natgillin/translations-raw huggingface dataset:
The European Medicines Agency has waived the obligation to submit the results of studies with Cholib in all subsets of the paediatric population in combined dyslipidaemia (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Cholib u svim podskupinama pedijatrijske populacije s miješanom dislipidemijom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Cholib: Cholib contains fenofibrate and simvastatin, which have different modes of action as described above. 
Cholib sadrži fenofibrat i simvastatin, koji imaju različite načine djelovanja, kao što je opisano u prethodnom tekstu.
Prescribing recommendations for interacting substances are summarised in the table below (see also sections 4.2 and 4.3). 
Preporuke za propisivanje lijekova s interakcijama sažete su u donjoj tablici (vidjeti također dijelove 4.2 i 4.3).
• Moderate to severe renal insufficiency (estimated glomerular filtration rate 
• Umjerena do teška insuficijencija bubrega (procijenjena brzina glomerularne filtracije
Some patients have experienced the following serious side effects whilst taking fenofibrate or simvastatin (both active substances in Cholib): 
Neki su bolesnici imali sljedeće ozbiljne nuspojave dok su uzimali fenofibrat ili simvastatin (obje djelatne tvari u Cholibu):
At maximally tolerated doses in both the rat and the rabbit, simvastatin produced no fetal malformations, and had no effects on fertility, reproductive function or neonatal development. 
Kod štakora i kunića, najviše podnošljive doze simvastatina nisu uzrokovale malformacije fetusa niti su utjecale na plodnost, reproduktivnu funkciju ili neonatalni razvoj.
Therefore, the dose of Cholib should not exceed 145 mg/20 mg daily in patients taking amiodarone, amlodipine, diltiazem or verapamil. 
Stoga doza Choliba ne smije prijeći 145 mg/20 mg dnevno u bolesnika koji uzimaju amiodaron, amlodipin, diltiazem ili verapamil.
• infection of the upper respiratory tract 
• infekcija gornjih dišnih puteva
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. 
Proučite informacije o propisivanju svih lijekova koji se uzimaju istodobno kako biste dobili više informacija o njihovim mogućim interakcijama sa simvastatinom i/ili potencijalu za utjecaj na enzime ili transportne proteine, te o mogućim prilagodbama doze i režima doziranja.
If any of the above applies to you, talk to your doctor or pharmacist before taking Cholib. 
Ako se bilo što od navedenog odnosi na Vas, razgovarajte s Vašim liječnikom ili ljekarnikom prije uzimanja Choliba.
Erectile dysfunction not known 
Erektilna disfunkcija nepoznato
• Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in section 6.1 (see also section 4.4) 
• Preosjetljivost na djelatne tvari, kikiriki, soju ili neku od pomoćnih tvari navedenih u dijelu 6.1 (također vidjeti dio 4.4)
This adverse reaction should be taken into account when driving vehicles or using machines under Cholib therapy. 
Potrebno je voditi računa o toj nuspojavi prilikom upravljanja vozilima ili rada na strojevima za vrijeme terapije Cholibom.
Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis. 
Nužan je oprez u bolesnika s predisponirajućim faktorima za rabdomiolizu.
There are no clinical data on fertility from the use of Cholib. 
Nema kliničkih podataka o plodnosti uz primjenu Choliba.
Alanine- aminotransferase increased 
Povišenje alanin-aminotransferaze često
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. 
Bolesnici koji primaju istodobno Cholib i lijekove metabolizirane putem CYP 2C19, CYP 2A6 ili naročito CYP 2C9 s uskim terapijskim indeksom moraju biti pažljivo praćeni i, ako je potrebno, preporučuje se prilagodba doze tih lijekova.
• a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis) (very rare) 
• ozbiljna alergijska reakcija koja uzrokuje otežano disanje ili omaglicu (anafilaksija) (vrlo rijetko)
Studies on mutagenicity of fenofibrate have been negative. 
Ispitivanja mutagenosti fenofibrata dala su negativne rezultate.
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). 
Cholib se koristi u odraslih s visokim rizikom od problema poput srčanog udara i moždanog udara s visokim razinama 2 vrste masnoća (trigliceridi i LDL kolesterol) u krvi.
