natgillin/translations-raw huggingface dataset:
Blood creatinine increased: 10% of patient had a creatinine increase from baseline greater than 30 µmol/L with co-administered fenofibrate and simvastatin versus 4.4% with statin monotherapy.
Zvišana raven kreatinina v krvi: zvišano raven kreatinina za več kot 30 µmol/l nad izhodiščno vrednostjo je imelo 10 % bolnikov, ki so sočasno prejemali fenofibrat in simvastatin, in 4,4 % bolnikov, ki so prejemali samo statin.
Cholib must not be co-administered with fusidic acid.
Zdravila Cholib ne smete dajati sočasno s fusidno kislino.
However reversible hypospermia and testicular vacuolation and immaturity of the ovaries were observed in a repeat-dose toxicity study with fenofibric acid in young dogs.
Vendar so v študiji toksičnosti ponavljajočih se odmerkov fenofibrinske kisline pri mladih psih ugotovili reverzibilno hipospermijo in testikularno vakuolizacijo ter nezrelost jajčnikov.
Combination with itraconazole, ketoconazole, posaconazole, HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone is contraindicated (see section 4.3).
Kombiniranje z itrakonazolom, ketokonazolom, posakonazolom, zaviralci proteaze HIV (npr. nelfinavirjem), eritromicinom, klaritromicinom, telitromicinom in nefazodonom je kontraindicirano (glejte poglavje 4.3).
Butylhydroxyanisole (E320), lactose monohydrate, sodium laurilsulfate, starch, pregelatinised (maize), docusate sodium, sucrose, citric acid monohydrate (E330), hypromellose (E464), crospovidone (E1202), magnesium stearate (E572), silicified microcrystalline cellulose (comprised of cellulose, microcrystalline and silica, colloidal anhydrous), ascorbic acid (E300).
butilhidroksianizol (E320), laktoza monohidrat, natrijev lavrilsulfat, predgelirani škrob (koruzni), natrijev dokusat, saharoza, citronska kislina monohidrat (E330), hipromeloza (E464), krospovidon (E1202), magnezijev stearat (E572), silicizirana mikrokristalna celuloza (sestavljena iz mikrokristalne celuloze in brezvodnega koloidnega silicijevega dioksida), askorbinska kislina (E300).
• Increase in the blood level of “creatinine” (substance excreted by the kidneys)
• zvišanje ravni „kreatinina“ (snovi, ki jo izločajo ledvice) v krvi,
• rifampicin (a medicine used to treat tuberculosis).
• rifampicin (zdravilo za tuberkulozo).
Gastrointestinal disorders Gastrointestinal signs and symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence)
Bolezni prebavil znaki in simptomi v prebavilih (kot so trebušne bolečine, siljenje na bruhanje, bruhanje, driska, vetrovi)
*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.
*Primerjavo zdravljenja sestavljata razlika med povprečjema najmanjših kvadratov za feno 145 + simva 40 in simva 40 ter pripadajoči 95-odstotni IZ.
• pain, redness or swelling in the legs - these may be signs of a blood clot in the leg (deep vein thrombosis)
• bolečine, pordelost ali otekanje nog - to so lahko znaki krvnega strdka v nogah (globoke venske tromboze),
Renal function Cholib is contraindicated in moderate to severe renal impairment (see section 4.3).
Zdravilo Cholib je kontraindicirano pri zmerno do hudo okvarjenem delovanju ledvic (glejte poglavje 4.3).
Muscle disorders (e.g. myalgia, myositis, muscular spasms and weakness)
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolezni mišic (npr. mialgija, miozitis, mišični spazmi in šibkost)
Immune system disorders Hypersensitivity rare
Bolezni imunskega sistema preobčutljivost redki anafilaksija zelo redki
Do not exceed one Cholib 145 mg/20 mg per day
Ne smete preseči odmerka ene tablete zdravila Cholib 145 mg/20 mg na dan.
Grapefruit juice inhibits CYP 3A4.
Grenivkin sok zavira CYP 3A4.
