FrancophonIA/ELRC3.0 huggingface dataset:
English: Unbound AUC was 38% higher in patients with severe renal impairment or ESRD requiring dialysis as compared to patients with normal renal function.
Maltese: AUC mhux mwaħħla kienet 38% ogħla f'pazjenti b'indeboliment sever tal-kliewi jew ESRD li teħtieġ dijalisi meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi.
English: The patient should be monitored for symptoms of peripheral neuropathy.
Maltese: Il-pazjent għandu jiġi monitorat għal sintomi ta' newropatija periferali.
English: It should not be crushed, chewed, or opened (see section 6.6).
Maltese: M'għandekx tfarrakha, tomgħodha jew tiftaħha (ara t-taqsima 6.6).
English: The frequency of severe (Grade 3-4) events of hypokalaemia was higher in the ixazomib regimen (5%) than the placebo regimen (<1%).
Maltese: Il-frekwenza ta' każijiet severi (Grad 3-4) ta' ipokalemija kien ogħla fil-programm ta' kura ta' ixazomib (5%) milli fil-programm ta' kura tal-plaċebo (< 1%).
English: Hard capsule.
Maltese: Kapsuli ibsin.
English: In the Phase 3 study (C16010), 10 patients (5 in each treatment regimen) had severe renal impairment at baseline.
Maltese: Fl-istudju ta' Fażi 3 (C16010), 10 pazjenti (5 f'kull grupp ta' programm ta' kura) kellhom indeboliment sever tal-kliewi fil-linja bażi.
English: NINLARO 2.3 mg hard capsules NINLARO 3 mg hard capsules NINLARO 4 mg hard capsules ixazomib
Maltese: NINLARO 2.3 mg kapsuli ibsin NINLARO 3 mg kapsuli ibsin NINLARO 4 mg kapsuli ibsin ixazomib
English: Do not store above 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30 °C.
English: Patients enrolled in the trial had multiple myeloma that was refractory, including primary refractory, had relapsed after prior therapy, or had relapsed and was refractory to any prior therapy.
Maltese: Pazjenti rreġistrati fil-prova kellhom majeloma multipla li kienet refrattorja, inkluż refrattorja primarja, jew b'episodju ġdid wara terapija preċedenti, jew b'episodju ġdid u refrattorja għal kwalunkwe terapija preċedenti.
English: The most commonly reported reaction was peripheral sensory neuropathy (16% and 12% in the ixazomib and placebo regimen, respectively).
Maltese: L-aktar reazzjoni rrappurtata b'mod komuni kienet newropatija sensorja periferali (16% u 12% fil-kors ta' ixazomib u tal-plaċebo, rispettivament).
English: Takeda Pharmaceuticals SRL Tel: +40 21 335 03 91
Maltese: Tel/Tél: +40 21 335 03 91
English: Brain imaging, preferably Magnetic Resonance Imaging, is used to confirm the diagnosis.
Maltese: Id-dijanjosi tiġi kkonfermata bi xbiehat tal-moħħ, preferibilment b'Magnetic Resonance Imaging.
English: Overall Response Rate‡, n (%) 282 (78.3) Response Category, n (%) Complete Response
Maltese: Kategorija ta' Rispons, n (%) Rispons Sħiħ
English: • Withhold lenalidomide until rash recovers to ≤ Grade 1.
Maltese: • Tkomplix tieħu lenalidomide sakemm ir-raxx jinżel għal ≤ Grad 1.
English: INFORMATION IN BRAILLE NINLARO 3 mg
Maltese: INFORMAZZJONI BIL-BRAILLE NINLARO 3 mg
English: • vision conditions including blurred vision, dry eye and pink eye (conjunctivitis)
Maltese: • kundizzjonijiet tal-vista inkluża vista mċajpra, għajnejn xotti u għajnejn ħomor (konġuntivite)
English: Thrombocytopenia can be managed with dose modifications (see section 4.2) and platelet transfusions as per standard medical guidelines.
