natgillin/translations-raw huggingface dataset:
• Warning about possible loss of effectiveness of oral contraceptives due to diarrhoea or vomiting and need for additional contraception until 7 days after resolution of symptoms;
• Upozorenje o mogućem gubitku učinkovitosti peroralnih kontraceptiva zbog proljeva ili povraćanja, i o potrebi za dodatnom kontracepcijom još 7 dana nakon prestanka simptoma.
Data in the pivotal clinical study were analysed with respect to the impact of potential covariates on lomitapide exposure.
Podaci pivotalnog kliničkog ispitivanja analizirani su s obzirom na utjecaj potencijalnih kovarijanata na izloženost lomitapidu.
It is important to avoid dehydration by drinking enough fluids (see section 4).
Važno je izbjeći dehidraciju uzimanjem dovoljne količine tekućine (vidjeti dio 4).
Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX12
Farmakoterapijska skupina: pripravci koji modificiraju lipide, drugi pripravci koji modificiraju lipide, ATK oznaka: C10AX12
Patients taking Lojuxta should avoid consumption of grapefruit juice.
Bolesnici koji uzimaju Lojuxtu trebaju izbjegavati konzumaciju soka od grejpa.
• vomiting blood
• povraćanje krvi
Risk of supratherapeutic or subtherapeutic anticoagulation with coumarin based anticoagulants
Rizik od supraterapijske ili supterapijske antikoagulacije uz primjenu kumarinskih antikoagulansa
• purple discoloration of the skin, solid bumps on the skin, rash, yellow bumps on the skin
• ljubičaste kožne promjene, čvrste kvržice na koži, osip, žute kvržice na koži
Ask your doctor, or dietitian how to obtain these supplements.
Upitajte liječnika ili specijalista za prehranu kako uzimati ove dodatke (suplemente).
A pharmacokinetic study in patients with ESRD undergoing hemodialysis demonstrated a 36% increase in mean lomitapide plasma concentration compared to matched healthy controls.
Farmakokinetičko ispitivanje u bolesnika s ESRD koji su bili na hemodijalizi pokazalo je povećanje srednje vrijednosti koncentracije lomitapida u plazmi od 36% u usporedbi sa zdravim kontrolnim ispitanicima.
EU/1/13/851/001 - Lojuxta 5 mg hard capsules EU/1/13/851/002 - Lojuxta 10 mg hard capsules EU/1/13/851/003 - Lojuxta 20 mg hard capsules EU/1/13/851/004 - Lojuxta 30 mg hard capsules EU/1/13/851/005 - Lojuxta 40 mg hard capsules EU/1/13/851/006 - Lojuxta 60 mg hard capsules
EU/1/13/851/001 - Lojuxta 5 mg tvrde kapsule EU/1/13/851/002 - Lojuxta 10 mg tvrde kapsule EU/1/13/851/003 - Lojuxta 20 mg tvrde kapsule EU/1/13/851/004 - Lojuxta 30 mg tvrde kapsule EU/1/13/851/005 - Lojuxta 40 mg tvrde kapsule EU/1/13/851/006 - Lojuxta 60 mg tvrde kapsule
• The active substance is lomitapide.
• Djelatna tvar je lomitapid.
Dietary counselling should be provided.
Potrebno je savjetovanje o pravilnoj prehrani.
Patients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily.
Za bolesnike s blagim oštećenjem funkcije jetre (Child-Pugh A) ukupna dnevna doza ne smije prijeći 40 mg.
• Decrease the dose of Lojuxta by half.
• upola smanjite dozu Lojuxte.
Table 4 lists all adverse reactions for subjects who received lomitapide monotherapy (N=291) treated in Phase 2 studies in subjects with elevated LDL-C (N=462).
Tablica 4 navodi sve nuspojave u ispitanika koji su primali monoterapiju lomitapida (N=291) liječenih u ispitivanjima faze 2 provedenim u ispitanika s povišenim LDL kolesterolom (N=462).
Because bile acid sequestrants can interfere with the absorption of oral medicines, bile acid sequestrants should be taken at least 4 hours before or at least 4 hours after Lojuxta.
