natgillin/translations-raw huggingface dataset:
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%).
Pri pediatrični populaciji so varnost in učinkovitost odmerkov zdravila Cholestagel 1,9 oz. 3,8 g/dan ocenjevali v 8-tedenski multicentrični, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 194 fantih in dekletih po menarhi, starih od 10 do 17 let, s heterozigotno družinsko hiperholesterolemijo, ki so prejemali stabilen odmerek statinov (47 bolnikov, 24 %) ali se še niso zdravili z zdravili za nižanje ravni lipidov (147 bolnikov, 76 %).
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.
Poleg tega pa se na osnovi teoretičnih razprav priporoča jemanje zdravila Cholestagel najmanj 4 ure po vzetju ciklosporina, da bi še dodatno zmanjšali tveganja povezana s sočasno uporabo ciklosporina in zdravila Cholestagel.
Very common: Flatulence*, constipation* Common: Vomiting, diarrhoea*, dyspepsia*, abdominal pain, abnormal stools, nausea, abdominal distension
Zelo pogosto: flatulenca*, obstipacija* Pogosto: bruhanje, diareja*, dispepsija*,bolečine v trebuhu, nenormalno blato, navzea, abdominalna distenzija Občasno: disfagija
• Anticoagulant therapy (medicines, such as warfarin, used to thin blood).
• zdravljenje z antikoagulanti (zdravila, kot je varfarin, ki se uporablja za redčenje krvi).
The dosing of the statin and the ezetimibe should follow the instructions for that particular medicine.
Pri odmerjanju statina in ezetimiba morate upoštevati navodila za uporabo posameznega zdravila.
It should be noted that stopping Cholestagel therapy will result in increased ciclosporin blood concentrations.
Upoštevajte, da bo prenehanje zdravljenja z zdravilom Cholestagel zvišalo vrednosti ciklosporina v krvi.
Taking Cholestagel helps to lower the level of cholesterol in your blood.
Jemanje zdravila Cholestagel vam pomaga znižati koncentracijo holesterola v krvi.
Package sizes are: 180 tablets (1 X 180)
Velikosti pakiranj: 180 tablet (1 x 180)
The incidence of intestinal obstruction is likely to be increased among patients with a history of bowel obstruction or removal.
Pojavnost intestinalne obstrukcije bo verjetno višja med bolniki, ki so v preteklosti že imeli črevesno obstrukcijo ali jim je bil odstranjen del črevesja.
What Cholestagel looks like and contents of the pack
Izgled zdravila Cholestagel in vsebina pakiranja
Co-administration of colesevelam and metformin extended-release (ER) tablets increases the exposure of metformin.
Sočasno jemanje holesevelama in metformina v obliki tablet s podaljšanim sproščanjem (extended-release ER) poveča izpostavljenost metforminu.
• Ursodeoxycholic acid (a medicine used to dissolve gallstones or treat specific chronic liver diseases).
• ursodeoksiholna kislina (zdravilo za raztapljanje žolčnih kamnov ali zdravljenje specifičnih kroničnih bolezni jeter).
Your doctor should only give you Cholestagel if a diet low in fat and cholesterol did not work well enough on its own.
Zdravnik vam bo predpisal Cholestagel le, če sama dieta z malo maščob in holesterola ni bila dovolj učinkovita.
In comparison, in patients given placebo, LDL-C, Total-C, HDL-C and Apo-B were unchanged, while triglycerides increased 5%.
Pri bolnikih, ki so prejemali placebo, se koncentracije holesterola LDL, celokupnega holesterola, holesterola HDL in Apo B niso spremenile, medtem ko se je koncentracija trigliceridov povečala za 5 %.
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.
Sočasno jemanje zdravil Cholestagel in gliburid (znano tudi kot glibenklamid) je povzročilo znižanje vrednosti AUC0-inf gliburida za 32 % in vrednosti Cmax gliburida za 47 %.
If you are taking medicines for diabetes, you should consult with your physician so that you can be closely monitored.
Če jemljete antidiabetična zdravila, to povejte zdravniku, da vas lahko redno nadzira.
- 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.
