FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to further investigate the long-term toxicity and developmental effects of larotrectinib in paediatric patients, with particular focus on neurodevelopment including cognitive function, the MAH should submit the final report of study LOXO-TRK-15003 (SCOUT) including 5 year follow up data.
Maltese: Sabiex jiġu investigati aktar it-tossiċità fit-tul u l-effetti fuq l-iżvilupp ta' larotrectinib f'pazjenti pedjatriċi, b'enfasi partikolari fuq l-iżvilupp newrolettiku inkluż il-funzjoni konoxxittiva, l-MAH għandu jissottometti r-rapport finali talistudju LOXO-TRK-15003 (SCOUT) inkluż data ta' segwitu ta' 5 snin.
English: Clinical signs of gastrointestinal toxicity were dose limiting in monkeys.
Maltese: Sinjali kliniċi ta' tossiċità gastro-intestinali llimitaw id-doża fix-xadini.
English: The fraction excreted as unchanged drug in urine was 29% following IV microtracer dose, indicating that direct renal excretion accounted for 29% of total clearance.
Maltese: Il-porzjon imneħħi bħala mediċina mhux mibdula fl-awrina kien ta' 29% wara doża ta' mikrotraċċatur IV (ġol-vini), li jindika li t-tneħħija diretta mill-kliewi kienet responsabbli għal 29% tat-tneħħija totali.
English: Paediatric patients
Maltese: Fibrosarkoma infantilia
English: The safety profile in elderly patients (≥ 65 years) is consistent with that seen in younger patients (< 65 years).
Maltese: Il-profil tas-sigurtà f'pazjenti anzjani (≥ 65 sena) huwa konsistenti ma' dak osservat f'pazjenti iżgħar (< 65 sena).
English: ALT and AST increases leading to dose modifications occurred in 7 (6%) patients and 6 (5%) patients, respectively (see section 4.4).
Maltese: Żidiet fl-ALT u l-AST li wasslu għal modifikazzjonijiet fid-doża seħħew f'7 (6%) pazjenti u 6 (5%) pazjenti, rispettivament (ara sezzjoni 4.4).
English: Each mL of oral solution contains larotrectinib sulfate equivalent to 20 mg of larotrectinib.
Maltese: U KWANTITATTIVA Kull mL ta' soluzzjoni orali fih larotrectinib sulfate ekwivalenti għal 20 mg ta' larotrectinib.
English: Pre-weaning mortality (before PND 21) was observed at the high dose level corresponding to 2.5- to 4-times the AUC at the recommended dose.
Maltese: Mortalità qabel il-ftim (qabel PND 21) kienet osservata fil-livell ta' doża għolja li jikkorrispondi għal 2.5 sa 4 darbiet l-AUC bid-doża rakkomandata.
English: Larotrectinib was not mutagenic in bacterial reverse mutation (Ames) assays and in in vitro mammalian mutagenesis assays.
Maltese: Larotrectinib ma kienx mutaġeniku f'assays ta' mutazzjoni riversa (reverse mutation) fil-batterja (Ames) u f'assays tal-mutaġenesi fil-mammiferi in vitro. Larotrectinib kien negattiv fit-test talmikronukleu tal-ġurdien in vivo bid-doża massima ttollerata ta' 500 mg/kg.
English: In-frame gene fusion events resulting from chromosomal rearrangements of the human genes NTRK1, NTRK2, and NTRK3 lead to the formation of oncogenic TRK fusion proteins.
Maltese: NTRK1, NTRK2, u NTRK3 iwasslu għall-formazzjoni ta' proteini tal-fużjoni TRK onkoġeniċi.
English: Larotrectinib was not teratogenic and embryotoxic when dosed daily during the period of organogenesis to pregnant rats and rabbits at maternotoxic doses, i.e. corresponding to 32-times (rats) and 16-times (rabbits) the human AUC at the recommended clinical dose.
