FrancophonIA/ELRC3.0 huggingface dataset:
English: Cmax for R(+)-warfarin and S(-)-warfarin increased 14% and
Croatian: Vrijednosti Cmax za R(+)-varfarin povećale su se 14% a za S(-)-varfarin 15%.
English: Dizziness Headache Migraine
Croatian: Često omaglica glavobolja migrena
English: • Patients with a known significant or chronic bowel disease such as inflammatory bowel disease or malabsorption.
Croatian: • Bolesnici s poznatom značajnom ili kroničnom bolešću crijeva kao što je upalna bolest crijeva ili malapsorpcija.
English: • That Lomitapide was teratogenic in non-clinical studies and is contraindicated in women who are or may become pregnant.
Croatian: • Lomitapid je bio teratogen u pretkliničkim ispitivanjima pa je kontraindiciran u žena koje su trudne ili bi mogle zatrudnjeti.
English: In the renal impairment population, lomitapide was only studied in patients with end-stage renal disease (ESRD).
Croatian: U populaciji s oštećenjem funkcije bubrega lomitapid je ispitan samo u bolesnika s terminalnim stadijem kroničnog bubrežnog zatajenja (engl. end-stage renal disease, ESRD).
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta
English: • coumarin anticoagulants for thinning the blood ( e.g. warfarin)
Croatian: • kumarinske antikoagulanse za razrjeđivanje krvi (npr. varfarin)
English: Total Cholesterol (TC) (mg/dL)
Croatian: Ukupni kolesterol (TC) (mg/dl)
English: In high-dose males, an increased incidence of pancreatic acinar cell adenoma was observed at an exposure 6 times that in humans at 60 mg based on AUC.
Croatian: U mužjaka koji su primali visoku dozu, incidencija adenoma acinarnih stanica pankreasa opažena je pri izloženosti 6 puta većoj od one u ljudi uz 60 mg na temelju AUC-a.
English: Incidences of small intestinal carcinoma and/or combined adenoma and carcinoma (rare tumours in mice) were significantly increased at doses ≥15 mg/kg/day in males (≥ 26 times the human exposure at 60 mg based on AUC) and at 15 mg/kg/day in females (22 times the human exposure at 60 mg based on AUC).
Croatian: Incidencije karcinoma tankog crijeva i/ili kombinacije adenoma i karcinoma (rijetki tumori u miševa) bili su značajno povećane pri dozama ≥ 15 mg/kg na dan u mužjaka (≥ 26 puta veća izloženost u odnosu na izloženost u ljudi uz 60 mg na dan na temelju AUC-a) i pri dozi od 15 mg/kg na dan u ženki (22 puta veća izloženost u odnosu na izloženost u ljudi uz 60 mg na dan na temelju AUC-a).
English: There have been no concomitant or subsequent clinically meaningful elevations in serum bilirubin, INR, or alkaline phosphatase.
Croatian: Nije bilo istodobnih ili kasnijih klinički značajnih povišenja serumskog bilirubina, međunarodnog normaliziranog omjera (INR) ili alkalne fosfataze.
English: • medicines to treat cancer (e.g. everolimus, imatinib, lapatinib, nilotinib, topotecan)
Croatian: • lijekove za liječenje raka (npr. everolimus, imatinib, lapatinib, nilotinib, topotekan)
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).
Croatian: Bolesnice koje upotrebljavaju peroralne kontraceptive na bazi estrogena treba upozoriti na mogući prestanak učinkovitosti u slučaju proljeva i/ili povraćanja (vidjeti dio 4.5).
English: clotrimazole)
Croatian: klotrimazol)
English: The MAH shall provide an educational pack prior to launch targeting all physicians who are expected to prescribe/use lomitapide.
Croatian: Prije stavljanja lijeka na tržište nositelj odobrenja osigurat će edukacijski komplet namijenjen svim liječnicima za koje se očekuje da će propisivati / davati lomitapid.
English: • Importance of fatty acid and fat soluble vitamin (Vitamin E) supplementation;
Croatian: • Važnost nadomjestaka masnih kiselina i vitamina topivih u mastima (vitamin E).