S obzirom da sekvestranti žučne kiseline mogu interferirati s apsorpcijom peroralnih lijekova, sekvestrante žučne kiseline treba uzimati najmanje 4 sata prije ili najmanje 4 sata poslije Lojuxte.
A single-dose, open-label study was conducted to evaluate the pharmacokinetics of 60 mg lomitapide in healthy volunteers with normal hepatic function compared with patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment.
Otvoreno ispitivanje s jednostrukom dozom provedeno je kako bi se procijenila farmakokinetika doze lomitapida od 60 mg u zdravih dobrovoljaca s normalnom funkcijom jetre, u usporedbi s bolesnicima s blagim (Child-Pugh A) i umjerenim (Child-Pugh B) oštećenjem funkcije jetre.
CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Induktori CYP3A4 iskazuju svoj učinak u ovisnosti o vremenu pa nakon uvođenja može trebati najmanje 2 tjedna da dosegnu maksimalni učinak.
• tetracycline antibiotics to treat infections such as urinary tract infections
• tetraciklinske antibiotike za liječenje infekcija kao što su infekcije mokraćnog sustava
Increases in the dose of Lojuxta may lead to supratherapeutic anticoagulation, and decreases in the dose may lead to subtherapeutic anticoagulation.
Povećanja doze Lojuxte mogu dovesti do supraterapijske antikoagulacije, a smanjenja doze do supterapijske antikoagulacije.
Patients with results suggesting the presence of steatohepatitis or fibrosis should be considered for liver biopsy.
Za bolesnike čiji rezultati učinjenih pretraga upućuju na steatohepatitis ili fibrozu treba razmotriti biopsiju jetre.
• Information that Lojuxta may cause liver problems;
• Informacije da Lojuxta može prouzročiti tegobe s jetrom.
Of the 23 patients who completed through Week 26, 19 (83%) had LDL-C reductions ≥25% with 8 (35%) having LDL-C <100 mg/dL and 1 having LDL-C <70 mg/dL at that time point.
Od 23 bolesnika koji su završili liječenje do 26. tjedna u 19 (83%) bolesnika smanjenje LDL kolesterola bilo je ≥ 25% s tim da je njih 8 (35%) imalo LDL kolesterol < 100 mg/dl i 1 bolesnik LDL kolesterol < 70 mg/dl u toj vremenskoj točki.
Gastrointestinal reactions contributed to the reasons for early discontinuation from the study for 4 (14%) patients.
Gastrointestinalne nuspojave su pridonijele prijevremenom prekidu sudjelovanja u ispitivanju u 4 (14%) bolesnika.
Patients receiving Lojuxta as adjunctive therapy to a statin should be monitored for adverse events that are associated with the use of high doses of statins.
Bolesnike koji primaju Lojuxtu kao dodatnu terapiju statinu treba nadzirati zbog nuspojava povezanih s primjenom visokih doza statina.
Elevations in ALT and/or AST >5 x ULN were managed with a dose reduction or temporary suspension of lomitapide dosing, and all patients were able to continue with study drug treatment.
Povišene vrijednosti ALT i/ili AST > 5 x GGN zbrinjavane su smanjenjem doze ili privremenim prekidom doziranja lomitapida, i svi su bolesnici mogli nastaviti terapiju ispitivanim lijekom.
Given its mechanism of action in the small intestine, lomitapide may reduce the absorption of fat-soluble nutrients.
S obzirom na mehanizam djelovanja u tankom crijevu, lomitapid može smanjiti apsorpciju nutrijenata topivih u masti.
Inhibition of MTP reduces lipoprotein secretion and circulating concentrations of lipoprotein-borne lipids including cholesterol and triglycerides.
Inhibicija MTP-a smanjuje sekreciju lipoproteina i cirkulirajućih koncentracija lipida koje prenose lipoproteini, uključujući kolesterol i trigliceride.
• flu or cold, fever, inflammation of your sinuses, cough
• gripa ili prehlada, vrućica, upala sinusa, kašalj
At steady state the accumulation of lomitapide was 2.7 at 25 mg and 3.9 at 50 mg.
U stanju dinamičke ravnoteže akumulacija lomitapida bila je 2,7 uz 25 mg i 3,9 uz 50 mg.
Diarrhoea occurred in 79% of patients, nausea in 65%, dyspepsia in 38%, and vomiting in 34%.
