FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Gastrointestinalne nuspojave javljale su se u ispitivanju češće za vrijeme faze povećanja doze, a smanjivale su se kad je bolesnicima utvrđena maksimalna podnošljiva doza lomitapida.
English: • glucocorticoids (e.g. beclometasone, prednisolone) steroid medicines used to treat inflammation in conditions such as severe asthma, arthritis
Croatian: • glukokortikoide (npr. beklometazon, prednizolon), steroidne lijekove kojima se liječi upala u stanjima kao što su teška astma, artritis
English: • changes to blood clotting tests
Croatian: • promjene nalaza pretraga zgrušavanja krvi
English: Do not take Lojuxta: • if you are allergic to lomitapide or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na lomitapid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Following administration of a radiolabeled oral solution dose to healthy subjects, 93% of the administered dose was recovered in urine and faeces.
Croatian: Nakon primjene doze radioaktivno obilježene peroralne otopine zdravim ispitanicima, 93% primijenjene doze nađeno je u mokraći i stolici.
English: • Not to take Lojuxta if patient has liver problems, or unexplained abnormal liver tests;
Croatian: • Ne uzimati Lojuxtu ako bolesnik ima tegobe s jetrom ili neobjašnjene abnormalne rezultate pretraga jetre.
English: Lomitapide does not inhibit breast cancer resistance protein (BCRP).
Croatian: Lomitapid ne inhibira protein koji uzrokuje rezistenciju raka dojke na lijekove (engl. breast cancer resistance protein, BCRP).
English: Lomitapide was teratogenic in rats in the absence of maternal toxicity at an exposure (AUC) estimated to be twice that in humans at 60 mg.
Croatian: Lomitapid je bio teratogen u štakora u odsutnosti maternalne toksičnosti uz izloženost (AUC) za koju je procijenjeno da je dva puta veća od one u ljudi uz 60 mg.
English: Other medicines may affect the way Lojuxta works.
Croatian: Drugi lijekovi mogu utjecati na način djelovanja lijeka Lojuxta.
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.
Croatian: U slučajevima produljenog ili teškog proljeva i/ili povraćanja koji traju više od 2 dana, potrebne su dodatne kontracepcijske mjere koje treba upotrebljavati još 7 dana nakon nestanka simptoma.
English: Lomitapide increases the plasma concentrations of warfarin.
Croatian: Lomitapid povećava plazmatske koncentracije varfarina.
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo često (mogu se pojaviti u više od 1 na 10 osoba):
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.
Croatian: Prije početka liječenja bolesnici se trebaju pridržavati dijete pri kojoj se iz masti zadovoljava manje od 20% energijskih potreba i takvu dijetu trebaju nastaviti tijekom liječenja.
English: even if their signs of illness are the same as yours.
Croatian: Može im štetiti, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: • muscle pain (myalgia)
Croatian: • bol u mišićima (mijalgija)
English: Capsule content:
Croatian: Sadržaj kapsule:
English: 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.
Croatian: Ovaj popis nije namijenjen kao sveobuhvatan pa liječnici koji propisuju lijek moraju provjeriti podatke o propisivanju lijekova koji se mogu uzimati istodobno s Lojuxtom, zbog potencijalnih interakcija posredovanih enzimom CYP3A4.
English: Liver enzyme abnormalities and liver monitoring
Croatian: Abnormalnosti jetrenih enzima i nadzor jetre
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.
Croatian: Bolesnici će biti obaviješteni da je karticu s upozorenjima za bolesnika potrebno imati uza se, te ju pokazati svim liječnicima koji ih liječe.
English: The effect of concomitant administration of lomitapide with other hepatotoxic medicine is unknown.
Croatian: Učinak istodobne primjene lomitapida s drugim hepatotoksičnim lijekom nije poznat.
English: Please tell your doctor if you are breastfeeding or planning to breast-feed.
Croatian: Molimo obavijestite liječnika ako dojite ili planirate dojiti.
English: Table 3 lists all adverse reactions reported across the 35 patients treated in the Phase 2 Study UP1001 and in the Phase 3 Study UP1002/AEGR-733-005 or its extension study AEGR-733-012.
Croatian: Tablica 3 navodi sve nuspojave zabilježe u 35 bolesnika liječenih u ispitivanju UP1001 faze 2 i ispitivanju UP1002/AEGR-733-005 faze 3 ili u njegovu nastavku, ispitivanje AEGR-733-012.
