FrancophonIA/ELRC3.0 huggingface dataset:
English: If treatment with antifungal azoles (e.g., itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole); the antiarrhythmic dronedarone; macrolide antibiotics (e.g., erythromycin, clarithromycin); ketolide antibiotics (e.g., telithromycin); HIV protease inhibitors; the calcium channel blockers diltiazem and verapamil is unavoidable, therapy with Lojuxta should be suspended during the course of treatment (see sections 4.3 and 4.4).
Croatian: Ako je liječenje antifungalnim azolima (npr. itrakonazol, ketokonazol, flukonazol, vorikonazol, posakonazol); antiaritmikom dronedaronom; makrolidnim antibioticima (npr. eritromicin, klaritromicin); ketolidnim antibioticima (npr. telitromicin); inhibitorima proteaze HIVa; blokatorima kalcijevih kanala diltiazemom i verapamilom neophodno, terapiju Lojuxtom treba obustaviti za vrijeme liječenja navedenim lijekovima (vidjeti dijelove 4.3 i 4.4).
English: • if you take any of these medicines that affect the way lomitapide is broken down in the body: o itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole (for fungal infections) ; o telithromycin, clarithromycin, erythromycin (for bacterial infections) o indinavir, nelfinavir, saquinavir (for HIV infection) ; o diltiazem, verapamil (for high blood pressure, or angina), and dronedarone (to regulate heart rhythm).
Croatian: • ako uzimate bilo koji od ovih lijekova koji utječu na način na koji se lomitapid razgrađuje u tijelu: o itrakonazol, ketokonazol, flukonazol, vorikonazol, posakonazol (za gljivične infekcije) o telitromicin, klaritromicin, eritromicin (protiv bakterijskih infekcija) o indinavir, nelfinavir, sakvinavir (protiv infekcije HIV-a) o diltiazem, verapamil (protiv visokog krvnog tlaka ili angine) te dronedaron (za regulaciju srčanog ritma)
English: • medicines to treat and prevent blood clots (e.g. cilostazol, ticagrelor)
Croatian: • lijekove za liječenje i sprječavanje stvaranja krvnih ugrušaka (npr. cilostazol, tikagrelor)
English: • oral contraceptives (see section 2 under ‘Pregnancy and breast-feeding')
Croatian: • kontracepcijske tablete koje se uzimaju na usta (pogledajte dio 2 pod ‘Trudnoća i dojenje')
English: • medicines to treat epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
Croatian: • lijekove protiv epilepsije (npr. fenobarbital, karbamazepin, fenitoin)
English: • medicines to regulate heart rhythm (e.g. digoxin)
Croatian: • lijekove za regulaciju srčanog ritma (npr. digoksin)
English: • some medicines for high blood pressure, angina or to regulate heart rhythm (see section 2 under ‘Do not take Lojuxta')
Croatian: • neke lijekove protiv visokog krvnog tlaka, srčane angine ili za regulaciju srčanog ritma (pogledajte dio 2 pod ‘Ne uzimajte lijek 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').
Croatian: • Drugi sastojci su: prethodno geliran škrob, natrijev škroboglikolat (vrsta A), mikrokristalična celuloza, laktoza hidrat, koloidni bezvodni silicijev dioksid i magnezijev stearat (podatke o laktozi hidrat pogledajte u dijelu 2. pod „Lojuxta sadrži laktozu“).
English: In ferrets, lomitapide was both maternally toxic and teratogenic at <1 times the MRHD.
Croatian: U tvorova lomitapid je bio i maternalno toksičan i teratogen pri dozi < 1 puta većoj od maksimalne preporučene doze u ljudi.
English: • medicines to regulate heart rhythm (e.g. amiodarone)
Croatian: • lijekove za regulaciju srčanog ritma (npr. amiodaron)
English: Before initiating treatment in women of child-bearing potential, appropriate advice on effective methods of contraception should be provided, and effective contraception initiated.
Croatian: Prije nego što se započne liječenje žena reproduktivne dobi treba ih posavjetovati o učinkovitim metodama kontracepcije te uvesti učinkovitu kontracepciju.
