FrancophonIA/ELRC3.0 huggingface dataset:
English: Testicular toxicity was observed in dogs at 205 times the human exposure (AUC) at 60 mg in a 6-month study.
Maltese: Tossiċità testikulari kienet osservata fil-klieb f'esponiment ta' 205 darbiet dik tal-bnedmin (AUC) f'60 mg fi studju fuq 6 xhur.
English: • hair loss (alopecia)
Maltese: • telf ta' xagħar (alopeċja)
English: • Information that Lojuxta may cause liver problems;
Maltese: • Informazzjoni li Lojuxta jista' jikkawża problemi fil-fwied;
English: • medicines to reduce blood pressure (e.g. talinolol, aliskiren, ambrisentan)
Maltese: • mediċini biex inaqqsu l-pressjoni tad-demm (eż. talinolol, aliskiren, ambrisentan)
English: Lomitapide is extensively metabolised, predominantly by CYP3A4.
Maltese: Lomitapide jiġi metabolizzat b'mod estensiv, prinċipalment minn CYP3A4.
English: Concomitant use of moderate CYP3A4 inhibitors are expected to increase lomitapide exposure by 4-10 fold based on the results of the study with the strong CYP3A4 inhibitor ketoconazole and on historical data for the model CYP3A4 probe midazolam.
Maltese: L-użu konkomitanti ta' inibituri moderati ta' CYP3A4 huma mistennija jżidu l-esponiment ta' lomitapide b'4-10 darbiet abbażi tar-riżultati tal-istudju bl-inibitur qawwi ta' CYP3A4 ketoconazole u minn dejta storika għall-mudell CYP3A4 probe midazolam.
English: Incidences of small intestinal carcinoma and/or combined adenoma and carcinoma (rare tumours in mice) were significantly increased at doses ≥15 mg/kg/day in males (≥ 26 times the human exposure at 60 mg based on AUC) and at 15 mg/kg/day in females (22 times the human exposure at 60 mg based on AUC).
Maltese: L-inċidenzi ta' karċinoma tal-intestini ż-żgħar u/jew kombinazzjoni ta' adenoma u karċinoma (tumuri rari fil-ġrieden) żdiedu b'mod sinifikanti f'dożi ta' ≥15 mg/kg/kuljum fl-irġiel (≥ 26 darba l-esponiment uman f'60 mg abbażi tal-AUC) u ta' 15 mg/kg/kuljum fin-nisa (22 darba l-esponiment uman f'60 mg abbażi tal-AUC).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: A pharmacokinetic study in patients with ESRD undergoing hemodialysis demonstrated a 36% increase in mean lomitapide plasma concentration compared to matched healthy controls.
Maltese: Studju farmakokinetiku fuq pazjenti b'ESRD li kienet qed issirilhom emodijaliżi wera żieda ta' 36% fil-konċentrazzjoni medja ta' lomitapide fil-plasma meta mqabbla ma' kontrolli b'saħħithom.
English: Frequent bowel movements Gastric dilatation Gastric disorder
Maltese: Ippurgar frekwenti Twessigħ gastriku Disturb gastriku
English: o Hepatic events o Gastrointestinal events o Small bowel, hepatic, colorectal and pancreatic tumours o Events associated with coagulopathy o Major Adverse Cardiovascular Events (MACE) events o Death, including cause of death
Maltese: o Avvenimenti epatiċi o Avvenimenti gastrointestinali o Tumuri tal-musrana ż-żgħira, tal-fwied, tal-kolorektum u tal-frixa o Avvenimenti assoċjati ma' koagulopatija o Avvenimenti Avversi Kardjovaskulari Maġġuri (MACE)
English: Alanine aminotransferase increased Aspartate aminotransferase increased Weight decreased
Maltese: Żieda fl-alanina aminotransferażi Żieda fl-aspartat aminotransferażi Tnaqqis fil-piż
English: How to take Lojuxta
Maltese: Tiħux Lojuxta:
English: The physician educational pack should contain:
Maltese: Id-daqsijiet tal-pakketti huma:
English: Interactions between moderate CYP3A4 inhibitors and lomitapide have not been studied.