LDL-C
LDL-holesterol
Concomitant administration of amiodarone, verapamil, amlodipine or diltiazem (see section 4.5) 4.4 Special warnings and precautions for use
• Sočasno zdravljenje z amiodaronom, verapamilom, amlodipinom ali diltiazemom (glejte poglavje 4.5)
No preclinical studies have been performed with the fixed dose combination Cholib.
Predkliničnih študij fiksne kombinacije odmerkov v zdravilu Cholib niso izvedli.
Cholib should be used with caution in patients with mild renal insufficiency whose estimated glomerular filtration rate is 60 to 89 mL/min/1.73 m2 (see section 4.2).
Zdravilo Cholib je treba uporabljati previdno pri bolnikih z blago ledvično insuficienco, ki imajo ocenjeno hitrost glomerulne filtracije od 60 do 89 ml/min/1,73 m2 (glejte poglavje 4.2).
Therefore, Cholib is contraindicated during breast-feeding (see section 4.3).
Zato je uporaba zdravila Cholib med dojenjem kontraindicirana (glejte poglavje 4.3).
Cholib should be used with caution in patients with mild renal insufficiency whose estimated glomerular filtration rate is 60 to 89 mL/min/1.73 m
Zdravilo Cholib je treba uporabljati previdno pri bolnikih z blago ledvično insuficienco, ki imajo ocenjeno hitrost glomerulne filtracije od 60 do 89 ml/min/1,73 m
• sexual difficulties
• motnje spolnosti.
(Also see section 4.4).
(Glejte tudi poglavje 4.4).
N Means (SD) Treatment Comparison*
N Povprečje (SD)*
Prolongation of the gestation period and difficulties during delivery were observed at high doses.
Pri velikih odmerkih so opazili podaljšanje gestacije in težave pri kotitvi.
The dose of simvastatin should not exceed 10 mg daily in patients taking danazol.
Pri bolnikih, ki jemljejo danazol, odmerek simvastatina ne sme preseči 10 mg na dan.
Cholib is contraindicated in patients with moderate to severe renal insufficiency whose estimated glomerular filtration rate is < 60 mL/min/1.73 m
Zdravilo Cholib je kontraindicirano pri bolnikih z zmerno do hudo ledvično insuficienco, ki imajo ocenjeno hitrost glomerulne filtracije < 60 ml/min/1,73 m
• increase in “alkaline phosphatase” - produced by the bile system - shown in tests
• zvišanje ravni „alkalne fosfataze“ (snovi, ki jo tvori žolčni sistem), kar pokažejo preiskave,
Cholib 145/40
Zdravilo Cholib 145/40
Constipation, dyspepsia rare
redki zaprtje, dispepsija občasni
Cholib 145/20
Zdravilo Cholib 145/20
During clinical trials, 10% of patients had a creatinine increase from baseline greater than 30 µmol/L with co-administered fenofibrate and simvastatin versus 4.4% with statin monotherapy.
V kliničnih preskušanjih je imelo zvišano raven kreatinina za več kot 30 μmol/l nad izhodiščno vrednostjo 10 % bolnikov, ki so sočasno prejemali fenofibrat in simvastatin, in 4,4 % bolnikov, ki so prejemali samo statin.
• rifampicin (a medicine used to treat tuberculosis)
• rifampicin (zdravilo za tuberkulozo),
The primary efficacy criterion was superiority of the combination fenofibrate 145 and simvastatin 40 mg versus simvastatin 40 mg on TG and LDL-C decrease and HDL-C increase at 12 weeks.
Merilo primarne učinkovitosti je bila večja učinkovitost kombinacije fenofibrata 145 mg in simvastatina 40 mg v primerjavi s simvastatinom 40 mg pri znižanju TG in LDL-holesterola in zvišanju HDL-holesterola po 12 tednih.
The mechanism of the LDL lowering effect of simvastatin may involve both reduction of VLDL-C concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL-C. Apolipoprotein B also falls substantially during treatment with simvastatin.
