natgillin/translations-raw huggingface dataset:
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.
Interactions relevant to monotherapies Inhibitors of CYP 3A4
Interakcije, ki se nanašajo na posamezni učinkovini Zaviralci CYP 3A4
• Female gender
• Ženske bolnice
Reversible elevations in serum creatinine have been reported in patients receiving fenofibrate monotherapy or co-administered with statins.
Poročali so o reverzibilnih zvišanjih serumskih ravni kreatinina pri bolnikih, ki se zdravijo samo s fenofibratom ali pri sočasnem jemanju fenofibrata in statinov.
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
Fibrinogen (g/l) *Primerjava zdravljenja: razlika med povprečjema najmanjših kvadratov za feno 145 + simva 20 in simva 40 ter povezani 95-odstotni interval zaupanja
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.
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.
• increase in blood platelets count
• zvišano število krvnih ploščic,
In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
Pri bolnikih, kjer je sistemska uporaba fusidne kisline nujna, je treba zdravljenje s statini v času zdravljenja s fusidno kislino prekiniti.
This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol.
Ta encim katalizira pretvorbo HMG-CoA v mevalonat, ki je zgodnja stopnja biosinteze holesterola, ki omejuje hitrost sinteze.
After oral administration, fenofibrate is rapidly hydrolyzed by esterases to the active metabolite fenofibric acid.
Fenofibrat po peroralnem dajanju esteraze hitro hidrolizirajo v aktivni presnovek fenofibrinsko kislino.
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.
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.
Some patients have experienced the following side effects whilst taking Cholib, fenofibrate or simvastatin:
Pri določenih bolnikih so se pojavili naslednji neželeni učinki med jemanjem zdravila Cholib, fenofibrata ali simvastatina:
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%).
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 %).
• 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)
• 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),
Following an intravenous injection of the beta-hydroxyacid metabolite, its half-life averaged 1.9 hours.
Razpolovni čas presnovka betahidroksi kisline je po intravenskem injiciranju v povprečju 1,9 ure.
• high doses of at least 1 gram per day of niacin (nicotinic acid) or a treatment containing niacin
• niacin (nikotinska kislina) ali zdravila, ki vsebujejo niacin, v odmerkih več kot 1 gram na dan
• increase in “gamma-glutamyltransferase” - produced by the liver - shown in tests
• zvišanje ravni „gama-glutamiltransferaze“ (snovi, ki jo tvorijo jetra), kar pokažejo preiskave,
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).
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).
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
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
Overall, 7,583 subjects with mixed dyslipidemia entered a 6 week statin run-in period.
V 6-tedensko uvajalno fazo je bilo vključenih skupno 7.583 preiskovancev z mešano dislipidemijo.
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%).
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 %).
Embryotoxic effects were observed at doses in the range of maternal toxicity.
Toksični učinki na plod so bili pri živalih ugotovljeni pri odmerkih v razponu toksičnosti pri materi.
• 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)
• 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),
• 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)
• če se že zdravite ali boste nadaljevali zdravljenje s:  fibratom (npr. gemfibrozilom),  statinom (zdravilom za nižanje ravni maščob v krvi, npr. simvastatin, atorvastatin),
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).
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).
• Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5)
• Sočasno jemanje glekaprevirja/pibrentasvirja (glejte poglavje 4.5)
Do not use Cholib after the expiry date which is stated on the carton and the blister after EXP.
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.
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
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
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.
Zvišane serumske ravni kreatinina so bile ponavadi stabilne skozi čas in ni dokazov za stalno povečevanje teh ravni pri dolgotrajnem zdravljenju.
Concomitant administration of diltiazem and simvastatin caused a 2.7-fold increase in exposure of simvastatin acid, presumable due to inhibition of CYP 3A4.
Sočasna uporaba diltiazema in simvastatina privede do 2,7-kratnega povečanja izpostavljenosti simvastatinski kislini, verjetno zaradi zaviranja CYP 3A4.
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.
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.
