natgillin/translations-raw huggingface dataset:
I ét studie var der imidlertid en tendens til, at triglycerider steg mere, når Cholestagel blev givet som en enkelt dosis sammen med morgenmaden. 
However, in one study triglycerides tended to increase more when Cholestagel was given as a single dose with breakfast.
Desuden faldt Total-C 7 til 10%, HDL-C steg 3% og triglycerider steg 9 til 10%. 
In addition, Total-C decreased 7 to 10%, HDL-C increased 3% and triglycerides increased 9 to 10%.
De lægemidler kan tages samtidig eller hver for sig, afhængig af lægens ordination. 
The medicines may be taken at the same time or at separate times according to what your doctor has prescribed.
Derfor skal der udvises forsigtighed, når Cholestagel anvendes til patienter med disse sygdomme. 
Consequently, caution should be exercised when Cholestagel is used in patients with these disorders.
Specifikke kliniske interaktionsstudier med colesevelam og vitamin K er ikke gennemført. 
Specific clinical interaction studies with colesevelam and vitamin K have not been performed.
Monitorering af den kliniske virkning af behandling med ursodeoxycholsyre bør overvejes. 
Monitoring of the clinical effects of treatment with ursodeoxycholic acid should be considered.
Sekundære årsager til hyperkolesterolæmi 
Secondary causes of hypercholesterolaemia
Tabletterne skal synkes hele og må ikke deles, knuses eller tygges. 
The tablets should be swallowed whole and not broken, crushed or chewed.
Forstoppelse eller oppustethed kan forekomme. 
Constipation or bloating could occur.
Indtil videre er der ikke udført nogen studier der direkte viser, om behandling med Cholestagel i monoterapi eller i kombinationsbehandling har nogen effekt på kardiovaskulær morbiditet eller mortalitet. 
So far, no studies have been conducted that directly demonstrate whether treatment with Cholestagel as monotherapy or combination therapy has any effect on cardiovascular morbidity or mortality.
I kontrollerede kliniske studier med ca. 1.400 patienter og ved brug efter godkendelse blev følgende bivirkninger indberettet hos de patienter, der fik Cholestagel. 
In controlled clinical studies involving approximately 1400 patients and during post-approval use, the following adverse reactions were reported in patients given Cholestagel.
Tabletterne er emballeret i plastbeholder med børnesikret lukning. 
The tablets are packed in plastic bottles with child resistant closures.
YDRE KARTON OG FLASKEETIKET (24, 100 og 180 TABLETTER) MED KARTON FLASKEETIKET (180 TABLETTER) UDEN KARTON 
OUTER CARTON AND BOTTLE LABEL (24, 100 AND 180 TABLETS) WITH CARTON BOTTLE LABEL (180 TABLETS) WITHOUT CARTON
Hos disse patienter anbefales overvågning af vitamin A-, D- og Eniveauer og vurdering af vitamin K-status via måling af koagulationsparametre, og disse vitaminer skal suppleres, hvis der er behov for det. 
In these patients, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
Deres evne til at køre bil og betjene maskiner påvirkes ikke af, at De tager Cholestagel tabletter. 
Driving and using machines Your ability to drive or operate machines is not affected by taking Cholestagel tablets.
Der blev også set fald i non-HDL-C, Total-C og Apo B. En lille 5 % ikkesignifikant stigning i triglycerider blev observeret. 
Reductions were also seen for non-HDL-C, Total-C and Apo B. A small 5%, non-significant increase in triglycerides was noted.
Studier, der undersøgte indtagelse af Cholestagel som en enkelt dosis sammen med morgenmaden, en enkelt dosis sammen med aftensmaden, eller som delte doser sammen med morgenmad og aftensmad, viste ikke signifikante forskelle i LDL-C reduktionen for de forskellige doseringsplaner. 
Studies examining administration of Cholestagel as a single dose with breakfast, a single dose with dinner, or as divided doses with breakfast and dinner did not show significant differences in LDL-C reduction for different dosing schedules.
Virkningsmekanismen for colesevelam, det aktive stof i Cholestagel, er vurderet i flere in vitro og in vivo studier. 
The mechanism of action for the activity of colesevelam, the active substance in Cholestagel, has been evaluated in several in vitro and in vivo studies.
Under behandlingen skal den kolesterolsænkende diæt fortsætte, og serum total-C, LDL-C og triglyceridniveauer skal måles jævnligt under behandlingen for at bekræfte gunstig initial og tilstrækkelig langsigtet effekt. 
