natgillin/translations-raw huggingface dataset:
In the 12-week studies (Kodiac 4 and 5), the frequency of back pain AEs was 4.3% for naloxegol 25 mg versus 2.0% for placebo, and the frequency of extremity pain AEs was 2.2% for naloxegol 25 mg, versus 0.7% for placebo. 
V dveh 12-tedenskih študijah (Kodiac 4 in 5) je bila pogostnost neželenega učinka bolečine v hrbtu v skupini s 25 mg naloksegola 4,3 % in v skupini s placebom 2,0 %, neželenega učinka bolečine v udih pa v skupini s 25 mg naloksegola 2,2 % in v skupini s placebom 0,7 %.
Mean number of days per week with at least one SBM There was an increase in the mean number of days per week with at least one SBM in the LIR subgroup for the 25 mg dose in Kodiak 4 and Kodiac 5 (p<0.001 in both studies) and also for the 12.5 mg dose (p=0.006 in both studies). 
V podskupini LIR se je povprečno tedensko število dni z vsaj enim spontanim iztrebljanjem povečalo v Kodiac 4 in Kodiac 5 tako z odmerkom 25 mg (p < 0,001 v obeh študijah) kot z odmerkom 12,5 mg (p = 0,006 v obeh študijah).
6.5 Nature and contents of container 
6.5 Vrsta ovojnine in vsebina alu/alu pretisni omot
Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets 
Moventig 12,5 mg filmsko obložene tablete Moventig 25 mg filmsko obložene tablete
No dosage adjustment is required for patients taking weak CYP3A4 inhibitors. 
Bolnikom, ki jemljejo šibke zaviralce CYP3A4, odmerka ni treba prilagoditi.
• stomach pain • diarrhoea (passing of frequent, watery stools) 
• driska (pogosto odvajanje blata, ki je vodeno)
In a thorough QT/QTc study, as defined by the ICH E14 Guideline, there were no clinically important changes in HR, RR, QT, PR or QRS intervals or T wave morphology observed. 
ICH E14, ni bilo klinično pomembnih sprememb srčne frekvence, intervalov RR, QT, PR ali QRS ali morfologije vala T. Poleg tega v tej študiji vse do največjega uporabljenega odmerka (150 mg) niso ugotovili nobenih zadržkov glede varnosti in prenašanja.
Pack sizes of 30 x 1 and 90 x 1 film-coated tablets in perforated unit dose blisters. 
Pakiranje s 30 x 1 in 90 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za posamezni odmerek.
Table 1 Adverse reactions by System Organ Class (SOC) and frequency System Organ Classification 
Neželeni učinki po organskem sistemu in pogostnosti
• Patients with underlying cancer who are at heightened risk of GI perforation, such as those with: 
Stanja pri bolnikih z bolečinami zaradi raka • Bolniki z osnovno onkološko boleznijo, ki imajo večje tveganje za perforacijo prebavil, npr.
Severe hepatic impairment 
Klinično pomembna prizadetost krvno-možganske pregrade
− tablet core: mannitol (E421), cellulose microcrystalline (E460), croscarmellose sodium (E468) - see section 2 under ‘Moventig contains sodium', magnesium stearate (E470b), propyl gallate (E310) 
• Druge sestavine zdravila so: jedro tablete: manitol (E421), mikrokristalna celuloza (E460), premreženi natrijev karmelozat (E468) - glejte poglavje 2 pod 'Zdravilo Moventig vsebuje natrij', magnezijev stearat (E470b), propilgalat (E310), filmska obloga: hipromeloza (E464), titanov dioksid (E171), makrogol (E1521), rdeči železov oksid (E172) in črni železov oksid (E172).
Patients should be advised to discontinue therapy with naloxegol and promptly notify their physician if they develop unusually severe or persistent abdominal pain. 
Bolnikom je treba naročiti, naj v primeru nenavadno hudih ali dolgotrajnih bolečin v trebuhu nehajo jemati naloksegol in nemudoma obvestijo zdravnika.
Therefore, caution should be used when prescribing naloxegol to such patients (see section 4.3). 