Maltese: It-tromboċitopenija għandha tkun immaniġġjata b'modifiki fid-dożi (ara sezzjoni 4.2) u trasfużjonijiet tal-plejtlits skont il-linji gwida mediċi standard.
English: Posterior reversible encephalopathy syndrome (PRES) has occurred in patients receiving ixazomib.
Maltese: Sindromu ta' enċefalopatija posterjuri riversibbli (PRES, posterior reversible encephalopathy syndrome) seħħew f'pazjenti li ħadu ixazomib.
English: NINLARO 2.3 mg hard capsules
Maltese: NINLARO 2.3 mg kapsuli ibsin
English: CYP inducers
Maltese: Indutturi ta' CYP
English: EXP:
Maltese: Puh/Tel:
English: Peripheral neuropathy has been reported with ixazomib (see section 4.8).
Maltese: Newropatija periferali kienet rapportata b'ixazomib (ara sezzjoni 4.8).
English: Co-administration of ixazomib with strong CYP1A2 inhibitors did not result in a clinically meaningful change in the systemic exposure of ixazomib based on the results of a population pharmacokinetic (PK) analysis.
Maltese: L-għoti flimkien ta' ixazomib ma' inibituri qawwija ta' CYP1A2, ma rriżultax f'bidla klinikament sinifikanti fl-esponiment sistematiku ta' ixazomib fuq il-bażi tar-riżultati ta' analiżi farmakokinetika (PK, pharmacokinetic) tal-popolazzjoni.
English: Seventy seven percent of patients relapsed after prior therapies and 11% were refractory to prior therapies.
Maltese: Sebgħa u sebgħin fil-mija tal-pazjenti rkadew wara terapiji preċedenti u 11% kienu refrattorji għal terapiji preċedenti.
English: The PK of ixazomib is similar in patients with normal hepatic function and in patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin > 1-1.5 x ULN and any AST) based on the results of a population PK analysis.
Maltese: Il-PK ta' ixazomib hija simili fil-pazjenti b'funzjoni normali tal-fwied u f'pazjenti b'indeboliment ħafif tal-fwied (bilirubina totali ta' ≤ ULN u AST > ULN jew bilirubina totali ta' > 1-1.5 x ULN u kwalunkwe AST) fuq il-bażi tar-riżultati ta' analiżi tal-PK tal-popolazzjoni.
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg ixazomib
Maltese: IL-PRODOTT MEDIĊINALI NINLARO 2.3 mg ixazomib
English: Refer to the lenalidomide SmPC, section 4.2 for the dose reduction steps for these toxicities.
Maltese: Irreferi għall-SmPC ta' lenalidomide, sezzjoni 4.2 għall-passi għat-tnaqqis fid-doża għal dawn it-tossiċitajiet.
English: What NINLARO contains NINLARO 2.3 mg hard capsule: The active substance is ixazomib.
Maltese: X'fih NINLARO NINLARO 2.3 mg kapsuli ibsin: - Is-sustanza attiva hi ixazomib.
English: Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate).
Maltese: Kull kapsula fiha 2.3 mg ta' ixazomib (bħala 3.3 mg ta' ixazomib citrate)
English: Thrombocytopenia (platelet count) Platelet count < 30,000/mm3
Maltese: Azzjonijiet rakkomandati Tromboċitopenija (Għadd ta' plejtlits) Għadd ta' plejtlits < 30,000/mm3
English: In multi-cycle repeated-dose toxicity studies conducted in rats and dogs, the principal target organs included the gastrointestinal tract, lymphoid tissues, and the nervous system.
Maltese: Fi studji tat-tossiċità multiċikliċi b'dożi ripetuti mwettqa fil-firien u fil-klieb, l-organi prinċipali fil-mira kienu jinkludu l-passaġġ gastrointestinali, it-tessuti limfojdi, u s-sistema nervuża.
