FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Lipid parameter (mmol/L)
Slovenian: Lipidni parameter (mmol/l)
English: • digestive disturbances (stomach pain, nausea, vomiting, diarrhoea and flatulence)
Slovenian: • motnje prebave (bolečine v želodcu, siljenje na bruhanje, bruhanje, driska in vetrovi),
English: Statin monotherapy
Slovenian: Statinska monoterapija
English: Fenofibrate cannot be eliminated by haemodialysis.
Slovenian: Fenofibrata ni možno odstraniti s hemodializo.
English: Poly (vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171)
Slovenian: polivinilalkohol, delno hidroliziran (E1203), titanov dioksid (E171),
English: Therefore, the co-administration of Cholib with danazol is contraindicated (see section 4.3).
Slovenian: Zato je sočasna uporaba zdravila Cholib in danazola kontraindicirana (glejte poglavje 4.3).
English: No hepatic microsomal metabolism is involved.
Slovenian: Do jetrna mikrosomske presnove ne prihaja.
English: 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).
Slovenian: 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).
English: What Cholib contains
Slovenian: Kaj vsebuje zdravilo Cholib
English: Mylan IRE Healthcare Ltd, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13Ireland.
Slovenian: Mylan IRE Healthcare Ltd, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 - Irska.
English: Interaction between simvastatin and fenofibrate
Slovenian: Interakcija med simvastatinom in fenofibratom.
English: Your doctor can measure your lipids with a simple blood test. Visit your doctor regularly to keep track of your lipids level.
Slovenian: Redno obiskujte svojega zdravnika, da boste spremljali raven maščob.
English: Muscle
Slovenian: Mišičje
English: 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.
Slovenian: Sočasna uporaba verapamila in simvastatina privede do 2,3-kratnega povečanja plazemske izpostavljenosti simvastatinski kislini, verjetno delno zaradi zaviranja CYP 3A4.
English: • you have kidney disease
Slovenian: • imate bolezen ledvic,
English: • dyspepsia
Slovenian: • dispepsija.
English: • drop in haemoglobin (that carries oxygen in blood) and white blood cells- shown in tests
Slovenian: • upad ravni hemoglobina (ki prenaša kisik v krvi) in belih krvničk, kar pokažejo preiskave,
English: 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)).
Slovenian: Ena filmsko obložena tableta vsebuje 194,7 mg laktoze (v obliki monohidrata), 145 mg saharoze, 0,8 mg lecitina (pridobljenega iz soje (E322)).
English: 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.
Slovenian: 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.
English: Do not crush or chew the tablet.
Slovenian: Tablete ne smete drobiti ali žvečiti.
English: 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).
Slovenian: 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.
English: Marketing Authorisation Holder: Mylan IRE Healthcare Ltd, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 - Ireland.
Slovenian: Imetnik dovoljenja za promet: Mylan IRE Healthcare Ltd, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 - Irska.
English: There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Slovenian: Med zdravljenjem z nekaterimi statini oziroma po njem so zelo redko poročali o imunsko pogojeni nekrotizirajoči miopatiji (immune-mediated necrotizing myopathy - IMNM).
English: 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.
Slovenian: 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.
English: Glitazones
Slovenian: Glitazoni
English: Adverse reactions observed with the co-administration of fenofibrate and simvastatin (Cholib)
Slovenian: Neželeni učinki, ki so ugotovljeni pri sočasni uporabi fenofibrata in simvastatina (Cholib) Organski sistem
English: You must continue a low fat diet or other measures (e.g. exercise, weight reduction) during treatment with Cholib.
Slovenian: Med zdravljenjem z zdravilom Cholib morate nadaljevati s prehrano z majhnim vnosom maščob in drugimi ukrepi (npr. telesna vadba, hujšanje).
English: 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.
Slovenian: 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.
English: • 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).
Slovenian: • rumeno obarvanje kože in beločnic (zlatenica) ali zvišane ravni jetrnih encimov - to so lahko znaki vnetja jeter (hepatitisa ali jetrne odpovedi),
English: • erectile dysfunction
Slovenian: • motnje erekcije,
English: Temporary suspension of Cholib treatment may be considered
Slovenian: Preučiti je treba potrebo po začasni prekinitvi zdravljenja z zdravilom Cholib.
English: • Previous history of muscular toxicity with a statin or a fibrate
Slovenian: • Mišična toksičnost pri uporabi statina ali fibrata v anamnezi
English: 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.
Slovenian: 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.
English: Week 0 to Week 12
Slovenian: 0. do 12. teden
English: 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.
Slovenian: 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.
English: EU/1/13/866/001-002 EU/1/13/866/005
Slovenian: EU/1/13/866/005
English: Cholib must not be co-administered with fusidic acid.