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. 
Ponovljena primjena 40 ili 80 mg simvastatina, najviše registrirane doze, nije utjecala na razine fenofibrične kiseline u plazmi u stanju dinamičke ravnoteže.
• hypersensitivity (allergic) reactions including swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema) (rare) 
• reakcije preosjetljivosti (alergijske reakcije) uključujući: oticanje lica, jezika i grla, što može uzrokovati otežano disanje (angioedem) (rijetko)
If it is suspected a patient has developed interstitial lung disease, Cholib therapy should be discontinued. 
Ako postoji sumnja da je bolesnik razvio intersticijsku bolest pluća, potrebno je prekinuti terapiju Cholibom.
• If you are pregnant or breast-feeding 
• Ako ste trudni ili dojite
Maximum plasma concentration of active inhibitors is reached approximately 1-2 hours after administration of simvastatin. 
Najviša koncentracija aktivnih inhibitora u plazmi postiže se približno 1-2 sata nakon primjene simvastatina.
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 - Francuska.
Gemfibrozil, Other statins and fibrates 
Gemfibrozil, drugi statini i fibrati
• 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) 
• Miopatija i/ili rabdomioliza sa statinima i/ili fibratima ili potvrđeno povišenje kreatin-fosfokinaze preko 5 puta iznad gornje granice normale (GGN) pri prethodnom liječenju statinom u osobnoj anamnezi (vidjeti dio 4.4)
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. 
U iznimnim okolnostima, kada je potrebna produžena sistemska primjena fusidatne kiseline, npr. za liječenje teških infekcija, potreba za istodobnom primjenom lijeka Cholib i fusidatne kiseline mora se razmotriti za svaki pojedini slučaj i pod strogim liječničkim nadzorom.
• Hypoalbuminaemia 
• Hipoalbuminemija
Animal studies have shown embryo-toxic effects at doses in the range of maternal toxicity (see section 5.3). 
Ispitivanja na životinjama pokazala su embriotoksične učinke pri rasponu doza koje izazivaju toksičnost za majku (vidjeti dio 5.3).
Upper respiratory tract infection, Gastroenteritis 
Infekcija gornjeg respiratornog trakta, gastroenteritis često
The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. 
Bolesnika je potrebno savjetovati da odmah zatraži liječnički savjet ako osjete simptome slabosti, boli ili osjetljivosti mišića.
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 Francuska
Monitor patients for any signs and symptoms of muscle pain, tenderness or weakness 
Pratite bolesnike na bilo koje znakove i simptome boli, osjetljivosti ili slabosti mišića
Treatment Comparison* 
Usporedba liječenja*
Cases of interstitial lung disease have been reported with some statins and with fenofibrate, especially with long term therapy (see section 4.8). 
Slučajevi intersticijske bolesti pluća prijavljeni su s nekim statinima i s fenofibratom, naročito kod dugotrajne terapije (vidjeti dio 4.8).
Therefore, Cholib is not expected to affect plasma concentrations of substances metabolised via CYP 3A4. 
Stoga se ne očekuje da će Cholib utjecati na koncentracije lijekova u plazmi koji se metaboliziraju putem CYP 3A4.
• high doses of at least 1 gram per day of niacin (nicotinic acid) or a treatment containing niacin 
• visoke doze od najmanje 1 grama dnevno niacina (nikotinske kiseline) ili liječenje koje sadrži niacin (lijek za snižavanje razina masnoća u krvi)
They are both used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. 
Obje djelatne tvari koriste se za snižavanje razina ukupnog kolesterola, "lošeg" kolesterola (LDL kolesterol) i masnih tvari koje se zovu trigliceridi u krvi.
Pancreatitis* 
Pankreatitis*
Pharmacotherapeutic group: Lipid modifying substances, HMG-CoA reductase inhibitors in combination with other lipid modifying substances, ATC code: C10BA04 
Farmakoterapijska skupina: lijekovi koji modificiraju lipide, inhibitori HMG-CoA reduktaze u kombinaciji s drugim lijekovima koji modificiraju lipide, ATK oznaka: C10BA04
If you are allergic to peanut, soya or arachis oil do not use Cholib. 
