara sezzjoni 4.8).
English: Moderate CYP3A inhibitors (e.g., diltiazem and verapamil) may increase the AUC of brigatinib by approximately 40% based on simulations from a physiologically-based pharmacokinetic model.
Maltese: Inibituri moderati ta' CYP3A (eż., diltiazem u verapamil) jistgħu jżidu l-AUC ta' brigatinib b'madwar 40% abbażi ta' simulazzjonijiet minn mudell farmakokinetiku bbażat fiżjoloġikament.
English: 7 film-coated tablets of Alunbrig 90 mg 21 film-coated tablets of Alunbrig 180 mg
Maltese: 7 pilloli miksija b'rita ta' Alunbrig 90 mg 21 pilloli miksija b'rita ta' Alunbrig 180 mg
English: Symptoms may be similar to symptoms from lung cancer.
Maltese: Issintomi jistgħu jkunu simili għas-sintomi mill-kanċer tal-pulmun.
English: Dose reduction for visual disturbance occurred in two patients (1.8%) at the 180 mg regimen (see sections 4.2 and 4.4).
Maltese: It-tnaqqis tad-doża għal disturbi tal-vista seħħ f'żewġ pazjenti (1.8%) fuq il-kors ta' 180 mg (ara sezzjonijiet 4.2 u 4.4).
English: In healthy subjects, coadministration of multiple 200 mg twice daily doses of itraconazole, a strong CYP3A inhibitor, with a single 90 mg brigatinib dose increased brigatinib Cmax by 21%, AUC0-INF by 101% (2-fold), and AUC0-120 by 82% (< 2-fold), relative to a 90 mg brigatinib dose administered alone.
Maltese: F'individwi b'saħħithom, l-għoti flimkien ta' dożi multipli ta' 200 mg ta' itraconazole li jingħataw darbtejn kuljum, inibitur qawwi ta' CYP3A, b'doża waħda ta' 90 mg ta' brigatinib żied is-Cmax ta' brigatinib b'21%, AUC0INF b'101% (darbtejn aktar), u AUC0-120 b'82% (< darbtejn aktar), b'mod relattiv għal doża ta' 90 mg ta' brigatinib li tingħata waħedha.
English: Moderate CYP3A inducers may decrease the AUC of brigatinib by approximately 50% based on simulations from a physiologically-based pharmacokinetic model.
Maltese: Indutturi moderati ta' CYP3A jistgħu jnaqqsu l-AUC ta' brigatinib b'madwar 50% abbażi ta' simulazzjonijiet minn mudell farmakokinetiku bbażat fiżjoloġikament.
English: • colchicine: a medicine to treat gout attacks
Maltese: • colchicine: mediċina għall-kura ta' attakki tal-gotta
English: Tredegar
Maltese: Tqala
English: In healthy subjects, coadministration of multiple 600 mg twice daily doses of gemfibrozil, a strong CYP2C8 inhibitor, with a single 90 mg brigatinib dose reduced brigatinib Cmax by 41%, AUC0-INF by 12%, and AUC0-120 by 15%, relative to a 90 mg brigatinib dose administered alone.
Maltese: F'individwi b'saħħithom, l-għoti flimkien ta' dożi multipli ta' 600 mg ta' gemfibrozil li jingħataw darbtejn kuljum, inibitur qawwi ta' CYP2C8, b'doża waħda ta' 90 mg ta' brigatinib naqqas is-Cmax ta' brigatinib b'41%, AUC0INF bi 12%, u AUC0-120 bi 15%, b'mod relattiv għal doża ta' 90 mg ta' brigatinib li tingħata waħedha.
English: Peripheral neuropathyd Headachec
Maltese: Newropatija periferalid Uġigħ ta' rasc
English: Common Memory impairment Dysgeusia
Maltese: Indeboliment fil-memorja Disturbi fit-togħma
English: Post-authorisation efficacy study (PAES): In order to further characterise the efficacy and safety of brigatinib in the treatment of patients with ALK positive NSCLC, the MAH should submit the clinical study report of the phase III study AP26113-13-301 comparing brigatinib versus crizotinib in patients with advanced ALK+ NSCLC who have not previously received ALK-directed therapy.