Slovenian: Zdravila Cholib ne smete dajati sočasno s fusidno kislino.
English: 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.
Slovenian: Vendar so v študiji toksičnosti ponavljajočih se odmerkov fenofibrinske kisline pri mladih psih ugotovili reverzibilno hipospermijo in testikularno vakuolizacijo ter nezrelost jajčnikov.
English: Combination with itraconazole, ketoconazole, posaconazole, HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone is contraindicated (see section 4.3).
Slovenian: Kombiniranje z itrakonazolom, ketokonazolom, posakonazolom, zaviralci proteaze HIV (npr. nelfinavirjem), eritromicinom, klaritromicinom, telitromicinom in nefazodonom je kontraindicirano (glejte poglavje 4.3).
English: EU/1/13/866/003-004 EU/1/13/866/006
Slovenian: EU/1/13/866/006
English: 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).
Slovenian: 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).
English: • Increase in the blood level of “creatinine” (substance excreted by the kidneys)
Slovenian: • zvišanje ravni „kreatinina“ (snovi, ki jo izločajo ledvice) v krvi,
English: • rifampicin (a medicine used to treat tuberculosis).
Slovenian: • rifampicin (zdravilo za tuberkulozo).
English: Gastrointestinal disorders Gastrointestinal signs and symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence)
Slovenian: Bolezni prebavil znaki in simptomi v prebavilih (kot so trebušne bolečine, siljenje na bruhanje, bruhanje, driska, vetrovi)
English: *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: *Primerjavo zdravljenja sestavljata razlika med povprečjema najmanjših kvadratov za feno 145 + simva 40 in simva 40 ter pripadajoči 95-odstotni IZ.
English: • pain, redness or swelling in the legs - these may be signs of a blood clot in the leg (deep vein thrombosis)
Slovenian: • bolečine, pordelost ali otekanje nog - to so lahko znaki krvnega strdka v nogah (globoke venske tromboze),
English: Renal function Cholib is contraindicated in moderate to severe renal impairment (see section 4.3).
Slovenian: Zdravilo Cholib je kontraindicirano pri zmerno do hudo okvarjenem delovanju ledvic (glejte poglavje 4.3).
English: Muscle disorders (e.g. myalgia, myositis, muscular spasms and weakness)
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolezni mišic (npr. mialgija, miozitis, mišični spazmi in šibkost)
English: Immune system disorders Hypersensitivity rare
Slovenian: Bolezni imunskega sistema preobčutljivost redki anafilaksija zelo redki
English: Do not exceed one Cholib 145 mg/20 mg per day
Slovenian: Ne smete preseči odmerka ene tablete zdravila Cholib 145 mg/20 mg na dan.
English: Grapefruit juice inhibits CYP 3A4.
Slovenian: Grenivkin sok zavira CYP 3A4.
English: LDL-C
Slovenian: LDL-holesterol
English: Concomitant administration of amiodarone, verapamil, amlodipine or diltiazem (see section 4.5) 4.4 Special warnings and precautions for use
Slovenian: • Sočasno zdravljenje z amiodaronom, verapamilom, amlodipinom ali diltiazemom (glejte poglavje 4.5)
English: No preclinical studies have been performed with the fixed dose combination Cholib.
Slovenian: Predkliničnih študij fiksne kombinacije odmerkov v zdravilu Cholib niso izvedli.
English: 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).
Slovenian: 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).
English: Therefore, Cholib is contraindicated during breast-feeding (see section 4.3).
Slovenian: Zato je uporaba zdravila Cholib med dojenjem kontraindicirana (glejte poglavje 4.3).
English: 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
Slovenian: 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
English: • sexual difficulties
Slovenian: • motnje spolnosti.
English: (Also see section 4.4).
Slovenian: (Glejte tudi poglavje 4.4).
English: N Means (SD) Treatment Comparison*
Slovenian: N Povprečje (SD)*
English: Prolongation of the gestation period and difficulties during delivery were observed at high doses.
Slovenian: Pri velikih odmerkih so opazili podaljšanje gestacije in težave pri kotitvi.
English: The dose of simvastatin should not exceed 10 mg daily in patients taking danazol.
Slovenian: Pri bolnikih, ki jemljejo danazol, odmerek simvastatina ne sme preseči 10 mg na dan.
