natgillin/translations-raw huggingface dataset:
A food-effect study involving administration of this formulation of fenofibrate 145 mg tablets to healthy male and female subjects under fasting conditions and with a high fat meal indicated that exposure (AUC and Cmax) to fenofibric acid is not affected by food. 
V študiji učinka hrane na uporabo formulacije tablet s 145 mg fenofibrata pri zdravih moških in ženskah na tešče in po obroku z visoko vsebnostjo maščobe so ugotovili, da hrana ni vplivala na izpostavljenost (AUC in Cmax) fenofibrinski kislini.
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. 
Močni zaviralci citokroma P450 3A4 povečajo tveganje za miopatijo in rabdomiolizo zaradi povečanja koncentracije zaviralne aktivnosti HMG-CoA-reduktaze v plazmi med zdravljenjem s simvastatinom.
HIV protease inhibitors (e.g. nelfinavir) Nefazodone 
Zaviralci proteaze HIV (npr. nelfinavir) Nefazodon
Because rifampicin is a potent CYP 3A4 inducer that interferes with simvastatin metabolism, patients undertaking long-term rifampicin therapy (e.g. treatment of tuberculosis) may experience loss of efficacy of simvastatin. 
Ker je rifampicin močan induktor CYP 3A4, ki moti presnovo simvastatina, lahko pri bolnikih, ki se dolgotrajno zdravijo z rifampicinom (npr. zdravljenje tuberkuloze), učinkovitost simvastatina upade.
The availability of the beta-hydroxyacid to the systemic circulation following an oral dose of simvastatin was found to be less than 5% of the dose. 
Uporabnost betahidroksi kisline v sistemskem obtoku po peroralnem odmerku simvastatina je manj kot 5 % odmerka.
Therefore, Cholib is not expected to affect plasma concentrations of substances metabolised via CYP 3A4. 
Zato za zdravilo Cholib ne pričakujemo učinka na plazemske koncentracije snovi, ki se presnavljajo s CYP 3A4.
The combination F145/S40 showed superiority over S40 for LDL-C reduction only at 24 weeks from a non-significant additional 1.2% reduction of LDL-C at 12 weeks to a statistically significant 7.2% reduction at 24 weeks. 
Kombinacija F145/S40 se je izkazala za učinkovitejšo v primerjavi z S40 pri znižanju LDL-holesterola le po 24 tednih; z neznačilnega 1,2-odstotnega dodatnega znižanja LDL-holesterola po 12 tednih je po 24 tednih prišlo do statistično značilnega 7,2-odstotnega znižanja.
The adverse reactions of Cholib are in line with what is known from its two active substances: fenofibrate and simvastatin. 
Neželeni učinki zdravila Cholib so v skladu s tem, kar je znanega o obeh zdravilnih učinkovinah: fenofibratu in simvastatinu.
Maximum plasma concentration of active inhibitors is reached approximately 1-2 hours after administration of simvastatin. 
Aktivni zaviralci dosežejo najvišje ravni v plazmi v približno 1 do 2 urah po dajanju simvastatina.
Some patients have experienced the following serious side effects whilst taking fenofibrate or simvastatin (both active substances in Cholib): 
Pri določenih bolnikih so se pojavili naslednji resni neželeni učinki med jemanjem fenofibrata ali simvastatina (oba sta učinkovini v zdravilu Cholib):
Drugs or herbal products that inhibit certain enzymes (e.g. CYP3A4) and/or transporter (e.g. OATP1B) pathways may increase simvastatin and simvastatin acid plasma concentrations and may lead to an increased risk of myopathy/rhabdomyolysis. 
Zdravila ali pripravki rastlinskega izvora, ki zavirajo določene encime (npr. CYP3A4) in/ali poti prenašalcev (npr. OATP1B), lahko povečajo koncentracije simvastatina in/ali simvastatinske kisline v plazmi ter povečajo tveganje za miopatijo/rabdomiolizo.
(medicine for lowering fat levels in the blood) 
(zdravilo za zniževanje ravni maščob v krvi),
No unchanged fenofibrate can be detected in the plasma. 
