FrancophonIA/ELRC3.0 huggingface dataset:
English: At 100 mg once daily, the geometric mean (% coefficient of variation [CV]) peak plasma concentration was 577 (42) ng/mL and the AUC24 was 5,650 (39) ng·h/mL in patients with cancer.
Maltese: F'doża ta' 100 mg darba kuljum, il-medja ġeometrika (% tal-koeffiċjent ta' varjazzjoni [CV]) talkonċentrazzjoni massima fil-plażma kienet ta' 577 (42) ng/mL u l-AUC 24 kienet ta' 5,650 (39) ng h/mL f'pazjenti bil-kanċer.
English: Other adverse reactions Grade 1: Mild
Maltese: Reazzjonijiet avversi oħra Grad 1: Ħafif
English: Atrioventricular block occurred in 1.0% of patients.
Maltese: Imblukkar atrijoventrikulari seħħ f'1.0% tal-pazjenti.
English: Consider pacemaker placement if symptomatic AV block persists.
Maltese: Ikkunsidra t-tqegħid ta' pacemaker jekk l-imblukkar AV sintomatiku jippersisti.
English: Lipase/Amylase increase Grade 3: Severe
Maltese: Żieda fil-Lipażi/Amilażi Grad 3: Sever
English: Adverse reactions of increase in serum cholesterol or triglycerides were reported in 84.4% and 67.1% of patients, respectively.
Maltese: Reazzjonijiet avversi ta' żieda fil-kolesterol jew fit-trigliċeridi fis-serum ġew irrappurtati f'84.4% u f'67.1% tal-pazjenti, rispettivament.
English: h Vision disorder (including diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters).
Maltese: Disturbi fil-vista (inkluż diplopja, fotofobija, fotopsja, vista mċajpra, tnaqqis fl-akutezza viżwali, vista batuta, żlieġa fl-għajnejn).
English: In vitro studies also indicated that lorlatinib is an inducer of CYP2B6 and activates the human constitutive androstane receptor (CAR).
Maltese: Studji in vitro indikaw ukoll li lorlatinib huwa induttur ta' CYP2B6 u jattiva r-riċettur androstane kostituttiv (CAR, constitutive androstane receptor) tal-bniedem.
English: Central nervous system effects (changes in cognition, mood or speech) Grade 2: Moderate
Maltese: Effetti tas-sistema nervuża ċentrali (tibdil fil-konjizzjoni, fil-burdata jew fid-diskors) Grad 2: Moderat
English: Median duration of cognitive, mood and speech effects was 224, 83 and 106 days, respectively.
Maltese: It-tul medjan tal-effetti konjittivi, fuq il-burdata u fuq id-diskors kien ta' 224, ta' 83 u ta' 106 jum, rispettivament.
English: Peripheral neuropathy (including burning sensation, carpal tunnel syndrome, dysaesthesia, formication, gait disturbance, hypoaesthesia, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity,
Maltese: Newropatija periferika (inkluż sensazzjoni ta' ħruq, is-sindrome tal-carpal tunnel, disestesija, formikazzjoni, disturb fil-mixi, ipoestesija, dgħufija fil-muskoli, nevralġija, newropatija periferika, newrotossiċità, parastesija, newropatija sensorjali periferika, paraliżi tan-nervituri peroneali, disturb sensorjali).
English: This medicine contains less than 1 mmol sodium (23 mg) per 25 mg or 100 mg tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola ta' 25 mg jew 100 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: • enzalutamide (used to treat prostate cancer)
Maltese: • enzalutamide (jintuża għall-kura tal-kanċer tal-prostata)
English: b Hypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia).
Maltese: Ipertrigliċeridemija (inkluż żieda fit-trigliċeridi fid-demm, ipertrigliċeridemija).
English: Oval (8.5 × 17 mm) dark pink immediate release film-coated tablet, debossed with “Pfizer” on one side and “LLN 100” on the other side.
