FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk management plan has been developed to ensure that Vantobra is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Vantobra jintuża bl-aktar mod sigur possibbli.
English: Side effects with Vantobra are not common.
Maltese: Effetti sekondarji b'Vantobra mhumiex komuni.
English: Vantobra is available as a nebuliser solution in single-dose containers called ‘ampoules'.
Maltese: Vantobra jiġi bħala soluzzjoni għan-nebulizzatur f'kontenituri b'doża waħda li jissejħu “ampulli”.
English: For the full list of all side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet, ara l-fuljett ta'
English: However, Vantobra differs from Tobi by having a higher concentration of the active substance and is inhaled using a different type of nebuliser.
Maltese: Madankollu, Ventobra huwa differenti minn Tobi peress li għandu konċentrazzjoni ogħla tas-sustanza attiva u jittieħed man-nifs permezz ta' tip differenti ta' nebulizzatur.
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily causing infections.
Maltese: Fibrożi ċistika hija marda li tintiret fejn ikun hemm akkumulazzjoni ta' mukus oħxon fil-pulmun li tippermetti lill-batterji jikbru aktar faċilment, u dan jikkawża infezzjonijiet.
English: Vantobra is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and older who have cystic fibrosis.
Maltese: Vantobra huwa antibjotiku użat għall-kura ta' infezzjoni tal-pulmun għal żmien twil ikkawżata millbatterja Pseudomonas aeruginosa f'pazjenti li għandhom sitt snin jew aktar u li għandhom fibrożi ċistika.
English: What measures are being taken to ensure the safe and effective use of Vantobra?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Vantobra?
English: It is not intended to provide practical advice on how to use Vantobra.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Vantobra.
English: The CHMP noted that inhaled tobramycin was the ‘gold standard' for treating P. aeruginosa infection in patients with cystic fibrosis and that some patients cannot use the dry powder form because they cannot tolerate it. For these patients Vantobra, which is inhaled as a solution from a nebuliser, would be a
Maltese: Is-CHMP innota li tobramycin li jittieħed man-nifs kien il-metodu li miegħu jridu jitqabblu l-oħrajn kollha għallkura tal-infezzjoniP. aeruginosa f'pazjenti b'fibrożi ċistika u li xi pazjenti ma jistgħux jużaw l-għamla fi trab xott peress li ma jistgħux jittollerawha.
English: P. aeruginosa is a frequent cause of infections in cystic fibrosis
Maltese: P. aeruginosa hija kawża frekwenti ta' infezzjonijiet f'pazjenti b'fibrożi ċistika.
English: Vantobra is inhaled using a device called Tolero nebuliser, which converts the solution in the ampoule into a fine mist.
Maltese: Vantobra jittieħed man-nifs permezz ta' apparat imsejjaħ nebulizzatur ta' Tolero, li jibdel is-soluzzjoni tal-ampulla f'raxx ħafif.
English: There were no unusual safety findings with Vantobra.
Maltese: Ma kien hemm ebda sejbiet mhux normali b'Vantobra.
English: After 28 days of treatment, the patient stops treatment for 28 days, before starting another 28-day treatment.
Maltese: Wara 28 jum ta' kura, il-pazjent iwaqqaf il-kura għal 28 jum, qabel jibda kura oħra ta' 28 jum.
English: SME definition
Maltese: Definizzjoni ta' SME
English: Regulatory assistance
Maltese: Assistenza regolatorja
English: Telephone +44 (0)20 3660 8787 Fax +44 (0)20 3660 5555
Maltese: 3660 8787 fax +44 (0)20
English: https://ec.europa.eu/programmes/horizon2020/
Maltese: Orizzont 2020 https://ec.europa.eu/programmes/horizon2020/
English: 6Excluding parallel distribution
Maltese: Minbarra distribuzzjoni parallella
English: • employ less than 250 employees and have an annual turnover of not more than €50 million or an annual balance-sheet total of not more than €43 million.
Maltese: • jimpjegaw inqas minn 250 impjegat, u jkollhom fatturat annwali ta' mhux aktar minn €50 miljun jew total annwali fuq il-karta tal-bilanċ ta' mhux aktar minn €43 miljun.
English: • fee incentives (see table)
Maltese: • inċentivi fuq tariffi (ara t-tabella)
English: 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2 ta' Marzu 2017
English: Commission Recommendation 2003/361/EC defines micro, small and medium-sized enterprises.
Maltese: Ir-Rakkomandazzjoni tal-Kummissjoni 2003/361/KE tiddefinixxi l-intrapriżi mikro, żgħar u ta' daqs medju.
