FrancophonIA/ELRC3.0 huggingface dataset:
English: The location of such potential obstruction, the degree of obstruction and the presence or absence of normal gut motility would determine treatment.
Danish: Placeringen af en sådan obstruktion, obstruktionsgraden og tilstedeværelsen eller fraværet af normal tarmbevægelighed ville være afgørende for behandlingen.
English: These compensatory effects result in increased clearance of LDL-C from the blood, resulting in decreased serum LDL-C levels.
Danish: Disse kompenserende virkninger medfører øget clearance af LDL-C fra blodet, hvilket medfører faldende LDL-C-niveauer i serum.
English: HDL-C and hsCRP levels were also not significantly different compared to placebo at 12 weeks.
Danish: HDL-C- og hsCRP-niveauer var heller ikke signifikant forskellige sammenlignet med placebo i uge 12.
English: A total of 85% of the patients were on either atorvastatin (50% of whom received 80 mg dose) or rosuvastatin (72% of whom received 40 mg dose).
Danish: I alt 85 % af patienterne fik enten atorvastatin (heraf fik 50 % af patienterne en dosis på 80 mg) eller rosuvastatin (heraf fik 72 % af patienterne en dosis på 40 mg).
English: Since Cholestagel is not absorbed, the risk of systemic toxicity is low.
Danish: Da Cholestagel ikke absorberes, er risikoen for systemisk toksicitet lav.
English: Gastrointestinal symptoms could occur.
Danish: Der kan eventuelt forekomme gastrointestinale symptomer.
English: Since there is a high degree of variability in the bioavailability of verapamil, the clinical significance of this finding is unclear.
Danish: Da der er stor variation i verapamils biotilgængelighed, er dette resultats kliniske signifikans uklar.
English: The safety and efficacy of Cholestagel in children aged 0 to 17 years have not yet been established.
Danish: Cholestagels sikkerhed og virkning hos børn i alderen 0 til 17 år er endnu ikke klarlagt.
English: Effects on triglyceride levels
Danish: Påvirkning af triglyceridniveauet
English: Common: Headache
Danish: Almindelig: Hovedpine
English: Cholestagel did not induce any clinically significant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year.
Danish: Cholestagel fremkaldte ingen klinisk signifikant reduktion i optagelsen af vitamin A, D, E eller K i kliniske studier varende op til ét år.
English: Additionally, if you have any condition that could cause you to have a deficiency of vitamins A, D, E or K, your doctor may want to check your vitamin levels periodically while you are taking Cholestagel.
Danish: Desuden gælder det, at hvis De har en sygdom, der eventuelt kan medføre mangel på vitamin A, D, E eller K, vil Deres læge måske ønske at kontrollere Deres vitaminniveau jævnligt, medens De tager Cholestagel.
English: Interaction with ciclosporin
Danish: Interaktioner med ciclosporin
English: This is especially important for patients with coronary heart disease and angina pectoris.
Danish: Dette er især vigtigt for patienter med koronar hjertesygdom og angina pectoris.
English: However, in one study triglycerides tended to increase more when Cholestagel was given as a single dose with breakfast.
Danish: I ét studie var der imidlertid en tendens til, at triglycerider steg mere, når Cholestagel blev givet som en enkelt dosis sammen med morgenmaden.
English: In addition, Total-C decreased 7 to 10%, HDL-C increased 3% and triglycerides increased 9 to 10%.
Danish: Desuden faldt Total-C 7 til 10%, HDL-C steg 3% og triglycerider steg 9 til 10%.
English: The medicines may be taken at the same time or at separate times according to what your doctor has prescribed.
Danish: De lægemidler kan tages samtidig eller hver for sig, afhængig af lægens ordination.
English: Consequently, caution should be exercised when Cholestagel is used in patients with these disorders.
Danish: Derfor skal der udvises forsigtighed, når Cholestagel anvendes til patienter med disse sygdomme.
English: Specific clinical interaction studies with colesevelam and vitamin K have not been performed.
Danish: Specifikke kliniske interaktionsstudier med colesevelam og vitamin K er ikke gennemført.
English: Monitoring of the clinical effects of treatment with ursodeoxycholic acid should be considered.
Danish: Monitorering af den kliniske virkning af behandling med ursodeoxycholsyre bør overvejes.
English: Secondary causes of hypercholesterolaemia
Danish: Sekundære årsager til hyperkolesterolæmi
English: The tablets should be swallowed whole and not broken, crushed or chewed.
Danish: Tabletterne skal synkes hele og må ikke deles, knuses eller tygges.
English: Constipation or bloating could occur.
Danish: Forstoppelse eller oppustethed kan forekomme.
English: 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.
Danish: 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.
English: In controlled clinical studies involving approximately 1400 patients and during post-approval use, the following adverse reactions were reported in patients given Cholestagel.
