FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhibition of MTP reduces lipoprotein secretion and circulating concentrations of lipoprotein-borne lipids including cholesterol and triglycerides.
Maltese: L-inibizzjoni tal-MTP tnaqqas it-tnixxija tal-lipoproteini u lkonċentrazzjonijiet ta' lipidi li jġorru l-lipoproteini li jiċċirkolaw inkluż il-kolesterol u t-trigliċeridi.
English: Patients treated with Lojuxta should take daily supplements that contain 400 international units vitamin E and approximately 200 mg linoleic acid, 210 mg ALA, 110 mg EPA, and 80 mg DHA.
Maltese: Pazjenti li rċevew kura b'Lojuxta għandhom jieħdu supplimenti kuljum li fihom 400 unità internazzjonali ta' vitamina E u madwar 200 mg ta' aċidu linolejku, 210 mg ta' ALA, 110 mg ta' EPA, u 80 mg ta' DHA.
English: Lojuxta 10 mg: each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Maltese: Lojuxta 10 mg: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 10 mg ta' lomitapide.
English: gamma-GT, serum albumin (liver injury); high sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK-18 Fragment, NashTest (liver inflammation);
Maltese: Dan għandu jinkludi mill-inqas markatur wieħed f'kull kategorija li ġejjin: gamma-GT, albumina fis-serum (ħsara lill-fwied); high sensitivity C-reactive protein (hs-CRP), rata ta' sedimentazzjoni tal-eritroċiti (ESR), CK-18 Fragment, NashTest (infjammazzjoni tal-fwied); Enhanced Liver Fibrosis (ELF) panel, Fibrometer, proporzjon tal-AST/ALT, punteġġ tal-Fib-4, Fibrotest (fibrożi tal-fwied).
English: • medicines to treat and prevent blood clots (e.g. dabigatran etexilate)
Maltese: • mediċini għall-kura u l-prevenzjoni ta' għoqiedi tad-demm (eż. dabigatran etexilate)
English: Lactose
Maltese: Pożoloġija
English: Lojuxta 20 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.
Maltese: Lojuxta 20 mg kapsuli ibsin Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 20 mg ta' lomitapide.
English: Blood bilirubin increased Gamma-glutamyltransferase increased Neutrophil percentage increased Protein urine
Maltese: Żieda fil-bilirubina fid-demm Żieda fil-gamma-glutamyltransferase Żieda fil-perċentwal tan-newtrofili Proteina fl-awrina
English: Lojuxta contains lactose
Maltese: Kif jidher Lojuxta u l-kontenut tal-pakkett
English: Lojuxta 40 mg: each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Maltese: Lojuxta 40 mg: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 40 mg ta' lomitapide.
English: No adverse effects on fertility were observed in male and female rats administered lomitapide at systemic exposures (AUC) estimated to be 4 to 5 times higher than in humans at the maximum recommended human dose (see section 5.3).
Maltese: F'firien irġiel u nisa li ngħataw lomitapide f'esponimenti sistemiċi (AUC) stmati li kienu 4 sa 5 darbiet ogħla milli fil-bnedmin fid-doża massima rakkomandata (ara s-sezzjoni 5.3) ma kienu osservati l-ebda effetti avversi fuq il-fertilità.
English: The use of St. John's Wort should be avoided with Lojuxta.
Maltese: John's Wort ma' Lojuxta għandu jiġi evitat.
English: Lojuxta 30 mg hard capsules Gelatin
Maltese: Lojuxta 30 mg kapsuli ibsin Ġelatina
English: Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.
Maltese: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 5 mg ta' lomitapide.
English: The capsule is an orange cap/orange body hard capsule of 19.4 mm, printed with black ink imprinted with “5 mg” on body and “A733” on cap.
Maltese: Il-kapsula hija kapsula iebsa b'għatu oranġjo/parti prinċipali oranġjo ta' 19.4 mm, stampata b'linka sewda u stampata b'“5 mg” fuq il-parti prinċipali u b'“A733” fuq l-għatu.
English: Mean Percent Change from Baseline in LDL-C
Maltese: Tibdil % Valur-pb
English: Lojuxta 60 mg hard capsules
Maltese: Lojuxta 60 mg kapsuli ibsin
English: Lojuxta 20 mg hard capsules
Maltese: Lojuxta 20 mg kapsuli ibsin
English: Lojuxta is used to treat adult patients with very high cholesterol because of a condition that runs in their families (homozygous familial hypercholesterolaemia or HoFH).