Zato je pri predpisovanju naloksegola takšnim bolnikom potrebna previdnost (glejte poglavje 4.3) Moventig vsebuje natrija
Moventig 12.5 mg film-coated tablet (tablet). 
Moventig 12,5 mg filmsko obložena tableta (tableta)
25 mg film-coated tablets 
25 mg filmsko obložene tablete
Naloxegol was not studied in the clinical trial programme in patients who had a recent history of myocardial infarction within 6 months, symptomatic congestive heart failure, overt cardiovascular (CV) disease or patients with a QT interval of ≥ 500 msec. Moventig should be used with caution in these patients. 
Naloksegol ni bil raziskan v programu kliničnih preskušanj pri bolnikih z anamnezo nedavnega miokardnega infarkta v zadnjih 6 mesecih, simptomatskega kongestivnega srčnega popuščanja,
Naloxegol has not been studied in patients with severe hepatic impairment. 
Huda okvara jeter Naloksegol ni raziskan pri bolnikih s hudo okvaro jeter.
No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin (see section 4.5). 
Bolnikom, ki jemljejo šibke zaviralce CYP3A4 (npr. alprazolam, atorvastatin), odmerka ni treba prilagoditi (glejte poglavje 4.5).
Stool consistency in the LIR subgroup as measured by the Bristol stool scale improved in Kodiac 5 versus placebo (p<0.001) but not in Kodiac 4 (p=0.156). 
Konsistenca blata, merjena z Bristolsko lestvico blata (Bristol stool scale), se je v podskupini LIR v Kodiac 5 v primerjavi s placebom izboljšala (p < 0,001), v Kodiac 4 pa ne
Gastrointestinal perforation (see section 4.4) 
rifampin, šentjanževko) (glejte poglavje 4.5).
• if you have cancer-related pain 
• če imate hudo bolezen jeter, • če imate bolečine zaradi raka.
Interaction with strong CYP3A4 inducers 
Medsebojno delovanje z močnimi induktorji CYP3A4
12.5 mg film-coated tablets 
12,5 mg filmsko obložene tablete
The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 5.2). 
Odmerek je mogoče povečati na 25 mg, če bolnik dobro prenaša odmerek 12,5 mg (glejte poglavje 5.2).
Therefore, a dose adjustment of naloxegol is recommended when co-administered with diltiazem and other moderate CYP3A4 inhibitors (see section 4.2). 
Zato je med sočasno uporabo naloksegola in diltiazema ali drugih zmernih zaviralcev CYP3A4 odmerek naloksegola priporočljivo prilagoditi (glejte poglavje
Studies in animals have shown reproductive toxicity where systemic exposures were several times above the therapeutic exposure level (see section 5.3). 
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri sistemski izpostavljenosti,
The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.2). 
Odmerek je mogoče povečati na 25 mg, če bolnik dobro prenaša odmerek 12,5 mg (glejte poglavje 4.2).
Mechanism of action and pharmacodynamic effects Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone. 
Naloksegol je PEGiliran derivat antagonista mi-opioidnih receptorjev naloksona.
The 12.5 mg dose in the LIR subgroup also demonstrated shorter time to first post-dose SBM as compared to placebo in Kodiac 4 (p=0.002) and Kodiac 5 (p<0.001). 
12,5 mg je bil čas do prvega spontanega iztrebljanja po odmerku v podskupini LIR krajši kot s placebom tako v Kodiac 4 (p = 0,002) kot v Kodiac 5 (p < 0,001).
Conditions with increased potential for gastrointestinal perforation Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal cases when naloxegol was used in patients who were at an increased risk of gastrointestinal (GI) perforation. 
Bolezni in motnje, povezane z večjo možnostjo za perforacijo prebavil V obdobju trženja zdravila so poročali o primerih perforacije prebavil, vključno s smrtnimi primeri,
Naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in the gastrointestinal tract, thereby decreasing the constipating effects of opioids without impacting opioid-mediated analgesic effects on the central nervous system. 
Tako zmanjša konstipacijski učinek opioidov, ne da bi poslabšal njihove analgetične učinke v osrednjem živčevju.
• The active substance is naloxegol. 
• Učinkovina je naloksegol.