Maltese: Interazzjonijiet bejn inibituri moderati ta' CYP3A4 u lomitapide ma ġewx studjati.
English: Safety phase weeks 26-78 N (%)
Maltese: Fażi taleffikaċja ġimgħat 0-26 N (%)
English: Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX12
Maltese: Aġenti li jimmodifikaw il-lipidi, aġenti oħra li jimmodifikaw il-lipidi, Kodiċi ATC:
English: Frequency of adverse reactions in elevated LDL-C patients System Organ Class
Maltese: Tabella 4: Frekwenza tar-reazzjonijiet avversi f'pazjenti b'żieda fl-LDL-C Sistema tal-Klassifika tal-Organi Frekwenza
English: • Gamma-GT and serum albumin to detect possible liver injury
Maltese: • Gamma-GT u albumina fis-serum biex tiġi skoperta ħsara possibbli fil-fwied
English: Concomitant use of CYP3A4 inducers
Maltese: Indutturi ta' CYP3A4
English: Lomitapide had no effect on reproductive function in female rats at doses up to 1 mg/kg or in male rats at doses up to 5 mg/kg.
Maltese: Lomitapide ma kellu l-ebda effett fuq il-funzjoni riproduttiva fil-firien nisa f'dożi sa 1 mg/kg jew f'firien irġiel f'dożi sa 5 mg/kg.
English: Haematuria
Maltese: Lattożju
English: Patients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily.
Maltese: Pazjenti b'indeboliment epatiku ħafif (Child-Pugh A) ma għandhomx jaqbżu 40 mg kuljum.
English: Based on observations of decreased essential fatty acid and vitamin E levels in clinical studies, patients should take daily dietary supplements that provide 400 IU vitamin E and approximately 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), 210 mg alpha linolenic acid (ALA) and 80 mg docosahexaenoic acid (DHA) per day, throughout treatment with Lojuxta.
Maltese: Abbażi ta' osservazzjonijiet ta' tnaqqis fil-livelli tal-aċidu xaħmi essenzjali u l-vitamina E fi studji kliniċi, pazjenti għandhom jieħdu supplimenti tad-dieta kuljum li jipprovdu 400 IU ta' vitamina E u madwar 200 mg ta' aċidu linolejku, 110 mg ta' aċidu ejkosapentenojku (EPA), 210 mg ta' aċidu linoleniku alpha (ALA) u 80 mg ta' aċidu dokosaħessenojku (DHA) kuljum, matul il-kura b'Lojuxta.
English: PER - Pregnancy exposure registry - to evaluate the occurrence and outcomes of pregnancy in females of reproductive potential treated with lomitapide who decide to continue the pregnancy following advice from a teratologist.
Maltese: PER (Pregnancy exposure registry) - Reġistru tal-esponiment għat-tqala - biex jevalwa l-okkorrenza u r-riżultati tat-tqala f'nisa b'potenzjal riproduttiv ittrattati b'lomitapide li jiddeċiedu li jkomplu t-tqala wara parir minn teratoloġista.
English: • medicines to treat diabetes (e.g. pioglitazone, linagliptin)
Maltese: • mediċini għall-kura tad-dijabete (eż. pioglitazone, linagliptin)
English: (dehydration)
Maltese: fluvoxamine)
English: Absolute values and percent changes from baseline to Weeks 26 and 78 in lipids and lipoproteins (major effectiveness study UP1002/AEGR-733-005) Parameter (units)
Maltese: Valuri assoluti u l-bidla perċentwali mil-linja bażi sal-Ġimgħat 26 u 78 fil-lipidi u l-lipoproteini (l-istudju tal-effikaċja maġġuri UP1002/AEGR-733-005)
English: Measure ALT, AST, alkaline phosphatase, total bilirubin, gamma-glutamyl transferase (gamma-GT) and serum albumin before initiation of treatment with Lojuxta.
Maltese: Qabel il-bidu tal-kura b'Lojuxta kejjel l-ALT, l-AST, l-alkaline phosphatase, il-bilirubin totali, ilgamma-glutamyl transferase (gamma-GT) u l-albumina fis-serum.
