FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP decided that Zeffix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Zeffix huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The full EPAR for Exforge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Exforge amlodipine / valsartan
Maltese: Exforge amlodipina / valsartan
English: The European Commission granted a marketing authorisation valid throughout the EU for Exforge on 17 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Exforge fis17 ta' Jannar 2007.
English: The most common side effects with Exforge (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Maltese: L-effetti sekondarji l-aktar komuni b'Exforge (li dehru f'bejn pazjent 1 u 10 minn 100) huma wġigħ ta' ras, nasofarinġite (infjammazzjoni tal-imnieħer u tal-gerżuma), influwenza, ipokalemija (livelli baxxi ta' potassju fid-demm), tipi varji ta' edema (nefħa), għeja, ħmura, astenija (debbulizza) u fwawar.
English: This is a summary of the European public assessment report (EPAR) for Exforge.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Exforge.
English: What is the risk associated with Exforge?
Maltese: X'inhu r-riskju assoċjat ma' Exforge?
English: Exforge contains two active substances, amlodipine and valsartan.
Maltese: Exforge fih żewġ sustanzi attivi, l-amlodipina u l-valsartan.
English: What is Exforge?
Maltese: X'inhu Exforge?
English: Exforge is a medicine that contains two active substances, amlodipine and valsartan.
Maltese: Exforge huwa mediċina li fiha żewġ sustanzi attivi, l-amlodipina u l-valsartan.
English: The CHMP decided that Exforge's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Exforge huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Exforge been studied?
Maltese: Kif ġie studjat Exforge?
English: Exforge must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Maltese: Exforge ma għandux jintuża minn pazjenti bi problemi gravi fil-fwied, jew problemi biljari, jew minn pazjenti b'ċerti problemi tal-qalb u minn pazjenti b'ipotensjoni gravi (pressjoni tad-demm baxxa).
English: Exforge must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Maltese: Exforge ma għandux jintuża f'pazjenti li jkunu ipersensittivi (allerġiċi) għall-amlodipina jew mediċini oħra tal-klassi tad-'derivati diidropiridiniċi', għall-valsartan, jew għal kwalunkwe wieħed mill-ingredjenti l-oħra.
English: How is Exforge used?
Maltese: Għal xiex jintuża Exforge?
English: Why has Exforge been approved?
Maltese: Għaliex ġie approvat Exforge?
English: Exforge is taken by mouth as one tablet once a day with some water.
Maltese: Exforge jittieħed oralment bħala pillola waħda darba kuljum bi ftit ilma.
English: Dietary sodium
Maltese: Sodium dietarju
English: Grade 2: Moderate
Maltese: Grad 2: Moderat
English: Grades 3-4
Maltese: Grad 3-4
English: Date of first authorisation: 6 May 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 6 ta' Mejju 2019
English: Film-coating: Hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E171), iron oxide black (E172), and iron oxide red (E172).
Maltese: Hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E171), iron oxide black (E172), u iron oxide red (E172).
English: Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free)
Maltese: Pfizer Healthcare L-Irlanda Tel: 1800 633 363 (toll free)
English: • medicines containing St. John's wort (Hypericum perforatum, a herbal preparation)
Maltese: John's wort (Hypericum perforatum, preparazzjoni erbali)
English: • carbamazepine, phenytoin (used to treat epilepsy)
Maltese: • carbamazepine, phenytoin (jintużaw għall-kura tal-epilessija)
English: Lactose monohydrate
Maltese: Lactose monohydrate Macrogol
English: a Alectinib, brigatinib, or ceritinib.
Maltese: Alectinib, brigatinib, jew ceritinib Skont ICR.
English: Rash (including dermatitis acneiform, maculopapular rash, pruritic rash, rash).
Maltese: Raxx (inkluż dermatite akneiform, raxx makulopapulari, raxx pruritiku, raxx).
English: Effective contraception must be continued for at least 35 days after completing therapy.
