natgillin/translations-raw huggingface dataset:
1400 patienter blev følgende bivirkninger indberettet hos de patienter, der fik Cholestagel.
In controlled clinical studies involving approximately 1400 patients, the following adverse reactions were reported in patients given Cholestagel.
Indberetningshyppigheden klassificeres som 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), ikke kendt (kan ikke estimeres ud fra forhåndendeværende data).
The reporting rate is classified as very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000), including isolated.
Forhøjet serumtransaminase Nervesystemet Almindelig:
Serum triglycerides increased Uncommon: Serum transaminase increased Nervous system disorders Common:
Hovedpine Mave- tarm- kanalen Meget almindelig:
Headache Gastrointestinal disorders Very common:
Flatulens, obstipation Almindelig:
Flatulence, constipation Common:
Opkastning, diarré, dyspepsi, abdominalsmerte, unormal afføring, kvalme Knogler, led, muskler og bindevæv Ikke almindelig:
Vomiting, diarrhoea, dyspepsia,, abdominal pain, abnormal stools, nausea Musculoskeletal and connective tissue disorders Uncommon:
5 Baggrundsincidensen af flatulens og diarré var højere hos patienter, der fik placebo i de samme kontrollerede undersøgelser.
The background incidence of flatulence and diarrhoea were higher in patients receiving placebo in the same controlled clinical studies.
Bivirkningerne var generelt af mild eller moderat intensitet.
Adverse reactions were generally mild or moderate in intensity.
Cholestagel i kombination med statiner medførte ikke nogen hyppige, uventede bivirkninger sammenlignet med statiner givet alene.
5 Cholestagel in combination with statins did not result in any frequent unexpected adverse reactions compared with statins alone.
Doser på over den maksimale anbefalede dosis (4, 5 g pr. dag [7 tabletter]) er ikke afprøvet.
Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been tested.
Farmakoterapeutisk klassifikation: galdesyrebindende midler, ATC- kode:
Pharmacotherapeutic group: bile acid sequestrants, ATC code:
Virkningsmekanismen for colesevelam, det aktive stof i Cholestagel, er vurderet i flere in vitro og in vivo undersøgelser.
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.
Disse undersøgelser 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.
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.
Galdesyre sekvestranternes LDL- C- sænkende mekanisme er tidligere konstateret som følger:
The LDL-C lowering mechanism of bile acid sequestrants has been previously established as follows:
Når galdesyredepotet tømmes, reguleres det hepatiske ensym, kolesterol 7- α - hydroxylase, opad, hvilket øger omdannelsen af kolesterol til galdesyrer.
As the bile acid pool becomes depleted, the hepatic enzyme, cholesterol 7-α -hydroxylase, is upregulated, which increases the conversion of cholesterol to bile acids.
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- glutaryl- coenzym 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.
En samtidig stigning i very low- density lipoprotein syntesen kan forekomme.
A concomitant increase in very low density lipoprotein synthesis can occur.
Disse kompenserende virkninger medfører øget clearance af LDL- C fra blodet, hvilket medfører faldende LDL- C- niveauer i serum.
These compensatory effects result in increased clearance of LDL-C from the blood, resulting in decreased serum LDL-C levels.
I en 6- måneders undersøgelse af dosisrespons hos patienter med primær hyperkolesterolæmi, der modtog 3, 8 eller 4, 5 g Cholestagel, 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, a 15 to 18% decrease in LDL-C levels was observed, which was evident within 2 weeks of administration.
Desuden faldt total- C 7 til 10%, HDL- C steg 3% og triglycerider steg 9 til 10%.
In addition, total-C decreased 7 to 10%, HDL-C increased 3% and triglycerides increased 9 to 10%.
Apo- B faldt med 12%.
Apo B decreased by 12%.
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%.
Undersøgelser, der undersøgte indtagelse af Cholestagel som en enkelt dosis sammen med morgenmaden, en enkelt dosis sammen med aftensmaden, eller som delte doser sammen med morgenmad og aftensmad, viste ikke signifikante forskelle i LDL- C reduktionen for de forskellige doseringsplaner.