During therapy, the cholesterol-lowering diet should be continued, and serum total-C, LDL-C and triglyceride levels should be determined periodically during treatment to confirm favourable initial and adequate long-term responses.
Sikkerhed og effekt er ikke undersøgt hos patienter med triglyceridniveauer på mere end 3,4 mmol/l, idet sådanne patienter var udelukket fra deltagelse i de kliniske studier. 
Safety and efficacy are not established for patients with triglyceride levels greater than 3.4 mmol/L, since such patients were excluded from the clinical studies.
Uden denne recirkulation skal leveren fremstille yderligere galdesyrer. 
Without the recycling process, your liver has to make additional bile acids.
Deres læge kan eventuelt øge dosis til 7 tabletter om dagen. 
Your doctor may increase your dose to 7 tablets per day.
Hvis De skal tage anden medicin mere end én gang om dagen, skal De huske, at De kan tage Deres Cholestagel-tabletter én gang om dagen. 
If you need to take other medicines more than once a day, remember that your Cholestagel tablets can be taken once a day.
Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler. 
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Hvis De tager diabetesmedicin, skal De spørge Deres læge til råds, så De kan blive nøje overvåget. 
If you are taking medicines for diabetes, you should consult with your physician so that you can be closely monitored.
Der har været meget sjældne rapporter om nedsatte phenytoin-niveauer hos patienter, der har fået Cholestagel samtidig med phenytoin. 
There have been very rare reports of reduced phenytoin levels in patients who have received Cholestagel administered with phenytoin.
Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP. 
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP.
Kontakt lægen eller apotekspersonalet, før De tager Cholestagel - hvis Deres triglyceridniveauer (et fedtstof i blodet) er større end 3,4 mmol/l - hvis De har problemer med at synke eller har en alvorlig mave- eller tarmsygdom - hvis De lider af forstoppelse, da Cholestagel kan fremkalde eller forværre denne tilstand. 
Talk to your doctor or pharmacist before taking Cholestagel - if your triglyceride levels (a blood fat) are greater than 3.4 mmol/L - if you have difficulty in swallowing, or have a major stomach or intestinal disorder - if you suffer from constipation, as Cholestagel may induce or worsen this condition.
Hvis De får ordineret Cholestagel og et statin sammen, er det vigtigt, at De fortæller Deres læge det, hvis De er gravid, eller hvis De planlægger at blive gravid, idet statiner ikke må anvendes under graviditet; der henvises til den indlægsseddel, der følger med det pågældende statin. 
If you are prescribed Cholestagel and a statin together it is important that you tell your doctor if you are pregnant or if you are planning to become pregnant because statins must not be used during pregnancy; the patient information leaflet that comes with that particular statin should be consulted.
Cholestagel anbefales derfor ikke til brug til denne aldersgruppe. 
Therefore, Cholestagel is not recommended for use in this population.
Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditet, fosterudvikling, fødsel eller postnatal udvikling (se pkt. 
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development,
Cholestagel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner. 
Cholestagel has no or negligible influence on the ability to drive and use machines.
Cholestagel kan påvirke andre lægemidlers biotilgængelighed. 
Cholestagel may affect the bioavailability of other medicinal products.
Doseringen af statinet og ezetimib skal følge anvisningerne for det pågældende lægemiddel. 
The dosing of the statin and the ezetimibe should follow the instructions for that particular medicine.
Der er ingen data om Cholestagels effekt på human fertilitet. 
There are no data on the effect of Cholestagel on fertility in humans.
Der var ingen signifikante virkninger på vækst, seksuel modning, niveauer af fedtopløslige vitaminer eller koaguleringsfaktorer, og bivirkningsprofilen var sammenlignelig med den for placebo. 
There were no significant effects on growth, sexual maturation, fat-soluble vitamin levels or clotting factors, and the adverse reaction profile for Cholestagel was comparable to that seen with placebo.
• Ciclosporin (et lægemiddel, der bruges til undertrykkelse af immunsystemet). 
• Ciclosporin (a medicine used to suppress the immune system).
Når Cholestagel blev givet sammen med statiner i kliniske studier blev der observeret en forventet, yderligere LDL-C-sænkende virkning, og der blev ikke observeret nogen uventede virkninger. 
When Cholestagel was co-administered with statins in clinical studies, an expected add-on LDL-C lowering effect was observed, and no unexpected effects were observed.
