FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown.
Slovenian: Mehanizem tega medsebojnega delovanja (ali gre za farmakodinamiko, farmakokinetiko ali oboje) še ni znan.
English: Safety in pregnant women has not been established.
Slovenian: Varnosti pri nosečnicah še niso ugotovili.
English: The liver is the primary site of action of the active form.
Slovenian: Jetra so primarno mesto delovanja aktivne oblike.
English: Concomitant food intake does not affect the absorption.
Slovenian: Sočasni vnos hrane ne vpliva na absorpcijo.
English: These changes are specific to rodents and have not been observed in other species at comparable dose levels.
Slovenian: Te spremembe so specifične za glodavce in jih niso odkrili pri drugih živalskih vrstah pri primerljivih odmerkih.
English: Supportive study
Slovenian: Podporna študija
English: The usual dose is one tablet per day.
Slovenian: Običajni odmerek je ena tableta na dan.
English: Biotransformation and Elimination
Slovenian: Biotransformacija in izločanje
English: Treatment should be interrupted when creatinine level is 50% above the upper limit of normal.
Slovenian: Zdravljenje je treba prekiniti, kadar je raven kreatinina 50 % nad zgornjo mejo normalne vrednosti.
English: This also concerns medicines obtained without a prescription including herbal medicines.
Slovenian: To velja tudi za zdravila, ki ste jih dobili brez recepta, vključno z zeliščnimi zdravili.
English: Four pivotal clinical studies were carried out in the clinical program.
Slovenian: V kliničnem programu so bile izvedene štiri ključne klinične študije.
English: • increased sensitivity of your skin to sunlight, sun lamps and sunbeds
Slovenian: • povečana občutljivost vaše kože za sončno svetlobo ter za svetilke in naprave za sončenje.
English: Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Slovenian: Fenofibrinska kislina je močno vezana na plazemski albumin (več kot 99 %).
English: It is recommended that the dose of those oral anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.
Slovenian: Priporočljivo je, da se odmerek teh peroralnih antikoagulantov na začetku zdravljenja zmanjša za približno tretjino in nato postopoma po potrebi prilagodi glede na spremljanje INR (internacionalno normalizirano razmerje).
English: Simvastatin is contraindicated during pregnancy.
Slovenian: Simvastatin je kontraindiciran med nosečnostjo.
English: This is of no relevance to therapeutic use in man.
Slovenian: Ta pojav ni pomemben pri terapevtski uporabi pri človeku.
English: The results on the biological parameters of interest at 24 weeks are presented in the table below.
Slovenian: Rezultati preiskovanih bioloških parametrov po 24 tednih so predstavljeni v spodnji preglednici.
English: The frequencies of adverse reactions are ranked according to the following: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti neželenih učinkov so razvrščene glede na naslednje: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: There is no specific treatment in the event of overdose.
Slovenian: Specifično zdravljenje v primeru prevelikega odmerjanja ne obstaja.
English: Cholib with food and drink
Slovenian: Zdravilo Cholib skupaj s hrano in pijačo
English: There are no adequate data from the use of fenofibrate in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi fenofibrata pri nosečnicah.
English: < PC: {number} [product code]
Slovenian: <PC: {številka} [koda zdravila]
English: In the majority of cases these elevations were transient, minor and asymptomatic without the need for treatment discontinuation.
Slovenian: V večini primerov so bila ta zvišanja prehodne narave, manj pomembna in asimptomatska, brez potrebe po prekinitvi zdravljenja.
English: Treatment Comparison*
Slovenian: Primerjava zdravljenja*
English: They may be taken with or without food (see section 5.2).
Slovenian: Tablete se lahko vzamejo s hrano ali brez nje (glejte poglavje 5.2).
English: • Paediatric population (age below 18 years)
Slovenian: • Pediatrična populacija (starost do 18 let)
English: Each tablet should be swallowed whole with a glass of water.
Slovenian: Vsako tableto je treba pogoltniti celo s kozarcem vode.
English: If an overdose is suspected, symptomatic treatment and appropriate supportive measures should be provided as required.
Slovenian: Če sumite preveliko odmerjanje, je treba po potrebi zagotoviti simptomatično zdravljenje in ustrezne podporne ukrepe.
English: After 24 weeks
Slovenian: Po 24 tednih
English: Prescribing recommendations
Slovenian: Priporočila za predpisovanje
English: It is higher in female patients or in patients 65 years or older.
Slovenian: Tveganje je večje pri bolnikih ženskega spola in bolnikih, starejših od 65 let.