Studies examining administration of Cholestagel as a single dose with breakfast, a single dose with dinner, or as divided doses with breakfast and dinner did not show significant differences in LDL-C reduction for different dosing schedules.
I én undersøgelse var der imidlertid en tendens til, at triglycerider steg mere, når Cholestagel blev givet som en enkelt dosis sammen med morgenmaden.
However, in one study triglycerides tended to increased more when Cholestagel was given as a single dose with breakfast.
Randomiserede, dobbeltblindede, placebokontrollerede multicenterundersøgelser 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.
Iværksættelse af yderligere behandling med Cholestagel efter behandling med et statin er ikke undersøgt specifikt.
Initiation of add-on treatment with Cholestagel subsequent to statin therapy has not been specifically studied.
Cholestagel er ikke sammenlignet direkte med andre galdesyre sekvestranter i kliniske undersøgelser.
Cholestagel has not been compared directly to other bile acid sequestrants in clinical trials.
6 I en 6- ugers undersøgelse blev 129 patienter med forskellige former af hyperlipidæmi randomiseret til fenofibrat 160 mg plus 3, 8 g Cholestagel eller kun fenofibrat alene.
The fenofibrate plus Cholestagel group (64 patients)
Gruppen med fenofibrat og Cholestagel (64 patienter) udviste et 10% fald i LDL- C- niveauer kontra en 2% stigning i fenofibrat - gruppen (65 patienter).
6 demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group (65 patients).
Der blev også set fald i non- HDL- C, total- C og Apo B.
Reductions were also seen for non-HDL-C, Total-C and Apo B.
En lille 5% ikke - signifikant stigning i triglycerider blev observeret.
A small 5%, non-significant increase in triglycerides was noted.
Effekten af kombinationen af fenofibrat og Cholestagel på risikoen for myopati og hepatotoksititet er ikke kendt.
The effects of combination of fenofibrate and Cholestagel on the risks of myopathy or hepatotoxicity are not known.
5. 2 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Effekt i non- kliniske undersøgelser er kun set med doser, der i væsentlig grad anses for at overstige den maksimale humane dosis, hvilket indikerer ringe relevans for den kliniske brug.
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.
Cellulose (E460), mikrokrystallinsk Silika, kolloid vandfri Magnesiumstearat Vand, renset
Cellulose (E460), microcrystalline Silica, colloidal anhydrous Magnesium stearate Water, purified
7 6. 5 Emballagetype og pakningsstørrelse
6.5 Nature and contents of container
24 tabletter (1 X 24) 100 tabletter (2 X 50) 180 tabletter (1 X 180)
24 tablets (1 X 24) 100 tablets (2 X 50) 180 tablets (1 X 180)
Flaske med høj massefylde af polyethylen med polypropylenlåg uden ydre pakning.
7 High density polyethylene bottles with a polypropylene cap without outer carton.
6. 6 Regler for destruktion og anden håndtering
6.6 Instructions precautions for disposal and other handling
Genzyme Europe B. V., Gooimeer 10, NL- 1411 DD Naarden, Holland.
Genzyme Europe B. V., Gooimeer 10, NL-1411 DD Naarden, The Netherlands.
EU/ 1/ 3/ 268/ 001- 004
EU/ 1/ 03/ 268/ 001-004
Detaljerede oplysninger om dette produkt er tilgængelige på det europæiske lægemiddelagenturs hjemmeside (EMEA) http: // www. emea. europa. eu / U
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
BILAG II
8 ANNEX II
FREMSTILLER( E) AF DET( DE) BIOLOGISK AKTIVE STOF( FER) OG FREMSTILLER( E) ANSVARLIG FOR BATCHFRIGIVELSE
Α MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
FREMSTILLER/ FREMSTILLERE AF DET( DE) BIOLOGISK AKTIVE STOF( FER) OG FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
9 A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Navn og adresse på fremstilleren (fremstillerne) ansvarlig( e) for batchfrigivelse U
Name and address of the manufacturer(s) responsible for batch release
Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
YDRE EMBALLAGE OG FLASKEETIKET (24 TABLETTER)
OUTER CARTON AND BOTTLE LABEL (24 TABLETS)
Cholestagel 625 mg filmovertrukne tabletter Colesevelam hydroklorid
Cholestagel 625 mg film-coated tablets Colesevelam hydrochloride
ANVENDELSESMÅDE OG INDTAGELSESVEJ( E)
METHOD AND ROUTE(S) OF ADMINISTRATION
Tabletterne skal tages med væske og sammen med et måltid.