English: • medicines to treat tuberculosis (e.g. isoniazid, rifampicin)
Croatian: • lijekove za liječenje tuberkuloze (e.g. izoniazid, rifampicin)
English: Oestrogen-containing oral contraceptives are weak CYP3A4 inhibitors (see section 4.2).
Croatian: Peroralni kontraceptivi koji sadrže estrogen slabi su inhibitori CYP3A4 (vidjeti dio 4.2).
English: Table 6:
Croatian: Tablica 6:
English: • Advice to exercise caution if Lojuxta is used with other hepatotoxic medicinal products and to consider more frequent monitoring of liver-related tests;
Croatian: • savjet o oprezu ako se Lojuxta uzima s drugim hepatotoksičnim lijekovima te o potrebi učestalijih kontrola jetrenih parametara;
English: o Hepatic events o Gastrointestinal events o Small bowel, hepatic, colorectal and pancreatic tumours o Events associated with coagulopathy o Major Adverse Cardiovascular Events (MACE) events o Death, including cause of death
Croatian: o hepatičkih događaja o gastrointestinalnih događaja o tumora tankog crijeva, jetre, kolorektalnog tumora i tumora pankreasa o događaja povezanih s koagulopatijom o velikih kardiovaskularnih događaja (MACE)
English: There were statistically significant increases in the incidences of liver adenoma and carcinoma at doses ≥1.5 mg/kg/day in males (≥ 2 times the human exposure at 60 mg daily based on AUC) and ≥7.5 mg/kg/day in females (≥ 9 times the human exposure at 60 mg based on AUC).
Croatian: Opaženo je statistički značajno povećanje incidencije adenoma jetre i karcinoma pri dozama ≥ 1,5 mg/kg na dan u mužjaka (≥ 2 puta veća izloženost u odnosu na izloženost u ljudi uz 60 mg na dan na temelju AUC-a) i ≥ 7,5 mg/kg na dan u ženki (≥ 9 puta veća izloženost u odnosu na izloženost u ljudi uz 60 mg na dan na temelju AUC-a).
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje česte (mogu se pojaviti u do 1 na 100 osoba):
English: Treatment with Lojuxta should be initiated and monitored by a physician experienced in the treatment of lipid disorders.
Croatian: Liječenje lijekom Lojuxta treba započeti i pratiti liječnik s iskustvom u liječenju poremećaja metabolizma lipida.
English: • swelling of the eye
Croatian: • oticanje oka
English: • Your dose of Lojuxta may need to be adjusted if you consume peppermint oil or Seville oranges.
Croatian: • Ako konzumirate ulje peperminta ili seviljske naranče, možda Vam je potrebno prilagoditi dozu lijeka Lojuxta.
English: Dehydration Increased appetite
Croatian: Manje često dehidracija pojačan apetit
English: o Goldenseal (for inflammation and infection)
Croatian: o kanadska žutika (protiv upale i infekcije).
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).
Croatian: Lomitapid je kontraindiciran u bolesnika s umjerenim ili teškim oštećenjem jetre uključujući i bolesnike koji imaju abnormalne nalaze jetrenih enzima duže razdoblje a bez poznatog uzroka (vidjeti dijelove 4.3 i 5.2).
English: If you forget to take Lojuxta
Croatian: Ako ste zaboravili uzeti lijek Lojuxta
English: Change p-valueb
Croatian: promjene p-vrijed nostb
English: If aminotransferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin ≥2x ULN, or active liver disease, discontinue treatment with Lojuxta and refer the patient to a hepatologist for further investigation.
Croatian: Ako su povišene vrijednosti aminotransferaza praćene kliničkim simptomima oštećenja jetre (kao što su mučnina, povraćanje, bol u trbuhu, vrućica, žutica, letargija, simptomi nalik gripi), povećanjem bilirubina ≥ 2 x GGN ili aktivnom bolešću jetre, prekinite liječenje Lojuxtom i uputite bolesnika hepatologu radi dodatne obrade.
English: If you stop taking Lojuxta
Croatian: Ako prestanete uzimati lijek Lojuxta
English: Name and address of the manufacturers responsible for batch release
Croatian: Nazivi i adresae proizvođača odgovornih za puštanje serije lijeka u promet
English: • medicines to treat bacterial or fungal infections (e.g. nafcillin, azithromycin, roxithromycin,
Croatian: • lijekove za liječenje bakterijskih ili gljivičnih infekcija (npr. nafcilin, azitromicin, roksitromicin,
English: Use of strong or moderate inhibitors of CYP3A4 is contraindicated with Lojuxta.