Proljev se pojavio u 79% bolesnika, mučnina u 65%, dispepsija u 38% a povraćanje u 34% bolesnika.
Consistent with the mechanism of action of lomitapide, most treated patients exhibited increases in hepatic fat content.
U skladu s mehanizmom djelovanja lomitapida, većina liječenih bolesnika pokazala je povećanje sadržaja masti u jetri.
Caution should be exercised when Lojuxta is used with other medicinal products known to have potential for hepatotoxicity, such as isotretinoin, amiodarone, acetaminophen (>4 g/day for ≥3 days/week), methotrexate, tetracyclines, and tamoxifen.
Treba postupati oprezno kada se Lojuxta primjenjuje s drugim lijekovima koji su potencijalno hepatotoksični kao što su izotretinoin, amiodaron, acetaminofen (> 4 g na dan tijekom ≥ 3 dana tjedno), metotreksat, tetraciklini i tamoksifen.
If a patient has biopsy-proven steatohepatitis or fibrosis, the benefit-risk should be reassessed and treatment stopped if necessary.
Ako se biopsijom dokaže dijagnoza steatohepatitisa ili fibroze, potrebno je ponovno procijeniti omjer koristi i rizika te, ako je potrebno, prekinuti terapiju.
Upon multiple dosing Cmax and AUC increased in approximate proportion to lomitapide dose.
U višekratnom doziranju vrijednosti Cmax i AUC povećale su se približno proporcionalno dozi lomitapida.
What Lojuxta contains
Što Lojuxta sadrži
A single arm, open-label study (UP1002/AEGR-733-005) evaluated the efficacy and safety of lomitapide when co-administered with a low-fat diet and other lipid-lowering therapies in adult patients with HoFH.
U otvorenom ispitivanju (UP1002/AEGR-733-005) s jednom skupinom ispitanika procjenjivala se djelotvornost i sigurnost lomitapida kada se primjenjivao istodobno s dijetom s niskim udjelom masti i drugim lijekovima za snižavanje lipida u odraslih bolesnika s HoFH-om.
Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
Obrnuto, u slučaju prekida, za smanjenje indukcije CYP3A4 može trebati najmanje 2 tjedna.
• antacids (e.g. ranitidine, cimetidine)
• antacide (npr. ranitidin, cimetidin)
The occurrence and severity of gastrointestinal adverse reactions associated with the use of Lojuxta decreases in the presence of a low fat diet.
Pojava i težina gastrointestinalnih nuspojava povezanih s primjenom Lojuxte smanjuju se uz dijetu s malim udjelom masti.
• Information on undesirable effects, including diarrhoea, nausea, flatulence, abdominal pain or discomfort, abdominal distension, vomiting, dyspepsia, eructation and decreased appetite;
• podaci o neželjenim učincima uključujući proljev, mučninu, flatulenciju, abdominalnu bol ili nelagodu, abdominalnu distenziju, povraćanje, dispepsiju, eruktaciju i oslabjeli apetit;
Use of Lojuxta is contraindicated in patients treated with high doses of simvastatin (>40 mg) (see sections 4.3 and 4.4).
Primjena Lojuxte kontraindicirana je u bolesnika liječenih visokim dozama simvastatina (> 40 mg) (vidjeti dijelove 4.3 i 4.4).
• low density lipoprotein (LDL) cholesterol (“bad” cholesterol)
• lipoproteina male gustoće (LDL) kolesterol („loš“ kolesterol)
Do not use this medicine after the expiry date which is stated on the label or carton after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici ili kutiji iza „Rok valjanosti“.
− The need to follow a low-fat diet (i.e. patients should follow a diet supplying less than 20% of energy from fat);
− potrebi pridržavanja dijete s niskim udjelom masti (tj. bolesnici bi se trebali pridržavati dijete u kojoj masti sudjeluju kao izvor energije manje od 20%);
• If you take another medicine that lowers cholesterol by binding bile acids, such as colesevelam or cholestyramine, take the medicine that binds bile acids at least 4 hours before or 4 hours after you take Lojuxta.
