FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Very rare (may affect up to 1 in 10,000 people): inflammation of the pancreas.
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): betændelse i bugspytkirtlen.
English: Only constipation and dyspepsia were reported by a higher percentage among those receiving Cholestagel, compared with placebo.
Danish: Kun obstipation og dyspepsi blev indberettet med en højere procentdel blandt de patienter, der fik Cholestagel, sammenlignet med placebo.
English: Your doctor should only give you Cholestagel if a diet low in fat and cholesterol did not work well enough on its own.
Danish: Deres læge bør kun give Dem Cholestagel, hvis en fedt- og kolesterolfattig kost alene ikke virkede godt nok.
English: In a clinical study Cholestagel did not affect the faecal excretion of endogenous (hydrophilic) ursodeoxycholic acid.
Danish: I et klinisk studie påvirkede Cholestagel ikke den fækale ekskretion af endogen (hydrofil) ursodeoxycholinsyre.
English: 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.
Danish: 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.
English: The risk of constipation should especially be considered in patients with coronary heart disease and angina pectoris.
Danish: Risikoen for obstipation bør især tages i betragtning hos patienter med koronarsygdomme og angina pectoris.
English: Before starting therapy with Cholestagel, you should be advised to follow a cholesterol-lowering diet and you should continue this diet during treatment.
Danish: 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.
English: Cholestagel decreased the Cmax and AUC of sustained-release verapamil by approximately 31% and 11%, respectively.
Danish: Cholestagel reducerede Cmax og AUC for verapamil depottabletter med henholdsvis ca. 31% og 11%.
English: • Anti-epileptic medicines (medicines, such as phenytoin, used to treat epilepsy).
Danish: • Antiepileptika (medicin såsom phenytoin, der anvendes til behandling af epilepsi).
English: Cholestagel is prescribed to treat a condition known as primary hypercholesterolaemia (when cholesterol in the blood is elevated) in adults.
Danish: Cholestagel ordineres til behandling af en tilstand, der kaldes primær hyperkolesterolæmi (når kolesteroltallet i blodet er for højt) hos voksne.
English: In comparison, in patients given placebo, LDL-C, Total-C, HDL-C and Apo-B were unchanged, while triglycerides increased 5%.
Danish: Til sammenligning var LDL-C, Total-C, HDL-C og Apo-B uændret hos patienter, der fik placebo, medens triglycerider steg 5%.
English: This prevents your body from recycling the bile acids from your intestines in the usual way.
Danish: Dette forhindrer kroppen i at recirkulere galdesyrerne fra tarmene, som det normalt sker.
English: Cholestagel can affect the bioavailability of the oral contraceptive pill when administered simultaneously.
Danish: Cholestagel kan påvirke biotilgængeligheden af orale antikonceptiva ved samtidig indtagelse.
English:  MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Cholestagel tablets are off-white, capsule-shaped film-coated tablets and imprinted with ‘C625' on one side.
Danish: Cholestagel tabletter er offwhite, kapselformede, filmovertrukne tabletter med ‘C625' påtrykt på den ene side.
English: Off-white, capsule-shaped film-coated tablets imprinted with “C625” on one side.
Danish: Offwhite, kapselformet, filmovertrukne tabletter med “C625” påtrykt på den ene side.
English: If you stop taking Cholestagel Your cholesterol may increase to the level it was before treatment was started.
Danish: Deres kolesteroltal kan stige til det niveau, det lå på før behandlingens start.
English: INFORMATION IN BRAILLE Cholestagel
Danish: INFORMATION I BRAILLESKRIFT
English: • Thyroid replacement therapy (medicines, such as thyroxine or levothyroxine, used to treat low thyroid hormone levels)
Danish: • Thyroidea-erstatningsterapi (lægemidler, f.eks. thyroxin eller levothyroxin, der anvendes til at behandle lave niveauer af skjoldbruskkirtelhormon).
English: 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.
Danish: Cholestagel virker i Deres tarmsystem ved at binde galdesyrer, som leveren producerer, og føre galdesyrerne ud af kroppen med afføringen.
English: Pack sizes are 24 (1 x 24), 100 (2 x 50) and 180 (1 x 180) tablets.
Danish: Pakningsstørrelserne er 24 (1 x 24), 100 (2 x 50) og 180 (1 x 180) tabletter.
English: Other medicines and Cholestagel
Danish: Brug af anden medicin sammen med Cholestagel
English: The fenofibrate plus Cholestagel group (64 patients) demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group
Danish: Gruppen med fenofibrat og Cholestagel (64 patienter) udviste et 10 % fald i LDL-C-niveauer versus en 2 % stigning i fenofibratgruppen (65 patienter).
