FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been no concomitant or subsequent clinically meaningful elevations in serum bilirubin, INR, or alkaline phosphatase.
Slovenian: Sočasnega ali poznejšega klinično pomembnega povečanja koncentracije bilirubina, INR ali alkalne fosfataze v serumu ni bilo.
English: What Lojuxta looks like and contents of the pack
Slovenian: Izgled zdravila Lojuxta in vsebina pakiranja
English: • medicines to treat cancer (e.g. everolimus, imatinib, lapatinib, nilotinib, topotecan)
Slovenian: • zdravila za zdravljenje raka (npr. everolimus, imatinib, lapatinib, nilotinib, topotekan),
English: Work with a dietitian to learn what you can eat while taking Lojuxta.
Slovenian: Sodelujte z nutricionistom, ki vam bo svetoval, kako se prehranjevati med jemanjem zdravila Lojuxta.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
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.
Slovenian: Če povišanje ravni aminotransferaze spremljajo klinični simptomi jetrne poškodbe (kot sonavzea, bruhanje, bolečina v trebuhu, povišana telesna temperatura, zlatenica, letargija, gripi podobni simptomi), povečanje vrednosti bilirubina na ≥ 2-kratno vrednost ULN ali aktivna jetrna bolezen, prekinite zdravljenje z zdravilom Lojuxta in bolnika napotite k hepatologu, ki bo opravil nadaljnje preiskave.
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).
Slovenian: Opazili so statistično pomembno povečanje incidence jetrnega adenoma in karcinoma pri odmerkih ≥ 1,5 mg/kg/dan pri samcih (≥ 2-krat večji kot pri izpostavljenosti 60 mg na dan pri človeku na podlagi AUC) ter ≥ 7,5 mg/kg/dan pri samicah (≥ 9-krat večji kot pri izpostavljenosti 60 mg na dan pri človeku na podlagi AUC).
English: The medicinal product is contraindicated in patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests.
Slovenian: Zdravilo je kontraindicirano pri bolnikih z zmerno ali hudo jetrno okvaro in bolnikih z nepojasnjenimi, stalno nenormalnimi rezultati preiskav jetrnega delovanja.
English: • medicines to reduce the activity of the immune system (e.g. sirolimus)
Slovenian: • zdravila za zmanjšanje dejavnosti imunskega sistema (npr. sirolimus),
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).
Slovenian: Incidenca karcinoma tankega črevesa in/ali kombinacije adenoma ter karcinoma (redkih tumorjev pri miših) je bila pomembno povečana pri odmerkih ≥ 15 mg/kg/dan pri samcih (≥ 26-krat večji kot pri izpostavljenosti 60 mg pri človeku na podlagi AUC) in 15 mg/kg/dan pri samicah (22-krat večji kot pri izpostavljenosti 60 mg pri človeku na podlagi AUC).
English: Number of evaluable patients 22
Slovenian: Število bolnikov, ki jih je bilo mogoče oceniti
English: In rare cases, myopathy may take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and can lead to fatality.
Slovenian: V redkih primerih se lahko miopatija razvije v rabdomiolizo z akutno ledvično odpovedjo, ki je posledica mioglobinurije, ali brez nje, kar lahko povzroči smrt.
English: There is insufficient information to determine if Lojuxta requires dose adjustment in other races.
Slovenian: Podatki, s katerimi bi lahko ugotovili, ali je prilagajanje odmerka zdravila Lojuxta potrebno pri drugih rasah, niso zadostni.
English: • flu or cold, fever, inflammation of your sinuses, cough
Slovenian: • gripa ali prehlad, povišana telesna temperatura, vnetje sinusov, kašelj,
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.
Slovenian: V 26. tednu je bil v populaciji, ki so jo nameravali zdraviti, povprečen odstotek spremembe holesterola LDL od izhodišča -40 % (p < 0,001).
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.
Slovenian: • V predkliničnih študijah je bilo zdravilo Lojuxta teratogeno, zato ženske v rodni dobi ne smejo zanositi in morajo pred uvedbo zdravljenja uporabljati učinkovito kontracepcijo.
English: Testicular toxicity was observed in dogs at 205 times the human exposure (AUC) at 60 mg in a 6-month study.
Slovenian: Testikularno toksičnost so v 6-mesečni študiji opazili pri psih, pri katerih je bila izpostavljenost 205-krat večja kot izpostavljenost (AUC) 60 mg pri človeku.
