natgillin/translations-raw huggingface dataset:
Den øgede risiko for venøse trombotiske hændelser kan være relateret til stigningen i homocysteinniveauet, en risikofaktor for trombose, og andre uidentificerede faktorer.
The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors.
Behandling med Cholib har ikke været associeret med blødning hos patienter, der ikke tager antikoagulanter.
Cholib therapy has not been associated with bleeding in patients not taking anticoagulants.
• Du må ikke tage Cholib, hvis du er gravid, forsøger at blive gravid, eller hvis du tror, at du er gravid.
• Do not take Cholib if you are pregnant, trying to get pregnant or think you may be pregnant.
Den maksimale plasmakoncentration af aktive hæmmere nås ca. 1-2 timer efter administration af simvastatin.
Maximum plasma concentration of active inhibitors is reached approximately 1-2 hours after administration of simvastatin.
I de fleste tilfælde blev der ikke rapporteret nogen symptomer på overdosering.
In the majority of cases no overdose symptoms were reported.
• Samtidig administration af fibrater, statiner, danazol, ciclosporin eller potent cytokrom
• Concomitant administration of fibrates, statins, danazol, ciclosporin or potent cytochrome
Denne bivirkning bør tages i betragtning, når man fører motorkøretøj eller betjener maskiner under behandling med Cholib.
This adverse reaction should be taken into account when driving vehicles or using machines under Cholib therapy.
Fenofibrat har også en urikosurisk effekt, der medfører en reduktion af urinsyreniveauerne med ca. 25 %.
Fenofibrate also has a uricosuric effect leading to reduction in uric acid levels of approximately 25%.
F145/S40 påviste statistisk signifikant superioritet for alle parametre undtagen for stigning af Apo A1.
F145/S40 demonstrated statistically significant superiority on all parameters except on ApoA1 increase.
Derudover øger de begge indholdet af "godt" kolesterol (HDL-kolesterol).
In addition, they both raise levels of “good” cholesterol (HDL cholesterol).
Der foreligger ingen kliniske data om fertiliteten fra anvendelse af Cholib.
There are no clinical data on fertility from the use of Cholib.
Interagerende stoffer
Interacting substances
• hvis du er gravid eller ammer
• If you are pregnant or breast-feeding
<Der er anført en 2D-stregkode, som indeholder en entydig identifikator>
<2D barcode carrying the unique identifier included.>
Simvastatins vigtigste metabolitter i humant plasma er beta-hydroxysyre og fire yderligere aktive metabolitter.
The major metabolites of simvastatin present in human plasma are the beta-hydroxyacid and four additional active metabolites.
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natriumfrit.
This medicine contains less than 1 mmol sodium (23 mg) per one tablet, that is to say essentially ‘sodium-free'.
I alt 7.583 forsøgspersoner med blandet dyslipidæmi indgik i en indkøringsperiode på 6 uger med statin.
Overall, 7,583 subjects with mixed dyslipidemia entered a 6 week statin run-in period.
• seksuelle problemer
• sexual difficulties
Hos ældre patienter ændres den tilsyneladende totale plasmaclearance af fenofibrinsyre ikke.
In elderly patients, the fenofibric acid apparent total plasma clearance is not modified.
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.
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.
Der er ingen eller utilstrækkelige data fra anvendelse af fenofibrat til gravide kvinder.
There are no adequate data from the use of fenofibrate in pregnant women.
Derfor tilrådes omhyggelig klinisk monitorering af patienter, der tager colchicin og Cholib.
Therefore, close clinical monitoring of such patients taking colchicine and Cholib is advised.
Myopati**
Myopathy**
Efter oral administration hydrolyseres fenofibrat hurtigt af esteraser til den aktive metabolit fenofibrinsyre.
After oral administration, fenofibrate is rapidly hydrolyzed by esterases to the active metabolite fenofibric acid.
Dit totale kolesterol består hovedsagelig af LDL- og HDL-kolesterol.
Your total cholesterol is made up mainly of LDL and HDL cholesterol.
