FrancophonIA/ELRC3.0 huggingface dataset:
English: • carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain pain conditions
Maltese: • carbamazepine: mediċina għall-kura tal-epilessija, episodji ewforiċi/dipressivi u ċertu kundizzjonijiet ta' uġigħ
English: See also the beginning of section 4.
Maltese: Ara wkoll il-bidu ta' sezzjoni 4.
English: Tablet coating Talc
Maltese: Kisja tal-pillola Talc
English: In urine and faeces combined, 48%, 27%, and 9.1% of the radioactive dose was excreted as unchanged brigatinib, N-desmethyl brigatinib (AP26123), and brigatinib cysteine conjugate, respectively.
Maltese: Fl-awrina u fl-ippurgar flimkien, 48%, 27% u 9.1% tad-doża radjuattiva tneħħew bħala brigatinib mhux mibdul, Ndesmethyl brigatinib (AP26123), u bħala brigatinib ikkonjugat biċ-ċisteina, rispettivament.
English: Alunbrig 30 mg film-coated tablets EU/1/18/1264/001 60 tablets in bottle EU/1/18/1264/002 120 tablets in bottle EU/1/18/1264/011 28 tablets in carton EU/1/18/1264/003 56 tablets in carton EU/1/18/1264/004 112 tablets in carton Alunbrig 90 mg film-coated tablets EU/1/18/1264/005 7 tablets in bottle EU/1/18/1264/006 30 tablets in bottle EU/1/18/1264/007 7 tablets in carton EU/1/18/1264/008 28 tablets in carton Alunbrig 180 mg film-coated tablets EU/1/18/1264/009 30 tablets in bottle EU/1/18/1264/010 28 tablets in carton Alunbrig treatment initiation pack EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tablets in carton
Maltese: EU/1/18/1264/005 7 pilloli fi flixkun EU/1/18/1264/006 30 pillola fi flixkun EU/1/18/1264/007 7 pillola f'kartuna EU/1/18/1264/008 28 pillola f'kartuna Alunbrig 180 mg pilloli miksija b'rita EU/1/18/1264/009 30 pillola fi flixkun EU/1/18/1264/010 28 pillola f'kartuna Alunbrig pakkett tal-bidu tal-kura
English: Grade 3 elevation of lipase or amylase (> 2.0 × ULN)
Maltese: Elevazzjoni ta' grad 3 ta' lipażi jew amilażi (> 2.0 × ULN)
English: Age, body weight, and albumin concentrations
Maltese: Età, piż tal-ġisem, u konċentrazzjonijiet tal-albumina
English: Nausea Dyspepsia Pancreatitis
Maltese: Dardir Dispepsija Pankreatite
English: For elevations to Grade 3 and 4, the incidences for amylase and lipase were 8.2% and 10%, respectively.
Maltese: Għall-elevazzjonijiet għal Grad 3 u 4, linċidenzi għall-amilażi u l-lipażi kienu ta' 8.2% u 10%, rispettivament.
English: The incidence of Grade 3-4 elevations of CPK was 13.6%.
Maltese: L-inċidenza ta' elevazzjonijiet ta' Grad 3-4 ta' CPK kienu 13.6%.
English: 7 tablets of Alunbrig 90 mg
Maltese: 7 pilloli ta' Alunbrig 90 mg
English: Adverse reaction Severity*
Maltese: Severità*
English: In a pharmacokinetic study, unbound AUC0-INF was 94% higher in patients with severe renal impairment (eGFR < 30 mL/min, N = 6) as compared to patients with normal renal function (eGFR ≥ 90 mL/min, N = 8) (see section 4.2).
Maltese: Fi studju farmakokinetiku, AUC0-INF mhux marbuta kienet 94% ogħla f'pazjenti b'indeboliment renali sever (eGFR < 30 mL/min, N = 6) meta mqabbla ma' pazjenti b'funzjoni renali normali (eGFR ≥ 90 mL/min, N=8) (ara sezzjoni 4.2).