English: When lomitapide 60 mg was administered to steady state prior to rosuvastatin 20 mg, rosuvastatin Tmax increased from 1 to 4 hours, AUC was increased 32%, and its Cmax was unchanged.
Maltese: Meta lomitapide 60 mg ingħata fi stat stabbli qabel rosuvastatin 20 mg, it-Tmax ta' rosuvastatin żdied minn siegħa għal 4 sigħat, l-AUC żdiedet b'32%, u s-Cmax tiegħu baqa' mhux mibdula.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100):
English: Accumulation of lomitapide in plasma was consistent with that predicted after a single dose following once daily oral dosing above 25 mg for up to 4 weeks.
Maltese: L-akkumulazzjoni ta' lomitapide fil-plasma kienet konsistenti ma' dik prevista wara doża unika wara doża orali darba kuljum ta' aktar minn 25 mg sa 4 ġimgħat.
English: See section 4.8 for how to report adverse reactions.
Maltese: Ara s-sezzjoni 4.8 dwar kif għandhom jiġu rappurtati reazzjonijiet avversi.
English: Bile acid sequestrants Lomitapide has not been tested for interaction with bile acid sequestrants (resins such as colesevelam and cholestyramine).
Maltese: Lomitapide ma ġiex ittestjat għal interazzjoni ma' sekwestranti tal-aċidu biljari (reżini bħal colesevelam u cholestyramine).
English: • oral contraceptives (see section 2 under ‘Pregnancy and breast-feeding')
Maltese: • kontraċettivi orali (ara s-sezzjoni 2 taħt ‘Tqala u treddigħ')
English: The risk of myopathy with simvastatin is dose related.
Maltese: Ir-riskju ta' mijopatija b'simvastatin huwa relatat mad-doża.
English: Lojuxta with food, drink and alcohol
Maltese: Lojuxta ma' ikel, xorb u alkoħol
English: • Compliance with the supplementation regimen should be verified at regular scheduled appointments and the importance emphasised.
Maltese: • Konformità mar-reġimen ta' supplimentazzjoni għandha tiġi vverifikata waqt appuntamenti regolari skedati u l-importanza għandha tiġi enfasizzata.
English: • muscle pain
Maltese: • spażmi fil-muskoli
English: Apheresis was discontinued in 3 out of 13 patients who were on it at Week 26, and frequency was reduced in 3 patients while maintaining low LDL-C levels through Week 78.
Maltese: L-aferesi twaqqfet fi 3 minn 13-il pazjent li kienu qegħdin fuqha fil-Ġimgħa 26, u lfrekwenza tnaqqset fi 3 pazjenti filwaqt li nżammu livelli baxxi tal-LDL-C sal-Ġimgħa 78.
English: Highest liver function test results post first dose (major effectiveness study UP1002/AEGR-733-005)
Maltese: L-ogħla riżultati tat-test tal-funzjoni tal-fwied wara l-ewwel doża (studju taleffikaċja maġġuri UP1002/AEGR-733-005) Parametru/Anormalità
English: A single arm, open-label study (UP1002/AEGR-733-005) evaluated the efficacy and safety of lomitapide when co-administered with a low-fat diet and other lipid-lowering therapies in adult patients with HoFH.
Maltese: Studju b'fergħa waħda, b'tikketta miftuħa (UP1002/AEGR-733-005) evalwa l-effikaċja u s-sigurtà ta' lomitapide meta ngħata flimkien ma' dieta b'kontenut baxx ta' xaħam u ma' terapiji oħra li jbaxxu llipidi f'pazjenti adulti b'HoFH.
English: • medicines to treat gout (e.g. colchicine)
Maltese: • mediċini għall-kura tal-gotta (eż. colchicine)
English: Caution should be exercised when Lojuxta is used with other medicinal products known to have potential for hepatotoxicity, such as isotretinoin, amiodarone, acetaminophen (>4 g/day for ≥3 days/week), methotrexate, tetracyclines, and tamoxifen.
