FrancophonIA/ELRC3.0 huggingface dataset:
English: • pioglitazone (a particular class of medicines to treat diabetes)
Slovenian: • pioglitazon (posebna skupina zdravil za zdravljenje sladkorne bolezni),
English: 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.
Slovenian: 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.
English: If treatment with itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with Cholib must be suspended during the course of treatment.
Slovenian: Če se zdravljenju z itrakonazolom, ketokonazolom, posakonazolom, eritromicinom, klaritromicinom ali telitromicinom ni mogoče izogniti, je treba med terapijo zdravljenje z zdravilom Cholib začasno prekiniti.
English: 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.
Slovenian: 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.
English: TG, LDL-C and HDL-C Percent Change from Baseline to 12 and 24 Weeks Full Analysis Subject Sample
Slovenian: Odstotna sprememba TG, LDL-holesterola in HDL-holesterola po 12 in 24 tednih od izhodišča Celotna analiza vzorca preiskovancev
English: Simvastatin is a substrate of CYP 3A4 and of the efflux transporter BCRP.
Slovenian: Simvastatin je substrat CYP 3A4 in izločevalnega prenašalca BCRP.
English: • you have an underactive thyroid gland (hypothyroidism)
Slovenian: • imate premalo delujočo ščitnico (hipotiroidizem),
English: Simvastatin is a substrate of cytochrome P450 3A4.
Slovenian: Simvastatin je substrat citokroma P450 3A4.
English: Fenofibrate is not a substrate for CYP 3A4.
Slovenian: Fenofibrat ni substrat CYP 3A4.
English: 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
Slovenian: 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).
English: not known
Slovenian: redki neznana
English: 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).
Slovenian: 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 %).
English: Upper respiratory tract infection, Gastroenteritis
Slovenian: Infekcijske in parazitske bolezni okužba zgornjih dihal, gastroenteritis pogosti
English: In elderly patients, the fenofibric acid apparent total plasma clearance is not modified.
Slovenian: Pri starostnikih navidezni skupni plazemski očistek fenofibrinske kisline ni spremenjen.
English: Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - France.
Slovenian: Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - Francija
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness.
Slovenian: Bolnikom je treba naročiti, da v primeru mišične šibkosti, bolečine ali občutljivosti takoj poiščejo zdravniško pomoč.
English: Cholib The respective effects of simvastatin and fenofibrate are complementary.
Slovenian: Zdravilo Cholib Učinki simvastatina in fenofibrata so dopolnjujejo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • elevations in blood tests of liver function (transaminases)
Slovenian: • zvišane vrednosti krvnih preiskav delovanja jeter (transaminaze),
English: No interaction studies have been performed with Cholib.
Slovenian: Študij medsebojnega delovanja z zdravilom Cholib niso izvedli.
English: 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.
Slovenian: 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.
English: Interactions relevant to monotherapies Inhibitors of CYP 3A4
Slovenian: Interakcije, ki se nanašajo na posamezni učinkovini Zaviralci CYP 3A4
English: • Female gender
Slovenian: • Ženske bolnice
English: Reversible elevations in serum creatinine have been reported in patients receiving fenofibrate monotherapy or co-administered with statins.
Slovenian: Poročali so o reverzibilnih zvišanjih serumskih ravni kreatinina pri bolnikih, ki se zdravijo samo s fenofibratom ali pri sočasnem jemanju fenofibrata in statinov.
English: Fibrinogen (g/L) *Treatment Comparison: difference between the LS Means for Feno 145 + Simva 20 and Simva 40, as well as the associated 95% confidence interval
Slovenian: Fibrinogen (g/l) *Primerjava zdravljenja: razlika med povprečjema najmanjših kvadratov za feno 145 + simva 20 in simva 40 ter povezani 95-odstotni interval zaupanja
English: In the available clinical data, the effect on LDL-C reduction was not considered to be significantly different to simvastatin monotherapy when LDL-C is controlled at the time of initiating treatment.
