FrancophonIA/ELRC3.0 huggingface dataset:
English: Intake of 240 mL of grapefruit juice in the morning and simvastatin in the evening also resulted in a 1.9-fold increase in plasma exposure to simvastatin acid.
Danish: Indtag af 240 ml grapefrugtjuice om morgenen og simvastatin om aftenen resulterede også i en 1,9 gange stor øgning for eksponeringen af simvastatinsyre i plasma.
English: • feeling exhausted (astenia)
Danish: • udmattethed (asteni)
English: Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate.
Danish: Kinetiske studier efter administration af en enkelt dosis og kontinuerlig behandling har påvist, at lægemidlet ikke akkumuleres.
English: Monitor patients for any signs and symptoms of muscle pain, tenderness or weakness
Danish: Monitorér patienter for eventuelle tegn og symptomer på muskelsmerter, -ømhed eller -svækkelse
English: Concomitant intake of large quantities (over 1 liter daily) of grapefruit juice and simvastatin resulted in a 7-fold increase in plasma exposure to simvastatin acid.
Danish: Samtidigt indtag af store mængder (over 1 liter dagligt) grapefrugtjuice og simvastatin resulterede i en 7 gange stor øgning for eksponeringen af simvastatinsyre i plasma.
English: Cholib contains types of sugars called lactose and sucrose.
Danish: Cholib indeholder sukkerarter, der hedder laktose og saccharose.
English: If it is suspected a patient has developed interstitial lung disease, Cholib therapy should be discontinued.
Danish: Hvis der er mistanke om, at en patient har udviklet interstitiel lungesygdom, skal behandlingen med Cholib seponeres.
English: • high doses of at least 1 gram per day of niacin (nicotinic acid) or a treatment containing niacin
Danish: • høje doser på mindst 1 gram om dagen af niacin (nikotinsyre) eller lægemidler, der indeholder niacin (medicin, der sænker fedtindholdet i blodet)
English: Prolongation of the gestation period and difficulties during delivery were observed at high doses.
Danish: Der sås en forlænget drægtighedsperiode og vanskeligheder under fødslen ved høje doser.
English: Starch, pregelatinised (maize)
Danish: Stivelse, pregelatineret (majsstivelse)
English: The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness.
Danish: Patienten bør tilrådes at søge læge øjeblikkeligt, hvis vedkommende får symptomer såsom muskelsvækkelse, -smerter eller -ømhed.
English: Some cases of reversible paradoxical reduction of HDL-C have been reported during concomitant administration of fenofibrate and glitazones.
Danish: Der er rapporteret nogle tilfælde af reversibel paradoksal reduktion af HDL-kolesterol under samtidig administration af fenofibrat og glitazoner.
English: Cases of interstitial lung disease have been reported with some statins and with fenofibrate, especially with long term therapy (see section 4.8).
Danish: Der er indberettet tilfælde af interstitiel lungesygdom med visse statiner og med fenofibrat, især ved langvarig behandling (se pkt.
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)
Danish: • øget indhold af homocystein (for meget af denne aminosyre i blodet er forbundet med en højere risiko for sygdom i kranspulsåren, slagtilfælde og perifer karsygdom, selvom der ikke er fastlagt en bestemt årsagssammenhæng) i blodet
English: In a clinical trial, myopathy was reported in 6% of patients receiving simvastatin 80 mg and amiodarone, versus 0.4% in patients on simvastatin 80 mg only.
Danish: I et klinisk forsøg blev der rapporteret myopati hos 6 % af de patienter, der fik simvastatin 80 mg og amiodaron, kontra 0,4 % af patienterne på simvastatin 80 mg alene.
English: LDL is formed from very-low-density protein (VLDL) and is catabolised predominantly by the high affinity LDL receptor.
Danish: LDL dannes af very low density protein (VLDL) og kataboliseres primært af LDL-receptorer med høj affinitet.
English: Maternal treatment with simvastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis.
Danish: Behandling af moderen med simvastatin kan reducere fosterniveauerne af mevalonat, som er en prækursor for kolesterolbiosyntese.
English: Cholib has not been studied in patients with hepatic impairment and is therefore contraindicated in this population (see section 4.3).
Danish: Cholib er ikke undersøgt hos patienter med leverinsufficiens og er derfor kontraindiceret til denne population (se pkt.
English: Therefore, fenofibrate in Cholib may be taken without regard to meals.
