natgillin/translations-raw huggingface dataset:
This leaflet was last revised in <{MM/YYYY}>. 
Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
This medicinal product contains sunset yellow FCF (E110) that may cause allergic reactions. 
To zdravilo vsebuje barvilo sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
Creatine Kinase should not be measured following strenuous exercise or in the presence of any plausible alternative cause of Creatine Kinase increase as this makes value interpretation difficult. 
Kreatin-kinaze ne merite po naporni telesni vadbi ali v prisotnosti katerega koli morebitnega drugega vzroka zvišanja ravni kreatin-kinaze, saj to zelo oteži interpretacijo.
Do not take fusidic acid (a medicine for bacterial infections) while using this medicine. 
Med jemanjem tega zdravila ne jemljite fusidne kisline (zdravilo za bakterijske okužbe).
Animal studies have shown embryo-toxic effects at doses in the range of maternal toxicity (see section 5.3). 
Študije pri živalih so pokazale embriotoksične učinke odmerkov v razponu toksičnosti pri materi (glejte poglavje 5.3).
The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins. 
Skupni učinek je znižanje razmerja med lipoproteini nizke gostote in zelo nizke gostote ter lipoproteini visoke gostote.
Posology The recommended dose is one tablet per day. 
Priporočeni odmerek je ena tableta na dan.
Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis. 
Previdnost je potrebna pri bolnikih z dejavniki nagnjenosti k rabdomiolizi.
ANCOVA (analysis of covariance) of Percent Change in TC, non-HDL-C, ApoAI, ApoB, ApoB/ApoAI and fibrinogen from Baseline to 24 Weeks - Full Analysis Subject Sample Parameter 
ANCOVA (analiza kovariance) odstotne spremembe skupnega holesterola, ne-HDL-holesterola, ApoAI, ApoB, ApoB/ApoAI in fibrinogena po 24 tednih od izhodišča - celotna analiza vzorca preiskovancev
LDL and VLDL triglycerides are reduced. 
Ravni LDL- in VLDL-trigliceridov se znižajo.
Statin therapy may be re-introduced seven days after the last dose of fusidic acid. 
Zdravljenje s statini se lahko nadaljuje sedem dni po zadnjem odmerku fusidne kisline.
Pancreatitis has been reported in patients taking fenofibrate (see sections 4.3 and 4.8). 
Poročali so o pankreatitisu pri bolnikih, ki jemljejo fenofibrat (glejte poglavji 4.3 in 4.8).
• infection of the upper respiratory tract 
• okužba zgornjih dihal.
Therapy with Cholib should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes. 
Zdravljenje z zdravilom Cholib je treba začasno prekiniti nekaj dni pred načrtovanim velikim kirurškim posegom ali če se nepričakovano pojavi pomembno bolezensko ali kirurško stanje.
If you get pregnant while taking Cholib, stop taking it immediately and contact your doctor. 
Če zanosite med zdravljenjem z zdravilom Cholib, nemudoma prekinite jemanje in se posvetujte s svojim zdravnikom.
Treatment with simvastatin must be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant. 
Zdravljenje s simvastatinom je treba začasno prekiniti za čas nosečnosti ali do izključitve nosečnosti.
Fenofibrate and simvastatin are not inhibitors of CYP 2D6, CYP 2E1, or CYP 1A2. 
Fenofibrat in simvastatin nista zaviralca CYP 2D6, CYP 2E1 ali CYP 1A2.
Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p=0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069). 
V drugi analizi vnaprej določene podskupine so ugotovili statistično pomembno interakcijo med zdravljenjem in spolom (p = 0,01), ki kaže morebitno korist zdravljenja s kombinacijo pri moških (p = 0,037), vendar možno večje tveganje za primarni izid pri ženskah, ki so se zdravile s kombinacijo, v primerjavi z zdravljenjem samo s simvastatinom (p = 0,069).