English: Danmark Sanofi A/S Tlf: +45 45 16 70 00
Danish: Sanofi A/S Tlf: +45 45 16 70 00
English: There is no need for dose adjustment when Cholestagel is administered to elderly patients.
Danish: Ældre population Der er ikke nødvendigt at justere dosis, når Cholestagel gives til ældre mennesker.
English: 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.
Danish: 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.
English: If you forget to take Cholestagel
Danish: Hvis De har glemt at tage Cholestagel
English: Taking Cholestagel helps to lower the level of cholesterol in your blood.
Danish: Cholestagel er med til at sænke kolesterolindholdet i Deres blod.
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: Each tablet contains 625 mg colesevelam.
Danish: Hver tablet indeholder 625 mg colesevelam.
English: 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.
Danish: I prækliniske studier blev der kun iagttaget virkninger af doser, der bliver anset for at overstige den maksimale humane eksponering i væsentlig grad.
English: Antidiabetic agents
Danish: Antidiabetika
English: - 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.
Danish: - Cholestagel kan anvendes sammen med et statin og den fedt- og kolesterolfattige diæt, når patienterne ikke behandles hensigtsmæssigt med statin alene.
English: 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).
Danish: 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).
English: Very common: Flatulence*, constipation* Common: Vomiting, diarrhoea*, dyspepsia*, abdominal pain, abnormal stools, nausea, abdominal distension
Danish: Meget almindelig: Flatulens*, obstipation* Almindelig: Opkastning, diarré*, dyspepsi*, abdominalsmerte, unormal afføring, kvalme, abdominal distension Ikke almindelig: Dysfagi
English: Patients receiving concomitant metformin ER and colesevelam should be monitored for clinical response as is usual for the use of anti-diabetes drugs.
Danish: Patienter, som får metformin depottabletter og colesevelam samtidigt, skal monitoreres for klinisk respons, som det er almindeligt ved behandling med antidiabetika.
English: 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.
Danish: 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.
English: Cholestagel has not been compared directly to other bile acid sequestrants in clinical trials.
Danish: Cholestagel er ikke blevet sammenlignet direkte med andre galdesyrebindende stoffer i kliniske undersøgelser.
English: 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.
Danish: Ved samtidig brug af anden medicin, der skal indgives i delte doser, skal det erindres, at Cholestagel kan indtages én gang om dagen.
English: 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.
Danish: 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.
English: 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.
Danish: Sikkerhed og effekt for Cholestagel hos patienter med synkebesvær, synkesygdomme, svære gastrointestinale bevægelighedssygdomme, inflammatorisk tarmsygdom, leverinsufficiens eller større operationer i mavetarmkanalen er ikke undersøgt.
English: 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.
Danish: 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.
English: • Anticoagulant therapy (medicines, such as warfarin, used to thin blood).
Danish: • Koagulationshæmmende behandling (lægemidler som warfarin, der anvendes til at fortynde blodet).
English: Cholesterol is the sole precursor of bile acids.
Danish: Kolesterol er galdesyrernes eneste prodrom.
English: Hypromellose (E464) Diacetylated monoglycerides
Danish: Hypromellose (E464) Diacetylerede monoglycerider
English: Hypromellose (E464)
Danish: Filmovertræk: hypromellose (E464)
English: Cholestagel tablets should be taken orally with a meal and liquid.
Danish: Cholestageltabletterne skal tages oralt sammen med et måltid og væske.
English: 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.
Danish: 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.
English: The incidence of intestinal obstruction is likely to be increased among patients with a history of bowel obstruction or removal.
Danish: Incidensen af intestinal obstruktion vil sandsynligvis være højere hos patienter, som tidligere har haft tarmobstruktion eller fået fjernet tarm.
English: Description of selected adverse events
Danish: Beskrivelse af udvalgte bivirkninger
English: 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).
Danish: 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.
English: Cellulose (E460), microcrystalline Silica, colloidal anhydrous Magnesium stearate Water, purified
Danish: Cellulose (E460), mikrokrystallinsk Silica, kolloid vandfri Magnesiumstearat Vand, renset
English: 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.
Danish: Samtidig indtagelse af Cholestagel og repaglinid havde ingen effekt på AUC men medførte en 19% reduktion i Cmax af repaglinid.
English: The recommended dose of Cholestagel for combination with a statin with or without ezetimibe is 4 to 6 tablets per day.
Danish: Den anbefalede dosis af Cholestagel i kombination med statin med eller uden ezetimib er 4 til 6 tabletter om dagen.
English: 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%).
Danish: 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 %).
