FrancophonIA/ELRC3.0 huggingface dataset:
English: Each VITRAKVI 100 mg capsule contains 100 mg of larotrectinib (as sulfate).
Maltese: Kull kapsula ta' VITRAKVI 100 mg fiha 100 mg ta' larotrectinb (bħala sulfate).
English: The adverse drug reactions reported in patients treated with VITRAKVI are shown in Table 2 and Table 3.
Maltese: Ir-reazzjonijiet avversi tal-mediċina rrappurtati f'pazjenti ttrattati b'VITRAKVI huma murija fitTabella 2 u t-Tabella 3.
English: Propylene glycol: co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
Maltese: Propylene glycol: l-għoti flimkien ma' kwalunkwe substrat għal alcohol dehydrogenase bħal ethanol jista' jikkaġuna effetti avversi serji fi trabi tat-twelid.
English: The area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of larotrectinib after a single dose in healthy adult subjects were dose proportional up to 400 mg and slightly greater than proportional at doses of 600 to 900 mg.
Maltese: L-erja taħt il-kurva tal-konċentrazzjoni mal-ħin fil-plażma (AUC - area under the plasma concentration-time curve) u l-konċentrazzjoni massima fil-plażma (Cmax - maximum plasma concentration) ta' larotrectinib wara doża waħda f'individwi adulti f'saħħithom kienu proporzjonali mad-doża sa 400 mg u ftit iktar minn proporzjonali b'dożi ta' 600 mg sa 900 mg.
English: There are no clinical data on the effect of larotrectinib on fertility.
Maltese: M'hemmx data klinika dwar l-effett ta' larotrectinib fuq il-fertilità.
English: Effect of larotrectinib on other transporter substrates In vitro studies indicate that larotrectinib is an inhibitor of OATP1B1.
Maltese: Effett ta' larotrectinib fuq substrati ta' trasportaturi oħra Studji in vitro jindikaw li larotrectinib huwa inibitur ta' OATP1B1.
English: Patients with primary CNS tumours
Maltese: Pazjenti b'tumuri primarji tas-CNS
English: Based on population pharmacokinetic analyses exposure (Cmax and AUC) in paediatric patients (1 month to <3 months of age) at the recommended dose of 100 mg/m2 with a maximum of 100 mg BID was 3-fold higher than in adults (≥18 years of age) given the dose of 100 mg BID.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni l-esponiment (Cmax u AUC) f'pazjenti pedjatriċi (b'età minn xahar sa <3 xhur) bid-doża rakkomandata ta' 100 mg/m2 b'massimu ta' 100 mg BID kien 3 darbiet ogħla minn dak fl-adulti (età ta' ≥18-il sena) mogħtija d-doża ta' 100 mg BID.
English: Doses up to 100 mg/m2 twice daily (25 mg, 100 mg capsules or 20 mg/mL oral solution)
Maltese: Dożi sa 100 mg/m2 darbtejn kuljum (kapsuli ta' 25 mg, 100 mg jew soluzzjoni orali ta' 20 mg/mL)
English: Larotrectinib had minimal activity in cell lines with point mutations in the TRKA kinase domain, including the clinically identified acquired resistance mutation, G595R.
Maltese: Ġew osservati mutazzjonijiet ta' reżistenza akkwistata wara progressjoni fuq inibituri ta' TRK. Larotrectinib kellu attività minima f'linji ta' ċelluli b'mutazzjonijiet f'punt fid-dominju ta' TRKA kinase, inkluża l-mutazzjoni ta' reżistenza akkwistata identifikata klinikament, G595R.
English: Missed dose
Maltese: Ilma ppurifikat
English: The safety profile in the paediatric population (< 18 years) was consistent in types of reported adverse reactions to those observed in the adult population.
Maltese: Il-profil tassigurtà fil-popolazzjoni pedjatrika (< 18-il sena) kien konsistenti fit-tipi ta' reazzjonijiet avversi rrappurtati ma' dawk osservati fil-popolazzjoni adulta.
