FrancophonIA/ELRC3.0 huggingface dataset:
English: Consult the prescribing information of all concomitantly used drugs to obtain further information about their potential interactions with simvastatin and/or the potential for enzyme or transporter alterations and possible adjustments to dose and regimens.
Danish: Se ordinationsoplysningerne for alle samtidigt anvendte lægemidler for at få yderligere oplysninger om deres potentielle interaktioner med simvastatin og/eller muligheden for enzym- eller transportørændringer samt mulige justeringer af dosering og regimer.
English: Statin therapy may be re-introduced seven days after the last dose of fusidic acid.
Danish: Statinbehandlingen kan påbegyndes igen syv dage efter den sidste dosis fusidinsyre.
English: No effects on fertility were detected in non-clinical reproductive toxicity studies conducted with fenofibrate.
Danish: Der blev ikke påvist nogen virkning på fertiliteten i ikke-kliniske reproduktionstoksicitetsstudier udført med fenofibrat.
English: During four double blind clinical trials of 24-week duration 1,237 patients have received treatment with co-administered fenofibrate and simvastatin.
Danish: I fire dobbeltblindede kliniske forsøg over 24 uger fik 1.237 patienter samtidig behandling med fenofibrat og simvastatin.
English: In this case, symptomatic and supportive measures should be adopted.
Danish: Skulle det forekomme, skal der gives symptomatisk og støttende behandling.
English: C virus infection)
Danish: virusinfektion)
English: very common
Danish: Meget almindelig
English: Statin type and dose used:
Danish: Anvendt statindosis og -type:
English: • a statin (e.g. simvastatin, atorvastatin)
Danish: • et statin (f.eks. simvastatin, atorvastatin)
English: • muscle problems
Danish: • muskelproblemer
English: Therefore, the dose of Cholib should not exceed 145 mg/20 mg daily in patients taking amiodarone, amlodipine, diltiazem or verapamil.
Danish: Derfor bør Cholib-dosis ikke overstige 145 mg/20 mg dagligt til patienter, der tager amiodaron, amlodipin, diltiazem eller verapamil.
English: In order to establish a reference baseline value, creatine phosphokinase levels should be measured and clinical monitoring is recommended.
Danish: For at kunne fastsætte en reference-baselineværdi skal kreatinfosfokinase måles, og klinisk monitorering anbefales.
English: The dose of simvastatin should not exceed 10 mg daily in patients taking danazol.
Danish: Simvastatindosis bør ikke overstige 10 mg dagligt til patienter, der tager danazol.
English: Cases of myopathy/rhabdomyolysis have been associated with concomitant administration of statins and niacin (nicotinic acid) at lipid-modifying doses (≥ 1 g/day), knowing that niacin and statins can cause myopathy when given alone.
Danish: Tilfælde af myopati/rhabdomyolyse har været associeret med samtidig administration af statiner og niacin (nikotinsyre) ved lipidmodificerende doser (≥ 1 g/dag), da det er kendt, at niacin og statiner kan forårsage myopati, når de gives alene.
English: No hepatic microsomal metabolism is involved.
Danish: Der er ikke involveret nogen mikrosomal metabolisme i leveren.
English: These may be signs of a blood clot in the lung
Danish: Dette kan være tegn på en blodprop i lungerne
English: Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPAR).
Danish: Fenofibrat er et fibrinsyrederivat, hvis lipidmodificerende virkninger, der er rapporteret hos mennesker, medieres via aktivering af peroxisom proliferator-aktiveret receptor af alfa-typen (PPARα).
English: When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus) and diagnosis is confirmed by laboratory testing, Cholib therapy should be discontinued.
Danish: Hvis der opstår symptomer, der tyder på hepatitis (f.eks. gulsot, pruritus), og diagnosen bekræftes med laboratorieprøver, skal behandling med Cholib seponeres.
English: If Creatine Kinase levels are significantly elevated at baseline (> 5 x ULN), treatment should not be started.
Danish: Hvis kreatinkinaseniveauerne er signifikant forhøjede ved baseline (> 5 gange den øvre normalgrænse), må behandlingen ikke indledes.
English: They are both used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood.
Danish: De bruges begge til at sænke indholdet af totalt kolesterol, "dårligt" kolesterol (LDL-kolesterol) og fedtstoffer kaldet triglycerider i blodet.
