natgillin/translations-raw huggingface dataset:
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). 
V odprti študiji 3. faze se je pri 18 od 23 bolnikov s HoFH razvila jetrna steatoza (maščoba v jetrih > 5,56 %), ki se meri z jedrsko magnetnoresonančno spektroskopijo (MRS) (glejte poglavje 5.1).
Safety phase weeks 26-78 N (%) 
Faza varnosti Tedni 26-78 N (%)
Inter-individual variability in lomitapide AUC was approximately 50%. 
Variabilnost vrednosti AUC lomitapida med posamezniki je bila približno 50-odstotna.
Prescribers are encouraged to enrol all patients treated with Lojuxta into a global registry. 
Zdravnikom priporočamo, da vse bolnike, zdravljene z zdravilom Lojuxta, vključijo v svetovni register.
A pharmacokinetic study in patients with ESRD undergoing hemodialysis demonstrated a 36% increase in mean lomitapide plasma concentration compared to matched healthy controls. 
Farmakokinetična študija pri bolnikih z ESRD na hemodializi je pokazala 36-odstotno povečanje povprečne koncentracije lomitapida v plazmi v primerjavi z ustrezajočimi zdravimi kontrolami.
• Information about taking Lojuxta at bedtime with water at least 2 hours after the evening meal and without food; 
• Informacije o jemanju zdravila Lojuxta zvečer z vodo, vsaj 2 uri po večerji, in brez hrane;
Monitoring of liver function tests 
Spremljanje preiskav jetrnega delovanja
Administration with food may increase exposure to lomitapide. 
Zaužitje skupaj s hrano lahko poveča izpostavljenost lomitapidu.
• Take this medicine once a day at bedtime with a glass of water at least 2 hours after your evening meal (see section 2 under ‘Lojuxta with food, drink and alcohol'). 
• To zdravilo vzemite enkrat na dan, zvečer s kozarcem vode, vsaj 2 uri po večerji (glejte poglavje 2 „Zdravilo Lojuxta skupaj s hrano, pijačo in alkoholom“).
Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolaemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded. 
Izključiti je treba druge oblike primarne hiperlipoproteinemije in sekundarne vzroke hiperholesterolemije (npr. nefrotski sindrom, hipotiroidizem).
• if you take more than 40 mg of simvastatin daily (another medicine used to lower cholesterol). 
• če jemljete več kot 40 mg simvastatina na dan (drugega zdravila za zniževanje ravni holesterola);
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1;
Animal studies have shown developmental toxicity (teratogenicity, embryotoxicity, see section 5.3). 
Študije na živalih so pokazale vpliv na razvoj ploda (teratogenost, embriotoksičnost, glejte poglavje 5.3).
Lomitapide does not induce CYPs 1A2, 3A4, or 2B6, and does not inhibit CYPs 1A2, 2B6, 2C9, 2C19, 2D6, or 2E1. 
Lomitapid ne inducira CYP 1A2, 3A4 ali 2B6 in ne zavira CYP 1A2, 2B6, 2C9, 2C19, 2D6 ali 2E1.
Adverse clinical consequences of these reductions were not observed with lomitapide treatment of up to 78 weeks. 
Pri zdravljenju z lomitapidom neželenih kliničnih posledic tega znižanja niso opazili do 78 tedna.
• loss of fluid that may cause headache, dry mouth, dizziness, tiredness or unconsciousness 
• izguba tekočine, ki lahko povzroči glavobol, suha usta, omotico, utrujenost ali nezavest
Elevations in ALT and/or AST >5 x ULN were managed with a dose reduction or temporary suspension of lomitapide dosing, and all patients were able to continue with study drug treatment. 
Povišane ravni ALT in/ali AST, > 5-kratna vrednost ULN, so se obravnavale z zmanjšanjem odmerka ali začasno prekinitvijo odmerjanja lomitapida in vsi bolniki so lahko nadaljevali zdravljenje s študijskim zdravilom.