English: Each mL of oral solution contains 20 mg of larotrectinib (as sulfate).
Maltese: Kull mL ta' soluzzjoni orali fih 20 mg ta' larotrectinib (bħala sulfate).
English: In 36 healthy adult subjects receiving single doses ranging from 100 mg to 900 mg, VITRAKVI did not prolong the QT interval to any clinically relevant extent.
Maltese: F'36 individwu adulti f'saħħithom li kienu qed jirċievu dożi waħdiena li jvarjaw minn 100 mg sa 900 mg, VITRAKVI ma estendiex l-intervall QT għal xi punt klinikament rilevanti.
English: An increase in larotrectinib Cmax and AUC0-inf, of 1.25 and 1.46-fold respectively was observed in renally impaired subjects versus those with normal renal function.
Maltese: F'individwi b'indeboliment tal-kliewi ġiet osservata żieda fis-Cmax u l-AUC0-inf ta' larotrectinib ta' 1.25 u 1.46 darbiet aktar rispettivament meta mqabbel ma' dawk b'funzjoni normali tal-kliewi.
English: Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with rifampin (a strong CYP3A and P-gp inducer) 600 mg twice daily for 11 days decreased larotrectinib Cmax and AUC by 71% and 81%, respectively.
Maltese: Data klinika dwar individwi adulti f'saħħithom tindika li l-għoti ta' doża waħda ta' 100 mg VITRAKVI flimkien ma'rifampin (induttur qawwi ta' CYP3A u P-gp) 600 mg darbtejn kuljum għal 11-il jum naqqas is-Cmax u l-AUC ta' larotrectinib b'71% u 81%, rispettivament.
English: 100 mg twice daily (25 mg, 100 mg capsules or 20 mg/mL oral solution)
Maltese: 100 mg darbtejn kuljum (kapsuli ta' 25 mg, 100 mg jew soluzzjoni orali ta' 20 mg/mL)
English: Common Blood alkaline phosphatase increased a Infant/toddlers (28 days to 23 months): one Grade 4 Neutrophil count decreased (Neutropenia) reaction reported.
Maltese: Żieda fl-alkaline phosphatase fid demm a Trabi/tfal żgħar (28 jum sa 23 xahar): kienet irrappurtata reazzjoni waħda ta' tnaqqis fl-għadd ta' Newtrofili (Newtropenija) ta' Grad 4.
English: No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A) (see section 5.2).
Maltese: Mhux rakkomandat aġġustament fid-doża għall-pazjenti b'indeboliment ħafif (Child-Pugh A) tal-fwied (ara sezzjoni 5.2).
English: - For instructions for use of oral syringes and feeding tubes see section 6.6.
Maltese: - Għal istruzzjonijiet dwar l-użu ta' siringi orali u tubi għall-għoti tal-ikel ara s-sezzjoni 6.6.
English: Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with itraconazole (a strong CYP3A inhibitor and P-gp and BCRP inhibitor) 200 mg once daily for 7 days increased larotrectinib Cmax and AUC by 2.8-fold and 4.3-fold, respectively.
Maltese: Data klinika dwar individwi adulti f'saħħithom tindika li l-għoti ta' doża waħda ta' 100 mg VITRAKVI flimkien ma' itraconazole (inibitur qawwi ta' CYP3A u inibitur ta' P-gp u BCRP) 200 mg darba kuljum għal 7 ijiem żied is-Cmax u l-AUC ta' larotrectinib bi 2.8 darbiet u b'4.3 darbiet, rispettivament.
English: SD: stable disease + denotes ongoing response a independent review committee analysis by RECIST v1.1 b patients with a primary CNS tumour were evaluated per investigator assessment using either RANO or RECIST v1.1
Maltese: SD: marda stabbli + jindika rispons kontinwu a valutazzjoni ta' kumitat ta' analiżi indipendenti skont RECIST v1.1 b pazjenti b'tumur primarju tas-CNS ġew evalwati skont il-valutazzjoni tal-investigatur bl-użu ta' kriterji RANO jew
English: Of 125 patients in the overall safety population who received VITRAKVI, 28 (22%) patients were 65 years or older and 8 (6%) patients were 75 years or older.