Maltese: Pillola roża skur, ovali (8.5 × 17 mm), miksija b'rita ta' rilaxx immedjat, imnaqqxa b'“Pfizer” fuq naħa waħda u “LLN 100” fuq in-naħa l-oħra.
English: In a study conducted in healthy volunteers, the concomitant use of lorlatinib and rifampin, a strong CYP3A4/5 inducer, was associated with increases of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) with no increase of total bilirubin and alkaline phosphatase (see section 4.5).
Maltese: Fi studju li sar fuq voluntiera b'saħħithom, l-użu konkomitanti ta' lorlatinib u rifampin, induttur qawwi ta' CYP3A4/5, kien assoċjat ma' żidiet fl-alanine aminotransferase (ALT, alanine aminotransferase) u fl-aspartate aminotransferase (AST, aspartate aminotransferase) mingħajr żieda fil-bilirubina totali u fl-alkaline phosphatase (ara sezzjoni 4.5).
English: Information for lorlatinib use in patients with severe renal impairment (CLcr < 30 mL/min) is limited (n = 1).
Maltese: L-informazzjoni dwar l-użu ta' lorlatinib f'pazjenti b'indeboliment tal-kliewi sever (CLcr < 30 mL/min) hija limitata (n = 1).
English: g Speech effects (dysarthria, slow speech, speech disorder).
Maltese: Effetti fuq id-diskors (disartrija, diskors bil-mod, disturbi fid-diskors).
English: The plasma half-life of lorlatinib after a single 100 mg dose was 23.6 hours.
Maltese: Il-half-life ta' lorlatinib fil-plażma wara doża unika ta' 100 mg kienet ta' 23.6 sigħat.
English: In vitro binding of lorlatinib to human plasma proteins is 66% with moderate binding to albumin or to α1-acid glycoprotein.
Maltese: L-irbit in vitro ta' lorlatinib mal-proteini tal-plażma tal-bniedem huwa ta' 66% bi rbit moderat malalbumina jew mal-glikoproteina aċiduża-α1.
English: Pfizer Luxembourg SARL filialas Lietuvoje Tel. + 370 52 51 4000
Maltese: Pfizer Luxembourg SARL filiāle Latvijā Tel.: + 371 670 35 775
English: In addition, the effect of a single oral dose of lorlatinib (50 mg, 75 mg, and 100 mg) with and without 200 mg once daily itraconazole was evaluated in a 2-way crossover study in 16 healthy volunteers.
Maltese: Barra minn hekk, l-effett ta' doża unika ta' lorlatinib mill-ħalq (50 mg, 75 mg, u 100 mg) bi u mingħajr itraconazole 200 mg darba kuljum kien evalwat fi studju crossover 2-way fuq 16il voluntiera b'saħħithom.
English: Abbreviations: ALK=anaplastic lymphoma kinase; CI=confidence interval; ICR=Independent Central Review; N/n=number of patients; NR=not reached; TKI= tyrosine kinase inhibitor.
Maltese: ALK=kinażi tal-limfoma anaplastiku; CI=intervall ta' kunfidenza; ICR=Reviżjoni Ċentrali Indipendenti; N/n=numru ta' pazjenti; TKI=inibitur tat-tirożina kinażi.
English: In 295 patients who received lorlatinib at the recommended dose of 100 mg once daily and had a ECG measurement in Study A, lorlatinib was studied in a population of patients that excluded those with QTc interval > 470 msec.
Maltese: Fil-295 pazjent li rċevew lorlatinib bid-doża rakkomandata ta' 100 mg darba kuljum u li kellhom kejl tal-ECG fi Studju A, lorlatinib ġie studjat f'popolazzjoni ta' pazjenti li eskludiet dawk b'intervall QTc > 470 msec.
English: (N = 28)
Maltese: NUMRU(I)
English: The main toxicities observed were inflammation across multiple tissues (skin and cervix of rats and lung, trachea, skin, lymph nodes and/or the oral cavity including mandibular bone of dogs; associated with increases in white blood cells, fibrinogen, and/or globulin and decreases in albumin) and changes in the pancreas (with increases in amylase and lipase), hepatobiliary system (with increases in liver enzymes), male reproductive system, cardiovascular system, kidneys and gastrointestinal tract, peripheral nerves and the CNS (potential for cognitive functional impairment) at dose equivalent to human clinical exposure at the recommended posology.