English: Activity/application Fee incentives
Maltese: Attività/Applikazzjoni
English: 90% fee reduction and deferral 100% fee reduction for designated orphan products
Maltese: Tnaqqis fit-tariffi ta' 90 % u differiment Tnaqqis fit-tariffi ta' 100 % fuq prodotti kklassifikati bħala orfni
English: Administrative services6
Maltese: Servizzi amministrattivi
English: • inclusion in the public SME register
Maltese: • inklużjoni fir-reġistru pubbliku tal-SME
English: For information on EU funding: Cordis http://cordis.europa.eu/
Maltese: Għal informazzjoni dwar il-finanzjament mill-UE: Cordis http://cordis.europa.eu/
English: For information on administrative and procedural aspects of the pharmaceutical legislation
Maltese: Għal informazzjoni dwar aspetti amministrattivi u proċedurali tal-leġiżlazzjoni farmaċewtika.
English: 100% fee reduction for products granted eligibility to the Priority Medicines (PRIME) scheme
Maltese: Tnaqqis fit-tariffi ta' 100 % għall-prodotti li jingħataw eliġibbiltà għall-iskema Mediċini ta' Prijorità (PRIME, Priority Medicines)
English: • regulatory updates via SME Newsletters and mailings targeted to SMEs
Maltese: • aġġornamenti regolari permezz ta' Bullettini tal-SME u ittri mmirati għall-SMEs
English: Post-authorisation procedures, including pharmacovigilance activities
Maltese: Proċeduri ta' wara l-awtorizzazzjoni, inkluż attivitajiet ta' farmkoviġilanza
English: Further information on the definition of an SME is available in the ‘User guide to the SME definition'2.
Maltese: Aktar informazzjoni dwar id-definizzjoni ta' SME hija disponibbli fil-”Gwida għall-utent dwar iddefinizzjoni ta' SME'
English: 8See fees area at www.ema.europa.eu
Maltese: Indirizz elettroniku sme@ema.europa.eu Sit elettroniku www.ema.europa.eu
English: The applicant will receive an EMA-SME number once the SME status has been assigned.
Maltese: L-applikant se jirċievi numru EMA-SME ladarba l-istatus ta' SME jkun ġie assenjat.
English: For information on the whole spectrum of EU policies, legislation, programmes and initiatives relevant to Europe's SMEs:
Maltese: Għal informazzjoni dwar l-ispettru sħiħ ta' politiki, leġiżlazzjoni, programmi u inizjattivi tal-UE rilevanti għall-SMEs tal-Ewropa: http://ec.europa.eu/small-business/index_en.htm
English: SMEs can benefit from direct regulatory assistance including SME briefing meetings, which aim to facilitate the interaction with the Agency and provide guidance on the EU regulatory framework and the tools to support innovation.
Maltese: L-SMEs jistgħu jibbenefikaw minn assistenza regolatorja diretta inkluż laqgħat ta' tagħrif tal-SME, li għandhom l-għan li jiffaċilitaw l-interazzjoni mal-Aġenzija u jipprovdu gwida dwar il-qafas regolatorju tal-UE u l-għodod biex jappoġġjaw l-innovazzjoni.
English: MedDRA licence7
Maltese: Liċenzja MedDRA
English: • guidance on clinical data publication and provision of a free redaction tool license
Maltese: • gwida dwar pubblikazzjoni ta' data klinika u għoti ta' reviżjoni bla ħlas tal-liċenzja tal-għodda Inċentivi fuq tariffi
English: The form 'Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME)3', available from the Agency's website, should be completed and submitted to the SME Office, together with the most recent annual accounts, information on ownership, and proof of establishment in the EEA.
Maltese: 3, disponibbli mis-sit elettroniku tal-Aġenzija, għandha timtela u tiġi ppreżentata lill-Uffiċċju għall-SMEs, flimkien mal-kontijiet annwali l-aktar reċenti, l-informazzjoni dwar sjieda, u prova ta' stabbiliment fiż-ŻEE.
English: Establishment of MRLs5
Maltese: Appoġġ lill-SMEs
English: EMA user guide for SMEs3
Maltese: Reġistru pubbliku tal-SMEs
English: 1According to Commission Regulation (EC) No 2049/2005 2See European Commission/Growth/Publications 3See SME Office area at www.ema.europa.eu
Maltese: Skont ir-Regolament tal-Kummissjoni (KE) Nru 2049/2005 Ara Kummissjoni Ewropea/Tkabbir/Pubblikazzjonijiet
English: E-mail sme@ema.europa.eu
Maltese: Ara żona tal-Uffiċċju għall-SMEs fuq ema.europa.eu
English: Useful sources of information
Maltese: Aktar informazzjoni
English: A substantial fee reduction for scientific advice is available to SMEs (see table).