Maltese: Minn 125 pazjenti fil-popolazzjoni globali tas-sigurtà li rċevew VITRAKVI, 28 (22%) pazjent kellhom 65 sena jew aktar u 8 (6%) pazjenti kellhom 75 sena jew aktar.
English: A pharmacokinetic study was conducted in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, and in healthy adult control subjects with normal hepatic function matched for age, body mass index and sex. All subjects received a single 100 mg dose of larotrectinib.
Maltese: Twettaq studju farmakokinetiku f'individwi b'indeboliment tal-fwied ħafif (Child-Pugh A), moderat (Child-Pugh B) u sever (Child-Pugh C), u f'individwi adulti f'saħħithom bħala kontroll b'funzjoni talfwied normali mqabbla għall-età, indiċi tal-massa tal-ġisem u sess.
English: • Adult patients (≥ 18 years) with advanced solid tumours with an NTRK gene fusion
Maltese: • Pazjenti adulti (≥ 18-il sena) b'tumuri solidi avvanzati b'fużjoni ta' ġene
English: The adverse drug reactions are classified according to the System Organ Class.
Maltese: Ir-reazzjonijiet avversi tal-mediċina huma klassifikati skont il-Klassi tas-Sistemi u tal-Organi.
English: White opaque hard gelatine capsule, size 2 (18 mm long x 6 mm wide), with blue printing of BAYER-cross and “LARO 25 mg” on body of capsule.
Maltese: Kapsula iebsa tal-ġelatina, bajda, opaka, b'daqs ta' 2 (twila 18 mm x wiesa' 6 mm), bi stampar blu tassalib ta' BAYER u “LARO 25 mg” fuq il-parti prinċipali tal-kapsula.
English: There was not enough data to investigate the potential influence of race on the systemic exposure of larotrectinib.
Maltese: Ma kienx hemm biżżejjed data biex tiġi investigata l-influwenza potenzjali tar-razza fuq l-esponiment sistemiku għal larotrectinib.
English: c Adolescents (12 to <18 years): no Grades 3 and 4 reactions were reported.
Maltese: c Adoloxxenti (12 sa <18-il sena): ma kienet irrappurtata l-ebda reazzjoni ta' Grad 3 u 4.
English: The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as determined by a blinded independent review committee (BIRC).
Maltese: Il-miżuri tarriżultat maġġuri tal-effikaċja kienu r-rata ta' rispons globali (ORR - overall response rate) u t-tul ta' żmien tar-rispons (DOR - duration of response), kif iddeterminat minn kumitat ta' analiżi indipendenti blinded (BIRC - blinded independent review committee).
English: It is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives.
Maltese: Bħalissa mhux magħruf jekk larotrectinib jistax inaqqas l-effikaċja ta' kontraċettivi ormonali li jaġixxu b'mod sistemiku.
English: Adult and paediatric patients with body surface area of at least 1.0 m2
Maltese: Pazjenti adulti u pedjatriċi b'erja tas-superfiċje tal-ġisem ta' mill-inqas 1.0 m2
English: VITRAKVI 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE VITRAKVI 25 mg
English: NSCLC (n=1)c Soft tissue sarcoma (n=1) Thyroid (n=1)
Maltese: GIST (n=2)a NSCLC (n=1)c Sarkoma tat-tessut artab (n=1) Tirojde (n=1)
English: VITRAKVI 100 mg hard capsules
Maltese: VITRAKVI 100 mg kapsuli iebsa
English: 56 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 56 kapsula
English: For volumes of 1 mL and higher use a 5 mL oral syringe with 0.2 mL graduation.
Maltese: Għal volumi ta' 1 mL u aktar uża siringa orali ta' 5 mL b'marki ta' 0.2 mL.