English: Contrarily to previous fenofibrate formulations, the maximum plasma concentration and overall exposure of this formulation is independent from food intake.
Slovenian: V nasprotju s prejšnjimi formulacijami fenofibrata sta najvišja raven v plazmi in skupna izpostavljenost pri tej formulaciji neodvisni od vnosa hrane.
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines (taking Cholib with any of these medicines can increase the risk of muscle problems):
Slovenian: Posebej pomembno je, da obvestite zdravnika ali farmacevta, če jemljete katero koli od naslednjih zdravil (jemanje zdravila Cholib s katerim koli od teh zdravil lahko poveča tveganje za težave z mišicami):
English: F145/S40 demonstrated statistically significant superiority on all parameters except on ApoA1 increase.
Slovenian: Pri F145/S40 so dokazali statistično boljšo učinkovitost pri vseh parametrih, razen pri zvišanju ApoA1.
English: • numbness or weakness of the arms and legs
Slovenian: • odrevenelost ali šibkost v rokah in nogah,
English: • sleep disturbances including nightmares
Slovenian: • motnje spanja, vključno z nočnimi morami,
English: Adjust the dose of these oral anticoagulants according to INR monitoring
Slovenian: Prilagodite odmerek teh peroralnih antikoagulantov glede na spremljanje INR.
English: What Cholib is and what it is used for
Slovenian: Kaj je zdravilo Cholib in za kaj ga uporabljamo
English: The drug is excreted mainly in the urine.
Slovenian: Zdravilo se v glavnem izloča v urin.
English: This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.
Slovenian: To tveganje pa ne odtehta zaradi statinov zmanjšanega tveganja za bolezni žil, zato ne sme biti razlog za prekinitev zdravljenja s statini.
English: After 12 weeks
Slovenian: Po 12 tednih
English: Transaminase levels have to be monitored before treatment begins, every 3 months during the first 12 months of treatment and thereafter periodically.
Slovenian: Ravni transaminaz je treba začeti spremljati pred uvedbo zdravljenja, nato pa jih določati vsake 3 mesece v prvih 12 mesecih zdravljenja in redno še naprej.
English: Fenofibrate also has a uricosuric effect leading to reduction in uric acid levels of approximately 25%.
Slovenian: Fenofibrat ima tudi urikozurični učinek, ki vodi do znižanja ravni sečne kisline za približno 25 %.
English: Studies in mice, rats and rabbits did not reveal any teratogenic effect.
Slovenian: Študije, opravljene pri miših, podganah in kuncih, niso pokazale nikakršnih teratogenih učinkov.
English: The protein binding of simvastatin and its active metabolite is > 95%.
Slovenian: Vezava simvastatina in njegovega aktivnega presnovka na beljakovine je > 95 %.
English: Cholib should be used with caution in patients who consume substantial quantities of alcohol.
Slovenian: Zdravilo Cholib je treba uporabljati previdno pri bolnikih, ki uživajo večje količine alkohola.
English: Once a stable INR has been documented, it can be monitored at the intervals usually recommended for patients on those oral anticoagulants.
Slovenian: Ko dosežete stabilno vrednost INR, jo lahko spremljate v presledkih, ki se običajno priporočajo za bolnike, ki prejemajo te peroralne antikoagulante.
English: • Active liver disease or unexplained persistent elevations of serum transaminases
Slovenian: • Aktivna jetrna bolezen ali nepojasnjeno trajno zvišanje ravni transaminaz v serumu
English: Glecaprevir Pibrentasvir
Slovenian: Glekaprevir Pibrentasvir
English: Statin type and dose used:
Slovenian: Uporabljeni tip in odmerek statina:
English: Important information about some of the ingredients of Cholib
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Cholib
English: The extraction in the liver is dependent on the hepatic blood flow.
Slovenian: Ekstrakcija v jetrih je odvisna od jetrnega krvnega obtoka.
English: Following an oral dose of radioactive simvastatin to man, 13% of the radioactivity was excreted in the urine and 60% in the faeces within 96 hours.
Slovenian: Po dajanju peroralnega odmerka radioaktivno označenega simvastatina človeku se v 96 urah 13 % radioaktivnosti izloči v urinu, 60 % radioaktivnosti pa v blatu.
English: • Elderly ≥ 65 years
Slovenian: • Starejši bolniki ≥ 65 let
English: • Do not take Cholib if you are breast-feeding or plan to breast-feed your baby, because it is not known if the medicine passes into breast milk.