Nespremenjenega fenofibrat v plazmi ne zaznamo.
Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Cholib. 
Vaš zdravnik bo morda želel, da opravite krvne preiskave za spremljanje delovanja jeter tudi po začetku jemanja zdravila Cholib.
IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment. 
Klinična znaka IMNM sta dolgotrajna oslabelost proksimalnih mišic in povišana vrednost serumske kreatin kinaze, ki kljub ukinitvi zdravljenja s statini ne izzvenita.
• elbasvir or grazoprevir (used to treat hepatitis C virus infection) 
• elbasvir ali grazoprevir (zdravili za zdravljenje okužbe z virusom hepatitisa C).
• If you are allergic to fenofibrate or simvastatin or any of the other ingredients of Cholib (listed in section 6) 
• če ste alergični na fenofibrat ali simvastatin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Intake of grapefruit juice during treatment with Cholib should therefore be avoided. 
Uživanju grenivkinega soka med zdravljenjem z zdravilom Cholib se je zato treba izogniti.
Statin 6 weeks run-in 
Študija 6-tedensko uvajanje statina
Physicians contemplating combined therapy with Cholib and lipid-modifying doses (≥ 1 g/day) of niacin (nicotinic acid) or medicinal products containing niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased. 
Zdravniki, ki načrtujejo kombinirano terapijo z zdravilom Cholib in lipide modificirajočimi odmerki (≥ 1 g/dan) niacina (nikotinske kisline) ali zdravili, ki vsebujejo niacin, morajo skrbno pretehtati možne koristi in tveganja ter natančno spremljati bolnike glede znakov in simptomov mišičnih bolečin, občutljivosti ali šibkosti, zlasti v prvih mesecih zdravljenja in po povečanju odmerka enega ali drugega zdravila.
• Unexplained muscle pain, tenderness, or weakness may be sign of muscle break down. 
• Nepojasnjene bolečine v mišicah, občutljivost ali šibkost mišic so lahko znaki razpadanja mišic.
Cholib has not been studied in patients with hepatic impairment and is therefore contraindicated in this population (see section 4.3). 
Zdravilo Cholib ni bilo preučeno pri bolnikih z okvarjenim delovanjem jeter, zato je v tej populaciji kontraindicirano (glejte poglavje 4.3.
As simvastatin is contraindicated during pregnancy (see hereafter), Cholib is contraindicated during pregnancy (see section 4.3). 
Ker je simvastatin med nosečnostjo kontraindiciran (glejte nadaljevanje), je zdravilo Cholib kontraindicirano med nosečnostjo (glejte poglavje 4.3).
Because the dose of simvastatin should not exceed 10 mg daily in patients taking ciclosporin, the co-administration of Cholib with ciclosporin is contraindicated (see section 4.3). 
Ker odmerek simvastatina pri bolnikih, ki jemljejo ciklosporin, ne sme preseči 10 mg na dan, je sočasna uporaba zdravila Cholib in ciklosporina kontraindicirana (glejte poglavje 4.3).
Inhibitors of Breast Cancer Resistant Protein (BCRP) Concomitant administration of medicinal products that are inhibitors of BCRP, including products containing elbasvir or grazoprevir, may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy (see sections 4.2 and 4.4). 
Zaviralci proteina odpornosti pri raku dojke (BCRP) Sočasno dajanje zdravil, ki so zaviralci BCRP, vključno z zdravili, ki vsebujejo elbasvir ali grazoprevir, lahko zviša koncentracijo simvastatina v plazmi in poveča tveganje miopatije (glejte poglavji 4.2 in 4.4).
% Change Mean (SD) 
Povprečna sprememba v % (SD)
This was not significantly different from the 29% (90% CI 22%-35%) reduction in AUC of SVA observed when co-administration was 12 hours apart: simvastatin 40 mg in the evening and fenofibrate 145 mg in the morning. 