Maltese: Il-kontraċezzjoni effettiva għandha tkompli għal mill-inqas 35 jum wara li jtemmu t-terapija.
English: Pfizer PFE, spol.
Maltese: Česká republika Pfizer PFE, spol.
English: The most frequently reported adverse reactions were hypercholesterolaemia (84.4%), hypertriglyceridaemia (67.1%), oedema (54.6%), peripheral neuropathy (47.8%), cognitive effects (28.8%), fatigue (28.1%), weight increased (26.4%) and mood effects (22.7%).
Maltese: L-aktar reazzjonijiet avversi li ġew irrappurtati b'mod frekwenti kienu iperkolesterolemija (84.4%), ipertrigliċeridemija (67.1%), edema (54.6%), newropatija periferika (47.8%), effetti konjittivi (28.8%), għeja (28.1%), żieda fil-piż (26.
English: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.
Maltese: Qalba tal-pillola: microcrystalline cellulose, calcium hydrogen phosphate, starch glycolate tassodju, magnesium stearate.
English: Lorlatinib demonstrated marked antitumour activity in mice bearing tumour xenografts that express echinoderm microtubule-associated protein-like 4 (EML4) fusions with ALK variant 1 (v1), including ALK mutations L1196M, G1269A, G1202R, and I1171T.
Maltese: Lorlatinib wera attività sinifikanti kontra t-tumuri fi ġrieden b'xenografi ta' tumuri li kienu jesprimu fużjonijiet tal-proteina-simili 4 assoċjata mal-mikrotubi ta' ekinodermi (EML4) ma' varjant talALK 1 (v1), inkluż il-mutazzjonijiet tal-ALK L1196M, G1269A, G1202R, u I1171T.
English: • rifampicin (used to treat tuberculosis)
Maltese: • rifampicin (jintuża għall-kura tat-tuberkulożi)
English: Česká republika
Maltese: Slovenská republika
English: Lorlatinib is a selective, adenosine triphosphate (ATP)-competitive inhibitor of ALK and c-ros oncogene 1 (ROS1) tyrosine kinases.
Maltese: Lorlatinib huwa inibitur selettiv kompetittiv tat-trifosfat tal-adenożina (ATP) tal-ALK u tal-kinażi tattirożina c-ros oncogene 1 (ROS1).
English: Age, gender, race, body weight, and phenotype
Maltese: Età, sess, razza, piż tal-ġisem, u fenotip
English: Oedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling).
Maltese: Edema (inkluż edema ġeneralizzata, edema, edema periferali, nefħa periferali, nefħa).
English: The ORR for Asians was 49.1% (95% CI: 35.1, 63.2) and 31.5% for non-Asians (95% CI: 21.1, 43.4).
Maltese: L-ORR għall-Asjatiċi kienet 49.1% (95% CI: 35.1, 63.2) u 31.5% għal dawk li mhumiex Asjatiċi (95% CI: 21.1, 43.4).
English: Grade 3: Severe
Maltese: Grad 3: Sever
English: Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE44
Maltese: Kategorija farmakoterapewtika: aġenti anti-neoplastiċi, inibituri tal-proteina kinażi, Kodiċi ATC:
English: Lorlatinib dosing PR interval prolongation/Atrioventricular (AV) block
Maltese: Doża ta' lorlatinib Titwil tal-intervall tal-PR/Imblukkar atrijoventrikulari (AV)
English: What Lorviqua contains - The active substance is lorlatinib.
Maltese: X'fih Lorviqua - Is-sustanza attiva hi lorlatinib.
English: Atrioventricular block
Maltese: Imblukkar atrijoventrikulari
English: Iron oxide black (E172)
Maltese: Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172)
English: Among the 284 patients with PR interval < 200 msec, 14% had PR interval prolongation ≥ 200 msec after starting lorlatinib.