If treatment with fusidic acid is necessary, Cholib treatment should be discontinued throughout the duration of the fusidic acid treatment.
Če je zdravljenje s fusidno kislino nujno, je treba zdravljenje z zdravilom Cholib v času zdravljenja s fusidno kislino prekiniti.
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.
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.
Monitor HDL-C and stop either therapy (glitazone or Cholib) if HDL-C is too low
Spremljajte HDL-holesterol in prekinite eno od terapij (glitazon ali zdravilo Cholib), če je raven HDL-holesterola prenizka.
How to take Cholib
Kako jemati zdravilo Cholib
The active substances are fenofibrate and simvastatin.
Učinkovini sta fenofibrat in simvastatin.
Tendinopathy Immune-mediated necrotizing myopathy (see section 4.4)
redki miopatija** tendinopatija imunsko pogojena nekrotizirajoča miopatija (glejte poglavje 4.4)
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.
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.
Cholib is not expected to affect you being able to drive or use tools or machines.
Ne pričakuje se, da bi zdravilo Cholib vplivalo na sposobnost vožnje in upravljanja s stroji.
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.
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.
In normal volunteers, the plasma exposure to simvastatin acid was decreased by 93% with concomitant administration of rifampicin.
Pri sočasni uporabi rifampicina se je pri zdravih prostovoljcih plazemska izpostavljenost simvastatinski kislini zmanjšala za 93 %.
Rhabdomyolysis with or without renal failure (see section 4.4),
občasni rabdomioliza z ledvično odpovedjo ali brez nje (glejte poglavje 4.4)
Contains: lactose, sucrose, lecithin (derived from soya bean (E322)), sunset yellow FCF (E110).
Vsebuje: laktozo, saharozo, lecitin (sojin (E322)), barvilo sončno rumeno FCF (E110).
In order to establish a reference baseline value, creatine phosphokinase levels should be measured and clinical monitoring is recommended.
Za določitev referenčne izhodiščne vrednosti je treba izmeriti raven kreatin-fosfokinaze.
• Concomitant administration of glecaprevir, pibrentasvir, elbasvir or grazoprevir (see section
• Sočasno jemanje glekaprevirja, pibrentasvirja, elbasvirja ali grazoprevirja (glejte poglavje 4.5)
Contains: lactose, sucrose, lecithin (derived from soya bean (E322))
Vsebuje: laktozo, saharozo, lecitin (sojin (E322)).
Such inhibitors include itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors (e.g. nelfinavir), and nefazodone.
Takšni zaviralci so itrakonazol, ketokonazol, posakonazol, eritromicin, klaritromicin, telitromicin, zaviralci proteaze HIV (npr. nelfinavir) in nefazodon.
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.
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.
• increase in “glycosylated haemoglobin” and blood glucose levels - (markers for blood glucose control in diabetes mellitus - shown in tests
• zvišanje ravni „glikoziliranega hemoglobina“ in glukoze v krvi (pokazateljev obvladovanja glukoze v krvi pri sladkorni bolezni), kar pokažejo preiskave.
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.
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.
Study 0502 was evaluated a constant dose of fenofibrate-simvastatin combination and statin comparator throughout the 24 week double-blind period.
V študiji 0502 so v 24-tedenskem obdobju dvojno slepega zdravljenja vrednotili stalni odmerek kombinacije fenofibrata in simvastatina in primerjalnega statina.
• Personal or familial history of hereditary muscular disorders
• Dedne mišične bolezni v osebni ali družinski anamnezi
• stomach pain - this may be a sign that your pancreas is inflamed (pancreatitis)
• bolečine v želodcu - to je lahko znak vnetja trebušne slinavke (pankreatitisa),
• severe allergic skin rash with blisters
• hud alergijski izpuščaj na koži z mehurji,
• you are taking hepatitis C antiviral agents such as elbasvir or grazoprevir (used to treat hepatitis
• jemljete protivirusne učinkovine proti hepatitisu C, kot sta elbasvir ali grazoprevir (zdravili za zdravljenje okužbe z virusom hepatitisa C).