Daily Amount Vitamin E 
Vitamin E
CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction. 
Induktorji CYP3A4 učinkujejo na od časa odvisen način, zato lahko traja 2 tedna, da se po njihovem uvajanju doseže največji učinek.
Lomitapide is not expected to directly influence the efficacy of oestrogen based oral contraceptives; however diarrhoea and/or vomiting may reduce hormone absorption. 
Ni pričakovati, da bo lomitapid neposredno vplival na učinkovitost estrogenskih peroralnih kontracepcijskih sredstev, vendar lahko diareja in/ali bruhanje zmanjšata absorpcijo hormonov.
The safety and efficacy of lomitapide in children <18 years have not been established and the use of this medicinal product in children is therefore not recommended. 
Varnost in učinkovitost lomitapida pri otrocih, starih do 18 let, nista bili dokazani, zato uporaba tega zdravila pri otrocih ni priporočljiva.
• dehydration, dry mouth 
• dehidracija, suha usta,
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. 
V 26. in 78. tednu je prišlo do pomembnega zmanjšanja ravni holesterola LDL, TC, apo B, TG, nonHDL-C, VLDL-C, spremembe HDL-C pa so bile manjše v 26. tednu in so se do 78. tedna vrnile na izhodiščno raven.
• To evaluate whether prescribers of lomitapide are following the screening and monitoring recommendations as specified in the product information and the educational materials. 
• Oceniti, ali zdravniki, ki predpišejo lomitapid, upoštevajo priporočila glede presejanja in spremljanja, kot je navedeno v podatkih o zdravilu ter izobraževalnem gradivu.
This medicine has been authorised under ‘exceptional circumstances'. 
Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
You may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea. 
V nekaterih primerih lahko pride do izgube tekočine/dehidracije, npr. v primeru bruhanja, slabosti in driske.
After 2 weeks the dose may be increased, based on acceptable safety and tolerability, to 10 mg and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and to the maximum recommended dose of 60 mg (see section 4.8). 
Po 2 tednih se lahko odmerek na podlagi sprejemljive varnosti ter tolerance poveča na 10 mg, potem pa v najmanj 4-tedenskih presledkih na 20 mg, 40 mg in največji priporočeni odmerek 60 mg (glejte poglavje 4.8).
Cmax and AUC were increased following either a high-fat meal (77% and 58%, respectively) or low fat meal (70% and 28%, respectively). 
Vrednosti Cmax in AUC sta se povečali po obroku z veliko vsebnostjo maščob (77 % oziroma 58 %) ali obroku z majhno vsebnostjo maščob (70 % oziroma 28 %).
There is no specific treatment in the event of overdose. 
Pri prevelikem odmerjanju posebnega zdravljenja ni.
Lomitapide pharmacokinetics is approximately dose-proportional for oral single doses in the therapeutic range. 
Farmakokinetika lomitapida je približno sorazmerna peroralnim enkratnim odmerkom v terapevtskem razponu.
Patients should be advised to immediately contact their physician and stop taking Lojuxta if they become pregnant (see section 4.6). 
Bolnicam je treba svetovati, naj se takoj posvetujejo s svojim zdravnikom in prekinejo jemanje zdravila Lojuxta, če zanosijo (glejte poglavje 4.6).
Of the parameters examined (race, body mass index (BMI), gender, weight, age), only BMI could be classified as a potential covariate. 
Od preučenih parametrov (rasa, indeks telesne mase (ITM), spol, telesna masa, starost) je bilo mogoče samo ITM razvrstiti kot morebitno sospremenljivko.
Alternatively, your doctor may decrease your dose of Lojuxta. 
Druga možnost je, da zdravnik zmanjša vaš odmerek zdravila Lojuxta.
Haemodialysis is unlikely to be beneficial given that lomitapide is highly protein bound. 
Hemodializa verjetno pri jemanju lomitapida ne bo koristna glede na to, da se lomitapid dobro veže na beljakovine.