English: • joint pain or swelling, pain in hands or feet
Croatian: • bol u zglobovima ili oticanje zglobova šaka ili stopala
English: At Week 26, the mean percent change in LDL-C from baseline of LDL-C was -40% (p<0.001) in the Intent to Treat (ITT) population.
Croatian: U 26. tjednu, u populaciji predviđenoj za liječenje (ITT) srednja vrijednost postotka promjene vrijednosti LDL kolesterola u odnosu na početnu vrijednost LDL kolesterola iznosila je -40% (p < 0,001).
English: • ulcer or sore spot in the throat
Croatian: • čir ili bolno mjesto u grlu
English: • Information about interactions with CYP3A4 inhibitors and inducers, coumarin anticoagulants, statins, P-gp substrates, oral contraceptives, bile acid sequestrants;
Croatian: • Informacije o interakcijama s inhibitorima i induktorima CYP3A4, kumarinskim antikoagulansima, statinima, supstratima P-gp-a, peroralnim kontraceptivima, sekvestrantima žučne kiseline.
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.
Croatian: Bolesnici liječeni Lojuxtom trebaju svakodnevno uzimati dodatke prehrani koji sadrže 400 međunarodnih jedinica vitamina E i približno 200 mg linolne kiseline, 210 mg alfa linolenske kiseline, 110 mg eikosapentaenske kiseline i 80 mg dokosaheksaenske kiseline .
English: Patient brochure
Croatian: Brošura za bolesnika
English: • changes to your walking (gait)
Croatian: • promjene u načinu hoda
English: Pregelatinised starch (maize) Sodium starch glycolate (Type A) Microcrystalline cellulose Lactose monohydrate Silica, colloidal anhydrous Magnesium stearate
Croatian: škrob, prethodno geliran (kukuruzni) natrijev škroboglikolat (vrsta A) celuloza, mikrokristalična laktoza hidrat silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: Gastroenteritis Gastrointestinal infection Influenza
Croatian: Manje često gastroenteritis gastrointestinalna infekcija gripa nazofaringitis sinusitis
English: • medicines to reduce the activity of the immune system (e.g. ciclosporin, tacrolimus)
Croatian: • lijekove za smanjenje aktivnosti imunosnog sustava (npr. ciklosporin, takrolimus)
English: Embryofoetal toxicity was observed in rabbits in the absence of maternal toxicity at ≥6.5 times the MRHD.
Croatian: Embriofetalna toksičnost opažena je u kunića u odsutnosti maternalne toksičnosti pri dozi ≥ 6,5 puta većoj od maksimalne preporučene doze u ljudi.
English: • medicines to treat and prevent blood clots (e.g. dabigatran etexilate)
Croatian: • lijekove za liječenje i sprječavanje stvaranja krvnih ugrušaka (npr. dabigatran eteksilat)
English: Dose adjustment and monitoring for patients with elevated aminotransferases
Croatian: Tablica 1: Prilagodba doze i praćenje bolesnika s povišenim aminotransferazama ALT ili AST
English: Absolute values and percent changes from baseline to Weeks 26 and 78 in lipids and lipoproteins (major effectiveness study UP1002/AEGR-733-005) Parameter (units)
Croatian: Tablica 5: Apsolutne vrijednosti i postoci promjene lipida i lipoproteina u odnosu na početne vrijednosti do 26. tjedna i 78. tjedna (glavno ispitivanje učinkovitosti UP1002/AEGR-733-005)
English: • medicines to treat diabetes (e.g. pioglitazone, linagliptin)
Croatian: • lijekove za liječenje dijabetesa (npr. pioglitazon, linagliptin)
English: The medicinal product is contraindicated in patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests.
Croatian: Lijek je kontraindiciran u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre i u bolesnika koji trajno imaju abnormalne nalaze jetrenih enzima bez poznatog uzroka.
English: • medicines to treat excessive daytime sleepiness (e.g. modafinil)
Croatian: • lijekove za liječenje prekomjerne pospanosti tijekom dana (npr. modafinil)
English: Oral use.
Croatian: Peroralna primjena.
English: When lomitapide 60 mg was administered to steady state prior to simvastatin 40 mg, simvastatin acid AUC and Cmax increased 68% and 57%, respectively.
