FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Predlagatelj bo izvedel klinično študijo z zadostnimi nadomestnimi opazovanimi dogodki glede žilnih izidov z uporabo tehnik slikanja za spremljanje žilnega delovanja, stabilizacije bolezni in/ali regresije.
English: When lomitapide 20 mg was co-administered simultaneously with atorvastatin, a weak CYP3A4 inhibitor, lomitapide AUC and Cmax increased approximately 2-fold.
Slovenian: 20 mg z atorvastatinom, šibkim zaviralcem CYP3A4, sta se AUC in Cmax lomitapida povečala za približno 2-krat.
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.
Slovenian: • Podatki o obstoju in pomembnosti svetovnega opazovalnega registra za ocenjevanje lomitapida, ki je namenjen sistematičnemu zbiranju podatkov o varnosti ter učinkovitosti izidov pri bolnikih,
English: • Information about interactions with CYP3A4 inhibitors and inducers, coumarin anticoagulants,
Slovenian: • Podatke o interakcijah z zaviralci in induktorji CYP3A4, kumarinskimi antikoagulanti, statini,
English: • swelling of the eye
Slovenian: • otekanje očesa,
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.
Slovenian: Pri samcih, ki so prejeli velike odmerke, so pri 6-krat večji izpostavljenosti kot pri človeku s 60 mg na podlagi AUC opazili povečano incidenco acinarnega adenoma pankreasa.
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
Slovenian: • Pri bolnikih, zdravljenih z lomitapidom, oceniti pojavnost: o jetrnih dogodkov o prebavnih dogodkov o tumorjev tankega črevesa, jeter, debelega črevesa in pankreasa o dogodkov, povezanih s koagulopatijo o velikih neželenih kardiovaskularnih dogodkov o smrti, vključno z vzrokom smrti
English: • excessive sweating
Slovenian: • čezmerno potenje,
English: • medicines to regulate heart rhythm (e.g. amiodarone)
Slovenian: • zdravila za uravnavanje srčnega ritma (npr. amiodaron),
English: Doses of simvastatin >40 mg should not be used with Lojuxta (see section 4.3).
Slovenian: V kombinaciji z zdravilom Lojuxta se ne smejo uporabljati odmerki simvastatina > 40 mg (glejte poglavje 4.3).
English: Measure ALT, AST, alkaline phosphatase, total bilirubin, gamma-glutamyl transferase (gamma-GT) and serum albumin before initiation of treatment with Lojuxta.
Slovenian: Pred uvedbo zdravljenja z zdravilom Lojuxta izmerite ravni ALT, AST, alkalne fosfataze, celokupnega bilirubina, gama-glutamiltransferaze (gama-GT) in albumina v serumu.
English: Change p-valueb
Slovenian: Vrednost pb
English: clotrimazole)
Slovenian: klotrimazol),
English: Co-administration of a CYP3A4 inducer is expected to reduce the effect of lomitapide.
Slovenian: Pričakovano je, da bo sočasna uporaba induktorja CYP3A4 zmanjšala učinek lomitapida.
English: Apolipoprotein B (apo B) (mg/dL)
Slovenian: Apolipoprotein B (apo B) (mg/dl) trigliceridi (TG) (mg/dl)a
English: • medicines to reduce the activity of the immune system (e.g. ciclosporin, tacrolimus)
Slovenian: • zdravila za zmanjšanje dejavnosti imunskega sistema (npr. ciklosporin, takrolimus),
English: In patients with moderate hepatic impairment, lomitapide AUC and Cmax were 164% and 361% 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 164 %,
English: LOWER registry - long term prospective observational study to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.
Slovenian: Register LOWER - dolgotrajna prospektivna opazovalna študija za sistematično zbiranje podatkov o varnost ter učinkovitosti izidov pri bolnikih, zdravljenih z lomitapidom.
English: Frequency of adverse reactions in elevated LDL-C patients System Organ Class
Slovenian: Preglednica 4: Pogostnost neželenih učinkov pri bolnikih s povečano koncentracijo holesterola LDL Organski sistem
English: • stomach pain, discomfort or stomach bloating
Slovenian: • bolečina ali neugodje v trebuhu ali napihnjenost trebuha,
English: Therefore the use of this medicine in children and adolescents is not recommended.
Slovenian: Pri otrocih in mladostnikih, mlajših od 18 let, niso opravili nobenih študij, zato uporaba tega zdravila pri otrocih in mladostnikih ni priporočljiva.