English: The tablets are provided in carton boxes with blisters containing 10, 30 or 90 tablets.
Danish: Tabletterne fås i kartoner med blisterkort, som indeholder 10, 30 eller 90 tabletter.
English: Simvastatin is a substrate of the Breast Cancer Resistant Protein (BCRP) efflux transporter.
Danish: Simvastatin er et substrat for BCRP (Breast Cancer Resistant Protein)-effluxtransportøren.
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.
Danish: Alle patienter, der starter i behandling, eller hvis dosis simvastatin øges, bør informeres om risikoen for myopati og bedes om straks at rapportere eventuelle uforklarlige muskelsmerter, -ømhed eller -svækkelse.
English: In order to establish a reference baseline value, a Creatine Kinase level should be measured before starting a treatment in the following situations:
Danish: For at kunne fastsætte en reference-baselineværdi skal kreatinkinase måles inden behandlingsstart i følgende situationer:
English: Do not use Cholib after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke Cholib efter den udløbsdato, der står på kartonen og blisterkortet efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Personal or familial history of hereditary muscular disorders
Danish: • Personlig anamnese eller familieanamnese med arvelige muskelsygdomme
English: Fenofibrate and simvastatin enhance effects of Vitamin K antagonists and may increase the risk of bleeding.
Danish: Fenofibrat og simvastatin forstærker virkningen af K-vitaminantagonister og kan øge risikoen for blødning.
English: Treatment Comparison*
Danish: Sammenligning af behandlinger*
English: Mean (SD)
Danish: Middel (SD)
English: At maximally tolerated doses in both the rat and the rabbit, simvastatin produced no fetal malformations, and had no effects on fertility, reproductive function or neonatal development.
Danish: Ved maksimalt tolererede doser producerede simvastatin ingen fostermisdannelser hos hverken rotter eller kaniner, og der var ingen påvirkning af fertiliteten, reproduktionsevnen eller den neonatale udvikling.
English: Mean plasma half-life: the plasma elimination half-life of fenofibric acid is approximately 20 hours.
Danish: Gennemsnitlig halveringstid: Halveringstiden for eliminering af fenofibrinsyre i plasma er ca. 20 timer.
English: Increases in transaminase levels have been reported in some patients treated with simvastatin or fenofibrate.
Danish: Der er rapporteret stigninger i transaminaseniveauerne hos visse patienter i behandling med simvastatin eller fenofibrat.
English: Some patients have experienced the following serious side effects whilst taking fenofibrate or simvastatin (both active substances in Cholib):
Danish: Nogle patienter har fået følgende alvorlige bivirkninger, mens de tog fenofibrat eller simvastatin (begge aktive stoffer i Cholib):
English: The use of micronised fenofibrate and NanoCrystal® technology for the formulation of the fenofibrate 145 mg tablet enhances its absorption.
Danish: Brug af mikroniseret fenofibrat og NanoCrystal teknologi til formuleringen af fenofibrat 145 mg tabletter forbedrer absorptionen.
English: 10 film-coated tablets 30 film-coated tablets 90 film coated tablets
Danish: 10 filmovertrukne tabletter 30 filmovertrukne tabletter 90 filmovertrukne tabletter
English: In rats and mice, liver tumours have been found in carcinogenicity studies, which are attributable to peroxisome proliferation.
Danish: Der er fundet levertumorer hos rotter og mus i carcinogenicitetsstudier, hvilket skyldes peroxisom-proliferation.
English: • Hypoalbuminaemia
Danish: • Hypoalbuminæmi
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.
Danish: Der blev imidlertid observeret reversibel hypospermi, vakuolisering af testiklerne og umodne ovarier i et toksicitetsstudie med gentagne doser af fenofibrinsyre hos unge hunde.
English: Multiple mechanisms may contribute to potential interactions with HMG Co-A reductase inhibitors.
Danish: Flere mekanismer kan bidrage til potentielle interaktioner med HMG Co-A-reduktasehæmmere.
English: Response to therapy should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)).
Danish: Respons på behandlingen bør monitoreres ved bestemmelse af serumlipidværdier (total kolesterol (TC), LDL-kolesterol og triglycerider (TG)).
English: Frequency categories are based on information available from simvastatin and fenofibrate Summary of Product Characteristics available in the EU.
Danish: Hyppighedskategorierne er baseret på tilgængelig information fra produktresuméer for simvastatin og fenofibrat i EU.