Maltese: It-tossiċitajiet ewlenin osservati kienu infjammazzjoni mifruxa fuq diversi tessuti (il-ġilda u ċ-ċerviċi fil-firien u l-pulmun, it-trakea, il-ġilda, għoqod tal-limfa u/jew il-kavità orali inkluż l-għadma mandibolari fil-klieb; assoċjata ma' żidiet fiċ-ċelluli bojod tad-demm, fil-fibrinoġen, u/jew filglobulina u tnaqqis fil-albumina) u tibdil fil-frixa (b'żidiet fil-amilażi u fil-lipażi), fis-sistema epatobiljari (b'żidiet fl-enzimi tal-fwied), fis-sistema riproduttiva maskili, fis-sistema kardjovaskulari, fil-kliewi u fil-passaġġ gastrointestinali, fin-nervituri periferali u fis-CNS (potenzjali għal indeboliment tal-funzjonijiet konjittivi) f'doża ekwivalenti għall-esponiment kliniku tal-bniedem filpożoloġija rakkomandata.
English: CYP3A4/5 inducers
Maltese: Indutturi ta' CYP3A4/5
English: Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis have occurred with lorlatinib (see section 4.8).
Maltese: Reazzjonijiet avversi pulmonari severi jew ta' periklu għall-ħajja konsistenti ma' ILD/pulmonite seħħew b'lorlatinib (ara sezzjoni 4.8).
English: Pneumonitis (including interstitial lung disease, pneumonitis).
Maltese: Pulmonite (inkluż mard tal-pulmun interstizjali, pulmonite).
English: Moderate hypercholesterolaemia (cholesterol between 301 and 400 mg/dL or between 7.76 and 10.34 mmol/L)
Maltese: Iperkolesterolemija moderata (kolesterol bejn 301 u 400 mg/dL jew bejn 7.76 u 10.
English: Table 2 presents adverse reactions occurring in 295 adult patients treated with lorlatinib 100 mg once daily with advanced NSCLC from Study A.
Maltese: It-Tabella 2 tippreżenta r-reazzjonijiet avversi li seħħew f'295 pazjent adult li ngħataw kura b'lorlatinib 100 mg darba kuljum b'NSCLC avvanzat minn Studju A.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 25 mg or 100 mg tablet.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) għal kull 25 mg jew 100 mg pillola.
English: Introduce or modify lipid-lowering therapyb in accordance with respective prescribing information; continue lorlatinib at same dose.
Maltese: Introduċi jew immodifika t-terapija li tnaqqas il-lipidi skont l-informazzjoni rispettiva dwar l-għoti; kompli lorlatinib fl-istess doża.
English: uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Maltese: Ir-reazzjonijiet avversi elenkati fit-Tabella 2 huma ppreżentati skont is-sistema tal-klassifika tal-organi u l-kategoriji ta' frekwenza, definiti bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: Consider effects of concomitant medicinal products, and assess and correct electrolyte imbalance that may prolong PR interval.
Maltese: Ikkunsidra l-effetti ta' prodotti mediċinali konkomitanti, u evalwa u kkoreġi l-iżbilanċ fl-elettroliti li jista' jtawwal l-intervall tal-PR.
English: There is no antidote for lorlatinib.
Maltese: Ma hemm l-ebda antidotu għal lorlatinib.
English: Population pharmacokinetic analyses have shown that lorlatinib exposure was not clinically meaningfully altered in patients with mild (n = 103) or moderate (n = 41) renal impairment (CLcr > 30 mL/min).
Maltese: Analiżijiet farmakokinetiċi tal-popolazzjoni wrew li l-esponiment għal lorlatinib ma nbidilx b'mod klinikament sinifikanti f'pazjenti b'indeboliment tal-kliewi ħafif (n = 103) jew moderat (n = 41) (CLcr > 30 mL/min).