Croatian: Primijena lomitapida 60 mg u stanju dinamičke ravnoteže prije simvastatina 40 mg uzrokovala je povećanje AUC i Cmax simvastatinske kiseline za 68% odnosno 57%.
English: Medicinal products that induce CYP3A4 would be expected to increase the rate and extent of metabolism of lomitapide.
Croatian: Od lijekova koji induciraju CYP3A4 očekuje se da će povećati brzinu i opseg metabolizma lomitapida.
English: Pulmonary histiocytosis was observed in rodents.
Croatian: Plućna histiocitoza opažena je u glodavaca.
English: • stomach pain, discomfort or stomach bloating
Croatian: • bol u trbuhu, nelagoda ili nadutost trbuha
English: p-value is based on the mean percent change b p-value on the mean percent change from baseline based on paired t-test
Croatian: Medijan prikazan za TG i Lp(a); p-vrijednost temelji se na srednjoj vrijednosti postotka promjene b p-vrijednost za srednju vrijednost postotka promjene od početnih vrijednosti na temelju uparenog t testa
English: Concomitant use of CYP3A4 inducers
Croatian: Istodobna primjena induktora CYP3A4
English: Decreased appetite
Croatian: Često oslabljen apetit
English: The applicant shall set up a long term prospective observational study to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.
Croatian: Podnositelj će poduzeti dugoročno prospektivno opservacijsko ispitivanje kako bi sustavno prikupljao podatke o ishodima sigurnosti i učinkovitosti u bolesnika liječenih lomitapidom.
English: The median absolute increase in hepatic fat was 6% after both 26 weeks and 78 weeks of treatment, from 1% at baseline, measured by MRS. Hepatic steatosis is a risk factor for progressive liver disease including steatohepatitis and cirrhosis.
Croatian: Medijan apsolutnog povećanja masti u jetri bio je 6% i nakon 26 i nakon 78 tjedana liječenja, s tim da je na početku bio 1% , mjereno spektroskopskom metodom nuklearne magnetske rezonancije.
English: Black iron oxide (E172) Propylene glycol
Croatian: Tinta za označavanje: šelak željezov oksid, crni (E172) propilenglikol
English: This card will give information about interactions with: o CYP 3A4 inhibitors o CYP 3A4 inducers o coumarin anticoagulants o statins o P-gp substrates o Oestrogen-containing oral contraceptives
Croatian: Ova kartica sadržavat će podatke o interakcijama s: o inhibitorima CYP 3A4 o induktorima CYP 3A4 o kumarinskim antikoagulansima o statinima o P-gp supstratima o peroralnim kontraceptivima koji sadrže estrogen.
English: Paraesthesia Somnolence
Croatian: Manje često parestezija somnolencija
English: Use in women of childbearing potential
Croatian: Primjena u žena reproduktivne dobi
English: • medicines to treat low blood sodium level (e.g. tolvaptan)
Croatian: • lijekove za liječenje niske razine natrija u krvi (e.g. tolvaptan)
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: PRILOG II. OZNAČIVANJE I UPUTA O LIJEKU
English: How to take Lojuxta
Croatian: Kako uzimati lijek Lojuxta
English: Safety phase weeks 26-78 N (%)
Croatian: Faza ispitivanja sigurnosti od 26. do 78. tjedna
English: LOWER registry - long term prospective observational study to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.
Croatian: LOWER registar - dugoročno prospektivno opservacijsko ispitivanje radi sustavnog prikupljanja informacija o sigurnosti i učinkovitosti ishoda bolesnika liječenih lomitapidom.
English: • The Prescriber Guide
Croatian: • upute za liječnike koji propisuju lijek
English: • medicines to treat gout (e.g. colchicine)
Croatian: • lijekove za liječenje gihta (e.g. kolhicin)
English: How to store Lojuxta
Croatian: Kako čuvati lijek Lojuxta
English: 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.
Croatian: Pri uključivanju u ispitivanje, bolesnici su dobili upute da se od 6 tjedana prije početka ispitivanja do najmanje 26. tjedna pridržavaju dijete s niskim udjelom masti (< 20% kalorija iz masti) te da uzimaju svoju uobičajenu terapiju za snižavanje lipida, uključujući aferezu ako je primjenjivo.