English: • purple discoloration of the skin, solid bumps on the skin, rash, yellow bumps on the skin
Slovenian: • povečana, poškodovana ali zamaščena jetra, • vijoličasto obarvanje kože, trdne izbokline na koži, izpuščaj, rumene izbokline na koži,
English: • decreased appetite
Slovenian: • zmanjšan tek,
English: Liver function test abnormal Prothrombin time prolonged Transaminases increased Vitamin E decreased Vitamin K decreased
Slovenian: povišana raven transaminaz, znižana raven vitamina E, znižana raven vitamina K
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.
Slovenian: Pri dajanju lomitapida 20 mg sočasno ali z 12-urnim zamikom z etinilestradiolom/norgestimatom, šibkim zaviralcem CYP3A4,
English: Medicinal products that induce CYP3A4 would be expected to increase the rate and extent of metabolism of lomitapide.
Slovenian: Pri zdravilih, ki inducirajo CYP3A, se pričakuje, da bodo povečala hitrost in obseg presnove lomitapida.
English: Weak CYP3A4 inhibitors are expected to increase the exposure of lomitapide when taken simultaneously.
Slovenian: Pričakuje se, da bodo šibki zaviralci CYP3A4 pri sočasni uporabi povečali izpostavljenost lomitapidu.
English: Prothrombin time prolonged Pulmonary function test abnormal White blood cell count increased
Slovenian: podaljšan protrombinski čas, nenormalne preiskave pljučnega delovanja,
English: Although cases of hepatic dysfunction (elevated aminotransferase with increase in bilirubin or International Normalized Ratio [INR]) or hepatic failure have not been reported, there is concern that lomitapide could induce steatohepatitis, which can progress to cirrhosis over several years.
Slovenian: Normalized Ratio)) ali jetrni odpovedi, obstajajo pomisleki, da bi lahko lomitapid sprožil steatohepatitis, ki lahko v več letih napreduje v cirozo.
English: • medicines to treat low blood sodium level (e.g. tolvaptan)
Slovenian: • zdravila za zdravljenje nizke ravni natrija v krvi (npr. tolvaptan),
English: − Appropriate advice on effective methods of contraception should be provided, and effective contraception initiated;
Slovenian: - je treba potrditi odsotnost nosečnosti; - omogočiti ustrezno svetovanje glede učinkovitih kontracepcijskih metod in uvesti učinkovito kontracepcijo;
English: Medicinal products
Slovenian: ZDRAVILA
English: Mean Percent Change from Baseline in LDL-C
Slovenian: Povprečna odstotna sprememba holesterola LDL od izhodišča
English: • Women of childbearing potential should have adequate birth control and should tell their doctors immediately if they suspect they may be pregnant;
Slovenian: • Ženske v rodni dobi morajo uporabljati zadostno kontracepcijo in morajo takoj obvestiti zdravnika,
English: • Information on undesirable effects, including diarrhoea, nausea, flatulence, abdominal pain or discomfort, abdominal distension, vomiting, dyspepsia, eructation and decreased appetite;
Slovenian: Učinki na prebavila • Podatki o neželenih učinkih, vključno z diarejo, navzeo, flatulenco, bolečino ali neugodjem v trebuhu, distenzijo trebuha, bruhanjem, dispepsijo, eruktacijo in zmanjšanim tekom; • Kontraindicirano za uporabo pri bolnikih s potrjeno pomembno ali kronično črevesno boleznijo,
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.
Slovenian: CYP3A4 (tj. aminoglutetimid, nafcilin, zaviralce nenukleozidne reverzne transkriptaze, fenobarbital, rifampicin, karbamazepin, pioglitazon, šentjanževko, glukokortikoide, modafinil ter fenitoin) in zdravilo Lojuxta, je treba upoštevati možnost medsebojnega delovanja med zdraviloma, ki vpliva na učinkovitost.
English: Pregelatinised starch (maize) Sodium starch glycolate (Type A) Microcrystalline cellulose Lactose monohydrate Silica, colloidal anhydrous Magnesium stearate
Slovenian: mikrokristalna celuloza laktoza monohidrat koloidni brezvodni silicijev dioksid magnezijev stearat
English: A copy of the patient brochure and patient alert card shall be provided to all patients at the time Lojuxta treatment is initiated.
Slovenian: Vsi bolniki, pri katerih se uvede zdravljenje z zdravilom Lojuxta, morajo prejeti kopijo brošure za bolnika in kartico z opozorili za bolnika.
English: • anti-histamine medicines to treat hayfever (e.g. fexofenadine)
Slovenian: • antihistaminiki za zdravljenje senenega nahoda (npr. feksofenadin).