Maltese: Lojuxta jintuża fil-kura ta' pazjenti adulti b'kolesterol għoli ħafna minħabba kundizzjoni fil-familji tagħhom (iperkolesterolemija omozigota familjali jew HoFH).
English: • The capsule shell for the 20 mg capsule contains gelatin and titanium dioxide (E171).
Maltese: • Il-qoxra tal-kapsula għall-kapsula ta' 20 mg fiha l-ġelatina u titanium dioxide (E171).
English: Genetic confirmation of HoFH should be obtained whenever possible.
Maltese: Għandha tinkiseb konferma ġenetika ta' HoFH kull meta jkun possibbli.
English: Gastrooesophageal reflux disease Haemorrhoidal haemorrhage Regurgitation
Maltese: Marda tar-rifluss gastroesofagali Emorraġija tal-murliti Rigurġitazzjoni
English: Moderate CYP3A4 inhibitors are predicted to have a substantial impact on lomitapide's pharmacokinetics.
Maltese: Inibituri moderati ta' CYP3A4 huma mistennija jkollhom impatt sostanzjali fuq ilfarmakokinetika ta' lomitapide.
English: Lojuxta 30 mg: each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Maltese: Lojuxta 30 mg: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 30 mg ta' lomitapide.
English: Excipient with known effect Each hard capsule contains 194.84 mg of lactose (as monohydrate) (see section 4.4).
Maltese: Eċċipjent(i) b'effett magħruf Kull kapsula iebsa fiha 194.84 mg ta' lattożju (bħala monoidrat) (ara s-sezzjoni 4.4).
English: • medicines which lower cholesterol (e.g. atorvastatin)
Maltese: • mediċini li jbaxxu l-kolesterol (eż. atorvastatin)
English: Adverse clinical consequences of these reductions were not observed with lomitapide treatment of up to 78 weeks.
Maltese: Il-konsegwenzi kliniċi avversi ta' dan it-tnaqqis ma kienux osservati b'kura b'lomitapide sa 78 ġimgħa.
English: • The capsule shell for the 5 mg and 10 mg capsules contains gelatin, titanium dioxide (E171) and red iron oxide (E172).
Maltese: • Il-qoxra tal-kapsula għall-kapsuli ta' 5 mg u 10 mg fiha l-ġelatina, titanium dioxide (E171) u red iron oxide (E172).
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measure:
Maltese: Peress li din hi approvazzjoni taħt ċirkustanzi ta' eċċezzjoni u skont l-Artikolu 14(8) tarRegolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Medicinal products that induce CYP3A4 would be expected to increase the rate and extent of metabolism of lomitapide.
Maltese: Prodotti mediċinali li jinduċu CYP3A4 huma mistennija jżidu r-rata u l-firxa tal-metaboliżmu ta' lomitapide.
English: Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolaemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded.
Maltese: Forom oħra ta' hyperlipoproteinemia primarja u kawżi sekondarji ta' iperkolesterolemija (eż., sindromu nefrotiku, ipotirojdiżmu) għandhom jiġu esklużi.
English: • muscle spasms
Maltese: • ġilda xotta
English: In patients taking coumarins (such as warfarin) and Lojuxta concomitantly, INR should be determined before starting Lojuxta and monitored regularly with dosage of coumarins adjusted as clinically indicated (see section 4.4).
Maltese: F'pazjenti li qed jieħdu coumarins (bħal warfarina) u Lojuxta b'mod konkomitanti, l-INR għandu jiġi determinat qabel ma jinbeda Lojuxta u jiġi mmonitorjat regolarment u d-dożi ta' coumarins jiġu aġġustati kif klinikament indikat (ara s-sezzjoni 4.4).
English: • The capsule shell for the 60 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
Maltese: • Il-qoxra tal-kapsula għall-kapsula ta' 60 mg fiha l-ġelatina, titanium dioxide (E171) u yellow iron oxide (E172).
English: Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.
Maltese: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 60 mg ta' lomitapide.
English: In the renal impairment population, lomitapide was only studied in patients with end-stage renal disease (ESRD).
Maltese: Fil-popolazzjoni b'indeboliment renali, lomitapide kien studjat biss f'pazjenti b'mard tal-kliewi flistadju aħħari (ESRD).
