FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients who are genetically deficient in CYP2D6 activity (poor metabolisers).
Maltese: Abbażi tal-kobor ta' dawn il-bidliet, ma hija mistennija l-ebda interazzjoni mediċinali klinikament relevanti meta fluticasone furoate/umeclidinium/vilanterol jingħata flimkien ma' inibituri ta' CYP2D6 jew meta jingħata lill-pazjenti ġenetikament defiċjenti fl-attività ta' CYP2D6 (metabolizzaturi dgħajfa).
English: The primary metabolic routes for vilanterol are O-dealkylation to a range of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity.
Maltese: Ir-rotot metaboliċi primarji għal vilanterol huma dealkilazzjoni-O għal firxa ta' metaboliti b'attività agonista beta1- u beta2-adrenerġika konsiderevolment imnaqqsa.
English: Plasma metabolic profiles following oral administration of vilanterol in a human radiolabel study were consistent with high first-pass metabolism.
Maltese: Il-profili metaboliċi tal-plażma wara għoti orali ta' vilanterol fi studju radjutikkettat fil-bniedem kienu konsistenti ma' metaboliżmu għoli tal-ewwel passaġġ.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trelegy Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeferiet l-obbligu li jiġu ppreżentati r-riżultati tal-istudji bi Trelegy Ellipta fis-subsettijet kollha tal-popolazzjoni pedjatrika f'COPD (ara sezzjoni 4.2 għal informazzjoni dwar lużu pedjatriku).
English: Beta2-adrenergic agonists may produce transient hyperglycaemia in some patients.
Maltese: F'xi pazjenti l-agonisti beta2 adrenerġiċi jistgħu jikkawżaw ipergliċemija tranżitorja.
English: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Maltese: Tibqax tieħu din il-mediċina u fittex għajnuna medika immedjatament, billi jista' jkollok kondizzjoni serja magħrufa bħala bronkospażmu paradossali.
English: Mouthpiece Air vent
Maltese: Popolazzjonijiet speċjali oħra
English: • painful and frequent urination (may be signs of a urinary tract infection)
Maltese: • uġigħ meta tgħaddi l-awrina u tgħaddi l-awrina b'mod frekwenti (jistgħu jkunu sinajli ta' infezzjoni fl-apparat tal-awrina)
English: It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Maltese: M3 in vitro u durata twila ta' azzjoni in vivo meta jingħata direttament fil-pulmuni f'mudelli ta' qabel l-użu kliniku.
English: Each inhaler contains either 14 or 30 doses (14 or 30 day supply).
Maltese: Kull inalatur fih jew 14 jew 30 doża (provvista ta' 14 jew 30 jum).
English: Desiccant Tray
Maltese: TIKKETTA TAT-TREJ
English: Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening.
Maltese: L-għoti ta' fluticasone furoate/umeclidinium/vilanterol jista' jipproduċi bronkospażmu paradossali bi tħarħir (man-nifs) immedjat u qtugħ ta' nifs wara d-dożaġġ u jista' jkun ta' periklu għall-ħajja.
English: An approximately 1.3-fold increase in umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax.
Maltese: Ġiet osservata żieda ta' madwar 1.3 darbiet fl-AUC ta' umeclidinium b'doża 16-il darba ogħla bl-ebda effett fuq is-Cmax ta' umeclidinium.
English: The “Discard by” date should be written on the inhaler label and carton in the space provided.
Maltese: Id-data “Armi sa” għandha tinkiteb fuq it-tikketta u l-kartuna tal-inalatur fl-ispazju pprovdut.
English: Treatment with Trelegy Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Maltese: Il-kura b'Trelegy Ellipta għandha titwaqqaf immedjatament jekk ikun iseħħ bronkospażmu paradossali.
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with Trelegy Ellipta at the recommended therapeutic dose.
Maltese: Ma ġie osservat l-ebda effett klinikament relevanti li kien jeħtieġ aġġustament fid-doża.
English: Trelegy Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: GlaxoSmithKline (Cyprus) Ltd
Maltese: GlaxoSmithKline Lietuva UAB
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose was excreted in faeces and approximately 22% of the administered radiolabelled dose was excreted in urine.
