FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara s-sezzjoni 6.1.
English: Ecchymosis Papule
Maltese: Ekkimosi Papule
English: There was no clinically relevant effect of age (18-64 years) or gender on the pharmacokinetics of lomitapide.
Maltese: Ma kien hemm l-ebda effett klinikament rilevanti tal-età (18-64 sena) jew is-sess fuq ilfarmakokinetika ta' lomitapide.
English: Coumarin anticoagulants: When lomitapide 60 mg was administered to steady state and 6 days following warfarin 10 mg, INR increased 1.26-fold.
Maltese: Meta lomitapide 60 mg ingħata fi stat stabbli u 6 ijiem wara warfarina 10 mg, l-INR żdied b'1.26-darba.
English: Effects on lomitapide levels
Maltese: Effetti fuq il-livelli ta' lomitapide
English: At baseline, 93% were on a statin, 76% were on ezetimibe, 10% on niacin, 3% on a bile acid sequestrant and 62% were receiving apheresis.
Maltese: Fil-linja bażi, 93% kienu fuq statin, 76% kienu fuq ezetimibe, 10% fuq niacin, 3% fuq sekwestrant talaċidu biljari u 62% kienu qed jirċievu aferesi.
English: Gastroenteritis Gastrointestinal infection Influenza
Maltese: Gastroenterite Infezzjoni gastro-intestinali Influwenza
English: The most common adverse reactions were gastrointestinal effects.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni kienu effetti gastrointestinali.
English: • medicines to treat epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
Maltese: • mediċini għall-kura tal-epilessija (eż. phenobarbital, carbamazepine, phenytoin)
English: Absorption is not limited by penetration of the active substance across the intestinal barrier but is predominantly influenced by an extensive first pass effect.
Maltese: L-assorbiment mhuwiex limitat millpenetrazzjoni tas-sustanza attiva fil-barriera intestinali imma huwa predominantement influwenzat minn effett first pass estensiv.
English: 4.5 Interaction with other medicinal products and other forms of interaction Effects of other medicinal products on lomitapide and other forms of interaction Table 2:
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Effetti ta' prodotti mediċinali oħra fuq lomitapide u forom oħra ta' interazzjoni Tabella 2:
English: HMG-CoA Reductase Inhibitors (“Statins”): Lomitapide increases plasma concentrations of statins.
Maltese: Inibituri ta' HMG-CoA reductase (“Statins”): Lomitapide jżid il-konċentrazzjonijiet tal-istatins filplasma.
English: At steady state the accumulation of lomitapide was 2.7 at 25 mg and 3.9 at 50 mg.
Maltese: Fi stat stabbli l-akkumulazzjoni ta' lomitapide kienet ta' 2.7 f'25 mg u ta' 3.9 f'50 mg.
English: • medicines to treat tuberculosis (e.g. isoniazid, rifampicin)
Maltese: • mediċini għall-kura tat-tuberkulożi (eż. isoniazid, rifampicin)
English: A single-dose, open-label study was conducted to evaluate the pharmacokinetics of 60 mg lomitapide in healthy volunteers with normal hepatic function compared with patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment.
Maltese: Sar studju b'tikketta miftuħa b'doża unika biex jevalwa jekk il-farmakokinetika ta' 60 mg ta' lomitapide f'voluntiera b'saħħithom b'funzjoni epatika normali kinitx komparabbli ma' dik ta' pazjenti b'indeboliment epatiku ħafif (Child-Pugh A) u moderat (Child-Pugh B).
English: Sixteen males (55%) and 13 females (45%) were included with a mean age of 30.7 years, ranging from 18 to 55 years.
Maltese: Ħadu sehem sittax-il raġel (55%) u 13-il mara (45%) b'età medja ta' 30.7 snin, b'firxa minn 18 sa 55 sena.
English: Following intravenous administration, the volume of distribution of lomitapide was high (mean=1200 litres) despite a high degree (>99.8%) of binding to plasma protein.