English: At steady-state, the systemic exposure (AUC24 and Cmax) increased less than proportionally over the 10 to 200 mg dose range.
Maltese: Fi stat fiss, l-esponiment sistemiku (AUC24 u Cmax) żdied b'mod inqas milli proporzjonali bejn ilmedda ta' dożi bejn 10 mg u 200 mg.
English: Population pharmacokinetic analyses in patients with advanced NSCLC and healthy volunteers indicate that there are no clinically relevant effects of age, gender, race, body weight, and phenotypes for CYP3A5 and CYP2C19.
Maltese: Analiżi farmakokinetika tal-popolazzjoni fuq pazjenti b'NSCLC avvanzat u fuq voluntiera b'saħħithom tindika li ma hemm l-ebda effett klinikament rilevanti tal-età, tas-sess, tar-razza, tal-piż tal-ġisem, u tal-fenotipi fuq is-CYP3A5 u s-CYP2C19.
English: Lorviqua contains the active substance lorlatinib, a medicine that is used for treatment of adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC).
Maltese: Lorviqua fih is-sustanza attiva lorlatinib, mediċina li tintuża għall-kura ta' adulti bi stadji avvanzati ta' forma ta' kanċer tal-pulmun imsejjaħ kanċer tal-pulmun mhux taċ-ċelluli ż-żgħar (NSCLC).
English: Median time to onset for cognitive, mood and speech effects was 92, 44 and 42 days, respectively.
Maltese: Il-ħin medjan għall-bidu ta' effetti konjittivi, fuq il-burdata u fuq id-diskors kien ta' 92, ta' 44 u ta' 42 jum, rispettivament.
English: Dose reductions due to adverse reactions occurred in 23.4% of patients receiving lorlatinib.
Maltese: 23.4% tal-pazjenti li kienu qed jirċievu lorlatinib tnaqsitilhom id-doża minħabba reazzjonijiet avversi.
English: Of those, mild or moderate adverse reactions of hypercholesterolaemia or hypertriglyceridaemia occurred in 67.8% and 50.5% of patients, respectively (see section 4.4).
Maltese: Minn dawn, reazzjonijiet avversi ħfief jew moderati ta' iperkolesterolemija jew ta' ipertrigliċeridemija seħħew f'67.8% u f'50.5% tal-pazjenti, rispettivament (ara sezzjoni 4.4).
English: In plasma, a benzoic acid metabolite of lorlatinib resulting from the oxidative cleavage of the amide and aromatic ether bonds of lorlatinib was observed as a major metabolite, accounting for 21% of the circulating radioactivity.
Maltese: Fil-plażma, metabolit tal-aċidu benżojku ta' lorlatinib li jirriżulta mill-qsim ossidattiv tal-irbit bejn lamide u l-etere aromatiku ta' lorlatinib kien osservat bħala metabolit ewlieni, li jirrappreżenta 21% tarradjuattività ċirkolanti.
English: Recommended lorlatinib dose modifications for adverse reactions Adverse reactiona
Maltese: Modifiki rakkomandati fid-doża ta' lorlatinib għal reazzjonijiet avversi Reazzjoni avversa
English: Interstitial lung disease (ILD)/Pneumonitis Grade 1: Mild
Maltese: Mard tal-pulmun interstizjali (ILD, interstitial lung disease)/Pulmonite
English: Following oral administration of a 100 mg radiolabelled dose of lorlatinib, a mean 47.7% of the radioactivity was recovered in urine and 40.9% of the radioactivity was recovered in faeces, with overall mean total recovery of 88.6%.
Maltese: 7% tar-radjuattività kienet irkuprata fl-awrina u 40.9% tar-radjuattività kienet irkuprata fl-ippurgar, bi rkupru medju totali globali ta' 88.6%.