• Kendt fotoallergi eller fototoksisk reaktion under behandling med fibrater eller ketoprofen
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
• Moderat til svær nyreinsufficiens (estimeret glomerulær filtrationshastighed
• Moderate to severe renal insufficiency (estimated glomerular filtration rate
Studier af fenofibrats mutagenicitet har været negative.
Studies on mutagenicity of fenofibrate have been negative.
• Kronisk eller akut pancreatitis med undtagelse af akut pancreatitis, der skyldes alvorlig hypertriglyceridæmi
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia
Gentagen administration af simvastatin 40 eller 80 mg, den højeste, registrerede dosis, påvirkede ikke plasmaniveauerne af fenofibrinsyre ved steady state.
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.
Derfor forventes Cholib ikke at påvirke plasmakoncentrationerne af stoffer, der metaboliseres via CYP 3A4.
Therefore, Cholib is not expected to affect plasma concentrations of substances metabolised via CYP 3A4.
Risikoen for myopati i forbindelse med højdosis (80 mg) simvastatin er generelt omkring 1 % uden genetisk test.
The risk of high dose (80 mg) simvastatin related myopathy is about 1 % in general, without genetic testing.
Mylan IRE Healthcare Ltd
Ireland Mylan IRE Healthcare Ltd
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.
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.
Hvis kreatinkinaseniveauerne er signifikant forhøjede ved baseline (> 5 gange den øvre normalgrænse), skal de måles igen 5-7 dage senere for at bekræfte resultaterne.
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.
Hvis patienter indtager produkter, som indeholder elbasvir eller grazoprevir, samtidig med Cholib, må dosen af simvastatin ikke overstige 20 mg/dag.
In patients taking products containing elbasvir or grazoprevir concomitantly with Cholib the dose of simvastatin should not exceed 20 mg/day.
LS (mindste kvadraters metode) SD (standardafvigelse)
LS (less square mean) SD (standard deviation)
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.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Cholib indeholder fenofibrat og simvastatin, som har forskellige virkningsmekanismer som beskrevet ovenfor.
Cholib: Cholib contains fenofibrate and simvastatin, which have different modes of action as described above.
Juster dosis af disse orale antikoagulanter ifølge måling af INR
Adjust the dose of these oral anticoagulants according to INR monitoring
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.
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.
Øvre luftvejsinfektion, gastroenteritis
Upper respiratory tract infection, Gastroenteritis
Risikoen for myopati med statiner og fibrater vides at være relateret til dosis af hver komponent og til typen af fibrat.
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.
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.
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.
Anbefalinger for ordinering af interagerende stoffer er opsummeret i tabellen nedenfor (se også pkt.
Prescribing recommendations for interacting substances are summarised in the table below (see also sections 4.2 and 4.3).
Kun gennemsnitligt 0,3 % af den intravenøse dosis blev udskilt med urinen som hæmmere.
An average of only 0.3% of the intravenous dose was excreted in urine as inhibitors.
Cholib indeholder to forskellige aktive stoffer: fenofibrat (som tilhører en lægemiddelgruppe, der hedder fibrater) og simvastatin (som tilhører en lægemiddelgruppe, der hedder statiner).
Cholib contains two different active substances: fenofibrate (belongs to the group called ‘fibrates') and simvastatin (belongs to the group called ‘statins').
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.
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.
• hvis du er allergisk over for fenofibrat eller simvastatin eller et af de øvrige indholdsstoffer i Cholib (angivet i punkt 6)
• If you are allergic to fenofibrate or simvastatin or any of the other ingredients of Cholib (listed in section 6)
Gennem aktivering af PPARα aktiverer fenofibrat produktion af lipoproteinlipase og reducerer produktion af apoprotein CIII.
Through activation of PPAR, fenofibrate activates lipoprotein lipase production and reduces production of apoprotein CIII.
• ciclosporin (et lægemiddel, der ofte bruges til patienter, som har fået organtransplantation)
• ciclosporin (a medicine often used in organ transplant patients)
% ændring i middelværdi (SD)
% Change Mean (SD)
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.
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.
Statinbehandlingen kan påbegyndes igen syv dage efter den sidste dosis fusidinsyre.
Statin therapy may be re-introduced seven days after the last dose of fusidic acid.