Slovenian: Pri razpoložljivih kliničnih podatkih učinek na znižanje LDL-holesterola ni bil pomembno drugačen od monoterapije s simvastatinom po tem, ko je bil LDL-holesterol pred uvedbo zdravljenja s kombinacijo obvladan.
English: • increase in blood platelets count
Slovenian: • zvišano število krvnih ploščic,
English: In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
Slovenian: Pri bolnikih, kjer je sistemska uporaba fusidne kisline nujna, je treba zdravljenje s statini v času zdravljenja s fusidno kislino prekiniti.
English: This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol.
Slovenian: Ta encim katalizira pretvorbo HMG-CoA v mevalonat, ki je zgodnja stopnja biosinteze holesterola, ki omejuje hitrost sinteze.
English: After oral administration, fenofibrate is rapidly hydrolyzed by esterases to the active metabolite fenofibric acid.
Slovenian: Fenofibrat po peroralnem dajanju esteraze hitro hidrolizirajo v aktivni presnovek fenofibrinsko kislino.
English: This is because on rare occasions, there have been cases of serious muscle problems including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
Slovenian: Če se pri vas pojavijo našteti simptomi, morate o tem nemudoma obvestiti svojega zdravnika, saj obstajajo redki primeri resnih težav z mišicami, vključno z razpadanjem mišic, ki povzroči poškodbe ledvic, v zelo redkih primerih pa je prišlo do smrti.
English: Some patients have experienced the following side effects whilst taking Cholib, fenofibrate or simvastatin:
Slovenian: Pri določenih bolnikih so se pojavili naslednji neželeni učinki med jemanjem zdravila Cholib, fenofibrata ali simvastatina:
English: In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (≤ 34 mg/dl or 0.88 mmol/L) and highest tertile of TG (≥ 204 mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p=0.03; absolute risk reduction: 4.95%).
Slovenian: V vnaprej določeni podskupini dislipidemičnih bolnikov (in sicer osebe, ki so imele v izhodišču ravni HDL-holesterola v najnižjem tercilu [≤ 34 mg/dl ali 0,88 mmol/l] in ravni TG v najvišjem tercilu [≥ 204 mg/dl ali 2,3 mmol/l]) je zdravljenje s fenofibratom in simvastatinom pokazalo 31-odstotno zmanjšanje tveganja v primerjavi z zdravljenjem samo s simvastatinom z vidika sestavljenega primarnega izida (razmerje ogroženosti [RO] 0,69; 95-odstotni IZ 0,49-0,97, p = 0,03; absolutno zmanjšanje tveganja: 4,95 %).
English: • If you have a history of muscle problems during treatment to lower the level of fats in the blood either of the active substances in this medicine, or with other statins (such as atorvastatin, pravastatin or rosuvastatin) or fibrates (such as bezafibrate or gemfibrozil)
Slovenian: • če ste v preteklosti imeli težave z mišicami med zdravljenjem, namenjenim zniževanju maščob v krvi, bodisi z učinkovinami iz tega zdravila ali z drugimi statini (kot so atorvastatin, pravastatin ali rosuvastatin) ali fibrati (kot so fenofibrat, bezafibrat ali gemfibrozil),
English: Following an intravenous injection of the beta-hydroxyacid metabolite, its half-life averaged 1.9 hours.
Slovenian: Razpolovni čas presnovka betahidroksi kisline je po intravenskem injiciranju v povprečju 1,9 ure.
English: • high doses of at least 1 gram per day of niacin (nicotinic acid) or a treatment containing niacin
Slovenian: • niacin (nikotinska kislina) ali zdravila, ki vsebujejo niacin, v odmerkih več kot 1 gram na dan
English: • increase in “gamma-glutamyltransferase” - produced by the liver - shown in tests
Slovenian: • zvišanje ravni „gama-glutamiltransferaze“ (snovi, ki jo tvorijo jetra), kar pokažejo preiskave,
English: Pancreatitis * In the FIELD study, a randomised placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p=0.031).
