FrancophonIA/ELRC3.0 huggingface dataset:
English: The PFS benefit was consistent for patients with CNS metastases at baseline (HR = 0.40, 95% CI: 0.25-0.64, median PFS for Alecensa = NE, 95% CI: 9.2-NE, median PFS for crizotinib = 7.4 months, 95%CI: 6.6-9.6) and without CNS metastases at baseline (HR = 0.51, 95% CI: 0.33-0.80, median PFS for Alecensa = NE, 95% CI: NE, NE, median PFS for crizotinib = 14.8 months, 95% CI:10.8-20.3), indicating benefit of Alecensa over crizotinib in both subgroups.
Maltese: Il-benefiċċju ta' PFS kien konsistenti għall-pazjenti b'metastasi fis-CNS fil-linja bażi (HR = 0.40, CI ta' 95%: 0.25-0.64, PFS medjana għal Alecensa = NE, CI ta' 95%: 9.2-NE, PFS medjana għal crizotinib = 7.4 xhur, CI ta' 95%: 6.6-9.6) u mingħajr metastasi fis-CNS fil-linja bażi (HR = 0.51, CI ta' 95%: 0.33-0.80, PFS medjana għal Alecensa = NE, CI ta' 95%: NE, NE, PFS medjana għal crizotinib = 14.8 xhur, CI ta' 95%:10.
English: Red iron oxide (E172) Yellow iron oxide (E172) Indigo carmine aluminum lake (E132) Carnauba wax
Maltese: Iron oxide isfar (E172) Indigo carmine aluminum lake (E132) Carnauba wax
English: Efficacy data are summarised in Table 4 and the Kaplan-Meier curve for investigator assessed PFS is shown in Figure 1.
Maltese: Data tal-effikaċja hija miġbura fil-qosor fit-Tabella 4 u l-kurva KaplanMeier għall-PFS evalwata mill-investigatur hija murija fil-Figura 1.
English: ● lung inflammation (pneumonitis).
Maltese: ● infjammazzjoni tal-pulmun (pulmonite).
English: ● Printing ink: red iron oxide (E172), yellow iron oxide (E172), indigo carmine aluminium lake (E132), carnauba wax, white shellac and glyceryl monooleate.
Maltese: ● Linka għall-istampar: iron oxide aħmar (E172), iron oxide isfar (E172), indigo carmine aluminium lake (E132), carnauba wax, shellac abjad u glyceryl monooleate.
English: ● medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir)
Maltese: ● mediċini li jintużaw biex jikkuraw l-AIDS/HIV (eż. ritonavir, saquinavir)
English: Effects of other medicinal products on alectinib
Maltese: Effetti ta' prodotti mediċinali oħra fuq alectinib
English: Grade 2 or Grade 3 (symptomatic, may be severe and medically significant, medical intervention indicated)
Maltese: Bradikardijaa ta' Grad 2 jew Grad 3 (sintomatika, tista' tkun severa u medikament sinifikanti, intervent mediku indikat)
English: Contraception, pregnancy, and breast-feeding - information for women Contraception - information for women
Maltese: Kontraċezzjoni, tqala, u treddigħ - informazzjoni għan-nisa Kontraċezzjoni - informazzjoni għan-nisa
English: The most common adverse drug reactions (ADRs) (≥ 20%) were constipation (35%), oedema (30%, including oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema), and myalgia (28%, including myalgia and musculoskeletal pain).
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADRs - adverse drug reactions) komuni (≥ 20%) kienu stitikezza (35%), edima (30%, inklużi edima periferali, edima, edima ġeneralizzata, edima fil-kappell tal-għajn, edima madwar l-għajn, edima fil-wiċċ u edima lokalizzata), u majalġja (28%, inklużi majalġja u uġigħ muskolu-skeletriku).
English: Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Maltese: Kull kapsula iebsa fiha alectinib hydrochloride ekwivalenti għal 150 mg alectinib.
English: In 1.2% and 1.5% of the patients, AST and ALT elevations, respectively, led to withdrawal from Alecensa treatment.
Maltese: F'1.2% u 1.5% tal-pazjenti, żidiet f'AST u ALT, rispettivament, wasslu għallwaqfien tat-trattament b'Alecensa.