Maltese: Wara l-għoti ġol-vina, il-volum tad-distribuzzjoni ta' lomitapide kien għoli (medja=1200 litri) minkejja grad għoli (>99.8%) ta' rbit mal-proteini tal-plasma.
English: In vitro assessment of drug interactions: Lomitapide inhibits CYP3A4.
Maltese: Valutazzjoni in vitro ta' interazzjonijiet bejn il-mediċini: Lomitapide jinibixxi CYP3A4.
English: • low density lipoprotein (LDL) cholesterol (“bad” cholesterol)
Maltese: • kolesterol ta' lipoproteina ta' densità baxxa (LDL) (kolesterol “ħażin”)
English: Frequency of adverse reactions in HoFH patients System Organ Class
Maltese: Tabella 3: Frekwenza ta' reazzjonijiet avversi f'pazjenti b'HoFH Sistema tal-Klassifika tal-Organi Frekwenza
English: o Goldenseal (for inflammation and infection)
Maltese: o Goldenseal (għall-infjammazzjoni u l-infezzjoni)
English: P-gp substrates: Lomitapide inhibits P-gp in vitro, and may increase the absorption of P-gp substrates.
Maltese: Substrati ta' P-gp: Lomitapide jinibixxi P-gp in vitro, u jista' jżid l-assorbiment ta' substrati ta' P-gp.
English: • Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI), or magnetic resonance (MR) elastography
Maltese: • Immaġni għall-elastiċità tat-tessut, eż. Fibroscan, acoustic radiation force impulse (ARFI), jew elastography b'reżonanza manjetika (MR)
English: The terminal half-life of lomitapide was not affected.
Maltese: Il-half-life terminali ta' lomitapide ma kinitx affettwata.
English: Table 6:
Maltese: Tabella 6:
English: Examples of weak CYP3A4 inhibitors include: alprazolam, amiodarone, amlodipine, atorvastatin, azithromycin, bicalutamide, cilostazol, cimetidine, ciclosporin, clotrimazole, fluoxetine, fluvoxamine, fosaprepitant, ginkgo, goldenseal, isoniazid, ivacaftor, lacidipine, lapatinib, linagliptin, nilotinib, oestrogen-containing oral contraceptives, pazopanib, peppermint oil, propiverine, ranitidine, ranolazine, roxithromycin, Seville oranges, tacrolimus, ticagrelor and tolvaptan.
Maltese: Eżempji ta' inibituri dgħajfa ta' CYP3A4 jinkludu: alprazolam, amiodarone, amlodipine, atorvastatin, azithromycin, bicalutamide, cilostazol, cimetidine, ciclosporin, clotrimazole, fluoxetine, fluvoxamine, fosaprepitant, ginkgo, goldenseal, isoniazid, ivacaftor, lacidipine, lapatinib, linagliptin, nilotinib, kontraċettivi orali li fihom l-estroġenu, pazopanib, żejt tal-pepermint, propiverine, ranitidine, ranolazine, roxithromycin, larinġ ta' Sivilja, tacrolimus, ticagrelor u tolvaptan.
English: Effects of lomitapide on other medicinal products
Maltese: Effetti ta' lomitapide fuq prodotti mediċinali oħra
English: Triglycerides (TG) (mg/dL)a
Maltese: Trigliċeridi (TG) (mg/dL)
English: • medicines to treat cancer (e.g. everolimus, imatinib, lapatinib, nilotinib, topotecan)
Maltese: • mediċini għall-kura tal-kanċer (eż. everolimus, imatinib, lapatinib, nilotinib, topotecan)
English: Hepatic events related to elevated aminotransferases and progressive liver disease
Maltese: Avvenimenti epatiċi relatati ma' żieda fl-aminotransferażi u mard progressiv tal-fwied
English: Renal insufficiency
Maltese: Indeboliment renali
English: • muscle pain (myalgia)
Maltese: • uġigħ tal-muskoli (majalġja)
English: Gastroenteritis
Maltese: Gastroenterite
English: CYP isoforms 2E1, 1A2, 2B6, 2C8, and 2C19 are involved to a lesser extent and isoforms 2D6 and 2C9 are not involved in the metabolism of lomitapide.