Maltese: Larotrectinib ma kienx teratoġeniku u ma kellux effett tossiku fuq l-embrijun meta ġie mogħti kuljum waqt il-perjodu ta' organoġenesi lill-firien u fniek tqal b'dożi tossiċi għall-omm, jiġifieri li jikkorrispondu għal 32 darba (firien) u 16-il darba (fniek) l-AUC tal-bniedem bid-doża klinika rakkomandata.
English: Nervous system effects (i.e. altered hindlimb functionality and, likely, increases in eyelid closure) demonstrated partial recovery.
Maltese: Effetti fuq is-sistema nervuża (jiġifieri funzjonalità mibdula tar-riġlejn ta' wara u, probabbilment, żieda fl-għeluq tal-kappell tal-għajn) urew irkupru parzjali.
English: Gait disturbance
Maltese: Disturb fittogħma
English: At the time of data cut-off, 8 of 9 enrolled patients with primary CNS tumours were evaluable for response by investigator assessment.
Maltese: Fiż-żmien meta waqfet tinġabar id-data, 8 minn 9 pazjenti rreġistrati b'tumuri primarji tas-CNS setgħu jiġu evalwati għal rispons permezz ta' valutazzjoni tal-investigatur.
English: - less than 1 mmol (or 23 mg) of sodium per 5 mL, that is to say essentially ‘sodium free'.
Maltese: - anqas minn 1 mmol (jew 23 mg) ta' sodium f'kull 5 mL, jiġifieri essenzjalment ‘ħieles missodium'.
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Maltese: NTRK1, NTRK2 u NTRK3, rispettivament.
English: For paediatric patients older than 12 years of age, the recommended dose is likely to give similar Cmax and AUC as observed in adults.
Maltese: Għal pazjenti pedjatriċi b'età ta' aktar minn 12-il sena, id-doża rakkomandata x'aktarx tagħti Cmax u AUC simili għal dawk osservati fl-adulti.
English: In rats, severe toxicity (STD10) was observed at doses corresponding to 1- to 2-times the human AUC at the recommended clinical dose.
Maltese: Fil-firien, ġiet osservata tossiċità severa (STD10) b'dożi li jikkorrispondu għal darba sa darbtejn l-AUC fil-bniedem bid-doża klinika rakkomandata.
English: In addition, 9 patients with primary CNS tumours and measurable disease at baseline were treated in Study 2 (“NAVIGATE”) and in Study 3 (“SCOUT”).
Maltese: Barra minn hekk, 9 pazjenti b'tumuri primarji tas-CNS u marda li setgħet titkejjel fil-linja bażi ġew ittrattati fi Studju 2 (“NAVIGATE”) u fi Studju 3 (“SCOUT”).
English: clarithromycin, telithromycin, troleandomycin - a medicine used to treat Cushing's syndrome called ketoconazole - medicines used to treat HIV infection called atazanavir, indinavir, nelfinavir, ritonavir,
Maltese: B'mod partikolari, għid lit-tabib, lill-ispiżjar jew lill-infermier tiegħek jekk qed tieħu xi waħda millmediċini li ġejjin: - mediċini msejħa itraconazole, voriconazole, clarithromycin, telithromycin, troleandomycin,
English: Women of childbearing potential must use highly effective contraception while taking VITRAKVI and for at least one month after stopping treatment (see sections 4.5 and 4.6).
Maltese: Nisa li jistgħu joħorġu tqal iridu jużaw kontraċezzjoni effettiva ħafna waqt li jkunu qed jieħdu VITRAKVI u għal mill-inqas xahar wara li jwaqqfu t-trattament (ara sezzjonijiet 4.5 u 4.6).
English: Larotrectinib had no effect on respiratory function in rats; at exposures (Cmax) at least 8-times the human therapeutic exposure.
Maltese: Larotrectinib ma kellu l-ebda effett fuq ilfunzjoni respiratorja fil-firien; b'esponiment (Cmax) mill-inqas 8 darbiet l-esponiment terapewtiku filbniedem.