English: If you have taken more Cholib than you should or if someone else has taken your medicine, tell your doctor or pharmacist or contact your nearest hospital
Danish: Hvis du har taget for meget Cholib, eller en anden har taget din medicin, skal du fortælle det til lægen eller på apoteket eller kontakte det nærmeste hospital.
English: Because rifampicin is a potent CYP 3A4 inducer that interferes with simvastatin metabolism, patients undertaking long-term rifampicin therapy (e.g. treatment of tuberculosis) may experience loss of efficacy of simvastatin.
Danish: Eftersom rifampicin er en potent CYP 3A4-inducer, der interfererer med omsætningen af simvastatin, kan patienter i langvarig behandling med rifampicin (f.eks. behandling af tuberkulose) opleve tab af effekt af simvastatin.
English: In the available clinical data, the effect on LDL-C reduction was not considered to be significantly different to simvastatin monotherapy when LDL-C is controlled at the time of initiating treatment.
Danish: I de foreliggende, kliniske data blev effekten på LDL-kolesterol ikke anset for at være signifikant anderledes end simvastatin monoterapi, når LDL-kolesterol kontrolleres på tidspuntet for behandlingsstart.
English: Fenofibrate has no or negligible influence on the ability to drive and use machines.
Danish: Fenofibrat påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol.
Danish: Dette enzym katalyserer konvertering af HMG-CoA til mevalonat, et tidligt og hastighedsbegrænsende trin i kolesterolbiosyntesen.
English: • a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis) (very rare)
Danish: • en alvorlig allergisk reaktion, som forårsager åndedrætsbesvær eller svimmelhed (anafylaksi) (meget sjælden)
English: If you forget to take Cholib
Danish: Hvis du har glemt at tage Cholib
English: HDL cholesterol is often called ‘good' cholesterol because it helps keep the ‘bad' cholesterol from building up in the arteries and because it protects against heart disease.
Danish: HDL-kolesterol kaldes ofte "god" kolesterol, fordi det er med til at forhindre det "dårlige" kolesterol i at sætte sig i arterierne, og fordi det beskytter mod hjertesygdom.
English: Mean Percent Change from Baseline to 12 Weeks Full Analysis Subject Sample
Danish: Procentvis ændring fra baseline til uge 12 Fuld analyse af deltagerprøve
English: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5,518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin.
Danish: Lipidforsøget Action to Control Cardiovascular Risk in Diabetes (ACCORD) var et randomiseret, placebokontrolleret studie af 5.518 patienter med type 2-diabetes mellitus, der blev behandlet med fenofibrat og simvastatin.
English: The amount recovered in the faeces represents absorbed medicinal product equivalents excreted in bile as well as unabsorbed medicinal product.
Danish: Den genfundne mængde i fæces repræsenterer absorberede ækvivalenter af lægemiddel udskilt som galde samt som ikke-absorberet lægemiddel.
English: • you or a close family member have a muscle problem which runs in the family
Danish: • hvis du eller et medlem i din nærmeste familie har et arveligt muskelproblem
English: Sleep disorder, including nightmares, depression not known
Danish: Søvnforstyrrelser, herunder mareridt, depression
English: Niacin (nicotinic acid)
Danish: Niacin (nikotinsyre)
English: Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p=0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069).
Danish: En anden præspecificeret subgruppeanalyse identificerede en statistisk signifikant behandling ifølge interaktion mellem køn (p=0,01), der tydede på en mulig behandlingsfordel ved kombinationsterapi hos mænd (p=0,037), men en potentielt højere risiko for det primære resultat hos kvinder behandlet med kombinationsterapi sammenlignet med simvastatinmonoterapi (p=0,069).
English: The extraction in the liver is dependent on the hepatic blood flow.
Danish: Metabolismen i leveren er afhængig af blodgennemstrømningen i leveren.
English: Reversible effects on fertility have been observed in animals (see section 5.3).
Danish: Der er observeret reversible virkninger på fertiliteten hos dyr (se pkt.
English: Embryotoxic effects were observed at doses in the range of maternal toxicity.
Danish: Embryotoksiske virkninger sås ved doser i området for maternel toksicitet.