Maltese: L-isoformi ta' CYP 2E1, 1A2, 2B6, 2C8, u 2C19 huma involuti fuq livell inqas u l-isoformi 2D6 u 2C9 mhumiex involuti filmetaboliżmu ta' lomitapide.
English: Pack sizes are: 28 capsules
Maltese: Id-daqsijiet tal-pakketti huma: 28 kapsula
English: Lomitapide is contraindicated in patients with moderate or severe hepatic impairment including patients with unexplained persistent abnormal liver function tests (see sections 4.3 and 5.2).
Maltese: Lomitapide huwa kontraindikat f'pazjenti b'indeboliment epatiku moderat jew sever inkluż pazjenti b'testijiet anormali persistenti u inspjegabbli tal-funzjoni tal-fwied (ara sezzjonijiet 4.3 u 5.2).
English: • medicines to reduce the activity of the immune system (e.g. ciclosporin, tacrolimus)
Maltese: • mediċini biex inaqqsu l-attività tas-sistema immunitarja (eż. ciclosporin, tacrolimus)
English: • Lojuxta is only indicated for use in adult patients with HoFH;
Maltese: • Lojuxta huwa indikat biss għall-użu f'pazjenti adulti b'HoFH;
English: • Information about interactions with CYP3A4 inhibitors and inducers, coumarin anticoagulants, statins, P-gp substrates, oral contraceptives, bile acid sequestrants;
Maltese: • Informazzjoni dwar interazzjonijiet ma' inibituri u indutturi ta' CYP3A4, antikoagulanti ta' coumarin, statins, substrati ta' P-gp, kontraċettivi orali, sekwestranti tal-aċidu biljari;
English: • abnormal lung function test
Maltese: • test anormali tal-funzjoni tal-pulmun
English: In an open-label Phase 3 study, 18 of 23 patients with HoFH developed hepatic steatosis (hepatic fat >5.56%) as measured by nuclear magnetic resonance spectroscopy (MRS) (see section 5.1).
Maltese: Fi studju b'tikketta miftuħa tal-Fażi 3, 18 minn 23 pazjent bl-HoFH żviluppaw stejatożi epatika (xaħam fil-fwied >5.56%) kif imkejla permezz ta' riżonanza manjetika nukleari spektroskopika (MRS) (ara s-sezzjoni 5.1).
English: Parameter/Abnormality
Maltese: Parametri (unitajiet)
English: Lomitapide was not mutagenic or genotoxic in a battery of in vitro and in vivo studies.
Maltese: Lomitapide ma kienx mutaġeniku jew ġenotossiku f'serje ta' studji in vitro u in vivo.
English: Week 2
Maltese: Dublin 2
English: When lomitapide 60 mg was administered to steady state prior to simvastatin 40 mg, simvastatin acid AUC and Cmax increased 68% and 57%, respectively.
Maltese: Meta lomitapide 60 mg ingħata fi stat stabbli qabel simvastatin 40 mg, l-AUC u s-Cmax ta' aċidu simvastatin żdiedu b'68% u 57%, rispettivament.
English: Capsule shell:
Maltese: Qoxra tal-kapsula:
English: • Concomitant administration of >40 mg simvastatin (see section 4.5).
Maltese: • L-għoti konkomitanti ta' >40 mg ta' simvastatin (ara s-sezzjoni 4.5).
English: • medicines to treat urinary incontinence (e.g. propiverine)
Maltese: • mediċini għall-kura tal-inkontinenza urinarja (eż. propiverine)
English: Lojuxta is contraindicated during pregnancy.
Maltese: Lojuxta huwa kontraindikat matul it-tqala.
English: Coadministration of Lojuxta with P gp substrates (such as aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, imatinib, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, saxagliptin, sirolimus, sitagliptin, talinolol, tolvaptan, topotecan) may increase the absorption of P gp substrates.