To ni bilo pomembno drugače od 29-odstotnega zmanjšanja AUC SVK (90-odstotni IZ 22 %-35 %), ki so ga opazili, ko so zdravili dajali z razmakom 12 ur: simvastatin 40 mg zvečer in fenofibrat 145 zjutraj.
Studies with fenofibrate on lipoprotein fractions show decreases in levels of LDL and VLDL cholesterol (VLDL-C). 
Študije učinkovanja fenofibrata na lipoproteinske frakcije kažejo, da se ravni LDL-holesterola in VLDL-holesterola znižajo.
• muscle weakness that is constant 
• stalna oslabelost mišic,
Treatment emergent adverse reactions reported in patients receiving co-administration of fenofibrate and simvastatin occurring are listed below by system organ class and frequency. 
Neželeni učinki, ki so se pojavili med zdravljenjem bolnikov, ki so sočasno prejemali fenofibrat in simvastatin, so v nadaljevanju navedeni po organskih sistemih in pogostnosti.
Fenofibric acid is not eliminated by hemodialysis. 
Fenofibrinske kisline ni mogoče odstraniti s hemodializo.
There have been reports of myopathy and rhabdomyolysis with the concomitant administration of colchicine and simvastatin in patients with renal insufficiency. 
Poročali so o miopatiji in rabdomiolizi pri sočasni uporabi kolhicina in simvastatina pri bolnikih z ledvično insuficienco.
This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, an induced pancreatic enzymes increase or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct. 
Ta pojav lahko predstavlja neučinkovitost pri bolnikih s hudo hipertrigliceridemijo, inducirano zvišanje encimov trebušne slinavke ali pojav, ki je posledica nastanka žolčnega kamna ali grudice, ki zapre skupni žolčni vod.
Amiodarone, amlodipine, diltiazem and verapamil The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, amlodipine, diltiazem or verapamil with simvastatin 40 mg per day. 
Amiodaron, amlodipin, diltiazem in verapamil Pri sočasni uporabi amiodarona, amlodipina, diltiazema ali verapamila s simvastatinom v odmerku 40 mg na dan se poveča tveganje za miopatijo in rabdomiolizo.
Concomitant administration of products that are inhibitors of BCRP (e.g., elbasvir and grazoprevir) may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy; therefore, a dose adjustment of simvastatin should be considered depending on the prescribed dose. 
Sočasno zdravljenje z zdravili, ki so zaviralci BCRP (npr. elbasvir in grazoprevir), lahko zviša koncentracijo simvastatina v plazmi in poveča tveganje miopatije, zato je treba razmisliti o prilagoditvi odmerka simvastatina glede na predpisani odmerek.
Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations. 
Za simvastatin je dokazano znižanje normalnih in zvišanih ravni LDL-holesterola.
Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin and increase the risk of myopathy and rhabdomyolysis. 
Zmanjšano delovanje transportnih proteinov OATP v jetrih lahko zveča sistemsko izpostavljenost simvastatinu in zveča tveganje za miopatijo in rabdomiolizo.
Severe cutaneous reactions (e.g erythema multiforme, Ste vens-Johnson syndrome, toxic epidermal necrolysis, etc.) 
Bolezni kože in podkožja hude reakcije na koži (npr. multiformni eritem, Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, itd.)
Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). 
Bolezen se kaže z dispnejo, neproduktivnim kašljem in poslabšanjem splošnega zdravja (utrujenost, izguba telesne mase in zvišana telesna temperatura).
During four double blind clinical trials of 24-week duration 1,237 patients have received treatment with co-administered fenofibrate and simvastatin. 
V štirih dvojno slepih kliničnih preskušanjih, ki so trajala 24 tednov, je 1.237 bolnikov sočasno prejemalo fenofibrat in simvastatin.
Mylan Laboratories SAS Route de Belleville - Lieu-dit Maillard 01400 Châtillon-sur-Chalaronne France 
Mylan Laboratories SAS Route de Belleville - Lieu-dit Maillard 01400 Châtillon-sur-Chalaronne Francija
Increased blood homocysteine level ***** In the FIELD study the average increase in blood homocysteine level in patients treated with fenofibrate was 6.5 µmol/L, and was reversible on discontinuation of fenofibrate treatment. 