Croatian: Upotreba snažnih ili umjerenih inhibitora CYP3A4 kontraindicirana je s Lojuxtom.
English: The use of alcohol during lomitapide treatment is not recommended.
Croatian: Tijekom liječenja lomitapidom ne preporučuje se uzimanje alkohola.
English: • medicines to reduce blood pressure (e.g. talinolol, aliskiren, ambrisentan)
Croatian: • lijekove za snižavanje krvnog tlaka (npr. talinolol, aliskiren, ambrisentan)
English: Hepatic steatosis Hepatotoxicity Hepatomegaly
Croatian: Često steatoza jetre hepatotoksičnost hepatomegalija
English: At both Week 26 and Week 78, there were significant reductions in LDL-C, TC, apo B, TG, non-HDL-C, VLDL-C and changes in HDL-C trended lower at Week 26 and returned to baseline levels by Week 78.
Croatian: U 26. i u 78. tjednu bilo je značajnih smanjenja vrijednosti LDL kolesterola, ukupnog kolesterola, apolipoproteina B, triglicerida, ne-HDL kolesterola, VLDL kolesterola, a promjene HDL kolesterola pokazivale su tendenciju snižavanja u 26. tjednu i vratile su se na početne vrijednosti do 78. tjedna.
English: • medicines to reduce the activity of the immune system (e.g. sirolimus)
Croatian: • lijekove za smanjenje aktivnosti imunosnog sustava (npr. sirolimus)
English: Lomitapide is extensively metabolised, predominantly by CYP3A4.
Croatian: Lomitapid se ekstenzivno metabolizira, uglavnom enzimom CYP3A4.
English: P-gp substrates: Lomitapide inhibits P-gp in vitro, and may increase the absorption of P-gp substrates.
Croatian: P-gp in vitro i može povećati apsorpciju supstrata P-gp-a.
English: Grapefruit juice is a moderate inhibitor of CYP3A4 and is expected to substantially increase exposure to lomitapide.
Croatian: Sok od grejpa umjereni je inhibitor CYP3A4 i očekuje se da znatno poveća izloženost lomitapidu.
English: In rodents, single oral doses of lomitapide ≥600 times higher than the maximum recommended human dose (1 mg/kg) were well tolerated.
Croatian: Ispitivanja na glodavacima su pokazala dobru podnošljivost jednostruke peroralne doze lomitapida ≥ 600 puta više od maksimalne preporučene doze u ljudi (1 mg/kg).
English: Testicular toxicity was observed in dogs at 205 times the human exposure (AUC) at 60 mg in a 6-month study.
Croatian: Testikularna toksičnost opažena je u pasa tijekom ispitivanja u trajanju od 6 mjeseci, pri izloženosti 205 puta većoj od ljudske izloženosti (AUC) uz dozu od 60 mg.
English: 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.
Croatian: Ako su početne vrijednosti testova jetrene funkcije abnormalne, potrebno je razmotriti uvođenje lijeka tek nakon konzultacije hepatologa i kada je otkriven uzrok abnormalnih nalaza jetrenih enzima ili kada se početni patološki nalazi normaliziraju.
English: • medicines which lower cholesterol (e.g. atorvastatin)
Croatian: • lijekove koji snižavaju kolesterol (npr. atorvastatin)
English: • medicines to reduce blood pressure (e.g. amlodipine, lacidipine)
Croatian: • lijekove za snižavanje krvnog tlaka (npr. amlodipin, lacidipin)
English: • decreased appetite
Croatian: • oslabljen apetit
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.
Croatian: U ispitivanju oralne kancerogenosti u štakora, lomitapid je primjenjivan do 99 tjedana u dozama do 7,5 mg/kg na dan u mužjaka i 2,0 mg/kg na dan u ženki.
English: Common (may affect up to 1 in 10 people):
Croatian: Česte (mogu se pojaviti u do 1 na 10 osoba):
English: The dose of Lojuxta should be administered 12 hours apart from any other weak CYP3A4 inhibitor.