Der blev ikke påvist nogen virkning på fertiliteten i ikke-kliniske reproduktionstoksicitetsstudier udført med fenofibrat.
No effects on fertility were detected in non-clinical reproductive toxicity studies conducted with fenofibrate.
I fire dobbeltblindede kliniske forsøg over 24 uger fik 1.237 patienter samtidig behandling med fenofibrat og simvastatin.
During four double blind clinical trials of 24-week duration 1,237 patients have received treatment with co-administered fenofibrate and simvastatin.
Skulle det forekomme, skal der gives symptomatisk og støttende behandling.
In this case, symptomatic and supportive measures should be adopted.
virusinfektion)
C virus infection)
Meget almindelig
very common
Anvendt statindosis og -type:
Statin type and dose used:
• et statin (f.eks. simvastatin, atorvastatin)
• a statin (e.g. simvastatin, atorvastatin)
• muskelproblemer
• muscle problems
Derfor bør Cholib-dosis ikke overstige 145 mg/20 mg dagligt til patienter, der tager amiodaron, amlodipin, diltiazem eller verapamil.
Therefore, the dose of Cholib should not exceed 145 mg/20 mg daily in patients taking amiodarone, amlodipine, diltiazem or verapamil.
For at kunne fastsætte en reference-baselineværdi skal kreatinfosfokinase måles, og klinisk monitorering anbefales.
In order to establish a reference baseline value, creatine phosphokinase levels should be measured and clinical monitoring is recommended.
Simvastatindosis bør ikke overstige 10 mg dagligt til patienter, der tager danazol.
The dose of simvastatin should not exceed 10 mg daily in patients taking danazol.
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.
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.
Der er ikke involveret nogen mikrosomal metabolisme i leveren.
No hepatic microsomal metabolism is involved.
Dette kan være tegn på en blodprop i lungerne
These may be signs of a blood clot in the lung
Fenofibrat er et fibrinsyrederivat, hvis lipidmodificerende virkninger, der er rapporteret hos mennesker, medieres via aktivering af peroxisom proliferator-aktiveret receptor af alfa-typen (PPARα).
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).
Hvis der opstår symptomer, der tyder på hepatitis (f.eks. gulsot, pruritus), og diagnosen bekræftes med laboratorieprøver, skal behandling med Cholib seponeres.
When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus) and diagnosis is confirmed by laboratory testing, Cholib therapy should be discontinued.
Hvis kreatinkinaseniveauerne er signifikant forhøjede ved baseline (> 5 gange den øvre normalgrænse), må behandlingen ikke indledes.
If Creatine Kinase levels are significantly elevated at baseline (> 5 x ULN), treatment should not be started.
De bruges begge til at sænke indholdet af totalt kolesterol, "dårligt" kolesterol (LDL-kolesterol) og fedtstoffer kaldet triglycerider i blodet.
They are both used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood.
Tabletterne fås i kartoner med blisterkort, som indeholder 10, 30 eller 90 tabletter.
The tablets are provided in carton boxes with blisters containing 10, 30 or 90 tablets.
Simvastatin er et substrat for BCRP (Breast Cancer Resistant Protein)-effluxtransportøren.
Simvastatin is a substrate of the Breast Cancer Resistant Protein (BCRP) efflux transporter.
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.
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.
For at kunne fastsætte en reference-baselineværdi skal kreatinkinase måles inden behandlingsstart i følgende situationer:
In order to establish a reference baseline value, a Creatine Kinase level should be measured before starting a treatment in the following situations:
Brug ikke Cholib efter den udløbsdato, der står på kartonen og blisterkortet efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use Cholib after the expiry date which is stated on the carton and the blister after EXP.
• Personlig anamnese eller familieanamnese med arvelige muskelsygdomme
• Personal or familial history of hereditary muscular disorders
Fenofibrat og simvastatin forstærker virkningen af K-vitaminantagonister og kan øge risikoen for blødning.
Fenofibrate and simvastatin enhance effects of Vitamin K antagonists and may increase the risk of bleeding.
Sammenligning af behandlinger*
Treatment Comparison*
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.
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.