Maltese: III AP26113-13-301 li jqabbel brigatinib kontra crizotinib f'pazjenti b'ALK+ NSCLC avvanzata li fil-passat ma rċivewx terapija diretta lejn ALK.
English: 180 mg regimen† (N = 18)
Maltese: kors ta' 180 mg† N = 18
English: • If ILD/pneumonitis recurs, Alunbrig should be permanently discontinued.
Maltese: • Jekk ILD/pulmonite terġa' titfaċċa, Alunbrig għandu jitwaqqaf għal dejjem.
English: EU/1/18/1264/009 30 tablets
Maltese: EU/1/18/1264/006 30 pillola
English: In ALTA, elevations of amylase and lipase were reported in 43% and 50% of patients treated with Alunbrig, respectively at the 180 mg regimen.
Maltese: F'ALTA, l-elevazzjonijiet fil-livelli ta' amilażi u lipażi kienu rrappurtati f'43% u 50% tal-pazjenti ttrattati b'Alunbrig, rispettivament fuq il-kors ta' 180 mg.
English: Film-coated tablets 28 film-coated tablets 56 film-coated tablets 112 film coated tablets
Maltese: Pilloli miksija b'rita 28 pilloli miksija b'rita 56 pilloli miksija b'rita 112 pilloli miksija b'rita
English: There are no available data on patients over 85 years of age.
Maltese: M'hemm ebda data disponibbli ghal pazjenti li għandhom aktar minn 85 sena.
English: Median (months) 95% CI
Maltese: Rata ta' Rispons Oġġettiv Intrakranjali 95% CI
English: • Alunbrig should be withheld until hypertension has recovered to Grade ≤ 1 (SBP < 140 mmHg and DBP < 90 mmHg), then resumed at the next lower dose level per Table 1 or permanently discontinued.
Maltese: • Alunbrig għandu jitwaqqaf sakemm il-pressjoni għolja tirkupra sa Grad ≤ 1 (SBP < 140 mmHg u DBP < 90 mmHg), imbagħad jitkompla fil-livell tad-doża aktar baxx li jmiss skont Tabella 1 jew jitwaqqaf għal dejjem.
English: Film-coated tablets
Maltese: Żieda fil-lipażi
English: Patients were randomised in a 1:1 ratio to receive Alunbrig either 90 mg once daily (90 mg regimen, N = 112) or 180 mg once daily with 7-day lead-in at 90 mg once daily (180 mg regimen, N = 110).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu Alunbrig f'doża ta' 90 mg darba kuljum t (kors ta' 90 mg, n=112)) jew ta' 180 mg darba kuljum b'7 ijiem jieħdu 90 mg darba kuljum (kors ta' 180 mg, n=110).
English: Dyspnoeah
Maltese: Pnewmonitei
English: The population pharmacokinetic analyses showed that body weight, age, and albumin concentration had no clinically relevant impact on the pharmacokinetics of brigatinib.
Maltese: L-analiżi farmakokinetiċi tal-popolazzjoni wrew li l-piż tal-ġisem, l-età u l-konċentrazzjoni talalbumina ma kellhom ebda impatt klinikament rilevanti fuq il-farmakokinetika ta' brigatinib.
English: Alkaline phosphatase increased Hyperbilirubinaemia
Maltese: Żieda fil-livell ta' fosfatażi alkalina
English: If concomitant use of strong CYP3A inhibitors cannot be avoided, the dose of Alunbrig should be reduced by approximately 50% (i.e. from 180 mg to 90 mg, or from 90 mg to 60 mg).
Maltese: Jekk l-użu fl-istess ħin ta' inibituri qawwija ta' CYP3A ma jistax jiġi evitat, id-doża ta' Alunbrig għandha titnaqqas b'madwar 50% (jiġifieri, minn 180 mg għal 90 mg, jew minn 90 mg għal 60 mg).