Maltese: Fost il-284 pazjent b'intervall tal-PR ta' < 200 msec, 14% kellhom titwil tal-intervall tal-PR ta' ≥ 200 msec wara li bdew lorlatinib.
English: See Possible side effects in section 4 for more information.
Maltese: Ara Effetti sekondarji possibbli fis-sezzjoni 4 għal aktar informazzjoni.
English: In vitro studies with drug transporters
Maltese: Studji in vitro bi trasportaturi tal-mediċini
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1355/001 (120 film-coated tablets) EU/1/19/1355/003 (90 film-coated tablets)
Maltese: EU/1/19/1355/001 (120 pillola miksija b'rita) EU/1/19/1355/003 (90 pillola miksija b'rita)
English: Central nervous system effects
Maltese: Effetti tas-sistema nervuża ċentrali
English: Lorviqua 25 mg is provided in blisters of 10 tablets, which are available in packs containing 90 tablets (9 blisters) or 120 tablets (12 blisters).
Maltese: Lorviqua 25 mg jiġi f'folji ta' 10 pilloli, li huma disponibbli f'pakketti ta' 90 pillola (9 folji) jew 120 pillola (12-il folja).
English: Two of these ALK mutants, G1202R and I1171T, are known to confer resistance to alectinib, brigatinib, ceritinib, and crizotinib.
Maltese: Tnejn minn dawn il-mutazzjonijiet tal-ALK, G1202R u I1171T, huma magħrufa li joffru reżistenza għal alectinib, brigatinib, ceritinib, u crizotinib.
English: Nervous system disorders Cognitive effectse Peripheral neuropathyf Headache Speech effectsg
Maltese: Disturbi fis-sistema nervuża Effetti konjittivi Newropatija periferika Uġigħ ta' ras
English: k Myalgia (including musculoskeletal pain, myalgia).
Maltese: Mijalġija (inkluż uġigħ muskoluskeletriku, mijalġija)
English: Lorlatinib should be withheld and/or permanently discontinued based on severity (see section 4.2).
Maltese: Lorlatinib għandu jitwaqqaf temporanjament u/jew b'mod permanenti abbażi tas-severità (ara sezzjoni 4.2).
English: In Study A, 2 patients (0.7%) had absolute Fridericia's correction QTc (QTcF) values > 500 msec and 5 patients (1.8%) had a change in QTcF from baseline > 60 msec.
Maltese: Fi Studju A, 2 pazjenti (0.7%) kellhom korrezzjoni ta' Fridericia assoluta tal-valuri QTc (QTcF) > 500 msec u 5 pazjenti (1.8%) kellhom bidla fil-QTcF mil-linja bażi > 60 msec.
English: Gastrointestinal disorders Diarrhoea
Maltese: Disturbi gastro-intestinali Dijarea
English: Frequency category All Grades
Maltese: Kategorija ta' frekwenza Il-Gradi Kollha
English: - ciclosporin, sirolimus, and tacrolimus - medicines used in organ transplantation to prevent organ rejection.
Maltese: - ciclosporin, sirolimus, u tacrolimus - mediċini li jintużaw fi trapjanti tal-organi biex jiġi evitat ir-rifjut ta' organu.
English: Progression-free survival Median, months (95% CI)
Maltese: Sopravivenza mingħajr progressjoni Medjan, xhur (95% CI)
English: The median duration of hypercholesterolaemia and hypertriglyceridaemia was 381 and 405 days, respectively.
Maltese: Id-durata medjana ta' iperkolesterolemija u ipertrigliċeridemija kienet 381 u 405 ijiem, rispettivament.
English: - Fertility
Maltese: - Fertilità
English: The effects on male reproductive organs were partially to fully reversible.
Maltese: L-effetti fuq l-organi riproduttivi maskili kienu parzjalment għal kompletament riversibbli.