Maltese: L-għoti ta' Lojuxta flimkien ma' substrati ta' P gp (bħal aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, imatinib, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, saxagliptin, sirolimus, sitagliptin, talinolol, tolvaptan, topotecan) jista' jżid l-assorbiment tas-substrati ta' P gp.
English: − The need to take daily dietary supplements (i.e. 400 IU vitamin E, approximately 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), 210 mg alpha linolenic acid (ALA) and 80 mg docosahexaenoic acid (DHA) per day).
Maltese: − Il-ħtieġa li jieħdu supplimenti kuljum mad-dieta (jiġifieri 400 IU vitamina E, madwar 200 mg aċidu linolejku, 110 mg aċidu ejkosapentenojku (EPA), 210 mg aċidu linoleniku alpha (ALA) u 80 mg aċidu dokosaħessenojku (DHA) kuljum);
English: Of the parameters examined (race, body mass index (BMI), gender, weight, age), only BMI could be classified as a potential covariate.
Maltese: Mill-parametri eżaminati (razza, indiċi tal-massa tal-ġisem (BMI), sess, piż, età), l-BMI biss seta' jiġi kklassifikat bħala kovarjant potenzjali.
English: • Importance of fatty acid and soluble vitamins supplementation;
Maltese: • L-importanza ta' supplimentazzjoni b'aċidu xaħmi u vitamini solubbli;
English: Gastrointestinal adverse reactions of severe intensity were reported by 6 (21%) of 29 patients in the Phase 3 clinical study, with the most common being diarrhoea (4 patients, 14%); vomiting (3 patients, 10%); and abdominal pain, distension, and/or discomfort (2 patients, 7%).
Maltese: Reazzjonijiet avversi gastrointestinali ta' intensità severa kienu rrapportati minn 6 (21%) minn 29 pazjent fl-istudju kliniku tal-Fażi 3, bl-aktar komuni kienu d-dijarea (4 pazjenti, 14%); rimettar (3 pazjenti, 10%); u wġigħ addominali, nefħa, u/jew skonfort (2 pazjenti, 7%).
English: Of the 23 patients who completed through Week 26, 19 (83%) had LDL-C reductions ≥25% with 8 (35%) having LDL-C <100 mg/dL and 1 having LDL-C <70 mg/dL at that time point.
Maltese: Mit-23 pazjent li temmew sa Ġimgħa 26, 19 (83%) kellhom tnaqqis fl-LDL-C ≥25% bi 8 (35%) kellhom l-LDL-C <100 mg/dL u 1 kellu l-LDL-C <70 mg/dL f'dak il-punt fiż-żmien.
English: Gastritis
Maltese: Gastrite
English: Table 3 lists all adverse reactions reported across the 35 patients treated in the Phase 2 Study UP1001 and in the Phase 3 Study UP1002/AEGR-733-005 or its extension study AEGR-733-012.
Maltese: Tabella 3 telenka r-reazzjonijiet avversi kollha rapportata fit-35 pazjent li rċevew kura fl-Istudju UP1001 tal-Fażi 2 u fl-Istudju UP1002/AEGR-733-005 tal-Fażi 3 jew fl-istudju ta' estensjoni tiegħu AEGR-733-012.
English: Embryofoetal toxicity was observed in rabbits in the absence of maternal toxicity at ≥6.5 times the MRHD.
Maltese: Tossiċità embrijofetali kienet osservata fil-fniek fin-nuqqas ta' tossiċità materna f'≥ 6.5 darbiet l-MRHD.
English: You also need to take daily vitamin E and essential fatty acid (omega-3 and omega-6) supplements while taking this medicine.
Maltese: Teħtieġ tieħu wkoll supplimenti tal-vitamina E u tal-aċidu xaħmi essenzjali (omega-3 u omega-6) kuljum waqt li tkun qed tieħu din il-mediċina.
