natgillin/translations-raw huggingface dataset:
Patients treated with lomitapide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. 
Bolnike, ki se zdravijo z lomitapidom, je treba seznaniti z možnim tveganjem za dehidracijo v povezavi z gastrointestinalnimi neželenimi učinki in s previdnostnimi ukrepi za preprečitev izgube tekočine.
At steady state the accumulation of lomitapide was 2.7 at 25 mg and 3.9 at 50 mg. 
V stanju dinamičnega ravnovesja je bilo kopičenje lomitapida 2,7 pri 25 mg in 3,9 pri 50 mg.
Careful titration may then be considered according to LDL-C response and safety/tolerability. 
Potem lahko razmislite o previdnem titriranju odmerka glede na odziv holesterola LDL in varnost/toleranco.
Increases in the dose of Lojuxta may lead to supratherapeutic anticoagulation, and decreases in the dose may lead to subtherapeutic anticoagulation. 
Povečanje odmerka zdravila Lojuxta lahko povzroči supraterapevtsko antikoagulacijo, zmanjšanje pa subterapevtsko antikoagulacijo.
The “bad” cholesterol can lead to heart attacks, strokes or other events at an early age. 
„Slab“ holesterol lahko pri nizki starosti povzroči srčno kap, možgansko kap ali druge dogodke.
The MAH shall provide an educational pack prior to launch targeting all physicians who are expected to prescribe/use lomitapide. 
Imetnik dovoljenja za promet z zdravilom mora pred dajanjem zdravila v promet pripraviti izobraževalni komplet za vse zdravnike, za katere se pričakuje, da bodo predpisovali/uporabljali lomitapid.
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. 
Opravili so odprto študijo z enkratnim odmerkom, s katero so ocenili farmakokinetiko 60 mg lomitapida pri zdravih prostovoljcih z normalnim jetrnim delovanjem v primerjavi z bolniki z blago (stadij A po Child-Pughu) in zmerno (stadij B po Child-Pughu) jetrno okvaro.
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. 
Lomitapid je selektivni zaviralec mikrosomalnega transportnega proteina (MTP), znotrajceličnega proteina za prenos lipidov, ki je v svetlini endoplazemskega retikuluma in je odgovoren za vezavo ter premikanje posameznih lipidnih molekul med membranami.
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. 
Fenofibrat, niacin in ezetimib: Ko se je lomitapid dajal do stanja dinamičnega ravnovesja pred uvajanjem mikroniziranega fenofibrata 145 mg, niacinom s podaljšanim sproščanjem 1000 mg ali ezetimibom 10 mg, niso opazili nobenih klinično pomembnih učinkov na izpostavljenost kateremu koli od teh zdravil.
Lomitapide is not a P-gp substrate but does inhibit P-gp. 
Lomitapid ni substrat P-gp, vendar zavira P-gp.
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. 
Izooblike CYP 2E1, 1A2, 2B6, 2C8 ter 2C19 so vključene v manjši meri, izoobliki 2D6 ter 2C9 pa nista vključeni v presnovo lomitapida.
Lojuxta has not been studied in patients with severe hepatic impairment (Child-Pugh score 10-15). 
Zdravilo Lojuxta se ni preučevalo pri bolnikih s hudo jetrno okvaro (rezultat 10-15 po Child-Pughu).
The risk of myopathy with simvastatin is dose related. 
Tveganje miopatije pri sočasni uporabi s simvastatinom je odvisno od odmerka.
Patients taking Lojuxta should avoid consumption of grapefruit juice. 
Bolniki, ki prejemajo zdravilo Lojuxta, se morajo izogibati uživanju soka grenivke.
• changes to blood clotting tests 
• spremembe izvidov preiskav strjevanja krvi,
• The need to avoid grapefruit juice; 
• Potrebo po izogibanju alkoholu; • Potrebo po izogibanju soku grenivke;
Coumarin anticoagulants: When lomitapide 60 mg was administered to steady state and 6 days following warfarin 10 mg, INR increased 1.26-fold. 