• Ako uzimate drugi lijek koji snižava kolesterol vezanjem žučnih kiselina, kao što su kolesevelam ili kolestiramin, uzmite taj lijek koji veže žučne kiseline najmanje 4 sata prije ili 4 sata nakon što ste uzeli lijek Lojuxta.
Gastrointestinal adverse reactions of severe intensity were reported by 6 (21%) of 29 patients in the Phase 3 clinical study, with the most common being diarrhoea (4 patients, 14%); vomiting (3 patients, 10%); and abdominal pain, distension, and/or discomfort (2 patients, 7%).
Gastrointestinalne nuspojave jakog intenziteta prijavilo je 6 (21%) od 29 bolesnika u kliničkom ispitivanju faze 3, a najčešće nuspojave bile su proljev (4 bolesnika, 14%), povraćanje (3 bolesnika, 10%), te abdominalna bol, distenzija i/ili nelagoda (2 bolesnika, 7%).
• Lojuxta may cause diarrhoea and vomiting and if it does, patients using oral contraception should use additional contraceptive methods for 7 days after symptoms have resolved;
• Lojuxta može prouzročiti proljev i povraćanje i ako se to dogodi, bolesnice koje uzimaju oralne kontraceptive moraju primjenjivati dodatne metode kontracepcije još 7 dana nakon povlačenja simptoma.
• bleeding from your rectum (back passage) or blood in your stool
• krvarenje iz rektuma (čmara) ili krv u stolici
What you need to know before you take Lojuxta
Što morate znati prije nego počnete uzimati lijek Lojuxta
When administered with atorvastatin, the dose of Lojuxta should either be taken 12 hours apart or be decreased by half (see section 4.2).
Kad se primjenjuje s atorvastatinom, dozu Lojuxte treba uzeti ili u razmaku od 12 sati ili je upola smanjiti (vidjeti dio 4.2).
The clinical benefit of reductions in background lipid-lowering therapy, including apheresis, is not certain.
Klinička korist od smanjivanja osnovne terapije za snižavanje vrijednosti lipida, uključujući aferezu, nije sigurna.
In patients taking coumarins (such as warfarin) and Lojuxta concomitantly, INR should be determined before starting Lojuxta and monitored regularly with dosage of coumarins adjusted as clinically indicated (see section 4.4).
U bolesnika koji istodobno uzimaju kumarine (kao što je varfarin) i Lojuxtu, INR treba odrediti prije nego što započnu uzimati Lojuxtu te redovito kontrolirati a dozu kumarinskih antikoagulansa prilagoditi kliničkoj indikaciji (vidjeti dio 4.4).
Post-marketing reports of dehydration and hospitalisation in patients treated with lomitapide have been reported.
Nakon stavljanja lijeka u promet prijavljeni su slučajevi dehidracije i hospitalizacije u bolesnika liječenih lomitapidom.
The terminal half-life of lomitapide was not affected.
Terminalni poluvijek lomitapida nije se mijenjao.
It is not known whether lomitapide is excreted into human milk.
Nije poznato izlučuje li se lomitapid u majčino mlijeko u ljudi.
No clinically meaningful elevations in total bilirubin or alkaline phosphatase were observed.
Nisu opažena klinički značajna povišenja ukupnog bilirubina ili alkalne fosfataze.
There was no evidence of embryofoetal toxicity in rabbits at 3 times the maximum recommended human dose (MRHD) of 60 mg based on body surface area.
Nije bilo dokaza za embriofetalnu toksičnost u kunića pri dozi 3 puta većoj od maksimalne preporučene doze u ljudi (MRHD) od 60 mg na temelju tjelesne površine.
Regular screening for steatohepatitis/fibrosis should be performed at baseline and on an annual basis using the following imaging and biomarker evaluations:
Redoviti probir na steatohepatitis/fibrozu treba provoditi na početku liječenja te jedanput godišnje primjenom sljedećih slikovnih metoda i biomarkera:
Lojuxta is contraindicated during pregnancy.
Lijek Lojuxta kontraindiciran je u trudnoći.
Patients treated with lomitapide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Bolesnike liječene lomitapidom potrebno je upozoriti na potencijalan rizik od dehidracije u vezi s gastrointestinalnim nuspojavama i poduzeti mjere opreza kako bi se izbjegla deplecija tekućine.