English: Other adverse reactions
Maltese: Reazzjonijiet avversi
English: In ALTA, elevations of ALT and AST were reported in 46% and 65% of patients treated with Alunbrig, respectively at the 180 mg regimen.
Maltese: F'ALTA, l-elevazzjonijiet fl-ALT u AST kienu rrappurtati f'46% u 65% tal-pazjenti ttrattati b'Alunbrig, rispettivament fuq il-kors ta' 180 mg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR TREATMENT INITIATION PACK - 21 TABLETS, 180 MG21 DAY TREATMENT (WITHOUT BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' ĠEWWA GĦAL PAKKETT TAL-BIDU TAL-KURA -21 PILLOLI, 180 MGKURA TA' 21 IJIEM (MINGĦAJR IL-KAXXA L-BLU)
English: Eye disorders Very common Visual disturbancee Common
Maltese: Komuni ħafna Disturbi tal-Vistae Komuni
English: Hyperglycaemia For Grade 3 (greater than 250 mg/dL or
Maltese: Għal Grad 3 (aktar minn 250 mg/dL jew 13.9 mmol/L) jew akbar
English: Bradycardia In ALTA, bradycardia was reported in 4.5% of patients treated with Alunbrig at the 180 mg regimen.
Maltese: F'ALTA, il-bradikardija kienet irrappurtata f'4.5% tal-pazjenti ttrattati b'Alunbrig fuq il-kors ta' 180 mg.
English: Pneumoniaa
Maltese: Anemija
English: Alunbrig 90 mg film-coated tablets Alunbrig 180 mg film-coated tablets brigatinib
Maltese: Alunbrig 90 mg pilloli miksija b'rita Alunbrig 180 mg pilloli miksija b'rita brigatinib
English: • Alunbrig 90 mg: 7 or 30 film-coated tablets
Maltese: • Alunbrig 90 mg: 7 jew 30 pillola miksija b'rita
English: Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing either 28, 56 or 112 film-coated tablets.
Maltese: Folja ċara tat-thermoform polychlorotrifluoroethylene (PCTFE) b'kisja bil-fojl li tissiġġilha ruħha bissħana laminata bil-karta f'kartuna, li fiha 28, 56 jew 112 pillola miksija b'rita.
English: Pneumonitisi Dyspnoeah
Maltese: Disturbi psikjatriċi
English: • abdominal (belly) pain
Maltese: • uġigħ addominali (uġigħ ta' żaqq)
English: • Alunbrig 90 mg: 7 or 28 film-coated tablets
Maltese: • Alunbrig 90 mg: 7 jew 28 pillola miksija b'rita
English: Brigatinib may reduce plasma levels of coadministered medicinal products that are predominantly metabolised by CYP3A.
Maltese: Brigatinib jista' jnaqqas illivelli fil-plażma ta' prodotti mediċinali li jingħataw flimkien u li jkunu fil-biċċa l-kbira tagħhom metabolizzati minn CYP3A.
English: EU/1/18/1264/010 28 tablets
Maltese: EU/1/18/1264/008 28 pillola
English: Alunbrig 90 mg once daily for the first 7 days, then Alunbrig 180 mg once daily.
Maltese: Alunbrig 90 mg darba kuljum għall-ewwel 7 ijiem, imbagħad 180 mg darba kuljum.
English: • bosentan: a medicine to treat pulmonary hypertension
Maltese: • bosentan: mediċina għall-kura ta' pressjoni għolja pulmonari
English: EU/1/18/1264/011 28 tablets EU/1/18/1264/003 56 tablets EU/1/18/1264/004 112 tablets
Maltese: EU/1/18/1264/001 60 pillola fi flixkun EU/1/18/1264/002 120 pillola fi flixkun EU/1/18/1264/011 28 pillola f'kartuna EU/1/18/1264/003 56 pillola f'kartuna EU/1/18/1264/004 112 pillola f'kartuna Alunbrig 90 mg pilloli miksija b'rita
English: 180 mg once daily reduce to 120 mg once daily reduce to 90 mg once daily reduce to 60 mg once daily
Maltese: 180 mg darba kuljum wieħed għandu jnaqqas għal 120 mg darba kuljum wieħed għandu jnaqqas għal 90 mg darba kuljum wieħed għandu jnaqqas għal 60 mg darba kuljum
English: Population pharmacokinetic analyses showed that race and gender had no impact on the pharmacokinetics of brigatinib.