Oral use Tablets should be taken with liquid and with a meal.
Gooimeer 10 1411 DD Naarden Holland
Gooimeer 10 1411 DD Naarden The Netherlands
14 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE YDRE EMBALLAGE OG FLASKEETIKET (100 TABLETTER)
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Cholestagel 625 mg filmovertrukne tabletter Colesevelam hydroklorid.
Cholestagel 625 mg film-coated tablets Colesevelam hydrochloride
16 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
YDRE EMBALLAGE OG FLASKEETIKET (180 TABLETTER)
OUTER CARTON AND BOTTLE LABEL (180 TABLETS)
18 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
FLASKEETIKET 180 TABLETTER) UDEN YDRE PAKNING
BOTTLE LABEL (180 TABLETS) WITHOUT CARTON
Læs hele denne indlægsseddel grundigt, inden De begynder at tage medicinen.
Read all of this leaflet carefully before you start using this medicine.
- Lægen har ordineret Cholestagel til Dem personligt.
- This medicine has been prescribed for you.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Virkning og anvendelse 2.
What Cholestagel is and what it is used for 2.
Det skal De vide, før De begynder at tage Cholestagel 3.
Before you take Cholestagel 3.
Sådan skal De tager Cholestagel 4.
How to take Cholestagel 4.
Opbevaring 6.
How to store Cholestagel 6.
VIRKNING OG ANVENDELSE
WHAT CHOLESTAGEL IS AND WHAT IT IS USED FOR
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.
Cholestagel ordineres til behandling af en tilstand, der kaldes isoleret primær hyperkolesterolæmi (når kolesteroltallet i blodet er for højt).
Cholestagel is prescribed to treat a condition known as isolated primary hypercholesterolaemia (when cholesterol in the blood is elevated).
- Cholestagel kan ordineres alene sammen med en diæt, der er fedt - og kolesterolfattig, når
- Cholestagel may be prescribed on its own in addition to a diet low in fat and cholesterol when
behandling med et statin (en type kolesterolsænkende medicin, der virker i leveren) er uhensigtsmæssigt eller ikke tåles godt.
treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inappropriate or not well tolerated.
- Cholestagel kan anvendes sammen med et statin og den fedt - og kolesterolfattige diæt, når
- Cholestagel may be used together with a statin and the diet low in fat and cholesterol when patients
patienterne ikke behandles hensigtsmæssigt med statin alene.
are not appropriately controlled by the statin on its own.
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE CHOLESTAGEL
BEFORE YOU TAKE CHOLESTAGEL
Tag ikke Cholestagel
Do not take Cholestagel
- hvis De er allergisk (overfølsom) over for colesevelam eller et af de øvrige indholdsstoffer i
- if you are allergic (hypersensitive) to colesevelam or to any of the other ingredients of Cholestagel
- hvis De har en blokering i tarmene eller galdegangene
- if you have a blockage in your intestines or bile ducts (tubes that carry bile)
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 medication together you must also read the patient information leaflet that comes with that particular medicine before you start to take your medicine.
22 Vær særlig forsigtig med at tage Cholestagel
22 Take special care with Cholestagel
- hvis Deres triglyceridniveauer (et fedtstof i blodet) er større end 3, 4 mmol/ l
- if your triglyceride levels (a blood fat) are greater than 3.4 mmol/ l
- hvis De har problemer med at synke eller har en alvorlig mave - eller tarmsygdom
- if you have difficulty in swallowing, or have a major stomach or intestinal disorder
- hvis De tager medicin, der indeholder ciclosporin (et lægemiddel, der bruges til undertrykkelse af
- if you are taking another medication called ciclosporin (a medicine used to suppress the immune
immunsystemet)
system)
- hvis De tager oral prævention på samme tid eller en time inden Cholestagel, da det kan påvirke
- when taking the oral contraceptive pill at the same time or an hour before Cholestagel as it can
præventionsmidlets effekt.
affect the effectiveness of the contraceptive.