Ako ste alergični na kikiriki, soju ili ulje od kikirikija nemojte uzimati Cholib.
• muscle problems 
• problemi s mišićima
Cholib contains sunset yellow FCF (E110) that may cause allergic reactions. 
Cholib sadrži bojilo sunset yellow FCF (E110) koje može uzrokovati alergijske reakcije.
Interaction between simvastatin and fenofibrate 
Interakcije između simvastatina i fenofibrata
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 pokazala je superiornost u odnosu na S40 u snižavanju LDL-C-a samo u 24. tjednu, od beznačajnog dodatnog 1,2%-tnog sniženja LDL-C-a u 12. tjednu do statistički značajnog 7,2%-tnog sniženja u 24. tjednu.
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). 
Analiza druge unaprijed definirane podskupine pokazala je statistički značajni utjecaj spola na ishod liječenja (p=0,01), pokazujući moguću korist liječenja kombiniranom terapijom kod muškaraca (p=0,037), ali potencijalno viši rizik za primarni ishod kod žena liječenih kombiniranom terapijom u usporedbi s monoterapijom simvastatinom (p=0,069).
P450 (CYP) 3A4 inhibitors (see section 4.5) 
P450 (CYP) 3A4 (vidjeti dio 4.5)
In rats and mice, liver tumours have been found in carcinogenicity studies, which are attributable to peroxisome proliferation. 
U ispitivanjima karcinogenosti na štakorima i miševima nađeni su tumori jetre, što se pripisuje proliferaciji peroksisoma.
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. 
Budući da je rifampicin potentni induktor CYP 3A4 koji interferira s metabolizmom simvastatina, kod bolesnika koji započinju dugotrajnu terapiju rifampicinom (npr. liječenje tuberkuloze) može doći do gubitka djelotvornosti simvastatina.
Do not exceed one Cholib 145 mg/20 mg per day, unless clinical benefit outweigh the risk 
Ne smije se prekoračiti doza od jedne tablete lijeka Cholib 145 mg/20 mg dnevno, osim ako je klinička korist veća od rizika
• Unexplained muscle pain, tenderness, or weakness may be sign of muscle break down. 
• Neobjašnjiva bol, osjetljivost ili slabost mišića može biti znak razgradnje mišića.
Pancreatitis has been reported in patients taking fenofibrate (see sections 4.3 and 4.8). 
Pankreatitis je prijavljen u bolesnika koji su uzimali fenofibrat (vidjeti dijelove 4.3 i 4.8).
Fenofibric acid is not eliminated by hemodialysis. 
Fenofibrična kiselina ne eliminira se hemodijalizom.
Through activation of PPAR, fenofibrate activates lipoprotein lipase production and reduces production of apoprotein CIII. 
Kroz aktivaciju PPARα, fenofibrat aktivira stvaranje lipoprotein lipaze i smanjuje stvaranje apoproteina CIII.
All patients starting therapy, or whose dose of simvastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. 
Potrebno je savjetovati sve bolesnike koji započinju terapiju, ili čija je doza simvastatina povećana, na rizik od miopatije i reći im da odmah prijave bilo koju neobjašnjivu bol, osjetljivost ili slabost mišića.
• a fibrate (e.g. fenofibrate, gemfibrozil) 
• fibrat (npr. fenofibrat, gemfibrozil)
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. 
Istodobni unos velikih količina (više od 1 litre dnevno) soka od grejpa i simvastatina rezultiralo je povećanjem izloženosti simvastatinskoj kiselini od 7 puta u plazmi.
LDL cholesterol is often called ‘bad' cholesterol because it can build up in the walls of your arteries and form plaque. 
LDL kolesterol često se naziva "lošim" kolesterolom zato što se može nakupiti u stijenkama arterija i stvoriti plak.
Week 12 to Week 24 
Od 12. tjedna do 24. tjedna
Simvastatin is well absorbed and undergoes extensive hepatic first-pass extraction. 
Simvastatin se dobro apsorbira i prolazi opsežan prvi prolazak kroz jetru.
This medicinal product contains sunset yellow FCF (E110) that may cause allergic reactions. 