English: • The capsule shell for the 40 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
Maltese: • Il-qoxra tal-kapsula għall-kapsuli ta' 40 mg fiha l-ġelatina, titanium dioxide (E171) u yellow iron oxide (E172).
English: Lower gastrointestinal haemorrhage Reflux oesophagitis
Maltese: Esofaġite tar-rifluss
English: Mean percent changes from baseline in LDL-C in the major effectiveness study UP1002/AEGR-733-005 through Week 26 (the Primary Endpoint) using LOCF to each assessment (N=29)
Maltese: Bidliet perċentwali medji mil-linja bażi fl-LDL-C fl-istudju tal-effikaċja maġġuri UP1002/AEGR-733-005 sal-Ġimgħa 26 (l-Punt ta' tmiem Primarju) bl-użu ta' LOCF għal kull valutazzjoni (N=29)
English: Excipient with known effect Each hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4).
Maltese: Eċċipjent(i) b'effett magħruf Kull kapsula iebsa fiha 129.89 mg ta' lattożju (bħala monoidrat) (ara s-sezzjoni 4.4).
English: In ferrets, lomitapide was both maternally toxic and teratogenic at <1 times the MRHD.
Maltese: Fl-inmsa, lomitapide kien kemm tossiku u teratoġeniku għall-omm f'<darba 1 l-MRHD.
English: • burping
Maltese: • tifwiq
English: Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Maltese: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 30 mg ta' lomitapide.
English: • Repeat tests weekly and withhold dosing if there are signs of abnormal liver function (increase in bilirubin or INR), if aminotransferase levels rise above 5x ULN, or if aminotransferase levels do not fall below 3x ULN within approximately 4 weeks.
Maltese: • Irrepeti t-testijiet kull ġimgħa u waqqaf id-doża jekk ikun hemm sinjali ta' funzjoni anormali tal-fwied (żieda fil-bilirubin jew fl-INR), jekk illivelli tal-aminotransferażi jogħlew aktar minn 5x ULN, jew jekk illivelli tal-aminotransferażi ma jaqgħux taħt it-3x ULN wara madwar 4 ġimgħat.
English: − Appropriate advice on effective methods of contraception should be provided, and effective contraception initiated;
Maltese: − Għandu jingħata parir xieraq dwar metodi effettivi ta' kontraċezzjoni, u għandha tinbeda kontraċezzjoni effettiva;
English: Haemodialysis is unlikely to be beneficial given that lomitapide is highly protein bound.
Maltese: L-emodijalisi mhix mistennija li tkun ta' benefiċċju għax lomitapide jeħel ħafna mal-proteini.
English: CYP3A4, lomitapide AUC increased approximately 27-fold and Cmax increased approximately 15-fold.
Maltese: 27-darba u s-Cmax żdied madwar 15-darba.
English: • medicines to treat cancer (e.g. bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or nausea/vomiting with cancer treatment (e.g. fosaprepitant)
Maltese: • mediċini għall-kura tal-kanċer (eż. bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib,
English: Lojuxta 30 mg hard capsules
Maltese: Lojuxta 30 mg kapsuli ibsin
English: Lomitapide increases plasma concentrations of statins.
Maltese: Lomitapide jżid il-konċentrazzjonijiet tal-istatins fil-plasma.
English: Interactions between Lojuxta and other medicinal products and other forms of interaction
Maltese: Interazzjonijiet bejn Lojuxta u prodotti mediċinali oħra u forom oħra ta'
English: Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Maltese: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 40 mg ta' lomitapide.
English: Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Maltese: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 10 mg ta' lomitapide.
English: • Not to take Lojuxta if patient has liver problems, or unexplained abnormal liver tests;
Maltese: • Biex Lojuxta ma jitteħidx jekk il-pazjent ikollu problemi fil-fwied, jew testijiet anormali inspjegabbli tal-fwied;
English: Systemic exposures to lomitapide at these doses were estimated to be 4 times (females) and 5 times (males) higher than the human exposure at 60 mg based on AUC.
Maltese: Esponimenti sistemiċi għal lomitapide f'dawn id-dożi kienu stmati li kienu 4 darbiet (nisa) u 5 darbiet (irġiel) ogħla mill-esponiment tal-bniedem f'60 mg abbażi tal-AUC.
English: • Lojuxta 60 mg is a yellow cap/yellow body hard capsule with “60 mg” printed on the body and “A733” printed on the cap in black ink.