- hvis De får koagulationshæmmende medicin, skal De aftale med Deres læge, at Deres
- if you are taking anticoagulant therapy you should consult with your physician to closely monitor
antikoagulationsniveauer kontrolleres nøje, da Cholestagel kan påvirke optagelsen af vitamin K og derfor kan have indflydelse på warfarins virkning (et lægemiddel, der anvendes til at fortynde blodet).
anticoagulation levels, as Cholestagel may affect the absorption of vitamin K and therefore interfere with the activity of warfarin, a medicine used to thin blood.
- hvis De lider af forstoppelse, da Cholestagel kan fremkalde eller forværre denne tilstand.
- if you suffer from constipation, as Cholestagel may induce or worsen this condition.
især vigtigt for patienter med koronar hjertesygdom og angina pectoris.
especially important for patients with coronary heart disease and angina pectoris
Cholestagel anbefales ikke til anvendelse til børn og unge, da sikkerheden og effekten ved anvendelse til disse patienter ikke er fastlagt.
Cholestagel is not recommended for use in children and adolescents since its safety and efficacy have not been determined in these patients.
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 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 after taking the other medication.
Det er vigtigt, at De tager Cholestagel mindst 4 timer efter orale præventionsmidler, for at sikre at den svangerskabsforebyggende virkning ikke påvirkes. • Verapamil (et lægemiddel, der anvendes til behandling af for højt blodtryk) • Antidiabetika (medicin såsom pioglitazon, repaglinid eller glyburid, der anvendes til behandling af diabetes) • Antiepileptika (medicin såsom phenytoin, der anvendes til behandling af epilepsi). • Ciclosporin (et lægemiddel, der bruges til undertrykkelse af immunsystemet).
Cholestagel may affect the way in which the following medicines work: • Anticoagulant therapy (medicines, such as warfarin, used to thin blood) • Thyroid replacement therapy (medicines, such as thyroxine or levothyroxine, used to treat low thyroid hormone levels) • 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. • Verapamil (a medicine used to treat high blood pressure) • Antidiabetic medications (medicines, such as pioglitazone, repaglinide or glyburide used to treat diabetes) • Anti-epileptic medicines (medicines, such as phenytoin, used to treat epilepsy). • Ciclosporin (a medicine used to suppress the immune system).
23 Brug af Cholestagel sammen med mad og drikke De skal tage Deres Cholestagel tabletter sammen med mad og væske.
Taking Cholestagel with food and drink You should take your Cholestagel tablets with food and liquid.
Graviditet og amning Fortæl Deres læge det, hvis De er eller ønsker at blive gravid.
23 Pregnancy and breast-feeding Tell your doctor if you are pregnant or want to become pregnant.
Trafik - og arbejdssikkerhed Deres evne til at køre bil og betjene maskiner påvirkes ikke af, at De tager Cholestagel tabletter.
Driving and using machines Your ability to drive or operate machines is not affected by taking Cholestagel tablets.
SÅDAN SKAL DE TAGE CHOLESTAGEL
HOW TO TAKE CHOLESTAGEL
Cholestagel bør altid tages i nøje overensstemmelse med lægens instruktioner.
Always take Cholestagel exactly as your doctor has instructed you.
Som beskrevet i punkt 2 er det, hvis De tager andre lægemidler sammen med Cholestagel, muligt, at Deres læge vil råde Dem til at tage sådanne andre lægemidler mindst 1 time før eller mindst 4 timer efter at De har taget Cholestagel.
As described in Section 2, if you will be taking another medicine along with Cholestagel it is possible that your doctor will advise you to take this other medicine at least 1 hour prior to or at least 4 hours after taking Cholestagel.
Kombinationsbehandling:
Combination therapy:
I begge tilfælde skal Cholestagel tages sammen med et måltid.
The usual dose for Cholestagel, when used with a statin, is 4 to 6 tablets a day by mouth.