Der blev ikke observeret interaktion, når Cholestagel og pioglitazon blev indtaget samtidig hos raske frivillige 
No interaction was observed when Cholestagel and pioglitazone were administered simultaneously in healthy volunteers
Desuden bør Cholestagel altid indgives på de samme tidspunkter, da tidspunktet for indtagelse af Cholestagel og ciclosporin teoretisk kan have betydning for, hvor meget ciclosporins biotilgængelighed nedsættes. 
Furthermore, Cholestagel should always be administered at the same times consistently since the timing of intake of Cholestagel and ciclosporin could theoretically influence the degree of reduced bioavailability of ciclosporin.
Cholestagel var veltolereret i kombination med statiner og i kombination med ezetimib, og de observerede bivirkninger var i overensstemmelse med den kendte sikkerhedsprofil for statiner eller ezetimib givet alene. 
Cholestagel in combination with statins and in combination with ezetimibe was well tolerated and the adverse reactions observed were consistent with the known safety profile of statins or ezetimibe alone.
Farmakoterapeutisk klassifikation: Lipidregulerende midler, galdesyrebindende midler, ATC-kode: C10A C 04 
Pharmacotherapeutic group: Lipid modifying agent, bile acid sequestrants, ATC code: C10A C 04
Hvis De mener, at én af disse to betingelser gælder for Dem, skal De underrette Deres læge eller apotek, før De begynder at tage Cholestagel. 
If you think any of these apply to you, you should inform your doctor or pharmacist before taking Cholestagel.
Indflydelsen af kombinationsbehandling med fenofibrat og Cholestagel på risikoen for myopati og hepatotoksicitet er ikke kendt. 
The effects of combination of fenofibrate and Cholestagel on the risks of myopathy or hepatotoxicity are not known.
Baggrundsincidensen af flatulens og diarré var højere hos patienter, der fik placebo i de samme kontrollerede studier. 
The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies.
Det er vigtigt at sikre, at Cholestagel indtages mindst 4 timer efter orale antikonceptiva for at minimere risikoen for en eventuel interaktion (se også punkt 4.5). 
It is important to ensure that Cholestagel is administered at least 4 hours after the oral contraceptive pill to minimise the risk of any interaction (see also section 4.5).
Kliniske undersøgelser har vist, at Cholestagel og statiner kan indgives samtidig eller adskilt, og at Cholestagel og ezetimib kan indgives samtidig eller alene. 
Clinical trials have shown that Cholestagel and statins can be co-administered or dosed apart, and that Cholestagel and ezetimibe can be coadministered or dosed apart.
Den maksimale anbefalede dosis er 7 tabletter om dagen. 
The maximum recommended dose is 7 tablets per day.
Sammendrag over sikkerheden 
Summary of the safety profile
Man skal være opmærksom på, at seponering af behandling med Cholestagel vil medføre øget koncentration af ciclosporin i blodet. 
It should be noted that stopping Cholestagel therapy will result in increased ciclosporin blood concentrations.
En større del af galdesyrerne absorberes så fra tarmkanalen og returneres til leveren via det enterohepatiske kredsløb. 
A major portion of bile acids is then absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation.
Generelt 
In general
Deres lever bruger kolesterol fra blodet til dette, hvilket sænker kolesterolindholdet i Deres blod. 
Your liver uses cholesterol from your blood to do this, which lowers the level of cholesterol in your blood.
Der er ingen data fra anvendelse af Cholestagel til gravide kvinder. 
No clinical data are available on the use of Cholestagel in pregnant women.
• Verapamil eller olmesartan (lægemidler, der anvendes til behandling af for højt blodtryk). 
• Verapamil or olmesartan (medicines used to treat high blood pressure).
Der er dog ikke udført formelle interaktionsstudier med ursodeoxycholinsyre. 
However, formal interaction studies with ursodeoxycholic acid have not been performed.
Colesevelam er et ikke-absorberet, lipidsænkende polymer, der binder galdesyrerne i tarmen og derved hæmmer deres genoptagelse. 
Colesevelam is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.
Der kan være tale om dårligt kontrolleret diabetes, ubehandlet hypothyroidea (lavt niveau for thyroidhormon, som der ikke aktuelt gives nogen behandling for), protein i urinen (nefrotisk syndrom), ændret proteinniveau i blodet (dysproteinæmi) og blokering af transporten af galde til galdeblæren (obstruktiv leversygdom). 