English: In vitro studies demonstrated that brigatinib is a substrate of CYP2C8.
Maltese: Studji in vitro wrew li brigatinib hu substrat ta' CYP2C8.
English: Of these, three Grade 3 adverse reactions (2.7%) including macular oedema and cataract were reported.
Maltese: Minn dawn, tliet reazzjonijiet avversi ta' Grad 3 (2.7%) inkluż edeme makulari u katarretti kienu rrappurtati.
English: Each film-coated tablet contains 168 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 168 mg ta' lactose monohydrate.
English: Each film-coated tablet contains 336 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 336 mg ta' lactose monohydrate.
English: Other possible side effects are:
Maltese: Effetti sekondarji oħra possibbli:
English: • Alunbrig should be withheld until hypertension has recovered to Grade ≤ 1 (SBP < 140 mmHg and DBP < 90 mmHg), then resumed at same dose.
Maltese: • Alunbrig għandu jitwaqqaf sakemm il-pressjoni għolja tirkupra sa Grad ≤ 1 (SBP < 140 mmHg u DBP < 90 mmHg), imbagħad jitkompla fl-istess doża.
English: In in vitro kinase and cellular assays, the metabolite, AP26123, inhibited ALK with approximately 3-fold lower potency than brigatinib.
Maltese: Fl-assaġġi tal-kinase u ċellulari in vitro, il-metabolit AP26123, inibixxa ALK b'saħħa madwar 3 darbiet anqas minn brigatinib.
English: Each film-coated tablet contains 56 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 56 mg ta' lactose monohydrate.
English: In vitro studies demonstrated that brigatinib is a substrate of CYP3A4/5.
Maltese: Studji in vitro wrew li brigatinib hu substrat ta' CYP3A4/5.
English: Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
Maltese: +32 2 464 06 11 takeda-belgium@takeda.com
English: Rashm
Maltese: Raxxm
English: Elevations of hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) and bilirubin have occurred in patients treated with Alunbrig (see section 4.8).
Maltese: Elevazzjonijiet ta' enzimi tal-fwied (aspartataminotransferażi, alanina aminotransferażi) u bilirubina seħħew f'pazjenti ttrattati b'Alunbrig (ara sezzjoni 4.8).
English: In vitro studies demonstrated that brigatinib is primarily metabolised by CYP2C8 and CYP3A4, and to a much lesser extent by CYP3A5.
Maltese: Studji in vitro wrew li brigatinib huwa metabolizzat primarjament minn CYP2C8 u CYP3A4, u fi grad anqas minn CYP3A5.
English: Early pulmonary adverse reactions also occurred in a dose escalation study in patients (N = 137) (Study 101) including three fatal cases (hypoxia, acute respiratory distress syndrome and pneumonia).
Maltese: Reazzjonijiet avversi pulmonari bikrin seħħew ukoll fi studju dwar l-eskalazzjoni tad-doza fuq pazjenti (N = 137) (Studju 101) inkluż tliet każijiet fatali (ipossija, sindrome ta' problemi akuti respiratorji u pnewmonja).
English: The pharmacokinetics of brigatinib was similar between healthy subjects with normal hepatic function and patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
Maltese: Il-farmakokinetika ta' brigatinib kienet simili bejn individwi b'saħħithom b'funzjoni epatika normali u pazjent b'indeboliment epatiku ħafif (Child Pugh klassi A) jew moderat (Child Pugh klassi B).
English: In Study 101, the QT interval prolongation potential of Alunbrig was assessed in 123 patients with advanced malignancies following once daily brigatinib doses of 30 mg to 240 mg.
Maltese: Fi Studju 101, il-potenzjal għat-titwil fl-intervall tal-QT ta' Alunbrig kien evalwat f'123 pazjent b'tumuri malinni avvanzati wara dożi ta' 30 mg sa 240 mg ta' brigatinib darba kuljum.
English: In patients, at steady state, the plasma AUC of AP26123 was < 10% of brigatinib exposure.