Mehanizem simvastatinovega učinka zniževanja ravni LDL morda obsega tako znižanje ravni VLDL-holesterola in indukcijo LDL receptorja, kar privede do zmanjšane tvorbe in povečanega katabolizma LDL-holesterola.
Potent CYP 3A4 inhibitors:
Močni zaviralci CYP 3A4: Itrakonazol
Dizziness has been reported rarely in post-marketing experience with simvastatin.
V obdobju trženja simvastatina so poročali o redkih primerih omotice.
If you are worried about this, talk to your doctor or pharmacist.
Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom.
Patients carrying the SLCO1B1 gene allele (c.521T>C) coding for a less active OATP1B1 protein have an increased systemic exposure of simvastatin and increased risk of myopathy.
Zmanjšano delovanje je lahko posledica zaviranja pri medsebojnem delovanju z drugimi zdravili (npr. ciklosporin) ali pri bolnikih, ki so nosilci genotipa SLCO1B1 c.521T>C.Bolniki z alelom gena SLCO1B1 (c.521T>C), ki nosi zapis za manj aktiven protein OATP1B1, imajo večjo sistemsko izpostavljenost simvastatinu in večje tveganje za miopatijo.
Reversible ulcers and erosions in the gastro-intestinal tract occurred in dogs treated during 3 months at exposures approximately 7-fold the clinical AUC.
Pri psih, ki so bili 3 mesece izpostavljeni 7-kratniku klinične vrednosti AUC, so se pojavili reverzibilne razjede in erozije v prebavilih.
Pancreatitis*
pogosti pankreatitis*
In the FIELD study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p=0.022) and a statistically non significant increase in deep vein thrombosis (placebo 1.0% 48/4900 patients) versus fenofibrate 1.4% (67/4895); p=0.074.
V študiji FIELD so ugotovili statistično značilno povečanje pojavnosti pljučne embolije (0,7 % v skupini, ki je prejemala placebo, v primerjavi z 1,1 % v skupini, ki je prejemala fenofibrat; p=0,022) in statistično neznačilno zvišanje pojavnosti globoke venske tromboze (1,0 % v skupini, ki je prejemala placebo (48/4900 bolnikov), v primerjavi z 1,4 % v skupini, ki je prejemala fenofibrat (67/4895 bolnikov); p=0,074).
Gamma-glutamyltransferase increase rare
neznana zvišana raven gama-glutamiltransferaze redki hepatitis/zlatenica jetrna odpoved zelo redki
Adverse reactions (fenofibrate)
Organski sistem Neželeni učinki (fenofibrat)
Talk to your doctor or pharmacist before taking Cholib if:
Pred začetkom jemanja zdravila Cholib se posvetujte z zdravnikom ali farmacevtom, če
Your doctor may do a blood test to check your muscles before and after starting treatment.
Pred in po začetku jemanja zdravila Cholib boste morda morali opraviti krvno preiskavo, da se preverijo vaše mišice.
HDL-C
HDL-holesterol
• chest pain and feeling breathless - these may be signs of a blood clot in the lung (pulmonary embolism)
• bolečine v prsnem košu in zasoplost - to so lahko znaki krvnega strdka v pljučih (pljučne embolije),
The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of simvastatin with potent inhibitors of (CYP) 3A4 (see section 4.5).
Pri sočasni uporabi simvastatina z močnimi zaviralci (CYP) 3A4 se pomembno poveča tveganje miopatije in rabdomiolize (glejte poglavje 4.5).
Thromboembolism * In the FIELD study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% [32/4900 patients] in the placebo group versus 1.1% [53/4895 patients] in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0% [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p=0.074).
Tromboembolija * V študiji FIELD so ugotovili statistično pomembno zvišanje pojavnosti pljučne embolije (0,7 % [32/4900 bolnikov] v skupini, ki je prejemala placebo, v primerjavi z 1,1 % [53/4895 bolnikov] v skupini, ki je prejemala fenofibrat; p = 0,022) in statistično neznačilno zvišanje pojavnosti globoke venske tromboze (1,0 % v skupini, ki je prejemala placebo [48/4900 bolnikov], v primerjavi z 1,4 % v skupini, ki je prejemala fenofibrat [67/4895 bolnikov]; p=0,074).
