FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently occurring adverse reactions are flatulence and constipation, found within the gastrointestinal disorders system organ class.
Danish: De hyppigste bivirkninger er flatulens og obstipation - begge inden for systemorganklassen mavetarm-kanalen.
English: Check with your doctor or pharmacist if you are unsure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, De er i tvivl om.
English: It is important that you take olmesartan at least 4 hours before you take Cholestagel.
Danish: Det er vigtigt, at De tager olmesartan mindst 4 timer inden, De tager Cholestagel.
English: Marketing authorisation holder Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Danish: Indehaver af markedsføringstilladelsen Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Holland
English: Prior to initiating therapy with Cholestagel, if secondary causes of hypercholesterolaemia (i.e., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease) are considered, these should be diagnosed and properly treated.
Danish: Hvis der er mistanke om sekundære årsager til hyperkolesterolæmi (f.eks. utilstrækkeligt reguleret diabetes, hypotyroidisme, nefrotisk syndrom, dysproteinæmi, obstruktiv leversygdom), skal disse diagnosticeres og behandles behørigt, før behandling med Cholestagel påbegyndes.
English: It is important that you take glimepiride and glipizide at least 4 hours before you take Cholestagel.
Danish: Det er vigtigt, at De tager glimepirid og glipizid mindst 4 timer inden, De tager Cholestagel.
English: Patients starting on ciclosporin already taking Cholestagel should have their ciclosporin blood concentrations monitored as normal and their dose adjusted as normal.
Danish: Patienter, der starter behandling med ciclosporin, og som allerede får Cholestagel, skal have ciclosporinkoncentrationen i blodet monitoreret som normalt, og dosis skal justeres på normal vis.
English: The addition of Cholestagel 3.8 g daily to maximally-tolerated statin and ezetimibe therapy was assessed in a multi-centre, randomised, double-blind, placebo-controlled study in 86 patients with familial hypercholesterolaemia.
Danish: Tilføjelse af Cholestagel 3,8 g dagligt til den maksimalt tolererede behandling med statin og ezetimibe blev vurderet hos 86 patienter med familiær hyperkolesterolæmi i et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie.
English: 625 mg
Danish: Cholestagel 625 mg
English: Anticoagulant therapy should be monitored closely in patients receiving warfarin or similar agents, since bile acid sequestrants, like Cholestagel, have been shown to reduce absorption of vitamin K and therefore interfere with warfarin's anticoagulant effect (see also section 4.5).
Danish: Antikoagulansbehandling skal overvåges nøje hos patienter, der får warfarin eller lignende præparater, idet det er vist, at galdesyrebindende præparater, såsom Cholestagel, reducerer optagelsen af vitamin K og derfor påvirker warfarins koagulationshæmmende virkning (se også punkt 4.5).
English: No interaction was observed when Cholestagel was administered at least four hours after levothyroxine.
Danish: Der blev ikke observeret interaktion, når Cholestagel blev indtaget mindst fire timer efter levothyroxin.
English: Common: Serum triglycerides increased Uncommon :Serum transaminases increased
Danish: Almindelig: Forhøjede serumtriglyderider.
English: No interaction was observed when Cholestagel was administered one hour after repaglinide.
Danish: Der blev ikke observeret interaktion, når Cholestagel blev indgivet en time efter repaglinid.
English: No interaction was observed when glimepiride was taken at least 4 hours before colesevelam.
Danish: Ingen interaktion blev set, når glimepirid blev taget mindst 4 timer før colesevelam.
English: Anticoagulant therapy should be monitored closely in patients receiving warfarin or similar agents, since bile acid sequestrants, like Cholestagel, have been shown to reduce absorption of vitamin K and therefore interfere with warfarin's anticoagulant effect.
Danish: Antikoagulansbehandling skal overvåges nøje hos patienter, der får warfarin eller tilsvarende præparater, idet det er vist, at galdesyrebindende præparater, såsom Cholestagel, nedsætter absorptionen af vitamin K og derfor påvirker warfarins koagulationshæmmende virkning.
English: Iron oxide black (E172) Hypromellose (E464) Propylene glycol
Danish: Jernoxid sort (E172) Hypromellose (E464) Propylenglycol
English: 100 film-coated tablets
Danish: 100 filmovertrukne tabletter.
English: As described in Section 2, if you will be taking Cholestagel along with another medicine it is possible that your doctor will advise you to take Cholestagel at least 4 hours before or at least 4 hours after taking the other medicine.