English: This card will give information about interactions with: o CYP 3A4 inhibitors o CYP 3A4 inducers o coumarin anticoagulants o statins o P-gp substrates o Oestrogen-containing oral contraceptives
Maltese: Din l-iskeda se tagħti informazzjoni dwar interazzjonijiet ma': o inibituri ta' CYP 3A4 o indutturi ta' CYP 3A4 o antikoagulanti ta' coumarin o statins o substrati ta' P-gp o kontraċettivi orali li fihom l-estroġenu
English: When lomitapide 60 mg was administered to steady state prior to atorvastatin 20 mg, atorvastatin acid AUC and Cmax increased 52% and 63%, respectively.
Maltese: Meta lomitapide 60 mg ingħata fi stat stabbli qabel atorvastatin 20 mg, l-AUC u s-Cmax tal-aċidu atorvastatin żdiedu b'52% u 63%, rispettivament.
English: Non high-density lipoprotein cholesterol (Non-HDL-C) (mg/dL)
Maltese: Kolesterol ta' lipoproteini mhux ta' densità għolja (Non-HDL-C) (mg/dL)
English: Lomitapide increases the plasma concentrations of warfarin.
Maltese: Lomitapide jżid il-konċentrazzjonijiet ta' warfarina fil-plasma.
English: • anti-histamine medicines to treat hayfever (e.g. fexofenadine)
Maltese: • mediċini anti-istamini għall-kura tal-hayfever (eż. fexofenadine)
English: Lomitapide appears to be a sensitive substrate for CYP3A4 metabolism.
Maltese: Lomitapide jidher li huwa substrat sensittiv għall-metaboliżmu ta' CYP3A4.
English: • aminoglutethimide - a medicine used to treat Cushing's syndrome
Maltese: • aminoglutethimide -mediċina użata għall-kura tas-sindromu ta' Cushing
English: • paracetamol - to treat pain
Maltese: • paracetamol - għall-kura tal-uġigħ
English: In the lomitapide clinical studies, one patient with HoFH developed markedly elevated aminotransferase (ALT 24x ULN, AST 13x ULN) within days of initiating the strong CYP3A4 inhibitor clarithromycin.
Maltese: Fl-istudji kliniċi ta' lomitapide, pazjent wieħed b'HoFH żviluppa żieda notevoli flaminotransferażi (ALT 24x ULN, AST 13x ULN) wara jiem li beda l-inibitur qawwi ta' CYP3A4 clarithromycin.
English: Inter-individual variability in lomitapide AUC was approximately 50%.
Maltese: Il-varjabbiltà bejn persuni differenti fl-AUC ta' lomitapide AUC kienet ta' madwar 50%.
English: Table 4 lists all adverse reactions for subjects who received lomitapide monotherapy (N=291) treated in Phase 2 studies in subjects with elevated LDL-C (N=462).
Maltese: Tabella 4 telenka r-reazzjonijiet kollha għal individwi li rċevew monoterapija b'lomitapide (N=291) li rċevew kura fl-istudji tal-Fażi 2 fuq individwi b'żieda fl-LDL-C (N=462).
English: The elimination half-life of lomitapide was approximately 29 hours.
Maltese: Il-half-life tal-eliminazzjoni ta' lomitapide kienet ta' madwar 29 siegħa.
English: Patients with rare hereditary problems of galactose intolerance, total-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din ilmediċina.
English: Serious side effects:
Maltese: Effetti sekondarji serji:
English: In rodents, single oral doses of lomitapide ≥600 times higher than the maximum recommended human dose (1 mg/kg) were well tolerated.
Maltese: Fl-annimali gerriema, dożi uniċi orali ta' lomitapide ≥600 darba ogħla mid-doża massima rakkomandata (1 mg/kg) kienu ttollerati sew.
English: • medicines to reduce blood pressure (e.g. amlodipine, lacidipine)
Maltese: • mediċini biex inaqqsu l-pressjoni tad-demm (eż. amlodipine, lacidipine)
English: • medicines to treat HIV (e.g. maraviroc)
Maltese: • mediċini għall-kura tal-HIV (eż. maraviroc)
English: Lojuxta 5 mg, 10 mg hard capsules Gelatin
Maltese: Lojuxta 5 mg, 10 mg kapsuli ibsin Ġelatina
English: This medicine has been authorised under ‘exceptional circumstances'.