English: NAME OF THE MEDICINAL PRODUCT NINLARO 4 mg ixazomib
Maltese: TAL-PRODOTT MEDIĊINALI NINLARO 4 mg ixazomib
English: Other medicines and NINLARO
Maltese: Mediċini oħra u NINLARO
English: • Absolute neutrophil count should be ≥ 1,000/mm3
Maltese: • L-għadd totali ta' newtrofili għandu jkun ta' ≥ 1,000/mm3
English: There was no clinically meaningful effect of age (23-91 years), sex, body surface area (1.2-2.7 m2), or race on the clearance of ixazomib based on the results of a population PK analysis.
Maltese: Ma kien hemm l-ebda effett klinikament sinifikanti tal-età (23-91 sena), is-sess tal-persuna, l-erja tal-wiċċ tal-ġisem (1.2-2.7 m2), jew ir-razza fuq it-tneħħija ta' ixazomib fuq il-bażi tar-riżultati ta' analiżi tal-PK tal-popolazzjoni.
English: The PK of ixazomib was characterized in patients with normal hepatic function at 4 mg (N=12), moderate hepatic impairment at 2.3 mg (total bilirubin > 1.5-3 x ULN, N=13) or severe hepatic impairment at 1.5 mg (total bilirubin > 3 x ULN, N=18).
Maltese: dawk b'indeboliment moderat tal-fwied f'2.3 mg (bilirubina totali ta' > 1.5-3 x ULN, N = 13) jew indeboliment sever tal-fwied f'1.5 mg (bilirubina totali ta' > 3 x ULN, N = 18).
English: C16014: In order to further investigate the efficacy the MAH should conduct a phase 3, randomized, double-blind, multicenter study comparing ixazomib plus lenalidomide and dexamethasone versus placebo plus lenalidomide and dexamethasone in adult patients with newly diagnosed multiple myeloma not eligible for stem cell transplantation (SCT) and provide the final report for primary endpoint PFS.
Maltese: Sabiex tiġi investigata b'mod addizzjonali l-effikaċja, l-MAH għandu jwettaq studju ta' fażi 3, li fih il-parteċipanti jintgħażlu b'mod każwali, double-blind u multiċentriku, li jqabbel ixazomib flimkien ma' lenalidomide u dexamethasone, kontra plaċebo flimkien ma' lenalidomide u dexamethasone f'pazjenti adulti b'majeloma multipla li tkun ġiet iddijanjostikata għall-ewwel darba, u li ma jkunux eliġibbli għal trapjant ta' ċelluli staminali (SCT, stem cell transplantation), u jipprovdi r-rapport finali għall-punt aħħari primarju ta' PFS.
English: Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate).
Maltese: Kull kapsula fiha 3 mg ta' ixazomib (bħala 4.3 mg ta' ixazomib citrate)
English: Post-authorisation efficacy study (PAES) C16010: To provide an interim report of overall survival at the time of the 3rd interim analysis and to provide a final report for the final analysis of OS from the phase 3, randomized, double-blind study C16010 in adult patients with relapsed and/or refractory multiple myeloma.
Maltese: C16010: Biex tipprovdi rapport interim tas-sopravivenza ġenerali fiż-żmien meta ssir it-3et analiżi u biex tipprovdi rapport finali għall-analiżi finali ta' OS mill-istudju C16010 ta' fażi 3, li fih il-parteċipanti ntgħażlu b'mod każwali, double blind, f'pazjenti adulti b'majeloma multipla li rkadiet u/jew refrattarja.
English: ‡ORR = CR+VGPR+PR §Based on responders in the response-evaluable population
Maltese: ‡ORR = CR+VGPR+PR §Fuq il-bażi ta' dawk li kellhom rispons fil-popolazzjoni b'rispons li jista' jiġi evalwat
English: Ninety three percent of patients had an ECOG performance status of 0-1 and 12% had baseline ISS stage III disease (N=90).
Maltese: Tlieta u disgħin fil-mija tal-pazjenti kellhom stat ta' prestazzjoni ECOG ta' 0-1 u 12% kellhom marda tal-ISS ta' stadju III (N = 90) fil-linja bażi.
English: *Recommended reduced dose of 3 mg in the presence of moderate or severe hepatic impairment, severe renal impairment or end-stage renal disease (ESRD) requiring dialysis.