Danish: Hvis De tager andre lægemidler sammen med Cholestagel, er det muligt, at Deres læge − som beskrevet i punkt 2 − vil råde Dem til at tage Cholestagel mindst 4 timer før eller mindst 4 timer efter, at De har taget de andre lægemidler.
English: Co-administration of colesevelam and glipizide decreases the exposure of glipizide.
Danish: Samtidig administration af colesevelam og glipizid reducerer eksponeringen af glipizid.
English: Co-administration of Cholestagel and glyburide (also known as glibenclamide) caused a decrease in the AUC0-inf and Cmax of glyburide by 32% and 47%, respectively.
Danish: Samtidig indtagelse af Cholestagel og glibenclamid medførte et fald i AUC0-inf og Cmax af glibenclamid med hhv. 32% og 47%.
English: - Cholestagel may also be used together with ezetimibe (a cholesterol-lowering medicine that works by reducing cholesterol absorption from the gut), with or without a statin.
Danish: - Cholestagel kan også − med eller uden statin − anvendes sammen med ezetimib (et kolesterolsænkende lægemiddel, der virker ved at nedsætte optagelsen af kolesterol fra tarmen).
English: For statin-naïve patients on monotherapy, Cholestagel resulted in a statistically significant LDL-C reduction of 12% at 3.8 g/day and 7% at 1.9 g/day, versus a 1% reduction in the placebo group (see section 4.2).
Danish: Hos patienter, der ikke tidligere havde modtaget behandling med statin, resulterede Cholestagel i en statistisk signifikant LDL-C-reduktion på 12 % ved 3,8 g/dag og 7 % ved 1,9 g/dag versus en reduktion på 1 % i placebogruppen (se pkt.
English: Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam The Netherlands
Danish: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Holland.
English: Patients starting on Cholestagel already taking ciclosporin should have their blood concentrations monitored prior to combination therapy and frequently monitored immediately starting co-therapy with the ciclosporin dose adjusted accordingly.
Danish: Patienter, der starter behandling med Cholestagel, og som allerede får ciclosporin, skal have kontrolleret koncentrationen i blodet inden kombinationsbehandlingen og flere gange umiddelbart efter iværksættelse af den samtidige behandling, og dosis af ciclosporin skal justeres i henhold hertil.
English: How to take Cholestagel
Danish: Sådan skal De tage Cholestagel
English: Puh/Tel: + 358 (0) 201 200 300
Danish: Sanofi Oy Puh/Tel: + 358 (0) 201 200 300
English: Your doctor may tell you to take the Cholestagel dose either once a day or twice a day; in either case Cholestagel should be taken with a meal.
Danish: Deres læge vil muligvis bede Dem om at tage Deres dosis af Cholestagel enten én gang om dagen eller to gange om dagen.
English: The maximum recommended dose is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets taken once per day with a meal.
Danish: Den maksimale anbefalede dosis er 6 tabletter pr. dag doseret som 3 tabletter to gange om dagen sammen med måltider eller 6 tabletter doseret én gang om dagen sammen med ét måltid.
English: High density polyethylene bottles with a polypropylene cap.
Danish: Flaske med høj massefylde af polyethylen med polypropylenlåg med ydre pakning.
English: Sanofi AB
Danish: Sanofi S.p.A.
English: Cholestagel had no effect on the bioavailability of lovastatin in an interaction study.
Danish: Ved et interaktionsstudie havde Cholestagel ingen indvirkning på biotilgængeligheden af lovastatin.
English: However no interaction was observed when Cholestagel was administered four hours after the oral contraceptive pill.
Danish: Der blev dog ikke observeret interaktion, når Cholestagel blev indtaget fire timer efter orale kontraceptiva.
English: Do not break, crush or chew the tablets.
Danish: Tabletterne må ikke deles, knuses eller tygges.
English: Therefore, patients taking both ciclosporin and Cholestagel should have their blood concentrations monitored prior to and frequently after when Cholestagel therapy is stopped with their ciclosporin dose adjusted accordingly.
Danish: Patienter, der får både ciclosporin og Cholestagel, skal derfor have koncentrationen kontrolleret inden og flere gange efter seponering af Cholestagel, og ciclosporindosis skal justeres i henhold hertil.
English: Co-administration of colesevelam and olmesartan decreases the exposure of olmesartan.