Maltese: • Lojuxta 60 mg jikkonsisti minn kapsula iebda b'għatu isfar/parti prinċipali safra b'“60 mg” stampat fuq il-parti prinċipali u b'“A733” stampat fuq l-għatu b'linka sewda.
English: • Information on undesirable effects, including diarrhoea, nausea, flatulence, abdominal pain or discomfort, abdominal distension, vomiting, dyspepsia, eructation and decreased appetite;
Maltese: • Informazzjoni dwar effetti mhux mixtieqa, inkluż dijarea, dardir, gass fl-istonku, uġigħ jew skonfort addominali, nefħa addominali, rimettar, dispepsja, tifwiq u tnaqqis fl-aptit;
English: • medicines to treat severe acne (e.g. isotretinoin)
Maltese: • mediċini għall-kura tal-akne severa(eż. isotretinoin)
English: In rare cases, myopathy may take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and can lead to fatality.
Maltese: F'każijiet rari, mijopatija tista' tieħu l-forma ta' rabdomijoliżi bi jew mingħajr falliment renali akut sekondarju għal mijoglobina, u tista' twassal għal fatalità.
English: • Lojuxta 10 mg is an orange cap/white body hard capsule with “10 mg” printed on the body and “A733“ printed on the cap in black ink.
Maltese: • Lojuxta 10 mg huwa kapsula ibsin b'għatu oranġjo/parti prinċipali bajda b'“10 mg” stampat fuq il-parti prinċipali u b'“A733“stampat fuq l-għatu b'linka sewda.
English: • medicines to regulate heart rhythm (e.g. digoxin)
Maltese: • mediċini biex jirregolaw ir-ritmu tal-qalb (eż. digoxin)
English: • medicines to treat anxiety disorders and depression (e.g. alprazolam, fluoxetine, fluvoxamine)
Maltese: • mediċini għall-kura ta' disturbi ta' ansjetà u d-dipressjoni (eż. alprazolam, fluoxetine,
English: Eructation
Maltese: Manifattur
English: Although cases of hepatic dysfunction (elevated aminotransferase with increase in bilirubin or International Normalized Ratio [INR]) or hepatic failure have not been reported, there is concern that lomitapide could induce steatohepatitis, which can progress to cirrhosis over several years.
Maltese: Għalkemm ma ġewx irrapportati każijiet ta' disfunzjoni epatika (żidiet fl-aminotransferażi b'żieda filbilirubin jew fil-Proporzjon Normalizzat Internazzjonali [INR]) jew insuffiċjenza epatika, hemm tħassib li lomitapide jista' jinduċi steatohepatitis, li tista' tavvanza għal ċirrożi wara diversi snin.
English: Alanine aminotransferase increased Aspartate aminotransferase increased Hepatic enzyme increased Liver function test abnormal Neutrophil count decreased White blood cell count decreased
Maltese: Żieda fl-alanina aminotransferażi Żieda fl-aspartat aminotransferażi Żieda fl-enzimi epatiċi Test anormali tal-funzjoni tal-fwied Tnaqqis fl-għadd tan-newtrofili Tnaqqis fl-għadd taċ-ċelloli tad-demm bojod
English: • Lojuxta 30 mg is an orange cap/yellow body hard capsule with “30 mg” printed on the body and “A733” printed on the cap in black ink.
Maltese: • Lojuxta 30 mg jikkonsisti minn kapsula iebsa b'għatu oranġjo/parti prinċipali safra b'“30 mg” stampat fuq il-parti prinċipali u b'“A733“ stampat fuq l-għatu b'linka sewda.
English: Peak plasma concentrations of lomitapide were reached 4-8 hours following oral dosing.
Maltese: Il-konċentrazzjonijiet massimi fil-plasma ta' lomitapide ntlaħqu 4-8 sigħat wara l-għoti ta' doża orali.
English: Data in the pivotal clinical study were analysed with respect to the impact of potential covariates on lomitapide exposure.
Maltese: Dejta fl-istudju kliniku pivotali kienet analizzata fir-rigward tal-impatt ta' kovarjanti potenzjali fuq lesponiment ta' lomitapide.
English: Careful titration may then be considered according to LDL-C response and safety/tolerability.
Maltese: Wara tista' tiġi kkunsidrata titrazzjoni b'attenzjoni skont ir-rispons tal-LDL-C u s-sigurtà/tolleranza.