Maltese: *Doża rakkomandata mnaqqsa ta' 3 mg fil-preżenza ta' indeboliment moderat jew sever tal-fwied, indeboliment sever tal-kliewi jew mard tal-kliewi fl-aħħar stadju (ESRD, end-stage renal disease) li jeħtieġ dijalisi.
English: Women of childbearing potential must use highly effective contraception while taking ixazomib and for 90 days after stopping treatment (see sections 4.5 and 4.6).
Maltese: Nisa li jista' jkollhom it-tfal għandhom jużaw kontraċettiv effettiv ħafna waqt li jkunu qed jieħdu ixazomib u għal 90 jum wara li jwaqqfu t-trattament (ara sezzjonijiet 4.5 u 4.6).
English: NINLARO 4 mg hard capsules
Maltese: NINLARO 4 mg kapsuli ibsin
English: In the 9-month study (10 cycles) in dogs orally administered with a dosing schedule mimicking the clinical regimen (28-day cycle), microscopic neuronal effects were generally minimal in nature and only observed at 0.2 mg/kg (4 mg/m2).
Maltese: Fi studju ta' 9 xhur (10 ċikli) fi klieb mogħtija oralment skeda ta' dożaġġ li kienet tixbah il-kors kliniku (ċiklu ta' 28 jum), l-effetti fuq in-newroni mikroskopiċi kienu ġeneralment żgħar fin-natura tagħhom u osservati biss f'doża ta' 0.2 mg/kg (4 mg/m2).
English: Three percent of patients in the ixazomib regimen and 1% of patients in the placebo regimen had a platelet count ≤ 10,000/mm3 during treatment.
Maltese: Inqas minn 1% tal-pazjenti fiż-żewġ korsijiet kellhom għadd ta' plejtlits ta' ≤ 5,000/mm3 matul it-trattament.
English: If contact occurs, wash thoroughly with soap and water.
Maltese: Jekk iseħħ kuntatt, aħsel sew bis-sapun u l-ilma.
English: Hepatic enzymes should be monitored regularly and the dose should be adjusted for Grade 3 or 4 symptoms (see section 4.2).
Maltese: Enzimi epatiċi għandhom jiġi monitorati regolarment u d-doża għandha tiġi aġġustata għal sintomi ta' Grad 3 jew 4 (ara sezzjoni 4.2).
English: As multiple myeloma is a heterogeneous disease, benefit may vary across subgroups in the Phase 3 study (C16010) (see Figure 2).
Maltese: Peress li l-majeloma multipla hija marda eteroġena, il-benefiċċju jista' jvarja tul is-sottogruppi fl-istudju ta' Fażi 3 (C16010) (ara Figura 2).
English: Thrombocytopenia has been reported with ixazomib (see section 4.8) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle (see section 4.8).
Maltese: Tromboċitopenija kienet irrappurtata b'ixazomib (ara sezzjoni 4.8) b'livelli minimi tal-plejtlits li jseħħu tipikament bejn Jiem 14-21 ta' kull ċiklu ta' 28-jum u l-irkupru għal-linja bażi sal-bidu taċ-ċiklu li jmiss (ara sezzjoni 4.8).
English: • The capsule shell contains: gelatin, titanium dioxide (E171) and black iron oxide (E172)
Maltese: • Il-qoxra tal-kapsula fiha: ġelatina, titanium dioxide (E171) u black iron oxide (E172)
English: Diarrhoea, constipation, nausea and vomiting have been reported with ixazomib, occasionally requiring use of antiemetic and antidiarrhoeal medicinal products and supportive care (see section 4.8).
Maltese: Dijarea, stitikezza, nawsja u rimettar kienu rrappurtati b'ixazomib, u okkażjonalment kienu jeħtieġu l-użu ta' prodotti mediċinali antiemetiċi u kontra d-dijarea u kura ta' appoġġ (ara sezzjoni 4.8).