Slovenian: Pankreatitis * V študiji FIELD, randomiziranem, s placebom kontroliranem preskušanju, opravljenem pri 9795 bolnikih s sladkorno boleznijo tipa 2, so ugotovili statistično značilno povečanje števila primerov pankreatitisa pri bolnikih, ki so prejemali fenofibrat, v primerjavi z bolniki, ki so prejemali placebo (0,8 % v primerjavi z 0,5 %; p = 0,031).
English: EU/1/13/866/001 10 film-coated tablets EU/1/13/866/002 30 film-coated tablets EU/1/13/866/005 90 film coated tablets
Slovenian: EU/1/13/866/001 10 filmsko obloženih tablet EU/1/13/866/002 30 filmsko obloženih tablet EU/1/13/866/005 90 filmsko obloženih tablet
English: Overall, 7,583 subjects with mixed dyslipidemia entered a 6 week statin run-in period.
Slovenian: V 6-tedensko uvajalno fazo je bilo vključenih skupno 7.583 preiskovancev z mešano dislipidemijo.
English: Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32; absolute risk reduction: 0.74%).
Slovenian: Zdravljenje s fenofibratom in simvastatinom ni pokazalo pomembnih razlik glede na zdravljenje samo s simvastatinom z vidika sestavljenega primarnega izida miokardnega infarkta brez smrtnega izida, možganske kapi brez smrtnega izida in smrti zaradi srčno-žilnih vzrokov (razmerje ogroženosti [RO] 0,92; 95-odstotni IZ 0,79-1,08, p = 0,32; absolutno zmanjšanje tveganja: 0,74 %).
English: Embryotoxic effects were observed at doses in the range of maternal toxicity.
Slovenian: Toksični učinki na plod so bili pri živalih ugotovljeni pri odmerkih v razponu toksičnosti pri materi.
English: • Hypersensitivity reaction to Cholib with symptoms like: pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells)
Slovenian: • preobčutljivostna reakcija na zdravilo Cholib s simptomi, kot so bolečine ali vnetje sklepov, vnetje žil, nenavadne podplutbe, kožni izbruhi in otekanje, koprivnica, občutljivost kože na sonce, vročina, pordelost, zasoplost in slabo počutje, lupusu podobno klinično stanje (vključno z izpuščajem, težavami s sklepi in vplivom na bele krvničke),
English: • If you are already being treated and will continue your treatment with: o a fibrate (e.g. gemfibrozil) o a statin (medicines to lower the levels of fats in the blood, e.g. simvastatin, atorvastatin)
Slovenian: • če se že zdravite ali boste nadaljevali zdravljenje s:  fibratom (npr. gemfibrozilom),  statinom (zdravilom za nižanje ravni maščob v krvi, npr. simvastatin, atorvastatin),
English: Simvastatin, which is an inactive lactone, is hydrolyzed in the liver to the corresponding active beta-hydroxyacid form which has a potent activity in inhibiting HMG-CoA reductase (3 hydroxy - 3 methylglutaryl CoA reductase).
Slovenian: Simvastatin, ki je neaktiven lakton, se hidrolizira v jetrih v ustrezno aktivno betahidroksi kislino, ki močno zavira reduktazo HMG-CoA (3-hidroksi-3-metilglutaril-CoA-reduktaza).
English: • Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5)
Slovenian: • Sočasno jemanje glekaprevirja/pibrentasvirja (glejte poglavje 4.5)
English: Do not use Cholib after the expiry date which is stated on the carton and the blister after EXP.
Slovenian: Zdravila Cholib ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
English: EU/1/13/866/003 10 film-coated tablets EU/1/13/866/004 30 film-coated tablets EU/1/13/866/006 90 film coated tablets
Slovenian: EU/1/13/866/003 10 filmsko obloženih tablet EU/1/13/866/004 30 filmsko obloženih tablet EU/1/13/866/006 90 filmsko obloženih tablet
English: Elevations in serum creatinine were generally stable over time with no evidence for continued increases in serum creatinine with long term therapy and tended to return to baseline following discontinuation of treatment.