English: Repeat-dose toxicity
Maltese: Tossiċità b'doża ripetuta
English: The primary efficacy endpoint in the Phase 2 portion of the study was objective response rate (ORR), including intracranial (IC)-ORR, as per Independent Central Review (ICR) according to modified response evaluation criteria in solid tumours (modified RECIST version 1.1).
Maltese: Ċentrali Indipendenti (ICR, Independent Central Review) skont modifika tal-kriterji ta' evalwazzjoni tar-reazzjoni f'tumuri solidi (RECIST, Response Evaluation Criteria in Solid Tumours, verżjoni 1.1 modifikat).
English: b Per ICR.
Maltese: Skont ICR.
English: The oxidative cleavage metabolite is pharmacologically inactive.
Maltese: Il-metabolit mill-qsim ossidattiv huwa farmakoloġikament inattiv.
English: Other medicines and Lorviqua
Maltese: Mediċini oħra u Lorviqua
English: System organ class and adverse reaction
Maltese: Sistema tal-klassifika tal-organi u reazzjoni avversa
English: Hyperlipidaemia
Maltese: Iperlipidemija
English: Strong cytochrome P-450 (CYP) 3A4/5 inhibitors
Maltese: Inibituri qawwija taċ-ċitokromju P-450 (CYP) 3A4/5
English: Pneumonitisi
Maltese: Pulmonite
English: Grade 4: Life-threatening/Urgent intervention indicated
Maltese: Grad 4: Ta' periklu għall-ħajja/Intervent urġenti indikat
English: Lorlatinib dosing Hypercholesterolaemia or hypertriglyceridaemia Mild hypercholesterolaemia (cholesterol between ULN and 300 mg/dL or between ULN and 7.75 mmol/L)
Maltese: Iperkolesterolemija jew ipertrigliċeridemija Iperkolesterolemija ħafifa (kolesterol bejn l-ULN u 300 mg/dL jew bejn l-ULN u 7.75 mmol/L)
English: CNS adverse reactions were primarily cognitive effects (28.8%), mood effects (22.7%), and speech effects (9.8%), and were generally mild, transient, and reversible spontaneously upon dose delay and/or dose reduction (see sections 4.2 and 4.4).
Maltese: Ir-reazzjonijiet avversi tas-CNS kienu primarjament effetti konjittivi (28.8%), effetti fuq ilburdata (22.7%), u effetti fuq id-diskors (9.8%), u ġeneralment kienu ħfief, temporanji, u riversibbli b'mod spontanju wara li d-doża ġiet posposta u/jew tnaqqset (ara sezzjonijiet 4.2 u 4.4).
English: Patient demographics of the 139 ALK-positive advanced NSCLC patients after treatment with at least one second-generation ALK TKI, were 56% female, 48% White, 38% Asian, and the median age was 53 years (range: 29-83 years) with 16% of patients ≥ 65 years of age.
Maltese: Il-karatteristiċi demografiċi tal-139 pazjent b'NSCLC avvanzat pożittiv wara kura b'tal-inqas TKI għall-ALK wieħed tat-tieni ġenerazzjoni kienu: 56% nisa, 48% bojod, 38% Asjatiċi, u l-età medjana kienet ta' 53 sena (medda: 29-83 sena) b'16% tal-pazjenti ta' ≥ 65 sena.
English: INFORMATION IN BRAILLE Lorviqua 100 mg
Maltese: Lorviqua 100 mg
English: The IC ORR was 54.5% for Asians (95% CI: 32.2, 75.6) and 46.4% for non-Asians (95% CI: 27.5, 66.1).
Maltese: L-ORR tal-IC kienet 54.5% għall-Asjatiċi (95% CI: 32.2, 75.6) u 46.4% għal dawk li mhumiex Asjatiċi (95% CI:
English: a Hypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia).
Maltese: Iperkolesterolemija (inkluż żieda fil-kolesterol fid-demm, iperkolesterolemija).
English: Concomitant administration of lorlatinib with strong CYP3A4/5 inducers (e.g. rifampicin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort) may decrease lorlatinib plasma concentrations.