Zvišana raven homocisteina v krvi ***** V študiji FIELD se je raven homocisteina v krvi bolnikov, zdravljenih s fenofibratom, v povprečju zvišala za 6,5 µmol/l.
Reversible effects on fertility have been observed in animals (see section 5.3). 
Pri živalih so ugotovili reverzibilne vplive na plodnost (glejte poglavje 5.3).
Whether fenofibrate had an effect on other active metabolites of simvastatin was not investigated. 
Morebitnega učinka fenofibrata na druge aktivne presnovke simvastatina niso preučevali.
The use of micronised fenofibrate and NanoCrystal® technology for the formulation of the fenofibrate 145 mg tablet enhances its absorption. 
Uporaba mikroniziranega fenofibrata in tehnologije NanoCrystal pri izdelavi tablet s 145 mg fenofibrata absorpcijo pospeši.
In the other study [Bergman et al, 2004] repeated co-administration of both simvastatin 80 mg and fenofibrate 160 mg led to a reduction in the AUC of the SVA of 36% (90% CI 30%-42%). 
V drugi študiji [Bergman in sod., 2004] je večkratno sočasno dajanje simvastatina 80 mg in fenofibrata 160 mg zmanjšalo vrednost AUC SVK za 36 % (90-odstotni IZ 30 %-42 %).
Only anecdotal cases of fenofibrate overdose have been received. 
Obstajajo samo poročila o nepotrjenih primerih prevelikega odmerjanja fenofibrata.
Immune-mediated necrotizing myopathy (IMNM) 
Imunsko pogojena nekrotizirajoča miopatija (IMNM)
Blood creatinine increased (see sections 4.3 and 4.4) 
Preiskave zvišana raven kreatinina v krvi (glejte poglavji 4.3 in 4.4)
• you have severe lung disease 
• imate hudo bolezen pljuč,
Effects of repeated administration of fenofibrate on the pharmacokinetics of single or multiple doses of simvastatin have been investigated in two small studies (n=12) followed by a larger one (n=85) in healthy subjects. 
Učinke večkratnega dajanja fenofibrata na farmakokinetiko enkratnega ali večkratnih odmerkov simvastatina so preučevali na zdravih osebah v dveh manjših študijah (n=12), ki jima je sledila večja študija (n=85).
Cholib contains types of sugars called lactose and sucrose. 
Zdravilo Cholib vsebuje sladkorja, imenovana laktoza in saharoza.
The corresponding risk is 0.3% in patients having the most common genotype (TT) (See section 
Tveganje pri bolnikih z najpogostejšim genotipom (TT) je 0,3 % (glejte poglavje 5.2).
As this medicinal product contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 
Ker to zdravilo vsebuje saharozo, bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkljivostjo saharaze-izomaltaze, tega zdravila ne smejo jemati.
Mean Percent Change from Baseline to 12 Weeks Full Analysis Subject Sample 
Povprečna odstotna sprememba po 12 tednih od izhodišča Celotna analiza vzorca preiskovancev
If it is suspected a patient has developed interstitial lung disease, Cholib therapy should be discontinued. 
Če pri bolniku sumite na intersticijsko pljučno bolezen, je treba zdravljenje z zdravilom Cholib prekiniti.
Additional information on the individual active substances of the fixed dose combination Additional adverse reactions associated with the use of medicinal products containing simvastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Cholib are listed below. 
Dodatne informacije o posameznih učinkovinah v fiksni kombinaciji odmerkov V nadaljevanju so navedeni dodatni neželeni učinki, ki so povezani z uporabo zdravil, ki vsebujejo simvastatin ali fenofibrat, in so bili ugotovljeni v kliničnih preskušanjih ali v obdobju trženja zdravila, ki se lahko pojavijo pri uporabi zdravila Cholib.
Paediatric population Cholib is contraindicated in children and adolescents up to 18 years old. 