Maltese: Għal parir xjentifiku li jieħdu l-SMEs, hemm disponibbli tnaqqis sostanzjali fit-tariffa (ara t-tabella).
English: • organisation of info days and training sessions for SMEs
Maltese: • organizzazzjoni ta' jiem ta' informazzjoni u sessjonijiet ta' taħriġ għall-SMEs
English: Fee deferral Conditional fee exemption4
Maltese: L-Aġenzija Ewropea għall-Mediċini Uffiċċju għall-SMEs
English: SME support
Maltese: Appoġġ lil SME
English: SME Office
Maltese: Servizzi xjentifiċi
English: 4In the event of a negative outcome, where EMA scientific advice has been sought and followed 5Maximum Residue Limits
Maltese: F'każ ta' riżultat negattiv, fejn ikun tfittex u ġie segwit il-parir xjentifiku tal-EMA. Limiti Massimi ta' Residwi
English: Details on fees and fee reductions are available in the explanatory note on general fees payable to the European Medicines Agency8.
Maltese: Dettalji dwar it-tariffi u t-tnaqqis fit-tariffi huma disponibbli fin-nota ta' spjega dwar it-tariffi ġenerali li jridu jitħallsu lill-Aġenzija Ewropea għall-Mediċini
English: Further information
Maltese: Sorsi utli ta' informazzjoni
English: 31 Dec 2020
Maltese: 31 Diċ 2020
English: Version 4.0 (NCI CTCAE v4).
Maltese: Verżjoni 4.0 (NCI CTCAE v4).
English: Day 8 to Day 28
Maltese: Jum 8 sa Jum 28
English: Transporter substrates
Maltese: Substrati tat-trasportaturi
English: Bradycardia (HR less than 60 bpm)
Maltese: Bradikardija (HR anqas minn 60 bpm)
English: • The active substance is brigatinib.
Maltese: • Is-sustanza attiva hi brigatinib.
English: Alunbrig contains lactose monohydrate.
Maltese: Alunbrig fih lactose monohydrate.
English: Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-kategoriji tal-frekwenza huma komuni ħafna (≥ 1/10), komuni (≥ 1/100 to < 1/10) u mhux komuni (≥ 1/1,000 to < 1/100).
English: Date of first authorisation: 22 November 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 Novembru 2018
English: Tafarnaubach Industrial Estate Gwent
Maltese: Tafarnaubach Industrial Estate Tredegar
English: (see sections 4.2 and 4.4).
Maltese: (ara sezzjonijiet 4.2 u 4.4).
English: Elevations of pancreatic enzymes
Maltese: Elevazzjonijiet ta' enzimi pankreatiċi
English: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate (type A) Silica colloidal hydrophobic Magnesium stearate
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate (tip A) Silica colloidal hydrophobic Magnesium stearate
English: • ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections
Maltese: • ketoconazole, itraconazole, voriconazole: mediċini għall-kura ta' infezzjonijiet fungali
English: Creatine phosphokinase (CPK) elevation
Maltese: Elevazzjoni tal-fosfokinażi tal-kreatina (CPK, creatine phosphokinase)
English: Study 101
Maltese: Studju 101
English: • vision problems
Maltese: • problemi tal-vista
English: Brigatinib is a substrate of the transporter proteins P-gp and BCRP.
Maltese: Brigatinib huwa substrat talproteini trasportaturi Pgp u BCRP.
English: EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg tablets
Maltese: EU/1/18/1264/012 7 x 90 mg + 21 x 180 mg pillola f'kartuna
English: Day 1 to Day 7
Maltese: Jum 1 sa Jum 7
English: • The other excipients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), silica colloidal hydrophobic, magnesium stearate, talc, macrogol, polyvinyl alcohol, and titanium dioxide.
Maltese: • L-eċċipjenti l-oħra huma lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (tip A), silica colloidal hydrophobic, magnesium stearate, talc, macrogol, polyvinyl alcohol, u titanium dioxide.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitors, ATC code: L01XE43
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, inibituri ta' proteina kinase, Kodiċi ATC:
English: • abnormal electrical activity of the heart (prolonged electrocardiogram QT interval)
Maltese: • attività elettrika mhux normali tal-qalb (intervall tal-QT bl-elettrokardjogramma mtawwal)
English: Takeda Pharmaceuticals Czech Republic s.r.o.