Kumarinski antikoagulanti: Ko se je lomitapid 60 mg dajal do stanja dinamičnega ravnovesja in 6 dni po dajanju varfarina 10 mg, se je vrednost INR povečala za 1,26-krat.
It is recommended to increase the frequency of LDL-C assessment during such concomitant use and consider increasing the dose of Lojuxta to ensure maintenance of the desired level of efficacy if the CYP3A4 inducer is intended for chronic use. 
Priporočeno je, da med tako sočasno uporabo povečate pogostnost ocenjevanja ravni holesterola LDL in razmislite o povečanju odmerka zdravila Lojuxta, da se zagotovi vzdrževanje želene stopnje učinkovitosti, če je induktor CYP3A4 namenjen kronični uporabi.
Patients were instructed to maintain a low-fat diet (<20% calories from fat) and their lipid-lowering therapies at study entry, including apheresis if applicable, from 6 weeks prior to baseline through at least Week 26. 
Bolnikom so ob vključitvi v študijo naročili, naj vzdržujejo dieto z majhnim vnosom maščob (< 20 % kalorij iz maščob) in zdravljenje za zniževanje ravni lipidov, vključno z aferezo, če je primerno, od 6 tednov pred izhodiščem do zadnjega, 26. tedna.
• hair loss (alopecia) 
• izpadanje las (alopecija),
The recommended starting dose is a 5 mg capsule each day. 
Priporočeni začetni odmerek je 5 miligramska kapsula enkrat na dan.
Ask your doctor, or dietitian how to obtain these supplements. 
Obrnite se na zdravnika ali nutricionista, ki vam bo svetoval, kje dobiti ta prehranska dopolnila.
On withdrawal of a CYP3A4 inducer, the possibility of increased exposure should be considered and a reduction in the dose of Lojuxta may be necessary. 
Pri prekinitvi uporabe induktorja CYP3A4 je treba upoštevati možnost povečane izpostavljenosti in morda bo potrebno zmanjšanje odmerka zdravila Lojuxta.
Interactions between moderate CYP3A4 inhibitors and lomitapide have not been studied. 
Interakcij med zmernimi zaviralci CYP3A4 in lomitapidom niso preučevali.
Upon discontinuation of atorvastatin the dose of Lojuxta should be up-titrated according to LDL-C response and safety/tolerability. 
Ko prekinete uporabo atorvastatina, je treba odmerek zdravila Lojuxta večati glede na odziv holesterola LDL in varnost/toleranco.
Lojuxta may affect the way other medicines work. 
Zdravilo Lojuxta lahko vpliva na delovanje drugih zdravil.
p-value is based on the mean percent change b p-value on the mean percent change from baseline based on paired t-test 
b Vrednost p za srednjo odstotno spremembo od izhodiščne vrednosti na podlagi parnega t-testa.
• The Summary of Product Characteristics 
• povzetek glavnih značilnosti zdravila
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). 
Pri bolnikih, ki sočasno jemljejo kumarine (kot je varfarin) in zdravilo Lojuxta, je treba vrednost INR izmeriti pred uvajanjem zdravila Lojuxta, jo redno spremljati in prilagoditi odmerek kumarina, kot je klinično indicirano (glejte poglavje 4.4).
Liver related tests should be monitored. 
Treba je spremljati jetrne teste.