Maltese: Għandha tiġi eżerċitata kawtela meta Lojuxta jintuża flimkien ma' prodotti mediċinali oħra magħrufa li għandhom il-potenzjal għal epatotossiċità, bħal isotretinoin, amiodarone, acetaminophen (>4 g/kuljum għal ≥3 ijiem/ġimgħa), methotrexate, tetraċiklini, u tamoxifen.
English: In a dietary carcinogenicity study in mice, lomitapide was administered up to 104 weeks at doses ranging from 0.3 to 45 mg/kg/day.
Maltese: Fi studju ta' karċinoġeniċità djetetika fil-ġrieden, lomitapide ngħata sa 104 ġimgħat f'dożi f'firxa bejn 0.3 sa 45 mg/kg/kuljum.
English: Myalgia
Maltese: Majalġja
English: Concomitant use of CYP3A4 inhibitors
Maltese: Inibituri ta' CYP3A4
English: • medicines to treat cystic fybrosis (e.g. ivacaftor)
Maltese: • mediċini għall-kura tal-fibrożi ċistika (eż. ivacaftor)
English: Cmax and AUC were increased following either a high-fat meal (77% and 58%, respectively) or low fat meal (70% and 28%, respectively).
Maltese: Is-Cmax u l-AUC żdiedu wara jew ikla b'kontenut għoli ta' xaħam (77% u 58%, rispettivament) jew ikla b'kontenut baxx ta' xaħam (70% u 28%, rispettivament).
English: High density polyethylene (HDPE) bottle fitted with a polyester/aluminium foil/cardboard induction seal and polypropylene screw cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Flixkun tal-polietelin ta' densità għolja (HDPE) mgħammar b'siġill tal-induzzjoni tal-polijester/fojl/kartun u b'għatu tal-kamin tal-polypropylene.
English: Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules lomitapide
Maltese: Lojuxta 5 mg kapsuli ibsin Lojuxta 10 mg kapsuli ibsin Lojuxta 20 mg kapsuli ibsin lomitapide
English: Adverse reaction
Maltese: RESPONSABBLI
English: Lomitapide is a selective inhibitor of microsomal transfer protein (MTP), an intracellular lipid-transfer protein that is found in the lumen of the endoplasmic reticulum and is responsible for binding and shuttling individual lipid molecules between membranes.
Maltese: Lomitapide huwa inibitur selettiv tal-proteina tat-trasferiment mikrosomali (MTP), proteina fiċ-ċelloli li ġġorr il-lipidi li tinstab fil-lumen tar-retikulu endoplażmiku u hija responsabbli għall-irbit u l-ġarr ta'
English: Concomitant use of moderate or strong CYP3A4 inhibitors with Lojuxta is contraindicated (see section 4.3).
Maltese: L-użu konkomitanti ta' inibituri moderati jew qawwija ta' CYP3A4 ma' Lojuxta huwa kontraindikat (ara ssezzjoni 4.3).
English: In an oral carcinogenicity study in rats, lomitapide was administered up to 99 weeks at doses up to 7.5 mg/kg/day in males and 2.0 mg/kg/day in females.
Maltese: Fi studju ta' karċinoġeniċità orali fil-firien, lomitapide ngħata sa 99 ġimgħa f'dożi sa 7.5 mg/kg/kuljum fl-irġiel u ta' 2.0 mg/kg/kuljum fin-nisa.
English: • medicines to treat diabetes (e.g. saxagliptin, sitagliptin)
Maltese: • mediċini għall-kura tad-dijabete (eż. saxagliptin, sitagliptin)
English: Maximum categorical changes in % hepatic fat (major effectiveness study UP1002/AEGR-733-005) Maximum absolute increase in % hepatic fat
Maltese: Tibdil massimu kategoriku fil-% ta' xaħam fil-fwied (studju tal-effikaċja maġġuri UP1002/AEGR-733-005)
English: No studies have been conducted in children and adolescents under the age of 18.
Maltese: Lojuxta ma ġiex investigat fit-tfal ta' anqas minn 18-il sena.