In addition, simvastatin moderately increases HDL-C and reduces plasma TG. 
Poleg tega simvastatin zmerno zviša HDL-holesterol in zniža plazemske ravni TG.
Carriers of the SLCO1B1 gene c.521T>C allele have lower OATP1B1 activity. 
Nosilci alela c.521T>C gena SLCO1B1 imajo manjšo aktivnost OATP1B1.
Monitor patients for any signs and symptoms of muscle pain, tenderness or weakness 
Bolnike spremljajte za znake in simptome mišičnih bolečin, občutljivosti ali šibkosti.
In most people, there are no signs of cholesterol or triglycerides problems at first. 
Pri večini ljudi nenormalna raven holesterola ali trigliceridov sprva ne povzroča nobenih bolezenskih znakov.
• hypersensitivity (allergic) reactions including swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema) (rare) 
• preobčutljivostne (alergijske) reakcije, vključno z/s: otekanjem obraza, jezika in grla, kar lahko povzroči težave pri dihanju (angioedem) (redki),
• Concomitant administration of fibrates, statins, danazol, ciclosporin or potent cytochrome 
• Sočasna uporaba fibratov, statinov, danazola, ciklosporina ali močnih zaviralcev citokroma
Consult the prescribing information of all concomitantly used drugs to obtain further information about their potential interactions with simvastatin and/or the potential for enzyme or transporter alterations and possible adjustments to dose and regimens. 
Glejte navodila za predpisovanje vseh sočasno uporabljenih zdravil, da se boste dobili več informacij o morebitnem medsebojnem delovanju teh zdravil s simvastatinom in/ali o možnosti spreminjanja encimov ali prenašalcev, dobili pa boste tudi več informacij o morebitnih prilagoditvah odmerkov in režimov.
Although the mechanism is not fully understood, ciclosporin has been shown to increase the plasma exposure (AUC) to simvastatin acid, presumably due in part to inhibition of CYP 3A4 and OATP-1B1 transporter. 
Čeprav mehanizem ni popolnoma pojasnjen, so dokazali, da ciklosporin poveča plazemsko izpostavljenost (AUC) simvastatinski kislini, verjetno delno zaradi zaviranja CYP 3A4 in prenašalca OATP-1B1.
Do not take Cholib if any of above applies to you. 
Zdravila Cholib ne smete jemati, če se kaj od zgoraj naštetega nanaša na vas.
• feeling exhausted (astenia) 
• utrujenost (astenija),
In patients with SLCO1B1 polymorphism there is a risk of increased exposure of simvastatin, which may lead to an increased risk of rhabdomyolysis (see section 4.4). 
Pri bolnikih s polimorfizmom SLCO1B1 obstaja tveganje za povečano izpostavljenost simvastatinu, ki lahko privede do zvečanega tveganja za rabdomiolizo (glejte poglavje 4.4.
In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended. 
V teh primerih je treba pretehtati tveganje zdravljenja v primerjavi z možno koristjo.
• you or a close family member have a muscle problem which runs in the family 
• imate sami ali bližnji družinski član mišično bolezen, ki je dedna,
Cholib contains soya lecithin. 
Zdravilo Cholib vsebuje sojin lecitin.
• Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in section 6.1 (see also section 4.4) 
• Preobčutljivost na učinkovini, arašide, sojo ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte tudi poglavje 4.4)
The major metabolites of simvastatin present in human plasma are the beta-hydroxyacid and four additional active metabolites. 
Poglavitni presnovki simvastatina v človeški plazmi so betahidroksi kislina in še štirje drugi aktivni presnovki.
The risk of muscle toxicity may be increased if Cholib is administered with another fibrate, statin, niacin, fusidic acid or other specific concomitant substances (for specific interactions see section 4.5). 
Tveganje toksičnosti za mišičje se lahko poveča, če se zdravilo Cholib daje z drugim fibratom, statinom, niacinom, fusidno kislino ali drugimi specifičnimi snovmi (za specifične interakcije glejte poglavje 4.5).