Co- administration of elbasvir and grazoprevir with simvastatin has not been studied; however, the dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with products containing elbasvir or grazoprevir (see section 4.5).
Študije sočasnega dajanja elbasvirja in grazoprevirja ter simvaststina niso bile izvedene, kljub temu pa odmerek simvastatina pri bolnikih, ki sočasno jemljejo zdravila, ki vsebujejo elbasvir ali grazoprevir, ne sme presegati 20 mg na dan (glejte poglavje 4.5).
The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 m where Cholib is contraindicated (see section 4.3).
Priporoča se običajni odmerek, razen v primeru zmanjšanega delovanja ledvic z ocenjeno hitrostjo glomerulne filtracije < 60 ml/min/1,73 m2, kjer je uporaba zdravila Cholib kontraindicirana (glejte poglavje 4.3).
Lipid parameter (mmol/L)
Lipidni parameter (mmol/l)
• digestive disturbances (stomach pain, nausea, vomiting, diarrhoea and flatulence)
• motnje prebave (bolečine v želodcu, siljenje na bruhanje, bruhanje, driska in vetrovi),
Statin monotherapy
Statinska monoterapija
Fenofibrate cannot be eliminated by haemodialysis.
Fenofibrata ni možno odstraniti s hemodializo.
Poly (vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171)
polivinilalkohol, delno hidroliziran (E1203), titanov dioksid (E171),
Therefore, the co-administration of Cholib with danazol is contraindicated (see section 4.3).
Zato je sočasna uporaba zdravila Cholib in danazola kontraindicirana (glejte poglavje 4.3).
No hepatic microsomal metabolism is involved.
Do jetrna mikrosomske presnove ne prihaja.
One film-coated tablet contains 160.1 mg of lactose (as monohydrate), 145 mg of sucrose, 0.7 mg of lecithin (derived from soya bean (E322)) and 0.17 mg of sunset yellow FCF (E110).
Ena filmsko obložena tableta vsebuje 160,1 mg laktoze (v obliki monohidrata), 145 mg saharoze, 0,7 mg lecitina (pridobljenega iz soje (E322)) in 0,17 mg barvila sončno rumeno FCF (E110).
What Cholib contains
Kaj vsebuje zdravilo Cholib
Interaction between simvastatin and fenofibrate
Interakcija med simvastatinom in fenofibratom.
Your doctor can measure your lipids with a simple blood test. Visit your doctor regularly to keep track of your lipids level.
Redno obiskujte svojega zdravnika, da boste spremljali raven maščob.
Concomitant administration of verapamil and simvastatin resulted in a 2.3-fold increase in plasma exposure to simvastatin acid, presumably due, in part, to inhibition of CYP 3A4.
Sočasna uporaba verapamila in simvastatina privede do 2,3-kratnega povečanja plazemske izpostavljenosti simvastatinski kislini, verjetno delno zaradi zaviranja CYP 3A4.
• you have kidney disease
• imate bolezen ledvic,
• dyspepsia
• dispepsija.
• drop in haemoglobin (that carries oxygen in blood) and white blood cells- shown in tests
• upad ravni hemoglobina (ki prenaša kisik v krvi) in belih krvničk, kar pokažejo preiskave,
One film-coated tablet contains, 194.7 mg of lactose (as monohydrate), 145 mg of sucrose and 0.8 mg of lecithin (derived from soya bean (E322)).
Ena filmsko obložena tableta vsebuje 194,7 mg laktoze (v obliki monohidrata), 145 mg saharoze, 0,8 mg lecitina (pridobljenega iz soje (E322)).
After the first 12 weeks of treatment, the combination of fenofibrate 145 mg and simvastatin 20 mg showed superiority over simvastatin 40 mg for TG reduction and HDL-C increase but did not meet the criteria for non-inferiority on LDL-C.