Co-administration of naloxegol and quinidine did not antagonize the morphine-induced miosis effect, suggesting that P-gp inhibition does not meaningfully change the capacity of naloxegol to cross the blood-brain barrier at therapeutic doses. 
To kaže, da zavrtje P-gp pri terapevtskih odmerkih ne spremeni pomembno zmožnosti naloksegola za prehod skozi krvno-možgansko pregrado.
Naloxegol acts by binding to mu-opioid receptors in the GI tract targeting the underlying causes of OIC (i.e. reduced GI motility, hypertonicity and increased fluid absorption resulting from long-term opioid treatment). 
zmanjšano motiliteto prebavil, hipertoničnost in večjo absorpcijo tekočine kot posledico dolgotrajnega zdravljenja z opioidi).
None of the metabolites were present in > 10% of the plasma concentrations of parent or total parent and metabolite related material. 
plazemske koncentracije matične snovi ali celotne koncentracije matične spojine in s presnovki povezanih snovi.
Name and address of the manufacturers responsible for batch release 
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij
No dosage adjustment is required for patients with mild renal impairment. 
Bolnikom z blago okvaro ledvic odmerka ni treba prilagoditi.
It is used when laxatives have not provided acceptable relief of constipation. 
Uporabimo ga, če odvajala ne dosežejo ustreznega izboljšanja zaprtja.
Moventig 25 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol. 
Moventig 25 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 25 mg naloksegola v obliki naloksegolijevega oksalata.
The mixture can also be administered via a nasogastric tube (CH8 or greater), in this case the tablet can be crushed to a powder and mixed with water (120 ml). 
V tem primeru lahko tableto zdrobite v prašek in zmešate z vodo (120 ml).
• if you take diltiazem or verapamil (for high blood pressure or angina) Your doctor may tell you to increase the dose to 25 mg depending on how you respond to the medicine. 
• če jemljete diltiazem ali verapamil (za visok krvni tlak ali angino pektoris).
− Each Moventig 25 mg film-coated tablet (tablet) contains 25 mg naloxegol as naloxegol oxalate. 
Ena filmsko obložena tableta (tableta) zdravila Moventig 25 mg vsebuje 25 mg naloksegola v obliki naloksegolijevega oksalata.
Moventig 12.5 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol. 
Moventig 12,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 12,5 mg naloksegola v obliki naloksegolijevega oksalata.
In patients taking opioids with constipation, who have tried at least one laxative and had incomplete relief of constipation, Moventig has been shown in clinical trials to increase the number of bowel movements and improve symptoms of constipation caused by opioids. 
Klinična preskušanja so pokazala, da zdravilo Moventig poveča število iztrebljanj in izboljša simptome zaprtja, ki jih povzročajo opioidi, pri bolnikih, ki jemljejo opioide, so zaprti ter so poskusili vsaj eno odvajalo, vendar z njim niso dosegli popolnega olajšanja zaprtja.
GENERAL CLASSIFICATION FOR SUPPLY 
Organski sistem Razvrstitev
How to store Moventig 
Shranjevanje zdravila Moventig
Moventig contains the active substance naloxegol. 
Zdravilo Moventig vsebuje zdravilno učinkovino naloksegol.
Patients with CV conditions 
Bolniki s srčno-žilnimi boleznimi
Each film-coated tablet contains 25 mg naloxegol (as naloxegol oxalate). 
Ena filmsko obložena tableta vsebuje 25 mg naloksegola (v obliki naloksegolijevega oksalata).
There was a statistically significant difference for the 25 mg dose versus placebo for the LIR subgroup responder rate in Kodiac 4 (p=0.002) and Kodiac 5 (p=0.014). 
Delež odzivnih bolnikov v podskupini LIR se je med odmerkom 25 mg in placebom statistično značilno razlikoval tako v študiji Kodiac 4 (p = 0,002) kot Kodiac 5 (p = 0,014).
Interaction with strong CYP3A4 inhibitors 
Medsebojno delovanje z močnimi zaviralci CYP3A4
Moventig 25 mg film-coated tablets naloxegol 
Moventig 25 mg filmsko obložene tablete naloksegol
Package leaflet: Information for the patient Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets naloxegol 
Navodilo za uporabo Moventig 12,5 mg filmsko obložene tablete Moventig 25 mg filmsko obložene tablete naloksegol
A possible treatment-related foetal skeletal malformation of fused arches was noted at highest dose tested in the rabbit embryo-foetal development study, in the absence of maternal toxicity. 