English: Tube length (cm)
Maltese: Rispons sħiħ (CR)
English: Oral syringe - Use a suitable oral syringe with CE marking and bottle adapter (28 mm diameter) if applicable.
Maltese: - Uża siringa orali xierqa b'marki CE u addattatur tal-flixkun (dijametru ta' 28 mm) jekk applikabbli.
English: White opaque hard gelatine capsule, size 0 (22 mm long x 7 mm wide), with blue printing of BAYER-cross and “LARO 100 mg” on body of capsule.
Maltese: Kapsula iebsa tal-ġelatina, bajda, opaka, b'daqs ta' 0 (twila 22 mm x wiesa' 7 mm), bi stampar blu tassalib ta' BAYER u “LARO 100 mg” fuq il-parti prinċipali tal-kapsula.
English: Therefore, it cannot be excluded whether co-administration of larotrectinib with OATP1B1 substrates (e.g. valsartan, statins) may increase their exposure.
Maltese: Għalhekk, ma jistax jiġi eskluż jekk lgħoti ta' larotrectinib flimkien ma' substrati ta' OATP1B1 (eż. valsartan, statins) jistax iżid l esponiment tagħhom.
English: c Paediatric patient (6 months old at enrolment) with locally advanced unresectable infantile fibrosarcoma with complete surgical response.
Maltese: c Pazjent pedjatriku (età ta' 6 xhur meta kien irreġistrat fl-istudju) b'fibrosarkoma infantili avvanzata lokalment li ma' tistax titneħħa u b'rispons kirurġiku sħiħ.
English: Gender did not appear to influence larotrectinib pharmacokinetics to a clinically significant extent.
Maltese: Is-sess ma deherx li jinfluwenza l-farmakokinetika ta' larotrectinib b'mod klinikament sinifikanti.
English: Baseline characteristics for the pooled 93 patients with solid tumours with an NTRK gene fusion were as follows: median age 41 years (range 0.1-78 years); 30% < 18 years of age, and 70% ≥ 18 years;
Maltese: Karatteristiċi tal-linja bażi għat-93 pazjent miġbura flimkien b'tumuri solidi b'fużjoni tal-ġene NTRK kienu kif ġej: età medjana ta' 41 sena (firxa 0.1-78 sena); 30% b'età ta' < 18-il sena, u 70% b'età ta' ≥ 18 -il sena; 70% bojod u 53% irġiel; u ECOG PS ta' 0-1 (89%), jew 2 (11%).
English: 75 mg twice daily
Maltese: 75 mg/m darbtejn kuljum
English: No relevant effects on fertility were observed in repeat-dose toxicity studies (see section 5.3).
Maltese: Ma kinux osservati effetti rilevanti fuq il-fertilità fi studji dwar l-effett tossiku minn dożi ripetuti (ara sezzjoni 5.3).
English: below.
Maltese: JIS.
English: 100 mL oral solution
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 mL soluzzjoni orali
English: The mean volume of distribution of larotrectinib in healthy adult subjects was 48 L following intravenous administration of an IV microtracer in conjunction with a 100 mg oral dose, indicating moderate distribution into tissues from the plasma.
Maltese: Il-volum medju ta' distribuzzjoni ta' larotrectinib f'individwi adulti f'saħħithom kien ta' 48 L wara lgħoti fil-vina ta' mikrotraċċatur IV flimkien ma' doża orali ta' 100 mg, li jindika distribuzzjoni moderata fit-tessuti mill-plażma.
English: Sorbitol: patients with hereditary fructose intolerance (HFI) should not take this medicinal product.
Maltese: Sorbitol: pazjenti li għandhom intolleranza ereditarja għall-fructose (HFI - hereditary fructose intolerance) m'għandhomx jieħdu dan il-prodott mediċinali.
English: It is used in adults, adolescents and children to treat solid tumours (cancer) in various parts of the body that are caused by a change in the NTRK gene (neurotrophic tyrosine receptor kinase).