• tetracycline antibiotics to treat infections such as urinary tract infections 
• tetraciklinski antibiotiki za zdravljenje okužb, kot so okužbe sečil,
EU/1/13/851/001 - Lojuxta 5 mg hard capsules EU/1/13/851/002 - Lojuxta 10 mg hard capsules EU/1/13/851/003 - Lojuxta 20 mg hard capsules EU/1/13/851/004 - Lojuxta 30 mg hard capsules EU/1/13/851/005 - Lojuxta 40 mg hard capsules EU/1/13/851/006 - Lojuxta 60 mg hard capsules 
EU/1/13/851/001 - Lojuxta 5 mg trde kapsule EU/1/13/851/002 - Lojuxta 10 mg trde kapsule EU/1/13/851/003 - Lojuxta 20 mg trde kapsule EU/1/13/851/004 - Lojuxta 30 mg trde kapsule EU/1/13/851/005 - Lojuxta 40 mg trde kapsule EU/1/13/851/006 - Lojuxta 60 mg trde kapsule
• Advice on monitoring liver function (measuring hepatic enzymes and total bilirubin) before and during treatment with Lojuxta and routine screening to detect presence of steatohepatitis and hepatic fibrosis including specific details of the screening tests at baseline and annually as follows: - Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI), or magnetic resonance (MR) elastography; - Measurement of biomarkers and/or scoring methods. 
• Nasvet o spremljanju jetrnega delovanja (merjenju jetrnih encimov in celokupnega bilirubina) pred ter med zdravljenjem z zdravilom Lojuxta in rednem presejanju, s katerim se ugotavlja prisotnost steatohepatitisa ter jetrne fibroze, vključno s posebnimi podrobnostmi preiskav za presejanje ob izhodišču in potem enkrat na leto: - slikanje za preverjanje elastičnosti tkiva, npr. Fibroscan, prehodna elastografija (ARFI), ali magnetnoresonančna (MR) elastografija; - merjenje bioloških označevalcev in/ali metode za ocenjevanje.
The long term consequences of hepatic steatosis associated with lomitapide treatment are unknown. 
Dolgotrajne posledice jetrne steatoze, povezane z zdravljenjem z lomitapidom, niso znane.
• The Prescriber Guide 
• navodila za predpisovanje
Regular screening for steatohepatitis/fibrosis should be performed at baseline and on an annual basis using the following imaging and biomarker evaluations: 
Spremljanje dokazov za napredujočo jetrno bolezen Redno presejanje za steatohepatitis/fibrozo je treba opravljati na izhodišču in potem enkrat na leto z uporabo naslednjih oblik slikanja in ocen bioloških označevalcev:
Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX12 
Farmakoterapevtska skupina: zdravila za spreminjanje ravni serumskih lipidov, druga zdravila za spreminjanje ravni serumskih lipidov, oznaka ATC: C10AX12
Because bile acid sequestrants can interfere with the absorption of oral medicines, bile acid sequestrants should be taken at least 4 hours before or at least 4 hours after Lojuxta. 
Ker lahko snovi, ki vežejo žolčno kislino, ovirajo absorpcijo peroralnih zdravil, jih je treba jemati vsaj 4 ure pred odmerkom zdravila Lojuxta ali vsaj 4 ure po njem.
Patients should follow a diet supplying less than 20% of energy from fat prior to initiating treatment, and should continue this diet during treatment. 
Bolnikova prehrana mora vsebovati manj kot 20 % energije, pridobljene iz maščob, preden se uvede zdravljenje.
Name and address of the manufacturers responsible for batch release 
Ime in naslov izdelovalcev, odgovorneih za sproščanje serij
Table 1 summarizes recommendations for dose adjustment and monitoring for patients who develop elevated aminotransferase during therapy with Lojuxta. 
Preglednica 1 povzema priporočila za prilagajanje odmerka in spremljanje bolnikov, pri katerih med zdravljenjem z zdravilom Lojuxta pride do povišanih ravni aminotransferaze
The effect of concomitant administration of lomitapide with other hepatotoxic medicine is unknown. 
Učinek sočasne uporabe lomitapida z drugimi hepatotoksičnimi zdravili ni znan.
Patients taking oestrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhoea and/or vomiting (see section 4.5). 
Bolnicam, ki jemljejo estrogenska peroralna kontracepcijska sredstva, je treba svetovati glede morebitne izgube učinkovitosti zaradi diareje in/ali bruhanja (glejte poglavje 4.5).
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. 
Kopičenje lomitapida v plazmi je bilo skladno s predvidenim kopičenjem po enkratnem odmerku, pri čemer so upoštevali peroralno odmerjanje nad 25 mg enkrat na dan do 4 tedne.