Maltese: L-għoti konkomitanti ta' lorlatinib u indutturi qawwija ta' CYP3A4/5 (eż. rifampicin, carbamazepine, enzalutamide, mitotane, phenytoin u St John's wort) jistgħu jnaqqsu l-konċentrazzjonijiet ta' lorlatinib fil-plażma.
English: In vitro, lorlatinib has a low potential to cause drug-drug interactions by induction of CYP1A2.
Maltese: In vitro, lorlatinib għandu potenzjal baxx li jikkawża interazzjonijiet mediċinali permezz tal-induzzjoni tas-CYP1A2.
English: Musculoskeletal and connective tissue disorders Arthralgia Myalgiak
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Artralġja Mijalġija
English: Objective response rateb (95% CI) Complete response, n Partial response, n Duration of intra-cranial response Median, months (95% CI)
Maltese: Rata ta' rispons oġġettiv (95% CI) Rispons komplet, n Rispons parzjali, n Tul ta' rispons intrakranjali Medjan, xhur (95% CI)
English: • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
Maltese: • alectinib jew ceritinib bħala l-ewwel terapija tal-inibitur tat-tirożina kinażi (TKI) għall-ALK;
English: The geometric mean (% CV) oral clearance was 17.7 (39) L/h.
Maltese: Il-medja ġeometrika (% CV) tat-tneħħija orali kienet ta' 17.7 (39) L/h.
English: Amylase increased Electrocardiogram PR prolongation
Maltese: Titwil tal-elettrokardjogramma PR
English: Lorviqua 100 mg is provided in blisters of 10 tablets, which are available in packs containing 30 tablets (3 blisters).
Maltese: Lorviqua 100 mg jiġi f'folji ta' 10 pilloli, u huwa disponibbli f'pakketti ta' 30 pillola (3 folji).
English: Withhold lorlatinib.
Maltese: Waqqaf lorlatinib.
English: Permanently discontinue lorlatinib.
Maltese: Waqqaf lorlatinib b'mod permanenti.
English: In vitro data indicate that lorlatinib is metabolised primarily by CYP3A4 and UGT1A4, with minor contribution from CYP2C8, CYP2C19, CYP3A5 and UGT1A3.
Maltese: Data in vitro tindika li lorlatinib jiġi metabolizzat primarjament mis-CYP3A4 u mill-UGT1A4, b'kontribuzzjoni minuri mis-CYP2C8, CYP2C19, CYP3A5 u UGT1A3.
English: Mild hypertriglyceridaemia (triglycerides between 150 and 300 mg/dL or 1.71 and 3.42 mmol/L)
Maltese: Ipertrigliċeridemija ħafifa (trigliċeridi bejn 150 u 300 mg/dL jew 1.71 u 3.42 mmol/L)
English: Rifampin, a strong inducer of CYP3A4/5, administered at oral doses of 600 mg once daily for 12 days, reduced the mean lorlatinib area under curve (AUC) by 85% and Cmax by 76% of a single 100 mg oral dose of lorlatinib in healthy volunteers; increases in AST and ALT were also observed.
Maltese: Rifampin, induttur qawwi ta' CYP3A4/5, mogħti f'dożi orali ta' 600 mg darba kuljum għal 12-il jum, naqqas l-erja ta' taħt il-kurva (AUC) medja ta' lorlatinib bi 85% u s-Cmax b'76% ta' doża orali unika ta' lorlatinib ta' 100 mg f'voluntiera b'saħħithom; ġew osservati wkoll żidiet fl-AST u fl-ALT.
English: In vitro data indicate that lorlatinib is primarily metabolised by CYP3A4 and uridine diphosphate-glucuronosyltransferase (UGT)1A4, with minor contributions from CYP2C8, CYP2C19, CYP3A5 and UGT1A3.