Danish: Derfor kan fenofibrat i Cholib tages uafhængigt af indtagelse af mad.
English: Grapefruit juice should be avoided (see section 4.5).
Danish: Grapefrugtjuice skal undgås (se pkt.
English: Cholib must not be co-administered with fusidic acid.
Danish: Cholib må ikke administreres sammen med fusidinsyre.
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Fortæl det til lægen eller på apoteket, hvis du tager et af følgende lægemidler:
English: • rashes, itching, red patches on the skin.
Danish: • udslæt, kløe, røde pletter på huden
English: Although the mechanism is not fully understood, ciclosporin has been shown to increase the plasma exposure (AUC) to simvastatin acid, presumably due in part to inhibition of CYP 3A4 and OATP-1B1 transporter.
Danish: Selvom virkningsmekanismen ikke er helt klarlagt, er det påvist, at ciclosporin øger eksponeringen i plasma (AUC) for simvastatinsyre, antageligt delvist på grund af hæmning af CYP 3A4 og OATP1B1-transporter.
English: LDL cholesterol is often called ‘bad' cholesterol because it can build up in the walls of your arteries and form plaque.
Danish: LDL-kolesterol kaldes ofte "dårlig" kolesterol, fordi det kan sætte sig på dine arterievægge og danne belægninger.
English: Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - France.
Danish: Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-surChalaronne - Frankrig.
English: • infection of the upper respiratory tract
Danish: • infektion i de øvre luftveje
English: Treatment emergent adverse reactions reported in patients receiving co-administration of fenofibrate and simvastatin occurring are listed below by system organ class and frequency.
Danish: Behandlingsopståede bivirkninger, der blev rapporteret hos patienter i samtidig behandling med fenofibrat og simvastatin, er anført nedenfor efter systemorganklasse og hyppighed.
English: The pharmacokinetics of single and multiple doses of simvastatin showed that no accumulation of medicinal product occurred after multiple dosing.
Danish: Farmakokinetikken af enkeltdoser og flerdoser simvastatin viste, at der ikke forekom akkumulering af lægemidlet efter flere doser.
English: Cholib is used in adults at high risk of problems like heart attack and stroke who have high blood levels of 2 types of fats (triglycerides and LDL cholesterol).
Danish: Cholib anvendes til voksne med høj risiko for problemer såsom hjerte- og slagtilfælde, og som har forhøjet indhold i blodet af to typer fedtstoffer (triglycerider og LDL-kolesterol).
English: Concomitant administration of amlodipine and simvastatin caused a 1.6-fold increase in exposure of simvastatin acid.
Danish: Samtidig administration af amlodipin og simvastatin forårsagede en 1,6 gange stigning i eksponeringen for simvastatinsyre.
English: No interaction studies have been performed with Cholib.
Danish: Der er ikke udført interaktionsstudier med Cholib.
English: Studies with fenofibrate on lipoprotein fractions show decreases in levels of LDL and VLDL cholesterol (VLDL-C).
Danish: Studier med fenofibrat på lipoproteinfraktioner viser nedsatte niveauer af LDL- og VLDL-kolesterol.
English: Fenofibrate is a mild to moderate inhibitor of CYP 2C9 and a weak inhibitor of CYP 2C19 and CYP 2A6.
Danish: Fenofibrat er en let til moderat CYP 2C9-hæmmer og en svag CYP 2C19- og CYP 2A6-hæmmer.
English: This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, an induced pancreatic enzymes increase or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.
Danish: Denne forekomst kan være forårsaget af manglende effekt hos patienter med alvorlig hypertriglyceridæmi, en induceret stigning i pancreasenzymer eller et sekundært fænomen medieret gennem sten i galdevejene eller dannelse af affaldsstoffer med obstruktion af den fælles galdegang.
English: Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy.
Danish: Potente cytokrom P450 3A4-hæmmere øger risikoen for myopati og rhabdomyolyse ved at øge koncentrationen af HMG-CoA-reduktases hæmmende aktivitet i plasma under simvastatinbehandling.
English: Pharmacotherapeutic group: Lipid modifying substances, HMG-CoA reductase inhibitors in combination with other lipid modifying substances, ATC code: C10BA04
Danish: Farmakoterapeutisk klassifikation: Lipidmodificerende stoffer, HMG-CoA reduktase-inhibitorer i kombination med andre lipid-modificerende midler, ATC-kode: C10BA04
English: • Unexplained muscle pain, tenderness, or weakness may be sign of muscle break down.