Data in the pivotal clinical study were analysed with respect to the impact of potential covariates on lomitapide exposure. 
Posebne skupine bolnikov Podatke v ključni klinični študiji so analizirali glede na vpliv morebitnih sospremenljivk na izpostavljenost lomitapidu.
Reintroduction of treatment may be considered if the benefits are considered to outweigh the risks associated with potential liver disease. 
O ponovni uvedbi zdravljenja je treba razmisliti le v primeru, če so morebitne koristi večje od tveganj,
Other liver-related changes in repeat-dose toxicity studies in rats and dogs included increased serum aminotransferases, subacute inflammation (rats only), and single-cell necrosis. 
Druge jetrne spremembe v študijah toksičnosti z večkratnimi odmerki na podganah in psih so vključevale povečano vrednost aminotransferaz v serumu, subakutno vnetje (samo pri podganah) ter enocelično nekrozo.
HMG-CoA Reductase Inhibitors (“Statins”): Lomitapide increases plasma concentrations of statins. 
Zaviralci reduktaze HMG-CoA (statini): Lomitapid poveča koncentracijo statinov v plazmi.
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). 
Zdravilo Lojuxta se uporablja za zdravljenje odraslih bolnikov z zelo visoko ravnjo holesterola, ki je posledica dednega stanja (homozigotne družinske hiperholesterolemije ali HoFH).
Oral contraceptives: When lomitapide 50 mg was administered to steady state along with an oestrogen-based oral contraceptive, no clinically meaningful or statistically significant impact on the pharmacokinetics of the components of the oral contraceptive (ethinyl estradiol and 17-deacetyl norgestimate, the metabolite of norgestimate) was observed. 
Peroralna kontracepcijska sredstva: Ko se je lomitapid 50 mg dajal do stanja dinamičnega ravnovesja skupaj z estrogenskimi peroralnimi kontracepcijskimi sredstvi, niso opazili nobenih klinično ali statistično pomembnih učinkov na farmakokinetiko sestavin peroralnega kontracepcijskega sredstva (etinilestradiol in 17-deacetilnorgestimat, presnovek norgestimata).
Other reactions reported by at least 20% of patients include abdominal pain, abdominal discomfort, abdominal distension, constipation, and flatulence. 
Drugi neželeni učinki, o katerih je poročalo vsaj 20 % bolnikov, vključujejo bolečino v trebuhu, neugodje v trebuhu, distenzijo trebuha, obstipacijo in flatulenco.
CARTON AND BOTTLE (5 mg, 10 mg, 20 mg, 30 mg, 40 mg and 60 mg) 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN PLASTENKA (5 mg, 10 mg, 20 mg, 30 mg, 40 mg in 60 mg)
Do not take any of the following medicines with Lojuxta: 
Skupaj z zdravilom Lojuxta ne jemljite naslednjih zdravil:
Gastrointestinal adverse reactions occurred more frequently during the dose escalation phase of the study and decreased once patients established the maximum tolerated dose of lomitapide. 
Neželeni učinki na prebavila so se v študiji pogosteje pojavili med fazo povečevanja odmerka in so se zmanjšali, ko se je pri bolnikih dosegel največji tolerirani odmerek lomitapida.
• Patient Brochures 
• brošure za bolnike
If you use contraceptive pills and suffer from an episode of diarrhoea or vomiting that lasts more than 2 days, you must use an alternative method of contraception (e.g. condoms, diaphragm) for 7 days following resolution of symptoms. 
Če uporabljate kontracepcijske tablete in imate epizodo driske ali bruhanja, ki traja vsaj 2 dneva, morate 7 dni po izginotju simptomov uporabljati dodatno metodo kontracepcije (npr. kondome, diafragmo).
• low red blood cell count (anaemia) 
• majhno število rdečih krvničk (anemija),
Lojuxta can lower blood levels of: 
Zdravilo Lojuxta lahko zniža ravni naslednjih parametrov v krvi:
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%). 