Maltese: Wara għoti ġol-vini, madwar58 % tad-doża radjutikkettata mogħtija kienet eliminata fl-ippurgar u madwar 22 % tad-doża radjutikkettata mogħtija kienet eliminata fl-awrina.
English: Discontinue Iclusig *IULN = institution upper limit of normal
Maltese: Waqqaf Iclusig *IULN = institution upper limit of normal
English: June 2019
Maltese: Ġunju 2019
English: Transporter substrates
Maltese: Sottostrati trasportaturi
English: System organ class
Maltese: Klassi tal-Organi tas-Sistema
English: • The active substance is ponatinib.
Maltese: • Is-sustanza attiva hi ponatinib.
English: 93055 Regensburg, Germany
Maltese: 93055 Regensburg, Il-Ġermanja
English: *Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Maltese: *Rapportaġġ skont in-Cancer Institute Common Terminology Criteria għal Każijiet Avversi verżjoni 4.0.
English: Ponatinib is metabolized by CYP3A4.
Maltese: Ponatinib huwa metabolizzat minn CYP3A4.
English: An updated RMP shall be submitted by 24 November 2014.
Maltese: RMP aġġornat għandu jiġi ppreżentat sal-24 ta' Novembru 2014.
English: Vascular occlusion (see section 4.2 and 4.4).
Maltese: Okklużjoni vaskulari (ara sezzjoni 4.2 u 4.4)
English: Leukopenia (WBC decreased)
Maltese: Leukopenia (WBC imnaqqsa)
English: ALT=alanine aminotransferase, ANC=absolute neutrophil count, AST=aspartate aminotransferase, Hgb=haemoglobin, WBC=white blood cell count.
Maltese: ALT = alanine aminotransferase, ANC=għadd assolut ta' newtrofili (absolute neutrophil count), AST=aspartate aminotransferase, Hgb=emaglobina (hemoglobin), WBC=għadd ta' ċelluli bojod tad-demm (white blood cell count).
English: Ponatinib is highly bound (>99%) to plasma proteins in vitro.
Maltese: Ponatinib jintrabat b'mod qawwi (> 99%) ma' proteini fil-plażma in vitro.
English: Majora (MaHR)
Maltese: Maġġuria (MaHR)
English: Total safety population N=449
Maltese: Popolazzjoni totali ta' sigurtà N = 449
English: Blast Phase CML
Maltese: Fażi Blast CML
English: • phenobarbital, phenytoin: medicines to treat epilepsy.
Maltese: • phenobarbital, phenytoin: mediċini użati fil-kura ta' epilessija.
English: Riverbridge House Guildford Road
Maltese: Guildford Road
English: • The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 3000, polyvinyl alcohol, titanium dioxide (E171).
Maltese: • Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 4000, polyvinyl alcohol, titanium dioxide (E171).
English: Haupt Pharma Amareg GmbH Donaustaufer Str. 378
Maltese: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378
English: - increased levels of the serum proteins lipase or amylase.
Maltese: - livelli ogħla tal-proteini tas-serum lipase jew amylase.
English: In vitro, ponatinib is an inhibitor of P-gp and BCRP.
Maltese: In vitro, ponatinib huwa impeditur ta' P-gp u BCRP.
English: Anaemia (Hgb decreased)
Maltese: Anemija (Hgb imnaqqas)
English: Iclusig is available as:
Maltese: Iclusig huwa disponibbli bħala:
English: The carboxylic acid and the N-desmethyl metabolite comprise 58% and 2% of the circulating levels of ponatinib, respectively.
Maltese: Il-carboxylic acid u l-metabolit N-desmethyl jinkludu 58% u 2% rispettivament tal-livelli ta' ponatinib li jiċċirkulaw.
English: Important adverse reactions
Maltese: Reazzjonijiet avversi importanti
English: Cytogenetic Response Major (MCyR) a
Maltese: Rispons Ċitoġeniku Maġġuri (MCyR)a
English: (< 1.5 x IULN)
Maltese: ≤ Grad 1 (< 1.5 x IULN)
English: Of the 449 patients in the clinical study of Iclusig, 155 (35%) were ≥ 65 years of age.