Danish: • Uforklarlige muskelsmerter, -ømhed eller -svækkelse kan være tegn på nedbrydning af musklerne.
English: Some patients have experienced the following side effects whilst taking Cholib, fenofibrate or simvastatin:
Danish: Nogle patienter har haft følgende bivirkninger, mens de tog Cholib, fenofibrat eller simvastatin:
English: Gemfibrozil increases the AUC of simvastatin acid by 1.9-fold, possibly due to inhibition of the glucuronidation pathway.
Danish: Gemfibrozil øger simvastatinsyres AUC 1,9 gange, muligvis på grund af hæmning af glucuronideringsforløbet.
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.
Danish: Patienter med genallel SLCO1B1 (c.521T>C), der koder for et mindre aktivt OATP1B1-protein, har øget systemisk eksponering for simvastatin og øget risiko for myopati.
English: Immune-mediated necrotizing myopathy (IMNM)
Danish: Immunmedieret nekrotiserende myopati (IMNM)
English: Additional information on the individual active substances of the fixed dose combination Additional adverse reactions associated with the use of medicinal products containing simvastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Cholib are listed below.
Danish: Yderligere information om de enkelte aktive stoffer i fastdosiskombination Nedenfor er anført yderligere bivirkninger, der er associeret med brug af lægemidler indeholdende simvastatin eller fenofibrat som observeret i kliniske forsøg og efter markedsføring og potentielt kan forekomme med Cholib.
English: Thromboembolism (pulmonary embolism, deep vein thrombosis)*
Danish: Tromboemboli (lungeemboli, dyb venetrombose)*
English: • dyspepsia
Danish: • dyspepsi
English: • danazol (a man-made hormone used to treat endometriosis)
Danish: • danazol (et kunstigt hormon til behandling af endometriose)
English: This leaflet was last revised in <{MM/YYYY}>.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: A few cases of simvastatin overdose have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae.
Danish: Den maksimale dosis, der blev taget, var 3,6 g. Alle patienter kom sig uden følgevirkninger.
English: ANCOVA (analysis of covariance) of Percent Change in TC, non-HDL-C, ApoAI, ApoB, ApoB/ApoAI and fibrinogen from Baseline to 24 Weeks - Full Analysis Subject Sample Parameter
Danish: ANCOVA (kovariansanalyse) af procentvis ændring i TC, non-HDL-kolesterol, Apo AI, Apo B, Apo B/Apo AI og fibrinogen fra baseline til uge 24 - Fuld analyse af deltagerprøve Parameter
English: As well as the medicines listed previously, tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:
Danish: Udover de førnævnte lægemidler skal du fortælle det til lægen eller på apoteket, hvis du tager, for nyligt har taget eller vil tage et af følgende lægemidler:
English: • elevations in blood tests of liver function (transaminases)
Danish: • forhøjede værdier ved blodprøver for leverfunktion (transaminaser)
English: In patients with SLCO1B1 polymorphism there is a risk of increased exposure of simvastatin, which may lead to an increased risk of rhabdomyolysis (see section 4.4).
Danish: Hos patienter med SLCO1B1-polymorfi er der risiko for øget eksponering for simvastatin, hvilket kan føre til en øget risiko for rabdomyolyse (se pkt.
English: Cholib contains sunset yellow FCF (E110) that may cause allergic reactions.
Danish: Cholib indeholder Sunset Yellow FCF (E110), der kan give allergiske reaktioner.
English: • itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections)
Danish: • itraconazol, ketoconazol, fluconazol eller posaconazol (mod svampeinfektioner)
English: If you are allergic to peanut, soya or arachis oil do not use Cholib.
Danish: Hvis du er allergisk over for jordnødder, soja eller jordnøddeolie, må du ikke tage Cholib.
English: • If you are allergic to peanut, arachis oil, soya lecithin or related substances
Danish: • hvis du er allergisk over for jordnødder, jordnøddeolie, sojalecithin eller lignende stoffer
English: Ascorbic acid (E300)
Danish: Ascorbinsyre (E300)
English: Gamma-glutamyltransferase increase rare
Danish: Stigning i gamma-glutamyltransferase
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.