Doseringen af statinet skal følge anvisningerne for det pågældende statin.
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. The dosing of the statin should follow the instructions for that particular statin.
De to lægemidler kan tages samtidig eller hver for sig, afhængig af lægens ordination.
The two medicines may be taken at the same time or at separate times according to what your doctor has prescribed.
Enkeltstofbehandling:
Monotherapy:
Den normale dosis for Cholestagel er 3 tabletter to gange om dagen sammen med et måltid eller 6 tabletter om dagen sammen med et måltid.
The usual dose for Cholestagel is 3 tablets taken twice a day with meals or 6 tablets a day with a meal.
Hvis De har taget for meget Cholestagel Kontakt Deres læge.
If you take more Cholestagel than you should Please contact your doctor.
Hvis De har glemt at tage Cholestagel De kan tage Deres dosis sammen med et senere måltid, men De må aldrig på én dag tage mere end det samlede antal tabletter, som Deres læge har ordineret til Dem.
If you forget to take Cholestagel You may take your dose with a later meal, but never take in one day more than the total number of tablets that your doctor has prescribed to you in a single day.
Hvis De holder op med at tage Cholestagel 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.
Spørg lægen eller på apoteket, hvis De har yderligere spørgsmål til brugen af produktet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Cholestagel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Cholestagel can cause side effects, although not everybody gets them.
Meget almindelige (forekommer hos flere end 1 ud af 10 brugere): flatulens (luft i maven), forstoppelse.
Very common (affects more than 1 user in 10): flatulence (wind), constipation.
24 Almindelige (forekommer hos mellem 1 og 10 brugere ud af 100): opkastning, diarré, fordøjelsesbesvær, mavesmerter, unormal afføring, kvalme, hovedpine, forhøjede niveauer af triglycerider (fedtstoffer) i blodet.
24 Common (affects 1 to 10 users in 100): vomiting, diarrhoea, indigestion, abdominal pain, abnormal stools, feeling sick, headache, raised levels of triglycerides (fats) in your blood.
Ikke almindelige (forekommer hos mellem 1 og 10 brugere ud af 1. 000): muskelsmerter, forhøjede niveauer af leverenzymer i blodet.
Uncommon (affects 1 to 10 users in 1,000): muscle pain, raised levels of liver enzymes in your blood.
Patienter, der fik Cholestagel i kliniske undersøgelser, havde mindre tendens til flatulens (luft i maven) og diarré end patienter, som fik placebo (inaktiv tablet).
Patients receiving Cholestagel in clinical studies were less likely to suffer flatulence (wind) and diarrhoea as patients receiving placebo (inactive tablet).
Kun forstoppelse og fordøjelsesbesvær blev indberettet hyppigere hos de patienter, der fik Cholestagel.
Only constipation and indigestion were reported in higher numbers among those patients receiving Cholestagel.
Alle bivirkninger var normalt milde eller moderate i intensitet.
All side effects were usually mild or moderate in intensity.
OPBEVARING
HOW TO STORE CHOLESTAGEL
Må ikke anvendes efter den udløbsdato, der er angivet på kartonen og flaskeetiketten efter “ EXP ’’
Do not use after the expiry date which is stated on the carton and bottle label after “ EXP’’
Cholestagel indeholder
What Cholestagel contains
- Det aktive stof er colesevelam hydroklorid.
- The active substance is colesevelam hydrochloride.
Hver tablet indeholder 625 mg colesevelam
Each tablet contains 625 mg colesevelam
hydroklorid.
hydrochloride.
- Tabletkerne:
- Tablet core:
- mikrokrystallinsk cellulose (E460)
- Microcrystalline cellulose (E460)
- kolloid vandfri silica
- Silica colloidal anhydrous
- magnesiumstearat
- Magnesium stearate
- renset vand
- Purified water
- Filmovertræk:
- Film-coating:
- hypromellose (E464)
- Hypromellose (E464)
- diacetylerede monoglycerider
- Diacetylated monoglycerides
- Tryk:
- Printing ink:
- jernoxid, sort (E172)
- Iron oxide black (E172)
- propylenglycol
- Propylene glycol