Post-marketing reports of dehydration and hospitalisation in patients treated with lomitapide have been reported. 
V obdobju trženja zdravila so poročali o dehidraciji in hospitalizaciji bolnikov, zdravljenih z lomitapidom.
All patients receiving lomitapide in addition to a statin should be advised of the potential increased risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness. 
Vsem bolnikom, ki sočasno prejemajo lomitapid ter statin, je treba svetovati glede morebitnega povečanega tveganja za miopatijo in jim naročiti, naj takoj poročajo o kakršni koli nepojasnjeni mišični bolečini, občutljivosti ali šibkosti.
• Information on the importance of following a low-fat diet (a diet supplying less than 20% of energy from fat); 
• Informacije o pomembnosti upoštevanja diete z majhnim vnosom maščob (diete, pri kateri bolnik dobi manj kot 20 % energije iz maščob);
The most serious adverse reactions during treatment were liver aminotransferase abnormalities (see section 4.4). 
Najresnejši neželeni učinki med zdravljenjem so bile abnormalnosti jetrnih aminotransferaz (glejte poglavje 4.4).
• Advice to exercise caution if Lojuxta is used with other hepatotoxic medicinal products and to consider more frequent monitoring of liver-related tests; 
• Nasvet o previdnosti, če se zdravilo Lojuxta uporablja z drugimi hepatotoksičnimi zdravili, in o razmisleku o pogostejšem spremljanju rezultatov jetrnih preiskav;
Patients with rare hereditary problems of galactose intolerance, total-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
However, since the medicinal product is dosed in an escalating fashion according to individual patient safety and tolerability, no adjustment to the dosing regimen is recommended based on race. 
Ker pa se odmerjanje zdravila veča postopoma ter skladno z varnostjo in toleranco pri posameznem bolniku, se glede na raso ne priporoča nobeno prilagajanje režima odmerjanja.
Your doctor may advise you to stop taking Lojuxta or to stop breast-feeding. 
Zdravnik vam bo svetoval, da prekinete jemanje zdravila Lojuxta ali prenehate dojiti.
Decrease the dose of Lojuxta if elevations of aminotransferase are observed and discontinue treatment for persistent or clinically significant elevations (see Table 1 for specific recommendations). 
Odmerek zdravila Lojuxta je treba zmanjšati, če se opazi povišanje ravni aminotransferaze, in zdravljenje prekiniti, če je prisotno persistentno ali klinično pomembno povišanje (glejte preglednico 1 za posebna priporočila).
What Lojuxta is and what it is used for What you need to know before you take Lojuxta How to take Lojuxta 
Kaj je zdravilo Lojuxta in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Lojuxta Kako jemati zdravilo Lojuxta
What Lojuxta is and what it is used for 
Kaj je zdravilo Lojuxta in za kaj ga uporabljamo
In a 1 year repeat-dose study in dogs there were no microscopic changes in the liver although serum AST was minimally increased in females. 
V enoletni študiji z večkratnimi odmerki na psih ni bilo nobenih mikroskopskih sprememb v jetrih, čeprav je bila raven AST v serumu pri samicah rahlo povišana.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte z zdravnikom.
• Before starting treatment you should confirm you are not pregnant and are using effective contraception, as advised by your doctor. 
• Pred začetkom zdravljenja je treba potrditi, da niste noseči in da uporabljate učinkovito kontracepcijo po navodilih zdravnika.
Contact your doctor immediately if you experience any unexplained muscle aches and pains, tenderness or weakness. 
Takoj se posvetujte z zdravnikom, če imate kakršno koli nepojasnjeno bolečino, občutljivost ali šibkost v mišicah.
During the first year, measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first. 
V prvem letu je treba jetrne preiskave (vsaj ALT in AST) izvajati pred vsakim povečanjem odmerka ali enkrat na mesec, do česar pride prej.
It is not known whether lomitapide is excreted into human milk. 