English: Treatment with ixazomib in combination with lenalidomide and dexamethasone for longer than 24 cycles should be based on an individual benefit risk assessment, as the data on the tolerability and toxicity beyond 24 cycles are limited (see section 5.1).
Maltese: It-trattament b'ixazomib flimkien ma' lenalidomide u dexamethasone għal iżjed minn 24 ċiklu għandu jkun ibbażat fuq evalwazzjoni tar-riskji u l-benefiċċji individwali, għaliex id-dejta dwar it-tollerabilità u t-tossiċità lil hinn minn 24 ċiklu hija limitata (ara t-taqsima 5.1).
English: • The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172)
Maltese: • Il-qoxra tal-kapsula fiha: ġelatina, titanium dioxide (E171), yellow iron oxide (E172) u red iron oxide (E172)
English: Women using hormonal contraceptives should additionally use a barrier method of contraception.
Maltese: Nisa li jkunu qed jużaw kontraċettivi ormonali għandhom jużaw ukoll metodu barriera ta' kontraċezzjoni.
English: However, the relevance to humans is unknown.
Maltese: Reference source not found..
English: The combination of ixazomib and lenalidomide demonstrated synergistic cytotoxic effects in multiple myeloma cell lines.
Maltese: Il-kombinazzjoni ta' ixazomib u lenalidomide urew effetti ċitotossiċi sinerġistiċi f'diversi linji ta' ċelluli tal-majeloma multipla.
English: The efficacy and safety of ixazomib in combination with lenalidomide and dexamethasone was evaluated in an international randomised, double-blind, placebo-controlled, multicenter Phase 3 superiority study (C16010) in patients with relapsed and/or refractory multiple myeloma who had received at least one prior therapy.
Maltese: L-effikaċja u s-sigurtà ta' ixazomib flimkien ma' lenalidomide u dexamethasone kienu evalwati fi studju dwar is-superjorità, ta' Fażi 3 (C16010), multiċentriku, internazzjonali, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi placebo, f'pazjenti b'majeloma multipla b'episodju ġdid u/jew refrattorja, li rċivew mill-inqas terapija waħda preċedenti.
English: Grade 3 adverse reactions of peripheral neuropathy were reported in 2% of patients in both regimens.
Maltese: Reazzjonijiet avversi ta' Grad 3 ta' newropatija periferali kienu rrappurtati fi 2% tal-pazjenti fiż-żewġ korsijiet.
English: Grade 2 peripheral neuropathy with pain or Grade 3 peripheral
Maltese: Newropatija Periferali ta' Grad 2 bl-Uġigħ jew Newropatija Periferali ta' Grad 3
English: NAME OF THE MEDICINAL PRODUCT NINLARO 3 mg ixazomib
Maltese: TAL-PRODOTT MEDIĊINALI NINLARO 3 mg ixazomib
English: Takeda GmbH Podružnica Slovenija Tel.+ 386 (0) 59 082 480
Maltese: Tel.+ 386 (0) 59 082 480
English: • not feeling like eating (decreased appetite)
Maltese: • ma jkollokx aptit tiekol (nuqqas ta' aptit)
English: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have been uncommonly reported with ixazomib (see section 4.8).
Maltese: Grieħi tal-fwied, ġrieħi epatoċellulari, steatosi epatika, epatite kolestatika u tossiċita tal-fwied imqanqlin mill-mediċina ġew rapportati mhux komunement b'ixazomib (ara sezzjoni 4.8).
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14a(4) tar-Regolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: The PK of ixazomib is similar in patients with normal renal function and in patients with mild or moderate renal impairment (creatinine clearance ≥ 30 mL/min) based on the results of a population PK analysis.
Maltese: Il-PK ta' ixazomib hija simili fil-pazjenti b'funzjoni normali tal-kliewi u f'pazjenti b'indeboliment ħafif jew moderat tal-kliewi (tneħħija tal-krejatinina ta' ≥ 30 mL/min) fuq il-bażi tar-riżultati ta' analiżi tal-PK tal-popolazzjoni.