English: • oral contraceptives (see section 2 under ‘Pregnancy and breast-feeding')
Slovenian: • peroralna kontracepcijska sredstva (glejte poglavje 2 „Nosečnost in dojenje“), • druga zdravila za zniževanje ravni holesterola, kot so:
English: Alanine aminotransferase increased Aspartate aminotransferase increased Hepatic enzyme increased Liver function test abnormal Neutrophil count decreased White blood cell count decreased
Slovenian: Pogosti povišana raven alaninaminotransferaze, povišana raven aspartataminotransferaze, povišanje ravni jetrnih encimov, nenormalne preiskave delovanja jeter, zmanjšano število nevtrofilcev, zmanjšano število levkocitov
English: For patients on a stable maintenance dose of Lojuxta who receive atorvastatin either: • Separate the dose of the medicinal products by 12 hours
Slovenian: Pri bolnikih na stabilnem vzdrževalnem odmerku zdravila Lojuxta, ki prejmejo atorvastatin:
English: Gastroenteritis
Slovenian: Pogosti gastroenteritis
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.
Slovenian: V prehranski študiji kancerogenosti na miših se je lomitapid uporabljal do 104 tedne v odmerkih od
English: • abnormal lung function test
Slovenian: • nenormalni izvidi preiskav pljučnega delovanja.
English: Following administration of a radiolabeled oral solution dose to healthy subjects, 93% of the administered dose was recovered in urine and faeces.
Slovenian: Izločanje Po uporabi odmerka radioizotopsko označene peroralne raztopine pri zdravih preskušancih se je 93 %
English: − The need to follow a low-fat diet (i.e. patients should follow a diet supplying less than 20% of energy from fat);
Slovenian: - potrebe po vzdrževanju diete z majhnim vnosom maščob (tj. bolniki morajo biti na dieti, s katero manj kot 20 % energije dobijo iz maščob); - časovnega razporeda jemanja zdravila (zdravilo Lojuxta se sme jemati samo na prazen želodec, vsaj 2 uri po večerji);
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Lojuxta Vsebina pakiranja in dodatne informacije
English: Dizziness Headache Migraine
Slovenian: Pogosti omotica, glavobol, migrena
English: • medicines to treat diabetes (e.g. saxagliptin, sitagliptin)
Slovenian: • zdravila za zdravljenje sladkorne bolezni (npr. saksagliptin, sitagliptin),
English: General disorders and administrative site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije
English: Alanine aminotransferase increased Aspartate aminotransferase increased Weight decreased
Slovenian: Zelo pogosti povišana raven alaninaminotransferaze, povišana raven aspartataminotransferaze, zmanjšana telesna masa
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.
Slovenian: V enoletni študiji na psih s 64-krat večjo izpostavljenostjo, kot je izpostavljenost 60 mg pri človeku, niso opazili nobenih neželenih učinkov na moda.
English: • ulcer or sore spot in the throat
Slovenian: • ulkus ali boleče mesto v grlu ali žrelu,
English: Concomitant use of CYP3A4 inhibitors
Slovenian: Sočasna uporaba zaviralcev CYP3A4
English: • weight loss
Slovenian: • izguba telesne mase.
English: Lojuxta contains lactose
Slovenian: Zdravilo Lojuxta vsebuje laktozo
English: • Your dose of Lojuxta may need to be adjusted if you consume peppermint oil or Seville oranges.
Slovenian: • Če uživate olje poprove mete ali plodove grenkega pomarančevca, bo morda treba prilagoditi odmerek zdravila Lojuxta.
English: • coumarin anticoagulants for thinning the blood ( e.g. warfarin)
Slovenian: • kumarinski antikoagulanti za redčenje krvi (npr, varfarin),
English: Recommendation concerning co-administration with Lojuxta no clinically meaningful increase in lomitapide exposure was observed.
Slovenian: niso opazili klinično pomembnega povečanja izpostavljenosti lomitapidu.
English: Consistent with the mechanism of action of lomitapide, most treated patients exhibited increases in hepatic fat content.
Slovenian: Jetrna steatoza in tveganje napredujoče jetrne bolezni Pri večini zdravljenih bolnikov se pojavi povečanje vsebnosti maščob v jetrih, kar je skladno z mehanizmom delovanja lomitapida.
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
Slovenian: o zaviralci CYP 3A4 o induktorji CYP 3A4 o kumarinskimi antikoagulanti o statini o substrati P-gp o estrogenskimi peroralnimi kontracepcijskimi sredstvi
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.