English: White shellac
Maltese: Shellac abjad
English: * Key secondary endpoints part of the hierarchical testing ** Competing risk analysis of CNS progression, systemic progression and death as competing events *** 2 patients in the crizotinib arm and 6 patients in the alectinib arm had CR CI = confidence interval; CNS = central nervous system; CR = complete response; DOR = duration of response; HR = hazard ratio; IRC = Independent Review Committee; INV = investigator; NE = not estimable; ORR = objective response rate; PFS = progression free survival
Maltese: * Punti finali sekondarji ewlenin li huma parti mill-ittestjar tal-ġerarkija ** Analiżi tar-riskju ta' kompetizzjoni ta' progressjoni għas-CNS, progressjoni sistemika u mewt bħala avvenimenti ta' kompetizzjoni *** 2 pazjenti fil-grupp ta' crizotinib u 6 pazjenti fil-grupp ta' alectinib kellhom CR CI = intervall ta' kunfidenza; CNS = sistema nervuża ċentrali; CR = rispons komplut;
English: CPK elevation > 5 times ULN
Maltese: Żieda ta' CPK ta' > 5 darbiet l-ULN
English: Most of these events were of mild or moderate severity; Grade 3 events were reported for diarrhea (0.7%), nausea (0.5%), and vomiting (0.2%).
Maltese: Il-biċċa l-kbira ta' dawn lavvenimenti kienu ta' severità ħafifa jew moderata; avvenimenti ta' Grad 3 kienu rrappurtati għal dijarea (0.7%), dardir (0.5%), u rimettar (0.2%).
English: The geometric mean steady-state Cmax, Cmin and AUC0-12hr for M4 were approximately 246 ng/mL (45.4%), 222 ng/mL (46.6%) and 2810 ng*h/mL (45.9%), respectively.
Maltese: Il-medja ġeometrika ta' Cmax, Cmin u AUC0-12-il siegħa fi stat fiss għal M4 kienet madwar 246 ng/mL (45.4%), 222 ng/mL (46.6%) u 2810 ng*siegħa/mL (45.9%), rispettivament.
English: Metabolite M1b was detected as a minor metabolite from in vitro and in human plasma in healthy subjects.
Maltese: Il-metabolit M1b kien osservat bħala metabolit minuri in vitro u fil-plażma umana f'individwi f'saħħithom.
English: ● The recommended dose is 3 capsules (450 mg) twice a day.
Maltese: ● Id-doża rakkomandata hija 3 kapsuli (450 mg) darbtejn kuljum.
English: Patients should be monitored for pulmonary symptoms indicative of pneumonitis (see sections 4.2 and 4.4).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sintomi pulmonari li jindikaw pulmonite (ara sezzjonijiet 4.2 u 4.4).
English: In vitro, alectinib and M4 are inhibitors of the efflux transporter Breast Cancer Resistance Protein (BCRP).
Maltese: In vitro, alectinib u M4 huma inibituri tat-trasportatur tal-effluss il-Proteina ta' Reżistenza għallKanċer tas-Sider (BCRP - Breast Cancer Resistance Protein).
English: Alecensa 150 mg hard capsules alectinib
Maltese: Alecensa 150 mg kapsuli iebsin alectinib
English: When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Maltese: Meta Alecensa jingħata flimkien ma' sottostrati ta' P-gp (eż., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib u lapatinib), huwa rakkomandat monitoraġġ xieraq.
English: In vitro, alectinib and its major active metabolite M4 are inhibitors of the efflux transporter P-glycoprotein (P-gp).
Maltese: In vitro, alectinib u l-metabolit attiv maġġuri tiegħu M4 huma inibituri tat-trasportatur tal-effluss ilglikoproteina P (P-gp - P-glycoprotein).
English: The geometric mean Metabolite/Parent ratio at steady state is 0.399.
Maltese: Il-medja ġeometrika tal-proporzjon tal-Metabolit/Sustanza oriġinali fi stat fiss hija 0.399.
English: The majority of these events were of Grade 1 and 2 intensity, and events of Grade ≥ 3 were reported in 3.7% and 3.7% of the patients, respectively.
Maltese: Il-maġġoranza ta' dawn l-avvenimenti kellhom intensità ta' Grad 1 u 2, u avvenimenti ta' Grad ≥ 3 kienu rrappurtati fi 3.7% u 3.7% tal-pazjenti, rispettivament.
English: In the phase III clinical trial BO28984, one patient (0.2%) experienced a Grade 4 event of nausea in the Alecensa arm and the incidence of Grade 3 and 4 events for nausea, vomiting, and diarrhoea was 3.3%, 3.3%, and 2.0%, respectively, in the crizotinib arm.