Slovenian: Zvišane serumske ravni kreatinina so bile ponavadi stabilne skozi čas in ni dokazov za stalno povečevanje teh ravni pri dolgotrajnem zdravljenju.
English: Concomitant administration of diltiazem and simvastatin caused a 2.7-fold increase in exposure of simvastatin acid, presumable due to inhibition of CYP 3A4.
Slovenian: Sočasna uporaba diltiazema in simvastatina privede do 2,7-kratnega povečanja izpostavljenosti simvastatinski kislini, verjetno zaradi zaviranja CYP 3A4.
English: It is given to lower triglycerides and increase the good cholesterol (HDL cholesterol) in patients whose bad cholesterol (LDL cholesterol) is already controlled with simvastatin alone in a dose of 20 mg.
Slovenian: Namenjen je zniževanju ravni trigliceridov in zviševanju ravni dobrega holesterola (holesterola HDL) pri bolnikih, ki že imajo obvladan slabi holesterol (holesterola LDL) samo s simvastatinom v odmerku 20 mg.
English: If treatment with fusidic acid is necessary, Cholib treatment should be discontinued throughout the duration of the fusidic acid treatment.
Slovenian: Če je zdravljenje s fusidno kislino nujno, je treba zdravljenje z zdravilom Cholib v času zdravljenja s fusidno kislino prekiniti.
English: Of these, 2,474 subjects were randomized for 24 weeks treatment, 1,237 subjects received fenofibrate and simvastatin co-administration and 1,230 subjects received statin monotherapy all administered in the evening.
Slovenian: 2.474 preiskovancev iz te skupine je bilo naključno razporejenih v 24-tedensko zdravljenje, 1.237 preiskovancev je sočasno prejemalo fenofibrat in simvastatin, 1.230 preiskovancev pa je prejemalo samo statine.
English: Monitor HDL-C and stop either therapy (glitazone or Cholib) if HDL-C is too low
Slovenian: Spremljajte HDL-holesterol in prekinite eno od terapij (glitazon ali zdravilo Cholib), če je raven HDL-holesterola prenizka.
English: How to take Cholib
Slovenian: Kako jemati zdravilo Cholib
English: The active substances are fenofibrate and simvastatin.
Slovenian: Učinkovini sta fenofibrat in simvastatin.
English: Tendinopathy Immune-mediated necrotizing myopathy (see section 4.4)
Slovenian: redki miopatija** tendinopatija imunsko pogojena nekrotizirajoča miopatija (glejte poglavje 4.4)
English: It is given to lower triglycerides and increase the good cholesterol (HDL cholesterol) in patients whose bad cholesterol (LDL cholesterol) is already controlled with simvastatin alone in a dose of 40 mg.
Slovenian: Namenjen je zniževanju ravni trigliceridov in zviševanju ravni dobrega holesterola (holesterola HDL) pri bolnikih, ki že imajo obvladan slabi holesterol (holesterola LDL) samo s simvastatinom v odmerku 40 mg.
English: Cholib is not expected to affect you being able to drive or use tools or machines.
Slovenian: Ne pričakuje se, da bi zdravilo Cholib vplivalo na sposobnost vožnje in upravljanja s stroji.
English: Compared to a fibrate or a statin alone, the risk of muscle breakdown is increased when you take these 2 medicines together, as in Cholib.
Slovenian: Če jemljete skupaj fibrat in statin (kot je to pri zdravilu Cholib), je tveganje za razpadanje mišic večje, kot če jemljete samo fibrat ali samo statin.
English: In normal volunteers, the plasma exposure to simvastatin acid was decreased by 93% with concomitant administration of rifampicin.
Slovenian: Pri sočasni uporabi rifampicina se je pri zdravih prostovoljcih plazemska izpostavljenost simvastatinski kislini zmanjšala za 93 %.