If any of the above applies to you, talk to your doctor or pharmacist before taking Cholib.
Pred jemanjem zdravila Cholib se posvetujte z zdravnikom ali farmacevtom, če se kaj od zgoraj naštetega nanaša na vas.
Musculoskeletal, connective tissue disorders
Pogostnost mišično-skeletnega sistema in vezivnega tkiva
As a result of these changes the ratios of TC to HDL-C and LDL-C to HDL-C are reduced.
Posledica teh sprememb je znižanje razmerij skupnega holesterola v primerjavi s HDL-holesterolom in LDL-holesterola v primerjavi s HDL-holesterolom.
• colchicine (a medicine used to treat gout).
• kolhicin (zdravilo za zdravljenje putike).
• Do not take Cholib if you are pregnant, trying to get pregnant or think you may be pregnant.
• Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, ne vzemite zdravila Cholib.
• increase in “creatine phosphokinase” - produced by the muscle - shown in tests
• zvišanje ravni „kreatin-fosfokinaze“ (snovi, ki jo tvorijo mišice), kar pokažejo preiskave,
In one study the AUC of the simvastatin acid (SVA), a major active metabolite of simvastatin, was reduced by 42% (90% CI 24%-56%) when a single dose of 40 mg simvastatin was combined with repeated administration of fenofibrate 160 mg.
V eni od študij se je pri kombinaciji enkratnega odmerka simvastatina 40 mg in večkratnega dajanja fenofibrata 160 mg vrednost AUC simvastatinske kisline (SVK), glavnega aktivnega presnovka simvastatina, zmanjšala za 42 % (90-odstotni IZ 24 %-56 %).
Contraindicated with Cholib
Kontraindicirani z zdravilom Cholib.
Fenofibrate/Simvas tatin in combination
Kombinacija fenofibrata in simvastatina
Secondary causes of hyperlipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment (like oral oestrogens), alcoholism should be adequately treated, before Cholib therapy is considered and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment.
Pred uvedbo zdravljenja z zdravilom Cholib je treba ustrezno zdraviti sekundarne vzroke hiperlipidemije, kot so neobvladovana sladkorna bolezen tipa 2, hipotiroidizem, nefrotski sindrom, disproteinemija, obstruktivna jetrna bolezen, farmakološko zdravljenje (kot so peroralni estrogeni) in alkoholizem.
If you get any side effects, talk to your doctor or pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte s svojim zdravnikom ali farmacevtom.
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.
Vse bolnike, ki začnejo zdravljenje, ali po zvišanju odmerka simvastatina, je treba seznaniti s tveganjem za miopatijo.
Paresthesia, dizziness, peripheral neuropathy rare
Bolezni živčevja glavobol občasni parestezija, omotica, periferna nevropatija redki motnje spomina/izguba spomina redki
(see section 4.3).
(glejte poglavje 4.3).
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja dermatitis in ekcem občasni
How to store Cholib
Shranjevanje zdravila Cholib
Asthenia rare
Jetrne bolezni
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska pljučna bolezen neznana
The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of gemfibrozil with simvastatin.
Pri sočasni uporabi gemfibrozila in simvastatina se pomembno poveča tveganje za miopatijo in rabdomiolizo.
Hypersensitivity syndrome rare
Preobčutljivostni sindrom
Simvastatin is well absorbed and undergoes extensive hepatic first-pass extraction.
V jetrih poteka obsežna ekstrakcija prvega prehoda.
In patients taking products containing elbasvir or grazoprevir concomitantly with Cholib the dose of simvastatin should not exceed 20 mg/day.
Zato pri bolnikih, ki jemljejo amiodaron, amlodipin, diltiazem ali verapamil, odmerek zdravila Cholib ne sme preseči 145 mg/20 mg na dan.