Ni znano, ali se lomitapid izloča v materino mleko.
In this study, 10 patients experienced elevations in AST and/or ALT >3 x ULN (see Table 6). 
V tej študiji je pri 10 bolnikih prišlo do povišanja ravni AST in/ali ALT > 3-kratna vrednost ULN (glejte preglednico 6).
Gastrointestinal reactions contributed to the reasons for early discontinuation from the study for 4 (14%) patients. 
Neželeni učinki na prebavila so povzročili prezgodnjo prekinitev študije pri 4 (14 %) bolnikih.
• It is not known if Lojuxta is passed into breast milk. 
• Ni znano, ali zdravilo Lojuxta prehaja v materino mleko.
Additional contraceptive measures should be used until resolution of symptoms (see section 4.5). 
Do izginotja simptomov je treba uporabljati dodatne kontracepcijske metode (glejte poglavje 4.5).
• have had liver problems, including liver problems whilst taking other medicines. 
• če imate težave z jetri, vključno z jetrnimi težavami med jemanjem drugih zdravil.
• abnormal blood tests for liver function have been reported commonly (may affect up to 1 in 10 people). 
• pogosto so poročali o nenormalnih izvidih krvnih preiskav jetrnega delovanja (pojavijo se lahko pri največ 1 od 10 bolnikov).
• The active substance is lomitapide. 
• Zdravilna učinkovina je lomitapid.
• aminoglutethimide - a medicine used to treat Cushing's syndrome 
• aminoglutetimid - zdravilo za zdravljenje Cushingovega sindroma,
≥5x ULN 
≥ 5-krat ULN
Contraception measures in women of child-bearing potential 
Kontracepcijski ukrepi pri ženskah v rodni dobi
Peak plasma concentrations of lomitapide were reached 4-8 hours following oral dosing. 
Največje koncentracije lomitapida v plazmi so bile dosežene 4 do 8 ur po peroralnem odmerjanju.
400 IU* 
400 i.e.*
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. 
Lomitapid nima vpliva na funkcijo razmnoževanja pri podganjih samicah pri odmerkih do 1 mg/kg ali pri podganjih samcih pri odmerkih do 5 mg/kg.
Difficulty controlling INR contributed to early discontinuation from the Phase 3 study for one of five patients taking concomitant warfarin. 
Težavno nadzorovanje INR v študiji 3. faze je povzročilo prekinitev jemanja pri enem od petih bolnikov, ki so sočasno jemali varfarin.
Effects of lomitapide on other medicinal products 
Učinek lomitapida na druga zdravila
• The use of alcohol during Lojuxta treatment is not recommended. 
• Uporaba alkohola med zdravljenjem z zdravilom Lojuxta ni priporočljiva.
Patients taking warfarin should undergo regular monitoring of the INR, especially after any changes in the dose of Lojuxta. 
Pri bolnikih, ki jemljejo varfarin, je treba redno spremljati INR, predvsem po spremembah odmerka zdravila Lojuxta.
Patients with results suggesting the presence of steatohepatitis or fibrosis should be considered for liver biopsy. 
Pri bolnikih z rezultati, ki kažejo na steatohepatitis ali fibrozo, je treba razmisliti o biopsiji jeter.
Patients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily. 
Pri bolnikih z blago jetrno okvaro (stadij A po Child-Pughu) odmerek ne sme preseči 40 mg na dan.
If you get pregnant while taking this medicine, call your doctor immediately and stop taking the capsules. 
Če med jemanjem tega zdravila zanosite, se nemudoma posvetujte s svojim zdravnikom in prekinite jemanje kapsul.
Baseline Week 26/LOCF (N=29) 
Izhodišče 26. teden/LOCF (N = 29)
The recommended starting dose is 5 mg once daily. 
Odmerjanje Priporočeni začetni odmerek je 5 mg enkrat na dan.
By blocking this protein, the medicine decreases the level of fats and cholesterol (lipids) in the blood. 
