FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Patients should follow a diet supplying less than 20% of energy from fat prior to initiating treatment, and should continue this diet during treatment.
Slovenian: Bolnikova prehrana mora vsebovati manj kot 20 % energije, pridobljene iz maščob, preden se uvede zdravljenje.
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov izdelovalcev, odgovorneih za sproščanje serij
English: Table 1 summarizes recommendations for dose adjustment and monitoring for patients who develop elevated aminotransferase during therapy with Lojuxta.
Slovenian: Preglednica 1 povzema priporočila za prilagajanje odmerka in spremljanje bolnikov, pri katerih med zdravljenjem z zdravilom Lojuxta pride do povišanih ravni aminotransferaze
English: The effect of concomitant administration of lomitapide with other hepatotoxic medicine is unknown.
Slovenian: Učinek sočasne uporabe lomitapida z drugimi hepatotoksičnimi zdravili ni znan.
English: Patients taking oestrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhoea and/or vomiting (see section 4.5).
Slovenian: Bolnicam, ki jemljejo estrogenska peroralna kontracepcijska sredstva, je treba svetovati glede morebitne izgube učinkovitosti zaradi diareje in/ali bruhanja (glejte poglavje 4.5).
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.
Slovenian: 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.
English: Data in the pivotal clinical study were analysed with respect to the impact of potential covariates on lomitapide exposure.
Slovenian: Posebne skupine bolnikov Podatke v ključni klinični študiji so analizirali glede na vpliv morebitnih sospremenljivk na izpostavljenost lomitapidu.
English: Reintroduction of treatment may be considered if the benefits are considered to outweigh the risks associated with potential liver disease.
Slovenian: O ponovni uvedbi zdravljenja je treba razmisliti le v primeru, če so morebitne koristi večje od tveganj,
English: 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.
Slovenian: 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.
English: HMG-CoA Reductase Inhibitors (“Statins”): Lomitapide increases plasma concentrations of statins.
Slovenian: Zaviralci reduktaze HMG-CoA (statini): Lomitapid poveča koncentracijo statinov v plazmi.
English: Lojuxta is used to treat adult patients with very high cholesterol because of a condition that runs in their families (homozygous familial hypercholesterolaemia or HoFH).
Slovenian: Zdravilo Lojuxta se uporablja za zdravljenje odraslih bolnikov z zelo visoko ravnjo holesterola, ki je posledica dednega stanja (homozigotne družinske hiperholesterolemije ali HoFH).
English: 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.
Slovenian: 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).
English: Other reactions reported by at least 20% of patients include abdominal pain, abdominal discomfort, abdominal distension, constipation, and flatulence.
Slovenian: Drugi neželeni učinki, o katerih je poročalo vsaj 20 % bolnikov, vključujejo bolečino v trebuhu, neugodje v trebuhu, distenzijo trebuha, obstipacijo in flatulenco.
English: CARTON AND BOTTLE (5 mg, 10 mg, 20 mg, 30 mg, 40 mg and 60 mg)
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN PLASTENKA (5 mg, 10 mg, 20 mg, 30 mg, 40 mg in 60 mg)
English: Do not take any of the following medicines with Lojuxta:
Slovenian: Skupaj z zdravilom Lojuxta ne jemljite naslednjih zdravil:
English: 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.
Slovenian: 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.
English: • Patient Brochures
Slovenian: • brošure za bolnike
English: 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.
Slovenian: 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).
English: • low red blood cell count (anaemia)
Slovenian: • majhno število rdečih krvničk (anemija),
English: Lojuxta can lower blood levels of:
Slovenian: Zdravilo Lojuxta lahko zniža ravni naslednjih parametrov v krvi:
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%).
Slovenian: 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,
English: 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.
Slovenian: 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.
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.
Slovenian: 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.
English: Lomitapide increases the plasma concentrations of warfarin.
Slovenian: Lomitapid poveča koncentracijo varfarina v plazmi.
English: 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.
Slovenian: 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.
English: The use of alcohol during lomitapide treatment is not recommended.
Slovenian: Uporaba alkohola med zdravljenjem z lomitapidom ni priporočljiva.
English: 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.
Slovenian: Pri bolnikih, ki prejemajo zdravilo Lojuxta kot dodatno zdravljenje k statinom, je treba izvajati spremljanje neželenih učinkov, povezanih z uporabo velikih odmerkov statinov.
English: See section 2 under ‘ Lojuxta with food, drink and alcohol'.
Slovenian: Glejte poglavje 2 „Zdravilo Lojuxta skupaj s hrano, pijačo in alkoholom“.