Maltese: Dan il-prodott mediċinali ġie awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: Fifteen of 23 (65%) patients had their lipid-lowering treatment reduced by Week 78, including planned and unplanned reductions/interruptions.
Maltese: Ħmistax minn 23 (65%) pazjent kellhom il-kura tagħhom li tbaxxi l-lipidi mnaqqsa sal-Ġimgħa 78, inkluż tnaqqis/interruzzjonijiet ippjanati u mhux ippjanati.
English: • Information about contraindication in patients with moderate or severe pre-existing hepatic impairment/disease, including those with unexplained persistent abnormal liver function tests;
Maltese: • Informazzjoni dwar kontraindikazzjoni f'pazjenti b'indeboliment epatiku/mard moderat jew sever pre-eżistenti, inkluż dawk b'testijiet persistenti anormali inspjegabbli tal-funzjoni tal-fwied;
English: Pulmonary histiocytosis was observed in rodents.
Maltese: Istjoċitożi pulmonari kienet osservata f'annimali gerriema.
English: Very-low-density lipoprotein cholesterol (VLDL-C) (mg/dL)
Maltese: Kolesterol ta' lipoproteini ta' densità baxxa ħafna (VLDL-C) (mg/dL)
English: Approximately 33% of the radioactivity was excreted in urine as metabolites.
Maltese: Madwar 33% tar-radjuattività kienet eliminata flawrina bħala metaboliti.
English: • medicines to treat and prevent blood clots (e.g. cilostazol, ticagrelor)
Maltese: • mediċini għall-kura u l-prevenzjoni ta' għoqiedi tad-demm (eż. cilostazol, ticagrelor)
English: Lomitapide was teratogenic in rats in the absence of maternal toxicity at an exposure (AUC) estimated to be twice that in humans at 60 mg.
Maltese: Lomitapide kien teratoġeniku fil-firien fin-nuqqas ta' tossiċità materna f'esponiment (AUC) stmat li kien darbtejn dik fil-bnedmin f'60 mg.
English: Lomitapide pharmacokinetics is approximately dose-proportional for oral single doses in the therapeutic range.
Maltese: Il-farmakokinetika ta' Lomitapide hija kważi proporzjonali għad-doża għal dożi uniċi orali fil-medda terapewtika.
English: Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH).
Maltese: Lojuxta huwa indikat biex jiżdied ma' dieta b'kontenut baxx ta' xaħam u ma' prodotti mediċinali oħra li jbaxxu l-lipidi bi jew mingħajr aferesi ta' lipoproteini ta' densità baxxa (LDL) f'pazjenti adulti b'iperkolesterolemija omozigota familjali (HoFH).
English: The mean dose of lomitapide was 45 mg at Week 26 and 40 mg at Week 78.
Maltese: Id-doża medja ta' lomitapide kienet ta' 45 mg fil-Ġimgħa 26 u ta' 40 mg fil-Ġimgħa 78.
English: • Concomitant use of Lojuxta with strong or moderate cytochrome P450 (CYP) 3A4 inhibitors (e.g., antifungal azoles such as itraconazole, fluconazole,ketoconazole, voriconazole, posaconazole; macrolide antibiotics such as erythromycin or clarithromycin; ketolide antibiotics such as telithromycin; HIV protease inhibitors; the calcium channel blockers diltiazem and verapamil, and the anti-arrhythmic dronedarone [see section 4.5]).
Maltese: • L-użu konkomitanti ta' Lojuxta ma' inibituri qawwija jew moderati taċ-ċitokromju P450 (CYP) 3A4 (eż., azoles antifungali bħal itraconazole, fluconazole, ketoconazole, voriconazole, posaconazole; antibijotiċi makrolidi bħal erythromycin jew clarithromycin; antibijotiċi ketolide bħal telithromycin; inibituri tal-protease tal-HIV; l-imblokkaturi tal-kanali tal-kalċju diltiazem u verapamil, u l-aġent anti-arritmiku dronedarone [ara s-sezzjoni 4.5]).
