FrancophonIA/ELRC3.0 huggingface dataset:
English: Cholib should be used with caution in patients who consume substantial quantities of alcohol.
Danish: Cholib bør anvendes med forsigtighed hos patienter, der indtager betragtelige mængder alkohol.
English: • sleep disturbances including nightmares
Danish: • søvnforstyrrelser, inklusive mareridt
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).
Danish: Hyppigheden af bivirkningerne er opstillet efter følgende kategorier: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Contrarily to previous fenofibrate formulations, the maximum plasma concentration and overall exposure of this formulation is independent from food intake.
Danish: I modsætning til tidligere formuleringer med fenofibrat er den maksimale plasmakoncentration og samlede eksponering af denne formulering uafhængig af indtagelse af mad.
English: Hydrolysis takes place mainly in the liver; the rate of hydrolysis in human plasma is very slow.
Danish: Hydrolyse finder hovedsageligt sted i leveren; hydrolysehastigheden i humant plasma er meget langsom.
English: Supportive study
Danish: Understøttende studie
English: You may need to stop taking Cholib for a short time.
Danish: Du bliver måske nødt til at stoppe med at tage Cholib i en kort periode.
English: Cholib with food and drink
Danish: Brug af Cholib sammen med mad og drikke
English: Treatment with simvastatin must be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant.
Danish: Behandling med simvastatin skal afbrydes under graviditeten, eller indtil det er fastslået, at kvinden ikke er gravid.
English: If you get pregnant while taking Cholib, stop taking it immediately and contact your doctor.
Danish: Hvis du bliver gravid, mens du tager Cholib, skal du straks stoppe med at tage det og kontakte lægen.
English: • If you have moderate or severe kidney problems
Danish: • hvis du har moderate eller alvorlige nyreproblemer
English: HDL-C levels are frequently increased.
Danish: HDL-kolesterolniveauerne stiger ofte.
English: Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Danish: Fenofibrinsyre bindes stærkt til plasmaalbumin (mere end 99 %).
English: Compared to a fibrate or a statin alone, the risk of muscle breakdown is increased when you take these 2 medicines together, as in Cholib.
Danish: Sammenlignet med et fibrat eller et statin alene er risikoen for nedbrydning af musklerne øget, hvis du tager disse 2 lægemidler sammen som i Cholib.
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.
Danish: Dette blev ikke observeret i den førnævnte subgruppe af patienter med dyslipidæmi, men der var heller ikke klar evidens for en fordel hos dyslipidæmiske kvinder behandlet med fenofibrat plus simvastatin, og en mulig skadelig virkning hos denne subgruppe kunne ikke udelukkes.
English: • Uncontrolled hypothyroidism
Danish: • Ukontrolleret hypothyroidisme
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.
Danish: Du kan have risiko for at udvikle diabetes, hvis du har et højt indhold af sukker- og fedtstoffer i blodet, er overvægtig og har højt blodtryk.
English: While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes.
Danish: Din læge vil kontrollere dig nøje, mens du tager dette lægemiddel, hvis du har diabetes eller har risiko for at udvikle diabetes.
English: The availability of the beta-hydroxyacid to the systemic circulation following an oral dose of simvastatin was found to be less than 5% of the dose.
Danish: Tilgængeligheden af beta-hydroxysyre for det systemiske kredsløb efter en oral dosis simvastatin blev fundet at være mindre end 5 % af dosen.
English: Important information about some of the ingredients of Cholib
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Cholib
English: Co-administration of this combination may cause increased plasma concentrations of both agents.
Danish: Samtidig administration af denne kombination kan forårsage øgede plasmakoncentrationer af begge stoffer.
English: They may be taken with or without food (see section 5.2).
Danish: De kan tages med eller uden mad (se pkt.
English: You can take Cholib with or without food.
Danish: Cholib kan tages med eller uden mad.
English: Plasma concentrations are stable during continuous treatment in any given individual.
Danish: Plasmakoncentrationerne er stabile under kontinuerlig behandling hos vilkårlige individer.