English: In vitro studies indicate that larotrectinib is not a substrate for either OATP1B1 or OATP1B3.
Maltese: Studji in vitro jindikaw li larotrectinib la huwa sottostrat għal OATP1B1 u lanqas għal OATP1B3.
English: In order to further confirm the appropriate dose recommended in paediatric patients, the MAH should submit an updated pop PK model based on additional PK sampling in patients aged 1 month to 6 years from study LOXO-TRK-15003 (SCOUT).
Maltese: Sabiex tiġi kkonfermata aktar id-doża xierqa rakkomandata f'pazjenti pedjatriċi, ilMAH għandu jissottometti mudell pop PK aġġornat ibbażat fuq teħid ta' kampjuni PK addizzjonali f'pazjenti b'età minn xahar sa 6 snin mill-istudju LOXO-TRK15003 (SCOUT).
English: Clinical data in healthy adult subjects indicate that co-administration of VITRAKVI (100 mg twice daily for 10 days) increased the Cmax and AUC of oral midazolam 1.7-fold compared to midazolam alone, suggesting that larotrectinib is a weak inhibitor of CYP3A.
Maltese: Data klinika dwar individwi adulti f'saħħithom tindika li l-għoti flimkien ta' VITRAKVI (100 mg darbtejn kuljum għal 10 ijiem) żied is-Cmax u l-AUC ta' midazolam orali b'1.7 darbiet meta mqabbel ma' midazolam waħdu, li jissuġġerixxi li larotrectinib huwa inibitur dgħajjef ta' CYP3A.
English: This being a conditional marketing authorisation and pursuant to Article 14a of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14a tarRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: glioblastoma and astrocytoma) with investigator tumour response assessment a GIST: gastrointestinal stromal tumour b brain metastases observed in one thyroid, one NSCLC, and one SCLC patient c NSCLC: non-small cell lung cancer d SCLC: small cell lung cancer
Maltese: VITRAKVI bħala monoterapija huwa indikat għat-trattament ta' pazjenti adulti u pedjatriċi b'tumuri solidi li juru fużjoni tal-ġene ta' Neurotrophic Tyrosine Receptor Kinase (NTRK):
English: Children and adolescents
Maltese: Adolexxenti
English: Bone sarcoma (n=1) Pancreas (n=1)
Maltese: Nefroma mesoblastika konġenitali (n=1) Melanoma (n=1)
English: Soft tissue sarcomaa Salivary glanda Infantile fibrosarcomaa Thyroida
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata.
English: VITRAKVI is a clear yellow to orange oral solution.
Maltese: Soluzzjoni ċara safra sa oranġjo.
English: Each mL of oral solution contains larotrectinib sulfate, equivalent to 20 mg of larotrectinib.
Maltese: Kull mL ta' soluzzjoni orali fih larotrectinib sulfate, ekwivalenti għal 20 mg ta' larotrectinib.
English: 50 mg twice daily
Maltese: 50 mg/m darbtejn kuljum
English: Neurologic reactions including dizziness, gait disturbance and paraesthesia were reported in patients receiving larotrectinib (see section 4.8).
Maltese: Reazzjonijiet newroloġiċi li jinkludu sturdament, disturb fil-mixi u parasteżija ġew irrappurtati f'pazjenti li kienu qed jirċievu larotrectinib (ara sezzjoni 4.8).
English: Gastrointestinal stromal tumoura Bone sarcomaa Cholangiocarcinomaa
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Table 5: Pooled efficacy results in solid tumours including and excluding primary CNS tumours Efficacy parameter
Maltese: Riżultati tal-effikaċja miġbura f'daqqa f'tumuri solidi inklużi u esklużi tumuri primarji tas-CNS
English: Use a 1 mL syringe with 0.1 mL marks for doses less than 1 mL.