Pharmacotherapeutic group: Lipid modifying substances, HMG-CoA reductase inhibitors in combination with other lipid modifying substances, ATC code: C10BA04 
Farmakoterapevtska skupina: zdravila za spreminjanje ravni serumskih lipidov, zaviralci reduktaze HMG-CoA v kombinaciji z drugimi zdravili za spreminjanje serumske ravni lipidov, oznaka ATC: C10BA04
Prescribing recommendations for interacting substances are summarised in the table below (see also sections 4.2 and 4.3). 
Priporočila za predpisovanje zdravil, ki lahko privedejo do interakcij, so povzeta v spodnji preglednici (glejte tudi poglavja 4.2 in 4.3).
What Cholib is and what it is used for What you need to know before you take Cholib How to take Cholib 
Kaj je zdravilo Cholib in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Cholib Kako jemati zdravilo Cholib Možni neželeni učinki
Response to therapy should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)). 
Odziv na zdravljenje je treba spremljati z določanjem ravni lipidov v serumu (skupni holesterol (TC), LDL-holesterol, trigliceridi (TG)).
LDL is formed from very-low-density protein (VLDL) and is catabolised predominantly by the high affinity LDL receptor. 
LDL se tvori iz proteinov zelo nizke gostote (VLDL) in katabolizira predvsem preko visokoafinitetnega receptorja LDL.
Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate. 
V študijah kinetike po dajanju enega odmerka in neprekinjenega zdravljenja so dokazali, da se zdravilo ne kopiči.
Do not exceed one Cholib 145 mg/20 mg per day, unless clinical benefit outweigh the risk 
Ne smete preseči odmerka ene tablete zdravila Cholib 145 mg/20 mg na dan, razen če klinična korist odtehta tveganje.
The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5,518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin. 
Preskušanje za lipide Action to Control Cardiovascular Risk in Diabetes (ACCORD) je bila randomizirana, s placebom kontrolirana študija 5518 bolnikov s sladkorno boleznijo tipa 2, ki so bili zdravljeni s fenofibratom in simvastatinom.
They are both used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. 
Obe učinkovini se uporabljata za nižanje ravni skupnega holesterola, „slabega“ holesterola (holesterola LDL) in maščobnih snovi v krvi, imenovanih trigliceridi.
Therefore, close clinical monitoring of such patients taking colchicine and Cholib is advised. 
Zato je priporočljivo natančno spremljanje bolnikov, ki jemljejo kolhicin in zdravilo Cholib.
• If you have liver or gallbladder problems 
• če imate težave z jetri ali žolčnikom,
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen 
• Znana alergija na svetlobo ali fototoksična reakcija med zdravljenjem s fibrati ali ketoprofenom
Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPAR). 
Fenofibrat je derivat fibrinske kisline, katerega učinek spreminjanja ravni lipidov pri človeku naj bi posredovala aktivacija s peroksisomskim proliferatorjem aktiviranega receptorja tipa alfa (PPARα).
If the dose of Cholib is changed or discontinued, the same procedure should be repeated. 
Če odmerek zdravila Cholib spremenite ali zdravljenje prekinete, spet izvedite ta postopek.
There are no clinical data on fertility from the use of Cholib. 
Kliničnih podatkov o plodnosti pri uporabi zdravila Cholib ni.
This adverse reaction should be taken into account when driving vehicles or using machines under Cholib therapy. 
Ta neželeni učinek je treba upoštevati pri vožnji in upravljanju s stroji med zdravljenjem z zdravilom Cholib.
Cholib must not be given to children and adolescents (age below 18 years). 
Otroci in mladostniki (mlajši od 18 let) ne smejo jemati zdravila Cholib.