- Zdravilo Cholestagel se lahko uporablja tudi skupaj z ezetimibom (zdravilom za zniževanje koncentracije holesterola, ki deluje tako, da zmanjšuje absorpcijo holesterola iz prebavil) s statinom ali brez njega.
Cholestagel decreased the Cmax and AUC of sustained-release verapamil by approximately 31% and 11%, respectively.
Cholestagel je pri verapamilu s podaljšanim sproščanjem zmanjšal cmax za približno 31 % in AUC za približno 11 %.
• Thyroid replacement therapy (medicines, such as thyroxine or levothyroxine, used to treat low thyroid hormone levels)
• zdravljenje z nadomeščanjem hormona ščitnice (zdravila, kot je tiroksin ali levotiroksin, ki se uporablja za zdravljenje nizkih koncentracij hormona ščitnice),
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.
Če so vam skupaj predpisali zdravilo Cholestagel in katerokoli drugo zdravilo, morate pred začetkom jemanja zdravila prebrati tudi navodilo za uporabo tega drugega zdravila.
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.
Če prejemate antikoagulantno zdravljenje, se morate posvetovati s svojim zdravnikom, da bo skrbno spremljal antikoagulacijske vrednosti, saj lahko zdravilo Cholestagel vpliva na absorpcijo vitamina K in zaradi tega ovira delovanje varfarina.
NAME OF THE MEDICINAL PRODUCT Cholestagel 625 mg film-coated tablets
IME ZDRAVILA Cholestagel 625 mg filmsko obložene tablete
Combination therapy:
Kombinirano zdravljenje:
During therapy, the cholesterol-lowering diet should be continued, and serum total-C, LDL-C and triglyceride levels should be determined periodically during treatment to confirm favourable initial and adequate long-term responses.
Med zdravljenjem mora bolnik nadaljevati z dieto za zniževanje holesterola, občasno pa morajo biti določene koncentracije celokupnega holesterola (total-C), holesterola LDL (LDL-C) in trigliceridov, da bi potrdili ugodne začetne in ustrezne dolgoročne odzive.
OUTER CARTON AND BOTTLE LABEL (24, 100 AND 180 TABLETS) WITH CARTON BOTTLE LABEL (180 TABLETS) WITHOUT CARTON
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI NALEPKA NA ŠKATLI IN PLASTENKI (24, 100 IN 180 TABLET) Z NALEPKO NA PLASTENKI (180 TABLET) BREZ ŠKATLE
If you take more Cholestagel than you should Please contact your doctor.
Če ste vzeli večji odmerek zdravila Cholestagel, kot bi smeli Obvestite svojega zdravnika.
Iron oxide black (E172) Hypromellose (E464) Propylene glycol
Črnilo za tisk: črni železov oksid (E172) hipromeloza (E464) propilenglikol
PHARMACEUTICAL FORM AND CONTENTS 24 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 24 filmsko obloženih tablet 100 filmsko obloženih tablet 180 filmsko obloženih tablet
The recommended dose for Cholestagel, when used with a statin or ezetimibe or both together, is 4 to 6 tablets a day by mouth.
Priporočeni odmerek zdravila Cholestagel, ko ga jemljete skupaj s statinom ali ezetimibom ali obema skupaj, je 4 do 6 tablet dnevno, ki jih zaužijete skozi usta.
Colesevelam binds to glimepiride and reduces glimepiride absorption from the gastrointestinal tract.
Holesevelam veže glimepirid in zmanjša absorbcijo glimepirida iz prebavil.
Hypromellose (E464) Diacetylated monoglycerides
Filmska obloga: hipromeloza (E464) diacetilirani monogliceridi
When Cholestagel was co-administered with statins in clinical studies, an expected add-on LDL-C lowering effect was observed, and no unexpected effects were observed.
Pri sočasni uporabi zdravila Cholestagel in statinov v kliničnih študijah so opazili pričakovan skupni učinek zniževanja koncentracije holesterola LDL (LDL-C), nepričakovanih učinkov pa niso opazili.
Caution should be exercised when prescribing to breast-feeding women.
Pri predpisovanju zdravila ženskam, ki dojijo, je potrebna previdnost.
Therefore, Cholestagel is not recommended for use in this population.