Danish: Samtidig administration af colesevelam og olmesartan reducerer eksponeringen af olmesartan.
English: When a drug interaction cannot be excluded with a concomitant medicinal product for which minor variations in the therapeutic level would be clinically important, or where no clinical data are available on co-administration, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication in order to minimize the risk of reduced absorption of the concomitant medication (see section 4.5).
Danish: Når interaktion med et andet lægemiddel, for hvilke mindre variationer i det terapeutiske niveau vil være klinisk vigtige, ikke kan udelukkes, eller når der ikke findes kliniske data vedrørende samtidig indgivelse, skal Cholestagel indtages mindst fire timer før eller mindst fire timer efter det pågældende lægemiddel for at minimere risikoen for nedsat absorption af det andet lægemiddel (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 625 mg colesevelam (as hydrochloride).
Danish: Hver tablet indeholder 625 mg colesevelam (som hydrochlorid).
English: A concomitant increase in very low density lipoprotein synthesis can occur.
Danish: En samtidig stigning i LDL syntesen kan forekomme.
English: The recommended starting dose of Cholestagel is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets once per day with a meal.
Danish: Den anbefalede startdosis for Cholestagel er 6 tabletter pr. dag doseret som 3 tabletter to gange om dagen sammen med måltider eller 6 tabletter én gang om dagen sammen med ét måltid.
English: • Oral contraceptives (medicines to prevent pregnancy) It is important you take Cholestagel at least 4 hours after you take the oral contraceptive to ensure that the effectiveness of the contraceptive is not affected.
Danish: Det er vigtigt, at De tager Cholestagel mindst 4 timer efter orale præventionsmidler for at sikre, at den svangerskabsforebyggende virkning ikke påvirkes.
English: NAME OF THE MEDICINAL PRODUCT Cholestagel 625 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Cholestagel 625 mg filmovertrukne tabletter
English: Cholestagel is not absorbed from the gastrointestinal tract.
Danish: Cholestagel optages ikke fra mavetarmkanalen.
English: 24 tablets
Danish: 24 filmovertrukne tabletter.
English: België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 (0)2 710 54 00
Danish: Sanofi Belgium Tél/Tel: + 32 (0)2 710 54 00
English: Uncommon: Dysphagia
Danish: Ikke almindelig: Myalgi
English: Therefore when a drug interaction cannot be excluded with a concomitant medicinal product for which minor variations in the therapeutic level would be clinically important, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication to minimize the risk of reduced absorption of the concomitant medication.
Danish: Når interaktion med et andet lægemiddel, for hvilke mindre variationer i det terapeutiske niveau vil være klinisk vigtige, ikke kan udelukkes, skal Cholestagel derfor indgives mindst 4 timer før eller mindst 4 timer efter det andet lægemiddel for at minimere risikoen for nedsat absorption af det andet lægemiddel.
English: The recommended dose for Cholestagel is 3 tablets taken twice a day with meals or 6 tablets a day with a meal.
Danish: Den anbefalede dosis for Cholestagel er 3 tabletter to gange om dagen sammen med et måltid eller 6 tabletter om dagen sammen med et måltid.
English: What you need to know before you take Cholestagel
Danish: Det skal De vide, før De begynder at tage Cholestagel Tag ikke Cholestagel:
English: No interaction was observed when Cholestagel was administered four hours after glyburide.
Danish: Der blev ikke observeret interaktion, når Cholestagel blev indtaget fire timer efter glibenclamid.
English: As noted in general, when a drug interaction cannot be excluded with a concomitant medicinal product, Cholestagel should be administered at least four hours before or at least four hours after the concomitant medication to minimise the risk of reduced absorption of the concomitant medication.
Danish: Når interaktion med et andet lægemiddel ikke kan udelukkes, skal Cholestagel − som tidligere beskrevet − indtages mindst fire timer før eller mindst fire timer efter det pågældende lægemiddel for at minimere risikoen for nedsat absorption af det andet lægemiddel.
English: Therefore glimepiride should be administered at least 4 hours prior to colesevelam.
Danish: Glimepirid skal derfor gives mindst 4 timer inden colesevelam.
English: Glipizide should be administered at least 4 hours prior to colesevelam.
Danish: Glipizid skal derfor gives mindst 4 timer inden colesevelam.
English: Cholestagel predominantly binds hydrophobic bile acids.
Danish: Cholestagel binder hovedsagligt hydrofobe galdesyrer.
