FrancophonIA/ELRC3.0 huggingface dataset:
English: 1) includes cases of anaemia and haemoglobin decreased includes cases of dysgeusia and hypogeusia 3) includes cases of blurred vision, visual impairment, vitreous floaters, reduced visual acuity, asthenopia, and diplopia 4) includes cases of bradycardia and sinus bradycardia includes cases of stomatitis and mouth ulceration 6) includes cases of blood bilirubin increased, hyperbilirubinaemia and bilirubin conjugated increased includes two patients with reported MedDRA term of drug-induced liver injury as well as one patient with reported Grade 4 increased AST and ALT who had documented drug-induced liver injury by liver biopsy includes cases of rash, rash maculopapular, dermatitis acneiform, erythema, rash generalised, rash papular, rash pruritic, rash macular and exfoliative rash includes cases of myalgia and musculoskeletal pain includes cases of oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema
Maltese: 8) jinkludi każijiet ta' raxx, raxx makulopapulari, dermatite b'dehra simili għall-akne, eritema, raxx ġeneralizzat, raxx bl-infafet, raxx bil-ħakk, raxx makulari u raxx bil-qxur 9) tinkludi każijiet ta' uġigħ fil-muskoli u uġigħ muskolu-skeletriku tinkludi każijiet ta' edima periferali, edima, edima ġeneralizzata, edima fil-kappell tal-għajn, edima madwar lgħajn, edima fil-wiċċ u edima lokalizzata
English: The capsules are also available in plastic bottles containing 240 hard capsules.
Maltese: Il-kapsuli huma disponibbli wkoll fi fliexken tal-plastik li fihom 240 kapsula iebsa.
English: Cardiac disorders Bradycardia4)
Maltese: Disturbi fil-qalb Bradikardija
English: ● rapid loss of kidney function (kidney problems).
Maltese: • telf mgħaġġel tal-funzjoni tal-kliewi (problemi fil-kliewi).
English: ILD/pneumonitis was not observed in patients receiving Alecensa versus 2.0% of patients receiving crizotinib.
Maltese: ILD/pulmonite ta' Grad 3 jew 4 f'pazjenti li kienu qed jirċievu Alecensa kontra 2.0% tal-pazjenti li kienu qed jirċievu crizotinib.
English: Table 5 Efficacy results from studies NP28673 and NP28761
Maltese: Riżultati tal-effikaċja minn studji NP28673 and NP28761
English: Patients with rare hereditary problems of galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza konġenitali ta' lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: No adverse effects on male and female reproductive organs were observed in general toxicology studies.
Maltese: Ma kinux osservati effetti avversi fuq organi riproduttivi maskili u femminili fi studji ġenerali dwar l-effett tossiku.
English: The recommended dose of Alecensa is 600 mg (four 150 mg capsules) taken twice daily with food (total daily dose of 1200 mg).
Maltese: Id-doża rakkomandata ta' Alecensa hija 600 mg (erba' kapsuli ta' 150 mg) meħuda darbtejn kuljum mal-ikel (doża totali ta' kuljum ta' 1200 mg).
English: Do not give this medicine to children or adolescents under the age of 18 years.
Maltese: M'għandekx tagħti din il-mediċina lil tfal jew adolexxenti ta' età inqas minn 18-il sena.
English: Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitor; ATC code: L01XE36.
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, inibitur ta' protein kinase;
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1169/002
English: ● medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine, or phenobarbital)
Maltese: ● mediċini li jintużaw biex iwaqqfu aċċessjonijiet (anti-epilettiċi bħal phenytoin, carbamazepine, jew phenobarbital)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1169/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1169/001
English: Based on a population PK analysis, the apparent clearance (CL/F) of alectinib was 81.9 L/hour.
Maltese: Abbażi ta' analiżi tal-PK tal-popolazzjoni, it-tneħħija apparenti (CL/F - apparent clearance) ta' alectinib kienet 81.
English: Cases of myalgia (28%) including myalgia events (22%) and musculoskeletal pain (7.4%) have been reported in patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Maltese: Każijiet ta' uġigħ fil-muskoli (28%) inklużi avvenimenti ta' uġigħ fil-muskoli (22%) u uġigħ muskolu-skeletriku (7.4%) kienu rrappurtati f'pazjenti ttrattati b'Alecensa fil-provi kliniċi kollha(NP28761, NP28673, BO28984).