Danish: I kontrollerede kliniske studier med ca. 1.400 patienter og ved brug efter godkendelse blev følgende bivirkninger indberettet hos de patienter, der fik Cholestagel.
English: The tablets are packed in plastic bottles with child resistant closures.
Danish: Tabletterne er emballeret i plastbeholder med børnesikret lukning.
English: OUTER CARTON AND BOTTLE LABEL (24, 100 AND 180 TABLETS) WITH CARTON BOTTLE LABEL (180 TABLETS) WITHOUT CARTON
Danish: YDRE KARTON OG FLASKEETIKET (24, 100 og 180 TABLETTER) MED KARTON FLASKEETIKET (180 TABLETTER) UDEN KARTON
English: 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.
Danish: 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.
English: Driving and using machines Your ability to drive or operate machines is not affected by taking Cholestagel tablets.
Danish: Deres evne til at køre bil og betjene maskiner påvirkes ikke af, at De tager Cholestagel tabletter.
English: Reductions were also seen for non-HDL-C, Total-C and Apo B. A small 5%, non-significant increase in triglycerides was noted.
Danish: Der blev også set fald i non-HDL-C, Total-C og Apo B. En lille 5 % ikkesignifikant stigning i triglycerider blev observeret.
English: 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.
Danish: 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.
English: 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.
Danish: Virkningsmekanismen for colesevelam, det aktive stof i Cholestagel, er vurderet i flere in vitro og in vivo studier.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Without the recycling process, your liver has to make additional bile acids.
Danish: Uden denne recirkulation skal leveren fremstille yderligere galdesyrer.
English: Your doctor may increase your dose to 7 tablets per day.
Danish: Deres læge kan eventuelt øge dosis til 7 tabletter om dagen.
English: If you need to take other medicines more than once a day, remember that your Cholestagel tablets can be taken once a day.
Danish: 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.
English: 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.
Danish: 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.
English: If you are taking medicines for diabetes, you should consult with your physician so that you can be closely monitored.
Danish: Hvis De tager diabetesmedicin, skal De spørge Deres læge til råds, så De kan blive nøje overvåget.
English: There have been very rare reports of reduced phenytoin levels in patients who have received Cholestagel administered with phenytoin.
Danish: Der har været meget sjældne rapporter om nedsatte phenytoin-niveauer hos patienter, der har fået Cholestagel samtidig med phenytoin.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Therefore, Cholestagel is not recommended for use in this population.
Danish: Cholestagel anbefales derfor ikke til brug til denne aldersgruppe.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development,
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditet, fosterudvikling, fødsel eller postnatal udvikling (se pkt.
English: Cholestagel has no or negligible influence on the ability to drive and use machines.
Danish: Cholestagel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Cholestagel may affect the bioavailability of other medicinal products.
Danish: Cholestagel kan påvirke andre lægemidlers biotilgængelighed.
English: The dosing of the statin and the ezetimibe should follow the instructions for that particular medicine.
Danish: Doseringen af statinet og ezetimib skal følge anvisningerne for det pågældende lægemiddel.
English: There are no data on the effect of Cholestagel on fertility in humans.
Danish: Der er ingen data om Cholestagels effekt på human fertilitet.
English: 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.
Danish: Der var ingen signifikante virkninger på vækst, seksuel modning, niveauer af fedtopløslige vitaminer eller koaguleringsfaktorer, og bivirkningsprofilen var sammenlignelig med den for placebo.
English: • Ciclosporin (a medicine used to suppress the immune system).
Danish: • Ciclosporin (et lægemiddel, der bruges til undertrykkelse af immunsystemet).
English: 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.
Danish: 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.
English: No interaction was observed when Cholestagel and pioglitazone were administered simultaneously in healthy volunteers
Danish: Der blev ikke observeret interaktion, når Cholestagel og pioglitazon blev indtaget samtidig hos raske frivillige
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Pharmacotherapeutic group: Lipid modifying agent, bile acid sequestrants, ATC code: C10A C 04
Danish: Farmakoterapeutisk klassifikation: Lipidregulerende midler, galdesyrebindende midler, ATC-kode: C10A C 04
English: If you think any of these apply to you, you should inform your doctor or pharmacist before taking Cholestagel.
Danish: 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.
English: The effects of combination of fenofibrate and Cholestagel on the risks of myopathy or hepatotoxicity are not known.
Danish: Indflydelsen af kombinationsbehandling med fenofibrat og Cholestagel på risikoen for myopati og hepatotoksicitet er ikke kendt.
English: The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies.
Danish: Baggrundsincidensen af flatulens og diarré var højere hos patienter, der fik placebo i de samme kontrollerede studier.
English: 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).
Danish: 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).
English: 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.
Danish: Kliniske undersøgelser har vist, at Cholestagel og statiner kan indgives samtidig eller adskilt, og at Cholestagel og ezetimib kan indgives samtidig eller alene.
English: The maximum recommended dose is 7 tablets per day.