Slovenian: • Zdravila Cholib ne jemljite, če dojite ali nameravate dojiti svojega otroka, saj ni znano, ali zdravilo prehaja v mleko.
English: You can take Cholib with or without food.
Slovenian: Zdravilo Cholib lahko vzamete s hrano ali brez nje.
English: Adverse reactions (simvastatin)
Slovenian: Neželeni učinki (simvastatin)
English: Blood homocysteine level increased (see section 4.4)*****
Slovenian: Preiskave zvišana raven homocisteina v krvi (glejte poglavje 4.4)*****
English: Studies on mutagenicity of fenofibrate have been negative.
Slovenian: Rezultati študij mutagenosti fenofibrat so bili negativni.
English: Fenofibrate is water-insoluble and must be taken with food to facilitate absorption.
Slovenian: Fenofibrat ni vodotopen, zato ga je treba jemati s hrano, ki olajša absorpcijo.
English: LS (less square mean) SD (standard deviation)
Slovenian: LS (povprečje najmanjših kvadratov) SD (standardni odklon)
English: Fenofibrate and simvastatin enhance effects of Vitamin K antagonists and may increase the risk of bleeding.
Slovenian: Fenofibrat in simvastatin povečata učinke antagonistov vitamina K in lahko povečata tveganje za krvavitve.
English: It is unknown whether fenofibrate, simvastatin and/or their metabolites are excreted in human milk.
Slovenian: Ni znano, ali se fenofibrat, simvastatin in/ali njuni presnovki izločajo v materino mleko pri človeku.
English: The tablets should not be crushed or chewed.
Slovenian: Tablet se ne sme drobiti ali žvečiti.
English: If myopathy is suspected for any other reason, treatment should be discontinued.
Slovenian: Če zaradi kakšnega drugega vzroka sumite na miopatijo, je treba zdravljenje prekiniti.
English: In addition, they both raise levels of “good” cholesterol (HDL cholesterol).
Slovenian: Poleg tega obe učinkovini zvišujeta raven „dobrega“ holesterola (holesterola HDL).
English: This was not observed in the aforementioned subgroup of patients with dyslipidaemia but there was also no clear evidence of benefit in dyslipidaemic women treated with fenofibrate plus simvastatin, and a possible harmful effect in this subgroup could not be excluded.
Slovenian: V prej omenjeni podskupini bolnikov z dislipidemijo tega niso opazili, vendar tudi ni bilo jasnega dokaza koristi pri dislipidemičnih ženskah, ki so se zdravile s fenofibratom in simvastatinom, zato možnih škodljivih učinkov v tej podskupini ni mogoče izključiti.
English: Grapefruit juice contains one or more components that alter how the body uses Cholib.
Slovenian: Grenivkin sok vsebuje eno ali več sestavin, ki spremenijo način izrabe zdravila Cholib v telesu.
English: If Creatine Kinase levels are significantly elevated at baseline (> 5 x ULN), levels should be re-measured within 5 to 7 days later to confirm the results.
Slovenian: Če so ravni kreatin-kinaze v izhodišču pomembno zvišane (> 5-kratnik ULN), jih je treba ponovno določiti 5 do 7 dni kasneje za potrditev rezultatov.
English: The risk of myopathy with statins and fibrates is known to be related to the dose of each component and to the nature of the fibrate.
Slovenian: Za tveganje za miopatijo pri uporabi statinov in fibratov je znano, da je odvisno od odmerka vsake komponente in od narave fibrata.
English: Cholib therapy has not been associated with bleeding in patients not taking anticoagulants.
Slovenian: Zdravljenje z zdravilom Cholib ni bilo povezano s krvavitvami pri bolnikih, ki ne jemljejo antikoagulantov.
English: Therefore, fenofibrate should only be used during pregnancy after a careful benefit/risk assessment.
Slovenian: Zato se sme fenofibrat uporabljati med nosečnostjo šele po natančni preučitvi razmerja med koristnimi učinki in potencialnimi tveganji.
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination.
Slovenian: Obstajajo poročila o rabdomiolizi (tudi o nekaj smrtnih primerih) pri bolnikih, ki so prejemali to kombinacijo.
English: • Moderate to severe renal insufficiency (estimated glomerular filtration rate
Slovenian: • Zmerna do huda ledvična insuficienca (ocenjena hitrost glomerulne filtracije
English: • Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia
Slovenian: • Kronični ali akutni pankreatitis z izjemo akutnega pankreatitisa zaradi hude hipertrigliceridemije
English: Swallow the tablet with a glass of water.