English: • decrease in levels of potassium, carotene, vitamin E, vitamin K in your blood
Maltese: • tnaqqis fil-livelli tal-potassju, l-karotina, l-vitamina E, l-vitamina K fid-demm tiegħek
English: When co-administering CYP3A4 inducers (i.e., aminoglutethimide, nafcillin, non-nucleoside reverse transcriptase inhibitors, phenobarbital, rifampicin, carbamazepine, pioglitazone, St John's Wort, glucocorticoids, modafinil and phenytoin) with Lojuxta, the possibility of a drug-drug interaction affecting efficacy should be considered.
Maltese: (jiġifieri, aminoglutethimide, nafcillin, inibituri tan-non-nucleoside reverse transcriptase, phenobarbital, rifampicin, carbamazepine, pioglitazone, St John's Wort, glukokortikojdi, modafinil u phenytoin) jingħataw flimkien ma' Lojuxta, għandha tiġi kkunsidrata lpossibbiltà ta' interazzjoni bejn ilmediċini li taffettwa l-effikaċja.
English: Lojuxta contains the active substance called lomitapide.
Maltese: Lojuxta fih is-sustanza attiva msejħa lomitapide.
English: At both Week 26 and Week 78, there were significant reductions in LDL-C, TC, apo B, TG, non-HDL-C, VLDL-C and changes in HDL-C trended lower at Week 26 and returned to baseline levels by Week 78.
Maltese: Kemm fil-Ġimgħa 26 u fil-Ġimgħa 78, kien hemm tnaqqis sinifikanti fl-LDL-C, it-TC, l-apo B, it-TG, in-non-HDL-C, il-VLDL-C u t-tibdil fl-HDL-C naqas fil-Ġimgħa 26 u reġa' lura għal-linja bażi salĠimgħa 78.
English: The remainder was excreted in faeces, primarily as oxidised metabolites.
Maltese: Il-bqija kienet eliminata fl-ippurgar, primarjament bħala metaboliti ossidizzati.
English: You should not take more than 40 mg of simvastatin when using Lojuxta (see section 2 under ‘Do not take Lojuxta')
Maltese: simvastatin waqt li qed tuża Lojuxta (ara s-sezzjoni 2 taħt ‘Tiħux Lojuxta')
English: Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules lomitapide
Maltese: Lojuxta 30 mg kapsuli ibsin Lojuxta 40 mg kapsuli ibsin Lojuxta 60 mg kapsuli ibsin lomitapide
English: Other reactions reported by at least 20% of patients include abdominal pain, abdominal discomfort, abdominal distension, constipation, and flatulence.
Maltese: Reazzjonijiet oħra rrapportati b'mill-inqas 20% tal-pazjenti jinkludu wġigħ addominali, skonfort addominali, nefħa addominali, stitikezza, u gass fl-istonku.
English: The most commonly reported adverse reactions of severe intensity were diarrhoea (4 subjects, 14%), vomiting (3 patients, 10%), and abdominal distension and ALT increased (2 subjects each, 7%).
Maltese: Ir-reazzjonijiet avversi ta' intensità severa komunament l-aktar irrapportati kienu dijarea (4 individwi, 14%), rimettar (3 pazjenti, 10%), u nefħa addominali u żieda fl-ALT (2 individwi kull waħda, 7%).
English: • feeling of incomplete defaecation (bowel movement), urgent need to defaecate
Maltese: • sensazzjoni ta' ppurgar mhux komplet (moviment tal-musrana), bżonn urġenti li tipporga
English: • Lojuxta may cause diarrhoea and vomiting and if it does, patients using oral contraception should use additional contraceptive methods for 7 days after symptoms have resolved;
Maltese: • Twissija dwar it-telf possibbli tal-effikaċja ta' kontraċettivi orali minħabba dijarea jew rimettar u lħtieġa għal kontraċezzjoni addizzjonali sa 7 ijiem wara li s-sintomi jkunu rriżolvew.