Maltese: Fil-pazjenti, fi stat fiss, lAUC tal-plażma ta' AP26123 kienet < 10% tal-esponiment ta' brigatinib.
English: • quinidine: a medicine to treat irregular heart rhythm
Maltese: • quinidine: mediċina għall-kura ta' ritmu irregolari tal-qalb.
English: 21 tablets of Alunbrig 180 mg
Maltese: 21 pillola ta' Alunbrig 180 mg
English: Figure 1: Investigator-Assessed Systemic Progression-Free Survival: ITT Population by Treatment Arm (ALTA)
Maltese: Sistemika Mingħajr Progressjoni Evalwata mill-Investigatur: Popolazzjoni ITT skont il-Fergħa tat-Trattament (ALTA)
English: The concomitant use of strong CYP3A inducers with Alunbrig, including but not limited to rifampicin, carbamazepine, phenytoin, rifabutin, phenobarbital, and St. John's wort should be avoided.
Maltese: L-użu fl-istess ħin ta' indutturi qawwija ta' CYP3A ma' Alunbrig, inklużi iżda mhux limitati għal rifampicin, carbamazepine, phenytoin, rifabutin, phenobarbital, u St.
English: The pharmacokinetics of brigatinib is similar in patients with normal renal function and in patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min) based on the results of population pharmacokinetic analyses.
Maltese: Il-farmakokinetika ta' brigatinib hija simili f'pazjenti f'funzjoni renali normali u f'pazjenti b'indeboliment renali ħafif jew moderat (eGFR ≥ 30 mL/min) abbażi tar-riżultati minn analiżi farmakokinetiċi tal-popolazzjoni.
English: Unchanged brigatinib represented 41% and 86% of the total radioactivity in faeces and urine, respectively, the remainder being metabolites.
Maltese: Brigatinib mhux mibdul kien jirrappreżenta 41% u 86% tar-radjuattività totali fl-ippurgar u fl-awrina, rispettivament, bil-bqija jkunu metaboliti.
English: bpm = beats per minute; CPK = Creatine Phosphokinase; DBP = diastolic blood pressure; HR = heart rate; SBP = systolic blood pressure; ULN = upper limit of normal *Graded per National Cancer Institute Common Terminology Criteria for Adverse Events.
Maltese: HR = rata tat-taħbit tal-qalb; SBP = pressjoni sistolika tad-demm; ULN = il-limitu ta' fuq tannormal * Ikklassifikati skont il-Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kanċer.
English: Elevation of lipase or amylase
Maltese: Elevazzjoni ta' lipażi jew amilażi
English: P-gp and BCRP inhibitors
Maltese: Pgp u inibituri ta' BCRP
English: • modafinil: a medicine to treat narcolepsy
Maltese: • modafinil: mediċina għall-kura ta' narkolessija
English: • indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection
Maltese: • indinavir, nelfinavir, ritonavir, saquinavir: mediċini għall-kura ta' infezzjoni bl-HIV
English: • a slow heartbeat (bradycardia)
Maltese: • rata ta' taħbit tal-qalb bil-mod (bradikardija)
English: CPK levels should be monitored regularly during Alunbrig treatment.
Maltese: Il-livelli tas-CPK għandhom ikunu mmonitorjati regolarment waqt li jkun għaddej it-trattament b'Alunbrig.
English: Alunbrig contains the active substance brigatinib, a type of cancer medicine called a kinase inhibitor.
Maltese: Alunbrig fih is-sustanza attiva brigatinib, tip ta' mediċina kontra l-kanċer li tissejjaħ inibitur talkinase.
English: Heart rates of less than 50 beats per minute (bpm) were reported in 8.2% of patients at the 180 mg regimen.
Maltese: Rati tat-taħbit tal-qalb ta' inqas minn 50 taħbita kull minuta (bpm, beats per minute) kienu rrappurtati fi 8.2% tal-pazjenti fuq il-kors ta' 180 mg.
English: The major outcome measure was confirmed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) as evaluated by investigator.
