natgillin/translations-raw huggingface dataset:
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.
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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.
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 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.
Offwhite, kapselformet, filmovertrukne tabletter med “C625” påtrykt på den ene side.
Off-white, capsule-shaped film-coated tablets imprinted with “C625” on one side.
Deres kolesteroltal kan stige til det niveau, det lå på før behandlingens start.
If you stop taking Cholestagel Your cholesterol may increase to the level it was before treatment was started.
INFORMATION I BRAILLESKRIFT
INFORMATION IN BRAILLE Cholestagel
• Thyroidea-erstatningsterapi (lægemidler, f.eks. thyroxin eller levothyroxin, der anvendes til at behandle lave niveauer af skjoldbruskkirtelhormon).
• Thyroid replacement therapy (medicines, such as thyroxine or levothyroxine, used to treat low thyroid hormone levels)
Cholestagel virker i Deres tarmsystem ved at binde galdesyrer, som leveren producerer, og føre galdesyrerne ud af kroppen med afføringen.
Cholestagel works in your intestinal system by binding bile acids produced by your liver and carrying the bile acids out of your body with your faeces.
Pakningsstørrelserne er 24 (1 x 24), 100 (2 x 50) og 180 (1 x 180) tabletter.
Pack sizes are 24 (1 x 24), 100 (2 x 50) and 180 (1 x 180) tablets.
Brug af anden medicin sammen med Cholestagel
Other medicines and Cholestagel
Gruppen med fenofibrat og Cholestagel (64 patienter) udviste et 10 % fald i LDL-C-niveauer versus en 2 % stigning i fenofibratgruppen (65 patienter).
The fenofibrate plus Cholestagel group (64 patients) demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group
Ældre population Der er ikke nødvendigt at justere dosis, når Cholestagel gives til ældre mennesker.
There is no need for dose adjustment when Cholestagel is administered to elderly patients.
Randomiserede, dobbeltblindede, placebokontrollerede multicenterstudier med 487 patienter påviste en øget reduktion på 8 til 16 % i LDL-C, når 2,3 til 3,8 g Cholestagel og et statin (atorvastatin, lovastatin eller simvastatin) blev givet samtidig.
Multi-centre, randomised, double-blind, placebo-controlled studies in 487 patients demonstrated an additive reduction of 8 to 16% in LDL-C when 2.3 to 3.8 g Cholestagel and a statin (atorvastatin, lovastatin or simvastatin) were administered at the same time.
Hvis De har glemt at tage Cholestagel
If you forget to take Cholestagel
Cholestagel er med til at sænke kolesterolindholdet i Deres blod.
Taking Cholestagel helps to lower the level of cholesterol in your blood.
Cholestagel kan også anvendes i kombination med ezetimib, med eller uden statin, hos voksne patienter med primær hyperkolesterolæmi, herunder patienter med familiær hyperkolesterolæmi (se pkt.
Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).
I et 6-måneders studie af dosisrespons hos patienter med primær hyperkolesterolæmi, der fik 3,8 eller 4,5 g Cholestagel daglig, blev der observeret et 15 til 18% fald i LDL-C-niveauer, der var tydeligt inden 2 ugers indtagelse.
In a 6-month dose-response study in patients with primary hypercholesterolaemia receiving 3.8 or 4.5 g Cholestagel daily, a 15 to 18% decrease in LDL-C levels was observed, which was evident within 2 weeks of administration.
Hver tablet indeholder 625 mg colesevelam.
Each tablet contains 625 mg colesevelam.
I prækliniske studier blev der kun iagttaget virkninger af doser, der bliver anset for at overstige den maksimale humane eksponering i væsentlig grad.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
- Cholestagel kan anvendes sammen med et statin og den fedt- og kolesterolfattige diæt, når patienterne ikke behandles hensigtsmæssigt med statin alene.
- Cholestagel may be used together with a statin and the diet low in fat and cholesterol when patients are not appropriately controlled by the statin on its own.
Ikke kendt (kan ikke vurderes ud fra forhåndenværende data): blokeret tarm (tarmslyng - som kan være hyppigere hos patienter, som tidligere har haft tarmslyng eller har fået dele af tarmen fjernet).
Not known (frequency cannot be estimated from the available data): blockage of the intestines (which can increase among patients with a history of blockage of the intestines or intestinal removal).
Meget almindelig: Flatulens*, obstipation* Almindelig: Opkastning, diarré*, dyspepsi*, abdominalsmerte, unormal afføring, kvalme, abdominal distension Ikke almindelig: Dysfagi
Very common: Flatulence*, constipation* Common: Vomiting, diarrhoea*, dyspepsia*, abdominal pain, abnormal stools, nausea, abdominal distension
Patienter, som får metformin depottabletter og colesevelam samtidigt, skal monitoreres for klinisk respons, som det er almindeligt ved behandling med antidiabetika.