Maltese: Fil-prova klinika ta' fażi III BO28984, pazjent wieħed (0.2%) kellu avveniment ta' dardir ta' Grad 4 fil-grupp ta' Alecensa u l-inċidenza ta' avvenimenti ta' Grad 3 u 4 għal dardir, rimettar u dijarea kienet ta' 3.3%, 3.3%, u 2.0%, rispettivament, fil-grupp ta' crizotinib.
English: The safety and efficacy of Alecensa in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Alecensa fi tfal u adolexxenti ta' età inqas minn 18-il sena ma ġewx determinati s'issa.
English: The majority of the events were of Grade 1 and 2 intensity; Grade 3 events were reported in 3.2% of the patients.
Maltese: Il-maġġoranza ta' dawn l-avvenimenti kellhom intensità ta' Grad 1 u 2; avvenimenti ta' Grad 3 kienu rrappurtati fi 3.2% tal-pazjenti.
English: Alecensa 600 mg twice daily
Maltese: Alecensa 600 mg darbtejn kuljum
English: Primary efficacy parameters ORR (IRC) in RE population Responders N (%) [95% CI]
Maltese: Parametri primarji tal-effikaċja ORR (IRC) fil-popolazzjoni RE Persuni b'Rispons N (%) [CI ta' 95%]
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 February 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta' Frar 2017
English: The corresponding values for M4 were 217 L/hour and 30.7 hours, respectively.
Maltese: Il-valuri korrispondenti għal M4 kienu 217-il L/siegħa u 30.7 sigħat, rispettivament.
English: Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor.
Maltese: Alectinib huwa inibitur selettiv ħafna u potenti ta' ALK u RET tyrosine kinase.
English: Interstitial lung disease (ILD) / pneumonitis
Maltese: Marda tal-interstizju tal-pulmun (ILD - interstitial lung disease) / pulmonite
English: Alectinib absorbs UV light between 200 and 400 nm and demonstrated a phototoxic potential in an in vitro photosafety test in cultured murine fibroblasts after UVA irradiation.
Maltese: Alectinib jassorbi dawl UV bejn 200 u 400 nm u wera potenzjal fototossiku f'test dwar il-fotosigurtà in vitro f'fibroblasti tal-ġrieden ikkultivati wara irradjazzjoni UVA.
English: The incidence of Grade 3 elevations of CPK was 3.7%.
Maltese: L-inċidenza ta' żidiet ta' CPK ta' Grad 3 kienet ta' 3.7%.
English: Table 3 ADRs reported in Alecensa clinical trials (NP28761, NP28673, BO28984; N=405) and during post-marketing
Maltese: Tabella 3 ADRs irrappurtati fi provi kliniċi b'Alecensa (NP28761, NP28673, BO28984; N=405) u fil-perjodu ta' wara t-tqegħid fis-suq
English: ● The recommended dose is 4 capsules (600 mg) twice a day.
Maltese: ● Id-doża rakkomandata hija 4 kapsuli (600 mg) darbtejn kuljum.
English: In the phase III clinical trial BO28984, Grade 3 or 4
Maltese: Fil-prova klinika ta' fażi III BO28984, ma kinux osservati
English: Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Maltese: Alecensa bħala monoterapija huwa indikat għat-trattament tal-ewwel għażla ta' pazjenti adulti b'kanċer tal-pulmun taċ-ċelluli mhux żgħar (NSCLC - non-small cell lung cancer) avanzat, pożittiv għal anaplastic lymphoma kinase (ALK).
English: Severe myalgia and creatine phosphokinase (CPK) elevation Myalgia or musculoskeletal pain was reported in patients in pivotal trials with Alecensa, including Grade 3 events (see section 4.8).
Maltese: Majalġja severa u żieda ta' creatine phosphokinase (CPK) Majalġja jew uġigħ muskolu-skeletriku kien irrappurtat f'pazjenti fil-provi pivotali b'Alecensa, inklużi avvenimenti ta' Grad 3 (ara sezzjoni 4.8).
English: Based on population pharmacokinetic analysis, the geometric mean (coefficient of variation %) steady-state Cmax, Cmin and AUC0-12hr for alectinib were approximately 665 ng/mL (44.3%), 572 ng/mL (47.8%) and 7430 ng*h/mL (45.7%), respectively.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni, il-medja ġeometrika (koeffiċjent tal-varjazzjoni %) ta' Cmax, Cmin u AUC0-12-il siegħa fi stat fiss għal alectinib kienet madwar 665 ng/mL (44.3%), 572 ng/mL (47.8%) u 7430 ng*siegħa/mL (45.7%), rispettivament.