Gennemsnitlig halveringstid: Halveringstiden for eliminering af fenofibrinsyre i plasma er ca. 20 timer.
Mean plasma half-life: the plasma elimination half-life of fenofibric acid is approximately 20 hours.
Der er rapporteret stigninger i transaminaseniveauerne hos visse patienter i behandling med simvastatin eller fenofibrat.
Increases in transaminase levels have been reported in some patients treated with simvastatin or fenofibrate.
Nogle patienter har fået følgende alvorlige bivirkninger, mens de tog fenofibrat eller simvastatin (begge aktive stoffer i Cholib):
Some patients have experienced the following serious side effects whilst taking fenofibrate or simvastatin (both active substances in Cholib):
Brug af mikroniseret fenofibrat og NanoCrystal teknologi til formuleringen af fenofibrat 145 mg tabletter forbedrer absorptionen.
The use of micronised fenofibrate and NanoCrystal® technology for the formulation of the fenofibrate 145 mg tablet enhances its absorption.
10 filmovertrukne tabletter 30 filmovertrukne tabletter 90 filmovertrukne tabletter
10 film-coated tablets 30 film-coated tablets 90 film coated tablets
Der er fundet levertumorer hos rotter og mus i carcinogenicitetsstudier, hvilket skyldes peroxisom-proliferation.
In rats and mice, liver tumours have been found in carcinogenicity studies, which are attributable to peroxisome proliferation.
• Hypoalbuminæmi
• Hypoalbuminaemia
Der blev imidlertid observeret reversibel hypospermi, vakuolisering af testiklerne og umodne ovarier i et toksicitetsstudie med gentagne doser af fenofibrinsyre hos unge hunde.
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.
Flere mekanismer kan bidrage til potentielle interaktioner med HMG Co-A-reduktasehæmmere.
Multiple mechanisms may contribute to potential interactions with HMG Co-A reductase inhibitors.
Respons på behandlingen bør monitoreres ved bestemmelse af serumlipidværdier (total kolesterol (TC), LDL-kolesterol og triglycerider (TG)).
Response to therapy should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)).
Hyppighedskategorierne er baseret på tilgængelig information fra produktresuméer for simvastatin og fenofibrat i EU.
Frequency categories are based on information available from simvastatin and fenofibrate Summary of Product Characteristics available in the EU.
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.
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
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.
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.
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.
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.
Fenofibrat påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
Fenofibrate has no or negligible influence on the ability to drive and use machines.
Dette enzym katalyserer konvertering af HMG-CoA til mevalonat, et tidligt og hastighedsbegrænsende trin i kolesterolbiosyntesen.
This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol.
• en alvorlig allergisk reaktion, som forårsager åndedrætsbesvær eller svimmelhed (anafylaksi) (meget sjælden)
• a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis) (very rare)
Hvis du har glemt at tage Cholib
If you forget to take Cholib
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.
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.
Procentvis ændring fra baseline til uge 12 Fuld analyse af deltagerprøve
Mean Percent Change from Baseline to 12 Weeks Full Analysis Subject Sample
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.
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.
Den genfundne mængde i fæces repræsenterer absorberede ækvivalenter af lægemiddel udskilt som galde samt som ikke-absorberet lægemiddel.
The amount recovered in the faeces represents absorbed medicinal product equivalents excreted in bile as well as unabsorbed medicinal product.
• hvis du eller et medlem i din nærmeste familie har et arveligt muskelproblem
• you or a close family member have a muscle problem which runs in the family
Søvnforstyrrelser, herunder mareridt, depression
Sleep disorder, including nightmares, depression not known
Niacin (nikotinsyre)
Niacin (nicotinic acid)
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).
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).
Metabolismen i leveren er afhængig af blodgennemstrømningen i leveren.
The extraction in the liver is dependent on the hepatic blood flow.
Der er observeret reversible virkninger på fertiliteten hos dyr (se pkt.
Reversible effects on fertility have been observed in animals (see section 5.3).
Embryotoksiske virkninger sås ved doser i området for maternel toksicitet.
Embryotoxic effects were observed at doses in the range of maternal toxicity.
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.
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.