Maltese: Jintuża f'adulti, adolexxenti u tfal biex jittratta tumuri solidi (kanċer) f'diversi partijiet tal-ġisem li huma kkawżati minn bidla fil-ġene NTRK (neurotrophic tyrosine receptor kinase).
English: Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with a single dose of 600 mg rifampin (a P-gp and BCRP inhibitor) increased larotrectinib Cmax and AUC by 1.8-fold and 1.7-fold, respectively.
Maltese: Data klinika dwar individwi adulti f'saħħithom tindika li l-għoti ta' doża waħda ta' 100 mg VITRAKVI flimkien ma' doża waħda ta' 600 mg rifampin (inibitur ta' P-gp u BCRP) żied is-Cmax u lAUC ta' larotrectinib b'1.8 darbiet u b'1.7 darbiet, rispettivament.
English: Alanine aminotransferase (ALT) increased Aspartate aminotransferase (AST) increased Weight increased (Abnormal weight gain) Blood alkaline phosphatase increased
Maltese: Żieda fl-aspartate aminotransferase (AST) Żieda fil-piż (Żieda mhux normali filpiż)
English: Myalgia Muscular weakness
Maltese: Uġigħ fil-muskoli
English: • Phase 1/2 multinational, open-label, dose escalation and expansion study; Phase 2 expansion cohort required advanced solid tumours with an NTRK gene fusion, including locally advanced infantile fibrosarcoma
Maltese: Il-koorti ta' espansjoni ta' Fażi 2 kienet teħtieġ tumuri solidi avvanzati b'fużjoni ta' ġene NTRK, inkluża fibrosarkoma infantili avvanzata lokalment
English: Clear yellow to orange solution.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni orali.
English: - The maximum recommended dose is 100 mg (5 mL), two times a day.
Maltese: - Id-doża massima rakkomandata hija ta' 100 mg (5 mL), darbtejn kuljum.
English: Larotrectinib had no neurobehavioural findings in adult animals (rats, mice, cynomolgus monkeys) at exposure (Cmax) at least 7-fold higher than the human exposure.
Maltese: Larotrectinib ma kellu l-ebda riżultat newroloġiku u ta' mġieba f'annimali adulti (firien, ġrieden, xadini cynomolgus) b'esponiment (Cmax) mill-inqas 7 darbiet ogħla mill-esponiment fil-bniedem.
English: Very common Dizziness Paraesthesia
Maltese: Komuni ħafna Sturdament Parasteżija
English: Each carton contains one bottle of 100 mL oral solution.
Maltese: Kull kartuna fiha flixkun wieħed ta' 100 mL ta' soluzzjoni orali.
English: Withholding, reducing, or discontinuing VITRAKVI dosing should be considered, depending on the severity and persistence of these symptoms (see section 4.2).
Maltese: Għandhom jiġu kkunsidrati twaqqif temporanju, tnaqqis jew twaqqif permanenti tad-dożaġġ ta' VITRAKVI, skont is-severità u lpersistenza ta' dawn is-sintomi (ara sezzjoni 4.2).
English: Pancreasa
Maltese: Pożoloġija
English: As it is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives, women using systemically acting hormonal contraceptives should be advised to add a barrier method.
Maltese: Peress li bħalissa mhux magħruf jekk larotrectinib jistax inaqqas l-effikaċja ta' kontraċettivi ormonali li jaġixxu b'mod sistemiku, nisa li jużaw kontraċettivi ormonali li jaġixxu b'mod sistemiku għandhom jingħataw parir biex iżidu metodu ta' barriera.
English: Elderly There are limited data in elderly.
Maltese: Hemm data limitata fl-anzjani.
English: VITRAKVI contains the active substance larotrectinib.
Maltese: Gћalxiex jintuża VITRAKVI VITRAKVI fih is-sustanza attiva larotrectinib.
English: All patients had received prior treatment for their cancer, defined as surgery, radiotherapy, or systemic therapy.