Maltese: Česká republika Takeda Pharmaceuticals Czech Republic s.r.o.
English: Brigatinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in vitro.
Maltese: Brigatinib hu substrat ta' Pglycoprotein (Pgp) u proteina reżistenti għall-kanċer tas-sider (BCRPbreast cancer resistance protein) in vitro.
English: Symptomatic bradycardia
Maltese: Bradikardija sintomatika
English: Interstitial lung disease (ILD)/pneumonitis
Maltese: Mard interstizjali tal-pulmun (ILD, interstital lung disease)/pulmonite
English: Table 3: Adverse reactions reported in patients treated with Alunbrig in ALTA and Study 101 (per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0) System organ class
Maltese: Tabella 3: Reazzjonijiet avversi rrappurtati f'pazjenti ttrattati b'Alunbrig f'ALTA u Studju 101 (skont il-Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi (CTCAE, Common Terminology Criteria for Adverse Events), verżjpni 4.0) Sistema talklassifika talorgani
English: Takeda Pharma A/S.
Maltese: FIS-SUQ Takeda Pharma A/S.
English: Coadministration of brigatinib with substrates of P-gp, (e.g., digoxin, dabigatran, colchicine, pravastatin), BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine), organic cation transporter 1 (OCT1), multidrug and toxin extrusion protein 1 (MATE1), and 2K (MATE2K) may increase their plasma concentrations.
Maltese: L-għoti flimkien ta' brigatinib ma' substrati ta' Pgp (eż., digoxin, dabigatran, colchicine, pravastatin), BCRP (eż., methotrexate, rosuvastatin, sulfasalazine), trasportatur katjoniku organiku 1 (OCT1, organic cation transporter) proteina tal-multimediċina u estrużjoni ta' tossina 1 (MATE1, multidrug and toxin extrusion protein 1), u 2K (MATE2K) jista' jżid il-konċentrazzjonijiet fil-plażma tagħhom.
English: Baseline demographics and disease characteristics in ALTA were median age 54 years old (range 18 to 82; 23% 65 and over), 67% White and 31% Asian, 57% female, 36% ECOG PS 0 and 57% ECOG PS 1, 7% ECOG PS2, 60% never smoker, 35% former smoker, 5% current smoker, 98% Stage IV, 97% adenocarcinoma, and 74% prior chemotherapy.
Maltese: Id-demografija fil-linja bażi u l-karatteristiċi tal-mard f'ALTA kienu età medjana ta' 54 sena (firxa ta' 18 sa 82; 23% 65 u akbar), 67% Bojod u 31% Ażjatiċi, 57% nisa, 36% ECOG PS 0 u 57% ECOG PS 1, 7% ECOG PS2, 60% qatt ma kienu jpejpu, 35% kienu jpejpu qabel, 5% ipejpu bħalissa, 98% Stadju IV, 97% adenokarċinoma, u 74% kimoterapija minn qabel.
English: 90 mg regimen* N = 112
Maltese: kors ta' 90 mg* N = 112
English: • phenobarbital, phenytoin: medicines to treat epilepsy
Maltese: • phenobarbital, phenytoin: mediċini għall-kura tal-epilessija
English: Elevation of CPK Grade 3 elevation of CPK (> 5.0 × ULN)
Maltese: Elevazzjoni ta' grad 3 ta' CPK (> 5.0 × ULN)
English: Grade 4 elevation of CPK (> 10.0 × ULN)
Maltese: Elevazzjoni ta' grad 4 ta' CPK (> 10.0
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Takeda Belgium Tel/Tél:
English: See also section 2, “Warnings and precautions”.
Maltese: Ara s-sezzjoni 2, “Twissijiet u prekawzjonijiet”.
English: Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signalling protein STAT3 in in vitro and in vivo assays.
Maltese: Brigatinib inibixxa l-awtofosforilazzjoni ta' ALK u l-fosforilazzjoni medjata minn ALK tal-proteina downstream signalling STAT3 fl- analiżi in vitro u in vivo.
English: Takeda Austria GmbH St. Peter-Strasse 25 4020 Linz
Maltese: Peter-Strasse 25 4020
English: Brigatinib inhibited the in vitro and in vivo viability of cells expressing mutant forms of EML4-ALK associated with resistance to ALK inhibitors, including G1202R and L1196M.