English: The geometric mean of the individual elimination half-life estimates for alectinib was 32.5 hours.
Maltese: Il-medja ġeometrika tal-estimi tal-half-life tal-eliminazzjoni individwali għal alectinib kienet 32.5 sigħat.
English: The capsules are provided in blisters and are available in cartons containing 224 hard capsules (4 packs of 56).
Maltese: Il-kapsuli huma pprovduti f'folji u huma disponibbli f'kartun li fihom 224 kapsula iebsa (4 pakketti ta' 56).
English: NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules
Maltese: Alecensa 150 mg kapsuli iebsin
English: Co-administration of multiple oral doses of 400 mg posaconazole twice daily, a strong CYP3A inhibitor, with a single oral dose of 300 mg alectinib increased alectinib exposure Cmax and AUCinf by 1.18 and 1.75-fold respectively, and reduced M4 Cmax and AUCinf by 71% and 25% respectively.The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax by 7% and increasing AUCinf 1.36-fold.
Maltese: Għoti ta' dożi orali multipli ta' 400 mg posaconazole darbtejn kuljum, inibitur qawwi ta' CYP3A, flimkien ma' doża orali waħda ta' 300 mg alectinib żied is-Cmax u l-AUCinf ta' esponiment għal alectinib b'1.18 u 1.75 darba rispettivament u naqqas is-Cmax u l-AUCinf ta' M4 b'71% u 25% rispettivament.
English: Table 6 Summary of the pooled analysis of CNS endpoints from studies NP28673 and NP28761 CNS Parameters (NP28673 and NP28761)
Maltese: Tabella 6 Sommarju tal-analiżi miġbura ta' punti finali tas-CNS minn studji NP28673 u NP28761
English: Abnormal erythrocyte morphology was observed at exposures equal or greater than 10-60% the human exposure by AUC at the recommended dose.
Maltese: Kienet osservata morfoloġija mhux normali tal-eritroċiti b'esponimenti daqs jew akbar minn 10-60% l-esponiment fil-bniedem skont l-AUC bid-doża rakkomandata.
English: The geometric mean volume of distribution at steady state (Vss) of alectinib following IV administration was 475 L, indicating extensive distribution into tissues.
Maltese: Il-medja ġeometrika tal-volum ta' distribuzzjoni fi stat fiss (Vss) ta' alectinib wara għoti IV kien ta' 475 L, li jindika distribuzzjoni estensiva fit-tessuti.
English: Table 2 Dose modification advice for specified Adverse Drug Reactions (see sections 4.4 and 4.8) CTCAE grade
Maltese: Tabella 2 Pariri dwar tibdil fid-doża għal Reazzjonijiet Avversi tal-Mediċina speċifikati (ara sezzjonijiet 4.4 u 4.8)
English: Based on in vitro data, CYP3A4 is the primary enzyme mediating the metabolism of both alectinib and its major active metabolite M4, and CYP3A contributes to 40% − 50% of total hepatic metabolism.
Maltese: Abbażi ta' dejta in vitro, CYP3A4 hija l-enzima primarja li tikkawża l-metaboliżmu kemm ta' alectinib kif ukoll tal-metabolit attiv maġġuri tiegħu M4, u CYP3A jikkontribwixxi għal 40% − 50% tal-metaboliżmu epatiku totali.
English: Adverse reactions of increased AST and ALT levels (15% and 14% respectively) were reported in patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Maltese: Reazzjonijiet avversi ta' żieda fil-livelli ta' AST u ALT (15% u 14% rispettivament) kienu rrappurtati f'pazjenti ttrattati b'Alecensa fil-provi kliniċi kollha(NP28761, NP28673, BO28984).
English: The subjects in the Child Pugh B group however did in general not suffer from abnormal bilirubin, albumin or prothrombin time, indicating that they may not be fully representative of moderately hepatically impaired subjects with decreased metabolic capacity.
Maltese: Pugh B b'mod ġenerali ma batewx minn bilirubina, albumina jew ħin ta' prothrombin anormali, u danjindika li huma jistgħu ma jkunux rappreżentanti bis-sħiħ tal-individwi b'indeboliment moderat talfwied b'kapaċità metabolika mnaqqsa.
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Maltese: FIS-SUQ Roche Registration GmbH
English: Across clinical trials (NP28761, NP28673, BO28984) two patients with Grade 3-4 AST/ALT elevations had documented drug induced liver injury by liver biopsy.