Pediatrična populacija Zdravilo Cholib je kontraindicirano pri otrocih in mladostnikih do 18 let (glejte poglavje 4.3).
• complications of gall stones such as colic because of stones in bile duct, infection of the bile ducts or gall bladder 
• zapleti zaradi žolčnih kamnov, kot je kolika zaradi kamnov v žolčevodu, okužba žolčevoda ali žolčnika,
Therefore, the co-administration of Cholib with gemfibrozil, other fibrates, or statins is contraindicated (see section 4.3). 
Zato je sočasna uporaba zdravila Cholib in gemfibrozila, drugih fibratov ali statinov kontraindicirana (glejte poglavje 4.3).
Therefore it is recommended to monitor HDL-C if Cholib is co-administered with a glitazone and stopping either therapy if HDL-C is too low. 
Zato je priporočljivo spremljati HDL-holesterol, če se zdravilo Cholib uporablja sočasno z glitazonom, in ukiniti eno od zdravil, če je raven HDL-holesterola prenizka.
• anticoagulants such as warfarin, fluindione, phenprocoumone or acenocoumarol 
• antikoagulanti, kot so varfarin, fluindion, fenprokumon ali acenokumarol (zdravila za preprečevanje strjevanja krvi),
No effects on fertility were detected in non-clinical reproductive toxicity studies conducted with fenofibrate. 
Učinka na plodnost niso zaznali tudi v nekliničnih študijah učinkov fenofibrata na razmnoževanje.
Simva 40 (N=505) Mean (SD) 
Simva 40 (N=505) Povprečje (SD)
• pioglitazone (a particular class of medicines to treat diabetes) 
• pioglitazon (posebna skupina zdravil za zdravljenje sladkorne bolezni),
The most commonly reported adverse drug reactions (ADRs) during Cholib therapy are increased blood creatinine, upper respiratory tract infection, increased platelet count, gastroenteritis and increased alanine- aminotransferase. 
Najpogosteje navedeni neželeni učinki med zdravljenjem z zdravilom Cholib so zvišana raven kreatinina v krvi, okužba zgornjih dihal, zvišano število trombocitov, gastroenteritis in zvišana raven alanin-aminotransferaze.
If treatment with itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with Cholib must be suspended during the course of treatment. 
Če se zdravljenju z itrakonazolom, ketokonazolom, posakonazolom, eritromicinom, klaritromicinom ali telitromicinom ni mogoče izogniti, je treba med terapijo zdravljenje z zdravilom Cholib začasno prekiniti.
Cases of myopathy/rhabdomyolysis have been associated with concomitant administration of statins and niacin (nicotinic acid) at lipid-modifying doses (≥ 1 g/day), knowing that niacin and statins can cause myopathy when given alone. 
Primere miopatije/rabdomiolize so povezali s sočasno uporabo statinov in niacina (nikotinske kisline) v lipide modificirajočih odmerkih (≥ 1 g/dan), čeprav lahko niacin in statini povzročijo miopatijo tudi pri samostojni uporabi.
TG, LDL-C and HDL-C Percent Change from Baseline to 12 and 24 Weeks Full Analysis Subject Sample 
Odstotna sprememba TG, LDL-holesterola in HDL-holesterola po 12 in 24 tednih od izhodišča Celotna analiza vzorca preiskovancev
Simvastatin is a substrate of CYP 3A4 and of the efflux transporter BCRP. 
Simvastatin je substrat CYP 3A4 in izločevalnega prenašalca BCRP.
• you have an underactive thyroid gland (hypothyroidism) 
• imate premalo delujočo ščitnico (hipotiroidizem),
Simvastatin is a substrate of cytochrome P450 3A4. 
Simvastatin je substrat citokroma P450 3A4.
Fenofibrate is not a substrate for CYP 3A4. 
Fenofibrat ni substrat CYP 3A4.