English: • medicines to treat severe acne (e.g. isotretinoin)
Croatian: • lijekove za liječenje teških akni (e.g. izotretinoin)
English: Measure ALT, AST, alkaline phosphatase, total bilirubin, gamma-glutamyl transferase (gamma-GT) and serum albumin before initiation of treatment with Lojuxta.
Croatian: Prije započinjanja liječenja Lojuxtom, potrebno je odrediti ALT, AST, alkalnu fosfatazu, ukupni bilirubin, gamaglutamiltransferazu (gama-GT) i serumski albumin.
English: You should contact your doctor before you stop taking this medicine.
Croatian: Prije nego što prestanete uzimati ovaj lijek morate se obratiti svom liječniku.
English: Table 1 summarizes recommendations for dose adjustment and monitoring for patients who develop elevated aminotransferase during therapy with Lojuxta.
Croatian: Prilagodba doze na temelju povišenih jetrenih aminotransferaza Tablica 1 sažeto prikazuje preporuke za prilagodbu doze i praćenje bolesnika kod kojih dođe do porasta vrijednosti aminotransferaza tijekom liječenja Lojuxtom.
English: When co-administering CYP3A4 inducers (i.e. aminoglutethimide, nafcillin, non-nucleoside reverse transcriptase inhibitors, phenobarbital, rifampicin, carbamazepine, pioglitazone, glucocorticoids, modafinil and phenytoin) with Lojuxta, the possibility of a drug-drug interaction affecting efficacy should be considered.
Croatian: Kad se Lojuxta primjenjuje istodobno s induktorima CYP3A4 (tj. aminoglutetimidom, nafcilinom, nenukleozidnim inhibitorima reverzne transkriptaze, fenobarbitalom, rifampicinom, karbamazepinom, pioglitazonom, gospinom travom, glukokortikoidima, modafinilom i fenitoinom), potrebno je uzeti u obzir mogućnost interakcije lijekova koja utječe na djelotvornost.
English: See package leaflet for further information.
Croatian: Vidjeti uputu o lijeku za dodatne informacije.
English: Drug interactions
Croatian: Interakcije lijekova
English: Examples of weak CYP3A4 inhibitors include: alprazolam, amiodarone, amlodipine, atorvastatin, azithromycin, bicalutamide, cilostazol, cimetidine, ciclosporin, clotrimazole, fluoxetine, fluvoxamine, fosaprepitant, ginkgo, goldenseal, isoniazid, ivacaftor, lacidipine, lapatinib, linagliptin, nilotinib, oestrogen-containing oral contraceptives, pazopanib, peppermint oil, propiverine, ranitidine, ranolazine, roxithromycin, Seville oranges, tacrolimus, ticagrelor and tolvaptan.
Croatian: fluoksetin, fluvoksamin, fosaprepitant, ginkgo, kanadska žutika, izoniazid, ivakaftor, lacidipin, lapatinib, linagliptin, nilotinib, peroralni kontraceptivi koji sadrže estrogen, pazopanib, ulje peperminta, propiverin, ranitidin, ranolazin, roksitromicin, seviljske naranče, takrolimus, tikagrelor i tolvaptan.
English: • medicines to treat urinary incontinence (e.g. propiverine)
Croatian: • lijekove za liječenje mokraćne inkontinencije (e.g. propiverin)
English: Co-administration of a CYP3A4 inducer is expected to reduce the effect of lomitapide.
Croatian: Očekuje se da će istodobna primjena induktora CYP3A4 smanjiti učinak lomitapida.
English: OR
Croatian: ILI
English: In patients with mild hepatic impairment, lomitapide AUC and Cmax were 47% and 4% higher, respectively, compared with healthy volunteers.
Croatian: U usporedbi sa zdravim dobrovoljcima, u bolesnika s blagim oštećenjem funkcije jetre, AUC i Cmax lomitapida bili su viši 47% odnosno 4%.
English: Hepatobiliary disorders
Croatian: Hepatotoksični lijekovi
English: Gastroenteritis
Croatian: Često gastroenteritis
English: • To evaluate the occurrence of the following in patients treated with lomitapide:
Croatian: • u bolesnika liječenih lomitapidom procijeniti pojavu sljedećeg:
English: Since the recommended dose regimen involves starting at the low end of the dosing range and escalating cautiously according to individual patient tolerability, no adjustment to the dosing regimen is recommended for the elderly.