Maltese: Fil-provi kliniċi kollha (NP28761, NP28673, BO28984), żewġ pazjenti b'żidiet ta' AST/ALT ta' Grad 3-4 kellhom ħsara fil-fwied ikkawżata mill-mediċina dokumentata permezz ta' bijopsija talfwied.
English: When Alecensa is co-administered with BCRP substrates (e.g., methotrexate, mitoxantrone, topotecan and lapatinib), appropriate monitoring is recommended.
Maltese: Meta Alecensa jingħata flimkien ma' sottostrati ta' BCRP (eż., methotrexate, mitoxantrone, topotecan u lapatinib), huwa rakkomandat monitoraġġ xieraq.
English: M4 Cmax and AUCinf was 39% and 34% lower respectively, resulting in a combined exposure of alectinib and M4 (AUCinf) 1.8-fold higher in patients with severe hepatic impairment compared with matched healthy subjects.
Maltese: Is-Cmax u l-AUCinf ta' M4 kienu 39% u 34% aktar baxxi rispettivament, li wasslu għal esponiment ikkombinat għal alectinib u M4 (AUCinf) 1.8 darbiet ogħla f'pazjenti b'indeboliment sever tal-fwied meta mqabbla ma' individwi f'saħħithom b'karatteristiċi simili.
English: CI = confidence interval; DOR = duration of response; IRC = independent review committee; ORR = objective response rate; NE = not estimable
Maltese: IRC = Kumitat ta' Analiżi Indipendenti; INV = investigatur; NE = ma jistax jiġi stmat;
English: In pregnant rats, alectinib caused total embryo-foetal loss (miscarriage) at exposures 4.5-fold of the human AUC exposure and small foetuses with retarded ossification and minor abnormalities of the organs at exposures 2.7-fold of the human AUC exposure.
Maltese: F'firien tqal, alectinib ikkawża telf totali tal-embrijuni u l-feti (korriment) b'esponimenti 4.5 darbiet l-esponiment fil-bniedem skont lAUC u feti żgħar b'ossifikazzjoni ttardjata u anormalitajiet minuri tal-organi b'esponimenti 2.7 darbiet l-esponiment fil-bniedem skont l-AUC.
English: Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Maltese: Monitoraġġ xieraq huwa rakkomandat għal pazjenti li jieħdu indutturi qawwija ta' CYP3A fl-istess waqt (inklużi, iżda mhux limitat għal, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin u St.
English: Increased AST
Maltese: Gradi kollha
English: Musculoskeletal and connective tissues disorders Myalgia9)
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi
English: ● This means you take a total of 6 capsules (900 mg) each day.
Maltese: ● Dan ifisser li inti tieħu total ta' 6 kapsuli (900 mg) kuljum.
English: A total of 303 patients were included in the Phase III trial, 151 patients randomised to the crizotinib arm and 152 patients randomised to the Alecensa arm receiving Alecensa orally, at the recommended dose of 600 mg twice daily.
Maltese: III, 151 pazjent randomised għall-grupp ta' crizotinib u 152 pazjent randomised għall-grupp ta' Alecensa li rċevew Alecensa mill-ħalq, bid-doża rakkomandata ta' 600 mg darbtejn kuljum.
English: Female patients of child-bearing potential receiving Alecensa, must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alecensa (see sections 4.6 and 5.3).
Maltese: Pazjenti nisa li jistgħu joħorġu tqal li jirċievu Alecensa, għandhom jużaw metodi ta' kontraċezzjoni effettivi ħafna waqt it-trattament u għal mill-inqas 3 xhur wara l-aħħar doża ta' Alecensa (ara sezzjonijiet 4.6 u 5.3).
English: ● if you have an inherited problem called ‘galactose intolerance', ‘congenital lactase deficiency' or
Maltese: ● jekk għandek problema li tintiret li tissejjaħ ‘intolleranza għal galactose', ‘defiċjenza konġenitali ta' lactase' jew ‘assorbiment ħażin ta' glucose-galactose'.
English: In faeces, 84% and 5.8% of the dose was excreted as unchanged alectinib or M4, respectively.
Maltese: Fl-ippurgar, 84% u 5.8% tad-doża tneħħew bħala alectinib jew M4 mhux mibdula, rispettivament.
English: The dose of Alecensa should be reduced in steps of 150 mg twice daily based on tolerability.