English: Gastrointestinal disorders Constipation
Maltese: Disturbi gastro-intestinali Stitikezza
English: Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors (including, but not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole nefazodone, grapefruit or Seville oranges).
Maltese: Monitoraġġ xieraq huwa rakkomandat għal pazjenti li jieħdu inibituri qawwija ta' CYP3A fl-istess waqt (inklużi, iżda mhux limitat għal, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole nefazodone, grejpfrut jew larinġ tal-bakkaljaw.
English: Alectinib did not inhibit OATP1B1/OATP1B3, OAT1, OAT3 or OCT2 at clinically relevant concentrations in vitro.
Maltese: Alectinib ma inibixxiex OATP1B1/OATP1B3, OAT1, OAT3 jew OCT2 f'konċentrazzjonijiet klinikament rilevanti in vitro.
English: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 5 times the ULN as well as bilirubin elevations of more than 3 times the ULN occurred in patients in pivotal clinical trials with Alecensa (see section 4.8).
Maltese: Żidiet f'alanine aminotransferase (ALT) u aspartate aminotransferase (AST) ta' aktar minn 5 darbiet lULN kif ukoll żidiet fil-bilirubina ta' aktar minn 3 darbiet l-ULN seħħew f'pazjenti fi provi kliniċi pivotali b'Alecensa (ara sezzjoni 4.8).
English: 12-month cumulative incidence of CNS progression (IRC) [95% CI]
Maltese: Inċidenza kumulattiva ta' progressjoni għas-CNS ta' 12-il xahar (IRC) [CI ta' 95%]
English: No starting dose adjustment is required in patients with underlying mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Maltese: Mhux meħtieġ aġġustament fid-doża tal-bidu f'pazjenti b'indeboliment ħafif (Child-Pugh A) jew moderat (Child-Pugh B) tal-fwied.
English: In vitro, alectinib and M4 show weak time-dependent inhibition of CYP3A4, and alectinib exhibits a weak induction potential of CYP3A4 and CYP2B6 at clinical concentrations.
Maltese: In vitro, alectinib u M4 juru inibizzjoni dgħajfa dipendenti fuq il-ħin ta' CYP3A4, u f'konċentrazzjonijiet kliniċi alectinib juri potenzjal dgħajjef ta' induzzjoni ta' CYP3A4 u CYP2B6.
English: In the phase II clinical trials (NP28761, NP28673; N=253), the median duration of exposure to Alecensa was 11 months.
Maltese: Fil-provi kliniċi ta' fażi II (NP28761, NP28673; N=253), it-tul medjan ta' esponiment għal Alecensa kien ta' 11-il xahar.
English: The safety profile of Alecensa was generally consistent across the pivotal phase III clinical trial BO28984 (ALEX) and phase II trials (NP28761, NP28673).
Maltese: Il-profil tas-sigurtà ta' Alecensa ġeneralment kien konsistenti tul il-prova klinika pivotali ta' fażi III BO28984 (ALEX) u l-provi ta' fażi II (NP28761, NP28673).
English: The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax and AUCinf by 4% and 18%, respectively.
Maltese: L-effett fuq lesponiment ikkombinat għal alectinib u M4 kien żgħir, u naqqas Cmax u AUCinf b'4% u 18%, rispettivament.
English: The primary endpoint was to evaluate the efficacy of Alecensa by Objective Response Rate (ORR) as per central Independent Review Committee (IRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the overall population (with and without prior exposure of cytotoxic chemotherapy treatments).
Maltese: Il-punt finali primarju kien li tiġi evalwata l-effikaċja ta' Alecensa mir-Rata ta' Rispons Oġġettiv (ORR - Objective Response Rate) skont valutazzjoni ta' Kumitat ta' Analiżi Indipendenti (IRCIndependent Review Committee) ċentrali bl-użu ta' Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST - Response Evaluation Criteria in Solid Tumors) verżjoni 1.1 fil-popolazzjoni globali (bi jew mingħajr esponiment minn qabel għal trattamenti b'kimoterapija ċitotossika).
English: Other medicines and Alecensa
Maltese: Mediċini oħra u Alecensa
English: Grade 3 or 4 ALT or AST elevations were each observed in 5% of patients receiving Alecensa versus 15% and 11% of patients receiving crizotinib in the phase III clinical trial BO28984.