Croatian: Preporučeni režim doziranja uključuje početak liječenja s niskim dozama a zatim pažljivo titriranje prema višim vrijednostima u skladu s individualnom podnošljivošću bolesnika.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Dry mouth
Croatian: Primjena kroz usta
English: The dose of lomitapide was escalated from 5 mg to an individually determined maximum tolerated dose up to 60 mg. After Week 26, patients remained on lomitapide to determine the effects of longer-term treatment and were allowed to change background lipid-lowering therapies.
Croatian: Nakon 26. tjedna bolesnici su ostali na lomitapidu kako bi se odredili učinci dugotrajnije terapije, a bila im je dopuštena promjena osnovne terapije za snižavanje lipida.
English: Week 14
Croatian: 14. tjedan
English: When lomitapide 60 mg was administered to steady state prior to atorvastatin 20 mg, atorvastatin acid AUC and Cmax increased 52% and 63%, respectively.
Croatian: Primjena lomitapida 60 mg u stanju dinamičke ravnoteže prije atorvastatina 20 mg, uzrokovala je povećanje AUC i Cmax atorvastatinske kiseline za 52% odnosno 63%.
English: ANNEX II
Croatian: Dublin 2
English: Diarrhoea Nausea Flatulence
Croatian: Vrlo često proljev mučnina flatulencija
English: When lomitapide 20 mg was co-administered simultaneously with atorvastatin, a weak CYP3A4 inhibitor, lomitapide AUC and Cmax increased approximately 2-fold.
Croatian: Učinci na razine lomitapida Preporuke za istodobnu primjenu s Lojuxtom primjenjivao istodobno s atorvastatinom, slabim inhibitorom CYP3A4, AUC i Cmax lomitapida povećali su se približno dvaput.
English: Lomitapide pharmacokinetics is approximately dose-proportional for oral single doses in the therapeutic range.
Croatian: Pri peroralno primjenjenim pojedinačnim dozama u terapijskom rasponu, farmakokinetika lomitapida približno je proporcionalna dozi.
English: For patients on a stable maintenance dose of Lojuxta who receive atorvastatin either: • Separate the dose of the medicinal products by 12 hours
Croatian: Kod bolesnika na stabilnoj dozi održavanja Lojuxte koji primaju atorvastatin ili:
English: Concomitant use of CYP3A4 inhibitors
Croatian: Inhibitori CYP3A4
English: Careful titration may then be considered according to LDL-C response and safety/tolerability.
Croatian: Sukladno odgovoru LDL kolesterola i sigurnosti/podnošljiovsti se potom može razmotriti pažljiva titracija doze.
English: Interactions between Lojuxta and other medicinal products and other forms of interaction
Croatian: Učinci drugih lijekova na lomitapid i drugi oblici interakcija Tablica 2: Interakcije Lojuxte i drugih lijekova i drugi oblici interakcija Lijekovi
English: Lojuxta 5 mg hard capsules
Croatian: Lojuxta 5 mg tvrde kapsule
English: • Patient Alert Cards
Croatian: • kartice s upozorenjima za bolesnika
English: • medicines to treat HIV (e.g. maraviroc)
Croatian: • lijekove za liječenje HIV-a (npr. maravirok)
English: Very common
Croatian: Često umor
English: No dose adjustments are required when co-administered with Lojuxta.
Croatian: Kad se primjenjuju s Lojuxtom nisu potrebne prilagodbe doze.
English: Week 18
Croatian: 18. tjedan
English: • medicines to treat diabetes (e.g. saxagliptin, sitagliptin)
Croatian: • lijekove za liječenje dijabetesa (npr. saksagliptin, sitagliptin)
English: Maximum categorical changes in % hepatic fat (major effectiveness study UP1002/AEGR-733-005) Maximum absolute increase in % hepatic fat
Croatian: Tablica 7: Maksimalne kategoričke promjene % masti u jetri (glavno ispitivanje učinkovitosti UP1002/AEGR-733-005)
English: More frequent monitoring of liver-related tests may be warranted.
Croatian: Opravdano je češće prećenje laboratorijskih parametara za procjenu jetrene funkcije.