Slovenian: Sočasna uporaba zdravila Lojuxta in substratov P-gp (kot so aliskiren, ambrisentan, kolhicin, dabigatran eteksilat, digoksin, everolimus, feksofenadin, imatinib, lapatinib, maravirok, nilotinib, posakonazol,
English: Dose reduction of the P gp substrate should be considered when used concomitantly with Lojuxta.
Slovenian: Pri sočasni uporabi z zdravilom Lojuxta je treba razmisliti o zmanjšanju odmerka substrata P-gp.
English: High-density lipoprotein cholesterol (HDL-C) (mg/dL)
Slovenian: Lipoproteinski holesterol velike gostote (HDL-C) (mg/dl)
English: Maximum categorical changes in % hepatic fat (major effectiveness study UP1002/AEGR-733-005) Maximum absolute increase in % hepatic fat
Slovenian: Preglednica 7: Največje kategorične spremembe v % maščob v jetrih (velika študija učinkovitosti UP1002/AEGR-733-005)
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.
Slovenian: To temelji na rezultatih študije z močnim zaviralcem CYP3A4, ketokonazolom, in na preteklih podatkih poskusov, pri katerih so kot model za določanje aktivnosti CYP3A4 uporabili midazolam.
English: You should not take more than 40 mg of simvastatin when using Lojuxta (see section 2 under ‘Do not take Lojuxta')
Slovenian: 40 mg (glejte poglavje 2 „Ne jemljite zdravila Lojuxta“),
English: What you need to know before you take Lojuxta
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lojuxta Ne jemljite zdravila Lojuxta:
English: • medicines to treat severe acne (e.g. isotretinoin)
Slovenian: • zdravila za zdravljenje hude mozoljavosti (npr. izotretinoin),
English: Driving and using machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev
English: Very common (may affect more than 1 in 10 people):
Slovenian: Pojavili so se tudi naslednji neželeni učinki: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: • changes to your walking (gait)
Slovenian: • spremembe pri hoji,
English: Hepatic steatosis and risk of progressive liver disease
Slovenian: Jetrna steatoza je dejavnik tveganja za napredujočo jetrno bolezen, vključno s steatohepatitisom in cirozo.
English: The signs and symptoms of liver problems include: o nausea (feeling sick) o vomiting (being sick) o stomach pain o muscle aches and pains o fever o skin or whites of your eyes turn yellow o being more tired than usual o feeling like you have the flu
Slovenian: o porumenelost kože ali beločnice (belega dela oči), o večja utrujenost, kot običajno, o občutek, kot da imate gripo.
English: Hepatic steatosis Hepatotoxicity Hepatomegaly
Slovenian: Občasni hepatomegalija
English: Non high-density lipoprotein cholesterol (Non-HDL-C) (mg/dL)
Slovenian: Lipoproteinski holesterol nevelike gostote (nonHDL-C) (mg/dl)
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.
Slovenian: alprazolam, amiodaron, amlodipin, atorvastatin, azitromicin, bikalutamid, cilostazol, cimetidin, ciklosporin, klotrimazol, fluoksetin, fluvoksamin, fosaprepitant, ginko, kanadski zlati koren
English: • increased appetite
Slovenian: povečan tek
English: • medicines to treat angina - chest pain caused by the heart (e.g. ranolazine)
Slovenian: • zdravila za zdravljenje in preprečevanje krvnih strdkov (npr. dabigatran eteksilat), • zdravila za zdravljenje angine - bolečine v prsnem košu, ki jo povzroča srce (npr. ranolazin),
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)
Slovenian: Preglednica 5: Absolutne vrednosti in odstotne spremembe lipidov in lipoproteinov od izhodišča do 26. in 78. tedna (velika študija učinkovitosti
English: There is limited experience with lomitapide in patients aged 65 years or older.
Slovenian: Pri bolnikih, starih 65 let ali več, so izkušnje z lomitapidom omejene, zato je pri teh bolnikih še zlasti potrebna previdnost.
English: Hepatic insufficiency
Slovenian: Ledvična insuficienca
English: Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules lomitapide
Slovenian: Lojuxta 30 mg trde kapsule Lojuxta 40 mg trde kapsule Lojuxta 60 mg trde kapsule lomitapid
English: Blood alkaline phosphatase increased Blood potassium decreased Carotene decreased International normalised ratio abnormal
Slovenian: Pogosti povečano mednarodno umerjeno razmerje, povišana raven alkalne fosfataze v krvi, znižana raven kalija v krvi, znižana raven karotena, nenormalno mednarodno umerjeno razmerje, nenormalne preiskave delovanja jeter,
English: Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules lomitapide
Slovenian: Navodilo za uporabo Lojuxta 5 mg trde kapsule Lojuxta 10 mg trde kapsule Lojuxta 20 mg trde kapsule lomitapid
English: You should contact your doctor before you stop taking this medicine.