Slovenian: Tableto je treba pogoltniti s kozarcem vode.
English: You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Slovenian: Pri vas je pojav sladkorne bolezni verjeten, če imate v krvi visoke ravni sladkorja in maščob, ste pretežki in imate visok krvni tlak.
English: Simvastatin is taken up actively into the hepatocytes by the transporter OATP1B1.
Slovenian: Hepatociti aktivno privzemajo simvastatin skozi transporter OATP1B1.
English: Store below 30°C.
Slovenian: Zdravilo shranjujte pri temperaturi do 30 °C.
English: Plasma concentrations are stable during continuous treatment in any given individual.
Slovenian: Koncentracije v plazmi so med neprekinjenem zdravljenjem stabilne pri vseh osebah.
English: If any of the previously listed serious side effects happen, stop taking Cholib and tell your doctor immediately or go to the emergency room at your nearest hospital - you may need urgent medical treatment.
Slovenian: Če se pojavi kateri koli od naštetih resnih neželenih učinkov, prenehajte z jemanjem zdravila Cholib in se nemudoma posvetujte s svojim zdravnikom ali pa obiščite enoto nujne medicinske pomoči v najbližji bolnišnici - morda potrebujete nujno zdravljenje.
English: Cholib: Cholib contains fenofibrate and simvastatin, which have different modes of action as described above.
Slovenian: Zdravilo Cholib vsebuje fenofibrat in simvastatin, ki imata različna načina delovanja, kot je opisano zgoraj.
English: Avoid with Cholib unless clinical benefit outweigh the risk
Slovenian: Ne uporabljajte z zdravilom Cholib, razen če klinična korist odtehta tveganje.
English: This medicine contains less than 1 mmol sodium (23 mg) per one tablet, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Cholib in all subsets of the paediatric population in combined dyslipidaemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Cholib za vse podskupine pediatrične populacije s kombinirano dislipidemijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Do not take Cholib:
Slovenian: Ne jemljite zdravila Cholib:
English: Do not consume grapefruit juice with Cholib as it may increase your risk of muscle problems.
Slovenian: Ne pijte grenivkinega soka skupaj z zdravilom Cholib, saj se lahko poveča tveganje za težave z mišicami.
English: Niacin (nicotinic acid) ≥ 1 g/day
Slovenian: Niacin (nikotinska kislina) ≥ 1 g/dan
English: Cholib contains two different active substances: fenofibrate (belongs to the group called ‘fibrates') and simvastatin (belongs to the group called ‘statins').
Slovenian: Zdravilo Cholib vsebuje dve učinkovini: fenofibrat (ki spada v skupino „fibratov“) in simvastatin (ki spada v skupino „statinov“).
English: For these reasons, simvastatin must not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.
Slovenian: Zaradi tega se simvastatin ne sme uporabljati pri nosečnicah, ženskah, ki želijo zanositi, ali ženskah, ki sumijo, da so noseče.
English: HDL-C levels are frequently increased.
Slovenian: Ravni HDL-holesterola se pogosto zvišajo.
English: Veno-thromboembolic events
Slovenian: Vensko-trombembolični dogodki
English: 10 film-coated tablets 30 film-coated tablets 90 film coated tablets
Slovenian: 10 filmsko obloženih tablet 30 filmsko obloženih tablet 90 filmsko obloženih tablet
English: • specific lung disease with difficulties breathing (called interstitial lung disease)
Slovenian: • posebna bolezen pljuč z oteženim dihanjem (imenovana intersticijska pljučna bolezen),
English: In order to establish a reference baseline value, a Creatine Kinase level should be measured before starting a treatment in the following situations:
Slovenian: Za določitev referenčne izhodiščne vrednosti je treba izmeriti raven kreatin-kinaze pred začetkom zdravljenja v naslednjih primerih:
English: • Increase in blood levels of “homocysteine” (too much of this amino acid in the blood is related to a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal link has not been established)
Slovenian: • zvišanje ravni „homocisteina“ v krvi (prevelike količine te aminokisline v krvi so povezane z večjim tveganjem za koronarno srčno bolezen, možgansko kap in periferno žilno bolezen, čeprav vzročna povezava ni dokazana).
English: The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors.
Slovenian: Povečano tveganje venskih trombotičnih dogodkov je lahko povezano z zvišanjem ravni homocisteina, ki je dejavnik tveganja za trombozo in z drugimi neodkritimi dejavniki.
English: Mean plasma half-life: the plasma elimination half-life of fenofibric acid is approximately 20 hours.