Maltese: Data in vitro tindika li lorlatinib jiġi metabolizzat primarjament minn CYP3A4 u minn uridine diphosphate-glucuronosyltransferase (UGT)1A4, b'kontribuzzjonijiet minuri mis-CYP2C8, CYP2C19, CYP3A5 u UGT1A3.
English: Serum cholesterol and triglycerides should be monitored before initiation of lorlatinib; 2, 4 and 8 weeks after initiating lorlatinib; and regularly thereafter.
Maltese: Il-kolesterol u ttrigliċeridi fis-serum għandhom jiġu mmonitorjati qabel jinbeda lorlatinib; 2, 4 u 8 ġimgħat wara li jinbeda lorlatinib; u regolarment wara dan.
English: Itraconazole, a strong inhibitor of CYP3A4/5, administered at oral doses of 200 mg once daily for 5 days, increased the mean lorlatinib AUC by 42% and Cmax by 24% of a single 100 mg oral dose of lorlatinib in healthy volunteers.
Maltese: Itraconazole, inibitur qawwi ta' CYP3A4/5, mogħti f'dożi orali ta' 200 mg darba kuljum għal 5 ijiem, żied l-AUC medja ta' lorlatinib bi 42% u s-Cmax b'24% ta' doża unika ta' lorlatinib ta' 100 mg f'voluntiera b'saħħithom.
English: Lorlatinib was also capable of penetrating the blood-brain barrier.
Maltese: Lorlatinib kien kapaċi wkoll jippenetra l-barriera ematoenċefalika.
English: INFORMATION IN BRAILLE Lorviqua 25 mg
Maltese: Lorviqua 25 mg
English: Secondary endpoints included duration of response (DOR), IC-DOR, time-to-tumour response (TTR), and progression-free survival (PFS).
Maltese: Il-punti ta' tmiem sekondarji kienu jinkludu t-tul tar-rispons (DOR, duration of response), l-IC-DOR, iż-żmien għarrispons tat-tumur (TTR, time to tumour response), u s-sopravivenza mingħajr progressjoni (PFS, progressionfree survival).
English: Of the 139 patients, 20% received 1 prior ALK TKI, excluding crizotinib, 47% received 2 prior ALK TKIs, and 33% received 3 or more prior ALK TKIs.
Maltese: Mill-139 pazjent, 20% irċevew TKI għall-ALK wieħed preċedenti, eskluż crizotinib, 47% irċevew 2 TKIs għall-ALK preċedenti, u 33% irċevew 3 jew aktar TKIs għall-ALK preċedenti.
English: Moderate hypertriglyceridaemia (triglycerides between 301 and 500 mg/dL or 3.43 and 5.7 mmol/L)
Maltese: Ipertrigliċeridemija moderata (trigliċeridi bejn 301 u 500 mg/dL jew 3.43 u 5.7 mmol/L)
English: Lorlatinib 150 mg orally once daily for 15 days decreased AUCinf and Cmax of a single oral 2 mg dose of midazolam (a sensitive CYP3A substrate) by 61% by 50%, respectively; hence, lorlatinib is a moderate CYP3A inducer.
Maltese: Lorlatinib 150 mg mill-ħalq darba kuljum għal 15-il jum naqqas l-AUCinf u s-Cmax ta' doża unika mill-ħalq ta' 2 mg ta' midazolam (sottostrat sensittiv ta' CYP3A) b'61% u b'50%, rispettivament; għalhekk, lorlatinib huwa induttur moderat ta' CYP3A.
English: Concomitant administration of lorlatinib with strong CYP3A4/5 inhibitors (e.g. boceprevir, cobicistat, itraconazole, ketoconazole, posaconazole, troleandomycin, voriconazole, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or dasabuvir, and ritonavir in combination with either elvitegravir, indinavir, lopinavir or tipranavir) may increase lorlatinib plasma concentrations.