Patients receiving concomitant metformin ER and colesevelam should be monitored for clinical response as is usual for the use of anti-diabetes drugs.
Almindelig (kan forekomme hos op til 1 ud af 10 personer): opkastning, diarré, fordøjelsesbesvær, mavesmerter, unormal afføring, kvalme, oppustethed, hovedpine, forhøjede niveauer af triglycerider (fedtstoffer) i blodet.
Common (may affect up to 1 in 10 people): vomiting, diarrhoea, indigestion, abdominal pain, abnormal stools, feeling sick, bloating, headache, raised levels of triglycerides (fats) in your blood.
Cholestagel er ikke blevet sammenlignet direkte med andre galdesyrebindende stoffer i kliniske undersøgelser.
Cholestagel has not been compared directly to other bile acid sequestrants in clinical trials.
Ved samtidig brug af anden medicin, der skal indgives i delte doser, skal det erindres, at Cholestagel kan indtages én gang om dagen.
For concomitant medications which require administration via divided doses, it should be noted that the required dose of Cholestagel can be taken once a day.
Behandling med kombinationen ezetimib 10 mg og Cholestagel 3,8 g daglig uden statin resulterede i en signifikant kombineret effekt med reduktion af LDL-C på 32 % svarende til en yderligere effekt med reduktion af LDL-C på 11 % med Cholestagel og ezetimib sammenlignet med ezetimib givet alene.
The combination of ezetimibe 10 mg and Cholestagel 3.8 g daily therapy in the absence of a statin resulted in a significant combined effect for LDL-C lowering by 32% demonstrating an additional effect of 11% LDL-C lowering with Cholestagel and ezetimibe compared to ezetimibe alone.
Sikkerhed og effekt for Cholestagel hos patienter med synkebesvær, synkesygdomme, svære gastrointestinale bevægelighedssygdomme, inflammatorisk tarmsygdom, leverinsufficiens eller større operationer i mavetarmkanalen er ikke undersøgt.
The safety and efficacy of Cholestagel in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or major gastrointestinal tract surgery have not been established.
Cholestagel indgivet sammen med en 3-hydroxy-3-methyl-glutaryl-coenzym A (HMG-CoA) reduktasehæmmer (statin) er indiceret som supplerende behandling til diæt med henblik på at fremkalde en yderligere reduktion i niveauet af low density lipoprotein-kolesterol (LDL-C) hos voksne patienter med primær hyperkolesterolæmi, der ikke kontrolleres tilstrækkeligt med statin alene.
Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.
• Koagulationshæmmende behandling (lægemidler som warfarin, der anvendes til at fortynde blodet).
• Anticoagulant therapy (medicines, such as warfarin, used to thin blood).
Kolesterol er galdesyrernes eneste prodrom.
Cholesterol is the sole precursor of bile acids.
Hypromellose (E464) Diacetylerede monoglycerider
Hypromellose (E464) Diacetylated monoglycerides
Filmovertræk: hypromellose (E464)
Hypromellose (E464)
Cholestageltabletterne skal tages oralt sammen med et måltid og væske.
Cholestagel tablets should be taken orally with a meal and liquid.
Cholestagel som monoterapi er indiceret som supplerende behandling til diæt med henblik på en reduktion af forhøjet total-kolesterol og LDL-C hos voksne patienter med primær hyperkolesterolæmi, hos hvem statin anses for uhensigtsmæssigt eller ikke tåles godt.
Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well-tolerated.
Incidensen af intestinal obstruktion vil sandsynligvis være højere hos patienter, som tidligere har haft tarmobstruktion eller fået fjernet tarm.
The incidence of intestinal obstruction is likely to be increased among patients with a history of bowel obstruction or removal.
Beskrivelse af udvalgte bivirkninger
Description of selected adverse events
For patienter i behandling med ciclosporin, der starter eller afbryder behandling med Cholestagel, eller patienter i behandling med Cholestagel, der skal starte behandling med ciclosporin: Cholestagel nedsætter biotilgængeligheden af ciclosporin (se også pkt.
For patients on ciclosporin starting or stopping Cholestagel or patients on Cholestagel with a need to start ciclosporin: Cholestagel reduces the bioavailability of ciclosporin (see also section 4.5).
Cellulose (E460), mikrokrystallinsk Silica, kolloid vandfri Magnesiumstearat Vand, renset
Cellulose (E460), microcrystalline Silica, colloidal anhydrous Magnesium stearate Water, purified
Samtidig indtagelse af Cholestagel og repaglinid havde ingen effekt på AUC men medførte en 19% reduktion i Cmax af repaglinid.