English: An alternating dose modification approach is recommended for ixazomib and lenalidomide for overlapping toxicities of thrombocytopenia, neutropenia and rash.
Maltese: Approċċ ta' modifika fid-doża alternanti huwa rakkomandat għal ixazomib u lenalidomide għal tossiċitajiet f'daqqa' ta' tromboċitopenija, newtropenija u raxx.
English: • severe skin rashes such as red to purple bumps (Sweet's syndrome) or rash with skin peeling and mouth sores (Stevens-Johnson syndrome)
Maltese: • raxx tal-ġilda sever bħal ponot ħomor jew vjola (sindrome ta' Sweet) jew raxx bi tqaxxir tal-ġilda u ġrieħi fil-ħalq (sindrome ta' Stevens-Johnson)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION NINLARO 2.3 mg hard capsules
Maltese: U KWANTITATTIVA NINLARO 2.3 mg kapsuli ibsin
English: Eighty five percent of the population was White, 9% Asian and 2% Black.
Maltese: Ħamsa u tmenin fil-mija tal-popolazzjoni kienu Bojod, 9% Asjatiċi u 2% Suwed.
English: Non-clinical safety pharmacology studies both in vitro (on hERG channels) and in vivo (in telemetered dogs following single oral administration) demonstrated no effects of ixazomib on cardiovascular or respiratory functions at AUC more than 8-fold higher than the clinical value.
Maltese: Studji farmakoloġiċi dwar is-sigurtà mhux kliniċi kemm in vitro (fuq kanali hERG) kif ukoll in vivo (fi klieb bit-telemetrija wara amministrazzjoni orali waħda) ma wrew l-ebda effett ta' ixazomib fuq il funzjonijiet kardjovaskulari jew respiratorji f'AUC aktar minn 8 darbiet ogħla mill-valur kliniku.
English: As NINLARO is given in combination with lenalidomide, you should adhere to the pregnancy prevention programme of lenalidomide because lenalidomide can be harmful to the unborn child.
Maltese: Minħabba li NINLARO jingħata flimkien ma' lenalidomide, għandek issegwi l-programm ta' prevenzjoni ta' tqala ta' lenalidomide għax lenalidomide jista' jkun ta' ħsara għat-tarbija mhux imwielda.
English: Discontinuations in patients > 75 years of age were reported in 13 patients (28%) in the ixazomib regimen and 10 patients (16%) in the placebo regimen.
Maltese: Twaqqif tad-doża f'pazjenti ta' > 75 sena kien irrappurtat fi 13-il pazjent (28%) fil-kors ta' ixazomib u 10 pazjenti (16%) fil-kors tal-plaċebo.
English: • reactivation of the chicken pox virus (shingles) that can cause a skin rash and pain (herpes zoster)
Maltese: • reattivazzjoni tal-virus tal-ġidri r-riħ (ħruq ta' Sant'Antnin) li tista' tikkawża raxx tal-ġilda u wġigħ (herpes zoster)
English: Ixazomib is an oral, highly selective and reversible proteasome inhibitor.
Maltese: Ixazomib huwa inibitur tal-proteasomes selettiv ħafna u riversibbli.
English: Peripheral neuropathy Grade 1 peripheral neuropathy with pain or Grade 2 peripheral neuropathy
Maltese: Newropatija Periferali ta' Grad 1 bl-Uġigħ jew Newropatija Periferali ta' Grad 2
English: NINLARO 3 mg hard capsules
Maltese: NINLARO 3 mg kapsuli ibsin
English: PFS results are summarised in Table 4 and Figure 1.
Maltese: Ir-riżultati tal-PFS qed jintwerew fil-qosor f'Tabella 4 u Figura 1.
English: Patients included in studies with ixazomib who received antiviral prophylaxis had a lower incidence of herpes zoster infection compared to patients who did not receive prophylaxis.
Maltese: Pazjenti inklużi fl-istudji b'ixazomib li rċivew profilassi antivirali kellhom inċidenza aktar baxxa tal-infezzjoni tal-herpes zoster meta mqabbla ma' pazjenti li ma rċivewx profilassi.