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).
Slovenian: - potrebe po jemanju dnevnih prehranskih dodatkov (tj. 400 i.e. vitamina E, približno 200 mg linolne kisline, 110 mg eikozapentaenojske kisline (EPA), 210 mg alfa-linolenske kisline (ALA) in 80 mg dokozaheksaenojske kisline (DHA) na dan).
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.
Slovenian: Ko se je lomitapid 60 mg dajal do stanja dinamičnega ravnovesja pred uvedbo rosuvastatina 20 mg, se je vrednost Tmax rosuvastatina podaljšala z 1 na 4 ure, vrednost AUC povečala za 32 %, vrednost Cmax pa je ostala nespremenjena.
English: Package sizes are:
Slovenian: Velikosti pakiranja:
English: Interactions between Lojuxta and other medicinal products and other forms of interaction
Slovenian: Preglednica 2: Medsebojno delovanje zdravila Lojuxta z drugimi zdravili in druge oblike interakcij
English: In vitro assessment of drug interactions: Lomitapide inhibits CYP3A4.
Slovenian: Ocena medsebojnega delovanja med zdravili in vitro: Lomitapid zavira CYP3A4.
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)
Slovenian: Povprečne odstotne spremembe ravni holesterola LDL od izhodišča velike študije učinkovitosti UP1002/AEGR-733-005 do 26. tedna (primarni opazovani dogodek) z uporabo LOCF za vsako oceno (N = 29)
English: Frequency of adverse reactions in HoFH patients System Organ Class
Slovenian: Preglednica 3: Pogostnost neželenih učinkov pri bolnikih s HoFH
English: • Patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests (see section 4.2).
Slovenian: • bolniki z zmerno ali hudo jetrno okvaro in bolniki z nepojasnjenimi, stalno nenormalnimi rezultati preiskav jetrnega delovanja (glejte poglavje 4.2);
English: Lomitapide is extensively metabolised, predominantly by CYP3A4.
Slovenian: Lomitapid se obširno presnavlja, večinoma s CPY3A4.
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.
Slovenian: Preden se zdravljenje uvede pri ženskah v rodni dobi, je treba potrditi odsotnost nosečnosti, jim ustrezno svetovati o učinkovitih kontracepcijskih metodah in uvesti učinkovito kontracepcijo.
English: Dietary counselling should be provided.
Slovenian: Bolnikom je treba omogočiti svetovanje glede prehrane.
English: Cmax for R(+)-warfarin and S(-)-warfarin increased 14% and
Slovenian: Vrednost Cmax za R(+)-varfarin se je povečala za 14 %, za (S-)-varfarin pa za 15 %.
English: No dose adjustment is required for Caucasian or Latino patients.
Slovenian: Pri belcih ali bolnikih latinskega porekla odmerka ni treba prilagajati.
English: MTP plays a key role in the assembly of apo B containing lipoproteins in the liver and intestines.
Slovenian: Protein MTP ima ključno vlogo pri sestavljanju lipoproteinov, ki vsebujejo apolipoprotein B, v jetrih in črevesu.
English: Gastrooesophageal reflux disease Haemorrhoidal haemorrhage Regurgitation
Slovenian: gastroezofagealni refluks, krvavitev hemoroidov, regurgitacija
English: • That Lomitapide was teratogenic in non-clinical studies and is contraindicated in women who are or may become pregnant.
Slovenian: • Da je bil lomitapid v predkliničnih študijah teratogen, zato je kontraindiciran pri nosečnicah ali ženskah, ki lahko zanosijo.
English: Given its mechanism of action in the small intestine, lomitapide may reduce the absorption of fat-soluble nutrients.
Slovenian: Zmanjšana absorpcija liposolubilnih vitaminov in maščobnih kislin v serumu Glede na mehanizem delovanja v tankem črevesu lahko lomitapid zmanjša absorpcijo liposolubilnih hranilnih snovi.
English: • medicines to reduce blood pressure (e.g. talinolol, aliskiren, ambrisentan)
Slovenian: • zdravila za zniževanje krvnega tlaka (npr. talinolol, aliskiren, ambrisentan),
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Renal insufficiency
Slovenian: Jetrna insuficienca
English: Before initiating treatment in women of child-bearing potential, appropriate advice on effective methods of contraception should be provided, and effective contraception initiated.
Slovenian: Preden se zdravljenje uvede pri ženskah v rodni dobi, jim je treba ustrezno svetovati o učinkovitih kontracepcijskih metodah in uvesti učinkovito kontracepcijo.