English: Concurrent administration of lorlatinib with CYP3A4/5 substrates with narrow therapeutic indices, including but not limited to alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, hormonal contraceptives, pimozide, quinidine, sirolimus and tacrolimus, should be avoided since the concentration of these medicinal products may be reduced by lorlatinib (see section 4.5).
Maltese: L-għoti konkomitanti ta' lorlatinib ma' sottostrati ta' CYP3A4/5 b'indiċi terapewtiċi dojoq, li jinkludu, iżda mhux limitati għal alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, kontraċettivi ormonali, pimozide, quinidine, sirolimus u tacrolimus, għandu jiġi evitat peress li lorlatinib jista' jnaqqas il-konċentrazzjoni ta' dawn il-prodotti mediċinali (ara sezzjoni 4.5).
English: Median time of occurrence of increase in serum lipase and amylase is 70 days (range: 7 to 696 days) and 41 days (range: 7 to 489 days), respectively.
Maltese: Iżżmien medjan għal okkorrenza ta' żieda fil-lipażi u fl-amilażi fis-serum hija 70 jum (medda: 7 sa 696 jum) u 41 jum (medda: 7 sa 489 jum), rispettivamet.
English: Also troleandomycin, a medicine used to treat certain types of bacterial infections.
Maltese: Anke troleandomycin, mediċina li tintuża għall-kura ta' ċerti tipi ta' infezzjonijiet batteriċi.
English: Lorlatinib may reduce the effectiveness of hormonal contraceptive methods (for example, birth control pill); therefore, hormonal contraceptives may not be considered highly effective.
Maltese: Lorlatinib jista' jnaqqas l-effettività tal-metodi kontraċettivi ormonali (pereżempju, pillola tal-kontroll tat-twelid); għalhekk, il-kontraċettivi ormonali jistgħu ma jitqisux bħala effettivi ħafna.
English: Peak lorlatinib concentrations in plasma are rapidly reached with the median Tmax of 1.2 hours following a single 100 mg dose and 2.0 hours following multiple dosing of 100 mg once daily.
Maltese: Il-konċentrazzjonijiet massimi ta' lorlatinib fil-plażma jintlaħqu malajr b'Tmax medjan ta' 1.2 sigħat wara doża unika ta' 100 mg u ta' sagħtejn wara dożi multipli ta' 100 mg darba kuljum.
English: Lorlatinib demonstrated activity in mice bearing orthotopic EML4-ALK or EML4-ALKL1196M brain tumour implants.
Maltese: Lorlatinib wera attività fi ġrieden b'impjanti ta' tumuri ortotopiċi fil-moħħ EML4-ALK jew EML4-ALK
English: Round (8 mm) light pink immediate release film-coated tablet, debossed with “Pfizer” on one side and “25” and “LLN” on the other side.
Maltese: Pillola roża ċar, tonda (8 mm), miksija b'rita ta' rilaxx immedjat, imnaqqxa b'“Pfizer” fuq naħa waħda u “25” u “LLN” fuq in-naħa l-oħra.
English: Interstitial lung disease/Pneumonitis
Maltese: Mard tal-pulmun interstizjali/Pulmonite
English: Monitor ECG/symptoms potentially related to AV block closely.
Maltese: Immonitorja mill-qrib l-ECG/sintomi potenzjalment relatati ma' imblukkar AV.
English: Median time of occurrence of severe increase in serum cholesterol and triglycerides is 201 days (range: 42 to 518 days) and 127 days (range: 15 to 358 days), respectively.
Maltese: Iż-żmien medjan għal okkorrenza ta' żieda severa fil-kolesterol u fit-trigliċeridi fis-serum hija 201 jum (medda: 42 sa 518-il jum) u 127 jum (medda: 15 sa 358 jum), rispettivament.
English: What Lorviqua looks like and contents of the pack Lorviqua 25 mg is supplied as round light pink film-coated tablets, debossed with “Pfizer” on one side and “25” and “LLN” on the other side.