English: Ixazomib was positive in an in vitro clastogenicity test in human peripheral blood lymphocytes.
Maltese: Ixazomib kien pożittiv f'test ta' klastoġeniċità in vitro fil-limfoċiti tad-demm periferali tal-bniedem.
English: Num of events:
Maltese: JIS:
English: No dose adjustment of ixazomib is required for patients with mild hepatic impairment (total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) > ULN or total bilirubin > 1-1.5 x ULN and any AST).
Maltese: L-ebda aġġustament fid-doża ta' ixazomib ma hu meħtieġ għal pazjenti b'indeboliment ħafif tal-fwied (bilirubina totali ≤ limitu ta' fuq tan-normal (ULN, upper limit of normal) u aspartate aminotransferase
English: Please refer to the current lenalidomide SmPC.
Maltese: Jekk jogħġbok irreferi għall-SKP kurrenti ta' lenalidomide.
English: As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional undesirable effects.
Maltese: Billi ixazomib jingħata flimkien ma' lenalidomide u dexamethasone, irreferi għas-SKP għal dawn il-prodotti mediċinali għall-effetti mhux mixtieqa addizzjonali.
English: NAME OF THE MEDICINAL PRODUCT NINLARO 4 mg hard capsules ixazomib
Maltese: TAL-PRODOTT MEDIĊINALI NINLARO 4 mg kapsuli ibsin ixazomib
English: • Withhold ixazomib and lenalidomide until platelet count ≥ 30,000/mm3.
Maltese: • Tkomplix tieħu ixazomib u lenalidomide sakemm l-għadd assolut ta' newtrofili jkun ≥ 500/mm3.
English: Ixazomib citrate, a prodrug, is a substance that rapidly hydrolyses under physiological conditions to its biologically active form, ixazomib.
Maltese: Ixazomib citrate, promediċina, hija sustanza li tidrolizza malajr taħt kundizzjonijiet fiżjoloġiċi għall-forma bijoloġikament attiva tagħha, ixazomib.
English: Peripheral motor neuropathy was not commonly reported in either regimen (< 1%).
Maltese: Newropatija motorja periferali kienet irrappurtata b'mod inqas komuni fiż-żewġ korsijiet (< 1%).
English: The Phase 3 study excluded patients who were refractory to lenalidomide or proteasome inhibitors and patients who received more than three prior therapies.
Maltese: L-istudju ta' Fażi 3 eskluda pazjenti li kienu refrattorji għal inibituri ta' lenalidomide jew proteasomes u pazjenti li rċivew aktar minn tliet terapiji preċedenti.
English: Co-administration of ixazomib with rifampicin decreased ixazomib Cmax by 54% and AUC by 74%.
Maltese: L-għoti flimkien ta' ixazomib ma' rifampicin naqqas is-Cmax ta' ixazomib b'54% u l-AUC b'74%.
English: Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate).
Maltese: Kull kapsula fiha 4 mg ta' ixazomib (bħala 5.7 mg ta' ixazomib citrate)
English: Vomiting
Maltese: infezzjoni
English: • If platelet count falls to < 30,000/mm3 again, withhold ixazomib and lenalidomide until platelet count ≥ 30,000/mm3.
Maltese: • Jekk l-għadd ta' plejtlits jerġa' jaqa' taħt < 30,000/mm3, tkomplix tieħu ixazomib u lenalidomide sakemm l-għadd ta' plejtlits jilħaq ≥ 30,000/mm3.
English: Unbound dose-normalized AUC was 27% higher in patients with moderate or severe hepatic impairment as compared to patients with normal hepatic function (see section 4.2).
Maltese: AUC mhux imwaħħla normalizzata għad-doża kienet 27% ogħla f'pazjenti b'indeboliment moderat jew sever tal-fwied meta mqabbla ma' pazjenti b'funzjoni normali tal-fwied (ara sezzjoni 4.2).
English: 1 hard capsule
Maltese: Kapsula iebsa 1
English: Discontinue
Maltese: Twaqqif