Ovaj lijek sadrži bojilo sunset yellow FCF (E110) koje može uzrokovati alergijske reakcije.
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. 
Raspoloživost beta-hidroksi kiseline u sistemskoj cirkulaciji nakon peroralne doze simvastatina niža je od 5% primijenjene doze.
Multiple mechanisms may contribute to potential interactions with HMG Co-A reductase inhibitors. 
Više mehanizama može doprinijeti mogućim interakcijama s inhibitorima HMG Co-A reduktaze.
If you are worried about this, talk to your doctor or pharmacist. 
Ako ste zabrinuti zbog toga, razgovarajte sa svojim liječnikom ili ljekarnikom.
The risk of rhabdomyolysis is also increased in patients concomitantly receiving other fibrates or statins. 
Rizik od rabdomiolize također je povećan u bolesnika koji istodobno primaju druge fibrate ili statine.
• cramps or painful, tender or weak muscles - these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death 
• grčevi ili bolni, osjetljivi ili slabi mišići - to mogu biti znakovi upale ili razgradnje mišića, što može dovesti do oštećenja bubrega ili čak do smrti
Temporary suspension of Cholib treatment may be considered 
Možda će biti potrebno razmotriti privremenu obustavu liječenja Cholibom
Creatine kinase measurement 
Mjerenje kreatin kinaze
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. 
Potrebno je obratiti pažnju na bolesnike koji razviju povišenje razina transaminaza, a terapiju treba prekinuti ako je povišenje razina aspartat-aminotransferaze (AST), također poznata i kao serumska glutamat-oksaloacetat transaminaza (SGOT), i alanin-aminotransferaze (ALT), također poznata i kao serumska glutamat-piruvat-transaminaza (SGPT), preko 3 puta iznad raspona gornje granice normale.
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). 
U bolesnika s polimorfizmom SLCO1B1 postoji rizik od povećane izloženosti simvastatinu, što može rezultirati povećanim rizikom od rabdomiolize (vidjeti dio 4.4).
• Pregnancy and breast-feeding (see section 4.6) 
• Trudnoća i dojenje (vidjeti dio 4.6)
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. 
Unos 240 ml soka od grejpa ujutro i simvastatina navečer također je rezultirao povećanjem izloženosti simvastatinskoj kiselini od 1,9 puta u plazmi.
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). 
Budući da doza simvastatina ne smije prijeći 10 mg dnevno u bolesnika koji uzimaju ciklosporin, istodobna primjena Choliba sa ciklosporinom je kontraindicirana (vidjeti dio 4.3).
As simvastatin is contraindicated during pregnancy (see hereafter), Cholib is contraindicated during pregnancy (see section 4.3). 
Budući da je simvastatin kontraindiciran tijekom trudnoće (vidjeti u nastavku), Cholib je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
Carriers of the SLCO1B1 gene c.521T>C allele have lower OATP1B1 activity. 
Nositelji alela c.521T>C gena SLCO1B1 imaju nižu aktivnost OATP1B1.
Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations. 
Pokazalo se da simvastatin snižava koncentraciju normalnog i povišenog LDL-C-a.
Fenofibrate is water-insoluble and must be taken with food to facilitate absorption. 
Fenofibrat je topiv u vodi i mora se uzimati uz hranu radi bolje apsorpcije.
Cholib contains types of sugars called lactose and sucrose. 
Cholib sadrži vrste šećera koji se zovu laktoza i saharoza.
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. 
Iako mehanizam nije posve jasan, pokazalo se da ciklosporin povećava izloženost u plazmi (AUC) simvastatinskoj kiselini, a pretpostavlja se djelomično zbog inhibicije CYP 3A4 i OATP-1B1 transportera.
• nefazodone (a medicine for depression) 
• nefazodon (lijek za depresiju)
Based on the results of the SEARCH trial, homozygote C allele carriers (also called CC) treated with 80 mg have a 15% risk of myopathy within one year, while the risk in heterozygote C allele carriers (CT) is 1.5%. 
Na temelju rezultata ispitivanja SEARCH, nositelji homozigotnog alela C (koji se još nazivaju CC) liječeni s 80 mg imaju 15%-tni rizik od javljanja miopatije unutar jedne godine, dok je u nositelja heterozigotnog alela C (CT) rizik 1,5%.