Croatian: Dozu Lojuxte treba primijeniti u razmaku od 12 sati od bilo kojeg drugog slabog inhibitora CYP3A4.
English: The extent to which lomitapide-associated hepatic steatosis promotes the elevations in aminotransferase is unknown.
Croatian: Nije poznato u kojoj mjeri steatoza jetre povezana s lomitapidom dovodi do porasta koncentracije aminotransferaza.
English: Moderate CYP3A4 inhibitors are predicted to have a substantial impact on lomitapide's pharmacokinetics.
Croatian: Očekuje se da će umjereni inhibitori CYP3A4 imati znatni utjecaj na farmakokinetiku lomitapida.
English: Coadministration of Lojuxta with P gp substrates (such as aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, imatinib, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, saxagliptin, sirolimus, sitagliptin, talinolol, tolvaptan, topotecan) may increase the absorption of P gp substrates.
Croatian: Istodobna primjena Lojuxte i supstrata P-gp-a (kao što su aliskiren, ambrisentan, kolhicin, dabigatran eteksilat, digoksin, everolimus, feksofenadin, imatinib, lapatinib, maravirok, nilotinib, posakonazol, ranolazin, saksagliptin, sirolimus, sitagliptin, talinolol, tolvaptan, topotekan) može povećati apsorpciju supstrata P-gp-a.
English: 4.5 Interaction with other medicinal products and other forms of interaction Effects of other medicinal products on lomitapide and other forms of interaction Table 2:
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Liver related tests should be monitored.
Croatian: Potrebno je pratiti jetrene testove.
English: • Information about contraindication in patients with moderate or severe pre-existing hepatic impairment/disease, including those with unexplained persistent abnormal liver function tests;
Croatian: • podaci o kontraindikacijama u bolesnika s otprije postojećim umjerenim ili teškim oštećenjem funkcije jetre/bolešću jetre, uključujući bolesnike s trajno poremećenim nalazima pretraga funkcije jetre nepoznatog uzroka;
English: Arthralgia Myalgia
Croatian: Nepoznato mijalgija
English: LDL-C, direct (mg/dL)
Croatian: LDL kolesterol, direktni (mg/dl)
English: • medicines to treat angina - chest pain caused by the heart (e.g. ranolazine)
Croatian: • lijekove za liječenje angine - bol u prsnom košu srčanog podrijetla (npr. ranolazin)
English: • Patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests (see section 4.2).
Croatian: • Bolesnici s umjerenim ili teškim oštećenjem funkcije jetre i oni koji imaju abnormalne nalaze jetrenih enzima duže razdoblje a bez poznatog uzroka (vidjeti dio 4.2).
English: When lomitapide 60 mg was administered to steady state prior to rosuvastatin 20 mg, rosuvastatin Tmax increased from 1 to 4 hours, AUC was increased 32%, and its Cmax was unchanged.
Croatian: Primjena lomitapida 60 mg u stanju dinamičke ravnoteže prije rosuvastatina 20 mg, vrijednost Tmax rosuvastatina povećala se s 1 na 4 sata, AUC se povećao 32%, a Cmax bio je nepromijenjen.
English: Before initiating treatment in women of child-bearing potential, the absence of pregnancy should be confirmed, appropriate advice on effective methods of contraception provided, and effective contraception initiated.
Croatian: Prije nego što se započne liječenje u žena reproduktivne dobi, potrebno je isključiti trudnoću, pružiti odgovarajuće savjetovanje o učinkovitim metodama kontracepcije te započeti učinkovitu kontracepciju.
English: • Enhanced Liver Fibrosis (ELF) panel, Fibrometer, AST/ALT ratio, Fib-4 score, Fibrotest (liver fibrosis)
Croatian: • panel biomarkera za uznapredovalu fibrozu jetre (Enhanced Liver Fibrosis, ELF), Fibrometer test, omjer AST/ALT, rezultat Fib-4, Fibrotest (fibroza jetre)
English: Hepatic fat was prospectively measured using MRS in all eligible patients during the clinical study (Table 7).