Zato jemanje zdravila Cholestagel v tej populaciji ni priporočljivo.
Caution should be exercised when treating patients with triglyceride levels greater than 3.4 mmol/L due to the triglyceride increasing effect with Cholestagel.
Posebno morate biti pozorni pri zdravljenju bolnikov, ki imajo koncentracije trigliceridov nad 3,4 mmol/L, kajti Cholestagel povečuje koncentracije trigliceridov.
Patients receiving concomitant metformin ER and colesevelam should be monitored for clinical response as is usual for the use of anti-diabetes drugs.
Bolnike, ki sočasno jemljejo metformin ER in holesevelam, je potrebno klinično nadzirati, kot je to običajno pri anti-diabetični terapiji.
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.
Če bo zdravnik menil, da zdravilo Cholestagel lahko vpliva na absorpcijo drugega zdravila, vam bo morda svetoval, da zdravilo Cholestagel jemljete vsaj 4 ure pred ali vsaj 4 ure po jemanju drugega zdravila.
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.
Če predvidevate sekundarne vzroke hiperholesterolemije (npr. slabo nadzorovan diabetes mellitus, hipotiroidizem, nefrotski sindrom, disproteinemije, obstruktivna jetrna bolezen), morate pred začetkom zdravljenja z zdravilom Cholestagel določiti diagnozo in jih ustrezno zdraviti.
Cholestagel is prescribed to treat a condition known as primary hypercholesterolaemia (when cholesterol in the blood is elevated) in adults.
Zdravilo Cholestagel se predpisuje za zdravljenje bolezni, ki ji rečemo primarna hiperholesterolemija (nenormalno zvišana koncentracija holesterola v krvi) pri odraslih.
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.
Koncentracija trigliceridov se je pri bolnikih, ki so prejemali Cholestagel, po 6 tednih zvišala za 19 %, po 12 tednih pa za 13 %, v placebo skupini pa se je koncentracija trigliceridov po 6 tednih zvišala za 6 %, po 12 tednih pa za 13 %, vendar zvišanje ni bilo pomembno različno.
The recommended dose of Cholestagel for combination with a statin with or without ezetimibe is 4 to 6 tablets per day.
Priporočeni odmerek zdravila Cholestagel v kombinaciji s statinom z ezetimibom ali brez njega je od 4 do 6 tablet dnevno.
You should take your Cholestagel tablets with food and liquid.
Tablete Cholestagel morate jemati s hrano in tekočino.
Tablets should be taken with liquid and with a meal.
Tablete morate jemati s tekočino in ob obroku.
Each tablet contains 625 mg colesevelam.
Ena tableta vsebuje 625 mg holesevelama.
Before starting therapy with Cholestagel, you should be advised to follow a cholesterol-lowering diet and you should continue this diet during treatment.
Pred začetkom zdravljenja z zdravilom Cholestagel vam morajo predpisati dieto za znižanje koncentracije holesterola, ki jo morate nadaljevati med zdravljenjem.
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.
Zdravilo Cholestagel kot monoterapija je indicirano kot dodatno zdravljenje ob dieti za zniževanje zvišanega celokupnega holesterola in holesterola LDL (LDL-C) pri odraslih bolnikih s primarno hiperholesterolemijo, za katere se smatra, da statin ni ustrezen ali ga slabo prenašajo.
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.
V klinični raziskavi medsebojnega delovanja pri zdravih prostovoljcih je sočasno jemanje zdravila Cholestagel in ciklosporina znatno znižalo vrednosti AUC0-inf ciklosporina za 34% in vrednosti Cmax ciklosporina za 44%.
The most frequently occurring adverse reactions are flatulence and constipation, found within the gastrointestinal disorders system organ class.
Neželena učinka, o katerih so poročali najpogosteje sta flatulenca in obstipacija, ki po klasifikaciji spadata v organski sistem bolezni prebavil.
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.
V šestmesečni študiji odzivnosti na odmerke pri bolnikih s primarno hiperholesterolemijo, ki so dnevno prejemali 3,8 ali 4,5 g zdravila Cholestagel, so v prvih dveh tednih opazili od 15 do 18 % znižanje koncentracije holesterola LDL.