Maltese: Il-pazjenti kollha kienu rċivew trattament minn qabel għallkanċer tagħhom, definit bħala kirurġija, radjuterapija, jew terapija sistemika.
English: An increase in larotrectinib AUC0-inf was observed in subjects with mild, moderate and severe hepatic impairment of 1.3, 2 and 3.2-fold respectively versus those with normal hepatic function.
Maltese: F'individwi b'indeboliment tal-fwied ħafif, moderat u sever kienet osservata żieda fl-AUC0-inf ta' larotrectinib ta' 1.3, 2 u 3.2 darbiet aktar rispettivament meta mqabbel ma' dawk b'funzjoni normali tal-fwied.
English: Bayer S.p.A. Tel: +39 02 397 8 1
Maltese: Tel: +39 02 397 8 1
English: VITRAKVI 25 mg hard capsules
Maltese: VITRAKVI 25 mg kapsuli ibsin
English: Biliary (n=2) SCLC (n=1)b, d Appendix (n=1) Breast (n=1)
Maltese: SCLC (n=1)b, d Musrana l-għamja (n=1)
English: Aspartate aminotransferase (AST) increased
Maltese: Żieda fl-aspartate aminotransferase
English: tacrolimus - a medicine used to treat an abnormal heart rhythm called quinidine - medicines used to treat migraines called dihydroergotamine, ergotamine - a medicine used to treat long-term pain called fentanyl - a medicine used to control involuntary movements or sounds called pimozide - a medicine to help you stop smoking called bupropion - medicines to reduce blood sugar levels called repaglinide, tolbutamide - a medicine that prevents blood clots called warfarin - a medicine used to reduce the amount of acid produced in the stomach called omeprazole - a medicine used to help control high blood pressure called valsartan - a group of medicines used to help lower cholesterol called statins - hormonal medicines used for contraception, see section “contraception - for men and women”
Maltese: John's wort, użata biex tittratta d-depressjoni - mediċina msejħa rifampicin, użata biex tittratta t-tuberkulosi - mediċina msejħa alfentanil, użata għal serħan minn uġigħ qawwi - mediċini msejħa ciclosporin, sirolimus, tacrolimus, użati biex jipprevjenu r-rifjut tal-organu wara trapjant ta' organu - mediċina msejħa quinidine, użata biex tittratta ritmu tal-qalb mhux normali - mediċini msejħa dihydroergotamine, ergotamine, użati biex jittrattaw l-migranja - mediċina msejħa fentanyl, użata biex tittratta uġigħ fit-tul - mediċina msejħa pimozide, użata biex tikkontrolla movimenti jew ħsejjes involontarji - mediċina msejħa bupropion biex tgħinek tieqaf tpejjep - mediċini msejħa repaglinide, tolbutamide, biex inaqqsu l-livelli taz-zokkor fid-demm - mediċina msejħa warfarin li tipprevjeni emboli tad-demm - mediċina msejħa omeprazole, użata biex tnaqqas l-ammont ta' aċidu magħmul fl-istonku - mediċina msejħa valsartan, użata biex tgħin tikkontrolla l-pressjoni għolja - grupp ta' mediċini msejħa statins użati biex jgħinu jbaxxu l-kolesterol - mediċini ormonali użati għall-kontraċezzjoni, ara s-sezzjoni “kontraċezzjoni - għall-irġiel u għan-nisa” hawn taħt.
English: VITRAKVI 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE VITRAKVI 100 mg
English: A pharmacokinetic study was conducted in subjects with end stage renal disease requiring dialysis, and in healthy adult control subjects with normal renal function matched for age, body mass index and sex. All subjects received a single 100 mg dose of larotrectinib.
Maltese: Twettaq studju farmakokinetiku f'individwi b'marda tal-kliewi tal-aħħar stadju li jeħtieġu d-dijalisi, u f'individwi adulti f'saħħithom bħala kontroll b'funzjoni tal-kliewi normali mqabbla għall-età, indiċi tal-massa tal-ġisem u sess.