Maltese: Lorviqua 25 mg jiġi bħala pilloli tondi miksija b'rita ta' lewn roża ċar, imnaqqxa b'“Pfizer” fuq naħa waħda u “25” u “LLN” fuq in-naħa l-oħra.
English: dementia, disturbance in attention, memory impairment, mental impairment; and also including events from SOC Psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder).
Maltese: Alluċinazzjonijiet (inkluż alluċinazzjoni, alluċinazzjoni awditorja, alluċinazzjoni viżiva) Effetti konjittivi (inklużi avvenimenti mis-SOC Disturbi fis-sistema nervuża, amnesija, disturbi konjittivi, dimenzja, disturb fl-attenzjoni, indeboliment tal-memorja, indeboliment mentali, u jinkludi wkoll avvenimenti mis-SOC Disturbi psikjatriċi: disturb ta' nuqqas ta' attenzjoni/iperattività, stat konfużjonali, delirju, diżorjentament, disturbi relatati mal-qari).
English: In the prostate, minimal to mild glandular atrophy was observed in dogs at dose equivalent to human clinical exposure at the recommended posology).
Maltese: Fil-prostata, kienet osservata atrofija glandulari minima għal ħafifa fil-klieb f'doża ekwivalenti għall-esponiment kliniku fil-bniedem filpożoloġija rakkomandata).
English: NAME OF THE MEDICINAL PRODUCT Lorviqua 25 mg tablets lorlatinib
Maltese: Lorviqua 25 mg pilloli lorlatinib
English: In the overall efficacy population of 139 patients, 56 patients had a confirmed objective response by ICR with a median TTR of 1.4 months (range: 1.2 to 16.6 months).
Maltese: Fil-popolazzjoni tal-effikaċja globali ta' 139 pazjent, 56 pazjent kellhom rispons oġġettiv ikkonfermat minn ICR b'medjan ta' 1.4 xhur (medda: 1.2 sa 16.6 xhur).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1355/002
Maltese: EU/1/19/1355/002
English: Central nervous system (CNS) effects have been observed in patients receiving lorlatinib, including changes in cognitive function, mood or speech (see section 4.8).
Maltese: Effetti tas-sistema nervuża ċentrali (CNS, central nervous system) ġew osservati f'pazjenti li kienu qed jingħataw lorlatinib, inkluż tibdil fil-funzjoni konjittiva, fil-burdata jew fid-diskors (ara sezzjoni 4.8).
English: The use of a strong CYP3A4/5 inducer with lorlatinib is contraindicated (see sections 4.3 and 4.4).
Maltese: L-użu ta' induttur qawwi ta' CYP3A4/5 ma' lorlatinib huwa kontraindikat (ara sezzjonijiet 4.3 u 4.4).
English: Pfizer Kft. Tel.: +36-1-488-37-00
Maltese: Pfizer Croatia d.o.o. Tel: +385 1 3908 777
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattożju, b'defiċjenza totali għal-lattożju, jew b'malassorbiment talglukożju-galattożju ma għandhomx jieħdu dan il-prodott mediċinali.
English: Lorviqua 100 mg is supplied as oval dark pink film-coated tablets, debossed with “Pfizer” on one side and “LLN 100” on the other side.
Maltese: Lorviqua 100 mg jiġi bħala pilloli ovali miksija b'rita ta' lewn roża skur, imnaqqxa b'“Pfizer” fuq naħa waħda u “LLN 100” fuq in-naħa l-oħra.
English: The most common mood effect of any grade was irritability (6.1%), which was also the most common Grade 3 or 4 reaction (1.0%).
Maltese: L-aktar effett fuq il-burdata komuni ta' kwalunkwe grad kien irritabilità (6.1%), li kien ukoll l-aktar reazzjoni komuni tal-Grad 3 jew 4 (1.0%).
English: Lorviqua 25 mg: each film-coated tablet (tablet) contains 25 mg lorlatinib.
Maltese: Lorviqua 25 mg: kull pillola miksija b'rita (pillola) fiha 25 mg ta' lorlatinib.