Slovenian: Povprečna plazemski razpolovni čas: plazemski razpolovni čas odstranjevanja fenofibrinske kisline je približno 20 ur.
English: In rats and mice, liver tumours have been found in carcinogenicity studies, which are attributable to peroxisome proliferation.
Slovenian: Pri podganah in miših so se v študijah karcinogenosti pojavili tumorji v jetrih, ki jih pripisujejo proliferaciji peroksisomov.
English: Based on conventional animal studies regarding pharmacodynamics, repeated dose toxicity, genotoxicity and carcinogenicity, there are no other risks for the patient than may be expected on account of the pharmacological mechanism.
Slovenian: Na osnovi običajnih živalskih študij farmakodinamike, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala z vidika farmakološkega mehanizma ni pričakovati drugih tveganj za bolnika.
English: However, it should be taken into account that some people get dizzy after taking Cholib.
Slovenian: Vendar je treba upoštevati, da se nekateri po uporabi zdravila Cholib počutijo omotični.
English: Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate.
Slovenian: Fenofibrat se v glavnem izloča v obliki fenofibrinske kisline in njenega glukuronidnega konjugata.
English: In the majority of cases no overdose symptoms were reported.
Slovenian: V večini primerov ni bilo navedenih simptomov prevelikega odmerjanja.
English: Co-administration of this combination may cause increased plasma concentrations of both agents.
Slovenian: Sočasno dajanje te kombinacije lahko zviša plazemske koncentracije obeh zdravil.
English: Simvastatin is a substrate of the Breast Cancer Resistant Protein (BCRP) efflux transporter.
Slovenian: Simvastatin je substrat izločevalnega prenašalca proteina odpornosti pri raku dojke (BCRP).
English: When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus) and diagnosis is confirmed by laboratory testing, Cholib therapy should be discontinued.
Slovenian: Če se pojavijo simptomi, ki nakazujejo hepatitis (npr. zlatenica, srbenje), in diagnozo potrdijo laboratorijske preiskave, je treba zdravljenje z zdravilom Cholib prekiniti.
English: The risk of high dose (80 mg) simvastatin related myopathy is about 1 % in general, without genetic testing.
Slovenian: Tveganje za miopatijo, povezano z večjim odmerkom simvastatina (80 mg) je na splošno (brez genetskega testiranja) približno 1 %.
English: Activation of PPAR also induces an increase in the synthesis of apoproteins AI and AII.
Slovenian: Aktivacija PPARα sproži tudi povečanje sinteze apoproteinov AI in AII.
English: If you forget to take Cholib
Slovenian: Če ste pozabili vzeti zdravilo Cholib
English: P450 (CYP) 3A4 inhibitors (see section 4.5)
Slovenian: P450 (CYP) 3A4 (glejte poglavje 4.5)
English: • If you are pregnant or breast-feeding
Slovenian: • če ste noseči ali dojite.
English: Pack sizes: 10, 30 and 90 film-coated tablets.
Slovenian: Velikosti pakiranja: 10, 30 in 90 filmsko obloženih tablet.
English: • If you have pancreatitis (inflamed pancreas which causes abdominal pain), which is not caused by high levels of fats in the blood
Slovenian: • če imate pankreatitis (vnetje trebušne slinavke, ki povzroča trebušne bolečine), ki ga ne povzročajo visoke ravne maščob v krvi,
English: While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes.
Slovenian: Med jemanjem zdravila vas bo zdravnik natančno spremljal, če imate sladkorno bolezen ali je pri vas večje tveganje za pojav sladkorne bolezni.
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete katero koli od naslednjih zdravil:
English: It is recommended that creatinine is measured during the first 3 months after initiation of treatment and periodically thereafter.
Slovenian: Priporočljivo je, da ravni kreatinina določate prve 3 mesece po uvedbi zdravljenja in redno še naprej.
English: very common
Slovenian: zelo pogosti
English: Like all medicines, Cholib can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Cholib neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Fenofibrate has no or negligible influence on the ability to drive and use machines.
Slovenian: Fenofibrat ne vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: • Uncontrolled hypothyroidism
Slovenian: • Neobvladan hipotiroidizem
English: What you need to know before you take use Cholib
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Cholib
English: • If you have moderate or severe kidney problems
Slovenian: • če imate zmerne ali hude težave z ledvicami,
English: If you are allergic to peanut, soya or arachis oil do not use Cholib.
Slovenian: Če ste alergični na arašide, sojo ali arašidovo olje, ne uporabljajte zdravila Cholib.