Hard, capsule.
Tvrda kapsula.
• burning or prickling of the skin
• žarenje ili peckanje kože;
Monitoring of liver function tests
Nadzor pretraga funkcije jetre
Apheresis was discontinued in 3 out of 13 patients who were on it at Week 26, and frequency was reduced in 3 patients while maintaining low LDL-C levels through Week 78.
Afereza je prekinuta u 3 od 13 bolesnika koji su joj bili podvrgnuti u 26. tjednu, a učestalost je smanjena u 3 bolesnika dok su se niske razine LDL kolesterola održale do 78. tjedna.
Accumulation of lomitapide in plasma was consistent with that predicted after a single dose following once daily oral dosing above 25 mg for up to 4 weeks.
Nakupljanje lomitapida u plazmi bilo je u skladu s onim predviđenim za jednostruku dozu nakon peroralnih doza većih od 25 mg uzimanih jedanput na dan u trajanju do 4 tjedna.
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%).
Najčešće prijavljivane nuspojave jakog intenziteta bile su proljev (4 ispitanika, 14%), povraćanje (3 bolesnika, 10%) te abdominalna distenzija i povišene vrijednosti ALT (za svaku nuspojavu 2 ispitanika, 7%).
Oral contraceptives: When lomitapide 50 mg was administered to steady state along with an oestrogen-based oral contraceptive, no clinically meaningful or statistically significant impact on the pharmacokinetics of the components of the oral contraceptive (ethinyl estradiol and 17-deacetyl norgestimate, the metabolite of norgestimate) was observed.
Oralni kontraceptivi: Kada je lomitapid 50 primjenjivan u stanju dinamičke ravnoteže zajedno s kontraceptivima na bazi estrogena, nije opažen klinički važan ili statistički značajan utjecaj na farmakokinetiku komponenata peroralnog kontraceptiva (etinilestradiol i 17-deacetil norgestimat, metabolit norgestimata).
Lomitapide can cause elevations in the liver enzymes alanine aminotransferase [ALT] and aspartate aminotransferase [AST] and hepatic steatosis (see section 5.1).
Lomitapid može uzrokovati porast vrijednosti jetrenih enzima alanin aminotransferaze [ALT] i aspartat aminotransferaze [AST] te steatozu jetre (masnu jetru) (vidjeti dio 5.1).
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.
Iako nisu zabilježeni slučajevi hepatičke disfunkcije (porast aminotransferaza s povećanjem bilirubina ili produljenim međunarodnim normaliziranim omjerom [INR]) ili zatajenja jetre, postoji zabrinutost da bi lomitapid, tijekom nekoliko godina, mogao izazvati steatohepatitis koji dalje može napredovati u cirozu.
Doses of simvastatin >40 mg should not be used with Lojuxta (see section 4.3).
Doze simvastatina >40 mg ne smiju se primjenjivati s Lojuxtom (vidjeti dio 4.3).
≥5x ULN
≥ 5 x GGN
In rare cases, myopathy may take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and can lead to fatality.
U rijetkim slučajevima miopatija može poprimiti oblik rabdomiolize sa ili bez akutnog zatajenja bubrega uslijed mioglobinurije, što može dovesti do smrtnog ishoda.
Mean percent change from baseline through Week 26 using last observation carried forward (LOCF) to each assessment is shown in Figure 1.
Srednja vrijednost postotka promjene u odnosu na početne vrijednosti do 26. tjedna na temelju zadnjeg prenesenog opažanja (LOCF) za svaku procjenu prikazana je u slici 1.
In animal studies lomitapide was highly concentrated (200-fold) in the liver.
U ispitivanjima na životinjama nađene su visoke koncentracije lomitapida u jetri (200 puta više).
In repeat-dose oral toxicology studies in rodents and dogs, the principal drug-related findings were lipid accumulation in the small intestine and/or liver associated with decreases in serum cholesterol and/or triglyceride levels.
U toksikološkim ispitivanjima peroralnih ponovljenih doza u glodavaca i pasa, glavni nalazi povezani s lijekom bili su akumulacija lipida u tankom crijevu i/ili jetri povezana sa smanjenjem razina serumskog kolesterola i/ili triglicerida.