Maltese: Żidiet ta' ALT jew AST ta' Grad 3 jew 4 kienu osservati f'5% talpazjenti li kienu qed jirċievu Alecensa kontra 15% u 11% tal-pazjenti li kienu qed jirċievu crizotinib fil-prova klinika ta' fażi III BO28984.
English: ● abnormal results of blood tests to check for liver problems (high levels of alanine aminotransferase, aspartate aminotransferase and bilirubin)
Maltese: ● riżultati mhux normali ta' testijiet tad-demm biex tiċċekkja għal problemi fil-fwied (livelli għoljin ta' alanine aminotransferase, aspartate aminotransferase u bilirubina)
English: ● This means you take a total of 8 capsules (1200 mg) each day.
Maltese: ● Dan ifisser li inti tieħu total ta' 8 kapsuli (1200 mg) kuljum.
English: Effects of alectinib on other medicinal products
Maltese: Effetti ta' alectinib fuq prodotti mediċinali oħra
English: CYP substrates
Maltese: Sottostrati ta' CYP
English: Patients should be monitored for pulmonary symptoms indicative of pneumonitis.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sintomi pulmonari indikattivi ta' pulmonite.
English: Alecensa has not been studied in children or adolescents.
Maltese: Alecensa ma ġiex studjat fi tfal jew adolexxenti.
English: 300 mg twice daily
Maltese: 300 mg darbtejn kuljum
English: Elevations of CPK occurred in pivotal trials with Alecensa, including Grade 3 events (see section 4.8).
Maltese: Żidiet ta' CPK seħħew fil-provi pivotali b'Alecensa, inklużi avvenimenti ta' Grad 3 (ara sezzjoni 4.8).
English: Across clinical trials (NP28761, NP28673, BO28984), 1 out of 405 patients treated with Alecensa (0.2%) had a Grade 3 ILD.
Maltese: Fil-provi kliniċi kollha(NP28761, NP28673, BO28984), 1 minn 405 pazjenti ttrattati b'Alecensa (0.2%) kellhom ILD ta' Grad 3. Dan lavveniment wassal għall-waqfien tat-trattament b'Alecensa.
English: Medicinal products that increase gastric pH
Maltese: Prodotti mediċinali li jżidu l-pH gastriku
English: Alecensa contains lactose
Maltese: Alecensa fih lactose
English: ADRs (MedDRA)
Maltese: Medjan (xhur)
English: The events generally occurred during the first 3 months of treatment, were usually transient and resolved upon temporary interruption of Alecensa treatment (reported for 1.5% and 3.0% of the patients, respectively) or dose reduction (2.2% and 1.2%, respectively).
Maltese: L-avvenimenti ġeneralment seħħew matul l-ewwel 3 xhur ta' trattament, normalment kienu temporanji u għaddew wara waqfien temporanju tat-trattament b'Alecensa (irrappurtat għal 1.5% u 3.0% tal-pazjenti, rispettivament) jew tnaqqis fid-doża (2.2% u 1.2%, rispettivament).
English: Increased hepatic alkaline phosphatase (ALP) and direct bilirubin as well as vacuolation/degeneration/necrosis of bile duct epithelium and enlargement/focal necrosis of hepatocytes was observed in rats and/or monkeys at exposures equal to or greater than 20-30% of the human exposure by AUC at the recommended dose.
Maltese: Żieda f'alkaline phosphatase (ALP) talfwied u fil-bilirubina diretta kif ukoll formazzjoni ta' vacuole/deġenerazzjoni/nekrosi tal-epitelju talkanal tal-bile u tkabbir/nekrosi fokali tal-epatoċiti kienu osservati fil-firien u/jew xadini b'esponimenti daqs jew akbar minn 20-30% l-esponiment fil-bniedem skont l-AUC bid-doża rakkomandata.
English: ● severe muscle pain, tenderness, and weakness (myalgia).
Maltese: ● uġigħ sever fil-muskoli, sensittività, u dgħjufija (majalġja).
English: CNS DOR (IRC)
Maltese: CNS-DOR, medjan (xhur)
English: In preclinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signalling pathways including STAT 3 and PI3K/AKT and induction of tumour cell death (apoptosis).
Maltese: Fi studji ta' qabel lużu kliniku, inibizzjoni tal-attività ta' ALK tyrosine kinase wasslet għal imblukkar ta' rotot ta' sinjalazzjoni l-isfel (downstream signalling pathways) inklużi STAT 3 u PI3K/AKT u induzzjoni ta' mewt ta' ċelluli tat-tumur (apoptożi).