English: Crospovidone (E1202)
Danish: Crospovidon (E1202)
English: Other statins and fibrates
Danish: Andre statiner og fibrater
English: Transaminase levels have to be monitored before treatment begins, every 3 months during the first 12 months of treatment and thereafter periodically.
Danish: Transaminaseniveauerne skal måles, inden behandlingen påbegyndes, hver 3. måned i løbet af de første 12 måneders behandling og derefter periodisk.
English: If an overdose is suspected, symptomatic treatment and appropriate supportive measures should be provided as required.
Danish: Hvis der er mistanke om overdosering, skal der gives symptomatisk behandling og passende støttende tiltag efter behov.
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):
Danish: Du skal især fortælle det til lægen eller på apoteket, hvis du tager et eller flere af følgende lægemidler (hvis du tager Cholib med et af disse lægemidler, kan det øge risikoen for muskelproblemer):
English: The liver is the primary site of action of the active form.
Danish: Leveren er den aktive forms primære virkningssted.
English: Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis.
Danish: Der bør udvises forsigtighed ved patienter med prædisponerende faktorer for rhabdomyolyse.
English: Therapy with Cholib should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.
Danish: Behandling med Cholib skal midlertidigt stoppes i et par dage inden større elektiv operation, og når der opstår en større medicinsk eller kirurgisk tilstand.
English: The drug is excreted mainly in the urine.
Danish: Lægemidlet elimineres hovedsageligt med urinen.
English: If myopathy is suspected for any other reason, treatment should be discontinued.
Danish: Hvis der er mistanke om myopati af nogen anden årsag, skal behandlingen seponeres.
English: Talc (E553b)
Danish: Talkum (E553b)
English: LDL and VLDL triglycerides are reduced.
Danish: LDL- og VLD- triglycerider nedsættes.
English: • feeling depressed
Danish: • føle sig deprimeret
English: • increased sensitivity of your skin to sunlight, sun lamps and sunbeds
Danish: • øget følsomhed af huden for sollys, sollamper og solarier
English: • Paediatric population (age below 18 years)
Danish: • Pædiatrisk population (under 18 år)
English: • poor memory or memory loss
Danish: • dårlig hukommelse eller hukommelsestab
English: Like all medicines, Cholib can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Simvastatin is taken up actively into the hepatocytes by the transporter OATP1B1.
Danish: Simvastatin optages aktivt i hepatocytter af transportøren OATP1B1.
English: Vitamin K antagonists
Danish: K-vitaminantagonister
English: Avoid with Cholib unless clinical benefit outweigh the risk
Danish: Undgå kombination med Cholib, medmindre den kliniske fordel opvejer risikoen
English: In normal volunteers, the plasma exposure to simvastatin acid was decreased by 93% with concomitant administration of rifampicin.
Danish: Hos normale frivillige faldt eksponeringen for simvastatinsyre i plasma med 93 % med samtidig administration af rifampicin.
English: Fenofibrate Acute toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Danish: Fenofibrat Studier af akut toksicitet har ikke givet nogen relevant information om specifik toksicitet af fenofibrat.
English: Creatine Kinase should not be measured following strenuous exercise or in the presence of any plausible alternative cause of Creatine Kinase increase as this makes value interpretation difficult.
Danish: Kreatinkinase bør ikke måles efter anstrengende træning eller ved tilstedeværelse af andre plausible årsager til forhøjet kreatinkinase, da dette vanskeliggør tolkning af værdien.
English: Niacin (nicotinic acid) ≥ 1 g/day
Danish: Niacin (nikotinsyre) ≥ 1 g/dag
English: • numbness or weakness of the arms and legs
Danish: • følelsesløshed eller svækkelse i arme og ben
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.
Danish: • Du må ikke tage Cholib, hvis du ammer eller planlægger at amme dit barn, fordi man ikke ved, om medicinen udskilles i modermælk.
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.
Danish: Baseret på konventionelle dyreforsøg vedrørende farmakodynamik, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet er der ingen andre risici for patienten, end der kan forventes ud fra den farmakologiske mekanisme.
English: Posology The recommended dose is one tablet per day.
Danish: Dosering Den anbefalede dosis er 1 tablet dagligt.