English: Patients receiving co-administration of Cholib and drugs metabolised by CYP 2C19, CYP 2A6, or especially CYP 2C9 with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Danish: Patienter, der får samtidig behandling med Cholib og lægemidler, der metaboliseres af CYP 2C19, CYP 2A6 eller især CYP 2C9, med et smalt terapeutisk indeks, bør monitoreres nøje, og dosisjustering af disse lægemidler anbefales om nødvendigt.
English: Increased blood homocysteine level ***** In the FIELD study the average increase in blood homocysteine level in patients treated with fenofibrate was 6.5 µmol/L, and was reversible on discontinuation of fenofibrate treatment.
Danish: Forhøjet homocysteinniveau i blodet ***** I FIELD-studiet var den gennemsnitlige stigning i homocysteinniveauet hos patienter, der fik fenofibrat, 6,5 µmol/l, og var reversibel efter seponering af fenofibrat.
English: • Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous statin treatment (see section 4.4)
Danish: • Tidligere myopati og/eller rhabdomyolyse med statiner og/eller fibrater eller bekræftet stigning i kreatininfosfokinase over 5 gange den øvre normalgrænse (ULN) under tidligere statinbehandling (se pkt.
English: Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate.
Danish: Fenofibrat udskilles primært i form af fenofibrinsyre og dets glucuronid-konjugat.
English: No unchanged fenofibrate can be detected in the plasma.
Danish: Der kan ikke detekteres uændret fenofibrat i plasma.
English: Cholib is not expected to affect you being able to drive or use tools or machines.
Danish: Cholib påvirker sandsynligvis ikke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
English: Do not exceed one Cholib 145 mg/20 mg per day, unless clinical benefit outweigh the risk
Danish: Der må ikke tages mere end én Cholib 145 mg/20 mg pr. dag, medmindre den kliniske fordel opvejer risikoen
English: • increase in blood platelets count
Danish: • forhøjet antal blodplader
English: Statin 6 weeks run-in
Danish: Studie 6 ugers indkøring med statin
English: Maximum plasma concentrations (Cmax) of fenofibrate occur within 2 to 4 hours after oral administration.
Danish: Maksimal plasmakoncentration (Cmax) af fenofibrat opnås inden for 2 til 4 timer efter indtagelse.
English: Contraindicated with Cholib
Danish: Kontraindiceret med Cholib
English: In addition, simvastatin moderately increases HDL-C and reduces plasma TG.
Danish: Derudover øger simvastatin moderat HDL-kolesterol og reducerer plasma-TG.
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination.
Danish: Der er rapporteret rhabdomyolyse (inklusive nogle fatale tilfælde) hos patienter, der fik denne kombination.
English: Adverse reactions (simvastatin)
Danish: Bivirkninger (simvastatin)
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.
Danish: Der opstod reversible sår og erosioner i mave-tarm-kanalen hos hunde, der blev behandlet i 3 måneder ved eksponeringer, der er ca. 7 gange større end det kliniske AUC.
English: Cholib contains soya lecithin.
Danish: Cholib indeholder sojalecithin.
English: Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations.
Danish: Det er påvist, at simvastatin reducerer både normale og forhøjede koncentrationer af LDL-kolesterol.
English: As simvastatin is contraindicated during pregnancy (see hereafter), Cholib is contraindicated during pregnancy (see section 4.3).
Danish: Eftersom simvastatin er kontraindiceret under graviditeten (se nedenfor), er Cholib kontraindiceret under graviditeten (se pkt.
English: The adverse reactions of Cholib are in line with what is known from its two active substances: fenofibrate and simvastatin.
Danish: Bivirkningerne af Cholib ligner de bivirkninger, man ved, der er ved de to aktive stoffer: fenofibrat og simvastatin.
English: Activation of PPAR also induces an increase in the synthesis of apoproteins AI and AII.
Danish: Aktivering af PPARα inducerer også en forøget syntese af apoproteiner AI og AII.
English: Fenofibrate and simvastatin are not inhibitors of CYP 2D6, CYP 2E1, or CYP 1A2.
Danish: Fenofibrat og simvastatin er ikke hæmmere af CYP 2D6, CYP 2E1 eller CYP 1A2.
English: A food-effect study involving administration of this formulation of fenofibrate 145 mg tablets to healthy male and female subjects under fasting conditions and with a high fat meal indicated that exposure (AUC and Cmax) to fenofibric acid is not affected by food.