V študiji embrio-fetalnega razvoja na kuncih so ob največjem testiranem odmerku (in v odsotnosti toksičnih učinkov za samice matere) opažali morebitno z zdravilom povezano malformacijo okostja pri plodu, in sicer zraščenih lokov.
− Each Moventig 12.5 mg film-coated tablet (tablet) contains 12.5 mg naloxegol as naloxegol oxalate. 
Ena filmsko obložena tableta (tableta) zdravila Moventig 12,5 mg vsebuje 12,5 mg naloksegola v obliki naloksegolijevega oksalata.
In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of diltiazem on the single dose PK of naloxegol, co-administration of diltiazem and naloxegol resulted in a 3.4-fold (90% CI: 3.2-3.7) increase in naloxegol AUC and a 2.9fold increase in naloxegol Cmax (90% CI: 2.6-3.1), compared to when naloxegol was administered alone. 
IZ: 3,2-3,7) zvišanje AUC naloksegola in 2,9-kratno (90 % IZ: 2,6-3,1) zvišanje Cmax naloksegola v primerjavi z uporabo naloksegola samega.
In Kodiac 4, placebo, 12.5 mg and 25 mg dose had median time to first post dose SBM of 43.4, 20.6, and 5.4 hours, respectively. 
Mediani čas do prvega spontanega iztrebljanja po odmerku je bil v Kodiac 4 s placebom 43,4 ure, z 12,5 mg 20,6 ure in s 25 mg 5,4 ure.
Naloxegol 25 mg dose, compared with placebo, also resulted in greater improvement (change from baseline) of week 12 PAC-SYM rectal domain scores in both studies (p=0.004 and p<0.001, Kodiac 4 and 5, respectively) and for the stool domain scores in Kodiac 4 (p=0.031) and Kodiac 5 (p<0.001). 
SYM (Kodiac 4 p = 0,004 in Kodiac 5 p < 0,001) in ocene domene blata (Kodiac 4 p = 0,031 in Kodiac 5 p < 0,001).
Nervous system disorders 
Bolezni živčevja glavobol sindrom odtegnitve opioidov
Both studies were powered and stratified so that at least 50% of patients randomized to each treatment arm met baseline criteria to be categorized as a laxative inadequate responder (LIR). 
bolnikov, randomiziranih v vsako terapevtsko skupino, izpolnjevalo merila za uvrstitev med bolnike z nezadostnim odzivom na odvajala.
Each film-coated tablet contains 12.5 mg naloxegol (as naloxegol oxalate). 
Ena filmsko obložena tableta vsebuje 12,5 mg naloksegola (v obliki naloksegolijevega oksalata).
In an open-label, non-randomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of ketoconazole on the single dose PK of naloxegol, co-administration of ketoconazole and naloxegol resulted in a 12.9 fold (90% CI: 11.3-14.6) increase in naloxegol AUC and a 9.6-fold increase in naloxegol Cmax (90% CI: 8.1-11.3), compared to when naloxegol was administered alone. 
(90 % IZ: 11,3-14,6) zvišanje AUC naloksegola in 9,6-kratno (90 % IZ: 8,1-11,3) zvišanje Cmax naloksegola v primerjavi z uporabo naloksegola samega.
Potential for interference with opioid-mediated analgesia There were no clinically relevant differences between naloxegol 12.5 mg, 25 mg, and placebo in average pain intensity, daily opioid dose or in opioid withdrawal scores over the 12-week study. 
dnevnem odmerku opioidov ali oceni odtegnitve opioidov med 12,5 mg naloksegola, 25 mg naloksegola in placebom.
Grapefruit juice has been classified as a potent CYP3A4 inhibitor when consumed in large quantities. 
Grenivkin sok, zaužit v veliki količini, se uvršča med močne zaviralce CYP3A4.