Ker zdravilo zavira ta protein, zmanjša raven maščob in holesterola (lipidov) v krvi.
Risk of supratherapeutic or subtherapeutic anticoagulation with coumarin based anticoagulants 
Tveganje supraterapevtske ali subterapevtske antikoagulacije s kumarinskimi antikoagulanti
The dose should be escalated gradually to minimise the incidence and severity of gastrointestinal adverse reactions and aminotransferase elevations. 
Odmerek je treba večati postopoma, da se čim bolj zmanjša incidenca in resnost neželenih učinkov na prebavila ter povišanja ravni aminotransferaze.
If a patient has biopsy-proven steatohepatitis or fibrosis, the benefit-risk should be reassessed and treatment stopped if necessary. 
Če se pri bolniku steatohepatitis ali fibroza potrdi z biopsijo, je treba ponovno oceniti razmerje med tveganji ter koristmi in zdravljenje po potrebi prekiniti.
• triglycerides (fat carried in the blood) 
• trigliceridov (maščobe v krvnem obtoku).
Patients will be instructed to carry this card and show it to all doctors who treat them. 
Bolnikom je treba naročiti, naj imajo to kartico ves čas pri sebi in naj jo pokažejo vsakemu zdravniku, ki jih zdravi.
The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary. 
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke o tem zdravilu.
Your treatment may affect your ability to drive or use machines. 
Zdravljenje lahko vpliva na sposobnost uporabe vozil in strojev.
More frequent monitoring of liver-related tests may be warranted. 
Morda bo potrebno pogostejše spremljanje rezultatov jetrnih preiskav.
Do not take this medicine if you are pregnant, trying to get pregnant, or think you may be pregnant, as there is a possibility that it could harm an unborn baby. 
Če ste noseči, načrtujete zanositev ali menite, da bi lahko bili noseči, ne jemljite tega zdravila, saj lahko poškoduje nerojenega otroka.
Upon multiple dosing Cmax and AUC increased in approximate proportion to lomitapide dose. 
Pri večkratnih odmerkih sta se vrednosti Cmax in AUC povečali približno sorazmerno z odmerkom lomitapida.
• Information about clinical findings (i.e., hepatic enzyme increases and steatosis) in subjects treated with Lojuxta during the developmental phase; 
• Podatki o kliničnih ugotovitvah (tj. povišanih ravneh jetrnih encimov in steatozi) pri preskušancih, zdravljenih z zdravilom Lojuxta med razvojno fazo;
Use of Lojuxta is contraindicated in patients treated with high doses of simvastatin (>40 mg) (see sections 4.3 and 4.4). 
Uporaba zdravila Lojuxta je kontraindicirana pri bolnikih, ki se zdravijo z velikimi odmerki simvastatina (> 40 mg) (glejte poglavji 4.3 in 4.4).
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
Consider limiting the maximum dose of Lojuxta according to desired LDL-C response. 
Razmislite o omejitvi največjega odmerka zdravila Lojuxta glede na želeni odziv holesterola LDL.
Since the recommended dose regimen involves starting at the low end of the dosing range and escalating cautiously according to individual patient tolerability, no adjustment to the dosing regimen is recommended for the elderly. 
Ker priporočeni režim odmerjanja vključuje začetek z nizkim odmerkom in previdno postopno povečevanje v skladu z toleranco posameznega bolnika, posebna priporočila za prilagajanje odmerka pri starejših bolnikih niso potrebna.
• decrease in levels of potassium, carotene, vitamin E, vitamin K in your blood 
• znižanje ravni kalija, karotena, vitamina E, vitamina K v krvi,
P-gp substrates: Lomitapide inhibits P-gp in vitro, and may increase the absorption of P-gp substrates. 
Substrati P-gp: Lomitapid zavira P-gp in vitro, kar lahko poveča absorpcijo substratov P-gp.
You also need to take daily vitamin E and essential fatty acid (omega-3 and omega-6) supplements while taking this medicine. 