The MAH must agree the content and format of the educational materials together with a communication plan with the national competent authority in each Member State prior to distribution in their territory.
Prije distribucije na njezinom teritoriju, nositelj odobrenja mora s nacionalnim nadležnim tijelom svake države članice dogovoriti sadržaj i format tih edukacijskih materijala zajedno s planom priopćavanja.
On withdrawal of a CYP3A4 inducer, the possibility of increased exposure should be considered and a reduction in the dose of Lojuxta may be necessary.
Prilikom povlačenja induktora CYP3A4 treba uzeti u obzir mogućnost povećane izloženosti pa je možda potrebno smanjiti dozu Lojuxte.
Gastrointestinal adverse reactions were reported by 27 (93%) of 29 patients in the Phase 3 clinical study.
U kliničkom ispitivanju faze 3 gastrointestinalne nuspojave zabilježene su u 27 (93%) od 29 bolesnika.
Monitoring for evidence of progressive liver disease.
Praćenje dokaza za progresivnu bolest jetre
Lomitapide is a selective inhibitor of microsomal transfer protein (MTP), an intracellular lipid-transfer protein that is found in the lumen of the endoplasmic reticulum and is responsible for binding and shuttling individual lipid molecules between membranes.
Lomitapid je selektivni inhibitor mikrosomalnog transportnog proteina (MTP), unutarstaničnog transportnog proteina za prijenos lipida koji se nalazi u lumenu endoplazmatskog retikuluma, a odgovoran je za vezivanje i prebacivanje pjedinačnih molekula lipida između membrana.
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.
Klinički podaci upućuju na to da je nakupljanje masti u jetri reverzibilno nakon prekida liječenja Lojuxtom, ali ostaje nepoznato ima li histoloških posljedica, osobito nakon dugotrajne primjene.
• Women of childbearing potential should have adequate birth control and should tell their doctors immediately if they suspect they may be pregnant;
• Žene reproduktivne dobi trebaju na odgovarajući način sprječavati začeće i moraju odmah obavijestiti liječnike ako sumnjaju da bi mogle biti trudne.
• Advice on monitoring liver function (measuring hepatic enzymes and total bilirubin) before and during treatment with Lojuxta and routine screening to detect presence of steatohepatitis and hepatic fibrosis including specific details of the screening tests at baseline and annually as follows: - Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI), or magnetic resonance (MR) elastography; - Measurement of biomarkers and/or scoring methods.
• savjet o praćenju funkcije jetre (mjerenje jetrenih enzima i ukupnog bilirubina) prije i tijekom liječenja Lojuxtom i rutinskog probira kako bi se detektirala prisutnost steatohepatitisa i hepatičke fibroze uključujući specifične pojedinosti o testovima probira na početku te jednom godišnje, kako slijedi: - snimanje elastičnosti tkiva, npr. Fibroscan, ARFI (engl. acoustic radiation force impulse) ili elastografija magnetskom rezonancijom (MR); - mjerenje biomarkera i/ili metode bodovanja.
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
Znakovi i simptomi tegoba s jetrom uključuju: o mučninu o povraćanje o bol u trbuhu o bolove u mišićima o vrućicu o koža ili bjeloočnice postanu žute boje o umorniji ste nego inače o osjećate se kao da imate gripu
Number of Patients with Assessments >3 to ≤5 x ULN >5 to ≤10 x ULN >10 to ≤20 x ULN >20 x ULN
Broj bolesnika s procjenom > 3 do ≤ 5 x GGN > 5 do ≤ 10 x GGN > 10 do ≤ 20 x GGN > 20 x GGN
You also need to take daily vitamin E and essential fatty acid (omega-3 and omega-6) supplements while taking this medicine.
Također, dok uzimate ovaj lijek, svakodnevno morate uzimati dodatke prehrani (suplemente) vitamina E i esencijalnih masnih kiselina (omega-3 i omega-6).
Gastrointestinal adverse reactions occurred more frequently during the dose escalation phase of the study and decreased once patients established the maximum tolerated dose of lomitapide.
Gastrointestinalne nuspojave javljale su se u ispitivanju češće za vrijeme faze povećanja doze, a smanjivale su se kad je bolesnicima utvrđena maksimalna podnošljiva doza lomitapida.