Maltese: Il-kejl maġġuri tar-riżultati kien rispons tar-rata oġġettiv ikkonfermat (ORR, objective response rate) skont il-Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST, Response Evaluation Criteria in Solid Tumours v1.1) kif evalwat mill-investigatur.
English: Tηλ: +30 210 6387800 gr.info@takeda.com
Maltese: TAKEDA ΕΛΛΑΣ Α.Ε Tηλ: +30 210 6387800 gr.info@takeda.com
English: • Alunbrig 30 mg: 28, 56 or 112 film-coated tablets
Maltese: • Alunbrig 30 mg: 28, 56 jew 112 pillola miksija b'rita
English: Weight decreased a Includes atypical pneumonia, pneumonia, pneumonia aspiration, pneumonia pseudomonal, lower respiratory tract infection, lower respiratory tract infection viral, lung infection b Grade not applicable c Includes headache, sinus headache, head discomfort, migraine, tension headache d Includes paraesthesia, peripheral sensory neuropathy, dysaesthesia, hyperaesthesia, hypoaesthesia, neuralgia, neuropathy peripheral, neurotoxicity, peripheral motor neuropathy, polyneuropathy e Includes altered visual depth perception, asthenopia, cataract, colour blindness acquired, diplopia, glaucoma, intraocular pressure increased, macular oedema, photophobia, photopsia, retinal oedema, vision blurred, visual acuity reduced, visual field defect, visual impairment, vitreous detachment, vitreous floaters, amaurosis fugax f Includes sinus tachycardia, tachycardia g Includes bradycardia, sinus bradycardia h Includes dyspnoea, dyspnoea exertional i Includes interstitial lung disease, pneumonitis j Includes diarrhoea, diarrhoea infectious k Includes abdominal discomfort, abdominal distension, abdominal pain, abdominal pain lower, abdominal pain upper, epigastric discomfort l Includes aphthous stomatitis, stomatitis, aphthous ulcer, mouth ulceration, oral mucosal blistering m Includes dermatitis acneiform, erythema, exfoliative rash, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, dermatitis, dermatitis allergic, generalised erythema, rash follicular, urticaria n Includes musculoskeletal pain, myalgia, muscle spasms, muscle tightness, muscle twitching, musculoskeletal discomfort o Includes asthenia, fatigue p Includes eyelid oedema, face oedema, localised oedema, oedema peripheral, periorbital oedema, swelling face, generalised oedema, peripheral swelling † The frequencies for ADR terms associated with chemistry and haematology laboratory changes were determined based on the frequency of abnormal laboratory shifts from baseline.
Maltese: L-aktar reazzjonijiet avversi komuni (≥ 25%) irrappurtati f'pazjenti ttrattati b'Alunbrig fil-kors ta' dożaġġ rakkomandat kienu żieda fl-AST, ipergliċemija, livelli għoljin ta' insulina fid-demm, anemija, żieda fis-CPK, dardir, żieda fil-livell tal-lipażi, nuqqas fl-għadd ta' limfoċiti, żieda fl-ALT, dijarea, żieda fil-livell tal-amilażi, għeja, sogħla, uġigħ ta' ras, żieda fil-fosfatażi alkalina, ipofosfatimija, żieda fl-APTT, raxx, rimettar, dispnea, pressjoni għolja, nuqqas fl-għadd ta' ċelluli tad-demm bojod, mijalġija, u newropatija periferali,
English: Table 2: Recommended Alunbrig dose modifications for adverse reactions Adverse reaction Severity*
Maltese: Tabella 2: Modifiki fid-doża ta' Alunbrig rakkomandati għal reazzjonijiet avversi Reazzjoni avversa
English: Adverse reactions seen in animals at exposure levels similar to clinical exposure levels with possible relevance to clinical use were as follows: gastrointestinal system, bone marrow, eyes, testes, liver, kidney, bone, and heart.