These could include poorly controlled diabetes, untreated hypothyroidism (low levels of thyroid hormone for which no treatment is being given currently), proteins in urine (nephrotic syndrome), altered protein levels in the blood (dysproteinaemias), and blockage of the bile transport to your gall bladder (obstructive liver disease).
Der bør imidlertid udvises forsigtighed ved behandling af patienter med tilbøjelighed til insufficiens mht. vitamin K eller fedtopløselige vitaminer, f.eks. patienter med malabsorption. 
However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption.
Hvis De skal tage Cholestagel og ét af disse lægemidler samtidig, vil Deres læge måske ønske at tage prøver for at sikre, at Cholestagel ikke påvirker den måde, hvorpå disse lægemidler virker. 
If you are going to take Cholestagel and one of these medicines, your doctor may want to do tests to make sure that Cholestagel does not interfere with these medicines.
• Antidiabetika (medicin, der anvendes til behandling af sukkersyge, såsom metformin depottabletter, glimepirid, glipzid, pioglitazon, repaglinid eller glibenclamid). 
• Antidiabetic medications (medicines used to treat diabetes, such as metformin extended-release (ER) tablets, glimepiride, glipizide, pioglitazone, repaglinide or glyburide).
I et 6-ugers studie blev 129 patienter med forskellige former af hyperlipidæmi randomiseret til fenofibrat 160 mg plus 3,8 g Cholestagel eller fenofibrat alene. 
In a 6 week study 129 patients with mixed hyperlipidaemia were randomised to fenofibrate 160 mg plus 3.8 g Cholestagel or fenofibrate alone.
Hvis De får ordineret Cholestagel og anden medicin sammen, skal De også læse den indlægsseddel, der følger med den pågældende medicin, før De begynder at tage medicinen. 
If you are prescribed Cholestagel and any other medicine together you must also read the patient information leaflet that comes with that particular medicine before you start to take your medicine.
Fremstiller Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland 
Manufacturer Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Der skal udvises forsigtighed ved behandling af patienter med triglyceridniveauer på over 3,4 mmol/l på grund af Cholestagels triglyceridforøgende virkning. 
Caution should be exercised when treating patients with triglyceride levels greater than 3.4 mmol/L due to the triglyceride increasing effect with Cholestagel.
Der bør udvises forsigtighed ved ordination til gravide. 
Caution should be exercised when prescribing to pregnant women.
I tilfælde af overdosering ville den vigtigste, potentielle skade imidlertid være obstruktion af mavetarmkanalen. 
Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract.
I Cholestagel-gruppen steg triglycerider med 19 % og 13 % i uge 6 og 12 versus en stigning på 6 % og 13 % i placebogruppen, men stigningerne var ikke signifikant forskellige. 
Triglycerides in the Cholestagel group increased by 19% and 13% at 6 and 12 weeks vs an increase of 6% and 13% in the placebo group, but the increases were not significantly different.
Før De påbegynder behandlingen med Cholestagel, skal Deres læge sikre, at visse tilstande ikke bidrager til Deres forhøjede kolesteroltal. 
Before starting therapy with Cholestagel, your physician should make sure that certain conditions do not contribute to your elevated cholesterol levels.
Nøje monitorering af niveauerne af ciclosporin i blodet tilrådes derfor (se også pkt. 
Therefore advice is given to closely monitor ciclosporin blood concentrations (see also section 4.4).
I interaktionsstudier med raske frivillige havde Cholestagel ikke nogen virkning på biotilgængeligheden af digoxin, metoprolol, quinidin, valproinsyre og warfarin. 
In interaction studies in healthy volunteers, Cholestagel had no effect on the bioavailability of digoxin, metoprolol, quinidine, valproic acid, and warfarin.
Obstipation Cholestagel kan fremkalde eller forværre eksisterende obstipation. 
Cholestagel can induce or worsen present constipation.
Ursodeoxycholsyre 
Ursodeoxycholic acid
• Ursodeoxycholsyre (medicin, der bruges til at opløse galdesten eller behandle specifikke kroniske leversygdomme). 
• Ursodeoxycholic acid (a medicine used to dissolve gallstones or treat specific chronic liver diseases).
Disse studier har påvist, at colesevelam binder galdesyrer, herunder glykokolsyre, den vigtigste galdesyre hos mennesker. 
These studies have demonstrated that colesevelam binds bile acids, including glycocholic acid, the major bile acid in humans.
Tabletterne skal tages med væske og sammen med et måltid. 
Tablets should be taken with liquid and with a meal.