Maltese: Uża siringa ta' 1 mL b'marki ta' 0.1 mL għal dożi inqas minn 1 mL.
English: - For doses below 1 mL a 1 mL oral syringe should be used.
Maltese: - Għal dożi inqas minn 1 mL għandha tintuża siringa orali ta' 1 mL.
English: saquinavir, rifabutin, efavirenz - a medicine used to treat depression called nefazodone - medicines used to treat epilepsy called phenytoin, carbamazepine, phenobarbital - a herbal medicine used to treat depression called St. John's wort - a medicine used to treat tuberculosis called rifampicin - a medicine used for strong pain relief called alfentanil - medicines used to prevent organ rejection after an organ transplant called ciclosporin, sirolimus,
Maltese: użati biex jittrattaw infezzjonijiet ikkawżati minn fungi jew batterja - mediċina msejħa ketoconazole, użata biex tittratta s-sindrome ta' Cushing - mediċini msejħa atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, rifabutin, efavirenz, użati biex jittrattaw infezzjoni tal-HIV - mediċina msejħa nefazodone, użata biex tittratta d-depressjoni - mediċini msejħa phenytoin, carbamazepine, phenobarbital, użati biex jittrattaw l-epilessija - mediċina mill-ħxejjex imsejħa St.
English: Infantile fibrosarcoma (n=13)
Maltese: Fibrosarkoma infantili (n=13) Sarkoma tat-tessut artab (n=11) Primarju tas-CNS (n=5)
English: Common (may affect up to 1 in 10 people): - change in how things taste (dysgeusia) - increased amount of “alkaline phosphatase” in blood tests (very common in children).
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10): - bidla fit-togħma (dysgeusia) - żieda fl-ammont ta' “alkaline phosphatase” fit-testijiet tad-demm (komuni ħafna fit-tfal).
English: No effects on female reproductive organs were seen in the 3-months toxicity studies in rats and monkeys at doses corresponding to approximately 3-times (female rats) and 17-times (female monkeys) the human AUC at the recommended clinical dose.
Maltese: Ma kinux osservati effetti fuq l-organi riproduttivi tan-nisa fl-istudji ta' 3 xhur dwar l-effett tossiku fil-firien u xxadini b'dożi li jikkorrispondu għal madwar 3 darbiet (firien nisa) u madwar 17-il darba (xadini nisa) l-AUC tal-bniedem bid-doża klinika rakkomandata.
English: Breast-feeding should be discontinued during treatment with VITRAKVI and for 3 days following the final dose.
Maltese: It-treddigħ għandu jitwaqqaf waqt it-trattament b'VITRAKVI u għal 3 ijiem wara d-doża finali.
English: The highest reported grade was Grade 3 for adverse reactions anaemia, weight increased, fatigue, increased AST, dizziness, paraesthesia, nausea, myalgia, and leukocyte count decreased.
Maltese: Grad 3 kien logħla grad irrappurtat għar-reazzjonijiet avversi anemija, żieda fil-piż tal-ġisem, għeja, żieda fl-AST, sturdament, parasteżija, dardir, uġigħ fil-muskoli, u tnaqqis fl-għadd ta' lewkoċiti.
English: Effects of other agents on larotrectinib
Maltese: Effetti ta' sustanzi oħra fuq larotrectinib
English: Mean clearance (CL) of larotrectinib was approximately 34 L/h following intravenous administration of an IV microtracer in conjunction with a 100 mg oral dose of VITRAKVI.
Maltese: It-tneħħija (CL - clearance) medja ta' larotrectinib kienet bejn wieħed u ieħor 34 L/siegħa wara l-għoti fil-vina ta' mikrotraċċatur IV flimkien ma' doża orali ta' 100 mg ta' VITRAKVI.
English: Dose modification
Maltese: Modifikazzjoni fiddoża
English: Paediatric patients (n=37)
Maltese: (n=37)
English: It is unknown whether larotrectinib/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk larotrectinib/metaboliti jiġux eliminati fil-ħalib tas-sider tal-bniedem.