In addition, Total-C decreased 7 to 10%, HDL-C increased 3% and triglycerides increased 9 to 10%.
10 %, koncentracija holesterola HDL se je zvišala za 3 %, koncentracija trigliceridov pa za 9 do 10 %.
Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract.
Ob morebitnem prevelikem odmerjanju bi bila osnovna potencialna težava obstrukcija prebavil.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 625 mg colesevelam (as hydrochloride).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka tableta vsebuje 625 mg holesevelama (v obliki holesevelamijevega klorida).
High density polyethylene bottles with a polypropylene cap without outer carton.
Plastenke iz polietilena visoke gostote s pokrovom iz polipropilena brez zunanje ovojnine.
Antidiabetic agents
Antidiabetična zdravila
Your liver uses cholesterol from your blood to do this, which lowers the level of cholesterol in your blood.
Za to jetra uporabijo holesterol iz krvi, kar znižuje njegovo koncentracijo v krvi.
• Anti-epileptic medicines (medicines, such as phenytoin, used to treat epilepsy).
• antiepileptična zdravila (zdravila za zdravljenje epilepsije, kot je fenitoin),
Ursodeoxycholic acid
Ursodeoksiholna kislina
The fenofibrate plus Cholestagel group (64 patients) demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group
V skupini, ki je jemala fenofibrat in zdravilo Cholestagel (64 bolnikov), je prišlo do 10 % znižanja ravni holesterola LDL v primerjavi z 2 % zvišanjem v skupini, ki je jemala samo fenofibrat (65 bolnikov).
Cholestagel tablets are off-white, capsule-shaped film-coated tablets and imprinted with ‘C625' on one side.
Tablete Cholestagel so sivobele filmsko obložene tablete v obliki kapsul z napisom "C625" na eni strani.
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.
Zdravilo Cholestagel, uporabljeno sočasno z inhibitorjem 3-hidroksi-3-metilglutaril-koencim A (HMG-CoA) reduktazo (statinom), je indicirano kot dodatno zdravljenje ob dieti za dodatno zniževanje koncentracije holesterola z lipoproteini nizke gostote (LDL-C) pri odraslih bolnikih s primarno hiperholesterolemijo, pri katerih zgolj statin ni dovolj učinkovit.
Microcrystalline cellulose (E460) Silica colloidal anhydrous Magnesium stearate Purified water
Jedro tablete: mikrokristalna celuloza (E460) brezvodni koloidni silicijev dioksid magnezijev stearat prečiščena voda
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.
S kombinacijo 10 mg ezetimiba in 3,8 g zdravila Cholestagel dnevno brez statina so dosegli statistično pomemben kombiniran učinek znižanja koncentracije holesterola LDL za 32 %, kar pomeni, da je kombinacija zdravila Cholestagel in ezetimiba dodatno znižala koncentracijo holesterola LDL za 11 % v primerjavi z ezetimibom samim.
If you stop taking Cholestagel Your cholesterol may increase to the level it was before treatment was started.
Koncentracija holesterola se lahko dvigne do koncentracije, kakršno ste imeli pred začetkom zdravljenja.
Do not take Cholestagel: - if you are allergic to colesevelam or to any of the other ingredients of this medicine (listed in section 6) - if you have a blockage in your intestines or bile ducts (tubes that carry bile)
Kaj morate vedeti, preden boste vzeli zdravilo Cholestagel Ne jemljite zdravila Cholestagel - če ste alergični na holesevelam ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če imate zaporo v črevesju ali žolčevodih (vodi za izločanje žolča).
This prevents your body from recycling the bile acids from your intestines in the usual way.
To telesu preprečuje običajno ponovno uporabo žolčnih kislin iz črevesja.
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.
V študiji o medsebojnem delovanju pri zdravih prostovoljcih je zdravilo Cholestagel znižalo vrednosti Cmax noretindrona ter vrednosti AUC in Cmax etinilestradiola ob sočasnem jemanju s peroralno kontracepcijsko tabletko.
How to take Cholestagel
Kako jemati zdravilo Cholestagel
Cholestagel is not absorbed from the gastrointestinal tract.