English: • joint pain or swelling, pain in hands or feet
Slovenian: • bolečina ali otekanje sklepa, bolečina v dlaneh ali stopalih,
English: Focal hepatic fibrosis was observed in males and females and hepatic cystic degeneration was observed in males only.
Slovenian: Fokalno jetrno fibrozo so opazili pri samcih in samicah, jetrno cistično degeneracijo pa samo pri samcih.
English: Hepatomegaly
Slovenian: hepatomegalija
English: Capsule content:
Slovenian: Vsebina kapsule:
English: Entire trial weeks 0-78 N (%)
Slovenian: Celotno preskušanje Tedni 0-78 N (%)
English: • 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.
Slovenian: • Oceniti pojavnost in izide nosečnosti pri ženskah v rodni dobi, zdravljenih z lomitapidom, ki se odločijo za nadaljevanje nosečnosti po posvetovanju s teratologom.
English: Patients treated with Lojuxta should take daily supplements that contain 400 international units vitamin E and approximately 200 mg linoleic acid, 210 mg ALA, 110 mg EPA, and 80 mg DHA.
Slovenian: 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.
English: In rodents, single oral doses of lomitapide ≥600 times higher than the maximum recommended human dose (1 mg/kg) were well tolerated.
Slovenian: Glodavci so dobro prenašali enkratne peroralne odmerke lomitapida, ≥ 600-krat večje od največjega priporočenega odmerka pri človeku (1 mg/kg).
English: Patients shall be informed of the necessity to carry the patient alert card with them and show it to all doctors that treat them.
Slovenian: 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.
English: High density polyethylene (HDPE) bottle fitted with a polyester/aluminium foil/cardboard induction seal and polypropylene screw cap.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE) z indukcijskim tesnilom iz poliestra/aluminijaste folije/kartona in navojno zaporko iz polipropilena.
English: • If you take another medicine that lowers cholesterol by binding bile acids, such as colesevelam or cholestyramine, take the medicine that binds bile acids at least 4 hours before or 4 hours after you take Lojuxta.
Slovenian: • 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.
English: When administered with atorvastatin, the dose of Lojuxta should either be taken 12 hours apart or be decreased by half (see section 4.2).
Slovenian: Pri dajanju z atovrastatinom je treba odmerek zdravila Lojuxta zamakniti za 12 ur kasneje ali ga zmanjšati za polovico (glejte poglavje 4.2).
English: • low density lipoprotein (LDL) cholesterol (“bad” cholesterol)
Slovenian: • lipoproteinskega holesterola majhne gostote (LDL) („slabega“ holesterola);
English: Other medicines and Lojuxta
Slovenian: Druga zdravila in zdravilo Lojuxta
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).
Slovenian: 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
English: Decreased red blood cell parameters as well as poikilocytosis and/or anisocytosis were observed in dogs.
Slovenian: Pri psih so opazili zmanjšanje parametrov rdečih krvničk ter poikilocitozo in/ali anizocitozo.
English: No clinically meaningful elevations in total bilirubin or alkaline phosphatase were observed.
Slovenian: Opazili niso nobenih klinično pomembnih povečanj koncentracije celokupnega bilirubina ali alkalne fosfataze.
English: Hepatic events related to elevated aminotransferases and progressive liver disease
Slovenian: Jetrni dogodki, povezani s povišano ravnijo aminotransferaz, in napredujoča jetrna bolezen
English: 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.
Slovenian: 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.
English: • Information that Lojuxta was teratogenic in non-clinical studies and should not be taken during pregnancy or by patients trying to get pregnant;
Slovenian: • Informacije, da je bilo zdravilo Lojuxta v predkliničnih študijah teratogeno, zato se ne sme jemati med nosečnostjo ali uporabljati pri bolnicah, ki poskušajo zanositi;
English: • muscle pain (myalgia)
Slovenian: • bolečina v mišicah (mialgija),
English: Lojuxta is used with a low-fat diet and other lipid lowering treatments to decrease your cholesterol levels.
Slovenian: Zdravilo Lojuxta se skupaj z dieto z majhnim vnosom maščob in drugimi oblikami zdravljenja za zniževanje ravni lipidov uporablja za zniževanje ravni holesterola.
English: Patients taking oestrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhoea and/or vomiting.
Slovenian: Bolnicam, ki jemljejo estrogenska peroralna kontracepcijska sredstva, je treba svetovati glede morebitne izgube učinkovitosti zaradi diareje in/ali bruhanja.
English: • Withhold dosing and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR).
Slovenian: • Prekinite odmerjanje in izvedite dodatne jetrne preiskave, če jih še niste (kot so alkalna fosfataza, celokupni bilirubin in INR).