Danish: Sekundære årsager til hyperlipidæmi, f.eks. ukontrolleret type 2-diabetes mellitus, hypothyroidisme, nefrotisk syndrom, dysproteinæmi, obstruktiv leversygdom, farmakologisk behandling (f.eks. orale østrogener) og alkoholisme, skal behandles tilstrækkeligt, inden behandling med Cholib overvejes, og patienterne skal sættes på en almindelig kolesterol- og triglyceridsænkende diæt, som skal fortsættes under behandlingen.
English: The risk of myopathy is increased by high levels of HMG CoA reductase inhibitory activity in plasma (i.e., elevated simvastatin and simvastatin acid plasma levels), which may be due, in part, to interacting drugs that interfere with simvastatin metabolism and/or transporter pathways (see section
Danish: Risikoen for myopati øges med høje niveauer af HMG CoA-reduktasehæmmende aktivitet i plasma (dvs. forhøjede niveauer af simvastatin og simvastatinsyr i plasma), som til dels kan skyldes brug af lægemidler, der påvirker metabolismen af simvastatin og/eller transportvejene (se pkt.
English: • If you have pancreatitis (inflamed pancreas which causes abdominal pain), which is not caused by high levels of fats in the blood
Danish: • hvis du har betændelse i bugspytkirtlen (giver mavesmerter), som ikke skyldes højt indhold af fedtstoffer i blodet
English: In a pooled analysis of these four trials, the rate of discontinuation due to treatment emergent adverse reactions was 5.0% (51 subjects on 1012) after 12 weeks of treatment with fenofibrate and simvastatin 145 mg/20 mg per day and 1.8% (4 subjects on 225) after 12 weeks of treatment with fenofibrate and simvastatin 145 mg/40 mg per day.
Danish: I en poolet analyse af disse fire forsøg var frekvensen af seponering pga. behandlingsopståede bivirkninger 5,0 % (51 forsøgspersoner ud af 1.012) efter 12 ugers behandling med fenofibrat og simvastatin 145 mg/20 mg dagligt og 1,8 % (4 forsøgspersoner ud af 225) efter 12 ugers behandling med fenofibrat og simvastatin 145 mg/40 mg dagligt.
English: • cramps or painful, tender or weak muscles - these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death
Danish: • kramper eller smertefulde, ømme eller svækkede muskler - dette kan være tegn på inflammation eller nedbrydning af musklerne, hvilket kan give nyreskade eller medføre død
English: • hypersensitivity (allergic) reactions including swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema) (rare)
Danish: • Overfølsomhedsreaktioner (allergi) inklusive: hævelse af ansigt, tunge og svælg, som kan give åndedrætsbesvær (angioødem) (sjælden)
English: Interstitial lung disease not known
Danish: Interstitiel lungesygdom Ikke kendt
English: Carriers of the SLCO1B1 gene c.521T>C allele have lower OATP1B1 activity.
Danish: Bærere af allelen c.521T>C af SLCO1B1-genet har lavere aktivitet af OATP1B1.
English: Because the dose of simvastatin should not exceed 10 mg daily in patients taking ciclosporin, the co-administration of Cholib with ciclosporin is contraindicated (see section 4.3).
Danish: Eftersom simvastatindosis ikke bør overstige 10 mg dagligt til patienter, der tager ciclosporin, er samtidig administration af Cholib og ciclosporin kontraindiceret (se pkt.
English: 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.
Danish: Skeletmuskeltoksicitet, herunder sjældne tilfælde af rhabdomyolyse med eller uden nyresvigt, er rapporteret med administration af lipidsænkende stoffer såsom fibrater og statiner.
English: If treatment with fusidic acid is necessary, Cholib treatment should be discontinued throughout the duration of the fusidic acid treatment.
Danish: Hvis behandling med fusidinsyre er nødvendig, bør behandling med Cholib afbrydes under hele behandlingsforløbet med fusidinsyre.
English: Your doctor should do a blood test before you start taking Cholib.
Danish: Din læge skal også tage en blodprøve, før du begynder at tage Cholib.
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving a statin in combination with fusidic acid (see section 4.5).
Danish: Der er rapporteret rhabdomyolyse (inklusive nogle fatale tilfælde) hos patienter, der fik et statin i kombination med fusidinsyre (se pkt.