The risk of myopathy is increased by high levels of HMG CoA reductase inhibitory activity in plasma (i.e., elevated simvastatin and simvastatin acid plasma levels), which may be due, in part, to interacting drugs that interfere with simvastatin metabolism and/or transporter pathways (see section 
Tveganje za miopatijo je povečano zaradi visokih ravni zaviralne aktivnosti HMG-CoA-reduktaze v plazmi (tj. zvišane ravni simvastatina in simvastatinske kisline v plazmi), kar je deloma lahko posledica medsebojnega delovanja zdravil, ki vplivajo na presnovo simvastatina in/ali poti prenašalcev (glejte poglavje 4.5).
not known 
redki neznana
Myopathy ** In a clinical trial, myopathy occurred commonly in patients treated with simvastatin 80 mg/day compared to patients treated with 20 mg/day (1.0% vs 0.02%, respectively). 
Miopatija **V kliničnem preskušanju se je miopatija pogosto pojavljala pri bolnikih, ki so prejemali simvastatin 80 mg na dan, v primerjavi z bolniki, ki so prejemali 20 mg/dan (1,0 % v primerjavi z 0,02 %).
Upper respiratory tract infection, Gastroenteritis 
Infekcijske in parazitske bolezni okužba zgornjih dihal, gastroenteritis pogosti
In elderly patients, the fenofibric acid apparent total plasma clearance is not modified. 
Pri starostnikih navidezni skupni plazemski očistek fenofibrinske kisline ni spremenjen.
Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - France. 
Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - Francija
Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy. 
Zdravilo Cholib je indicirano kot pomožna terapija k dieti in telesni vadbi pri bolnikih z velikim tveganjem srčno-žilnih bolezni z mešano dislipidemijo za zmanjšanje ravni trigliceridov in zvišanje ravni HDL-holesterola, če so ravni LDL-holesterola primerno obvladane z ustreznim odmerkom simvastatina v monoterapiji.
Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30 kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. 
Bolnike s tveganjem (raven glukoze na tešče od 5,6 do 6,9 mmol/l, ITM >30 kg/m2, zvišane ravni trigliceridov, hipertenzija) je treba spremljati klinično in biokemijsko v skladu z veljavnimi smernicami.
The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. 
Bolnikom je treba naročiti, da v primeru mišične šibkosti, bolečine ali občutljivosti takoj poiščejo zdravniško pomoč.
Cholib The respective effects of simvastatin and fenofibrate are complementary. 
Zdravilo Cholib Učinki simvastatina in fenofibrata so dopolnjujejo.
As this medicinal product contains lactose, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Ker to zdravilo vsebuje laktozo, bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze, tega zdravila ne smejo jemati.
Diabetes mellitus ****Diabetes mellitus: Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30 kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. 
Sladkorna bolezen **** Sladkorna bolezen: Bolnike s tveganjem (raven glukoze na tešče od 5,6 do 6,9 mmol/l, ITM >30 kg/m2, zvišane ravni trigliceridov, hipertenzija) je treba spremljati klinično in biokemijsko v skladu z veljavnimi smernicami.
• elevations in blood tests of liver function (transaminases) 
• zvišane vrednosti krvnih preiskav delovanja jeter (transaminaze),
No interaction studies have been performed with Cholib. 
Študij medsebojnega delovanja z zdravilom Cholib niso izvedli.
In a pooled analysis of these four trials, the rate of discontinuation due to treatment emergent adverse reactions was 5.0% (51 subjects on 1012) after 12 weeks of treatment with fenofibrate and simvastatin 145 mg/20 mg per day and 1.8% (4 subjects on 225) after 12 weeks of treatment with fenofibrate and simvastatin 145 mg/40 mg per day. 
V združeni analizi teh štirih preskušanj je bila stopnja prekinitve zaradi neželenih učinkov, ki so se pojavili med zdravljenjem, 5,0 % (51 preiskovancev od 1012) po 12 tednih zdravljenja s fenofibratom in simvastatinom 145 mg/20 mg na dan in 1,8 % (4 preiskovanci od 225) po 12 tednih zdravljenja s fenofibratom in simvastatinom 145 mg/40 mg na dan.