Co-administration of Cholestagel and repaglinide had no effect on the AUC and caused a 19% reduction in the Cmax of repaglinide, the clinical significance of which is unknown.
Den anbefalede dosis af Cholestagel i kombination med statin med eller uden ezetimib er 4 til 6 tabletter om dagen.
The recommended dose of Cholestagel for combination with a statin with or without ezetimibe is 4 to 6 tablets per day.
Sikkerheden og virkningen af Cholestagel 1,9 eller 3,8 g daglig hos den pædiatrisk population blev vurderet i en 8 ugers randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie med 194 drenge og postmenarche piger i alderen 10-17 år med heterozygot FH på en stabil dosis statin (47 patienter, 24 %) eller patienter, der ikke tidligere har fået lipidsænkende behandling (147 patienter, 76 %).
In the paediatric population, the safety and efficacy of 1.9 or 3.8 g/day Cholestagel was assessed in an 8 week multi-centre, randomised, double-blind, placebo-controlled study in 194 boys and postmenarchal girls, aged 10-17 years, with heterozygous FH on a stable dose of statins (47 patients, 24%) or treatment-naïve to lipid-lowering therapy (147 patients, 76%).
• Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Bowel or biliary obstruction
Hos alle patienter resulterede Cholestagel i en statistisk signifikant LDL-C-reduktion på 11 % ved 3,8 g/dag og 4 % ved 1,9 g/dag versus en stigning på 3 % i placebogruppen.
For all patients, Cholestagel resulted in a statistically significant LDL-C reduction of 11% at 3.8 g/day and 4% at 1.9 g/day, versus a 3% increase in the placebo group.
Et rottestudie viste ikke i nogen forskelle i parametrene for reproduktion i de grupper, der fik colesevelam.
A study conducted in rats did not result in any differences in reproductive parameters between the groups that might imply reproductive effects attributable to colesevelam.
Virkningen af 3,8 g Cholestagel plus 10 mg ezetimib versus 10 mg ezetimib alene på LDL-C-niveauer blev vurderet i en randomiseret, dobbeltblindet, placebokontrolleret multicenterstudier med parallelgrupper med 86 patienter med primær hyperkolesterolæmi over en behandlingsperiode på 6 uger.
The effect of 3.8 g Cholestagel plus 10 mg ezetimibe versus 10 mg ezetimibe alone on LDL-C levels was assessed in a multicentre, randomised, double-blind, placebo-controlled, parallel-group study in 86 patients with primary hypercholesterolaemia over a 6-week treatment period.
Cholestagel indeholder det aktive stof colesevelam (som hydrochlorid).
Cholestagel contains the active substance colesevelam (as hydrochloride).
Pakningsstørrelser: 180 tabletter (1 X 180)
Package sizes are: 180 tablets (1 X 180)
180 filmovertrukne tabletter.
180 film-coated tablets
- Aktivt stof: colesevelam (som hydrochlorid).
- The active substance is colesevelam (as hydrochloride).
Der bør udvises forsigtighed ved ordination til kvinder, der ammer.
Caution should be exercised when prescribing to breast-feeding women.
I et interaktionstudie på raske frivillige personer medførte samtidig indgivelse af Cholestagel og ciclosporin en markant reduktion af AUC0-inf og Cmax for ciclosporin med henholdsvis 34% og 44%.
In an interaction study in healthy volunteers, co-administration of Cholestagel and ciclosporin significantly reduced the AUC0-inf and Cmax of ciclosporin by 34% by 44%, respectively.
- Cholestagel kan ordineres alene sammen med en diæt, der er fedt- og kolesterolfattig, når behandling med et statin (en type kolesterolsænkende medicin, der virker i leveren) er uhensigtsmæssigt eller ikke tåles godt.
- Cholestagel may be prescribed on its own in addition to a diet low in fat and cholesterol when treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inappropriate or not well tolerated.
Colesevelam binder til glimepirid og reducerer absorption af glimepirid fra mave-tarmkanalen.
Colesevelam binds to glimepiride and reduces glimepiride absorption from the gastrointestinal tract.
Hvis Deres læge har en mistanke om, at Cholestagel kan påvirke optagelsen af det andet lægemiddel, vil De måske blive rådet til at tage Cholestagel mindst 4 timer før eller mindst 4 timer efter, at De har taget det andet lægemiddel.
If your doctor suspects that Cholestagel may have an effect on the absorption of the other medication, you may be advised to take Cholestagel at least 4 hours before or at least 4 hours after taking the other medication.