Danish: Den maksimale anbefalede dosis er 7 tabletter om dagen.
English: Summary of the safety profile
Danish: Sammendrag over sikkerheden
English: It should be noted that stopping Cholestagel therapy will result in increased ciclosporin blood concentrations.
Danish: Man skal være opmærksom på, at seponering af behandling med Cholestagel vil medføre øget koncentration af ciclosporin i blodet.
English: A major portion of bile acids is then absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation.
Danish: En større del af galdesyrerne absorberes så fra tarmkanalen og returneres til leveren via det enterohepatiske kredsløb.
English: In general
Danish: Generelt
English: Your liver uses cholesterol from your blood to do this, which lowers the level of cholesterol in your blood.
Danish: Deres lever bruger kolesterol fra blodet til dette, hvilket sænker kolesterolindholdet i Deres blod.
English: No clinical data are available on the use of Cholestagel in pregnant women.
Danish: Der er ingen data fra anvendelse af Cholestagel til gravide kvinder.
English: • Verapamil or olmesartan (medicines used to treat high blood pressure).
Danish: • Verapamil eller olmesartan (lægemidler, der anvendes til behandling af for højt blodtryk).
English: However, formal interaction studies with ursodeoxycholic acid have not been performed.
Danish: Der er dog ikke udført formelle interaktionsstudier med ursodeoxycholinsyre.
English: Colesevelam is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.
Danish: Colesevelam er et ikke-absorberet, lipidsænkende polymer, der binder galdesyrerne i tarmen og derved hæmmer deres genoptagelse.
English: 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).
Danish: 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).
English: However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption.
Danish: Der bør imidlertid udvises forsigtighed ved behandling af patienter med tilbøjelighed til insufficiens mht. vitamin K eller fedtopløselige vitaminer, f.eks. patienter med malabsorption.
English: 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.
Danish: 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.
English: • Antidiabetic medications (medicines used to treat diabetes, such as metformin extended-release (ER) tablets, glimepiride, glipizide, pioglitazone, repaglinide or glyburide).
Danish: • Antidiabetika (medicin, der anvendes til behandling af sukkersyge, såsom metformin depottabletter, glimepirid, glipzid, pioglitazon, repaglinid eller glibenclamid).
English: In a 6 week study 129 patients with mixed hyperlipidaemia were randomised to fenofibrate 160 mg plus 3.8 g Cholestagel or fenofibrate alone.
Danish: 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.
English: 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.
Danish: 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.
English: Manufacturer Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Danish: Fremstiller Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland
English: Caution should be exercised when treating patients with triglyceride levels greater than 3.4 mmol/L due to the triglyceride increasing effect with Cholestagel.
Danish: Der skal udvises forsigtighed ved behandling af patienter med triglyceridniveauer på over 3,4 mmol/l på grund af Cholestagels triglyceridforøgende virkning.
English: Caution should be exercised when prescribing to pregnant women.
Danish: Der bør udvises forsigtighed ved ordination til gravide.
English: Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract.
Danish: I tilfælde af overdosering ville den vigtigste, potentielle skade imidlertid være obstruktion af mavetarmkanalen.
English: 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.
Danish: 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.
English: Before starting therapy with Cholestagel, your physician should make sure that certain conditions do not contribute to your elevated cholesterol levels.
Danish: Før De påbegynder behandlingen med Cholestagel, skal Deres læge sikre, at visse tilstande ikke bidrager til Deres forhøjede kolesteroltal.
English: Therefore advice is given to closely monitor ciclosporin blood concentrations (see also section 4.4).
Danish: Nøje monitorering af niveauerne af ciclosporin i blodet tilrådes derfor (se også pkt.
English: In interaction studies in healthy volunteers, Cholestagel had no effect on the bioavailability of digoxin, metoprolol, quinidine, valproic acid, and warfarin.
Danish: I interaktionsstudier med raske frivillige havde Cholestagel ikke nogen virkning på biotilgængeligheden af digoxin, metoprolol, quinidin, valproinsyre og warfarin.
English: Cholestagel can induce or worsen present constipation.
Danish: Obstipation Cholestagel kan fremkalde eller forværre eksisterende obstipation.
English: Ursodeoxycholic acid
Danish: Ursodeoxycholsyre
English: • Ursodeoxycholic acid (a medicine used to dissolve gallstones or treat specific chronic liver diseases).
Danish: • Ursodeoxycholsyre (medicin, der bruges til at opløse galdesten eller behandle specifikke kroniske leversygdomme).
English: These studies have demonstrated that colesevelam binds bile acids, including glycocholic acid, the major bile acid in humans.
Danish: Disse studier har påvist, at colesevelam binder galdesyrer, herunder glykokolsyre, den vigtigste galdesyre hos mennesker.
English: Tablets should be taken with liquid and with a meal.
Danish: Tabletterne skal tages med væske og sammen med et måltid.