English: ALT and AST increase were reported in patients receiving larotrectinib (see section 4.8).
Maltese: Żieda fl-ALT u l-AST kienet irrappurtata f'pazjenti li kienu qed jirċievu larotrectinib (ara sezzjoni 4.8).
English: Table 4: Clinical studies contributing to the efficacy analyses in solid and primary CNS tumours Study name, design and patient population
Maltese: Tabella 4: Studji kliniċi li jikkontribwixxu għall-analiżi tal-effikaċja f'tumuri solidi u primarji tas-CNS
English: After the inhibitor has been discontinued for 3 to 5 elimination half-lives, VITRAKVI should be resumed at the dose taken prior to initiating the CYP3A4 inhibitor (see section 4.5).
Maltese: Wara li l-inibitur ikun twaqqaf għal 3 sa 5 half-lives tal-eliminazzjoni, VITRAKVI għandu jinbeda mill-ġdid bid-doża meħuda qabel ma nbeda l-inibitur ta' CYP3A4
English: Printing ink
Maltese: Modifikazzjoni fid-doża
English: Use a 5 mL syringe with 0.2 mL marks for doses of 1 mL or more.
Maltese: Uża siringa ta' 5 mL b'marki ta' 0.2 mL għal dożi ta' 1 mL jew aktar.
English: Dizziness Paraesthesia Gait disturbance
Maltese: Disturbi taddemm u tassistema limfatika
English: NR: not reached + denotes ongoing a Independent review committee analysis by RECIST v1.1 for solid tumours except primary CNS tumours (93 patients).
Maltese: NR: ma ntlaħaqx + jindika li għadu għaddej a Valutazzjoni ta' kumitat ta' analiżi indipendenti skont RECIST v1.1 għal tumuri solidi minbarra tumuri primarji tas-CNS
English: Neonate
Maltese: Pulmuna
English: VITRAKVI 25 mg hard capsules Each hard capsule contains larotrectinib sulfate equivalent to 25 mg of larotrectinib.
Maltese: Kull kapsula iebsa fiha larotrectinib sulfate ekwivalenti għal 25 mg ta' larotrectinib.
English: Blood and lymphatic system disorders
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: Males of reproductive potential with a non-pregnant woman partner of child bearing potential should be advised to use highly effective contraception during treatment with VITRAKVI and for at least one month after the final dose (see section 4.6).
Maltese: Irġiel b'potenzjal riproduttiv li għandhom sieħba mara mhux tqila li jista' jkollha t-tfal għandhom jingħataw parir biex jużaw kontraċezzjoni effettiva ħafna waqt it-trattament b'VITRAKVI u għal millinqas xahar wara l-aħħar doża (ara sezzjoni 4.6).
English: - For doses of 1 mL and higher a 5 mL oral syringe should be used.
Maltese: - Għal dożi ta' 1 mL u aktar għandha tintuża siringa orali ta' 5 mL.
English: These resultant novel chimeric oncogenic proteins are aberrantly expressed, driving constitutive kinase activity subsequently activating downstream cell signalling pathways involved in cell proliferation and survival leading to TRK fusion-positive cancer.
Maltese: Dawn il-proteini kimeriċi onkoġeniċi ġodda li jirriżultaw huma espressi b'mod mhux normali u jmexxu attività kostituttiva ta' kinase li sussegwentement jattivaw mogħdijiet ta' sinjalar taċ-ċelluli downstream involuti fil-proliferazzjoni u s-sopravivenza taċ-ċelluli li jwasslu għall-kanċer pożittiv għall-fużjoni ta' TRK.
English: The pooled efficacy results for overall response rate, duration of response and time to first response, in the primary analysis population (n=93) and with post-hoc addition of primary CNS tumours (n=9) resulting in the pooled population (n=102), are presented in Table 5 and Table 6.