Maltese: Analiżi farmakokinetiċi tal-popolazzjoni wrew li r-razza u s-sess tal-persuna ma kellhom ebda impatt fuq il-farmakokinetika ta' brigatinib.
English: • memory impairment
Maltese: • indeboliment fil-memorja
English: In vitro studies in hepatocytes have shown that brigatinib is an inducer of CYP3A4.
Maltese: Studji in vitro f'epatoċiti wrew li brigatinib hu induttur ta' CYP3A4.
English: Brigatinib was moderately bound (91%) to human plasma proteins and binding was not concentration-dependent.
Maltese: Brigatinib kien marbut b'mod moderat (91%) mal-proteini tal-plażma tal-bniedem u t-twaħħil ma kienx dipendenti fuq il-konċentrazzjoni.
English: Adverse reactions reported in ALTA and Study 101 at the recommended dosing regimen are presented in Table 3 and are listed by system organ class, preferred term and frequency.
Maltese: Ir-reazzjonijiet avversi rrappurtati f'ALTA u Stujdu 101 fil-kors tad-dożaġġ rakkomandat huma ppreżentati fit-Tabella 3 u huma elenkati skont is-sistema tal-klassifika tal-organi, terminu ppreferut u frekwenza.
English: Common Dyspepsia Flatulence
Maltese: Kategorija talfrekwenza
English: • pain
Maltese: • gass
English: Study 101: An open-label multicentre phase 1/2 dose escalation/expansion trial in patients with advanced malignancies.
Maltese: Prova ta' fażi 1/2 dwar eskalazzjoni/espansjoni tad-doża, openlabel u multiċentrika fuq pazjenti b'tumuri malinni avvanzati.
English: In six healthy male subjects given a single 180 mg oral dose of [14C]brigatinib, 65% of the administered dose was recovered in faeces and 25% of the administered dose was recovered in urine.
Maltese: F'sitt individwi rġiel b'saħħithom li ngħataw doża orali waħda ta' 180 mg ta' [14C]brigatinib, 65% tad-doża mgħotija kienet irkuprata fl ippurgar u 25% tad-doża mgħotija kienet irkuprata fl-awrina.
English: The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.
Maltese: L-użu fl-istess ħin ta' indutturi moderati ta' CYP3A ma' Alunbrig, inklużi iżda mhux limitati għal efavirenz, modafinil, bosentan, etravirine, u nafcillin għandu jkun evitat.
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Takeda Belgium Tel/Tél:
English: EU/1/18/1264/001 60 tablets EU/1/18/1264/002 120 tablets
Maltese: EU/1/18/1264/002 120 pillola
English: Neutrophil count decreased
Maltese: Disturbi filfwied u filmarrara
English: Overall, these effects on the male reproductive organs in rats and monkeys occurred at exposures ≥ 0.2-times the AUC observed in patients at the 180 mg once daily dose.
Maltese: B'mod globali, dawn l-effetti fuq l-organi riproduttivi tal-irġiel fil-firien u x-xadini seħħew f'esponimenti ≥ 0.2 darbiet aktar l-AUC osservata f'pazjenti bid-doża darba kuljum ta' 180 mg.
English: The concomitant use of Alunbrig with strong and moderate CYP3A inducers should be avoided (see section 4.5).
Maltese: L-użu fl-istess ħin ta' Alunbrig ma' indutturi qawwija u moderati ta CYP3A għandu jkun evitat (ara sezzjoni 4.5).
English: Myalgian
Maltese: Pożoloġija
English: Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing 28 film-coated tablets.
Maltese: Folja ċara tat-thermoform polychlorotrifluoroethylene (PCTFE) b'kisja bil-fojl li tissiġġilha ruħha bissħana laminata bil-karta f'kartuna, li fiha 28 pillola miksija b'rita.