Danish: Et food-effect studie, der involverede administration af denne formulering af 145 mg fenofibrattabletter til raske, fastende mænd og kvinder sammen med et meget fedtholdigt måltid, tydede på, at eksponeringen (AUC og Cmax) for fenofibrinsyre ikke påvirkes af føde.
English: The risk of rhabdomyolysis is also increased in patients concomitantly receiving other fibrates or statins.
Danish: Risikoen for rhabdomyolyse er også øget hos patienter, der samtidig får andre fibrater eller statiner.
English: In exceptional circumstances, where prolonged systemic fusidic acid is needed e.g. for the treatment of severe infections, the need for co-administration of Cholib and fusidic acid should only be considered on a case by case basis and under close medical supervision.
Danish: Under særlige omstændigheder, hvor det er nødvendigt med længerevarende, systemisk fusidinsyre f.eks. til behandling af alvorlige infektioner, bør samtidig administration af Cholib og fusidinsyre overvejes i hvert enkelt tilfælde og kun under nøje tilsyn af en læge.
English: • Previous history of muscular toxicity with a statin or a fibrate
Danish: • Tidligere anamnese med muskeltoksicitet med et statin eller fibrat
English: • If while taking other medicines, you have had an allergic reaction or skin damage from sunlight or UV light (these medicines include other fibrates and an anti-inflammatory medicine called “ketoprofen”)
Danish: • hvis du, mens du tager anden medicin, har fået en allergisk reaktion eller hudskade på grund af sollys eller UV-lys (sådanne lægemidler omfatter andre fibrater og et lægemiddel, der hedder ketoprofen)
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).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Cholib i alle undergrupper af den pædiatriske population med kombineret dyslipidæmi (se pkt.
English: Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin and increase the risk of myopathy and rhabdomyolysis.
Danish: Nedsat funktion af hepatiske OATP-transportproteiner kan øge den systemiske eksponering for simvastatin og risikoen for myopati og rabdomyolyse.
English: Mylan Laboratories SAS Route de Belleville - Lieu-dit Maillard 01400 Châtillon-sur-Chalaronne France
Danish: Mylan Laboratories SAS Route de Belleville - Lieu-dit Maillard 01400 Châtillon-sur-Chalaronne Frankrig
English: Your doctor may do a blood test to check your muscles before and after starting treatment.
Danish: Din læge vil måske også tage en blodprøve for at kontrollere dine muskler, inden og efter du starter på behandlingen.
English: Based on the results of the SEARCH trial, homozygote C allele carriers (also called CC) treated with 80 mg have a 15% risk of myopathy within one year, while the risk in heterozygote C allele carriers (CT) is 1.5%.
Danish: Resultaterne af SEARCH-studiet viste, at homozygote bærere af C-alleler (også kaldet CC), der er blevet behandlet med 80 mg, har en risiko på 15 % for myopati inden for et år, mens risikoen for heterozygote bærere af C-alleler (CT) er 1,5 %.
English: • you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (a medicine for bacterial infection)
Danish: • hvis du tager eller inden for de sidste 7 dage har taget eller fået et lægemiddel, der hedder fusidinsyre (et lægemiddel mod bakterieinfektion)
English: Effects of repeated administration of fenofibrate on the pharmacokinetics of single or multiple doses of simvastatin have been investigated in two small studies (n=12) followed by a larger one (n=85) in healthy subjects.
Danish: Virkninger af gentagen administration af fenofibrat på farmakokinetikken af enkeltdoser eller gentagne doser simvastatin er undersøgt i to små studier (n=12) efterfulgt af et større (n=85) hos raske personer.
English: This medicinal product contains sunset yellow FCF (E110) that may cause allergic reactions.
Danish: Dette lægemiddel indeholder Sunset Yellow FCF (E110), der kan give allergiske reaktioner.
English: Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if aspartate aminotransferase (AST) or also known as serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) or also known as serum glutamic pyruvic transaminase (SGPT) levels increase to more than 3 times the upper limit of the normal range.
Danish: Der skal udvises opmærksomhed ved patienter, der udvikler stigning i transaminaseniveauerne, og behandlingen bør seponeres, hvis aspartataminotransferase (ASAT), også kaldet serum glutamin oxalsyre transaminase (SGOT), og alaninaminotransferase (ALAT), også kaldet serum glutamin pyruvat transaminase (SGPT), stiger til mere end 3 gange den øvre normalgrænse.