Contraindicated with Cholib 145 mg/40 mg
Kontraindicirani z zdravilom Cholib 145 mg/40 mg.
• If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression) o amiodarone (a medicine for an irregular heartbeat) or verapamil (a medicine for high blood pressure, chest pain associated with heart disease, or other heart conditions) o hepatitis C antiviral agents such as elbasvir, grazoprevir, glecaprevir or pibrentasvir (used to treat hepatitis C virus infection)
• če že jemljete naslednja zdravila:  danazol (umetno izdelan hormon za zdravljenje endometrioze),  ciklosporin (zdravilo, ki ga uporabljajo po presaditvah organov),  itrakonazol, ketokonazol, flukonazol ali posakonazol (zdravila za glivične okužbe),  zaviralce proteaze HIV, kot so indinavir, nelfinavir, ritonavir in sakvinavir (zdravila za okužbo z virusom HIV in za AIDS),  eritromicin, klaritromicin ali telitromicin (zdravila za bakterijske okužbe),  nefazodon (zdravilo za depresijo),  amiodaron (zdravilo za nereden srčni utrip) ali verapamil (zdravilo za visok krvni tlak, bolečine v prsnem košu, povezane s srčno boleznijo, ali druge srčne bolezni),  protivirusne učinkovine proti hepatitisu C, kot so elbasvir, grazoprevir, glekaprevir ali pibrentasvir (zdravila za zdravljenje okužbe z virusom hepatitisa C);
• If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o glecaprevir or pibrentasvir (used to treat hepatitis C virus infection) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression)
• če že jemljete naslednja zdravila:  danazol (umetno izdelan hormon za zdravljenje endometrioze),  ciklosporin (zdravilo, ki ga uporabljajo po presaditvah organov),  itrakonazol, ketokonazol, flukonazol ali posakonazol (zdravila za glivične okužbe),  zaviralce proteaze HIV, kot so indinavir, nelfinavir, ritonavir in sakvinavir (zdravila za okužbo z virusom HIV in za AIDS),  glekaprevir ali pibrentasvir (zdravili za zdravljenje okužbe z virusom hepatitisa C),  eritromicin, klaritromicin ali telitromicin (zdravila za bakterijske okužbe),  nefazodon (zdravilo za depresijo);
Sexual dysfunction uncommon
Motnje reprodukcije in dojk spolna disfunkcija občasni erektilna disfunkcija neznana
One film-coated tablet contains 145 mg of fenofibrate and 20 mg of simvastatin.
Ena filmsko obložena tableta vsebuje 145 mg fenofibrata in 20 mg simvastatina.
Poly (vinyl alcohol), partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), lecithin (derived from soya bean (E322)), xanthan gum (E415), iron oxide red (E172).
polivinilalkohol, delno hidroliziran (E1203), titanov dioksid (E171), smukec (E553b), lecitin (sojin (E322)), ksantanski gumi (E415), rdeči železov oksid (E172).
Non-HDL-C (mmol/L)
Ne-HDL-holesterol (mmol/l)
The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax for fenofibric acid, simvastatin and simvastatin acid of the fixed dose combination Cholib 145 mg/40 mg tablet and the co-administration of the separate 145 mg fenofibrate and 40 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval.
Razmerja geometričnih sredin in 90-odstotni intervali zaupanja primerjave AUC, AUC(0-t) in Cmax fenofibrinske kisline, simvastatina in simvastatinske kisline pri fiksni kombinaciji odmerkov v zdravilu Cholib 145 mg/40 mg tablete in pri sočasni uporabi ločenih tablet fenofibrata 145 mg in simvastatina 40 mg v kliničnem programu so bili znotraj 80- do 125-odstotnega bioekvivalenčnega intervala.
Rash, pruritus, urticaria)
neznana kožna preobčutljivost (npr. izpuščaj, pruritus, urtikarija)
Effects on the pharmacokinetics of other medicinal products Fenofibrate and simvastatin are not CYP 3A4 inhibitors or inducers.