Sleep disorder, including nightmares, depression not known 
Psihiatrične motnje nespečnost zelo redki motnje spanja, vključno z nočnimi morami, depresija neznana
Patients receiving co-administration of Cholib and drugs metabolised by CYP 2C19, CYP 2A6, or especially CYP 2C9 with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended. 
Priporočljivo je, da se bolnike, ki sočasno uporabljajo zdravilo Cholib in zdravila, ki se presnavljajo s CYP 2C19, CYP 2A6 in zlasti CYP 2C9 z ozkim terapevtskim indeksom, natančno spremlja in se jim po potrebi prilagodi odmerek teh zdravil.
There have been reports of rhabdomyolysis (including some fatalities) in patients receiving a statin in combination with fusidic acid (see section 4.5). 
Obstajajo poročila o rabdomiolizi (tudi o nekaj smrtnih primerih) pri bolnikih, ki so prejemali statin v kombinaciji s fusidno kislino (glejte poglavje 4.5).
Through activation of PPAR, fenofibrate activates lipoprotein lipase production and reduces production of apoprotein CIII. 
Fenofibrat preko aktivacije PPARα sproži tvorbo lipoproteinske lipaze in zmanjša tvorbo apoproteina CIII.
Other medicines and Cholib: 
Druga zdravila in zdravilo Cholib
Fibrinogen* (g/L) Feno 145 + Simva 40 
Fibrinogen* (g/l) feno 145 +
• Known gallbladder disease 
• Znana bolezen žolčnika
If you have taken more Cholib than you should or if someone else has taken your medicine, tell your doctor or pharmacist or contact your nearest hospital 
Če ste vzeli večji odmerek zdravila Cholib, kot bi smeli Če ste vzeli večji odmerek zdravila Cholib, kot bi smeli, ali če kdo drug vzame vaše zdravilo, se posvetujte s svojim zdravnikom, farmacevtom ali najbližjo bolnišnico.
Gemfibrozil increases the AUC of simvastatin acid by 1.9-fold, possibly due to inhibition of the glucuronidation pathway. 
Gemfibrozil poveča AUC simvastatinske kisline za 1,9-krat, morda zaradi zaviranja glukuronidacijske poti.
If a patient has previously experienced a muscle disorder on a fibrate or a statin, treatment with a different member of the class should only be initiated with caution. 
Če se je pri bolniku prej pojavila mišična bolezen med zdravljenjem s fibratom ali statinom, je treba zdravljenje z drugim predstavnikom tega razreda zdravil uvesti s previdnostjo.
In a clinical trial, myopathy was reported in 6% of patients receiving simvastatin 80 mg and amiodarone, versus 0.4% in patients on simvastatin 80 mg only. 
V kliničnem preskušanju so o miopatiji poročali pri 6 % bolnikov, ki so prejemali simvastatin 80 mg in amiodaron, in pri 0,4 % bolnikov, ki so prejemali samo simvastatin 80 mg.
Fenofibrate is a mild to moderate inhibitor of CYP 2C9 and a weak inhibitor of CYP 2C19 and CYP 2A6. 
Fenofibrat je blag do zmeren zaviralec CYP 2C9 in šibek zaviralec CYP 2C19 in CYP 2A6.
• cramps or painful, tender or weak muscles - these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death 
• krči ali boleče, občutljive ali šibke mišice - to so lahko znaki vnetja ali razpadanja mišic, ki lahko povzroči poškodbe ledvic ali celo smrt,
As well as the medicines listed previously, tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines: 
Kot pri zdravilih, naštetih zgoraj, obvestite zdravnika ali farmacevta tudi, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli od naslednjih zdravil:
Some evidence suggests that statins as a class raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. 
Nekateri podatki nakazujejo, da statini kot razred zdravil zvišajo raven glukoze v krvi, pri določenih bolnikih z visokim tveganjem za razvoj sladkorne bolezni pa lahko povzročijo hiperglikemijo, ki zahteva uradno obravnavo sladkorne bolezni.