English: Do not consume grapefruit juice with Cholib as it may increase your risk of muscle problems.
Danish: Du må ikke drikke grapefrugtjuice, mens du tager Cholib, da det kan øge risikoen for muskelproblemer.
English: It is recommended that creatinine is measured during the first 3 months after initiation of treatment and periodically thereafter.
Danish: Det anbefales, at kreatinin måles i løbet af de første 3 måneder efter behandlingsstart og regelmæssigt efterfølgende.
English: The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
Danish: Den samlede virkning er et fald i forholdet mellem low densitity/very low density lipoproteiner og high density lipoproteiner.
English: Paresthesia, dizziness, peripheral neuropathy rare
Danish: Paræstesi, svimmelhed, perifer neuropati
English: Following an intravenous injection of the beta-hydroxyacid metabolite, its half-life averaged 1.9 hours.
Danish: Efter intravenøs injektion af metabolitten beta-hydroxysyre var den gennemsnitlige halveringstid 1,9 timer.
English: The corresponding risk is 0.3% in patients having the most common genotype (TT) (See section
Danish: Den tilsvarende risiko er 0,3 % hos de patienter, der har den mest almindelige genotype (TT) (se pkt.
English: Fenofibrate is water-insoluble and must be taken with food to facilitate absorption.
Danish: Fenofibrat er uopløseligt i vand og skal tages sammen med et måltid for at lette absorptionen.
English: • Active liver disease or unexplained persistent elevations of serum transaminases
Danish: • Aktiv leversygdom eller uforklarlige, vedvarende stigninger i serumtransaminaser
English: Interaction between simvastatin and fenofibrate
Danish: Interaktion mellem simvastatin og fenofibrat
English: (pulmonary embolism)
Danish: (lungeemboli)
English: Intake of grapefruit juice during treatment with Cholib should therefore be avoided.
Danish: Indtag af grapefrugtjuice under behandling med Cholib skal derfor undgås.
English: Swallow the tablet with a glass of water.
Danish: Synk tabletterne hele med et glas vand.
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.
Danish: Den øgede risiko for venøse trombotiske hændelser kan være relateret til stigningen i homocysteinniveauet, en risikofaktor for trombose, og andre uidentificerede faktorer.
English: Cholib therapy has not been associated with bleeding in patients not taking anticoagulants.
Danish: Behandling med Cholib har ikke været associeret med blødning hos patienter, der ikke tager antikoagulanter.
English: • Do not take Cholib if you are pregnant, trying to get pregnant or think you may be pregnant.
Danish: • Du må ikke tage Cholib, hvis du er gravid, forsøger at blive gravid, eller hvis du tror, at du er gravid.
English: Maximum plasma concentration of active inhibitors is reached approximately 1-2 hours after administration of simvastatin.
Danish: Den maksimale plasmakoncentration af aktive hæmmere nås ca. 1-2 timer efter administration af simvastatin.
English: In the majority of cases no overdose symptoms were reported.
Danish: I de fleste tilfælde blev der ikke rapporteret nogen symptomer på overdosering.
English: • Concomitant administration of fibrates, statins, danazol, ciclosporin or potent cytochrome
Danish: • Samtidig administration af fibrater, statiner, danazol, ciclosporin eller potent cytokrom
English: This adverse reaction should be taken into account when driving vehicles or using machines under Cholib therapy.
Danish: Denne bivirkning bør tages i betragtning, når man fører motorkøretøj eller betjener maskiner under behandling med Cholib.
English: Fenofibrate also has a uricosuric effect leading to reduction in uric acid levels of approximately 25%.
Danish: Fenofibrat har også en urikosurisk effekt, der medfører en reduktion af urinsyreniveauerne med ca. 25 %.
English: F145/S40 demonstrated statistically significant superiority on all parameters except on ApoA1 increase.
Danish: F145/S40 påviste statistisk signifikant superioritet for alle parametre undtagen for stigning af Apo A1.
English: In addition, they both raise levels of “good” cholesterol (HDL cholesterol).
Danish: Derudover øger de begge indholdet af "godt" kolesterol (HDL-kolesterol).