English: Number of Patients with Assessments >3 to ≤5 x ULN >5 to ≤10 x ULN >10 to ≤20 x ULN >20 x ULN
Slovenian: 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
English: Lomitapide can cause elevations in the liver enzymes alanine aminotransferase [ALT] and aspartate aminotransferase [AST] and hepatic steatosis (see section 5.1).
Slovenian: Abnormalnosti jetrnih encimov in spremljanje delovanja jeter Lomitapid lahko poviša ravni jetrnih encimov alanin-aminotransferaze (ALT) ter aspartataminotransferaze (AST) in povzroči jetrno steatozo (glejte poglavje 5.1).
English: CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing exposure approximately 27-fold.
Slovenian: Zaviralci CYP3A4 povečajo izpostavljenost lomitapidu, pri čemer močni zaviralci povečajo izpostavljenost za približno 27-krat.
English: Patient Alert card
Slovenian: Opozorilna kartica za bolnika
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.
Slovenian: V kliničnih študijah lomitapida se je pri enem bolniku s HoFH znatno povišala raven aminotransferaze (ALT 24-kratna vrednost ULN, AST 13-kratna vrednost ULN) v nekaj dneh po uvedbi močnega zaviralca CYP3A4, klaritromicina.
English: Oestrogen-containing oral contraceptives are weak CYP3A4 inhibitors (see section 4.2).
Slovenian: Estrogenska peroralna kontracepcijska sredstva so šibki zaviralci CYP3A4 (glejte poglavje 4.2).
English: • Importance of fatty acid and fat soluble vitamin (Vitamin E) supplementation;
Slovenian: • Pomembnost nadomeščanja maščobnih kislin in vitaminov, topnih v maščobi (vitamin E);
English: The terminal half-life of lomitapide was not affected.
Slovenian: Učinka na končni razpolovni čas lomitapida ni bilo.
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.
Slovenian: V študiji peroralne kancerogenosti pri podganah se je lomitapid dajal do 99 tednov v odmerkih do 7,5 mg/kg/dan pri samcih in 2,0 mg/kg/dan pri samicah.
English: • medicines to treat excessive daytime sleepiness (e.g. modafinil)
Slovenian: • zdravila za zdravljenje čezmerne dnevne zaspanosti (npr. modafinil),
English: Inhibition of MTP reduces lipoprotein secretion and circulating concentrations of lipoprotein-borne lipids including cholesterol and triglycerides.
Slovenian: Zaviranje proteina MTP zmanjša sekrecijo lipoproteinov in koncentracijo lipoproteinskih lipidov, vključno s holesterolom ter trigliceridi, v krvnem obtoku.
English: The remainder was excreted in faeces, primarily as oxidised metabolites.
Slovenian: Preostali delež se je izločil z blatom, predvsem v obliki oksidiranih presnovkov.
English: • some medicines for bacterial, fungal or HIV infection (see section 2 under ‘Do not take Lojuxta')
Slovenian: • nekatera zdravila za zdravljenje bakterijske ali glivične okužbe ali okužbe z virusom HIV (glejte poglavje 2 „Ne jemljite zdravila Lojuxta“);
English: The occurrence and severity of gastrointestinal adverse reactions associated with the use of Lojuxta decreases in the presence of a low fat diet.
Slovenian: Pojavnost in resnost neželenih učinkov na prebavila, povezanih z uporabo zdravila Lojuxta, se zmanjšata ob prehrani z majhnim vnosom maščob.
English: Hepatic fat was prospectively measured using MRS in all eligible patients during the clinical study (Table 7).
Slovenian: Maščobe v jetrih so se med klinično študijo prospektivno merile s slikanjem MRS pri vseh primernih bolnikih (Preglednica 7).
English: The extent to which lomitapide-associated hepatic steatosis promotes the elevations in aminotransferase is unknown.
Slovenian: Ni znano, v kolikšni meri jetrna steatoza, povezana z lomitapidom, vpliva na povišanje ravni aminotransferaze.
English: The clinical benefit of reductions in background lipid-lowering therapy, including apheresis, is not certain.
Slovenian: Klinična korist zmanjšanja odmerkov osnovnih zdravil za zniževanje ravni lipidov, vključno z aferezo, ni določena.
English: • changes to blood cell count
Slovenian: • spremembe števila krvnih celic,
English: Mean (SD)
Slovenian: Povprečj e (SD)
English: If you stop taking Lojuxta
Slovenian: Če ste prenehali jemati zdravilo Lojuxta
English: SN: {number}
Slovenian: PC: {številka} SN: {številka} NN: {številka}
English: Treatment with Lojuxta should be initiated and monitored by a physician experienced in the treatment of lipid disorders.