The tablets are provided in carton boxes with blisters containing 10, 30 or 90 tablets. 
Tablete so v kartonskih škatlah s pretisnimi omoti po 10, 30 ali 90 tablet.
Fenofibrate Acute toxicity studies have yielded no relevant information about specific toxicity of fenofibrate. 
Fenofibrat V študijah akutne toksičnosti niso ugotovili pomembnih informacij o specifični toksičnosti fenofibrata.
Cholib is used in adults at high risk of problems like heart attack and stroke who have high blood levels of 2 types of fats (triglycerides and LDL cholesterol). 
Zdravilo Cholib se uporablja pri odraslih bolnikih z velikim tveganjem za težave, kot sta srčni infarkt in možganska kap, ki imajo zvišane ravni dveh vrst maščob (trigliceridov in holesterola LDL).
The pharmacokinetics of single and multiple doses of simvastatin showed that no accumulation of medicinal product occurred after multiple dosing. 
Farmakokinetika enkratnega in večkratnih odmerkov simvastatina kaže, da se po večkratnih odmerkih zdravilo ne akumulira.
In exceptional circumstances, where prolonged systemic fusidic acid is needed e.g. for the treatment of severe infections, the need for co-administration of Cholib and fusidic acid should only be considered on a case by case basis and under close medical supervision. 
V izjemnih okoliščinah, kadar je potrebno daljše sistemsko zdravljenje s fusidno kislino, npr. za zdravljenje hujših okužb, se potreba po sočasnem dajanju zdravila Cholib in fusidne kisline ocenjuje od primera do primera, zdravljenje pa se izvaja pod strogim zdravniškim nadzorom.
Other statins and fibrates 
Drugi statini in fibrati
• If while taking other medicines, you have had an allergic reaction or skin damage from sunlight or UV light (these medicines include other fibrates and an anti-inflammatory medicine called “ketoprofen”) 
• če ste med jemanjem drugih zdravil imeli alergijsko reakcijo ali kožno reakcijo na sončno ali UV svetlobo (med ta zdravila spadajo drugi fibrati in protivnetno zdravilo, imenovano „ketoprofen“),
INR should be determined before starting Cholib and frequently enough during early therapy to ensure that no significant alteration of INR occurs. 
Na začetku zdravljenja pa je treba vrednost INR določati dovolj pogosto, da se preprečijo pomembne spremembe vrednosti INR.
Creatine kinase measurement 
Meritve kreatin-kinaze
Some cases of reversible paradoxical reduction of HDL-C have been reported during concomitant administration of fenofibrate and glitazones. 
Poročali so o določenih primerih reverzibilnega paradoksalnega znižanja ravni HDL-holesterola pri sočasni uporabi fenofibrata in glitazonov.
• Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous statin treatment (see section 4.4) 
• Osebna anamneza miopatije in/ali rabdomiolize pri jemanju statinov in/ali fibratov ali potrjeno zvišanje ravni kreatin-fosfokinaze nad 5-kratnik zgornje normalne meje (ULN) pri prejšnjem zdravljenju s statini (glejte poglavje 4.4)
Concomitant intake of large quantities (over 1 liter daily) of grapefruit juice and simvastatin resulted in a 7-fold increase in plasma exposure to simvastatin acid. 
Sočasen vnos velikih količin grenivkinega soka (več kot 1 liter dnevno) in simvastatina privede do 7-kratnega povečanja plazemske izpostavljenosti simvastatinski kislini.
• Pregnancy and breast-feeding (see section 4.6) 
• Nosečnost in dojenje (glejte poglavje 4.6)
Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if aspartate aminotransferase (AST) or also known as serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) or also known as serum glutamic pyruvic transaminase (SGPT) levels increase to more than 3 times the upper limit of the normal range. 