O hudih neželenih učinkih na prebavila je poročalo 6 (21 %) od 29 bolnikov v klinični študiji 3. faze, pri čemer so bili najpogostejši diareja (4 bolniki, 14 %), bruhanje (3 bolniki, 10 %) ter bolečina,
In cases of protracted or severe diarrhoea and/or vomiting lasting more than 2 days, additional contraceptive measures should be used for 7 days after resolution of symptoms. 
Če se pojavi dolgotrajna ali huda diareja in/ali bruhanje, ki traja več kot 2 dneva, je treba 7 dni po izginotju simptomov uporabljati dodatne kontracepcijske metode.
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. 
PER - Register izpostavitve med nosečnostjo - oceniti pojavnost in izide nosečnosti pri ženskah v rodni dobi, zdravljenih z lomitapidom, ki se odločijo za nadaljevanje nosečnosti po posvetovanju s teratologom.
Lomitapide increases the plasma concentrations of warfarin. 
Lomitapid poveča koncentracijo varfarina v plazmi.
The effect of administration of more than one weak CYP3A4 inhibitor has not been tested, but the effect on the exposure of lomitapide is expected to be greater than for co-administration of the individual inhibitors with lomitapide. 
Učinka uporabe več kot enega šibkega zaviralca CYP3A4 niso preučevali, vendar pričakujejo, da bo učinek na izpostavljenost lomitapidu večji kot pri sočasni uporabi posameznega zaviralca z lomitapidom.
The use of alcohol during lomitapide treatment is not recommended. 
Uporaba alkohola med zdravljenjem z lomitapidom ni priporočljiva.
Patients receiving Lojuxta as adjunctive therapy to a statin should be monitored for adverse events that are associated with the use of high doses of statins. 
Pri bolnikih, ki prejemajo zdravilo Lojuxta kot dodatno zdravljenje k statinom, je treba izvajati spremljanje neželenih učinkov, povezanih z uporabo velikih odmerkov statinov.
See section 2 under ‘ Lojuxta with food, drink and alcohol'. 
Glejte poglavje 2 „Zdravilo Lojuxta skupaj s hrano, pijačo in alkoholom“.
• joint pain or swelling, pain in hands or feet 
• bolečina ali otekanje sklepa, bolečina v dlaneh ali stopalih,
Focal hepatic fibrosis was observed in males and females and hepatic cystic degeneration was observed in males only. 
Fokalno jetrno fibrozo so opazili pri samcih in samicah, jetrno cistično degeneracijo pa samo pri samcih.
Capsule content: 
Vsebina kapsule:
Entire trial weeks 0-78 N (%) 
Celotno preskušanje Tedni 0-78 N (%)
• 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. 
• Oceniti pojavnost in izide nosečnosti pri ženskah v rodni dobi, zdravljenih z lomitapidom, ki se odločijo za nadaljevanje nosečnosti po posvetovanju s teratologom.
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. 
Bolniki, ki se zdravijo z zdravilom Lojuxta, morajo jemati dnevne nadomestke, ki vsebujejo 400 internacionalnih enot vitamina E in približno 200 mg linolne kisline, 210 mg ALA, 110 mg EPA ter 80 mg DHA.
In rodents, single oral doses of lomitapide ≥600 times higher than the maximum recommended human dose (1 mg/kg) were well tolerated. 
Glodavci so dobro prenašali enkratne peroralne odmerke lomitapida, ≥ 600-krat večje od največjega priporočenega odmerka pri človeku (1 mg/kg).
Patients shall be informed of the necessity to carry the patient alert card with them and show it to all doctors that treat them. 
Bolnike je treba poučiti o nujnosti, da imajo kartico z opozorili za bolnika ves čas pri sebi in jo pokažejo vsakemu zdravniku, ki jih zdravi.
High density polyethylene (HDPE) bottle fitted with a polyester/aluminium foil/cardboard induction seal and polypropylene screw cap. 
Plastenka iz polietilena visoke gostote (HDPE) z indukcijskim tesnilom iz poliestra/aluminijaste folije/kartona in navojno zaporko iz polipropilena.