Maltese: Mill-449 pazjent fl-istudju kliniku ta' Iclusig, 155 (35%) kellhom ≥ 65 sena.
English: Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, and phototoxicity studies.
Maltese: Iclusig ġie evalwat fi studji ta' sigurtà farmakoloġika, tossiċità dovuta għal dożi ripetuti, ġenotossiċità tossiċità riproduttiva u studji ta' fototossiċità.
English: INFORMATION IN BRAILLE Outer Carton:
Maltese: INFORMAZZJONI BIL-BRAILLE Kartuna ta' Barra:
English: ANC* < 1.0 x 109/L or platelet < 50 x 109/L
Maltese: ANC* < 1.0 x 109/L jew plejtlets < 50 x 109/L
English: The most common serious adverse reactions >1% (treatment-emergent frequencies) were pancreatitis (5.6%), pyrexia (4.2%), abdominal pain (4.0%), myocardial infarction (3.6%), atrial fibrillation (3.3%), anaemia, (3.3%), platelet count decreased (3.1%), febrile neutropenia (2.9%), cardiac failure (2.0%), lipase increased (1.8%), dyspnea (1.6%), diarrhoea (1.6%), neutrophil count decreased (1.3%), pancytopenia (1.3%), and pericardial effusion (1.3%).
Maltese: L-aktar reazzjonijiet avversi komuni serji ta' >1% (frekwenzi li dehru mal-kura) kienu pankreatite (5.6%), deni (4.2%), uġigħ addominali (4.0%), infart mijokardijaku (3.6%), fibrillazzjoni tal-atriju (3.3%), anemija, (3.3%), tnaqqis fl-għadd tal-plejtlits (3.1%), newtropenija bid-deni (2.9%), insuffiċjenza tal-qalb (2.0%), żieda fil-lipase (1.8%), qtugħ ta' nifs (1.6%), dijarea (1.6%), tnaqqis fl-għadd ta' newtrofili (1.3%), panċitopenija (1.3%) u effużjoni tal-perikardju (1.3%).
English: • palpitation
Maltese: • palpitazzjoni
English: Adverse reactions
Maltese: Reazzjonijiet Avversi
English: ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD United Kingdom
Maltese: Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD Ir-Renju Unit
English: Overall, 55% of patients had one or more BCR-ABL kinase domain mutation at entry with the most frequent being: T315I (29%), F317L (8%), E255K (4%) and E359V (4%).
Maltese: T315I (29%), F317L (8%), E255K (4%) u E359V (4%).
English: Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL with IC50 values of 0.4 and 2.0 nM, respectively.
Maltese: Ponatinib jimpedixxi l-attività ta' tyrosine kinase ta' ABL u l-mutanti T315I ABL b'valuri ta' IC50 ta' 0.4 u 2.0 nM, rispettivament.
English: (95% CI) Major Molecular Response b
Maltese: (95% CI) Rispons Molekulari Maġġurb
English: Overall (N=62)
Maltese: Globali (N = 62)
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3).
English: Overall (N=83)
Maltese: Globali (N = 83)
English: Table 8 Efficacy of Iclusig in resistant or intolerant Ph+ ALL patients Overall (N=32)
Maltese: Tabella 8 L-effikaċja ta' Iclusig f'pazjenti b'Ph+ ALL reżistenti jew intolleranti Globali (N=32)
English: Grade 4 pancreatitis
Maltese: Pankreatite ta' Grad 4
English: PHARMACEUTICAL FORM AND CONTENTS 60 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 60 pillola
English: • clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections.
Maltese: • clarithromycin, telithromycin, troleandomycin: mediċini biex jikkuraw infezzjonijiet batteriċi.
English: Each film-coated tablet contains 120 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 120 mg lactose monohydrate.