English: Recommendation concerning co-administration with Lojuxta
Maltese: Kif taħżen Lojuxta
English: Lojuxta 40 mg hard capsules
Maltese: Lojuxta 40 mg kapsuli ibsin
English: Other medicines and Lojuxta
Maltese: X'fih Lojuxta
English: Statins occasionally cause myopathy.
Maltese: Xi kultant statins jikkawżaw mijopatija.
English: In animal studies lomitapide was highly concentrated (200-fold) in the liver.
Maltese: Fl-istudji fuq l-annimali lomitapide kien ikkonċentrat ħafna (200-darba) fil-fwied.
English: Prothrombin time prolonged Pulmonary function test abnormal White blood cell count increased
Maltese: Titwil tal-ħin ta' prothrombin Test anormali tal-funzjoni pulmonari Żieda fl-għadd taċ-ċelloli tad-demm bojod
English: When lomitapide 20 mg was co-administered simultaneously with atorvastatin, a weak CYP3A4 inhibitor, lomitapide AUC and Cmax increased approximately 2-fold.
Maltese: 200 mg darbtejn kuljum, inibitur qawwi ta' CYP3A4, l-AUC ta' lomitapide żdied madwar
English: Diarrhoea
Maltese: Deidrazzjoni
English: Lojuxta 60 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.
Maltese: Lojuxta 60 mg kapsuli ibsin Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 60 mg ta' lomitapide.
English: Liver function test abnormal Prothrombin time prolonged Transaminases increased Vitamin E decreased Vitamin K decreased
Maltese: Test anormali tal-funzjoni tal-fwied Titwil tal-ħin ta' prothrombin Żieda fit-transaminażi Tnaqqis fil-vitamina E Tnaqqis fil-vitamina K
English: Lojuxta 5 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.
Maltese: Lojuxta 5 mg kapsuli ibsin Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 5 mg ta' lomitapide.
English: • If you take another medicine that lowers cholesterol by binding bile acids, such as colesevelam or cholestyramine, take the medicine that binds bile acids at least 4 hours before or 4 hours after you take Lojuxta.
Maltese: • Jekk tieħu mediċina oħra li tbaxxi l-kolesterol billi tintrabat mal-aċidi biljari, bħal colesevelam jew cholestyramine, ħu l-mediċina li tintrabat mal-aċidi biljari mill-inqas 4 sigħat qabel jew 4 sigħat wara li tieħu Lojuxta.
English: The capsule is an orange cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “10 mg” on body and “A733” on cap.
Maltese: Il-kapsula hija kapsula iebsa b'għatu oranġjo/parti prinċipali bajda ta' 19.4 mm, stampata b'linka sewda u stampata b'“10 mg” fuq il-parti prinċipali u b'“A733” fuq l-għatu.
English: Patients with end-stage renal disease receiving dialysis should not exceed 40 mg daily (see section 5.2).
Maltese: Pazjenti b'mard tal-kliewi fl-istadju aħħari li qed jirċievu dijaliżi ma għandhomx jaqbżu 40 mg kuljum (ara s-sezzjoni 5.2).
English: Diarrhoea occurred in 79% of patients, nausea in 65%, dyspepsia in 38%, and vomiting in 34%.
Maltese: Reazzjonijiet avversi gastrointestinali kienu rrapportati f'27 (93%) minn 29 pazjent fl-istudju kliniku tal-Fażi 3. Id-dijarea seħħet f'79% tal-pazjenti, nawżja f'65%, dispepsja f'38%, u rimettar f'34%.
English: • Advice on escalating Lojuxta dose gradually to improve tolerability of the medicine;
Maltese: • Parir dwar iż-żieda gradwali tad-doża ta' Lojuxta biex ittejjeb it-tollerabbiltà tal-mediċina;
English: • if you take any of these medicines that affect the way lomitapide is broken down in the body: o itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole (for fungal infections) ; o telithromycin, clarithromycin, erythromycin (for bacterial infections) o indinavir, nelfinavir, saquinavir (for HIV infection) ; o diltiazem, verapamil (for high blood pressure, or angina), and dronedarone (to regulate heart rhythm).