English: Rhabdomyolysis with or without renal failure (see section 4.4),
Slovenian: občasni rabdomioliza z ledvično odpovedjo ali brez nje (glejte poglavje 4.4)
English: Contains: lactose, sucrose, lecithin (derived from soya bean (E322)), sunset yellow FCF (E110).
Slovenian: Vsebuje: laktozo, saharozo, lecitin (sojin (E322)), barvilo sončno rumeno FCF (E110).
English: In order to establish a reference baseline value, creatine phosphokinase levels should be measured and clinical monitoring is recommended.
Slovenian: Za določitev referenčne izhodiščne vrednosti je treba izmeriti raven kreatin-fosfokinaze.
English: • Concomitant administration of glecaprevir, pibrentasvir, elbasvir or grazoprevir (see section
Slovenian: • Sočasno jemanje glekaprevirja, pibrentasvirja, elbasvirja ali grazoprevirja (glejte poglavje 4.5)
English: Contains: lactose, sucrose, lecithin (derived from soya bean (E322))
Slovenian: Vsebuje: laktozo, saharozo, lecitin (sojin (E322)).
English: Such inhibitors include itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors (e.g. nelfinavir), and nefazodone.
Slovenian: Takšni zaviralci so itrakonazol, ketokonazol, posakonazol, eritromicin, klaritromicin, telitromicin, zaviralci proteaze HIV (npr. nelfinavir) in nefazodon.
English: Simva 40 Simva 40 Fibrinogen* (g/L) Feno 145 + Simva 40 Simva 40 *Treatment Comparison consists of the difference between the LS-means for Feno 145 + Simva 40 an d Simva 40, as well as the corresponding 95% CI.
Slovenian: feno 145 + simva 40 simva 40 Fibrinogen* (g/l) feno 145 + simva 40 simva 40 *Primerjavo zdravljenja sestavljata razlika med povprečjema najmanjših kvadratov za feno 145 + simva 40 in simva 40 ter pripadajoči 95-odstotni IZ.
English: • increase in “glycosylated haemoglobin” and blood glucose levels - (markers for blood glucose control in diabetes mellitus - shown in tests
Slovenian: • zvišanje ravni „glikoziliranega hemoglobina“ in glukoze v krvi (pokazateljev obvladovanja glukoze v krvi pri sladkorni bolezni), kar pokažejo preiskave.
English: At 12 weeks and 24 weeks the combination of fenofibrate 145 mg and simvastatin 40 mg (F145/S40) showed superiority over simvastatin 40 mg (S40) for TG reduction and HDL-C increase.
Slovenian: Po 12 in 24 tednih se je zdravljenje s kombinacijo fenofibrata 145 mg in simvastatina 40 mg (F145/S40) izkazalo za učinkovitejše od zdravljenja s simvastatinom 40 mg (S40) pri znižanju TG in povišanju HDL-holesterola.
English: Study 0502 was evaluated a constant dose of fenofibrate-simvastatin combination and statin comparator throughout the 24 week double-blind period.
Slovenian: V študiji 0502 so v 24-tedenskem obdobju dvojno slepega zdravljenja vrednotili stalni odmerek kombinacije fenofibrata in simvastatina in primerjalnega statina.
English: • Personal or familial history of hereditary muscular disorders
Slovenian: • Dedne mišične bolezni v osebni ali družinski anamnezi
English: • stomach pain - this may be a sign that your pancreas is inflamed (pancreatitis)
Slovenian: • bolečine v želodcu - to je lahko znak vnetja trebušne slinavke (pankreatitisa),
English: • severe allergic skin rash with blisters
Slovenian: • hud alergijski izpuščaj na koži z mehurji,
English: • you are taking hepatitis C antiviral agents such as elbasvir or grazoprevir (used to treat hepatitis
Slovenian: • jemljete protivirusne učinkovine proti hepatitisu C, kot sta elbasvir ali grazoprevir (zdravili za zdravljenje okužbe z virusom hepatitisa C).