Cholestagel se ne absorbira iz prebavil.
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.
Mehanizem nižanja koncentracije holesterola LDL absorbentov žolčnih kislin deluje na naslednji način: Ko začne zmanjkovati žolčnih kislin, se poveča delovanje jetrnega encima holesterol 7--hidroksilaze, kar poveča pretvorbo holesterola v žolčne kisline.
MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands.
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska.
- 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.
- Zdravilo Cholestagel se lahko predpiše samostojno, poleg diete z nizko vsebnostjo maščob in holesterola, kadar zdravljenje s statinom (vrsta zdravil za zniževanje koncentracije holesterola, ki delujejo v jetrih) ni ustrezno ali če ga bolniki ne prenašajo dobro.
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).
Zdravilo Cholestagel se pri odraslih bolnikih s primarno hiperholesterolemijo, vključno z bolniki z družinsko hiperholesterolemijo, lahko uporabi tudi v kombinaciji z ezetimibom s statinom ali brez njega (glejte poglavje 5.1).
It is important that you take olmesartan at least 4 hours before you take Cholestagel.
Pomembno je, da vzamete olmesartan vsaj 4 ure pred zaužitjem zdravila Cholestagel.
It is important that you take glimepiride and glipizide at least 4 hours before you take Cholestagel.
Pomembno je, da vzamete glimepirid in glipizid vsaj 4 ure pred zaužitjem zdravila Cholestagel.
Cholestagel tablets should be taken orally with a meal and liquid.
Tablete Cholestagel je treba jemati peroralno s tekočino in ob obroku.
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.
Multicentrične, randomizirane, dvojno slepe s placebom kontrolirane študije na 487 bolnikih so pri sočasni uporabi 2,3 do 3,8 g zdravila Cholestagel in statina (atorvastatina, lovastatina ali simvastatina) pokazale dodatno znižanje koncentracije holesterola LDL za 8 do 16 %.
Driving and using machines Your ability to drive or operate machines is not affected by taking Cholestagel tablets.
Vpliv na sposobnost upravljanja vozil in strojev Jemanje tablet Cholestagel ne vpliva na vašo sposobnost upravljanja vozil in strojev.
There is no need for dose adjustment when Cholestagel is administered to elderly patients.
Starejši bolniki Pri uporabi zdravila Cholestagel pri starejših bolnikih ni potrebno prilagoditi odmerka.
Always take Cholestagel exactly as your doctor or pharmacist has told you.
Pri uporabi zdravila Cholestagel natančno upoštevajte navodila svojega zdravnika ali farmacevta.
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.
Zdravilo Cholestagel deluje v prebavilih tako, da veže žolčne kisline, ki jih proizvajajo jetra, ter jih izloči z blatom.
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).
Kadar ne morete izključiti medsebojnega delovanja s sočasno uporabljenim zdravilom, pri katerem bi lahko bile manjše spremembe pri zdravljenju klinično pomembne ali kadar ni kliničnih podatkov o sočasni uporabi, je potrebno zdravilo Cholestagel vzeti vsaj štiri ure pred ali vsaj štiri ure po sočasno uporabljenem zdravilu, da bi zmanjšali tveganje zmanjšane absorpcije sočasno uporabljenega zdravila (glejte poglavje 4.5).
- 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.
- Zdravilo Cholestagel se lahko uporablja skupaj s statini in dieto z nizko vsebnostjo maščob in holesterola, kadar zdravljenje samo s statini ne zadostuje.
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.
Zdravilo Cholestagel je povzročilo statistično pomembno znižanje koncentracije holesterola LDL za 11 % po 6 tednih in 11 % po 12 tednih iz povprečne izhodiščne koncentracije 3,75 mmol/L, v placebo skupini pa se je koncentracija holesterola LDL po 6 tednih zvišala za 7 %, po 12 tednih pa za 1 % iz povprečne izhodiščne koncentracije 3,86 mmol/L.
Marketing authorisation holder Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Imetnik dovoljenja za promet z zdravilom Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska
Co-administration of colesevelam and glipizide decreases the exposure of glipizide.
Sočasno jemanje holesevelama in glipizida zmanjša izpostavljenost glipizidu.