English: Table 4 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥2% of patients in any disease group Laboratory Test
Maltese: Tabella 4 Inċidenza ta' abnormalitajiet tal-laboratorju klinikament rilevanti ta' Grad 3/4* f' ≥ 2% ta' pazjenti f'kull grupp ta' mard Test tal-Laboratorju
English: Grade 3 or 4 asymptomatic elevation of lipase/amylase (> 2.0 x IULN*) only
Maltese: Livell mhux simptomatiku ogħla ta' Grad 3 jew 4 ta' lipase/amylase (> 2.0 x IULN*) biss
English: Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase.
Maltese: Iclusig jista' jirriżulta f' livelli ogħla ta' ALT, AST, bilirubin u, alkaline phosphatase.
English: * of 427 patients reporting prior TKI therapy with dasatinib or nilotinib
Maltese: * minn 427 pazjent li rraportaw qabel terapija b'TKI b' dasatinib jew nilotinib
English: • lethargy, migraine
Maltese: • letarġija, emigranja
English: Resistant or Intolerant R/I Cohort (N=10)
Maltese: Reżistenti jew Intolleranti Koorti R/I (N=10)
English: The secondary efficacy endpoints in AP-CML and BP-CML/Ph+ ALL were MCyR and MMR.
Maltese: Il-punti tat-tmiem ta' effikaċja sekondarji f'AP-CML u BP-CML/Ph+ ALL kienu MCyR u MMR.
English: Surrey KT22 9AD, United Kingdom
Maltese: Leatherhead, Surrey KT22 9AD, Ir-Renju Unit
English: In vitro studies indicate that clinical medicinal product interactions are unlikely to occur as a result of ponatinib-mediated inhibition of the metabolism of substrates for CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A or CYP2D6.
Maltese: Studji in vitro jindikaw li interazzjonijiet kliniċi ma' prodotti mediċinali mhux probabbli li jseħħu bħala riżultat ta' inibizzjoni tal-metaboliżmu ta' sottostrati ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A jew CYP2D6 kkawżat minn ponatinib.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE24
Maltese: Kategorija farmakoterapewtika: sustanza antineoplastika, impeditur tal-proteina kinase, Kodiċi ATC:
English: Grade 3 pancreatitis
Maltese: Pankreatite ta' Grad 3
English: (95% CI) Complete (CCyR)
Maltese: (95% CI) Komplut (CCyR)
English: b CHR: WBC ≤ institutional ULN, ANC ≥1000/mm3, platelets ≥100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils <5% in peripheral blood, No extramedullary involvement (including no hepatomegaly or splenomegaly).
Maltese: b CHR: WBC ≤ ULN instituzzjonali, ANC ≥ 1000/mm3, plejtlets ≥ 100,000/mm3, l-ebda blasts jew promajeloċiti fid-demm periferali, blasts fil-mudullun ≤ 5%, < 5% majeloċiti flimkien ma' metamajeloċiti fid-demm periferali, bażofili < 5% fid-demm periferali, L-ebda involviment ekstramedullari (li jinkludi nuqqas ta' epatomegalija jew splenomegalija).
English: Ponatinib inhibits the activity of other clinically relevant kinases with IC50 values below 20 nM and has demonstrated cellular activity against RET, FLT3, and KIT and members of the FGFR, PDGFR, and VEGFR families of kinases.
Maltese: Ponatinib jimpedixxi l-attività ta' kinases rilevanti oħra b'valuri ta' IC50 taħt 20 nM u wera attività ċellulari kontra RET, FLT3, u KIT u l-membri tal-familji ta' kinases ta' FGFR, PDGFR, u VEGFR..
English: • ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections.
Maltese: • ketoconazole, itraconazole, voriconazole: mediċini li jintużaw għall-kura ta' infezzjonijiet tal-moffa.
English: Table 3 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class
Maltese: Tabella 3 Reazzjonijiet avversi osservati f'pazjenti b'CML u Ph+ ALL - frekwenza rrappurtati skont l-inċidenza tal-avvenimenti li ħarġu mal-kura Klassi tal-Organi tas-Sistema
English: The geometric mean (CV%) Cmax and AUC(0-τ) exposures achieved for ponatinib 45 mg daily at steady state were 77 ng/mL (50%) and 1296 ng•hr/mL (48%), respectively.