English: • The capsule shell for the 5 mg and 10 mg capsules contains gelatin, titanium dioxide (E171) and red iron oxide (E172).
Croatian: • Ovojnica kapsule od 5 mg i 10 mg sadrži želatinu, titanijev dioksid (E171) i crveni željezov oksid (E172).
English: Hepatic insufficiency
Croatian: Insuficijencija jetre
English: Muscle aches and pains (myalgia) or weakness
Croatian: (mijalgija) i slabost u mišićima (miopatija).
English: Excipient with known effect Each hard capsule contains 259.79 mg of lactose (as monohydrate) (see section 4.4).
Croatian: Jedna tvrda kapsula sadrži 259,79 mg laktoze (u obliku hidrata) (vidjeti dio 4.4).
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORANNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Lomitapide is a “lipid-modifying agent” which works by blocking the action of “microsomal triglyceride transfer protein.” This protein is located within the liver and the gut cells, where it is involved in assembling fatty substances into larger particles that are then released into the blood stream.
Croatian: Ta bjelančevina se nalazi u jetri i stanicama crijeva gdje je uključena u 'uklapanje' masnih tvari u veće čestice koje se zatim otpuštaju u optok krvi.
English: When the dose of lomitapide was taken 12 hours apart from atorvastatin,
Croatian: Kad se doza lomitapida uzimala u razmaku od 12 sati od atorvastatina, nije bilo opaženo klinički značajno povećanje u izloženosti lomitapidu.
English: • The capsule shell for the 20 mg capsule contains gelatin and titanium dioxide (E171).
Croatian: • Ovojnica kapsule od 20 mg sadrži želatinu i titanijev dioksid (E171).
English: Excipient with known effect Each hard capsule contains 389.68 mg of lactose (as monohydrate) (see section 4.4).
Croatian: Jedna tvrda kapsula sadrži 389,68 mg laktoze (u obliku hidrata) (vidjeti dio 4.4).
English: Gastrooeosophageal reflux disease Abdominal tenderness Epigastric discomfort Gastric dilatation
Croatian: Manje često suha usta tvrda stolica gastroezofagealna refluksna bolest abdominalna osjetljivost nelagoda u epigastriju dilatacija želuca hematemeza krvarenje donjeg dijela probavnog sustava refluksni ezofagitis
English: Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules lomitapide
Croatian: Lojuxta 5 mg tvrde kapsule Lojuxta 10 mg tvrde kapsule Lojuxta 20 mg tvrde kapsule lomitapid
English: • if you have liver problems or unexplained abnormal liver tests.
Croatian: • ako imate tegoba s jetrom ili abnormalne nalaze testova za procjenu jetrene funkcije čiji uzrok je nepoznat
English: • indigestion
Croatian: • podrigivanje
English: • The capsule shell for the 30 mg capsule contains gelatin, titanium dioxide (E171), red iron oxide
Croatian: • Ovojnica kapsule od 30 mg sadrži želatinu, titanijev dioksid (E171), crveni željezov oksid
English: High-density lipoprotein cholesterol (HDL-C) (mg/dL)
Croatian: HDL kolesterol (lipoproteini visoke gustoće) (mg/dl)
English: Excipient with known effect Each hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4).
Croatian: Jedna tvrda kapsula sadrži 70,12 mg laktoze (u obliku hidrata) (vidjeti dio 4.4).
English: Lojuxta 5 mg: each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.
Croatian: Lojuxta 5 mg: jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 5 mg lomitapida.
English: Lojuxta 20 mg: each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.
Croatian: Lojuxta 20 mg: jedna tvrda kapsula sadrži lomitapidmesilat koji odgovara 20 mg lomitapida.
English: Excipient with known effect Each hard capsule contains 194.84 mg of lactose (as monohydrate) (see section 4.4).
Croatian: Jedna tvrda kapsula sadrži 194,84 mg laktoze (u obliku hidrata) (vidjeti dio 4.4).
English: Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules
Croatian: Lojuxta 5 mg tvrde kapsule Lojuxta 10 mg tvrde kapsule Lojuxta 20 mg tvrde kapsule Lojuxta 30 mg tvrde kapsule
English: Haematemesis
Croatian: Nuspojave