Maltese: Ir-riżultati tal-effikaċja miġbura f'daqqa għar-rata ta' rispons globali, it-tul tar-rispons u ż-żmien salewwel rispons, fil-popolazzjoni tal-analiżi primarja (n=93) u b'żieda post-hoc ta' tumuri primarji tasCNS (n=9) li jwasslu għall-popolazzjoni miġbura f'daqqa (n=102), huma ppreżentati fit-Tabella 5 u tTabella 6.
English: a Grade 4 reactions were reported
Maltese: a Kienu rrappurtati reazzjonijiet ta' grad 4
English: Nausea Vomiting
Maltese: Kolanġjokarsinomaa
English: In 85 patients with wide molecular characterisation before larotrectinib treatment, the ORR in 48 patients who had other genomic alterations in addition to NTRK gene fusion was 58%, and in 37 patients without other genomic alterations ORR was 84%.
Maltese: F'85 pazjent b'karatterizzazzjoni molekulari wiesgħa qabel it-trattament b'larotrectinib, l-ORR fi 48 pazjent li kellhom tibdil ġenomiku ieħor flimkien ma' fużjoni tal-ġene NTRK kienet ta' 58%, u f'37 pazjent mingħajr tibdil ġenomiku ieħor l-ORR kienet ta' 84%.
English: Table 7: Recommended tube dimensions per age group Patient
Maltese: Daqsijiet rakkomandati tat-tubu għal kull grupp ta' età
English: For volumes less than 1 mL use a 1 mL oral syringe with 0.1 mL graduation.
Maltese: Għal volumi ta' inqas minn 1 mL uża siringa orali ta' 1 mL b'marki ta' 0.1 mL.
English: 25 mg/m2 twice daily
Maltese: 100 mg darba kuljum25 mg/m2 darbtejn kuljum
English: Analysis in solid tumours excluding primary CNS tumours (n=93)a
Maltese: Analiżi f'tumuri solidi inklużi tumuri primarji tas-CNS
English: Each carton contains 1 child-resistant plastic bottle containing 56 hard gelatine capsules.
Maltese: Kull kartuna fiha flixkun wieħed ta' 56 kapsula iebsa.
English: Appendixa
Maltese: Deskrizzjoni
English: How VITRAKVI works
Maltese: X'fih VITRAKVI
English: Primary CNSb
Maltese: Tirojdea Primarju tas-CNS
English: Neutrophil count decreased (Neutropenia)a Leukocyte count decreased (Leukopenia)
Maltese: (Newtropenija)a Tnaqqis fl-għadd ta' lewkoċiti (Lewkopenija)
English: VITRAKVI 100 mg hard capsules Each hard capsule contains larotrectinib sulfate equivalent to 100 mg of larotrectinib.
Maltese: Kull kapsula iebsa fiha larotrectinib sulfate ekwivalenti għal 100 mg ta' larotrectinib.
English: Effect of CYP3A and P-gp inducers on larotrectinib Co-administration of VITRAKVI with strong or moderate CYP3A and P-gp inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or St. John's Wort) may decrease larotrectinib plasma concentrations and should be avoided (see section 4.4).
Maltese: L-għoti ta' VITRAKVI flimkien ma' indutturi qawwija jew moderati ta' CYP3A u P-gp (eż. carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, jew St.
English: - The feeding should be stopped and the tube flushed with at least 10 mL water.
Maltese: - It-tmigħ għandu jitwaqqaf u t-tubu għandu jitlaħlaħ b'mill-inqas 10 mL ilma.
English: The only other kinase activity occurred at 100-fold higher concentrations.
Maltese: L-unika attività oħra ta' kinase seħħet f'konċentrazzjonijiet ta' 100 darba ogħla.
English: All primary CNS tumour patients had received prior cancer treatment (surgery, radiotherapy and/or previous systemic therapy).
Maltese: Il-pazjenti kollha b'tumuri primarji tasCNS kienu rċivew trattament minn qabel għall-kanċer (kirurġija, radjuterapija u/jew terapija sistemika preċedenti).