English: • apolipoprotein-B, a protein that carries “bad cholesterol” in the blood
Maltese: • apolipoproteina-B, proteina li ġġorr il-“kolesterol ħażin” fid-demm
English: • medicines to treat bacterial or fungal infections (e.g. nafcillin, azithromycin, roxithromycin,
Maltese: • mediċini għall-kura ta' infezzjonijiet batteriċi jew fungali (eż. nafcillin, azithromycin,
English: There is limited experience with lomitapide in patients aged 65 years or older.
Maltese: L-esperjenza b'lomitapide f'pazjenti ta' aktar minn 65 sena hija limitata.
English: Arthralgia Myalgia
Maltese: Użu orali
English: • Lojuxta 5 mg is an orange cap/orange body hard capsule with “5 mg” printed on the body and “A733“ printed on the cap in black ink.
Maltese: • Lojuxta 5 mg huwa kapsula iebsa b'għatu oranġjo/parti prinċipali oranġjo b'“5 mg” stampat fuq il-parti prinċipali u b'“A733“ stampat fuq l-għatu b'linka sewda.
English: Lojuxta 5 mg hard capsules
Maltese: Lojuxta 5 mg kapsuli ibsin
English: No clinically meaningful elevations in total bilirubin or alkaline phosphatase were observed.
Maltese: Ma kienet osservata l-ebda żieda klinikament sinifikanti fil-bilirubin totali jew flalkaline phosphatase.
English: At Week 26, the mean percent change in LDL-C from baseline of LDL-C was -40% (p<0.001) in the Intent to Treat (ITT) population.
Maltese: Fil-Ġimgħa 26, il-bidla perċentwali medja fl-LDL-C mil-linja bażi tal-LDL-C kienet ta' -40% (p<0.001) fil-popolazzjoni Intenzjoni li Tikkura (ITT).
English: Vertigo
Maltese: Vertiġini
English: Diarrhoea Nausea Flatulence
Maltese: Deidrazzjoni Żieda fl-aptit
English: • To lower the chance of stomach problems, you must stay on a low-fat diet whilst taking this medicine.
Maltese: • Biex tnaqqas il-possibbiltà ta' problemi fl-istonku, għandek toqgħod fuq dieta b'kontenut baxx ta' xaħam waqt li qed tieħu din il-mediċina.
English: • glucocorticoids (e.g. beclometasone, prednisolone) steroid medicines used to treat inflammation in conditions such as severe asthma, arthritis
Maltese: • glukokortikojdi (eż. beclometasone, prednisolone) mediċini sterojdi użati fil-kura tal infjammazzjoni f'kundizzjonijiet bħal ażma severa, artrite
English: Refer patients with persistent elevations in aminotransferase >3x ULN to a hepatologist for further investigation.
Maltese: Irreferi pazjenti b'żidiet persistenti flaminotransferażi >3x ULN lill-epatoloġista għal aktar investigazzjoni.
English: Excipient with known effect Each hard capsule contains 259.79 mg of lactose (as monohydrate) (see section 4.4).
Maltese: Eċċipjent(i) b'effett magħruf Kull kapsula iebsa fiha 259.79 mg ta' lattożju (bħala monoidrat) (ara s-sezzjoni 4.4).
English: Doses of simvastatin >40 mg should not be used with Lojuxta (see section 4.3).
Maltese: Dożi ta' simvastatin >40 mg ma għandhomx jintużaw ma' Lojuxta (ara s-sezzjoni 4.3).
English: Inducers of CYP3A4 Medicines that induce CYP3A4 would be expected to increase the rate and extent of metabolism of lomitapide.
Maltese: Mediċini li jinduċu CYP3A4 ikunu mistennija jżidu r-rata u lfirxa tal-metaboliżmu ta' lomitapide.
English: • some herbal medicines:
Maltese: • xi mediċini erbali:
English: Lojuxta has not been investigated in patients aged 65 years or older.
Maltese: Lojuxta ma ġiex investigat f'pazjenti ta' aktar minn 65 sena.
English: • medicines to regulate heart rhythm (e.g. amiodarone)
Maltese: • mediċini biex jirregolaw ir-ritmu tal-qalb (eż. amiodarone)
English: • Patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests (see section 4.2).
Maltese: • Pazjenti b'indeboliment epatiku moderat jew sever u dawk b'testijiet anormali persistenti talfunzjoni tal-fwied (ara sezzjoni 4.2).