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
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.
Slovenian: Predlagatelj bo uvedel dolgotrajno prospektivno opazovalno študijo, s katero bo sistematično zbiral podatke o izidih, povezanih z varnostjo in učinkovitostjo, pri bolnikih, zdravljenih z lomitapidom.
English: Lojuxta contains the active substance called lomitapide.
Slovenian: Zdravilo Lojuxta vsebuje zdravilno učinkovino, imenovano lomitapid.
English: These side-effects are listed in section 4 and you must tell your doctor immediately if you have any of these signs and symptoms, as they may be caused by liver damage.
Slovenian: Če se kateri koli od teh znakov ali simptomov pojavi pri vas, o tem nemudoma obvestite svojega zdravnika, saj jih lahko povzroča poškodba jeter.
English: Use in women of childbearing potential
Slovenian: Uporaba pri ženskah v rodni dobi
English: • medicines to treat tuberculosis (e.g. isoniazid, rifampicin)
Slovenian: • zdravila za zdravljenje tuberkuloze (npr. izoniazid, rifampicin),
English: Highest liver function test results post first dose (major effectiveness study UP1002/AEGR-733-005)
Slovenian: Preglednica 6: Največji rezultati preiskav jetrnega delovanja po prvem odmerku (velika študija učinkovitosti UP1002/AEGR-733-005)
English: See package leaflet for further information.
Slovenian: Za več informacij glejte navodilo za uporabo.
English: Dry skin Hyperhidrosis
Slovenian: Občasni mehur, suha koža, hiperhidroza
English: • medicines to treat bacterial or fungal infections (e.g. nafcillin, azithromycin, roxithromycin,
Slovenian: • zdravila za zdravljenje bakterijskih ali glivičnih okužb (npr. nafcilin, azitromicin, roksitromicin,
English: • feeling of incomplete defaecation (bowel movement), urgent need to defaecate
Slovenian: • občutek nepopolnega odvajanja blata, nujnost odvajanja blata,
English: • If resuming Lojuxta after aminotransferase levels resolve to <3x ULN, reduce the dose and monitor liver-related tests more frequently.
Slovenian: • Če želite ponovno uvesti zdravilo Lojuxta, ko ravni aminotransferaze padejo na < 3-kratno vrednost ULN, zmanjšajte odmerek in pogosteje spremljajte jetrne preiskave.
English: After the first year, do these tests at least every 3 months and before any increase in dose.
Slovenian: 3 mesece in pred vsakim povečanjem odmerka.
English: 4.7 Effects on ability to drive and use machines Lojuxta has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Lojuxta ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: • glucocorticoids (e.g. beclometasone, prednisolone) steroid medicines used to treat inflammation in conditions such as severe asthma, arthritis
Slovenian: • glukokortikoidi (npr. beklometazon, prednizolon), steroidna zdravila za zdravljenje vnetja pri boleznih, kot sta huda astma ali artritis,
English: Moderate CYP3A4 inhibitors are predicted to have a substantial impact on lomitapide's pharmacokinetics.
Slovenian: Predvidevajo, da imajo zmerni zaviralci CYP3A4 pomemben vpliv na farmakokinetiko lomitapida.
English: Total Cholesterol (TC) (mg/dL)
Slovenian: Celokupni holesterol (TC) (mg/dl)
English: • An explanation of the types of tests required (imaging and blood) to check liver function and the importance of them being performed regularly;
Slovenian: • Simptome jetrne bolezni, pri katerih se mora bolnik posvetovati z zdravnikom; • Obrazložitev preiskav (slikanje in krvne preiskave), potrebnih za preverjanje jetrnega delovanja, in pomembnost njihovega rednega opravljanja;
English: The most commonly reported adverse reactions of severe intensity were diarrhoea (4 subjects, 14%), vomiting (3 patients, 10%), and abdominal distension and ALT increased (2 subjects each, 7%).
Slovenian: Najpogosteje poročani hudi neželeni učinki so bili diareja (4 bolniki, 14 %), bruhanje (3 bolniki,
English: Dose modification based on elevated hepatic aminotransferases
Slovenian: Prilagajanje odmerka glede na povišane ravni jetrnih aminotransferaz
English: • If confirmed, reduce the dose and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR).