Po prvih 12 tednih se je zdravljenje s kombinacijo fenofibrata 145 mg in simvastatina 20 mg izkazalo za učinkovitejše od zdravljenja s simvastatinom 40 mg pri znižanju TG in povišanju HDL-holesterola, vendar ni izpolnjevalo meril za neinferiornost pri LDL-holesterolu.
Do not crush or chew the tablet.
Tablete ne smete drobiti ali žvečiti.
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).
V primerjavi z bolniki, ki imajo najpogostejši genotip (TT) je povprečna izpostavljenost (AUC) glavnega aktivnega presnovka, simvastatinske kisline, 120 % pri heterozigotnih nosilcih (CT) alela C in 221 % pri homozigotnih (CC) nosilcih.
Marketing Authorisation Holder: Mylan IRE Healthcare Ltd, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 - Ireland.
Imetnik dovoljenja za promet: Mylan IRE Healthcare Ltd, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 - Irska.
There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Med zdravljenjem z nekaterimi statini oziroma po njem so zelo redko poročali o imunsko pogojeni nekrotizirajoči miopatiji (immune-mediated necrotizing myopathy - IMNM).
Hypersensitivity syndrome *** An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, erythrocyte sedimentation rate (ESR) increased, arthritis and arthralgia, urticaria, photosensitivity, fever, flushing, dyspnoea and malaise.
Preobčutljivostni sindrom *** V redkih primerih so poročali o preobčutljivostnem sindromu, ki je obsegal nekatere od naslednjih pojavov: angioedem, lupusu podoben sindrom, revmatična polimialgija, dermatomiozitis, vaskulitis, trombocitopenija, eozinofilija, povečana hitrost sedimentacije eritrocitov (ESR), artritis in artralgija, urtikarija, fotosenzitivnost, zvišana telesna temperatura, zardevanje, dispneja in slabo počutje.
Adverse reactions observed with the co-administration of fenofibrate and simvastatin (Cholib)
Neželeni učinki, ki so ugotovljeni pri sočasni uporabi fenofibrata in simvastatina (Cholib) Organski sistem
You must continue a low fat diet or other measures (e.g. exercise, weight reduction) during treatment with Cholib.
Med zdravljenjem z zdravilom Cholib morate nadaljevati s prehrano z majhnim vnosom maščob in drugimi ukrepi (npr. telesna vadba, hujšanje).
The combination of fenofibrate 145 mg with simvastatin 20 mg demonstrated statistically significant superiority on apoA1 increase and fibrinogen decrease compared to simvastatin 40 mg.
Zdravljenje s kombinacijo fenofibrata 145 mg s simvastatinom 20 mg je v primerjavi s simvastatinom 40 mg pokazalo statistično značilno učinkovitejše delovanje na zvišanje apoA1 in znižanje fibrinogena.
• yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes - these may be signs of an inflamed liver (hepatitis and hepatic failure).
• rumeno obarvanje kože in beločnic (zlatenica) ali zvišane ravni jetrnih encimov - to so lahko znaki vnetja jeter (hepatitisa ali jetrne odpovedi),
• erectile dysfunction
• motnje erekcije,
Temporary suspension of Cholib treatment may be considered
Preučiti je treba potrebo po začasni prekinitvi zdravljenja z zdravilom Cholib.
• Previous history of muscular toxicity with a statin or a fibrate
• Mišična toksičnost pri uporabi statina ali fibrata v anamnezi
The geomean maximum plasma level (Cmax) of the inactive parent simvastatin was 2.7 ng/mL for the fixed dose combination Cholib 145 mg/20 mg tablet and 3.9 ng/mL for the co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program.
Geometrijska sredina najvišje ravni v plazmi (Cmax) neaktivne matične spojine,simvastatina, je bila 2,7 ng/ml pri fiksni kombinaciji odmerkov v zdravilu Cholib 145 mg/20 mg tablete in 3,9 ng/ml pri sočasni uporabi ločenih tablet fenofibrata 145 mg in simvastatina 20 mg v kliničnem programu.
Week 0 to Week 12
0. do 12. teden