Maltese: Reazzjonijiet avversi li dehru f'annimali f' livelli ta' esponiment simili għal-livelli ta' esponiment kliniċi u li jista' jkollhom rilevanza għall-użu kliniku, kienu kif spjegat: sistema gastrointestinali, mudullun, għajnejn, testikoli, fwied, kliewi, għadam u qalb.
English: Other medicines and Alunbrig
Maltese: Mediċini oħra u Alunbrig
English: Adverse reactions† all grades
Maltese: Reazzjonijiet avversi† il-gradi kollha
English: After a single dose and at steady state, systemic exposure was dose proportional over the dose range of 60-240 mg once daily.
Maltese: Wara doża waħda u fi stat fiss, l-esponiment sistemiku kien proporzjonali għad-doża fuq il-medda tad-doża ta' 60-240 mg darba kuljum.
English: • efavirenz, etravirine: medicines to treat HIV infection
Maltese: • efavirenz, etravirine: mediċini għall-kura ta' infezzjoni bl-HIV
English: Brigatinib may impair male fertility.
Maltese: Brigatinib jista' jaffettwa ħażin il-fertilità fl-irġiel.
English: Safety pharmacology studies with brigatinib identified potential for pulmonary effects (altered respiration rate; 1-2 times the human Cmax), cardiovascular effects (altered heart rate and blood pressure; at 0.5 times the human Cmax), and renal effects (reduced renal function; at 1-2.5 times the human Cmax), but did not indicate any potential for QT prolongation or neurofunctional effects.
Maltese: Studji dwar sigurtà farmakoloġika bi brigatinib identifikaw potenzjal għal effetti pulmonari (rata respiratorja mibdula; 1-2-il darba aktar is-Cmax tal-bniedem), effetti kardjovaskulari (rata tat-taħbit talqalb u pressjoni tad-demm mibdula; 0.5 darbiet aktar is-Cmax tal-bniedem), u effetti fuq il-kliewi (funzjoni renali mnaqqsa; 1-2.5 drabi aktar is-Cmax tal-bniedem), iżda ma ndikaw ebda potenzjal għattitwil tal-QT jew effetti newrofunzjonali.
English: Grade 3 or 4
Maltese: Grad 3-4
English: Alunbrig is available in plastic foil strips (blisters) packed in a carton with:
Maltese: Alunbrig huwa disponibbli fi strixxi ta' fojl tal-plastik (folji) ippakkjati f'kartuna bi:
English: The blood-to-plasma concentration ratio is 0.69.
Maltese: Il-proporzjon tal-konċentrazzjoni tad-demm għall-plażma hija 0.69.
English: Additional outcome measures included confirmed ORR as evaluated by an Independent Review Committee (IRC); time to response; progression free survival (PFS); duration of response (DOR); overall survival; and intracranial ORR and intracranial DOR as evaluated by an IRC.
Maltese: Il-kejl tar-riżultat addizzjonali kien jinkludi ORR ikkonfermat kif evalwat minn Kumitat ta' Reviżjoni Indipendenti (IRC, Independent Review Committee); ħin għar-rispons; sopravivenza bla progressjoni (PFS, progression free survival), tul tarrispons (DOR, duration of response), sopravivenza globali; u ORR intrakranjali u DOR intrakranjali kif evalwat minn IRC.
English: The KM median PFS was 16.3 months (95% CI: 9.2, NE) and the 12-month probability of overall survival was 84.0% (95% CI: 62.8, 93.7).
Maltese: 0% (95% CI: 62.8, 93.7).
English: • sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation
Maltese: • sulfasalazine: mediċina għall-kura ta' infjammazzjoni severa tal-musrana jew fil-ġogi rewmatiċi
English: The median time to onset for amylase elevations and lipase elevations was 17 days and 29 days, respectively.
Maltese: Iż-żmien medjan għall-bidu ta' elevazzjonijiet fil-livelli ta' amilażi u lipażi kien ta' 17-il jum u 29 jum, rispettivament.
English: Clinical drug-drug interaction studies with CYP3A sensitive substrates have not been conducted.