Slovenian: Preden prenehate jemati to zdravilo, se posvetujte z zdravnikom.
English: Hepatobiliary disorders
Slovenian: Hepatotoksična zdravila
English: Grapefruit juice must be omitted from the diet while patients are treated with Lojuxta.
Slovenian: Med zdravljenjem z zdravilom Lojuxta je treba sok grenivke izločiti iz prehrane.
English: • The capsule shell for the 5 mg and 10 mg capsules contains gelatin, titanium dioxide (E171) and red iron oxide (E172).
Slovenian: • Ovojnica kapsul 5 mg in 10 mg vsebuje želatino, titanov oksid (E 171) in rdeči železov oksid
English: Very-low-density lipoprotein cholesterol (VLDL-C) (mg/dL)
Slovenian: Lipoproteinski holesterol zelo majhne gostote (VLDL-C) (mg/dl)
English: Lojuxta contains lactose.
Slovenian: Zdravilo Lojuxta vsebuje laktozo.
English: • Advice on escalating Lojuxta dose gradually to improve tolerability of the medicine;
Slovenian: kot je vnetna črevesna bolezen ali malabsorpcija; • Nasvet glede postopnega večanja odmerka zdravila Lojuxta, da se izboljša prenašanje zdravila;
English: Abdominal pain upper Abdominal distension Abdominal pain Vomiting
Slovenian: bolečina v trebuhu, bolečina v zgornjem delu trebuha,
English: Excipient with known effect Each hard capsule contains 389.68 mg of lactose (as monohydrate) (see section 4.4).
Slovenian: Ena trda kapsula vsebuje 389,68 mg laktoze (v obliki laktoze monohidrata) (glejte poglavje 4.4).
English: Excipient with known effect Each hard capsule contains 259.79 mg of lactose (as monohydrate) (see section 4.4).
Slovenian: Ena trda kapsula vsebuje 259,79 mg laktoze (v obliki laktoze monohidrata) (glejte poglavje 4.4).
English: • inflammation of the stomach and intestine that causes diarrhoea and vomiting
Slovenian: • vnetje želodca in črevesa, ki povzroča drisko ter bruhanje, • regurgitacija (vračanje hrane iz želodca),
English: gamma-GT, serum albumin (liver injury); high sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK-18 Fragment, NashTest (liver inflammation);
Slovenian: C-reaktivni protein z veliko občutljivostjo (hs-CRP), hitrost sedimentacije eritrocitov (ESR), fragment citokeratina-18 (CK-18), preiskava za NASH (vnetje jeter); izboljšana preiskava za jetrno fibrozo (ELF), Fibrometer, razmerje AST/ALT, rezultat Fib-4, Fibrotest (jetrna fibroza).
English: How to store Lojuxta
Slovenian: Shranjevanje zdravila Lojuxta
English: • The capsule shell for the 20 mg capsule contains gelatin and titanium dioxide (E171).
Slovenian: • Ovojnica kapsul 20 mg vsebuje želatino in titanov oksid (E 171).
English: Muscle aches and pains (myalgia) or weakness
Slovenian: Lahko se pojavita tudi bolečina v mišicah (mialgija) ali šibkost v mišicah (miopatija).
English: • Compliance with the supplementation regimen should be verified at regular scheduled appointments and the importance emphasised.
Slovenian: • Pomembnost nadomeščanja maščobnih kislin in liposolubilnih vitaminov; • Bolnikovo upoštevanje režima nadomeščanja je treba preverjati pri rednih načrtovanih obiskih.
English: Just take your normal dose at the usual time the next day.
Slovenian: Če ste pozabili vzeti zdravilo Lojuxta Vzemite normalni odmerek ob običajnem času naslednji dan. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Blood bilirubin increased Gamma-glutamyltransferase increased Neutrophil percentage increased Protein urine
Slovenian: Občasni zmanjšana telesna masa, povišana raven bilirubina v krvi, povišana raven gamaglutamiltransferaze,
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.
Slovenian: Ta protein je v jetrih in celicah črevesa, kjer je vključen v sestavljanje maščobnih snovi v večje dele, ki se nato sprostijo v krvni obtok.
English: • Contraindication for use in patients with a known significant or chronic bowel disease such as inflammatory bowel disease or malabsorption;
Slovenian: • Podatki o kontraindikacijah pri bolnikih z zmerno ali hudo potrjeno jetrno okvaro/boleznijo,