English: • Adult and paediatric patients ≥ 12 years with advanced solid tumours with an NTRK gene fusion
Maltese: • Pazjenti adulti u pedjatriċi ta' ≥ 12-il sena b'tumuri solidi avvanzati, b'fużjoni ta' ġene NTRK
English: Growth and nervous system effects were seen at 0.5- to 4-times the AUC at the recommended dose.
Maltese: L-effetti fuq it-tkabbir u s-sistema nervuża kienu osservati b'0.5 sa 4 darbiet l-AUC bid-doża rakkomandata.
English: [range]
Maltese: (ALT)
English: Ελλάδα Bayer Ελλάς ΑΒΕΕ
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Bayer AG
English: Paediatric patients with body surface area less than 1.0 m2
Maltese: Pazjenti pedjatriċi b'erja tassuperfiċje tal-ġisem ta' inqas minn 1.0 m2
English: Effect of larotrectinib on substrates of PXR regulated enzymes In vitro studies indicate that larotrectinib may induce PXR regulated enzymes (e.g. CYP2C family and UGT).
Maltese: Effett ta' larotrectinib fuq substrati ta' enzimi regolati minn PXR Studji in vitro jindikaw li larotrectinib jista' jinduċi enzimi regolati minn PXR (eż. il-familja ta' CYP2C u UGT). L-għoti ta' larotrectinib flimkien ma' substrati ta' CYP2C8, CYP2C9 jew CYP2C19 (eż. repaglinide, warfarin, tolbutamide jew omeprazole) jista' jnaqqas l-esponiment tagħhom.
English: Alanine aminotransferase (ALT) increaseda Aspartate aminotransferase (AST) increased
Maltese: Investigazzjonijiet Komuni ħafna Żieda fl-alanine aminotransferase (ALT)
English: Each capsule contains larotrectinib sulfate, equivalent to 100 mg of larotrectinib.
Maltese: Kull kapsula fiha larotrectinib sulfate, ekwivalenti għal 100 mg ta' larotrectinib.
English: Table 2: Adverse drug reactions reported in TRK fusion-positive cancer patients treated with VITRAKVI at recommended dose (n=125)
Maltese: Tabella 2: Reazzjonijiet avversi tal-mediċina rrappurtati f'pazjenti b'kanċer pożittiv għallfużjoni ta' TRK ittrattati b'VITRAKVI bid-doża rakkomandata (n=125) Klassi tas-sistemi u tal-organi
English: Each capsule contains larotrectinib sulfate, equivalent to 25 mg of larotrectinib.
Maltese: Kull kapsula fiha larotrectinib sulfate, ekwivalenti għal 25 mg ta' larotrectinib.
English: In in vitro and in vivo tumour models, larotrectinib demonstrated anti-tumour activity in cells with constitutive activation of TRK proteins resulting from gene fusions, deletion of a protein regulatory domain, or in cells with TRK protein overexpression.
Maltese: F'mudelli in vitro u in vivo ta' tumuri, larotrectinib wera attività kontra t-tumur f'ċelluli b'attivazzjoni kostituttiva tal-proteini TRK li tirriżulta minn fużjonijiet tal-ġeni, tħassir ta' dominju regolatorju tal-proteina, jew f'ċelluli b'espressjoni żejda ta' proteini TRK
English: Permanent discontinuation of VITRAKVI for treatment emergent adverse reactions, regardless of attribution occurred in 3% of patients (one case each of ALT increase, AST increase, intestinal perforation, jaundice, small intestinal obstruction).
Maltese: Twaqqif permanenti ta' VITRAKVI minħabba reazzjonijiet avversi li ħarġu mat-trattament, irrispettivament mill-attribuzzjoni seħħ fi 3% tal-pazjenti (każ wieħed kull wieħed għal żieda fl-ALT, żieda fl-AST, perforazzjoni intestinali, suffejra, ostruzzjoni tal-musrana ż-żgħira).