English: Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Maltese: • Alunbrig huwa indikat bħala monoterapija għat-trattament ta' pazjenti adulti b'kanċer avvanzat tal-pulmun ta' ċelluli mhux żgħar (NSCLC, non-small cell lung cancer) pożittivi għal kinase limfoma anaplastika (ALK, anaplastic lymphoma kinase) li qabel ġew ittrattati bi crizotinib.
English: • chest pain and discomfort
Maltese: • uġigħ fis-sider u skonfort
English: Vascular disorders
Maltese: Dispepsija Gass
English: Alunbrig 30 mg film-coated tablets Alunbrig 90 mg film-coated tablets Alunbrig 180 mg film-coated tablets
Maltese: Alunbrig 30 mg pilloli miksija b'rita Alunbrig 90 mg pilloli miksija b'rita Alunbrig 180 mg pilloli miksija b'rita
English: • joint or muscle pain
Maltese: • uġigħ muskolu-skeletrali fis-sider
English: Outer Carton: Alunbrig 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Alunbrig 30 mg
English: Alunbrig is available as a treatment initiation pack.
Maltese: Alunbrig huwa disponibbli bħala pakkett tal-bidu tal-kura.
English: Stomatitisl
Maltese: Uġigħ
English: A reduced starting dose of 60 mg once daily for the first 7 days, then 90 mg once daily is recommended for patients with severe renal impairment (eGFR < 30 mL/min) (see section 5.2).
Maltese: Doża mnaqqsa tal-bidu ta' 60 mg darba kuljum għall-ewwel 7 ijiem, imbagħad 90 mg darba kuljum hija rakkommandata għal pazjenti b'indeboliment renali sever (eGFR < 30 mL/min) (ara sezzjoni 5.2).
English: • flatulence
Maltese: • sogħla
English: • mibefradil: a medicine to treat irregular heart rhythm and high blood pressure
Maltese: • mibefradil:: mediċina għall-kura ta' ritmu tat-taħbit tal-qalb irregolari u pressjoni tad-demm għolja
English: Common Pain in extremity Musculoskeletal stiffness
Maltese: Uġigħ fl-estremitajiet Ebusija muskolu-skeletrali
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR TREATMENT INITIATION PACK - 7 TABLETS, 90 MG - 7 DAY TREATMENT (WITHOUT BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' ĠEWWA GĦAL PAKKETT TAL-BIDU TAL-KURA -7 PILLOLI, 90 MGKURA TA' 7 IJIEM (MINGĦAJR IL-KAXXA L-BLU)
English: Intracranial disease control rate
Maltese: Rata ta' Kontroll tal-Mard Intrakranjali
English: Alunbrig contains lactose
Maltese: Kif jidher Alunbrig u l-kontenut tal-pakkett
English: Treatment initiation pack Alunbrig 90 mg and 180 mg film-coated tablets Each pack consists of an outer carton with two inner cartons containing:
Maltese: Pakkett tal-bidu tal-kura Alunbrig 90 mg u 180 mg pilloli miksija b'rita Kull pakkett jikkonsiti minn kartuna ta' barra b'żewġ kartuni ġewwa li fihom:
English: Alunbrig 30 mg film-coated tablets brigatinib
Maltese: Alunbrig 30 mg pilloli miksija b'rita brigatinib
English: In an embryo-foetal development study in which pregnant rats were administered daily doses of brigatinib during organogenesis; dose-related skeletal anomalies were observed at doses as low as approximately 0.7-times the human exposure by AUC at the 180 mg once daily dose.
Maltese: Fi studju dwar l-iżvilupp embrijufetali fejn il-firien tqal ingħataw dożi kuljum ta' brigatinib matul organoġenesi, anomaliji skeletriċi relatati mad-doża kienu osservati f'dożi baxxi sa madwar 0.7 dabiet aktar l-esponiment tal-bniedem bl-AUC bid-doża darba kuljum ta' 180 mg.
English: Each 30 mg film-coated tablet contains 30 mg brigatinib.