Slovenian: Zdravljenje z zdravilom Lojuxta mora uvesti in spremljati zdravnik z izkušnjami z zdravljenjem lipidnih motenj.
English: Systemic exposures to lomitapide at these doses were estimated to be 4 times (females) and 5 times (males) higher than the human exposure at 60 mg based on AUC.
Slovenian: Ocenili so, da je bila sistemska izpostavljenost lomitapidu pri teh odmerkih 4-krat (samice) in 5-krat (samci) večja kot izpostavljenost 60 mg pri človeku na podlagi AUC.
English: Gastrointestinal adverse reactions were reported by 27 (93%) of 29 patients in the Phase 3 clinical study.
Slovenian: faze je o neželenih učinkih na prebavila poročalo 27 (93 %) od 29 bolnikov.
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.
Slovenian: Kadar se zdravilo Lojuxta uporablja skupaj z drugimi zdravili, za katera je znano, da imajo potencial za hepatotoksičnost, kot so izotretinoin, amiodaron, acetaminofen (> 4 g/dan ≥ 3 dni/teden),
English: In repeat-dose oral toxicology studies in rodents and dogs, the principal drug-related findings were lipid accumulation in the small intestine and/or liver associated with decreases in serum cholesterol and/or triglyceride levels.
Slovenian: V študijah toksičnosti večkratnih peroralnih odmerkov na glodavcih in psih je bila glavna, z odmerkom povezana ugotovitev kopičenje lipidov v tankem črevesu in/ali jetrih, povezano z znižanimi ravnmi holesterola in/ali trigliceridov v serumu.
English: Pack sizes are: 28 capsules
Slovenian: Velikosti pakiranja: 28 kapsul
English: Lomitapide appears to be a sensitive substrate for CYP3A4 metabolism.
Slovenian: Videti je, da je lomitapid občutljiv substrat za presnovo CYP3A4.
English: Tell your doctor immediately if you have any of these symptoms as your doctor may decide to stop the treatment.
Slovenian: Če imate katerega koli od teh simptomov, se nemudoma posvetujte z zdravnikom, saj se ta lahko odloči, da prekine zdravljenje.
English: • Treatment with Lojuxta should be initiated and monitored by a physician experienced in the treatment of lipid disorders;
Slovenian: • Zdravljenje z zdravilom Lojuxta mora uvesti in spremljati zdravnik z izkušnjami z zdravljenjem lipidnih motenj;
English: • some medicines for high blood pressure, angina or to regulate heart rhythm (see section 2 under ‘Do not take Lojuxta')
Slovenian: • nekatera zdravila za zdravljenje visokega krvnega tlaka ali angine ali za uravnavanje srčnega ritma (glejte poglavje 2 „Ne jemljite zdravila Lojuxta“).
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').
Slovenian: • Druge sestavine zdravila so: predgelirani škrob, natrijev karboksimetilškrob (tip A), mikrokristalna celuloza, laktoza monohidrat, koloidni brezvodni silicijev dioksid in magnezijev stearat (za informacije o laktozi monohidratu glejte poglavje 2: Zdravilo Lojuxta vsebuje laktozo)
English: Refer patients with persistent elevations in aminotransferase >3x ULN to a hepatologist for further investigation.
Slovenian: Bolnike s persistentnim povišanjem ravni aminotransferaze na > 3-kratno vrednost ULN napotite k hepatologu, ki bo opravil nadaljnje preiskave.
English: AUCs for R(+)-warfarin and S(-)-warfarin increased 25% and 30%, respectively.
Slovenian: Vrednost AUC za R(+)-varfarin se je povečala za 25 %, za (S-)-varfarin pa za 30 %.
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.
Slovenian: V izhodišču je 93 % bolnikov prejemalo statin, 76 % ezetimib, 10 % niacin, 3 % smole, ki vežejo žolčno kislino, 62 % bolnikov pa je bilo na aferezi.
English: Do not take Lojuxta: • if you are allergic to lomitapide or any of the other ingredients of this medicine (listed in section
Slovenian: • če ste alergični na lomitapid ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: • Enhanced Liver Fibrosis (ELF) panel, Fibrometer, AST/ALT ratio, Fib-4 score, Fibrotest (liver fibrosis)
Slovenian: • izboljšana preiskava za jetrno fibrozo (ELF), Fibrometer, razmerje AST/ALT, rezultat Fib-4, Fibrotest (jetrna fibroza).
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).
Slovenian: Okvara jeter Lomitapid je kontraindiciran pri bolnikih z zmerno ali hudo jetrno okvaro, vključno z bolniki, ki imajo nepojasnjene, stalno nenormalne rezultate preiskav delovanja jeter (glejte poglavji 4.3 in 5.2).