Maltese: Brigatinib inibixxa l-vijabilità in vitro u in vivo ta' ċelloli li jesprimu forom mutanti ta' EML4-ALK assoċjati mar-reżistenza għal inibituri ta' ALK, inkluż G1202R u L1196M.
English: The median duration of follow-up was 22.9 months.
Maltese: It-tul medjan tal-follow-up kien ta' 22.9 xhur.
English: The geometric mean steady state Cmax of brigatinib at doses of 90 mg and 180 mg once daily was 552 and 1,452 ng/mL, respectively, and the corresponding AUC0-τ was 8,165 and 20,276 h∙ng/mL, respectively.
Maltese: Il-medja ġeometrika ta' Cmax fi stat fiss ta' brigatinib bid-dożi ta' 90 mg u 180 mg darba kuljum kienet ta' 552 u 1452 ng/mL, rispettivament, u lAUC0 korrispondenti kienet 8165 u 20276 h∙ng/mL, rispettivament.
English: In ALTA, 13.5% of patients ≥ 65 years of age experienced an early pulmonary adverse reaction compared with 4.2% of patients < 65 years of age.
Maltese: F'ALTA, 13.5% tal-pazjenti li kellhom ≥ 65 sena esperjenzaw reazzjoni avversa pulmonari bikrija meta mqabbla ma' 4.2% tal-pazjenti li kellhom < 65 sena.
English: • pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels
Maltese: • pravastatin, rosuvastatin: mediċini li jbaxxu livelli elevati tal-kolesterol
English: CI = Confidence Interval; NE = Not Estimable; NA = Not Applicable *90 mg once daily regimen †180 mg once daily with 7-day lead-in at 90 mg once daily ‡Confidence Interval for investigator assessed ORR is 97.5% and for IRC assessed ORR is 95%
Maltese: CI = Intervall ta' Kunfidenza; NE = Mhux Estimabbli; NA = Mhux Applikabbli *kors ta' 90 mg darba kuljum †180 mg darba kuljum b'7 ijiem jieħdu 90 mg darba kuljum ‡Intervall ta' Kunfidenza għal ORR evalwat mill-investigatur huwa 97.5% u għal ORR evalwat minn IRC huwa 95%.
English: Outer Carton: PC:
Maltese: Kartuna ta' Barra: PC:
English: • alfentanil, fentanyl: medicines to treat pain
Maltese: • alfentanil, fentanyl: mediċini għall-kura ta' uġigħ
English: Hepatotoxicity Grade ≥ 3 elevation (> 5.0 × ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) with bilirubin ≤ 2 × ULN
Maltese: Tossiċità tal-fwied Elevazzjoni ta' grad ≥ 3 (> 5.0 × ULN) ta' alanina aminotransferażi (ALT, alanine aminotransferase) jew aspartataminotransferażi
English: In ALTA, 6.4% of patients experienced pulmonary adverse reactions of any grade, including ILD/pneumonitis, pneumonia and dyspnoea, early in treatment (within 9 days, median onset: 2 days); 2.7% of patients had Grade 3-4 pulmonary adverse reactions and 1 patient (0.5%) had fatal pneumonia.
Maltese: F'ALTA, 6.4% tal-pazjenti esperjenzaw reazzjonijiet avversi pulmonari ta' kull grad, inkluż ILD/ pulmonite, pnewmonja, dispnea, aktar kmieni fit-trattament (fi żmien 9 ijiem, bidu medjan: jumejn); 2.7% tal-pazjenti kellhom reazzjonijiet avversi pulmonari ta' Grad 3-4 u pazjent wieħed kellu pnewmonja fatali (0.5%).
English: • clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections
Maltese: • clarithromycin, telithromycin, troleandomycin: mediċini għall-kura ta' infezzjonijiet batterjali
English: The pharmacokinetics of brigatinib was characterised in healthy subjects with normal hepatic function (N = 9), and patients with mild hepatic impairment (Child-Pugh class A, N = 6), moderate hepatic impairment (Child-Pugh class B, N = 6), or severe hepatic impairment (Child-Pugh class C, N = 6).
Maltese: Il-farmakokinetika ta' brigatinib kienet ikkaratterizzata f'individwi b'saħħithom b'funzjoni epatika normali (N=9), u f'pazjenti b'indeboliment epatiku ħafif (Child Pugh klassi A, N=6), indeboliment epatiku moderat (Child Pugh klassi B, N=6), jew indeboliment epatiku sever (Child Pugh klassi Ċ, N = 6).