English: Doses higher than 60 mg suggest a trend toward nonlinearity and are not recommended.
Maltese: Dożi ogħla minn 60 mg jissuġġerixxu tendenza lejn nuqqas ta' linearità u mhumiex rakkomandati.
English: • some medicines for bacterial, fungal or HIV infection (see section 2 under ‘Do not take Lojuxta')
Maltese: • ċerti mediċini għal infezzjoni batterika, fungali jew tal-HIV (ara s-sezzjoni 2 taħt ‘Tiħux Lojuxta')
English: Use of Lojuxta is contraindicated in patients treated with high doses of simvastatin (>40 mg) (see sections 4.3 and 4.4).
Maltese: L-użu ta' Lojuxta huwa kontraindikat f'pazjenti li qed jirċievu dożi għoljin ta' simvastatin (>40 mg) (ara s-sezzjonijiet 4.3 u 4.4).
English: Hepatic insufficiency
Maltese: Indeboliment epatiku
English: • The other ingredients are: pregelatinized starch, sodium starch glycolate (Type A), microcrystalline cellulose, lactose monohydrate, silica colloidal anhydrous and magnesium stearate (for information on lactose monohydrate, see section 2 under ‘Lojuxta contains lactose').
Maltese: • Is-sustanzi mhux attivi: pregelatinized starch, sodium starch glycolate (Tip A), microcrystalline cellulose, lactose monohydrate, silica colloidal anhydrous u magnesium stearate (għal informazzjoni dwar lactose monohydrate, ara s-sezzjoni 2 taħt ‘Lojuxta fih il-lattożju').
English: In patients with mild hepatic impairment, lomitapide AUC and Cmax were 47% and 4% higher, respectively, compared with healthy volunteers.
Maltese: F'pazjenti b'indeboliment epatiku ħafif, lAUC u s-Cmax ta' lomitapide kienu 47% u 4% ogħla, rispettivament, meta mqabbla ma' voluntiera b'saħħithom.
English: • indigestion
Maltese: • indiġestjoni
English: If treatment with antifungal azoles (e.g., itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole); the antiarrhythmic dronedarone; macrolide antibiotics (e.g., erythromycin, clarithromycin); ketolide antibiotics (e.g., telithromycin); HIV protease inhibitors; the calcium channel blockers diltiazem and verapamil is unavoidable, therapy with Lojuxta should be suspended during the course of treatment (see sections 4.3 and 4.4).
Maltese: Jekk kura b'azoles antifungali (eż., itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole); l-antiarritmiku dronedarone; antibijotiċi makrolidi (eż., erythromycin, clarithromycin); antibijotiċi ketolide (eż., telithromycin); inibituri tal-protease tal-HIV; limblokkaturi tal-kanal tal-kalċju diltiazem u verapamil ma tistax tiġi evitata, it-terapija b'Lojuxta għandha tiġi sospiża matul il-kors ta' kura (ara ssezzjonijiet 4.3 u 4.4).
English: Gastrooeosophageal reflux disease Abdominal tenderness Epigastric discomfort Gastric dilatation
Maltese: Marda tar-rifluss gastroesofagali Sensittività addominali Skonfort epigastriku Twessigħ gastriku Ematemesi
English: There were statistically significant increases in the incidences of liver adenoma and carcinoma at doses ≥1.5 mg/kg/day in males (≥ 2 times the human exposure at 60 mg daily based on AUC) and ≥7.5 mg/kg/day in females (≥ 9 times the human exposure at 60 mg based on AUC).
Maltese: Kien hemm żidiet statistikament sinifikanti fl-inċidenzi ta' adenoma u karċinoma tal-fwied f'dożi ≥ 1.5 mg/kg/kuljum fl-irġiel (≥ 2 darbiet l-esponiment uman f'60 mg kuljum abbażi tal-AUC) u ta' ≥ 7.5 mg/kg/kuljum fin-nisa (≥ 9 darbiet l-esponiment uman f'60 mg kuljum abbażi tal-AUC).