English: Cholib is contraindicated in patients with moderate to severe renal insufficiency whose estimated glomerular filtration rate is < 60 mL/min/1.73 m
Slovenian: Zdravilo Cholib je kontraindicirano pri bolnikih z zmerno do hudo ledvično insuficienco, ki imajo ocenjeno hitrost glomerulne filtracije < 60 ml/min/1,73 m
English: • increase in “alkaline phosphatase” - produced by the bile system - shown in tests
Slovenian: • zvišanje ravni „alkalne fosfataze“ (snovi, ki jo tvori žolčni sistem), kar pokažejo preiskave,
English: Cholib 145/40
Slovenian: Zdravilo Cholib 145/40
English: Constipation, dyspepsia rare
Slovenian: redki zaprtje, dispepsija občasni
English: Cholib 145/20
Slovenian: Zdravilo Cholib 145/20
English: 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.
Slovenian: 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.
English: • rifampicin (a medicine used to treat tuberculosis)
Slovenian: • rifampicin (zdravilo za tuberkulozo),
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Potent CYP 3A4 inhibitors:
Slovenian: Močni zaviralci CYP 3A4: Itrakonazol
English: Dizziness has been reported rarely in post-marketing experience with simvastatin.
Slovenian: V obdobju trženja simvastatina so poročali o redkih primerih omotice.
English: If you are worried about this, talk to your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom.
English: 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.
Slovenian: 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.
English: Reversible ulcers and erosions in the gastro-intestinal tract occurred in dogs treated during 3 months at exposures approximately 7-fold the clinical AUC.
Slovenian: Pri psih, ki so bili 3 mesece izpostavljeni 7-kratniku klinične vrednosti AUC, so se pojavili reverzibilne razjede in erozije v prebavilih.
English: Pancreatitis*
Slovenian: pogosti pankreatitis*
English: 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.
Slovenian: 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).
English: Gamma-glutamyltransferase increase rare
Slovenian: neznana zvišana raven gama-glutamiltransferaze redki hepatitis/zlatenica jetrna odpoved zelo redki
English: Adverse reactions (fenofibrate)
Slovenian: Organski sistem Neželeni učinki (fenofibrat)
English: Talk to your doctor or pharmacist before taking Cholib if:
Slovenian: Pred začetkom jemanja zdravila Cholib se posvetujte z zdravnikom ali farmacevtom, če
English: Your doctor may do a blood test to check your muscles before and after starting treatment.
Slovenian: Pred in po začetku jemanja zdravila Cholib boste morda morali opraviti krvno preiskavo, da se preverijo vaše mišice.
English: HDL-C
Slovenian: HDL-holesterol
English: • chest pain and feeling breathless - these may be signs of a blood clot in the lung (pulmonary embolism)
Slovenian: • bolečine v prsnem košu in zasoplost - to so lahko znaki krvnega strdka v pljučih (pljučne embolije),
English: The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of simvastatin with potent inhibitors of (CYP) 3A4 (see section 4.5).
Slovenian: Pri sočasni uporabi simvastatina z močnimi zaviralci (CYP) 3A4 se pomembno poveča tveganje miopatije in rabdomiolize (glejte poglavje 4.5).
English: 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).
Slovenian: 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).
English: If any of the above applies to you, talk to your doctor or pharmacist before taking Cholib.
Slovenian: Pred jemanjem zdravila Cholib se posvetujte z zdravnikom ali farmacevtom, če se kaj od zgoraj naštetega nanaša na vas.
English: Musculoskeletal, connective tissue disorders
Slovenian: Pogostnost mišično-skeletnega sistema in vezivnega tkiva
English: As a result of these changes the ratios of TC to HDL-C and LDL-C to HDL-C are reduced.
Slovenian: Posledica teh sprememb je znižanje razmerij skupnega holesterola v primerjavi s HDL-holesterolom in LDL-holesterola v primerjavi s HDL-holesterolom.
English: • colchicine (a medicine used to treat gout).
Slovenian: • kolhicin (zdravilo za zdravljenje putike).
English: • Do not take Cholib if you are pregnant, trying to get pregnant or think you may be pregnant.
Slovenian: • Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, ne vzemite zdravila Cholib.
English: • increase in “creatine phosphokinase” - produced by the muscle - shown in tests
Slovenian: • zvišanje ravni „kreatin-fosfokinaze“ (snovi, ki jo tvorijo mišice), kar pokažejo preiskave,
English: 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.
Slovenian: 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 %).
English: Contraindicated with Cholib
Slovenian: Kontraindicirani z zdravilom Cholib.
English: Fenofibrate/Simvas tatin in combination
Slovenian: Kombinacija fenofibrata in simvastatina
English: 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.
Slovenian: 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.
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte s svojim zdravnikom ali farmacevtom.
English: 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.
Slovenian: Vse bolnike, ki začnejo zdravljenje, ali po zvišanju odmerka simvastatina, je treba seznaniti s tveganjem za miopatijo.