Croatian: Mast u jetri prospektivno je mjerena tijekom kliničkog ispitivanja s pomoću spektroskopske metode magnetske rezonancije (MRS) u svih bolesnika koji su bili prikladni (tablica 7).
English: • abnormal lung function test
Croatian: • nepravilni nalazi pretrage plućne funkcije
English: • Information about the existence and importance of the Lomitapide Observational Worldwide Evaluation Registry aiming to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.
Croatian: • Informacije o postojanju i važnosti svjetskog opservacijskog registra procjene lomitapida u cilju sustavnog prikupljanja podataka o ishodima sigurnosti i učinkovitosti u bolesnika liječenih lomitapidom.
English: Alanine aminotransferase increased Aspartate aminotransferase increased Hepatic enzyme increased Liver function test abnormal Neutrophil count decreased White blood cell count decreased
Croatian: Često povišena alanin aminotransferaza povišena aspartat aminotransferaza povišeni jetreni enzimi poremećeni nalazi pretraga funkcije jetre smanjeni broj neutrofila smanjeni broj bijelih krvnih stanica
English: • changes to blood cell count
Croatian: • promjene broja krvnih stanica
English: Exercise additional caution if administering more than 1 weak CYP3A4 inhibitor with Lojuxta.
Croatian: Budite dodatno oprezni ako uz Lojuxtu primjenjujete više od 1 slabog inhibitora CYP3A4.
English: Alternatively, your doctor may decrease your dose of Lojuxta.
Croatian: Druga je mogućnost da Vam liječnik snizi dozu Lojuxte.
English: Weak CYP3A4 inhibitors are expected to increase the exposure of lomitapide when taken simultaneously.
Croatian: Očekuje se da će slabi inhibitori CYP3A4 povisiti izloženost lomitapidu kad se uzimaju istovremeno.
English: • some medicines for bacterial, fungal or HIV infection (see section 2 under ‘Do not take Lojuxta')
Croatian: • neke lijekove protiv bakterijskih, gljivičnih infekcija ili infekcije HIV-om (pogledajte dio 2 pod ‘Ne uzimajte lijek Lojuxta')
English: • Concomitant use of Lojuxta with strong or moderate cytochrome P450 (CYP) 3A4 inhibitors (e.g., antifungal azoles such as itraconazole, fluconazole,ketoconazole, voriconazole, posaconazole; macrolide antibiotics such as erythromycin or clarithromycin; ketolide antibiotics such as telithromycin; HIV protease inhibitors; the calcium channel blockers diltiazem and verapamil, and the anti-arrhythmic dronedarone [see section 4.5]).
Croatian: • Istodobna primjena Lojuxte i jakih ili umjerenih inhibitora citokroma P450 (CYP) 3A4 (npr. azoli protiv gljivica kao što su itrakonazol, flukonazol, ketokonazol, vorikonazol, posakonazol; makrolidni antibiotici kao što su eitromicin ili klaritromicin; ketolidni antibiotici kao što je telitromicin; inhibitori proteaze HIV-a; blokatori kalcijevih kanala diltiazem i verapamil te antiaritmik dronedaron [vidjeti dio 4.5]).
English: Marketing Authorisation Holder Amryt Pharmaceuticals DAC 90 Harcourt Street Dublin 2
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Amryt Pharmaceuticals DAC 90 Harcourt Street
English: Mean percent changes from baseline in LDL-C in the major effectiveness study UP1002/AEGR-733-005 through Week 26 (the Primary Endpoint) using LOCF to each assessment (N=29)
Croatian: Srednja vrijednost postotka promjene u odnosu na početnu za LDL kolesterol u glavnom ispitivanju učinkovitosti UP1002/AEGR-733-005 do 26. tjedna (primarni ishod), na temelju zadnjeg prenesenog opažanja za svaku procjenu (N=29)
English: − The need to take daily dietary supplements (i.e. 400 IU vitamin E, approximately 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), 210 mg alpha linolenic acid (ALA) and 80 mg docosahexaenoic acid (DHA) per day).
Croatian: − potrebi za svakodnevnim uzimanjem dodataka prehrani (tj. 400 IU vitamina E, približno 200 mg linolne kiseline, 110 mg eikosapentaenske kiseline (EPA), 210 mg alfa linolenske kiseline (ALA) i 80 mg dokosaheksaenske kiseline (DHA) na dan);
English: In patients with moderate hepatic impairment, lomitapide AUC and Cmax were 164% and 361% higher, respectively, compared with healthy volunteers.