English: 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.
Croatian: Sve bolesnike koji uz statin primaju lomitapid valja upozoriti na potencijalni povećan rizik od miopatije i reći im da odmah prijave bilo kakve bolove u mišićima te osjetljivost ili slabost mišića za koje ne postoji objašnjenje.
English: Coumarin anticoagulants: When lomitapide 60 mg was administered to steady state and 6 days following warfarin 10 mg, INR increased 1.26-fold.
Croatian: Kumarinski antikoagulansi: Primjena lomitapida 60 mg u stanju dinamičke ravnoteže i 6 dana nakon 10 mg varfarina dovela je do povećanja INR 1,26 puta.
English: Lomitapide increases plasma concentrations of statins.
Croatian: Lomitapid povećava plazmatske koncentracije statina.
English: • It is not known if Lojuxta is passed into breast milk.
Croatian: • Nije poznato prelazi li Lojuxta u majčino mlijeko.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: No adverse effects on fertility were observed in male and female rats administered lomitapide at systemic exposures (AUC) estimated to be 4 to 5 times higher than in humans at the maximum recommended human dose (see section 5.3).
Croatian: Nisu opaženi štetni učinci na plodnost u ženki i mužjaka štakora kojima je davan lomitapid pri sistemskoj izloženosti (AUC) 4 do 5 puta višoj od maksimalno preporučene doze izloženosti za ljude (vidjeti dio 5.3).
English: − Appropriate advice on effective methods of contraception should be provided, and effective contraception initiated;
Croatian: − potrebno je omogućiti odgovarajuće savjetovanje o djelotvornim metodama kontracepcije i uvesti djelotvornu kontracepciju.
English: Patients with end-stage renal disease receiving dialysis should not exceed 40 mg daily (see section 5.2).
Croatian: Za bolesnike s terminalnim stadijem bubrežnog zatajenja koji su na dijalizi ukupna dnevna doza ne smije prijeći 40 mg (vidjeti dio 5.2).
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.
Croatian: • Procijeniti pojavu i ishode trudnoće u žena s reprodukcijskim potencijalom liječenih lomitapidom, koje su nakon savjetovanja s teratologom odlučile nastaviti trudnoću.
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.
Croatian: Fenofibrat, niacin i ezetimib: Pri primjeni lomitapida u stanju dinamičke ravnoteže prije mikroniziranog fenofibrata 145 mg, niacina s produljenim otpuštanjem 1000 mg ili ezetimiba 10 mg, nisu opaženi nikakvi klinički značajni učinci na izloženost bilo kojem od tih lijekova.
English: In vitro assessment of drug interactions: Lomitapide inhibits CYP3A4.
Croatian: In vitro procjena interakcije lijekova: Lomitapid inhibira CYP3A4.
English: • Concomitant administration of >40 mg simvastatin (see section 4.5).
Croatian: • Istodobna primjena simvastatina >40 mg (vidjeti dio 4.5).
English: Concomitant use of HMG-CoA reductase inhibitors (‘statins')
Croatian: Istodobna primjena inhibitora reduktaze HMG-CoA (‘statini')
English: Package sizes are:
Croatian: Veličine pakiranja:
English: The long term consequences of hepatic steatosis associated with lomitapide treatment are unknown.
Croatian: Dugotrajne posljedice steatoze jetre povezane s liječenjem lomitapidom nisu poznate.
English: Omega-6 Linoleic acid
Croatian: Omega-6 Linolna kiselina 200 mg
English: Lojuxta contains the active substance called lomitapide.
Croatian: Lojuxta sadrži djelatnu tvar pod nazivom lomitapid.
English: High density polyethylene (HDPE) bottle fitted with a polyester/aluminium foil/cardboard induction seal and polypropylene screw cap.
Croatian: Bočica od polietilena visoke gustoće (HDPE) s pričvršćenim pokrovom od poliestera/aluminijske folije/kartona i navojnim polipropilenskim zatvaračem.
English: • Patient Brochures
Croatian: • brošure za bolesnike
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.
Croatian: Očekuje se da će istodobna primjena umjerenih inhibitora CYP3A4 povećati izloženost lomitapidu za 4-10 puta na temelju rezultata ispitivanja sa snažnim inhibitorom CYP3A4 ketokonazolom te povijesnih podataka za midazolam, probni supstrat enzima CYP3A4.