Time to first spontaneous bowel movement 
Čas do prvega spontanega iztrebljanja blata Čas do prvega spontanega iztrebljanja je bil v podskupini LIR po uporabi prvega odmerka v skupini s
In the pooled data from Kodiac 4 and Kodiac 5, responder rates in the LIR subgroup were 30.1% for placebo, 42.5% for the 12.5 mg dose, and 47.7% for the 25 mg dose, with the relative risk (95% CI) for treatment effect versus placebo of 1.410(1.106, 1.797) and 1.584(1.253, 2.001) for the 12.5 mg and 25 mg groups, respectively. 
12,5 mg 1,410 (1,106, 1,797) in med prejemniki 25 mg 1,584 (1,253, 2,001).
Talk to your doctor, pharmacist or nurse whilst taking Moventig: 
Med jemanjem zdravila Moventig se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Talk to your doctor, pharmacist or nurse before taking Moventig: 
Pred začetkom jemanja zdravila Moventig se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Interaction with CYP3A4 inhibitors and inducers 
Medsebojno delovanje z zaviralci in induktorji CYP3A4
12.5 mg is well tolerated by the patient (see section 5.2). 
12,5 mg (glejte poglavje 4.5).
In the LIR subgroup, the 25 mg dose increased the symptom responder rates in both studies as compared to placebo (Kodiac 4 p=0.001, Kodiac 5 p=0.005). 
V podskupini LIR je odmerek 25 mg v primerjavi s placebom povečal delež odziva simptomov v obeh študijah (Kodiac 4
Moventig 12.5 mg film-coated tablets naloxegol 
Moventig 12,5 mg filmsko obložene tablete naloksegol
Naloxegol is not recommended in patients who are taking strong CYP3A4 inducers (e.g. carbamazepine, rifampin, St. John's Wort) (see section 4.5). 
Naloksegol ni priporočljiv za bolnike, ki jemljejo močne zaviralce CYP3A4 (npr. karbamazepin,
The dose can be increased to 25 mg if 
Zdravnik vam bo morda naročil, da zvišate odmerek na 25 mg glede na to, kako se boste odzvali na zdravilo.
Oval, 13x7 mm, mauve tablet. 
Moventig 25 mg filmsko obložena tableta (tableta) Ovalna, 13 x 7 mm velika tableta svetlo vijoličaste barve.
The time to first SBM in the LIR subgroup after taking the first dose was shorter for the 25 mg dose as compared to placebo in Kodiac 4 (p<0.001) and Kodiac 5 (p=0.002). 
25 mg krajši kot s placebom tako v Kodiac 4 (p < 0,001) kot v Kodiac 5 (p = 0,002).
The glass should be rinsed with a further half glass of water (120 ml) and the contents drunk. 
Kozarec morajo nato splakniti z dodatnega pol kozarca vode
Patients taking a minimum of 30 morphine equivalent units (meu) of opioids per day for at least 4 weeks before enrolment and self-reported OIC were eligible. 
Za vključitev so bili primerni bolniki, ki so pred vključitvijo vsaj 4 tedne jemali najmanj 30
The tablets need to be taken with food and drink. 
Tablete se vzamejo s hrano in pijačo.
It is available as white tablets (625 mg). 
Na voljo je v obliki tablet bele barve (625 mg).
This document is a summary of the European Public Assessment Report (EPAR) for Cholestagel. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cholestagel.
They can either be taken all at once, or split into two doses during the day. 
Vzamejo se bodisi naenkrat ali v dveh odmerkih na dan.
Lowering cholesterol, especially LDL cholesterol, can reduce the risk of heart disease. 
Znižanje holesterola, zlasti LDL-holesterola, lahko zmanjša tveganje za srčno obolenje.
Cholestagel is used in the following ways: 
Zdravilo Cholestagel se uporablja na naslednje načine:
Other information about Cholestagel: 
Druge informacije o zdravilu Cholestagel:
In comparison, the patients taking placebo had no changes in LDL-cholesterol levels. 
V primerjavi s tem pri bolnikih, ki so jemali placebo, ni bilo nobenih sprememb ravni LDL-holesterola.
For more information about treatment with Cholestagel, read the Package Leaflet (also part of the EPAR). 
Za več informacij o zdravljenju z zdravilom Cholestagel preberite navodilo za uporabo (ki je prav tako del EPAR).