English: ORR results for studies NP28673 and NP28761 were consistent across subgroups of baseline patient characteristics such as age, gender, race, ECOG performance status, Central Nervous System (CNS) metastasis and prior chemotherapy use, especially when considering the small number of patients in some subgroups.
Maltese: Riżultati tal-ORR għall-istudji NP28673 u NP28761 kienu konsistenti fis-sottogruppi ta' karatteristiċi tal-pazjent fil-linja bażi bħall-età, is-sess, ir-razza, l-istat ta' ħila ta' ECOG, metastasi fis-Sistema Nervuża Ċentrali (CNS - Central Nervous System) u l-użu minn qabel ta' kimoterapija, speċjalment meta wieħed iqis l-għadd żgħir ta' pazjenti f'xi sottogruppi.
English: Co-administration of multiple oral doses of 600 mg rifampicin once daily, a strong CYP3A inducer, with a single oral dose of 600 mg alectinib reduced alectinib Cmax, and AUCinf by 51% and 73% respectively and increased M4 Cmax and AUCinf 2.20 and 1.79-fold respectively.
Maltese: Għoti ta' dożi orali multipli ta' 600 mg rifampicin darba kuljum, induttur qawwi ta' CYP3A, flimkien ma' doża orali waħda ta' 600 mg alectinib naqqas is-Cmax u l-AUCinf ta' alectinib b'51% u 73% rispettivament u żied is-Cmax u l-AUCinf ta' M4 b'2.20 u 1.79 darba rispettivament.
English: Name and address of the manufacturer(s) responsible for batch release Roche Pharma AG
Maltese: Manifattur Roche Pharma AG
English: Alectinib and M4 are not substrates of BCRP or organic anion-transporting polypeptide (OATP) 1B1/B3.
Maltese: Abbażi ta' dejta in vitro, alectinib mhuwiex sottostrat ta' P-gp. Alectinib u M4 mhumiex sottostrati ta' BCRP jew tal-polipeptid organiku li jġorr l-anjoni (OATP - organic anion-transporting polypeptide) 1B1/B3.
English: Alectinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay but induced a slight increase in numerical aberrations in the in vitro cytogenetic assay using Chinese Hamster Lung (CHL) cells with metabolic activation, and micronuclei in a rat bone marrow micronucleus test.
Maltese: Alectinib ma kienx mutaġeniku in vitro fl-analiżi ta' mutazzjoni inversa fil-batterj1 (bacterial reverse mutation) (Ames) iżda kkawża żieda żgħira fl-anormalitajiet numeriċi (numerical aberrations) flanaliżi ċitoġenetiku in vitro bl-użu ta' ċelluli tal-Pulmun tal-Ħamster Ċiniż (CHL - Chinese Hamster Lung) b'attivazzjoni metabolika, u mikronuklei f'test tal-mikronukleu tal-mudullun tal-far.
English: Nausea
Maltese: Stomatite
English: Symptomatic bradycardia can occur with Alecensa (see section 4.8).
Maltese: B'Alecensa tista' sseħħ bradikardja sintomatika (ara sezzjoni 4.8).
English: ● dabigatran etexilate, a medicine used to treat blood clots
Maltese: ● dabigatran etexilate, mediċina li tintuża biex tikkura emboli tad-demm
English: This medicinal product contains 48 mg sodium per daily dose (1200 mg), equivalent to 2.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 48 mg sodium f'kull doża ta' kuljum (1200 mg), ekwivalenti għal 2.4% tal-ammont massimu rakkomandat mid-WHO ta' 2 g sodium li għandu jittieħed kuljum minn adult.
English: The trial met its primary endpoint at the primary analysis, demonstrating a statistically significant improvement in PFS by investigator.
Maltese: Il-prova laħqet il-punt finali primarju tagħha fl-analiżi primarja, li turi titjib statistikament sinifikanti f'PFS skont l-investigatur.
English: In the phase III clinical trial BO28984 15% of patients treated with Alecensa had post-dose heart rate values below 50 bpm versus 20% of patients treated with crizotinib.
Maltese: III, BO28984 15% tal-pazjenti ttrattati b'Alecensa kellhom valuri tar-rata tal-qalb wara d-doża taħt 50 bpm kontra 20% tal-pazjenti ttrattati b'crizotinib.
English: CTCAE grade
Maltese: Grad ta' CTCAE