Zdravljenje je treba prekiniti, če se ravni aspartat-aminotransferaze (AST), ki jo imenujejo tudi serumska glutamat-oksalacetat transaminaza (SGOT), in alanin-aminotransferaze (ALT), ki jo imenujejo tudi serumska glutamat-piruvat transaminaza (SGPT), zvišajo na več kot 3-kratnik zgornje meje normalnega razpona.
A few cases of simvastatin overdose have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae. 
Največji uporabljen odmerek je bil 3,6 g. Vsi bolniki so okrevali brez posledic.
It is particularly important to tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Zelo pomembno je, da obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo.
Multiple mechanisms may contribute to potential interactions with HMG Co-A reductase inhibitors. 
Več mehanizmov lahko prispeva k morebitnemu medsebojnemu delovanju z zaviralci HMG-CoAreduktaze.
The repeated administration of simvastatin 40 or 80 mg, the highest dose registered, did not affect the plasma levels of fenofibric acid at steady state. 
Večkratno dajanje simvastatina 40 ali 80 mg, kar je največji registrirani odmerek, ni imelo učinka na plazemske ravni fenofibrinske kisline v dinamičnem ravnovesju.
What Cholib looks like and contents of the pack 
Izgled zdravila Cholib in vsebina pakiranja
Intake of 240 mL of grapefruit juice in the morning and simvastatin in the evening also resulted in a 1.9-fold increase in plasma exposure to simvastatin acid. 
Vnos 240 ml grenivkinega soka zjutraj in simvastatina zvečer privede do 1,9-kratnega povečanja plazemske izpostavljenosti simvastatinski kislini.
The risk of rhabdomyolysis is also increased in patients concomitantly receiving other fibrates or statins. 
Tveganje za rabdomiolizo se poveča tudi pri sočasni uporabi drugih fibratov ali statinov.
Cholib contains sunset yellow FCF (E110) that may cause allergic reactions. 
Zdravilo Cholib vsebuje barvilo sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
Maximum plasma concentrations (Cmax) of fenofibrate occur within 2 to 4 hours after oral administration. 
Fenofibrat doseže najvišje ravni v plazmi (Cmax) v 2 do 4 urah po peroralnem dajanju.
Concomitant administration of amlodipine and simvastatin caused a 1.6-fold increase in exposure of simvastatin acid. 
Sočasna uporaba amlodipina in simvastatina privede do 1,6-kratnega povečanja izpostavljenosti simvastatinski kislini.
Maternal treatment with simvastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis. 
Zdravljenje matere s simvastatinom lahko zniža plodove ravni mevalonata, ki je prekurzor v biosintezi holesterola.
Therefore, caution should be exercised in patients with history of pulmonary embolism. 
Zato je potrebna previdnost pri bolnikih s pljučno embolijo v anamnezi.
In a three-month oral nonclinical study in the rat species with fenofibric acid, the active metabolite of fenofibrate, toxicity for the skeletal muscles (particularly those rich in type I -slow oxidative- myofibres) and cardiac degeneration, anemia and decreased body weight were seen at exposure levels ≥50- fold the human exposure for the skeletal toxicity and >15 fold for the cardiomyotoxicity. 
V trimesečni peroralni neklinični študiji fenofibrinske kisline, aktivnega presnovka fenofibrata, na podganah so opazili toksičnost za skeletne mišice (zlasti tiste z veliko počasnih oksidativnih miofibril tipa I) in degeneracijo srca, anemijo in znižano telesno maso pa so ugotovili pri ≥ 50-kratni človeški izpostavljenosti za skeletno toksičnost in pri >15-kratniku za kardiomiotoksičnost.
Cases of interstitial lung disease have been reported with some statins and with fenofibrate, especially with long term therapy (see section 4.8). 
Poročali so o primerih intersticijske pljučne bolezni pri sočasni uporabi določenih statinov in fenofibrata, zlasti pri dolgotrajnem zdravljenju (glejte poglavje 4.8).