English: Second degree AV block Symptomatic
Maltese: Imblukkar AV tat-tieni grad Bis-sintomi
English: CYP3A4/5 inhibitors
Maltese: Inibituri ta' CYP3A4/5
English: Concomitant administration of lorlatinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may result in reduced plasma concentrations of the CYP2B6 substrate.
Maltese: L-għoti konkomitanti ta' lorlatinib ma' sottostrati ta' CYP2B6 (eż. bupropion, efavirenz) jista' jwassal għal konċentrazzjonijiet aktar baxxi tas-sottostrat ta' CYP2B6 fil-plażma.
English: Among the 31 patients with a confirmed IC objective tumour response and at least one measurable brain metastasis at baseline by ICR, the median IC-TTR was 1.4 months (range: 1.2 to 16.2 months).
Maltese: Fost il-31 pazjent b'rispons oġġettiv ikkonfermat ta' tumur IC u tal-inqas metastasi wieħed fil-moħħ li jista' jitkejjel fillinja bażi, minn ICR, l-IC-TTR medjan kien ta' 1.4 xhur (medda: 1.2 sa 16.2 xhur).
English: Concomitant use of strong CYP3A4/5 inducers (see sections 4.4 and 4.5).
Maltese: L-użu konkomitanti ta' indutturi qawwija ta' CYP3A4/5 (ara sezzjonijiet 4.4 u 4.5).
English: Lorviqua 100 mg film-coated tablets
Maltese: Lorviqua 100 mg pilloli lorlatinib
English: Lorlatinib is not mutagenic but is aneugenic in vitro and in vivo with a no observed effect level for aneugenicity approximately 16.5 times human clinical exposure at 100 mg based on AUC.
Maltese: Lorlatinib mhuwiex mutaġeniku iżda anewġeniku in vitro u in vivo b'livell tal-ebda effett osservat għal anewġeniċità ta' madwar 16.5 darbiet akbar mill-esponiment kliniku tal-bniedem f'doża ta' 100 mg abbażi tal-AUC.
English: Drug-drug interactions
Maltese: Interazzjonijiet mediċinali
English: See Lorviqua contains lactose and Lorviqua contains sodium in section 2.
Maltese: Dawn huma mniżżla taħt Tiħux Lorviqua, fil-bidu tas-sezzjoni 2.
English: The use of lorlatinib has been associated with increases in serum cholesterol and triglycerides (see section 4.8).
Maltese: L-użu ta' lorlatinib ġie assoċjat ma' żidiet fil-kolesterol u fit-trigliċeridi fis-serum (ara sezzjoni 4.8).
English: Pacemaker placement may be indicated for severe symptoms associated with AV block.
Maltese: Ittqegħid ta' pacemaker jista' jiġi indikat għal sintomi severi assoċjati ma' imblukkar AV.
English: Concomitant use of a strong CYP3A4/5 inducer is contraindicated (see sections 4.3 and 4.5).
Maltese: L-użu konkomitanti ta' induttur qawwi ta' CYP3A4/5 huwa kontraindikat (ara sezzjonijiet 4.3 u 4.5).
English: Concurrent use of lorlatinib with medicinal products that are strong CYP3A4/5 inhibitors and grapefruit juice products may increase lorlatinib plasma concentrations.
Maltese: L-użu konkomitanti ta' lorlatinib ma' prodotti mediċinali li huma inibituri qawwija ta' CYP3A4/5 u ma' prodotti tal-meraq tal-grejpfrut jista' jżid il-konċentrazzjonijiet ta' lorlatinib fil-plażma.
English: Lorviqua 100 mg: each film-coated tablet (tablet) contains 100 mg lorlatinib.
Maltese: Lorviqua 100 mg: kull pillola miksija b'rita (pillola) fiha 100 mg ta' lorlatinib.
English: OPA/Al/PVC blisters with aluminium foil backing containing 10 film-coated tablets.
Maltese: Folji tal-OPA/Al/PVC b'wara tal-fojl tal-aluminju li fihom 10 pilloli miksija b'rita.