Croatian: U usporedbi sa zdravim dobrovoljcima, u bolesnika s umjerenim oštećenjem funkcije jetre, AUC i Cmax lomitapida bili su viši 164% odnosno 361%.
English: Frequency of adverse reactions in HoFH patients System Organ Class
Croatian: Tablica 3: Učestalost nuspojava u bolesnika s HoFH-om Klasifikacija organskih sustava Učestalost
English: Capsule shell:
Croatian: Ovojnica kapsule:
English: System Organ Class
Croatian: Klasifikacija organskih sustava Učestalost
English: CAPTURE study - effects of lomitapide on carotid and aortic atherosclerosis in patients treated with lomitapide in usual care.The applicant shall conduct a clinical study with adequate surrogate endpoints on vascular outcomes using imaging techniques to monitor vascular function, disease stabilisation and/or regression.
Croatian: Podnositelj će provesti kliničko ispitivanje s odgovarajućim surogatnim mjerama vaskularnih ishoda upotrebom tehnika snimanja kojima će se nadzirati funkcija vaskularnog sustava, stabilizacija bolesti i/ili regresija.
English: Concomitant use of moderate or strong CYP3A4 inhibitors with Lojuxta is contraindicated (see section 4.3).
Croatian: Kontraindicirana je istodobna primjena umjerenih ili jakih inhibitora CYP3A4 s Lojuxtom (vidjeti dio 4.3).
English: Upon discontinuation of atorvastatin the dose of Lojuxta should be up-titrated according to LDL-C response and safety/tolerability.
Croatian: Lujoxte je potrebno postupno povećavati sukladno odgovoru LDL kolesterola i sigurnosti/podnošljivosti.
English: • medicines to treat anxiety disorders and depression (e.g. alprazolam, fluoxetine, fluvoxamine)
Croatian: • lijekove za liječenje anksioznih poremećaja i depresije (npr. alprazolam, fluoksetin,
English: Patients taking oestrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhoea and/or vomiting.
Croatian: Bolesnice koje uzimaju peroralne kontraceptive na bazi estrogena treba upozoriti na mogući gubitak učinkovitosti u slučaju proljeva i/ili povraćanja.
English: • Withhold dosing and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR).
Croatian: • Obustaviti terapiju i ako nisu učinjene, učinite dodatne pretrage za procjenu jetrene funkcije (kao što su alkalna fosfataza, ukupni bilirubin i INR).
English: Lojuxta contains lactose
Croatian: Lojuxta sadrži laktozu
English: • Contraindication for use in patients with a known significant or chronic bowel disease such as inflammatory bowel disease or malabsorption;
Croatian: • kontraindicirana je za primjenu u bolesnika s ustanovljenom značajnom ili kroničnom bolešću crijeva kao što je upalna bolest crijeva ili malapsorpcija;
English: • Importance of fatty acid and soluble vitamins supplementation;
Croatian: • Važnost nadomjestaka masnih kiselina i vitamina topivih u mastima;
English: Lojuxta contains lactose.
Croatian: Lojuxta sadrži laktozu.
English: 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).
Croatian: U slučaju trajnog ili klinički značajnog povišenja transaminaza potrebno je obustaviti liječenje (za specifične preporuke vidjeti tablicu 1).
English: Patient Alert card
Croatian: Kartica s upozorenjima za bolesnika
English: In the Phase 3 study, patients were provided daily dietary supplements of vitamin E, linoleic acid, ALA, EPA and DHA.
Croatian: U ispitivanju faze 3 bolesnici su svakodnevno primali dodatke prehrani vitamina E, linolne kiseline, alfa linolenske kiseline, eikosapentaenske kiseline i dokosaheksaenske kiseline.
English: Highest liver function test results post first dose (major effectiveness study UP1002/AEGR-733-005)
Croatian: Najviši rezultati pretrage funkcije jetre nakon prve doze (glavno ispitivanje učinkovitosti UP1002/AEGR-733-005) Parametar/abnormalnost