Med jemanjem tega zdravila morate vsak dan jemati tudi nadomestke vitamina E in bistvenih maščobnih kislin (omega-3 in omega-6).
Lojuxta with food, drink and alcohol 
Zdravilo Lojuxta skupaj s hrano, pijačo in alkoholom
list is not intended to be comprehensive and prescribers should check the prescribing information of medicinal products to be co-administered with Lojuxta for potential CYP3A4 mediated interactions. 
Ta seznam ni izčrpen, zato morajo zdravniki preveriti informacije o predpisovanju zdravil, ki se bodo uporabljala skupaj z zdravilom Lojuxta, zaradi morebitnih interakcij, ki jih povzroča CYP3A4.
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. 
Od 23 bolnikov, ki so končali 26. teden, jih je imelo na tej časovni točki 19 (83 %) znižanje ravni holesterola LDL ≥ 25 %, 8 (35 %) vrednost holesterola LDL < 100 mg/dl, 1 bolnik pa vrednost holesterola LDL < 70 mg/dl.
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. 
Odprta študija z eno skupino (UP1002/AEGR-733-005) je ocenila učinkovitost in varnost lomitapida v kombinaciji z dieto z majhnim vnosom maščob ter drugimi oblikami zdravljenja za zniževanje ravni lipidov pri odraslih bolnikih s HoFH.
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. 
Preglednica 3 navaja vse neželene učinke, o katerih so poročali pri 35 bolnikih, ki so se zdravili v študiji 2. faze UP1001 in študiji 3. faze UP1002/AEGR-733-005 ali njeni podaljšani študiji AEGR-733-012.
Lojuxta has not been investigated in patients aged 65 years or older. 
Zdravilo Lojuxta se ni preučevalo pri bolnikih, starih 65 let ali več.
Diarrhoea occurred in 79% of patients, nausea in 65%, dyspepsia in 38%, and vomiting in 34%. 
Diareja se je pojavila pri 79 % bolnikov, navzea pri 65 %, dispepsija pri 38 %, bruhanje pa pri 34 %.
Lojuxta is contraindicated during pregnancy. 
Nosečnost Zdravilo Lojuxta je med nosečnostjo kontraindicirano.
• if you have liver problems or unexplained abnormal liver tests. 
• če imate težave z jetri ali nepojasnjene nenormalne rezultate jetrnih preiskav;
* IU - international units, mg - milligrams 
200 mg * i.e. - mednarodne enote, mg - miligrami
Data from individuals who had repeat measurements after stopping lomitapide show that hepatic fat accumulation is reversible, but whether histological sequelae remain is unknown. 
Podatki posameznikov, pri katerih so meritve ponovili po prekinitvi lomitapida, kažejo, da je kopičenje maščob v jetrih reverzibilno, vendar ni znano, ali ostanejo histološke posledice.
If the baseline liver-related tests are abnormal, consider initiating the medicinal product after appropriate investigation by a hepatologist and the baseline abnormalities are explained or resolved. 
Če so izhodiščni rezultati jetrnih preiskav nenormalni, je treba o uvedbi zdravila razmisliti šele, ko stanje ustrezno razišče hepatolog in se izhodiščne nenormalnosti pojasnijo ali odpravijo.
Lojuxta has not been investigated in children less than 18 years of age. 
Zdravilo Lojuxta se ni preučevalo pri otrocih, mlajših od 18 let.
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. 
Afereza se je ukinila pri 3 od 13 bolnikov, ki so jo prejemali v 26. tednu, njena pogostnost pa se je zmanjšala pri 3 bolnikih, pri čemer so se nizke ravni holesterola LDL
If aminotransferase levels do not fall below 3x ULN within approximately 4 weeks refer the patient to a hepatologist for further investigation. 
Če ravni aminotransferaze v približno 4 tednih ne padejo pod 3-kratno vrednost ULN, bolnika napotite k hepatologu, ki bo opravil nadaljnje preiskave.