English: There are no clinical data on fertility from the use of Cholib.
Danish: Der foreligger ingen kliniske data om fertiliteten fra anvendelse af Cholib.
English: Interacting substances
Danish: Interagerende stoffer
English: • If you are pregnant or breast-feeding
Danish: • hvis du er gravid eller ammer
English: <2D barcode carrying the unique identifier included.>
Danish: <Der er anført en 2D-stregkode, som indeholder en entydig identifikator>
English: The major metabolites of simvastatin present in human plasma are the beta-hydroxyacid and four additional active metabolites.
Danish: Simvastatins vigtigste metabolitter i humant plasma er beta-hydroxysyre og fire yderligere aktive metabolitter.
English: This medicine contains less than 1 mmol sodium (23 mg) per one tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natriumfrit.
English: Overall, 7,583 subjects with mixed dyslipidemia entered a 6 week statin run-in period.
Danish: I alt 7.583 forsøgspersoner med blandet dyslipidæmi indgik i en indkøringsperiode på 6 uger med statin.
English: • sexual difficulties
Danish: • seksuelle problemer
English: In elderly patients, the fenofibric acid apparent total plasma clearance is not modified.
Danish: Hos ældre patienter ændres den tilsyneladende totale plasmaclearance af fenofibrinsyre ikke.
English: Elevations in serum creatinine were generally stable over time with no evidence for continued increases in serum creatinine with long term therapy and tended to return to baseline following discontinuation of treatment.
Danish: Stigninger i serumkreatinin var generelt stabile over tid uden evidens for fortsatte stigninger i serumkreatinin ved langvarig behandling og havde tendens til at returnere til baseline efter seponering af behandlingen.
English: There are no adequate data from the use of fenofibrate in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af fenofibrat til gravide kvinder.
English: Therefore, close clinical monitoring of such patients taking colchicine and Cholib is advised.
Danish: Derfor tilrådes omhyggelig klinisk monitorering af patienter, der tager colchicin og Cholib.
English: Myopathy**
Danish: Myopati**
English: After oral administration, fenofibrate is rapidly hydrolyzed by esterases to the active metabolite fenofibric acid.
Danish: Efter oral administration hydrolyseres fenofibrat hurtigt af esteraser til den aktive metabolit fenofibrinsyre.
English: Your total cholesterol is made up mainly of LDL and HDL cholesterol.
Danish: Dit totale kolesterol består hovedsagelig af LDL- og HDL-kolesterol.
English: • Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
Danish: • Kendt fotoallergi eller fototoksisk reaktion under behandling med fibrater eller ketoprofen
English: • Moderate to severe renal insufficiency (estimated glomerular filtration rate
Danish: • Moderat til svær nyreinsufficiens (estimeret glomerulær filtrationshastighed
English: Studies on mutagenicity of fenofibrate have been negative.
Danish: Studier af fenofibrats mutagenicitet har været negative.
English: • Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia
Danish: • Kronisk eller akut pancreatitis med undtagelse af akut pancreatitis, der skyldes alvorlig hypertriglyceridæmi
English: The repeated administration of simvastatin 40 or 80 mg, the highest dose registered, did not affect the plasma levels of fenofibric acid at steady state.
Danish: Gentagen administration af simvastatin 40 eller 80 mg, den højeste, registrerede dosis, påvirkede ikke plasmaniveauerne af fenofibrinsyre ved steady state.
English: Therefore, Cholib is not expected to affect plasma concentrations of substances metabolised via CYP 3A4.
Danish: Derfor forventes Cholib ikke at påvirke plasmakoncentrationerne af stoffer, der metaboliseres via CYP 3A4.
English: The risk of high dose (80 mg) simvastatin related myopathy is about 1 % in general, without genetic testing.
Danish: Risikoen for myopati i forbindelse med højdosis (80 mg) simvastatin er generelt omkring 1 % uden genetisk test.
English: Ireland Mylan IRE Healthcare Ltd
Danish: Mylan IRE Healthcare Ltd
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.
Danish: Hvis nogen af ovenstående alvorlige bivirkninger forekommer, skal du straks stoppe med at tage Cholib og kontakte lægen eller tage på nærmeste skadestue - du kan have brug for akut lægehjælp.