Slovenian: • Če je povišanje potrjeno, zmanjšajte odmerek in izvedite dodatne jetrne preiskave, če jih še niste (kot so alkalna fosfataza, celokupni bilirubin in
English: • medicines which lower cholesterol (e.g. atorvastatin)
Slovenian: • zdravila za zniževanje ravni holesterola (npr. atorvastatin),
English: The dose of Lojuxta should be administered 12 hours apart from any other weak CYP3A4 inhibitor.
Slovenian: Odmerek zdravila Lojuxta je treba zamakniti za 12 ur od katerega koli drugega šibkega zaviralca CYP3A4.
English: Other medicines may affect the way Lojuxta works.
Slovenian: Na delovanje zdravila Lojuxta lahko vplivajo druga zdravila.
English: • medicines to reduce blood pressure (e.g. amlodipine, lacidipine)
Slovenian: • zdravila za zniževanje krvnega tlaka (npr. amlodipin, lacidipin),
English: Recommendation concerning co-administration with Lojuxta
Slovenian: Priporočila glede sočasne uporabe z zdravilom Lojuxta
English: • If resuming Lojuxta after aminotransferase levels resolve to <3x ULN, consider reducing the dose and monitor liver-related tests more frequently.
Slovenian: • Če želite ponovno uvesti zdravilo Lojuxta, ko ravni aminotransferaze padejo na < 3-kratno vrednost ULN, razmislite o zmanjšanju odmerka in pogosteje spremljajte rezultate jetrnih preiskav.
English: If treatment with moderate or strong CYP3A4 inhibitors is unavoidable, Lojuxta should be stopped during the course of treatment.
Slovenian: Če se zdravljenju z zmernim ali močnim zaviralcem CYP3A4 ni mogoče izogniti, je treba med tem zdravljenjem prekiniti uporabo zdravila
English: • vomiting blood
Slovenian: • bruhanje krvi,
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.
Slovenian: Lomitapid je bil teratogen pri podganah, vendar pri izpostavljenosti (AUC), ocenjeni kot dvakrat večji od izpostavljenosti 60 mg pri človeku, ni bilo toksičnosti za mater.
English: Clinical data suggest that hepatic fat accumulation is reversible after stopping treatment with Lojuxta, but whether histological sequelae remain is unknown, especially after long-term use.
Slovenian: Klinični podatki kažejo, da je kopičenje maščob v jetrih reverzibilno po prekinitvi zdravljenja z zdravilom Lojuxta, vendar ni znano,
English: Capsule shell:
Slovenian: Ovojnica kapsule:
English: • Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI), or magnetic resonance (MR) elastography
Slovenian: • slikanje za preverjanje elastičnosti tkiva, npr. Fibroscan, prehodna elastografija (ARFI) ali magnetnoresonančna (MR) elastografija;
English: LDL-C, direct (mg/dL)
Slovenian: Holesterol LDL, direktni (mg/dl)
English: In ferrets, lomitapide was both maternally toxic and teratogenic at <1 times the MRHD.
Slovenian: Pri belih dihurjih je lomitapid povzročil toksičnost za mater in teratogenost pri odmerku < 1-kratnem največjem priporočenem odmerku pri človeku.
English: • dizziness, headache, migraine
Slovenian: • omotica, glavobol, migrena,
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.
Slovenian: Ko se je lomitapid 60 mg dajal do stanja dinamičnega ravnovesja pred dajanjem simvastatina 40 mg, se vrednost AUC simvastatinske kisline poveča za 68 %, Cmax pa za 57 %.
English: • medicines to treat anxiety disorders and depression (e.g. alprazolam, fluoxetine, fluvoxamine)
Slovenian: • zdravila za zdravljenje anksioznih motenj (tesnobe) in depresije (npr. alprazolam, fluoksetin,
English: Dose adjustment and monitoring for patients with elevated aminotransferases
Slovenian: Preglednica 1: Prilagajanje odmerka in spremljanje pri bolnikih s povišanimi ravnmi aminotransferaz
English: • medicines to regulate heart rhythm (e.g. digoxin)
Slovenian: • zdravila za uravnavanje srčnega ritma (npr. digoksin),
English: statins, P-gp substrates, oral contraceptives, bile acid sequestrants and grapefruit juice;
Slovenian: substrati P-gp, peroralnimi kontracepcijskimi sredstvi, smolami, ki vežejo žolčno kislino, ter sokom grenivke;
English: Paraesthesia Somnolence
Slovenian: Občasni parestezija, somnolenca
English: In patients with mild hepatic impairment, lomitapide AUC and Cmax were 47% and 4% higher, respectively, compared with healthy volunteers.