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: 
Osim navedenih lijekova, obavijestite svog liječnika ili ljekarnika ako uzimate nedavno ste uzeli ili biste mogli uzeti bilo koji od sljedećih lijekova:
The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins. 
Sveukupni učinak je smanjeni omjer lipoproteina male i vrlo male gustoće u odnosu na lipoproteine visoke gustoće.
Gemfibrozil increases the AUC of simvastatin acid by 1.9-fold, possibly due to inhibition of the glucuronidation pathway. 
Gemfibrozil povećava AUC simvastatinske kiseline za 1,9 puta, vjerojatno zbog inhibicije glukuronidacijskog puta.
In order to establish a reference baseline value, creatine phosphokinase levels should be measured and clinical monitoring is recommended. 
Radi utvrđivanja referentne početne vrijednosti, potrebno je izmjeriti razine kreatin fosfokinaze i preporučuje se kliničko praćenje.
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. 
U kliničkom ispitivanju, miopatija je prijavljena u 6% bolesnika koji su primali simvastatin 80 mg i amiodaron, naspram 0,4% u bolesnika koji su primali samo simvastatin 80 mg.
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. 
Neki dokazi ukazuju da statini kao skupina lijekova povisuju glukozu u krvi, a u nekih bolesnika, s visokim rizikom od razvoja šećerne bolesti, mogu prouzročiti razinu hiperglikemije kod koje je prikladno propisano zbrinjavanje šećerne bolesti.
The mean exposure (AUC) of the main active metabolite, simvastatin acid is 120% in heterozygote carriers (CT) of the C allele and 221% in homozygote (CC) carriers relative to that of patients who have the most common genotype (TT). 
Srednja izloženost (AUC) glavnom aktivnom metabolitu, simvastatinskoj kiselini, je 120% u heterozigotnih nositelja (CT) alela C i 221% u homozigotnih nositelja (CC) u odnosu na onu u bolesnika koji imaju najčešći genotip (TT).
• If you are allergic to peanut, arachis oil, soya lecithin or related substances 
• Ako ste alergični na kikiriki, ulje od kikirikija, sojin lecitin ili srodne tvari
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). 
Rizik od mišićne toksičnosti može se povećati ako se Cholib primjenjuje istodobno s drugim fibratom, statinom, niacinom, fusidatnom kiselinom ili drugim specifičnim lijekovima (za specifične interakcije vidjeti dio 4.5).
• itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) 
• itrakonazol, ketokonazol, flukonazol ili posakonazol (lijekovi za gljivične infekcije)
• If you have moderate or severe kidney problems 
• Ako imate umjerene ili teške probleme s bubrezima
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 fibrične kiseline, čiji su dokumentirani učinci na modifikaciju lipida u čovjeka posredovani aktivacijom peroksisomskih proliferator aktivirajućih receptora tipa alfa (Peroxisome Proliferator Activated Receptor type alpha, PPARα).
Maximum plasma concentrations (Cmax) of fenofibrate occur within 2 to 4 hours after oral administration. 
Maksimalne koncentracije fenofibrata u plazmi (Cmax) postižu se 2 do 4 sata nakon peroralne primjene.
• stomach pain - this may be a sign that your pancreas is inflamed (pancreatitis) 
• bol u trbuhu - to može biti znak da Vam je gušterača upaljena (pankreatitis)
Frequency categories are based on information available from simvastatin and fenofibrate Summary of Product Characteristics available in the EU. 
Kategorije učestalosti temelje se na informacijama dostupnim iz Sažetaka opisa svojstava lijeka simvastatina i fenofibrata koji su dostupni u EU.
In order to establish a reference baseline value, a Creatine Kinase level should be measured before starting a treatment in the following situations: 
Radi utvrđivanja referentne početne vrijednosti, u sljedećim je situacijama potrebno izmjeriti razinu kreatin kinaze prije početka liječenja:
A few cases of simvastatin overdose have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae. 
Prijavljeno je nekoliko slučajeva predoziranja simvastatinom; maksimalna uzeta doza bila je 3,6 g.