Maltese: Il-medja ġeometrika (CV%) Cmax u l-espożizzonijiet ta' AUC(0-τ) miksuba għal ponatinib 45 mg kuljum fl-istadju fiss kienu 77 ng/mL (50%) u 1296 ng•hr/mL (48%), rispettivament.
English: Pancreatitis and serum lipase
Maltese: Il-pankreatite u lipase fis-serum
English: (95% CI) Completeb (CHR)
Maltese: (95% CI) Komplutb (CHR)
English: At doses of 15 mg or greater, 32 of 34 patients (94%) demonstrated a ≥50% reduction of CRKL phosphorylation, a biomarker of BCR-ABL inhibition, in peripheral blood mononuclear cells.
Maltese: F'dożi ta' 15 mg jew aktar, 32 minn 34 pazjent (94%) wera tnaqqis ta' ≥ 50% ta' fosforilazzjoni ta' CRKL, markatur bijoloġiku ta' impediment ta' BCR-ABL, fiċ-ċelluli mononukleari ta' demm periferali.
English: Of the CP-CML patients previously treated with one, two, or three prior TKIs, 81% (13/16), 61% (65/105), and 46% (66/143) achieved a MCyR while on Iclusig, respectively.
Maltese: Mill-pazjenti b'CP-CML li kienu ngħataw il-kura preċedenti b'TKI wieħed, tnejn jew aktar, 81% (13/16), 61% (65/105), u 46% (66/143) rispettivament kisbu MCyR waqt li kienu fuq Iclusig.
English: • Available data on the relationship between dose and risk of vascular occlusive events.
Maltese: • Dejta disponibbli dwar ir-relazzjoni bejn id-doża u r-riskju ta' avvenimenti okklussivi vaskulari.
English: Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporters OCT-1.
Maltese: Ponatinib mhuwiex sottostrat għall-polipeptidi organiċi umani li jġorru l-anjoni, OATP1B1 u OATP1B3 u għat-trasportatur organiku tal-katajoni, OCT-1.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentement, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Dose modifications for neutropenia (ANC* < 1.0 x 109/L) and thrombocytopenia (platelet < 50 x 109/L) that are unrelated to leukaemia are summarized in Table 1.
Maltese: Modifikazzjonijiet fid-doża għal newtropenija (ANC* < 1.0 x 109/L) u tromboċitopenija (plejtlet < 50 x 109/L) li mhumiex relatati ma' lewkimja huma mqassra f'Tabella 1.
English: Table 2 Dose modifications for pancreatitis and elevation of lipase/amylase Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase
Maltese: Tabella 2 Modifikazzjonijiet fid-doża għal pankreatite u żieda ta' lipase/amylase Pankreatite ta' Grad 2 u/jew elevazzjoni mhux sintomatika ta' lipase/amylase
English: Resistant or Intolerant
Maltese: Reżistenti jew Intolleranti
English: CYP3A inhibitors
Maltese: Impedituri CYP3A
English: • indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection.
Maltese: • indinavir, nelfinavir, ritonavir, saquinavir: mediċini għall-kura ta' infezzjoni ta' HIV.
English: • Information on important adverse reactions for which monitoring and/or dose adjustment are recommended as outlined in the SmPC: pancreatitis, increased amylase and lipase levels, myelosuppression, liver function test abnormalities, haemorrhage, cardiac failure/left ventricular dysfunction, vascular occlusive events and hypertension.
Maltese: • Informazzjoni dwar reazzjonijiet avversi importanti li għalihom monitoraġġ u/jew aġġustament fid-doża huma rakkomandati kif deskritt fl-SmPC: pankreatite, żieda fl-amylase u fil-livelli ta' lipase, majelosoppressjoni, anormalitajiet fit-testijiet tal-funzjoni tal-fwied, emorraġija, insuffiċjenza kardijaka/disfunzjoni tal-ventriklu tax-xellug, avvenimenti okklussivi vaskulari u pressjoni għolja.
English: Iclusig contains lactose
Maltese: Iclusig fih lactose
English: The rates of treatment-related adverse events resulting in discontinuation were 14% in CP-CML, 7% in APCML and 4% in BP-CML/Ph+ ALL.