Maltese: L-għoti konkomitanti ta' lorlatinib ma' inibituri qawwija ta' CYP3A4/5 (eż. boceprevir, cobicistat, itraconazole, ketoconazole, posaconazole, troleandomycin, voriconazole, ritonavir, paritaprevir f'kombinazzjoni ma' ritonavir u ombitasvir u/jew dasabuvir, u ritonavir f'kombinazzjoni ma' jew elvitegravir, indinavir, lopinavir jew tipranavir) jista' jżid ilkonċentrazzjonijiet ta' lorlatinib fil-plażma.
English: - efavirenz, cobicistat, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or dasabuvir, and ritonavir in combination with either elvitegravir, indinavir, lopinavir or tipranavir - medicines used to treat AIDS/HIV.
Maltese: - efavirenz, cobicistat, ritonavir, paritaprevir f'kombinazzjoni ma' ritonavir u ombitasvir u/jew dasabuvir, u ritonavir f'kombinazzjoni ma' jew elvitegravir, indinavir, lopinavir jew tipranavirmediċini li jintużaw għall-kura tal-AIDS/HIV. - ketoconazole, itraconazole, voriconazole, posaconazole - mediċini li jintużaw għall-kura ta' infezzjonijiet fungali.
English: Unchanged lorlatinib was the major component of human plasma and faeces, accounting for 44% and 9.1% of total radioactivity, respectively.
Maltese: Lorlatinib mhux mibdul kien il-komponent ewlieni fil-plażma u fl-ippurgar tal-bniedem, li jirrappreżenta 44% u 9.1% tar-radjuattività totali, rispettivament.
English: At single dose, lorlatinib systemic exposure (AUCinf and Cmax) increased in a dose-related manner over the 10 to 200 mg dose range.
Maltese: F'doża unika, l-esponiment sistemiku għal lorlatinib (AUCinf u Cmax) naqas b'mod relatat mad-doża fuq medda ta' dożi bejn 10 mg u 200 mg.
English: In the study population, the maximum mean change from baseline for PR interval was 16.4 msec (2-sided 90% upper CI 19.4 msec) (see sections 4.2, 4.4 and 4.8).
Maltese: Fil-popolazzjoni tal-istudju, l-akbar tibdil medju mil-linja bażi għall-intervall tal-PR kien ta' 16.4 msec (2-sided limitu ta' fuq tad-90% tas-CI ta' 19.4 msec) (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: Lorviqua may affect male fertility.
Maltese: Lorviqua jista' jaffettwa l-fertilità maskili.
English: The most common cognitive effect of any grade was memory impairment (11.5%), and the most common Grade 3 or 4 reactions were cognitive effect and confusional state (0.7% each).
Maltese: L-aktar effett konjittiv komuni ta' kwalunkwe grad kienet indeboliment tal-memorja (11.5%), u l-aktar reazzjonijiet komuni tal-Grad 3 jew 4 kienu effetti konjittivi u stat konfużjonali (0.7% kull waħda).
English: Hypercholesterolaemia/hypertriglyceridaemia
Maltese: Iperkolesterolemija/ipertrigliċeridemija
English: Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events; ECG=electrocardiogram; HMG CoA=3-hydroxy-3-methylglutaryl coenzyme A; NCI=National Cancer Institute; ULN=upper limit of normal.
Maltese: HMG CoA=3-hydroxy-3-methylglutaryl coenzyme A; NCI=Istitut Nazzjonali talKanċer; ULN=l-ogħla limitu tan-normal.
English: Severe hypertriglyceridaemia (triglycerides between 501 and 1,000 mg/dL or 5.71 and 11.4 mmol/L)
Maltese: Ipertrigliċeridemija severa (trigliċeridi bejn 501 u 1,000 mg/dL jew 5.71 u 11.4 mmol/L)
English: Lorlatinib dosing
Maltese: Doża ta' lorlatinib
English: Film-coating
Maltese: Żieda fil-lipażi