Slovenian: Pri bolnikih z zmerno jetrno okvaro je bila v primerjavi z zdravimi prostovoljci vrednost AUC lomitapida večja za 47 %, vrednost Cmax pa večja za 4 %.
English: Patient brochure
Slovenian: Brošura za bolnike
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.
Slovenian: DHA in arahidonske kisline v serumu od izhodišča do 26 tedna znižale, vendar so ostale nad spodnjo mejo referenčnega razpona.
English: • combined oral contraceptives (e.g. ethinylestradiol, norgestimate)
Slovenian: • kombinirana peroralna kontracepcijska sredstva (npr. etinilestradiol, norgestimat),
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).
Slovenian: Plodnost Pri samcih in samicah podgan, ki so prejemale lomitapid v obliki sistemske izpostavitve (AUC), za katero so ocenili, da je 4- do 5-krat večja kot največji priporočeni odmerek za človeka (glejte poglavje 5.3), niso opazili nobenih neželenih učinkov na plodnost.
English: ALT or AST
Slovenian: ALT ali AST
English: How to take Lojuxta
Slovenian: Kako jemati zdravilo Lojuxta
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:
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: • burning or prickling of the skin
Slovenian: • pekoč ali zbadajoč občutek na koži,
English: • medicines to treat HIV (e.g. maraviroc)
Slovenian: • zdravila za zdravljenje okužbe z virusom HIV (npr. maravirok),
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).
Slovenian: Če se zdravljenju z antimikotiki, ki so derivati azola (npr. itrakonazol, ketokonazol, flukonazol, vorikonazol, posakonazol), antiaritmikom dronedaronom, makrolidnimi antibiotiki (npr. eritromicin, klaritromicin), ketolidnimi antibiotiki (npr. telitromicin), zaviralci HIV-proteaze in blokatorji kalcijevih kanalčkov, diltiazemom ter verapamilom, ni mogoče izogniti, je treba zdravljenje z zdravilom Lojuxta med uporabo teh zdravil prekiniti (glejte poglavji 4.3 in 4.4).
English: • medicines to treat cancer (e.g. bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or nausea/vomiting with cancer treatment (e.g. fosaprepitant)
Slovenian: • zdravila za zdravljenje raka (npr. bikalutamid, lapatinib, metotreksat, nilotinib, pazopanib, tamoksifen) ali slabosti/bruhanja pri zdravljenju raka (npr. fosaprepitant),
English: Concomitant use of CYP3A4 inducers
Slovenian: Sočasna uporaba induktorjev CYP3A4
English: Lomitapide was not mutagenic or genotoxic in a battery of in vitro and in vivo studies.
Slovenian: V naboru študij in vitro ter in vivo lomitapid ni bil mutagen ali genotoksičen.
English: • medicines to treat epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
Slovenian: • zdravila za zdravljenje epilepsije (npr. fenobarbital, karbamazepin, fenitoin),
English: Use of strong or moderate inhibitors of CYP3A4 is contraindicated with Lojuxta.
Slovenian: Sočasna uporaba zmernih ali močnih zaviralcev CYP3A4 in zdravila Lojuxta je kontraindicirana
English: Based on observations of decreased essential fatty acid and vitamin E levels in clinical studies, patients should take daily dietary supplements that provide 400 IU vitamin E and approximately 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), 210 mg alpha linolenic acid (ALA) and 80 mg docosahexaenoic acid (DHA) per day, throughout treatment with Lojuxta.
Slovenian: Ker so v kliničnih študijah opazili znižanje ravni esencialnih maščobnih kislin in vitamina E, morajo bolniki med celotnim zdravljenjem z zdravilom Lojuxta jemati dnevne prehranske dodatke, ki zagotavljajo 400 i.e. vitamina E in približno 200 mg linolne kisline, 110 mg eikozapentaenojske kisline (EPA), 210 mg alfa-linolenske kisline (ALA) ter 80 mg dokozaheksaenojske kisline (DHA) na dan.
English: • medicines to treat diabetes (e.g. pioglitazone, linagliptin)
Slovenian: • zdravila za zdravljenje sladkorne bolezni (npr. pioglitazon, linagliptin),
English: Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
Slovenian: Prav tako lahko po prekinitvi traja vsaj 2 tedna, da indukcija CYP3A4 oslabi.