Maltese: • jekk tieħu xi waħda minn dawn il-mediċini li jaffettwaw il-mod kif lomitapide jitkisser filġisem: o itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole (għal infezzjonijiet fungali) o telithromycin, clarithromycin, erythromycin (għal infezzjonijiet batteriċi) o indinavir, nelfinavir, saquinavir (għall-infezzjoni tal-HIV) o diltiazem, verapamil (għall-pressjoni għolja tad-demm, jew anġina), u dronedarone (biex jirregola r-ritmu tal-qalb)
English: Lojuxta 30 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Maltese: Lojuxta 30 mg kapsuli ibsin Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 30 mg ta' lomitapide.
English: CAPTURE study - effects of lomitapide on carotid and aortic atherosclerosis in patients treated with lomitapide in usual care.The applicant shall conduct a clinical study with adequate surrogate endpoints on vascular outcomes using imaging techniques to monitor vascular function, disease stabilisation and/or regression.
Maltese: Studju CAPTURE - l-effetti ta' lomitapide fuq aterosklerożi karotida u aortika f'pazjenti trattati b'lomitapide fit-trattament tas-soltu.
English: Hepatic fat was prospectively measured using MRS in all eligible patients during the clinical study (Table 7).
Maltese: Ix-xaħam fil-fwied kien prospettivament imkejjel bl-użu ta' MRS fil-pazjenti eliġibbli kollha matul l-istudju klinika (Tabella 7).
English: There have been no concomitant or subsequent clinically meaningful elevations in serum bilirubin, INR, or alkaline phosphatase.
Maltese: Ma kien hemm l-ebda żidiet klinikament sinifikanti fl-istess ħin jew sussegwenti tal-bilirubina fis-seum, INR, jew alkaline phosphatase.
English: • Lojuxta 40 mg is a yellow cap/white body hard capsule with “40 mg” printed on the body and “A733” printed on the cap in black ink.
Maltese: • Lojuxta 40 mg jikkonsisti minn kapsula iebsa b'għatu safra/parti prinċipali bajda b'“40 mg” stampat fuq il-parti prinċipali u b'“A733“stampat fuq l-għatu b'linka sewda.
English: Upon discontinuation of atorvastatin the dose of Lojuxta should be up-titrated according to LDL-C response and safety/tolerability.
Maltese: Wara l-waqfien ta' atorvastatin id-doża ta' Lojuxta għandha tiġi ttitrata 'l fuq skont ir-rispons talLDL-C u s-sigurtà/tolleranza.
English: The dose should be escalated gradually to minimise the incidence and severity of gastrointestinal adverse reactions and aminotransferase elevations.
Maltese: Id-doża għandha tiżdied b'mod gradwali biex tiġi minimizzata l-inċidenza u s-severità ta' reazzjonijiet avversi gastrointestinali u żidiet fl-aminotransferażi.
English: The capsule is a yellow cap/white body hard capsule of 23.4 mm, printed with black ink imprinted with “40 mg” on body and “A733” on cap.
Maltese: Il-kapsula hija kapsula iebsa b'għatu isfar/parti prinċipali bajda ta' 23.4 mm, stampata b'linka sewda u stampata b'“40 mg” fuq il-parti prinċipali u b'“A733” fuq l-għatu.
English: The capsule is a yellow cap/yellow body hard capsule of 23.4 mm, printed with black ink imprinted with “60 mg” on body and “A733” on cap.
Maltese: Il-kapsula hija kapsula iebsa b'għatu isfar/parti prinċipali safra ta' 23.4 mm, stampata b'linka sewda u stampata b'“60 mg” fuq il-parti prinċipali u b'“A733” fuq l-għatu.
English: Lojuxta 10 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Maltese: Lojuxta 10 mg kapsuli ibsin Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 10 mg ta' lomitapide.
English: Change p-valueb
Maltese: Għadd ta' pazjenti evalwabbli 22
English: Lojuxta contains lactose.
Maltese: Lojuxta fih il-lattożju.
English: Liver enzyme abnormalities and liver monitoring
Maltese: Anormalitajiet fl-enzimi tal-fwied u l-monitoraġġ tal-fwied
English: Lojuxta 40 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Maltese: Lojuxta 40 mg kapsuli ibsin Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 40 mg ta' lomitapide.
English: Amryt Pharmaceuticals DAC Tlf: +44 1604 549952 medinfo@amrytpharma.com
Maltese: Amryt Pharmaceuticals DAC Teл.: +44 1604 549952 medinfo@amrytpharma.com