English: • Information that Lojuxta was teratogenic in non-clinical studies and should not be taken during pregnancy or by patients trying to get pregnant;
Croatian: • Informacije da je Lojuxta bila teratogena u pretkliničkim ispitivanjima te da se ne smije uzimati u trudnoći ili ako bolesnica pokušava zatrudnjeti.
English: • feeling of incomplete defaecation (bowel movement), urgent need to defaecate
Croatian: • osjećaj nepotpunog pražnjenja crijeva (stolice), potreba za hitnim pražnjenjem crijeva
English: Interactions between moderate CYP3A4 inhibitors and lomitapide have not been studied.
Croatian: Interakcije između umjerenih inhibitora CYP3A4 i lomitapida nisu ispitane.
English: Bile acid sequestrants Lomitapide has not been tested for interaction with bile acid sequestrants (resins such as colesevelam and cholestyramine).
Croatian: Lomitapid nije bio ispitan za interakciju sa sekvestrantima žučne kiseline (smole kao što su kolesevelam i kolestiramin).
English: • inflammation of the stomach and intestine that causes diarrhoea and vomiting
Croatian: • upala želuca i crijeva koja uzorkuje proljev i povraćanje
English: (E172) and yellow iron oxide (E172).
Croatian: (E172) i žuti željezov oksid (E172).
English: • increased appetite
Croatian: • pojačan apetit
English: • Treatment with Lojuxta should be initiated and monitored by a physician experienced in the treatment of lipid disorders;
Croatian: • liječenje Lojuxtom treba započeti i pratiti liječnik s iskustvom u liječenju poremećaja lipida;
English: Lojuxta has not been studied in patients with severe hepatic impairment (Child-Pugh score 10-15).
Croatian: Lijek Lojuxta nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (rezultat Child-Pugh 10 - 15).
English: Lomitapide appears to be a sensitive substrate for CYP3A4 metabolism.
Croatian: Čini se da je lomitapid osjetljiv supstrat za metabolizam CYP3A4.
English: Do not take any of the following medicines with Lojuxta:
Croatian: Nemojte uzimati lijek Lojuxta:
English: In this study, the median levels of serum vitamin E, ALA, linoleic acid, EPA, DHA, and arachidonic acid decreased from baseline to Week 26 but remained above the lower limit of the reference range.
Croatian: U ovom ispitivanju medijan serumskih vrijednosti vitamina E, alfa linolenske kiseline, linolne kiseline, eikosapentaenske kiseline, dokosaheksaenske kiseline i arahidonske kiseline je bio manji u odnosu na početne vrijednosti do 26. tjedna, ali je ostao iznad donje granice referentnog raspona.
English: Twenty-nine patients were enrolled, of whom 23 completed through Week 78.
Croatian: Bilo je uključeno 29 bolesnika, a ispitivanje do 78. tjedna završilo je 23 bolesnika.
English: Contraception measures in women of child-bearing potential
Croatian: Mjere kontracepcije u žena reproduktivne dobi
English: Reduced absorption of fat-soluble vitamins and serum fatty acids
Croatian: Smanjena apsorpcija vitamina topivih u masti i serumskih masnih kiselina
English: - If you have any further questions, ask your doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: The most serious adverse reactions during treatment were liver aminotransferase abnormalities (see section 4.4).
Croatian: Najozbiljnije nuspojave tijekom liječenja bile su abnormalnosti jetrenih aminotransferaza (vidjeti dio
English: MTP plays a key role in the assembly of apo B containing lipoproteins in the liver and intestines.
Croatian: MTP ima ključnu ulogu u sintezi lipoproteina koji sadrže apolipoprotein B u jetri i crijevima.
English: • Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI), or magnetic resonance (MR) elastography
Croatian: • oslikavanje u svrhu procjene elastičnosti tkiva, npr. Fibroscan, ARFI (engl. acoustic radiation force impulse) ili elastografija magnetskom rezonancijom (MR)
English: • If resuming Lojuxta after aminotransferase levels resolve to <3x ULN, consider reducing the dose and monitor liver-related tests more frequently.
Croatian: • Ako se liječenje Lojuxtom nastavi nakon snižavanja vrijednosti aminotransferaza na < 3 x GGN, razmotrite mogućnost smanjenja doze i češće kontrolirajte jetrene nalaze.
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.