English: Exercise caution with concomitant use of CYP3A substrates with narrow therapeutic range (e.g. alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, or tacrolimus) in patients taking VITRAKVI.
Maltese: Għandu jkun hemm attenzjoni bl-użu konkomitanti ta' substrati ta' CYP3A b'firxa terapewtika dejqa (eż. alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, jew tacrolimus) f'pazjenti li jieħdu VITRAKVI. Jekk ikun meħtieġ użu konkomitanti ta' dawn issubstrati ta' CYP3A b'firxa terapewtika dejqa f'pazjenti li jkunu qed jieħdu VITRAKVI, jista' jkun meħtieġ tnaqqis fid-doża tas-substrati ta' CYP3A minħabba reazzjonijiet avversi.
English: Clinical relevance of this finding has not been established.
Maltese: Ir-rilevanza klinika ta' din is-sejba ma ġietx stabbilita.
English: In order to further confirm the histology-independent efficacy of larotrectinib and to investigate the primary and secondary resistance mechanisms, the MAH should submit a pooled analysis for the increased sample size including the final report of study LOXO-TRK-15002 (NAVIGATE).
Maltese: Sabiex tiġi kkonfermata aktar l-effikaċja indipendenti mill-istoloġija ta' larotrectinib u biex jiġu investigati l-mekkaniżmi ta' reżistenza primarja u sekondarja, l-MAH għandu jissottometti analiżi miġbura għad-daqs miżjud talkampjun inkluż ir-rapport finali tal-istudju LOXO-TRK-15002 (NAVIGATE).
English: The recommended dose in adults is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs.
Maltese: Id-doża rakkomandata fl-adulti hija ta' 100 mg larotrectinib darbtejn kuljum, sal-progressjoni talmarda jew sakemm isseħħ tossiċità inaċċettabbli.
English: Elderly No dose adjustment is recommended in elderly patients (see section 5.2).
Maltese: Mhux rakkomandat aġġustament fid-doża f'pazjenti anzjani (ara sezzjoni 5.2).
English: No patient permanently discontinued the treatment due to Grade 3-4 ALT and AST increases.
Maltese: L-ebda pazjent ma waqqaf it-trattament b'mod permanenti minħabba żidiet fl-ALT u l-AST ta' Grad 3-4.
English: The recommended dose in paediatric patients is 100 mg/m2 larotrectinib twice daily with a maximum of 100 mg per dose until disease progression or until unacceptable toxicity occurs.
Maltese: Id-doża rakkomandata f'pazjenti pedjatriċi hija ta' 100 mg/m2 larotrectinib darbtejn kuljum b'massimu ta' 100 mg f'kull doża sal-progressjoni tal-marda jew sakemm isseħħ tossiċità inaċċettabbli.
English: Tube diameter for high density feeds
Maltese: Dijametru tat-tubu għal ikliet ta' densità għolja
English: Nasogastric feeding tube - Use a suitable nasogastric feeding tube.
Maltese: Tubu nażo-gastriku għall-għoti tal-ikel - Uża tubu nażo-gastriku għall-għoti tal-ikel xieraq.
English: Dysgeusia
Maltese: Dimeticone
English: Very common Myalgia Muscular weakness
Maltese: Komuni ħafna Uġigħ fil-muskoli Indebboliment muskolari
English: Atriance (nelarabine)
Maltese: Atriance (nelarabina)
English: Further information on Atriance can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/atriance
Maltese: Aktar informazzjoni dwar Atriance tinstab fis-sit web tal-Aġenzija: https://www.ema.europa.eu/en/medicines/human/EPAR/atriance
English: In the second study, involving a total of 40 adults and adolescents above the age of 16.
Maltese: Fit-tieni studju, kien jinvolvi total ta' 40 adult u adoloxxent li għandhom aktar minn 16-il sena.