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.
Danish: Hvis kreatinkinaseniveauerne er signifikant forhøjede ved baseline (> 5 gange den øvre normalgrænse), skal de måles igen 5-7 dage senere for at bekræfte resultaterne.
English: In patients taking products containing elbasvir or grazoprevir concomitantly with Cholib the dose of simvastatin should not exceed 20 mg/day.
Danish: Hvis patienter indtager produkter, som indeholder elbasvir eller grazoprevir, samtidig med Cholib, må dosen af simvastatin ikke overstige 20 mg/dag.
English: LS (less square mean) SD (standard deviation)
Danish: LS (mindste kvadraters metode) SD (standardafvigelse)
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Danish: Hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter, skal du tale med din læge, inden du begynder at tage denne medicin.
English: Cholib: Cholib contains fenofibrate and simvastatin, which have different modes of action as described above.
Danish: Cholib indeholder fenofibrat og simvastatin, som har forskellige virkningsmekanismer som beskrevet ovenfor.
English: Adjust the dose of these oral anticoagulants according to INR monitoring
Danish: Juster dosis af disse orale antikoagulanter ifølge måling af INR
English: If a patient has previously experienced a muscle disorder on a fibrate or a statin, treatment with a different member of the class should only be initiated with caution.
Danish: Hvis en patient tidligere har haft en muskelsygdom pga. et fibrat eller statin, skal behandling med et andet lægemiddel i denne klasse indledes med forsigtighed.
English: Upper respiratory tract infection, Gastroenteritis
Danish: Øvre luftvejsinfektion, gastroenteritis
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.
Danish: Risikoen for myopati med statiner og fibrater vides at være relateret til dosis af hver komponent og til typen af fibrat.
English: Reduced function can occur as the result of inhibition by interacting medicines (eg ciclosporin) or in patients who are carriers of the SLCO1B1 c.521T>C genotype.
Danish: Nedsat funktion kan opstå som følge af inhibering fra interagerende lægemidler (f.eks. ciclosporin) eller hos patienter, som er bærere af genotypen SLCO1B1 c.521T>C.
English: Prescribing recommendations for interacting substances are summarised in the table below (see also sections 4.2 and 4.3).
Danish: Anbefalinger for ordinering af interagerende stoffer er opsummeret i tabellen nedenfor (se også pkt.
English: An average of only 0.3% of the intravenous dose was excreted in urine as inhibitors.
Danish: Kun gennemsnitligt 0,3 % af den intravenøse dosis blev udskilt med urinen som hæmmere.
English: Cholib contains two different active substances: fenofibrate (belongs to the group called ‘fibrates') and simvastatin (belongs to the group called ‘statins').
Danish: Cholib indeholder to forskellige aktive stoffer: fenofibrat (som tilhører en lægemiddelgruppe, der hedder fibrater) og simvastatin (som tilhører en lægemiddelgruppe, der hedder statiner).
English: Some evidence suggests that statins as a class raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate.
Danish: Der er en vis evidens for, at statiner som klasse øger blodglukoseniveauet og hos nogle patienter, som har høj risiko for fremtidig diabetes, kan producere et niveau af hyperglykæmi, hvor det er passende med formel diabetesbehandling.
English: • If you are allergic to fenofibrate or simvastatin or any of the other ingredients of Cholib (listed in section 6)
Danish: • hvis du er allergisk over for fenofibrat eller simvastatin eller et af de øvrige indholdsstoffer i Cholib (angivet i punkt 6)
English: Through activation of PPAR, fenofibrate activates lipoprotein lipase production and reduces production of apoprotein CIII.
Danish: Gennem aktivering af PPARα aktiverer fenofibrat produktion af lipoproteinlipase og reducerer produktion af apoprotein CIII.
English: • ciclosporin (a medicine often used in organ transplant patients)
Danish: • ciclosporin (et lægemiddel, der ofte bruges til patienter, som har fået organtransplantation)
English: % Change Mean (SD)
Danish: % ændring i middelværdi (SD)