Croatian: U kliničkim ispitivanjima lomitapida, jedan bolesnik s HoFH-om razvio je izrazito povišene aminotransferaze (ALT 24 x GGN, AST 13 x GGN) unutar nekoliko dana od uvođenja klaritromicina, snažnog inhibitora enzima CYP3A4.
English: Data from individuals who had repeat measurements after stopping lomitapide show that hepatic fat accumulation is reversible, but whether histological sequelae remain is unknown.
Croatian: Podaci dobiveni za osobe kojima se ponavljalo mjerenje nakon prekida terapije lomitapidom pokazuju da je akumulacija masti u jetri reverzibilna, ali nije poznato jesu li ostale histološke posljedice.
English: • The use of alcohol during Lojuxta treatment is not recommended.
Croatian: • Tijekom liječenja Lojuxtom ne preporučuje se uzimanje alkohola.
English: 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.
Croatian: Preporučuje se povećati učestalost mjerenja LDL kolesterola tijekom takvih istodobnih primjena i razmisliti o povećanju doze Lojuxte kako bi se osiguralo održavanje željene razine djelotvornost ako je induktor CYP3A4 namijenjen za kroničnu upotrebu.
English: • All capsules have edible black ink for printing.
Croatian: • Sve kapsule imaju oznake otisnute jestivom tintom za označavanje.
English: • That Lojuxta was teratogenic in non-clinical studies and that women of child-bearing potential must be non-pregnant and using effective contraception prior to initiating treatment.
Croatian: • Lojuxta se pokazala teratogenom u pretkliničkim ispitivanjima pa žene reproduktivne dobi ne smiju biti trudne i moraju upotrebljavati učinkovitu kontracepciju prije nego što započnu liječenje.
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.
Croatian: U ispitivanju prehrambene kancerogenosti provedenom u miševa, lomitapid je primjenjivan do 104 tjedna u rasponu doza od 0,3 do 45 mg/kg na dan.
English: AUCs for R(+)-warfarin and S(-)-warfarin increased 25% and 30%, respectively.
Croatian: Vrijednosti AUC za R(+)-varfarin povećale su se 25% a za S(-)-varfarin 30%.
English: Lomitapide is not a P-gp substrate but does inhibit P-gp.
Croatian: Lomitapid nije supstrat P-gp-a ali inhibira P-gp.
English: The physician educational pack should contain:
Croatian: Taj će edukacijski komplet sadržavati:
English: • High sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK18 Fragment, NashTest (liver inflammation)
Croatian: • C-reaktivni protein visoke osjetljivosti (hs-CRP), brzina sedimentacije eritrocita (ESR), fragment citokeratina CK-18, NASH test (upala jetre)
English: CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing exposure approximately 27-fold.
Croatian: Inhibitori enzima CYP3A4 povećavaju izloženost lomitapidu, s tim da jaki inhibitori povećavaju izloženost približno 27 puta.
English: Alanine aminotransferase increased Aspartate aminotransferase increased Weight decreased
Croatian: Vrlo često povišena alanin aminotransferaza povišena aspartat aminotransferaza smanjena težina
English: When lomitapide 20 mg was coadministered simultaneously or 12 hours apart with ethinyl estradiol/norgestimate, a weak CYP3A4 inhibitor, no clinically meaningful increase in lomitapide exposure was observed.
Croatian: Kad se lomitapid 20 mg primjenjivao istovremeno ili u razmaku od 12 sati s etinilestradiolom/norgestimatom, slabim inhibitorom CYP3A4, nije bilo opaženo klinički značajno povećanje u izloženosti lomitapidu.
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.
Croatian: Ako uzimate kontracepcijske tablete, a već više od 2 dana patite od proljeva ili povraćanja, morate upotrijebiti neku drugu metodu kontracepcije (npr. prezervative, dijafragmu) i koristiti je još 7 dana nakon što Vam prestanu simptomi.
English: See section 2 under ‘Lojuxta with food, drink and alcohol'.
Croatian: Pogledajte dio 2 pod „Lojuxta s hranom, pićem i alkoholom“.
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.
Croatian: PER (Pregnancy exposure registry) - ovaj registar služi za procjenu pojave i ishoda trudnoća u žena s reprodukcijskim potencijalom liječenih lomitapidom koje su nakon savjetovanja s teratologom odlučile nastaviti trudnoću.
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.