Maltese: Id-doża ta' Alecensa għandha titnaqqas f'passi ta' 150 mg darbtejn kuljum abbażi tat-tollerabilità.
English: Population PK analysis supports dose proportionality for alectinib across the dose range of 300 to 900 mg under fed conditions.
Maltese: Analiżi tal-PK tal-popolazzjoni jappoġġja proporzjonalità tad-doża għal alectinib matul il-firxa ta' dożi ta' 300 sa 900 mg wara l-ikel.
English: Severe ILD/pneumonitis occurred in patients treated with Alecensa.
Maltese: ILD severa/pulmonite seħħew f'pazjenti ttrattati b'Alecensa.
English: No adverse effects on male and female reproductive organs were observed in general toxicology studies (see section 5.3).
Maltese: Fi studji ġenerali dwar it-tossikoloġija ma kinux osservati effetti avversi fuq organi riproduttivi maskili u femminili (ara sezzjoni 5.3).
English: Cases of bradycardia (8.9%) of Grade 1 or 2 have been reported in patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Maltese: Każijiet ta' bradikardija (8.9%) ta' Grad 1 jew 2 kienu rrappurtati f'pazjenti ttrattati b'Alecensa filprovi kliniċi kollha(NP28761, NP28673, BO28984).
English: Alectinib steady-state is reached within 7 days with continuous 600 mg twice daily dosing.
Maltese: Stat fiss ta' Alectinib jintlaħaq fi żmien 7 ijiem b'dożaġġ kontinwu ta' 600 mg darbtejn kuljum.
English: Multiple doses of esomeprazole, a proton pump inhibitor, 40 mg once daily, demonstrated no clinically relevant effect on the combined exposure of alectinib and M4.
Maltese: Dożi multipli ta' esomeprazole, inibitur tal-pompi tal-protoni, 40 mg darba kuljum, ma wera l-ebda effett rilevanti b'mod kliniku fuq l-esponiment ikkombinat għal alectinib u M4.
English: There were 66 of 365 patients (18%) treated with Alecensa who had post-dose heart rate values below 50 beats per minutes (bpm).
Maltese: L-ebda pazjent ma kellu avvenimenti b'severità ta' Grad ≥ 3 Kien hemm 66 minn 365 pazjent (18%) ittrattati b'Alecensa li kellhom valuri tar-rata ta' tħabbit tal-qalb wara d-doża inqas minn 50 taħbita kull minuta (bpm - beats per minutes).
English: ● St. John's Wort, a herbal medicine used to treat depression
Maltese: ● St.John's Wort, mediċina tal-ħxejjex li tintuża biex tikkura d-depressjoni
English: Alecensa treatment
Maltese: Trattament b'Alecensa
English: The mean in vitro human blood-to-plasma concentration ratios of alectinib and M4 are 2.64 and 2.50, respectively, at clinically relevant concentrations.
Maltese: F'konċentrazzjonijiet klinikament rilevanti, il-proporzjonijiet medji in vitro tal-konċentrazzjoni fid-demm għal plażma ta' alectinib u M4 filbniedem huma 2.64 u 2.50, rispettivament.
English: At the time of entry in the study, 99% of patients had stage IV disease, 61% had brain metastases and in 96% of patients tumours were classified as adenocarcinoma.
Maltese: Meta daħlu fl-istudju, 99% tal-pazjenti kellhom marda ta' stadju IV, 61% kellhom metastasi fil-moħħ u f'96% tal-pazjenti t-tumuri kienu kklassifikati bħala adenokarċinoma.
English: ULN) with total bilirubin ≤ 2 times ULN
Maltese: Żieda ta' ALT jew AST ta' Grad ≥ 3 (> 5 darbiet l-ULN) b'bilirubina totali ≤ darbtejn l-ULN
English: Based on a population pharmacokinetic analysis alectinib and M4 exposures were similar in patients with mild and moderate renal impairment and normal renal function.
Maltese: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni esponimenti għal alectinib u M4 kienu simili f'pazjenti b'indeboliment ħafif u moderat tal-kliewi u funzjoni normali tal-kliewi.
English: Median time to Grade 3 CPK elevation was 14 days across clinical trials (NP28761, NP28673, BO28984).
Maltese: Iż-żmien medjan sa żieda ta' CPK ta' Grad 3 kien 14-il ġurnata fil-provi kliniċi kollha (NP28761, NP28673, BO28984).