English: Propylene glycol
Danish: diacetylerede monoglycerider
English: Cholestagel resulted in a statistically significant LDL-C reduction of 11% and 11% at 6 and 12 weeks vs an increase of 7% and 1% in the placebo group; mean baseline levels were 3.75 mmol/L and 3.86 mmol/L, respectively.
Danish: Cholestagel resulterede i en statistisk signifikant LDL-C-reduktion på 11 % og 11 % i uge 6 og 12 versus en stigning på 7 % og 1 % i placebogruppen.
English: Very common (may affect more than 1 in 10 people): flatulence (wind), constipation.
Danish: Følgende bivirkninger er indberettet fra patienter, der har fået Cholestagel: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer): flatulens (luft i maven), forstoppelse.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/268/001-004
Danish: EU/1/03/268/001 24 tabletter EU/1/03/268/002 100 tabletter EU/1/03/268/003 180 tabletter med karton EU/1/03/268/004 180 tabletter uden karton
English: Olmesartan should be administered at least 4 hours prior to colesevelam.
Danish: Olmesartan bør gives mindst 4 timer før colesevelam.
English: * see section below for further information ** adverse reactions from post-marketing experience
Danish: **Bivirkninger efter markedsføring
English: Package sizes are: 24 tablets (1 X 24)
Danish: Pakningsstørrelser: 24 tabletter (1 X 24) 100 tabletter (2 X 50) 180 tabletter (1 X 180)
English: CLINICAL PARTICULARS
Danish: Enkeltstofbehandling
English: What Cholestagel is and what it is used for What you need to know before you take Cholestagel How to take Cholestagel
Danish: Det skal De vide, før De begynder at tage Cholestagel Sådan skal De tage Cholestagel Bivirkninger
English: Constipation
Danish: Amning
English: Breast-feeding
Danish: Colesevelam
English: - The other ingredients (excipients) are:
Danish: Pakningsstørrelser og yderligere oplysninger Cholestagel indeholder:
English: Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
Danish: Τηλ: +30 210 900 16 00
English: If you are taking anticoagulant therapy you should consult with your physician to closely monitor anticoagulation levels, as Cholestagel may affect the absorption of vitamin K and therefore interfere with the activity of warfarin.
Danish: Cholestagel kan påvirke optagelsen af vitamin K og derfor også aktiviteten af warfarin.
English: This percentage may vary according to ethnic background.
Danish: Denne procent kan variere efter etnisk baggrund.
English: Date of first authorisation: 15 January 2001 Date of latest renewal: 15 January 2006
Danish: Dato for første markedsføringstilladelse: 15. januar 2001 Dato for seneste fornyelse: 15. januar 2006
English: Symptomatic and supportive treatment is recommended.
Danish: Symptomatisk og understøttende behandling anbefales.
English: Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
Danish: Lindring af disse symptomer varer en hel dag og hjælper dig til at genoptage dine normale daglige aktiviteter og søvn.
English: It helps control your allergic reaction and its symptoms.
Danish: Det hjælper med at regulere din allergiske reaktion og dens symptomer.
English: Common Common (children less than 2 years) Very rare
Danish: Almindelig Almindelig (børn under 2 år) Meget sjælden
English: ● severe allergic reactions
Danish: • alvorlige allergiske reaktioner
English: Patients should be informed that most people do not experience drowsiness.
Danish: Patienterne skal informeres om, at de fleste mennesker ikke oplever døsighed.
English: Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Danish: Desloratadin er moderat bundet (83 % - 87 %) til plasmaproteiner.
English: The clinical relevance of these observations remains to be confirmed.
Danish: Den kliniske betydning af disse fund skal bekræftes.
English: Children 1 through 5 years of age:
Danish: Børn i alderen 1 til 5 år:
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret således: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000), Meget sjælden (< 1/10.000) og Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Swallow the dose of oral solution and then drink some water.
Danish: Synk dosen af oral opløsning, og drik herefter noget vand.
English: In case an oral measuring syringe is provided with the bottle of oral solution, you can alternatively use it to take the appropriate amount of oral solution.
Danish: I tilfælde af at flasken med oral opløsning er forsynet med en oral målesprøjte, kan du alternativt bruge den til at udtage den passende mængde oral opløsning.
English: Hallucinations Abnormal behaviour, aggression
Danish: Hallucinationer Unormal adfærd, aggression
English: The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded.