English: Brigatinib is a tyrosine kinase inhibitor that targets ALK, c-ros oncogene 1 (ROS1), and insulin-like growth factor 1 receptor (IGF-1R).
Maltese: Brigatinib huwa inibitur ta' tyrosine kinase li jimmira ALK, cros oncogene 1 (ROS1), u r-riċettur talfattur tat-tkabbir 1 li jixbah lill-insulina (IGF1R, insulinlike growth factor 1 receptor).
English: 180 mg regimen† N = 110
Maltese: kors ta' 180 mg† N = 110
English: Investigator assessment
Maltese: Evalwazzjoni tal-investigatur)
English: Outer Carton PC:
Maltese: Kartuna ta' Barra PC:
English: Visual Disturbance Grade 2 or 3
Maltese: Disturbi tal-Vista Grad 2 jew 3
English: The concomitant use of strong CYP3A inhibitors with Alunbrig, including but not limited to certain antivirals (e.g., indinavir, nelfinavir, ritonavir, saquinavir), macrolide antibiotics (e.g., clarithromycin, telithromycin, troleandomycin), antifungals (e.g., ketoconazole, voriconazole), mibefradil, and nefazodone should be avoided.
Maltese: L-użu fl-istess ħin ta' inibituri qawwija ta' CYP3A b'Alunbrig, inkluż iżda mhux limitati għal ċertu mediċini antivirali (eż., indinavir, nelfinavir, ritonavir, saquinavir), antibijotiċi makrolidi (eż., clarithromycin, telithromycin, troleandomycin), aġenti antifungali (eż., (e.g., ketoconazole, voriconazole), mibefradil, u nefazodone għandu jkunu evitat.
English: Unchanged brigatinib was the major circulating radioactive component (92%) along with AP26123 (3.5%), the primary metabolite also observed in vitro.
Maltese: Brigatinib mhux mibdul kien il-komponent radjuattiv maġġuri li jiċċirkola (92%) flimkien ma' AP26123 (3.5%), il-metabolit primarju osservat ukoll in vitro.
English: 12-month survival probability (%)
Maltese: Probabbiltà ta' sopravivenza ta' 12il xahar (%)
English: Grade 3 hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg, medical intervention indicated, more than one anti-hypertensive medicinal product, or more intensive therapy than previously used indicated)
Maltese: Pressjoni għolja Pressjoni għolja ta' Grad 3 (SBP ≥ 160 mmHg jew DBP ≥ 100 mmHg, intervent mediku indikat, aktar minn prodott mediċinali wieħed kontra lpressjoni, jew aktar terapija intensiva milli użata qabel indikata )
English: Of these, 19 patients had an investigator-assessed confirmed objective response (76%; 95% CI: 55, 91) and the KM estimate median duration of response among the 19 responders was 26.1 months (95% CI: 7.9, 26.1).
Maltese: Minn dawn, 19-il pazjent kellhom rispons oġġettiv ikkonfermat evalwat millinvestigatur (76%; 95% CI:) 55, 91) u l-medjan tat-tul ta' żmien tar-rispons ibbażat fuq l-istima KM fost 19-il pazjent li kellhom rispons kien ta' 26.1 xhur (95% CI: 7.9, 26.1).
English: • cyclosporine, sirolimus, tacrolimus: medicines to suppress the immune system
Maltese: • cyclosporine, sirolimus, tacrolimus: mediċini biex irażżnu s-sistema immunitarja
English: Uncommon Pancreatitis
Maltese: Mhux komuni Pankreatite
English: For elevations to Grade 3 and 4, the incidences for ALT and AST were 5.5% and 3.6%, respectively.
Maltese: Għall-elevazzjonijiet għal Grad 3 u 4, l-inċidenzi għall-ALT u AST kienu ta' 5.5% u 3.6%, rispettivament.
English: Alunbrig may also induce other enzymes and transporters (e.g., CYP2C, P-gp) via the same mechanisms responsible for induction of CYP3A (e.g., pregnane X receptor activation).
Maltese: Alunbrig jista' jinduċi enzimi u trasportaturi oħra (eż., CYP2C, Pgp) permezz tal-istess mekkaniżmi responsabbli għall-induzzjoni ta' CYP3A (eż., attivazzjoni tar-riċettur pregnane X ).
English: Table 1: Recommended Alunbrig dose reduction levels Dose
Maltese: Tabella 1: Livelli għat-tnaqqis tad-doża ta' Alunbrig rakkomandati Doża