English: Elevations of CPK occurred in 43% of 362 patients with CPK laboratory data available across clinical trials (NP28761, NP28673, BO28984) with Alecensa.
Maltese: Żidiet ta' CPK seħħew f'43% ta' 362 pazjent b'dejta ta' CPK tal-laboratorju disponibbli fil-provi kliniċi kollha(NP28761, NP28673, BO28984) b'Alecensa.
English: Central testing for ALK protein expression positivity of tissue samples from all patients by Ventana anti-ALK (D5F3) immunohistochemistry (IHC) was required before randomisation into the study.
Maltese: Qabel randomisation fl-istudju kien meħtieġ ittestjar ċentrali għall-pożittività tal-espressjoni tal-proteina ALK ta' kampjuni tat-tessuti mill-pazjenti kollha permezz tal-immunoistokimika (IHCimmunohistochemistry) Ventana anti-ALK (D5F3).
English: Extreme body weight (>130 kg)
Maltese: Piż tal-ġisem għoli ħafna (>130 kg)
English: Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily (total dose of 900 mg) (see section 5.2).
Maltese: Pazjenti b'indeboliment sever tal-fwied (Child-Pugh C) preżenti flistess waqt għandhom jirċievu doża tal-bidu ta' 450 mg meħuda darbtejn kuljum (doża totali ta' 900 mg) (ara sezzjoni 5.2).
English: Adverse reactions of bilirubin elevations were reported in 18% of the patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Maltese: Reazzjonijiet avversi ta' żidiet fil-bilirubina kienu rrappurtati fi 18% tal-pazjenti ttrattati b'Alecensa fil-provi kliniċi kollha(NP28761, NP28673, BO28984).
English: Immediately interrupt and permanently discontinue Alecensa if no other potential causes of ILD/pneumonitis have been identified.
Maltese: ILD/pulmonite ta' kwalunkwe grad ta' severità Interrompi immedjatament u waqqaf Alecensa b'mod permanenti jekk ma ġewx identifikati lebda kawżi potenzjali oħra ta' ILD/pulmonite.
English: This is equivalent to 2.4% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 2.4% tal-ammont massimu rakkomandat ta' sodium li għandu jittieħed kuljum mad-dieta minn adult.
English: Patients should also be advised to use a broad-spectrum Ultraviolet A (UVA)/ Ultraviolet B (UVB) sun screen and lip balm (SPF ≥50) to help protect against potential sunburn.
Maltese: Il-pazjenti għandhom jiġu avżati wkoll biex jużaw krema ta' protezzjoni mix-xemx u balzmu għax-xofftejn bi spettru wiesgħa ta' Ultravjola A (UVA - Ultraviolet A)/ Ultravjola B (UVB - Ultraviolet B) (SPF ≥ 50) biex jgħinu filprotezzjoni kontra ħruq mix-xemx potenzjali.
English: CI = confidence interval; DOR = duration of response; IRC = independent review committee; NE = not estimable; ORR = objective response rate; PFS= progression free survival; RE = response evaluable a
Maltese: ORR = rata ta' rispons oġġettiv; PFS= sopravivenza mingħajr progressjoni; RE = rispons li jista' jiġi evalwat a
English: Cause-specific HR [95% CI]
Maltese: HR speċifiku għall-kawża [CI ta' 95%]
English: The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity), and not a clastogenic effect on chromosomes.
Maltese: Ilmekkaniżmu ta' induzzjoni tal-mikronukleu kien segregazzjoni mhux normali tal-kromosomi (anewġeniċità), u mhux effett klastoġeniku fuq il-kromożomi.
English: The limited data on the safety and efficacy of Alecensa in patients aged 65 years and older do not suggest that a dose adjustment is required in elderly patients (see section 5.2).
Maltese: Id-data limitata dwar is-sigurtà u l-effikaċja ta' Alecensa f'pazjenti b'età minn 65 sena 'l fuq ma tissuġġerixxix li huwa meħtieġ aġġustament fid-doża f'pazjenti anzjani (ara sezzjoni 5.2).
English: Patient demographics were consistent with that of a NSCLC ALK positive population.
Maltese: Id-demografiċi tal-pazjenti kienu konsistenti ma' dawk ta' popolazzjoni b'NSCLC pożittiv għal ALK.
English: ● Alecensa is taken by mouth.
Maltese: Alecensa jista' jnaqqas jew iwaqqaf it-tkabbir tal-kanċer tiegħek.