Maltese: Studji kliniċi dwar interazzjoni bejn il-mediċini b'substrati sensittivi għal CYP3A ma ġewx imwettqa.
English: • Each 30 mg tablet contains 30 mg brigatinib.
Maltese: • Kull pillola ta' 30 mg fiha 30 mg brigatinib.
English: Alunbrig film-coated tablets are white to off-white, oval (90 mg and 180 mg) or round (30 mg).
Maltese: Alunbrig pilloli miksija b'rita huma bojod għal kważi bojod, ovali (90 mg u 180 mg) jew tondi (30 mg).
English: In patients given brigatinib 180 mg once daily, the geometric mean apparent volume of distribution (Vz/F) of brigatinib at steady state was 153 L, indicating moderate distribution into tissues.
Maltese: F'pazjenti li jingħataw brigatinib f'doża ta' 180 mg darba kuljum, il-medja ġeometrika tal-volum apparenti tad-distribuzzjoni (Vz/F) ta' brigatinib fi stat fiss kienet ta' 153 L, li tindika distribuzzjoni moderata fis-tessuti.
English: *90 mg once daily regimen †180 mg once daily with 7-day lead-in at 90 mg once daily
Maltese: *kors ta' 90 mg darba kuljum †180 mg darba kuljum b'7 ijiem jieħdu 90 mg darba kuljum
English: Abdominal paink Dry mouth
Maltese: Ħalq xott Stomatitel
English: Brigatinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) or the mammalian cell chromosomal aberration assays, but slightly increased the number of micronuclei in a rat bone marrow micronucleus test.
Maltese: Brigatinib ma kienx mutaġeniku in vitro fil-mutazzjoni invertita batterjali (Ames) jew fl-assaġġi ta' aberazzjonijiet kromosomali f'sistemi ta' ċelluli mammiferi, iżda kemmxejn żied in-numru ta' mikronuklei f'test tal-mikronukleu fuq il-mudullun tal-far.
English: Brigatinib inhibited the in vitro proliferation of cell lines expressing EML4-ALK and NPM-ALK fusion proteins and demonstrated dose-dependent inhibition of EML4-ALK-positive NSCLC xenograft growth in mice.
Maltese: Brigatinib inibixxa l-proliferazzjoni in vitro tal-linji ta' ċelloli li jesprimu l-proteini tal-fużjoni EML4ALK u NPM-ALK, u wera inibizzjoni dipendenti fuq id-doża ta' tkabbir xenograft ta' NSCLC pożittiv għal EML4-ALK fil-ġrieden.
English: • Alunbrig 90 mg film-coated tablets 1 clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing 7 film-coated tablets.
Maltese: • Alunbrig 90 mg pilloli miksija b'rita 1 folja ċara tat-thermoform polychlorotrifluoroethylene (PCTFE) b'kisja bil-fojl li tissiġġilha ruħha bis-sħana laminata bil-karta f'kartuna, li fiha 7 pillola miksija b'rita.
English: Musculoskeletal chest pain
Maltese: Uġigħ muskolu-skeletrali fissider
English: Grade 3 hyperglycemia occurred in 7.3% of patients.
Maltese: Ipergliċemija Grad 3 seħħet f'7.3% tal-pazjenti.
English: In patients with any brain metastases at baseline, intracranial disease control rate was 77.8% (95% CI 67.2-86.3) in the 90 mg arm (N = 81) and 85.1% (95% CI 75-92.3) in the 180 mg arm (N=74).
Maltese: F'pazjenti bi kwalunkwe metastasi tal-moħħ fil-linja bażi, ir-rata ta' kontroll tal-mard intrakranjali kienet ta' 77.8% (95% CI 67.2-86.3) fil-fergħa ta' 90 mg (N = 81) u 85.
English: • Each 180 mg tablet contains 180 mg brigatinib.
Maltese: • Kull pillola ta' 180 mg fiha 180 mg brigatinib.
English: Dose reduction for CPK elevation occurred in 6.4% patients at the 180 mg regimen (see sections 4.2 and 4.4).