Maltese: Ir-rati ta' trattament relatati ma' effetti avversi li wasslu għal twaqqif kienu 14% f'CP-CML, 7% f'AP-CML u 4% f'BP-CML/Ph+ ALL.
English: Based on the Kaplan-Meier estimates, 87% (95% CI: [78%-92%]) of CP-CML (median duration of treatment: 866 days) patients who achieved a MCyR and 66% (95% CI: [55%- 75%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 24 months.
Maltese: Abbażi tal-istimi ta' Kaplan-Meier, 87% (95% CI: [78%-92%]) ta' pazjenti b'CP-CML (tul medjan tal-kura: 866 jum) li kisbu MCyR u 66% (95% CI: [55%- 75%]) ta' pazjenti b'CP-CML li kisbu MMR huma proġettati li jżommu dak ir-rispons sa 24 xahar.
English: Each film-coated tablet contains 40 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 40 mg lactose monohydrate.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 July 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 1 ta' Lulju 2013
English: Table 1 Dose modifications for myelosuppression
Maltese: Tabella 1 Modifikazzjonijiet tad-Doża għal majelosoppressjoni
English: Fertility The effect of Iclusig on male and female fertility is unknown.
Maltese: Fertilità L-effett ta Iclusig fuq il-fertilità maskili u femminili mhux magħruf.
English: Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triplebond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase.
Maltese: Ponatinib huwa impeditur qawwi għal pan BCR-ABL b'elementi strutturali, li jinkludu bond tripliku ta' karbonju-karbonju, li jippermetti affinità għolja għal BCR-ABL nattivi u għamliet mutanti tal-kinase ABL.
English: The risk of vascular occlusive events is likely to be dose-related.
Maltese: Ir-riskju ta' avvenimenti okklussivi vaskulari x'aktarx li huwa relatat mad-doża.
English: The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients who received 30 mg, 45 mg, or 60 mg Iclusig once daily.
Maltese: Il-potenzjal ta' titwil tal-intervall ta' QT ta' Iclusig kien evalwat f'39 pazjent b' lewkimja li ngħataw 30 mg, 45 mg, jew 60 mg Iclusig darba kuljum.
English: BCR-ABL mutation detected at entry, n (%) None
Maltese: BCR-ABL mutazzjoni misjuba fid-dħul, n (%) Xejn
English: • sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation.
Maltese: • sulfasalazine: mediċina għall-kura ta' infjammazzjoni tal-imsaren severa u għal ġogi rewmatiċi.
English: Defined as a ≤0.1% ratio of BCR-ABL to ABL transcripts on the International Scale (IS) (ie, ≤0.1% BCR-ABLIS; patients must have the b2a2/b3a2 (p210) transcript), in peripheral blood measured by quantitative reverse transcriptase polymerase chain reaction (qRT PCR).
Maltese: Imfisser bħala proporzjon ta' ≤ 0.1% ta' BCR-ABL għal traskrizzjonijiet t'ABL fuq l-Iskala Internazzjonali (IS) (ie, ≤ 0.1% BCR-ABL IS; il-pazjenti għandhom jkollhom l-b2a2/b3a2 (traskrizzjoni ta' (p210)), fid-demm periferali mkejjel bil-quantitative reverse transcriptase polymerase chain reaction (qRT PCR).
English: • rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections.
Maltese: • rifabutin, rifampicin: mediċini użati fil-kura ta' tuberkolosi jew ċertu tip ta' infezzjonijiet.
English: Further data on maintenance of response are required in order to make a formal recommendation for dose modifications in the absence of an adverse event as a risk minimisation strategy (see sections 4.2 and 4.4).
Maltese: Aktar dejta dwar manteniment ta' rispons hija meħtieġa sabiex issir rakkomandazzjoni formali għallmodifikazzjonijiet fid-doża fin-nuqqas ta' avveniment avvers bħala strateġija ta' minimizzazzjoni tarriskju (ara sezzjonijiet 4.2 u 4.4).
English: All Patients (N=449)
Maltese: Pazjenti Kollha (N=449)
English: Maintained MMR
Maltese: MMR Miżmum