English: • If you are already being treated and will continue your treatment with: o a fibrate (e.g. gemfibrozil) o a statin (medicines to lower the levels of fats in the blood, e.g. simvastatin, atorvastatin)
Danish: • hvis du allerede bliver behandlet med og vil fortsætte behandlingen med:  et fibrat (f.eks. gemfibrozil)  et statin (medicin, der sænker indholdet af fedtstoffer i blodet, f.eks. simvastatin, atorvastatin)
English: This is because on rare occasions, there have been cases of serious muscle problems including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
Danish: Der har været sjældne tilfælde af alvorlige muskelproblemer, herunder nedbrydning af musklerne, der kan medføre nyreskade.
English: • you have an underactive thyroid gland (hypothyroidism)
Danish: • hvis du har en underaktiv skjoldbruskkirtel (hypotyreoidisme)
English: In a three-month oral nonclinical study in the rat species with fenofibric acid, the active metabolite of fenofibrate, toxicity for the skeletal muscles (particularly those rich in type I -slow oxidative- myofibres) and cardiac degeneration, anemia and decreased body weight were seen at exposure levels ≥50- fold the human exposure for the skeletal toxicity and >15 fold for the cardiomyotoxicity.
Danish: I et tre måneder langt oralt ikke-klinisk studie af rotter med fenofibrinsyre, fenofibrats aktive metabolit, sås der toksicitet for skeletmusklerne (især dem, der er rige på langsomme oxidative myofibre af type I), hjertesvækkelse, anæmi og nedsat legemsvægt ved eksponeringsniveauer ≥ 50 gange større end eksponeringen hos mennesker for skeletal toksicitet og > 15 gange større for kardiel myotoksicitet.
English: Veno-thromboembolic events
Danish: Venøse tromboemboliske hændelser
English: Citric acid monohydrate (E330)
Danish: Citronsyremonohydrat (E330)
English: Animal studies have shown embryo-toxic effects at doses in the range of maternal toxicity (see section 5.3).
Danish: Dyreforsøg har påvist embryotoksiske virkninger ved doser i intervallet for maternel toksicitet (se pkt.
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).
Danish: Den gennemsnitlige eksponering (AUC) for den aktive hovedmetabolit, simvastatinsyre, er 120 % hos heterozygote bærere (CT) af C-allelen og 221 % hos homozygote (CC) bærere i forhold til eksponeringen hos patienter, som har den mest almindelige genotype (TT).
English: The risk of muscle toxicity may be increased if Cholib is administered with another fibrate, statin, niacin, fusidic acid or other specific concomitant substances (for specific interactions see section 4.5).
Danish: Risikoen for muskeltoksicitet kan være øget, hvis Cholib administreres sammen med et andet fibrat, statin, niacin, fusidinsyre eller andre specifikke, samtidigt administrerede stoffer (se pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Cholib findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Simva 40 (N=505) Mean (SD)
Danish: Simva 40 (N=505) Middel (SD)
English: Dermatitis and eczema
Danish: Dermatitis og eksem
English: • pioglitazone (a particular class of medicines to treat diabetes)
Danish: • pioglitazon (en særlig lægemiddelgruppe til behandling af diabetes)
English: • Concomitant administration of glecaprevir, pibrentasvir, elbasvir or grazoprevir (see section
Danish: • Samtidig administration af glecaprevir, pibrentasvir, elbasvir eller grazoprevir (se pkt.
English: Cholib The respective effects of simvastatin and fenofibrate are complementary.
Danish: Cholib Simvastatins og fenofibrats respektive virkninger er komplementære.
English: Gastrointestinal disorders Gastrointestinal signs and symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence)
Danish: Gastrointestinale tegn og symptomer (mavesmerter, kvalme, opkastning, diarré, flatulens)
English: Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever).
Danish: Dette kan vise sig ved dyspnø, tør hoste og forringelse af det generelle helbred (træthed, vægttab og feber).
English: • If you have liver or gallbladder problems
Danish: • hvis du har problemer med leveren eller galdeblæren
English: Silicified microcrystalline cellulose (comprised of cellulose, microcrystalline and silica, colloidal anhydrous)
Danish: Silicificeret mikrokrystallinsk cellulose (bestående af mikrokrystallinsk cellulose og kolloid vandfri silica)
English: As this medicinal product contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Da dette lægemiddel indeholder saccharose, bør patienter med sjældne arvelige problemer med fructose såsom fructoseintolerans, glucose-galactose-malabsorption eller sucrase-isomaltase insufficiens ikke tage dette lægemiddel.
English: • severe allergic skin rash with blisters
Danish: • alvorligt allergisk hududslæt med blærer