• 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. 
• Če jemljete drugo zdravilo za zniževanje ravni holesterola, ki veže žolčne kisline, kot je kolesevelam ali holestiramin, to zdravilo vzemite vsaj 4 ure pred uporabo zdravila Lojuxta ali vsaj 4 ure po njej.
When administered with atorvastatin, the dose of Lojuxta should either be taken 12 hours apart or be decreased by half (see section 4.2). 
Pri dajanju z atovrastatinom je treba odmerek zdravila Lojuxta zamakniti za 12 ur kasneje ali ga zmanjšati za polovico (glejte poglavje 4.2).
• low density lipoprotein (LDL) cholesterol (“bad” cholesterol) 
• lipoproteinskega holesterola majhne gostote (LDL) („slabega“ holesterola);
Other medicines and Lojuxta 
Druga zdravila in zdravilo Lojuxta
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). 
Zdravilo Lojuxta je indicirano kot dodatno zdravljenje skupaj z dieto z malo maščobami in drugimi zdravili za zniževanje ravni lipidov z aferezo lipoproteinov majhne gostote (LDL - low density lipoprotein -) ali brez nje pri odraslih bolnikih s homozigotno družinsko hiperholesterolemijo (HoFH
Decreased red blood cell parameters as well as poikilocytosis and/or anisocytosis were observed in dogs. 
Pri psih so opazili zmanjšanje parametrov rdečih krvničk ter poikilocitozo in/ali anizocitozo.
No clinically meaningful elevations in total bilirubin or alkaline phosphatase were observed. 
Opazili niso nobenih klinično pomembnih povečanj koncentracije celokupnega bilirubina ali alkalne fosfataze.
Hepatic events related to elevated aminotransferases and progressive liver disease 
Jetrni dogodki, povezani s povišano ravnijo aminotransferaz, in napredujoča jetrna bolezen
For patients on a stable maintenance dose of Lojuxta who receive any other weak CYP3A4 inhibitor, separate the dose of the medicinal products (Lojuxta and the weak CYP3A4 inhibitor) by 12 hours. 
Pri bolnikih na stabilnem vzdrževalnem odmerku zdravila Lojuxta, ki prejmejo kateri koli drugi šibek zaviralec CYP3A4, je treba odmerek zdravil (zdravila Lojuxta in šibkega zaviralca CYP3A4) zamakniti za 12 ur.
• Information that Lojuxta was teratogenic in non-clinical studies and should not be taken during pregnancy or by patients trying to get pregnant; 
• Informacije, da je bilo zdravilo Lojuxta v predkliničnih študijah teratogeno, zato se ne sme jemati med nosečnostjo ali uporabljati pri bolnicah, ki poskušajo zanositi;
• muscle pain (myalgia) 
• bolečina v mišicah (mialgija),
Lojuxta is used with a low-fat diet and other lipid lowering treatments to decrease your cholesterol levels. 
Zdravilo Lojuxta se skupaj z dieto z majhnim vnosom maščob in drugimi oblikami zdravljenja za zniževanje ravni lipidov uporablja za zniževanje ravni holesterola.
Patients taking oestrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhoea and/or vomiting. 
Bolnicam, ki jemljejo estrogenska peroralna kontracepcijska sredstva, je treba svetovati glede morebitne izgube učinkovitosti zaradi diareje in/ali bruhanja.
• Withhold dosing and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR). 
• Prekinite odmerjanje in izvedite dodatne jetrne preiskave, če jih še niste (kot so alkalna fosfataza, celokupni bilirubin in INR).
Number of Patients with Assessments >3 to ≤5 x ULN >5 to ≤10 x ULN >10 to ≤20 x ULN >20 x ULN 
Število bolnikov z ocenami > 3- do ≤ 5-kratna vrednost ULN > 5- do ≤ 10-kratna vrednost ULN > 10- do ≤ 20-kratna vrednost ULN 0 > 20-kratna vrednost ULN