Maltese: It-tnaqqis tad-doża għall-elevazzjoni ta' CPK seħħ f'6.4% tal-pazjenti fuq il-kors ta' 180 mg (ara sezzjonijiet 4.2 u 4.4).
English: • Alunbrig 180 mg: 28 film-coated tablets
Maltese: • Alunbrig 180 mg: 28 pillola miksija b'rita
English: • If adequate hyperglycaemic control cannot be achieved with optimal medical management, Alunbrig should be withheld until adequate hyperglycaemic control is achieved.
Maltese: • Jekk ma jistax jintlaħaq kontroll tal-ipergliċemija b'immaniġġjar mediku ottimali, Alunbrig għandu jitwaqqaf sakemm jintlaħaq kontroll talipergliċemija xieraq.
English: % CI = Confidence Interval; NE = Not Estimable *90 mg once daily regimen †180 mg once daily with 7-day lead-in at 90 mg once daily ‡Events include intracranial disease progression (new lesions, intracranial target lesion diameter growth ≥ 20% from nadir, or unequivocal progression of intracranial non-target lesions) or death.
Maltese: CI = intervall ta' kunfidenza; NE = mhux estimabbli *kors ta' 90 mg darba kuljum †180 mg darba kuljum b'7 ijiem jieħdu 90 mg darba kuljum ‡Avvenimenti jinkludu progressjoni ta' mard intrakranjali (leżjonijiet ġodda, tkabbir fid-dijametru talleżjoni intrakranjali fil-mira ta' ≥ 20% mil-livell minimu, jew progressjoni definittiva ta'leżjonijiet intrakranjali mhux fil-mira) jew mewt.
English: Unbound AUC0-INF was 37% higher in patients with severe hepatic impairment (Child-Pugh class C) as compared to healthy subjects with normal hepatic function (see section 4.2).
Maltese: AUC0-INF mhux marbuta kienet 37% ogħla f'pazjenti b'indeboliment epatiku sever (Child Pugh klassi Ċ) kif imqabbel ma' individwi b'saħħithom b'funzjoni epatika normali (ara sezzjoni 4.2).
English: The safety and efficacy of Alunbrig was evaluated in a randomised (1:1), open-label, multicenter trial (ALTA) in 222 adult patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib.
Maltese: Is-sigurtà u effikaċja kienu evalwati fi prova fejn il-pazjenti ntagħżlu b'mod każwali (1:1), openlabel, multiċentrika (ALTA) fuq 222 pazjent adult b'NSCLC lokalment avvanzat jew metastatiku pożittiv għal ALK li kienu għamlu progress bi crizotinib.
English: Additionally, 2.3% of patients in ALTA experienced pneumonitis later in treatment, with 2 patients having Grade 3 pneumonitis (see sections 4.2 and 4.4).
Maltese: Barra minn hekk, 2.3% tal-pazjenti fl-ALTA kellhom pulmonite aktar tard fit-trattament, b'żewġ pazjenti jkollhom pulmonite ta' Grad 3 (ara sezzjonijiet 4.2 u 4.4).
English: • Alunbrig 180 mg film-coated tablets 3 clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blisters with heat sealable paper-laminated foil lidding in a carton, containing 21 film-coated tablets.
Maltese: • Alunbrig 180 mg pilloli miksija b'rita 3 folja ċara tat-thermoform polychlorotrifluoroethylene (PCTFE) b'kisja bil-fojl li tissiġġilha ruħha bis-sħana laminata bil-karta f'kartuna, li fiha 21 pillola miksija b'rita.
English: 90 mg once daily (first 7 days)
Maltese: 90 mg darba kuljum (L-ewwel 7 ijiem)
English: • Each 90 mg tablet contains 90 mg brigatinib.
Maltese: • Kull pillola ta' 90 mg fiha 90 mg brigatinib.
English: In ALTA, 69% of patients experienced hyperglycaemia.
Maltese: Ipergliċemija Fl-ALTA, 69% tal-pazjenti kellhom ipergliċemija.