Maltese: Kull pillola miksija b'rita ta' 30 mg fiha 30 mg brigatinib.
English: Very common Headachec Peripheral neuropathyd Dizziness
Maltese: edema ġeneralizzata, nefħa periferali †
English: Patients were randomised in a 1:1 ratio to receive Alunbrig either 90 mg once daily continuously (90 mg regimen) or 180 mg once daily with 7-day lead-in at 90 mg once daily (180 mg regimen).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu Alunbrig f'doża ta' 90 mg darba kuljum kontinwament (kors ta' 90 mg) jew ta' 180 mg darba kuljum b'7 ijiem jieħdu 90 mg darba kuljum (kors ta' 180 mg).
English: Eligibility criteria permitted enrolment of patients with a documented ALK rearrangement based on a validated test, ECOG Performance Status of 0-2, and prior chemotherapy.
Maltese: Il-kriterji ta' eliġibbiltà kienu jippermettu rreġistrazzjoni ta' pazjenti b'arranġament mill-ġdid ta' ALK iddokumentat ibbażat fuq test ivverifikat, Stat tal-Prestazzjoni ECOG ta' 0-2, u kimoterapija minn qabel.
English: IRC assessment
Maltese: Evalwazzjoni tal-IRC
English: • reduced number of red blood cells (anaemia)
Maltese: • tnaqqis fin-numru ta' ċelluli tad-demm ħomor (anemija)
English: Elevations of amylase and lipase have occurred in patients treated with Alunbrig (see section 4.8).
Maltese: Elevazzjonijiet ta' amilażi u lipażi seħħew f'pazjenti ttrattati b'Alunbrig (ara sezzjoni 4.8).
English: Outer Carton: Alunbrig 90 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Alunbrig 90 mg
English: Grade 1-2 pulmonary adverse reactions resolved with interruption of treatment or dose modification.
Maltese: Ir-reazzjonijiet avversi pulmonari ta' Grad 1-2 kienu mfejqa bl-interruzzjoni tat-trattament jew modifikazzjoni fid-doża.
English: Following Grade 1-2 pulmonary adverse reactions, treatment with Alunbrig was either interrupted and then restarted or the dose was reduced.
Maltese: Wara r-reazzjonijiet avversi pulmonari ta' Grad 1-2, it-trattament b'Alunbrig kien jew interrott u reġa' beda jew id-doża ġiet imnaqqsa.
English: The adverse reactions described in this section were identified from two clinical trials: Study 201 (ALTA): A randomised, open-label, multicentre trial in patients treated with Alunbrig (N = 219) with ALK+ NSCLC who previously progressed on crizotinib.
Maltese: Prova fejn il-pazjenti ntagħżlu b'mod każwali, openlabel u multiċentrika fuq pazjenti ttrattati b'Alunbrig (N = 219) b'ALK+ NSCLC li qabel kienu għamlu progress bi crizotinib.
English: The most common serious adverse reactions (≥ 2%) reported in patients treated with Alunbrig at the recommended dosing regimen other than events related to neoplasm progression were pneumonitis, pneumonia, and dyspnoea.
Maltese: L-aktar reazzjonijiet avversi komuni u serji (≥ 2%) irrappurtati f'pazjenti ttrattati b'Alunbrig fil-kors tad-dożaġġ rakkomandat apparti avvenimenti marbuta mal-progressjoni tan-neoplażma kienu pulmonite, pnewmonja, u dispnea.
English: Each 180 mg film-coated tablet contains 180 mg brigatinib.
Maltese: Kull 180 mg pillola miksija b'rita fiha 180 mg brigatinib.
English: Do not pass it on to others.
Maltese: Komuni ħafna Nuqqas ta' rqad
English: • nafcillin: a medicine to treat bacterial infections
Maltese: • nafcillin: mediċina għall-kura ta' infezzjonijiet batterjali.
English: Lipase and amylase should be monitored regularly during treatment with Alunbrig.
Maltese: Il-pressjoni tad-demm għandha tkun immonitorjata regolarment matul it-trattament b'Alunbrig.