Fenofibrat in simvastatin nista zaviralca ali induktorja CYP 3A4.
o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o glecaprevir or pibrentasvir (used to treat hepatitis C virus infection) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression) o a fibrate (e.g. fenofibrate, gemfibrozil) o a statin (e.g. simvastatin, atorvastatin)
 danazol (umetno izdelan hormon za zdravljenje endometrioze),  ciklosporin (zdravilo, ki ga uporabljajo po presaditvah organov),  itrakonazol, ketokonazol, flukonazol ali posakonazol (zdravila za glivične okužbe),  zaviralce proteaze HIV, kot so indinavir, nelfinavir, ritonavir in sakvinavir (zdravila za okužbo z virusom HIV in za AIDS),  glekaprevir ali pibrentasvir (zdravili za zdravljenje okužbe z virusom hepatitisa C),  eritromicin, klaritromicin ali telitromicin (zdravila za bakterijske okužbe),  nefazodon (zdravilo za depresijo),  fibrat (npr. fenofibrat, gemfibrozil),  statin (npr. simvastatin, atorvastatin),
The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax of the active metabolites, fenofibric acid and simvastatin acid, of the fixed dose combination Cholib 145 mg/20 mg tablet and the co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval.
Razmerja geometričnih sredin in 90-odstotni intervali zaupanja primerjave AUC, AUC(0-t) in Cmax aktivnih presnovkov, fenofibrinske kisline in simvastatinske kisline, pri fiksni kombinaciji odmerkov v zdravilu Cholib 145 mg/20 mg tablete in pri sočasni uporabi ločenih tablet fenofibrata 145 mg in simvastatina 20 mg v kliničnem programu so bili znotraj 80- do 125-odstotnega bioekvivalenčnega intervala.
Cholib 145 mg/20 mg film-coated tablets
Cholib 145 mg/20 mg filmsko obložene tablete
CYP 3A4 inhibitors: fluconazole, verapamil, or diltiazem (see sections 4.3 and 4.4).
Previdnost je potrebna pri kombiniranju zdravila Cholib in določenih drugih manj močnih zaviralcev CYP 3A4: flukonazol, verapamil ali diltiazem (glejte poglavja 4.3 in 4.4).
Cholib 145 mg/40 mg film-coated tablets
Cholib 145 mg/40 mg filmsko obložene tablete
The geometric mean ratios and 90% CIs for the comparison of plasma exposure (AUC and AUC(0-t)) to simvastatin after administration of the fixed dose combination Cholib 145 mg/20 mg tablet and after co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were within the 80-125% bioequivalence interval.
Razmerja geometrijčnih sredin in 90-odstotni intervali zaupanja primerjave plazemske izpostavljenosti (AUC in AUC (0-t)) simvastatinu pri uporabi fiksne kombinacije odmerkov v zdravilu Cholib 145 mg/20 mg tablete in pri sočasni uporabi ločenih tablet fenofibrata 145 mg in simvastatina 20 mg v kliničnem programu so bili znotraj 80- do 125-odstotnega bioekvivalenčnega intervala.
Haemoglobin decreased White blood cell count decreased rare
Bolezni krvi in limfatičnega sistema znižana raven hemoglobina zmanjšano število levkocitov redki anemija redki
HDL-C (mmol/L)
HDL-holesterol (mmol/l)
Skeletal muscle toxicity, including rare cases of rhabdomyolysis with or without renal failure, has been reported with administration of lipid-lowering substances like fibrates and statins.
Po dajanju učinkovin za nižanje ravni lipidov, kot so fibrati in statini, so zabeležili primere toksičnosti za skeletne mišice, vključno z redkimi primeri rabdomiolize z ledvično odpovedjo in brez nje.
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
Simvastatin je neaktiven lakton, ki se in vivo hitro hidrolizira v ustrezno betahidroksi kislino, ki močno zavira reduktazo HMG-CoA. Hidroliza v glavnem poteka v jetrih, hidroliza v človeški plazmi pa je zelo počasna.