English: Alectinib caused embryo-foetal toxicity in pregnant rats and rabbits.
Maltese: Alectinib ikkawża tossiċità għall-embrijuni u l-feti f'firien u fniek tqal.
English: ● sirolimus, a medicine used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
Maltese: ● sirolimus, mediċina li tintuża biex tipprevjeni s-sistema immunitarja tal-ġisem milli tirrifjuta kilwa,
English: Based on a population pharmacokinetic analysis, alectinib and M4 exposures were similar in patients with mild hepatic impairment and normal hepatic function.
Maltese: Abbażi ta' analiżi tal-farmakokinetika tal-popolazzjoni, esponimenti għal alectinib u M4 kienu simili f'pazjenti b'indeboliment ħafif tal-fwied u funzjoni normali tal-fwied.
English: ORR (IRC) in patients pre-treated with chemotherapy Responders N (%) [95% CI]
Maltese: ORR (IRC) f'pazjenti ttrattati minn qabel b'kimoterapija Persuni b'Rispons N (%) [CI ta' 95%]
English: Following administration of a single oral dose of 300 mg alectinib in subjects with severe (Child-Pugh C) hepatic impairment, alectinib Cmax was the same and AUCinf was 2.2-fold higher compared with the same parameters in matched healthy subjects.
Maltese: Wara l-għoti ta' doża orali waħda ta' 300 mg alectinib f'individwi b'indeboliment sever (Child-Pugh C) tal-fwied, is-Cmax ta' alectinib kienet l-istess u l-AUCinf kienet 2.2 darbiet ogħla meta mqabbel malistess parametri f'individwi f'saħħithom b'karatteristiċi simili.
English: Oral contraceptives If you take Alecensa whilst using oral contraceptives, the oral contraceptives may be less effective.
Maltese: Jekk tieħu Alecensa waqt li tkun qed tuża kontraċettivi orali, ilkontraċettivi orali jistgħu jkunu inqas effettivi.
English: Age, body weight, race and gender had no clinically meaningful effect on the systemic exposure of alectinib and M4.
Maltese: L-età, il-piż tal-ġisem, ir-razza u s-sess ma kellhom l-ebda l-effett sinifikanti klinikament fuq lesponiment sistemiku għal alectinib u M4.
English: There is no specific antidote for overdose with Alecensa.
Maltese: M'hemm l-ebda antidotu speċifiku għal doża eċċessiva ta' Alecensa.
English: Swallow each capsule whole.
Maltese: Ibla' kull kapsula sħieħa.
English: At the time of entry in the study, 99% of patients had stage IV disease, 60% had brain metastases and in 94% of patients tumours were classified as adenocarcinoma.
Maltese: Meta daħlu fl-istudju, 99% tal-pazjenti kellhom marda ta' stadju IV, 60% kellhom metastasi fil-moħħ u f'94% tal-pazjenti t-tumuri kienu kklassifikati bħala adenokarċinoma.
English: If patients experience symptomatic bradycardia or life-threatening events, concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products should be evaluated and Alecensa treatment should be adjusted as described in Table 2 (see sections 4.2 and 4.5, ‘P-gp substrates' and ‘BCRP substrates').
Maltese: Jekk il-pazjenti jkollhom bradikardija sintomatika jew avvenimenti ta' periklu għall-ħajja, prodotti mediċinali li jittieħdu fl-istess waqt magħrufa li jikkawżaw bradikardija, kif ukoll prodotti mediċinali kontra l-pressjoni għolja għandhom jiġu evalwati u t-trattament b'Alecensa għandu jiġi aġġustat kif deskritt fit-Tabella 2 (ara sezzjonijiet 4.2 u 4.5, ‘sottostrati ta' P-gp' u ‘sottostrati ta' BCRP').
English: of patients receiving crizotinib; and median time to Grade 3 CPK elevation was 27.5 days and 369 days, respectively, in the pivotal phase III clinical trial BO28984 (ALEX).
Maltese: Iż-żieda ta' CPK ta' Grad 3 kienet irrappurtata għal 2.6% talpazjenti li kienu qed jirċievu Alecensa u 1.3% tal-pazjenti li kienu qed jirċievu crizotinib; u ż-żmien medjan għal żieda ta' CPK ta' Grad 3 kien ta' 27.5 ijiem u 369 jum, rispettivament, fil-prova klinika pivotali ta' fażi III BO28984 (ALEX).