Danish: Enzymet, der er ansvarlig for metaboliseringen af desloratadin, er endnu ikke blevet identificeret, og nogle interaktioner med andre lægemidler kan derfor ikke fuldstændigt udelukkes.
English: The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.
Danish: Den største forbedring sås for områderne praktiske problemer og daglige aktiviteter, begrænset af symptomer.
English: ● weight increased, increased appetite
Danish: ● vægtforøgelse, øget appetit
English: However, cases of alcohol intolerance and intoxication have been reported during post-marketing use.
Danish: Der er dog rapporteret tilfælde af alkoholintolerans og alkoholforgiftning i forbindelse med brug efter markedsføring.
English: Desloratadine is the primary active metabolite of loratadine.
Danish: Desloratadin er den primære aktive metabolit af loratadin.
English: Pharmacotherapeutic group: antihistamines - H1 antagonist, ATC code: R06A X27
Danish: Farmakoterapeutisk klassifikation: Antihistaminer - H1 antagonist, ATC-kode: R06A X27
English: Desloratadine does not readily penetrate the central nervous system.
Danish: Desloratadin trænger ikke hurtigt ind i centralnervesystemet.
English: Swallow the tablet whole with water.
Danish: Slug tabletten hel med vand.
English: Treatment with Aerius also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Danish: Behandling med Aerius reducerede også signifikant påvirkningen af søvn og daglig funktionsevne, målt ved en fire-points skala, der anvendtes for at vurdere disse parametre.
English: ● abnormal behaviour
Danish: ● unormal adfærd
English: No serious problems are expected with accidental overdose.
Danish: Ved fejlagtig overdosis forventes ingen alvorlige problemer.
English: For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.
Danish: For nældefeber kan varigheden af behandling variere fra patient til patient, og du skal derfor følge din læges instruktioner.
English: At the recommended dose, this medicine is not expected to affect your ability to drive or use machines.
Danish: Ved den anbefalede dosis forventes dette lægemiddel ikke at påvirke evnen til at køre bil og betjene maskiner.
English: Therefore, caution is recommended if alcohol is taken concomitantly.
Danish: Det anbefales derfor at udvise forsigtighed ved samtidig indtagelse af alkohol.
English: Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
Danish: Fremstiller: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgien.
English: ● changes in the way the heart beats
Danish: ● ændringer i måden hjertet slår
English: Contains mannitol and aspartame.
Danish: Indeholder mannitol og aspartam.
English: There are no known interactions of Aerius with other medicines.
Danish: Der er ingen kendte interaktioner mellem Aerius og andre lægemidler.
English: Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Danish: Desloratadin hæmmer ikke CYP3A4 in vivo, og in vitro studier har vist, at lægemidlet ikke hæmmer CYP2D6 og hverken er et substrat for eller en hæmmer af P-glycoprotein.
English: Aerius effectively controlled symptoms for 24 hours.
Danish: Aerius regulerede effektivt symptomerne i 24 timer.
English: Very rare Not known
Danish: Meget sjælden Ikke kendt
English: The absence of upper respiratory tract infection or structural abnormalities, as well as patient history, physical examinations, and appropriate laboratory and skin tests should be considered.
Danish: Udelukkelse af øvre luftvejsinfektion eller strukturelle abnormaliteter bør, såvel som sygehistorie, fysiske undersøgelser og relevante laboratorie- og hudprøver, tages i betragtning.
English: In the event of overdose, consider standard measures to remove unabsorbed active substance.
Danish: I tilfælde af overdosering, skal standardbehandling til fjernelse af uabsorberet aktiv substans overvejes.
English: Desloratadine has demonstrated antiallergic properties from in vitro studies.
Danish: Desloratadin har vist antiallergiske egenskaber i in vitro studier.
English: In adolescents, headache was the most commonly reported side effect.
Danish: Hovedpine var den hyppigst rapporterede bivirkning hos unge.
English: The presence of food prolongs Tmax for desloratadine from 2.5 to 4 hours and Tmax for 3-OHdesloratadine from 4 to 6 hours.
Danish: Tilstedeværelsen af føde forlænger Tmax for desloratadin fra 2,5 til 4 timer og Tmax for 3-OHdesloratadin fra 4 til 6 timer.
English: The effect of desloratadine on newborns/infants is unknown.
Danish: Virkningen af desloratadin hos nyfødte/spædbørn er ikke kendt.