English: Nasopharyngitis Sinusitis
Maltese: Popolazzjoni anzjana
English: • Lojuxta 20 mg is a white cap/white body hard capsule with “20 mg” printed on the body and “A733” printed on the cap in black ink.
Maltese: • Lojuxta 20 mg huwa kapsula ibsin b'għatu abjad/parti prinċipali bajda b'“20 mg” stampat fuq il-parti prinċipali u b'“A733” stampat fuq l-għatu b'linka sewda.
English: This
Maltese: JIS
English: The capsule is an orange cap/yellow body hard capsule of 21.6 mm, printed with black ink imprinted with “30 mg” on body and “A733” on cap.
Maltese: Il-kapsula hija kapsula iebsa b'għatu oranġjo/parti prinċipali safra ta' 21.6 mm, stampata b'linka sewda u stampata b'“30 mg” fuq il-parti prinċipali u b'“A733” fuq l-għatu.
English: Upon multiple dosing Cmax and AUC increased in approximate proportion to lomitapide dose.
Maltese: Wara l-għoti ta' dożi multipli s-Cmax u l-AUC żdiedu fi proporzjon approssimattiv għad-doża ta' lomitapide.
English: There was no evidence of embryofoetal toxicity in rabbits at 3 times the maximum recommended human dose (MRHD) of 60 mg based on body surface area.
Maltese: Ma kien hemm ebda evidenza ta' tossiċità embrijofetali filfniek fi 3 darbiet id-doża massima rakkomandata fil-bniedem (MRHD) ta' 60 mg abbażi tal-erja tassuperfiċje tal-ġisem.
English: Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.
Maltese: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 20 mg ta' lomitapide.
English: Excipient with known effect Each hard capsule contains 389.68 mg of lactose (as monohydrate) (see section 4.4).
Maltese: Eċċipjent(i) b'effett magħruf Kull kapsula iebsa fiha 389.68 mg ta' lattożju (bħala monoidrat) (ara s-sezzjoni 4.4).
English: Lojuxta 5 mg: each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.
Maltese: Lojuxta 5 mg: Kull kapsula iebsa fiha lomitapide mesylate ekwivalenti għal 5 mg ta' lomitapide.
English: • Withhold dosing and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR).
Maltese: • Waqqaf id-doża u ikseb testijiet addizzjonali relatati mal-fwied jekk ma jkunux diġà tkejlu (bħall-alkaline phosphatase, il-bilirubin totali, u lINR).
English: • medicines to reduce the activity of the immune system (e.g. sirolimus)
Maltese: • mediċini biex inaqqsu l-attività tas-sistema immuni (eż. sirolimus)
English: Fenofibrate, niacin and ezetimibe: When lomitapide was administered to steady state prior to micronised fenofibrate 145 mg, extended release niacin 1000 mg, or ezetimibe 10 mg, no clinically significant effects on the exposure of any of these medicinal products were observed.
Maltese: Meta lomitapide ngħata fi stat stabbli qabel fenofibrate mikronizzat 145 mg, niacin b'rilaxx estiż 1000 mg, jew ezetimibe 10 mg, ma ġie osservat l-ebda effett klinikament sinifikanti fuq l-esponiment ta' xi wieħed minn dawn il-prodotti mediċinali.
English: Lojuxta 40 mg, 60 mg hard capsules Gelatin
Maltese: Lojuxta 40 , 60 mg kapsuli ibsin Ġelatina
English: Pyrexia
Maltese: Stitikezza
English: Lojuxta 20 mg hard capsules Gelatin
Maltese: Lojuxta 20 mg kapsuli ibsin Ġelatina
English: In this study, 10 patients experienced elevations in AST and/or ALT >3 x ULN (see Table 6).
Maltese: F'dan l-istudju, 10 pazjenti esperjenzaw żidiet fl-AST u/jew fl-ALT >3 x ULN (ara Tabella 6).
English: Lojuxta 10 mg hard capsules
Maltese: Lojuxta 10 mg kapsuli ibsin