Croatian: Na početku, 93% bolesnika uzimalo je statin, 76% ezetimib, 10% niacin, 3% sekvestrant žučne kiseline a 62% liječeno je aferezom.
English: No dose adjustment is required for Caucasian or Latino patients.
Croatian: Za bijelce ili latinoameričke bolesnike nije bila potrebna prilagodba doze.
English: Refer patients with persistent elevations in aminotransferase >3x ULN to a hepatologist for further investigation.
Croatian: Bolesnike s trajno povišenim vrijednostima aminotransferaza > 3 x GGN uputiti hepatologu radi dodatne obrade.
English: • If confirmed, reduce the dose and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR).
Croatian: • Ako se potvrdi, smanjiti dozu i ako nisu učinjene, učinite dodatne pretrage za procjenu jetrene funkcije (kao što su alkalna fosfataza, ukupni bilirubin i INR).
English: Pack sizes are: 28 capsules
Croatian: Veličine pakiranja: 28 kapsula
English: The Prescriber Guide shall include the following key elements:
Croatian: Upute za liječnike koji propisuju lijek uključivat će sljedeće ključne elemente:
English: The “bad” cholesterol can lead to heart attacks, strokes or other events at an early age.
Croatian: Bolesnik ima vrlo visoku razinu „lošeg“ kolesterola od ranog djetinjstva. „Loš“ kolesterol može dovesti do srčanih napadaja, moždanog udara ili drugih događaja u ranoj dobi.
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.
Croatian: Kod bolesnika na stabilnoj dozi održavanja Lojuxte koji primaju bilo koji drugi slabi inhibitor CYP3A4, primijenite doze tih lijekova (Lojuxte i slabog inhibitora CYP3A4) u razmaku od 12 sati.
English: Lojuxta is used with a low-fat diet and other lipid lowering treatments to decrease your cholesterol levels.
Croatian: Lojuxta se uzima uz dijetu s malim udjelom masti i drugim lijekovima za snižavanje lipida s ciljem smanjenja razine kolesterola.
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.
Croatian: Sistemske izloženosti lomitapidu pri tim dozama procijenjene su kao 4 puta veće (ženke) i 5 puta veće (mužjaci) od izloženosti u ljudi uz 60 mg na temelju AUC-a.
English: • Information about taking Lojuxta at bedtime with water at least 2 hours after the evening meal and without food;
Croatian: • Informacije o uzimanju Lojuxte prije spavanja, s vodom i bez hrane te najmanje 2 sata nakon večernjeg obroka.
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.
Croatian: Učinak primjene više od jednog slabog inhibitora CYP3A4 nije ispitan, ali očekuje se da će učinak na izloženost lomitapidu biti veći nego u slučaju istodobne primjene pojedinačnih inhibitora s lomitapidom.
English: Mean (SD)
Croatian: Srednja vrijednost (SD)
English: Consider limiting the maximum dose of Lojuxta according to desired LDL-C response.
Croatian: Razmotrite ograničenje maksimalne doze Lojuxte sukladno željenim vrijednostima LDL kolesterola.
English: No adverse effects on the testes were observed in a 1-year study in dogs at 64 times the human exposure at 60 mg.
Croatian: U 1-godišnjem ispitivanju u pasa nisu primijećeni štetni učinci na testisima pri izloženosti 64 puta većoj od izloženosti u ljudi uz 60 mg.
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.
Croatian: U ispitivanjima toksičnosti ponovljenih doza u štakora i pasa, druge promjene vezane uz jetru uključivale su povećane serumske aminotransferaze, subakutne upale (samo štakori) i nekrozu pojedinačnih stanica.
English: If treatment with moderate or strong CYP3A4 inhibitors is unavoidable, Lojuxta should be stopped during the course of treatment.
Croatian: Ako je liječenje umjerenim ili snažnim inhibitorima CYP3A4 neizbježno, Lojuxtu treba prekinuti za vrijeme liječenja navedenim lijekovima.
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).
Croatian: Lojuxta je indicirana kao dodatak prehrani s malim udjelom masti i drugim lijekovima za snižavanje lipida u odraslih bolesnika s homozigotnom obiteljskom hiperkolesterolemijom (HoFH), s aferezom lipoproteina niske gustoće (LDL) ili bez nje.
English: See section 2 under ‘ Lojuxta with food, drink and alcohol'.
Croatian: Pogledajte dio 2. pod 'Lojuxta s hranom, pićem i alkoholom'.