This combination can also be used in patients who have familial hypercholesterolaemia (primary hypercholesterolaemia that runs in the family). 
Ta kombinacija se lahko uporabi tudi pri bolnikih z družinsko hiperholesterolemijo (primarno hiperholesterolemijo, ki je prisotna v družini).
‘Primary' means that there is no disease causing the high cholesterol levels. 
„Primarna“ pomeni, da visokih ravni holesterola ne povzroča nobena bolezen.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cholestagel. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Cholestagel, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Cholestagel shown during the studies? 
Kakšne koristi je zdravilo Cholestagel izkazalo med študijami?
Patients should start a cholesterol-lowering diet before treatment and continue it throughout treatment. 
Bolniki morajo dieto za zniževanje ravni holesterola začeti pred zdravljenjem in jo nadaljevati med njim.
The European Commission granted a marketing authorisation valid throughout the European Union for Cholestagel to Genzyme Europe B.V. on 10 March 2004. 
Evropska komisija je dovoljenje za promet z zdravilom Cholestagel, veljavno po vsej Evropski uniji, odobrila družbi Genzyme Europe B.V.
• together with ezetimibe (another cholesterol-lowering medicine), with or without a statin. 
• skupaj z ezetimibom (drugim zdravilom za zniževanje rani holesterola) s statinom ali brez njega.
The maximum dose is seven tablets a day when it is taken on its own, and six tablets a day when it is taken with other medicines. 
Največji odmerek je sedem tablet na dan, če se jemljejo samostojno, in šest tablet na dan, če se jemljejo z drugimi zdravili.
The CHMP concluded that Cholestagel's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Cholestagel večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Cholestagel should not be used in people who may be hypersensitive (allergic) to colesevelam or any of the other ingredients. 
Zdravila Cholestagel ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) kolesevelam ali katero koli drugo sestavino zdravila.
The main measure of effectiveness was the decrease in LDL-cholesterol levels after four to six weeks, except for one of the studies looking at Cholestagel taken on its own, which measured the cholesterol levels after six months. 
Glavno merilo učinkovitosti je bilo znižanje ravni LDLholesterola po štirih do šestih tednih, razen v študiji, v katerih so proučevali samostojno jemanje zdravila Cholestagel in so raven holesterola izmerili po šestih mesecih.
Three of these studies looked at Cholestagel taken in combination with a statin (lovastatin, simvastatin or atorvastatin) in 491 patients, two looked at Cholestagel taken on its own in 592 patients, and one looked at Cholestagel in combination with ezetimibe in 86 patients. 
V treh študijah so proučevali jemanje zdravila Cholestagel v kombinaciji s statinom (lovastatinom, simvastatinom ali atorvastatinom) pri 491 bolnikih, v dveh študijah so proučevali samostojno jemanje zdravila Cholestagel pri 592 bolnikih, v eni študiji pa so proučevali jemanje zdravil Cholestagel v kombinaciji z ezetimibom pri 86 bolnikih.
The final study looked at Cholestagel as an add-on to ezetimibe and a statin in 86 adults with familial hypercholesterolaemia. 
V končni študiji so zdravilo Cholestagel proučevali kot dopolnilo k ezetimibinu in statinu pri 86 odraslih z družinsko hiperholesterolemijo.
What is the risk associated with Cholestagel? 
Kakšna tveganja so povezana z zdravilom Cholestagel?
Because the bile acids are prevented from being absorbed into the bloodstream, the liver is forced to make more bile acids. 
Absorpcija žolčnih kislin v krvni obtok je tako preprečena, zato morajo jetra tvoriti več žolčnih kislin.
As the liver uses cholesterol to make bile acids, this reduces cholesterol levels in the blood. 
Ker jetra porabijo holesterol za tvorjenje žolčnih kislin, se zmanjšajo ravni holesterola v krvi.
Cholestagel is used to lower cholesterol levels in adults with primary hypercholesterolaemia (high blood cholesterol levels). 
Zdravilo Cholestagel se uporablja za zmanjšanje ravni holesterola pri odraslih s primarno hiperholesterolemijo (visokimi ravnmi holesterola v krvi).