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Bowel or biliary obstruction
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: 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.
Danish: 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.
English: 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.
Danish: Et rottestudie viste ikke i nogen forskelle i parametrene for reproduktion i de grupper, der fik colesevelam.
English: 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.
Danish: 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.
English: Cholestagel contains the active substance colesevelam (as hydrochloride).
Danish: Cholestagel indeholder det aktive stof colesevelam (som hydrochlorid).
English: Package sizes are: 180 tablets (1 X 180)
Danish: Pakningsstørrelser: 180 tabletter (1 X 180)
English: 180 film-coated tablets
Danish: 180 filmovertrukne tabletter.
English: - The active substance is colesevelam (as hydrochloride).
Danish: - Aktivt stof: colesevelam (som hydrochlorid).
English: Caution should be exercised when prescribing to breast-feeding women.
Danish: Der bør udvises forsigtighed ved ordination til kvinder, der ammer.
English: 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.
Danish: 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%.
English: - 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.
Danish: - 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.
English: Colesevelam binds to glimepiride and reduces glimepiride absorption from the gastrointestinal tract.
Danish: Colesevelam binder til glimepirid og reducerer absorption af glimepirid fra mave-tarmkanalen.
English: 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.
Danish: 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.
English: The LDL-C lowering mechanism of bile acid sequestrants has been previously established as follows: As the bile acid pool becomes depleted, the hepatic enzyme, cholesterol 7--hydroxylase, is upregulated, which increases the conversion of cholesterol to bile acids.
Danish: Galdesyre sekvestranternes LDL-C-sænkende mekanisme er tidligere konstateret som følger: Når galdesyredepotet tømmes, reguleres det hepatiske ensym, kolesterol 7-α-hydroxylase, opad, hvilket øger omdannelsen af kolesterol til galdesyrer.
English: High density polyethylene bottles with a polypropylene cap without outer carton.
Danish: Flaske med høj massefylde af polyethylen med polypropylenlåg uden ydre pakning.
English: The recommended dose for Cholestagel, when used with a statin or ezetimibe or both together, is 4 to 6 tablets a day by mouth.
Danish: Den anbefalede dosis af Cholestagel, når det bruges sammen med et statin eller ezetimib eller begge samtidig, er 4 til 6 tabletter gennem munden pr. dag.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator
English: Co-administration of colesevelam and metformin extended-release (ER) tablets increases the exposure of metformin.
Danish: Samtidig administration af colesevelam og metformin depottabletter øger eksponeringen af metformin.
English: In an interaction study in healthy volunteers, Cholestagel reduced the AUC and Cmax of levothyroxine when administered either concomitantly or after 1 hour.
Danish: I et interaktionsstudie med raske frivillige reducerede Cholestagel AUC og Cmax af levothyroxin ved indtagelse enten samtidig eller efter en time.
English: Always take Cholestagel exactly as your doctor or pharmacist has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: During normal digestion, bile acids are secreted into the intestine.
Danish: Under normal fordøjelse afsondres galdesyrerne til tarmene.
English: 6.6 Instructions precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Cholestagel 625 mg film-coated tablets Colesevelam
Danish: Cholestagel 625 mg filmovertrukne tabletter Colesevelam
English: You should take your Cholestagel tablets with food and liquid.
Danish: De skal tage Cholestagel sammen med mad og væske.
English: In an interaction study in healthy volunteers, Cholestagel reduced the Cmax of norethindrone as well as the AUC and Cmax of ethinylestradiol when administered simultaneously with the oral contraceptive pill.
Danish: I et interaktionsstudie med raske frivillige reducerede Cholestagel Cmax af norethindron samt AUC og Cmax af ethinylestradiol ved indtagelse samtidig med orale kontraceptiva.
English: This interaction was also observed when Cholestagel was administered one hour after the oral contraceptive pill.
Danish: Denne interaktion blev også observeret, når Cholestagel blev indtaget en time efter orale kontraceptiva.
English: Tell your doctor if you are breast-feeding.
Danish: Fortæl Deres læge det, hvis De ammer.
English: Not known: Intestinal obstruction*,** Musculoskeletal and connective tissue disorders Uncommon: Myalgia
Danish: Ikke kendt: Intestinal obstruktion*,**
English: The safety of Cholestagel has not been established in breast-feeding women.
Danish: Cholestagels sikkerhed hos kvinder, der ammer, er ikke undersøgt.
English: Uncommon (may affect up to 1 in 100 people): muscle pain, raised levels of liver enzymes in your blood, difficulty in swallowing.
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer): muskelsmerter, forhøjede niveauer af leverenzymer i blodet, synkebesvær.