Uf fra teoretiske betragtninger bør Cholestagel desuden indgives mindst 4 timer efter ciclosporin for yderligere at minimere de risici, der er forbundet med samtidig indgivelse af ciclosporin og Cholestagel. 
In addition, based on theoretical grounds Cholestagel should be administered at least 4 hours after ciclosporin in order to further minimise the risks related to the concomitant administration of ciclosporin and Cholestagel.
Dette medfører et øget behov for kolesterol i levercellerne, hvilket har den dobbelte virkning, at det øger transkriptionen og aktiviteten for det kolesterol biosyntetiske enzym, hydroxymethyl-glutarylcoenzym A (HMG-CoA) reduktase, og øger antallet af hepatiske low-density lipoprotein receptorer. 
This causes an increased demand for cholesterol in the liver cells, resulting in the dual effects of increasing transcription and activity of the cholesterol biosynthetic enzyme, hydroxymethyl-glutaryl-coenzyme A (HMG-CoA) reductase, and increasing the number of hepatic low-density lipoprotein receptors.
Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): betændelse i bugspytkirtlen. 
Very rare (may affect up to 1 in 10,000 people): inflammation of the pancreas.
Kun obstipation og dyspepsi blev indberettet med en højere procentdel blandt de patienter, der fik Cholestagel, sammenlignet med placebo. 
Only constipation and dyspepsia were reported by a higher percentage among those receiving Cholestagel, compared with placebo.
Deres læge bør kun give Dem Cholestagel, hvis en fedt- og kolesterolfattig kost alene ikke virkede godt nok. 
Your doctor should only give you Cholestagel if a diet low in fat and cholesterol did not work well enough on its own.
I et klinisk studie påvirkede Cholestagel ikke den fækale ekskretion af endogen (hydrofil) ursodeoxycholinsyre. 
In a clinical study Cholestagel did not affect the faecal excretion of endogenous (hydrophilic) ursodeoxycholic acid.
Hvis De tager medicin med navnet Sandimmun Neoral® eller ciclosporin, skal De sørge for at tage det i et ensartet mønster sammen med Cholestagel, enten altid sammen eller adskilt af det samme antal timer. 
If you take a medicine called either Neoral® or ciclosporin, please ensure to take it with Cholestagel in a consistent pattern over the day; either always together or always separate for a set number of hours.
Risikoen for obstipation bør især tages i betragtning hos patienter med koronarsygdomme og angina pectoris. 
The risk of constipation should especially be considered in patients with coronary heart disease and angina pectoris.
Før De starter på behandling med Cholestagel, skal De have besked om at følge en kolesterolsænkende diæt, og De skal fortsætte med denne diæt under behandlingen. 
Before starting therapy with Cholestagel, you should be advised to follow a cholesterol-lowering diet and you should continue this diet during treatment.
Cholestagel reducerede Cmax og AUC for verapamil depottabletter med henholdsvis ca. 31% og 11%. 
Cholestagel decreased the Cmax and AUC of sustained-release verapamil by approximately 31% and 11%, respectively.
• Antiepileptika (medicin såsom phenytoin, der anvendes til behandling af epilepsi). 
• Anti-epileptic medicines (medicines, such as phenytoin, used to treat epilepsy).
Cholestagel ordineres til behandling af en tilstand, der kaldes primær hyperkolesterolæmi (når kolesteroltallet i blodet er for højt) hos voksne. 
Cholestagel is prescribed to treat a condition known as primary hypercholesterolaemia (when cholesterol in the blood is elevated) in adults.
Til sammenligning var LDL-C, Total-C, HDL-C og Apo-B uændret hos patienter, der fik placebo, medens triglycerider steg 5%. 
In comparison, in patients given placebo, LDL-C, Total-C, HDL-C and Apo-B were unchanged, while triglycerides increased 5%.
Dette forhindrer kroppen i at recirkulere galdesyrerne fra tarmene, som det normalt sker. 
This prevents your body from recycling the bile acids from your intestines in the usual way.
Cholestagel kan påvirke biotilgængeligheden af orale antikonceptiva ved samtidig indtagelse. 
Cholestagel can affect the bioavailability of the oral contraceptive pill when administered simultaneously.
A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE 
 MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Cholestagel tabletter er offwhite, kapselformede, filmovertrukne tabletter med ‘C625' påtrykt på den ene side. 
Cholestagel tablets are off-white, capsule-shaped film-coated tablets and imprinted with ‘C625' on one side.